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Consult the Reader Aids section at the end of this page for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws.
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Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
We are adopting a new airworthiness directive (AD) for the products listed above. This AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:
Certain main landing gear components have experienced premature failure during certification testing. Revision has been made to the DHC–8–400 Maintenance Requirements Manual, Airworthiness Limitation Items, to incorporate the revised safe life limits for the main landing gear lock actuator assembly, retraction actuator assembly rod end and piston, and the upper bearing in the main landing gear shock strut assembly. Failure of these components could adversely affect the structural integrity of the main landing gear.
This AD becomes effective August 17, 2010.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of August 17, 2010.
You may examine the AD docket on the Internet at
Craig Yates, Aerospace Engineer, Airframe and Mechanical Systems Branch, ANE–171, FAA, New York Aircraft Certification Office, 1600 Stewart Avenue, Suite 410, Westbury, New York 11590; telephone (516) 228–7355; fax (516) 794–5531.
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the
Certain main landing gear components have experienced premature failure during certification testing. Revision has been made to the DHC–8–400 Maintenance Requirements Manual, Airworthiness Limitation Items, to incorporate the revised safe life limits for the main landing gear lock actuator assembly, retraction actuator assembly rod end and piston, and the upper bearing in the main landing gear shock strut assembly. Failure of these components could adversely affect the structural integrity of the main landing gear.
This [Canadian airworthiness] directive is issued to ensure safe operation of the main landing gear during its service life.
We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public.
We reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed.
We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.
We might also have required different actions in this AD from those in the MCAI in order to follow our FAA policies. Any such differences are highlighted in a Note within the AD.
We estimate that this AD will affect 62 products of U.S. registry. We also estimate that it will take about 22 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $18,588 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these parts. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $1,268,396, or $20,458 per product.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures
We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this AD:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and
3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.
You may examine the AD docket on the Internet at
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
49 U.S.C. 106(g), 40113, 44701.
(a) This airworthiness directive (AD) becomes effective August 17, 2010.
(b) None.
(c) This AD applies to Bombardier, Inc. Model DHC–8–400, –401, and –402 airplanes, having serial numbers (S/Ns) 4001, 4003, 4004, 4006, and 4008 through 4227 inclusive, certificated in any category.
This AD requires revisions to certain operator maintenance documents to include new inspections. Compliance with these inspections is required by 14 CFR 91.403(c). For airplanes that have been previously modified, altered, or repaired in the areas addressed by these inspections, the operator may not be able to accomplish the inspections described in the revisions. In this situation, to comply with 14 CFR 91.403(c), the operator must request approval for an alternative method of compliance according to paragraph (j)(1) of this AD. The request should include a description of changes to the required inspections that will ensure the continued damage tolerance of the affected structure. The FAA has provided guidance for this determination in Advisory Circular (AC) 25.1529–1A.
(d) Air Transport Association (ATA) of America Code 32: Landing gear.
(e) The mandatory continuing airworthiness information (MCAI) states:
Certain main landing gear components have experienced premature failure during certification testing. Revision has been made to the DHC–8–400 Maintenance Requirements Manual, Airworthiness Limitation Items (ALI), to incorporate the revised safe life limits for the main landing gear lock actuator assembly, retraction actuator assembly rod end and piston, and the upper bearing in the main landing gear shock strut assembly. Failure of these components could adversely affect the structural integrity of the main landing gear.
This [Canadian airworthiness] directive is issued to ensure safe operation of the main landing gear during its service life.
(f) You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done.
(g) For Model DHC–8–400, –401, and –402 airplanes having S/Ns 4001, 4003, 4004, 4006, and 4008 through 4210 inclusive: Do the actions specified in paragraphs (g)(1) and (g)(2) of this AD.
(1) Within 60 days after the effective date of this AD: Revise the ALS of the Instructions for Continued Airworthiness by incorporating the revised structural safe life limit for the upper bearing having part number (P/N) 46114–1, as provided in Bombardier Temporary Revision (TR), ALI–82, dated August 15, 2008, to Part 2, Airworthiness Limitation Items, of the Bombardier Dash 8 Q400 Maintenance Requirements Manual (MRM), PSM 1–84–7. The initial compliance time for replacing the upper bearing is specified in paragraph (g)(2) of this AD.
(2) Replace the upper bearing having P/N 46114–1 with a new or serviceable upper bearing, in accordance with Goodrich Dressed Shock Strut Assembly Main Landing Gear Part No. 46100–29/–31/–33/–35/–37/–39/–41/–43/–45/–47/–49/–51/–53 and –55 Component Maintenance Manual with Illustrated Parts List 32–11–03, Revision 11, dated August 22, 2008, at the applicable time specified in paragraphs (g)(2)(i), (g)(2)(ii), and (g)(2)(iii), of this AD.
(i) For airplanes having accumulated fewer than 15,000 total flight cycles as of the effective date of this AD: Replace prior to the accumulation of 15,000 total flight cycles.
(ii) For airplanes having accumulated 15,000 total flight cycles or more, but fewer than 20,000 total flight cycles, as of the effective date of this AD: Replace prior to the accumulation of 20,000 total flight cycles.
(iii) For airplanes having accumulated 20,000 total flight cycles or more as of the effective date of this AD: Replace before further flight.
(h) For Model DHC–8–400, –401, and –402 series airplanes having S/Ns 4001, 4003, 4004, 4006, and 4008 through 4227 inclusive: Do the applicable actions specified in paragraphs (h)(1) and (h)(2) of this AD.
(1) Within 60 days after the effective date of this AD: Revise the ALS of the Instructions for Continued Airworthiness to incorporate the revised safe life limits for the retraction actuator assembly rod end having P/N P3A2750 and P3A2750–1; retraction actuator assembly piston having P/N 46570–5; lock actuator cylinder assembly having P/N 46601–1/–3; and lock actuator assembly having P/N 46600–1/–3/–5/–7; as provided in Bombardier TR ALI–89, dated March 27, 2009, to Part 2, Airworthiness Limitation Items, of the Bombardier Dash 8 Q400 MRM, PSM 1–84–7. The initial compliance time for the replacement is specified in the TR, except as provided by paragraph (h)(2) of this AD.
(2) For airplanes with a main landing gear retraction actuator assembly rod end that has accumulated more than 9,850 total flight cycles as of the effective date of this AD: Within 600 flight cycles after the effective date of this AD, replace any affected rod end having P/Ns P3A2750 and P3A2750–1 with a new or serviceable rod end, in accordance with Goodrich Dressed Shock Strut Assembly Main Landing Gear Part No. 46100–29/–31/–33/–35/–37/–39/–41/–43/–45/–47/–49/–51/
(i) After accomplishing the revision specified in paragraph (g)(1) or (h)(1) of this AD, except as provided in paragraph (j) of this AD, no alternative replacement times may be approved for this part.
The ALI revisions required by paragraphs (g) and (h) of this AD may be done by inserting copies of Bombardier TRs ALI–82 and ALI–89 into Part 2, Airworthiness Limitation Items, of the Bombardier Dash 8 Q400 MRM, PSM 1–84–7. When these TRs have been included in the general revision of the MRM, the general revision may be inserted into the MRM, provided the relevant information in the general revision is identical to that in Bombardier TRs ALI–82 and ALI–89.
This AD differs from the MCAI and/or service information as follows: The MCAI and service information do not contain replacement procedures for the upper bearings and rod ends. This AD requires replacing the upper bearings and rod ends in accordance with Goodrich Dressed Shock Strut Assembly Main Landing Gear Part No. 46100–29/–31/–33/–35/–37/–39/–41/–43/–45/–47/–49/–51/–53 and –55 Component Maintenance Manual with Illustrated Parts List 32–11–03, Revision 11, dated August 22, 2008.
(j) The following provisions also apply to this AD:
(1)
(2)
(3)
(4)
(k) Refer to MCAI Canadian Airworthiness Directive CF–2009–17, dated April 22, 2009; Bombardier TR ALI–82, dated August 15, 2008, and Bombardier TR ALI–89, dated March 27, 2009, to Part 2, Airworthiness Limitation Items, of the Bombardier Dash 8 Q400 Maintenance Requirements Manual, PSM 1–84–7; and Goodrich Dressed Shock Strut Assembly Main Landing Gear Part No. 46100–29/–31/–33/–35/–37/–39/–41/–43/–45/–47/–49/–51/–53 and –55 Component Maintenance Manual with Illustrated Parts List 32–11–03, Revision 11, dated August 22, 2008; for related information.
(l) You must use the service information listed in Table 1 of this AD, as applicable, to do the actions required by this AD, unless the AD specifies otherwise.
(The revision level of Goodrich Dressed Shock Strut Assembly Main Landing Gear Part No. 46100–29/–31/–33/–35/–37/–39/–41/–43/–45/–47/–49/–51/–53 and –55 Component Maintenance Manual with Illustrated Parts List 32–11–03, Revision 11, dated August 22, 2008, is indicated only on the Record of Revisions; no other page of this document contains this information. Page LEP–3/4 is missing from the List of Effective Pages of this document; page LEP 3/4 is dated August 22, 2008.)
(1) The Director of the Federal Register approved the incorporation by reference of this service information under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) For Bombardier service information identified in this AD, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; telephone 514–855–5000; fax 514–855–7401; e-mail
(3) For Goodrich service information identified in this AD, contact Goodrich Corporation, Landing Gear, 1400 South Service Road, West Oakville L6L 5Y7, Ontario, Canada; telephone 905–825–1568; e-mail
(4) You may review copies of the service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington. For information on the availability of this material at the FAA, call 425–227–1221.
(5) You may also review copies of the service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to:
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
We are superseding an existing airworthiness directive (AD) for the products listed above. This AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:
Uncontained APU [auxiliary power unit] generator failures on ground have occurred on Airbus A330 aircraft in service. APU generator design is common to all A330 and A340 aircraft.
Preliminary investigations confirmed that these failures have resulted in structural damage to the APU compartment and, in one case, to the stabiliser compartment. Loose APU generator parts can lead to damage to the APU firewall, reducing its fire extinguishing capability and potentially leading to a temporary uncontrolled fire.
Although the root cause has not yet been determined, the investigation showed a sequence of events where a collapse of the Drive End Bearing (DEB) leads to an uncontained failure. Evidence has also shown that the DEB failures are not instantaneous, and therefore, the detection of small debris could indicate early stage of a DEB failure.
This AD becomes effective August 17, 2010.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of August 17, 2010.
On June 26, 2007 (72 FR 31973, June 11, 2007), the Director of the Federal Register approved the incorporation by reference of certain other publications listed in this AD.
You may examine the AD docket on the Internet at
Vladimir Ulyanov, Aerospace Engineer, International Branch, ANM–116, Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton, Washington 98057–3356; telephone (425) 227–1138; fax (425) 227–1149.
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the
Uncontained APU [auxiliary power unit] generator failures on ground have occurred on Airbus A330 aircraft in service. APU generator design is common to all A330 and A340 aircraft.
Preliminary investigations confirmed that these failures have resulted in structural damage to the APU compartment and, in one case, to the stabiliser compartment. Loose APU generator parts can lead to damage to the APU firewall, reducing its fire extinguishing capability and potentially leading to a temporary uncontrolled fire.
Although the root cause has not yet been determined, the investigation showed a sequence of events where a collapse of the Drive End Bearing (DEB) leads to an uncontained failure. Evidence has also shown that the DEB failures are not instantaneous, and therefore, the detection of small debris could indicate early stage of a DEB failure.
To address this subject, EASA issued Emergency AD 2007–0188–E, requiring repetitive inspections of the APU generator Scavenge filter element and filter housing and of the APU generator Drain plug for signs of small debris coming from the APU generator, allowing detection of the early stage of APU generator failure. That AD was later revised to extend the compliance time and to provide another option for the repetitive inspection.
Subsequently, another uncontained APU generator failure occurred on ground on an A330 aircraft, operated within the provisions of MMEL [master minimum equipment list] item 36–11–01, with similar structural damages as the previous APU generator burst events. The investigation of this event revealed that the inspection required by paragraph 4 of AD 2007–0188R1 before the first flight under the MMEL rectification interval had not been performed and that the APU generator had not been properly installed (two seal plates instead of one).
Consequently, EASA issued AD 2008–0017, superseding AD 2007–0188R1 and requiring the following additional actions:
—a visual inspection of the APU generator seal plate fitting,
—an inspection following MMEL item 36–11–01 or 24–22–01 rectification and
—an inspection each time a new or serviceable APU generator or APU is installed on an aircraft.
EASA issued AD 2008–0017R1 to cancel the inspection of paragraph 4 for A330 aircraft, when operated within the provisions of MMEL item 36–11–01 further to ETOPS [Extended-Range Twin-Engine Operations Performance Standards] certification of A330 APU.
Finally, Airbus has developed a secondary housing for the APU generator that is designed to contain APU generator parts in the event of an APU generator burst.
For the above described reasons, this AD retains the requirements of EASA AD 2008–0017R1, which is superseded, and adds the requirement to install a secondary housing on the APU generator. After installation of the secondary APU generator housing on an aircraft, the repetitive inspections of this AD are no longer required for that aircraft.
The NPRM cited Airbus Service Bulletins A330–24–3045, dated June 13, 2008; A340–24–4058, dated June 13, 2008; and A340–24–5022, dated June 23, 2008. Airbus has released the following new service bulletins:
The latest revisions of the service information make minor updates and specify that no additional work is necessary on airplanes modified in accordance with the original documents. We have revised this final rule to incorporate the latest revisions of the service information. We have also added paragraph (h)(6) and Table 5 to this AD to give credit for actions done in accordance with the original service information. We have reidentified subsequent tables accordingly.
We gave the public the opportunity to participate in developing this AD. We considered the comment received.
EVA Airways Corporation (EVA) requests that we revise the NPRM to include a terminating modification for actions required by paragraphs (h)(3) and (h)(4) of the NPRM. Accomplishing the actions specified in paragraph (h)(5) of the NPRM would terminate the actions required by paragraphs (g)(2), (g)(3), and (h)(2) of the NPRM. EVA refers to a message it received from Airbus and states that installing the APU generator secondary housing terminates the repetitive inspections specified in paragraphs (g)(2), (g)(3), (h)(2), (h)(3), and (h)(4) of the NPRM.
We agree with the commenter's request. The EASA AD specifies that installing the secondary housing line replacement unit terminates repetitive inspections. We have also received information from Airbus indicating that installing the APU generator secondary housing terminates the repetitive inspections required by paragraphs (h)(3) and (h)(4) of the NPRM. We have revised paragraph (h)(5) of this final rule to specify that installing the APU generator secondary housing terminates the repetitive inspections specified in paragraphs (g)(2) and (g)(3) of this AD and the inspections specified in paragraphs (h)(2), (h)(3), and (h)(4) of this AD. We have also revised paragraphs (g)(2) and (g)(3) of this final rule to clarify that doing the installation required by paragraph (h)(5) of this AD terminates the repetitive inspections. We have also revised paragraphs (h)(2), (h)(3), and (h)(4) of this AD to clarify that doing the installation terminates the inspection requirements of those paragraphs.
In paragraphs (g)(1), (g)(2), and (g)(3) of this AD, we have clarified that the service information specified in Table 2 or Table 3 of this AD is acceptable for compliance with the applicable actions.
We reviewed the relevant data, considered the comment received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We also determined that these changes will not increase the economic burden on any operator or increase the scope of the AD.
We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.
We might also have required different actions in this AD from those in the MCAI in order to follow our FAA policies. Any such differences are highlighted in a NOTE within the AD.
Since issuance of the NPRM, we have increased the labor rate used in the Costs of Compliance from $80 per work-hour to $85 per work-hour. The Costs of Compliance information, below, reflects this increase in the specified hourly labor rate.
We estimate that this AD will affect about 41 products of U.S. registry.
The actions that are required by AD 2007–18–04 and retained in this AD take about 11 work-hours per product, at an average labor rate of $85 per work hour. Required parts cost $0 per product. Based on these figures, the estimated cost of the currently required actions is $935 per product.
We estimate that it will take about 10 work-hours per product to comply with the new basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $0 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these costs. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $34,850, or $850 per product.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this AD:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and
3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.
You may examine the AD docket on the Internet at
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
49 U.S.C. 106(g), 40113, 44701.
(a) This airworthiness directive (AD) becomes effective August 17, 2010.
(b) This AD supersedes AD 2007–18–04, Amendment 39–15184.
(c) This AD applies to the airplanes certificated in any category, identified in paragraphs (c)(1) and (c)(2) of this AD.
(1) Airbus Model A330–201, –202, –203, –223, –243, –301, –302, –303, –321, –322, –323, –341, –342, and –343 series airplanes, all serial numbers, except those on which Airbus modification 56985 has been embodied in production.
(2) Airbus Model A340–211, –212, –213, –311, –312, and –313 series airplanes; and Model A340–541 and A340–642 airplanes; all serial numbers, except those on which Airbus modification 56985 has been embodied in production.
(d) Air Transport Association (ATA) of America Code 24: Electrical power.
(e) The mandatory continuing airworthiness information (MCAI) states:
Uncontained APU [auxiliary power unit] generator failures on ground have occurred on Airbus A330 aircraft in service. APU generator design is common to all A330 and A340 aircraft.
Preliminary investigations confirmed that these failures have resulted in structural damage to the APU compartment and, in one case, to the stabiliser compartment. Loose APU generator parts can lead to damage to the APU firewall, reducing its fire extinguishing capability and potentially leading to a temporary uncontrolled fire.
Although the root cause has not yet been determined, the investigation showed a sequence of events where a collapse of the Drive End Bearing (DEB) leads to an uncontained failure. Evidence has also shown that the DEB failures are not instantaneous, and therefore, the detection of small debris could indicate early stage of a DEB failure.
To address this subject, EASA issued Emergency AD 2007–0188–E, requiring repetitive inspections of the APU generator Scavenge filter element and filter housing and of the APU generator Drain plug for signs of small debris coming from the APU generator, allowing detection of the early stage of APU generator failure. That AD was later revised to extend the compliance time and to provide another option for the repetitive inspection.
Subsequently, another uncontained APU generator failure occurred on ground on an A330 aircraft, operated within the provisions of MMEL [master minimum equipment list] item 36–11–01, with similar structural damages as the previous APU generator burst events. The investigation of this event revealed that the inspection required by paragraph 4 of AD 2007–0188R1 before the first flight under the MMEL rectification interval had not been performed and that the APU generator had not been properly installed (two seal plates instead of one).
Consequently, EASA issued AD 2008–0017, superseding AD 2007–0188R1 and requiring the following additional actions:
EASA issued AD 2008–0017R1 to cancel the inspection of paragraph 4 for A330 aircraft, when operated within the provisions of MMEL item 36–11–01 further to ETOPS [Extended-Range Twin-Engine Operations Performance Standards] certification of A330 APU.
Finally, Airbus has developed a secondary housing for the APU generator that is designed to contain APU generator parts in the event of an APU generator burst.
For the above described reasons, this AD retains the requirements of EASA AD 2008–0017R1, which is superseded, and adds the requirement to install a secondary housing on the APU generator. After installation of the secondary APU generator housing on an aircraft, the repetitive inspections of this AD are no longer required for that aircraft.
(f) Unless already done, do the following actions.
(1) For airplanes on which the date of issuance of the original French airworthiness certificate or the date of issuance of the original French or EASA export certificate of airworthiness is before March 1, 2007: Within 63 days after June 26, 2007 (the effective date of AD 2007–12–10), in accordance with the instructions of Airbus All Operators Telex (AOT) A330–24A3042, A340–24A4056, or A340–24A5020, all Revision 02, all dated April 12, 2007; as applicable, inspect the inlet screen (last chance filter) for the generator scavenge-oil pump for signs of debris and, as applicable, apply all associated corrective actions before further flight.
(2) For Model A330 aircraft operating under MMEL (master minimum equipment list) Item 24–22–01 `AC Main Generation' or MMEL Item 36–11–01 `Bleed Air Supply System Failure' and on which the date of issuance of the original French airworthiness certificate or the date of issuance of the original French or EASA export certificate of airworthiness is before March 1, 2007: As of June 26, 2007, before each flight, perform a check of the differential pressure indicator button on the lube filter and the generator scavenge filter in accordance with the instructions of Airbus AOT A330–24A3042, Revision 02, dated April 12, 2007, until accomplishment of paragraph (g)(5) of this AD.
The repetitive checks before each flight specified in paragraph (f)(2) of this AD are not required for airplanes operated under
(3) Actions done before June 26, 2007, in accordance with the applicable Airbus service information in Table 1 of this AD are acceptable for compliance with the corresponding provisions of paragraph (f) of this AD.
(g) Unless already done, do the following actions.
(1) For airplanes on which the date of issuance of the original French airworthiness certificate or the date of issuance of the original French or EASA export certificate of airworthiness is on or before July 1, 2007: Within 30 days after September 14, 2007 (the effective date of AD 2007–18–04), in accordance with the instructions of paragraph 4.2.1 of the applicable Airbus service information specified in Table 2 or 3 of this AD, clean and inspect the APU generator scavenge oil filter element and housing and inspect the APU generator drain plug to detect metallic debris, and apply all applicable associated corrective actions before further flight. After the effective date of this AD, use only the service information specified in Table 3 of this AD.
(2) Within 450 aircraft flight hours or 200 APU operating hours, whichever occurs later, after accomplishing the inspection required by paragraph (g)(1) of this AD, in accordance with the instructions of paragraph 4.2.2 of the applicable Airbus information specified in Table 2 or Table 3 of this AD: Inspect the APU generator scavenge oil filter element and housing and the APU generator drain plug to detect metallic debris; and apply all applicable associated corrective actions before further flight. Repeat the inspections thereafter at intervals not to exceed 450 aircraft flight hours or 200 APU operating hours, whichever occurs later until the installation required by paragraph (h)(5) of this AD is done. After the effective date of this AD, use only the service information specified in Table 3 of this AD.
(3) For airplanes on which the date of issuance of the original French airworthiness certificate or the date of issuance of the original French or EASA export certificate of airworthiness is after July 1, 2007: Within 450 aircraft flight hours or 200 APU operating hours after September 14, 2007, whichever occurs later, in accordance with the instructions of paragraph 4.2.2 of the applicable Airbus service information specified in Table 2 or Table 3 of this AD: Inspect the APU generator scavenge oil filter element and housing and the APU generator drain plug to detect metallic debris; and apply all applicable associated corrective actions before further flight. Repeat the inspections thereafter at intervals not to exceed 450 aircraft flight hours or 200 APU operating hours, whichever occurs later until the installation required by paragraph (h)(5) of this AD is done. After the effective date of this AD, use only the service information specified in Table 3 of this AD.
(4) Actions done before September 14, 2007, in accordance with the applicable Airbus service information in Table 4 of this AD are acceptable for compliance with the corresponding provisions of paragraph (g) of this AD.
(5) For Model A330 aircraft operating under MMEL Item 24–22–01, “AC Main Generation,” or MMEL Item 36–11–01, “Bleed Air Supply System Failure”: Unless the APU generator has been deferred in accordance with the MMEL by deactivation (quill shaft removed) or removal, the inspection required by paragraph (g)(2) or (g)(3), as applicable, of this AD must be performed prior to the first flight of the specified MMEL repair time interval. Accomplishing the actions in this paragraph terminates the actions required by paragraph (f)(2) of this AD.
For A330 aircraft, MMEL Item 24–22–01 (AC Main Generation) and/or MMEL Item 36–11–01 (Bleed Air Supply System Failure) require that the APU be used during the entire flight.
(h) Unless already done, do the following actions.
(1) As of the effective date of this AD, before further flight after an APU generator or an APU is installed on the airplane: Inspect the APU generator scavenge oil filter element for contamination (including metallic particles), the APU generator drain plug for contamination (including metallic particles), and the APU generator scavenge filter housing for contamination (including metallic particles), in accordance with paragraph 4.2 of the applicable service information specified in Table 3 of this AD. Do all applicable corrective actions before further flight in accordance with paragraph 4.2 of the applicable service information specified in Table 3 of this AD.
(2) Within 450 aircraft flight hours or 200 APU operating hours, whichever occurs later, after accomplishing the inspection required by paragraph (h)(1) of this AD, do the inspection as required by paragraph (g)(2) of this AD. Doing the installation required by paragraph (h)(5) of this AD terminates the requirements of this paragraph.
(3) For Model A330 airplanes operated within the provisions of MMEL Item 24–22–01, “AC Main Generation,” that are dispatched with the APU operating during the entire flight in accordance with the provisions of MMEL Item 24–22–01: Perform the inspection required by paragraph (g)(2) of this AD at the applicable time in paragraph (h)(3)(i) or (h)(3)(ii) of this AD, unless the APU generator is removed or deactivated (quill shaft removed as described in the MMEL item). Doing the installation required by paragraph (h)(5) of this AD terminates the requirements of this paragraph.
(i) Before the first flight of the MMEL rectification interval.
(ii) Before the first flight following MMEL rectification.
(4) Removing or deactivating the APU generator, or rendering the APU inoperative, in accordance with paragraph 4.3 of the applicable service information specified in Table 3 of this AD, defers the inspection required by paragraph (g)(2) of this AD. The deferred inspection must be performed before further flight after the system is reactivated. Doing the installation required by paragraph (h)(5) of this AD terminates the requirements of this paragraph.
(5) Within 6 months after the effective date of this AD, install a secondary housing line replaceable unit (LRU) over the end of the APU generator, in accordance with the Accomplishment Instructions of the applicable service information specified in Table 6 of this AD. Performing this modification terminates the repetitive inspections required by paragraphs (g)(2) and (g)(3) of this AD, and the inspections required by paragraphs (h)(2), (h)(3), and (h)(4) of this AD.
(6) Actions accomplished before the effective date of this AD in accordance with service information in Table 5 of this AD are acceptable for compliance with the corresponding actions specified in this AD.
This AD differs from the MCAI and/or service information as follows: No differences.
(i) The following provisions also apply to this AD:
(1)
(2)
(3)
(j) Refer to MCAI EASA Airworthiness Directive 2008–0173, dated September 15, 2008, and the service information identified in Table 6 of this AD for related information.
(k) You must use the service information contained in Table 7 of this AD, as applicable, to do the actions required by this AD, unless the AD specifies otherwise.
(1) The Director of the Federal Register approved the incorporation by reference of the service information contained in Table 8 of this AD under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) The Director of the Federal Register previously approved the incorporation by reference of the service information contained in Table 9 of this AD on June 26, 2007 (72 FR 31973, June 11, 2007).
(3) For service information identified in this AD, contact Airbus SAS—Airworthiness Office—EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45 80, e-mail:
(4) You may review copies of the service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, Washington. For information on the availability of this material at the FAA, call 425–227–1221.
(5) You may also review copies of the service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to:
Federal Aviation Administration (FAA), DOT.
Final rule; request for comments.
We are adopting a new airworthiness directive (AD) for the products listed above. This AD results from mandatory continuing airworthiness information (MCAI) issued by the aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:
A fatal accident occurred to a L–13 BLANÍK sailplane, in which the main spar of the right wing failed near the root due to positive load. The right wing detached from the aircraft and the pilots lost control of the sailplane.
The preliminary investigation has revealed that the fracture may have been due to fatigue.
This AD becomes effective July 19, 2010.
On July 19, 2010, the Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD.
We must receive comments on this AD by August 27, 2010.
You may send comments by any of the following methods:
•
•
•
•
You may examine the AD docket on the Internet at
Greg Davison, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329–4130; fax: (816) 329–4090.
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued Emergency AD No.: 2010–0122–E, dated June 23, 2010 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:
A fatal accident occurred to a L–13 BLANÍK sailplane, in which the main spar of the right wing failed near the root due to positive load. The right wing detached from the aircraft and the pilots lost control of the sailplane.
The preliminary investigation has revealed that the fracture may have been due to fatigue.
The Emergency AD 2010–0119–E required immediate inspection of the main spar at the root of the wing to detect fatigue cracking and the accomplishment of the relevant corrective actions as necessary. In addition, this AD 2010–0119–E imposed operational limitations. This AD retains the requirements of AD 2010–0119–E, which is superseded, and extends the applicability to L–13 A BLANÍK sailplanes.
The requirements of this AD are considered as interim action to immediately address this unsafe condition. If, as a result of the on-going investigation, a terminating action is later identified, further mandatory actions might be considered.
Aircraft Industries a.s. has issued Mandatory Bulletin MB No.: L13/109a, dated June 18, 2010. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI.
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with this State of Design Authority, they have notified us of the unsafe condition described in the MCAI and service information referenced above. We are issuing this AD because we evaluated all information provided by the State of Design Authority and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.
We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.
We might have also required different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are described in a separate paragraph of the AD. These requirements take precedence over those copied from the MCAI.
An unsafe condition exists that requires the immediate adoption of this AD. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because a fatal accident occurred in an L–13 Blanik glider. The main spar of the right wing of the accident glider failed near the root due to positive load. The right wing detached from the aircraft and the pilots lost control. The preliminary investigation has revealed that the fracture may have been due to fatigue. Therefore, we determined that notice and opportunity for public comment before issuing this AD are impracticable and that good cause exists for making this amendment effective in fewer than 30 days.
This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866;
(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and
(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
49 U.S.C. 106(g), 40113, 44701.
(a) This airworthiness directive (AD) becomes effective July 19, 2010.
(b) None.
(c) This AD applies to Models L–13 Blanik gliders, all serial numbers, certificated in any category.
(d) Air Transport Association of America (ATA) Code 57: Wings.
(e) The mandatory continuing airworthiness information (MCAI) states:
A fatal accident occurred to a L–13 BLANÍK sailplane, in which the main spar of the right wing failed near the root due to positive load. The right wing detached from the aircraft and the pilots lost control of the sailplane.
The preliminary investigation has revealed that the fracture may have been due to fatigue.
The Emergency AD 2010–0119–E required immediate inspection of the main spar at the root of the wing to detect fatigue cracking and the accomplishment of the relevant corrective actions as necessary. In addition, this AD 2010–0119–E imposed operational limitations. This AD retains the requirements of AD 2010–0119–E, which is superseded, and extends the applicability to L–13 A BLANÍK sailplanes.
The requirements of this AD are considered as interim action to immediately address this unsafe condition. If, as a result of the on-going investigation, a terminating action is later identified, further mandatory actions might be considered.
(f) Unless already done, do the following actions.
(1) As of July 19, 2010, aerobatics maneuvers (
(2) Before further flight after July 19, 2010, inspect the wing critical areas following Aircraft Industries a.s. Mandatory Bulletin MB No.: L13/109a, dated June 18, 2010, except use a 10X magnifier.
(3) If any cracks are found during the inspection required by paragraph (f)(2) of this AD, no further flights are permitted.
(4) Within 10 days after the inspection required by paragraph (f)(2) of this AD, submit the following information requested by Aircraft Industries a.s. Mandatory Bulletin MB No.: L13/109a, dated June 18, 2010, for further assessment. Send information to the address listed in paragraph (i)(2) of this AD.
(i) Appendix No. 1, Summary of L–13 glider Log book record; and
(ii) Paragraph H. RECORD IN GLIDER LOGBOOK AFTER BULLETIN EXECUTION.
The above limitation is an interim solution until a final action is identified, at which time the European Aviation Safety Agency (EASA) and the FAA may consider further AD action.
This AD differs from the MCAI and/or service information as follows. The service information requires a visual inspection with a 6X magnifier. We are requiring a 10X magnifier to detect cracks that could go undetected using only a 6X magnifier.
(g) The following provisions also apply to this AD:
(1) Alternative Methods of Compliance (AMOCs): The Manager, Standards Office, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Greg Davison, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329–4130; fax: (816) 329–4090. Before using any approved AMOC on any airplane to which the AMOC applies, notify your appropriate principal inspector (PI) in the FAA Flight Standards District Office (FSDO), or lacking a PI, your local FSDO.
(2) Airworthy Product: For any requirement in this AD to obtain corrective actions from a manufacturer or other source, use these actions if they are FAA-approved. Corrective actions are considered FAA-approved if they are approved by the State of Design Authority (or their delegated agent). You are required to assure the product is airworthy before it is returned to service.
(3) Reporting Requirements: For any reporting requirement in this AD, under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
(h) Refer to MCAI EASA Emergency AD No.: 2010–0122–E, dated June 23, 2010; and Aircraft Industries a.s. Mandatory Bulletin MB No.: L13/109a, dated June 18, 2010, for related information.
(i) You must use Aircraft Industries a.s. Mandatory Bulletin MB No.: L13/109a, dated June 18, 2010, to do the actions required by this AD, unless the AD specifies otherwise.
(1) The Director of the Federal Register approved the incorporation by reference of
(2) For service information identified in this AD, contact Aircraft Industries, a.s., Na Záhonech 1177, 686 04 Kunovice, Czech Republic; phone: +420 572 817 660; fax: +420 572 816 112; Internet:
(3) You may review copies of the service information incorporated by reference for this AD at the FAA, Central Region, Office of the Regional Counsel, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the Central Region, call (816) 329–3768.
(4) You may also review copies of the service information incorporated by reference for this AD at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call (202) 741–6030, or go to:
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
We are superseding an existing airworthiness directive (AD) for the products listed above. This AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:
Several cases have been reported where a loss of fluid in the No.2 hydraulic system has caused the power transfer unit (PTU) to overspeed, resulting in pressure fluctuations and increased fluid flow within the No. 1 hydraulic system. In one case, the hydraulic system control logic did not shut down the PTU and the overspeed condition persisted, resulting in the illumination of the No.1 HYD FLUID HOT caution light.
This AD becomes effective August 17, 2010.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of August 17, 2010.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of September 2, 2008 (73 FR 47818, August 15, 2008).
The Director of the Federal Register approved the incorporation by reference of certain other publications listed in this AD as of July 10, 2007 (72 FR 30968, June 5, 2007).
You may examine the AD docket on the Internet at
Fabio Buttitta, Aerospace Engineer, Airframe and Mechanical Systems Branch, ANE–171, FAA, New York Aircraft Certification Office, 1600 Stewart Avenue, Suite 410, Westbury, New York 11590; telephone (516) 228–7303; fax (516) 794–5531.
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the
Since we issued AD 2008–17–06, a modification of the power transfer unit (PTU) control logic, including the provision of automatic PTU shutdown in the event of loss of fluid in the No. 2 hydraulic system, has been developed. The modification addresses the identified unsafe condition. In addition, the applicability has been revised to remove airplanes having serial number 4185 and subsequent, since an equivalent modification has been installed in production on these airplanes. Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian Airworthiness Directive CF–2006–08R1, dated August 31, 2009 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:
Several cases have been reported where a loss of fluid in the No.2 hydraulic system has caused the power transfer unit (PTU) to overspeed, resulting in pressure fluctuations and increased fluid flow within the No. 1 hydraulic system. In one case, the hydraulic system control logic did not shut down the PTU and the overspeed condition persisted, resulting in the illumination of the No. 1 HYD FLUID HOT caution light.
As an interim action to avoid possible loss of both the No. 1 and No. 2 hydraulic systems, the Airplane Flight Manual (AFM) has been revised to include pulling the HYD PWR XFER circuit breaker in the event of the loss of all hydraulic fluid in the No. 2 hydraulic system.
Insertion of the resultant Temporary Amendment (TA) No. 13 into the AFM was mandated in the original issue of this [Canadian] directive. This instruction * * * remains in effect until * * * this [revised] directive is accomplished.
Revision 1 of this directive * * * mandates modification of the PTU control logic, including the provision of automatic PTU shutdown in the event of loss of fluid in the No. 2 hydraulic system. In addition, the applicability of the [Canadian] directive has been revised to remove aircraft Serial Number (SN) 4185 and subsequent, since an equivalent modification has been installed in production on these aircraft.
We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public.
We reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed.
We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use
We might also have required different actions in this AD from those in the MCAI in order to follow our FAA policies. Any such differences are highlighted in a NOTE within the AD.
We estimate that this AD will affect about 42 products of U.S. registry.
The actions that are required by AD 2008–17–06 and retained in this AD take about 1 work-hour per product, at an average labor rate of $85 per work hour. Required parts cost about $0 per product. Based on these figures, the estimated cost of the currently required actions is $85 per product.
We estimate that it will take about 165 work-hours per product to comply with the new basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $10,982 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these parts. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $1,050,294, or $25,007 per product.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this AD:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and
3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.
You may examine the AD docket on the Internet at
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
49 U.S.C. 106(g), 40113, 44701.
(a) This airworthiness directive (AD) becomes effective August 17, 2010.
(b) This AD supersedes AD 2008–17–06, Amendment 39–15644.
(c) This AD applies to Bombardier, Inc. Model DHC–8–400, –401, and –402 airplanes, certificated in any category; serial numbers 4001, 4003, 4004, 4006, and 4008 through 4184 inclusive.
(d) Air Transport Association (ATA) of America Code 29: Hydraulic power.
(e) The mandatory continuing airworthiness information (MCAI) states:
Several cases have been reported where a loss of fluid in the No.2 hydraulic system has caused the power transfer unit (PTU) to overspeed, resulting in pressure fluctuations and increased fluid flow within the No. 1 hydraulic system. In one case, the hydraulic system control logic did not shut down the PTU and the overspeed condition persisted, resulting in the illumination of the No. 1 HYD FLUID HOT caution light.
As an interim action to avoid possible loss of both the No. 1 and No. 2 hydraulic systems, the Airplane Flight Manual (AFM) has been revised to include pulling the HYD PWR XFER circuit breaker in the event of the loss of all hydraulic fluid in the No. 2 hydraulic system.
Insertion of the resultant Temporary Amendment (TA) No. 13 into the AFM was mandated in the original issue of this [Canadian] directive. This instruction * * * remains in effect until * * * this [revised] directive is accomplished.
Revision 1 of this directive * * * mandates modification of the PTU control logic, including the provision of automatic PTU shutdown in the event of loss of fluid in the No. 2 hydraulic system. In addition, the applicability of the [Canadian] directive has been revised to remove aircraft Serial Number (SN) 4185 and subsequent, since an equivalent modification has been installed in production on these aircraft.
(f) You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done.
(g) Within 14 days after July 10, 2007 (the effective date of AD 2007–12–03, Amendment 39–15081, which was superseded by AD 2008–17–06), revise the Limitations section of the applicable AFM to include the information in the applicable Bombardier temporary amendment specified in Table 1 of this AD, as specified in the temporary amendment. These temporary amendments introduce procedures for
This may be done by inserting a copy of the applicable temporary amendment into the applicable AFM. When the applicable temporary amendment has been included in general revisions of the AFM, the general revisions may be inserted into the AFM, provided the relevant information in the general revisions is identical to that in the temporary amendment.
(h) Within 14 days after September 2, 2008 (the effective date of AD 2008–17–06), revise the applicable AFM Normal and Abnormal Procedures section to include the information in the applicable Bombardier temporary amendment specified in Table 2 of this AD, as specified in the temporary amendment. These temporary amendments introduce additional procedures for ensuring that the “PTU CNTRL” switch is Normal, the “PTU CNTRL ON” advisory light is out, and the “HYD PWR XFER” circuit breaker is pulled in the event of the illumination of the “#2 HYD ISO VALVE” caution light. After accomplishing the AFM revision, the AFM limitation required by paragraph (g) in this AD may be removed from the AFM.
(i) Within 6,000 flight hours after the effective date of this AD, modify the PTU control logic, in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 84–29–22, Revision A, dated February 24, 2009. Doing this modification terminates the requirements of paragraphs (g) and (h) of this AD, and after the modification has been done, the AFM limitation required by paragraphs (g) and (h) of this AD may be removed from the AFM.
(j) Modifying the PTU control logic is also acceptable for compliance with the requirements of paragraph (i) of this AD if done before the effective date of this AD, in accordance with Bombardier Service Bulletin 84–29–22, dated December 5, 2008.
This AD differs from the MCAI and/or service information as follows: No differences.
(k) The following provisions also apply to this AD:
(1)
(2)
(3)
(l) Refer to MCAI Canadian Airworthiness Directive CF–2006–08R1, dated August 31, 2009; the Bombardier temporary amendments specified in Tables 1 and 2; and Bombardier Service Bulletin 84–29–22, Revision A, dated February 24, 2009; for related information.
(m) You must use Bombardier Service Bulletin 84–29–22, Revision A, dated February 24, 2009, and the applicable temporary amendment identified in Table 3 of this AD; as applicable; to do the actions required by this AD, unless the AD specifies otherwise.
(1) The Director of the Federal Register approved the incorporation by reference of Bombardier Service Bulletin 84–29–22, Revision A, dated February 24, 2009, under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) The Director of the Federal Register previously approved the incorporation by reference of the service information contained in Table 4 of this AD on September 2, 2008 (73 FR 47818, August 15, 2008).
(3) On July 10, 2007 (72 FR 30968, June 5, 2007), the Director of the Federal Register approved the incorporation by reference of the temporary amendments identified in Table 5 of this AD.
(4) For service information identified in this AD, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; telephone 514–855–5000; fax 514–855–7401; e-mail
(5) You may review copies of the service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington. For information on the availability of this material at the FAA, call 425–227–1221.
(6) You may also review copies of the service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to:
Federal Aviation Administration (FAA), DOT.
Final rule.
The FAA is adopting a new airworthiness directive (AD) for McCauley Propeller Systems model 4HFR34C653/L106FA propellers. This AD requires a onetime fluorescent penetrant inspection (FPI) and eddy current inspection (ECI) of the propeller hub for cracks. This AD results from reports of 10 hubs found cracked during propeller overhaul. We are issuing this AD to prevent failure of the propeller hub, which could cause blade separation, damage to the airplane, and loss of control of the airplane.
This AD becomes effective August 17, 2010. The Director of the Federal Register approved the incorporation by reference of certain publications listed in the regulations as of August 17, 2010.
You can get the service information identified in this AD from McCauley Propeller Systems, P.O. Box 7704, Wichita, KS 67277–7704; telephone (800) 621–7767.
The Docket Operations office is located at Docket Management Facility, U.S. Department of Transportation, 1200 New Jersey Avenue, SE., West Building Ground Floor, Room W12–140, Washington, DC 20590–0001.
Jeff Janusz, Aerospace Engineer, Wichita Aircraft Certification Office, FAA, Small Airplane Directorate, 1801 Airport Road, Wichita, KS 67209; e-mail:
The FAA proposed to amend 14 CFR part 39 with a proposed AD. The proposed AD applies to McCauley Propeller Systems model 4HFR34C653/L106FA propellers. We published the proposed AD in the
You may examine the AD docket on the Internet at
We provided the public the opportunity to participate in the development of this AD. We received one comment on the original proposed AD, which we responded to in the supplemental proposed AD. We received no comments on the supplemental proposed AD, or on the determination of the cost to the public.
We have carefully reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed.
We estimate that this AD will affect 128 propellers installed on airplanes of U.S. registry. We also estimate that it will take about 41.5 work-hours per propeller to perform the actions, and that the average labor rate is $85 per work-hour. Based on these figures, we estimate the total cost of the AD to U.S. operators to be $451,520.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We have determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866;
(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and
(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
We prepared a summary of the costs to comply with this AD and placed it in the AD Docket. You may get a copy of this summary at the address listed under
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
49 U.S.C. 106(g), 40113, 44701.
(a) This airworthiness directive (AD) becomes effective August 17, 2010.
(b) None.
(c) This AD applies to McCauley Propeller Systems model 4HFR34C653/L106FA propellers.
(d) This AD results from reports of 10 hubs found cracked during propeller overhaul. We are issuing this AD to prevent failure of the propeller hub, which could cause blade separation, damage to the airplane, and loss of control of the airplane.
(e) You are responsible for having the actions required by this AD performed within the compliance times specified unless the actions have already been done.
(f) For propeller hubs with 6,000 or more operating hours time-since-new (TSN) on the effective date of this AD, perform the procedures in paragraphs (h) through (k) of this AD within 100 operating hours time-in-service after the effective date of this AD.
(g) For propeller hubs with fewer than 6,000 operating hours TSN on the effective date of this AD, perform the procedures in paragraphs (h) through (k) of this AD before the propeller hub reaches 6,100 operating hours TSN.
(h) Remove and disassemble the propeller, and etch the propeller hub, using paragraphs 1.A. through 2.D. of the Accomplishment Instructions of McCauley Propeller Systems Alert Service Bulletin No. ASB254, dated August 20, 2007.
(i) Perform a onetime fluorescent penetrant inspection (FPI) of the propeller hub, using paragraphs 3.A through 3.G. of the Accomplishment Instructions of McCauley Propeller Systems Alert Service Bulletin No. ASB254, dated August 20, 2007.
(j) For hubs that pass the FPI, perform a onetime eddy current inspection of the propeller hub, using paragraphs 4.A. through 4.F. of the Accomplishment Instructions of McCauley Propeller Systems Alert Service Bulletin No. ASB254, dated August 20, 2007.
(k) Remove cracked hubs from service and any other propeller parts found cracked.
(l) If you performed the onetime inspection of the propeller hub using McCauley Propeller Systems Service Bulletin No. SB238A, or Alert Service Bulletin ASB254, both dated August 20, 2007, before the effective date of this AD, you have satisfied the inspection requirements of this AD.
(m) These actions are interim actions and we may take further rulemaking actions in the future.
(n) The Manager, Wichita Aircraft Certification Office, has the authority to approve alternative methods of compliance for this AD if requested using the procedures found in 14 CFR 39.19.
(o) Under 14 CFR part 39.23, we are limiting the special flight permits for this AD as follows:
(1) The propeller must have no signs of external oil leakage from the hub; and
(2) The propeller has no current reports of abnormal operation or vibration.
(p) Contact Jeff Janusz, Aerospace Engineer, Wichita Aircraft Certification Office, FAA, Small Airplane Directorate, 1801 Airport Road, Wichita, KS 67209; e-mail:
(q) You must use McCauley Propeller Systems, Service Bulletin No. ASB254, dated August 20, 2007, to perform the inspections required by this AD. The Director of the Federal Register approved the incorporation by reference of this service bulletin in
Federal Aviation Administration (FAA), DOT.
Final rule.
We are adopting a new airworthiness directive (AD) for the products listed above. This AD results from mandatory continuing airworthiness information (MCAI) issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:
Service has shown that the small outlet of the blow-by oil separators, part number 02–7250–18100R1; 02–7250–18100R2; 02–7250–18100R3; 02–7250–18100R4; 02–7250–18300R1; 02–7250–18300R2; 02–7250–18300R3; 02–7250–18300R4; or 02–7250–18300R5, may cause a blow-by gas pressure increase inside the crankcase of the engine in excess of the oil seal design pressure limits. Leaking engine oil may adversely affect the gearbox clutch or the engine lubrication system. This condition, if not corrected, could lead to in-flight cases of engine power loss or ultimately, shutdown.
This AD becomes effective August 17, 2010. The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of August 17, 2010.
The Docket Operations office is located at Docket Management Facility, U.S. Department of Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor, Room W12–140, Washington, DC 20590–0001.
Tara Chaidez, Aerospace Engineer, Engine Certification Office, FAA, Engine and Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803;
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the
Service has shown that the small outlet of the blow-by separators, part number 02–7250–18100R1; 02–7250–18100R2; 02–7250–18100R3; 02–7250–18100R4; 02–7250–18300R1; 02–7250–18300R2; 02–7250–18300R3; 02–7250–18300R4; or 02–7250–18300R5, may cause a blow-by gas pressure increase inside the crankcase of the engine in excess of the oil seal design pressure limits. Leaking engine oil may adversely affect the gearbox clutch or the engine lubrication system. This condition, if not corrected, could lead to in-flight cases of engine power loss or ultimately, shutdown.
We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public.
We reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed.
Based on the service information, we estimate that this AD will affect about 250 Thielert Aircraft Engines GmbH model TAE 125–01 engines installed on airplanes of U.S. registry. We also estimate that it will take about 1.5 work-hours per engine to comply with this AD. The average labor rate is $85 per work-hour. Required parts will cost about $1,500 per engine. Based on these figures, we estimate the cost of the AD on U.S. operators to be $406,875.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and
3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.
You may examine the AD docket on the Internet at
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
49 U.S.C. 106(g), 40113, 44701.
(a) This airworthiness directive (AD) becomes effective August 17, 2010.
(b) None.
(c) This AD applies to Thielert Aircraft Engines GmbH model TAE 125–01 reciprocating engines with any of the following part number blow-by oil separators installed:
These engines are installed in, but not limited to, Diamond Aircraft Industries Model DA 40, Piper PA–28–161 (Supplemental Type Certificate (STC) No. SA03303AT), and Cessna 172 (STC No. SA01303WI) airplanes.
(d) Service has shown that the small outlet of the blow-by oil separators, part number 02–7250–18100R1; 02–7250–18100R2; 02–7250–18100R3; 02–7250–18100R4; 02–7250–18300R1; 02–7250–18300R2; 02–7250–18300R3; 02–7250–18300R4; or 02–7250–18300R5, may cause a blow-by gas pressure increase inside the crankcase of the engine in excess of the oil seal design pressure limits. Leaking engine oil may adversely affect the gearbox clutch or the engine lubrication system. This condition, if not corrected, could lead to in-flight cases of engine power loss or ultimately, shutdown.
This AD results from mandatory continuing airworthiness information (MCAI) issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. We are issuing this AD to prevent loss of engine power or uncommanded engine shutdown during flight due to excessive crankcase blow-by gas pressure.
(e) Unless already done, do the following actions:
(1) Remove the blow-by oil separators listed by part number in Table 1 of this AD within the next 110 flight hours after the effective date of this AD.
(2) Use the Measures section of Thielert Aircraft Engines GmbH Service Bulletin No. TM TAE 125–0019, Revision 1, dated March 5, 2009, to do the removal from service.
(f) None.
(g) The Manager, Engine Certification Office, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19.
(h) Refer to European Aviation Safety Agency AD 2010–0020, dated February 8, 2010, for related information.
(i) Contact Tara Chaidez, Aerospace Engineer, Engine Certification Office, FAA, Engine and Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803;
(j) You must use Thielert Aircraft Engines GmbH Service Bulletin No. TM TAE 125–0019, Revision 1, dated March 5, 2009, to do the actions required by this AD, unless the AD specifies otherwise.
(1) The Director of the Federal Register approved the incorporation by reference of this service information under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) For service information identified in this AD, contact Thielert Aircraft Engines GmbH, Platanenstrasse 14 D–09350, Lichtenstein, Germany,
(3) You may review copies at the FAA, New England Region, 12 New England Executive Park, Burlington, MA; or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call (202) 741–6030, or go to:
Federal Aviation Administration (FAA), DOT.
Final rule.
We are adopting a new airworthiness directive (AD) for certain Model 757 airplanes, Model 767 airplanes, and Model 777–200 and –300 series airplanes. This AD requires repetitive inspections for damage of the electrical terminal at the left and right flightdeck window 1, and corrective actions if necessary. This AD also allows for replacing the flightdeck window 1 with a new improved flightdeck window equipped with different electrical connections, which terminates the repetitive inspections for that flightdeck window 1. This AD results from several reports of electrical arcs at the terminal blocks of the electrically heated flightdeck window 1. We are issuing this AD to prevent smoke and fire in the cockpit, which could lead to loss of visibility, and injuries to or incapacitation of the flightcrew.
This AD is effective August 17, 2010.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in the AD as of August 17, 2010.
For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H–65, Seattle, Washington 98124–2207; telephone 206–544–5000, extension 1; fax 206–766–5680; e-mail
You may examine the AD docket on the Internet at
Louis Natsiopoulos, Aerospace Engineer, Systems and Equipment Branch, ANM–130S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue, SW., Renton, Washington 98057–3356; telephone (425) 917–6478; fax (425) 917–6590.
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an airworthiness directive (AD) that would apply to certain Model 757 airplanes, Model 767 airplanes, and Model 777–200 and –300 series airplanes. That NPRM was published in the
After the NPRM was issued, Boeing issued the following service bulletins:
• Boeing Special Attention Service Bulletin 757–30–0019, Revision 2, dated April 19, 2010, for Model 757–200, –200CB, and –200PF series airplanes.
• Boeing Special Attention Service Bulletin 757–30–0020, Revision 2, dated March 31, 2010, for Model 757–300 series airplanes.
We referred to Boeing Special Attention Service Bulletin 757–30–0019, and Boeing Special Attention Service Bulletin 757–30–0020, both Revision 1, both dated December 19, 2007, as appropriate sources of service information for doing the actions proposed in the NPRM.
The actions specified in Boeing Special Attention Service Bulletins 757–30–0019 and 757–30–0020, both Revision 2, include an additional inspection of the J1 and J4 (upper) terminals; however, the inspection of the upper connections is not included in this AD. We find that to delay this action to include the inspection of the J1 and J4 terminals and to ensure that the public has sufficient time to consider and comment on the additional actions, would be inappropriate in light of the unsafe condition identified on the J5 terminal. We are considering additional rulemaking to require the inspection of the J1 and J4 terminals.
Boeing Special Attention Service Bulletins 757–30–0019 and 757–30–0020, both Revision 2, include a reduced compliance time of 500 flight hours or 150 days, whichever occurs first, for the detailed inspection for damage specified in paragraph (f) of this AD (paragraph (g) of the NPRM). We have not changed this AD to include the reduced compliance time. We have determined that the compliance time, as proposed, represents an appropriate interval of time in which the required actions can be performed in a timely manner within the affected fleet, while still maintaining an adequate level of safety. We find that to delay this action to ensure that the public has sufficient time to consider and comment on the reduced compliance time, would be inappropriate in light of the identified unsafe condition.
For Model 757 airplanes, Boeing Special Attention Service Bulletins 757–30–0019 and 757–30–0020, both Revision 2, also include a revised interval for repeating the detailed inspection for damage specified in paragraphs (f) and (g) of this AD (paragraphs (g) and (h) of the NPRM). We have determined that extending the repetitive intervals, as recommended by the manufacturer, is consistent with data on in-service failure reports and will not adversely affect safety for the affected airplane models. Therefore, we have changed paragraphs (f) and (g) of this AD (paragraphs (g) and (h) of the NPRM), to include the revised interval. For windows manufactured by GKN Aerospace Transparency Systems (GKN), the inspection is now specified at intervals not to exceed 12,000 flight hours or 48 months, whichever occurs later. For windows manufactured by PPG Aerospace (PPG), the inspection is now specified at intervals not to exceed 6,000 flight hours or 24 months, whichever occurs later. We have also revised this same repetitive interval for Model 767 airplanes, and Model 777–200 and –300 series airplanes, as explained under “Requests to Extend Repetitive Inspection Interval” below.
The Compliance paragraphs (1.E.) of Boeing Special Attention Service Bulletins 757–30–0019 and 757–30–0020, both Revision 2, give additional time for doing the corrective action if the screw is cross threaded and the terminal lug is tight. We have added paragraph (h)(1) to this AD to specify doing the corrective action within 150 days or 500 flight hours after the inspection, whichever occurs first, rather than before further flight.
We have changed Table 1 of this final rule to refer to Boeing Special Attention Service Bulletin 757–30–0019, Revision 2, dated April 19, 2010; and Boeing Special Attention Service Bulletin 757–30–0020, Revision 2, dated March 31, 2010; as appropriate sources of service information. We have also changed Table 2 of this final rule to state that actions done before the effective date of this AD in accordance with Boeing Special Attention Service Bulletin 757–30–0019 or Boeing Special Attention Service Bulletin 757–30–0020, both Revision 1, both dated December 19, 2007, are acceptable for compliance with the corresponding requirements of this AD.
We gave the public the opportunity to participate in developing this AD. We considered the comments received from the 10 commenters.
The National Transportation Safety Board (NTSB) fully supports the proposed action for the lower (J5) terminal.
Air Transport Association (ATA) agrees with the intent of the proposal, but specifies that the NPRM, as written, has fundamental and detailed flaws that may not resolve the unsafe condition; instead, the NPRM focuses on electrical connections on another side of the terminal block, which likely are not the cause of the unsafe condition. ATA recommends that we instead issue a
American Airlines (AAL) indicates that the proposed rule is premature and should be withdrawn until the NTSB has completed its investigation of an incident of window heat arcing on a Model 757 airplane at the J1 and J4 terminals. The NTSB also encourages amending the NPRM (we infer by supplemental NPRM) to include inspections of the J1 and J4 terminals on all of the affected flightdeck windows. The NTSB states that in a small number of cases it determined that a loose or inadequate connection at the J1 terminal or J4 terminal is the most likely cause of the smoke and/or fire in the cockpit.
AAL, Continental Airlines (CAL), Delta Airlines (DAL), and United Airlines (UAL) request we withdraw the NPRM until we do further investigation to identify the root cause of the window arcing events. The commenters state that the proposed AD should mandate a comprehensive and worthwhile solution; that a credible analysis providing the true root cause of the failure must be completed first; and that further investigation could alter or add to the solution, thus rendering it more meaningful. Certain commenters suggest what the root causes might be, including the following:
• AAL contends that material design choices contribute to unintended cross threading and apparent lack of screw retention over time; and that under-torque of the connector screw as the lone primary failure is speculative and that a more likely source of heating is arcing along the braided power wire downstream of the window heat connector. In addition, AAL service history shows the primary cause of failure to be arcing at the heat braided power wire at the lower window along with delamination between the window heat layer and the outer glass.
• CAL states that it appears the root cause attributed to cross threading might actually be faulty solder joints, and that stripping of the tapped brass block due to repetitive application of current torque requirements could be a driving force behind in-service failures.
• DAL notes that poor design/manufacture of the flightdeck window 1 terminal contributes to arcing events and that the design does not support a long-term robust connection to the screw.
We disagree with the requests to withdraw the NPRM or issue a supplemental NPRM.
The incident of window heat arcing at the J1 and J4 terminals that was investigated by the NTSB is related to the unsafe condition addressed by the NPRM that preceded this final rule. We have reports of four events involving arcing of the flightdeck window heat system at the upper aft (J1) and upper forward (J4) terminals on the first officer's flightdeck window that caused the inner pane of glass to fracture. The events, which occurred between January 2001 and August 2008, all occurred on Model 757 airplanes. Withdrawing the NPRM to include the upper terminals for Model 757 airplanes would be inappropriate as it would delay this AD action, which addresses failures of the lower (J5) terminal for Model 757 airplanes, Model 767 airplanes, and Model 777–200 and –300 series airplanes. However, we are considering additional rulemaking to address arcing at the upper (J1 and J4) terminals on Model 757 airplanes only.
Regarding the requests to determine the root causes, we disagree with withdrawing the NPRM until a different root cause is identified. Although we agree with the commenters that the failure mode that causes a significant arcing event is the melting of solder or the de-soldering of the terminal connection, we disagree as to the cause of the de-soldering of the terminal connection and subsequent arcing.
We have received reports that attribute the primary cause of the overheating of the terminal to a cross-threaded screw, a loose screw, or an incorrectly installed screw. We have also found that the majority of the arcing events happened within 500 flight hours after the flightdeck window was replaced or had undergone maintenance. The unintended cross threading and apparent lack of screw retention over time have been reported on flightdeck windows manufactured by both GKN and PPG. The failure of the moisture seal and the delamination of the flightdeck window plies are addressed by other ADs and other service bulletins; but we point out that such failures are detectable.
We find that the actions required by this AD will identify failures of the electrical terminals, regardless of the root cause, and that the corrective actions apply to all detected failures. However, if new information becomes available to justify revising this AD, we will consider further rulemaking.
For the above reasons, no change has been made to the AD in response to the requests to withdraw the NPRM or issue a supplemental NPRM.
Air France, ATA, and Northwest Airlines (NWA) request that we extend the interval for the repetitive inspection from 6,000 flight hours to 7,800 flight hours (Air France) or 8,000 flight hours (ATA and NWA). Air France contends that the inspections should be matched with the schedule for light maintenance checks. ATA recommends that we extend the interval based on service experience. NWA indicates there would not be an appreciable effect on safety in extending the inspection to an interval where the task can be performed during a scheduled “C” check in an environment more conducive to such maintenance.
We partially agree with the requests to extend the repetitive inspection interval. We agree with the request to extend the interval for GKN flightdeck windows. As explained previously under “Explanation of Revised Service Information,” for windows manufactured by GKN, the inspection is now specified in this AD at intervals not to exceed 12,000 flight hours or 48 months, whichever occurs later. According to reports the failure rate of GKN flightdeck windows seems to be substantially lower than the failure rate of the PPG flightdeck windows, and the severity of events of the GKN flightdeck windows is less.
We disagree with extending the inspection interval for PPG flightdeck windows from 6,000 flight hours; however, we have determined that specifying the compliance time as 6,000 flight hours or 24 months, whichever occurs later, will provide relief to operators. In establishing the 6,000-flight-hour interval for those flightdeck windows, we considered not only the frequency of occurrence of the electrical connection failures, the time required to perform the inspection, and the consequent risk of uncorrected unsafe conditions, but also the scheduling of the inspections so they can be accomplished during regular maintenance down time. We determined that an interval of 6,000 flight hours would give the operators ample time to schedule the proposed actions at a routine scheduled maintenance and detect an unsafe condition before an event.
We have changed paragraphs (f) and (g) of this AD (paragraphs (g) and (h) of the NPRM) to include the revised intervals.
AAL, DAL, and UAL request that we clarify the intent of the initial repetitive inspection that is proposed within 500 flight hours after the corrective action for certain airplanes. DAL points out that as written in the NPRM an operator
We agree that the 500-flight-hour compliance time for the initial repetitive inspection for certain airplanes, as required by paragraph (g) of this AD (paragraph (h) of the NPRM), should be clarified. The intent of the inspection of certain airplanes “within 500 flight hours after the corrective action,” as specified in paragraph (g) of this AD, is a quality assurance check. The phrase “within 500 flight hours after the corrective action” correctly allows for doing the initial repetitive inspection before further flight following accomplishment of the corrective action. According to the majority of the reported arcing events, the result of an incorrectly assembled screw/lug electrical connection (a heated terminal and the possibility of subsequent arcing) occurred in-service after the assembly of the electrical connection. Additionally, the phrase “within 500 flight hours after the corrective action” would also provide sufficient time for operators of mixed or large fleets to do the inspection without compromising safety. We have not changed the AD in this regard.
ATA, on behalf of its member AAL, requests that part number (P/N) 141T4800 flightdeck windows be excluded from the actions proposed in the NPRM. AAL has data that confirm it has not experienced what they deemed a “catastrophic” arcing or smoke event on a flightdeck window, P/N 141T4800. All of the “catastrophic” arcing and smoke events AAL has experienced have occurred on flightdeck window P/N 141T4801 with lug and screw electrical connections. AAL states that the P/N 141T4800 terminal blocks might show minor damage; however, the damage is limited and contained. AAL further asserts that the connection found in the terminating action proposed in the NPRM is exactly the P/N 141T4800 connection; therefore, the AD should exclude flightdeck windows that currently have P/N 141T4800.
We partially agree with the commenters. We agree that the performance of the P/N 141T4800 flightdeck window appears to be better than the P/N 141T4801 flightdeck window with lug and screw electrical connections; its failure rate is lower and the failures are not as severe. We disagree with excluding the P/N 141T4800 flightdeck windows from the AD because we have received reports of arcing events with the P/N 141T4800 flightdeck windows that require corrective action. However, we find that some mitigation is appropriate because the failure rate of the screw/lug terminal equipped PPG windshields to screw/lug equipped GKN flightdeck windows is about 2 to 1. Therefore, we have changed paragraphs (f) and (g) of this AD (paragraphs (g) and (h) of the NPRM) to specify a repetitive interval of 12,000 flight hours or 48 months, whichever occurs later, for screw/lug terminal equipped GKN flightdeck windows.
GKN and AAL state that flightdeck window P/N 141T800–13/–14 should be included as a terminating action in the NPRM. The commenters state that service information points to damaged solder joints as the primary cause of the electrical arcs and point out that the P/N 141T800–13/–14 flightdeck windows do not incorporate the design feature that causes extreme arcing, an ignition source, and melting of the glass; and that the design does not incorporate features that are subject to assembly error. Specifically, the commenters state that at the cockpit side, the flightdeck window P/N 141T800–13/–14 uses a screw connector which is seen as superior to the pin and socket connector used on the proposed terminating action windshield; this superiority is due to the high clamping pressure and ability to re-tighten or replace the screw in addition to the excellent material choice for the threaded insert.
We disagree with the request to include flightdeck window P/N 141T800–13/–14 as a terminating action. While we agree that damaged solder joints are the primary cause for the electrical arcs, we point out that the primary cause of loose connections is the incorrect torque of the screw or an incorrectly installed screw. A loose connection increases the heat at the terminal, which can cause damage to the internal solder joint. A loose screw or an incorrectly installed screw is due to limited access on the airplane. The pin/socket connector, which is the design proposed as the optional terminating action in the NPRM, is assembled in a controlled environment on a bench and with full access. The screw/lug design proposed by the commenters does not provide an equivalent level of safety to that of the pin/socket design, which is not subject to the same assembly errors. Therefore, we have not changed the AD in this regard.
CAL, DAL, and ATA on behalf of its member AAL, request that we and the manufacturer perform an engineering analysis to determine whether pin and socket connections, proposed as an optional terminating action, offer any advantage over screw and lug connections. AAL has had considerable experience with pin and socket connections and states that carrying any appreciable current through a pin and socket connection is less reliable than a ring terminal and screw connection. CAL states that it has had problems with pin and socket connections; however, it applauds the mechanical joining at the mesh to block interface. CAL considers that more time is needed to determine if the pin and socket design is more reliable. DAL is unaware of any destructive testing that has been performed to substantiate the use of the new design as the corrective action for flightdeck window arcing events.
We disagree with the need for further study. The pin and socket connection of the electrical heat terminal was designed and qualification tested for contact retention and current-carrying capacity by the suppliers as part of the certification process of the block. The testing verified the integrity of the design and showed it not to have nuisance failures. Further, the pin and socket technology is well-established and used in a significant number of electrical applications on the airplane. The pin and socket connectors for the flightdeck window heat terminal have been in service since 2004 without any reported failures. The failures that the commenters referred to were due to manufacturing error rather than a design defect. We have not changed the AD in this regard.
The NTSB asks that we make the installation of a new flightdeck window mandatory rather than optional and states that the installation would prevent similar events of smoke or fire in the cockpit. The NTSB notes that the NPRM proposes installation of a new
We partially agree. While we agree with the commenter that the installation of the new flightdeck window with the pin and socket electrical connection is more robust because it is not as susceptible to assembly errors as is the flightdeck window with the screw/lug connection, we disagree with the request to make the installation of the flightdeck window with the new pin and socket electrical connection mandatory. The repetitive inspections and corrective actions required by this AD provide adequate means to maintain the safety of the screw/lug flightdeck windows. Requiring the replacement of the flightdeck windows is not necessary to address the unsafe condition. We have not changed the AD in this regard.
CAL notes that access to the terminal block on Boeing Model 757 airplanes is “atrocious”; even with small hands it cannot be held. CAL does not consider it a coincidence that this connection is the “problem child” because access is so poor. This limited access, coupled with poor “view-ability” turns a simple installation into a very complex installation. CAL requests that certain aircraft improvements and modifications be addressed, as well as human factor items such as special tooling to be developed.
We infer that the commenter asks us to address this issue in the AD. We partially agree with the request. The commenter is correct in saying that access to the electrical terminal block makes it difficult to achieve the torque limits outlined in the airplane maintenance manual and that this could be the primary reason for incorrectly assembled electrical terminations. We note that the optional terminating action of this AD (pin and socket design) is much easier to accomplish in the existing limited space. In addition, we find that to delay this action to allow time for modifications and human factor changes would be inappropriate in light of the identified unsafe condition. The commenter should note that under the provisions of paragraph (k) of the final rule, we will consider requests for approval of an alternative method of compliance (AMOC) if sufficient data are submitted to substantiate that the design change would provide an acceptable level of safety.
We have not changed the AD in this regard.
AAL requests revisions to the service bulletins listed in the table titled “Requested revisions.”
AAL lists several editorial changes in the service bulletins in its comments, and specifies that revisions would reduce the burden of processing numerous requests for AMOCs.
UAL requests that we revise Boeing Special Attention Service Bulletin 777–30–0012, Revision 2, dated December 19, 2007, to clarify the following statement: “There is a time limit on how long the old number 1 flightdeck window can be used.” UAL would like to know if the time limit refers to the serviceability limit of the old flightdeck window, or the availability of the flightdeck window, or to future spares.
We have discussed AAL's concerns with Boeing. In addition, we agree with UAL that the statement about the time limit is in error and should not be included in the service bulletin. We have also referred this concern to Boeing. We have not changed the AD in this regard.
Boeing asks that we add a reference to Table 1 of the NPRM in the paragraph titled “Actions Accomplished Previously,” for the latest revision of the released service bulletins. Boeing points out that the service bulletins listed in both Table 1 and Table 2 are acceptable before the effective date of the AD.
We disagree with the request to refer to Table 1 in the “Credit for Actions Accomplished Previously” paragraph of this AD. The intent of the “Credit for Actions Accomplished Previously” paragraph is to list service bulletins that are acceptable for compliance before the effective date of the AD, but not after the effective date of the AD. The service bulletins listed in Table 1 of the AD are acceptable for compliance both before and after the effective date of the AD. The acceptable use of the service bulletins listed in Table 1 of this AD before the effective date is covered by the statement in paragraph (e) of this AD that says, “Comply with this AD within the compliance times specified, unless already done.” We have not changed the AD in this regard.
Boeing asks that we add the following statement to the “Alternative Methods of Compliance” paragraph of the NPRM: “These inspections are for the #1 flight deck windows regardless of window manufacturer.” Boeing explains that there are two different suppliers for the flightdeck windows, but each flightdeck window is connected to the airplane side wiring in the same manner and requires the specified inspections.
We disagree with the request to change this AD to add the statement. The AD requires inspection of the flightdeck windows according to the Accomplishment Instructions of the applicable service bulletin. The service bulletins listed in this AD apply to all flightdeck windows, regardless of manufacturer. We have not changed the AD in this regard.
The NTSB believes that we should take similar action for Model 747 series airplanes because a similar condition exists on those airplanes.
We agree with the NTSB and are considering rulemaking to address a similar unsafe condition on Model 747 series airplanes. We have not changed this AD in this regard.
The last column in the table in paragraph 1.E., “Compliance,” of Boeing Special Attention Service Bulletin 757–30–0020, Revision 2, dated March 31, 2010, specifies repeating the inspection for damage at “intervals not to exceed 6,000 flight hours or 24 months.” The intent of that column is to specify an interval “not to exceed 6,000 flight hours or 24 months, whichever occurs later.” We have included the correct interval in paragraphs (f) and (g) of this AD.
In several places of the Compliance paragraph (1.E.) of Boeing Special Attention Service Bulletin 757–30–0020, Revision 2, dated March 31, 2010; and Boeing Special Attention Service Bulletin 757–30–0019, Revision 2, dated April 19, 2010; the “Action” column implies that both the left and right windows must be replaced. For example, “* * * replace windshield in accordance with Work Package 1, step 3.
The Action column for Inspection Condition 4 in the table in paragraph 1.E., “Compliance,” of Boeing Special Attention Service Bulletin 757–30–0020, Revision 2, dated March 31, 2010, states “3. If terminal lug is still loose.” That statement should be “3. If terminal lug is still loose then disassemble, inspect and reassemble the electrical connection.”
We have clarified paragraph (f) of this AD (paragraph (g) of the NPRM) to specify that Work Packages 1 and 2 apply to the J5 terminal. As stated previously, the Accomplishment Instructions of Boeing Special Attention Service Bulletin 757–30–0020, Revision 2, dated March 31, 2010, and Boeing Special Attention Service Bulletin 757–30–0019, Revision 2, dated April 19, 2010, include an inspection of the J1 and J4 (upper) electrical connections; however, the inspection of these connections is not included in this AD.
We have clarified paragraph (g) of this AD (paragraph (h) of the NPRM) to remove the phrase “or tightening a loose screw” from the description of corrective actions that requires additional inspection within 500 flight hours. The only corrective action after which the inspection is necessary is replacement.
After the NPRM was issued, we reviewed the figures we have used over the past several years to calculate AD costs to operators. To account for various inflationary costs in the airline industry, we find it necessary to increase the labor rate used in these calculations from $80 per work hour to $85 per work hour. The cost impact information, below, reflects this increase in the specified hourly labor rate.
We have removed the “Service Bulletin Reference” paragraph from this AD. That paragraph was identified as paragraph (f) in the NPRM. Instead, we have provided the full service bulletin citations throughout this AD.
We also have revised this final rule to identify the legal name of the manufacturer as published in the most recent type certificate data sheet for the affected airplane models.
We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We also determined that these changes will not increase the economic burden on any operator or increase the scope of the AD.
We estimate that this AD affects 1,212 airplanes of U.S. registry. The following table provides the estimated costs for U.S. operators to comply with this AD. The average labor rate is $85 per work hour.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979), and
(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
You can find our regulatory evaluation and the estimated costs of compliance in the AD Docket.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
49 U.S.C. 106(f), 40113, 44701.
(a) This airworthiness directive (AD) is effective August 17, 2010.
(b) None.
(c) This AD applies to the airplanes identified in Table 1 of this AD, certificated in any category.
(d) This AD results from several reports of electrical arcs at the terminal blocks of the electrically heated flightdeck window 1. We are issuing this AD to prevent smoke and fire in the cockpit, which could lead to loss of visibility, and injuries to or incapacitation of the flightcrew.
(e) Comply with this AD within the compliance times specified, unless already done.
(f) Within 500 flight hours after the effective date of this AD, do a detailed inspection for damage (including arcing, loose terminal, or heat damage) of the electrical terminal (J5 terminal) at the left and right flightdeck window 1, and do all applicable corrective actions, by accomplishing all the actions for the J5 terminal specified in Work Packages 1 and 2 of the applicable service bulletin specified in Table 1 of this AD, except as provided by paragraph (h) of this AD. Except as provided by paragraph (h) of this AD, do all applicable corrective actions before further flight. Except as provided by paragraph (g) of this AD, repeat the detailed inspection at the applicable interval specified in paragraph (f)(1) or (f)(2) of this AD. Doing the replacement specified in paragraph (i) of this AD terminates the repetitive inspection requirements of this paragraph for the replaced flightdeck window 1.
(1) For flightdeck windows manufactured by GKN with SCREW/LUG electrical connections, repeat the detailed inspection thereafter at intervals not to exceed 12,000 flight hours or 48 months, whichever occurs later.
(2) For flightdeck windows manufactured by PPG with SCREW/LUG electrical connections, repeat the detailed inspection thereafter at intervals not to exceed 6,000 flight hours or 24 months, whichever occurs later.
(g) For airplanes on which replacement with a new window 1 that uses screws and lugs for the electrical connections is done in accordance with Work Package 1 or 2 of the applicable service bulletin specified in Table 1 of this AD: Do the next detailed inspection within 500 flight hours after the corrective action, and repeat the inspection thereafter at the applicable interval specified in paragraph (g)(1) or (g)(2) of this AD. Doing the replacement specified in paragraph (i) of this AD terminates the repetitive inspection requirements of this paragraph for the replaced flightdeck window 1.
(1) For flightdeck windows manufactured by GKN with SCREW/LUG electrical connections, repeat the detailed inspection thereafter at intervals not to exceed 12,000 flight hours or 48 months, whichever occurs later.
(2) For flightdeck windows manufactured by PPG with SCREW/LUG electrical connections, repeat the detailed inspection thereafter at intervals not to exceed 6,000 flight hours or 24 months, whichever occurs later.
(h) Do the applicable actions specified in paragraph (f) of this AD except as provided by paragraphs (h)(1) and (h)(2) of this AD.
(1) If, during the inspection required by paragraph (f) of this AD, the screw is cross threaded and the terminal lug is tight, do the applicable corrective action within 150 days or 500 flight hours after the inspection, whichever occurs first.
(2) Where paragraph 1.E. of Boeing Special Attention Service Bulletin 757–30–0020, Revision 2, dated March 31, 2010, and Boeing Special Attention Service Bulletin 757–30–0019, Revision 2, dated April 19, 2010, states in the “Action” column to (for example) “ * * * replace windshield in accordance with Work Package 1, step 3.
(i) Replacing a flightdeck window 1 that uses screws and lugs for the electrical connections with a flightdeck window that uses pins and sockets for the electrical connections in accordance with Work Packages 3 or 4 of the applicable service bulletin specified in Table 1 of this AD ends the repetitive inspection requirements of this AD for that window 1.
(j) Actions done before the effective date of this AD in accordance with the applicable service bulletin specified in Table 2 of this AD are acceptable for compliance with the corresponding requirements of this AD.
(k)(1) The Manager, Seattle Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Louis Natsiopoulos, Aerospace Engineer, Systems and Equipment Branch, ANM–130S, 1601 Lind Avenue SW., Renton, Washington 98057–3356; telephone (425) 917–6478; fax (425) 917–6590. Information may be e-mailed to:
(2) To request a different method of compliance or a different compliance time for this AD, follow the procedures in 14 CFR 39.19. Before using any approved AMOC on any airplane to which the AMOC applies, notify your principal maintenance inspector (PMI) or principal avionics inspector (PAI), as appropriate, or lacking a principal inspector, your local Flight Standards District Office. The AMOC approval letter must specifically reference this AD.
(l) You must use the applicable service information contained in Table 3 of this AD to do the actions required by this AD, unless the AD specifies otherwise. If you accomplish the optional actions specified by this AD, you must use the applicable service information specified in Table 3 of this AD to perform those actions, unless the AD specifies otherwise.
(1) The Director of the Federal Register approved the incorporation by reference of this service information under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H–65, Seattle, Washington 98124–2207; telephone 206–544–5000, extension 1, fax 206–766–5680; e-mail
(3) You may review copies of the service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington. For information on the availability of this material at the FAA, call 425–227–1221.
(4) You may also review copies of the service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to:
Federal Aviation Administration (FAA), DOT.
Final rule.
We are adopting a new airworthiness directive (AD) for certain Model 777 airplanes. This AD requires inspecting the bolt, nut, and downstop of the slat track assembly to determine if the bolt, nut, or stops are missing and to determine if the thread protrusion of the bolt from the nut is within specified limits and parts are correctly installed, and related investigative and corrective actions if necessary. For certain airplanes, this AD also requires inspecting the slat cans at the outboard slat number 3 and 12 outboard main track locations for holes and wear damage, and corrective actions if necessary; and replacing the downstop hardware for the outboard slats number 3 and 12 outboard and inboard main track locations. This AD results from a report of a hole in the inboard main track slat can for outboard slat number 12 on a Model 777 airplane. The hole was caused when the bolt securing the downstop migrated out of the fitting and contacted the slat can. We are issuing this AD to detect and correct damage to the outboard slat main track slat cans, which can allow fuel leakage into the fixed wing leading edge in excess of the capacity of the draining system. Excess fuel leakage could result in an uncontained fire.
This AD is effective August 17, 2010.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in the AD as of August 17, 2010.
For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H–65, Seattle, Washington 98124–2207; telephone 206–544–5000, extension 1; fax 206–766–5680; e-mail me.boecom@boeing.com; Internet
You may examine the AD docket on the Internet at
Duong Tran, Aerospace Engineer, Airframe Branch, ANM–120S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue SW., Renton, Washington 98057–3356; telephone (425) 917–6452; fax (425) 917–6590.
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an airworthiness directive (AD) that would apply to certain Model 777 airplanes. That NPRM was published in the
We have reviewed Boeing Service Bulletin 777–57A0064, Revision 1, dated May 6, 2010. The NPRM referred to Boeing Alert Service Bulletin 777–57A0064, dated March 26, 2009, as the appropriate source of service information. Boeing Service Bulletin 777–57A0064, Revision 1, dated May 6, 2010, clarifies procedures, deletes a requirement, adds a note to allow a different fastener, revises an incorrect chamfer callout, and adds information that was published in Boeing Information Notice 777–57A0064 IN 01 and 777–57A0064 IN 02. Boeing Service Bulletin 777–57A0064, Revision 1, dated May 6, 2010, does not require additional work.
We gave the public the opportunity to participate in developing this AD. We considered the comments received from the commenters.
Continental Airlines (Continental) supports the intent of the NPRM.
Boeing requests that we revise the NPRM to add a statement to paragraph (h) of the NPRM stating, “The outboard main track locations for slats 3 and 12 are excluded from the inspection defined in Table 3 of Boeing Alert Service Bulletin 777–57A0064, dated March 26, 2009.” Boeing states that, for Group 1 airplanes, the slat tracks do not penetrate into the wing fuel tank at these locations. Boeing also states that, for all Group 2 airplanes, this inspection is accomplished via Table 4 of Boeing Alert Service Bulletin 777–57A0064, dated March 26, 2009. Boeing Alert Service Bulletin 777–57A0064, dated March 26, 2009, states that for only Group 2 airplanes the outboard main track locations at slats 3 and 12 must be inspected. Boeing notes that it plans to issue a new revision to this service bulletin in June 2010 that contains this information.
We disagree with the commenter that such a revision is necessary. We have updated this final rule to refer to Boeing Service Bulletin 777–57A0064, Revision 1, dated May 6, 2010. Boeing Service Bulletin 777–57A0064, Revision 1, dated May 6, 2010, has corrected this information. We have added Boeing Service Bulletin 777–57A0064, Revision 1, dated May 6, 2010, as the appropriate source of service information for the actions required by this AD, including paragraph (g)(2) of this AD (in paragraph (g)(2) of the NPRM we referred to the original issue of the service bulletin for the compliance times but did not specifically reference the service bulletin as the applicable source of service information for doing the actions). We have also added paragraph (j) to this final rule to provide credit for actions done in accordance with Boeing Alert Service Bulletin 777–57A0064, dated March 26, 2009.
Boeing further requests that we revise paragraph (h) of the NPRM to state, “For airplanes defined as Group 2 in Boeing Alert Service Bulletin 777–57A0064, dated March 26, 2009, it is not necessary to perform the torque check on the downstop hardware for slats 3 and 12 as defined in Table 2 of Boeing Alert Service Bulletin 777–57A0064, dated March 26, 2009.” Boeing states that at locations where a fastener is to be replaced by subsequent instructions in Boeing Alert Service Bulletin 777–57A0064, dated March 26, 2009, a torque check is redundant and is not a technical requirement. Boeing states that the visual inspections are still in place to guarantee that damage caused by a loose fastener will be caught. Boeing also adds that Boeing Alert Service Bulletin 777–57A0064, dated March 26, 2009, specifies compliance times for the fastener replacement that are less than those for the torque check. Boeing notes that it plans to issue a new revision to this service bulletin in June 2010 that contains this information.
We agree with the commenter that such a revision is necessary. We have updated this final rule to refer to Boeing Service Bulletin 777–57A0064, Revision 1, dated May 6, 2010. However, we have added a new paragraph (i) to this final rule to clarify that this measurement is not necessary on slats 3 and 12. We have added Boeing Service Bulletin 777–57A0064, Revision 1, dated May 6, 2010, as the primary source of service information for accomplishing the actions required by this AD.
Continental requests that we revise the compliance time for the inspection from 6 months to 12 months after the effective date of the AD. Continental states that the current 6-month compliance time will not provide a practical period in which to complete the full inspection for its Model 777 fleet based on their maintenance schedule. Continental states that a 12-month threshold would not compromise the safety of the airplane because there are existing zonal inspection requirements in the referenced Maintenance Planning Document/Maintenance Review Board (MPD/MRB) tasks, discrepancies in the area of interest could be detected through the required routine inspections. Continental states that with a frequency of every 1,125 days from delivery, most affected airplanes should have had at least one inspection performed in accordance with the MPD/MRB tasks.
We disagree. Due to the urgent nature of a potential excessive fuel leakage, we do not find it appropriate to revise the inspection threshold. Furthermore, the MPD/MRB zonal inspection requirements are not intense enough to detect certain unobvious discrepancies (
EVA Airlines requests that we incorporate the information from Boeing Information Notice 777–57A0064 IN 01, dated May 28, 2009, which states that the chamfer for the −2 stop fitting in view B–B of Appendix A of Boeing Alert Service Bulletin 777–57A0064, dated March 26, 2009, should be “0.820−0.850 × 90 Degrees−120 Degrees” instead of “0.820−0.050 × 90 Degrees−120 Degrees.”
We agree that this information should be incorporated into the AD. Boeing Service Bulletin 777–57A0064, Revision 1, dated May 6, 2010, corrects this information. As stated previously, we have changed this AD to refer to Boeing Service Bulletin 777–57A0064, Revision 1, dated May 6, 2010, as the primary source of service information for accomplishing the actions required by this AD.
We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We also determined that these changes will not increase the economic burden on any operator or increase the scope of the AD.
Since issuance of the NPRM, we have increased the labor rate used in the Costs of Compliance from $80 per work-hour to $85 per work-hour. The Costs of Compliance information, below, reflects this increase in the specified hourly labor rate.
We estimate that this AD would affect 129 airplanes of U.S. registry. The following table provides the estimated costs for U.S. operators to comply with this AD.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979), and
(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
You can find our regulatory evaluation and the estimated costs of compliance in the AD Docket.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
49 U.S.C. 106(g), 40113, 44701.
(a) This airworthiness directive (AD) is effective August 17, 2010.
(b) None.
(c) This AD applies to The Boeing Company Model 777–200, -200LR, -300, and -300ER airplanes, certificated in any category; as identified in Boeing Service Bulletin 777–57A0064, Revision 1, dated May 6, 2010.
(d) Air Transport Association (ATA) of America Code 57: Wings.
(e) This AD results from a report of a hole in the inboard main track slat can for outboard slat number 12 on a Model 777 airplane. The Federal Aviation Administration is issuing this AD to detect and correct damage to the outboard slat main track slat cans, which can allow fuel leakage into the fixed wing leading edge in excess of the capacity of the draining system. Excess fuel leakage could result in an uncontained fire.
(f) You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done.
(g) At the applicable time specified in paragraph 1.E., “Compliance,” of Boeing Service Bulletin 777–57A0064, Revision 1, dated May 6, 2010, except as required by paragraph (h) of this AD: Do the applicable actions specified in paragraphs (g)(1) and (g)(2) of this AD.
(1) For all airplanes: Do a detailed inspection of the slat main track stop hardware to determine if the bolt, nut, or stops are missing and to determine if the thread protrusion of the bolt from the nut is within specified limits, and do all applicable
(2) For airplanes identified as Group 2 airplanes in Boeing Service Bulletin 777–57A0064, Revision 1, dated May 6, 2010: Do a detailed inspection of the slat cans at the outboard slat number 3 and 12 outboard main track locations for holes and wear damage and do all applicable corrective actions, and replace the downstop hardware for the outboard slats number 3 and 12 outboard and inboard main track locations, in accordance with the Accomplishment Instructions of Boeing Service Bulletin 777–57A0064, Revision 1, dated May 6, 2010. Do all applicable corrective actions at the applicable time specified in paragraph 1.E., “Compliance,” of Boeing Service Bulletin 777–57A0064, Revision 1, dated May 6, 2010.
(h) Where Boeing Service Bulletin 777–57A0064, Revision 1, dated May 6, 2010, specifies a compliance time after the date on the service bulletin, this AD requires compliance within the specified compliance time after the effective date of this AD.
(i) Where Boeing Service Bulletin 777–57A0064, Revision 1, dated May 6, 2010, specifies measuring torque of the nuts of the slat main track stop hardware of slats 3 and 12, this AD does not require that action for Group 2 airplanes.
(j) Actions accomplished before the effective date of this AD according to Boeing Alert Service Bulletin 777–57A0064, dated March 26, 2009, are considered acceptable for compliance with the corresponding actions specified in this AD.
(k)(1) The Manager, Seattle Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Duong Tran, Aerospace Engineer, Airframe Branch, ANM–120S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue, SW., Renton, Washington 98057–3356; telephone (425) 917–6452; fax (425) 917–6590. Or, e-mail information to
(2) To request a different method of compliance or a different compliance time for this AD, follow the procedures in 14 CFR 39.19. Before using any approved AMOC on any airplane to which the AMOC applies, notify your principal maintenance inspector (PMI) or principal avionics inspector (PAI), as appropriate, or lacking a principal inspector, your local Flight Standards District Office. The AMOC approval letter must specifically reference this AD.
(3) An AMOC that provides an acceptable level of safety may be used for any repair required by this AD, if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Seattle ACO, to make those findings. For a repair method to be approved, the repair must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
(l) You must use Boeing Service Bulletin 777–57A0064, Revision 1, dated May 6, 2010, to do the actions required by this AD, unless the AD specifies otherwise.
(1) The Director of the Federal Register approved the incorporation by reference of this service information under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H–65, Seattle, Washington 98124–2207; telephone 206–544–5000, extension 1; fax 206–766–5680; e-mail
(3) You may review copies of the service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington. For information on the availability of this material at the FAA, call 425–227–1221.
(4) You may also review copies of the service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to:
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
We are adopting a new airworthiness directive (AD) for the products listed above. This AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:
* * * [P]artial blockage of the water absorbing filter element P/N (part number) QA06123 was observed several times. The blockage was created by carbon debris from the cartridge and from the burst disc of the Halon bottle.
This water absorbing filter element is part of Halon Dual-Filter Assembly installed also in the Flow Metering System (FMS) of the cargo compartment Fire Extinguishing System used in the A330 and A340 aeroplanes.
Blockage of the water absorbing filter element could lead to reduction of Halon outflow, leading to incapacity to maintain fire extinguishing agent concentration. Combined with fire, this could result in an uncontrolled fire in the affected compartment, which would constitute an unsafe condition.
This AD becomes effective August 17, 2010.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of August 17, 2010.
You may examine the AD docket on the Internet at
Vladimir Ulyanov, Aerospace Engineer, International Branch, ANM–116, Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton, Washington 98057–3356; telephone (425) 227–1138; fax (425) 227–1149.
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the
During the qualification test campaign at the supplier site of the prototype Flow
This water absorbing filter element is part of Halon Dual-Filter Assembly installed also in the Flow Metering System (FMS) of the cargo compartment Fire Extinguishing System used in the A330 and A340 aeroplanes.
Blockage of the water absorbing filter element could lead to reduction of Halon outflow, leading to incapacity to maintain fire extinguishing agent concentration. Combined with fire, this could result in an uncontrolled fire in the affected compartment, which would constitute an unsafe condition.
To avoid water absorbing filter element blockage, this AD requires replacement [with improved dual-filter assemblies] or modification of the Halon dual-filter assemblies of the lower deck cargo compartment fire extinguishing system:
We gave the public the opportunity to participate in developing this AD. We considered the comments received.
Delta Air Lines (DAL) supports the intent of the NPRM.
Air Transport Association (ATA), on behalf of its member DAL, requests that we revise paragraph (f) of the NPRM to reference the most recent version of Airbus Mandatory Service Bulletin A330–26–3040 as an acceptable means of compliance.
We agree to refer to Airbus Mandatory Service Bulletin A330–26–3040, Revision 03, dated November 9, 2009. Airbus has also released Mandatory Service Bulletin A340–26–4038, Revision 03, dated November 9, 2009; and Mandatory Service Bulletin A340–26–5019, Revision 04, dated December 11, 2009. The revisions introduce minor changes and add the Halon filter part number, but do not add any additional work. We have revised this final rule accordingly.
ATA, on behalf of its member DAL, states that it will be unable to fully comply because of an inconsistency in the PALL service information. DAL requests that we revise the NPRM to mandate a specific issue of PALL Service Bulletin 6753–20–2. DAL states that specifying a specific issue level is necessary because acceptable part numbers vary in the work instruction in the different issues of this PALL service bulletin.
We disagree. Airbus has issued new service information, which specifies the specific part number, Halon filter having part number QA06753–03VSB or QA06753–03. The Airbus service information specified in Table 1 of this AD refers to PALL Service Bulletin 6753–20–2 only as an additional source of guidance for modifying the Halon dual-filter assembly. We have revised this final rule to include the latest version of the applicable Airbus service information and to provide credit for work done in accordance with previous revisions of the service information.
ATA, on behalf of its member DAL, requests that we postpone releasing the final rule until PALL revises its service information. DAL states that the paragraph 2.D of PALL Service Bulletin 6753–20–2 specifies when performing the modification in situ to continue to step 7 after accomplishing an airplane leak check. DAL states that PALL Service Bulletin 6753–20–2 specifies to proceed to step 4 if not performing the modification in situ. However, DAL notes that steps 2.D.7 and 2.D.8 state to remove tooling from the filter assembly, which is installed in step 5. DAL notes that if the modification is being performed in situ, then step 5 is not accomplished, and therefore, steps 7 and 8 cannot be accomplished.
We do not agree to wait to issue the final rule until PALL releases a revised service bulletin. However, we agree that clarification may be necessary. We have coordinated with Airbus, and it has confirmed that PALL Service Bulletin 6753–20–2, Issue 4, dated November 21, 2009, contains a discrepancy in a note. Airbus states that when performing the work `on-wing,' operators using PALL Service Bulletin 6753–20–2, Issue 4, dated November 21, 2009, for guidance should go to step 9, not step 7. We have not changed the AD in regard to this issue.
We reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We determined that these changes will not increase the economic burden on any operator or increase the scope of the AD.
We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.
We might also have required different actions in this AD from those in the MCAI in order to follow our FAA policies. Any such differences are highlighted in a
Since issuance of the NPRM, we have increased the labor rate used in the Costs of Compliance from $80 per work-hour to $85 per work-hour. The Costs of Compliance information, below, reflects this increase in the specified hourly labor rate.
We estimate that this AD will affect 32 products of U.S. registry. We also estimate that it will take about 13 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $708 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these parts. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $58,016, or $1,813 per product.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this AD:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and
3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.
You may examine the AD docket on the Internet at
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
49 U.S.C. 106(g), 40113, 44701.
(a) This airworthiness directive (AD) becomes effective August 17, 2010.
(b) None.
(c) This AD applies to airplanes certificated in any category, identified in paragraphs (c)(1), (c)(2), and (c)(3) of this AD.
(1) Airbus Model A330–201, –202, –203, –223, –243, –301, –302, –303, –321, –322, –323, –341, –342 and –343 airplanes, all serial numbers, except those on which Airbus modification 55590 has been embodied in production.
(2) Airbus Model A340–211, –212, –213, –311, –312, –313, –541, and –642 airplanes, all serial numbers fitted with lower deck cargo compartment (LDCC), except those on which Airbus modification 55590 has been embodied in production.
(3) Airbus Model A340–311, –312, –313, –541, and –642 airplanes, all serial numbers fitted with bulk cargo rest compartment (BCRC), except those on which Airbus modification 56047 has been embodied in production.
The BCRC is embodied in production on Model A340–300, A340–500, and A340–600 airplanes through the following Airbus modification (including but not limited to): 47198, 47884, 48895, 48710, 49136, 50107, 50900, 50901, or 51320.
The fire extinguishing system for the BCRC is embodied in production on Model A340–500 and A340–600 airplanes through Mod 47197 (partial BCRC); on Model A340–500 and A340–600 airplanes through Mod 47883 (full BCRC); and on Model A340–300 airplanes through Mod 50108 (partial BCRC).
(d) Air Transport Association (ATA) of America Code 26: Fire protection.
(e) The mandatory continuing airworthiness information (MCAI) states:
During the qualification test campaign at the supplier site of the prototype Flow Metering Compact Unit (FMCU) Part Number (P/N) QA07907–03, partial blockage of the water absorbing filter element P/N QA06123 was observed several times. The blockage was created by carbon debris from the cartridge and from the burst disc of the Halon bottle.
This water absorbing filter element is part of Halon Dual-Filter Assembly installed also in the Flow Metering System (FMS) of the cargo compartment Fire Extinguishing System used in the A330 and A340 aeroplanes.
Blockage of the water absorbing filter element could lead to reduction of Halon outflow, leading to incapacity to maintain fire extinguishing agent concentration. Combined with fire, this could result in an uncontrolled fire in the affected compartment, which would constitute an unsafe condition.
To avoid water absorbing filter element blockage, this AD requires replacement [with improved dual-filter assemblies] or modification of the Halon dual-filter assemblies of the lower deck cargo compartment fire extinguishing system:
(f) Unless already done, do the following actions.
(1) Replace or modify the Halon dual-filter assemblies of the flow metering fire extinguishing system in the forward and bulk cargo compartments, as applicable, in accordance with the Accomplishment Instructions of the applicable service bulletin identified in Table 1 of this AD, at the applicable time specified in paragraphs (f)(1)(i), (f)(1)(ii), and (f)(1)(iii) of this AD.
(i) For airplanes fitted with Halon dual-filter assemblies part number (P/N) QA06753: Within 18 months after the effective date of this AD.
(ii) For Model A340–642 series airplanes, weight variant 101, 102, and 103 fitted with Halon dual-filter assembly P/N QA06753–01 or P/N QA06753–02: Within 18 months after the effective date of this AD.
(iii) For airplanes other than those identified in paragraph (f)(1)(ii) of this AD and fitted with Halon dual-filter assembly P/N QA06753–01 or P/N QA06753–02: Within 24 months after the effective date of this AD.
The Halon dual-filter assembly P/N QA06753 is embodied in production through Airbus modification 40041. The Halon dual-filter assembly P/N QA06753–01 is only embodied in service through Airbus Service Bulletin A330–26–3030 or Airbus Service Bulletin A340–26–4038. The Halon dual-filter assembly P/N QA06753–02 is embodied in production through modification 47197 or 47883 or 50108 (BCRC) and 51065 or 51329 (LDCC) or in service through Airbus Service Bulletin A330–26–3030 or Airbus Service Bulletin A340–26–4038.
(2) Actions accomplished before the effective date of this AD according to the service bulletins listed in Table 2 of this AD are considered acceptable for compliance with the corresponding actions specified in this AD.
This AD differs from the MCAI and/or service information as follows:
(1) The second paragraph of the applicability of the MCAI specifies certain models except those on which Modification 55590 has been done. Paragraph (c)(2) of this AD specifies those models fitted with lower deck cargo compartment (LDCC), except those on which Modification 55590 has been done.
(2) Although the MCAI tells you to submit information to the manufacturer, this AD does not require such a submittal.
(g) The following provisions also apply to this AD:
(1)
(2)
(h) Refer to MCAI European Aviation Safety Agency Airworthiness Directive 2009–0064, dated March 12, 2009, and the service information identified in Table 3 of this AD, for related information.
(i) You must use the service information contained in Table 4 of this AD to do the actions required by this AD, unless the AD specifies otherwise.
(1) The Director of the Federal Register approved the incorporation by reference of this service information under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) For service information identified in this AD, contact Airbus SAS—Airworthiness
(3) You may review copies of the service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington. For information on the availability of this material at the FAA, call 425–227–1221.
(4) You may also review copies of the service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to:
Federal Aviation Administration (FAA), DOT.
Final rule.
We are adopting a new airworthiness directive (AD) for certain Model 747–100, 747–100B, 747–100B SUD, 747–200B, 747–200C, 747–200F, 747–300, 747–400, 747SR, and 747SP series airplanes. This AD requires repetitive detailed inspections of certain overwing intercostal webs, and related investigative and corrective actions if necessary. This AD results from reports of cracks in overwing intercostal webs. We are issuing this AD to detect and correct such cracking, which could grow and result in a severed intercostal. If an intercostal is severed, cracks could develop in the adjacent frame structure and skin, resulting in a rapid loss of cabin pressure.
This AD is effective August 17, 2010.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in the AD as of August 17, 2010.
For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H–65, Seattle, Washington 98124–2207; telephone 206–544–5000, extension 1; fax 206–766–5680; e-mail
You may examine the AD docket on the Internet at
Ivan Li, Aerospace Engineer, Airframe Branch, ANM–120S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue, SW., Renton, Washington 98057–3356; telephone (425) 917–6437; fax (425) 917–6590.
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an airworthiness directive (AD) that would apply to certain Model 747–100, 747–100B, 747–100B SUD, 747–200B, 747–200C, 747–200F, 747–300, 747–400, 747SR, and 747SP series airplanes. That NPRM was published in the
We gave the public the opportunity to participate in developing this AD. We considered the comment received. Boeing supports the NPRM.
We reviewed the relevant data, considered the comment received, and determined that air safety and the public interest require adopting the AD as proposed.
We estimate that this AD affects 86 airplanes of U.S. registry. The following table provides the estimated costs for U.S. operators to comply with this AD.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and
For the reasons discussed above, I certify that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979), and
(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
You can find our regulatory evaluation and the estimated costs of compliance in the AD Docket.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
49 U.S.C. 106(g), 40113, 44701.
(a) This airworthiness directive (AD) is effective August 17, 2010.
(b) None.
(c) This AD applies to The Boeing Company Model 747–100, 747–100B, 747–100B SUD, 747–200B, 747–200C, 747–200F, 747–300, 747–400, 747SR, and 747SP series airplanes, certificated in any category; as identified in Boeing Alert Service Bulletin 747–53A2750, dated August 27, 2009.
(d) Air Transport Association (ATA) of America Code 53: Fuselage.
(e) This AD results from reports of cracks in overwing intercostal webs between station (STA) 1160 and STA 1220. The Federal Aviation Administration is issuing this AD to detect and correct such cracking, which could grow and result in a severed intercostal. If an intercostal is severed, cracks could develop in the adjacent frame structure and skin, resulting in a rapid loss of cabin pressure.
(f) You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done.
(g) Before the accumulation of 8,000 total flight cycles, or within 1,500 flight cycles after the effective date of this AD, whichever occurs later: Do a detailed inspection of the left-side and right-side STAs 1160, 1180, 1200, and 1220 overwing intercostal webs, and do all applicable related investigative and corrective actions, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 747–53A2750, dated August 27, 2009, except as required by paragraph (i) of this AD. Do all applicable related investigative and corrective actions before further flight. If no cracking is found during any detailed inspection, repeat the inspection thereafter at intervals not to exceed 3,000 flight cycles.
(h) For any airplane with an overwing intercostal web replaced in accordance with Boeing Alert Service Bulletin 747–53A2750, dated August 27, 2009: Within 6,000 flight cycles after the web was replaced, do a detailed inspection of the replacement overwing intercostal web, and do all applicable related investigative and corrective actions, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 747–53A2750, dated August 27, 2009, except as required by paragraph (i) of this AD. Do all applicable related investigative and corrective actions before further flight. If no cracking is found during any detailed inspection, repeat the inspection thereafter at intervals not to exceed 3,000 flight cycles.
(i) If any cracking is found during any inspection required by this AD, and Boeing Alert Service Bulletin 747–53A2750, dated August 27, 2009, specifies contacting Boeing for appropriate action: Before further flight, repair the cracking using a method approved in accordance with the procedures provided in paragraph (j) of this AD.
(j)(1) The Manager, Seattle Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to
(2) To request a different method of compliance or a different compliance time for this AD, follow the procedures in 14 CFR 39.19. Before using any approved AMOC on any airplane to which the AMOC applies, notify your principal maintenance inspector (PMI) or principal avionics inspector (PAI), as appropriate, or lacking a principal inspector, your local Flight Standards District Office. The AMOC approval letter must specifically reference this AD.
(3) An AMOC that provides an acceptable level of safety may be used for any repair required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization that has been authorized by the Manager, Seattle ACO, to make those findings. For a repair method to be approved, the repair must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
(k) You must use Boeing Alert Service Bulletin 747–53A2750, dated August 27, 2009, to do the actions required by this AD, unless the AD specifies otherwise.
(1) The Director of the Federal Register approved the incorporation by reference of this service information under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H–65, Seattle, Washington 98124–2207; telephone 206–544–5000, extension 1; fax 206–766–5680; e-mail
(3) You may review copies of the service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington. For information on the availability of this material at the FAA, call 425–227–1221.
(4) You may also review copies of the service information that is incorporated
Federal Highway Administration (FHWA), DOT.
Final rule.
This final rule amends the Federal regulations on the Procedures for Abatement of Highway Traffic Noise and Construction Noise. The final rule clarifies and adds definitions, the applicability of this regulation, certain analysis requirements, and the use of Federal funds for noise abatement measures.
Mr. Mark Ferroni, Office of Natural and Human Environment, (202) 366–3233, or Mr. Robert Black, Office of the Chief Counsel, (202) 366–1359, Federal Highway Administration, 1200 New Jersey Avenue, SE., Washington, DC 20590.
This document and all comments received by the DOT Docket Facility, Room PL–401, may be viewed through
An electronic copy of this document may be downloaded by using a computer, modem, and suitable communications software from the Government Printing Office's Electronic Bulletin Board Service at (202) 512–1661. Internet users may also reach the Office of the Federal Register's home page at:
The FHWA developed the noise regulation as required by section 136 of the Federal-Aid Highway Act of 1970 (codified at 23 U.S.C. 109(i)). The regulation applies to highway construction projects where a State department of transportation has requested Federal funding for participation in the project. The FHWA noise regulation, found at 23 CFR 772, requires a highway agency to investigate traffic noise impacts in areas adjacent to federally funded highways for the proposed construction of a highway on a new location or the reconstruction of an existing highway that either significantly changes the horizontal or vertical alignment or increases the number of through-traffic lanes. If the highway agency identifies impacts, it must consider abatement. The highway agency must incorporate all feasible and reasonable noise abatement into the project design.
The FHWA published the “Highway Traffic Noise Analysis and Abatement Policy and Guidance” (Policy and Guidance), dated June 1995 (available at
As a result, the FHWA published a Notice of Proposed Rulemaking (NPRM) on September 17, 2009 (74 FR 47762). This final rule amends sections 772.1, 772.5 to 772.17, and Table 1—Noise Abatement Criteria. Sections 772.3 and 772.19 are not amended by this final rule, and Appendix A—National Reference Energy Mean Emission Levels as a Function of Speed, is removed by this final rule. This final rule also reorganizes various sections and parts of sections throughout the NPRM to institute a more logical order in the regulation. This reorganization does not change the meaning of the regulation and is not substantive in nature.
In the preamble of the NPRM, the FHWA specifically asked for comments on the cost of abatement, third party funding for abatement, and maintaining a noise abatement inventory. The FHWA appreciates the comments received on this section. A summary of the comments received and the FHWA's response to these comments can be found in the discussion of comments section.
The preamble of the NPRM requested comments on a proposed timeline for highway agencies to revise and have the FHWA approve their noise policies. Changes to this timeline have been made based on the comments received. Therefore, highway agencies will need to submit their revised noise policy, meeting the requirements of this final rule, to FHWA for approval within 6 months from the publication date of this final rule. The FHWA will review the highway agency's revised noise policy for conformance to the final rule and uniform and consistent application nationwide. The highway agency will provide FHWA a review schedule for approval of their revised noise policy that does not exceed 3 months from the highway agency's first submission of the revised noise policy to the FHWA. Each review of the document by FHWA should have a duration of at least 14 days for the initial and subsequent reviews. The highway agency's main point of contact for this review will be the FHWA Division Office in their State. Each highway agency's revised noise document will be concurrently reviewed by three FHWA offices to ensure uniform and consistent application of this final rule nationwide (one from the respective Division Office, one from the Resource Center, and one from Headquarters). Failure to submit a revised noise policy in accordance with the final rule could result in a delay in FHWA's approval of Federal-aid highway projects that require a noise analysis. The highway agency would be required to implement the new standard no later than 12 months from the date this final rule was published in the
Grandfathering to the pre-final rule of 23 CFR 772 should be considered for Federal-aid highway projects for which the Categorical Exclusion, Finding of No Significant Impact, or Record of Decision has been signed by the effective date of this final rule. The State highway agency should coordinate with their FHWA Division Office to determine which projects, if any, should be completed under the previous 23 CFR 772 and highway agency's previously approved noise policy.
The FHWA has updated the Policy and Guidance document to reflect what is presented in this final rule. Highway
The agency received comments from 25 State highway agencies (California, Florida, Georgia, Illinois, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, and Wisconsin), 1 county highway agency (Anoka County Highway Department, Minnesota), 1 national organization (American Association of State Highway and Transportation Officials (AASHTO)), 7 noise consultants or consulting firms (Bergmann Associates, Inc., Bowlby & Associates, Environmental Acoustics, Inc., Environmental Science Associates, HNTB Corporation, Karel Cubic and Sharon Paul Carpenter), 1 university (East Carolina University), and 1 private citizen (Jennifer Leigh Hanson).
There were several comments received that were general in nature. Three State highway agencies and one private consultant expressed that they generally agreed with the NPRM. One private consultant commented that the numbering of the regulation should not skip the even numbers. The FHWA will retain the numbering sequence that the regulation currently has. One private consultant commented on the parentheses used on the “A” of dB(A). It is FHWA's position that since the metric used to assess highway traffic noise levels is the A-weighted decibel, that decibel be illustrated by “dB” and the parentheses are needed around the “A” to illustrate the A-weighting. The parentheses are commonly used by the highway noise industry and will be retained in the final rule. Two State highway agencies and a university commented that quiet pavements should be allowed as a federally funded noise abatement measure. While the FHWA recognizes the efforts of many State highway agencies and the pavement industries, there are still too many unknowns that currently prohibit the use of pavement as a noise abatement measure. One national organization commented that while they recognize the importance of uniform and consistent application of this regulation nationwide, they encourage the FHWA to incorporate flexibility to accommodate regional and State-specific needs. The FHWA has incorporated flexibility while setting specific parameters throughout this final rule. There are numerous situations in the final rule where the State highway agency is permitted to completely define a definition or process, or define a definition or process within the parameters set by the FHWA.
Based on comments received, the FHWA has changed the order and titles of several of the sections. The current section 772.17 “Traffic Noise Predication” is now section 772.9, with the same title. The current section 772.9 “Analysis of traffic noise impacts and abatement measures” is now section 772.11, with the title “Analysis of traffic noise impacts.” The “and abatement measures” of this title has been removed as it is redundant with the noise abatement section. The current section 772.11 “Noise abatement” is now section 772.13, with the new title of “Analysis of noise abatement,” which keeps consistent with the previous section dealing with the analysis of traffic noise impacts. The current section 772.13 “Federal participation” is now section 772.15 with the same title. The current section 772.15 “Information for local officials” is now section 772.17 with the same title.
In section 772.1, the FHWA is adding the word “livability” to this section, not based on comments received, but to incorporate the DOT Secretary's livability initiative.
In section 772.3, no changes have been made to this section based on comments received; however, one State highway agency commented on the difference between the use of the words “accordance” and “conformance.” The FHWA did not use these two terms to show a difference in meaning, but rather to illustrate agreement between both the regulation and the noise standard.
In section 772.5, three State highway agencies and one private consultant commented that the definitions should be placed in alphabetical order. The FHWA agrees and the definitions are now listed and discussed in this final rule in alphabetical order. Also, one State highway agency suggested adding a definition for substantial noise reduction. The FHWA disagrees with the addition of “substantial noise reduction” since this principle is adequately addressed in the other sections of the final rule.
Benefited Receptor, 10 State highway agencies, 1 national organization, and 5 private consultants commented on the definition of benefited receptor. Eleven commenters generally support the definition with minor or no revisions, with two comments desiring additional flexibility in defining and applying benefited receptors. Three comments concerned the issues of benefited receptors that are impacted and benefited receptors that are not impacted, and two comments were concerned with a discernable 5 dB(A) change in noise versus a perceptible 3 dB(A) change in noise.
The FHWA has changed the definition to indicate that a benefited receptor is a “recipient of an abatement measure that receives a noise reduction at or above the minimum threshold of 5 dB(A), but not to exceed the highway agency's reasonableness design goal.” The definition retains the 5 dB(A) minimum threshold, but provides flexibility to State highway agencies by allowing the agency to define a benefited receptor as one benefitting from a reduction in noise level that is between 5 dB(A) and the agency's design goal. These changes ensure construction of effective noise abatement measures. Generally, a 5 dB(A) change in noise levels is deemed discernible by a person with normal hearing. Noise abatement activities should result in a discernible 5 dB(A) change in noise level rather than a perceptible 3 dB(A) change in noise level. This approach provides a consistent approach throughout this final rule. State highway agencies will still be able to differentiate between benefiting impacted and non-impacted receivers within their own policies. States may continue weighting impacted receptors greater than non-impacted receptors when making decisions about reasonableness of noise abatement.
Common Noise Environment, seven State highway agencies, one national organization, and three private consultants commented on the definition of common noise environment. The definition was generally supported with minor changes or clarifications requested. Two commenters disagreed with the definition. Based on a comment from the New York DOT, the FHWA has added “within the same Activity Category in Table 1” to the definition,
Date of Public Knowledge, one State highway agency, one national organization, and one private consultant agreed and supported the addition of this definition. No changes were made based on comments received, however, “CE” and “ROD” were spelled out and “as defined in 23 CFR 771” was added to provide additional clarification.
Noise Reduction Design Goal, based on comments received, the FHWA is defining “noise reduction design goal” to be “[t]he optimum desired dB(A) noise reduction determined from calculating the difference between future build noise levels with abatement, to future build noise levels without abatement. The noise reduction design goal shall be at least 7 dB(A), but not more than 10 dB(A).” The FHWA is defining “Noise Reduction Design Goal” to remove the disconnect that occurs with a 5 dB(A) substantial decrease criterion and substantial increase criteria's 5–15 dB(A) range.
Design Year, two State highway agencies, one national organization, and a private consultant commented in support of the definition of design year. The FHWA made no changes to this definition in the final rule.
Existing Noise Levels, two State highway agencies, one national organization, and one private consultant commented on the definition of existing noise levels. Most comments expressed support of the definition with minor clarifications. One State highway agency sought additional clarification on what are, and how to address, non-highway traffic noise sources. It is FHWA's position that an effective noise analysis should consider major noise sources in the environment including transportation, industry, and background noise.
Feasibility, two State highway agencies, one national organization, and two private consultants commented on the definition of feasibility. The definition was generally supported with minor revisions. Based on the comments, the FHWA added “considered in the evaluation of” to the definition to clarify that the combination of acoustical and engineering factions shall be examined when considering noise abatement measures. Other comments dealt with how to apply feasibility and therefore are better suited to in sec. 772.13 where feasible noise abatement is further addressed.
Impacted Receptor, four State highway agencies, one national organization, and two private consultants submitted comments generally supportive of the definition of impacted receptor, with minor revisions regarding redundancy, and allowing State highway agencies to define. The FHWA made several changes to this definition. The definition was simplified by removing the text that made it redundant with the definition of traffic noise impacts.
L10, four State highway agencies, one national organization, and two private consultants commented on this definition. Many of the comments recommended the definition be deleted because the metric is obsolete. Although currently the L10 metric is not the most applicable metric to use on highway projects, the L10 and Leq metrics were a part of this regulation from its genesis. As a result, the State of Minnesota has a law requiring the use of L10, and therefore this metric will remain in the final rule with no changes.
Multifamily Dwelling, six State highway agencies, a national organization, and two private consultants generally support the definition of multifamily dwellings with some minor revisions including, allowing the highway agency to define the term, and a request for addition flexibility and additional guidance from the FHWA. Massachusetts DOT disagreed with the definition, indicating that, as proposed, the definition of multifamily structures would skew the cost reasonableness calculations. It is FHWA's position that the purpose of any environmental analysis is to quantify impacts first, and explore methods to mitigate those impacts. The approach of only looking at first floor receptors ignores the possibility that impacts may occur at upper floor residences. The analysis to determine impacts shall be for all outdoor areas of frequent human use, both on the ground and on balconies (if present). This does not automatically result in feasible and reasonable noise abatement measures being determined for upper lever receptors. When a multifamily dwelling has a common exterior area of frequent human use, each unit of the multifamily dwelling that has access to that common exterior shall be included in the feasible and reasonable analysis. Multifamily development does not “skew” the determination of feasible and reasonable noise abatement measures. Providing noise abatement for multifamily development results in noise abatement for a higher number of people who may be using individual or common exterior areas. Frequency of use is not based on a comparison between how a single family dwelling would use their outdoor area versus how a multifamily dwelling would use their outdoor area. This process allows all receptors to be analyzed for noise impacts, and allows all impacted receptors to be considered for noise abatement. To add clarification, the FHWA added “when determining impacted and benefiting receptors” to the end of the second sentence.
Noise Barrier, based on comments received, the FHWA is defining “noise barrier” to be “[a] physical obstruction that is constructed between the highway noise source and the noise sensitive receptor(s) that lowers the noise environment, to include stand alone noise walls, noise berms (earth or other material), and combination berm/wall systems.” Noise barriers have been a longstanding proven noise abatement measure and therefore it is necessary to clarify that a noise barrier can be a wall, berm or a combination berm/wall system.
Permitted, three State highway agencies, one national organization, one county highway department, and one private consultant commented that there should be more of a definite commitment to develop, and therefore suggested renaming this definition “permitted” instead of “planned, designed and programmed.” There was also a comment to retain flexibility in interpreting a definite commitment. The FHWA agrees, and has changed this definition to “permitted” and removed all references to “planned, designed and programmed” from the final rule. The FHWA also added “as evidence by issuance of a building permit” to the definition.
Property Owner, three State highway agencies, one national organization, and a private consultant generally supported the definition of “property owner” with minor changes. The FHWA modifies this definition to include “holds a title,
Reasonableness, two State highway agencies, one national organization, and two private consultants commented on the definition of “reasonableness.” The definition was generally supported with minor revisions. Based on the comments of a private consultant, the FHWA added “considered in the evaluation of” to the definition to clarify that the combination of social, economic and environmental factions shall be considered when considering noise abatement measures. Other comments provided suggested adding that reasonableness is based on common sense and good judgment. It is FHWA's position that this leaves reasonableness open to personal opinion rather than using an objective approach and has not made the suggested change in the final rule.
Receptor, based on changes made from comments received, the FHWA is defining “receptor,” to be “a discrete or representative location of a noise sensitive area(s), for any of the land uses list in Table 1.”
Residence, four State highway agencies, one national organization and two private consultants commented on their general approval of this definition for “residence.” Additional comments include surveying multifamily residents and the use of a basic unit of measure. A discussion on how to survey multifamily residents is not appropriate for the definition section, but is address later in the final rule.
The NPRM had proposed to define “severe noise impact” in sec. 772.5(s). Nine State highway agencies, one county highway agency, one national organization, and five private consultants commented on the definition of severe noise impact. Based on the comments received, the FHWA has removed this definition from the final rule due to the conflict from the commenters on size and scale of the range, and since the definition would likely be misinterpreted to mean that the noise levels or noise level increases must fall within those ranges.
The NPRM had proposed to define “special land use facilities” in sec. 772.5(e). Seven State highway agencies, one national organization, and three private consultants commented on the definition of “special land use facilities.” The FHWA removed this term from the final rule based on changes to the activity categories presented in Table 1. There are now seven activity categories in order to break out various land uses into more appropriate groupings.
Statement of Likelihood, based on changes made from comments received, the FHWA is defining “statement of likelihood,” to be “a statement provided in the environmental clearance document based on the feasibility and reasonableness analysis completed at the time of environmental document is being approval.”
Substantial Construction, six State highway agencies, one county highway agency, one national organization and two private consultants comment on the definition of “substantial construction.” The definition was generally supported with recommendations. Based on the comments received, the FHWA is removing from the definition “the filing of a plat plan or an occurrence of a similar action,” and the word “original” before “highway.” The final rule will retain this definition to help State highway agencies clarify when development must occur for Type II eligibility and for potential Type I reasonableness considerations.
Substantial Noise Increase, based on comments received from eight State highway agencies and two private consultants, the FHWA is defining “substantial noise increase,” to be “One of two types of highway traffic noise impacts. For a Type I project, an increase in noise levels of 5 to 15 dB(A) in the design year over the existing noise level.”
Traffic Noise Impacts, four State highway agencies, a national organization, and two private consultants commented on the definition of traffic noise impacts, with general support of the definition. Comments pertained to the inclusion of design year and reference to future condition as well as how to address other noise sources. The FHWA has added “design year” and “design year build condition” to the final rule. It is FHWA's position that an effective noise analysis should consider major noise sources in the environment including transportation, industry, and background noise. Without a project noise levels may exist that exceed the noise abatement criteria (NAC), but there are no impacts without a project.
Type I Project, 14 State highway agencies, 1 national organization, and 6 private consultants commented on this section. The majority of the comments referenced the use of a 3 dB(A) increase in determining a significant change for a Type I project, followed by the redundancy of the first two sentences, and use of the word “significant.” The FHWA has revised this section to remove the first sentence and replace “significant” with “substantial.” The use of a 3 dB(A) increase in determining a substantial change has been removed. The factor for determining a substantial horizontal change is a halving the distance between the noise source and the closest receiver between the existing condition to the future build condition. The factor for determining a substantial vertical change is “a project that removes shielding therefore exposing the line-of-sight between the receptor and the traffic noise source exposing the receptor to additional traffic noise. This is done by either altering the vertical alignment of the highway or by altering the topography between the highway traffic noise source and the receptor.”
Twelve State highway agencies, 1 national organization, and 4 private consultant firms commented on what constitutes a Type I project for the addition of a through traffic lane or an auxiliary lane. Additional comments were provided on bus lanes, turn lanes, restriping travel lanes, weight stations, toll plazas, ride-share lots, and rest stops. Based on the comments received, the FHWA changed the definition of Type I project to now include bus lanes as through traffic lanes. The definition further clarifies that left turn lanes are not considered an auxiliary lane, and additional qualifying activities were added including “restriping existing pavement for the purpose of adding a through-traffic lane or an auxiliary lane” and “the addition of a new or substantial alteration of a weigh station, rest stop, ride-share lots and toll plaza.” Finally, the FHWA adds clarifying language to make clear that “if a project is determined to be a Type I project under this definition then the entire project area as defined in the environmental document is a Type I project.”
Five State highway agencies and one private consultant supported this section and suggested moving the addition of new interchanges or ramps to an existing facility to its own subsection. The FHWA agrees. The final rule will reflect that the “addition of new interchanges or ramps added to a quadrant to complete an existing partial interchange” will be its own section under the Type I definition.
Type II Project, one State highway agency and one private consultant commented that they were in support of this section on Type II projects. One State highway agency commented that it is not necessary for a State highway agency to develop a Type II program. The FHWA disagrees and did not change this section in the final rule. As supported in the 1995 guidance document, a Type II noise abatement program is appropriate to ensure statewide consistency.
Type III Project, nine State highway agencies and two private consultants commented on the creation of a Type III project. The majority of the comments were in support of the Type III project type, with some asking FHWA to provide examples of Type III projects and to develop a template for documenting Type III. One commenter requested clarifying that Type III projects do not need a noise analysis performed. The FHWA agrees and, as a result, added “Type III projects do not require a noise analysis” to the definition of a Type III project. Examples of Type III projects and a template for documenting Type III projects will be provided in FHWA guidance.
Two State highway agencies and a private consultant expressed support for the expansion of this section of the regulation. In sec. 772.7(a)(1), one State highway agency expressed support for the proposed change, but a private consultant requested additional clarification because item (1) requires applicability for any project requiring “FHWA approval regardless of funding sources.” Therefore, a highway agency, other than the State DOT, such as a county or local highway agency is required to comply with 23 CFR 772 when one of its projects involves a new or modified access to an Interstate highway. This is a correct interpretation of what the FHWA intended, therefore no changes to this section were made.
In sec. 772.7(a)(2), one State highway agency expressed support for this provision in the regulation. This applies to all Federal and Federal-aid highway projects authorized under Title 23, United States Code. Therefore, this regulation applies to any highway project or multimodal project that is funded with Federal-aid highway funds. A county highway agency stated that the above statement appears to contradict the statement made under the Regulatory Flexibility Act that the proposed rule would not have a significant economic impact on a substantial number of small entities. The rulemaking addresses the obligation of Federal funds to States for Federal-aid highway projects. As such, it affects only States, and States are not included in the definition of small entity set forth in 5 U.S.C. 601. Therefore, the Regulatory Flexibility Act does not apply and the FHWA certifies that the final rule would not have a significant economic impact on a substantial number of small entities. Local public agencies have never had an exemption from complying with 23 CFR 772. The proposed rule does not present a new economic impact. The proposed changes in the rule will not result in an increase in the likelihood of construction of noise abatement.
In sec. 772.7(b), no comments were received, but the FHWA has modified this section in the final rule to provide additional clarification and to tie into the proposed requirement in the NPRM that this final rule will require State highway agencies to revise their noise polices in conformance with this final rule. The section now states “For FHWA approval, the highway agency shall develop noise policies in conformance with this regulation and shall apply these policies uniformly and consistently statewide.”
Section 772.7(d) was proposed in the NPRM as sec. 772.7(c)(1), and is now listed as sec. 772.7(d). Two State highway agencies commented on this section. While one expressed support, the other State highway agency requested clarification on the intent of the section regarding use of State-only funds to avoid noise abatement. It is FHWA's position that the rule applies to any Federal or Federal-aid project. This means that the regulation applies to any project that includes a Federal action. No changes were made to this section.
Section 772.7(e) was proposed in the NPRM as sec. 772.7(c)(2) and is now listed as sec. 772.7(e). A national organization, eight State highway agencies, and three private consultants commented on this section. Some comments offered support for this clarification of Type II program requirements, while others questioned the need for a priority system and the status of States that already have a system in place. A private consultant recommended insertion of language that the ranking system serves as a guide, but not a requirement for selection for funding. A State highway agency requested a template for a priority system. The FHWA disagrees with the need to incorporate the ranking of potential Type II project as language in the final rule. State highway agencies will submit their existing ranking system to FHWA for approval when they submit their updated noise policies. The concept of a priority system is not new. This is a longstanding practice on the part of States with active Type II programs. The priority system restricts construction of “political” noise barriers under the guise of a Type II program when a State does not actually have a Type II program in place and has no intent of developing a Type II program. The priority system ensures uniform and consistent application of this provision of the rule. The following was added to this section “The highway agency shall re-analyze the priority system on a regular interval, not to exceed 5 years.” A private consultant recommended adding a new section (3) to include “If a highway agency chooses to participate in a Type II program, the highway agency must have a statewide outreach program to inform local officials and the public of the items in § 772.15(a)(i)–(iv).” If States choose to participate in a Type II program, they should also act to encourage local communities to enact noise compatible land use planning to limit the expenditure of Federal highway dollars to construct Type II noise barriers in the future. The FHWA agrees with the concept, but not with the application of this idea. The circumstances that lead to a Type II project occurred in the past. State highway agencies should take the opportunity of a Type II project to inform local officials about noise compatible planning concepts to avoid future Type I projects. The development of this outreach effort should be a part of any Type II program.
Section 772.7(f), was proposed in the NPRM as sec. 772.7(c)(3) and is now listed as 772.7(f). A State highway agency and a private consultant requested a listing of the types of projects classified as Type III. The FHWA believes the rule clearly states that Type III projects are any project that falls outside the definition of a Type I or Type II project. The FHWA noise guidance provides additional information on this topic. A private consultant suggested adding language that NEPA may require noise analysis on Type III projects. A State highway agency recommended changing “not required” to “optional.” The FHWA declines to make these changes in the final rule. The proposed and final language does not prohibit States from performing a noise analysis on Type III projects if they determine an analysis is necessary due to unusual characteristics of a particular project. Two State highway agencies commented on this section. One recommended elimination of Type III as a descriptor and the other expressed approval of the new designation. The FHWA retains the Type III project designation with no changes.
Section 772.9, traffic noise prediction, is sec. 772.17 in the existing regulation. Moving the traffic noise prediction section from 772.17 to 772.9 was done to place the activities associated with traffic noise prediction in chronological order with the overall procedures for
In sec. 772.9(a), one State highway agency and a private consultant commented that FHWA should continue to require use of the Traffic Noise Model (TNM) and remove reference to other models that may be compatible with TNM until alternate models are tested and approved for use through a change in the regulation. These entities further commented that FHWA should limit use of TNM to the most recent version. It is FHWA's position that the provision in the regulation to use other models determined compatible with TNM must appear in the regulation so that FHWA may work with other software developers in their efforts to implement the TNM acoustic code if their noise models for testing and approval. Therefore, “or any other model determined to by the FHWA to be consistent with the methodology of the FHWA TNM” will remain in the final rule. Lastly, the FHWA will update this regulation as necessary to require use of updated versions of the TNM.
Ten State highway agencies, a national organization, and two private consultants expressed concerns about proposed restrictions on use of the TNM Lookup Tables; four State highway agencies recommended additional restrictions on the use of the TNM Lookup Tables, and one State highway agency along with three private consultants recommended eliminating use of the Lookup Tables, or developing a replacement. This final rule eliminates use of the TNM Lookup Tables in either form to predict noise levels on Federal or Federal-aid projects. The FHWA developed the Lookup tables to provide TNM users with a simple screening tool for highway analyses. The tables were to supplement TNM to obtain quick estimates. The intended use of the estimates is to inform planners about the potential scope of their project, or to educate the public. The Lookup Tables are not a substitute for the TNM or for routine use in performing a noise analysis. Many practitioners started using the Lookup Tables due to long calculation times inherent with the use of the FHWA TNM when compared with the previous model. However, the dramatically increased speed of computers currently available on the market reduces the model run times to a fraction of what could be accomplished a few years ago. Further, a narrow interpretation of the previous rule indicates the changes to the regulation requiring use of the FHWA TNM eliminated the option to use the TNM Lookup Tables. However, use of the TNM Lookup Tables continued as a legacy. The FHWA has removed this provision proposed in the NPRM from this final rule. The FHWA clarifies through this final rule that the TNM Lookup Tables are not an acceptable model for use on Federal or Federal-aid highway projects. The FHWA will not update the TNM Lookup Tables for future versions of the FHWA TNM. The FHWA will retract the allowable use of the TNM Lookup as it has outlived its intended use.
In sec. 772.9(b), two State highway agencies and a university commented that quieter pavement should be allowed as a mitigation measure. As previously discussed, it is FHWA's position that there are still too many unknowns regarding the viability of quieter pavements as a mitigation measure. However, State highway agencies, the pavement industry, and the FHWA are researching various parts of this overall initiative. The FHWA is actively researching how to better incorporate more specific pavement types in the FHWA TNM. As a result the FHWA added this provision which states, “average pavement type shall be used in the FHWA TNM for future noise level prediction unless a highway agency substantiates the use of a different pavement type for approval by the FHWA.” However, the FHWA is actively seeking highway agencies to assist in our research to better account for pavements in the FHWA TNM by engaging themselves in the experimental use of the specific pavement types currently in the FHWA TNM on projects.
In sec. 772.9(c), six State highway agencies, a national organization, and two private consultants questioned restrictions or wanted additional clarification on the use of noise contours. The final rule ties use of noise contours to information provided to local officials to satisfy sec. 772.17 Information for Local Officials and permits use of contours for some preliminary studies.
Section 772.11, titled “analysis of traffic noise impacts,” was sec. 772.9 in the proposed regulation. The FHWA has removed “and abatement measures” from the title of this section since sec. 772.13 of the final rule now deals with abatement measures. Due to the new numbering of this section, the provisions presented below are identified as presented in this final rule and not how they were numbered in the NPRM. This and other organizational changes were done in response to a comment from a private consultant, who indicated that this section should separate the analysis and abatement portions into their respective sections of the regulation, and pointed out that there is a long-standing disconnect between the intent of this portion of the regulation and the practice of most State highway agencies in applying the regulation. The first condition is “where no exterior activities are to be affected by the traffic noise.” The typical application would be an apartment building with no outdoor balconies, patios, or common grounds activity areas. The second condition is “where the exterior activities are far from or physically shielded from the roadway in a manner that prevents an impact on exterior activities.” The implication of the second condition is that if the apartment, pool, and playground are on the side of the building away from the highway then one would need to consider the interior of the apartments facing the highway as Activity Category E. Few State highway agencies currently consider apartments as Category E. Instead, they analyze the playground and pool as exterior Category B, find that they are not impacted, and then fail to consider abatement for the apartments.
In sec. 772.11, one State highway agency had a general comment requesting that FHWA provide an opinion on a highway agency changing its definition of “substantial increase.” It is the opinion of the FHWA that highway agencies may decide at its discretion to change established criterion within the allowable requirement of this final rule. However, highway agencies should consider past practices and the possible consequences of any changes they make to their noise policy and procedures.
No comments were received on sec. 772.11(a), but to provide clarification on how to analyze projects, the FHWA added sec. 772.11(a)(1) “For projects on new alignments, determine traffic noise impacts by field measurements” and sec. 772.11(a)(2) “for projects on existing alignments, prediction of existing and design year traffic noise impacts.”
In sections 772.11(a)(1) and (a)(2), three State highway agencies and two private consultants requested rewording of this section to clarify determination of existing and future noise levels. The final rule clarifies that existing levels are determined through measurement or prediction. This is because there are times when the “existing” condition and the current year are not the same year.
Two private consultants commented on sec. 772.11(b). One requested a definition of frequent human use and the other recommended a connection between exterior areas and frequent human use. The FHWA did not provide a definition for frequent human use, but did make the connection between exterior areas and frequent human use, by stating “In determining traffic noise impacts, a highway agency shall give primary consideration to exterior areas where frequent human use occurs.” The FHWA also moved this provision to sec. 772.11 Analysis of traffic noise impacts.
In sec. 772.11(c)(1), one State highway agency expressed support for this provision while a second State highway agency requested expansion of the language to allow analysis of a single worst-case alternative in place of similar multiple project alternatives. It is FHWA's position that the language in the final rule does not preclude analysis of a worst-case scenario during preliminary engineering and early environmental studies; however, the highway agency must analyze all alternatives under detailed study as part of a final noise analysis.
Under sec. 772.11(c)(2), one national organization, four State highway agencies, and one private consultant sought additional clarification on the level of analysis necessary for various land use categories and project alternatives. They also suggested deemphasizing land uses previously listed in Activity Category C, which are primarily commercial activities. It is the FHWA's position that this provision of the rule does not require a separate noise analysis for each Activity Category. The rule requires that the noise analysis include a complete noise analysis of all land uses inside the project study area. Past practice of many highway agencies was to ignore certain Activity Categories, particularly Category C, because the highway agency determined that it is not reasonable to provide noise abatement for that Activity Category. Reasonableness decisions cannot precede determination of impacts. The regulation first requires consideration of impacts, then consideration for abatement. The focus of a noise analysis has always been, and will continue to be, on exterior areas of frequent human use. Consideration of Activity Category C land use is unlikely to result in a large increase in the number of receivers within a noise model because Category C receptors do not necessarily have areas of frequent human use.
In sec. 772.11(c)(2)(i), three State highway agencies and two private consultants commented on Activity Category A, offering general support or minor wording changes. One of the State highway agencies requested additional clarification on when to start the process to designate a land use as Category A and suggested that this may work better through inter-agency consultation rather than through FHWA approval. The FHWA has determined the recommended wording changes are unnecessary. It is appropriate for the determination of Activity Category A receptors to occur early in the process and through the inter-agency consultation process; however, the final determination for this designation remains a FHWA decision. To further clarify Activity Category A, “the exterior impact criteria for lands * * *.” has been added to this provision.
In sec. 772.11(c)(2)(ii), in response to comments received, the designation of Activity Category B has been revised to include the exterior criteria for only residential land uses. The provision states, “[t]his activity category includes the exterior impact criteria for single-family and multifamily residences.”
In sec. 772.11(c)(2)(iii), eight State highway agencies, one national organization, and one private consultant commented their general support of this provision and requested that FHWA provide a standardized method to evaluate reasonableness for special land use facilities. The term “special land use facilities” has been removed from the final rule. There are several logical and fair ways to evaluate certain types of land use, one approach is the Florida Department of Transportation's method. The FHWA will provide examples of other methods in the updated noise guidance document. The final rule changes references from special land uses to the actual activity category based on the reorganized Table 1. To provide additional clarification, the designation of Activity Category C has been revised to include a variety of land use facilities as listed in Table 1. This provision states “Activity Category C. This activity category includes the exterior impact criteria for a variety of land use facilities. Each highway agency shall adopt a standard practice for analyzing these land use facilities that is consistent and uniformly applied statewide.”
In sections 772.11(c)(2)(iv), (v), and (vi), three State highway agencies and three private consultants offered comments on this section. Two highway agencies offered general support, however, the remaining highway agency and the private consultants offered suggestions on consideration of commercial land use in a noise analysis. The final rule modifies Table 1 to segregate certain commercial land use from noise generating commercial and industrial land uses.
One private consultant requested additional clarification on the timing of interior noise studies in sec. 772.11(c)(2)(iv). The consideration for the analysis may occur prior to noise monitoring. It is FHWA's position that the noise analyst should be able to identify interior locations that require monitoring during preliminary field work while developing a monitoring plan. One national organization and eight State highway agencies requested additional clarification on the analysis requirements for interior areas. It is FHWA's position that an interior analysis is only required when all exterior analysis alternatives are exhausted or in cases where there are no exterior activities. To provide extra clarification on which land use categories can be considered for an interior noise analysis, the FHWA has indicated “exterior” and/or “interior” within each Activity Category.
In sec. 772.11(c)(2)(v), in response to comments received, the designation of Activity Category E has been revised to address the exterior impact criteria for less noise sensitive developed lands.
In response to comments received, a new Activity Category F was created in sec. 772.11(c)(2)(vi) to include developed lands that are not sensitive to highway traffic noise.
In sec. 772.11(c)(2)(vii), the FHWA provided clarification on undeveloped lands. Undeveloped lands were listed as Activity Category D in the NPRM, but due to the changes to Table I, undeveloped lands are now listed under Activity Category G in this final rule. Three State highway agencies commented that this section is overly broad for considering whether a property is planned for development and suggested limiting this consideration to issuance of a building permit. This final rule has revised the existing regulation to limit consideration to the issuing of a building permit. Five State highway agencies requested further clarification on the purpose of predicting noise levels on undeveloped land. It is FHWA's position that providing local officials with the best estimate of future
The FHWA received no comments on sec. 772.11(d) and (d)(1), but the FHWA wanted to clarify the intent of this section, sec. 772.11(d) now states “the analysis of traffic noise impacts shall include a(n):”. This was done to clarify that 772.11(d)(1) to (4) all must be a part of a noise analysis.
To provide additional clarification, the FHWA has added sections 772.11(d)(2) and 772.11(d)(3) on validation and the noise meter type to be used on projects. Section 772.11(d)(2) states “For projects on new or existing alignments, validate predicted noise level through comparison between measured and predicted levels” and sec. 772.11(d)(3) states “Measurement of noise levels. Use an ANSI Type I or Type II integrating sound level meter.” The inclusion on the type of noise meters to be used on a Federal-aid highway project is a result of industry standard and the FHWA guidance on which type of meters should be used.
Thirteen State highway agencies, a national organization, two private consultants, and a private individual expressed concern about the 500' study area as proposed in sec. 772.11(d)(4). The final rule eliminates this provision and instead requires State highway agencies to determine project limits to determine all traffic noise impacts for the design year. This section now states “Identification of project limits to determine all traffic noise impacts for the design year for the build alternative. For Type II projects, traffic noise impacts shall be determined from current year conditions.” Two State highway agencies and one private consultant commented on sec. 772.11(d)(4), indicating that this section is inconsistent in that it discusses evaluation of impacts prior to a determination of future noise levels. This approach in the regulation may lead to some confusion. The FHWA reorganized the final rule to include separate sections requiring determination of noise levels and evaluation of noise impacts. Three State highway agencies commented that a disconnect occurs with a 5 dB(A) substantial decrease criterion and a substantial increase criteria in the range of 10–15 dB(A). The FHWA is clarifying that a 5 dB(A) reduction meets the acoustic feasibility requirement. Essentially, this reduction means that the noise abatement measure decreases noise impacts, but may not be optimal. To address this, FHWA introduces a design goal reasonableness criterion in the final rule. The final rule also expands substantial increase to a range of 5–15 dB(A). This provides States with additional flexibility to define substantial increases. Three State highway agencies and two private consultants requested clarification or removal of the phrase “lower threshold limit,” in sec. 772.11(d)(3)(ii). The final rule clarifies this issue by stating in that, “[t]he substantial noise increase criterion is independent of the absolute noise level.” In the past, some highway agencies applied the substantial noise increase criterion by linking it to an absolute noise level, meaning that a substantial noise increase was only considered from that absolute noise level or higher noise level. Typically a highway agency's noise policy would state “a substantial noise increase occurs when the design year noise level results in an increase of 15 dB(A) or more over existing noise levels as long as the predicted noise level is 55 dB(A) or above,” or something similar. This language represented a misapplication of 23 CFR 772 and the noise guidance, and could result in situations where receptors may experience noise increases of more than 15 dB(A), but there would not be a substantial impact. Any noise increase that meets or exceeds that State highway agency criteria for a substantial increase is an impact, regardless of the absolute noise level.
Section 772.9(a) of NPRM has been moved to sec. 772.13(a) based on comments received. Three State highway agencies recommended wording changes to this section. The final rule uses “abate” rather than “mitigate” to clarify that the focus of the regulation when dealing with impacts is in on abatement of impacts rather than mitigation of impacts. The FHWA added for clarification “when traffic noise impacts are identified, noise abatement shall be considered and evaluated for feasibility and reasonableness.”
No comments were received on section 772.13(b), which in the NPRM was section 772.11(a) but the FHWA has revised it to stress that primary consideration is given to exterior areas where frequent human use occurs. Five State highway agencies expressed concerns with section 772.11(b) of the NPRM which states “In situations where no exterior activities are to be affected by the traffic noise, or where the exterior activities are far from or physically shielded from the roadway in a manner that prevents an impact on exterior activities, a highway agency shall use Activity Category E as the basis for determining noise impacts,” may result in additional interior analysis requirements. The FHWA agrees and has eliminated this section in the final rule.
Three States and one private consultant expressed support for including sec. 772.12(c)(1) in the rule. In sec. 772.13(c)(2), a private consultant commented on including a new provision on the proper use of absorptive treatment on noise barriers. As a result, the FHWA added sec. 772.13(c)(2), which states, “If a highway agency chooses to add absorptive treatments to a noise barrier as a functional enhancement, the highway agency shall adopt a standard practice for using absorptive treatment that is consistent and uniformly applied statewide.” It is FHWA position that if a highway agency wants to use absorptive treatments on noise barriers, that they develop a standard practice
In sec. 772.13(d)(1), seven State highway agencies, one national organization, six private consultants, and one private individual commented on this section. Comments were primarily about application of the “majority” requirement to the entire project rather than to each neighborhood or increasing the substantial reduction criterion to a higher threshold. It is FHWA's position that highway agencies should make noise abatement decisions on a neighborhood basis when determining achievement of a substantial reduction. Considering all noise abatement measures in a project could penalize some neighborhoods where noise abatement is clearly effective because it is not possible to provide an effective design for a different neighborhood. Similarly, considering all noise abatement measures in the project jointly may result in construction of noise abatement that is not feasible at some locations because of highly effective abatement at other locations within the project. The FHWA does not advocate, or support for funding, construction of ineffective noise abatement measures.
A private consultant commented that the 5 dB(A) threshold for acoustic feasibility is too small. As such, the final rule clarifies that 5 dB(A) is the minimum requirement for a feasible barrier. The final rule also incorporates a new reasonableness criterion that each highway agency must establish a design goal of 7–10 dB(A). Further explanation of reasonableness design goal can be found in the discussion of 772.13(d)(2)(iii). Changes to this section in the final rule provide greater flexibility to States to identify a targeted number of impacted receivers necessary for a noise abatement measure to meet feasibility requirements. The FHWA has added the following, “The highway agency shall define, and receive FHWA approval for, the number of receptors that must achieve this reduction for the noise abatement measure to be feasible and explain the basis for this determination.”
A State highway agency proposed averaging feasibility over the entire project. It is FHWA's position that averaging feasibility across the project to obtain a majority is a flawed approach to evaluate acoustic feasibility as it may result in construction of barriers that are not acoustically feasible. To take the example to the extreme, it is possible that one neighborhood could have 100 percent acoustic feasibility while a second has 0 percent acoustic feasibility and the State highway agency would build no barriers because there was no majority of receptors that achieved a 5 dB(A) reduction.
In sec. 772.13(d)(1)(ii), three State highway agencies and a private consultant requested additional clarification on what “safe” means. A private consultant recommended listing the non-acoustical feasibility factors to consider. Additional clarification will be provided in the guidance document. However, the final rule includes the factors to consider for feasibility. The following sentence was added “Factors to consider are safety, barrier height, topography, drainage, utilities, and maintenance of the abatement measure, maintenance access to adjacent properties, and access to adjacent properties (
In sec. 772.13(d)(2), one State highway agency commented that FHWA should establish the reasonable cost of abatement for all States. The FHWA disagrees with this comment. The final rule requires States to develop cost reasonableness criteria based on historical construction cost as published in the NPRM. This is necessary to accommodate the spectrum of costs for various States and the various approaches States take to quantify construction costs. For example, some States only consider the cost of post, panels, and foundations when estimating the construction cost of a noise barrier, while others may include other factors such as design, maintenance of traffic, clearing and grubbing, etc. A State highway agency and a private consultant recommended placing cost as the primary cost reasonableness criterion. The final rule has three reasonableness criteria State highway agencies must consider: cost effectiveness, desires of the public, and design goal. A State may determine the abatement measure is not reasonable if it does not meet any of the three criteria. A county highway agency expressed concern that only the State would determine the reasonableness factors in the State noise policy and recommended a broader definition of reasonableness. The rule intentionally provides a narrow selection of reasonableness factors to ensure uniform and consistent application of the rule nationwide. Similarly, each State highway agency noise policy will list reasonableness factors considered by the State on all projects within the State regardless of jurisdiction to ensure statewide uniform and consistent application of the noise policy. State highway agencies may not tailor reasonableness factors to suit a particular jurisdiction or project.
Nineteen State highway agencies, one national organization, seven private consultants, and one private individual were concerned about various provisions of sec. 772.13(d)(2)(i). The concerns centered on two issues: (1) the requirement to obtain responses from a majority of benefited receptors, and (2) the limitation of surveying property owners rather than residents. A State highway agency expressed concerns about Executive Order 12898 compliance. The FHWA recognizes that the requirement to obtain a majority is overly proscriptive. Highway agencies should devise public involvement programs that satisfy their State's needs. States may institute schemes to give additional weight to the views of impacted residents, but must consider the views of benefited residents. The final rule requires solicitation of the views of residents and property owners. One State highway agency and one private consultant indicated concern with the provision that, “The highway agency is not required to consider the viewpoints of other entities to determine reasonableness, unless explicitly authorized by the benefited property owner.” It is FHWA's position that this provision prevents entities other than benefiting residents from vetoing noise abatement on public right-of-way. Another State highway agency expressed that its current practice is to count a lack of response from a residence to a survey as a no vote for the barrier. Two State highway agencies requested clarifying language for the meaning of “desires” or substituting the word “views.” It is FHWA's position that the failure to respond to a survey may demonstrate lack interest in noise abatement, particularly when there is a low response rate from the community, but only explicit “no” votes should be considered as “no” votes. States may institute schemes to give additional weight to the views of impacted residents, but must consider the views of benefited residents. The final rule incorporates the phrase “point of view” in place of “desire.” This is to eliminate confusion over the meaning of “views,” which in the past version of the rule, may have been confused with what people could see rather than their opinion. To provide a more uniform and consistent application nationwide, the following was added to this provision “The highway agency shall solicit the viewpoints form all of the benefited receptors and obtain enough responses to document a decision on either desiring or not desiring the noise
In sec. 772.13(d)(2)(ii), a State highway agency and a private consultant expressed concern that the proposed rule appeared to change cost as a reasonableness factor from cost effectiveness, as historically applied, to cost of the measure. It is FHWA's position that this was an unintentional change in the language of the proposed rule. The final rule clarifies that State highway agencies must consider the cost effectiveness of the abatement measure rather than considering the overall cost of the abatement measure in terms of the project cost. “The maximum square footage of abatement/benefited receptor,” was added to this provision as a way to determine a baseline cost reasonableness value.
Seven State highway agencies and three private consultants commented on the proposed change in sec. 772.13(d)(2)(ii) on how States determine cost reasonableness. All generally agreed with the new provision, but expressed that the provision should provide flexibility to develop cost reasonableness criteria outside the traditional scheme of cost per benefited receptor. One State expressed concern about what factors to include in the cost estimate, and a consultant indicated that States with little or no experience in building noise barriers could have difficulty establishing cost reasonableness criteria due to limited experience. Another State expressed concern about how the reevaluation of construction costs could affect projects caught in the process. It is FHWA's position that the final rule provides flexibility for State highway agencies to use alternate cost reasonableness schemes based on construction cost. The State highway agency and the FHWA should coordinate consideration of factors to include in the construction cost estimate and apply the same values to all projects. The cost estimate is based on averages, which include projects that may cost more or less than the average. The FHWA recognizes that some States have less experience than others with noise abatement construction. The FHWA provides additional information in the noise guidance. The reevaluation should focus on the construction costs with resulting changes in the cost reasonableness threshold. For example, if construction costs increase by 10 percent between evaluations, the cost reasonableness threshold should increase by a like amount. This way, a location determined cost reasonable at one time, would not fail to meet the cost reasonableness criteria later. This is similar to the approach recommended below regarding geographic differences.
In sec. 772.13(d)(2)(ii), two private consultants expressed concern about the provision to allow for geographical differences for cost reasonableness within a State. One suggested removing the provision entirely because it could be difficult to implement and monitor. The other wanted to ensure that wording of the final rule would ensure that identical neighborhoods in a State would have the same opportunity for noise abatement despite geographical differences in construction cost. It is the FHWA's position that the final rule retains this subsection as an option provision as proposed in the NPRM. The language in the final rule ensures that geographical cost differences will not affect a neighborhood's opportunity to receive noise abatement. State highway agencies implementing this provision will ensure that the cost reasonableness criteria/construction cost ratio is the same statewide. For example, the unit cost in City A is $12.50/sq. ft. and the cost per benefiting residence is $25,000. City B is much more expensive with a unit cost of $25/sq. ft. Therefore, the cost per benefiting residence in City B is $50,000.
Based on comments received from four State highway agencies, two private consultants, and a private citizen on obtaining a substantial noise reduction, the FHWA is incorporating noise reduction design goals as the new sec. 772.13(d)(2)(iii). The FHWA is defining “Noise Reduction Design Goal” to remove the disconnect that occurs with a 5 dBA substantial decrease criterion and substantial increase criteria's 5–15 dBA range. This provision states, “[n]oise Reduction design goals for highway traffic noise abatement measures. When noise abatement measure(s) are being considered, a highway agency shall achieve a noise reduction design goal. The highway agency shall define the design goal of at least 7 dB(A) but not more than 10 dB(A), and define the value of benefited receptors that must achieve this design goal. The highway agency shall define the design goal of at least 7 dB(A) but not more than 10 dB(A). The highway agency shall define, and receive FHWA approval for, the number of benefited receptors that must achieve this design goal and explain the basis for this determination.” Defining the number of benefited receptors that must achieve this design goal assures that a too balanced approach is taken when defining a design goal.
In sections 772.13(d)(2)(vi) and (v), five State highway agencies and two private consultants commented on the optional reasonableness factors and the statement “No single reasonableness factor should be used as the sole basis for determining reasonableness.” One State recommended removal of the optional abatement measures and that States should define these criteria in their own policies. Another State also requested inclusion of factors related to local zoning compliance in the final rule. The final rule clarifies that the provision about single reasonableness factors only applies to the optional factors. Inclusion of the optional reasonableness factors is based on example reasonableness factors in the 1995 guidance. The rule provides flexibility for States to choose additional reasonableness factors that work best for them. States are not required to incorporate the optional reasonableness factors. The final rule does not explicitly address local zoning. The final rule provides flexibility to address this under the optional factor of date of development. The FHWA has no control over zoning practices of local governments. As a result of these comments the FHWA added sec. 772.13(d)(2)(iv) to state, “[t]he reasonableness factors listed in § 772.13(d)(5)(i), (ii) and (iii), must collectively be achieved in order for a noise abatement measure to be deemed reasonable. Failure to achieve § 772.13(d)(5)(i), (ii) or (iii), will result in the noise abatement measure being deemed not reasonable” and modified sec. 772.13(d)(2)(v) to indicated that in addition to the required factors listed in sec. 772.13(d)(2)(i), (ii) and (iii), a highway agency may use the factors within this provision. A sentence was added to clarify that no single optional reasonableness factor could be used to determine reasonableness. In sec. 772.13(e), a national organization, six State highway agencies, and a private consultant requested clarification on substantial increase and the benefited receiver thresholds. The final rule clarifies that benefited receptors must obtain a reduction at or above 5 dB(A), but not exceed the highway agency's reasonableness design goal. This approach provides flexibility to establish different reasonableness criteria for receptors that are impacted and benefiting, versus receptors that are not impacted and benefiting.
Thirteen State highway agencies and four private consultants commented on the inclusion of the noise barrier inventory in the regulation at sec.
There were no specific comments on actual text of sec. 772.13(g), but based on the comments received on various parts of this regulation regarding the disconnect between the environmental clearance and the final design noise analysis and documentation, the FHWA has included sec. 772.13(g)(3), which states, “[d]ocumentation of highway traffic noise impacts: The environmental document shall identify locations where noise impacts are predicted to occur, where noise abatement is feasible and reasonable and locations with impacts that have no feasible or reasonable noise abatement alternative. For environmental clearance, this analysis shall be completed to the extent that design information on the alterative(s) under study in the environmental document is available at the time the environmental clearance document is completed. A statement of likelihood shall be included in the environmental document since feasibility and reasonableness determinations may change due to changes in project design after approval of the environmental document. The statement of likelihood shall include the preliminary location and physical description of noise abatement measures determined feasible and reasonable in the preliminary analysis. The statement of likelihood shall also indicate that final recommendations on the construction of an abatement measure(s) is determined during the completion of the project's final design and the public involvement processes.”
In sec. 772.13(h), one State highway agency and one private consultant recommended a change from “planned, designed and programmed” to “permitted.” The final rule incorporates this change. One State highway agency wanted “in accordance with the Highway Agency approved noise Policy” added to the regulation. Because the FHWA requires all States to have an approved noise policy, the FHWA feels this change would be unnecessary.
In sec. 772.13(i), eight State highway agencies and two private consultants expressed general support for this new provision on design build projects in the regulation, but expressed concern that changes to the project during construction may result in implementation of unneeded environmental commitments, and commented on the relationship between the final and preliminary noise abatement design. The FHWA understands the concerns expressed in the comments; however, the FHWA is concerned that absent a commitment to provide abatement determined reasonable and feasible in the environmental document, and based on the acoustic design developed in the noise analysis, there may be cases where value engineering efforts or other cost savings measures may result in changes to the abatement design that reduce the effectiveness of the noise abatement measures. States are also encouraged to consider developing performance based specifications within their noise policies that apply to design build project to accommodate the project flexibility inherent in the design build process and ensure constructed noise abatement is effective.
Section 772.13(j) was proposed as sec. 772.9(d) in the NPRM. This provision was moved to the analysis of noise abatement since it deals with paying for noise abatement. Ten State highway agencies, two private consultants, and one private individual commented on this section largely supporting the provision and in some cases, seeking minor clarification. In one case, a State highway agency commented that this provision could force States to provide abatement that is not feasible or reasonable. Another commented that this provision could unfairly skew noise abatement to those with greater funds, and a private individual wanted clarification on the timing of the funding. One State also wanted clarification on the entities that count as third parties. Some of the comments make it clear that the wording in the NPRM was not clear. The intent is for all noise abatement measures to stand on their own without contributing additional funds. The final rule states, “Third party funding is not allowed on a Federal or Federal-aid Type I or Type II project if the noise abatement measure would require the additional funding from the third party to be considered feasible and/or reasonable. Third party funding is acceptable on a Federal or Federal-aid highway Type I or Type II project, to make functional enhancements, such as absorptive treatment and access doors or aesthetic enhancements to a noise abatement measure already determined feasible and reasonable.” The inclusion of functional enhancements in third party funding covers items that the third party may want in the noise barrier, but are not essential. Listing components such as absorptive treatment and functional enhancements differentiates between what a community may want in a noise barrier and what is necessary for an effective noise barrier. States should develop policies that include consideration for aesthetics, absorptive treatments, functional enhancements such as access doors, fire safety features, etc. Communities desiring functional enhancements or aesthetic treatment beyond that provided for in the State noise policy could contribute toward those enhancements. Third parties are any entity other than the State highway agency and DOT operating administrations.
Section 772.13(k) was proposed as provision 772.9(d) in the NPRM. This provision was moved to the analysis of noise abatement since it deals with cost averaging noise abatement. This
In sec. 772.15(b), a State highway agency remarked that this section was always confusing and offered clarifying language. The FHWA agrees and revised this provision to largely include the language as presented in section 339(b) of the National Highway System Designation Act of 1995. As a result, sec. 772.15(b)(1) states, “No funds made available out of the Highway Trust Fund may be used to construct Type II noise barriers, as defined by this regulation, if such barriers were not part of a project approved by the FHWA before the November 28, 1995.” November 28, 1995, is the date that the National Highway System Designation Act went into effect. A private consultant expressed that this section limits Type II projects to those that were “proposed where land development or substantial construction predated the existence of any highway.” The definition for substantial construction is “the granting of a building permit prior to right-of-way acquisition or construction approval for the highway.” The wording and meaning of definition and this provision differ and need to be reconciled. The FHWA agrees and the final rule addresses this by removing “any” and largely stating the language as presented in the National Highway System Designation Act of 1995. As a result, sec. 772.15(b)(2) states “Federal funds are available for Type II noise barriers along lands that were developed or were under substantial construction before approval of the acquisition of the rights-of-ways for, or construction of, the existing highway.”
In sec. 772.15(b)(3), two State highway agencies questioned the restriction on Type II funding eliminating locations previously determined not feasible or reasonable for a Type I project. One of these agencies questioned whether this is still the case after a re-evaluation of an environmental document. It is FHWA's position that if a Type I location is not cost-reasonable based on the construction of homes at the time of that project, then that location is not cost-reasonable later for a Type II project. Highway agencies typically divide the overall cost of a noise abatement measure by the number of benefiting residences to determine a cost per benefiting residence. An abatement measure is cost reasonable if the cost per residence does not exceed the State's criteria. The only way the neighborhood becomes cost reasonable is if the number of residences increases. The new residences would not predate the facility and cannot count in the cost-reasonableness calculation. The only way to consider the commenter's approach is if the highway agency increased the allowable cost per benefited residence relative to the construction cost. This potentially exposes the highway agency to going back to look at previous decisions on other Type I and Type II projects to see if the highway agency inappropriately excluded locations from receiving noise abatement. This situation would not necessarily include Type I projects that involve a re-evaluation of an existing environmental document, but those circumstances would be scarce. Typically, a location determined not reasonable in an environmental document that is later determined reasonable in a re-evaluation results from construction of additional residences that result in a lower average cost per benefited residence and result in abatement not cost reasonable under the earlier document achieving the cost-reasonableness threshold. In this case, the highway agency would offer noise abatement to the neighborhood as part of the Type I project, eliminating the need to consider the location for a Type II project. The FHWA made no changes to this provision.
In sec. 772.15(c), one State highway agency sought clarification on some of the available noise abatement measures, specifically regarding the need to meet the feasibility and reasonableness criteria and regarding the purchase of land. It is FHWA's position that any proposed noise abatement measure must achieve the feasibility and reasonableness requirements established in the highway agency's noise policy. The section on acquisition of real property provides highway agencies with the authority to acquire right-of-way for the purpose of noise barrier construction. The statement regarding unimproved property is there to highlight that highway agencies cannot use this provision to purchase a residence just so the State can tear it down and construct a noise barrier for the second row of houses. Three highway agencies and a university recommended including quieter pavements as noise abatement, with one noting a large body of research completed by the State to support this approach. It is FHWA's position that there are still too many unknowns regarding pavement to consider its use as a noise abatement measure. These issues include acoustic longevity and construction variability. The FHWA has provisions for highway agencies to enter into a Quiet Pavement Pilot Program or to perform Quiet Pavement Research. The FHWA acknowledges the valuable research performed by various highway agencies; however, the regulation must be applicable nationwide and not just in one State. No changes were made to this provision.
In sec. 772.15(c)(1), six State highway agencies and three private consultants expressed support for FHWA's position clarifying that vegetation is not an appropriate noise abatement measure, but recommended removal of references to funding for aesthetic purposes. The FHWA has removed reference to funding for landscaping from the regulation. One State highway agency and one private consultant indicated concerns with the approach to make five of the noise abatement alternatives optional and only require consideration of noise barriers because this approach contradicts the long-standing practice to avoid, minimize, and then mitigate. It is the FHWA's position that the language in the final rule allows States to consider all noise abatement measures listed in the regulation while requiring only consideration of noise barriers. This approach provides highway agencies with the flexibility they need to accomplish the recommended approach if the highway agency chooses to do so.
A private consultant recommended adding a new section to 772.15(c) regarding absorptive cladding applied to an existing reflective surface as a noise abatement measure. Because the final rule does not preclude States from considering this approach as a noise abatement measure, no changes were made to this provision.
In sec. 772.15(c)(4), two State highway agencies and one private consultant commented on buffer zones. One highway agency requested further clarification in the updated FHWA noise guidance. Another highway agency requested limitation to planned, designed, and programmed land use and
In sec. 772.15(c)(5), two State highway agencies and one private consultant expressed support for this provision regarding noise insulation and recommended incorporating any additional expenses accrued by the property owner after project completion. The FHWA agrees and the final rule incorporates this idea by referring to additional expenses as post-installation maintenance and operational costs. Also, to clarify what land uses are eligible for noise insulation, this provision now states, “noise insulation or Activity Category D land use facilities listed in table 1.”
Eight State highway agencies and three private consultants expressed concerns about the provision in the NPRM regarding severe noise impact criteria in the regulation. Based on these comments, the FHWA has removed this provision on severe noise impacts from the final rule. It is FHWA's position that the regulation currently requires a highway agency to define “substantial increase,” which recognizes all potential impacts that could result from the proposed project. Adding another layer of impact with the title of “severe” is problematic to the noise analysis and will create even more confusion to the public. Severe noise impacts could cause inconsistencies in the application of the noise analysis process, since it would require establishing another feasibility and cost reasonableness factor. As stated throughout this final rule, application of this regulation needs to be applied consistently and uniformly statewide. Also, “severe” noise impacts could be confusing to the public, since they typically feel that they are all severely impacted regardless of the noise level or increase in noise levels.
In sec. 772.17, 13 State highway agencies and 4 private consultants commented about the requirements in section 772.1 (section 772.15 in the NPRM) regarding information for local officials. Some comments were about the numbering of the section, which has been corrected in the final rule, and others were about the apparent redundancy in two of the subsections. There were also concerns about the extent of a statewide outreach program and some confusion about whether outreach to local officials is a new requirement. There was also opposition to the requirement to implement a statewide outreach program prior to considering date of development as a reasonableness criterion. It is FHWA's position that highway agencies may use information in the FHWA publication “The Audible Landscape.” The FHWA is considering updating this document to incorporate additional planning strategies. The final rule also clarifies the minimum information provided to local officials, which is the distance from the highway to the impact criteria for each exterior land use in Table 1 of this regulation. The requirement to inform local officials about future noise impacts on undeveloped lands has been part of this regulation since its inception. Unfortunately, few highway agencies properly fulfill this requirement. It is likely that many municipalities have never had a Federal project that provided the opportunity for the highway agency to inform them about noise compatible planning practices. The FHWA recognizes that State governments often have little control over local planning; however, FHWA has also promoted noise compatible planning strategies for more than 30 years with little active involvement by States on the issue. It is incumbent on State highway agencies, therefore, to demonstrate that they have educated local officials on noise issues if date of development may preclude some locations from receiving noise abatement. The FHWA noise guidance provides additional clarification on statewide outreach programs. For clarification, the FHWA modified sec. 772.17(a) to include reference to Type I projects and section 772.17(a)(2) to state, “[a]t a minimum, identify the distance to the exterior noise abatement criteria in Table 1. The best estimation of the future design year noise levels at various distances from the edge of the nearest travel lane * * *”
In sec. 772.17(b), a private individual expressed that the rule should expand the date of development to allow State highway agencies to give additional weight to older residences. It is FHWA's position that highway agencies with statewide noise compatible planning outreach programs may consider date of development in their decisions to provide abatement. The regulation currently authorizes highway agencies to fund Type II programs on a voluntary basis to provide abatement for locations that predate adjacent highways in the absence of a Type I project. For clarification, the FHWA modified this provision to state, “If a highway agency chooses to participate in a Type II noise program or to use the date of development as one of the factors in determining the reasonableness of a Type I noise abatement measure, the highway agency shall have a statewide outreach program * * * ”
In sec. 772.19, five State highway agencies, one national organization, and one private consultant commented that FHWA should provide additional regulatory guidance to address construction noise including a regulatory reference to the Roadway Construction Noise Model. It is FHWA's position that there is sufficient information regarding construction noise available in the construction noise handbook. The model will remain an option for use by States to predict construction noise impacts for projects. As such, no changes were made to this provision.
Eight State highway agencies, a national organization and two private consultants provided comments on Table 1. Some of the same entities also provided comments in other sections of the regulation related to Table 1. The comments generally centered on the opposition to include trails, trail crossings, and cemeteries; recommended inclusion of additional land use categories; recommended elimination of some Category C land uses; or recommended reorganization of the table to better differentiate between land use categories. The FHWA disagrees with removal of trails and trail crossing and cemeteries from Table 1. These are recreational and noise sensitive areas eligible for consideration under previous FHWA guidance. The FHWA disagrees with the elimination of Category C land uses. Historical data based on highway agencies not including Category C locations in their noise analyses or their public involvement may paint an inaccurate
Activity Category A, this activity category still provides the exterior activity criteria for “Lands on which serenity and quiet are of extraordinary significance and serve an important public need and where the preservation of those qualities is essential if the area is to continue to serve its intended purpose.” No changes were made to this activity category.
Activity Category B, this activity category now only includes the exterior activity criteria for residential properties. All other land uses that were associated with this activity category in the past have been reorganized into other activity categories.
Activity Category C, this activity category is now the exterior activity criteria for the following land uses: “active sport areas, amphitheaters, auditoriums, campgrounds, cemeteries, day care centers, hospitals, libraries, medical facilities, parks, picnic areas, places of worship, playgrounds, public meeting rooms, public or non-profit institutional structures, radio studios, recording studios, recreation areas, Section 4(f) sites, schools, television studios, trails, and trail crossings.” The exterior activity criteria for Activity Category C are the same as the exterior activity criteria for Activity Category B. The reason why the land uses associated with these activity categories are in separate categories is that the land used in Activity Category C includes a variety of land use facilities that require each highway agency to adopt a standard uniform and consistent practice in assessing their impacts and abatement measures.
Activity Category D, this activity category is now the interior activity criteria for the following land uses: “auditoriums, day care centers, hospitals, libraries, medical facilities, places of worship, public meeting rooms, public or non-profit institutional structures, radio studios, recording studios, schools, and television studios.” The activity description for Activity Category D is similar to the activity description for Activity Category C. The difference between the Activity Category C and D is the exterior verses interior criteria.
Activity Category E, this activity category is now the exterior activity criteria for the following land uses: “hotels, motels, offices, restaurants/bars, and other developed lands, properties or activities not included in A–D or F.” These land use facilities are less sensitive to highway traffic noise, and therefore have a higher activity criteria.
Activity Category F, this activity category has no activity criteria associated for the following land uses: “agriculture, airports, bus yards, emergency services, industrial, logging, maintenance facilities, manufacturing, mining, rail yards, retail facilities, shipyards, utilities (water resources, water treatment, electrical), and warehousing.” These land use facilities are not sensitive to highway traffic noise and/or do not have exterior areas of frequent human use and therefore no activity criteria is appropriate to apply.
Activity Category G, this activity category has no activity criteria associated for undeveloped lands that are not permitted. Undeveloped land is not sensitive to highway traffic noise and does not have exterior areas of frequent human use.
The FHWA has determined that this final rule is not a significant regulatory action within the meaning of Executive Order 12866 and is not significant within the meaning of the U.S. Department of Transportation regulatory policies and procedures.
The final rule revises requirements for traffic noise prediction on Federal-aid highway projects to be consistent with the current state-of-the-art technology for traffic noise prediction. It is anticipated that the economic impact of this rulemaking would be minimal; therefore, a full regulatory evaluation is not required.
In compliance with the Regulatory Flexibility Act (RFA) (Pub. L. 96–354, 5 U.S.C. 601–612), the FHWA has evaluated the effects of this final rule on small entities and anticipates that this action would not have a significant economic impact on a substantial number of small entities. The amendments address traffic noise prediction on certain State highway projects. As such, it affects only States, and States are not included in the definition of small entity set forth in 5 U.S.C. 601. Therefore, the RFA does not apply, and the FHWA certifies that the final rule would not have a significant economic impact on a substantial number of small entities.
This final rule would not impose unfunded mandates as defined by the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4, March 22, 1995, 109 Stat. 48). The actions proposed in this final rule would not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $141.3 million or more in any one year (2 U.S.C. 1532). Additionally, the definition of “Federal Mandate” in the Unfunded Mandates Reform Act excludes financial assistance of the type in which State, local, or tribal governments have authority to adjust their participation in the program in accordance with changes made in the program by the Federal Government. The Federal-aid highway program permits this type of flexibility.
This final rule has been analyzed in accordance with the principles and criteria contained in Executive Order 13132, dated August 4, 1999, and it has been determined that this final rule does not have a substantial direct effect or sufficient federalism implications on States that would limit the policymaking discretion of the States. Nothing in this final rule directly preempts any State law or regulation or affects the States' ability to discharge traditional State governmental functions.
Catalog of Federal Domestic Assistance Program Number 20.205, Highway Planning and Construction. The regulations implementing Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities apply to this program.
The FHWA has analyzed this final rule for the purpose of the National Environmental Policy Act (42 U.S.C. 4321
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501,
The FHWA has analyzed this final rule under Executive Order 13175, dated November 6, 2000, and believes that it would not have substantial direct effects on one or more Indian tribes; would not impose substantial direct compliance costs on Indian tribal governments; and would not preempt tribal law. This rulemaking primarily applies to noise prediction on State highway projects and would not impose any direct compliance requirements on Indian tribal governments; nor would it have any economic or other impacts on the viability of Indian tribes. Therefore, a tribal summary impact statement is not required.
The FHWA has analyzed this final rule under Executive Order 13211, Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution or Use. We have determined that this final rule would not be a significant energy action under that order because any action contemplated would not be likely to have a significant adverse effect on the supply, distribution, or use of energy. Therefore, the FHWA certifies that a Statement of Energy Effects under Executive Order 13211 is not required.
The FHWA has analyzed this final rule under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights. The FHWA does not anticipate that this final rule would affect a taking of private property or otherwise have taking implications under Executive Order 12630.
This action meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity and reduce burden.
The FHWA has analyzed this final rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. The FHWA certifies that this final rule would not cause an environmental risk to health or safety that may disproportionately affect children.
A regulation identification number (RIN) is assigned to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. The RIN number contained in the heading of this document can be used to cross-reference this action with the Unified Agenda.
Highways and roads, Incorporation by reference, Noise control.
23 U.S.C. 109(h) and (i); 42 U.S.C. 4331, 4332; sec. 339(b), Pub. L. 104–59, 109 Stat. 568, 605; 49 CFR 1.48(b).
To provide procedures for noise studies and noise abatement measures to help protect the public's health, welfare and livability, to supply noise abatement criteria, and to establish requirements for information to be given to local officials for use in the planning and design of highways approved pursuant to title 23 U.S.C.
The highway traffic noise prediction requirements, noise analyses, noise abatement criteria, and requirements for informing local officials in this regulation constitute the noise standards mandated by 23 U.S.C. 109(1). All highway projects which are developed in conformance with this regulation shall be deemed to be in accordance with the FHWA noise standards.
(2) The physical alteration of an existing highway where there is either:
(i) Substantial Horizontal Alteration. A project that halves the distance between the traffic noise source and the closest receptor between the existing condition to the future build condition; or,
(ii) Substantial Vertical Alteration. A project that removes shielding therefore exposing the line-of-sight between the receptor and the traffic noise source. This is done by either altering the vertical alignment of the highway or by altering the topography between the highway traffic noise source and the receptor; or,
(3) The addition of a through-traffic lane(s). This includes the addition of a through-traffic lane that functions as a HOV lane, High-Occupancy Toll (HOT) lane, bus lane, or truck climbing lane; or,
(4) The addition of an auxiliary lane, except for when the auxiliary lane is a turn lane; or,
(5) The addition or relocation of interchange lanes or ramps added to a quadrant to complete an existing partial interchange; or,
(6) Restriping existing pavement for the purpose of adding a through-traffic lane or an auxiliary lane; or,
(7) The addition of a new or substantial alteration of a weigh station, rest stop, ride-share lot or toll plaza.
(8) If a project is determined to be a Type I project under this definition then the entire project area as defined in the environmental document is a Type I project.
(a) This regulation applies to all Federal or Federal-aid Highway Projects authorized under title 23, United States Code. Therefore, this regulation applies to any highway project or multimodal project that:
(1) Requires FHWA approval regardless of funding sources, or
(2) Is funded with Federal-aid highway funds.
(b) In order to obtain FHWA approval, the highway agency shall develop noise policies in conformance with this regulation and shall apply these policies uniformly and consistently statewide.
(c) This regulation applies to all Type I projects unless the regulation specifically indicates that a section only applies to Type II or Type III projects.
(d) The development and implementation of Type II projects are not mandatory requirements of section 109(i) of title 23, United States Code.
(e) If a highway agency chooses to participate in a Type II program, the highway agency shall develop a priority system, based on a variety of factors, to rank the projects in the program. This priority system shall be submitted to and approved by FHWA before the highway agency is allowed to use Federal-aid funds for a project in the program. The highway agency shall re-analyze the priority system on a regular interval, not to exceed 5 years.
(f) For a Type III project, a highway agency is not required to complete a noise analysis or consider abatement measures.
(a) Any analysis required by this subpart must use the FHWA Traffic Noise Model (TNM), which is described in “FHWA Traffic Noise Model” Report No. FHWA–PD–96–010, including Revision No. 1, dated April 14, 2004, or any other model determined by the FHWA to be consistent with the methodology of the FHWA TNM. These publications are incorporated by reference in accordance with section 552(a) of title 5, U.S.C. and part 51 of title 1, CFR, and are on file at the National Archives and Record Administration (NARA). For information on the availability of this material at NARA, call (202) 741–6030 or go to
(b) Average pavement type shall be used in the FHWA TNM for future noise level prediction unless a highway agency substantiates the use of a different pavement type for approval by the FHWA.
(c) Noise contour lines may be used for project alternative screening or for land use planning to comply with § 772.17 of this part, but shall not be used for determining highway traffic noise impacts.
(d) In predicting noise levels and assessing noise impacts, traffic characteristics that would yield the worst traffic noise impact for the design year shall be used.
(a) The highway agency shall determine and analyze expected traffic noise impacts.
(1) For projects on new alignments, determine traffic noise impacts by field measurements.
(2) For projects on existing alignments, predict existing and design year traffic noise impacts.
(b) In determining traffic noise impacts, a highway agency shall give primary consideration to exterior areas where frequent human use occurs.
(c) A traffic noise analysis shall be completed for:
(1) Each alternative under detailed study;
(2) Each Activity Category of the NAC listed in Table 1 that is present in the study area;
(i)
(ii)
(iii)
(iv)
(v)
(vi)
(vii)
(A) A highway agency shall determine if undeveloped land is permitted for development. The milestone and its associated date for acknowledging when undeveloped land is considered permitted shall be the date of issuance of a building permit by the local jurisdiction or by the appropriate governing entity.
(B) If undeveloped land is determined to be perrmitted, then the highway agency shall assign the land to the appropriate Activity Category and analyze it in the same manner as developed lands in that Activity Category.
(C) If undeveloped land is not permitted for development by the date of public knowledge, the highway agency shall determine noise levels in accordance with 772.17(a) and document the results in the project's environmental clearance documents and noise analysis documents. Federal participation in noise abatement measures will not be considered for lands that are not permitted by the date of public knowledge.
(d) The analysis of traffic noise impacts shall include:
(1) Identification of existing activities, developed lands, and undeveloped lands, which may be affected by noise from the highway;
(2) For projects on new or existing alignments, validate predicted noise level through comparison between measured and predicted levels;
(3) Measurement of noise levels. Use an ANSI Type I or Type II integrating sound level meter;
(4) Identification of project limits to determine all traffic noise impacts for the design year for the build alternative. For Type II projects, traffic noise impacts shall be determined from current year conditions;
(e) Highway agencies shall establish an approach level to be used when determining a traffic noise impact. The approach level shall be at least 1 dB(A) less than the Noise Abatement Criteria for Activity Categories A to E listed in Table 1 to part 772;
(f) Highway agencies shall define substantial noise increase between 5 dB(A) to 15 dB(A) over existing noise levels. The substantial noise increase criterion is independent of the absolute noise level.
(g) A highway agency proposing to use Federal-aid highway funds for a Type II project shall perform a noise analysis in accordance with § 772.11 of this part in order to provide information needed to make the determination required by § 772.13(a) of this part.
(a) When traffic noise impacts are identified, noise abatement shall be considered and evaluated for feasibility and reasonableness. The highway agency shall determine and analyze alternative noise abatement measures to abate identified impacts by giving weight to the benefits and costs of abatement and the overall social, economic, and environmental effects by using feasible and reasonable noise abatement measures for decision-making.
(b) In abating traffic noise impacts, a highway agency shall give primary consideration to exterior areas where frequent human use occurs.
(c) If a noise impact is identified, a highway agency shall consider abatement measures. The abatement measures listed in § 772.15(c) of this part are eligible for Federal funding.
(1) At a minimum, the highway agency shall consider noise abatement in the form of a noise barrier.
(2) If a highway agency chooses to use absorptive treatments as a functional enhancement, the highway agency shall adopt a standard practice for using absorptive treatment that is consistent and uniformly applied statewide.
(d) Examination and evaluation of feasible and reasonable noise abatement measures for reducing the traffic noise impacts. Each highway agency, with FHWA approval, shall develop feasibility and reasonableness factors.
(1) Feasibility:
(i) Achievement of at least a 5 dB(A) highway traffic noise reduction at impacted receptors. The highway agency shall define, and receive FHWA approval for, the number of receptors that must achieve this reduction for the noise abatement measure to be acoustically feasible and explain the basis for this determination; and
(ii) Determination that it is possible to design and construct the noise abatement measure. Factors to consider are safety, barrier height, topography, drainage, utilities, and maintenance of
(2) Reasonableness:
(i) Consideration of the viewpoints of the property owners and residents of the benefited receptors. The highway agency shall solicit the viewpoints of all of the benefited receptors and obtain enough responses to document a decision on either desiring or not desiring the noise abatement measure. The highway agency shall define, and receive FHWA approval for, the number of receptors that are needed to constitute a decision and explain the basis for this determination.
(ii) Cost effectiveness of the highway traffic noise abatement measures. Each highway agency shall determine, and receive FHWA approval for, the allowable cost of abatement by determining a baseline cost reasonableness value. This determination may include the actual construction cost of noise abatement, cost per square foot of abatement, the maximum square footage of abatement/benefited receptor and either the cost/benefited receptor or cost/benefited receptor/dB(A) reduction. The highway agency shall re-analyze the allowable cost for abatement on a regular interval, not to exceed 5 years. A highway agency has the option of justifying, for FHWA approval, different cost allowances for a particular geographic area(s) within the State, however, the highway agancy must use the same cost reasonableness/construction cost ratio statewide.
(iii) Noise reduction design goals for highway traffic noise abatement measures. When noise abatement measure(s) are being considered, a highway agency shall achieve a noise reduction design goal. The highway agency shall define, and receive FHWA approval for, the design goal of at least 7 dB(A) but not more than 10 dB(A), and shall define the number of benefited receptors that must achieve this design goal and explain the basis for this determination.
(iv) The reasonableness factors listed in § 772.13(d)(5)(i), (ii) and (iii), must collectively be achieved in order for a noise abatement measure to be deemed reasonable. Failure to achieve § 772.13(d)(5)(i), (ii) or (iii), will result in the noise abatement measure being deemed not reasonable.
(v) In addition to the required reasonableness factors listed in § 772.13(d)(5)(i), (ii), and (iii), a highway agency has the option to also include the following reasonableness factors: Date of development, length of time receivers have been exposed to highway traffic noise impacts, exposure to higher absolute highway traffic noise levels, changes between existing and future build conditions, percentage of mixed zoning development, and use of noise compatible planning concepts by the local government. No single optional reasonableness factor can be used to determine reasonableness.
(e) Assessment of Benefited Receptors. Each highway agency shall define the threshold for the noise reduction which determines a benefited receptor as at or above the 5 dB(A), but not to exceed the highway agency's reasonableness design goal.
(f) Abatement Measure Reporting: Each highway agency shall maintain an inventory of all constructed noise abatement measures. The inventory shall include the following parameters: type of abatement; cost (overall cost, unit cost per/sq. ft.); average height; length; area; location (State, county, city, route); year of construction; average insertion loss/noise reduction as reported by the model in the noise analysis; NAC category(s) protected; material(s) used (precast concrete, berm, block, cast in place concrete, brick, metal, wood, fiberglass, combination, plastic (transparent, opaque, other); features (absorptive, reflective, surface texture); foundation (ground mounted, on structure); project type (Type I, Type II, and optional project types such as State funded, county funded, tollway/turnpike funded, other, unknown). The FHWA will collect this information, in accordance with OMB's Information Collection requirements.
(g) Before adoption of a CE, FONSI, or ROD, the highway agency shall identify:
(1) Noise abatement measures which are feasible and reasonable, and which are likely to be incorporated in the project; and
(2) Noise impacts for which no noise abatement measures are feasible and reasonable.
(3) Documentation of highway traffic noise abatement: The environmental document shall identify locations where noise impacts are predicted to occur, where noise abatement is feasible and reasonable, and locations with impacts that have no feasible or reasonable noise abatement alternative. For environmental clearance, this analysis shall be completed to the extent that design information on the alterative(s) under study in the environmental document is available at the time the environmental clearance document is completed. A statement of likelihood shall be included in the environmental document since feasibility and reasonableness determinations may change due to changes in project design after approval of the environmental document. The statement of likelihood shall include the preliminary location and physical description of noise abatement measures determined feasible and reasonable in the preliminary analysis. The statement of likelihood shall also indicate that final recommendations on the construction of an abatement measure(s) is determined during the completion of the project's final design and the public involvement processes.
(h) The FHWA will not approve project plans and specifications unless feasible and reasonable noise abatement measures are incorporated into the plans and specifications to reduce the noise impact on existing activities, developed lands, or undeveloped lands for which development is permitted.
(i) For design-build projects, the preliminary technical noise study shall document all considered and proposed noise abatement measures for inclusion in the NEPA document. Final design of design-build noise abatement measures shall be based on the preliminary noise abatement design developed in the technical noise analysis. Noise abatement measures shall be considered, developed, and constructed in accordance with this standard and in conformance with the provisions of 40 CFR 1506.5(c) and 23 CFR 636.109.
(j) Third party funding is not allowed on a Federal or Federal-aid Type I or Type II project if the noise abatement measure would require the additional funding from the third party to be considered feasible and/or reasonable. Third party funding is acceptable on a Federal or Federal-aid highway Type I or Type II project to make functional enhancements, such as absorptive treatment and access doors or aesthetic enhancements, to a noise abatement measure already determined feasible and reasonable.
(k) On a Type I or Type II projects, a highway agency has the option to cost average noise abatement among benefited receptors within common noise environments if no single common noise environment exceeds two times the highway agency's cost reasonableness criteria and collectively all common noise environments being averaged do not exceed the highway agency's cost reasonableness criteria.
(a)
(1) Traffic noise impacts have been identified; and
(2) Abatement measures have been determined to be feasible and
(b)
(2) Federal funds are available for Type II noise barriers along lands that were developed or were under substantial construction before approval of the acquisition of the rights-of-ways for, or construction of, the existing highway.
(3) FHWA will not approve noise abatement measures for locations where such measures were previously determined not to be feasible and reasonable for a Type I project.
(c)
(1) Construction of noise barriers, including acquisition of property rights, either within or outside the highway right-of-way. Landscaping is not a viable noise abatement measure.
(2) Traffic management measures including, but not limited to, traffic control devices and signing for prohibition of certain vehicle types, time-use restrictions for certain vehicle types, modified speed limits, and exclusive lane designations.
(3) Alteration of horizontal and vertical alignments.
(4) Acquisition of real property or interests therein (predominantly unimproved property) to serve as a buffer zone to preempt development which would be adversely impacted by traffic noise. This measure may be included in Type I projects only.
(5) Noise insulation of Activity Category D land use facilities listed in Table 1. Post-installation maintenance and operational costs for noise insulation are not eligible for Federal-aid funding.
(a) To minimize future traffic noise impacts on currently undeveloped lands of Type I projects, a highway agency shall inform local officials within whose jurisdiction the highway project is located of:
(1) Noise compatible planning concepts;
(2) The best estimation of the future design year noise levels at various distances from the edge of the nearest travel lane of the highway improvement where the future noise levels meet the highway agency's definition of “approach” for undeveloped lands or properties within the project limits. At a minimum, identify the distance to the exterior noise abatement criteria in Table 1;
(3) Non-eligibility for Federal-aid participation for a Type II project as described in § 772.15(b).
(b) If a highway agency chooses to participate in a Type II noise program or to use the date of development as one of the factors in determining the reasonableness of a Type I noise abatement measure, the highway agency shall have a statewide outreach program to inform local officials and the public of the items in § 772.17(a)(1) through (3).
For all Type I and II projects, a highway agency shall:
(a) Identify land uses or activities that may be affected by noise from construction of the project. The identification is to be performed during the project development studies.
(b) Determine the measures that are needed in the plans and specifications to minimize or eliminate adverse construction noise impacts to the community. This determination shall include a weighing of the benefits achieved and the overall adverse social, economic, and environmental effects and costs of the abatement measures.
(c) Incorporate the needed abatement measures in the plans and specifications.
Coast Guard, DHS.
Temporary interim rule with request for comments.
The Coast Guard is establishing a regulated navigation area (RNA) from Port Coeymans, New York on the Hudson River to Jersey City, New Jersey on Upper New York Bay, and from Jersey City to the Willis Avenue Bridge site on the Harlem River, New York, including all waters of the East River between these two locations. This action is necessary to provide for the safety of life on the navigable waters during the load out and transit of the Willis Avenue Bridge replacement span.
This rule is effective from July 13, 2010 through October 31, 2010. The RNA will be enforced from 3 a.m. on Monday, July 12, 2000, to 11:30 p.m. on Saturday, August 7, 2010. Comments and related material must reach the Coast Guard on or before August 12, 2010. Requests for public meetings must be received by the Coast Guard on or before August 12, 2010.
Documents indicated in this preamble as being available in the docket are part of docket USCG–2009–1056 and are available online by going to
You may submit comments identified by docket number USCG–2009–1056 using any one of the following methods:
(1)
(2)
(3)
(4)
To avoid duplication, please use only one of these four methods. See the “Public Participation and Request for Comments” portion of the
If you have questions on this interim rule, call or e-mail Mr. Jeff Yunker, Waterways Management Division at Coast Guard Sector New York, telephone 718–354–4195, e-mail
We encourage you to participate in this rulemaking by submitting comments and related materials. All comments received will be posted, without change, to
As this temporary interim rule will be in effect before the end of the comment period, the Coast Guard will evaluate and revise this rule as necessary to address significant public comments.
If you submit a comment, please include the docket number for this rulemaking (USCG–2009–1056), indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online (via
To submit your comment online, go to
To view comments, as well as documents mentioned in this preamble as being available in the docket, go to
Anyone can search the electronic form of comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union,
We do not now plan to hold a public meeting. You may submit a request for one using one of the four methods specified under
The Coast Guard is issuing this temporary interim rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule. This rule establishes an RNA to provide for the safety of life on the navigable waters during the load out and transit of the Willis Avenue Bridge replacement span. It is impracticable to issue an NPRM and take public comment before July 12, 2010, when the load out and transit is scheduled to begin. Due to delays on other construction projects in the Gulf of Mexico, the calendar dates for the load out and transit were not confirmed until early May 2010. This delayed the projected arrival of specialized self propelled transporters necessary to move the Willis Avenue Bridge replacement span from its construction site at Port Coeymans, New York onto the barges transporting the bridge span to its installation site on the Harlem River in New York City. This in turn delayed the dates for all of the subsequent restrictions. Delaying either the bridge load out and transit, or creation of the RNA, is contrary to the public interest because the bridge will be a public convenience and because the RNA will provide for public safety by safeguarding both mariners and construction workers during the bridge's construction and transportation of the replacement bridge span. We are requesting public comment on the RNA, and if we receive public input that indicates a need to revise the RNA or the conditions it imposes, or raises any other significant public concerns, we will address those concerns prior to issuing any final rule. For the same reasons, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
Under the Ports and Waterways Safety Act, the Coast Guard has the authority to establish RNAs in defined water areas that are determined to have hazardous conditions and in which vessel traffic can be regulated in the interest of safety.
The New York City Department of Transportation is replacing the Willis Avenue Bridge over the Harlem River. The replacement bridge span for this project is being constructed at Port Coeymans, NY on the Hudson River, approximately 115 nautical miles north of The Battery, Manhattan, NY. The transfer of the bridge span from the Port Coeymans Terminal to two Weeks Marine barges and transit to the installation site on the Harlem River is scheduled for the week of July 12, 2010. The week of July 19, 2010 will be used as a contingency in case of delays. The installation of the bridge span on the Harlem River is scheduled for August 2, 2010.
The load out of the new Willis Avenue Bridge span involves large machinery and construction vessel operations above and upon the navigable waters between Port Coeymans on the Hudson River, Upper New York Bay, the East River, and the bridge installation site at mile 1.5 on the Harlem River. Heavy-lift operations are sensitive to water movement, and wake from passing vessels could pose significant risk of injury or death to construction workers. The ongoing operations are, by their nature, hazardous and pose risks both to recreational and commercial vessel traffic and the bridge construction crew. In order to mitigate the inherent risks involved in the construction, it is necessary to control vessel movement through the area. The Coast Guard negotiated the terms of necessary navigation restrictions with the Kiewit and Weeks Marine contractors, and with Hudson River and Sandy Hook Pilots.
This temporary interim rule establishes an RNA on designated waters on the Hudson River and in the New York City area. It is intended to ensure the safety of the public and vessels during the transfer and transit of the 363 foot long bridge span from Port Coeymans, NY to the Harlem River, NY via Upper New York Bay and Buttermilk Channel. The enforcement times given in this discussion for the various restrictions depend on transit conditions and may be changed due to inclement weather or other circumstances. Changes will be provided to the public by the on scene patrol vessels, Coast Guard Vessel Traffic Service New York, and/or Safety Voice Broadcasts. Except for persons or vessels authorized by the Coast Guard Captain of the Port New York or the designated representative, no person or vessel may enter or remain in the RNA during the enforcement period.
No vessels will be authorized between Hudson River Light 191 LLNR 38865 and Hudson River Light 193 LLNR 38875 at Coeymans, NY from 3 a.m. on Monday, July 12, 2010 until 8 a.m. on Tuesday, July 13, 2010. In case of inclement weather or construction delays this restriction will be established from 7 a.m. on Monday, July 19, 2010 until 7 a.m. on Tuesday, July 20, 2010.
No vessels will be authorized within 100 yards of the two Weeks Marine barges once the bridge span has been loaded onto the barges at Port Coeymans. Vessels will be required to transit at No Wake speed when passing the two Weeks Marine barges.
A No Meeting and No Overtaking zone will be established as the barges and bridge span transit from Port Coeymans to just south of the entrance to Rondout Creek. This zone will be established on Tuesday, July 13, 2010 or Wednesday, July 14, 2010 for approximately 9 hours and 30 minutes based on the expected transit speed of 4 knots. In case of inclement weather or construction delays this restriction will be established from 5:30 a.m. to 3 p.m. on Tuesday, July 20, 2010.
A No Meeting and No Overtaking zone will be established as the barges and bridge span transit between the eastern and western sections of Anchorage Ground No. 19 on the Hudson River. This zone will be established for approximately 60 minutes on Tuesday, July 13, or Wednesday, July 14, 2010, based on the expected transit speed of 4 knots. In case of inclement weather or construction delays this restriction will be established from 7:45 a.m. to 8:45 a.m. on Wednesday, July 21, 2010.
A No Meeting and No Overtaking zone will be established as the barges and bridge span transit Buttermilk Channel from its entrance at Anchorage Channel until the barges pass the northwest corner of Pier 2, Brooklyn. This zone will be established on Wednesday, July 14, 2010 from approximately 11 a.m. to 11:45 a.m. based on the expected transit speed of 4 knots.
The East River will be closed to all other vessel traffic between the Con Ed East River Generating Station at East 14th Street, Manhattan, and the Hell Gate Railroad Bridge at river mile 8.2. This restriction will be established on Wednesday, July 14, 2010 from approximately 12:20 p.m. to 1:45 p.m. based on the expected transit speed of 4 knots.
The Harlem River will be closed to all other vessel traffic between the 125th Street/Triborough/RFK Bridge (mile 1.3) and 500 feet north of the Willis Ave Bridge (mile 1.5). This restriction will be established on Monday, August 2, 2010 from approximately 5 a.m. to 6 p.m. during the installation of the bridge span.
We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.
This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order.
We expect the economic impact of this rule will not be significant due to the limited duration that the regulated area would be in effect and enforced. Also, the Hudson River closure during the transfer of the bridge span from shore to the barges has been scheduled on a weekday when it is expected to have minimal impact on recreational vessels. The Harlem River closure will be coordinated with vessel operators that regularly schedule Manhattan Island tours.
In addition, advance notifications will be made to the maritime community via the Local Notice to Mariners, marine information broadcasts and online at
Under the Regulatory Flexibility Act (5 U.S.C. 601–612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.
The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
This rule will affect the following entities, some of which may be small entities: The owners or operators of vessels intending to transit or anchor in a portion of the Hudson, East and Harlem Rivers and Upper New York Bay south of 42°29′11.692″ N, 073°47′14.142″ W (Hudson River LIGHT 193 LLNR 38875) from 3 a.m. on July 12, 2010 to 11:30 p.m. on August 7, 2010.
This RNA will not have a significant economic impact on a substantial number of small entities for the following reasons: The RNA will only stop vessels from transiting three specified locations on the Hudson, Harlem, and East Rivers, the 24-hour closure of the Hudson River at Port Coeymans has been scheduled on a weekday to reduce the impact to recreational vessels that are more prevalent on weekends, the East River closure between the Con Ed East River Generating Station and the Hell Gate Railroad Bridge will only be in effect for approximately 85 minutes and vessels can adjust their schedules, the Harlem River closure at the bridge installation site will be coordinated with vessel operators that regularly schedule Manhattan Island tours; the No Meeting and No Overtaking zones are established in areas identified by Weeks Marine, Hudson River and Sandy Hook Pilots as requiring additional safety measures due to the waterway characteristics and characteristics of vessels using the waterways in those locations. Before the effective period, we will issue maritime advisories widely available to users of the waterway.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104–121), we offer to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process.
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1–888–REG–FAIR (1–888–734–3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531–1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or Tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.
This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.
This rule does not have Tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes.
We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.
The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (
This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.
We have analyzed this rule under Department of Homeland Security Management Directive 023–01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321–4370f), and have concluded this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded, under figure 2–1, paragraph (34)(g), of the Instruction. This rule involves the establishing of a RNA and therefore falls within the categorical exclusion noted above. An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated under
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; Pub. L. 107–295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(2) Weeks Marine barges means a barge operated by the Weeks Marine Company.
(c)
(1) No person or vessel may enter, transit, or remain in the RNA on the Hudson River between 42°28′42.100″ N, 073°47′19.100″ W (Hudson River LIGHT 191 LLNR 38865) and 42°29′11.692″ N, 073°47′14.142″ W (Hudson River LIGHT 193 LLNR 38875); on the East River between 40°43′36.210″ N, 073°58′17.750″ W, at the Con Ed East River Generating Station at East 14th Street Manhattan and the Hell Gate Railroad Bridge at river mile 8.2; on the Harlem River between the 125th Street/Triborough/RFK Bridge (mile 1.3) and 500 feet north of the Willis Ave Bridge (mile 1.5).
(2) No commercial vessel may meet, or overtake, the Weeks Marine barges when they are transiting the following waters:
(i) The Hudson River from Port Coeymans, NY to 41°54′59.712″ N, 073°57′36.126″ W (Hudson River Lighted Buoy 73 LLNR 38183) 500 yards south of the entrance to Rondout Creek. (ii) The Hudson River between the eastern and western sections of Anchorage Ground No. 19.
(iii) Buttermilk Channel from its entrance at Anchorage Channel, about 175 yards north of 40°40′18.971″ N, 074°02′24.006″ W (Gowanus Flats Lighted Bell Buoy 32 LLNR 34990) until the barges pass the northwest corner of Pier 2 Brooklyn.
(iv) The Harlem River from the 103rd Street Foot Bridge (mile 0.0) to the Willis Ave Bridge at mile 1.5.
(2) No vessels are authorized within 100 yards of the two Weeks Marine barges while carrying the bridge span.
(3) All vessels must transit at reduced speed to minimize wake and surge when transiting past the Weeks Marine barges carrying the bridge span.
(4) All persons and vessels shall comply with the instructions of the COTP or the designated representative. Upon being hailed by a U.S. Coast Guard or other law enforcement vessel by siren, radio, flashing light, or other means the operator of a vessel shall proceed as directed.
(5) Vessel operators desiring to enter or operate within the RNA shall request permission to do so by contacting the COTP at 203–354–4195, or VTS NY via VHF Channel 13 or 16.
(d)
Department of Veterans Affairs.
Final rule.
The Department of Veterans Affairs (VA) is amending its adjudication regulations governing service connection for posttraumatic stress disorder (PTSD) by liberalizing in some cases the evidentiary standard for establishing the required in-service stressor. This amendment eliminates the requirement for corroborating that the claimed in-service stressor occurred if a stressor claimed by a veteran is related to the veteran's fear of hostile military or terrorist activity and a VA psychiatrist or psychologist, or a psychiatrist or psychologist with whom VA has contracted, confirms that the claimed stressor is adequate to support a diagnosis of PTSD and that the veteran's symptoms are related to the claimed stressor, provided that the claimed stressor is consistent with the places, types, and circumstances of the veteran's service.
This amendment takes into consideration the current scientific research studies relating PTSD to exposure to hostile military and terrorist actions. The amendment acknowledges the inherently stressful nature of the places, types, and circumstances of service in which fear of hostile military or terrorist activities is ongoing. With this amendment, the evidentiary standard of establishing an in-service stressor will be reduced in these cases. The amendment will facilitate the timely processing of PTSD claims by simplifying the development and research procedures that apply to these claims.
• Is received by VA on or after July 12, 2010;
• Was received by VA before July 12, 2010 but has not been decided by a VA regional office as of that date;
• Is appealed to the Board of Veterans' Appeals (Board) on or after July 12, 2010;
• Was appealed to the Board before July 12, 2010 but has not been decided by the Board as of that date; or
• Is pending before VA on or after July 12, 2010 because the Court of Appeals for Veterans Claims (Veterans Court) vacated a Board decision on the application and remanded it for readjudication.
Thomas J. Kniffen, Chief, Regulations Staff (211D), Compensation and Pension Service, Veterans Benefits Administration, Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420, (202) 461–9725. (This is not a toll-free number.)
On August 24, 2009, VA published in the
Interested persons were invited to submit written comments on or before October 23, 2009. We received 126 comments on the proposed rule. VA received comments from veterans service organizations, including The American Legion, National Organization of Veterans' Advocates, Disabled American Veterans, Veterans for Common Sense, Paralyzed Veterans of America, and The Wounded Warrior Project; from public interest groups, including the Los Angeles Inner City Law Center and National Research Center for Women and Families; from government agencies, such as the New York City Department of Health and Mental Hygiene and the State of New York Division of Veterans Affairs; and from individuals. VA also received comments from members of the Subcommittee on Disability Assistance and Memorial Affairs of the House of Representatives Committee on Veterans' Affairs and other persons who participated in a roundtable discussion of the proposed rule, as well as from members of Congress.
We also received numerous comments from veterans and surviving spouses regarding their individual claims for veterans benefits. We do not respond to these comments in this notice as they are beyond the scope of this rulemaking.
Some commenters suggested that VA revise the rule to create a presumption of service connection for PTSD based upon receipt of imminent-danger or hostile-fire pay. We make no change based on these comments because they are beyond the scope of the rule, which is limited to providing a reduced evidentiary standard for establishing occurrence of the stressor based upon a particular type of stressor.
Some commenters suggested that the rule should be revised to reduce the evidentiary standard for veterans who had certain Military Occupational Specialties (MOS). A MOS may be considered as evidence of exposure to a stressor, including hostile military or terrorist activity.
Some commenters interpreted the proposed rule as limited to fear of hostile or terrorist activity while serving in a combat zone, and others suggested that the rule should be revised to provide a reduced evidentiary standard on the basis of service in a combat zone. One commenter asked whether the rule applies to veterans who served on a submarine. The rule has no geographic requirement and is not limited to service in a combat zone or on land. Rather, it applies to all persons who served in active military, naval, or air service, as defined in 38 U.S.C. 101(24), and were discharged or released from
One commenter stated the term “stressor” is ambiguous and may lead one to believe that the rule applies only if a veteran can identify a single specific event instead of hostile military or terrorist activity generally. One commenter suggested that the rule should apply as well to a series of events or the totality of circumstances of deployment to a combat zone. Another commenter questioned the meaning of the phrase “consistent with the . . . circumstances of service” and doubted whether an examiner would ever find that a traumatic event experienced by a veteran who had an MOS of cook is consistent with the circumstances of the veteran's service. Another commenter inquired about whether the examiner would be responsible for determining whether the stressor is consistent with the veteran's service.
VA believes that the language in the proposed rule is not ambiguous. As stated in the rule, “ `fear of hostile military or terrorist activity' means that a veteran experienced, witnessed, or was confronted with an event
One commenter stated that the term “confronted with an event or events that involved actual or threatened death or serious injury, or a threat to the physical integrity of self or others” implies that a veteran must experience an event that is close and highly lethal. As stated above, there is no geographic requirement for the regulation. However, the stressor must be consistent with the places, types, and circumstances of the veteran's service. 38 U.S.C. 1154. In addition, an event does not have to be lethal. As provided in the rule, the traumatic event can involve actual or threatened serious injury, as well as death, or a threat to the physical integrity of the veteran or others.
One commenter stated that the list of examples in the definition of “fear of hostile military or terrorist activity” is incomplete and would “likely result in [VA] rejecting as adequate stressors such events as injuring or killing of civilians.” Another commenter suggested adding language to clarify that an event or circumstance does not have to include one of the situations listed in the definition,
A commenter suggested that the definition of “fear of hostile military or terrorist activity” be extended to include domestic as well as foreign activity. The regulation is not limited to events or circumstances perpetrated by a foreign enemy. Therefore, VA makes no change based on the comment.
Some commenters said that VA should define when a stressor would be considered consistent with the places, types, and circumstances of the veteran's service. One commenter asked whether a veteran's claimed fear of hostile military activity during service in South Korea after the Korean Conflict ended or in the continental United States after September 11, 2001, would be consistent with the places, types, and circumstances of such service. Another commenter suggested that the rule should explain the types of evidence needed to establish consistency with the places, types, and circumstances of service.
The question of consistency is a matter involving application of 38 U.S.C. 1154(a) and 38 CFR 3.303(a) to the myriad of facts presented by individual claims. We note, however, that inclusion of the conjunction “and” in the statute and regulation means that a stressor must be consistent with all three of the enumerated criteria.
The epidemiologic literature on deployed vs[.] nondeployed veterans yielded sufficient evidence of an association between deployment to a war zone and psychiatric disorders, including [PTSD], other anxiety disorders, and depression; alcohol abuse; accidental death and suicide in the first few years after return from deployment; and marital and family conflict, including interpersonal violence.
Some commenters inquired whether the rule would cover a service member who experienced fear of hostile military or terrorist activity after learning about the experiences of others with such activity but before being deployed to a war zone. It is not our intention that the new evidentiary standard apply in such a situation, and we do not interpret the rule to cover that situation. Such a claim would be adjudicated under the generally applicable standard set forth in the introductory text of 38 CFR 3.304(f). The IOM Committee “defin[ed] deployment-related stress as deployment to a war zone” and “considered that military personnel deployed to a war zone, even if direct combat was not experienced, have the potential for exposure to deployment-related stressors that might elicit a stress response.” IOM Report at 13. Consistent with these findings, the rule is intended to apply only when the veteran's service is proximate in time and place to the traumatic event to which the veteran has responded with intense fear, helplessness, or horror. This is consistent with current provisions of 38 CFR 3.304(f) that do not require corroborating evidence of occurrence of a stressor if a veteran was diagnosed with PTSD in service, engaged in combat with the enemy, or was a prisoner of war,
VA also received comments suggesting that the rule should cover stressors such as MST, abuse by military personnel of subordinate military personnel, harassment, suicide of a fellow service member, witnessing a military vehicle accident in the United States, a fellow soldier's or sailor's post-service suicide, and social, political, and economic discrimination. One commenter suggested that VA should promulgate a similar rule to assist those with physical injuries due to hostile military or terrorist activity. These comments are outside the scope of this rule. Therefore, we make no change based on them. However, regarding MST, we note as well that 38 CFR 3.304(f)(5) (before this rulemaking codified at 38 CFR 3.304(f)(4)) permits evidence other than a veteran's service records to corroborate the occurrence of an in-service personal assault and prohibits VA from denying a claim for service connection for PTSD based on in-service personal assault without first advising the claimant that evidence from sources other than a veteran's service records may prove the stressor occurred.
A number of commenters suggested that use of the term PTSD is socially stigmatizing, is embarrassing to combat veterans, and may cause veterans to forego needed professional treatment. One commenter suggested that VA re-categorize PTSD rated as 70 percent or more disabling as post-combat stress disorder to diminish the stigma associated with a diagnosis of PTSD, encourage veterans to seek treatment, and prevent possible suicide. As explained in 38 CFR 4.130, the nomenclature in the VA schedule of ratings for mental disorders is based upon the DSM–IV, and 38 CFR 4.125 requires that a diagnosis of a mental disorder conform to the DSM–IV in order to substantiate a claim. Because the DSM–IV does not include post-combat stress disorder as a diagnosis, we make no change based on these comments.
VA received written comments objecting to the liberalizing evidentiary standard for PTSD claims based on fear of hostile military or terrorist activity. Several commenters alleged that the rule implies that all a veteran must do to be granted service connection is communicate that he or she experienced “fear” to corroborate a stressor, will invite frivolous or fraudulent claims against the Federal Government, is offensive to heroic combat veterans of current and past wartime periods, and will delay adjudication of their claims. One commenter suggested that VA should re-evaluate veterans diagnosed with PTSD.
The reduced evidentiary standard provided by the rule is not applicable solely because a veteran reports that he or she experienced fear. Under the rule, VA will not rely on a veteran's lay testimony alone to establish occurrence of the stressor unless the following requirements are satisfied. First, the veteran must have experienced, witnessed, or have been confronted by an event or circumstance that involved actual or threatened death or serious injury, or a threat to the physical integrity of the veteran or others, and the veteran's response to the event or circumstance must have involved a psychological or psycho-physiological state of fear, helplessness, or horror. Second, a VA psychiatrist or psychologist, or a psychiatrist or psychologist with whom VA has contracted, must confirm that the claimed stressor is adequate to support a diagnosis of PTSD and that the veteran's symptoms are related to the claimed stressor. Third, there must be in the record no clear and convincing evidence to the contrary, and fourth, the claimed stressor must be consistent with the places, types, and circumstances of the veteran's service. Because all of these requirements must be met for the veteran's lay testimony alone to establish the occurrence of the claimed stressor, we believe the likelihood of fraud to be minimal. Finally, 38 CFR 3.327(a) requires a reexamination whenever VA determines there is a need to verify either the continued existence or the current severity of a disability.
This rule is not intended to discount the heroic efforts of combat veterans, but rather is VA's response to scientific studies related to PTSD and military troop deployment. As noted in the proposed rule:
Combat is one of the most potent stressors that a person can experience, but as military conflicts have evolved to include more guerilla warfare and insurgent activities, restricting the definition of deployment-related stressors to combat may fail to acknowledge other potent stressors experienced by military personnel in a war zone or in the aftermath of combat. Those stressors include constant vigilance against unexpected attack, the absence of a defined front line, the difficulty of distinguishing enemy combatants from civilians, the ubiquity of improvised explosive devices, caring for the badly injured or dying, duty on the graves registration service, and being responsible for the treatment of prisoners of war.
Some commenters stated that the proposed rule is inconsistent with DSM–IV, which does not require “a psychological or psycho-physiological state of fear, helplessness, or horror” to a traumatic event. Another commenter stated that VA is prohibited from using terms in the regulation that do not appear in DSM–IV.
The commenters are incorrect. In order to satisfy the DSM–IV diagnostic criteria for PTSD, a person's response to a traumatic event must involve “intense fear, helplessness, or horror.” DSM–IV at 428. In addition, the traumatic event must be persistently reexperienced in one or more of several ways, including “intense psychological distress at exposure to internal or external cues that symbolize or resemble an aspect of the traumatic event” and “physiologic reactivity on exposure to internal or external cues that symbolize or resemble an aspect of the traumatic event,” all of which involve intense psychological stress or psycho-physiological response.
A commenter expressed concern that the rule is limited to “fear of hostile or terrorist activity” and asked whether a veteran would be entitled to the reduced evidentiary standard if the veteran manifested flashbacks and nightmares long after service. Both this rule and flashbacks and nightmares are related to the diagnostic criteria for PTSD, but they relate to distinct criteria. The rule relates to the criterion of a person's exposure to a traumatic event and the person's response to that event.
Another commenter asserted that the requirement in the rule that the stressor must be consistent with the places, types, and circumstances of a veteran's service renders the rule narrower than the DSM–IV definition of PTSD and that the requirement that the stressor relate to a veteran's fear of hostile military or terrorist activity narrows the DSM–IV definition of PTSD.
As indicated above, in replying to a comment about the meaning of the phrase “consistent with the * * * circumstances of service,” under 38 U.S.C. 1154(a), VA must duly consider the places, types, and circumstances of a veteran's service as shown by the veteran's service record, the official history of each organization in which such veteran served, the veteran's medical records, and all pertinent medical and lay evidence. Such consideration is a general requirement that applies to any service connection claim, not just claims for service connection of PTSD. Because section 1154 is the authority for this rule, we incorporate the statutory requirement into the rule.
Because the requirement that a claimed stressor relate to a veteran's fear of hostile military or terrorist activity has no effect on the diagnostic criteria for PTSD, the requirement does not narrow the DSM–IV definition of PTSD. The effect of the rule is to relax the evidentiary standard for establishing the occurrence of an in-service stressor for certain veterans, and the rule is limited to cases in which the claimed stressor is related to the veteran's fear of hostile military or terrorist activity for the reasons given in the notice of proposed rulemaking. Proposed Rule, 74 FR at 42618 (explaining that the rule is consistent with scientific studies related to PTSD and military troop deployment). The rule focuses on the procedure for establishing service connection for PTSD, not the criteria for establishing a legitimate diagnosis. Therefore, there is no inconsistency with the medical community at large, and we make no change based on the comment. In addition, the rule defines “fear of hostile military or terrorist activity” as “involv[ing] a psychological or psycho-physiological state of fear, helplessness, or horror.”
One commenter stated that fear of hostile military or terrorist activity may not be sufficient to give rise to a diagnosis of PTSD in accordance with DSM–IV absent occurrence of an actual event. We agree that the occurrence of an actual event or circumstance is necessary. In fact, as the commenter noted, the first DSM–IV diagnostic criterion for PTSD is exposure to a traumatic event. DSM–IV at 427. The rule does not permit diagnosis of PTSD in the absence of exposure to a traumatic event or circumstance. The rule lists several examples of events or circumstances that could give rise to the requisite fear. The rule eliminates the need for corroborating evidence of the event if the requirements of the rule are met.
Another commenter asserted that the Global Assessment of Functioning (GAF) score has limited use and should be replaced. Axis V of the DSM–IV multiaxial diagnosis system measures the overall severity of psychiatric disturbance based on the GAF Scale, which rates an individual's social, occupational, and psychological functioning. VA regulations do not require a GAF score for purposes of determining whether PTSD is service connected, although the score may be required or requested by the Veterans Court, the Board, or a rating specialist for purposes of assessing the extent of disability after service connection has been established. This comment is therefore beyond the scope of this rulemaking.
The majority of comments that VA received expressed disagreement with the requirement that the evidentiary standard for establishing occurrence of the stressor will be liberalized only if “a VA psychiatrist or psychologist, or a psychiatrist or psychologist with whom VA has contracted, confirms that the claimed stressor is adequate to support a diagnosis of [PTSD] and that the veteran's symptoms are related to the claimed stressor.” We have grouped these comments together by subject matter and address them below.
Some commenters asserted that the rule is contrary to 38 U.S.C. 5125, which one commenter contended means that VA must accept the opinion of a private physician if the opinion is adequate for rating purposes. In support of this contention, the commenter relied upon the heading of section 5125, “Acceptance of reports of private physician examinations.”
Section 5125 provides that, “[f]or purposes of establishing any claim for benefits under chapter 11 or 15 of [title 38], a report of a medical examination administered by a private physician that is provided by a claimant in support of a claim for benefits * * *
Commenters wrote that VA should accept the opinion of any psychiatrist or psychologist who evaluates the claimed condition based on the DSM–IV protocol or VA's protocol for PTSD examinations or who is certified by the APA. Several commenters asserted that private physicians provide more comprehensive and/or better examinations. Other commenters alleged that VA examiners refuse to diagnose PTSD and that their examinations are inconsistent and do not comply with DSM–IV. Also, one commenter contended that no confirmatory evidence from a VA psychiatrist or psychologist should be required because these examiners are often biased against claimants and likely to diagnose a mental disorder other than PTSD.
We decline to expand the rule to include the opinion of any psychiatrist or psychologist whose diagnosis conforms to DSM–IV or VA's protocol or who is certified by the APA because we believe that VA or contract examiners are uniquely qualified for the following reasons.
By making 38 U.S.C. 5125 discretionary rather than mandatory, Congress clearly recognized that there may be circumstances in which VA would require a confirmatory medical opinion. The situation described in this rule is such a circumstance because it eliminates the requirement of credible supporting evidence of the occurrence of an alleged non-combat stressor under 38 CFR 3.304(f) in the situation described. Because the rule permits the proof of an in-service stressor based on the claimant's lay statement alone, VA believes that it is reasonable to limit this liberalization to medical opinions from practitioners who it knows are well-skilled and well-equipped to provide such forensic evidence, rather than broaden the rule to include opinions from private physicians.
VA's need for such forensic evidence is particularly important in the case of a claim for service connection for a mental disorder.
When the DSM–IV categories, criteria, and textual descriptions are employed for forensic purposes, there are significant risks that diagnostic information will be misused or misunderstood. These dangers arise because of the imperfect fit between the questions of ultimate concern to the law and the information contained in a clinical diagnosis. * * *
Nonclinical decision makers should also be cautioned that a diagnosis does not carry any necessary implications regarding the causes of the individual's mental disorder or its associated impairments.
DSM–IV at xxiii;
A C&P examination for PTSD is particularly complex because an examiner must: (1) Make complex judgments about potential malingering in the context of an administrative evaluation that will have obvious financial implications for a veteran;
(2) Comprehensively diagnose all comorbid mental disorders and apportion disability to various disorders in veterans who increasingly have co-occurring mental disorders; and
(3) Render an informed opinion about the effects of PTSD on social and occupational functioning, requiring a careful and often time-consuming review of a veteran's history.
VA provides extensive guidance to VHA examiners about how to perform C&P examinations and gives specific guidance about PTSD examinations.
In addition, all PTSD C&P evaluations are performed by qualified examiners who utilize evidence-based instruments, as recommended in the Fiscal Year 2007 report of the VA Special Committee on PTSD. The Under Secretary for Health's Post-Traumatic Stress Disorder Special Committee: FY 2006 Annual Report, 9 (Jun. 5, 2007). In response to the Special Committee's recommendation, the Compensation and Pension Exam Program (CPEP), in conjunction with the Employee Education System and VHA/DoD Program Coordination Office, established a program requiring training and certification of all VHA clinicians who conduct C&P examinations, including Fee-for-Service Providers, which program includes special modules and tests for initial examinations for PTSD. VHA Directive 2008–005. In a May 2009 report to Congress, the Special Committee advised that the recommendation had been “met.”
The CPEP office also reviews the quality of examinations of claimants conducted by VHA clinicians, including PTSD examinations, and when CPEP identifies problems in the quality of examinations, steps are taken to improve the quality via CPEP-sponsored conferences and training.
VBA provides contract examiners with information regarding the requirements of C&P examinations, and the quality of examinations provided by VA contractors is reviewed quarterly by a physician and nurse employed by VBA.
In addition, VA psychiatrists and psychologists and contract examiners are often better informed about a veteran being examined than private practitioners are. When VBA requests a mental-disorder examination, including an examination for PTSD, it sends the claims folder to the examiner for the examiner's review. Manual M21–1 MR, Part III, subpart iv, ch. 3, sec. A, para. 1.e. The C&P examination worksheet for an initial evaluation for PTSD requires review of the veteran's claims file. The worksheet states, “A diagnosis of PTSD cannot be adequately documented or ruled out without obtaining a detailed military history and reviewing the claims folder.”
Finally, VA believes that the requirement in the rule for a confirmatory opinion from a VA psychiatrist or psychologist, or a psychiatrist or psychologist with whom VA has contracted, will “ensure standardization and consistency of mental health evaluations and reporting of these evaluations.” Proposed Rule, 74 FR at 42618. VHA performs over 700,000 C&P examinations annually, VHA Directive 2008–005, at 1, and contract physicians provide approximately 120,000 C&P examinations annually. As explained above, CPEP reviews VHA examination reports, and VBA reviews the reports of contract examiners. The review of these reports helps to guarantee the quality and consistency of PTSD examinations. However, VA has no control over the quality of examinations performed by private healthcare providers. Because VA is willing to liberalize the evidentiary standard for proving a stressor only in cases on which it can depend on the quality of the medical opinion, we decline to accept the opinion of any psychiatrist or psychologist as suggested.
With regard to the assertion that private physicians provide more comprehensive and/or better examinations, we believe that the protocol for initial VA examinations for PTSD, to which all VA and contract examiners must adhere, ensures comprehensive examinations addressing all aspects of a veteran's medical, social, and psychological history and the veteran's current mental status.
We are unaware of VA examiners who refuse to diagnose PTSD, are biased against claimants, or are likely to diagnose a mental disorder other than PTSD, as other commenters alleged. In fact, a VBA review revealed that, when C&P examinations were conducted, PTSD was diagnosed in 77% of initial claims.
Some commenters urged VA to accept confirmatory opinions from VA social workers, counselors, therapists, and former psychiatrists and psychologists. One commenter contended that consistency in examinations by such providers is guaranteed by VHA Handbook 1160.01, Uniform Mental Health Services in VA Medical Centers and Clinics,
With regard to former VA psychiatrists and psychologists, some former clinicians may not have been CPEP-certified depending upon when they were employed by VA. In addition, their examinations would not be subject to ongoing CPEP review, nor would they have access to a veteran's claims file to conduct the review required by the PTSD examination protocol. Therefore, VA would be unable to ensure standardization, consistency, and quality of their examinations. For that reason, we decline to permit their medical opinions to qualify for the evidentiary liberalization provided by this rule.
Two commenters stated that the rule might present a conflict for a VA examiner who is required to act in the best interests of his or her patient. VBA Fast Letter 06–03 acknowledges that, “[t]o maintain the integrity of the patient-provider relationship, it is preferable that a veteran's treating health care provider not perform the C&P examination,” and advises that, when an adjudicator requests a mental-disorder examination or opinion, the adjudicator “specify that the veteran's treating health care provider should not perform the examination if possible.” This should avert any conflict.
A commenter expressed concern about the training and education of psychiatrists or psychologists employed by VA or with whom VA has contracted and stated that it may be necessary for these examiners to receive training in military history. Another commenter said that the rule would require veterans to visit doctors who may be unfamiliar with their medical and treatment histories and could unnecessarily cause veterans to relive past stressors in order to establish service connection for a disability for which they have already been diagnosed. The commenter also said that the rule would impose on veterans who live in rural states an unreasonable burden to travel long distances to obtain the requisite examination by a VA psychiatrist or psychologist or an examiner with whom VA has contracted.
VA examiners are well-trained in how to interact with veterans during a C&P examination. As explained above, the PTSD examination protocol requires examiners to review the veteran's claims file so that the examiner will be familiar with the veteran's medical and military history. See
it is important to explain to the claimant that it is necessary to obtain a detailed description of one or more traumatic events related to military service, in order to complete the examination. Further, it is helpful to alert him or her to the fact that trauma assessment, though brief (about 15–20 minutes), may cause some distress. The veteran should be advised that trauma assessment is a mutual and collaborative process, and that he or she is not required to provide unnecessarily detailed answers to all questions, if it is too distressing to do so.
VA recognizes that an accurate diagnosis of PTSD requires extended discussion of experiences that may have been extremely traumatic and that repression, denial, and general haziness of memories are often hurdles in obtaining an adequate military history.
As for the availability of examiners to provide the opinions required by the rule, VA intends to carefully monitor the need for examiners in various regions of the country and to make examiners available in response to demand. In fact, one reason for using contract examiners is to provide qualified examiners in places far from the closest VA medical facility.
Some commenters suggested that VA expand the rule to include the opinion of a private licensed therapist, counselor, or social worker who has treated the claimant. To ensure that examiners are competent to provide findings and opinions that are valid and necessary for rating purposes, VBA determined that individuals who conduct C&P mental disorder examinations must have specific qualifications. VBA Fast Letter 06–03. Only mental health professionals with the following credentials are qualified to perform initial C&P mental disorder examinations: (1) Board-certified psychiatrists or board-“eligible” psychiatrists; (2) licensed doctorate-level psychologists; (3) doctorate-level mental health providers under the close supervision of a board-certified or board-eligible psychiatrist or licensed doctorate-level psychologist; (4) psychiatry residents under the close supervision of a board-certified or board-eligible psychiatrist or licensed doctorate-level psychologist; and (5) clinical or counseling psychologists completing a one-year internship or residency (for purposes of a doctorate-level degree) under the close supervision of a board-certified or board-eligible psychiatrist or licensed doctorate-level psychologist. Because VA has no guarantee that a private licensed therapist, counselor, or social worker who has treated a veteran has the qualifications required for a C&P mental disorder examination, we decline to adopt the commenters' suggestion.
Some commenters asserted that the requirement for a confirmatory opinion from a VA practitioner or contract examiner discriminates against veterans with PTSD or veterans whose claims are based on a particular type of stressor and potentially violates their right to equal protection under the law. Another commenter asserted that the rule violates due process by denying a claimant the ability to submit competent medical evidence from private mental health professionals to rebut the VA opinion. One commenter suggested that the rule should specifically provide for rebuttal of the VA examiner's opinion with non-VA evidence. Also, commenters asserted that the rule would not permit a veteran to submit evidence from a private physician or psychologist or would require VA to reject such an opinion, thereby conflicting with VA's obligation to consider all evidence of record, and would violate the benefit of the doubt rule. Another commenter asserted that, absent the opinion of a VA psychiatrist or psychologist confirming that the claimed stressor is adequate to support a PTSD diagnosis and that the veteran's symptoms are related to the claimed stressor, VA adjudicators would not weigh or analyze the evidence. Other commenters asserted that the rule would violate 38 CFR 3.303(a) and 38 U.S.C. 5107(b).
These concerns are unfounded. Nothing in the rule precludes a claimant from submitting private medical evidence, permits VA to ignore any evidence that is submitted, or requires VA to reject an opinion from a private physician or psychologist. Statute and regulation require VA to consider all information and lay and medical evidence of record when deciding a claim for veterans benefits. 38 U.S.C. 5107(b); 38 CFR 3.303(a). Service connection for PTSD requires medical evidence diagnosing the disability, medical evidence establishing a link between the veteran's current symptoms and an in-service stressor, and credible evidence corroborating occurrence of the stressor. 38 CFR 3.304. If a stressor claimed by a veteran is related to the veteran's fear of hostile military or terrorist activity, the evidentiary standard for establishing occurrence of the stressor can be reduced but only if a VA psychiatrist or psychologist, or a psychiatrist or psychologist with whom VA has contracted, confirms that the claimed stressor is adequate to support a PTSD diagnosis and that the veteran's symptoms are related to the stressor. If such confirmation is made in accordance with the rule, VA will not require evidence corroborating occurrence of the claimed stressor. Failure to obtain such confirmation, however, does not necessarily result in denial of the claim. If such confirmation is not made in accordance with the rule, VA will assist the claimant in obtaining evidence to corroborate occurrence of the claimed stressor. VA will consider all evidence of record, including evidence submitted by the claimant, give the claimant the benefit of the doubt when the evidence is in equipoise, and determine whether the requirements for establishing service connection for PTSD under 38 CFR 3.304(f) have been satisfied, notwithstanding any failure to satisfy the requirements of new section 3.304(f)(3). 38 U.S.C. 5103A and 5107(b); 38 CFR 3.303(a) and 3.102.
Some commenters asserted that the requirement for confirmatory evidence from a VA psychiatrist or psychologist conflicts with 38 CFR 3.159(a)(1), which defines “competent medical evidence” to include “evidence provided by a person who is qualified through education, training, or experience to offer medical diagnoses, statements, or opinions.”
There is no conflict because the definition in § 3.159(a)(1) concerns a matter different from the subject of this rule. This rule concerns whether “credible supporting evidence” will be required to establish the occurrence of a stressor in a claim for service connection of PTSD. Section 3.159(a)(1) defines the phrase “competent medical evidence” for purposes of explaining when VA will provide a medical examination or obtain a medical opinion in any service connection claim.
One commenter stated that the rule is in essence an “anti-treating physician” rule and that VA should adopt the “treating physician” rule used by the Social Security Administration. As explained above, the rule does not preclude a claimant from submitting and VA from considering evidence from the claimant's treating physician, if the claim cannot be granted under the new section 3.304(f)(3) procedures. Also, as the U.S. Court of Appeals for the Federal Circuit has recognized, adoption of the treating physician rule may conflict with the benefit of the doubt rule and would conflict with 38 CFR 3.303(a), which requires that service connection determinations will be based on the entire evidence of record and due consideration of VA's policy to administer the law under a broad and liberal interpretation, consistent with the facts of each case.
One commenter stated that the rule would increase the evidentiary burden on a claimant by requiring a confirmatory opinion by a VA psychiatrist or psychologist and a finding that the stressor is consistent with the places, types, and circumstances of the veteran's service.
Section 3.304(f) currently requires a medical-nexus opinion linking a veteran's current symptoms and the claimed stressor. This rule merely provides a liberalized evidentiary standard in certain situations based on the opinion of a VA psychiatrist or psychologist. Further, the requirement for consistency is mandated by 38 U.S.C. 1154(a) and 38 CFR 3.303(a). Also, pursuant to 38 U.S.C. 5103A(a) and (c), VA has a duty to assist a claimant for disability compensation in obtaining evidence necessary to substantiate the claim. In particular, VA is required to provide an examination or obtain a medical opinion when necessary to decide a claim for disability compensation. 38 U.S.C. 5103A(d). Section 5103A(d)(3) states that an examination or opinion is necessary if the record contains competent evidence of a current disability or persistent or recurrent symptoms, indicates that the disability or symptoms may be associated with the claimant's active service, and does not contain sufficient medical evidence for VA to make a decision on the claim.
One commenter asked whether the rule requires that the occurrence of a stressor be corroborated by evidence of a veteran's response to the stressor, such as behavioral changes as provided in former § 3.304(f)(4), or whether the veteran's lay testimony will be accepted as sufficient proof of the stressor. If the requirements of the rule are met, VA may accept the veteran's lay testimony as sufficient proof of the stressor. If, however, the requirements of the rule are not met, the record must contain corroborating evidence of the stressor. The rule does not require corroboration by evidence of the veteran's response, but evidence of the veteran's response is required for a legitimate diagnosis of PTSD resulting from exposure to the stressor. Furthermore, evidence of the veteran's response may be used to prove the occurrence of the stressor. Before deciding whether the stressor has been corroborated, VA will examine all the evidence of record to determine whether it corroborates occurrence of the stressor.
One commenter stated that the rule could be viewed as restricting or superseding the beneficial rule codified at 38 CFR 3.304(f)(2), which states that a veteran's lay testimony alone is sufficient to establish the occurrence of a claimed stressor if the veteran engaged in combat with the enemy and the claimed stressor is related to that combat. We make no change based on this comment because the new rule merely provides another avenue by which veterans seeking disability compensation for PTSD can establish service connection and does not restrict or supersede any existing VA rules intended to assist claimants. A qualifying veteran may still establish service connection under 38 CFR 3.304(f)(2) without regard to the new rule.
Another commenter asked whether corroborating evidence of a stressor would be required if a veteran is not a combat veteran or does not qualify for the reduced evidentiary standard under this rule. Section 3.304(f) relaxes the ordinary evidentiary standard in other situations also, such as PTSD diagnosed in service, a former prisoner of war as claimant, and a claim based on personal assault in service. However, in the absence of such circumstances, VA would not grant service connection for PTSD unless the record contains a medical diagnosis of PTSD, medical evidence of a nexus between current symptoms and the in-service stressor, and corroborating evidence of the occurrence of the stressor. 38 CFR 3.304(f).
One commenter also suggested that VA should provide a legal foundation for the regulation and suggests the Persian Gulf War Veterans Act of 1998, Public Law 105–277, Div. C, tit. XVI, sec. 1603, 112 Stat. 2681–742, 2681–745, and the Veterans Programs Enhancement Act of 1998, Public Law 105–368, sec. 105, 112 Stat. 3315, 3324, which authorized the 2008 IOM report.
As explained in the notice of proposed rulemaking, the authority for this rulemaking is 38 U.S.C. 501(a)(1), which authorizes the Secretary to promulgate regulations “with respect to the nature and extent of proof and evidence and the method of taking and furnishing them in order to establish the right to benefits under such laws,” and 38 U.S.C. 1154(a), which requires the Secretary to “include in the regulations pertaining to the service-connection of disabilities” provisions requiring “due consideration” of the places, types, and circumstances of a veteran's service. Proposed Rule, 74 FR 42617. We make no change to the rule based on this comment because the public laws cited by the commenter do not authorize regulations regarding the nature and extent of proof and evidence necessary to establish service connection for PTSD.
This final rule applies to an application for service connection for PTSD that is received by VA on or after the rule's effective date, was received by VA before the rule's effective date but has not been decided by a VA regional office as of that date, is appealed to the Board on or after the rule's effective date, was appealed to the Board before the rule's effective date but has not been
Some commenters suggested that the rule should be applied retroactively to claims that were finally denied by VA before the effective date of the regulation. Another commenter suggested that the effective date of an award of benefits under the rule should be the earlier of the date of the veteran's claim or October 21, 1998, the date of enactment of the Persian Gulf War Veterans Act of 1998. We do not adopt these suggestions.
Congress has provided that, once a decision on a claim for veterans benefits becomes “final,” “the claim will not thereafter be reopened or allowed, except as may otherwise be provided by regulations not inconsistent with [title 38, United States Code].” 38 U.S.C. 7105(c). There are only two exceptions to this statutory rule of finality.
The effective date of benefits awarded pursuant to this rule will be assigned in accordance with the facts found but will not be earlier than the date of claim. 38 U.S.C. 5110(a). Although 38 U.S.C. 5110(g) and 38 CFR 3.114(a) authorize in some circumstances an effective date of benefits before the date of claim, those provisions are applicable to “administrative issue[s]” that liberalize the basis for benefit entitlement. VAOPGCPREC 11–99, para. 10 (liberalizing issue is one which effects substantive change in regulation and creates a new basis for entitlement to a benefit); S. Rep. No. 87–2042, at 2, 4, 6 (1962) (enactment of former sec. 3010(g) (currently sec. 5110(g)) intended to eliminate, when feasible, VA practice of requiring “specific application for the new benefit” whenever new regulation was promulgated); H.R. Rep. No. 87–2123, at 2, 4, 6 (1962) (same). This regulation, however, governs procedural matters rather than creating a new basis for entitlement to service connection for PTSD because it merely relaxes under certain circumstances the evidentiary standard for establishing occurrence of a stressor. As a result, 38 U.S.C. 5110(a), rather than 38 U.S.C. 5110(g), is applicable to awards under this rule. Although VAOPGCPREC 7–92 held that provisions in the VBA Adjudication Procedures Administration Manual M21–1 relieving former prisoners of war and combat veterans of the burden of producing evidence to substantiate that they experienced a stressful event are substantive rules, the opinion concerns the dichotomy between substantive and interpretive rules for purposes of determining whether notice-and-comment rulemaking is required pursuant to 5 U.S.C. 553, a dichotomy that is not relevant for purposes of determining whether section 5110(g) applies.
Another commenter asked whether the rule would constitute new evidence for purposes of reopening a finally denied claim for service connection for PTSD. The change in the evidentiary standard for establishing occurrence of an in-service stressor would not constitute a basis on which to reopen a finally denied claim for service connection for PTSD because it is procedural in nature and does not effect a substantive change in the law governing service connection for disabilities.
Another commenter stated that surviving spouses should be entitled to receive the accrued benefits due their spouses under the rule. Section 5121(a) of title 38, United States Code, authorizes an award to certain survivors of a beneficiary of periodic monetary benefits to which the beneficiary was “entitled at death under existing ratings or decisions, or those based on evidence in the file at date of death * * * and due and unpaid.” Eligible survivors of a veteran who had filed a claim for compensation for PTSD during his or her lifetime could therefore file a claim for accrued benefits alleging that the veteran was entitled to service connection for PTSD under the rule based on evidence in the file at the date of the veteran's death, provided that the claim for accrued benefits (if not the deceased veteran's claim) was received by VA on or after July 12, 2010 or was pending before VA on that date, at either a regional office or the Board. In addition, under 38 U.S.C. 5121A, if a claimant dies on or after October 10, 2008, while a claim for veterans benefits or an appeal of a decision with respect to such a claim is pending, a living person who would be eligible to receive accrued benefits due the claimant under section 5121(a) may, not later than one year after the date of the claimant's death, file a request to be substituted as the claimant for the purposes of processing the claim to completion. This rule would apply to a claim for service connection for PTSD in which an eligible survivor is substituted under section 5121A, provided that the veteran's application was received by VA on or after July 12, 2010 or was pending before VA on that date, at either a regional office or the Board of Veterans' Appeals.
A commenter asked if VA has estimated the cost of the regulation. VA has determined that the rule will not have an annual effect on the economy of $100 million or more. Proposed Rule, 74 FR at 42619.
One commenter suggested that VA: (1) Work closely with the DoD to obtain reliable information to corroborate veterans' deployment and medical conditions; (2) mount an aggressive outreach campaign about the new regulation; (3) educate veterans and the public about PTSD; (4) monitor claims received and adjudicated under this regulation to evaluate its impact; and (5) promulgate regulations to cover claims for service connection for anxiety disorders, depression, and suicide based on deployment to a war zone. We make no change based on these comments as they are beyond the scope of this rulemaking.
Some commenters recommended that VA revise the rating schedule for mental disorders. We make no change based on these comments, which are beyond the scope of this rulemaking, which deals with service connection for PTSD, not evaluating it after service connection has been established.
Some commenters requested that the final rule be included in new part 5 of title 38, Code of Federal Regulations. This rule will be included in the part-5 notice of proposed rulemaking dealing with service-connection determinations.
The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are
This document contains no provisions constituting a collection of information under the Paperwork Reduction Act (44 U.S.C. 3501–3521).
Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Executive Order classifies a “significant regulatory action,” requiring review by the Office of Management and Budget (OMB), as any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.
The economic, interagency, budgetary, legal, and policy implications of this final rule have been examined, and it has been determined to be a significant regulatory action under the Executive Order because it is likely to result in a rule that will raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.
The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any year. This final rule would have no such effect on State, local, and tribal governments, or on the private sector.
The Catalog of Federal Domestic Assistance program numbers and titles for this rule are 64.109, Veterans Compensation for Service-Connected Disability and 64.110, Veterans Dependency and Indemnity Compensation for Service-Connected Death.
The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. John R. Gingrich, Chief of Staff, Department of Veterans Affairs, approved this document on May 6, 2010, for publication.
Administrative practice and procedure, Claims, Disability benefits, Health care, Pensions, Radioactive materials, Veterans, Vietnam.
38 U.S.C. 501(a), unless otherwise noted.
The revision and addition read as follows:
(f)
(3) If a stressor claimed by a veteran is related to the veteran's fear of hostile military or terrorist activity and a VA psychiatrist or psychologist, or a psychiatrist or psychologist with whom VA has contracted, confirms that the claimed stressor is adequate to support a diagnosis of posttraumatic stress disorder and that the veteran's symptoms are related to the claimed stressor, in the absence of clear and convincing evidence to the contrary, and provided the claimed stressor is consistent with the places, types, and circumstances of the veteran's service, the veteran's lay testimony alone may establish the occurrence of the claimed in-service stressor. For purposes of this paragraph, “fear of hostile military or terrorist activity” means that a veteran experienced, witnessed, or was confronted with an event or circumstance that involved actual or threatened death or serious injury, or a threat to the physical integrity of the veteran or others, such as from an actual or potential improvised explosive device; vehicle-imbedded explosive device; incoming artillery, rocket, or mortar fire; grenade; small arms fire, including suspected sniper fire; or attack upon friendly military aircraft, and the veteran's response to the event or circumstance involved a psychological or psycho-physiological state of fear, helplessness, or horror.
Environmental Protection Agency (EPA).
Guidance and interpretations.
In this document, the U.S. Environmental Protection Agency (EPA or the Agency) is providing guidance on various reporting options that States and local agencies may choose in implementing sections 311 and 312 of the Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA). In addition, the Agency is also providing some new interpretations and revising some existing ones to help facilities comply with certain of the requirements under EPCRA.
EPA has established a docket for this action under Docket ID No. EPA–HQ–SFUND–1998–0002. All documents in the docket are listed on the
Sicy Jacob, Office of Emergency Management, Mail Code 5104A, Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone number: (202) 564–8019; fax number: (202) 564–2620; e-mail address:
Here are the contents of the document:
This guidance is provided to States and local agencies on various reporting options that they may choose for implementing sections 311 and 312 of the Emergency Planning and Community Right-to-Know Act (EPCRA). Entities that would be affected by this guidance are those organizations and facilities subject to EPCRA and its implementing regulations found in 40 CFR parts 355 and 370.
EPCRA, which was enacted as Title III of the Superfund Amendments and Reauthorization Act of 1986 (Pub. L. 99–499), (SARA) Title III, establishes authorities for emergency planning and preparedness, emergency release notification, community right-to-know reporting, and toxic chemical release reporting. It is intended to encourage State and local planning and preparedness for releases of extremely hazardous substances (EHSs) and to provide the public, local agencies, fire departments, and other emergency officials with information concerning potential chemical risks in their communities.
Section 302 of EPCRA requires facilities to notify their State Emergency Response Commission (SERC) of any EHS present at their site above its threshold planning quantity (TPQ). This information is then used by the Local Emergency Planning Committee (LEPC) to develop emergency response plans for the community. The implementing regulations, EHSs and their TPQs are codified in 40 CFR part 355.
Section 304 of EPCRA requires facilities to notify their SERC and the community emergency coordinator for the LEPC of any release of an EHS or a CERCLA hazardous substance above its reportable quantity (RQ). The RQs for the CERCLA hazardous substances are in Table 302.4 of 40 CFR Part 302. The implementing regulations for section 304 of EPCRA are codified in 40 CFR part 355.
Sections 311 and 312 of EPCRA require facilities to submit information on hazardous chemicals at their sites above the threshold quantities. The information on hazardous chemicals is submitted to the SERC, LEPC and the local fire department. The implementing regulations for sections 311 and 312 are codified in 40 CFR part 370.
On June 8, 1998, EPA published a proposed rule (63 FR 31268) to streamline the reporting requirements under EPCRA.
In addition to the four regulatory revisions, EPA took comment on various reporting options to streamline the reporting requirements for facilities and to reduce the information management burden for SERCs, LEPCs and fire departments in the form of draft guidance in the preamble to the June 8, 1998 proposed rule. The main objective of the draft guidance was to provide flexibility to the States and local agencies in implementing sections 311 and 312. In particular, EPA stated that
EPA did not propose any regulatory revisions, but sought comments on various reporting options under sections 311 and 312. The reporting options discussed were: (1) The use of Underground Storage Tank (UST) forms to fulfill the requirements for Tier I Information under EPCRA section 312; (2) partnership programs for joint access to EPCRA sections 311 and 312 information by SERCs, LEPCs, and fire departments; (3) electronic submittal for EPCRA section 312 reporting; and (4) incorporation of previous submissions into EPCRA section 312 reporting. These four options, the Agency believed, would reduce the information management burden for States and local agencies, as well as minimize the reporting burden for the regulated community. (
EPA also suggested a few other options to streamline reporting and revise some existing regulatory interpretations for facilities. These additional options, the Agency believed, would also reduce the information management burden for States and local agencies. The options and suggested interpretations are: (1) Electronic access to a facility's databases of MSDSs; (2) interpretation of the hazardous chemical exemption for solids under EPCRA sections 311(e)(2); and (3) EPCRA section 312 reporting to fulfill the reporting requirements under section 311. (See preamble to the June 8, 1998 proposed rule for further discussion on the various options and suggested interpretations.)
In the June 1998 preamble, EPA also defined and took comment on several terms or phrases used in the regulations. EPA requested comments on whether the Agency should provide guidance on the meaning of the term “promptly” associated with providing notice of any changes relevant to emergency planning (40 CFR part 355) and the phrase “as soon as practicable” associated with providing a written follow-up emergency notice under the emergency release notification requirements (40 CFR part 355). The Agency did not intend to revise the regulatory requirements, but only to provide guidance for these two terms. However, EPA received comments from many States and local agencies that the term “promptly” should be defined in the regulations since receiving information from facilities on changes relevant to emergency planning is crucial in developing and/or updating emergency response plans. As a result, the Agency defined this term in the recent final rule published on November 3, 2008 (73 FR 65452). The requirement added to 40 CFR 355.20 states that any changes relevant to emergency planning must be provided to the LEPC within 30 days after the changes have occurred. EPA will define the phrase, “as soon as practicable” associated with providing written follow-up emergency notice under the emergency release notification requirements in this guidance.
EPA requested comments on the draft guidance in the preamble to the June 1998 proposed rule (63 FR 31268) in an effort to streamline compliance with the reporting requirements. EPA did not propose any regulatory changes, but sought comments on the options provided. The Agency stated in the 1998 preamble that States and local agencies may implement any or all of the options regardless of whether EPA issues final guidance, provided the approach adopted met the statutory and regulatory requirements.
In general, commenters supported some of the options provided in the draft guidance. However, a few commenters stated that the options may actually increase compliance costs and the risk of non-compliance at companies with multiple facilities due to the loss of consistency in data management and compliance reporting. As noted previously, the various reporting options under EPCRA sections 311 and 312 were to provide flexibility to the States and local agencies so they may implement the program as necessary for their community emergency planning and response efforts. States may need to develop specific methods to manage the information provided by facilities within their State so that LEPCs can develop emergency response plans and provide the public with information. Thus, States are not required to adopt or implement these options.
The following is a more specific discussion of each of the reporting options and guidance on implementing them.
At the time of the June 1998 proposal, many States were accepting the Tier I inventory form, which contains the minimum information about hazardous chemicals at a facility.
A few commenters supported the use of the UST form to fulfill the section 312 requirements, but most opposed it. These commenters argued that it would be confusing and burdensome for LEPCs and fire departments and would make electronic filing more difficult. Some of these commenters also stated that the differences in information and filing schedules would make this approach
The Tier I inventory form provides the minimum information required under EPCRA section 312 and its implementing regulations. When the proposed rule was published in June 1998, some States were accepting the Tier I form. However, all States now require facilities to submit a State specific form or the Federal Tier II inventory form. Therefore, use of the UST form as suggested in 1998 may not be beneficial for implementing agencies. Additionally, EPA expected that the UST form would be used instead of the Tier I form mainly by retail gas stations since they likely only have underground storage tanks containing hazardous chemicals. Since EPA raised the reporting threshold for gasoline and diesel fuel stored at retail gas stations on February 11, 1999 (64 FR 7047), most retail gas stations may not need to report. Therefore, the Agency's guidance is that the use of the UST form as a replacement of the Tier I form for reporting under EPCRA section 312 is not recommended.
To streamline the submission process, EPA suggested in the draft guidance that SERCs, LEPCs, and fire departments could partner together and agree that one agency would receive the section 311 and 312 reporting information and make it available electronically to the others. Although the statute and its implementing regulations in 40 CFR part 370 state that facilities are required to submit their MSDSs or chemical lists under section 311 of EPCRA and the Tier I or Tier II form to their SERC, LEPC and the local fire department, EPA believed the single point submission option satisfies the intent of the statute and its implementing regulations. If implementing agencies choose to use this option, EPA stated that they should ensure that all statutory and regulatory requirements are met, especially the deadline for submission.
Many commenters supported the idea of partnerships to allow filing of information to a single point. Other commenters, while supporting this approach, cited problems. For example, many LEPCs and fire departments do not have access to computers or the Internet. A few commenters also stated that they provide compliance assistance to facilities and a centralized compliance point would take away this working relationship.
The Agency suggested the single point submission to reduce the burden on the regulated community, as well as reduce information management burden on some implementing agencies. For example, a SERC could develop a reporting format for facilities to submit the Tier II form or an equivalent State form. The SERC could collect the information and then make it immediately available electronically to LEPCs and fire departments on-line. Electronic access eliminates searching through hundreds of papers during an emergency situation. If LEPCs and/or fire departments do not have the capability to access the information on-line, then the SERC could provide the information to these entities on diskettes or in hard copy.
At the time of the June 1998 proposed rule, only a few States were accepting the Tier II form or the State form electronically. Today, many States have developed their own electronic reporting system or are using EPA's Tier II reporting system (Tier2 Submit). Most of these States accept section 312 reports on-line. EPA encourages these States to explore ways to provide their LEPCs and fire departments joint access to the information. EPA also expects that today most LEPCs and fire departments can accept or access section 312 reports electronically.
EPA realizes that a lack of funding may limit a State's capability to set up a partnership or to develop database systems and access to information. Since the EPCRA program has matured over the past ten years, many States have established program funding mechanisms through reporting fee systems, Federal grants,
Although States have the flexibility to choose any method for submittal and joint access to information, that method must meet the March 1 reporting deadline specified in the statute. To ensure this deadline is met, States may want to revise their right-to-know program regulations to require facilities to submit the Tier II form or State equivalent before March 1 to allow enough time for processing and access by LEPCs and fire departments by March 1. If States choose to implement a partnership program for sharing of information, we believe that a formal agreement is necessary between the three entities. States should then notify the facilities about this agreement and the new submission process. That is, States should inform the facilities that they can submit their section 312 report to the SERC and it will provide access to the LEPC and the fire department.
Since the beginning of EPCRA, the Agency encouraged States to implement the EPCRA program as necessary to meet its goals: to prepare for and respond to emergency releases of extremely hazardous substances and provide information to the public on potential chemical risks in their communities. States have the flexibility to tailor the program to their needs by adding chemicals or setting lower reporting thresholds, etc. Over the years, States have reported that their biggest burden is handling thousands of paper Tier I/II form submissions. Some States requested that they be allowed to create an electronic reporting format for facilities to use to comply with EPCRA section 312. Electronic reporting would reduce the burden on facilities since they need to enter most of their information on the Tier II form only in the first year and then revise it as needed in subsequent years. As discussed in the previous section, electronic reporting makes joint access easier.
Many commenters supported electronic submittals, but noted that it would not be practical for many LEPCs, fire departments, and smaller facilities since they likely don't have the capability. Other commenters opposed the idea because of the financial burden on State and local agencies. Still other commenters supported electronic reporting and provided ideas for certification of electronic submissions.
The Agency understands the concerns raised by commenters on electronic reporting. Prior to the June 1998 proposed rule, many States and local agencies requested that the Agency develop an electronic reporting system to reduce the burden of information management at the State and local level. Some State and local agencies asked that they be allowed to develop their own electronic reporting format. This is why EPA suggested in the draft guidance that States and local agencies have the flexibility to choose any reporting options provided the statutory and regulatory requirements are met.
Recently, many States requested guidance on electronic signatures and certification of electronically submitted information. Currently, the regulations in part 370 require the facility owner or operator (or the officially designated representative of the owner or operator) submit a certification statement with their hazardous chemical inventory form containing an original signature that the information submitted is true, accurate and complete. The June 8, 1998 draft guidance stated that the States and local agencies may continue to develop their own reporting format, including electronic reporting as long as the information required includes the information required by the statute and its implementing regulations and that certification is required regardless of the format in which it is submitted. The draft guidance also stated that if States and local officials allow section 312 reporting information to be submitted via the Internet, it will be necessary for the facility owner or operator or its officially designated representative to certify the information submitted.
At the time the draft guidance was published in June 1998
EPA advises States and the regulated community that for electronic section 312 reporting, the original signature as required by 40 CFR part 370 may be provided on paper (
Under EPCRA section 312, facilities are required to submit a Tier I form or, if requested, a Tier II form annually to the SERC, LEPC and the fire department even though the information submitted in a previous year has not changed. To reduce the burden on facilities that have no changes in their data from the previous year's submission, EPA discussed several options in the June 1998 preamble for meeting the requirements under EPCRA section 312 without having to re-create the information.
One approach suggested in the draft guidance would be for the facility to simply reference and attach a copy of the unchanged information from the previous year's submittal to the current year's submission. This would mean that the facility would have to retain a copy of its previous submission. A second approach would be for the facility to reference previous submittals already retained by the SERC, LEPC and local fire department. A third approach would require reporting only if the information changed.
Some commenters opposed the option to require reporting only when changes have occurred. Few commenters supported the idea of simply referencing and/or attaching a copy of the unchanged information. They stated this approach could increase the burden on implementing agencies because they would need to maintain and reference previous years' files. These commenters also stated that facilities probably would forget to report and could consider some changes unimportant.
At the time the various approaches were discussed in the preamble to the June 1998 proposal, States did not have electronic reporting methods in place. Now that many States have established electronic reporting or are using the Tier2 Submit software developed by EPA, the burden for facilities to re-create information on paper does not exist for most facilities. Facilities can store their Tier II report electronically and revise as needed for subsequent years. Therefore, EPA is no longer suggesting that facilities be allowed to incorporate previous submissions as part of the EPCRA section 312 reporting requirement since it is unlikely to reduce the reporting burden. However, States that still require submission of a facility's Tier II or State equivalent forms on paper may still consider options for incorporation of previous submissions to reduce the paperwork burden.
Some facilities maintain an electronic database of MSDSs for the hazardous chemicals on their site. EPA requested comments whether a facility should be allowed to give the SERC, LEPC and the local fire department electronic access to its MSDS database instead of actually submitting the MSDSs to the three entities as required under EPCRA section 311.
A few commenters supported this option and some asked for development of a central database that would include MSDSs from all facilities. However, other commenters opposed the approach for a number of reasons, such as it would raise concerns about the security of a company's computer systems, it would not meet the requirements of the statute, as well as the fact that many LEPCs and fire departments do not have the capability to access databases electronically. Still other commenters stated that access would need to be assured even when power outages occur.
Submission of MSDSs for hazardous chemicals present at a facility to the SERC, LEPC and the fire department is a statutory requirement. EPA has codified this requirement in 40 CFR part 370. The Agency suggested electronic submission of MSDSs or providing access to a facility's MSDS database to reduce the burden on the regulated community and reduce the information management burden on implementing agencies. However, such an approach does raise a number of issues, including whether it would meet the statutory
EPA's draft guidance suggested another approach to reduce the reporting requirements for facilities. Specifically, the Agency sought comments on whether the section 312 reporting requirement can fulfill the section 311 reporting requirements provided that the section 312 reporting conforms to the required time frame and that the Tier II information is accurate and complete. Since reporting under both sections 311 and 312 are submitted to the SERC, LEPC and the fire department, this approach should not pose any additional burden on these entities.
Section 311 of EPCRA and its implementing regulations require the submission of MSDSs or a list of hazardous chemicals to the SERC, LEPC, and fire department within three months after becoming subject to the reporting requirements, or within three months after discovery of significant new information concerning a hazardous chemical that has already been reported, or within 30 days of a request from the SERC, LEPC or fire department. Section 312 of EPCRA requires a submission of a Tier I (or Tier II) form to these three entities by March 1 of each year. Since the section 312 report is due by March 1, for information from the previous calendar year, some facilities may submit their Tier I/II form between January 1 and March 1. Therefore, Section 312 could be used to meet the section 311 reporting requirements for those facilities that become subject to reporting under section 311, or discover significant new information concerning a hazardous chemical between October 1 and December 31 of any given calendar year.
All but one commenter who addressed this issue supported EPA's draft guidance regarding this matter. Many States indicated they already use this approach and find that it works well allowing them to utilize its resources in a more efficient manner. One commenter objected because it would require reprogramming of company systems.
After reviewing the comments, the Agency, recognizing that some States are already implementing this reporting option, is retaining this option in this final guidance. However, those States that choose to implement or are already implementing this reporting option will need to require facilities to submit a section 312 report three months after acquiring a new chemical in order to be in compliance with the section 311 reporting requirements.
In addition to providing draft guidance to the implementing agencies for various reporting options under EPCRA section 312, EPA also provided draft guidance to the regulated community on defining certain terms and phrases used in the regulations. In the June 1998 proposed rule, EPA requested comments on the Agency's interpretation of the meaning of the term “promptly” in section 355.20 and the phrase “as soon as practicable” in section 355.40. The Agency did not intend to revise the regulatory requirements, but only to provide guidance for these two terms.
EPA received comments from many States and local agencies that the term “promptly” should be defined in the regulations since receiving information from facilities on changes relevant to emergency planning is crucial in developing and/or updating emergency response plans. Therefore, to be consistent with EPCRA section 303(d)(2), the Agency proposed to add the term “promptly” to the regulations in 40 CFR 355.20 associated with providing the LEPC with notification of any changes occurring at the facility which may be relevant to emergency planning. Commenters supported this revision, but suggested that the Agency provide a specific time period, such as 10, 20 or 30 days because of the need for this information for emergency planning. As previously noted, the final rule published on November 3, 2008 (73 FR 65452) revised 40 CFR 355.20 to state that any changes relevant to emergency planning must be provided to the LEPC within 30 days after the changes have occurred.
EPA also requested comments on whether the Agency should provide guidance on the meaning of the phrase “as soon as practicable” under the emergency release notification in 40 CFR 355.40, which states (at 40 CFR 355.40(b)) that a written follow-up emergency notice must be provided by a facility “as soon as practicable” after a release. EPA sought comments on whether 30 days should be allowed to provide a written follow-up notice.
Commenters generally supported defining “as soon as practicable,” but differed on whether 30 days was a reasonable period. Some commenters stated that the period should be shorter (7 or 14 days) or longer (45 to 90 days), while other commenters supported the 30-day period. A few commenters noted that 30 days was inconsistent with EPA's guidance on enforcement actions.
Based on the comments and EPA's evaluation, the Agency has decided that 30 days should be sufficient to submit the written follow-up notice of the emergency release to the SERC and LEPC. The Agency will be revising its enforcement response policy to reflect this change. States may implement a more stringent timeframe if they so choose.
EPCRA section 311 provides some exemptions for certain substances from the definition of hazardous chemical. Under section 311(e)(2), “any substance present as a solid in any manufactured item to the extent exposure to the substance does not occur under normal conditions of use” is exempt from the definition of hazardous chemical and therefore need not be reported under sections 311 and 312. However, EPA's interpretation of this exemption has been that if portions of the solid metal are modified, such that exposure to a hazardous chemical can occur, then all of the solid metal should be included and counted to determine the quantity of hazardous chemical present for threshold purposes. For example, if there are 10,000 pounds of steel undergoing a welding process at a facility at any one time, then 10,000 pounds would need to be counted toward the quantity for threshold determination even if only a portion of the steel is welded. EPA believes this interpretation occasionally requires reporting of information that is unnecessary for emergency planning and community right-to-know purposes. To relieve the burden for facilities and to relieve the burden on information management for implementing agencies, the Agency suggested that this interpretation be modified in the preamble to the June 1998 proposed rule. Under the new interpretation, facilities would only have to include and count the amount of fume or dust emitted or released from a manufactured solid that is being modified to determine whether the EPCRA sections 311 and 312 reporting thresholds have been reached. EPA requested comments on this new interpretation and
Based on the comments provided by the regulated community and the implementing agencies, EPA is revising its interpretation for the exemption for solids under section 311(e)(2), such that facilities would only have to include and count the amount of fume or dust given off a piece of metal that is being modified toward the threshold determination. In addition, as EPA stated in the preamble to the June 1998 proposed rule, stamping a piece of metal doesn't negate the exemption for that piece of metal; the piece of metal would still qualify for the exemption. EPA believes that the stamping of sheet metal does not present exposure to a hazardous chemical.
This new interpretation would also apply to bricks or any other manufactured solid item that undergoes a modification process (for example, cutting). Thus, facilities would need to count the amount of fume or dust released during the modification process toward the threshold determination.
These interpretations are provided as guidance. States may implement more stringent requirements if they so choose.
The Agency realizes the format for this guidance is different from the usual EPA format. Since the Agency requested comments on the various reporting options and interpretations, we decided to publish the guidance in the
Federal Communications Commission.
Interim rule.
In this document, the Commission adopts an interim rule addressing the certification of provider information for Telecommunications Relay Services (TRS) calls. By requiring providers to be more accountable for their submissions, the Commission takes necessary, affirmative steps to preserve the Interstate TRS Fund (Fund).
Effective July 13, 2010, except for the amendment to 47 CFR 64.604 (c)(5)(iii)(I), which contains new information collection requirements subject to the Paperwork Reduction Act (PRA) that have not been approved by the Office of Management and Budget (OMB). Written comments by the public on the new information collections are due September 13, 2010. The Commission will publish a document in the
Federal Communications Commission, 445 12th Street, SW., Washington, DC 20554. In addition to filing comments with the Secretary, a copy of any comments on the information collection requirements contained herein should be submitted to Cathy Williams, Federal Communications Commission via e-mail at
Gregory Hlibok, Consumer and Governmental Affairs Bureau at (202) 559–5158 (VP), or e-mail:
This is a summary of the Commission's
The full text of document FCC 10–88 and copies of any subsequently filed documents in this matter will be available for public inspection and copying during regular business hours at the FCC Reference Information Center, Portals II, 445 12th Street, SW., Room CY–A257, Washington, DC 20554. Document FCC 10–88 and copies of subsequently filed documents in this matter may also be purchased from the Commission's duplicating contractor at Portals II, 445 12th Street, SW., Room CY–B402, Washington, DC 20554. Customers may contact the Commission's duplicating contractor at its Web site
Document FCC 10–88 contains new information collection requirements subject to the PRA. It will be submitted to OMB for review under section 3507 of the PRA. OMB, the general public, and other Federal agencies are invited to comment on the new information collection requirements contained in this proceeding. Public and agency comments are due September 13, 2010. In addition, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107–198,
The rapid growth of the Fund within a five year span requires the Commission to take immediate steps in preserving the Fund to ensure the continued availability of TRS. Indeed, the Commission has a fiduciary duty to ensure that the Fund operates efficiently, and to guard against waste, fraud, and abuse. The Commission takes steps in document FCC 10–88 to uphold that duty.
Section 553 of the Administrative Procedure Act requires that agencies provide notice of, and an opportunity for public comment on, their proposed rules except,
In this case, the Commission finds good cause to adopt the interim rule below to make providers more accountable by requiring senior executives to certify compliance with the Commission's regulations under penalty of perjury. By requiring providers to be more accountable for their submissions, the Commission takes necessary, affirmative steps to preserve the TRS Fund. The Commission adopts an interim rule to require the Chief Executive Officer (CEO), Chief Financial Officer (CFO), or other senior executive of a relay service provider to certify, under penalty of perjury, that: (1) Minutes submitted to the Fund administrator for compensation were handled in compliance with section 225 of the Communications Act and the Commission's rules and orders, and are not the result of impermissible financial incentives, or payments or kickbacks, to generate calls, and (2) cost and demand data submitted to the Fund administrator related to the determination of compensation rates or methodologies are true and correct. In the accompanying
The TRS rules currently require providers to “submit reports of * * * TRS minutes of use to the [Fund] administrator in order to receive payments.” The rules further require
The TRS rules also require providers to “provide the administrator with true and adequate data, and other historical, projected and state rate related information reasonably requested by the administrator, necessary to determine TRS Fund revenue requirements and payments.” Providers are also required to certify on their yearly submission forms as to the truth and accuracy of the data being submitted. The Commission similarly believes that to ensure the accuracy of this information, including the information requested on the Relay Services Data Request Form submitted annually, the TRS rules should require CEOs, CFOs, or other senior executives of providers to certify under penalty of perjury that this information is true and correct.
The Commission adopts this interim rule without notice and comment, pursuant to 5 U.S.C. 553(b)(3)(B). In light of the explosive growth in the TRS Fund in recent years and evidence of fraud against the Fund, as evidenced by the recent indictments and guilty pleas from call center managers and employees admitting to defrauding the Fund of tens of millions of dollars, the fact that minutes are submitted for payment on a monthly basis, and the expectation that providers seeking compensation from the Fund are doing so in compliance with the TRS rules, the Commission finds that it is unnecessary and contrary to the public interest to delay adoption of this interim rule. The Commission finds that an immediate interim rule is necessary and consistent with the public interest. In this case, the Commission finds good cause to adopt an interim rule to make providers more accountable by requiring senior executives to certify compliance with the Commission's regulations under penalty of perjury. By requiring providers to be more accountable for their submissions, the Commission takes necessary, affirmative steps to preserve the TRS Fund.
The Commission will send a copy of document FCC 10–88 in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act,
Pursuant to sections 1, 4(i) and (o), 225, 303(r), 403, 624(g), and 706 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154(i) and (o), 225, 303(r), 403, 554(g), and 606, document FCC 10–88 is adopted.
Document FCC 10–88 shall be effective July 13, 2010, pursuant to 5 U.S.C. 553(d)(3) and § 1.427(b) of the Commission's rules, 47 CFR 1.427(b), subject to OMB approval for new information collection requirements.
The Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, shall send a copy of document FCC 10–88 to the Chief Counsel for Advocacy of the Small Business Administration.
Individuals with disabilities, Reporting and recordkeeping requirements; Telecommunications.
Federal Communications Commission.
47 U.S.C. 154, 254(k); secs. 403(b)(2)(B), Pub. L. 104–104, 110 Stat. 56. Interpret or apply 47 U.S.C. 201, 218, 222, 225, 226, 228, and 254(k) unless otherwise noted.
(c) * * *
(5) * * *
(iii) * * *
(I)
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS is prohibiting directed fishing for pelagic shelf rockfish in the Western Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the 2010 total allowable catch (TAC) of pelagic shelf rockfish in the Western Regulatory Area of the GOA.
Effective 1200 hrs, Alaska local time (A.l.t.), July 8, 2010, through 2400 hrs, A.l.t., December 31, 2010.
Steve Whitney, 907–586–7269.
NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.
The 2010 TAC of pelagic shelf rockfish in the Western Regulatory Area of the GOA is 650 metric tons (mt) as established by the final 2010 and 2011 harvest specifications for groundfish of the GOA (75 FR 11749, March 12, 2010).
In accordance with § 679.20(d)(1)(i) and § 679.20(d)(1)(ii)(B), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2010 TAC of pelagic shelf rockfish in the Western Regulatory Area of the GOA will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 600 mt, and is setting aside the remaining 50 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for pelagic shelf rockfish in the Western Regulatory Area of the GOA.
After the effective date of this closure the maximum retainable amounts at § § 679.20(e) and (f) apply at any time during a trip.
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of pelagic shelf rockfish in the Western Regulatory Area of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of July 7, 2010.
The AA also finds good cause to waive the 30–day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
This action is required by § 679.20 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS is prohibiting directed fishing for northern rockfish in the Western Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the 2010 total allowable catch (TAC) of northern rockfish in the Western Regulatory Area of the GOA.
Effective 1200 hrs, Alaska local time (A.l.t.), July 8, 2010, through 2400 hrs, A.l.t., December 31, 2010.
Steve Whitney, 907–586–7269.
NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.
The 2010 TAC of northern rockfish in the Western Regulatory Area of the GOA is 2,703 metric tons (mt) as established by the final 2010 and 2011 harvest specifications for groundfish of the GOA (75 FR 11749, March 12, 2010).
In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2010 TAC of northern rockfish in the Western Regulatory Area of the GOA will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 2,603 mt, and is setting aside the remaining 100 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for northern rockfish in the Western Regulatory Area of the GOA.
After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment
The AA also finds good cause to waive the 30–day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
This action is required by § 679.20 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for the products listed above that would supersede an existing AD. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as: Analysis performed in the frame of the Extended Service Goal has led Airbus to modify the inspection programme [modification of thresholds, intervals and associated configurations] which is currently required by DGAC (Direction Générale de l'Aviation Civile) France AD F–2005–001. This modified inspection programme is necessary to detect and prevent damage associated with a structural fatigue phenomenon of the rear spar internal angle and the tee fitting located in the centre wing box. This condition, if not corrected, could affect the structural integrity of the centre wing box. The unsafe condition is reduced structural integrity of the wings. The proposed AD would require actions that are intended to address the unsafe condition described in the MCAI.
We must receive comments on this proposed AD by August 27, 2010.
You may send comments by any of the following methods:
•
•
•
•
For service information identified in this proposed AD, contact Airbus SAS—EAW (Airworthiness Office), 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone: +33 5 61 93 36 96; fax: +33 5 61 93 44 51; e-mail:
You may examine the AD docket on the Internet at
Dan Rodina, Aerospace Engineer, International Branch, ANM–116, FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington 98055–4056; telephone (425) 227–2125; fax (425) 227–1149.
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We have lengthened the 30-day comment period for proposed ADs that address MCAI originated by aviation authorities of other countries to provide adequate time for interested parties to submit comments. The comment period for these proposed ADs is now typically 45 days, which is consistent with the comment period for domestic transport ADs.
We will post all comments we receive, without change, to
On April 20, 2006, we issued AD 2006–09–05, Amendment 39–14575 (71 FR 25921, May 3, 2006). That AD required actions intended to address an unsafe condition on the products listed above.
Since we issued AD 2006–09–05, the manufacturer has modified the inspection program currently required by AD 2006–09–05 by reducing certain compliance times. The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA Airworthiness Directive 2008–0187, dated October 10, 2008 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:
Analysis performed in the frame of the Extended Service Goal has led Airbus to modify the inspection programme [modification of thresholds, intervals and associated configurations] which is currently required by DGAC (Direction Générale de l'Aviation Civile) France AD F–2005–001 [which corresponds to FAA AD 2006–09–05].
This modified inspection programme is necessary to detect and prevent damage associated with a structural fatigue phenomenon of the rear spar internal angle and the tee fitting located in the centre wing box. This condition, if not corrected, could affect the structural integrity of the centre wing box.
For the reason stated above, this new EASA AD retains the requirements of DGAC France AD F–2005–001, which is superseded, and refers to the latest revision of Airbus Service Bulletin (SB) A310–57–2047.
Airbus has issued Service Bulletin A310–57–2047, Revision 08, dated July 2, 2009; and Mandatory Service Bulletin A310–57–2035, Revision 10, dated March 25, 2008. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI.
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.
We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.
We might also have proposed different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are highlighted in a NOTE within the proposed AD.
Based on the service information, we estimate that this proposed AD would affect about 66 products of U.S. registry.
The actions that are required by AD 2006–09–05 and retained in this proposed AD take up to 600 work-hours per product, at an average labor rate of $85 per work hour. Required parts cost up to $38,900 per product. Based on these figures, the estimated cost of the currently required actions is up to $89,900 per product.
This new AD adds no new costs to affected operators; the manufacturer has modified the inspection program currently required by AD 2006–09–05, this proposed AD reduces the compliance times required by the existing AD.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and
3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
1. The authority citation for part 39 continues to read as follows:
49 U.S.C. 106(g), 40113, 44701.
2. The FAA amends § 39.13 by removing Amendment 39–14575 (71 FR 25921, May 3, 2006) and adding the following new AD:
(a) We must receive comments by August 27, 2010.
(b) This AD supersedes AD 2006–09–05, Amendment 39–14575. This AD also affects certain requirements of AD 98–26–01, Amendment 39–10942.
(c) This AD applies to all Airbus Model A310–203, –204, –221, –222, –304, –322, –324, and –325 airplanes, certificated in any category.
(d) Air Transport Association (ATA) of America Code 57: Wings.
(e) The mandatory continuing airworthiness information (MCAI) states:
Analysis performed in the frame of the Extended Service Goal has led Airbus to modify the inspection programme [modification of thresholds, intervals and associated configurations] which is currently required by DGAC (Direction Générale de l'Aviation Civile) France AD F–2005–001 [which corresponds to FAA AD 2006–09–05].
This modified inspection programme is necessary to detect and prevent damage associated with a structural fatigue phenomenon of the rear spar internal angle and the tee fitting located in the centre wing box. This condition, if not corrected, could affect the structural integrity of the centre wing box.
(f) You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done.
(g) For all airplanes except those that are modified by Airbus Modifications 06672S6812, 06673S6813, and 07387S7974 in production: Within 60 months after June 7, 2006 (the effective date of AD 2006–09–05), modify the holes in the internal angle and tee fitting and do all applicable related investigative and corrective actions by accomplishing all the actions specified in the Accomplishment Instructions of Airbus Service Bulletin A310–57–2035, Revision 08, dated September 19, 2005; or Airbus Mandatory Service Bulletin A310–57–2035, Revision 10, dated March 25, 2008; except as required by paragraph (h) of this AD. Do all applicable related investigative and corrective actions before further flight. As of the effective date of this AD, use only Airbus Mandatory Service Bulletin A310–57–2035, Revision 10, dated March 25, 2008.
(h) Where the service information specified in Table 1 of this AD specifies to contact the manufacturer if certain cracks are found, before further flight, repair those conditions according to a method approved by either the Manager, International Branch, ANM–116, Transport Airplane Directorate, FAA; or the Direction Générale de l'Aviation Civile (DGAC) (or its delegated agent); or EASA (or its delegated agent).
(i) Actions accomplished before June 7, 2006, in accordance with the service information specified in Table 2 of this AD, are considered acceptable for compliance with the corresponding actions specified in paragraph (g) of this AD.
(j) For airplanes on which an inspection of the rear spar internal angle has not been done in accordance with Airbus Service Bulletin A310–57–2047 as of the effective date of this AD: At the later of the times specified in paragraphs (j)(1) and (j)(2) of this AD, do a rotating probe inspection for any crack of the rear spar internal angle located in the center wing box and do all applicable related investigative and corrective actions, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A310–57–2047, Revision 08, dated July 2, 2009; except as required by paragraphs (n) and (o) of this AD. Do all applicable related investigative and corrective actions before further flight. Repeat the inspection thereafter at the applicable time specified in Table 4 of this AD. Certain compliance times are applicable to short range use, average flight time (AFT) equal to or less than 4 hours, or long range use, AFT exceeding 4 hours.
To establish the AFT, divide the accumulated flight time (counted from the take-off up to the landing) by the number of accumulated flight cycles. This gives the average flight time per flight cycle.
(1) Within the applicable time specified in Table 3 of this AD.
(2) Within the applicable time specified in paragraph (j)(2)(i), (j)(2)(ii), or (j)(2)(iii) of this AD:
(i) For A310–203, –204, –221, and –222 airplanes: Within 700 flight cycles or 1,500 flight hours after the effective date of this AD, whichever occurs first.
(ii) For A310–304, –322, –324, and –325 short range airplanes: Within 700 flight cycles or 1,900 flight hours after the effective date of this AD, whichever occurs first.
(iii) For A310–304, –322, –324, and –325 long range airplanes: Within 500 flight cycles or 2,500 flight hours after the effective date of this AD, whichever occurs first.
(k) For airplanes on which an inspection of the rear spar internal angle has been done in accordance with Airbus Service Bulletin A310–57–2047 as of the effective date of this AD: At the applicable time specified in paragraphs (k)(1), (k)(2), and (k)(3) of this AD, do a rotating probe inspection for any crack of the rear spar internal angle located in the center wing box and do all applicable related investigative and corrective actions, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A310–57–2047, Revision 08, dated July 2, 2009; except as required by paragraphs (n) and (o) of this AD. Do all applicable related investigative and corrective actions before further flight. Repeat the inspection thereafter at the applicable time specified in Table 4 of this AD. Certain compliance times are applicable to short range use, AFT equal to or less than 4 hours, or long range use, AFT exceeding 4 hours.
(1) For A310–203, –204, –221, and –222 airplanes: At the earlier of the times specified in paragraphs (k)(1)(i) and (k)(1)(ii) of this AD.
(i) Within 7,940 flight cycles or 15,880 flight hours after the most recent inspection, whichever occurs first.
(ii) At the later of the times specified in paragraphs (k)(1)(ii)(A) and (k)(1)(ii)(B) of this AD.
(A) Within the applicable interval specified in Table 4 of this AD.
(B) Within 740 flight cycles or 1,480 flight hours after the effective date of this AD, whichever occurs first.
(2) For A310–304, –322, –324, and –325 short range airplanes: At the later of the times
(i) Within the applicable interval specified in Table 4 of this AD.
(ii) Within 700 flight cycles or 1,900 flight hours after the effective date of this AD, whichever occurs first.
(3) For A310–304, –322, –324, and –325 long range airplanes: At the later of the times specified in paragraphs (k)(3)(i) and (k)(3)(ii) of this AD.
(i) Within the applicable interval specified in Table 4 of this AD.
(ii) Within 500 flight cycles or 2,500 flight hours after the effective date of this AD, whichever occurs first.
(l) For airplanes on which an inspection of the left and right sides of the tee fitting has not been done in accordance with Airbus Service Bulletin A310–57–2047 as of the effective date of this AD: At the later of the times specified in paragraphs (l)(1) and (l)(2) of this AD, do a rotating probe inspection for any crack of the left and right sides of the tee fitting, and do all applicable related investigative and corrective actions, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A310–57–2047, Revision 08, dated July 2, 2009; except as required by paragraphs (n) and (o) of this AD. Do all applicable related investigative and corrective actions before further flight. Repeat the inspection thereafter at the applicable time specified in Table 6 of this AD. Certain compliance times are applicable to short range use, AFT equal to or less than 4 hours, or long range use, AFT exceeding 4 hours.
(1) Within the applicable time specified in Table 5 of this AD.
(2) Within the applicable time in paragraph (l)(2)(i), (l)(2)(ii), or (l)(2)(iii) of this AD.
(i) For A310–203, –204, –221, and –222 airplanes: Within 800 flight cycles or 1,600 flight hours, whichever occurs first.
(ii) For A310–304, –322, –324, and –325 short range airplanes: Within 800 flight cycles or 2,200 flight hours, whichever occurs first.
(iii) For A310–304, –322, –324, and –325 long range airplanes: Within 600 flight cycles or 3,100 flight hours, whichever occurs first.
(m) For airplanes on which an inspection of the rear left and right sides of the tee fitting has been done in accordance with Airbus Service Bulletin A310–57–2047 as of the effective date of this AD: At the applicable time specified in paragraphs (m)(1) or (m)(2) of this AD, do a rotating probe inspection for any crack of the left and right sides of the tee fitting, and do all applicable related investigative and corrective actions, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A310–57–2047, Revision 08, dated July 2, 2009; except as required by paragraphs (n) and (o) of this AD. Do all applicable related investigative and corrective actions before further flight. Repeat the inspection thereafter at the applicable time specified in Table 6 of this AD. Certain compliance times are applicable to short range use, AFT equal to or less than 4 hours, or long range use, AFT exceeding 4 hours.
(1) For A310–203, –204, –221, and –222 airplanes: At the earlier of the times specified in paragraphs (m)(1)(i) and (m)(1)(ii) of this AD.
(i) Within 10,800 flight cycles or 17,400 flight hours after the most recent inspection, whichever occurs first.
(ii) At the later of the times specified in paragraphs (m)(1)(ii)(A) and (m)(1)(ii)(B) of this AD.
(A) Within the applicable interval specified in Table 6 of this AD.
(B) Within 700 flight cycles or 1,500 flight hours after the effective date of this AD, whichever occurs first.
(2) For A310–304, –322, –324, and –325 airplanes: At the later of the times specified in paragraphs (m)(2)(i) and (m)(2)(ii) of this AD.
(i) Within the applicable interval specified in Table 6 of this AD.
(ii) Within 700 flight cycles or 1,900 flight hours after the effective date of this AD, whichever occurs first.
(n) Where Airbus Service Bulletin A310–57–2047, Revision 08, dated July 2, 2009, specifies to contact the manufacturer if certain cracks are found, before further flight, repair those conditions according to a method approved by either the Manager, International Branch, ANM–116, Transport Airplane Directorate, FAA; or EASA (or its delegated agent).
(o) Although Airbus Service Bulletin A310–57–2047, Revision 06, dated July 13, 2004; and Revision 08, dated July 2, 2009; specify to submit certain information to the manufacturer, this AD does not include that requirement.
(p) Actions accomplished before the effective date of this AD in accordance with Airbus Mandatory Service Bulletin A310–57–2035, Revision 09, dated September 27, 2007, are considered acceptable for compliance with the corresponding actions specified in paragraph (g) of this AD.
(q) Actions accomplished before the effective date of this AD in accordance with the service information specified in Table 7 of this AD, are considered acceptable for compliance with the corresponding actions specified in paragraphs (j) through (m) of this AD.
(r) Accomplishing a rotating probe inspection of the rear spar internal angle and the tee fitting in accordance with Airbus Service Bulletin A310–57–2047, Revision 08, dated July 2, 2009, or a service bulletin listed in Table 7 of this AD, terminates the requirements specified in paragraph (o) of AD 98–26–01.
This AD differs from the MCAI and/or service information as follows:
(s) The following provisions also apply to this AD:
(1) Alternative Methods of Compliance (AMOCs): The Manager, International Branch, ANM–116, Transport Airplane Directorate, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Dan Rodina, Aerospace Engineer, International Branch, ANM–116, FAA, Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton, Washington 98055–4056; telephone (425) 227–2125; fax (425) 227–1149. Before using any approved AMOC on any airplane to which the AMOC applies, notify your principal maintenance inspector (PMI) or principal avionics inspector (PAI), as appropriate, or lacking a principal inspector, your local Flight Standards District Office. The AMOC approval letter must specifically reference this AD.
(2) AMOCs approved previously in accordance with AD 2006–09–05, Amendment 39–14575, are approved as AMOCs for the corresponding provisions of this AD.
(3) Airworthy Product: For any requirement in this AD to obtain corrective actions from a manufacturer or other source, use these actions if they are FAA-approved. Corrective actions are considered FAA-approved if they are approved by the State of Design Authority (or their delegated agent). You are required to assure the product is airworthy before it is returned to service.
(t) Refer to MCAI EASA Airworthiness Directive 2008–0187, dated October 10, 2008; and Airbus Service Bulletins A310–57–2047, Revision 08, dated July 2, 2009; and Airbus Mandatory Service Bulletin A310–57–2035, Revision 10, dated March 25, 2008; for related information.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for the products listed above. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as: An A330 experienced an uncommanded engine #1 in flight spool down, which occurred while applying fuel gravity feed procedure, in response to low pressure indications from all fuel boost pumps, in both left and right wings. The investigations revealed that the wing tank pressure switches P/N (part number) HTE69000–1 had frozen due to water accumulated in their external part, causing spurious low pressure indications. As per procedure, the main pumps are then switched off, increasing the level of unavailable fuel. This, in combination with very low fuel quantities or another independent trapped fuel failure scenarios, can lead to fuel starvation on the affected engine(s). The proposed AD would require actions that are intended to address the unsafe condition described in the MCAI.
We must receive comments on this proposed AD by August 27, 2010.
You may send comments by any of the following methods:
• Federal eRulemaking Portal: Go to
• Fax: (202) 493–2251.
• Mail: U.S. Department of Transportation, Docket Operations, M–30, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue, SE., Washington, DC 20590.
• Hand Delivery: U.S. Department of Transportation, Docket Operations, M–30, West Building Ground Floor, Room W12–40, 1200 New Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
For service information identified in this proposed AD, contact Airbus SAS—Airworthiness Office—EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45 80, e-mail
You may examine the AD docket on the Internet at
Vladimir Ulyanov, Aerospace Engineer, International Branch, ANM–116, Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton, Washington 98057–3356; telephone (425) 227–1138; fax (425) 227–1149.
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We have lengthened the 30-day comment period for proposed ADs that address MCAI originated by aviation authorities of other countries to provide adequate time for interested parties to submit comments. The comment period for these proposed ADs is now typically 45 days, which is consistent with the comment period for domestic transport ADs.
We will post all comments we receive, without change, to
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA Airworthiness Directive 2010–0018, dated February 4, 2010 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:
An A330 experienced an uncommanded engine #1 in flight spool down, which occurred while applying fuel gravity feed procedure, in response to low pressure indications from all fuel boost pumps, in both left and right wings.
The investigations revealed that the wing tank pressure switches P/N (part number) HTE69000–1 had frozen due to water accumulated in their external part, causing spurious low pressure indications.
As per procedure, the main pumps are then switched off, increasing the level of unavailable fuel. This, in combination with very low fuel quantities or another independent trapped fuel failure scenarios, can lead to fuel starvation on the affected engine(s). This condition, if not corrected, could lead to a potential unsafe condition.
This AD requires the replacement of all four wing tank fuel pressure switches associated to main pumps by new ones with a more robust design preventing water accumulation and freezing.
Airbus issued Mandatory Service Bulletin A330–28–3111, Revision 02, dated March 24, 2010. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI.
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.
We have reviewed the MCAI and related service information and, in
We might also have proposed different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are highlighted in a NOTE within the proposed AD.
Based on the service information, we estimate that this proposed AD would affect about 48 products of U.S. registry. We also estimate that it would take about 7 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Required parts would cost about $0 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these costs. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of the proposed AD on U.S. operators to be $28,560, or $595 per product.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and
3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
1. The authority citation for part 39 continues to read as follows:
49 U.S.C. 106(g), 40113, 44701.
2. The FAA amends § 39.13 by adding the following new AD:
(a) We must receive comments by August 27, 2010.
(b) None.
(c) This AD applies to Airbus Model A330–201, –202, –203, –223, –243, –301, –302, –303, –321, –322, –323, –341, –342, and –343 airplanes, certificated in any category, all manufacturer serial numbers, equipped with part number (P/N) HTE69000–1 wing tank pressure switches installed at Functional Item Number (FIN) locations 74QA1, 74QA2, 75QA1 or 75QA2.
(d) Air Transport Association (ATA) of America Code 28: Fuel.
(e) The mandatory continuing airworthiness information (MCAI) states:
An A330 experienced an uncommanded engine #1 in flight spool down, which occurred while applying fuel gravity feed procedure, in response to low pressure indications from all fuel boost pumps, in both left and right wings.
The investigations revealed that the wing tank pressure switches P/N HTE69000–1 had frozen due to water accumulated in their external part, causing spurious low pressure indications.
As per procedure, the main pumps are then switched off, increasing the level of unavailable fuel. This, in combination with very low fuel quantities or another independent trapped fuel failure scenarios, can lead to fuel starvation on the affected engine(s).
(f) You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done.
(g) Within 5 years after the effective date of this AD, replace the wing tank main pump pressure switches having P/N HTE69000–1 in accordance with the Accomplishment Instructions of Airbus Mandatory Service Bulletin A330–28–3111, Revision 02, dated March 24, 2010.
(h) Actions accomplished before the effective date of this AD according to Airbus Mandatory Service Bulletin A330–28–3111, dated August 12, 2009; or Revision 01, dated December 4, 2009; are considered acceptable for compliance with the corresponding actions specified in this AD.
This AD differs from the MCAI and/or service information as follows: No differences.
(i) The following provisions also apply to this AD:
(1)
(2)
(3)
(j) Refer to MCAI European Aviation Safety Agency Airworthiness Directive 2010–0018, dated February 4, 2010; and Airbus Mandatory Service Bulletin A330–28–3111, Revision 02, dated March 24, 2010; for related information.
Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD.
Proposed rule.
This proposed rule would amend the Federal Manufactured Home Construction and Safety Standards by adopting certain recommendations made to HUD by the Manufactured Housing Consensus Committee (MHCC). The National Manufactured Housing Construction and Safety Standards Act of 1974 (the Act) requires HUD to publish in the
Interested persons are invited to submit comments regarding this rule to the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451 7th Street, SW., Room 10276, Washington, DC 20410–0500. Communications must refer to the above docket number and title. There are two methods for submitting public comments. All submissions must refer to the above docket number and title.
1.
2.
To receive consideration as public comments, comments must be submitted through one of the two methods specified above. Again, all submissions must refer to the docket number and title of the rule.
The Office of Regulatory Affairs and Manufactured Housing, Office of Housing, Department of Housing and Urban Development, 451 7th Street, SW., Room 9164, Washington, DC 20410; telephone number 202–708–6401 (this is not a toll-free number). Persons with hearing or speech impairments may access this number through TTY by calling the toll-free Federal Information Relay Service at 800–877–8339.
The National Manufactured Housing Construction and Safety Standards Act of 1974 (42 U.S.C. 5401–5426) (the Act)
As amended, the purposes of the Act (enumerated at 42 U.S.C. 5401) are: “(1) to protect the quality, durability, safety, and affordability of manufactured homes; (2) to facilitate the availability of affordable manufactured homes and to increase homeownership for all Americans; (3) to provide for the establishment of practical, uniform, and, to the extent possible, performance-based Federal construction standards for manufactured homes; (4) to encourage innovative and cost-effective construction techniques for manufactured homes; (5) to protect residents of manufactured homes with respect to personal injuries and the amount of insurance costs and property damages in manufactured housing consistent with the other purposes of this section; (6) to establish a balanced consensus process for the development, revision, and interpretation of Federal construction and safety standards for manufactured homes and related regulations for the enforcement of such standards; (7) to ensure uniform and effective enforcement of Federal construction and safety standards for manufactured homes; and (8) to ensure that the public interest in, and need for, affordable manufactured housing is duly considered in all determinations relating to the Federal standards and their enforcement.”
In addition, the amended Act generally requires HUD to establish Construction and Safety Standards that are reasonable and practical, meet high standards of protection, are performance-based, and are objectively stated. Congress specifically established the MHCC to develop proposed revisions to the Construction and Safety Standards. The Act provides specific procedures (42 U.S.C. 5403) for the MHCC process.
After the passage of amendments to the Act in 2000, HUD, in accordance with the mandate of the Act, issued a request for proposals to interested organizations to be the “Administering Organization” that would serve as secretariat to the MHCC and therefore support the Construction and Safety Standards development process.
The MHCC held its first meeting in August 2002 and began work on reviewing possible revisions to the Construction and Safety Standards. The MHCC developed its own priorities for preparing proposed revisions for HUD to consider. As the MHCC proceeded, proposed revisions to the Construction and Safety Standards were divided into sets. On November 30, 2005, at 70 FR 72024, HUD published a final rule to amend various sections of the Construction and Safety Standards that was based on the first set of revisions the MHCC had proposed. This proposed rule is based on the second set of MHCC proposals to revise the Construction and Safety Standards. The MHCC proposals and recommendations can be viewed using the following link:
HUD has reviewed those proposals and has made certain editorial revisions. HUD believes this proposed rule represents revisions that HUD and the MHCC have agreed upon.
The proposed rule would revise the following sections of the Construction and Safety Standards and also revise the incorporated reference standards, where indicated. Most of the proposed changes would codify existing building practices or conform HUD standards to HUD interpretive bulletins or existing building codes. As noted elsewhere in this preamble, HUD has identified only two standards in this proposed rule that would have an economic impact on the production costs of manufactured homes: The requirement that shower and bath valves use anti-scald mixing valves, and the increase in minimum insulation levels for cross-under ducts. HUD is requesting comment, however, on whether any of the other proposed changes would have an economic impact or impose additional costs on the production of manufactured housing and specifically seeks comments on the analysis supporting this proposed rule and on the assumptions used.
The following is a discussion of the specific revisions to the Construction and Safety Standards that are proposed by this rule.
The proposed rule would amend
The proposed rule would amend § 3280.105(a)(2), by clarifying the method to be used when measuring the travel distance from the bedroom door to an exit door, a distance that must not exceed 35 feet. The proposed rule would clarify how the natural and unobstructed path is to be measured from the center of the bedroom door to the center of the exit door. Currently, there is no standardized method for making the travel distance measurement identified in the Standards. This proposed change would codify the method that is currently being used by manufacturers to make the 35-foot measurement to determine compliance with the Standards.
The proposed rule would also amend the provisions for exit facilities/exit doors in § 3280.105(b), by permitting door seals to reduce the minimum required exterior door opening by one inch. This proposed change would not change current construction requirements for exterior passage doors. Rather, it would codify an existing practice that has been previously permitted under Interpretative Bulletin B–1–76.
The proposed rule would make editorial revisions and amend the provisions for toilet requirements in § 3280.111, by adding an additional minimum clearance dimension from the centerline of a toilet to any adjacent wall of at least 15 inches. This proposed revision is consistent with current design practice in manufactured homes and is consistent with the requirements in residential building codes as well.
The proposed rule would modify and expand current § 3280.113, that sets requirements as to where safety glazing materials are to be located and how they are to be tested to determine if they can be considered safety glazing materials. The rule would also make the existing requirements for location and testing of safety glazing materials consistent with other model building codes and residential construction practices. Under the proposed revisions, safety glazing materials would be considered to be any glazing material capable of meeting the requirements of the Consumer Product Safety Commission (CPSC) or the Safety Performance Specifications and Methods of Test in ANSI Z97.1–1984.
The proposed rule would add an alternative means of complying with the kitchen cabinet protection requirements in § 3280.204, by allowing the metal hood,
The proposed rule would also add and expand upon fire safety and performance requirements for all types of thermal insulating materials under proposed new section § 3280.207, Requirements for Thermal Insulating Materials. This is consistent with the requirements for evaluation of fire performance characteristics of
The proposed rule would amend § 3280.305(c)(1)(i) by clarifying that the net uplift roof load must not be reduced by the dead load of the roof structure for the purposes of preparing engineering calculations or in performing structural load testing. This proposed change for roof uplift design would make no change to current engineering design practices. Rather, it would merely codify the current practices permitted under Interpretative Bulletin D–4–76.
The proposed rule would make editorial revisions and also clarify existing provisions in § 3280.305(c) that address areas where state or local building codes requirements exceed the provisions for design roof loads and wind loads required by the Standards. For consideration of state or local requirements for wind loads, the proposed rule would clarify that wind mapping data or records would need to indicate that higher design loads are necessary. The proposed rule would also change the title of each section to Consideration of Local Requirements.
The proposed rule would modify the existing requirements for control of formaldehyde emissions in § 3280.308, by lowering the maximum emission levels (as measured in the air chamber test specified in § 3280.406) for particleboard materials used in flooring applications from 0.3 parts per million (ppm) to 0.2 ppm; by limiting formaldehyde emissions from other uses of particleboard materials to 0.3 ppm; and by adding new formaldehyde emission controls for medium density fiberboard materials (MDF) of 0.3 ppm. These changes recommended by the MHCC, which are available on-line at
A conforming amendment would be made to § 3280.403, for the testing of skylights consistent with the revisions to § 3280.305(c)(3)(iv) of the Construction and Safety Standards published in the
Section 3280.404(c)(2) of the proposed rule would prohibit any window that requires the removal of a sash to meet the egress size provisions of the Manufactured Home Construction and Safety Standards from being classified as an egress window. This proposed change would enhance egress and occupant safety in the event of an emergency.
The proposed rule would add new section § 3280.504(c) to allow the use of liquid-applied vapor retarders, so long as a nationally recognized testing agency has approved its use on the specific substrate to which it is to be applied. This addition would codify the current practice of accepting liquid-applied vapor retarders as an alternative to other conventional vapor retarder materials required by this section.
Section 3280.506(c) would be revised to clarify that interior-mounted storm window frames must be sealed in Thermal Uo Value Zone 3. This would reduce air infiltration and heat loss for interior-mounted-type storm windows and improve overall energy efficiency for manufactured homes designed to be located in the most restrictive climatic regions of the country.
Section 3280.509(c) would be amended by replacing the graph for determining the effective R values of compressed insulation with a table that allows for more precisely determining the effects on R values of non-uniform and uniform insulation compression for batt and blown insulation. This proposal would provide a more accurate method for determining effective R value requirements when insulation is compressed or used in sloping roof cavities and would result in more accurate projections of heat loss and heat gain for manufactured homes than would be determined by the current graphical method.
The proposed rule would amend § 3280.510(c), by eliminating the requirement to determine and report the optimal outdoor winter certification temperature for operating economy and energy conservation on the heating certificate. The requirement is being eliminated because this information has been found to be too technical and is not a basis often relied upon by consumers in determining sites for installing their homes.
However, in view of the renewed interest in improving energy conservation, HUD is requesting comments from the public regarding any other information that could be provided on the heating certificate that could be more useful to consumers in this regard. In addition, the information on the comfort cooling certificates required by this section would be amended to refer to the 1997 edition of the ASHRAE Handbook of Fundamentals.
The proposed rule would make a conforming amendment to § 3280.603(a)(2) on water conservation to limit each water closet to 1.6 gallons of water per flush. Section 3280.607(b)(2)(iii) was amended in the final rule published in the
The proposed rule would amend § 3280.603(b)(4), by adding a requirement that the installation instructions required by § 3280.306(b)(4) include a statement that any heat tape or pipe heating cable used be listed for use in manufactured homes. The proposed rule would further amend this section with regard to the requirements for the receptacle outlet for connection of the heat tape or pipe heating cable to conform with the amended provisions of § 3280.806(d).
The proposed rule would amend the table in 3280.604(b)(2), by incorporating standards for the installation of cross-linked polyethylene (PEX) plastic cold and hot water systems. This proposal would permit the use of PEX plastic piping as an alternate piping material to other materials that may currently be used to supply hot and cold water systems.
A new provision would be added in § 3280.607(b)(v) to require that shower, bath, and tub-shower combination valves be either balanced pressure, thermostatic, or a combination of mixing valves that conforms to the requirements of ASSE 1016–1996, Performance Requirements for Individual Thermostatic Pressure-Balancing and Combination Control for Bathing Facilities. These valves would be required to have handle position stops that are adjustable to a maximum setting of 120 °F to prevent scalding and burn injuries to occupants from very hot water. This proposed change would reduce the number of injuries and deaths resulting from tap water scald burns. Further, the Centers for Disease Control (CDC) and other organizations report that a majority of scald burn victims are young children whose injuries may have been prevented by the use of an anti-scald valve.
The proposed rule would amend § 3280.607(b)(5)(ii) for the standpipe height required for laundry tubs from 30 inches to 42 inches above its trap and would require the standpipe to terminate in an accessible location no lower than the top of the clothes washing machine. This increase in standpipe height would be consistent with the International Residential Code requirements for Single and Two Family Dwellings and would prevent backflow and improve operation of clothes washers installed in manufactured homes.
The proposed rule would amend § 3280.609(a)(2), by allowing a two or three compartment sink, up to three individual sinks or up to three lavatories to be connected to one “P” trap, to be considered as a single fixture for the purposes of drainage and ventilation under certain circumstances. This proposal would allow more fixtures to be connected to one “P” trap than is currently permitted by the Standards and would be consistent with other residential model plumbing codes for similar three fixture configurations.
The proposed rule would amend § 3280.610(e), by permitting fixture drains that serve only a single lavatory fixture to be 1
The proposed rule would amend the existing requirements for anti-siphon trap vent devices in § 3280.611(d), by redefining these devices as mechanical vents (see § 3280.602) and by expanding the requirements to also include gravity-operated mechanical vents (also known as air admittance valves). This proposal would allow manufacturers to use either type of mechanical vent (anti-siphon vent or air admittance valve) for venting of certain plumbing fixtures. The current standard allows the use of anti-siphon type vents only. In addition, paragraph (f) of this section would be expanded to permit vent terminals either through wall extensions or into mechanical vent devices.
The proposed rule would amend § 3280.705(b), by allowing the use of corrugated stainless steel tubing (CSST) systems for use in gas piping systems. The inclusion of CSST piping as a permissible alternate gas piping/tubing material is currently permitted to be used in all other residential construction as a gas piping system by the model codes and state and local building codes. The proposed rule would require that CSST gas piping be installed in accordance with the requirements of ANSI/IAS LC–1–1997, Gas Piping Systems Using Corrugated Stainless Steel Tubing. In addition, a table for sizing CSST systems would be added in § 3280.705(d). Paragraph (h) of this section would also be amended by permitting CSST to be run inside walls, floors, partitions, and roofs under specified conditions.
Sections 3280.707(a) and (d) and 3280.714(a) would amend the energy efficiency and energy conservation requirements for comfort heating systems, water heaters, and cooling appliances so that they comply with the provisions of the National Appliance Energy Conservation Act of 1987, the current applicable requirements for these appliances.
Section 3280.715 would be amended by eliminating the use of Class 2 ducts and by deleting their definition from § 3280.703; by requiring manufacturers instructions to indicate that crossover ducts are not to be in contact with the ground and must be properly supported; and by requiring air supply crossover ducts in all Thermal Zones to have a minimal thermal resistance of R–8, unless installed in a basement. The proposed change to eliminate the use of Class 2 air handling ducts is consistent with the requirements of the International Residential Code for One and Two Family Dwellings, and would improve the fire safety and performance of air handling ducts by requiring the use of Class 0 or 1 ducts, which are more fire resistive than Class 2 ducts. In addition, HUD believes that Class 2 ducts are no longer being used in the production of manufactured homes. The proposal to increase the thermal resistance for crossover ducts would reduce heat loss and improve the energy efficiency of crossover ducts between sections of multi-section manufactured homes.
The proposed rule would amend § 3280.803 by indicating that a 1
Section 3280.804(f) would be amended to require the distribution panelboard to be located in an
The proposed rule would amend § 3280.805, by requiring all countertop outlets in the kitchen to be supplied by not less than two of the small appliance branch circuits. However, one or more of the small appliance branch circuits may also supply other receptacle outlets in the kitchen, pantry, dining room, and breakfast room. In addition, the proposed rule would amend paragraph (a)(3)(vi) of this section, by requiring that bathroom receptacle outlets be supplied by at least one 20 ampere branch circuit. While such circuits can have no other outlets, it is permissible to place the outlet for a heat tape or pipe heating cable on a bathroom circuit, provided that all of the bathroom outlets are on the load side of the ground fault circuit interrupter. These proposed changes would be consistent with the requirements in residential model codes and the NEC.
Section 3280.806(d) would be amended by not including receptacle outlets in the floor that are 18 inches or more from the wall as part of the required receptacle outlets for the room; by permitting the heat tape or pipe heating cable outlet to be on the bathroom circuit, provided that all bathroom outlets are on the load side of the ground fault circuit interrupter; and by requiring receptacles in any countertop to not be in a face-up position. These proposed changes would be consistent with the requirements in residential model codes and the NEC.
The following is a list of the standards incorporated by reference that would be revised by this proposed rule. Each reference standard is preceded with an indicator to identify the type of change being made. A new reference standard being added is indicated by the designation “N,” while a reference standard being updated is indicated by the designation “U.” The sections of the Construction and Safety Standards that would be amended by each modification are also shown on the right of each reference standard being added or updated.
In some situations, manufactured housing units which are subject to HUD's Manufactured Home Construction and Safety Standards may be provided through a program or activity that receives federal financial assistance from HUD. When this is the case, Section 504 of the Rehabilitation Act of 1973, as amended (29 U.S.C. 794), and HUD's implementing regulations at 24 CFR part 8 would be applicable, including the requirements at 24 CFR 8.22 that address accessibility in new construction. However, these requirements are not applicable to any individual or buyer that obtains Federal Housing Administration financing when purchasing a manufactured housing unit. When working with a recipient of HUD funds, manufacturers must be prepared to produce manufactured housing units that meet the accessibility standards provided in 24 CFR part 8. There regulations currently incorporate
The Office of Management and Budget (OMB) reviewed this rule under Executive Order 12866,
As the preamble highlights, this rule proposes to amend several construction and safety standards under the National Manufactured Housing and Construction and Safety Standards Act of 1974. However, most of the proposed changes would codify existing practices or conform HUD standards to existing building codes. Only two standards included in this rule would have an impact on the production cost of manufactured homes: the requirement that shower and bath valves use anti-scald mixing valves, and the increase in minimum insulation levels for cross-under ducts.
Currently, producers of manufactured housing may use non-pressure balanced mixing valves in bathtubs and showers. The cost of non-pressure balanced mixing value generally totals $30 per valve. If this proposed requirement is adopted in the final rule, the per-unit cost to producers to purchase pressure balanced/anti-scald mixing valve would be $55, or an increase of $25 per valve. The average number of mixing valves is one per single-section home and two per multi-section home. Thus, the cost is $25 per single-section home and $50 per multi-section home.
The number of placements annually since 1999 and the projected annualized aggregate placements from January 2009 through August 2009 have decreased considerably. This trend continues through the latest data, which indicates that the annual rate of placements through August 2009 was 58,100. Of these, 20,900 were single-section homes, 36,000 were double- section homes, and the remaining 1,200 had more than two sections. Although this trend is expected to continue, so that annual placements continue to decrease, this analysis assumes annual production of 58,100. In addition, this analysis assumes that the cost of requiring the use of an anti-scald valve at the point of production of the home is less than installation at some later time. This assumption is based on the fact that replacing a mixing valve with an anti-scald valve at some later date would require the use of a licensed plumber for several hours to make the change and a higher cost to purchase the anti-scald valve(s) due to the volume purchasing power of manufacturers as compared to individual purchasers.
Accordingly, based on current annual placement rates, the total cost of the anti-scald valve requirement is $523,000 ($25 per home * 20,900 single-section homes). For multi-section homes, the total cost is $1.86 million ($50 per home * 37,000 multi-section homes). The combined cost totals $2.383 million.
The second cost comes from the increase in the minimum insulation levels for cross-under ducts. These ducts are used in multi-section homes to carry heat from one section to another. Thus, there is no cost increase for single-section homes. The cost per square foot of insulation for multi-section homes would increase from $1.25 per square foot of R–4 insulated cross-under duct to $3.50 per square foot of R–8 insulated cross-under duct, or $2.25 per square foot. On average there are 20 square feet of insulation needed per multi-section home. Thus, the total cost of increasing the minimum insulation level is $2.615 million ($2.25 per square foot * 20 square feet per home * 58,100 homes).
In estimating the benefits of these two requirements, HUD has considered that requiring anti-scald valves would reduce the number of injuries and deaths resulting from tap water scald burns. Although statistics specific to scald burns in manufactured homes are unavailable, according to Safe Kids, a nonprofit organization dedicated to preventing accidental childhood injury, hot tap water accounts for nearly 25 percent of all scald burns among children and is associated with more deaths and hospitalizations than any other hot liquid burns. Statistics reported by the CDC indicate that almost 3,000 people are hospitalized annually due to scald burns from tap water in the home.
The Safe Kids organization estimates that hospital costs for admitted scald burn patients average $22,700.
In addition to prevented injuries and hospitalizations, the anti-scald valve requirement will also reduce the number of deaths resulting from scald burns. Aside from the 3,000 to 5,560 scald burns occurring each year, the National Coalition to Prevent Childhood Injury estimates that approximately 100 deaths result from scald burns annually. As explained above, newly placed manufactured housing represents 0.05 percent of occupied housing units. Thus, if tap water scalds are evenly
The insulation requirement will increase the energy efficiency of manufactured homes, which will decrease annual energy costs for homeowners. Based on estimates from the Department of Energy's Energy Gauge model, owners of multi-section homes, to which this requirement applies, would save approximately $3 in energy costs annually. Thus, the total annual benefit of this provision is $111,600 ($3 per home * 37,200 homes). Calculating the present value of the stream of benefits into the future yields a discounted present value of $3.832 million in energy savings using the 3 percent discount rate and $1.706 million using the 7 percent discount rate.
A summary of HUD's calculation of benefits from the anti-scald valve and insulation requirements follows:
In summary, this proposed rule would impose costs equaling $4.057 million and create discounted present value of benefits totaling $6.264 million to $14.069 million, depending on the discount rate. Thus, the total impact of this rule, the sum of the total costs and benefits, equals between $10.321 million and $18.126 million annually. Consequently, the rule was determined not economically significant within the meaning of the Executive Order.
The docket file is available for public inspection in the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451 7th Street, SW., Washington, DC 20410–0500. Due to security measures at the HUD Headquarters building, an advance appointment to review the public comments must be scheduled by calling the Regulations Division at 202–402–3055 (this is not a toll-free number). Individuals with speech or hearing impairments may access this number through TTY by calling the Federal Information Relay Service at 800–877–8339.
The proposed modified information collection requirements contained in this proposed rule, at §§ 3280.510, 3280.511, 3280.804, and 3280.813, have been submitted to the Office of Management and Budget (OMB) for review under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). In accordance with the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information, unless the collection displays a currently valid OMB control number. OMB has issued HUD the control number 2502–0253 for the information collection requirements under the current Manufactured Housing Construction and Safety Standards Program.
The public reporting burden for this modified collection of information is estimated to include the time for reviewing the instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. These proposed modifications to the existing heating and cooling certificates and two labels would result in no additional burden hours for completing the information collection currently accepted under control number 2502–0253.
In accordance with 5 CFR 1320.8(d)(1), HUD is soliciting comments from members of the public and affected agencies concerning the proposed collection of information to:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated collection techniques or other forms of information technology,
Interested persons are invited to submit comments regarding the information collection requirements in this proposal. Comments must refer to the proposal by name and docket number (FR–5221–P–01) and must be sent to:
Title II of the Unfunded Mandates Reform Act of 1995 establishes requirements for federal agencies to assess the effects of their regulatory actions on state, local, and tribal governments and the private sector. This rule will not impose any federal mandates on any state, local, or tribal government or the private sector within the meaning of the Unfunded Mandates Reform Act of 1995.
A Finding of No Significant Impact with respect to the environment has been made in accordance with HUD regulations at 24 CFR part 50, which implement section 102(2)(C) of the National Environmental Policy Act of 1969 (42 U.S.C. 4332(2)(C)). The Finding of No Significant Impact is available for public inspection between the hours of 8 a.m. and 5 p.m. weekdays in the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451 7th Street, SW., Room 10276, Washington, DC 20410–0500. Due to security measures at the HUD Headquarters building, please schedule an appointment to review the finding by calling the Regulations Division at 202–402–3055 (this is not a toll-free number). Individuals with speech or hearing impairments may access this number through TTY by calling the Federal Information Relay Service at 800–877–8339.
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601
Based on an analysis of the costs and the fact that a small manufacturer would just as likely produce homes at the higher end of the cost spectrum as would a major producer, evaluating the effect of the increase is not discernible based on the size of the manufacturing operation. For the reasons stated below, HUD knows of no instance of a manufacturer with fewer than 500 employees that would be economically affected significantly by this rule. As the preamble discusses, the overwhelming majority of the revisions to the Construction and Safety Standards proposed by this rule are directed to relieving burden on all manufacturers by having the Standards be consistent with current design and construction standards or state and local codes. Reducing the differences between the federal standards for design and construction of manufactured homes with current industry standards reduces burden for all manufacturers.
As discussed under the “Regulatory Planning and Review” section of this preamble, the annual economic impact of this rule is not significant, since the changes made by this rule are largely changes conforming to current industry practices and current building codes.
The relatively small increase in cost for the manufacturer associated with this proposed rule would not impose a significant burden on a small business for manufacturing homes that can cost the purchaser between $40,000 and $100,000. Therefore, although this rule would affect a substantial number of small entities, it would not have a significant economic impact on them. Therefore, the undersigned certifies that this rule will not have a significant impact on a substantial number of small entities.
Notwithstanding HUD's view that this rule will not have a significant economic effect on a substantial number of small entities, HUD specifically invites comments regarding this certification and any less burdensome alternatives to this rule that will meet HUD's objectives, as described in this preamble.
Executive Order 13132 (entitled “Federalism”) prohibits an agency from publishing any rule that has federalism implications if the rule either: (i) Imposes substantial direct compliance costs on state and local governments and is not required by statute, or (2) preempts state law, unless the agency meets the consultation and funding requirements of section 6 of the Order. This proposed rule does not have federalism implications, within the meaning of the Executive Orders, and would not impose substantial direct compliance costs on state and local governments nor preempt state law within the meaning of the Order.
Before HUD issues a final rule, these reference standards will be approved by the Director of the Federal Register for incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of these standards may be obtained from the following organizations:
Housing standards, Manufactured homes.
The Catalog of Federal Domestic Assistance number for Manufactured Housing Construction and Safety Standards is 14.171.
Accordingly, for the reasons stated in the preamble, HUD proposes to amend 24 CFR part 3280 as follows:
1. The authority citation for part 3280 continues to read as follows:
42 U.S.C. 3535(d), 5403, and 5424.
2. In § 3280.4, revise paragraph (a) and add a reference to RADCO in alphabetical order under paragraph (b) to read as follows:
(a) The specifications, standards, and codes of the following organizations are incorporated by reference. Reference standards have the same force and effect as the standards in this part. Where two or more referenced standards are equivalent in application, the manufacturer has the option to incorporate into the manufactured home design and construction the referenced standard of its choosing. When reference standards and the standards in this part are inconsistent, however, the requirements of this part must prevail to the extent of the inconsistency.
(b) * * *
3. In § 3280.105, revise paragraphs (a)(2)(iv) and (b)(2) to read as follows:
(a) * * *
(2) * * *
(iv) One of the required exit doors must be accessible from the doorway of each bedroom without traveling more than 35 feet. The travel distance to the exit door must be measured on the floor or other walking surface along the center-line of the natural and unobstructed path of travel starting at the center of the bedroom door, curving around any corners or permanent obstructions with a one foot clearance from, and ending at, the center of the exit door.
(b) * * *
(2) All exterior swinging doors must provide a minimum 28-inch wide x 74-inch high clear opening. Door seals are permitted to reduce the opening, either vertically or horizontally, a maximum of one inch. All exterior sliding glass doors must provide a minimum 28-inch wide x 72-inch high clear opening.
4. Revise § 3280.111 to read as follows:
Each toilet compartment must have a minimum width of 30 inches, with a minimum clear space of 21 inches in front of each toilet. A toilet located adjacent to a wall must have the center-line of the toilet located a minimum of 15 inches from the wall. A toilet located adjacent to a tub must have the center-line of the toilet located a minimum of 12 inches from the outside edge of the tub.
5. Amend § 3280.113 by revising paragraph (b) and adding new paragraphs (c) and (d) to read as follows:
(b)
(1) Glazing in all entrance or exit doors;
(2) Glazing in fixed and sliding panels of sliding glass doors;
(3) Glazing in storm type doors;
(4) Glazing in unframed side-hinged swinging doors;
(5) Glazing in doors and fixed panels less than 60 inches above the room floor level that enclose bathtubs, showers, hydromassage tubs, hot tubs, whirlpools, saunas;
(6) Glazing within 12 inches horizontally, as measured from the edge of the door in the closed position, and 60 inches vertically as measured from the room floor level, adjacent to and in the same plane of a door;
(7) Glazing within 36 inches of an interior room walking surface when the glazing meets all of the following:
(i) Individual glazed panels exceed 9 square feet in area in an exposed surface area;
(ii) The bottom edge of the exposed glazing is less than 19 inches above the room floor level; and
(iii) The top edge of the exposed glazing is greater than 36 inches above the room floor level.
(8) Glazing in rails and guardrails; and
(9) Glazing in unbacked mirrored wardrobe doors (
(c) Safety glazing material is considered to be any glazing material capable of meeting the requirements of CPSC 16 CFR part 1201, or the Safety Performance Specifications and Methods of Test for Safety Glazing Materials Used in Buildings, ANSI Z97.1–1984.
(d) Glazing in the following locations is not required to meet the requirements in paragraph (b) of this section:
(1) Openings in doors through which a 3-inch sphere is unable to pass;
(2) Leaded and decorative glazed panels;
(3) Glazing in jalousie type doors;
(4) Glazing as described in paragraph (b)(6) of this section when an intervening wall or other permanent barrier exists between the door and the glazing;
(5) Glazing as described in paragraph (b)(7) of this section when a protective bar or member is installed horizontally between 34 inches and 38 inches above the room floor level, as long as the bar or member is a minimum of 1
(6) Mirrors mounted on a flush door surface or solid wall surface.
6. In § 3280.204, revise paragraph (c) to read as follows:
(c)
(1) A microwave oven is installed between the cabinet and the range; and
(2) The microwave oven is equivalent in fire protection to the metal range hood required by paragraph (a) of this section; and
(3) The microwave oven is certified to be in conformance with Microwave Cooking Appliances, UL 923–2002.
7. Redesignate §§ 3280.207 through 3280.209 as §§ 3280.208 through 3280.210, respectively.
8. Add a new § 3280.207 to read as follows:
(a)
(1) Coverings and facings of insulation batts or blankets installed in concealed spaces when the facings are in substantial contact with the unexposed surface of wall, floor, or ceiling finish; or
(2) Cellulose loose-fill insulation that complies with paragraph (b) of this section.
(b)
(2) Other loose-fill insulation that cannot be mounted in the NFPA 255–96 test apparatus without a screen or other artificial support must be tested in accordance with CAN/ULC–S102.2–M88, Standard Method of Test for Surface Burning Characteristics of Flooring, Floor Covering, and Miscellaneous Materials and Assemblies, and must have a flame spread index of 25 or less and a smoke developed index of 450 or less.
(c)
9. Revise § 3280.301 to read as follows:
This subpart covers the minimum requirements for materials, products, equipment, and workmanship needed to assure that the manufactured home will provide the following:
(a) Structural strength and rigidity;
(b) Protection against corrosion, decay, insects, rodents, and other similar destructive forces;
(c) Protection against wind hazards;
(d) Resistance to the elements; and
(e) Durability and economy of maintenance.
10. In § 3280.304(b)(1), in the list under the undesignated heading “Wood and Wood Products”:
a. Revise the references to “Design and Fabrication of Glued Plywood-Lumber Beams,” “Design and Fabrication of Plywood Sandwich Panels,” and “Design and Fabrication of Plywood Stressed Skin Panels;”
b. Remove the reference to “Voluntary Product Standards, Performance Standard for Wood-Based Structural Use Panels,” and add in its place a reference to “Performance Standards for Wood-Based Structural Use Panels”; and
c. Add new reference standards for “Engineered Wood Construction Guide” and for “Medium Density Fiberboard (MDF),” immediately preceding the undesignated heading “Other”.
The revisions and additions read as follows:
(b)(1) * * *
Design and Fabrication of Glued Plywood-Lumber Beams, Suppl. 2—APA–S 812R, 1998.
Design and Fabrication of Plywood Sandwich Panels—APA–U814 H, 1993.
Performance Standard for Wood-Based Structural Use Panels—PS 2–04, 2005.
Design and Fabrication of Plywood Stressed-Skin Panels, Suppl. 3—APA–U 813L, 1996.
Engineered Wood Construction Guide—APA, 2001.
Medium Density Fiberboard (MDF)—ANSI A208.2–1999.
11. In § 3280.305, revise paragraphs (c)(1)(i), (c)(2)(iv), and (c)(3)(ii) to read as follows:
(c) * * *
(1) * * *
(i)
(2) * * *
(iv)
(3) * * *
(ii)
12. In § 3280.306, revise paragraphs (b)(2)(v) and (g)(2) to read as follows:
(b) * * *
(2) * * *
(v) That anchoring equipment should be certified by a registered professional engineer or architect to resist these specified forces in accordance with testing procedures in ASTM D3953, Standard Specification for Strapping, Flat Steel and Seals, 1997.
(g) * * *
(2) Type 1, Finish B, Grade 1 steel strapping, 1
13. In § 3280.308, revise paragraph (a)(2), and add paragraphs (a)(3) and (a)(4) to read as follows:
(a) * * *
(2) Particleboard used as flooring materials must not emit formaldehyde in excess of 0.20 parts per million (ppm), as measured by the air chamber test specified in § 3280.406.
(3) Particleboard materials used in applications other than flooring must not emit formaldehyde in excess of 0.30 ppm, as measured by the air chamber test specified in § 3280.406.
(4) Medium Density Fiberboard (MDF) must not emit formaldehyde in excess of 0.3 ppm, as measured by the air chamber test specified in § 3280.406.
14. In § 3280.403, revise the section heading, revise paragraph (a), redesignate paragraph (b) as (b)(1), add paragraph (b)(2), revise paragraph (c), and add paragraph (e)(3) to read as follows:
(a)
(b) * * *
(2) All skylights must comply with AAMA/WDMA 1600/I.S 7–00, Voluntary Specifications for Skylights. Skylights must withstand the roof loads for the applicable Roof Load Zone specified in § 3280.305(c)(3), and the following wind loads:
(i) For Wind Zone I, the wind loads specified in § 3280.305(c)(1)(i); and
(ii) For Wind Zones II and III, the wind loads specified for exterior roof coverings, sheathing, and fastenings in § 3280.305(c)(1)(ii).
(c)
(e) * * *
(3) All skylights installed in manufactured homes must be certified as complying with AAMA/WDMA 1600/I.S 7–00, Voluntary Specifications for Skylights. This certification must be based on applicable loads specified in paragraph (b) of this section.
15. In § 3280.404, revise paragraph (c)(2) and add paragraph (c)(3) to read as follows:
(c) * * *
(2) An operational check of each installed egress window or device must be made at the manufactured home factory. All egress windows and devices must be capable of being opened to the minimum required dimensions by normal operation of the window without binding or requiring the use of tools. Any window or device failing this check must be repaired or replaced. A repaired window must conform to its certification. Any repaired or replaced window or device must pass the operational check.
(3) Windows that require the removal of the sash to meet egress size requirements are prohibited.
16. Revise § 3280.503 to read as follows:
Materials used for insulation and the thermal and pressure envelopes must be of proven effectiveness and adequate durability to ensure that required design conditions concerning thermal transmission and energy conservation are attained.
17. In § 3280.504, redesignate existing paragraph (c) as paragraph (d) and add new paragraph (c) to read as follows:
(c)
18. In § 3280.505, revise paragraph (a) to read as follows:
(a)
19. In § 3280.506, revise paragraph (c) to read as follows:
(c) Manufactured homes designed for Uo Value Zone 3 must be factory-equipped with storm windows or insulating glass. Interior mounted storm window frames must be sealed.
20. In § 3280.508, revise paragraph (c) to read as follows:
(c) Areas where the insulation does not fully cover a surface or is compressed must be accounted for in the U-calculation. (See § 3280.506.) The effect of framing on the U-value must be included in the Uo calculation. Other low-R-value heat-flow paths (“thermal shorts”) must be explicitly accounted for in the calculation of the transmission heat loss coefficient if, in the aggregate, all types of low-R-value paths amount to more than one percent of the total exterior surface area, or 40 square feet, whichever is less. Areas will be considered low-R-value heat-flow paths if both of the following apply:
(1) They separate conditioned and unconditioned space; and
(2) They are not insulated to a level that is at least one-half the nominal insulation level of the surrounding building component.
21. In § 3280.509, revise paragraph (c) to read as follows:
(c)
22. In § 3280.510, revise paragraphs (b) and (c) to read as follows:
(b)
(c)
This manufactured home has been thermally insulated to conform with the requirements of the Federal Manufactured Home Construction and Safety Standards for all locations within Uo Value.
The above heating equipment has the capacity to maintain an average 70 °F temperature in this home at outdoor temperatures of __ °F.
23. In § 3280.511, revise paragraphs (a)(1) and (a)(2) to read as follows:
(a) * * *
(1)
(2)
The air distribution system of this home is suitable for the installation of central air conditioning.
The supply air duct system installed in this home is sized for a manufactured home central air conditioning system of up to __ BTU/Hr. This size assumes the air conditioner uses air circulators rated at 0.3 inch water column static pressure or greater for the cooling air delivered to the manufactured home supply air duct system.
24. In § 3280.602, remove the definition for
25. In § 3280.603, revise paragraphs (a)(2), (b)(4)(ii), and (b)(4)(iii) to read as follows:
(a) * * *
(2)
(b) * * *
(4) * * *
(ii) A statement in the installation instructions required by § 3280.306(b), stating that if the heat tape or pipe heating cable is used, it must be listed for use with manufactured homes.
(iii) A receptacle outlet complying with § 3280.806(d)(10).
26. In § 3280.604(b)(2), in the list under the undesignated heading “Plastic Pipe and Fittings,” add new reference standards for “Standard Specification for Crosslinked Polyethylene (PEX) Tubing,” and “Standard Specification for Crosslinked Polyethylene (PEX) Plastic Hot- and Cold-Water Distribution Systems,” immediately before the undesignated heading “Miscellaneous,” to read as follows:
(b) * * *
(2) * * *
Standard Specification for Crosslinked Polyethylene (PEX) Tubing—ASTM F876–1993.
Standard Specification for Crosslinked Polyethylene (PEX) Plastic Hot- and Cold-Water Distribution Systems—ASTM F877–1995.
27. In § 3280.605, redesignate paragraphs (a)(1) through (a)(7), as paragraphs (b) through (h); in newly redesignated paragraph (h), further redesignate paragraphs (i) and (ii) as paragraphs (h)(1) and (h)(2); and revise newly redesignated paragraph (h)(1) to read as follows:
(h) * * *
(1) Approved or listed hub-less pipe and fittings must be permitted to be joined with listed couplings or adapters, per the manufacturer's recommendations.
28. In § 3280.606, revise paragraph (a)(2) to read as follows:
(a) * * *
(2)
29. In § 3280.607, revise paragraphs (a)(3), (b)(2)(v), (b)(4)(i), (b)(5)(ii), and (c)(6)(i) through (c)(6)(iii), and add new paragraph (b)(3)(v) to read as follows:
(a) * * *
(3)
(i) 1
(ii) Not less than 1
(b) * * *
(2) * * *
(v)
(3) * * *
(v) Shower, bathtub, and tub-shower combination valves must be balanced pressure, thermostatic, or combination mixing valves that conform to the requirements of ASSE 1016–1996, Performance Requirements for Individual Thermostatic Pressure Balancing and Combination Control for Bathing Facilities. Such valves must be equipped with handle position stops that are adjustable in accordance with the valve manufacturer's instructions to a maximum setting of 120 °F.
(4) * * *
(i) A dishwashing machine must discharge its waste through a fixed air gap installed above the machine; through a high loop as specified by the dishwashing machine manufacturer; or into an open standpipe receptor with a height greater than the washing compartment of the machine. When a standpipe is used, it must be at least 18 inches, but not more than 30 inches, above the trap weir. The drain connections from the air gap or high loop are permitted to connect to an individual trap to a directional fitting installed in the sink tailpiece or to an opening provided on the inlet side of a food waste disposal unit.
(5) * * *
(ii) Standpipes must be either 1
(c) * * *
(6)
(ii)
(iii)
30. In § 3280.609, revise paragraphs (b)(7) and (b)(8) to read as follows:
(b) * * *
(7)
(8)
31. In § 3280.610, revise paragraphs (b)(1) and (e) to read as follows:
(b) * * *
(1)
(e)
(1) Fixture drains serving a single lavatory must be a minimum of 1
(2) Fixture drains serving two or three fixtures must be a minimum of 1
(3) Fixture drains serving four or more fixtures that are individually vented must be a minimum of 2 inches in diameter.
(4) Fixture drains for water closets must be a minimum of 3 inches in diameter.
32. In § 3280.611, revise paragraphs (b)(1), (d), and (f), to read as follows:
(b) * * *
(1)
(d)
(1) Spring-operated mechanical (anti-siphon) vents must comply with the following:
(i) No more than two fixtures individually protected by the spring-operated mechanical vent may be drained by a common 1
(ii) The drain size for three or more fixtures individually protected by a spring-operated mechanical vent must be at least 2 inches in diameter.
(iii) Spring-operated mechanical vents are restricted to venting fixtures with 1
(iv) A spring-operated mechanical vent must be installed in a location that allows a free flow of air and is accessible for inspection, maintenance, and replacement. The sealing function must be at least 6 inches above the top of the trap arm.
(v) Materials for the spring-operated mechanical vents must be as follows:
(A) Cap and housing must be listed acrylonitrile-butadiene-styrene, DWV grade;
(B) Stem must be DWV grade nylon or acetal;
(C) Spring must be stainless steel wire, Type 302; and
(D) Sealing disc must be either:
(
(
(2) Gravity-operated mechanical (air admittance valves) vents must comply with the following:
(i) Where installed to vent any fixture, the drain system must have a minimum 1
(ii) Where gravity-operated mechanical vent devices terminate in the attic cavity, the following requirements must be met:
(A) The attic cavity must be accessible.
(B) The sealing device must be installed a minimum of 6 inches above the insulation materials.
(C) The attic must be vented in accordance with § 3280.504(c)(1)(i).
(3) Mechanical vents must be installed in accordance with the vent manufacturer's instructions.
(f)
(1)
(2)
(i) Extensions must not be located beneath a door, window, or other opening;
(ii) Extensions must be a minimum of 10 feet above the finished floor;
(iii) Extensions must be located a minimum of 2 feet above any building opening that is within 10 feet horizontally of any extension; and
(iv) Extensions must not terminate under an overhang with soffit vents.
(3)
33. In § 3280.702, revise the definitions of “Class 0 air ducts,” “Class 1 air ducts,” “Heating appliance,” and “Water heater;” remove the definitions of “Class 2 air ducts” and “Energy Efficiency Ratio (EER);” and add definitions of “Combination space heating and water heating appliance,” “Direct-vent system,” and “Direct-vent system appliance” in alphabetical order, as follows:
34. In § 3280.703:
a. Under the undesignated heading “Appliances,” add a reference standard for “Decorative Gas Appliances for Installation in Solid Fuel Burning Appliances”
b. Under the undesignated heading “Miscellaneous,” revise the reference standards for “Gas Appliance Thermostats” and “Standard for the Installation of Oil-Burning Equipment”.
The revisions and additions to read as follows:
Decorative Gas Appliances for Installation in Solid Fuel Burning Appliances—RADCO Standard DS–010–1991.
Gas Appliance Thermostats─ANSI Z21.23, 1993.
Standard for the Installation of Oil-Burning Equipment, NFPA 31, 2001 Edition.
35. Remove and reserve § 3280.704.
36. In § 3280.705, add paragraph (b)(5), add Table 3280.705(d) following paragraph (d), and revise paragraph (h) (removing the Table designated “Part I” and the reference to “Part II [Reserved]”) to read as follows:
(b) * * *
(5) Corrugated stainless steel tubing (CSST) systems must be listed and installed in accordance with ANSI/IAS LC–1–1997, Gas Piping Systems Using Corrugated Stainless Steel Tubing, and the requirements of this section.
(d) * * *
(h)
(i) The CSST is protected from accidental puncture by a steel strike barrier not less than 0.058 inch thick, or the barrier's equivalent, installed
(ii) The CSST is installed in single runs and is not rigidly secured.
(2) Where tubing passes through exterior walls, floors, partitions, or similar construction, the tubing must be protected by the use of weather-resistant grommets that snugly fit both the tubing and the hole through which the tubing passes, or protected as specified in the tubing manufacturer's instructions.
(3) Concealed joints. Piping or tubing joints must not be located in any wall, floor, partition, or similar concealed construction space.
37. In § 3280.706, revise paragraph (j) to read as follows:
(j)
38. In § 3280.707, revise paragraphs (a)(2) and (d) to read as follows:
(a) * * *
(2) Each gas and oil burning comfort heating appliance must have an Annual Fuel Utilization Efficiency of not less than that specified in the National Appliance Energy Conservation Act of 1987.
(d)
39. Revise § 3280.711 to read as follows:
Operating instructions must be provided with each appliance. The operating and installation instructions for each appliance must be provided with the homeowner's manual.
40. In § 3280.714, revise paragraphs (a)(1)(i) and (ii) to read as follows:
(a) * * *
(1) * * *
(i) Electric motor-driven unitary air-cooled air conditioners and heat pumps in the cooling mode with rated capacity less than 65,000 BTU/hour (19,045 watts), when rated at ARI standard rating conditions in ARI Standard 210/240–89, Unitary Air Conditioning and Air Source Heat Pump Equipment, must have seasonal energy efficiency (SEER) values not less than as specified in the National Appliance Energy Conservation Act of 1987.
(ii) Heat pumps must be certified to comply with all requirements of the ARI Standard 210/240–89, Unitary Air Conditioning and Air-Source Heat Pump Equipment. Electric motor-driven vapor compression heat pumps with supplemental electrical resistance heat must be sized to provide by compression at least 60 percent of the calculated annual heating requirements for the manufactured home being served. A control must be provided and set to prevent operation of supplemental electrical resistance heat at outdoor temperatures above 40 °F (4 °C), except for defrost conditions. Electric motor-driven vapor compression heat pumps with supplemental electric resistance heat conforming to ARI Standard 210/240–89, Unitary Air Conditioning and Air-Source Heat Pump Equipment, must have Heating Season Performance Factor (HSPF) efficiencies not less than as specified in the National Appliance Energy Conservation Act of 1987.
41. In § 3280.715, revise the introductory text of paragraph (a)(1); revise the heading and add introductory text in paragraph (a)(2); and revise paragraphs (a)(4), (a)(5)(ii), (a)(6), (a)(7), and (d), to read as follows:
(a) * * *
(1) Supply air ducts, fittings, and any dampers contained therein must be made of galvanized steel, tin-plated steel, or aluminum, or must be listed as Class 0 or Class 1 air ducts and air connectors in accordance with UL 181–1998, Factory-Made Air Ducts and Air Connectors. Class 1 air ducts and air connectors must be located at least 3 feet from the furnace bonnet or plenum. Air connectors must not be used for exterior manufactured home duct connection. A duct system integral with the structure must be of durable construction that can be demonstrated to be equally resistant to fire and deterioration as required by this section. Furnace supply plenums must be constructed of metal that extends a minimum of 3 feet from the heat exchanger measured along the centerline of airflow. Ducts constructed from sheet metal must be in accordance with the following table:
(2)
(4)
(5) * * *
(ii) The manufacturer must provide installation instructions for supporting, mechanically fastening, sealing, and insulating each crossover duct. The instructions must indicate that no portion of the crossover duct is to be in contact with the ground, and must describe the means to support the duct without compressing the insulation and restricting airflow.
(6) Air supply ducts installed outside the thermal envelope must be insulated with material having an effective thermal resistance (R) of not less than 4, unless the ducts are within manufactured home insulation having a minimum effective value of R–4 for floors, or R–6 for ceilings.
(7) Unless installed in a basement, supply and return ducts, fittings, and crossover duct plenums exposed directly to outside air, such as those under-chassis crossover ducts or ducts connecting external heating, cooling, or combination heating/cooling appliances, must be insulated with material having a minimum thermal resistance of R–8 in all Thermal Zones. All such insulating materials must have a continuous vapor barrier retarder having a perm rating of not more than 1 perm. Where ducts are exposed underneath the manufactured home, they must comply with paragraph (a)(5)(ii) of this section, and shall be listed for exterior use.
(d)
42. In § 3280.802, revise paragraphs (a)(37) and (a)(39) to read as follows:
(a) * * *
(37)
(39)
43. In § 3280.803, revise paragraphs (d), (f), (i), (k)(2), and (k)(3) to read as follows:
(d) A suitable clamp or the equivalent must be provided at the distribution panelboard knockout to afford strain relief for the cord to prevent strain from being transmitted to the terminals when the power supply cord is handled in its intended manner.
(f) The attachment plug cap must be a 3-pole, 4-wire, grounding type, rated 50 amperes, 125/250 volts, intended for use with the 50-ampere, 125/250-volt receptacle configuration, as shown below. The cap must be listed, by itself or as part of a power-supply cord assembly, for the purpose, and must be molded to or installed on the flexible cord so that it is secured tightly to the cord at the point where the cord enters the attachment plug cap. If a right-angle cap is used, the configuration must be so oriented that the grounding member is farthest from the cord.
(i) Where the cord passes through walls or floors, it must be protected by means of conduits and bushings or the equivalent. The cord is permitted to be installed within the manufactured home walls, provided that a continuous raceway having a maximum size of 1
(k) * * *
(2) A listed metal raceway or listed rigid nonmetallic conduit from the disconnecting means in the manufactured home to the underside of the manufactured home, with provisions for the attachment of a suitable junction box or fitting to the raceway on the underside of the manufactured home. The manufacturer must provide written installation instructions stating the proper feeder conductor sizes for the raceway and the size of the junction box to be used; or
(3) Service equipment installed in or on the manufactured home, provided that all of the following conditions are met:
(i) In its written installation instructions, the manufacturer must include information indicating that the home must be secured in place by an anchoring system or installed on and secured to a permanent foundation;
(ii) The installation of the service equipment complies with Article 230 of the National Electrical Code, NFPA 70–2005. Exterior service equipment or the enclosure in which it is to be installed must be weatherproof, and conductors must be suitable for use in wet locations;
(iii) Means are provided for the connection of the grounding electrode conductor to the service equipment and routing it to the conductor outside the structure;
(iv) Bonding and grounding of the service must be in accordance with Article 250, NFPA 70–2005, National Electrical Code;
(v) The manufacturer must include in its installation instructions one method of grounding the service equipment at the installation site. The instructions must clearly state that other methods of grounding are found in Article 250 of NFPA 70–2005, National Electrical Code;
(vi) The minimum size grounding electrode conductor must be specified in the instructions; and
(vi) A red warning label must be mounted on or adjacent to the service equipment. The label must state the following: WARNING—DO NOT PROVIDE ELECTRICAL POWER UNTIL THE GROUNDING ELECTRODE(S) IS INSTALLED AND CONNECTED (SEE INSTALLATION INSTRUCTIONS).
44. In § 3280.804, revise paragraphs (a), (c), (e), and (f) to read as follows:
(a) The branch-circuit equipment is permitted to be combined with the disconnecting means as a single assembly. Such a combination is permitted to be designated as a distribution panelboard. If a fused distribution panelboard is used, the maximum fuse size for the mains shall be plainly marked, with the lettering at least 1/4-inch high and visible when fuses are changed. See Article 110–22 of NFPA 70–2005, National Electrical Code, concerning the identification of each disconnecting means and each service, feeder, or branch circuit at the point where it originated, and the type of marking needed.
(c) Disconnecting means. A single disconnecting means must be provided in each manufactured home, consisting of a circuit breaker, or a switch and fuses and its accessories, installed in a readily accessible location near the point of entrance of the supply cord or conductors into the manufactured home. The main circuit breakers or
(e) A distribution panelboard employing a main circuit breaker must be rated not less than 50 amperes and employ a 2-pole circuit breaker rated 40 amperes for a 40-ampere supply cord, or 50 amperes for a 50-ampere supply cord. A distribution panelboard employing a disconnect switch and fuses must be rated not less than 60 amperes and must employ a single, 2-pole fuseholder rated not less than 60-amperes with 40- or 50-ampere main fuses for 40- or 50-ampere supply cords, respectively. The outside of the distribution panelboard must be plainly marked with the fuse size.
(f) The distribution panelboard must be located in an accessible location, and must not be located in a bathroom or a clothes closet. A clear working space at least 30 inches wide and 30 inches in front of the distribution panelboard must be provided. This space must extend from the floor to the top of the distribution panelboard. Where used as switches, circuit breakers must be installed so that the center of the grip of the operating handle of the circuit breaker, when in its highest position, will not be more than 6 feet, 7 inches above the floor.
45. In § 3280.805, add a sentence at the end of paragraph (a)(1), revise paragraphs (a)(2) and (a)(3)(i), and add a new paragraph (a)(3)(vi), to read as follows:
(a) * * *
(1) * * * Lighting circuits are permitted to serve built-in gas ovens with electric service for lights, clocks, or timers, or for listed cord-connected garbage disposal units.
(2)
(3) * * *
(i) The ampere rating of fixed appliances must not exceed 50 percent of the circuit rating if lighting outlets are on the same circuit (receptacles in the kitchen, dining area, and laundry are not considered to be lighting outlets);
(vi) Bathroom receptacle outlets must be supplied by at least one 20-ampere branch circuit. Such circuits must have no other outlets, except that it is permissible to place the receptacle outlet for a heat tape or pipe heating cable required by § 3280.806(d)(10) on a bathroom circuit. (See § 3280.806(b).)
46. In § 3280.806, revise paragraph (b) and paragraph (d) introductory text, redesignate paragraph (d)(10) as paragraph (d)(11), and add new paragraphs (d)(10) and (g) to read as follows:
(b) All 125-volt, single-phase, 15- and 20-ampere receptacle outlets installed outdoors, or in compartments accessible from outside the manufactured home, and in bathrooms, including receptacles in light fixtures, must have ground-fault circuit-interrupter protection for personnel. Ground-fault circuit-interrupter protection for personnel must be provided for receptacles serving countertops in kitchens and receptacle outlets located within 6 feet of a wet bar sink, except for receptacles installed for appliances in dedicated spaces, such as for dishwashers, disposals, refrigerators, freezers, and laundry equipment.
(d)
(10) On the underside of the home for the connection of pipe heating cable(s) or heat tape(s), and the outlet must:
(i) Be located within 2 feet of the cold water inlet.
(ii) Be connected to an interior branch circuit, other than a small appliance branch circuit.
(iii) Be located on a circuit where all of the outlets are on the load side of the ground-fault circuit-interrupter protection for personnel.
(iv) Not be considered as the receptacle outlet required by paragraph (8) of this section.
(g) Receptacles must not be in a face-up position in any countertop.
47. In § 3280.807, revise paragraph (c) to read as follows:
(c) Where a lighting fixture is installed over a bathtub or in a shower stall, it must be listed for wet locations. [See also Article 410.4(D) of the National Electrical Code NFPA No. 70–2005.]
48. In § 3280.808,
a. Revise paragraphs (f), (h), (i) introductory text, (i)(1), and (k);
b. Remove paragraph (l);
c. Redesignate paragraphs (m) through (r) as paragraphs (l) through (q); and
d. Revise newly redesignated paragraph (o)(2).
The revisions read as follows:
(f) Where metal faceplates are used, they must be effectively grounded.
(h) Where rigid metal conduit or intermediate metal conduit is terminated at an enclosure with a locknut and bushing connection, two locknuts must be provided, one inside and one outside of the enclosure. Rigid nonmetallic conduit or electrical nonmetallic tubing is permitted. All cut ends of conduit and tubing must be reamed or otherwise finished to remove rough edges.
(i) Switches must be rated as follows:
(1) For lighting circuits, switches must be rated not less than 10 amperes, 120 to 125 volts, and in no case less than the connected load.
(k) When outdoor or under-chassis line-voltage (120 volts, nominal or higher) wiring is exposed to moisture or
(o) * * *
(2) Conductors having an insulation suitable for the temperature encountered may be run from the appliance terminal connections to a readily accessible outlet box placed at least one foot from the appliance. If provided, these conductors must be in a suitable raceway or Type AC or MC cable, of at least 18 inches but not more than 6 feet in length.
49. In § 3280.813, revise paragraph (b) to read as follows:
(b) A manufactured home provided with a branch circuit designed to energize outside heating equipment or air-conditioning equipment, other than room air conditioners, or both, located outside the manufactured home, other than room air conditioners, must have such branch-circuit conductors terminate in a listed outlet box, or disconnecting means, located on the outside of the manufactured home.
(1) A label must be permanently affixed adjacent to the outlet box. The label must be not less than 0.020-inches thick etched brass, stainless steel, anodized or alclad aluminum, or equivalent, and must not be less than 3 inches x 1–
(2) The label must include the correct voltage and ampere rating and the following information:
THIS CONNECTION IS FOR HEATING AND/OR AIR-CONDITIONING EQUIPMENT. THE BRANCH CIRCUIT IS RATED AT NOT MORE THAN____AMPERES, AT______VOLTS, 60-HERTZ,_______CONDUCTOR AMPACITY. A DISCONNECTING MEANS IS LOCATED WITHIN SIGHT OF THE EQUIPMENT.
(3) The correct voltage and ampere rating shall be given. The tag must be not less than 0.020-inches thick etched brass, stainless steel, anodized or alclad aluminum, or equivalent. The tag must have a minimum size of not less than 3 inches x 1
50. In § 3280.815, revise paragraph (a) as follows:
(a)(1) Except as provided in paragraph (a)(2) of this section, the white conductor must be employed for the grounded (neutral) circuit conductors only and must be connected to the white terminal or lead on receptacle outlets and fixtures. The grounded conductor must be the unswitched wire in switched circuits.
(2) A cable containing an insulated conductor with a white or natural gray outer finish or a marking of three continuous white stripes may be used for single-pole, 3-way, or 4-way switch loops, where this conductor is used for the supply to the switch, but not as a return conductor from the switch to the switched outlet. In these applications, the conductor with white or natural gray insulation or with three continuous white stripes must be permanently re-identified to indicate its use by painting or other effective means at its terminations and at each location where the conductor is visible and accessible.
Copyright Royalty Board, Library of Congress.
Proposed rule.
The Copyright Royalty Judges are publishing for comment negotiated royalty rates for the satellite carrier statutory license of the Copyright Act for the license period 2010–2014.
Objections to the proposed rates must be submitted no later than August 12, 2010.
Objections may be sent electronically to
Richard Strasser, Senior Attorney, or Gina Giuffreda, Attorney Advisor, by telephone at (202) 707–7658 or e-mail at
As required by section 119(c)(1)(B) of the Copyright Act, title 17 of the United States Code, the Copyright Royalty Judges published a Notice in the
On June 9, 2010, the Judges received a voluntary agreement from the Program Suppliers and Joint Sports Claimants (collectively, the “Copyright Owners”) and DIRECTV, Inc., DISH Network, LLC, and National Programming Service, LLC (collectively, the “Satellite Carriers”). The Copyright Owners and Satellite Carriers request that the Judges adopt the rates set forth in Article 2 of their agreement, which we are publishing today for comment. The Judges are publishing the rates as required by section 119(c)(1)(D)(ii)(II).
Section 119(c)(1)(D)(ii)(III) provides that the Judges shall adopt the negotiated rates “unless a party with an intent to participate in the proceeding and a significant interest in the outcome of that proceeding objects under clause
Copyright, Satellite, Television.
For the reasons set forth in the preamble, the Copyright Royalty Judges propose to add part 386 to Chapter III of title 37 of the Code of Federal Regulations to read as follows:
17 U.S.C. 119(c), 801(b)(1).
This part 386 adjusts the rates of royalties payable under the statutory license for the secondary transmission of broadcast stations under 17 U.S.C. 119.
(a)
(2) In the case of a station engaged in digital multicasting, the rates set forth in paragraph (b) of this section shall apply to each digital stream that a satellite carrier or distributor retransmits pursuant to 17 U.S.C. 119, provided however that no additional royalty shall be paid for the carriage of any material related to the programming on such stream.
(b)
(i) 2010: 25 cents per subscriber per month (for each month of 2010;
(ii) 2011: the 2010 rate, adjusted for the amount of inflation as measured by the change in the Consumer Price Index for all Urban Consumers All Items for October 2009 to October 2010;
(iii) 2012: the 2011 rate, adjusted for the amount of inflation as measured by the change in the Consumer Price Index for all Urban Consumers All Items for October 2010 to October 2011;
(iv) 2013: the 2012 rate, adjusted for the amount of inflation as measured by the change in the Consumer Price Index for all Urban Consumers All Items from October 2011 to October 2012;
(v) 2014: the 2013 rate, adjusted for the amount of inflation as measured by the change in the Consumer Price Index for all Urban Consumers All Items from October 2012 to October 2013.
(2)
(i) 2010: 50 cents per subscriber per month (for each month of 2010);
(ii) 2011: the 2010 rate, adjusted for the amount of inflation as measured by the change in the Consumer Price Index for all Urban Consumers All Items from October 2009 to October 2010;
(iii) 2012: the 2011 rate, adjusted for the amount of inflation as measured by the change in the Consumer Price Index for all Urban Consumers All Items from October 2010 to October 2011;
(iv) 2013: the 2012 rate, adjusted for the amount of inflation as measured by the change in the Consumer Price Index for all Urban Consumers All Items from October 2011 to October 2012;
(v) 2014: the 2013 rate, adjusted for the amount of inflation as measured by the change in the Consumer Price Index for all Urban Consumers All Items from October 2012 to October 2013.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Proposed rule; request for comments.
NMFS proposes to amend regulations that govern fisheries managed under the Western Alaska Community Development Quota (CDQ) Program. These revisions are needed to comply with certain changes made to the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) in 2006. Proposed changes include revising regulations associated with recordkeeping, vessel licensing, catch retention requirements, and fisheries observer requirements to ensure that they are no more restrictive than the regulations in effect for comparable non-CDQ fisheries managed under individual fishing quotas or cooperative allocations. In addition, NMFS proposes to remove CDQ Program regulations that now are inconsistent with the Magnuson-Stevens Act, including regulations associated with the CDQ allocation process, transfer of groundfish CDQ and halibut prohibited species quota, and the oversight of CDQ groups' expenditures.
Comments must be received no later than August 12, 2010.
Send comments to Sue Salveson, Assistant Regional Administrator, Sustainable Fisheries Division, Alaska Region, NMFS, Attn: Ellen Sebastian. You may submit comments, identified by RIN 0648–AV33, by any one of the following methods:
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•
•
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All comments received are a part of the public record. No comments will be posted to
NMFS will accept anonymous comments (enter N/A in the required fields, if you wish to remain anonymous). Attachments to electronic comments will be accepted in Microsoft Word, Excel, WordPerfect, or Adobe portable document file (pdf) formats only.
Written comments regarding the burden-hour estimates or other aspects
Copies of the Environmental Assessment (EA), Regulatory Impact Review (RIR), and Initial Regulatory Flexibility Analysis (IRFA) prepared for this action may be obtained from
Obren Davis, 907–586–7228.
NMFS manages the groundfish and crab fisheries of the Bering Sea and Aleutian Islands management area (BSAI) under the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (groundfish FMP) and the Fishery Management Plan for Bering Sea/Aleutian Islands King and Tanner Crabs (crab FMP). The North Pacific Fishery Management Council (Council) prepared the FMPs pursuant to the Magnuson-Stevens Act (16 U.S.C. 1801,
The CDQ Program is an economic development program associated with Federally managed fisheries in the BSAI. The purpose of the program is to provide western Alaska communities the opportunity to participate and invest in BSAI fisheries, to support economic development in western Alaska, to alleviate poverty and provide economic and social benefits for residents of western Alaska, and to achieve sustainable and diversified local economies in western Alaska. The large-scale commercial fisheries of the BSAI developed in the eastern Bering Sea without significant participation from rural western Alaska communities. These fisheries are capital-intensive and require large investments in vessels, infrastructure, processing capacity, and specialized gear. The CDQ Program was developed to redistribute some of the BSAI fisheries' economic benefits to adjacent communities by allocating a portion of commercially important BSAI species including pollock, crab, halibut, and various groundfish, to such communities. The percentage of each annual BSAI catch limit allocated to the CDQ Program varies by both species and management area. Regulations establishing the CDQ Program were first implemented in 1992. The CDQ Program was incorporated into the Magnuson-Stevens Act in 1996 through the Sustainable Fisheries Act (Pub. L. 104–297).
NMFS allocates a portion of the annual catch limits for a variety of commercially valuable marine species in the Bering Sea and Aleutian Islands area (BSAI) to the CDQ Program. These apportionments are in turn allocated among six different non-profit managing organizations representing different affiliations of communities (CDQ groups). There are 65 communities participating in the program. These communities, and their managing organizations, are identified in the Magnuson-Stevens Act at Section 305(i)(1)(D). CDQ groups use the revenue derived from the harvest of their fisheries allocations as a basis both for funding economic development activities and for providing employment opportunities. The successful harvest of CDQ Program allocations is integral to achieving the goals of the program. The National Marine Fisheries Service (NMFS), the State of Alaska (State), and the Western Alaska Community Development Association administer the CDQ Program.
The fisheries management regulations governing the CDQ fisheries are integrated into the regulations governing the concurrent fisheries for groundfish, halibut, and crab. These are often termed the “non-CDQ” fisheries. CDQ fisheries management regulations have been developed incrementally since the creation of the CDQ Program. These regulations were developed to ensure that catch of all species allocated to the CDQ Program should be limited to the amount of the allocations, with no catch from CDQ fisheries accruing against non-CDQ allocations. They also were developed to ensure that NMFS and the CDQ groups had timely, accurate catch information during the course of CDQ fishing activities. Applicable CDQ fisheries regulations may subject CDQ fishery participants to additional costs, additional catch reporting requirements, or be designed to control some aspect of CDQ fishing activities. This is typical of the development of regulations that govern catch share programs in the Alaska groundfish, halibut, and crab fisheries. Federal catch share programs convey harvesting privileges (licenses, fishing quota, exclusive access) for specific marine species to individuals, cooperatives, communities, or other eligible entities. In turn, the beneficiaries of such privileges are subject to higher levels of catch accounting, catch monitoring, and fisheries enforcement than they may have been subject to before receiving these privileges.
The original fishery management objectives for the groundfish, halibut, and crab CDQ fisheries include, in general, limiting the catch of all species to the amount allocated to the program and not allowing catch made under the program to accrue against non-CDQ portions of total allowable catch (TAC) limits or prohibited species catch (PSC) limits. These objectives also included managing target and non-target species allocations made to the CDQ groups with the same level of strict quota accountability, and holding each CDQ group responsible not to exceed any of its groundfish CDQ allocations.
Section 305(i)(1) of the Magnuson-Stevens Act includes requirements to establish the CDQ Program and allocate a percentage of the total allowable catch (TAC) of each Bering Sea (BS) and Aleutian Island (AI) directed fishery to the program. Corresponding Federal and State regulations implement various administrative and fisheries management aspects of the CDQ Program. The fisheries management regulations governing the groundfish, halibut, and crab CDQ fisheries are integrated into the regulations governing the concurrent, non-CDQ fisheries for such species.
Section 305(i)(1) of the Magnuson-Stevens Act was amended on July 11, 2006, by the Coast Guard and Maritime Transportation Act (Coast Guard Act) (Pub. L. 109–241). The Coast Guard Act revised all of the existing language in section 305(i)(1) with new language. The new requirements in section 305(i)(1) address all aspects of management and oversight of the CDQ Program including the purpose of the CDQ Program; allocations of groundfish, halibut, and crab to the program and among the CDQ groups; management of the CDQ fisheries with respect to non-CDQ fisheries; eligible communities; eligibility criteria; limits on allowable investments; the creation of a CDQ administrative panel; compliance with State reporting requirements; a decennial review and allocation adjustment process; and other features of program administration and oversight by the State and NMFS. These amendments were intended to address a variety of oversight and management
On January 12, 2007, the Magnuson-Stevens Fishery Conservation and Management Reauthorization Act of 2006 (Pub. L. 109–479) further amended section 305(i)(1) of the Magnuson-Stevens Act specifically by amending sections 305(i)(1)(B)(ii) and (C). The allocations of groundfish (other than pollock and sablefish) to the CDQ Program and among the CDQ groups were increased by this Reauthorization Act. Furthermore, it amended restrictions associated with the transfer of quota among the CDQ groups.
Most of the new CDQ Program requirements in the Magnuson-Stevens Act must be implemented through revisions to Federal regulations at 50 CFR parts 679 and 680. This action proposes regulatory amendments related to the regulation of harvest in select CDQ fisheries, as described below. This action also proposes to modify or remove other regulations related to the CDQ allocation and transfer process, as well as to remove regulations associated with the oversight of expenditures and investments by CDQ groups. These proposed regulatory amendments are described later in the preamble to this proposed rule. Other regulatory amendments to the CDQ Program required by the Coast Guard Act have been or are being addressed in other, separate regulatory actions.
NMFS prepared an EA/RIR/IRFA (
The regulation of CDQ harvest is directly addressed in the Magnuson-Stevens Act at section 305(i)(1)(B)(iv). This paragraph states:
The harvest of allocations under the program for fisheries with individual quotas or fishing cooperatives shall be regulated by the Secretary in a manner no more restrictive than for other participants in the applicable sector, including with respect to the harvest of non-target species.
Accordingly, this proposed action focuses on those BSAI fisheries with individual fishing quotas (IFQs) or those BSAI fisheries managed with cooperatives. The BSAI fisheries that include allocations of IFQs are the Pacific halibut, fixed gear sablefish, and crab fisheries. Recipients of IFQ receive a specific amount of a particular IFQ species to catch each year. The BSAI fisheries that include components managed with cooperatives include the BS pollock fishery, as well as the allocations of Atka mackerel, Aleutian Islands Pacific ocean perch, yellowfin sole, rock sole, flathead sole, and Pacific cod made to the non-American Fisheries Act (AFA) trawl catcher/processor sector (otherwise known as the Amendment 80 sector). Cooperatives allow multiple quota recipients to aggregate their annual quota amounts, coordinate their collective fishing operations, and benefit from the resulting efficiencies. Each of the BSAI fisheries managed with IFQs or cooperatives also include allocations to the CDQ Program.
NMFS interprets the statement “in a manner no more restrictive than for other participants in the applicable sector” from the Magnuson-Stevens Act to mean that the fishery management regulations associated with regulating the harvest of CDQ allocations should be no more costly, complex, or burdensome than those that apply to comparable non-CDQ sectors managed under IFQs or cooperative allocations. This applies to most of the major BSAI fisheries, although one noteworthy exception is the Pacific cod fishery conducted by hook-and-line catcher/processors. Hook-and-line catcher/processors are allocated 48.7 percent of the annual BSAI Pacific cod TAC, but are not rationalized as are most other major fishery sectors that fish for Pacific cod. Rationalization typically refers to programs that limit access to certain fisheries to balance the interests of competing participants, while providing a means to address overarching management and conservation issues. There are no IFQ or cooperative allocations associated with any fixed gear component of the Pacific cod fishery. Therefore, no changes are required by section 305(i)(1)(B)(iv) to regulations governing the harvest of Pacific cod by hook-and-line catcher/processors, although this is one of the major groundfish CDQ fisheries.
Furthermore, NMFS interprets the phrase “including with respect to the harvest of non-target species” in section 305(i)(1)(B)(iv) to apply to species that may legally be retained and sold while directed fishing for halibut, groundfish, or crab CDQ. In the BSAI groundfish fisheries, any given amount of catch may be composed of target species, some bycatch or incidental catch species, and some prohibited species. BSAI fisheries management regulations at § 679.2 define “harvesting or to harvest” as the catch and retention of any fish. The Magnuson-Stevens Act does not define “harvesting.”
Prohibited species may not be retained if caught while groundfish fishing in the BSAI, with the exception of those prohibited species that may be retained for donation to a food bank or are required to be retained for proper accounting. These types of prohibited species include salmon, as well as halibut delivered by catcher vessels using trawl gear to shoreside processors. Crab and herring are not part of the prohibited species donation program. Therefore, NMFS interprets the Magnuson-Stevens Act's requirements at section 305(i)(1)(B)(iv) as not applying to regulations governing the catch of prohibited species in the CDQ Program.
NMFS considered the need to propose changes to the regulations that govern the regulation of crab CDQ harvest during its assessment of current regulations governing the CDQ fisheries. The crab CDQ fisheries are managed under the regulations developed for the Crab Rationalization (CR) Program, which was implemented in 2005 (70 FR 10174, March 2, 2005). The crab FMP defers many aspects of BSAI crab management to the State, including most aspects of the regulation of harvest of crab CDQ. The crab CDQ fishery occurs in conjunction with the crab IFQ fishery under comparable Federal and State regulations. NMFS has not identified any crab CDQ regulations that are more restrictive than those in effect for the crab IFQ fishery. Therefore, this action does not propose changes to Federal regulations governing the crab CDQ fisheries.
Amendment 80 to the groundfish FMP (Amendment 80) allocated non-pollock groundfish fisheries among fishing sectors, and included provisions that allow the formation of fisheries cooperatives (72 FR 52668, September 14, 2007). NMFS already has integrated the applicable portion of the groundfish CDQ fisheries into the catch monitoring and enforcement requirements that were implemented for non-AFA trawl catcher/processors in conjunction with the implementation of Amendment 80. “Non-AFA trawl catcher/processors” refers to a class of vessels that did not qualify to fish for pollock under the authority of the AFA. These are typically referred to as Amendment 80 vessels. Such vessels typically have been involved in fisheries for species such as Atka mackerel, Pacific ocean perch, flathead sole, Pacific cod, rock sole, and yellowfin sole (Amendment 80 species). Therefore, this action does not
This proposed rule would revise regulations in 50 CFR part 679 to be consistent with Magnuson-Stevens Act requirements for the regulation of harvest of the CDQ fisheries, as described previously. Regulations governing the harvest of halibut and sablefish IFQ, and the harvest of pollock under the AFA, are different from regulations governing the harvest of other non-CDQ groundfish. Therefore, the Magnuson-Stevens Act now requires NMFS to manage the CDQ fisheries for halibut, sablefish, and pollock differently than the more restrictive CDQ regulations that currently are in effect. Thus, NMFS proposes to separately identify CDQ fisheries and separate the fisheries management regulations associated with the halibut, sablefish, pollock, and groundfish CDQ fisheries. This, in turn, would allow NMFS to amend regulations for the halibut, sablefish, and pollock CDQ fisheries to align them with those regulations in place for the equivalent non-CDQ fisheries.
The following is an overview of the proposed revisions to CDQ fisheries management regulations. Detailed explanations of, and rationales for, these proposed regulatory amendments are provided in following sections.
1. Add definitions of “sablefish CDQ fishing” and “pollock CDQ fishing” to provide a basis for establishing which fishery-specific regulations a vessel operator must comply with when participating in a particular CDQ fishery. The terms “halibut CDQ fishing” and “groundfish CDQ fishing” already are defined in regulation, but would be revised under this proposed rule. These proposed revisions are detailed in the
2. Exclude sablefish CDQ from the definition of “license limitation groundfish,” which would, in turn, exempt vessel operators from the requirement to have a License Limitation Program (LLP) groundfish license while fishing for sablefish CDQ under the CDQ Program. This would be consistent with the exemption allowed for vessels fishing for sablefish IFQ, which occurs under the IFQ Program. This proposed revision is detailed in the
3. Remove a requirement that CDQ groups annually submit a request to NMFS to designate specific vessels as eligible to harvest groundfish CDQ on their behalf, as well as remove a prohibition against harvesting groundfish CDQ unless a vessel is designated as eligible to do so. These proposed revisions are detailed in the
4. Revise CDQ catch monitoring and accounting requirements for the halibut, sablefish, and pollock CDQ fisheries to incorporate other applicable changes proposed by this action. This includes eliminating requirements that groundfish bycatch be retained for full catch accounting of all species caught by catcher vessels targeting halibut, sablefish, or pollock CDQ. These proposed revisions are detailed in the
5. Revise regulations to align observer coverage requirements for the sablefish CDQ, halibut CDQ, and pollock CDQ fisheries with comparable non-CDQ fisheries. These proposed revisions are detailed in the
In addition, there is a remove/add table at the end of the regulatory text portion of this proposed rule that portrays minor changes to wording or changes to cross-references. NMFS chose to propose some types of changes in the remove/add table because it is an efficient way to illustrate repetitive or simple changes. For example, the proposal to change the term “CDQ group number” to “CDQ number” affects multiple paragraphs of 50 CFR part 679.5, since this term is found in numerous locations in this section. The remove/add table clearly identifies the section and paragraph that is affected by each proposed change. The preamble refers the reader to the remove/add table whenever a proposed regulatory change is found there. All other regulatory changes are set forth in the proposed regulatory text following this preamble.
Revisions described below were specifically recommended by the Council in 2007 and are proposed under section 303(c) of the Magnuson-Stevens Act.
This proposed rule would add or revise a number of definitions in § 679.2 associated with the CDQ Program. These proposed changes are based upon the Magnuson-Stevens Act requirement that CDQ harvests must be managed no more restrictively than BSAI fisheries managed with individual quotas or fishing cooperatives. Adding or refining definitions for different types of CDQ fishing would help distinguish which regulations apply to a given CDQ fishing activity, and support the Council's recommendations for this action. Subsequent sections of the preamble discuss proposed changes to (1) eligible vessel requirements, (2) catch monitoring and accounting, and (3) observer coverage requirements, as well as explain the rationale for these proposed changes to definitions.
Definitions of pollock CDQ fishing and sablefish CDQ fishing would be added to § 679.2. This would enable NMFS and vessel operators in applicable fisheries to distinguish which particular CDQ fishery a vessel is participating in and the corresponding CDQ-specific regulations with which a vessel operator must comply. Groundfish CDQ fishing currently is defined. Pollock and sablefish are encompassed within the existing definition of groundfish CDQ fishing, along with numerous other groundfish species. This proposed rule would separate sablefish CDQ and pollock CDQ from the definition of groundfish CDQ fishing. This rule also proposes to apply different catch accounting and observer requirements to the sablefish, pollock, and groundfish CDQ fisheries; the new definitions proposed here primarily are to support such changes.
The proposed definition of “pollock CDQ fishing” would be modeled on a definition in § 679.2 used to define “AI directed pollock fishery,” which links a particular fishing activity to a distinct program allocation. This action proposes to define pollock CDQ fishing in a similar manner. Thus, a vessel would be considered directed fishing for pollock CDQ if it reported that its pollock catch accrued towards a pollock CDQ allocation. In addition, a new prohibition would be added at § 679.7(d) to prohibit a vessel operator from retaining more than the maximum retainable amount of pollock unless the vessel operator was pollock CDQ fishing. This would assist in clarifying that a vessel not otherwise eligible to target pollock (in other words, an Amendment 80 vessel) may not catch unlimited amounts of pollock while it is nominally targeting for other types of groundfish. The annual Bering Sea pollock catch limit already is fully apportioned between other industry sectors.
The definition of “halibut CDQ fishing” would be revised to remove references to conditions associated with retention of combinations of halibut CDQ, halibut IFQ, and other groundfish species. Instead of defining whether a vessel operator is halibut CDQ fishing based on the proportions of halibut and groundfish species retained onboard, NMFS proposes to define halibut CDQ
This proposed rule would revise the definition of “groundfish CDQ fishing” to remove pollock CDQ fishing and sablefish CDQ fishing from the definition. Those two types of fishing would each be defined separately. Additionally, the term “eligible vessel” would be removed from this definition, as CDQ eligible vessel requirements are proposed to be removed by this action. The revised definition of groundfish CDQ fishing primarily would apply to vessels using trawl gear fishing for groundfish species other than pollock and to vessels using fixed gear fishing for groundfish species other than sablefish.
This proposed rule would revise the definition of “license limitation groundfish” to exclude sablefish CDQ harvested with fixed gear. Such a revision would mean that vessels fishing for sablefish CDQ would no longer be required to possess an LLP groundfish license when they are directed fishing for sablefish CDQ. This is equivalent to the exception made for vessels that are sablefish IFQ fishing. Sablefish managed under the IFQ Program was exempted from being considered a license limitation groundfish because this species already was managed under a limited access program prior to the development of the LLP.
Each CDQ group must designate which vessels may fish for the group's groundfish CDQ or halibut CDQ by annually requesting that NMFS assign specific vessels with CDQ eligibility status. This requirement applies to each vessel of any length that will be groundfish CDQ fishing, and to each vessel equal to or greater than 60 ft (18.3 m) length overall (LOA) that will be halibut CDQ fishing. This requirement originally was implemented to provide specific information about which vessels would be participating in groundfish CDQ fisheries. NMFS required CDQ groups to submit detailed operational information about such vessels as part of the implementation of the multispecies groundfish CDQ Program in 1998. This was intended to ensure that the CDQ groups and their associated vessels were complying with increased observer coverage and catch reporting requirements. The eligible vessel designation also provided a means for the NOAA Office for Law Enforcement and U.S. Coast Guard enforcement personnel to verify that a vessel was authorized to participate in the CDQ fisheries.
As the groundfish CDQ fishery matured and stabilized between 1998 and 2003, the information submitted as part of the vessel eligibility process became unnecessary for management and enforcement. The information collected on the eligible vessels forms is available from other sources, such as observer data or NMFS fisheries permits data. In 2005, NMFS amended regulations governing the eligible vessel requirements to decrease the amount of information collected about each vessel and to remove the State from the administrative review process associated with vessel eligibility (70 FR 15010, March 24, 2005). Currently, vessel operators are required to maintain a copy of NMFS's eligibility approval onboard a vessel at all times while harvesting, transporting, or offloading groundfish CDQ. Permits are required to participate in the halibut IFQ, sablefish IFQ, and AFA pollock fisheries, but there are no requirements equivalent to the former CDQ eligible vessel requirements.
NMFS proposes to eliminate the CDQ eligible vessel requirements entirely, rather than just for the primary fisheries affected by this action. This includes the general requirement that a CDQ group must submit a request to NMFS for approval of a vessel as eligible to fish for CDQ allocations at § 679.32(c) and the specific eligibility information required to be submitted at § 679.5(n)(2). The U.S. Coast Guard, which is the enforcement agency most likely to board vessels at sea to verify a vessel's fishing status, has informed NMFS that it does not currently use information about a vessel's CDQ eligibility status for enforcement purposes. Instead, U.S. Coast Guard personnel use fisheries logbooks, required by NMFS, to determine if a vessel is CDQ fishing or is fishing under another management program.
Removal of the vessel eligibility requirements would eliminate the need for the prohibition at § 679.7(d)(4). This paragraph prohibits a vessel from harvesting groundfish CDQ on behalf of a CDQ group unless the vessel is listed as an eligible vessel for a CDQ group. The word “eligible” also would be removed from the term “eligible vessel” in prohibitions at § 679.7(d)(6) through (10), as is denoted in the remove/add table at the end of this proposed rule. Furthermore, § 679.7(f)(3)(ii), which prohibits the retention of sablefish unless certain permit conditions are met, would be revised to delete a cross-reference to § 679.32(c).
The proposed changes to CDQ catch monitoring and accounting regulations are based on the Council's recommendation to amend such regulations in order to comport with Magnuson-Stevens Act requirements for the CDQ Program. This recommendation is based on NMFS's comparison of applicable regulations governing the harvest of similar CDQ species and non-CDQ species. This includes an assessment of whether CDQ regulations, as compared to non-CDQ regulations, may be considered more restrictive in the context of relevant Magnuson-Stevens Act requirements, particularly to the degree that they either impose additional financial costs or operational requirements on CDQ fishery participants. Those CDQ-related regulations that were deemed more restrictive when compared to regulations governing IFQ or cooperative fisheries are proposed to be amended, per the Council's recommendation for this action. Such changes are intended to remove CDQ catch monitoring or reporting requirements beyond those in effect for non-CDQ fisheries for halibut and sablefish IFQ, as well as pollock harvested under the AFA. This should, in turn, decrease the operational restrictions, reporting complexities, and costs associated with additional observer coverage for participants in the sablefish, halibut, and pollock CDQ fisheries.
The CDQ Program's retention and catch reporting requirements, in conjunction with data from fisheries observers, allows NMFS to monitor the catch of the various CDQ species and prohibited species quota (PSQ) species categories on a timely, ongoing basis throughout the year. The original multispecies CDQ Program catch accounting design as implemented in 1998 stipulated that all groundfish CDQ and PSQ harvested by vessels participating in the groundfish CDQ fisheries must be accounted for in the allocations made to CDQ groups.
The CDQ catch accounting system was developed in the late 1990's and designed so that none of the groundfish or PSQ catch (except herring) made in the groundfish CDQ fisheries accrued to the non-CDQ TACs or PSC limits. Furthermore, groundfish CDQ accounting requirements were extended to the halibut CDQ fishery. Halibut CDQ vessels equal to or greater than 60 ft (18.3 m) LOA are required to comply with all groundfish CDQ and PSQ catch accounting requirements, including retention of all groundfish CDQ by
Such comprehensive retention and accounting requirements are not required in the fixed gear sablefish IFQ, halibut IFQ, AFA pollock, or Amendment 80 cooperative fisheries. These fisheries do not have requirements that all incidentally caught groundfish species be retained and accounted for against allocations of these species made to quota holders or cooperatives. One exception is that participants in the halibut and sablefish IFQ fisheries must retain and deliver all catch of Pacific cod and rockfish taken when IFQ halibut or IFQ sablefish are onboard (unless the Pacific cod and rockfish fisheries are closed to directed fishing). Another exception is that all catch of Amendment 80 species in the Amendment 80 cooperative fisheries accrues towards a cooperative's allocations, regardless of whether such catch is retained or not. With respect to the IFQ fisheries requirement to retain and deliver Pacific cod and rockfish, NMFS is not proposing to apply these retention and reporting requirements to the halibut and sablefish CDQ fisheries primarily because doing so would extend NMFS's Federal groundfish permit requirements to a relatively small number of halibut CDQ fishermen who are not currently required to retain groundfish. These fishermen deliver their catch to small halibut processing facilities that do not process groundfish. The Council concurred in NMFS's recommendation on this issue.
NMFS proposes to revise CDQ catch monitoring requirements for the fixed gear sablefish, halibut, and pollock CDQ fisheries at § 679.32 and other applicable sections of 50 CFR part 679 to align regulations with the retention and reporting requirements in place for IFQ fisheries or fisheries managed with cooperatives. These proposed amendments also are related to the changes in observer coverage requirements described under the next section titled “Observer Coverage Requirements.” The specific changes proposed to CDQ catch monitoring requirements follow.
Paragraph § 679.32(a) would be revised to identify the specific fisheries that paragraph (a) applies to: The CDQ fisheries for fixed gear sablefish, pollock, and other groundfish species. The halibut CDQ fishery no longer would be subject to groundfish retention for purposes of CDQ catch accounting, so this action proposes to remove the groundfish retention and catch monitoring requirements for the halibut CDQ fishery from § 679.32. Additionally, this proposed rule would add to paragraph (a) a cross-reference to the regulations governing halibut CDQ catch accounting at § 679.42(c).
Paragraph § 679.32(b) would be revised to state that the halibut caught by vessels that are sablefish CDQ fishing with fixed gear may be exempted from accrual against the CDQ groups' halibut PSQ if such an exemption is granted for vessels fishing for sablefish IFQ during the annual groundfish harvest specifications process. This exemption process already exists for the sablefish IFQ fishery. This exemption is proposed for vessels sablefish CDQ fishing to comply with section 305(i)(1)(B)(iv) of the Magnuson-Stevens Act. In addition, the proposed rule would update cross-references in paragraph (b) associated with prohibitions in § 679.7(d) and with halibut PSC limits in § 679.21(e).
This proposed rule also would revise the catch accounting requirements in § 679.32(c) to distinguish between the different catch monitoring requirements for vessels participating in three CDQ fisheries categories: fixed gear sablefish, pollock, and other groundfish. These categories would be in proposed paragraphs (c)(1), (c)(2), and (c)(3), respectively. These revisions include (1) describing the other general regulatory requirements with which participants in these fisheries must comply, (2) identifying the data sources used for CDQ catch accounting, and (3) specifying the operational requirements in place for different vessel categories.
Existing catch monitoring requirements for the groundfish CDQ fisheries other than fixed gear sablefish CDQ and pollock CDQ would be retained, but reorganized in § 679.32(c)(3). These proposed changes combine elements of existing regulations at § 679.32(c) through (e) that are associated with groundfish CDQ catch monitoring and reporting requirements, including the provision for CDQ groups and their affiliated vessels to use an alternative fishing plan to document how they will obtain groundfish catch data by means other than NMFS's standard data sources. This action also proposes to move an element associated with alternative fishing plans to revised § 679.32(c)(3) from § 679.50(c)(4)(ii). The particular element is associated with limitations on an observer's duty hours, but NMFS determined that it is more suitable to include that particular criterion with the balance of other, existing requirements for alternative fishing plans.
This proposed rule would add a requirement in revised § 679.32(c)(3) to require that operators of Amendment 80 catcher/processors using trawl gear to harvest groundfish CDQ comply with catch monitoring requirements in § 679.93(c). The monitoring requirements in § 679.93(c) were implemented as part of Amendment 80, as previously described. Operators of non-AFA trawl catcher/processors that are fishing in the BSAI must now adhere to the same catch monitoring standards, regardless of whether they are participating in CDQ, cooperative, or limited access fisheries.
Other proposed changes to § 679.32(c) include adding references in paragraphs (c)(2)(i)(B) through (F) to applicable observer coverage requirements at § 679.50(c)(4)(iii). In association with these changes, NMFS proposes to remove most occurrences of the qualifier “level 2” from the term “level 2 observer.” This would make references to observer types more general, while the proposed addition of references to observer requirements at § 679.50(c)(4)(iii) would clarify the type of observer(s) required for each groundfish CDQ vessel category.
Paragraph § 679.32(d) would be revised to describe catch monitoring requirements by fishery category for shoreside processors and stationary floating processors. These changes support the primary purpose of this proposed action by removing regulatory requirements for the halibut, fixed gear sablefish, and pollock CDQ fisheries that are more restrictive than regulations in place for comparable non-CDQ fisheries. This paragraph would contain information about general requirements and specific requirements associated with deliveries of pollock CDQ and with deliveries of groundfish CDQ. Proposed new paragraph § 679.32(d)(1) would refer managers of seafood processors to other sections of 50 CFR part 679 associated with non-CDQ pollock delivery requirements. Proposed new paragraph § 679.32(d)(2) addresses the requirements for groundfish CDQ deliveries. This paragraph would retain the existing processor requirements in § 679.32(d). Furthermore, § 679.32(d)(2) is proposed to be revised to incorporate a cross-reference to observer coverage requirements at § 679.50(d)(5)(iii) and to remove three occurrences of the qualifier “level 2.”
This rule proposes to remove paragraph § 679.32(e), except for paragraph (e)(3), as noted below. Paragraph (e) outlines the requirements
CDQ reporting requirements have been incorporated into generally applicable reporting requirements described in § 679.5. The information that once was collected through the CDQ delivery report and the CDQ catch report is now available through observer data, weekly production reports, and the Interagency Electronic Reporting System used to monitor various Alaska commercial fisheries. Catch reporting mechanisms for Federal fisheries in Alaska have undergone significant changes since the original groundfish CDQ fisheries catch reporting requirements were implemented in 1998. NMFS no longer needs separate reports from the CDQ groups acknowledging the groundfish catch that will accrue against their allocations. NMFS has enhanced CDQ groups' ability to access their groundfish CDQ and PSQ balances directly from the NMFS catch accounting system. This allows the groups to continue to monitor the status of their CDQ account balances on a timely basis.
Paragraph (e)(3) of § 679.32 is proposed to be moved to revised § 679.32(c)(3)(ii)(G) to address the use of alternative methods of CDQ catch accounting. This would allow catcher/processors to continue to use “alternative fishing plans.” In common practice, these plans allow a catcher/processor using longline gear to carry a single fisheries observer, rather than the two observers specified in regulation for this vessel category. Such plans typically contain performance standards that limit a vessel's fishing effort to the number of sets that can be sampled by a single observer. Vessel operators typically use alternative fishing plans to conduct CDQ fishing operations just prior to, and at the end of, the non-CDQ Pacific cod seasons. Once a non-CDQ cod season opens, catcher/processor vessels using these plans may switch to non-CDQ cod fishing, which has lower observer coverage levels than required of catcher/processors operating in the Pacific cod CDQ fishery. Alternative fishing plans allow vessel operators to avoid the costs associated with carrying a second observer during non-CDQ fishing operations or returning to port to disembark a second observer.
NMFS also is proposing to remove § 679.32(f). This paragraph describes the groundfish CDQ catch retention and monitoring requirements that are applicable to participants in the halibut CDQ fishery. It also includes observer coverage requirements for the halibut CDQ fishery. The halibut IFQ fishery is not subject to comparable requirements; thus, this proposed rule would remove these requirements in order to ensure that the halibut CDQ fishery is not managed more restrictively than the halibut IFQ fishery, per the Magnuson-Stevens Act. The halibut CDQ fishery would continue to be subject to the general halibut IFQ landing and reporting requirements in § 679.5(l).
This proposed rule would revise observer coverage requirements for the CDQ fisheries affected by this action. Existing CDQ observer coverage requirements were developed to support the comprehensive CDQ catch retention and reporting requirements developed for the groundfish CDQ fisheries (including the sablefish CDQ and pollock CDQ fisheries). The observer coverage requirements for vessels fishing for groundfish CDQ or vessels greater than or equal to 60 ft (18.3 m) LOA that are halibut CDQ fishing are different than those required in comparable non-CDQ fisheries. This action would align observer coverage requirements for the halibut CDQ, sablefish CDQ, and pollock CDQ fisheries by amending regulations in § 679.50(c) and (d). This is necessary to ensure that these CDQ fisheries are not subject to additional observer coverage requirements than those that are in place for participants in the halibut and sablefish IFQ fisheries, as well as the non-CDQ pollock fishery. If implemented, such changes would decrease the operational restrictions, reporting complexities, and costs associated with additional observer coverage for participants in the sablefish, halibut, and pollock CDQ fisheries.
Section 679.50(c)(4) would be revised to separate groundfish CDQ observer requirements into three distinct fisheries categories (sablefish, pollock, and groundfish). Each category would describe the applicable observer requirements by vessel type. Observer coverage requirements for vessels participating in the halibut CDQ fishery would be removed.
Observer coverage requirements for vessels sablefish CDQ fishing are proposed to be revised to match those in place for the sablefish IFQ fishery. A proposed, new paragraph (c)(4)(i) of § 679.50 would include a cross-reference to existing sablefish IFQ coverage requirements in § 679.50(c)(1) and (2). Those requirements are based on vessel length, gear type, the fishery category in which a vessel is operating, and the amount of time spent fishing for sablefish during a calendar quarter for those vessels in the 30 percent coverage category. For calculating the days fished per quarter, vessels would combine days fishing sablefish IFQ with days fishing sablefish CDQ.
Similarly, observer coverage requirements for the pollock CDQ fishery would be aligned with those in effect for the AFA pollock fishery by applying the non-CDQ pollock fishery's requirements to the pollock CDQ fishery. Existing observer requirements for both the CDQ and AFA pollock fisheries are almost identical, with the exception of observer coverage levels on trawl catcher vessels. Current regulations require 100 percent observer coverage on catcher vessels fishing for pollock CDQ. This action would revise regulations to base CDQ observer requirements for trawl catcher vessels on vessel length, as is required in the AFA pollock fishery.
In April 2009, the Council adopted Amendment 91 to the groundfish FMP to reduce Chinook salmon bycatch in the BS pollock fishery. Amendment 91 would establish caps on the amount of Chinook salmon that may be caught annually in the pollock fishery. If attained, directed fishing for pollock would be closed. In addition, Amendment 91 would allow industry participants to develop private-sector bycatch reduction incentive plans to assist in forestalling pollock fishery closures. The Council also recommended a suite of salmon bycatch monitoring requirements to improve estimates of Chinook salmon bycatch in the pollock fisheries. One element of these requirements would require all trawl catcher vessels directed fishing for pollock to carry an observer, regardless of vessel length. This would mean that trawl catcher vessels fishing for AFA pollock (or CDQ pollock) would have to carry at least one observer while directed fishing, which is the same requirement now borne by trawl catcher
This proposed rule also would eliminate observer requirements for vessels equal to or greater than 60 ft (18.3 m) LOA that are halibut CDQ fishing. Vessels that are halibut IFQ fishing are not required to carry observers. Therefore, paragraph (c)(4) of § 679.50 would be revised to remove references to observer requirements for vessels that are halibut CDQ fishing. Vessels that are greater than 60 ft (18.3 m) LOA that participate in the halibut CDQ fishery would no longer be required to carry an observer at any time.
NMFS is not proposing to change existing observer requirements for the groundfish CDQ fisheries that were not affected by Magnuson-Stevens Act requirements for the regulation of CDQ harvest. The proposed revisions to § 679.50(c)(4) would reorganize the paragraph by fishery category, but would retain existing observer requirements for the groundfish CDQ fisheries other than sablefish and pollock. Many of the remaining groundfish CDQ fisheries, such as flatfish and Atka mackerel caught with trawl gear, are now subject to the same observer and catch monitoring requirements that are required for the non-CDQ flatfish and Atka mackerel fisheries. This is due to the implementation of Amendment 80, which allocated BSAI non-pollock groundfish resources among fishing sectors and authorized the formation of harvesting cooperatives in the non-AFA trawl catcher/processor sector. That action applied identical monitoring and enforcement provisions to the non-CDQ and CDQ trawl fishing activities in this sector, as described earlier in this preamble.
In addition, this proposed rule would revise § 679.50(d)(5) to modify observer coverage requirements for shoreside processors. As with the proposed revision to vessel observer requirements described above, this paragraph would be separated into three fishery categories: fixed gear sablefish CDQ, pollock CDQ, and groundfish CDQ. Observer coverage requirements for the sablefish and pollock CDQ fisheries would be aligned with requirements in place for comparable non-CDQ fisheries. This proposed rule would retain the current requirement that each shoreside processor or stationary floating processor taking deliveries of groundfish CDQ (other than pollock, or sablefish caught with fixed gear) have a least one observer present at all times while groundfish CDQ is being received or processed.
NMFS also proposes to revise § 679.50(c)(2)(iii) to incorporate sablefish CDQ into this paragraph. Currently, this paragraph only encompasses the sablefish IFQ fishery. However, sablefish IFQ and sablefish CDQ are often fished concurrently because it is operationally efficient for vessel operators to combine fishing for IFQ and CDQ sablefish on a single trip. As discussed previously, this rule proposes to include retained sablefish IFQ in the definition of sablefish CDQ. Integrating sablefish CDQ into the description of the sablefish fishery category in this paragraph would, for purposes of observer coverage requirements, allow vessel operators to participate in the sablefish IFQ and CDQ fisheries without having to meet separate observer requirements for each fishery.
In addition to the fisheries management regulatory amendments necessary to implement section 305(i)(1)(B)(iv), NMFS also proposes revising or removing other regulations in 50 CFR part 679 that are no longer consistent with section 305(i)(1) of the Magnuson-Stevens Act. These inconsistencies were created as a result of the previously described amendments to the Magnuson-Stevens Act made through the Coast Guard Act and the Magnuson-Stevens Fishery Conservation and Management Reauthorization Act of 2006. NMFS also proposes updating and clarifying regulations and cross-references to support the proposed, primary regulatory amendments made by this action.
The statement of the purpose of the CDQ Program at § 679.1(e) would be revised to remove inconsistencies with the purpose of the CDQ Program specified in section 305(i)(1)(A) of the Magnuson-Stevens Act. Rather than including the statement of purpose from the Magnuson-Stevens Act in 50 CFR part 679, the text of § 679.1(e) is generalized to be consistent with the format and content of the other paragraphs in this section and to direct the reader to the purpose specified in the Magnuson-Stevens Act. Additionally, the other paragraphs of § 679.1 reference those subparts of 50 CFR part 679 that contain the regulations governing a particular fishery or program. Therefore, NMFS proposes revising § 679.1(e) to read “Regulations in this part govern the Western Alaska CDQ Program (
A CDP is defined at § 679.2 as a business plan for the economic and social development of a western Alaska community or group of communities under the CDQ Program. Under § 679.30, the CDP is both an application for allocations of the CDQ and PSQ reserves and an on-going business plan required to be amended by the CDQ groups under certain circumstances. However, amendments to the Magnuson-Stevens Act under the Coast Guard Act removed both the authority and the need for the CDPs as applications for allocations among the CDQ groups and as the primary tool for oversight of the CDQ Program by NMFS and the State.
Section 305(i)(1)(I) of the Magnuson-Stevens Act states the following:
(I) SECRETARIAL APPROVAL NOT REQUIRED.—Notwithstanding any other provision of law or regulation thereunder, the approval by the Secretary of a community development plan, or an amendment thereof, under the program is not required.
NMFS interprets this provision as prohibiting NMFS from requiring approval of CDPs and amendments to CDPs. In addition, CDPs are no longer needed as periodic applications for allocations of CDQ reserves among the CDQ groups because section 305(i)(1)(C) of the Magnuson-Stevens Act establishes the percentage allocations of groundfish, halibut, and crab among the CDQ groups as the percentage allocations in effect on March 1, 2006. A portion of these percentage allocations may be adjusted every 10 years starting in 2012 under the provisions of section 305(i)(1)(H). Therefore, NMFS proposes to remove the following regulations that are no longer consistent with the provisions of sections 305(i)(1)(I) and 305(i)(1)(C): (1) regulations at § 679.30(a) through § 679.30(d) that require submission, review, and approval of proposed CDPs; (2) regulations at § 679.30(g) related to monitoring of CDPs; and (3) regulations at § 679.30(h) related to suspension and termination of a CDP. Furthermore, NMFS proposes to delete from § 679.43(a) a reference associated with appealing initial administrative decisions made under § 679.30(d).
In addition, this proposed rule also would delete paragraph (d)(3) of § 679.7, which relates to community participation in the CDQ Program. This prohibition refers to a term (CDP) that would no longer be applicable to CDQ Program management. Similarly, NMFS proposes to delete § 679.7(d)(19), which is associated with complying with the requirements of a CDP.
This rule also proposes to revise or remove several definitions in § 679.2 associated with CDPs. The definition of “CDQ allocation” would be revised to remove a reference to the term CDP, since that term is proposed to be removed. The definition for “CDQ project” would be removed because this term is associated with requirements for the CDP in § 679.30. Finally, the definition of “Qualified applicant” is proposed to be removed because this term refers to applicants for CDQ and PSQ allocations under an allocation process described in § 679.30. This term is no longer in use and is not consistent with the Magnuson-Stevens Act.
On August 30, 2006, NMFS notified the State and the CDQ groups that it was suspending enforcement of regulations at 50 CFR part 679 related to the CDPs and the CDQ allocation process because of the inconsistencies with the Magnuson-Stevens Act. This notification and its attachments contain more detailed information about the requirements that are proposed to be removed from 50 CFR part 679 through this proposed rule. A copy of the letter is available at
The Magnuson-Stevens Act now specifically identifies the communities and entities eligible for the CDQ Program. Previously, communities were determined to be eligible based on specific criteria contained in regulation. This proposed rule would revise the definition of “CDQ group” in § 679.2 to reference 16 U.S.C. 1855(i)(1)(D), which identifies the villages and associated groups that are eligible for the CDQ Program. Similarly, this proposed rule would revise the definition of “eligible community” (for purposes of the CDQ Program) in § 679.2 to incorporate a cross-reference to 16 U.S.C. 1855(i)(1)(D) and to Table 7 of 50 CFR part 679. Table 7 also would be revised to include the CDQ groups and communities that are listed in 16 U.S.C. 1855(i)(1)(D) as a public convenience.
NMFS notes that, although the Magnuson-Stevens Act uses the term “entity” or “entities” in association with the managing organizations associated with specific groups of CDQ eligible communities, NMFS does not propose to amend regulations that contain the commonly used and accepted “CDQ group” or “CDQ groups” to replace it with the terms “CDQ entity” or “CDQ entities.” Besides being used in applicable Federal regulations, the term “CDQ group” has been commonly used since 1992 in association with general CDQ Program administration and by the public. NMFS does not believe that adopting the term CDQ entity or entities would enhance CDQ Program administration or that such terminology would be readily adopted by the public.
This proposed rule would revise the definition of “CDQ community” in § 680.2 to reference the list of communities eligible for the CDQ Program to incorporate a cross-reference to 16 U.S.C. 1855(i)(1)(D) and Table 7 to 50 CFR part 679. The current definition references the communities eligible under subpart C of 50 CFR part 679. If subpart C of 50 CFR part 679 is revised as proposed in this action, it will no longer include regulations about communities eligible for the CDQ Program. The definition of “CDQ group” in § 680.2 similarly would be revised to reference 16 U.S.C. 1855(i)(1)(D) and Table 7 to 50 CFR part 679. These changes correspond to the revisions proposed for comparable definitions in § 679.2.
The proposed rule would revise § 679.31 to consolidate regulations associated with (1) the establishment of CDQ and PSQ reserves, (2) the allocation of CDQ and PSQ reserves among CDQ groups, and (3) the implementation of quota transfers between CDQ groups. These proposed changes would make the regulations that are associated with the creation, distribution, and use of the fisheries resources allocated to the CDQ Program more clear and functional. The changes encompass many revisions to this section, as described in the following paragraphs.
This proposed rule would revise both the title and the introductory paragraph to § 679.31. The title would be revised to reflect that this section contains regulations governing CDQ and PSQ reserves, allocations, and transfers, rather than just CDQ and PSQ reserves. The introductory paragraph that refers to allocations to a CDQ group in accordance with NMFS-approved CDPs and the requirement that no more than 33 percent of each CDQ reserve be allocated to any one group with an approved CDP would be removed because they are not consistent with the Magnuson-Stevens Act. NMFS no longer makes CDQ allocations based on approved CDPs. The Magnuson-Stevens Act now contains requirements governing the percentage allocation of the CDQ reserves and any allocation adjustments that may be made in the future.
Paragraph (a)(2) of § 679.31 would be revised to remove phrases associated with CDPs and eligible communities, since these terms are now inconsistent with the Magnuson-Stevens Act; to remove an erroneous cross-reference within this paragraph; and to remove a definition of “proximate to” that would become obsolete if the other proposed changes in this paragraph are made.
Paragraph (b) would be added to § 679.31 to add language describing how CDQ and PSQ reserves are allocated among CDQ groups. Paragraph (b)(1) would state that the groundfish, halibut, and crab CDQ reserves would be allocated among the CDQ groups on the basis of the CDQ percentage allocations specified in section 305(i)(1)(C) of the Magnuson-Stevens Act, unless modified under section 305(i)(1)(H) of that act. Section 305(i)(1)(H) provides for a decennial review of the CDQ groups' performance and the possibility of an adjustment of up to 10 percent of each CDQ reserve allocated to each CDQ group. Regulations governing the decennial review and allocation adjustment process will be addressed in a future rulemaking. Proposed paragraph (b)(2) describes the allocation of nontarget groundfish species among CDQ groups by the CDQ administrative panel.
Furthermore, this proposed rule would add paragraph (b)(3) to § 679.31 to describe how annual allocations of PSQ are allocated among CDQ groups. These allocations are based on NMFS's determination about PSQ percentage allocations that were included in an August 31, 2006,
The proposed rule would revise requirements related to transfers of annual CDQ allocations at § 679.30(e)(1) to be consistent with section 305(i)(1)(C) of the Magnuson-Stevens Act. The proposed rule also would move the remaining transfer regulations from § 679.30(e)(1) to consolidate them with other regulations related to CDQ allocations at § 679.31(c).
The CDQ transfer regulations currently state that “NMFS will not
In 2005, prior to the Coast Guard Act and the revisions to the Magnuson-Stevens Act, the Council approved an action to modify elements of the CDQ Program. This included provisions to (1) only allocate target groundfish species to individual CDQ groups, (2) require NMFS to manage non-target species at the program level, rather than through individual allocations, and (3) allow post-delivery transfers of groundfish CDQ or halibut PSQ between CDQ groups to address in-season harvest overages. NMFS commenced rulemaking to implement these changes, but that effort was suspended due to the associated changes in the Magnuson-Stevens Act.
In conjunction with the proposed change to allow post-delivery transfers of groundfish CDQ, this proposed rule would incorporate the Council's recommendation to allow post-delivery transfers of halibut PSQ. This would provide CDQ groups the opportunity to work cooperatively among themselves to address future halibut PSQ overages. CDQ groups would still be prohibited from exceeding their annual halibut PSQ, but this measure would allow opportunities for CDQ groups to avoid such infractions. This parallels recent actions NMFS has taken to implement provisions for post-delivery transfers in other major Alaska fisheries, such as the Amendment 80 and Rockfish Program fisheries.
NMFS also proposes to remove § 679.30(e)(2), which contains requirements for transfers of percentage allocations of CDQ and PSQ between CDQ groups. These regulations are different from the regulations in paragraph (e)(1) that govern the transfer of the annual amounts of CDQ or PSQ allocated to each CDQ group. Annual quota amounts are derived by multiplying each annual CDQ reserve and PSQ reserve by the corresponding percentage allocation that has been established for each CDQ group. Section 305(i)(1)(C) of the Magnuson-Stevens Act now specifies the percentage allocations of groundfish, halibut, and crab CDQ in effect for each CDQ group. Thus, it is not consistent with this statutory requirement to continue to allow the CDQ groups to transfer their permanent percentage allocations among other CDQ groups. In addition, transfers of CDQ and PSQ percentage allocations are made through approval of amendments to the CDPs. As described above, section 305(i)(1)(e)(I) of the Magnuson-Stevens Act no longer allows NMFS to require approval of amendments to the CDP. Therefore, NMFS is proposing to remove all current regulations associated with approval of the CDP or amendments to the CDP. This would include the regulations at § 679.30(e)(2) related to amendments to transfer CDQ and PSQ percentage allocations.
This rule would revise regulations associated with allocating AI Chinook salmon PSC to the CDQ Program. Specifically, it would correct an error made when § 679.21(e) was restructured and revised as part of overlapping regulatory revisions. A final rule implementing Amendment 85 to the groundfish FMP (72 FR 50788, September 4, 2007) modified the allocation of the BSAI Pacific cod TAC among various harvest sectors. That action also made a suite of associated regulatory revisions, including a rearrangement of portions of § 679.21(e) to improve the organization of that section. Concurrently, Amendment 80 made other revisions to § 679.21, including increasing the CDQ Program allocations of crab PSC, halibut PSC, and non-Chinook salmon PSC.
When paragraph (e) was restructured, a reference to AI Chinook salmon was mistakenly omitted from § 679.21(e)(3)(i)(A)(
Paragraph (f) of § 679.30, which contains a list of CDQ group responsibilities, is proposed to be removed because these responsibilities are specified elsewhere in regulations, are duplicative, or are so general that they cannot effectively be enforced. It is not necessary for NMFS to require the CDQ groups to direct and supervise all activities of the managing organization, maintain the ability to communicate with all vessels fishing on their behalf, or monitor the catch of CDQ or PSQ. Regulations elsewhere in 50 CFR part 679 contain specific requirements for recordkeeping, reporting, catch monitoring, and catch accounting that provide the information needed to manage the groundfish and halibut CDQ fisheries. For example, requirements to submit various reports about fishing activities and to not exceed CDQ or PSQ allocations already are included in §§ 679.5 and 679.7.
This proposed rule also would implement other revisions to §§ 679.2, 679.7, and 679.24 to clarify definitions, clarify terms, and delete obsolete prohibitions and cross-references, as follows:
1. In § 679.2, the proposed rule would revise the definition of “PSQ reserve” to replace “a percentage” with “the amount,” which would align this definition with the commonly understood definition of this term. Additionally, cross references in this paragraph to other sections of 50 CFR part 679 would be corrected.
2. In § 679.2, the proposed rule would revise the definition of “CDQ group number” to remove “group.” NMFS proposes simply to use the phrase “CDQ number” to refer to the NMFS-issued identification numbers that are used to track each distinct CDQ group's permits, allocations, and catch. This change would align this definition with the term that already is used in common practice (
3. In § 679.7, the proposed rule would delete prohibitions at (d)(21) and (d)(22). These prohibitions are related to reporting requirements for the CDQ catch and delivery reports, formerly located at § 679.5(n), which were
4. In § 679.22, the proposed rule would revise paragraph (h) to update a cross-reference to prohibitions in § 679.7(d). This is associated with the proposed revisions to § 679.7(d), as previously described.
5. In § 679.24, the proposed rule would revise paragraph (b)(1)(ii) to remove the clause “except as provided in paragraph (c)(4)(ii) of this section.” Paragraph (c)(4) is associated with gear restrictions in the BSAI sablefish fisheries; it was revised by a final rule published May 19, 2008 (73 FR 28733). That action removed paragraph (c)(4)(ii), which was associated with a longline pot gear closure in the BS during the month of June. The proposed change to paragraph (b)(1)(ii) would correct the inadvertent retention of the cross-reference to a now non-existent paragraph.
6. In §§ 679.5, 679.7, 679.21, 679.26, 679.27, 679.28, 679.50, 679.84, and 679.93, the proposed rule would replace the term “NMFS-certified observer” with “observer.” The changes are detailed in the remove/add table at the end of the regulatory text portion of this proposed rule. This would ensure that the term observer is used consistently throughout 50 CFR part 679, and that the term is aligned with the definition of observer in § 679.2.
Pursuant to sections 304(b)(1)(A) and 305(d) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this proposed rule is consistent with the BSAI groundfish FMP, other provisions of the Magnuson-Stevens Act, and other applicable law, subject to further consideration after public comment.
This proposed rule has been determined to be not significant for the purposes of Executive Order 12866.
An initial regulatory flexibility analysis (IRFA) was prepared, as required by section 603 of the Regulatory Flexibility Act (RFA). The IRFA describes the economic impact this proposed rule, if adopted, would have on small entities. A description of the action, why it is being considered, and the legal basis for this action are contained at the beginning of this section in the preamble and in the SUMMARY section of the preamble. A summary of the analysis follows. A copy of this analysis is available from NMFS (
This action proposes alternatives that would amend regulations governing the harvest of select CDQ fisheries, per requirements of the Magnuson-Stevens Act. The Coast Guard Act of 2006 amended section 305(i)(1) of the Magnuson-Stevens Act by replacing all of the existing language in this section with new language. This substantially altered many components of the CDQ Program, including the oversight roles of the Federal and State governments, CDQ allocations and the allocation process, and fisheries management requirements. This action addresses specific fishery management provisions of the Magnuson-Stevens Act and proposes revisions to certain CDQ fisheries management regulations. The Magnuson-Stevens Act requires that the harvest of CDQ allocations be regulated no more restrictively than what is required for participants in applicable fishing sectors managed with individual fishing quotas (IFQ) or cooperatives.
The entities directly regulated by this action are the six CDQ groups that participate in the halibut, sablefish, groundfish, and pollock CDQ fisheries in the BSAI. CDQ groups are considered to be small entities under the RFA's categorization of small, non-profit organizations. This action is expected to reduce the costs associated with various aspects of participating in these CDQ fisheries. These include costs associated with different CDQ fisheries regulatory requirements governing: (1) Fisheries observer coverage levels, (2) catch retention and accounting, (3) vessel eligibility designation, and (4) licensing.
All six CDQ groups annually are allocated groundfish CDQ, halibut CDQ, and crab CDQ. These groups participate, either directly or indirectly, in the commercial harvest of these allocations. CDQ groups receive royalties from the successful harvest of CDQ by commercial fishing companies, as well as access to employment and training opportunities for their communities' residents. Royalties and income from CDQ harvesting activities are used to fund economic development projects in CDQ communities. In 2005, the CDQ groups received approximately $61 million in royalties from the harvest of CDQ allocations. Participants in the CDQ fisheries affected by this action would no longer be subject to regulations that are more costly, complex, or burdensome than those that apply to comparable IFQ fisheries or fisheries managed with cooperatives. Thus, this action is not expected to have an adverse economic impact on the small entities affected by this action.
NMFS evaluated three alternatives associated with this action. Alternative 1, the status quo, would maintain different fisheries management regulations for the halibut, fixed gear sablefish, and pollock CDQ fisheries. Each of these fisheries has a comparable IFQ or cooperative fishery. However, due to the different policies and objectives associated with the original development of the regulations governing the CDQ fisheries, CDQ harvest regulations sometimes differed from those in place for the non-CDQ fisheries associated with this action. Maintaining existing regulations associated with the CDQ fisheries that are more restrictive than those in place for comparable IFQ and cooperative fisheries would not comply with the Magnuson-Stevens Act.
Alternative 2, the preferred alternative, would revise CDQ fisheries management regulations in 50 CFR part 679 to align them with regulations that govern fisheries managed with IFQs and fisheries managed with cooperatives. Proposed regulatory revisions include (1) separating fixed gear sablefish CDQ and pollock CDQ from regulations associated with the other groundfish CDQ fisheries, (2) exempting participants in the sablefish CDQ fishery from having to have a license limitation program groundfish license by excluding fixed gear sablefish CDQ from the definition of “license limitation species,” (3) removing a requirement that CDQ groups annually submit a request to NMFS to designate specific vessels as eligible to harvest groundfish CDQ on their behalf, (4) revising CDQ catch monitoring requirements to incorporate changes to the basis for CDQ catch accounting, based on adjusting CDQ observer coverage requirements for the halibut, sablefish, and pollock CDQ fisheries, and (5) revising regulations to align observer coverage requirements for the sablefish CDQ, halibut CDQ, and pollock CDQ fisheries with comparable non-CDQ fisheries. On the basis of the best available information, this preferred alternative imposes the minimum adverse economic impact on directly regulated small entities, while achieving the objectives of the regulatory action, among all the alternatives available to the agency. The preferred alternative incorporates regulatory revisions that reduce the potential economic and operational burden on small entities.
Alternative 3 would amend regulations to fully integrate sablefish CDQ into the sablefish IFQ fisheries
Both Alternatives 2 and 3 would meet the requirement of the Magnuson-Stevens Act that CDQ fisheries be managed no more restrictively than fisheries managed with IFQs or harvesting cooperatives by matching regulations as closely as possible for relevant CDQ and non-CDQ fisheries. In the case of Alternative 3, the sablefish CDQ fishery would be fully integrated into both the regulations and the administrative structure in place for the sablefish IFQ fishery.
Alternative 2 was selected as the preferred alternative primarily based on the potential changes that each alternative would bring to the fixed gear sablefish CDQ fishery. NMFS believes that Alternative 2 would result in the least disruptive change to the CDQ groups and CDQ fisheries, while meeting the regulation of harvest requirements in the Magnuson-Stevens Act. Alternative 2 would amend regulations for the CDQ fisheries affected by this action to match regulations in place for most comparable non-CDQ fisheries, but would not make as many changes to the program as Alternative 3. Alternative 2 would not integrate the sablefish CDQ fishery into the sablefish IFQ program. CDQ groups would not be subject to sablefish CDQ permitting requirements and additional IFQ-related reporting requirements, nor would NMFS have to implement such requirements. Furthermore, retaining fixed gear sablefish CDQ under the comprehensive groundfish CDQ accounting and management system would make it easier for NMFS to monitor the catch and transfer of the multiple categories of sablefish CDQ allocated to the CDQ Program and CDQ groups.
NMFS is not aware of any additional alternatives to those considered that would accomplish the objectives of the Magnuson-Stevens Act and other applicable statutes that would minimize the economic impact of the proposed rule on small entities.
NMFS also is not aware of any other Federal rules that would duplicate, overlap, or conflict with this action.
This proposed rule contains collection-of-information requirements subject to the Paperwork Reduction Act (PRA) and which have been approved by OMB under control number 0648–0269. However, these approved PRA requirements would be removed from the collection with publication of the final rule. Public reporting burden per response is estimated at: Four hours for each Alternative Fishing Plan; one hour for CDQ vessel eligibility request; 520 hours for a community development plan (CDP); 20 hours for an annual budget report; eight hours for an annual budget reconciliation report; 40 hours for a substantial amendment to a CDP; eight hours for a technical amendment to a CDP; two minutes for prior notice to observers of CDQ catch aboard a vessel; and two minutes for prior notice to observers by shoreside processors and stationary floating processors of offloading schedule of each CDQ delivery. All requirements except the Alternative Fishing Plan, the two minutes for prior notice to observers of CDQ catch aboard a vessel, and the two minutes for prior notice to observers by shoreside processors and stationary floating processors of offloading schedule of each CDQ delivery would be removed from the collection with publication of the final rule.
Response times include the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden, to NMFS (
Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB Control Number.
Alaska, Fisheries, Recordkeeping and reporting requirements.
For the reasons stated in the preamble, NMFS proposes to amend 50 CFR parts 679 and 680 as follows:
1. The authority citation for part 679 continues to read as follows:
16 U.S.C. 773
2. In § 679.1, revise paragraph (e) to read as follows:
(e)
3. In § 679.2,
a. Remove the definitions for “CDQ group number”, “CDQ project”, “Community Development Plan”, “Eligible vessel”, “Managing organization”, and “Qualified applicant”,
b. Revise the definitions for “CDQ allocation”, “CDQ group”, “CDQ Program”, paragraph (1) of the definition for “Eligible community”, and the definitions for “Groundfish CDQ fishing”, “Halibut CDQ fishing”, “License limitation groundfish”, “PSQ allocation”, “PSQ reserve”, and
c. Add definitions for “CDQ number”, “Pollock CDQ fishing”, and “Sablefish CDQ fishing” in alphabetical order to read as follows:
(1) For purposes of the CDQ Program, a community identified as eligible for the CDQ Program under 16 U.S.C. 1855(i)(1)(D). Eligible communities are listed in Table 7 to this part.
4. In § 679.4, revise paragraph (e)(1)(i) to read as follows:
(e) * * *
(1) * * *
(i) The CDQ group, the operator of the vessel, the manager of a shoreside processor or stationary floating processor, and the Registered Buyer must comply with the requirements of this paragraph (e) for the catch of CDQ halibut.
5. In § 679.5,
a. Revise the heading of paragraph (n),
b. Remove paragraph (n)(2), and
c. Redesignate paragraphs according to the following table.
The revision reads as follows:
(n)
6. In § 679.7, remove paragraphs (d)(3), (d)(4), (d)(21), (d)(22), (d)(24), redesignate paragraphs according to the following table, add paragraph (d)(18), and revise paragraph (f)(3)(ii).
The revision and addition reads as follows:
(d) * * *
(18) For the operator of a vessel fishing on behalf of a CDQ group to retain more than the maximum retainable amount of pollock established under § 679.20(e) unless the pollock harvested by that vessel accrues against a CDQ group's pollock CDQ allocation.
(f) * * *
(3) * * *
(ii)
7. In § 679.21, revise paragraph (e)(3)(i)(A)(
(e) * * *
(3) * * *
(i) * * *
(A) * * *
(
(
8. In § 679.22, revise paragraph (h) to read as follows:
(h)
9. In § 679.24, revise paragraph (b)(1)(ii) to read as follows:
(b) * * *
(1) * * *
(ii) While directed fishing for sablefish in the Bering Sea subarea.
10. Remove and reserve § 679.30.
11. Revise § 679.31 to read as follows:
(a)
(2)
(ii) The proportions of the halibut catch limit annually withheld for the halibut CDQ program, exclusive of issued QS, are as follows for each IPHC regulatory area (
(A)
(B)
(C)
(D)
(3)
(4)
(b)
(2)
(3)
(c)
12. Revise § 679.32 to read as follows:
(a)
(b)
(c)
(i)
(ii)
(2)
(A) Comply with the observer coverage requirements at § 679.50(c)(5)(i)(A).
(B) Notify the observers of CDQ catch before CDQ catch is brought onboard the vessel and notify the observers of the CDQ group and CDQ number associated with the CDQ catch.
(C) Comply with the catch weighing and observer sampling station requirements at § 679.63(a).
(ii)
(B)
(3)
(
(
(B)
(
(
(
(
(C) C
(
(
(
(D)
(
(
(
(
(E)
(F)
(ii)
(A)
(B)
(C)
(D)
(E)
(F)
(G)
(
(
(
(
(
(d)
(ii)
(2)
(i) Comply with observer coverage requirements at § 679.50(d)(5)(iii) of this part.
(ii)
(iii)
(iv)
(v)
13. In § 679.43, paragraph (a) is revised to read as follows:
(a)
14. In § 679.50, paragraphs (c)(2)(iii), (c)(4), and (d)(5) are revised to read as follows:
(c) * * *
(2) * * *
(iii)
(4)
(i)
(ii)
(B) A catcher vessel that is pollock CDQ fishing must comply with the observer coverage requirements in paragraph (c)(1) of this section.
(iii)
(B)
(C)
(D)
(E)
(F)
(d) * * *
(5)
(i)
(ii)
(iii)
(iv)
15. At each of the locations shown in the “Location” column of the following table, remove the phrase indicated in the “Remove” column and replace it with the phrase indicated in the “Add” column for the number of times indicated in the “Frequency” column.
16. Table 7 to part 679 is revised to read as follows:
17. The authority citation for part 680 continues to read as follows:
16 U.S.C. 1862; Pub. L. 109–241; Pub. L. 109–479.
18. In § 680.2, revise the definitions for “CDQ community” and “CDQ group” to read as follows:
Forest Service, USDA.
Notice of meetings.
The Dixie Resource Advisory Committee will meet in Cedar City, Utah. The committee is meeting as authorized under the Secure Rural Schools and Community Self-Determination Act (Pub. L. 110–343) and in compliance with the Federal Advisory Committee Act. The purpose of the two meetings are to conduct “welcomes” and introductions, review the Federal Advisory Committee Act requirements, brief participants on Payments to States legislative history, discuss the guidelines for Title II and Title III funding and proposals, discuss preliminary project ideas, and receive public comment on the meeting subjects and proceedings.
July 27, 2010, 9 a.m. & August 18, 2010, 9 a.m.
July 27, 2010 meeting will be held at Southern Utah University, Sharwan Smith Center (Cedar Breaks Room), 351 West University Blvd. August 18, 2010 meeting will be held at the Cedar City Heritage Center, 105 North 100 East, Room 1, Cedar City, Utah. Written comments should be sent to Dixie National Forest, 1789 North Wedgewood, Cedar City, UT 84701. Comments may also be sent via e-mail to
All comments, including names and addresses when provided, are placed in the record and are available for public inspection and copying. The public may inspect comments received at Dixie National Forest, 1789 North Wedgewood, Cedar City, UT. Visitors are encouraged to call ahead to (435) 865–3730 to facilitate entry into the building.
Kenton Call, RAC Coordinator, Dixie National Forest, (435) 865–3730; e-mail:
Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1–800–877–8339 between 8 a.m. and 8 p.m., Eastern Standard Time, Monday through Friday.
The meetings are open to the public. The following business will be conducted: (1) Welcome and Committee introductions; (2) Federal Advisory Committee Act overview and powerpoint; (3) Review of Payments to States legislative history and discussion of requirements related to Title II and Title III funding; (4) Discussion of Committee member roles and operational guidelines; (5) Discussion of preliminary projects; (6) Election of committee chairperson, (7) Review of next meeting purpose, location, and date; and (8) Receive public comment. Persons who wish to bring related matters to the attention of the Committee may file written statements with the Committee staff before or after the meeting. Public input sessions will be provided and individuals who made written requests by July 19, 2010 will have the opportunity to address the Committee at those sessions. As time allows, there may be additional opportunity for public comment.
Forest Service, USDA.
Notice of meeting.
The Prince William Sound Resource Advisory Committee will convene for their first formal meeting in Anchorage, Alaska, for the purpose of establishing the Committee through the development of bylaws, a chairperson, and a future meeting schedule, under the provisions of Title II of the Secure Rural Schools and Community Self-Determination Act of 2008 (Pub. L. 110–343).
The meeting will be held on Monday, July 26, 2010.
The meeting will take place at the Chugach National Forest Supervisor's Office, 3301 “C” Street; Suite 300, Anchorage, Alaska 99503. Send written comments to Prince William Sound Resource Advisory Committee, c/o USDA Forest Service, PO Box 280, Cordova, AK 99574 or electronically to
Teresa Benson, Designated Federal Official, c/o USDA Forest Service, PO Box 280, Cordova, AK 99574, telephone (907) 424–4742.
The agenda will include background on the provisions of Title II of the Secure Rural Schools and Community Self-Determination Act of 2008 (Pub. L. 110–343) and an overview of the Federal Advisory Committee Act (FACA). In addition, the agenda will include time for the Committee to develop and adopt bylaws, a chairperson, and a future meeting schedule to discuss project proposals. All Resource Advisory Committee Meetings are open to the public. The public input and comment forum will take place in the afternoon of July 26, 2010. Interested citizens are encouraged to attend.
The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. chapter 35).
Copies of the above information collection proposal can be obtained by calling or writing Diana Hynek, Departmental Paperwork Clearance Officer, (202) 482–0266, Department of Commerce, Room 6616, 14th and Constitution Avenue, NW., Washington, DC 20230 (or via the Internet at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to Jasmeet Seehra, OMB Desk Officer, at
International Trade Administration, Department of Commerce.
Notice.
The United States Department of Commerce, International Trade Administration, U.S. and Foreign Commercial Service (CS) is organizing an Aerospace Supplier Development Mission to China from November 7–17, 2010.
The 2010 Aerospace Supplier Development Mission to China is being developed due to a successful similar trade mission to China in 2008 and due to continued requests from many small and medium-sized enterprises (SMEs) supplying the aviation industry. It is intended to include representatives from a variety of U.S. aerospace industry manufacturers and service providers, and it will introduce these suppliers to end-users and prospective partners whose needs and capabilities are targeted to each U.S. participant's strengths. Participating in an official U.S. industry delegation, rather than traveling to China on their own, will enhance the companies' ability to secure meetings in China. The mission will include appointments and briefings in Beijing, Shanghai, Xi'an, and Guangzhou, some of China's major aerospace industry hubs, as well as participation in Airshow China in Zhuhai to conclude the mission. The mission participants will have opportunities to interact extensively with CS China aviation specialists to discuss industry developments, opportunities, and sales strategies.
The Chinese aerospace sector ranks among the world's most dynamic, going far beyond the country's massive investment in aircraft (mainland carriers anticipate reaching 4,000 by 2025). Chinese aerospace companies have rapidly developed into serious players in the industry's global value chain. Chinese aerospace firms, including those linked to U.S. and European “primes,” now frequently make their own sourcing decisions, participate as “risk sharing partners” in new airframe and engine development programs, or take on the role of first-tier suppliers on Chinese programs.
The evolution of China's aerospace industry is part of a broader industry trend toward supply chain consolidation and lean manufacturing. Many traditional Tier 1 supplier responsibilities are being pushed down the supply chain to second- and third-tier suppliers. As the larger firms move into aerospace system integration, the lower-tier suppliers have little choice but to globalize themselves. This involves supplying China with products and services that might historically have been provided to U.S. and European suppliers that have since shifted production. In many cases, once established in China, the first-tier firms require their supply chain partners to begin dealing directly with Chinese members of the supply chain. While extremely challenging for SME suppliers, these new relationships bring an added benefit—the opportunity for additional sales with other aerospace companies doing business in China.
China Aviation Industry Corporation I and II (AVIC I and II), conglomerates of hundreds of companies, control the country's aerospace industry. Over the years, the main AVIC companies have formed joint-venture companies with key Western aerospace partners. The larger AVIC companies also have so-called “foreign divisions” engaged in manufacturing, design and engineering for Western customers on a semi-autonomous basis.
The goals of the 2010 Aerospace Supply Chain Development Mission to China are threefold: (1) To introduce U.S. companies to Chinese joint-venture groups and Western original equipment manufacturers (OEMs); (2) to explore supplier opportunities under other aerospace programs (including Chinese programs and Western programs with Chinese firms “risk sharing”); and (3) to facilitate an effective U.S. presence at Airshow China.
The mission's first stop is Beijing, home to AVIC's headquarters and the China National Aero-Technology Import and Export Corporation (CATIC), AVIC's trading and purchasing division. The second and third stops are Shanghai and Xi'an, home to Xi'an Aircraft Industry Group and the Yanliang National Aviation High-Tech Industrial Base. The fourth stop, Guangzhou, provides the opportunity to focus on Guangzhou Aircraft Maintenance Engineering Company Limited (GAMECO) as an example of a maintenance/repair/overhaul operation and a meeting with MTU Zhuhai.
The mission will conclude in Zhuhai, at the China International Aviation and Aerospace Exhibition (known as Airshow China), the only Chinese aerospace exhibition endorsed by the Chinese central government. The last Airshow China, in 2008, marked the largest ever in the show's history. It attracted 600 exhibitors from 35 countries, showcased 58 aircraft including the Airbus A380 and turned out over 90,000 trade visitors along with 200 media units. CS Guangzhou will provide entry to the trade show and will help facilitate the U.S. companies' participation in the American Product Literature Center.
Matchmaking efforts will involve coordination with the American
• Pre-travel briefings/webinar on subjects ranging from Chinese business practices to security;
• Pre-scheduled meetings with potential partners, distributors, end users, or local industry contacts in Beijing, Shanghai, Xi'an, Guangzhou, and at Airshow China in Zhuhai;
• Transportation to airports in Beijing, Shanghai, and Xi'an;
• Coach class airline tickets: Beijing to Shanghai, Shanghai to Xi'an, Xi'an to Guangzhou;
• Bus transportation from Guangzhou to Zhuhai;
• One Airshow China entry pass per company representative;
• Participation in the American Product Literature Center at Airshow China;
• Participation in industry receptions at Airshow China;
• Meetings with CS China aviation industry specialists in Beijing, Shanghai and Guangzhou;
All parties interested in participating in the Aerospace Supplier Development Mission to China must complete and submit an application for consideration by the Department of Commerce. All applicants will be evaluated on their ability to meet certain conditions and best satisfy the selection criteria as outlined below. The mission will open on a first come first served basis to a minimum of 12 qualified U.S. companies.
After a company has been selected to participate on the mission, a payment to the Department of Commerce in the form of a participation fee is required. The participation fee will be $5,100 per SME (less than 500 employees) plus $800 per additional company representative; or $6,000 per large company (more than 500 employees) plus $800 per additional company representative.
Expenses for lodging, some meals, incidentals, and travel (except for in-country arrangements previously noted) will be the responsibility of each mission participant.
• An applicant must submit a completed and signed mission application and supplemental application materials, including adequate information on the company's products and/or services, primary market objectives, and goals for participation.
• Each applicant must also certify that the products and services it seeks to export through the mission are either produced in the United States, or, if not, marketed under the name of a U.S. firm and have at least fifty-one percent U.S. content.
• Suitability of a company's products or services to the mission's goals.
• Consistency of the company's goals and objectives with the stated scope of the trade mission.
• Timeliness of company's signed application and participation agreement.
• Timely and adequate provision of information on company's products/services and market objectives, in order to facilitate appropriate matching with potential business partners.
Any partisan political activities (including political contributions) of an applicant are entirely irrelevant to the selection process.
Mission recruitment will be conducted in an open and public manner, including publication in the Federal Register, posting on the Commerce Department trade mission calendar (
The United States Patent and Trademark Office (USPTO) will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).
United States Patent and Trademark Office (USPTO), Commerce.
Once submitted, the request will be publicly available in electronic format through the Information Collection Review page at
Paper copies can be obtained by:
•
•
•
Written comments and recommendations for the proposed information collection should be sent on or before August 12, 2010 to Nicholas A. Fraser, OMB Desk Officer, via e-mail at
The United States Patent and Trademark Office (USPTO) will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).
Separate from the extension provisions of 35 U.S.C. 156, the USPTO may in some cases extend the term of an original patent due to certain delays in the prosecution of the patent application, including delays caused by interference proceedings, secrecy orders, or appellate review by the Board of Patent Appeals and Interferences or a Federal court in which the patent is issued pursuant to a decision reversing an adverse determination of patentability. The patent term provisions of 35 U.S.C. 154(b), as amended by Title IV, Subtitle D of the Intellectual Property and Communications Omnibus Reform Act of 1999, require the USPTO to notify the applicant of the patent term adjustment in the notice of allowance and give the applicant an opportunity to request reconsideration of the USPTO's patent term adjustment determination. The USPTO administers 35 U.S.C. 154 through 37 CFR 1.701–1.705.
The public uses this information collection to file requests related to patent term extensions and reconsideration or reinstatement of patent term adjustments. The information in this collection is used by the USPTO to consider whether an applicant is eligible for a patent term extension or reconsideration of a patent term adjustment and, if so, to determine the length of the patent term extension or adjustment.
Once submitted, the request will be publicly available in electronic format through the Information Collection Review page at
Paper copies can be obtained by:
•
•
•
Written comments and recommendations for the proposed information collection should be sent on or before August 12, 2010 to Nicholas A. Fraser, OMB Desk Officer, via e-mail to
National Oceanic and Atmospheric Administration (NOAA).
Notice.
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Written comments must be submitted on or before September 13, 2010.
Direct all written comments to Diana Hynek, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue, NW., Washington, DC 20230 (or via the Internet at
Requests for additional information or copies of the information collection instrument and instructions should be directed to Karl Moline, (301) 713–2328 or
The Office of Management and Budget (OMB) issued government-wide guidance to enhance the practice of peer review of government science documents. OMB's Final Information Quality Bulletin for Peer Review (“Peer Review Bulletin” or PRB) (available at
The Peer Review Bulletin also directs Federal agencies to adopt or adapt the National Academy of Sciences (NAS) policy for evaluating conflicts of interest when selecting peer reviewers who are not Federal government employees (federal employees are subject to Federal ethics requirements). For peer review purposes, the term “conflicts of interest” means any financial or other interest which conflicts with the service of the individual because it could: (1) Significantly impair the individual's objectivity; or (2) create an unfair competitive advantage for any person or organization.
NOAA has adapted the NAS policy and developed two confidential conflict disclosure forms which the agency will use to examine prospective reviewers' potential financial conflicts and other interests that could impair objectivity or create an unfair advantage. One form is for peer reviewers of studies related to government regulation and the other form is for all other influential scientific information subject to the Peer Review Bulletin. In addition, the latter form has been adapted by NOAA's Office of Oceanic and Atmospheric Research for potential reviewers of scientific laboratories.
The forms include questions about employment as well as investment and property interests and research funding. Both forms also require the submission of curriculum vitae. NOAA is seeking to collect this information from potential peer reviewers who are not government employees when conducting a peer review pursuant to the PRB. The information collected in the conflict of interest disclosure is essential to NOAA's compliance with the OMB PRB, and helps to ensure that government studies are reviewed by independent, impartial peer reviewers.
Forms may be downloaded from the Internet and are fillable and signable
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; receipt of application.
Notice is hereby given that Bruce Mate, Ph.D., Oregon State University, Hatfield Marine Science Center, Newport, OR has applied in due form for a permit to conduct research on marine mammals.
Written, telefaxed, or e-mail comments must be received on or before August 12, 2010.
The application and related documents are available for review by selecting “Records Open for Public Comment” from the Features box on the Applications and Permits for Protected Species (APPS) home page,
These documents are also available upon written request or by appointment in the following office(s):
Permits, Conservation and Education Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301)713–2289; fax (301)713–0376; and
Northwest Region, NMFS, 7600 Sand Point Way NE, BIN C15700, Bldg. 1, Seattle, WA 98115–0700; phone (206)526–6150; fax (206)526–6426.
Written comments on this application should be submitted to the Chief, Permits, Conservation and Education Division, at the address listed above. Comments may also be submitted by facsimile to (301)713–0376, or by email to NMFS.Pr1Comments@noaa.gov. Please include the File No. in the subject line of the email comment.
Those individuals requesting a public hearing should submit a written request to the Chief, Permits, Conservation and Education Division at the address listed above. The request should set forth the specific reasons why a hearing on this application would be appropriate.
Tammy Adams or Kristy Beard, (301)713–2289.
The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361
The applicant requests a five-year permit to test the effectiveness of an acoustic deterrent at keeping gray whales (
In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Concurrent with the publication of this notice in the
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of intent to prepare recovery plan; request for information.
The National Marine Fisheries Service (NMFS) is announcing its intent to prepare a recovery plan for the Sei Whale (
To allow NMFS adequate time to conduct the reviews, all information must be received no later than [
You may submit comments, identified by the code 0648–XX37 by any of the following methods:
1. Electronic Submissions: Submit all electronic comments via the Federal eRulemaking Portal:
2. Facsimile (fax): 301–713–0376, Please identify the fax comments as “Sei Whale Recovery Plan Information”
3. Mail: National Marine Fisheries Service, Office of Protected Resources, 1315 East West Highway, Silver Spring, MD 20910, ATTN: Greg Silber
Greg Silber at the above address, or at 301–713–2322.
Management responsibility for sei whales lies with the Secretary of Commerce and has been delegated to NMFS. As such, NMFS is charged with the recovery of sei whales which are listed as endangered under the ESA.
The recovery planning process is guided by the statutory language of Section 4(f) of the ESA and NMFS policies. Recovery planning identifies all methods and procedures which are necessary to recover any endangered species or threatened species. Section 4(f)(1)(B) of the ESA specifies that recovery plans must incorporate in each plan - (i) a description of such site-specific management actions as may be necessary to achieve the plan's goal for the conservation and survival of the species; (ii) objective, measurable criteria which when met, would result in a determination, that the species be removed from the list; and (iii) estimates of the time required and cost to carry out those measures needed to achieve the plan's goal and to achieve intermediate steps toward that goal.
The recovery planning process is guided by the statutory language of Section 4(f) of the ESA, which requires that public notice and an opportunity for public review and comment be provided during recovery plan development. NMFS requests relevant information from the public during preparation of the draft Recovery Plan. Such information should address: (a) criteria for removing the sei whale from the list of threatened and endangered species; (b) factors that are presently limiting, or threaten to limit, the survival of the sei whale; (c) actions to address limiting factors and threats; (d) estimates of time and cost to implement recovery actions; and (e) research, monitoring and evaluation needs.
Upon completion, the draft Recovery Plan will be available for public review and comment through the publication of a
16 U.S.C. 1531
Import Administration, International Trade Administration, Department of Commerce.
July 13, 2010.
Bob Palmer or Kathleen Marksberry, AD/CVD Operations, Office 9, Import Administration, International Trade Administration, Department of Commerce, 14th Street and Constitution Avenue, NW, Washington, DC 20230; telephone: (202) 482–9068 or (202) 482–7906, respectively.
On May 29, 2009, Department of Commerce (“Department”) published the notice of the initiation of the antidumping duty administrative review on certain activated carbon from the People's Republic of China (“PRC”), covering the period April 1, 2008, through March 31, 2009.
On November 24, 2009, the Department published a notice extending the time period for issuing the preliminary results by 120 days to April 30, 2010.
Section 751(a)(3)(A) of the Tariff Act of 1930, as amended (“Act”), requires the Department to issue the final results in an administrative review of an antidumping duty order 120 days after the date on which the preliminary results are published. The Department may, however, extend the deadline for completion of the final results of an administrative review to 180 days if it determines it is not practicable to complete the review within the foregoing time period.
The Department requires additional time to complete this review because the Department must fully analyze and consider significant issues related to surrogate values raised in the parties'
This notice is published in accordance with sections 751(a)(1) and 777(i)(1) of the Act.
Import Administration, International Trade Administration, Department of Commerce.
Matthew Jordan at (202) 482–1540; AD/CVD Operations, Office 1, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW, Washington, DC 20230.
On December 23, 2009, the Department of Commerce (“the Department”) published a notice of initiation of administrative review of the antidumping duty order on circular welded non–alloy steel pipe from the Republic of Korea, covering the period November 1, 2008 through October 31, 2009.
Section 751(a)(3)(A) of the Tariff Act of 1930, as amended (“the Act”), requires the Department to issue the preliminary results of an administrative review within 245 days after the last day of the anniversary month of an order for which a review is requested and the final results of review within 120 days after the date on which the preliminary results are published. If it is not practicable to complete the review within the time period, section 751(a)(3)(A) of the Act allows the Department to extend these deadlines to a maximum of 365 days and 180 days, respectively.
The Department requires additional time to review and sales and cost information submitted by the respondents in this administrative review because this review involves complex sales and cost accounting issues. Thus, it is not practicable to complete this review within the originally anticipated time limit (
We are issuing and publishing this notice in accordance with sections 751(a)(3)(A) and 777(i)(1) of the Act.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of receipt of an application for an exempted fishing permit; request for comments.
NMFS announces the receipt of an application for an exempted fishing permit (EFP) from Mr. Don DeMaria. If granted, the EFP would authorize Mr. DeMaria to collect and retain, with certain conditions, limited numbers of gorgonian corals from Federal waters, off the coast of North Carolina. The specimens would be used to support research efforts towards a grant awarded to the National Cancer Institute to screen marine invertebrates for possible anti-cancer compounds.
Comments must be received no later than 5 p.m., eastern time, on July 28, 2010.
You may submit comments on the application by any of the following methods:
• E-mail:
• Mail: Nikhil Mehta, Southeast Regional Office, NMFS, 263 13th Avenue South, St. Petersburg, FL 33701.
• Fax: 727–824–5308.
The application and related documents are available for review upon written request to any of the above addresses.
Nikhil Mehta, 727–824–5305; fax: 727–824–5308; e-mail:
The EFP is requested under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C 1801
This action involves activities covered by regulations implementing the Fishery Management Plan for Coral, Coral Reefs, and Live/Hardbottom Habitat of the South Atlantic Region. The applicant has requested authorization to collect a maximum of 11 lb (5 kg) of gorgonian corals belonging to the Genus
The overall intent of the project is to support research efforts to screen marine invertebrates for possible anti-cancer compounds. The research is part of a contract (No. HHSN261200900012C) between the National Cancer Institute (
NMFS finds this application warrants further consideration. Based on a preliminary review, NMFS intends to issue the requested EFP, pending receipt of public comments, as per 50 CFR 600.745(b)(3)(i). Possible conditions the agency may impose on this permit, if it is indeed granted, include but are not limited to, a prohibition on conducting research within marine protected areas, marine sanctuaries, special management zones, or artificial reefs without additional authorization. A report on the project findings would be due at the end of the collection period, to be submitted to NMFS and reviewed by the South Atlantic Fishery Management Council.
A final decision on issuance of the EFP will depend on NMFS' review of public comments received on the application, consultations with the affected state, the South Atlantic Fishery Management Council, and the U.S. Coast Guard, as well as a determination that it is consistent with all applicable laws.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of SEDAR Workshop for South Atlantic and Gulf of Mexico goliath grouper.
The SEDAR assessments of the South Atlantic and Gulf of Mexico stocks of goliath grouper will consist of a series of three workshops: a Data Workshop, an Assessment Workshop, and a Review Workshop. See
The Assessment Workshop will take place August 2–5, 2010. See
The Assessment Workshop will be held at the Hilton Bayfront, 333 First Street South, St. Petersburg, FL 33701; telephone: (727) 894–5000.
Julie A. Neer, SEDAR Coordinator, 4055 Faber Place Drive, Suite 201, North Charleston, SC 29405; telephone: (843) 571–4366.
The Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils, in conjunction with NOAA Fisheries and the Atlantic and Gulf States Marine Fisheries Commissions have implemented the Southeast Data, Assessment and Review (SEDAR) process, a multi-step method for determining the status of fish stocks in the Southeast Region. SEDAR includes three workshops: (1) Data Workshop, (2) Stock Assessment Workshop and (3) Review Workshop. The product of the Data Workshop is a data report which compiles and evaluates potential datasets and recommends which datasets are appropriate for assessment analyses. The product of the Stock Assessment Workshop is a stock assessment report which describes the fisheries, evaluates the status of the stock, estimates biological benchmarks, projects future population conditions, and recommends research and monitoring needs. The assessment is independently peer reviewed at the Review Workshop. The product of the Review Workshop is a Consensus Summary documenting Panel opinions regarding the strengths and weaknesses of the stock assessment and input data. Participants for SEDAR Workshops are appointed by the Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils and NOAA Fisheries Southeast Regional Office and Southeast Fisheries Science Center. Participants include data collectors and database managers; stock assessment scientists, biologists, and researchers; constituency representatives including fishermen, environmentalists, and NGO's; International experts; and staff of Councils, Commissions, and state and federal agencies.
Using datasets provided by the Data Workshop, participants will develop population models to evaluate stock status, estimate population benchmarks and reauthorized Magnuson-Stevens Act criteria, and project future conditions. Participants will recommend the most appropriate methods and configurations for determining stock status and estimating population parameters. Participants will prepare a workshop report, compare and contrast various assessment approaches, and determine whether the assessments are adequate for submission to the review panel.
Although non-emergency issues not contained in this agenda may come before these groups for discussion, those issues may not be the subject of formal action during these meetings. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to the Council office (see
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of SEDAR 24 Assessment Webinars 3 & 4 and Review Workshop for South Atlantic red snapper.
The SEDAR assessment of the South Atlantic stock of red snapper will consist of a series of workshops and webinars: a Data Workshop, a series of Assessment webinars, and a Review
Assessment Webinar 3 will take place August 13, 2010. Assessment Webinar 4 will take place August 24, 2010. The Review Workshop will take place October 12–14, 2010. See
The Assessment Webinars will be held live online via an internet based conferencing service. The Webinars may be attended by the public. Those interested in participating should contact Kari Fenske at SEDAR. See
The Review Workshop will be held at the Hilton DeSoto, 15 East Liberty St., Savannah, GA 31401; telephone: (912)232–9000.
Kari Fenske, SEDAR Coordinator, 4055 Faber Place Drive, Suite 201, North Charleston, SC 29405; telephone: (843) 571–4366; e-mail:
The Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils, in conjunction with NOAA Fisheries and the Atlantic and Gulf States Marine Fisheries Commissions have implemented the Southeast Data, Assessment and Review (SEDAR) process, a multi-step method for determining the status of fish stocks in the Southeast Region. SEDAR includes a Data Workshop, a Stock Assessment Process and a Review Workshop. The product of the Data Workshop is a data report which compiles and evaluates potential datasets and recommends which datasets are appropriate for assessment analyses. The product of the Stock Assessment Process is a stock assessment report which describes the fisheries, evaluates the status of the stock, estimates biological benchmarks, projects future population conditions, and recommends research and monitoring needs. The assessment is independently peer reviewed at the Review Workshop. The product of the Review Workshop is a Peer Review Evaluation Report documenting Panel opinions regarding the strengths and weaknesses of the stock assessment and input data. Participants for SEDAR Workshops and Assessment Process are appointed by the Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils; the Atlantic and Gulf States Marine Fisheries Commissions; and NOAA Fisheries Southeast Regional Office and Southeast Fisheries Science Center. Participants include data collectors and database managers; stock assessment scientists, biologists, and researchers; constituency representatives including fishermen, environmentalists, and NGO's; International experts; and staff of Councils, Commissions, and state and federal agencies.
Assessment panelists will: (1) discuss red snapper model exploratory runs (sensitivities), (2) select a preferred model, (3) review final model runs, results, (4) provide guidance on model projections, (5) characterize and quantify model uncertainty, and (6) recommend status determination. Workshop panelists will document their findings and recommendations in an Assessment Workshop Report that will be made available to the public.
Assessment panelists will review the Assessment Report.
The Review Workshop is an independent peer review of the assessments developed during the SEDAR 24 Data Workshop and Assessment Process. Workshop Panelists will review the assessment and document their comments and recommendations in a Peer Review Evaluation Report.
Although non-emergency issues not contained in this agenda may come before these groups for discussion, those issues may not be the subject of formal action during these meetings. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to the Council office (see
The Information Systems Technical Advisory Committee (ISTAC) will meet on July 28 and 29, 2010, 9 a.m., in the Herbert C. Hoover Building, Room 3884, 14th Street between Constitution and Pennsylvania Avenues, NW., Washington, DC. The Committee advises the Office of the Assistant Secretary for Export Administration on technical questions that affect the level of export controls applicable to information systems equipment and technology.
1. Welcome and Introductions.
2. Working Group Reports.
3. Smart Grid.
4. Civil Satellite Telecommunications.
5. GPU/CPU/Accelerators.
6. Discussion of matters determined to be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 section 10(a)(1) and 10(a)(3).
The open session will be accessible via teleconference to 20 participants on a first come, first serve basis. To join the conference, submit inquiries to Ms. Yvette Springer at
A limited number of seats will be available for the public session. Reservations are not accepted. To the extent time permits, members of the public may present oral statements to the Committee. The public may submit written statements at any time before or after the meeting. However, to facilitate distribution of public presentation materials to Committee members, the Committee suggests that public presentation materials or comments be forwarded before the meeting to Ms. Springer.
The Assistant Secretary for Administration, with the concurrence of
For more information, call Yvette Springer at (202) 482–2813.
The Sensors and Instrumentation Technical Advisory Committee (SITAC) will meet on July 27, 2010, 9:30 a.m., in the Herbert C. Hoover Building, Room 3884, 14th Street between Constitution and Pennsylvania Avenues, NW., Washington, DC. The Committee advises the Office of the Assistant Secretary for Export Administration on technical questions that affect the level of export controls applicable to sensors and instrumentation equipment and technology.
1. Welcome and Introductions.
2. Remarks from the Bureau of Industry and Security Management.
3. Industry Presentations.
4. New Business.
5. Discussion of matters determined to be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 §§ 10(a)(1) and 10(a)(3).
The open session will be accessible via teleconference to 20 participants on a first come, first serve basis. To join the conference, submit inquiries to Ms. Yvette Springer at
A limited number of seats will be available during the public session of the meeting. Reservations are not accepted. To the extent that time permits, members of the public may present oral statements to the Committee. The public may submit written statements at any time before or after the meeting. However, to facilitate distribution of public presentation materials to the Committee members, the Committee suggests that the materials be forwarded before the meeting to Ms. Springer.
The Assistant Secretary for Administration, with the concurrence of the General Counsel, formally determined on March 11, 2010 pursuant to Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. app. 2 § 10(d)), that the portion of this meeting dealing with pre-decisional changes to the Commerce Control List and U.S. export control policies shall be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 §§ 10(a)(1) and 10(a)(3). The remaining portions of the meeting will be open to the public.
For more information contact Yvette Springer on (202) 482–2813.
National Institute of Standards and Technology.
Notice.
The Information Security and Privacy Advisory Board (ISPAB) will meet Wednesday, August 4, 2010, from 9 a.m. until 5 p.m. Thursday, August 5, 2010, from 8:30 a.m. until 5 p.m., and Friday, August 6, 2010 from 8 a.m. until 12:30 p.m. All sessions will be open to the public.
The meeting will be held on Wednesday, August 4, 2010, from 9 a.m. until 5 p.m., Thursday, August 5, 2010, from 8:30 a.m. until 5 p.m. and Friday, August 6, 2010 from 8 a.m. until 12:30 p.m.
The meeting will take place at the Marriott Hotel Washington, 1221 22nd Street, NW., Washington, District of Columbia 20037 on August 4, 5, & 6, 2010. Please see admittance instructions in the
Mr. Matthew Scholl, Information Technology Laboratory, National Institute of Standards and Technology, 100 Bureau Drive, Stop 8930, Gaithersburg, MD 20899–8930, telephone: (301) 975–2941.
Pursuant to the Federal Advisory Committee Act, 5 U.S.C. App., notice is hereby given that the Information Security and Privacy Advisory Board (ISPAB) will meet Wednesday, August 4, 2010, from 9 a.m. until 5 p.m., Thursday, August 5, 2010, from 8:30 a.m. until 5 p.m. and Friday, August 6, 2010 from 8 a.m. until 12:30 p.m. All sessions will be open to the public. The ISPAB was established by the Computer Security Act of 1987 (Pub. L. 100–235) and amended by the Federal Information Security Management Act of 2002 (Pub.L. 107–347) to advise the Secretary of Commerce and the Director of NIST on security and privacy issues pertaining to federal computer systems. Details regarding the ISPAB's activities are available at
The agenda is expected to include the following items:
Note that agenda items may change without notice because of possible unexpected schedule conflicts of presenters. The final agenda will be posted on the website indicated above.
In addition, written statements are invited and may be submitted to the ISPAB at any time. Written statements should be directed to the ISPAB Secretariat, Information Technology Laboratory, 100 Bureau Drive, Stop 8930, National Institute of Standards and Technology, Gaithersburg, MD 20899–8930. Approximately 15 seats will be available for the public and media.
Department of Defense (DoD).
Meeting notice; correction.
On June 21, 2010, the Department of Defense (DoD) published a notice in the
Although the meeting is open to the public, an escort is required. Further details are provided in the June 21 meeting notice.
The meeting will be held on Thursday, July 22, 2010, from 9 a.m. to 9:45 a.m.
The meeting will be held at the Pentagon, Room 3D557, Washington, DC (escort required,
For meeting information please contact Ms. Debora Duffy, Defense Business Board, 1155 Defense Pentagon, Room 5B–1088A, Washington, DC 20301–1155,
See the June 21, 2010,
In the
On page 34987, in the third column, correct the
The meeting will be held at the Pentagon, Room 3D557, Washington, DC (escort required,
Defense Logistics Agency; DoD.
Notice to delete a system of records.
The Defense Logistics Agency proposes to delete a system of records notice in its existing inventory of records systems subject to the Privacy Act of 1974, (5 U.S.C. 552a), as amended.
This proposed action will be effective without further notice on August 12, 2010, unless comments are received which result in a contrary determination.
You may submit comments, identified by dock number and title, by any of the following methods:
•
•
Jody Sinkler at (703) 767–5045.
The Defense Logistics Agency systems of records notices subject to the Privacy Act of 1974, (5 U.S.C. 552a), as amended, have been published in the
The Defense Logistics Agency proposes to delete a system of records notice in its inventory of record systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended. The proposed deletion is not within the purview of subsection (r) of the Privacy Act of 1974, (5 U.S.C. 552a), as amended, which requires the submission of a new or altered system report.
Readiness and Accountability Records (November 16, 2004; 69 FR 67112).
Records formerly maintained under S600.40 are now being maintained under a DoD-wide Privacy Act system of records notice identified as DPR 39 DoD, entitled “DoD Personnel Accountability and Assessment System”
Department of Education.
The Director, Information Collection Clearance Division, Regulatory Information Management Services, Office of Management invites comments on the submission for OMB review as required by the Paperwork Reduction Act of 1995 (Pub. L. 104–13).
Interested persons are invited to submit comments on or before August 12, 2010.
Written comments should be addressed to the Office of Information and Regulatory Affairs, Attention: Education Desk Officer, Office of Management and Budget, 725 17th Street, NW., Room 10222, New Executive Office Building, Washington, DC 20503, be faxed to (202) 395–5806 or e-mailed to
Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35) requires that the Office of Management and Budget (OMB) provide interested Federal agencies and the public an early opportunity to comment on information collection requests. The OMB is particularly interested in comments which:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Requests for copies of the information collection submission for OMB review may be accessed from the RegInfo.gov Web site at
Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1–800–877–8339.
Department of Education.
The Director, Information Collection Clearance Division, Regulatory Information Management Services, Office of Management invites comments on the submission for OMB review as required by the Paperwork Reduction Act of 1995 (Pub. L. 104–13).
Interested persons are invited to submit comments on or before August 12, 2010.
Written comments should be addressed to the Office of Information and Regulatory Affairs, Attention: Education Desk Officer, Office of Management and Budget, 725 17th Street, NW., Room 10222, New Executive Office Building, Washington, DC 20503, be faxed to (202) 395–5806 or e-mailed to
Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that the Office of Management and Budget (OMB) provide interested Federal agencies and the public an early opportunity to comment on information collection requests. The OMB is
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Requests for copies of the information collection submission for OMB review may be accessed from the RegInfo.gov Web site at
Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1–800–877–8339.
Dates:
This priority is:
Applications to support pilot programs that expand the services of bookstores to provide the option for students to rent course materials in order to achieve savings for students.
The projects supported by this program may include, but are not limited to, activities that: (1) Acquire course materials that the entity will make available by rent to students; (2) develop or acquire equipment or software necessary for the conduct of a rental program; (3) hire staff needed for the conduct of a rental program, with priority given to hiring enrolled undergraduate students; (4) build or acquire extra storage space dedicated to course materials for rent; (5) place a priority on higher cost and introductory level classes; and (6) focus on students with the greatest financial need.
Section 803 of the Higher Education Opportunity Act, Pub. L. 110–315, 20 U.S.C. 1015b note; Consolidated Appropriations Act, 2010, Pub. L. 111–117.
The regulations in 34 CFR part 79 apply to all applicants except Federally recognized Indian Tribes.
The Department is not bound by any estimates in this notice.
1.
2.
1.
You can contact ED Pubs at its Web site, also:
If you request an application package from ED Pubs, be sure to identify this program or competition as follows: CFDA number 84.116T.
Individuals with disabilities can obtain a copy of the application package in an accessible format (
2.
• A “page” is 8.5′ × 11″, on one side only, with 1″ margins at the top, bottom, and both sides.
• Double space (no more than three lines per vertical inch) all text in the application narrative, including titles, headings, footnotes, quotations, references, and captions, as well as all text in charts, tables, figures, and graphs.
• Use a font that is either 12 point or larger, or no smaller than 10 pitch (characters per inch).
• Use one of the following fonts: Times New Roman, Courier, Courier New, or Arial. An application submitted in any other font (including Times Roman or Arial Narrow) will not be accepted.
The page limit does not apply to the cover sheet; the budget section, including the budget narrative; the assurances and certifications; the one-page abstract; the resumes; the bibliography; or the letters of support.
We will reject your application if you exceed the page limit.
3.
Applications for grants under this program must be submitted electronically using the Electronic Grant Application System (e-Application) accessible through the Department's e-Grants site. For information (including dates and times) about how to submit your application electronically, or in paper format by mail or hand delivery if you qualify for an exception to the electronic submission requirement, please refer to Section IV.7.
We do not consider an application that does not comply with the deadline requirements.
Individuals with disabilities who need an accommodation or auxiliary aid in connection with the application process should contact the person listed under
4.
5.
6.
You can obtain a DUNS number from Dun and Bradstreet. A DUNS number can be created within one business day.
If you are a corporate entity, agency, institution, or organization, you can obtain a TIN from the Internal Revenue Service. If you are an individual, you can obtain a TIN from the Internal Revenue Service or the Social Security Administration. If you need a new TIN, please allow 2–5 weeks for your TIN to become active.
The CCR registration process may take five or more business days to complete. If you are currently registered with the CCR, you may not need to make any changes. However, please make certain that the TIN associated with your DUNS number is correct. Also note that you will need to update your CCR registration on an annual basis. This may take three or more business days to complete.
7.
Applications for grants under the Pilot Program for Course Material Rental, CFDA Number 84.116T, must be submitted electronically using e-Application, accessible through the Department's e-Grants Web site at:
We will reject your application if you submit it in paper format unless, as described elsewhere in this section, you qualify for one of the exceptions to the electronic submission requirement
While completing your electronic application, you will be entering data online that will be saved into a database. You may not e-mail an electronic copy of a grant application to us.
• You must complete the electronic submission of your grant application by 4:30:00 p.m., Washington, DC time, on the application deadline date. E-Application will not accept an application for this competition after 4:30:00 p.m., Washington, DC time, on the application deadline date. Therefore, we strongly recommend that you do not wait until the application deadline date to begin the application process.
• The hours of operation of the e-Grants Web site are 6:00 a.m. Monday until 7:00 p.m. Wednesday; and 6:00 a.m. Thursday until 8:00 p.m. Sunday, Washington, DC time. Please note that, because of maintenance, the system is unavailable between 8:00 p.m. on Sundays and 6:00 a.m. on Mondays, and between 7:00 p.m. on Wednesdays and 6:00 a.m. on Thursdays, Washington, DC time. Any modifications to these hours are posted on the e-Grants Web site.
• You will not receive additional point value because you submit your application in electronic format, nor will we penalize you if you qualify for an exception to the electronic submission requirement, as described elsewhere in this section, and submit your application in paper format.
• You must submit all documents electronically, including all information you typically provide on the following forms: the Application for Federal
• Your electronic application must comply with any page limit requirements described in this notice.
• Prior to submitting your electronic application, you may wish to print a copy of it for your records.
• After you electronically submit your application, you will receive an automatic acknowledgment that will include a PR/Award number (an identifying number unique to your application).
• Within three working days after submitting your electronic application, fax a signed copy of the SF 424 to the Application Control Center after following these steps:
(1) Print SF 424 from e-Application.
(2) The applicant's Authorizing Representative must sign this form.
(3) Place the PR/Award number in the upper right hand corner of the hard-copy signature page of the SF 424.
(4) Fax the signed SF 424 to the Application Control Center at (202) 245–6272.
• We may request that you provide us original signatures on other forms at a later date.
(1) You are a registered user of e-Application and you have initiated an electronic application for this competition; and
(2)(a) E-Application is unavailable for 60 minutes or more between the hours of 8:30 a.m. and 3:30 p.m., Washington, DC time, on the application deadline date; or
(b) E-Application is unavailable for any period of time between 3:30 p.m. and 4:30:00 p.m., Washington, DC time, on the application deadline date.
We must acknowledge and confirm these periods of unavailability before granting you an extension. To request this extension or to confirm our acknowledgment of any system unavailability, you may contact either (1) the person listed elsewhere in this notice under
• You do not have access to the Internet; or
• You do not have the capacity to upload large documents to e-Application;
• No later than two weeks before the application deadline date (14 calendar days; or, if the fourteenth calendar day before the application deadline date falls on a Federal holiday, the next business day following the Federal holiday), you mail or fax a written statement to the Department, explaining which of the two grounds for an exception prevents you from using the Internet to submit your application. If you mail your written statement to the Department, it must be postmarked no later than two weeks before the application deadline date. If you fax your written statement to the Department, we must receive the faxed statement no later than two weeks before the application deadline date.
Address and mail or fax your statement to: Krish Mathur, U.S. Department of Education, 1990 K Street, NW., Room 6155, Washington, DC 20006–8544. FAX: (202) 502–7877.
Your paper application must be submitted in accordance with the mail or hand delivery instructions described in this notice.
If you qualify for an exception to the electronic submission requirement, you may mail (through the U.S. Postal Service or a commercial carrier) your application to the Department. You must mail the original and two copies of your application, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, Attention: (CFDA Number 84.116T), LBJ Basement Level 1, 400 Maryland Avenue, SW., Washington, DC 20202–4260.
You must show proof of mailing consisting of one of the following:
(1) A legibly dated U.S. Postal Service postmark.
(2) A legible mail receipt with the date of mailing stamped by the U.S. Postal Service.
(3) A dated shipping label, invoice, or receipt from a commercial carrier.
(4) Any other proof of mailing acceptable to the Secretary of the U.S. Department of Education.
If you mail your application through the U.S. Postal Service, we do not accept either of the following as proof of mailing:
(1) A private metered postmark.
(2) A mail receipt that is not dated by the U.S. Postal Service.
If your application is postmarked after the application deadline date, we will not consider your application.
The U.S. Postal Service does not uniformly provide a dated postmark. Before relying on this method, you should check with your local post office.
If you qualify for an exception to the electronic submission requirement, you (or a courier service) may deliver your paper application to the Department by hand. You must deliver the original and two copies of your application, by hand, on or before the application deadline date, to the Department at the following address: U.S. Department of Education, Application Control Center, Attention: (CFDA Number 84.116T), 550 12th Street, SW., Room 7041, Potomac Center Plaza, Washington, DC 20202–4260.
The Application Control Center accepts hand deliveries daily between 8:00 a.m. and 4:30:00 p.m., Washington, DC time, except Saturdays, Sundays, and Federal holidays.
If you mail or hand deliver your application to the Department—
(1) You must indicate on the envelope and—if not provided by the Department—in Item 11 of the SF 424 the CFDA number, including suffix letter, if any, of the competition under which you are submitting your application; and
(2) The Application Control Center will mail to you a notification of receipt of your grant application. If you do not receive this grant notification within 15 business days from the application deadline date, you should call the U.S. Department of Education Application Control Center at (202) 245–6288.
1.
If your application is not evaluated or not selected for funding, we notify you.
2.
We reference the regulations outlining the terms and conditions of an award in the
3.
4.
(1) The extent to which the best practices developed by the funded projects are being replicated (
(2) The extent to which the projects are being institutionalized and continued after funding.
(3) The effectiveness of the projects in achieving savings for the students served by this pilot program.
If funded, you will be asked to collect and report data from your project on steps taken toward achieving the outcomes evaluated by these performance measures (
If you use a TDD, call the FRS, toll free, at 1–800–877–8339.
To use PDF, you must have Adobe Acrobat Reader, which is available free at this site.
The official version of this document is the document published in the
Western Area Power Administration, DOE.
Notice of Record of Decision and Floodplain Statement of Findings.
The Western Area Power Administration (Western) received a request from Basin Electric Power Cooperative (Basin Electric) to interconnect its proposed Deer Creek Station Energy Facility Project (Project) to Western's transmission system. Basin Electric's Project includes the construction of a new 300-megawatt (MW) natural gas-fired combined-cycle generation facility in Brookings County, South Dakota, approximately 13.2 miles of new natural gas supply pipeline, a 0.75-mile transmission line, two water wells, a 1.25-mile water supply line, and 1 mile of local road improvements.
Western considered the interconnection request under the provisions of its Open Access Transmission Service Tariff (Tariff), along with the information in the environmental impact statement (EIS) and all comments received, and has made the decision to allow Basin Electric's request to interconnect at Western's existing White Substation. The U.S. Department of Agriculture, Rural Utilities Service (RUS), also received a request from Basin Electric for financial assistance for the Deer Creek Station Energy Facility Project. RUS is a cooperating agency in the EIS process.
Please contact Mr. Matt Marsh, National Environmental Policy Act (NEPA) Document Manager, Western Area Power Administration, P.O. Box 35800, Billings, MT 59107; telephone (406) 247–7385 or e-mail
Western is a Federal agency within the DOE that markets and transmits wholesale electrical power through an integrated 17,000-mile, high-voltage transmission system across 15 western states. Western received a request from Basin Electric to interconnect their proposed Project to Western's transmission system. Basin Electric's Project is located within Western's Upper Great Plains Region, which operates and maintains nearly 100 substations and nearly 7,800 miles of Federal transmission lines in Minnesota, South Dakota, North Dakota, Montana, Nebraska, and Iowa.
Western published a Notice of Intent to prepare an EIS for the project on February 6, 2009 (74 FR 6284). A Notice of Availability of the Draft EIS was published by the Environmental Protection Agency (EPA) on February 5, 2010 (75 FR 6026), and a Notice of Availability of the Final EIS was published by EPA on May 28, 2010 (75 FR 30022).
Western's need for action is triggered by Basin Electric's interconnection request. Western's Tariff describes the conditions necessary for access to its transmission system. Western provides an interconnection if there is available capacity on the transmission system, while considering transmission system reliability and power delivery to existing customers, and the applicant's objectives.
Western's Federal involvement is limited to consideration of Basin Electric's interconnection request for their Project, under the provisions of the Tariff. Western's Proposed Action is to interconnect the Project to Western's transmission system. This involves adding a transformer bay to the White Substation and making other minor system modifications within the substation.
Basin Electric's 2007 Power Supply Analysis (PSA) indicated that additional intermediate capacity would be needed by mid-2012 to meet its members' growing energy demand. Based on the PSA, a 700- to 800-megawatt (MW) capacity deficit is projected in the eastern portion of Basin Electric's service area by the year 2014. Basin Electric is proposing to meet this increased demand by implementing a resource expansion plan that includes 200 MW of peaking generation, 300 MW of wind generation, 250 MW of intermediate generation, and 600 MW of baseload generation.
As an intermediate capacity unit, Basin Electric's proposed Project would be cycled at low load periods, such as evenings and weekends. The unit would be capable of rapidly responding to load swings of the system. The Project has been sized for 300 MW in order to meet the 250-MW intermediate power supply need and have a 50-MW reserve to meet peak intermediate needs. The advantage of siting such a project in Brookings County is that wind generation on the grid in this area can be integrated with the combined-cycle natural gas generation. During periods of high wind generation, gas-fired generation can be reduced. During periods of low wind generation, the gas-fired generation will be available to back up the wind generation.
The Project would use combined-cycle technology, in which a gas turbine powers an electric generator. Under the combined-cycle configuration, the exhaust from the combustion turbine generator passes through a heat recovery steam generator that extracts heat from the turbine exhaust. The waste heat is used to generate steam that then passes through a steam turbine generator.
The EIS reviewed the options considered by Basin Electric in its PSA. Western has no decision-making authority over these options. Western's Federal involvement is limited to the determination of whether to allow the interconnection of Basin Electric's Project. For the purposes of furthering environmental decision making, the EIS evaluated three alternatives. Under the No Action Alternative, Western would not execute an interconnection agreement with Basin Electric. Given the lack of a Western interconnection, Basin Electric could not construct its Project as proposed. However, as Basin Electric is a regulated utility having load growth responsibility, it is reasonable to expect that it would construct a similar generation facility somewhere in eastern South Dakota. Such a facility may not connect to a Federal transmission system, involve Federal financing, or have any other Federal nexus that would require a NEPA process.
Under the Proposed Action, Western would execute an interconnection agreement. Basin Electric would construct a 300-MW combined-cycle combustion turbine natural gas generating facility and supporting infrastructure at one of two alternative sites in eastern South Dakota. The EIS analyzed the two alternative sites as White Site 1 and White Site 2. The sites were selected because of their proximity to a natural gas supply, to a Western transmission line, to a water supply, and constructability.
White Site 1 is located approximately six miles southeast of White, South Dakota, in the northeast quarter of Section 25, Township 111 North, Range 48 West, of the Fifth Principal Meridian, Brookings County. The footprint of the White Site 1 power generation facility would take up 40 acres of a 100-acre site. To provide natural gas, a 13.2-mile natural gas line would be constructed from the site to access the Northern Border Pipeline in Deuel County, South Dakota. Electricity generated by the facility would be transmitted to Western's White Substation by a 0.75-mile long, 345-kV transmission line. Cooling water would be provided by two wells located near Deer Creek, and the water would be transmitted to the site by a 1.25-mile water pipeline.
White Site 2 is located approximately four miles east-northeast of White, South Dakota, in the northwest quarter of Section 2, Township 111 North, Range 48 West, of the Fifth Principal Meridian, Brookings County. In addition to a 40-acre generation facility footprint, White Site 2 would also involve substation construction that would occupy an additional six acres. To provide natural gas, a 10-mile natural gas pipeline would be constructed from the site to access the Northern Border Pipeline in Deuel County. Electricity generated by the facility would be transmitted from the new substation to a Western transmission line located 0.5 miles from the site. Cooling water would be provided by municipal water supply. A water line extension of one mile would be constructed to the site.
White Site 1 is convenient to the White Substation, is further away from occupied residences, and has better drainage than White Site 2. White Site 2 would require construction of a substation for interconnection. As a result, Basin Electric selected White Site 1 as its preferred site.
As required by 40 CFR 1505.2(b), Western has identified an environmentally preferred alternative: the No Action Alternative. Under this alternative, Western would deny the interconnection request and not modify its transmission system to interconnect the Project with its transmission system. Under this alternative it is assumed that Basin Electric's proposed Project would
Under the No Action Alternative, Basin Electric's purpose and need would not be met. Basin Electric, as a regulated utility with load growth responsibility, would have to find an alternate means to meet the increase in intermediate generation demand for electric power in the eastern portion of its service area. It is reasonable to expect that Basin Electric would construct a similar generation facility somewhere in eastern South Dakota that may or may not have a Federal nexus requiring NEPA review and consideration of mitigation efforts as a part of that review.
The analysis in the EIS demonstrated that Basin Electric's Project would have no impacts or minimal impacts on geology, farmland, environmental justice, recreation, visual, and cultural resources. Expected impacts on other environmental resources are discussed below.
Air emissions from the Project would be those expected from a modern natural gas-fueled power plant, and would be less than applicable emissions standards for carbon monoxide (CO), nitrogen oxides (NO
Water resources concerns are related to erosion and sedimentation, and groundwater. Crossings of streams and wetlands by gas pipelines and waterlines have been minimized to the extent practicable by careful routing. Where crossings are unavoidable, construction would meet all permit conditions of the U.S. Army Corps of Engineers and State water quality agencies. The impacts to streams and wetlands from the Project would be temporary in nature, and were determined to be not significant. Construction-site storm-water management would also meet all State and Federal regulations. Groundwater for plant cooling water would be pumped from the Big Sioux aquifer in the Deer Creek floodplain near the Project site. Initial pump tests indicate that Deer Creek would not be affected by drawdown. Biological resources concerns in this mostly agricultural area are mostly related to small crossings of native prairie by the gas pipeline corridor. Two locations contain native prairie forb and warm season grass communities. These locations are potential habitat for the Dakota skipper, a candidate for listing under the Endangered Species Act. Impacts in these areas are expected to be temporary and the prairie would be restored following pipeline trenching.
Traffic and noise were also identified as potential impacts. While the local road network provides adequate capacity to meet projected traffic demands, access to the site would be on unpaved county and township roads. Peak traffic is estimated at 360 one-way trips to the site. Maximum noise levels are projected to increase, but not significantly over background levels. Noise levels would be below U.S. Housing and Urban Development guidelines.
A Notice of Intent (NOI) describing the proposed action was published in the
A Notice of Availability of the Draft EIS was published by the EPA in the
Because no substantive changes were needed to the Draft EIS, Western did not republish the Draft EIS but instead issued the comments, responses, and changes to the document, with a new cover sheet, as the Final EIS pursuant to 40 CFR part 1503.4(c). The complete Final EIS is composed of both the Draft EIS and the responses to comments found in the Final EIS. The mitigation measures for air quality recommended by the EPA in their comments on the Draft EIS have been adopted. The EPA provided comments on the Final EIS with concerns about groundwater withdrawal and monitoring. Additional details about groundwater issues are presented in the
Through public and agency participation in the NEPA process, Basin Electric has altered the design of the Project to minimize impacts to the environment. Best Management Practices will be used for sediment and erosion control, as described in a Project-specific Storm Water Pollution Prevention Plan, Spill Prevention Control and Countermeasure Plan, South Dakota Department of Environment and Natural Resources (SDDENR) General Permit for Storm Water Discharges with Industrial Activities, and SDDENR General Permit for Storm Water Discharges from
A dust control plan will be implemented for use of unpaved county and township roads in the plant vicinity. The air permit is expected to be issued in summer 2010. The draft permit establishes limits for NO
The 2 groundwater production wells will be located approximately 275 feet from Deer Creek. Based on the typical hydraulic characteristics of the Big Sioux aquifer the cone of influence around the production wells would be 21 to 112 feet at a pumping rate of 125 gallons per minute. Only one production well will be in service at any given time. A minimum buffer of 163 feet between the edge of the cone of influence and Deer Creek will thus be preserved. Two pumping tests will determine the actual extent of the cone of influence, which is expected to fall within the range identified above. Pumping tests will be performed during the initial pumping of the first production well and during the period of maximum withdrawal at Project start-up to fill the on-site water storage tank. Monitoring will take place at least every hour during these testing periods. Two groundwater monitoring wells would be left in place between the two production wells and Deer Creek. Given the existing data and buffer between the production well and Deer Creek, no impacts to Deer Creek are anticipated. If the cone of influence is larger than anticipated, Basin Electric will reassess the potential for impacts to Deer Creek in conjunction with Western.
The Project site, gas pipeline, transmission line and water line have the potential to impact wetlands. The Project area contains pothole wetlands, wetland swales (some of which are cultivated) and creeks. Construction in wetlands will be avoided to the extent practicable. Where impacts to wetlands are unavoidable, construction will be performed so that any impacts are minimized. Wetland areas are very common in the Project area, so complete avoidance is not possible.
Construction of Basin Electric's Project would impact 8.74 acres of wetlands along the natural gas pipeline and water pipeline alignments. In addition, construction of the access road into the power generation facility would permanently impact 0.02 acre of wetlands, and temporarily impact an additional 0.02 acre. All of the Project impacts will occur to drainage wetlands classified as riverine, according to the Natural Resources Conservation Service Hydrogeomorphic Classification System for wetlands. Similar wetland areas in the Project area are often cultivated when located in cropland, especially in dry years.
The following water body crossing procedures will be used. Hazardous and regulated materials, chemicals, fuels, and lubricating oils would not be stored and concrete coating activities would not be performed within 100 feet of any intermittent creek or other water body. All construction equipment would be refueled at least 100 feet from any water body. All spoil from creek crossings would be placed in the construction right-of-way (ROW) at least 10 feet from the water's edge, if present. Sediment barriers would be used to prevent the flow of spoil material into the water body. Where possible and practical, any large wetlands and perennial streams will be horizontally directional drilled (HDD). Drilling equipment and bell holes (entrance and exit pits) will be placed at least 25 feet away from the edge of any waterways and wetlands. Soil excavated from the bell holes will be backfilled and stabilized. Where HDD is not used, trenching will be accomplished by minimizing the extent of construction equipment usage in wetland areas and limiting equipment travel and use to the existing ROW. Equipment crossing of wetlands will be completed through use of timber mats if rutting in excess of four inches occurs. Impermeable material such as clay rich soils or sand bag trench blocks will be placed as soil block within the ditch at the entry and exit points of each individual wetland complex so as to minimize the potential of inadvertent drainage of the wetland area.
The following is a general list of procedures to be utilized to reduce wetland impact in areas where open-cut trench crossings in wetland areas will occur. The duration of construction-related disturbance within wetlands will be minimized by means of timely construction during the historically dry periods of the year, typically in the fall. If standing water or saturated soils are present, low ground-weight construction equipment will be used or normal equipment would be operated on timber riprap, prefabricated equipment mats, or geotextile fabric overlain with gravel. Geotextile fabric used for this purpose will be strong enough to allow removal of all gravel and fabric from the wetland. The top 12 inches of topsoil will be segregated from the area disturbed by trenching, except in areas where standing water or saturated soils are present. Once the trench has been backfilled, the segregated topsoil will be used to cover the trench. Impermeable material such as clay rich soils or sandbags will be placed as trench blocks at the entry and exit points of each individual wetland complex to minimize the potential of inadvertent drainage of the wetland area.
Temporary sediment barriers will be used to stop or reduce the flow of sediment coming into wetland locations. These barriers will be constructed of materials such as silt fence, staked hay or straw bales, or sand bags depending on conditions present and the most effective barrier for those conditions. Temporary sediment barriers will be installed as necessary at the base of slopes until disturbed vegetation has been reestablished.
During pipeline installation, the welding of a pipe string will be done at the edge of the wetland and the completed section will be pulled or pushed across (or under, if HDD is used) the wetland and tied into the rest of the pipeline. During wetland disturbance, erosion control structures will be placed as necessary to prevent flow of soil from spoil piles into undisturbed wetland areas. If the wetland has a vegetative mat that can be saved in large segments, the mat will be saved for replacement over the backfilled trench to help re-establish vegetation more rapidly. Once construction has been completed, wetland areas will be restored by grading, which will return the area's drainage patterns to pre-construction contours. Excess backfill will be disposed of on dry land in the ROW rather than on wetland areas. Excess backfill will not be placed on any wetland or floodplain area.
Restoration will be undertaken for temporary impacts to jurisdictional wetlands. Mitigation measures for temporary impacts may include placement of a horizontal marker (
SDGFP will be consulted if any active raptor nests were discovered within 0.25 miles of any of the Project facilities during construction. To ensure that impacts to the Dakota skipper are avoided, pipeline construction will not take place in the two locations of Dakota skipper suitable habitat during the growth and blooming period for the nectar source of the adult butterfly (May–July), which includes the summer breeding period of the butterfly. Nesting bird surveys will be completed prior to ground disturbance activities in accordance with protocols developed in consultation with Western and the USFWS. The seed mix and specifications for native plantings in disturbed area will be developed by Basin Electric, based on the NRCS-recommended seed mixes.
Traffic signage changes and intersection improvements will be implemented to manage the temporary increase in traffic volumes and loads during construction and for deliveries that will occur during Project operations.
Basin Electric will conduct a post-construction operational noise assessment to be completed by an independent third-party noise consultant, approved by the South Dakota Public Utilities Commission, to show compliance with the noise levels according to the predictive model used in the noise analysis. The noise assessment will be performed in accordance with American National Standards Institute (ANSI) B133.8—Gas Turbine Installation Sound Emissions. The results of that analysis will be evaluated by Basin Electric to determine if any modifications to the proposed facilities or operations are needed.
Western is the lead Federal agency for compliance with Section 106 of the National Historic Preservation Act. By letter of May 10, 2010, the South Dakota State Historic Preservation Officer concurred that no historic properties would be affected by the Project. RUS is the lead Federal agency for compliance with Section 7 of the Endangered Species Act. A biological assessment was prepared and submitted with a determination that the Project may affect, but would not likely adversely affect listed species. As stated above, the USFWS concurred with this determination.
In accordance with 10 CFR part 1022, Western considered the potential impacts of the Project on floodplains and wetlands. The natural gas pipeline for Basin Electric's Project would cross 100-year floodplains in eight places. There are no pipeline routes that would completely avoid floodplains, given the locations that existing pipelines would need to be tapped and drainage patterns in the region. As a result, there is no practicable alternative to construction of a natural gas pipeline in floodplains. In addition, the wells producing cooling water would be located in the floodplain of Deer Creek. Total impacts to the floodplain from the well facilities would be an approximately 200-foot by 200-foot area for two individual wellheads, a monitoring well, and an 8-by-10 foot control building. The access road, wells, and control building would be contoured to an elevation of one foot above the 100-year flood elevation. Consistent with the requirements of the National Flood Insurance Program, the building would be watertight and utilities would be capable of resisting flood damage. Because all other available water well supply sites are located in the Deer Creek floodplain, there is no practicable alternative to locating this site within the floodplain.
Permanent impacts to wetlands of 0.02 acres would occur on the Project site due to construction of facilities. Temporary impacts to wetlands would occur due to construction of the proposed Project facilities, including the Project site (0.02 acres), water pipeline (5.86 acres), and natural gas pipeline (2.88 acres). Impacts have been minimized by changing the site layout, use of HDD, and by construction of facilities adjacent to existing linear features such as county and township roads. Where unavoidable, impacts are minimized by use of pads for heavy equipment and restoration to preconstruction contours. There are no pipeline routes that completely avoid wetlands, given the locations that existing pipelines would need to be tapped and the constraints of the Project site. As a result, there is no practicable alternative to construction in wetlands. Project facilities in the floodplain would not impound or impede drainage of flood flows, or increase the severity of or damage from any flood flows.
Western's decision is to allow Basin Electric's request for interconnection at the White Substation in South Dakota and to complete modifications to the substation to support the interconnection.
Basin Electric has committed to minimize its proposed Project's impact on the environment through the Project's design, the use of pollution control technology, and the implementation of mitigation measures as incorporated in the Project description and summarized above. Western will adhere to its own standard mitigation measures for all modifications within White Substation. Western conditions its approval of Basin Electric's request to interconnect to Western's transmission system upon the adoption and implementation of the mitigation measures as described in the Final EIS.
This decision is based on the information contained in the Deer Creek Station Energy Facility Project Final EIS (DOE/EIS–0415). The EIS and this ROD were prepared pursuant to the requirements of the Council on Environmental Quality Regulations for Implementing NEPA (40 CFR parts 1500–1508), DOE Procedures for Implementing NEPA (10 CFR part 1021), and DOE's Floodplain/Wetland Review Requirements (10 CFR 1022). Full implementation of this decision is contingent upon the Project obtaining all applicable permits and approvals.
Environmental Protection Agency (EPA).
Notice.
In compliance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Comments must be received on or before September 13, 2010.
Submit your comments, identified by docket identification (ID) number EPA–HQ–OPPT–2010–0487, by one of the following methods:
•
•
•
Pursuant to section 3506(c)(2)(A) of PRA, EPA specifically solicits comments and information to enable it to:
1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility.
2. Evaluate the accuracy of the Agency's estimates of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.
3. Enhance the quality, utility, and clarity of the information to be collected.
4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. In particular, EPA is requesting comments from very small businesses (those that employ less than 25) on examples of specific additional efforts that EPA could make to reduce the paperwork burden for very small businesses affected by this collection.
You may find the following suggestions helpful for preparing your comments:
1. Explain your views as clearly as possible and provide specific examples.
2. Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used that support your views.
4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.
5. Provide specific examples to illustrate your concerns.
6. Offer alternative ways to improve the collection activity.
7. Make sure to submit your comments by the deadline identified under
8. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and
The rule includes a number of information reporting and recordkeeping requirements. State and local government agencies are required to provide employees with information about exposures to asbestos and the associated health effects. The rule also requires state and local governments to notify EPA before commencing any asbestos abatement project. State and local governments must maintain medical surveillance and monitoring records and training records on their employees, must establish a set of written procedures for respirator programs, and must maintain procedures and records of respirator fit tests. EPA will use the information to monitor compliance with the asbestos worker protection rule. This request addresses these reporting and recordkeeping requirements.
Responses to the collection of information are mandatory (see 40 CFR part 763, subpart G). Respondents may claim all or part of a notice confidential. EPA will disclose information that is covered by a claim of confidentiality only to the extent permitted by, and in accordance with, the procedures in TSCA section 14 and 40 CFR part 2.
The ICR provides a detailed explanation of this estimate, which is only briefly summarized here:
There is a decrease of 40,228 hours in the total estimated respondent burden compared with that identified in the ICR currently approved by OMB. The principal reason for this decrease is because Illinois has adopted an OSHA-approved state plan since OMB last approved this information collection, reducing the number of affected states from 26 to 25 (and the District of Columbia). This in turn reduced the number of respondents subject to this information collection. This change is an adjustment.
EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval pursuant to 5 CFR 1320.12. EPA will issue another
Environmental protection, Reporting and recordkeeping requirements.
Environmental Protection Agency (EPA).
Notice.
In compliance with the Paperwork Reduction Act (PRA) (44
Additional comments may be submitted on or before August 12, 2010.
Submit your comments, referencing Docket ID No. EPA–HQ–OW–2003–0064, to (1) EPA online using
Jason Bushta, Office of Water, Mail Code 4204M, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 564–3067; e-mail address:
EPA has submitted the following ICR to OMB for review and approval according to the procedures prescribed in 5 CFR 1320.12. On February 19, 2010 (75 FR 7476), EPA sought comments on this ICR pursuant to 5 CFR 1320.8(d). EPA received no comments. Any additional comments on this ICR should be submitted to EPA and OMB within 30 days of this notice.
EPA has established a public docket for this ICR under Docket ID No. EPA–HQ–OW–2003–0064, which is available for online viewing at
Use EPA's electronic docket and comment system at
This voluntary program has been updated to reflect new industry practices consistent with EPA's sustainable infrastructure initiatives and is authorized by Section 501(e) of the Clean Water Act (CWA). The Sustainable Water Leadership Program maintains elements from the previous Clean Water Act Recognition Awards Program, namely, excellence in operations and maintenance, biosolids, combined sewer overflows, pretreatment, and stormwater management, and also expands eligibility to community drinking water utilities and systems, as well as managed decentralized treatment systems (public or private). The development of the Sustainable Water Leadership Program is the latest evolution in EPA's commitment to recognize and award outstanding and innovative utility management practices.
Environmental Protection Agency (EPA).
Extension of public comment period to August 13, 2010.
EPA is announcing a second extension of the public comment period for two related draft documents: (1) “The Effects of Mountaintop Mines and Valley Fills on Aquatic Ecosystems of the Central Appalachian Coalfields” (EPA/600/R–09/138A) and (2) “A Field-based Aquatic Life Benchmark for Conductivity in Central Appalachian Streams” (EPA/600/R–10/023A). We are specifically extending the comment period to give the public additional time to evaluate the data used to derive a benchmark for conductivity. The original
Both documents will be reviewed by an independent Mountaintop Mining Advisory Panel convened by EPA's Science Advisory Board (SAB). The SAB's public meeting is scheduled for July 20–22, 2010, and was announced in the
EPA is releasing these draft documents for the purpose of pre-dissemination peer review under applicable information quality guidelines. The documents have not been formally disseminated by EPA. They do not represent and should not be construed to represent a final Agency policy or determination; however, the documents reflect EPA's best interpretation of the available science. The draft documents are available via the Internet on NCEA's home page under the Recent Additions and Publications menus at
The public comment period began on April 12, 2010 and ends on August 13, 2010. Technical comments should be in writing and must be received by EPA by August 13, 2010.
The draft reports, “The Effects of Mountaintop Mines and Valley Fills on Aquatic Ecosystems of the Central Appalachian Coalfields” and “A Field-based Aquatic Life Benchmark for Conductivity in Central Appalachian Streams” are available primarily via the Internet on the National Center for Environmental Assessment's home page under the Recent Additions and Publications menus at
Comments may be submitted electronically via
For information on submitting comments to the docket, please contact the Office of Environmental Information Docket; telephone: 202–566–1752; facsimile: 202–566–1753; or e-mail:
Environmental Protection Agency (EPA).
Notice of public meeting.
EPA will be conducting public meetings to provide an opportunity for public involvement during EPA's review of air regulations affecting the oil and natural gas industry. The review in progress covers oil and natural gas exploration and production, as well as natural gas processing, transmission, storage, and distribution. The primary purpose of these meetings is to establish a dialog among government, the affected industry, and other interested members of the public early in the rule development process, as well as to receive information that may be useful to EPA in its review. At these meetings, EPA will explain the regulatory process, provide a brief overview of its regulatory review, solicit information that may be useful to EPA in the review of these rules, and provide an opportunity for participants to ask questions and submit comments. These meetings will be open to the public.
The August 2, 2010, meetings will be held at the Arlington Municipal Building, 101 W. Abram St., Arlington, Texas 76010. The August 3, 2010, meetings will be held at the Holiday Inn Denver East-Stapleton, 3333 Quebec St., Denver, Colorado 80207.
EPA is in the process of reviewing air regulations affecting the oil and natural gas industry. This review may potentially affect any segment of the oil and natural gas industry, which includes, but is not limited to: Offshore drilling; onshore drilling; oil and natural gas production; natural gas processing; natural gas transmission; and natural gas distribution. You may be affected in some way by regulatory action following this review if you own, operate, work, or live near oil and natural gas operations in the segments listed above.
Under sections 111(b)(1)(B), 112(d)(6), and 112(f)(2) of the Clean Air Act (CAA), EPA has a mandatory duty to take actions relative to the review/revision of new source performance standards (NSPS) and national emission standards for hazardous air pollutants (NESHAP) within 8 years of the issuance of the standards. On January 14, 2009, WildEarth Guardians and San Juan Citizens Alliance brought suit against EPA in the District Court for the District of Columbia, alleging that EPA failed to meet its obligations under sections 111(b)(1)(B), 112(d)(6), and 112(f)(2) of the CAA with respect to the Oil and Natural Gas Production source category. On February 4, 2010, the Court entered a consent decree that resolves the claims in this lawsuit. The consent decree requires, among other things, that EPA sign by January 31, 2011, proposed standards and/or determinations not to issue standards pursuant to sections 111(b)(1)(B), 112(d)(6), and 112(f)(2) of the CAA, and that EPA finalize its proposals by November 30, 2011. The consent decree authorizes EPA to sign by January 31, 2011, a final determination not to review the NSPS pursuant to section 111(b)(1)(B) of the CAA without issuing a proposal for such determination.
EPA is in the process of taking actions under CAA sections 111 and 112 relative to the review/revision of the following NSPS and NESHAP: The NSPS for Equipment Leaks of VOC from Onshore Natural Gas Processing Plants (40 CFR part 60, subpart KKK); the NSPS for Onshore Natural Gas Processing: SO
Environmental Protection Agency (EPA).
Notice.
On March 22, 2010, Administrator Lisa P. Jackson announced the Drinking Water Strategy, a new vision to expand public health protection for drinking water by going beyond the traditional framework. The Drinking Water Strategy includes the following four principles: Addressing some contaminants as group(s) rather than one at a time so that enhancement of drinking water protection can be achieved cost-effectively; fostering development of new drinking water technologies to address health risks posed by a broad array of contaminants; using the authority of multiple statutes to help protect drinking water; and
The Web dialogue is a two-day event. It will open at 9 a.m., Eastern Daylight Time (6 a.m., Pacific Daylight Time) on Wednesday, July 28, 2010, and will close at 6 p.m., Eastern Daylight Time on Thursday, July 29, 2010.
This meeting will take place on the Internet at
For technical inquiries, contact Shari Bauman, Standards and Risk Management Division, Office of Ground Water and Drinking Water (MC 4607M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460 at (202) 564–0293, or
The meeting is open to the public. During the Web dialogue, EPA plans to solicit input on the potential approaches associated with addressing contaminants as group(s). The proposed discussion topics are:
• Addressing Drinking Water Contaminants as Groups.
• Fitting Groups Within the Safe Drinking Water Act.
• Defining Groups.
• Group Technical Approaches.
• Group Implementation Approaches.
Individuals interested in engaging in the Web dialogue information exchange must register at
The Web dialogue is an opportunity for all registered participants to exchange information and share ideas that they would like for EPA to consider when developing a framework to address contaminants as group(s).
For more information about the Drinking Water Strategy, visit
The Federal Communications Commission, as part of its continuing effort to reduce paperwork burden invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s), as required by the Paperwork Reduction Act (PRA) of 1995, 44 U.S.C. 3501 – 3520. Comments are requested concerning: (a) whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimate; (c) ways to enhance the quality, utility, and clarity of the information collected; (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology, and (e) ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a currently valid OMB control number.
Written Paperwork Reduction Act (PRA) comments should be submitted on or before September 13, 2010. If you anticipate that you will be submitting PRA comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the FCC contact listed below as soon as possible.
Direct all PRA comments to Nicholas A. Fraser, Office of Management and Budget, via fax at 202–395–5167 or via email to Nicholas_A._Fraser@omb.eop.gov and to the Federal Communications Commission via email to PRA@fcc.gov and Cathy.Williams@fcc.gov.
Cathy Williams on (202) 418–2918.
OMB Control Number: 3060–0466.
Title: Station Identification, Sections 73.1201, 74.783 and 74.1283.
Form Number: N/A.
Type of Review: Extension of a currently approved collection.
Respondents: Business or other for–profit entities; Not–for–profit institutions; State, Local and Tribal Government.
Number of Respondents and Responses: 4,200 respondents; 4,200 responses
Estimated Time per Response: 10 minutes to 1 hour.
Frequency of Response: Recordkeeping requirement; Third party disclosure requirement; On occasion reporting requirement.
Obligation to Respond: Required to obtain benefits – Statutory authority for this collection of information is contained in Sections 154(i), 303 and 308 of the Communications Act of 1934, as amended.
Total Annual Burden: 6,566 hours
Total Annual Costs: None.
Nature and Extent of Confidentiality: No need for confidentiality required with this collection of information.
Privacy Impact Assessment(s): No impact(s).
Needs and Uses: The information collection requirements covered under OMB control number 3060–0466 are as follows:
47 CFR Section 73.1201(a) requires television broadcast licensees to make broadcast station identification announcements at the beginning and ending of each time of operation, and hourly, as close to the hour as feasible, at a natural break in program offerings. Television and Class A television broadcast stations may make these announcements visually or aurally.
47 CFR Section 74.783(b) requires licensees of television translators whose station identification is made by the television station whose signals are being rebroadcast by the translator, must secure agreement with this television station licensee to keep in its file, and available to FCC personnel, the translator's call letters and location, giving the name, address and telephone number of the licensee or his service representative to be contacted in the event of malfunction of the translator. It shall be the responsibility of the translator licensee to furnish current information to the television station licensee for this purpose.
47 CFR Section 73.1201(b)(1) requires that the official station identification consist of the station's call letters immediately followed by the community or communities specified in its license as the station's location. The name of the licensee, the station's frequency, the station's channel number, as stated on the station's license, and/or the station's network affiliation may be inserted between the call letters and station location. Digital Television (DTV) stations, or DAB Stations, choosing to include the station's channel number in the station identification must use the station's major channel number and may distinguish multicast program streams. For example, a DTV station with major channel number 26 may use 26.1 to identify a High Definition Television (HDTV) program service and 26.2 to identify a Standard Definition Television (SDTV) program service. A radio station operating in DAB hybrid mode or extended hybrid mode shall identify its digital signal, including any free multicast audio programming streams, in a manner that appropriately alerts its audience to the fact that it is listening to a digital audio broadcast. No other insertion between the station's call letters and the community or communities specified in its license is permissible. A station may include in its official station identification the name of any additional community or communities, but the community to which the station is licensed must be named first.
47 CFR Section 74.783(e) permits low power TV permittees or licensees to request to be assigned four–letter call signs in lieu of the five–character alpha–numeric call signs.
47 CFR Section 74.1283(c)(1) requires a FM translator station licensee whose identification is made by the primary station must arrange for the primary station licensee to furnish the translator's call letters and location (name, address, and telephone number of the licensee or service representative) to the FCC. The licensee must keep this information in the primary station's files.
The Federal Communications Commission, as part of its continuing effort to reduce paperwork burden invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s), as required by the Paperwork Reduction Act (PRA) of 1995, 44 U.S.C. 3501 – 3520. Comments are requested concerning: (a) whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimate; (c) ways to enhance the quality, utility, and clarity of the information collected; (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology, and (e) ways to further reduce the information collection burden for small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a currently valid OMB control number.
Written Paperwork Reduction Act (PRA) comments should be submitted on or before September 13, 2010. If you anticipate that you will be submitting PRA comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the FCC contact listed below as soon as possible.
Direct all PRA comments to Nicholas A. Fraser, Office of Management and Budget, via fax at 202–395–5167 or via email to Nicholas_A._Fraser@omb.eop.gov and to the Federal Communications Commission via email to PRA@fcc.gov and Cathy.Williams@fcc.gov.
Cathy Williams on (202) 418–2918
OMB Control Number: 3060–0668.
Title: Section 76.936, Written Decisions.
Form Number: N/A.
Type of Review: Extension of a currently approved collection.
Respondents: State or Local, or Tribal government.
Number of Respondents and Responses: 600 respondents and 600 responses.
Estimated Hours per Response: 1 hour.
Frequency of Response: Third party disclosure requirement; On occasion reporting requirement.
Total Annual Burden: 600 hours.
Total Annual Costs: None.
Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection is contained in Section 4(i) of the Communications Act of 1934, as amended.
Nature and Extent of Confidentiality: Confidentiality is not required with this collection of information.
Privacy Impact Assessment: No impact(s).
Needs and Uses: 47 CFR 76.936 states that a franchising authority must issue a written decision in a rate–making proceeding whenever it disapproves an initial rate for the basic service tier or associated equipment in whole or in part, disapproves a request for a rate increase in whole or in part, or approves a request for an increase whole or in part over the objection of interested parties. Franchising authorities are required to issue a written decision in rate–making proceedings pursuant to Section 76.936 so that cable operators and the public are made aware of the proceeding.
The Federal Communications Commission, as part of its continuing effort to reduce paperwork burden invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s), as
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a currently valid OMB control number.
Written Paperwork Reduction Act (PRA) comments should be submitted on or before [September 13, 2010]. If you anticipate that you will be submitting PRA comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the FCC contact listed below as soon as possible.
Direct all PRA comments to Nicholas A. Fraser, Office of Management and Budget, via fax at 202–395–5167 or via email to Nicholas_A._Fraser@omb.eop.gov and to Cathy Williams, Federal Communications Commission via email to PRA@fcc.gov and to Cathy.Williams@fcc.gov.
Cathy Williams on (202) 418–2918.
OMB Control Number: 3060–xxxx.
Title: Structure and Practices of the Video Relay Service Program, CG Docket No. 10–51.
Form Number: N/A.
Type of Review: New Collection.
Respondents: Business or other for–profit entities.
Number of Respondents and Responses: 10 respondents; 130 responses.
Estimated Time per Response: .017 hours (1 minute average per response).
Frequency of Response: Annual and monthly reporting requirements.
Obligation to Respond: Required to obtain or retain benefits. The statutory authority for the information collection requirements is found at Sections 1, 4, 225, and 303(r) of the Communications Act of 1934, as amended (Act), 47 U.S.C. 151, 154, 225, and 303(r).
Total Annual Burden: 2.17 hours.
Total Annual Cost: None.
Nature and Extent of Confidentiality: An assurance of confidentiality is not offered because this information collection does not require the collection of personally identifiable information (PII) from individuals.
Privacy Impact Assessment: No impact(s).
Needs and Uses: In document FCC 10–88, the Commission finds good cause to adopt an interim rule requiring the Chief Executive Officer, Chief Financial Officer, or other senior executive of a Telecommunications Relay Service (TRS) provider submitting minutes to the Interstate TRS Fund (Fund) administrator for compensation on a monthly basis to certify, under penalty of perjury, that the submitted minutes were handled in compliance with Section 225 of the Act and the Commission's rules and orders. Also in this document, the Commission requires such an executive to certify, under penalty of perjury, that cost and demand data submitted to the Fund administrator on an annual basis related to the determination of compensation rates or methodologies are true and correct. The explosive growth in the Fund in recent years and evidence of fraud against the Fund, as evidenced by recent indictments and guilty pleas from call center managers and employees admitting to defrauding the Fund of tens of millions of dollars, require the Commission to take immediate steps in preserving the Fund to ensure the continued availability of TRS. By requiring providers to be more accountable for their submissions, the Commission takes necessary, affirmative steps to preserve the TRS Fund.
The Federal Communications Commission, as part of its continuing effort to reduce paperwork burden invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s), as required by the Paperwork Reduction Act (PRA) of 1995, 44 U.S.C. 3501 – 3520. Comments are requested concerning: (a) whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimate; (c) ways to enhance the quality, utility, and clarity of the information collected; (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology, and (e) ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a currently valid OMB control number.
Written Paperwork Reduction Act (PRA) comments should be submitted on or before September 13, 2010. If you anticipate that you will be submitting PRA comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the FCC contact listed below as soon as possible.
Direct all PRA comments to Nicholas A. Fraser, Office of Management and Budget, via fax at 202–395–5167 or via the Internet at Nicholas_A._Fraser@omb.eop.gov and to the Federal Communications Commission via email to PRA@fcc.gov.
Judith B. Herman, Office of Managing Director, (202) 418–0214. For additional information, contact Judith B. Herman, OMD, 202–418–0214 or email judith–b.herman@fcc.gov.
OMB Control Number: 3060–0975.
Title: Sections 68.3 and 1.4000, Promotion of Competitive Networks in Local Telecommunications Markets Multiple Tenant Environments (MTEs).
Form No.: N/A.
Type of Review: Extension of a currently approved collection.
Respondents: Business or other for–profit, not–for–profit institutions, federal government, state, local or tribal government.
Number of Respondents and Responses: 5,874 respondents, 5,874 responses.
Estimated Time Per Response: .5 – 10 hours.
Frequency of Response: On occasion reporting requirement and third party disclosure requirement.
Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. section 151.
Total Annual Burden: 194,284 hours.
Total Annual Cost: N/A.
Privacy Act Impact Assessment: N/A.
Nature and Extent of Confidentiality: There is no need for confidentiality.
Needs and Uses: The Commission will submit this expiring information collection to the Office of Management and Budget (OMB) after this comment period to obtain the full three year clearance from them. There is no change to the reporting and/or third party disclosure requirements. There is a 21,598 hour reduction. The Commission anticipated that this burden would decrease over time because the request for location information would have already been made at most buildings. Therefore, the number of respondents is decreasing as well as the total annual burden hours.
In a October 2001 Order, FCC 00–366, the Commission did the following: 1) prohibited carriers from entering into contracts that restrict or effectively restrict a property owner's ability to permit entry by competing carriers; 3) established procedures to facilitate moving the demarcation point to the minimum point of entry (“MPOE”) at the building owner's request, and requires incumbent local exchange carriers (LECs) to timely disclose the location of existing demarcation points where they are not located at the MPOE; 3) determined that, under Section 224 of the Communications Act of 1934, as amended, utilities, including LECs, must afford telecommunications carriers and cable service providers reasonable and non–discriminatory access to conduits and rights–of–way located in customer buildings and campuses, to the extent such conduits and rights–of–way are owned or controlled by the utility; and 4) extended to antennas that receive and transmit telecommunications and other fixed wireless signals the existing prohibition of restrictions that impair the installation, maintenance or use of certain video antennas on property within the exclusive use or control of the antenna user, where the user has a direct or indirect ownership or leasehold interest in the property.
a. The demarcation point burden consists of two components: 1) the LEC shall make available information on the location of the demarcation point within ten business days of a request from the premises owner (location information); and 2) at the time of installation, the LEC shall fully inform the premises owner of its options and rights regarding the placement of the demarcation point or points (options information).
b. The Over–the–Air Reception Devices (OTARD) portion of this information collection relates to the revision of the Commissions rules under 1.4000. Under those revisions, as a condition of invoking protection under 47 CFR 1.400 from government, landlord, and association restrictions, a licensee must ensure that subscriber antennas are labeled to give notice of potential radio frequency safety hazards of these antennas. Labeling information (third party disclosure requirement) should include minimum separation distances required between users and radiating antennas to meet the Commission's radio frequency exposure guidelines. Labels should also include reference to the Commission's applicable radio frequency exposure guidelines and should use the ANSI–specified warning symbol for radio frequency exposure. In addition, the instruction manuals and other information accompanying subscriber transceivers should include a full explanation of the labels, as well as a reference to the applicable Commission radio frequency exposure guidelines.
The Federal Communications Commission, as part of its continuing effort to reduce paperwork burden invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s), as required by the Paperwork Reduction Act (PRA) of 1995, 44 U.S.C. 3501 – 3520. Comments are requested concerning: (a) whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimate; (c) ways to enhance the quality, utility, and clarity of the information collected; (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and (e) ways to further reduce the information collection burden for small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a currently valid OMB control number.
Written Paperwork Reduction Act (PRA) comments should be submitted on or before August 12, 2010. If you anticipate that you will be submitting PRA comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the FCC contact listed below as soon as possible.
Direct all PRA comments to Nicholas A. Fraser, Office of Management and Budget, via fax at 202–395–5167 or via the Internet at Nicholas_A._Fraser@omb.eop.gov and to the Federal Communications Commission via email to PRA@fcc.gov. To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the web page http://reginfo.gov/public/do/PRAMain, (2) look for the section of the web page called “Currently Under Review”, (3)
Judith B. Herman, Office of Managing Director, (202) 418–0214. For additional information or copies of the information collection(s), contact Judith B. Herman, OMD, 202–418–0214 or email judith–b.herman@fcc.gov.
OMB Control Number: 3060–1135.
Title: Revisions to Rules Authorizing the Operation of Low Power Auxiliary Stations (Including Wireless Microphones).
Form Number: N/A.
Type of Review: Revision of a currently approved collection.
Respondents: Business or other for–profit, not–for–profit institutions and state, local or tribal government.
Number of Respondents and Responses: 5,100 responses; 127,500 responses.
Estimated Time per Response: .25 hours (15 minutes).
Frequency of Response: Third party disclosure requirements (disclosure and labeling requirements).
Obligation to Respond: Mandatory. Statutory authority for this information collection is contained in 47 U.S.C. sections 151, 152, 154(i),154(j), 301, 302(a), 303, 304, 307, 308, 309, 316, 332, 336 and 337.
Total Annual Burden: 31,875 hours.
Total Annual Cost: $1,625,000.
Privacy Act Impact Assessment: N/A.
Nature and Extent of Confidentiality: There is no need for confidentiality since these are third party disclosure and labeling requirements.
Needs and Uses: The Commission will submit this expiring information collection during this comment period to obtain the full three year clearance from the Office of Management and Budget (OMB). The Commission is reporting a revision which is due to elimination of the early clearing requirement burden as it will be unnecessary after June 12, 2010 while keeping the disclosure and labeling requirements that would allow the Commission to clear the 700 MHz band of wireless microphones and provide them a home in the core TV spectrum, where many wireless microphones are already operating. Therefore, the Commission is reporting a 1,049 hour program change reduction in burden.
The point–of–sale disclosure requirement is necessary for a successful transition of wireless microphones out of the 700 MHz band. The Commission anticipates that many wireless microphone users currently operating in the 700 MHz band will have to purchase or lease new equipment capable of operating in the core TV spectrum. The point–of–sale disclosure requirement will help these consumers make an educated decision as they obtain new microphones, and it will help them operate in the core TV spectrum without causing harmful interference to other services in the spectrum. Further, a label on 700 MHz band wireless microphones bound for export will help to ensure that these wireless microphones do not continue to be made available for use in the United States, in contravention of our efforts to remove them from the 700 MHz band.
Federal Communications Commission.
Notice.
The Federal Communications Commission (the “Commission”) debars Mr. Rowner from the schools and libraries universal service support mechanism for a period of three years.
Debarment commences on the date Mr. Benjamin Rowner receives the debarment letter or July 13, 2010, whichever date come first, for a period of three years.
Mindy Littell, Federal Communications Commission, Enforcement Bureau, Investigations and Hearings Division, Room 4–A331, 445 12th Street, SW., Washington, DC 20554. Mindy Littell may be contacted by phone at (202) 418–0789 or e-mail at
The Commission debarred Mr. Rowner from the schools and libraries universal service support mechanism for a period of three years pursuant to 47 CFR 521 and 47 CFR 0.111(a)(14). Attached is the debarment letter, DA 10–1112, which was mailed to Mr. Rowner and released on June 23, 2010. The complete text of the notice of debarment is available for public inspection and copying center during regular business hours at the FCC Reference Information Center, Portal II, 445 12th Street, SW., Room CY–A257, Washington, DC 20554, In addition, the complete text is available on the FCC's Web site at
The debarment letter follows:
Pursuant to section 54.8 of the rules of the Federal Communications Commission (the “Commission”), by this Notice of Debarment you are debarred from the schools and libraries universal service support mechanism (or “E-Rate program”) for a period of three years.
On April 7, 2010, the Enforcement Bureau (the “Bureau”) sent you a Notice of Suspension and Initiation of Debarment Proceedings (the “Notice of
Pursuant to the Commission's rules, any opposition to your suspension or its scope or to your proposed debarment or its scope had to be filed with the Commission no later than thirty (30) calendar days from the earlier date of your receipt of the Notice of Suspension or publication of the Notice of Suspension in the
As discussed in the Notice of Suspension, you pleaded guilty to and were sentenced to serve twenty-seven months in federal prison, to be followed by twenty-four months of supervised release for federal crimes in connection with your participation in a scheme to defraud the E-Rate program.
Debarment excludes you, for the debarment period, from activities associated with or related to the schools and libraries support mechanism, including the receipt of funds or discounted services through the schools and libraries support mechanism, or consulting with, assisting, or advising applicants or service providers regarding the schools and libraries support mechanism.
The Federal Communications Commission (“FCC” or “Commission”) has received notice of your guilty plea for conspiracy to defraud the United States in violation of 18 U.S.C. 371 in connection with your participation in the schools and libraries universal service support mechanism (“E-Rate program”).
The Commission has established procedures to prevent persons who have “defrauded the government or engaged in similar acts through activities associated with or related to the schools and libraries support mechanism” from receiving the benefits associated with that program.
On February 4, 2010, you were sentenced to serve twenty-seven months in prison, to be followed by twenty-four months of supervised release for your role in the scheme to defraud the E-Rate program.
Pursuant to section 54.8 of the Commission's rules, your conviction requires the Bureau to suspend you from participating in any activities associated with or related to the schools and libraries support mechanism.
Your suspension becomes effective upon the earlier of your receipt of this letter or publication of notice in the
Your guilty plea and conviction of criminal conduct in connection with the E-Rate program, in addition to serving as a basis for immediate suspension from the program, also serves as a basis for the initiation of debarment proceedings against you. Your conviction falls within the categories of causes for debarment defined in section 54.8(c) of the Commission's rules.
As with your suspension, you may contest debarment or the scope of the proposed debarment by filing arguments and any relevant documentation within 30 calendar days of the earlier of the receipt of this letter or of publication in the
If and when your debarment becomes effective, you will be prohibited from participating in activities associated with or related to the schools and libraries support mechanism for three years from the date of debarment.
Please direct any response, if by messenger or hand delivery, to Marlene H. Dortch, Secretary, Federal Communications Commission, 445 12th Street, S.W., Room TW–A325, Washington, DC 20554, to the attention of Rebekah Bina, Attorney Advisor, Investigations and Hearings Division, Enforcement Bureau, Room 4–C330, with a copy to Michele Levy Berlove, Acting Assistant Chief, Investigations and Hearings Division, Enforcement Bureau, Room 4–C330, Federal Communications Commission. If sent by commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail), the response should be sent to the Federal Communications Commission, 9300 East Hampton Drive, Capitol Heights, Maryland 20743. If sent by first-class, Express, or Priority mail, the response should be sent to Rebekah Bina, Attorney Advisor, Investigations and Hearings Division, Enforcement Bureau, Federal Communications Commission, 445 12th Street, S.W., Room 4–C330, Washington, DC 20554, with a copy to Michele Levy Berlove, Acting Assistant Chief, Investigations and Hearings Division, Enforcement Bureau, Federal Communications Commission, 445 12th Street, S.W., Room 4–C330, Washington, DC, 20554. You shall also transmit a copy of the response via e-mail to
If you have any questions, please contact Ms. Bina via mail, by telephone at (202) 418–7931 or by e-mail at
Federal Communications Commission.
Notice.
The Federal Communications Commission (the “Commission”) debars Mr. Soled from the schools and libraries universal service support mechanism for a period of three years.
Debarment commences on the date Mr. Jay H. Soled receives the debarment letter or July 13, 2010, whichever date comes first, for a period of three years.
Mindy Littell, Federal Communications Commission, Enforcement Bureau, Investigations and Hearings Division, Room 4–A331, 445 12th Street, SW., Washington, DC 20554. Mindy Littell may be contacted by phone at (202) 418–0789 or e-mail at
The Commission debarred Mr. Soled from the schools and libraries universal service support mechanism for a period of three years pursuant to 47 CFR 521 and 47 CFR 0.111(a)(14). Attached is the debarment letter, DA 10–1113, which was mailed to Mr. Soled and released on June 23, 2010. The complete text of the notice of debarment is available for public inspection and copying during regular business hours at the FCC Reference Information Center, Portal II, 445 12th Street, SW., Room CY–A257, Washington, DC 20554. In addition, the complete text is available on the FCC's Web site at
The debarment letter follows:
Pursuant to section 54.8 of the rules of the Federal Communications Commission (the “Commission”), by this Notice of Debarment you are debarred from the schools and libraries universal service support mechanism (or “E-Rate program”) for a period of three years.
On April 7, 2010, the Enforcement Bureau (the “Bureau”) sent you a Notice of Suspension and Initiation of Debarment Proceedings (the “Notice of Suspension”).
Pursuant to the Commission's rules, any opposition to your suspension or its scope or to your proposed debarment or its scope had to be filed with the Commission no later than thirty (30) calendar days from the earlier date of your receipt of the Notice of Suspension or publication of the Notice of Suspension in the
As discussed in the Notice of Suspension, you pleaded guilty to and were sentenced to serve twenty-seven months in federal prison, to be followed by twenty-four months of supervised release for federal crimes in connection with your participation in a scheme to defraud the E-Rate program.
Debarment excludes you, for the debarment period, from activities associated with or related to the schools and libraries support mechanism, including the receipt of funds or discounted services through the schools and libraries support mechanism, or consulting with, assisting, or advising
The Federal Communications Commission (“FCC” or “Commission”) has received notice of your guilty plea for conspiracy to defraud the United States in violation of 18 U.S.C. 371 in connection with your participation in the schools and libraries universal service support mechanism (“E-Rate program”).
The Commission has established procedures to prevent persons who have “defrauded the government or engaged in similar acts through activities associated with or related to the schools and libraries support mechanism” from receiving the benefits associated with that program.
On February 4, 2010, you were sentenced to serve twenty-seven months in prison, to be followed by twenty-four months of supervised release for your role in the scheme to defraud the E-Rate program.
Pursuant to section 54.8 of the Commission's rules, your conviction requires the Bureau to suspend you from participating in any activities associated with or related to the schools and libraries support mechanism.
Your suspension becomes effective upon the earlier of your receipt of this letter or publication of notice in the
Your guilty plea and conviction of criminal conduct in connection with the E-Rate program, in addition to serving as a basis for immediate suspension from the program, also serves as a basis for the initiation of debarment proceedings against you. Your conviction falls within the categories of causes for debarment defined in section 54.8(c) of the Commission's rules.
As with your suspension, you may contest debarment or the scope of the proposed debarment by filing arguments and any relevant documentation within 30 calendar days of the earlier of the receipt of this letter or of publication in the
If and when your debarment becomes effective, you will be prohibited from participating in activities associated with or related to the schools and libraries support mechanism for three years from the date of debarment.
Please direct any response, if by messenger or hand delivery, to Marlene H. Dortch, Secretary, Federal Communications Commission, 445 12th Street, SW., Room TW–A325, Washington, DC 20554, to the attention of Rebekah Bina, Attorney Advisor, Investigations and Hearings Division, Enforcement Bureau, Room 4–C330, with a copy to Michele Levy Berlove, Acting Assistant Chief, Investigations and Hearings Division, Enforcement Bureau, Room 4–C330, Federal Communications Commission. If sent by commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail), the response should be sent to the Federal Communications Commission, 9300 East Hampton Drive, Capitol Heights, Maryland 20743. If sent by first-class, Express, or Priority mail, the response should be sent to Rebekah Bina, Attorney Advisor, Investigations and Hearings Division, Enforcement Bureau, Federal Communications Commission, 445 12th Street, SW., Room 4–C330, Washington, DC 20554, with a copy to Michele Levy Berlove, Acting Assistant Chief, Investigations and Hearings Division, Enforcement Bureau, Federal Communications Commission, 445 12th Street, SW., Room 4–C330, Washington, DC 20554. You shall also transmit a copy of the response via e-mail
If you have any questions, please contact Ms. Bina via mail, by telephone at (202) 418–7931 or by e-mail at
Petition for Reconsideration has been filed in the Commission's Rulemaking Proceeding listed in this Public Notice and published pursuant to 47 CFR 1.429(e). The full text of this document is available on-line at
Subject: In the Matter of Amendment of Section 73.622(i), Final DTV Table of Allotments, Television Broadcast Stations (Seaford, Delaware) (MB Docket No. 09–230).
Number of Petitions Filed: 1.
Federal Communications Commission.
Notice.
In this document, the Commission reiterates that Interstate Telecommunications Relay Service (TRS) Fund (Fund) payments may be suspended to providers that do not submit to audits. The Commission is authorized to do so pursuant to its rules intended to protect the integrity of the Fund and to deter and detect waste, fraud, and abuse. The Commission and the Fund administrator have conducted some audits, but not all providers have submitted to the auditing process.
Effective July 13, 2010.
Gregory Hlibok, Consumer and Governmental Affairs Bureau at (202)
This is a summary of the Commission's
The full text of document FCC 10–88 and copies of any subsequently filed documents in this matter will be available for public inspection and copying during regular business hours at the FCC Reference Information Center, Portals II, 445 12th Street, SW., Room CY–A257, Washington, DC 20554. Document FCC 10–88 and copies of subsequently filed documents in this matter may also be purchased from the Commission's duplicating contractor at Portals II, 445 12th Street, SW., Room CY–B402, Washington, DC 20554. Customers may contact the Commission's duplicating contractor at its Web site
The TRS mandatory minimum standards expressly provide that the “Commission shall have the authority to audit providers and have access to all data, including carrier specific data, collected by the Fund administrator.” The Commission's rules also state that the “[F]und administrator shall have authority to audit TRS providers reporting data to the administrator.” Further, the rules state that “the administrator shall establish procedures to verify payment claims, and may suspend or delay payments to a TRS provider if the TRS provider fails to provide adequate verification of payment upon reasonable request, or if directed by the Commission to do so.” Finally, the rules state that the “Fund administrator shall make payments only to eligible TRS providers operating pursuant to the mandatory minimum standards as required in § 64.604 [of the Commission's rules].” These rules are intended to protect the integrity of the Fund and to deter and detect waste, fraud, and abuse.
The Commission and the TRS Fund administrator have conducted some audits, but not all providers have submitted to the auditing process. Therefore, the Commission reminds providers that the above-cited rules, which provide for the suspension or delay of payments to TRS providers who do not provide verification of payment upon reasonable request, authorize the Commission to withhold payment from providers who do not submit to audits, whether requested by the Commission or the Fund administrator.
The Commission will send a copy of document FCC 10–88 in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act,
Pursuant to sections 1, 4(i) and (o), 225, 303(r), 403, 624(g), and 706 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154(i) and (o), 225, 303(r), 403, 554(g), and 606, document FCC 10–88 is adopted.
The Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, shall send a copy of document FCC 10–88 to the Chief Counsel for Advocacy of the Small Business Administration.
The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board’s Regulation Y (12 CFR 225.41) to acquire a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the office of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than July 28, 2010.
Board of Governors of the Federal Reserve System, July 8, 2010.
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Additional information on all bank holding companies may be obtained from the National Information Center website at
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than August 6, 2010.
Board of Governors of the Federal Reserve System, July 8, 2010.
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed project or to obtain a copy of data collection plans and instruments, call the CDC Reports Clearance Officer on 404–639–5960 or send comments to CDC Assistant Reports Clearance Officer, 1600 Clifton Road, MS D–74, Atlanta, GA 30333 or send an e-mail to
National Ambulatory Medical Care Survey (NAMCS), (OMB No. 0920–0234 exp. 7/31/2012)—Revision—National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC).
Section 306 of the Public Health Service (PHS) Act (42 U.S.C. 242k), as amended, authorizes that the Secretary of Health and Human Services (DHHS), acting through NCHS, shall collect statistics on the utilization of health care provided by nonfederal office-based physicians in the United States.
On February 26, 2010, the Office of Management and Budget (OMB) approved data collection for three years. This revision is to notify the public that the President's fiscal year 2011 budget requests that Congress consider a budget increase for this survey for 2011. If the budget increase is approved by Congress, expanded data collection will begin in the first calendar quarter of 2011 or as soon thereafter as is possible. An increased sample size of approximately 6,800 physicians and 60,000 visit records (a doubling from 3,400 physicians and 30,000 visit records sampled in 2010) is requested. Currently the NAMCS produces national and regional estimates. If the full budget increase is approved by Congress, the survey will be able to produce the same estimates as it does currently as well as data on a limited number of states when data are combined across two years. This increase will greatly improve the ability to track providers' practice patterns, including their adoption and meaningful use of health information technology (HIT).
Congress may approve all, some or none of the budget increase requested in the President's budget. If approved, this notice would allow the proposed request for a sample increase to move forward to OMB for final review in sufficient time to implement the sample increase in the first quarter of 2011. This notice also covers increases in sample size that might result due to other budget allocations.
NAMCS was conducted annually from 1973 to 1981, again in 1985, and resumed as an annual survey in 1989. The purpose of NAMCS, a voluntary survey, is to meet the needs and demands for statistical information about the provision of ambulatory medical care services in the United States. Ambulatory services are rendered in a wide variety of settings, including physicians' offices and hospital outpatient and emergency departments. The NAMCS target universe consists of all office visits made by ambulatory patients to non-Federal office-based physicians (excluding those in the specialties of anesthesiology, radiology, and pathology) who are engaged in direct patient care. In 2006, physicians and mid-level providers (
There is no cost to the respondents other than their time.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the
Submit either electronic or written comments on the collection of information by September 13, 2010.
Submit electronic comments on the collection of information to
Denver Presley Jr., Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, 301–796–3793.
Under the PRA (44 U.S.C. 3501–3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
Resistance of parasites to one or more of the major classes of FDA approved antiparasitic drugs is a documented problem in cattle, horses, sheep, and goats in the United States. Further, FDA is aware that there are differing scientific opinions on the impact of the use of multiple antiparasitic drugs at the same time on the development of resistance to these drugs. The results from this survey will assist FDA in regulating antiparasitic drugs. FDA will also share their results with the veterinary parasitology community.
FDA plans to survey scientists and veterinarians with expertise in veterinary parasitology using a web-based tool. The questions in the survey are designed to elicit expert opinions and clarify areas of agreement and disagreement within the veterinary parasitology community. The survey will query subjects on topics such as: (1) Concurrent use of multiple antiparasitic drug products, (2) recommended tests to detect and monitor for antiparasitic resistance, (3) characteristics of combination antiparasitic drug products that may either slow or enhance the selection for multi-drug resistant parasites, and (4) regulatory considerations regarding combination antiparasitic drugs.
FDA estimates the burden of this collection of information as follows:
FDA will conduct a pre-test of the survey with five respondents, and it is estimated that it will take a respondent 20 minutes (0.33 hours) to complete the pre-test, for a total of 1.65 hours. One hundred respondents will complete the survey. It is estimated that it will take a respondent 20 minutes (0.33 hours) to complete the survey, for a total of 33 hours. Thus, the total estimated annual reporting burden is 34.65 hours. FDA's burden estimate is based on prior experience with consumer surveys that are similar.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the
Submit either electronic or written comments on the collection of information by September 13, 2010.
Submit electronic comments on the collection of information to
Elizabeth Berbakos, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, 301–796–3792, e-mail:
Under the PRA (44 U.S.C. 3501–3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
The “Guidance for Industry on Special Protocol Assessment” describes agency procedures to evaluate issues related to the adequacy (e.g., design, conduct, analysis) of certain proposed studies. The guidance describes procedures for sponsors to request special protocol assessment and for the agency to act on such requests. The guidance provides information on how the agency interprets and applies provisions of the Food and Drug Administration Modernization Act of 1997 and the specific Prescription Drug User Fee Act of 1992 (PDUFA) goals for special protocol assessment associated with the development and review of PDUFA products. The guidance describes two collections of information: (1) The submission of a notice of intent to request special protocol assessment of a carcinogenicity protocol, and (2) the submission of a request for special protocol assessment.
As described in the guidance, a sponsor interested in agency assessment of a carcinogenicity protocol should notify the appropriate division in FDA's Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER) of an intent to request special protocol assessment at least 30 days prior to submitting the request. With such notification, the sponsor should submit relevant background information so that the agency may review reference material related to carcinogenicity protocol design prior to receiving the carcinogenicity protocol.
The guidance asks that a request for special protocol assessment be submitted as an amendment to the investigational new drug application (IND) for the underlying product and that it be submitted to the agency in triplicate with Form FDA 1571 attached. The guidance also suggests that the sponsor submit the cover letter to a request for special protocol assessment via facsimile to the appropriate division in CDER or CBER. Agency regulations (21 CFR 312.23(d)) state that information provided to the agency as part of an IND is to be submitted in triplicate and with the appropriate cover form, Form FDA 1571. An IND is submitted to FDA under existing regulations in part 312 (21 CFR part 312), which specifies the information that manufacturers must submit so that FDA may properly evaluate the safety and effectiveness of investigational drugs and biological products. The information collection requirements resulting from the preparation and submission of an IND under part 312 have been estimated by FDA and the reporting and recordkeeping burden has been approved by OMB under OMB Control Number 0910–0014.
FDA suggests that the cover letter to the request for special protocol assessment be submitted via facsimile to the appropriate division in CDER or CBER to enable agency staff to prepare for the arrival of the protocol for
The guidance recommends that the following information should be submitted to the appropriate Center with each request for special protocol assessment so that the Center may quickly and efficiently respond to the request:
• Questions to the agency concerning specific issues regarding the protocol; and
• All data, assumptions, and information needed to permit an adequate evaluation of the protocol, including: (1) The role of the study in the overall development of the drug; (2) information supporting the proposed trial, including power calculations, the choice of study endpoints, and other critical design features; (3) regulatory outcomes that could be supported by the results of the study; (4) final labeling that could be supported by the results of the study; and (5) for a stability protocol, product characterization and relevant manufacturing data.
Based on data collected within CDER and CBER, including the number of notifications for carcinogenicity protocols and the number of carcinogenicity protocols submitted in fiscal year (FY) 2007, 2008, and 2009, CDER estimates that it will receive approximately 60 notifications of an intent to request special protocol assessment of a carcinogenicity protocol per year from approximately 28 sponsors. CBER estimates that it will receive approximately one notification of an intent to request special protocol assessment of a carcinogenicity protocol per year from approximately one sponsor. The hours per response, which is the estimated number of hours that a sponsor would spend preparing the notification and background information to be submitted in accordance with the guidance, is estimated to be approximately 8 hours.
Based on data collected within CDER and CBER, including the number of requests for special protocol assessment submitted in FY 2007, 2008, and 2009, CDER estimates that it will receive approximately 372 requests for special protocol assessment per year from approximately 216 sponsors. CBER estimates that it will receive approximately 10 requests from approximately 10 sponsors. The hours per response is the estimated number of hours that a respondent would spend preparing the information to be submitted with a request for special protocol assessment, including the time it takes to gather and copy questions to be posed to the agency regarding the protocol and data, assumptions, and information needed to permit an adequate evaluation of the protocol. Based on the agency's experience with these submissions, FDA estimates approximately 15 hours on average would be needed per response.
FDA estimates the burden of this collection of information as follows:
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Michael Montello, Pharm. D., CTEP, 6130 Executive Blvd., Rockville, MD 20852. At non-toll-free number 301–435–9206 or e-mail your request, including your address to:
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the
Submit either electronic or written comments on the collection of information by September 13, 2010.
Submit electronic comments on the collection of information to
Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, 301–796–5156,
Under the PRA (44 U.S.C. 3501–3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
FDA is authorized by section 1003(d)(2)(D) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 393(d)(2)(D)) to conduct educational and public information programs relating to the safety of regulated medical devices and radiation-emitting products. FDA must conduct needed research to ensure that such programs have the highest likelihood of being effective. Improving communications about medical devices and radiation-emitting products will involve many research methods, including individual indepth interviews, mall-intercept interviews, focus groups, self-administered surveys, gatekeeper reviews, and omnibus telephone surveys.
The information collected will serve three major purposes. First, as formative research it will provide critical knowledge needed about target audiences to develop messages and campaigns about medical device and radiation-emitting product use. Knowledge of consumer and health care professional decisionmaking processes will provide the better understanding of target audiences that FDA needs to design effective communication strategies, messages, and labels. These communications will aim to improve public understanding of the risks and benefits of using medical devices and radiation-emitting products by providing users with a better context in which to place risk information more completely.
Second, as initial testing, it will allow FDA to assess the potential effectiveness of messages and materials in reaching and successfully communicating with their intended audiences. Testing messages with a sample of the target audience will allow FDA to refine messages while still in the developmental stage. Respondents will be asked to give their reaction to the messages in either individual or group settings.
Third, as evaluative research, it will allow FDA to ascertain the effectiveness of the messages and the distribution method of these messages in achieving the objectives of the message campaign. Evaluation of campaigns is a vital link in continuous improvement of communications at FDA.
FDA estimates the burden of this collection of information as follows:
Annually, FDA projects about 30 studies using a variety of research methods, and lasting an average of 0.17 hours each (varying from 0.08–1.5 hours). The operating and maintenance costs include contractor expenses for designing and conducting information collection activities, specifically, drawing samples, training interviewers, collecting and analyzing information, and reporting and disseminating findings. FDA estimates the burden of this collection of information based on prior recent experience with the various types of data collection methods described earlier. FDA is requesting this burden so as not to restrict the agency's ability to gather information on public sentiment for its proposals in its regulatory and communications programs.
This is a Modification to the Basic Center Program Funding Opportunity Announcement (FOA), HHS–2010–ACF–ACYF–CY–0002, published to the ACF Grant Opportunities webpage on June 2, 2010,
The Family and Youth Services Bureau (FYSB) is accepting applications for the Basic Center Program (BCP), which is authorized by the Runaway and Homeless Youth Act to address Runaway and Homeless Youth (RHY) problems. BCPs provide an alternative for runaway and homeless youth who might otherwise end up with law enforcement or in the child welfare, mental health, or juvenile justice systems. Each BCP must provide runaway and homeless youth with a safe and appropriate shelter; individual, family, and group counseling, as appropriate; and aftercare.
The purpose of the modification is to correct information appearing in
Please delete the following under
“Applicants that do not adhere to the prescribed format will have points deducted from the overall total after the grant review:
Program narrative (which includes Objective and Need for Assistance, Results and Benefits, Approach, Organizational Profile, Staff and Position Data, and Budget
Margins less than
Font is not at least 12-point size or Times New Roman: Deduction of 2 points.”
Please replace the deleted language under
“Applications that do not adhere to the prescribed format will be converted to conform with the prescribed format. Should the conversion result in a document which exceeds 90 pages, all pages exceeding the 90-page limit will be removed and will not be considered in the reviewing process.”
All information in this modification is accurate and replaces information specified in the June 2, 2010 Funding Opportunity Announcement.
Victoria Marquez at 202–205–4866 and
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing a change in location for the upcoming public meeting entitled “Oversight of Laboratory Developed Tests.” A new address is given for those attending the public meeting.
The public meeting will be held on July 19 and 20, 2010, from 8 a.m. to 5 p.m. each day.
The public meeting will be held at The Marriott Inn & Conference Center, University of Maryland University College, 3501 University Blvd. E, Hyattsville, MD 20783.
Katherine Serrano, Center for Devices and Radiological Health, Food and Drug Administration 10903 New Hampshire Ave., Bldg. 66., rm 5613, Silver Spring, MD 20993–0002, 301–796–6652, e-mail:
In the
Because of greater than anticipated response for attending the public meeting, FDA is announcing in this notice a new location for the public meeting.
The new location will be The Marriott Inn & Conference Center, University of Maryland University College (see
Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a conference call meeting of the Scientific Management Review Board.
The NIH Reform Act of 2006 (Pub. L. 109–482) provides organizational authorities to HHS and NIH officials to: (1) Establish or abolish national research institutes; (2) reorganize the offices within the Office of the Director, NIH including adding, removing, or transferring the functions of such offices or establishing or terminating such offices; and (3) reorganize, divisions, centers, or other administrative units within an NIH national research institute or national center including adding, removing, or transferring the functions of such units, or establishing or terminating such units. The purpose of the Scientific Management Review Board (also referred to as SMRB or Board) is to advise appropriate HHS and NIH officials on the use of these organizational authorities and identify the reasons underlying the recommendations.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
The draft agenda, meeting materials, dial-in information, and other information about the SMRB, will be available at
Dated: July 6, 2010.
Science and Technology Directorate, DHS.
Committee Management; Notice of Partially Closed Federal Advisory Committee Meeting.
The Homeland Security Science and Technology Advisory Committee (HSSTAC) will meet July 20–21, 2010 at 4075 Wilson Blvd., Liberty Conference Center, 3rd Floor in Arlington, VA 22203. This meeting will be partially closed to the public.
The Homeland Security Science and Technology Advisory Committee meeting will be open to the public on July 20th from 8:30 a.m.–9 a.m. and on July 21st from 9 a.m.–10:30 a.m. All other times, the meeting will be closed.
The meeting will be held at 4075 Wilson Blvd., Liberty Conference Center, 3rd Floor in Arlington, VA 22203. Comments on this meeting must be identified by DHS–2010–0042 and may be submitted by one of the following methods:
•
•
•
•
Ms. Tiwanda Burse, Science and Technology Directorate, Department of Homeland Security, 245 Murray Lane, Bldg. 410, Washington, DC 20528, 202–254–6877.
Notice of this meeting is given under the Federal Advisory Committee Act, 5 U.S.C. App. (Pub. L. 92–463).
At this meeting, the Committee will receive sensitive and classified (Secret-level) briefings and presentations regarding Infrastructure Protection programs in Science & Technology and updates on homeland security sensitive Federally Funded Research and Development Centers (FFRDCs) projects.
The Federal Advisory Committee Act requires that notices of meetings of advisory committees be announced in the
Coast Guard, DHS.
Notice.
The Coast Guard announces that a Certificate of Alternative Compliance was issued for the offshore supply vessel MONICA W CALLAIS as required by 33 U.S.C. 1605(c) and 33 CFR 81.18.
The Certificate of Alternate Compliance was issued on JUNE 8, 2010.
The docket for this notice is available for inspection or copying at the Docket Management Facility (M–30), U.S. Department of Transportation, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. You may also find this docket on the Internet by going to
If you have questions on this notice, call LTJG Christine Dimitroff, District Eight, Prevention Branch, U.S. Coast Guard, telephone 504–671–2176. If you have questions on viewing or submitting material to the docket, call Renee V. Wright, Program Manager, Docket Operations, telephone 202–366–9826.
A Certificate of Alternative Compliance, as allowed for under Title 33, Code of Federal Regulation, Parts 81 and 89, has been issued for the offshore supply vessel MONICA W CALLAIS, O.N. 1226851. The horizontal distance between the forward and aft masthead lights may be 24′4″. Placing the aft masthead light at the horizontal distance from the forward masthead light as required by Annex I, paragraph 3(a) of the 72 COLREGS, and Annex I, Section 84.05(a) of the Inland Rules Act, would result in an aft masthead light location directly over the cargo deck where it would interfere with loading and unloading operations.
The Certificate of Alternative Compliance allows for the horizontal separation of the forward and aft masthead lights to deviate from the
This notice is issued under authority of 33 U.S.C. 1605(c), and 33 CFR 81.18.
By Direction of the Commander, Eighth Coast Guard District.
Coast Guard, DHS.
Notice.
The Coast Guard announces that a Certificate of Alternative Compliance was issued for the offshore supply vessel CALLAIS SEARCHER as required by 33 U.S.C. 1605(c) and 33 CFR 81.18.
The Certificate of Alternate Compliance was issued on June 8, 2010.
The docket for this notice is available for inspection or copying at the Docket Management Facility (M–30), U.S. Department of Transportation, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. You may also find this docket on the Internet by going to
If you have questions on this notice, call LTJG Christine Dimitroff, District Eight, Prevention Branch, U.S. Coast Guard, telephone 504–671–2167. If you have questions on viewing or submitting material to the docket, call Renee V. Wright, Program Manager, Docket Operations, telephone 202–366–9826.
A Certificate of Alternative Compliance, as allowed for under Title 33, Code of Federal Regulation, Parts 81 and 89, has been issued for the offshore supply vessel CALLAIS SEARCHER, O.N. 1226876. The horizontal distance between the forward and aft masthead lights may be 20′-8
A Certificate of Alternative Compliance, as allowed for under Title 33, Code of Federal Regulation, Parts 81 and 89, has been issued for the offshore supply vessel CALLAIS SEARCHER, O.N. 1226876. The Certificate of Alternative Compliance allows for the horizontal separation of the forward and aft masthead lights to deviate from the requirements of Annex I, paragraph 3(a) of 72 COLREGS, and Annex I, Section 84.05(a) of the Inland Rules Act as well as the offset of the RAM/NUC lights to deviate from the requirements of Annex I, paragraph 3(c) of 72 COLREGS and Annex I, Section 84.05(c) of the Inland Rules Act.
Coast Guard, DHS.
Notice.
The Coast Guard announces that a Certificate of Alternative Compliance was issued for the offshore supply vessel MARIE ELISE as required by 33 U.S.C. 1605(c) and 33 CFR 81.18.
The Certificate of Alternate Compliance was issued on June 8, 2010.
The docket for this notice is available for inspection or copying at the Docket Management Facility (M–30), U.S. Department of Transportation, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. You may also find this docket on the Internet by going to
If you have questions on this notice, call LTJG Christine Dimitroff, District Eight, Prevention Branch, U.S. Coast Guard, telephone 504–671–2176. If you have questions on viewing or submitting material to the docket, call Renee V. Wright, Program Manager, Docket Operations, telephone 202–366–9826.
A Certificate of Alternative Compliance, as allowed for under Title 33, Code of Federal Regulation, Parts 81 and 89, has been issued for the offshore supply vessel
In addition, due to the design of the vessel it would be difficult and impractical to build a supporting structure that would put the side lights within 10% inboard from the greatest breadth of the vessel, as required by Annex I, paragraph 3(b) of the 72 COLREGS and Annex I, Section 84.05(b), of the Inland Rules Act. Compliance with the rule would cause the side lights to be in a location which will be highly susceptible to damage from offshore platforms. Locating the side lights 7′
The Certificate of Alternative Compliance allows for the placement of the side lights to deviate from requirements set forth in Annex I, paragraph 3(b) of 72 COLREGS, and Annex I, paragraph 84.05(b) of the Inland Rules Act. In addition the Certificate of Alternative Compliance allows for the horizontal separation of the forward and aft masthead lights to deviate from the requirements of Annex I, paragraph 3(a) of 72 COLREGS, and Annex I, Section 84.05(a) of the Inland Rules Act.
Coast Guard, DHS.
Notice.
The Coast Guard announces that a Certificate of Alternative Compliance was issued for the offshore supply vessel BLUE TARPON as required by 33 U.S.C. 1605(c) and 33 CFR 81.18.
The Certificate of Alternate Compliance was issued on June 8, 2010.
The docket for this notice is available for inspection or copying at the Docket Management Facility (M–30), U.S. Department of Transportation, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. You may also find this docket on the Internet by going to
If you have questions on this notice, call LTJG Christine Dimitroff, District Eight, Prevention Branch, U.S. Coast Guard, telephone 504–671–2176. If you have questions on viewing or submitting material to the docket, call Renee V. Wright, Program Manager, Docket Operations, telephone 202–366–9826.
A Certificate of Alternative Compliance, as allowed under Title 33, Code of Federal Regulation, Parts 81 and 89, has been issued for the offshore supply vessel BLUE TARPON, O.N. 1226288. The horizontal distance between the forward and aft masthead lights may be 21′10″. Placing the aft masthead light at the horizontal distance from the forward masthead light as required by Annex I, paragraph 3(a) of the 72 COLREGS, and Annex I, Section 84.05(a) of the Inland Rules Act, would result in an aft masthead light location directly over the cargo deck where it would interfere with loading and unloading operations.
The Certificate of Alternative Compliance allows for the horizontal separation of the forward and aft masthead lights to deviate from the requirements of Annex I, paragraph 3(a) of 72 COLREGS, and Annex I, Section 84.05(a) of the Inland Rules Act.
This notice is issued under authority of 33 U.S.C. 1605(c), and 33 CFR 81.18.
U.S. Citizenship and Immigration Services, DHS.
Notice.
On January 21, 2010, the Secretary of the Department of Homeland Security designated Haiti under the Temporary Protected Status (TPS) program for a period of 18 months. DHS established a 180-day registration period (from January 21, 2010, through July 20, 2010). This notice extends the registration period through January 18, 2011. This extension is necessary to provide applicants more time to register for TPS.
DHS designated Haiti for TPS on January 21, 2010. The registration period that was to expire on July 20, 2010, will be extended for 180 days, with a new filing deadline of January 18, 2011.
• For further information on TPS, including guidance on the application process and additional information on eligibility, please visit the USCIS Web Site at
• You can also contact the TPS Operations Program Manager, Status and Family Branch, Service Center Operations Directorate, U.S. Citizenship and Immigration Services, Department of Homeland Security, 20 Massachusetts Avenue, NW., Washington, DC 20529–2060, telephone (202) 272–1533. This is not a toll-free call. Note: The phone number provided here is solely for questions regarding this TPS notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online available at the USCIS Web Site (
On January 21, 2010, the Secretary of Homeland Security (Secretary) designated Haiti under the Temporary Protected Status (TPS) program for a period of 18 months.
The Immigration and Nationality Act (INA) authorizes the Secretary to provide TPS applicants with a registration period of “not less than 180 days” and requires applicants to register to the extent and in a manner which the Secretary establishes.
The Secretary is extending the registration period to provide additional time to register for TPS. The Secretary has been advised that eligible individuals have not yet applied for several reasons; among them is that, due to the devastation in Haiti, Haitian nationals are having difficulty obtaining documents that establish their nationality and identity and are relevant to the TPS application process. It also takes time for many eligible individuals to gather together the funds needed to apply for TPS or, in the alternative, to learn fully the guidelines and procedures for fee waivers. This extended registration period will allow further time needed for eligible individuals to prepare their applications in light of these circumstances.
All TPS applicants must file Form I–821, Application for Temporary Protected Status, and Form I–765, Application for Employment Authorization, regardless of whether they are seeking employment authorization. All TPS applicants must also submit evidence of their Haitian nationality. Applicants who have no nationality, but whose last habitual residence was in Haiti, must submit evidence of such residence in Haiti. Lastly, all TPS applicants must submit evidence of their continuous residence in the United States since January 12, 2010, and continuous physical presence in the United States since January 21, 2010. A discussion of the required fees, supporting documents, and qualifying dates, is found in the
All applications must be received by USCIS on or before January 18, 2011. To be considered properly filed, your application, along with the appropriate fee or a fee waiver request, must be received at the address listed in the
Applications submitted without the proper fee will be rejected and returned to the applicants. USCIS will also reject and return any application where it has denied a fee waiver request. The fee waiver denial notice will contain specific instructions about resubmitting your application.
If USCIS rejected your TPS application because your fee waiver request was denied (including those instructed to re-file within 45 days), you may re-file your application with the required fees or a new fee waiver request at any time so long as it is received no later than the January 18, 2011 deadline.
In addition, if your TPS application package is received on or before January 18, 2011, and your fee waiver request is denied on or after December 3, 2010, you will be given 45 days from the date of the denial to re-file your application package with the required fee or a new fee waiver request. In that case, your application package will be considered timely filed provided the application package is received within 45 days of the date of the fee waiver denial notice. If your resubmitted TPS application package is received after January 18, 2011, and contains a new fee waiver request that is denied, your application will be rejected and you will be ineligible to register for TPS due to the expiration of the registration period.
The 45-day accommodation ensures that applicants who request a fee waiver during the period immediately before the application period closes, but whose fee waiver requests are denied, will have opportunity to amend their fee waiver requests or submit the required fees. Additionally, the 45-day accommodation is consistent with the applicable regulations, which state that a TPS application shall be filed during the registration period established by the Secretary of Homeland Security.
Yes. If your application was rejected due to incomplete information, you may re-file your completed application, addressing all of the deficiencies cited in the rejection notice, and include the proper fees or fee waiver request by January 18, 2011. Please note that a rejected application is different from a TPS application that has been denied on the merits where USCIS has informed the applicant that he or she is not eligible for TPS. If your TPS application was denied, you may seek review of that decision as described in the USCIS denial notice.
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of a major disaster for the State of Maine (FEMA–1920–DR), dated July 1, 2010, and related determinations.
Peggy Miller, Recovery Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646–3886.
Notice is hereby given that, in a letter dated July 1, 2010, the President issued a major disaster declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
I have determined that the damage in certain areas of the State of Maine resulting from severe storms and flooding during the period of March 12 to April 1, 2010, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the “Stafford Act”). Therefore, I declare that such a major disaster exists in the State of Maine.
In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses.
You are authorized to provide Public Assistance in the designated areas and Hazard Mitigation throughout the State. Consistent with the requirement that Federal assistance is supplemental, any Federal funds provided under the Stafford Act for Public Assistance and Hazard Mitigation will be limited to 75 percent of the total eligible costs.
Further, you are authorized to make changes to this declaration for the approved
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, James N. Russo, of FEMA is appointed to act as the Federal Coordinating Officer for this major disaster.
The following areas of the State of Maine have been designated as adversely affected by this major disaster:
Hancock and York Counties for Public Assistance.
All counties within the State of Maine are eligible to apply for assistance under the Hazard Mitigation Grant Program.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the Commonwealth of Virginia (FEMA–1874–DR), dated February 16, 2010, and related determinations.
Peggy Miller, Recovery Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646–3886.
The notice of a major disaster declaration for the Commonwealth of Virginia is hereby amended to include the following area among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of February 16, 2010.
The Independent City of Buena Vista for Public Assistance.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of West Virginia (FEMA–1903–DR), dated April 23, 2010, and related determinations.
Peggy Miller, Recovery Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646–3886.
The notice of a major disaster declaration for the State of West Virginia is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of April 23, 2010.
Grant, Mineral, and Monongalia Counties for Public Assistance.
Grant and Mineral Counties for emergency protective measures (Category B), including snow assistance, under the Public Assistance program for any continuous 48-hour period during or proximate to the incident period.
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of a major disaster for the State of Minnesota (FEMA–1921–DR), dated July 2, 2010, and related determinations.
Peggy Miller, Recovery Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646–3886.
Notice is hereby given that, in a letter dated July 2, 2010, the President issued a major disaster declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
I have determined that the damage in certain areas of the State of Minnesota resulting from severe storms, tornadoes, and flooding during the period of June 17–26, 2010, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the “Stafford Act”). Therefore, I declare that such a major disaster exists in the State of Minnesota.
In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses.
You are authorized to provide Public Assistance in the designated areas and Hazard Mitigation throughout the State. Consistent with the requirement that Federal assistance is supplemental, any Federal funds provided under the Stafford Act for Public Assistance and Hazard Mitigation will be limited to 75 percent of the total eligible costs.
Further, you are authorized to make changes to this declaration for the approved assistance to the extent allowable under the Stafford Act.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Lawrence Sommers, of FEMA is appointed to act as the Federal Coordinating Officer for this major disaster.
The following areas of the State of Minnesota have been designated as adversely affected by this major disaster:
Faribault, Freeborn, Olmsted, Otter Tail, Polk, Steele, and Wadena Counties for Public Assistance.
All counties within the State of Minnesota are eligible to apply for assistance under the Hazard Mitigation Grant Program.
Bureau of Indian Affairs, Interior.
Notice.
This notice publishes the Secretary's certification of the amendment to the Salt River Alcoholic Beverage Control Ordinance, Chapter 14, Articles I, II, and III of the Salt River Pima-Maricopa Indian Community's Code of Ordinances. An amended Chapter 14 of the Code of Ordinance was last published on April 1, 2009 (Vol. 74, No. 61, FR 14813). This amendment repeals Articles I and II of Chapter 14 of the Salt River Pima-Maricopa Indian Community Code of Ordinances in its entirety and adopts revised Articles, I, II and III to update and provide necessary clarifications to the regulated possession, community and to incorporate the January 29, 2009, initiative vote of the people regarding the sale of alcoholic beverages at certain restaurants within the community.
Sharlot Johnson, Tribal Government Services Officer, Western Regional Office, 2600 North Central Avenue, Phoenix, Arizona 85004–3050, Telephone (602) 379–6786; Fax (602) 379–4100; or Elizabeth Colliflower, Office of Tribal Services, 1849 C Street, NW., Mail Stop 4513–MIB, Washington, DC 20240; Telephone (202) 513–7641; Fax (202) 208–5113.
Pursuant to the Act of August 15, 1953, Public Law 83–277, 67 Stat. 586, 18 U.S.C. 1161, as interpreted by the Supreme Court in
This notice is published in accordance with the authority delegated by the Secretary of the Interior to the Assistant Secretary—Indian Affairs. I certify that the Salt River Pima-Maricopa Indian Community Council duly adopted this amendment to the Alcoholic Beverage Control Ordinance No. SRO–355–2010 on December 9, 2009.
The amendment to Salt River Pima-Maricopa Indian Community's Code of Ordinances, Chapter 14, Articles I, II, and III, reads as follows:
To Repeal Articles I & II Of Chapter 14 of the Salt River Pima-Maricopa Indian Community Code of Ordinances in Its Entirety and Adopt Revised Articles I, II & III, To Update and Provide Necessary Clarifications to the Regulated Possession, Consumption and Sales of Alcoholic Beverages Within the Community and to Incorporate The January 29, 2009 Initiative Vote of the People Regarding the Sale of Alcoholic Beverages at Certain Restaurants Within the Community.
Chapter 14, Articles I and II of the Salt River Pima-Maricopa Indian Community Code of Ordinances are repealed in their entirety and revised Articles I, II and III are hereby enacted; and Chapter 14, Articles III and IV are also hereby revised to read Articles IV and V (while retaining all text that is included in the existing Articles III and IV):
Nothing in this Chapter 14 of the SRPMIC Code of Ordinances is intended to be or shall be construed as a waiver of the sovereign immunity of the Salt River Pima-Maricopa Indian Community.
(a)
(b)
(c)
(d)
(e)
Chapter 14 of the Code of Ordinances of the Salt River Pima-Maricopa Indian Community constitutes the entire statutory law of the Community in regard to the sale, Possession and/or distribution of Alcoholic Beverages within the Community.
(a)
(b)
1. To grant and deny applications in accordance with this Article;
2. Adopt rules and regulations to implement this Article;
3. Hold hearings and make determinations on whether to grant or deny Licenses;
4. Employ necessary personnel;
5. Maintain a public record open to the public containing the names and addresses of each Licensee and any Person who is a Controlling Person;
6. Liaison between the Office and the Salt River Police Department to ensure enforcement of Articles II and III of Chapter 14 and any relevant regulations issued pursuant to Chapter 14;
7. Investigate and enforce compliance of Articles II and III of Chapter 14 and any relevant regulations that also pertain to the selling of Alcoholic Beverages within the Community; and
8. Inspect, during the hours in which a Premises is occupied, the Premises of a Licensee.
(c)
1. The Office shall establish a separate investigation unit which has as its responsibility the investigation of compliance within this Article.
2. A complete record of all applications, actions taken thereon, and any Licenses issued shall be maintained by the Office and shall be open for public inspection at the Office.
3. Office staff that are authorized to investigate pursuant to this Article shall have the authority to investigate and issue a notice
4. The Office or the Salt River Police Department may cite a Licensee to appear before the Hearing Officer for a hearing upon allegations of violations of Articles II and III or any relevant regulations issued pursuant to Chapter 14.
5. The Office or the Director may take evidence, administer oaths or affirmations, issue subpoenas requiring attendance and testimony of witnesses, cause depositions to be taken and require by subpoena duces tecum for the production of books, papers and other documents which are necessary for the enforcement of Article II and III of this Chapter.
6. The Office, including the Director may, in enforcing the provisions of this Article, inspect the Premises.
(a) Alcoholic Beverages may be possessed and consumed only at Private Residences, and Licensed Premises pursuant to this Chapter 14, and may be transported in unbroken containers to such places.
(b) Wine may be purchased, stored, distributed, and consumed in connection with the bona fide practice of a religious belief or as an integral part of a religious exercise of an organized church and in a manner not dangerous to public health or safety.
(c) The purchase, storage and use of Alcoholic Beverages solely for the purpose of cooking or preparing food and in a manner not dangerous to public health and safety are authorized.
(d) Alcoholic Beverages may also be served and consumed at a Premises licensed pursuant to a Business Ancillary License if the following conditions have been met: (1) A business serves Alcoholic Beverages as part of a cooking demonstration or cooking class, or (2) is an accredited school offering degree programs in the culinary arts.
(e) Alcoholic Beverages may be sold at Licensed Premises only under the conditions under which the License is issued.
(a)
(1) The December 9, 2009 Approved SRPMIC Liquor Licensing Area Corridor shall be kept with the official records of the Community in the Office of the Council Secretary.
(2) Upon majority vote by the Community Council and publication in the Community's newspaper, the Community Council may amend the December 9, 2009 Approved SRPMIC Liquor Licensing Area Corridor and any future amendments thereof.
(b)
(1)
a. The Director may issue a Hotel-Motel License to any hotel or motel that operates either a Restaurant or a bar in the hotel or motel, provided that the Applicant is otherwise qualified to hold a License.
b. The holder of a Hotel-Motel License is authorized to sell and serve Alcoholic Beverages solely for consumption on the Licensed Premises. For the purpose of this section “Licensed Premises” shall include all Minibars located within guest rooms accommodations, public bar rooms, outdoor patio enclosures, outdoor pool areas, public Restaurant rooms, facilities, areas, and private banquet or meeting rooms located within the hotel-motel Premises or connected to the hotel-motel Premises.
(2)
a. The Director may issue a Casino License to any casino authorized to operate as a casino by the Community.
b. The holder of a Casino License is authorized to sell and serve Alcoholic Beverages solely for consumption on the Licensed Premises. For the purpose of this section, “Licensed Premises” shall include all public bar rooms, gaming areas, private banquet or meeting rooms, restaurants, other food service facilities, outdoor patio enclosures, and land contiguous to the casino facility.
(3)
a. The Director may issue a Golf Course Clubhouse License to any golf course clubhouse.
b. The holder of a Golf Course Clubhouse License is authorized to sell and serve Alcoholic Beverages solely for consumption on the Licensed Premises and only to patrons of the golf course facility. For the purpose of this section, “Licensed Premises” shall include all restaurants and other food service facilities, private banquet or meeting rooms, bar rooms, outdoor patio enclosures, lounge facilities within the golf course clubhouse, and golf course enclosure. For purposes of this section a “golf course clubhouse” means a clubhouse located on a golf course. For purposes of this section a “golf course enclosure” means substantially undeveloped land, including amenities such as landscaping, irrigation systems, paths and golf greens and tees, that may be used for golfing or golfing practice by the public or by members and guests of a private club.
(4)
a. The Director may issue a Restaurant License to any Restaurant that is regularly open for the serving of food to guests for compensation and that has suitable kitchen facilities connected with the Restaurant for keeping, cooking and preparing foods required for ordinary meals .
b. The Restaurant shall be regularly open for the serving of food to guests for compensation and is an establishment which derives at least forty percent (40%) of its Gross Revenue from the sale of food (which includes non-alcoholic beverages), including sales of food for consumption off the Licensed Premises if the amount of these sales included in the calculation of Gross Revenue from the sale of food does not exceed fifteen percent (15%) of all Gross Revenue for the Restaurant. For purposes of meeting the Gross Revenue requirements, a Restaurant License Applicant may request that the License Premises include less than the entire establishment in which the Applicant operates its business; provided that Alcoholic Beverages are restricted to the Licensed Premises.
c. The holder of a Restaurant License may sell and serve Alcoholic Beverages solely for consumption on the Licensed Premises. For the purpose of this subsection, “Licensed Premises” may include rooms, areas or locations in which the Restaurant normally sells or serves Alcoholic Beverages or spirituous liquors pursuant to regular operating procedures and practices and that are contiguous to the Restaurant or a Public Patio Enclosure. For the purposes of this subsection, a Restaurant Licensee must submit proof of tenancy or permission from the landlord for all property to be included in the Licensed Premises.
d. The holder of a Restaurant License shall be required upon request of the Office to submit an audit of the records for the Premises to demonstrate compliance with Section 14–7(b)(4)(b). An establishment that averages at least forty percent (40%) of its Gross Revenue from the sale of food during a twelve (12) month audit period shall be deemed to comply with the Gross Revenue requirements of Section 14–7(b)(4)(b). The twelve (12) month audit period shall fall within the sixteen (16) months immediately preceding the beginning of the audit. The Office shall not require an establishment to submit to such an audit more than once a year after the initial twelve (12) months of operation. When conducting an audit, the Office shall use generally accepted auditing standards.
i. If the audit reveals that the Licensee did not meet the definition of a Restaurant as prescribed in Section14–7(b)(4)(b) and the percentage of food sales was less than thirty-seven (37%) percent, then the Office shall deem the License to have been revoked or the Office may recommend that the Licensee be granted an additional twelve (12) month period to attempt to increase their food percentage to at least thirty-seven percent (37%).
ii. If the audit reveals that the Licensee did not meet the definition of a Restaurant as prescribed in Section14–16–7(b)(4)(b) and the percentage of food sales was more than thirty-seven percent (37%) and less than forty percent (40%), then the Office shall allow the Licensee to continue to operate under the Restaurant License for a period of one (1) year, during which the Licensee shall attempt to increase the food percentage to at least forty percent (40%). If the Licensee does not increase the percentage of food sales to at least forty percent (40%), then the License issued pursuant to this Article shall be revoked or the Office may recommend that the Licensee be granted an additional twelve (12) month period to attempt to increase their food percentage to at least forty percent (40%).
(5)
a. The Director may issue a Government License to any Community governmental entity or commercial enterprise upon application by the governing board of that Community governmental or commercial enterprise entity for the sales of Alcoholic Beverages for consumption.
b. The holder of a Government License may sell and serve Alcoholic Beverages solely for consumption on the Licensed Premises. The holder of the Government License may sell and serve Alcoholic Beverages for consumption on the Premises for which the license is issued, including a stadium.
c. Any agreement entered into by a Community governmental entity to a concessionaire to sell or serve Alcoholic Beverages pursuant to this subsection shall contain the following provisions:
i. A provision that fully indemnifies and holds harmless the Community and any of its agencies, boards, commissions, Officers, and employees against any liability for loss or damage incurred either on or off Community property and resulting from the negligent serving of Alcoholic Beverages by the concessionaire or the concessionaire's agents or employees.
ii. A provision that either posts a surety bond in favor of the Community in an amount determined by the Community to be sufficient to indemnify the Community against the potential liability or that names the Community as an additional insured in a liability policy that provides sufficient coverage to indemnify the Community as determined by the Community.
(6)
a. The Director may issue a Business Ancillary License to (i) a business that serves Alcoholic Beverages as part of a cooking demonstration or cooking class or (ii) a school offering degree programs in the culinary arts.
i. A Business Ancillary License shall be issued pursuant to the process prescribed in Section 14–8 and 14–9 of this Article. Provided that certain provisions, as determined by the Director (in a written form), may not be applicable as a Business Ancillary Licensee is generally considered a social host and not engaged in the selling of Alcoholic Beverages.
ii. A Business Ancillary License shall only be available to a business that is not in the primary business of selling food or alcohol.
iii. The holder of a Business Ancillary License is authorized to serve Alcoholic Beverages solely for consumption on the Licensed Premises and only to guests of the business or in the case of a school, to students enrolled at the school.
iv. The holder of a Business Ancillary License shall not be authorized to sell Alcoholic Beverages separately or by the drink.
b. The Director may issue a Special Event License for a business for the purpose of holding a bona fide business-related networking function for its customers, clients, employees or business partners; or for the purpose of a bona fide charitable, civic, or religious organization to hold a special fundraising event. Provided that any License issued as a Special Event License meets the following conditions:
i. A Special Event License is only issued for one (1) day for a duration that shall not exceed eight (8) hours;
ii. A Special Event License may only be issued no more than once a year and shall only be issued to an Applicant that has obtained a special event license pursuant to the requirements of the State of Arizona; and
iii. A Special Event License shall only be available to a business that is not in the primary business of selling food or alcohol.
c. A Person applying for a Special Event License must make application to the Office at least forty-five (45) days prior to the special event. The Director in his/her administrative discretion, without a public hearing, shall consider the following factors in determining whether to approve or disapprove the Special Event License:
i. Whether the event will be open to the public;
ii. The criminal history of the Applicant;
iii. The nature of the event;
iv. The security measures taken by the Applicant;
v. The type of Alcoholic Beverages to be sold at the event;
vi. How the Alcoholic Beverages will be served at the event;
vii. Whether the Applicant, within the past three (3) years, has held an event that created a Community disturbance or whether the event site has generated Community disturbance complaints;
viii. The potential for noise, traffic, lack of parking, and other related concerns;
ix. The length of the event;
x. The sanitary facilities available to the participants;
xi. The anticipated amount of participants at the event;
xii. The availability of the Community's police and fire departments to provide coverage at the event (if deemed reasonably necessary by the Community);
xiii. Proof of adequate insurance (as deemed reasonably necessary by the Director) by the Applicant for this event; and
d. The nature of the sound amplification of the event. In addition to the Special Event License issued pursuant to this Article, the Applicant must obtain a Special Use Permit from the Community, and pay for any associated costs, including any overtime costs, for police, fire, or other Community departments whose presence is determined necessary, by the Community, for the special event.
(a)
1. Every Alcoholic Beverage Licensee shall be a citizen of the United States.
2. The Office shall require an Applicant and may require any Controlling Person to furnish background information and to submit a full set of fingerprints to the Office.
3. Each Applicant or Licensee shall designate a Person who shall be responsible for managing the Premises. The manager shall be a natural Person and shall meet all the requirements for licensure pursuant to this Article.
4. No License shall be issued to any Person who, within one (1) year before application, has had a License revoked in any jurisdiction.
5. No License shall be issued to or renewed for any Person who, within five (5) years before the application, has been convicted of a felony in any jurisdiction; provided that for a conviction of a corporation, LLC or partnership to serve as a reason for denial, conduct which constitutes the offense and was the bases for a felony conviction must have been engaged in, authorized, solicited, commanded or recklessly tolerated by the directors of the corporation, LLC or partnership or by a high managerial agent acting within the scope of employment. For purposes of this subsection, “high managerial agent” means an officer, partner or member of a corporation, LLC or partnership in a position of comparable authority with respect to the formulation of company policy.
6. No corporation shall be issued a License or a renewal of that License unless on file with the Office is a list of all of the corporations Officers and directors and any stockholders who owns ten percent (10%) or more of the corporation. The Office shall not issue or renew a License for any Person who at the request of the Director fails to provide the Office with complete financial disclosure statements indicating all financial holdings any Controlling Person. Provided that, publicly traded companies are exempt from the requirements set forth in this paragraph.
7. An Alcoholic Beverage License shall be issued only after a satisfactory showing of the capability, qualifications and reliability of the Applicant; and that the public convenience requires and that the best interest of the Community will be substantially served by the issuance of the License.
8. The License shall be to sell or deal in Alcoholic Beverages only at the place and in the manner provided in the License. A separate License shall be issued for each specific Premises.
9. All applications for an original License, the renewal of a License or the transfer of a License pursuant to this Article shall be filed with and determined by the Director, unless an appeal is filed and then the Hearing Officer will approve or disapprove of such License.
10. A Person who assigns, surrenders, transfers or sells control of a business which has an Alcoholic Beverage License shall notify the Office within fifteen (15) business days after the assignment, surrender, transfer or sale. An Alcoholic Beverage License shall not be leased or subleased. A concessional agreement is not considered a lease or a sublease in violation of this Article.
11. If a Person other than those Persons originally Licensed acquires control of a License or Licensee, the Person shall file notice of the acquisition with the Office within fifteen (15) business days after such acquisition of control. All Officers, directors or other Controlling Persons shall meet the qualifications for licensure as prescribed in this Article. On the request of the Licensee, the Director shall conduct a pre-investigation prior to the assignment, sale or transfer of control of a License or Licensee, the reasonable costs of such investigation shall be borne by the Applicant. The pre-investigation shall determine whether the qualifications for licensure as prescribed by this Article are met.
(b)
(c)
(d)
1. the public convenience requires the issuance of the License, and
2. the best interests of the Community will be substantially served by the issuance of the License.
(e)
1. Petitions and testimony from Persons in favor of or opposed to the issuance of a License who reside in the Community, or own or lease property located within the Community that is in close proximity to the proposed Premises.
2. The number and series of Licenses in close proximity.
3. Evidence that all necessary Licenses and permits have been obtained from the state and all other governing bodies.
4. The residential and commercial population of the Community and its likelihood of increasing, decreasing or remaining static.
5. The Community's residential and commercial population density in close proximity.
6. Evidence concerning the nature of the proposed business, its potential market, and its likely customers.
7. Effect on vehicular traffic in close proximity.
8. The compatibility of the proposed business with other activity in close proximity.
9. The effect or impact of the proposed Premises on businesses or the residential neighborhood whose activities might be affected by granting the License.
10. The history for the past five (5) years of liquor violations and reported criminal activity at the proposed Premises provided that the Applicant has received a detailed report(s) of such activity at least twenty (20) days before the hearing.
11. Comparison of the hours of operation of the proposed Premises to the existing businesses in close proximity.
12. Proximity to licensed childcare facilities and k-12 schools.
(f)
(g)
1. The hearing shall be announced by notice in the Community newspaper.
2. Notice shall be given no less than ten (10) business days prior to such hearing.
3. The hearing shall be conducted by the Director in an informal manner with rules adopted pursuant to this Article calculated to assure full disclosure of all relevant information.
4. Professional attorneys may be permitted to represent parties at any administrative hearing before the Office, the Director or the Hearing Officer pursuant to this Article.
5. The Director shall hear all relevant issues and, within thirty (30) days after the hearing is concluded, shall issue a written decision.
6. The decision will contain the findings of fact relied on by the Director for the decision as well as the decision.
7. The Applicant shall be provided notice of the hearing via standard and certified mail.
8. The Director shall enter an order recommending approval or disapproval of the License within sixty (60) days after the filing of the application.
(h)
1.
a. A notice of appeal shall be filed with the Community Manager within fifteen (15) business days after notice of the decision by the Director.
b. The notice of appeal shall state all the grounds for appeal relied on by the appellant.
c. The appellee may file a short written response to the grounds for appeal within fifteen (15) business days after the notice of appeal is filed.
d. The notice of appeal and response shall be mailed to the opposing party within two (2) business days on which it was filed.
e. If the appellant is the Applicant for the License, the appellee shall in all cases be the Director. If the appellant is a Person who filed a notice of appearance or the Community, the appellee shall in all cases be the Applicant.
f. In the event there is more than one notice of appeal filed, the appeals shall be consolidated and only one response shall be filed to the consolidated appeals.
2.
3.
a. The Hearing Officer shall conduct a hearing and may accept any relevant and material evidence and testimony.
b. An official record of the hearing shall be prepared. Persons, at their own costs, may request that the hearing record be transcribed and may be provided a copy of the transcribed record.
c. The Hearing Officer shall determine whether the decision is supported by the findings of fact and the law.
d. The Hearing Officer may affirm, reverse or modify any decision issued by the Director.
e. The Hearing Officer's decision shall be final and not subject to rehearing, review or appeal.
(a)
1. A Licensee who fails to renew the License on or before the due date shall pay a penalty of five hundred dollars ($500.00).
2. If the due date falls on a Saturday, Sunday or a legal holiday, the renewal shall be considered timely if it is received by the Office on the next business day.
3. A Licensee who fails to renew the License on or before the due date may not sell, purchase, or otherwise deal in Alcoholic Beverages until the License is renewed.
4. A License that is not renewed within sixty (60) days after its due date is deemed terminated. The Director may renew the terminated License if good cause is shown by the Licensee as to why the License was not renewed on its due date or the sixty (60) days following the due date.
5. Issuances fees for an original License and the renewal thereof shall be the following (excluding applicable surcharges):
a. Hotel-Motel License: Original $2,000.00, renewal $500.00.
b. Golf Course License: Original $2000.00, renewal $500.00.
c. Casino License: Original $2,500.00, renewal $750.00.
d. Restaurant License: Original $2,000.00, renewal $500.00.
e. Government License: Original $200.00, renewal $100.00.
f. Business Ancillary License: Original $200.00, renewal $100.00.
g. Special Event License: Original $200.00.
6. The Office may assess a surcharge on the annual renewals of Licenses to be used to help defray the costs of an auditor and support staff to review compliance of the requirements of the Licensees.
7. The Office may assess a surcharge to assist in the costs of enforcement programs that respond to complaints filed under this Article.
8. For purposes of this Article only, Licensee shall keep records of Licensee's business activity and all Persons employed at the Licensed Premises in a manner and location and for such duration as prescribed by the Director for a period of at least two (2) years. Business Activity shall include invoices, records, bills or other papers and/or documents relating to the purchase, sale and delivery of Alcoholic Beverages, and in the case of a Restaurant or Hotel-Motel Licensee, such documentation shall also be kept for the purchase, sale and delivery of food.
9. Licenses issued under this Article are nontransferable without the prior written approval of the Director after the application process has been completed.
a. The transfer fee of a License from one Person to another Person is $300.00 (excluding an application fee).
b. The transfer fee of License from one location to another location shall be $100.00 (excluding an application fee).
c. The Office may issue an interim permit to the transferee of a transferable License pursuant to regulations established by the Office.
(b)
(c)
1. There occurs on the Licensed Premises repeated acts of violence or disorderly conduct.
2. The Licensee fails to satisfactorily maintain the capability, qualifications and reliability requirements of an Applicant for a License prescribed pursuant to this Article.
3. The Licensee or Controlling Person knowingly files with the Office an application or other document which contains material information which is false or misleading or while under oath knowingly gives testimony in an investigation or other proceeding under this Article which is false or misleading.
4. The Licensee or the Controlling Person is habitually intoxicated while on the Premises.
5. The Licensed business is delinquent for more than ninety (90) days in the payment of taxes, penalties or interest to the Community.
6. The Licensee or the Controlling Person obtains, assigns, transfers or sells an Alcoholic Beverage License in a manner that is not compliant with Articles II and III of this Chapter 14.
7. The Licensee fails to keep for two (2) years and make available to the Office upon reasonable request all invoices, records, bills or other papers and/or documents relating to the purchase, sale and delivery of Alcoholic Beverages, and in the case of a Restaurant or Hotel-Motel License, all invoices, records, bills or other papers and/or documents relating to the purchase, sale and delivery of food.
8. The Licensee or Controlling Person violates or fails to comply with Articles II and III, any rule or regulation adopted pursuant to this Chapter 14 or any Alcoholic Beverage law of the Community.
9. The Licensee or an employee of a Licensee fails to take reasonable steps to protect the safety of a customer of the Licensee entering, leaving or remaining on the Licensed Premises when the Licensee knew or reasonably should have known of the danger to such Person, or the Licensee fails to take reasonable steps to intervene by notifying law enforcement officials or otherwise prevent or break up an act of violence or an altercation occurring on the Licensed Premises or immediately adjacent to the Premises when the Licensee knew or reasonably should have known of such acts of violence or altercations.
10. The Licensee or Controlling Person lacks good moral character.
11. The Licensee or Controlling Person knowingly associates with a Person who has engaged in racketeering or has been convicted of a felony, and the association is of such a nature as to create a reasonable risk that the Licensee will fail to conform to the requirements of this Article or of any Community law.
12. The Licensee or Controlling Person is convicted of a felony provided that for a conviction of a corporation, LLC or partnership to serve as a reason for any action by the Office, conduct which constitutes the offense and was the basis for the felony conviction must have been engaged in, authorized, solicited, commanded or recklessly tolerated by the directors of the corporation, LLC or partnership or by a high managerial agent acting within the scope of employment. For purposes of this subsection, “high managerial agent” means an officer, partner or member of a corporation, LLC or partnership or any other agent of the corporation, LLC or partnership in a position of comparable authority with respect to the formulation of company policy.
(d)
1. The Director may suspend, revoke or refuse to issue, transfer or renew a License based solely on the unrelated conduct or fitness of any officer, director, managing agent or other Controlling Person if that officer, director, managing agent or Controlling Person retains any interest in or control of the License after sixty (60) days following a written notice to the Licensee.
2. The Director may refuse to transfer any License or issue a new License at the same location if the Director has filed a complaint against a Licensee or the location which has not been resolved that alleges a violation of any of the grounds identified in Articles II and III of this Chapter until such time as the complaint has been finally adjudicated.
3. The Director may cause a complaint and notice of hearing to be directed to the Licensee setting forth the violations alleged against the Licensee.
e. Upon receipt of a complaint, the Licensee shall have ten (10) business days to respond to the allegations by filing a written response to the Director.
f. Failure by the Licensee to respond to the compliant within ten (10) business days shall be considered an admission by the Licensee of the allegations. The Director may then vacate a hearing and impose appropriate sanctions on the Licensee.
g. In lieu of or in addition to any suspension, revocation or refusal to renew a License, the Director may impose a civil penalty of not less than two hundred ($200.00) dollars and no more than three thousand ($3,000.00) dollars for each violation and/or require the Licensee to attend certain training.
h. The Licensee may appeal the decision by the Director to fine, revoke or not renew their License to the Community Manager who will appoint a Hearing Officer pursuant to the requirements of this Article. The Hearing Officer may affirm, modify or reverse the decision of the Director to impose the civil penalty.
If the Office or the Director has reasonable grounds to believe that a Person owns, operates, leases, manages or is controlling a business establishment or business Premises that is not properly licensed pursuant to this Article, then the Office or the Director may apply to the Community Court for a temporary restraining order or other injunctive relief prohibiting the specific acts complained of by the Office or the Director.
(a)
(b)
(a)
(b)
(a) It shall be unlawful for any Person to buy, sell or distribute Alcoholic Beverages in any manner not allowed by Chapter 14 of the SRPMIC Code of Ordinances
(b) It shall be unlawful to employ a Person under the age of nineteen (19) years in any capacity connected with the handling of Alcoholic Beverages.
(c) It shall be unlawful for a Licensee or other Person to give, sell or cause to be sold or otherwise distribute Alcoholic Beverages to a Person under the age of twenty-one (21) years.
1. If a Licensee, an employee of a Licensee or any other person questions or has reason to question that a person ordering, purchasing, attempting to purchase or otherwise procuring or attempting to procure the serving or delivery of spirituous liquor is under the legal drinking age, the Licensee, employee of the Licensee or other person shall do the following:
a. Demand identification from the person.
b. Examine the identification to determine that the identification reasonably appears to be a valid, unaltered identification that has not been defaced.
c. Examine the photograph in the identification and determine that the person reasonably appears to be the same person in the identification.
d. Determine that the date of birth in the identification indicates the person is not under the legal drinking age.
2. If a Licensee or an employee of a Licensee who follows the procedures prescribed above in Section 14–18(c)(1)(a)–(d), records and retains a record of the person's identification on this particular visit, the Licensee or employee of the Licensee shall not be in violation of Section 14–18(c)–(e).
3. Proof that a Licensee or employee followed the entire procedure proscribed above in Section 14–18(c)(1)(a)–(d), but did not record and retain a record of the identification is an affirmative defense to a violation of this Section 14–8(c)–(e).
4. A Licensee or employee of a Licensee who has not recorded and retained a record of the identification prescribed by Section 14–18(c)(1)(a)–(d), is presumed not to have followed any of the elements of Section 14–18(c)(1)(a)–(d).
(d) It shall be unlawful for a Person under the age of twenty-one (21) years to buy, Possess, or consume Alcoholic Beverages.
(e) It shall be unlawful for a Licensee or an employee of the Licensee to knowingly permit any Person on or about the Licensed Premises to give or furnish Alcoholic Beverages to any Person under the age of twenty-one (21) or knowingly permit any Person under the age of twenty-one (21) to have in the Person's Possession Alcoholic Beverages on the Licensed Premises.
j. It shall be unlawful for a Licensee or an employee of the Licensee to consume Alcoholic Beverages on or about the Licensed Premises during such periods as when such Person is working at the Licensed Premises, except that:
a. An employee of an On-Sale Retailer, during the employee's working hours in connection with the employment, while the employee is not engaged in waiting on or serving customers, may taste samples of beer or wine not to exceed four (4) ounces per day or distilled spirits not to exceed two (2) ounces per day provided by an employee of a wholesaler or distributor who is present at the time of sampling.
b. An employee of an On-Sale Retailer, under the supervision of a manager as part of the employee's training and education, while not engaged in waiting on or serving customers may taste samples of distilled spirits not to exceed two (2) ounces per educational session or beer/wine not to exceed four (4) ounces per educational session, and provided that a Licensee shall not have more than two (2) educational sessions in any thirty (30) day period.
c. An unpaid volunteer of a special event may purchase and consume Alcoholic Beverages while not engaged in waiting on or serving Alcoholic Beverages to customers at the special event. This subsection does not apply to unpaid volunteers whose responsibilities include verification of a person's legal drinking age, security or the operation of any vehicle or heavy machinery.
d. A Licensee or Employee of a Licensee of a Business Ancillary Licensee may consume Alcoholic Beverages as part of a meal prepared in connection with a cooking demonstration.
(g) It shall be unlawful for a Licensee or an employee of the Licensee to sell Alcoholic Beverages to a disorderly or obviously intoxicated Person, or for a Licensee or employee of a Licensee to allow or permit a disorderly or obviously intoxicated Person to remain on the Premises except that a Licensee or an employee of the Licensee may allow an obviously intoxicated person to remain on the Premises for a period of time of not to exceed thirty (30) minutes after the state of obvious intoxication is known or should have been known to the Licensee in order that a non-intoxicated person may transport the obviously intoxicated person from the Premises. For purposes of this Article, “obviously intoxicated” means inebriated to the extent that a Person's physical faculties are substantially impaired and the impairment is shown by significant uncoordinated physical action or physical dysfunction that would have been obvious to a reasonable Person.
(h) It shall be unlawful for a Licensee or an employee of the Licensee to sell Alcoholic Beverages that are in a Broken Package (all wine and Alcoholic Beverages shall have their seal broken by the Licensee or their employee before serving such Alcoholic Beverage to the customer).
(i) It shall be unlawful for a Licensee or an employee of the Licensee to sell Alcoholic Beverages as an Off-Sale Retailer.
(j) It shall be unlawful for a Licensee or an employee of the Licensee to sell Alcoholic Beverages within the Community without being also licensed by the State of Arizona to sell Alcoholic Beverages.
(k) It shall be unlawful for a Licensee or an employee of the Licensee to sell, dispose of, deliver or give Alcoholic Beverages to a Person between the hours of 2 a.m. and 6 a.m., on weekdays (which shall include Saturday), and 2 a.m. and 10 a.m. on Sundays.
(l) It shall be unlawful for a Licensee or an employee of the Licensee to allow a Person to consume or Possess Alcoholic Beverages on the Premises between the hours of 2:30 a.m. and 6 a.m. on weekdays (which shall include Saturday), and 2:30 a.m. and 10 a.m. on Sundays.
(m) It shall be unlawful for a Person to consume Alcoholic Beverages in a Public Place, thoroughfare or gathering. Any Licensee or employee of the Licensee permitting violations of this paragraph shall be subject to License revocation. This paragraph does not apply to the sale of Alcoholic Beverages on the Premises of and by an On-Sale Retailer.
(n) It shall be unlawful for an On-Sale Retailer or an employee of the Licensee to allow a Person under the age of twenty-one (21) to remain in an area on the Licensed Premises during those hours in which the primary use is the sale, dispensing or consumption of Alcoholic Beverages after the Licensee, or the Licensee's employees know or should have known that the Person is under the age of twenty-one (21). This subsection does not apply if the Person under the legal drinking age is accompanied by a spouse, parent or legal guardian who is of legal drinking age, is an on-duty employee of the Licensee, or to the area of the Premises used primarily for the serving of food when food is being served.
(o) It shall be unlawful for an On-Sale Retailer or employee of the Licensee to conduct drinking contests, to sell or deliver to a Person an unlimited number of Alcoholic Beverages during any set period of time for a fixed price, to deliver more than thirty-two (32) ounces of beer, one (1) liter of wine or four (4) ounces of distilled spirits in any Alcoholic Beverage drink to one Person at one time for that Person's consumption or to advertise any practice prohibited by this paragraph.
(p) It shall be unlawful for a Licensee or an employee of the Licensee to knowingly permit the unlawful Possession, use, sale or offer for sale of narcotics, dangerous drugs or marijuana on the Premises.
(q) It shall be unlawful for a Licensee or an employee of the Licensee to knowingly permit prostitution or the solicitation of prostitution on the Premises.
(r) It shall be unlawful for a Licensee or an employee of the Licensee to knowingly permit unlawful gambling on the Premises.
(s) It shall be unlawful for a Licensee or an employee of the Licensee to knowingly permit trafficking or attempted trafficking in stolen property on the Premises.
(t) It shall be unlawful for a Licensee or an employee of the Licensee to fail or refuse to make the Premises or records available for inspection and examination as or to comply with a lawful subpoena issued under this Chapter.
(u) It shall be unlawful for any Person other than a law enforcement officer, the Licensee or an employee of the Licensee acting with the permission of the Licensee to be in the Possession of a firearm while on the Licensed Premises of an On-Sale Retailer.
(v) It shall be unlawful for a Licensee or an employee of the Licensee to knowingly permit a Person in Possession of a firearm,
(w) It shall be unlawful for a Person under the age of twenty-one (21) to drive or be in physical control of a motor vehicle while there is any Alcoholic Beverage in the Person's body.
(x) It shall be unlawful for a Licensee or employee of the Licensee to purposely induce a voter, by means of alcohol, to vote or abstain from voting for or against a particular candidate or issue on Election Day.
(y) It shall be unlawful for a Licensee to fail to report an occurrence of an act of violence, within three (3) business days, to either the Office or the Salt River Police Department.
(z) It shall be unlawful for any Person to consume or be in Possession of any open container of Alcoholic Beverages while operating or while within the passenger compartment of a motor vehicle that is located on any roadways or public parking lots within the SRPMIC. This paragraph does not apply to a passenger on any bus, limousine or a passenger in the living quarters of a mobile home.
(1) Motor vehicle means any vehicle that is driven or drawn by mechanical power and that is designed for primary use on public roadways.
(2) Open container means any bottle, can, jar or other receptacle that contains Alcoholic Beverages and that has been opened, has had its seal broken or the contents of which have been partially removed.
(3) Passenger compartment means the area of a motor vehicle designed for seating of the driver and other passengers of the vehicle. Passenger compartments include an unlocked glove compartment and any unlocked portable devises within the immediate reach of the driver or any passengers.
(aa) It shall be unlawful for any Person over the age of eighteen (18) who lawfully exercises dominion and control within any Private Residence or the surrounding premises to knowingly permit any Person under the age of twenty-one (21) to Possess or consume Alcoholic Beverages within the private residence or within the immediate surrounding premises.
(bb) It shall be unlawful for a Licensee to sell Alcoholic Beverages in any manner not provided for by Chapter 14 of the SRPMIC Code of Ordinances or any regulations issued pursuant to this Chapter.
Replace “Article III. Possession in a Public Place” with “Article IV. Possession in a Public Place.” [All text to remain in Sections 14–21 through 14–30].
Replace “Article IV. Possession and Use of Narcotics, Hallucinogens or Dangerous Drugs, Seizure of Vehicles” with “Article V. Possession and Use of Narcotics, Hallucinogens or Dangerous Drugs, Seizure of Vehicles.” [All text to remain in Sections 14–31 through 14–32].
National Park Service, Department of the Interior.
Notice of Availability of a Final Environmental Impact Statement for the National Mall Plan.
Pursuant to the National Environmental Policy Act of 1969, 42 U.S.C. 4332 (2)(c), the National Park Service announces the availability of a Final Environmental Impact Statement (FEIS) for the National Mall Plan (Plan). The Plan establishes a long-term vision for the use and management of some of the most historic, symbolic, and heavily used public lands in our nation.
The FEIS for the Plan will remain available for public review for 30 days beginning on the date the U.S. Environmental Protection Agency publishes a Notice of Availability in the
Copies of the FEIS are available at National Mall and Memorial Parks Headquarters, 900 Ohio Drive, SW., Washington, DC, at local libraries around Washington, DC, and online at
Susan Spain, Project Executive, National Mall Plan at (202) 245–4692.
The National Mall and Memorial Parks is proposing to manage the National Mall according to the Plan's Preferred Alternative described below. The goals of this Plan are to restore resource conditions on the National Mall; better prepare it for the intense levels of use from First Amendment demonstrations, national celebrations, events, and annual visitation; and provide an enhanced experience for the visitors to this symbolic and historic cultural landscape.
During the preparation of the DEIS, the National Park Service (NPS) issued four newsletters about the Plan, including one which described a preliminary Preferred Alternative. The NPS issued press releases, contacted and worked with media to encourage public involvement, posted the DEIS on the NPS project Web site, sent out over 13,000 e-mail announcements, issued four “tweets,” held consultation meetings about historic preservation, and made informational presentations to the U.S. Commission of Fine Arts and the National Capital Planning Commission, which were open to the public. The NPS distributed over 5800 copies of the DEIS on CD and approximately 175 printed copies. The availability of the DEIS was announced on December 18, 2009 (74 FR 67206).
Comments received during the 90-day public comment period (December 18, 2009—March 17, 2010), as well as approximately 30,000 comments received before the DEIS was published, were considered in the preparation of the two-volume FEIS. Volume I of the FEIS includes revisions to the FEIS based on public comments received during review of the Plan. Volume II of the FEIS summarizes and provides the NPS response to public comments received on the Plan.
• The National Mall and Memorial Parks will fully accommodate demonstrations and special events on a first-come, first-served basis, consistent with the First Amendment and with 36 CFR 7.96.
• Cultural resources will be preserved, protected, and managed in accordance with
Bureau of Indian Affairs, Interior.
Notice.
This notice publishes the Liquor Control Ordinance of the Manchester Band of Pomo Indians of the Manchester-Point Arena Rancheria. The
Fred Doka Jr., Tribal Operations Officer, Pacific Regional Office, 2800 Cottage Way, Sacramento, CA 95825, Telephone (916) 978–6067; or Elizabeth Colliflower, Office of Tribal Services, 1849 C Street, NW., Mail Stop 4513–MIB, Washington, DC 20240; Telephone (202) 513–7641; Fax (202)–501–0679.
Pursuant to the Act of August 15, 1953, Public Law 83–277, 67 Stat. 586, 18 U.S.C. 1161, as interpreted by the Supreme Court in
The Liquor Control Ordinance for the Manchester Band of Pomo Indians of the Manchester-Point Arena Rancheria reads as follows:
The Business Committee of the Manchester Band of Pomo Indians (hereinafter “Tribe”), hereby enacts this Ordinance to govern the sale and consumption of alcoholic beverages on Rancheria lands in Mendocino County, California.
A. Title 18, United States Code, Section 1161, provides Indian tribes with authority to enact ordinances governing the consumption and sale of alcoholic beverages on their Reservations provided such ordinance is certified by the Secretary of the Interior and published in the Federal Register and such activities are in conformity with state law.
B. Pursuant to Article III of the Tribe's Constitution, the Community Council is the governing body of the Tribe. Pursuant to Resolution #0025 of the Community Council, dated 12–17–81, the Community Council delegated to the Business Committee full authority to promulgate ordinances as it finds necessary to the safe and productive environment on the Rancheria and for the Tribe's members, its economic development projects. Pursuant to that delegation of authority, and to the inherent authority of the Tribe and its members, the Business Committee is empowered to promulgate and enforce tribal laws exercising the Tribe's regulatory authority, to manage all economic affairs and enterprises of the Tribe for the protection of public health and safety, to administer all lands and assets and manage all economic affairs, planning and enterprises of the Tribe, and to regulate the conduct of all persons who enter the jurisdiction of the Tribe.
C. Pursuant to Article I of the Tribe's Constitution, the territorial jurisdiction of the Tribe includes the territory within the confines of the Manchester Rancheria, and such other lands as may hereafter be added thereto under any law of the United States.
D. The Casino will be an integral and indispensable part of the Tribe's economy, providing income to the Tribe and training and employment to its members. The Tribe has determined that it is in the Tribe's best interest to offer alcoholic beverages for sale and consumption in the Casino.
E. It is the purpose of this Ordinance to set out the terms and conditions under which the sale and consumption of said alcoholic beverages may take place at the Casino.
1. The sale of alcoholic beverages within the Casino, for on-Premises (within the Casino) consumption only, is hereby authorized.
2. No alcoholic beverages may be sold at any location on the Rancheria other than inside the Casino.
3. The sale of said alcoholic beverages authorized by this Ordinance shall be in conformity with all applicable laws of the State of California, and the sale of said beverages shall be subject to state sales tax, federal excise tax and any fees required by the Federal Bureau of Alcohol, Tobacco & Firearms. This includes
a. No person under the age of 21 years shall consume, acquire or have in his or her possession at the Casino any alcoholic beverage.
b. No person shall sell alcohol to any person under the age of 21 at the Casino.
c. No person shall sell alcohol to a person apparently under the influence of alcohol at the Casino.
4. Where there may be a question of a person's right to purchase alcohol by reason of his or her age, such person shall be required to present any one of the following types of identification which shows his or her correct age and bears his or her signature and photograph: (1) Driver's license or identification card issued by any state Department of Motor Vehicles; (2) United States Active Duty Military card; (3) passport.
5. All alcohol sales within the Casino shall be on a cash only basis and no credit shall be extended to any person, organization or entity, except that this provision does not prevent the use of major credit cards.
6. This Ordinance shall be conspicuously posted within the Casino at all times it is open to the public.
7. This Ordinance may be enforced by the Business Committee and by any additional tribal government agencies to which the Business Committee or Community Council may from time to time by resolution delegate such enforcement powers. Enforcement sanctions may include, but are not limited to, the assessment of monetary fines not to exceed $500 and revocation of authorization to sell alcohol at the Casino. Prior to any enforcement action, any alleged violator of this Ordinance shall be provided with at least three (3) days notice in writing of an opportunity to be heard during a hearing at which due process is provided. The decision of the Business Committee or other agency with delegated authority after such hearing shall be final.
8. If any provision or application of this Ordinance is determined by the Business Committee, Community Councilor other agency with delegated authority to be invalid, such adjudication shall not be held to render ineffectual the remaining portions of this Ordinance or to render such provisions inapplicable to other circumstances.
9. This Ordinance may only be amended by a majority vote of the Business Committee or Community Council and such amendment shall be subject to the provisions of Title 18, United States Code, Section 1161.
10. Nothing in this Ordinance in any way limits, alters, restricts or waives the Tribe's sovereign immunity from unconsented suit, claim, or action.
11. This Ordinance shall not be effective until it is certified by the Secretary of the Interior and published in the
The foregoing Ordinance was adopted by a vote of 1 for, and 0 against and 0 abstentions, at a duly called meeting of the Business Committee of the Manchester Band of Pomo Indians of the Manchester Rancheria at which a quorum was present, on this 30th day of May, 2009.
Bureau of Land Management, Interior.
Notice.
This notice is published in accordance with Section 9(a)(2) of the Federal Advisory Committee Act of 1972 (Pub. L. 92–463). Notice is hereby given that the Secretary of the Interior (Secretary) has re-established the Bureau of Land Management's (BLM) North Slope Science Initiative (NSSI) Science Technical Advisory Panel (Panel).
Allison Sandoval, BLM Advisory Committee Lead (600), Bureau of Land Management, 1620 L Street, NW., MS–LS–401, Washington, DC 20036, telephone (202) 912–7434.
The purpose of the Panel is to advise the NSSI Executive Director and NSSI Oversight Group on the inventory, monitoring, and research needed on the North Slope of Alaska, including the off-shore environments.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined to delegate authority to the Secretary to the Commission to publish notice of the receipt of future complaints under section 337 of the Tariff Act of 1930 and to solicit comments relating to the public interest.
James A. Worth, Office of the General Counsel, U.S. International Trade Commission, 500 E Street, SW., Washington, DC 20436, telephone (202) 205–3065. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street, SW., Washington, DC 20436, telephone (202) 205–2000. General information concerning the Commission may also be obtained by accessing its Internet server (
Section 337 of the Tariff Act of 1930 (“section 337”) provides that if the Commission finds a violation it shall exclude the articles concerned from the United States:
The Commission has determined to delegate to the Secretary to the Commission the authority to publish notice of receipt of a complaint and, in such a notice, to solicit comments on any public interest issues raised by the complaint.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of sections 201.10 and 210.50(a)(4) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.50(a)(4)).
By order of the Commission.
U.S. International Trade Commission.
Institution of investigation pursuant to 19 U.S.C. 1337.
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on May 13, 2010, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of FlashPoint Technology, Inc. of Peterborough, New Hampshire. An amended complaint was filed on June 16, 2010. The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain electronic imaging devices by reason of infringement of certain claims of U.S. Patent No. 6,134,606 (“the '606 patent”); U.S. Patent No. 6,163,816 (“the '816 patent”); and U.S. Patent No. 6,262,769 (“the '769 patent”) The complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337.
The complainant requests that the Commission institute an investigation and, after the investigation, issue an
The complaint, except for any confidential information contained therein, is available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street, SW., Room 112, Washington, DC 20436, telephone 202–205–2000. Hearing impaired individuals are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on 202–205–1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202–205–2000. General information concerning the Commission may also be obtained by accessing its Internet server at
Anne M. Goalwin, Esq., Office of Unfair Import Investigations, U.S. International Trade Commission, telephone (202) 205–2574.
(1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain electronic imaging devices that infringe one or more of claims 1, 11, and 21 of the '606 patent; claims 1–14 and 16 of the '816 patent; and claims 1–7, 11–13, 16–23, 26, 30–32, 40, and 41 of the '769 patent, and whether an industry in the United States exists as required by subsection (a)(2) of section 337;
(2) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served:
(a) The complainant is:
(b) The respondents are the following entities alleged to be in violation of section 337, and are the parties upon which the complaint is to be served:
(c) The Commission investigative attorney, party to this investigation, is Anne M. Goalwin, Esq., Office of Unfair Import Investigations, U.S. International Trade Commission, 500 E Street, SW., Suite 401, Washington, DC 20436; and
(3) For the investigation so instituted, the Honorable Paul J. Luckern, Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge.
Responses to the complaint and the notice of investigation must be submitted by the named respondents in accordance with section 210.13 of the Commission's Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(d)–(e) and 210.13(a), such responses will be considered by the Commission if received not later than 20 days after the date of service by the Commission of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown.
Failure of a respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing such findings, and may result in the issuance of an exclusion order or a cease and desist order or both directed against the respondent.
By order of the Commission.
60-Day Notice of Information Collection Under Review: Certification of Identity.
The Department of Justice (DOJ), Justice Management Division, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection is published to obtain comments from the public and affected agencies. Comments are encouraged and will be accepted for “sixty days” until September 13, 2010. This process is conducted in accordance with 5 CFR 1320.10.
If you have comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Stephen K. Myers, 1331 Pennsylvania Avenue, NW., Washington, DC 20530.
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
(1)
(2)
(3)
(4)
(5)
(6)
If additional information is required contact: Lynn Bryant, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street, NE., Suite 2E–502, Washington, DC 20530.
National Aeronautics and Space Administration.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, Public Law 92–463, as amended, the National Aeronautics and Space Administration announces a meeting of the Commercial Space Committee to the NASA Advisory Council.
Thursday, July 29, 2010, 9 a.m.–12 p.m., Eastern.
NASA Headquarters, 300 E Street, SW., PRC/Room 9H40, Washington, DC 20546.
Mr. John Emond, Innovative Partnerships Program, Office of Chief Technologist, National Aeronautics and Space Administration, Washington, DC 20546, at (202) 358–1686, fax: (202) 358–3878,
The agenda for the meeting is a deliberative session to reflect on the commercial crew and commercial cargo briefings received by the Committee over the past several months and to provide the Committee Chair with input to bring to the next NASA Advisory Council meeting in August. The meeting will be open to the public up to the seating capacity of the room. It is imperative that the meeting be held on this date to accommodate the scheduling priorities of the key participants. Visitors will need to show a valid picture identification such as a driver's license to enter the NASA Headquarters building (West Lobby—Visitor Control Center), and must state that they are attending the NASA Advisory Council Commercial Space Committee meeting in the PRC/Room 9H40, before receiving an access badge. All non-U.S citizens must fax a copy of their passport, and print or type their name, current address, citizenship, company affiliation (if applicable) to include address, telephone number, and their title, place of birth, date of birth, U.S. visa information to include type, number, and expiration date, U.S. Social Security Number (if applicable), and place and date of entry into the U.S., fax to John Emond, NASA Advisory Council Commercial Space Committee Executive Secretary, Fax: (202) 358–3878, by no later than July 20, 2010. To expedite admittance, attendees with U.S. citizenship can provide identifying information 3 working days in advance by contacting John Emond via e-mail at
National Aeronautics and Space Administration.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, Public Law 92–463, as amended, the National Aeronautics and Space Administration announces a meeting of the NASA Advisory Council.
Thursday, August 5, 2010, 8 a.m.–5 p.m. (local time)
Friday, August 6, 2010, 8 a.m.–12 a.m. (local time).
NASA Jet Propulsion Laboratory, Von Karman Auditorium, 4800 Oak Grove Drive, Pasadena, CA 91009.
Ms. Marla King, NAC Administrative Officer, National Aeronautics and Space Administration Headquarters, Washington, DC 20546, 202/358–1148.
The agenda for the meeting will include reports from the NAC Committees:
The meeting will be open to the public up to the seating capacity of the room. It is imperative that the meeting be held on this date to accommodate the scheduling priorities of the key participants.
National Aeronautics and Space Administration.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, Public Law 92–463, as amended, the National Aeronautics and Space Administration announces a meeting of the Space Operations Committee of the NASA Advisory Council.
Wednesday, July 28, 2010, 2–5 p.m. EDT.
Doubletree Hotel, 2080 North Atlantic Avenue, Cocoa Beach, FL 32931.
Mr. Jacob Keaton, Space Operations Mission Directorate, National Aeronautics and Space Administration Headquarters, Washington, DC 20546, 202/358–1507,
The agenda for the meeting includes the following topics:
—Recommendation Preparation.
The meeting will be open to the public up to the seating capacity of the room. It is imperative that the meeting be held on this date to accommodate the scheduling priorities of the key participants.
National Aeronautics and Space Administration.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, Public Law 92–463, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Planetary Protection Subcommittee of the NASA Advisory Council (NAC). This Subcommittee reports to the Science Committee of the NAC. The Meeting will be held for the purpose of soliciting from the scientific community and other persons scientific and technical information relevant to program planning.
Wednesday, August 4, 2010, 9 a.m. to 5 p.m., and Thursday, August 5, 2010, 9 a.m. to 5 p.m. EDT.
NASA Headquarters, 300 E Street, SW., Rooms 5H45 and 9H40, respectively, Washington, DC 20546.
Ms. Marian Norris, Science Mission Directorate, NASA Headquarters, Washington, DC 20546, (202) 358–4452, fax (202) 358–4118, or
The meeting will be open to the public up to the capacity of the room. The agenda for the meeting includes the following topics:
It is imperative that the meeting be held on these dates to accommodate the scheduling priorities of the key participants. Attendees will be requested to sign a register and to comply with NASA security requirements, including the presentation of a valid picture ID, before receiving an access badge. Foreign nationals attending this meeting will be required to provide a copy of their passport, visa, or green card in addition to providing the following information no less than 10 working days prior to the meeting: Full name; gender; date/place of birth; citizenship; visa/green card information (number, type, expiration date); passport information (number, country, expiration date); employer/affiliation information (name of institution, address, country, telephone); title/position of attendee. To expedite admittance, attendees with U.S. citizenship can provide identifying information 3 working days in advance by contacting Marian Norris via e-mail at
July 28, 2010, 2 p.m.–6 p.m.
Renaissance Washington, DC Downtown Hotel, 999 9th Street, NW., Washington, DC.
Open to the public.
(1) National Summit on Disability Policy 2010 Evaluation; (2) Council Strategic Planning.
Mark Quigley, Director of Communications, NCD, 1331 F Street, NW., Suite 850, Washington, DC 20004; 202–272–2004, 202–272–2074 (TTY).
9:30 a.m., Tuesday, July 27, 2010.
NTSB Conference Center, 429 L'Enfant Plaza, SW., Washington, DC 20594.
The one item is open to the public.
Telephone: (202) 314–6100.
The press and public may enter the NTSB Conference Center one hour prior to the meeting for set up and seating.
Individuals requesting specific accommodations should contact Rochelle Hall at (202) 314–6305 by Friday, July 23, 2010.
The public may view the meeting via a live or archived webcast by accessing
Candi Bing, (202) 314–6403.
Pursuant to section 189a.(2) of the Atomic Energy Act of 1954, as amended (the Act), the U.S. Nuclear Regulatory Commission (the Commission or NRC) is publishing this regular biweekly notice. The Act requires the Commission publish notice of any amendments issued, or proposed to be issued and grants the Commission the authority to issue and make immediately effective any amendment to an operating license upon a determination by the Commission that such amendment involves no significant hazards consideration, notwithstanding the pendency before the Commission of a request for a hearing from any person.
This biweekly notice includes all notices of amendments issued, or proposed to be issued from June 17, 2010, to June 30, 2010. The last biweekly notice was published on June 29, 2010 (75 FR 37471).
The Commission has made a proposed determination that the following amendment requests involve no significant hazards consideration. Under the Commission's regulations in Title 10 of the Code of Federal Regulations (10 CFR), § 50.92, this means that operation of the facility in accordance with the proposed amendment would not: (1) Involve a significant increase in the probability or consequences of an accident previously evaluated; or (2) create the possibility of a new or different kind of accident from any accident previously evaluated; or (3) involve a significant reduction in a margin of safety. The basis for this proposed determination for each amendment request is shown below.
The Commission is seeking public comments on this proposed determination. Any comments received within 30 days after the date of publication of this notice will be considered in making any final determination.
Normally, the Commission will not issue the amendment until the expiration of 60 days after the date of publication of this notice. The Commission may issue the license amendment before expiration of the 60-day period provided that its final determination is that the amendment involves no significant hazards consideration. In addition, the Commission may issue the amendment prior to the expiration of the 30-day comment period should circumstances change during the 30-day comment period such that failure to act in a timely way would result, for example in derating or shutdown of the facility. Should the Commission take action prior to the expiration of either the comment period or the notice period, it will publish in the
Written comments may be submitted by mail to the Chief, Rules, Announcements and Directives Branch (RADB), TWB–05–B01M, Division of Administrative Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001, and should cite the publication date and page number of this
Within 60 days after the date of publication of this notice, any person(s) whose interest may be affected by this action may file a request for a hearing and a petition to intervene with respect to issuance of the amendment to the subject facility operating license. Requests for a hearing and a petition for leave to intervene shall be filed in accordance with the Commission's “Rules of Practice for Domestic Licensing Proceedings” in 10 CFR part 2. Interested person(s) should consult a current copy of 10 CFR 2.309, which is available at the Commission's PDR, located at One White Flint North, Public File Area O1F21, 11555 Rockville Pike (first floor), Rockville, Maryland. Publicly available records will be accessible from the Agencywide Documents Access and Management System's (ADAMS) Public Electronic Reading Room on the Internet at the NRC Web site,
As required by 10 CFR 2.309, a petition for leave to intervene shall set forth with particularity the interest of the petitioner in the proceeding, and how that interest may be affected by the results of the proceeding. The petition should specifically explain the reasons why intervention should be permitted with particular reference to the following general requirements: (1) The name, address, and telephone number of the requestor or petitioner; (2) the nature of the requestor's/petitioner's right under the Act to be made a party to the proceeding; (3) the nature and extent of the requestor's/petitioner's property, financial, or other interest in the proceeding; and (4) the possible effect of any decision or order which may be entered in the proceeding on the requestor's/petitioner's interest. The petition must also identify the specific contentions which the requestor/petitioner seeks to have litigated at the proceeding.
Each contention must consist of a specific statement of the issue of law or fact to be raised or controverted. In addition, the requestor/petitioner shall provide a brief explanation of the bases for the contention and a concise statement of the alleged facts or expert opinion which support the contention and on which the requestor/petitioner intends to rely in proving the contention at the hearing. The requestor/petitioner must also provide references to those specific sources and documents of which the petitioner is aware and on which the requestor/petitioner intends to rely to establish those facts or expert opinion. The petition must include sufficient information to show that a genuine dispute exists with the applicant on a material issue of law or fact. Contentions shall be limited to
Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene, and have the opportunity to participate fully in the conduct of the hearing.
If a hearing is requested, the Commission will make a final determination on the issue of no significant hazards consideration. The final determination will serve to decide when the hearing is held. If the final determination is that the amendment request involves no significant hazards consideration, the Commission may issue the amendment and make it immediately effective, notwithstanding the request for a hearing. Any hearing held would take place after issuance of the amendment. If the final determination is that the amendment request involves a significant hazards consideration, any hearing held would take place before the issuance of any amendment.
All documents filed in NRC adjudicatory proceedings, including a request for hearing, a petition for leave to intervene, any motion or other document filed in the proceeding prior to the submission of a request for hearing or petition to intervene, and documents filed by interested governmental entities participating under 10 CFR 2.315(c), must be filed in accordance with the NRC E-Filing rule (72 FR 49139, August 28, 2007). The E-Filing process requires participants to submit and serve all adjudicatory documents over the internet, or in some cases to mail copies on electronic storage media. Participants may not submit paper copies of their filings unless they seek an exemption in accordance with the procedures described below.
To comply with the procedural requirements of E-Filing, at least ten (10) days prior to the filing deadline, the participant should contact the Office of the Secretary by e-mail at
Information about applying for a digital ID certificate is available on NRC's public Web site at
If a participant is electronically submitting a document to the NRC in accordance with the E-Filing rule, the participant must file the document using the NRC's online, Web-based submission form. In order to serve documents through EIE, users will be required to install a Web browser plug-in from the NRC Web site. Further information on the Web-based submission form, including the installation of the Web browser plug-in, is available on the NRC's public Web site at
Once a participant has obtained a digital ID certificate and a docket has been created, the participant can then submit a request for hearing or petition for leave to intervene. Submissions should be in Portable Document Format (PDF) in accordance with NRC guidance available on the NRC public Web site at
A person filing electronically using the agency's adjudicatory E-Filing system may seek assistance by contacting the NRC Meta System Help Desk through the “Contact Us” link located on the NRC Web site at
Participants who believe that they have a good cause for not submitting documents electronically must file an exemption request, in accordance with 10 CFR 2.302(g), with their initial paper filing requesting authorization to continue to submit documents in paper format. Such filings must be submitted by: (1) First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001, Attention: Rulemaking and Adjudications Staff; or (2) courier, express mail, or expedited delivery service to the Office of the Secretary, Sixteenth Floor, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852, Attention: Rulemaking and Adjudications Staff. Participants filing a document in this manner are responsible for serving the document on all other participants. Filing is considered complete by first-class mail as of the time of deposit in the mail, or by courier, express mail, or expedited delivery service upon depositing the document with the provider of the service. A presiding officer, having granted an exemption request from using E-Filing, may require a participant or party to use E-Filing if the presiding officer subsequently determines that the reason for granting the exemption from use of E-Filing no longer exists.
Documents submitted in adjudicatory proceedings will appear in NRC's electronic hearing docket which is available to the public at
Petitions for leave to intervene must be filed no later than 60 days from the date of publication of this notice. Non-timely filings will not be entertained absent a determination by the presiding officer that the petition or request should be granted or the contentions should be admitted, based on a balancing of the factors specified in 10 CFR 2.309(c)(1)(i)–(viii).
For further details with respect to this license amendment application, see the application for amendment which is available for public inspection at the Commission's PDR, located at One White Flint North, Public File Area O1F21, 11555 Rockville Pike (first floor), Rockville, Maryland. Publicly available records will be accessible from the ADAMS Public Electronic Reading Room on the Internet at the NRC Web site,
• SG Tube Rupture evaluation
• Steam Line Break/Feed Line Break evaluation
• Locked Rotor evaluation
• Control Rod Ejection evaluation
Loss of Coolant Accident conditions cause a compressive axial load to act on the tube. Therefore, since this accident tends to force the tube into the tubesheet rather than pull it out, it is not a factor in this amendment request. Another faulted load consideration is a safe Shutdown Earthquake; however, the seismic analysis of Model D5 SGs (the SGs at Catawba) has shown that axial loading of the tubes is negligible during this event.
At normal operating pressures, leakage from Primary Water Stress Corrosion Cracking (PWSCC) below 16.95 inches from the top of the tubesheet is limited by both the tube-to-tubesheet crevice and the limited crack opening permitted by the tubesheet constraint. Consequently, negligible normal operating leakage is expected from cracks within the tubesheet region.
For the SG Tube Rupture event, tube rupture is precluded for cracks in the hydraulic expansion region due to the constraint provided by the tubesheet. Therefore, the margin against tube burst/pullout is maintained during normal and postulated accident conditions and the proposed change does not result in a significant increase in the probability of a tube rupture. SG Tube Rupture consequences are not affected by the primary to secondary leakage flow during the event, as primary to secondary leakage flow through a postulated tube that has been pulled out of the tubesheet is essentially equivalent to that from a severed tube. Therefore, the proposed change does not result in a significant increase in the consequences of a tube rupture.
The probability of a Steam Line Break/Feed Line Break, Locked Rotor, and Control Rod Ejection are not affected by the potential failure of a SG tube, as the failure of a tube is not an initiator for any of these events. In WCAP–17072–P, leakage is modeled as flow through a porous medium via the use of the Darcy equation. The leakage model is used to develop a relationship between operational leakage and leakage at accident conditions that is based on differential pressure across the tubesheet and the viscosity of the fluid. A leak rate ratio was developed to relate the leakage at operating conditions to leakage at accident conditions. The fluid viscosity is based on fluid temperature and it has been shown that for the most limiting accident, the fluid temperature does not exceed the normal operating temperature. Therefore, the viscosity ratio is assumed to be 1.0 and the leak rate ratio is a function of the ratio of the accident differential pressure and the normal operating differential pressure.
The leakage factor of 2.65 for Catawba Unit 2 for a postulated Steam Line Break/Feed Line Break has been calculated as shown in WCAP–17072–P, as supplemented. The leakage factor has been increased to 3.27 per additional Westinghouse analysis specific to Catawba. Therefore, Catawba Unit 2 will apply a factor of 3.27 to the normal operating leakage associated with the tubesheet expansion region in the Condition Monitoring assessment and Operational Assessment. Through application of the limited tubesheet inspection scope, the proposed operating leakage limit provides assurance that excessive leakage (i.e., greater than accident analysis assumptions) will not occur. No leakage factor will be applied to the Locked Rotor or Control Rod Ejection due to their short duration, since the calculated leak rate ratio is less than 1.0. Therefore, the proposed change does not result in a significant increase in the consequences of these accidents.
For the Condition Monitoring assessment, the component of leakage from the prior cycle from below the H* distance will be multiplied by a factor of 3.27 and added to the total leakage from any other source and compared to the allowable accident induced leakage limit. For the Operational Assessment, the difference in the leakage between the allowable leakage and the accident induced leakage from sources other than the tubesheet expansion region will be divided by 3.27 and compared to the observed operational leakage.
Based on the above, the performance criteria of NEI 97–06, Revision 2 and RG [Regulatory Guide] 1.121 continue to be met and the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
Therefore, based on the above evaluation, the proposed change does not create the possibility of a new or different kind of accident from any accident previously evaluated.
For axially oriented cracking located within the tubesheet, tube burst is precluded due to the presence of the tubesheet. For circumferentially oriented cracking, WCAP–17072–P defines a length of degradation-free expanded tubing that provides the necessary resistance to tube pullout due to the pressure-induced forces, with applicable safety factors applied. Application of the limited hot and cold leg tubesheet inspection criteria will preclude unacceptable primary to secondary leakage during all plant conditions. The methodology for determining leakage as described in WCAP–17072–P shows that significant margin exists between an acceptable level of leakage during normal operating conditions that ensures meeting the accident induced leakage assumption and the TS leakage limit.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
An application that addressed similar issues was previously submitted on June 25, 2009, and noticed in the
1. The proposed amendment does not involve a significant increase in the probability or consequences of an accident previously evaluated.
The proposed changes to [technical specification] TS 4.4.8 will only provide for better assurance of required sampling and analysis of the reactor coolant system specific activity during thermal power changes and transient conditions (MODES 1, 2, 3, and 4). This will ensure potential consequences of a [defined-basis accident] DBA are bounded by the approved accident analyses.
The proposed changes to TS 3/4.7.5 itemize the system operability requirements and appropriate actions in the event that those requirements are not satisfied. These actions include actions to be taken during the allowed outage times (AOTs) specified in the actions to bring the system back into compliance with the system operability requirements. The actions also provide for restoration of the inoperable component or in some cases provide for placing and maintaining it in a safe condition until it can be restored. The actions may include compensatory measures that require initiation of mitigating actions involving operator action to manually align and place into service a compensatory filtration unit in the event that the normal filtration train is out-of-service. These compensatory measures are required to be taken within 24 hours compared to the current allowed outage time of 84 hours for system inoperability without any compensatory measures specified. Moreover, consistent with the current Turkey Point TS and TSTF–448 AOTs, manually aligning the compensatory filter within 24 hours to maintain [control room emergency ventilation system] CREVS operability is acceptable in order to ensure control room operations will be protected from analyzed radiological hazards. The other action statements for inoperability of a redundant active component provide for an AOT of 7 days consistent with the Westinghouse Standard Technical Specification. They are based on the low probability of occurrence of a DBA challenging the Control Room Habitability during this time period and the continued capability of the remaining system components to perform the required CREVS safety function.
The proposed changes have no effect on the probability of an accident previously evaluated as they do not affect any accident initiators. The proposed changes have no significant effect on the consequences of an accident previously evaluated as they either provide for better monitoring of plant operating parameters or for compensatory actions to be taken for out-of-service equipment not previously available. Design changes to enhance the system capabilities will be made to the same design and quality standards as the existing CREVS. System modifications required to support these proposed changes are evaluated under the 10 CFR 50.59 program and are enhancements to the mitigation strategies.
Therefore, the proposed changes do not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. The proposed amendment does not create the possibility of a new or different kind of accident from any accident previously evaluated.
The proposed changes to TS 4.4.8 will only provide for better assurance of required sampling and analysis of the reactor coolant system specific activity during MODES 1, 2, 3, and 4. The proposed modifications to the plant configuration will be fully qualified to the appropriate design requirements to assure their required function is available for accident mitigation. Additionally, functions of other equipment required for accident mitigation are also not adversely impacted. Design changes to enhance the system capabilities will be made to the same design and quality standards as the existing CREVS. The proposed changes to TS 3/4.7.5 will provide for better specification of system operability requirements and appropriate actions in the event that those requirements are not satisfied. The proposed changes have no effect on accident precursors or initiators and only enhance mitigation capabilities with regard to protecting control room personnel from radiological hazards.
Therefore, the proposed changes do not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. The proposed amendment does not involve a significant reduction in the margin of safety.
The proposed changes to TS 4.4.8 will only provide for better assurance of required sampling and analysis of the reactor coolant system specific activity during thermal power changes and transient conditions (MODES 1, 2, 3, and 4). No plant system or component design or operational requirements are affected by these changes.
The proposed changes to TS 3/4.7.5 will provide for better specification of system operability requirements and appropriate actions in the event that those requirements are not satisfied. The proposed increase in the specified AOT for inoperability of CREVS components from 84 hours to 7 days is considered insignificant as it is consistent with the Westinghouse Standard Technical Specification and based on the low probability of occurrence of a DBA challenging the Control Room Habitability during this time period and the continued capability of the remaining system components to perform the required CREVS safety function. Moreover, consistent with the current Turkey Point TS and TSTF-448 AOTs, manually aligning the compensatory filter within 24 hours to maintain CREVS operability is an acceptable margin of safety to ensure control room operations will be protected from analyzed radiological hazards. The proposed changes provide for compensatory actions to be taken for out-of-service equipment that were not previously
Therefore, the proposed change does not involve a significant reduction in the margin of safety.
Based on the above discussion, FPL has determined that the proposed change does not involve a significant hazards consideration.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of § 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. The proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
The proposed change does not impact the physical function of plant structures, systems, or components (SSCs) or the manner in which SSCs perform their design function. The proposed changes neither adversely affect accident initiators or precursors, nor alter design assumptions. The proposed changes do not alter or prevent the ability of operable [SSCs] to perform their intended function to mitigate the consequences of an initiating event within the assumed acceptance limits.
This change is a revision to the technical specifications (TS[s]) for the containment enclosure emergency air cleanup system (CEEACS), which is a mitigation system designed to prevent uncontrolled releases of radioactivity into the environment. The change would allow intermittent opening of the containment enclosure boundary under administrative controls. These controls would ensure that the opening will be quickly sealed to maintain the validity of the licensing basis analyses of accident consequences. The proposed change adds a new action requirement that would allow 24 hours to restore the containment enclosure boundary in the event that both trains of the CEEACS are inoperable due to an inoperable containment enclosure boundary. The proposed 24 hour completion time is reasonable based on the low probability of a design basis accident occurring during this time period and the use of preplanned compensatory measures. The CEEACS is not an initiator or precursor to any accident previously evaluated. Therefore, the probability of any accident previously evaluated is not increased.
2. The proposed change does not create the possibility of a new or different kind of accident from any accident previously evaluated.
The proposed change will not impact the accident analysis. The changes will not alter the requirements of the CEEACS or its function during accident conditions, and no new or different accidents result from the proposed changes to the TS[s]. The changes do not involve a physical alteration of the plant (i.e., no new or different type of equipment will be installed) or a significant change in the method of plant operation. The changes do not alter assumptions made in the safety analysis. Therefore, this request does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. The proposed change does not involve a significant reduction in a margin of safety.
Margin of safety is associated with confidence in the ability of the fission product barriers (i.e., fuel cladding, reactor coolant system pressure boundary, and containment structure) to limit the level of radiation dose to the public. The proposed changes do not involve a significant change in the method of plant operation, and no accident analyses will be affected by the proposed changes. Additionally, the proposed changes will not relax any criteria used to establish safety limits, will not relax any safety system settings, and will not relax the bases for any limiting conditions for operation. The safety analysis acceptance criteria are not affected by this change. The proposed change will not result in plant operation in a configuration outside the design bases. The proposed change does not adversely affect systems that respond to safely shutdown the plant and to maintain the plant in a safe shutdown condition. Therefore, these proposed changes do not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, and with the changes noted above, it appears that the three standards of §50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves NSHC.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
The proposed change to relocate TS 3/4.6.4 to station procedures is administrative in nature and does not involve the modification of any plant equipment or affect basic plant operation. Snubber operability and surveillance requirements will be contained in the station procedures to ensure design assumptions for accident mitigation are maintained.
The proposed change to add LCO 3.0.8 allows a delay time for entering a supported system TS when the inoperability is due solely to an inoperable snubber if risk is assessed and managed. Entrance into TS actions or delaying entrance into actions is not an initiator of any accident previously evaluated. Consequently, the probability of an accident previously evaluated is not significantly increased. The consequences of an accident while relying on allowance provided by proposed LCO 3.0.8 are no different than the consequences of an accident while relying on the current TS required actions in effect without the allowance provided by proposed LCO 3.0.8.
Revision of TS Table of Contents to reflect deletion of TS 3/4.6.4 is administrative in nature and therefore does not involve a significant increase in the probability or consequences of an accident previously evaluated.
Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of
The proposed change to relocate TS 3/4.6.4 to station procedures is administrative and does not involve any physical alteration of plant equipment. The proposed change does not change the method by which any safety related system performs its function. As such, no new or different types of equipment will be installed, and the basic operation of installed equipment is unchanged. The methods governing plant operation and testing remain consistent with current safety analysis assumptions. Therefore, the proposed change does not create the possibility of a new or different kind of accident from any accident previously evaluated.
The proposed change to add LCO 3.0.8 does not involve a physical alteration of the plant (no new or different type of equipment will be installed). Allowing delay times for entering supported system TSs when inoperability is due solely to inoperable snubbers, if risk is assessed and managed, will not introduce new failure modes or effects.
Revision of TS Table of Contents to reflect deletion of TS 3/4.6.4 is administrative in nature and therefore does not create the possibility of a new or different kind of accident from any previously evaluated.
Therefore, the proposed change does not create the possibility of a new or different kind of accident from any previously evaluated.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
The proposed change to relocate TS 3/4.6.4 to station procedures is administrative in nature, does not negate any existing requirement, and does not adversely affect existing plant safety margins or the reliability of the equipment assumed to operate in the safety analysis. As such, there are no changes being made to safety analysis assumptions, safety limits or safety system settings that would adversely affect plant safety as a result of the proposed change. Margins of safety are unaffected by requirements that are retained, but relocated from the TSs to station procedures.
The proposed change to add LCO 3.0.8 to TSs allows a delay time before declaring supported TS systems inoperable when the associated snubber(s) cannot perform the required safety function. The proposed change retains an allowance in the current NMPI TSs while upgrading it to be more conservative for snubbers supporting multiple trains or sub-systems of an associated system. The updated TS will continue to provide an adequate margin of safety for plant operation upon incorporation of LCO 3.0.8. The station design and safety analysis assumptions provide margin in the form of redundancy to account for periods of time when system capability is reduced.
Revision of TS Table of Contents to reflect deletion of TS 3/4.6.4 is administrative in nature and therefore does not involve a significant reduction in a margin of safety.
Therefore, the proposed change does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
The proposed change modifies the SR to verify that the Containment Spray System (CSS) drywell and torus spray nozzles are unobstructed after maintenance that could introduce material resulting in nozzle blockage. The requirement to test the headers will be removed as well as the type of test to be used. Since the opening within the pipes is much larger than the nozzles, they are not likely to become obstructed unless the nozzles become obstructed. The spray nozzles and headers are not assumed to be initiators of any previously analyzed accident. Therefore, the proposed change does not increase the probability of any accident previously evaluated. The spray nozzles are used in the accident analyses to mitigate design basis accidents. The revised SR to verify system operability following maintenance is considered adequate to ensure operability of the CSS. Since the system will still be able to perform its accident mitigation function, the consequences of accidents previously evaluated are not increased.
Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
The proposed change revises the SR to verify that the CSS nozzles are unobstructed after maintenance that could result in nozzle blockage. The requirement to test the headers will be removed as well as the type of test to be used. The spray nozzles and headers are not assumed to be initiators of any previously analyzed accident. The change does not introduce a new mode of plant operation and does not involve a physical modification to the plant. The change will not introduce new accident initiators or impact the assumptions made in the safety analysis.
Therefore, the proposed change does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
The proposed change revises the frequency for performance of the SR to verify that the CSS nozzles are unobstructed. The frequency is changed from “once per operating cycle” to “following maintenance that could result in nozzle blockage.” The requirement to test the headers will be removed as well as the type of test to be used. The revised testing requirement, along with the foreign material exclusion program, the normal environmental conditions for the system, and the remote physical location of the spray nozzles, provide assurance that the spray nozzles and headers will remain unobstructed. As the spray nozzles and headers are expected to remain unobstructed and able to perform their post-accident mitigation function, plant safety is not significantly affected.
Therefore, the proposed change does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
The proposed TS change to increase the CT for an inoperable Division 1 or Division 2 DG from 72 hours to 14 days does not affect the design, function, operational characteristics, or reliability of the DGs. The DGs are designed to mitigate the consequences of previously evaluated accidents and, as such, are not accident initiators.
Extending the CT for an inoperable DG will not significantly affect the capability of the DGs to perform their accident mitigation safety functions or adversely affect DG or offsite power availability. The consequences of previously evaluated accidents will not be significantly affected since the remaining DGs supporting the redundant Engineered Safety Feature (ESF) systems will continue to be available to perform the accident mitigation functions as designed.
Both a deterministic evaluation and a risk impact assessment were performed to support the proposed DG CT extension. The deterministic evaluation concluded that the defense-in-depth philosophy will be maintained with the proposed DG CT extension. The current TS and 10 CFR 50.65 (Maintenance Rule) programmatic requirements and additional administrative controls provide assurance that a loss of offsite power occurring concurrent with an inoperable DG will not result in a complete loss of function of critical systems. The duration of the proposed DG CT is determined considering that there is a minimal possibility that an accident will occur while a component is removed from service. A risk impact assessment was performed which concluded that the increase in plant risk due to the increased DG CT is small and consistent with the guidance contained in Regulatory Guide 1.177, “An Approach for Plant-Specific, Risk-Informed Decisionmaking: Technical Specifications.”
Based on the above discussion, it is concluded that the proposed amendment does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
The proposed amendment does not alter the design, configuration, or method of operation of the plant, and does not alter any safety analysis inputs or assumptions. The proposed extended DG CT will not reduce the number of DGs below the minimum required for safe shutdown or accident mitigation. No new component failure modes, system interactions, or accident responses will be created that could result in a new or different kind of accident from any accident previously evaluated.
Therefore, the proposed amendment does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
The proposed extension of the DG CT remains consistent with codes and standards applicable to the onsite alternating current (AC) sources, except that the extension deviates from the recommendations of Regulatory Guide 1.93, “Availability of Electric Power Sources.” The proposed amendment is justified based on the results of a deterministic evaluation and a risk impact assessment. These demonstrate that the defense-in-depth philosophy will be maintained and the increase in plant risk is small and consistent with the guidance contained in Regulatory Guide 1.177.
The DG reliability and availability are monitored and evaluated with respect to Maintenance Rule performance criteria to assure DG out of service times do not degrade operational safety over time. Furthermore, extension of the DG CT does not affect any safety analysis inputs or assumptions and will not erode the reduction in severe accident risk that was achieved with implementation of the Station Blackout (SBO) rule (10 CFR 50.63). The SBO coping analysis is unaffected by the CT extension since the DGs are not assumed to be available during the coping period. The assumptions used in the coping analysis regarding DG reliability are unaffected since preventive maintenance and testing will continue to be performed to maintain the reliability assumptions.
Based on the above discussion, it is concluded that the proposed amendment does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
During the period since publication of the last biweekly notice, the Commission has issued the following amendments. The Commission has determined for each of these amendments that the application complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commission's rules and regulations. The Commission has made appropriate findings as required by the Act and the Commission's rules and regulations in 10 CFR chapter I, which are set forth in the license amendment.
Notice of Consideration of Issuance of Amendment to Facility Operating License, Proposed No Significant Hazards Consideration Determination, and Opportunity for a Hearing in connection with these actions was published in the
Unless otherwise indicated, the Commission has determined that these amendments satisfy the criteria for categorical exclusion in accordance with 10 CFR 51.22. Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment need be prepared for these amendments. If the Commission has prepared an environmental assessment under the special circumstances provision in 10 CFR 51.22(b) and has made a determination based on that assessment, it is so indicated.
For further details with respect to the action see: (1) The applications for amendment; (2) the amendment; and (3) the Commission's related letter, Safety Evaluation and/or Environmental Assessment as indicated. All of these items are available for public inspection at the Commission's Public Document Room (PDR), located at One White Flint North, Public File Area 01F21, 11555 Rockville Pike (first floor), Rockville, Maryland. Publicly available records will be accessible from the Agencywide Documents Access and Management System (ADAMS) Public Electronic Reading Room on the internet at the NRC Web site,
The Commission's related evaluation of the amendment and final NSHC determination are contained in a safety evaluation dated June 28, 2010.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated June 28, 2010.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated June 28, 2010.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated June 28, 2010.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated June 28, 2010.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated June 30, 2010.
The supplemental information dated October 30, 2009, and March 19, 2010, contained clarifying information, did not change the scope of January 14, 2009, application or the initial no significant hazards consideration determination, and does not expand the scope of the original
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated June 24, 2010.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated June 29, 2010.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated June 29, 2010.
The supplemental letters contained clarifying information, did not change the initial no significant hazards consideration determination, and did not expand the scope of the original
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated June 21, 2010.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated June 28, 2010.
Revision 3.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated June 30, 2010.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated June 29, 2010.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated June 29, 2010.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated June 29, 2010.
For the Nuclear Regulatory Commission.
Aerotest Operations, Inc., (Aerotest) is the holder of Facility Operating License No. R–98 which authorizes the possession, use and operation of the Aerotest Radiography and Research Reactor (ARRR) located in San Ramon, California, under the provisions of 10 CFR 50.21(c) for research and development purposes. Aerotest is a wholly owned subsidiary of OEA Aerospace, Inc., which is wholly owned by OEA, Inc. OEA, Inc., was purchased by Autoliv ASP, Inc., (Autoliv) on May 9, 2000. Autoliv is owned by Autoliv, Inc., a Delaware corporation with a Board of Directors and Executive Officers the majority of whom are non-U.S. citizens. Pursuant to the May 9, 2000, transfer, and without the consent of the U. S. Nuclear Regulatory Commission (NRC), Aerotest became a subsidiary of Autoliv and Autoliv, Inc.
By application dated January 19, 2010, as supplemented by letters dated February 2, March 23, April 1, and April 19, 2010, (collectively, the application), Aerotest, X-Ray Industries, Inc., (X-Ray), and Autoliv requested that the NRC, pursuant to of Title 10 of the
The application also requested approval of a conforming amendment to reflect the proposed transfer of ownership of Aerotest, from OEA, Inc., to X-Ray. After completion of the transfer, X-Ray would be the indirect owner of Aerotest, which operates the ARRR.
Notice of request for approval and an opportunity for hearing was published in the
Under 10 CFR 50.80, no license or any right thereunder, shall be transferred, directly or indirectly, through transfer of control of the license, unless the Commission gives its consent in writing. Upon review of the information submitted in the application and other information before the Commission, the NRC staff has determined that the indirect license transfer of Facility Operating License R–98, as described above, is otherwise consistent with the applicable provisions of law, regulations, and orders issued by the NRC, pursuant thereto, subject to the conditions set forth below. The NRC staff further finds that the application for the proposed conforming license amendment complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commission's rules and regulations set forth in 10 CFR Chapter I; the facility will operate in conformity with the application, the provisions of the Act and the rules and regulations of the Commission; there is reasonable assurance that the activities authorized by the proposed license amendment can be conducted without endangering the health and safety of the public and that such activities will be conducted in compliance with the Commission's regulations; the issuance of the proposed license amendment will not be inimical to the common defense and security or to the health and safety of the public; and the issuance of the proposed amendment will be in accordance with 10 CFR Part 51 of the Commission's regulations and all applicable requirements have been satisfied. The findings set forth above are supported by a safety evaluation dated July 7, 2010.
Accordingly, pursuant to Sections 161b, 161i, 161o, and 184 of the Atomic Energy Act of 1954, as amended (the Act), 42 U.S.C. 2201(b), 2201(i), 2201(o), and 2234; and 10 CFR 50.80,
A. By no later than the time the proposed transaction and indirect license transfer occur, $2 million in decommissioning trust funds will be deposited in a Decommissioning Trust established and maintained by Aerotest Operations, Inc. The funds will be segregated from other assets of Aerotest Operations, Inc., and will be outside of the administrative control of Aerotest Operations, Inc.
B. No later than the date of the transaction, the licensee will provide to the Director of the Office of Nuclear Reactor Regulation, a copy of the letter of credit for $300,000 in a form acceptable to the NRC.
C. X-Ray Industries, Inc., shall enter into an $850,000 support agreement with Aerotest Operations, Inc., no later than the time the proposed transaction and indirect license transfer occur. Aerotest Operations, Inc., shall take no action to cause X-Ray Industries, Inc., or its successors and assigns, to void, cancel, or modify the support agreement or cause it to fail to perform, or impair its performance under the support agreement, without the prior written consent of the NRC. The support agreement may not be amended or modified without 30 days prior written notice to the Director of the Office of Nuclear Reactor Regulation or his designee. An executed copy of the support agreement shall be submitted to the NRC no later than 30 days after the completion of the proposed transaction and the indirect license transfer. Aerotest Operations, Inc., shall inform the NRC in writing anytime it draws upon the support agreement.
This Order is effective upon issuance.
For further details with respect to this Order, see the application dated January 19, 2010, (Agencywide Documents Access and Management System (ADAMS) Accession No. ML100490068), as supplemented by letters dated February 2, March 23, April 1, and April 19, 2010, (ADAMS Accession No. ML100880295, ML100880338, ML100980153, and ML101120070, respectively), and the safety evaluation dated July 7, 2010, which are available for public inspection at the Commission's Public Document Room (PDR), located at One White Flint North, Public File Area 01 F21, 11555 Rockville Pike (first floor), Rockville, Maryland, and accessible electronically from the ADAMS Public Electronic Reading Room on the Internet at the NRC Web site,
For The Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Issuance of Order for Implementation of Additional Security Measures and Fingerprinting for Unescorted Access to Entergy Operations, Inc.
L. Raynard Wharton, Senior Project Manager, Licensing and Inspection Directorate, Division of Spent Fuel Storage and Transportation, Office of Nuclear Material Safety and Safeguards (NMSS), U.S. Nuclear Regulatory Commission (NRC), Rockville, MD 20852.
Pursuant to 10 CFR 2.106, NRC (or the Commission) is providing notice, in the matter of Waterford Steam Electric Station Independent Spent Fuel Storage Installation (ISFSI) Order Modifying License (Effective Immediately).
NRC has issued a general license to Entergy Operations, Inc. (Entergy), authorizing the operation of an ISFSI, in accordance with the Atomic Energy Act of 1954, as amended, and Title 10 of the
Inasmuch as an insider has an opportunity equal to, or greater than, any other person, to commit radiological sabotage, the Commission has determined these measures to be prudent. Comparable Orders have been issued to all licensees that currently store spent fuel or have identified near-term plans to store spent fuel in an ISFSI.
On September 11, 2001, terrorists simultaneously attacked targets in New York, NY, and Washington, DC, using large commercial aircraft as weapons. In response to the attacks and intelligence information subsequently obtained, the Commission issued a number of Safeguards and Threat Advisories to its licensees, to strengthen licensees' capabilities and readiness to respond to a potential attack on a nuclear facility. On October 16, 2002, the Commission issued Orders to the licensees of operating ISFSIs, to place the actions taken in response to the Advisories into the established regulatory framework and to implement additional security enhancements that emerged from NRC's ongoing comprehensive review. The Commission has also communicated with other Federal, State, and local government agencies and industry representatives to discuss and evaluate the current threat environment in order to assess the adequacy of security measures at licensed facilities. In addition, the Commission has conducted a comprehensive review of its safeguards and security programs and requirements.
As a result of its consideration of current safeguards and security requirements, as well as a review of information provided by the intelligence community, the Commission has determined that certain additional security measures (ASMs) are required to address the current threat environment, in a consistent manner throughout the nuclear ISFSI community. Therefore, the Commission is imposing requirements, as set forth in Attachments 1 and 2 of this Order, on all licensees of these facilities. These requirements, which supplement existing regulatory requirements, will provide the Commission with reasonable assurance that the public health and safety, the environment, and common defense and security continue to be adequately protected in the current threat environment. These requirements will remain in effect until the Commission determines otherwise.
The Commission recognizes that licensees may have already initiated many of the measures set forth in Attachments 1 and 2 to this Order, in response to previously issued Advisories, or on their own. It also recognizes that some measures may not be possible or necessary at some sites, or may need to be tailored to accommodate the specific circumstances existing at Entergy's facility, to achieve the intended objectives and avoid any unforeseen effect on the safe storage of spent fuel.
Although the ASMs implemented by licensees in response to the Safeguards and Threat Advisories have been sufficient to provide reasonable assurance of adequate protection of public health and safety, in light of the continuing threat environment, the Commission concludes that these actions must be embodied in an Order, consistent with the established regulatory framework.
To provide assurance that licensees are implementing prudent measures to achieve a consistent level of protection to address the current threat environment, licenses issued pursuant to 10 CFR 72.210 shall be modified to include the requirements identified in Attachments 1 and 2 to this Order. In addition, pursuant to 10 CFR 2.202, I find that, in light of the common defense and security circumstances described above, the public health, safety, and interest require that this Order be effective immediately.
Accordingly, pursuant to Sections 53, 103, 104, 147, 149, 161b, 161i, 161o, 182, and 186 of the Atomic Energy Act of 1954, as amended, and the Commission's regulations in 10 CFR 2.202 and 10 CFR Parts 50, 72, and 73,
A. Entergy shall comply with the requirements described in Attachments 1 and 2 to this Order, except to the extent that a more stringent requirement is set forth in the Waterford Steam Electric Station's physical security plan. Entergy shall complete implementation of the requirements in Attachments 1 and 2 to the Order no later than 365 days from the date of this Order or 90 days before the first day that spent fuel is initially placed in the ISFSI, whichever is earlier. Additionally, Entergy must receive written verification from the NRC that the ASMs have been adequately implemented before initially placing spent fuel in the ISFSI.
B. 1. Entergy shall, within twenty (20) days of the date of this Order, notify the Commission: (1) If it is unable to comply with any of the requirements described in Attachments 1 and 2; (2) if compliance with any of the requirements is unnecessary, in its specific circumstances; or (3) if implementation of any of the requirements would cause Entergy to be in violation of the provisions of any Commission regulation or the facility license. The notification shall provide Entergy's justification for seeking relief from, or variation of, any specific requirement.
2. If Entergy considers that implementation of any of the requirements described in Attachments 1 and 2 to this Order would adversely impact the safe storage of spent fuel, Entergy must notify the Commission, within twenty (20) days of this Order, of the adverse safety impact, the basis for its determination that the requirement has an adverse safety impact, and either a proposal for achieving the same objectives specified in Attachments 1 and 2 requirements in question, or a schedule for modifying the facility, to address the adverse safety condition. If neither approach is appropriate, Entergy must supplement its response, to Condition B.1 of this Order, to identify the condition as a requirement with which it cannot comply, with attendant justifications, as required under Condition B.1.
C. 1. Entergy shall, within twenty (20) days of this Order, submit to the Commission, a schedule for achieving compliance with each requirement described in Attachments 1 and 2.
2. Entergy shall report to the Commission when it has achieved full compliance with the requirements described in Attachments 1 and 2.
D. All measures implemented or actions taken in response to this Order shall be maintained until the Commission determines otherwise.
Entergy's response to Conditions B.1, B.2, C.1, and C.2, above, shall be submitted in accordance with 10 CFR 72.4. In addition, submittals and documents produced by Entergy as a result of this order, that contain Safeguards Information as defined by 10 CFR 73.22, shall be properly marked and handled, in accordance with 10 CFR 73.21 and 73.22.
The Director, Office of Nuclear Material Safety and Safeguards, may, in writing, relax or rescind any of the above conditions, for good cause.
In accordance with 10 CFR 2.202, Entergy must, and any other person adversely affected by this Order may, submit an answer to this Order within 20 days of its publication in the
The answer may consent to this Order. If the answer includes a request for a hearing, it shall, under oath or affirmation, specifically set forth the matters of fact and law on which Entergy relies and the reasons as to why the Order should not have been issued. If a person other than Entergy requests a hearing, that person shall set forth with particularity the manner in which his/her interest is adversely affected by this Order and shall address the criteria set forth in 10 CFR 2.309(d).
All documents filed in NRC adjudicatory proceedings, including a request for hearing, a petition for leave to intervene, any motion or other document filed in the proceeding prior to the submission of a request for hearing or petition to intervene, and documents filed by interested governmental entities participating under 10 CFR 2.315(c), must be filed in accordance with the NRC E-Filing rule (72 FR 49139, August 28, 2007). The E-Filing process requires participants to submit and serve all adjudicatory documents over the internet, or in some cases to mail copies on electronic storage media. Participants may not submit paper copies of their filings unless they seek an exemption in accordance with the procedures described below.
To comply with the procedural requirements of E-Filing, at least ten (10) days prior to the filing deadline, the participant should contact the Office of the Secretary by e-mail at
Information about applying for a digital ID certificate is available on NRC's public Web site at
If a participant is electronically submitting a document to the NRC in accordance with the E-Filing rule, the participant must file the document using the NRC's online, Web-based submission form. In order to serve documents through Electronic Information Exchange (EIE), users will be required to install a Web browser plug-in from the NRC Web site. Further information on the Web-based submission form, including the installation of the Web browser plug-in, is available on the NRC's public Web site at
Once a participant has obtained a digital ID certificate and a docket has been created, the participant can then submit a request for hearing or petition for leave to intervene. Submissions should be in Portable Document Format (PDF) in accordance with NRC guidance available on the NRC public Web site at
A person filing electronically using the agency's adjudicatory E-Filing system may seek assistance by contacting the NRC Meta System Help Desk through the “Contact Us” link located on the NRC Web site at
Participants who believe that they have a good cause for not submitting documents electronically must file an exemption request, in accordance with 10 CFR 2.302(g), with their initial paper filing requesting authorization to continue to submit documents in paper format. Such filings must be submitted by: (1) First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001,
Documents submitted in adjudicatory proceedings will appear in NRC's electronic hearing docket which is available to the public at
If a hearing is requested by Entergy or a person whose interest is adversely affected, the Commission will issue an Order designating the time and place of any hearing. If a hearing is held, the issue to be considered at such hearing shall be whether this Order should be sustained.
Pursuant to 10 CFR 2.202(c)(2)(i), Entergy may, in addition to requesting a hearing, at the time the answer is filed or sooner, move the presiding officer to set aside the immediate effectiveness of the Order on the grounds that the Order, including the need for immediate effectiveness, is not based on adequate evidence, but on mere suspicion, unfounded allegations, or error.
In the absence of any request for hearing, or written approval of an extension of time in which to request a hearing, the provisions as specified in Section III shall be final twenty (20) days from the date this Order is published in the
For The Nuclear Regulatory Commission.
1. These additional security measures (ASMs) are established to delineate an independent spent fuel storage installation (ISFSI) licensee's responsibility to enhance security measures related to authorization for unescorted access to the protected area of an ISFSI in response to the current threat environment.
2. Licensees whose ISFSI is collocated with a power reactor may choose to comply with the U.S. Nuclear Regulatory Commission (NRC)-approved reactor access authorization program for the associated reactor as an alternative means to satisfy the provisions of sections B through G below. Otherwise, licensees shall comply with the access authorization and fingerprinting requirements of section B through G of these ASMs.
3. Licensees shall clearly distinguish in their 20-day response which method they intend to use in order to comply with these ASMs.
1. The licensee shall develop, implement and maintain a program, or enhance its existing program, designed to ensure that persons granted unescorted access to the protected area of an ISFSI are trustworthy and reliable and do not constitute an unreasonable risk to the public health and safety for the common defense and security, including a potential to commit radiological sabotage.
a. To establish trustworthiness and reliability, the licensee shall develop, implement, and maintain procedures for conducting and completing background investigations, prior to granting access. The scope of background investigations must address at least the past three years and, as a minimum, must include:
i. Fingerprinting and a Federal Bureau of Investigation (FBI) identification and criminal history records check (CHRC). Where an applicant for unescorted access has been previously fingerprinted with a favorably completed CHRC, (such as a CHRC pursuant to compliance with orders for access to safeguards information) the licensee may accept the results of that CHRC, and need not submit another set of fingerprints, provided the CHRC was completed not more than three years from the date of the application for unescorted access.
ii. Verification of employment with each previous employer for the most recent year from the date of application.
iii. Verification of employment with an employer of the longest duration during any calendar month for the remaining next most recent two years.
iv. A full credit history review.
v. An interview with not less than two character references, developed by the investigator.
vi. A review of official identification (
vii. Licensees shall confirm eligibility for employment through the regulations of the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, and shall verify and ensure, to the extent possible, the accuracy of the provided social security number and alien registration number, as applicable.
b. The procedures developed or enhanced shall include measures for confirming the term, duration, and character of military service for the past three years, and/or academic enrollment and attendance in lieu of employment, for the past five years.
c. Licensees need not conduct an independent investigation for individuals employed at a facility who possess active “Q” or “L” clearances or possess another active U.S. Government-granted security clearance (
d. A review of the applicant's criminal history, obtained from local criminal justice resources, may be included in addition to the FBI CHRC, and is encouraged if the results of the FBI CHRC, employment check, or credit check disclose derogatory information. The scope of the applicant's local criminal history check shall cover all residences of record for the past three years from the date of the application for unescorted access.
2. The licensee shall use any information obtained as part of a CHRC solely for the purpose of determining an individual's suitability for unescorted access to the protected area of an ISFSI.
3. The licensee shall document the basis for its determination for granting or denying access to the protected area of an ISFSI.
4. The licensee shall develop, implement, and maintain procedures for updating background investigations for persons who are applying for reinstatement of unescorted access. Licensees need not conduct an independent reinvestigation for individuals who possess active “Q” or “L” clearances or possess another active U.S. Government granted security clearance,
5. The licensee shall develop, implement, and maintain procedures for reinvestigations of persons granted unescorted access, at intervals not to exceed five years. Licensees need not conduct an independent reinvestigation for individuals employed at a facility who possess active “Q” or “L” clearances or possess another active U.S. Government granted security clearance,
6. The licensee shall develop, implement, and maintain procedures designed to ensure that persons who have been denied unescorted access authorization to the facility are not allowed access to the facility, even under escort.
7. The licensee shall develop, implement, and maintain an audit program for licensee and contractor/vendor access authorization programs that evaluate all program elements and include a person knowledgeable and practiced in access authorization program performance objectives to assist in the overall assessment of the site's program effectiveness.
1. In a letter to the NRC, the licensee must nominate an individual who will review the results of the FBI CHRCs to make trustworthiness and reliability determinations for unescorted access to an ISFSI. This individual, referred to as the “reviewing official,” must be someone who requires unescorted access to the ISFSI. The NRC will review the CHRC of any individual nominated to perform the reviewing official function. Based on the results of the CHRC, the NRC staff will determine whether this individual may have access. If the NRC determines that the nominee may not be granted such access, that individual will be prohibited from obtaining access.
2. No person may have access to Safeguards Information (SGI) or unescorted access to any facility subject to NRC regulation, if the NRC has determined, in accordance with its administrative review process based on fingerprinting and an FBI identification and CHRC, that the person may not have access to SGI or unescorted access to any facility subject to NRC regulation.
3. All fingerprints obtained by the licensee under this Order, must be submitted to the Commission for transmission to the FBI.
4. The licensee shall notify each affected individual that the fingerprints will be used to conduct a review of his/her criminal history record and inform the individual of the procedures for
5. Fingerprints need not be taken if the employed individual (
1. A licensee shall not base a final determination to deny an individual unescorted access to the protected area of an ISFSI solely on the basis of information received from the FBI involving: An arrest more than one (1) year old for which there is no information of the disposition of the case, or an arrest that resulted in dismissal of the charge, or an acquittal.
2. A licensee shall not use information received from a CHRC obtained pursuant to this Order in a manner that would infringe upon the rights of any individual under the First Amendment to the Constitution of the United States, nor shall the licensee use the information in any way that would discriminate among individuals on the basis of race, religion, national origin, sex, or age.
1. For the purpose of complying with this Order, licensees shall, using an appropriate method listed in 10 CFR 73.4, submit to the NRC's Division of Facilities and Security, Mail Stop TWB–05B32M, one completed, legible standard fingerprint card (Form FD–258, ORIMDNRCOOOZ) or, where practicable, other fingerprint records for each individual seeking unescorted access to an ISFSI, to the Director of the Division of Facilities and Security, marked for the attention of the Division's Criminal History Check Section. Copies of these forms may be obtained by writing the Office of Information Services, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001, by calling (301) 415–5877, or by e-mail to
2. The NRC will review submitted fingerprint cards for completeness. Any Form FD–258 fingerprint record containing omissions or evident errors will be returned to the licensee for corrections. The fee for processing fingerprint checks includes one re-submission if the initial submission is returned by the FBI because the fingerprint impressions cannot be classified. The one free re-submission must have the FBI Transaction Control Number reflected on the re-submission. If additional submissions are necessary, they will be treated as initial submittals and will require a second payment of the processing fee.
3. Fees for processing fingerprint checks are due upon application. The licensee shall submit payment of the processing fees electronically. To be able to submit secure electronic payments, licensees will need to establish an account with Pay.Gov (
4. The Commission will forward to the submitting licensee all data received from the FBI as a result of the licensee's application(s) for CHRCs, including the FBI fingerprint record.
1. Prior to any final adverse determination, the licensee shall make available to the individual the contents of any criminal history records obtained from the FBI for the purpose of assuring correct and complete information. Written confirmation by the individual of receipt of this notification must be maintained by the licensee for a period of one (1) year from the date of notification.
2. If, after reviewing the record, an individual believes that it is incorrect or incomplete in any respect and wishes to change, correct, or update the alleged deficiency, or to explain any matter in the record, the individual may initiate challenge procedures. These procedures include either direct application by the individual challenging the record to the agency (
1. The licensee shall develop, implement, and maintain a system for personnel information management with appropriate procedures for the protection of personal, confidential information. This system shall be designed to prohibit unauthorized access to sensitive information and to
2. Each licensee who obtains a criminal history record on an individual pursuant to this Order shall establish and maintain a system of files and procedures, for protecting the record and the personal information from unauthorized disclosure.
3. The licensee may not disclose the record or personal information collected and maintained to persons other than the subject individual, his/her representative, or to those who have a need to access the information in performing assigned duties in the process of determining suitability for unescorted access to the protected area of an ISFSI. No individual authorized to have access to the information may re-disseminate the information to any other individual who does not have the appropriate need to know.
4. The personal information obtained on an individual from a CHRC may be transferred to another licensee if the gaining licensee receives the individual's written request to re-disseminate the information contained in his/her file, and the gaining licensee verifies information such as the individual's name, date of birth, social security number, sex, and other applicable physical characteristics for identification purposes.
5. The licensee shall make criminal history records, obtained under this section, available for examination by an authorized representative of the NRC to determine compliance with the regulations and laws.
Nuclear Regulatory Commission.
Weeks of July 12, 19, 26, August 2, 9, 16, 2010.
Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland.
Public and Closed.
There are no meetings scheduled for the week of July 19, 2010.
There are no meetings scheduled for the week of July 26, 2010.
There are no meetings scheduled for the week of August 2, 2010.
This meeting will be webcast live at the Web address—
There are no meetings scheduled for the week of August 16, 2010.
*The schedule for Commission meetings is subject to change on short notice. To verify the status of meetings, call (recording)—(301) 415–1292. Contact person for more information: Rochelle Bavol, (301) 415–1651.
The NRC Commission Meeting Schedule can be found on the Internet at:
The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings, or need this meeting notice or the transcript or other information from the public meetings in another format
This notice is distributed electronically to subscribers. If you no longer wish to receive it, or would like to be added to the distribution, please contact the Office of the Secretary, Washington, DC 20555 (301–415–1969), or send an e-mail to
Nuclear Regulatory Commission (NRC)
Notice of availability.
The NRC is announcing the availability of the proposed model application (with model no significant hazards consideration determination) and model safety evaluation (SE) for plant-specific adoption of Technical Specifications Task Force (TSTF) Traveler TSTF–446, Revision 3, “Risk Informed Evaluation of Extensions to Containment Isolation Valve Completion Times (WCAP–15791).” TSTF–446, Revision 3, is available in the Agencywide Documents Access and Management System (ADAMS) under Accession Number ML080510164. The proposed changes revise Standard Technical Specifications (TS) with respect to completion times for containment isolation valves. This model SE will facilitate expedited approval of plant-specific adoption of TSTF–446, Revision 3.
You can access publicly available documents related to this notice using the following methods:
The proposed model application (with model no significant hazards consideration determination) and model SE for plant-specific adoption of TSTF–
Ravinder Grover, Technical Specifications Branch, Mail Stop: O–7 C2A, Division of Inspection and Regional Support, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC, 20555–0001; telephone 301–415–2166 or e-mail at
TSTF–446, Revision 3, is applicable to all Westinghouse plants. Licensees opting to apply for this TS change are responsible for reviewing the NRC staff's model SE, referencing the applicable technical justifications, and providing any necessary plant-specific information. The NRC will process each amendment application responding to this notice of availability according to applicable NRC rules and procedures.
The proposed models do not prevent licensees from requesting an alternate approach or proposing changes other than those proposed in TSTF–446, Revision 3. However, significant deviations from the approach recommended in this notice or the inclusion of additional changes to the license require additional NRC staff review. This may increase the time and resources needed for the review or result in NRC staff rejection of the license amendment request (LAR). Licensees desiring significant deviations or additional changes should instead submit an LAR that does not claim to adopt TSTF–446, Revision 3.
For the Nuclear Regulatory Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recently-filed Postal Service request to add two additional Global Expedited Package Services 2 (GEPS 2) contracts to the Competitive Product List. This notice addresses procedural steps associated with these filings.
Comments are due: July 14, 2010.
Submit comments electronically via the Commission's Filing Online system at
Stephen L. Sharfman, General Counsel,
On July 2, 2010, the Postal Service filed a notice announcing that it has entered into two additional Global Expedited Package Services 2 (GEPS 2) contracts.
In support of its Notice, the Postal Service filed four attachments as follows:
1. Attachments 1A and 1B–redacted copies of the two contracts and applicable annexes;
2. Attachments 2A and 2B–a certified statement required by 39 CFR 3015.5(c)(2) for each contract;
3. Attachment 3–a redacted copy of Governors' Decision No. 08–7 which establishes prices and classifications for GEPS contracts, a description of applicable GEPS contracts, formulas for prices, an analysis and certification of the formulas and certification of the Governors' vote; and
4. Attachment 4–an application for non–public treatment of materials to maintain redacted portions of the contracts and supporting documents under seal.
The Notice advances reasons why the instant GEPS 2 contracts fit within the Mail Classification Schedule language for GEPS 2. The Postal Service identifies customer–specific information, general contract terms, and other differences that distinguish the instant contracts from the baseline GEPS 2 agreement, all of which are highlighted in the Notice.
The Postal Service contends that the instant contracts are functionally equivalent to previously filed GEPS contracts and are substantially similar to that in Docket No. CP2009–50 in terms of the product being offered, the market in which it is offered, and its cost characteristics.
The Postal Service also contends that its filings demonstrate that each of the new GEPS 2 contracts complies with the requirements of 39 U.S.C. 3633. It requests that the contracts be included within the GEPS 2 product.
The Commission establishes Docket Nos. CP2010–64 and CP2010–65 for consideration of matters related to the contracts identified in the Postal Service's Notice.
These dockets are addressed on a consolidated basis for purposes of this
Interested persons may submit comments on whether the Postal Service's contracts are consistent with the policies of 39 U.S.C. 3632, 3633 or 3642. Comments are due no later than July 14, 2010. The public portions of these filings can be accessed via the Commission's Web site (
The Commission appoints Paul L. Harrington to serve as Public Representative in the captioned proceedings.
1. The Commission establishes Docket Nos. CP2010–64 and CP2010–65 for consideration of matters raised by the Postal Service's Notice.
2. Comments by interested persons in these proceedings are due no later than July 14, 2010.
3. Pursuant to 39 U.S.C. 505, Paul L. Harrington is appointed to serve as officer of the Commission (Public Representative) to represent the interests of the general public in these proceedings.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
U.S. Small Business Administration.
Notice.
This is a notice of an Administrative declaration of a disaster for the State of Illinois dated 07/06/2010.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street, SW., Suite 6050, Washington, DC 20416.
Notice is hereby given that as a result of the Administrator's disaster declaration, applications for disaster loans may be filed at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 12220C and for economic injury is 122210.
The State which received an EIDL Declaration # is Illinois.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of MAINE (FEMA—1920—DR), dated 07/01/2010.
07/01/2010.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
Alan Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street, SW., Suite 6050, Washington, DC 20416.
Notice is hereby given that as a result of the President's major disaster declaration on 07/01/2010, Private Non-Profit organizations that provide essential services of governmental nature may file disaster loan applications at the address listed above or other locally announced locations.
The Interest Rates are:
The number assigned to this disaster for physical damage is 12222B and for economic injury is 12223B
U.S. Small Business Administration.
Amendment 3.
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of South Dakota (FEMA–1915–DR), dated 05/13/2010.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street, SW., Suite 6050, Washington, DC 20416.
The notice of the President's major disaster declaration for Private Non-Profit organizations in the State of South Dakota, dated 05/13/2010, is hereby amended to include the following areas as adversely affected by the disaster.
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Minnesota (FEMA–1921–DR), dated 07/02/2010.
INCIDENT: Severe Storms, Tornadoes, and Flooding.
INCIDENT PERIOD: 06/17/2010 through 06/26/2010.
07/02/2010.
PHYSICAL LOAN APPLICATION DEADLINE DATE: 08/31/2010.
ECONOMIC INJURY (EIDL) LOAN APPLICATION DEADLINE DATE: 04/02/2011.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street, SW., Suite 6050, Washington, DC 20416.
Notice is hereby given that as a result of the President's major disaster declaration on 07/02/2010, Private Non-Profit organizations that provide essential services of governmental nature may file disaster loan applications at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 12224B and for economic injury is 12225B.
Securities and Exchange Commission (“SEC” or the “Commission”).
Notice of application for an order pursuant to Section 26(c) of the Investment Company Act of 1940 (“1940 Act” or “Act”), approving certain substitutions of securities and for an order of exemption pursuant to Section 17(b) of the Act.
AXA Equitable Life Insurance Company (“AXA Equitable”), Separate Account 45 of AXA Equitable (“Separate Account 45”), Separate Account 49 of AXA Equitable (“Separate Account 49”), Separate Account A of AXA Equitable (“Separate Account A”), Separate Account FP of AXA Equitable (“Separate Account FP”) (together, “AXA Equitable Separate Accounts”), MONY Life Insurance Company of America (“MLOA”) and MONY America Variable Account L (“MLOA Separate Account L”) (collectively, the “Section 26 Applicants”), Separate Account 65 of AXA Equitable (“Separate Account 65”), and the AXA Premier VIP Trust (the “Trust”) (Separate Account 65 and the Trust, together with the Section 26 Applicants, the “Section 17 Applicants” or “Applicants”).
The Section 26 Applicants request an order pursuant to Section 26(c) of the 1940 Act, approving the proposed substitution of securities of the Multimanager Aggressive Equity Portfolio (the “Replacement Portfolio”) for securities of the Multimanager Large Cap Growth Portfolio (the “Removed Portfolio”) (the “Substitution”). Each of these portfolios currently serves as an underlying investment option for certain variable annuity contracts issued by AXA Equitable (“Annuity Contracts”) and/or variable life insurance policies issued by AXA Equitable and MLOA (“Life Insurance Contracts”) (collectively, the “Contracts”), as more fully described below.
The application was filed on August 27, 2009, and amended on December 18, 2009, March 29, 2010, and June 10, 2010. Applicants have agreed to file an amendment during the notice period, the substance of which is reflected in this notice.
An order granting the application will be issued unless the Commission orders a hearing. Interested persons may request a hearing by writing to the Secretary of the Commission and serving Applicants with a copy of the request, personally or by mail. Hearing requests should be received by the Commission by 5:30 p.m. on July 28, 2010, and should be accompanied by proof of service on Applicants in the form of an affidavit or, for lawyers, a certificate of service. Hearing requests should state the nature of the requester's interest, the reason for the request, and the issues contested. Persons who wish to be notified of a hearing may request notification by writing to the Secretary of the Commission.
Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549–1090. Applicants, c/o AXA Equitable Life Insurance Company, 1290 Avenue of the Americas, New York, NY 10104, Attn: Steven M. Joenk, Senior Vice President.
Sonny Oh, Staff Attorney, or Harry Eisenstein, Branch Chief, Office of Insurance Products, Division of Investment Management at (202) 551–6795.
The following is a summary of the application. The complete application may be obtained via the Commission's Web site by searching for the file number, or an applicant using the Company name box at
1. AXA Equitable is a New York stock life insurance company authorized to sell life insurance and annuities in 50 states, the District of Columbia, Puerto Rico and the Virgin Islands. AXA Equitable is an investment adviser registered under the Investment Advisers Act of 1940, as amended, and is a wholly owned subsidiary of AXA Financial, Inc. (“AXA Financial”). AXA Financial is an indirect, wholly owned subsidiary of AXA, which is a publicly traded French holding company.
2. MLOA is an Arizona stock life insurance company licensed to sell life insurance and annuities in 49 states (not including New York), the District of Columbia, Puerto Rico, and the U.S. Virgin Islands. AXA Financial is the parent company of MLOA.
3. AXA Equitable serves as depositor for Separate Account 45, Separate Account 49 and Separate Account A, which fund certain Contracts, and for Separate Account FP, which funds certain Life Insurance Contracts. AXA Equitable also serves as depositor for Separate Account 65, which funds group pension and profit-sharing plans under group Annuity Contracts issued by AXA Equitable (Separate Account 65 is also an “AXA Equitable Separate Account” and may be referred to herein as a “Separate Account” and collectively with MLOA Separate Account L and the AXA Equitable Separate Accounts, the “Separate Accounts”).
4. Each AXA Equitable Separate Account is a segregated asset account of AXA Equitable and, except for Separate Account 65, is registered with the Commission as a unit investment trust under the 1940 Act. Separate Account 65 is excluded from registration under the 1940 Act pursuant to Section 3(c)(11) of the 1940 Act. Units of interest in the AXA Equitable Separate Accounts, except Separate Account 65, are registered under the Securities Act of 1933, as amended (“1933 Act”). Units of interest in Separate Account 65 are exempt from registration under the 1933 Act, pursuant to Section 3(a)(2) of the 1933 Act.
5. MLOA serves as depositor for MLOA Separate Account L, which funds variable benefits available under certain Life Insurance Contracts issued by MLOA.
6. MLOA Separate Account L is a segregated asset account of MLOA and is registered with the Commission as a unit investment trust under the 1940 Act. Units of interest in MLOA Separate Account L under the Life Insurance Contracts are registered under the 1933 Act.
7. The Trust is organized as a Delaware statutory trust and is registered as an open-end management investment company under the 1940 Act and its shares are registered under the 1933 Act on Form N–1A. The Trust is a series investment company and currently offers 21 separate series (each a “Portfolio” and collectively, the “Portfolios”).
8. The Trust currently offers two classes of shares, Class A and Class B shares. The Class A and Class B shares differ only in that Class B shares are subject to a distribution plan adopted and administered pursuant to Rule 12b–1 under the 1940 Act. The 12b–1 fees with respect to the Class B Shares of each Portfolio of the Trust currently are limited to an annual rate of 0.25% of the average daily net assets attributable to the Class B shares of the Portfolio and may be increased to an annual rate of 0.50% by the Board of Trustees without shareholder approval.
9. AXA Equitable currently serves as investment manager (“Manager”) of each of the Portfolios. The Trust has received an exemptive order from the Commission that permits the Manager, or any entity controlling, controlled by, or under common control (within the meaning of Section 2(a)(9) of the 1940 Act) with the Manager, subject to certain conditions, including approval of the Board of Trustees of the Trust, and without the approval of shareholders, to appoint, dismiss, or replace investment sub-advisers (“Advisers”) and to amend investment advisory agreements.
10. Each Insurance Company, on its own behalf and on behalf of its Separate Accounts, proposes to exercise its contractual right to substitute a different underlying investment option for one of the current underlying investment options offered as a funding option under the Contracts. In particular, the Section 26 Applicants request an order from the Commission pursuant to Section 26(c) of the 1940 Act approving the proposed substitution (“Substitution”) of (i) Class A shares of the Multimanager Aggressive Equity Portfolio for Class A shares of the Multimanager Large Cap Growth Portfolio; and (ii) Class B shares of the Multimanager Aggressive Equity Portfolio for Class B shares of the Multimanager Large Cap Growth Portfolio.
11. The Section 26 Applicants propose the Substitution as part of a continued and overall business plan by each of the Insurance Companies to make its Contracts more attractive to existing Contract owners, Participants or prospective purchasers, as the case may be, and more efficient to administer and oversee.
12. Among the principal purposes of the Substitutions, the Section 26 Applicants assert the proposed Substitution is designed and intended to simplify the prospectuses and related materials with respect to the Contracts and the investment options available through the Separate Accounts. The Section 26 Applicants believe that the Replacement Portfolio and the Removed Portfolio overlap and largely duplicate one another by having substantially similar investment objectives, policies and risks, and that consolidating the Removed Portfolio into the Replacement Portfolio would simplify the Contract prospectuses and related materials provided to Contract owners, thereby reducing the potential for Contract owner confusion.
13. The Section 26 Applicants believe that the deletion of an overlapping investment option should not adversely affect Contract owners and Participants given that a similar investment option will remain available under the Contracts and the Contracts will offer the same number of investment options or, in those cases where the number of investment options is being reduced, continue to offer a significant number of alternative investment options offering a full range of investment objectives, strategies and Advisers (currently expected to range in number from 27 to 66 after the Substitution versus 28 to 67 before the Substitution).
14. The Removed Portfolio and the Replacement Portfolio have identical investment objectives and substantially similar investment policies. Each Portfolio seeks long-term growth of capital as its investment objective. Under normal circumstances, each Portfolio invests at least 80% of its net assets, plus borrowings for investment purposes, in equity securities. Under normal circumstances, the Removed Portfolio invests at least 80% of its net assets in the equity securities of U.S. large capitalization companies, and the Replacement Portfolio invests at least 80% of its net assets in equity securities, primarily investing in the securities of large capitalization growth companies but also investing, to a lesser extent, in the equity securities of small- and mid-capitalization growth companies. Although the Replacement Portfolio may invest in a broader range of companies to a greater extent than the Removed Portfolio, both Portfolios seek to achieve the same long-term investment goal by emphasizing investments in large capitalization U.S. companies.
15. Each Portfolio invests primarily in common stocks, but may invest in other securities that its respective Advisers believe provide opportunities for capital growth, such as preferred stocks, warrants and securities convertible into common stock. In addition, each Portfolio may invest in derivatives: the Removed Portfolio may invest up to approximately 10% of its net assets in futures and options, while the Replacement Portfolio may invest up to 25% of its net assets in derivatives, such as exchange-traded futures and options contracts on indices or other similar instruments.
16. To achieve its investment objectives, each Portfolio combines active and passive management strategies. With respect to each Portfolio, AXA Equitable allocates approximately 50% of the Portfolio's net assets to a portion of the Portfolio that seeks to achieve the total return performance of an index (the Russell 1000 Growth Index in the case of the Removed Portfolio and the Russell 3000 Growth Index for the Replacement Portfolio) while maintaining as minimal tracking error as possible (“Index Allocated Portion”). The Russell 1000 Growth Index includes those Russell 1000 companies (the 1,000 largest companies of the Russell 3000 Index) with higher price-to-book ratios and higher forecasted growth values, while the Russell 3000 Growth Index includes those Russell 3000 companies (the 3,000 largest U.S. securities) with higher price-to-book ratios and higher forecasted growth values. The Russell 3000 Growth Index generally has greater exposure to small- and mid-capitalization companies than the Russell 1000 Growth Index, and thus has greater exposure to the risks of investing in such companies. However, the average weighted market capitalization of each Portfolio is almost the same (approximately $76.3 billion for the Russell 1000 Growth Index and approximately $70.7 billion for the Russell 3000 Growth Index, each as of December 31, 2009).
17. With respect to each Portfolio, AXA Equitable allocates the remaining 50% of the Portfolio's net assets among the other portions of the Portfolio that are actively managed by multiple Advisers (the “Active Allocated Portions”) utilizing similar growth style strategies. The Active Allocated Portions of each Portfolio may invest, to a limited extent, in illiquid securities and in securities of foreign companies, including companies based in developing countries. The Replacement Portfolio's Active Allocated Portions may invest up to 25% of their total assets in foreign securities. The Active Allocated Portions of the Removed Portfolio also may invest in foreign securities, to a limited extent, but have no stated limit. Given the similarity between the Portfolios' holdings and investment objectives and strategies, the Trust intends to retain the Advisers to the Active Allocated Portions of the Removed Portfolio to manage the assets of the Active Allocated Portions of the Removed Portfolio that are transferred to the Replacement Portfolio in connection with the Substitution.
18. The Portfolios have substantially similar risk profiles. Each Portfolio is subject to the following principal risks: derivatives risk, equity risk, index strategy risk, large-cap company risk and leverage risk. The primary differences between the principal risks of the Portfolios are that the Replacement Portfolio also is subject to foreign securities risk, which is not a principal risk of the Removed Portfolio, and the Removed Portfolio also is subject to investment style risk, which is not a principal risk of the Replacement Portfolio. However, the Section 26 Applicants do not believe that these differences are significant. While the Replacement Portfolio has the flexibility to invest in foreign securities to a greater extent than the Removed Portfolio, each Portfolio's investments in foreign securities generally have been limited to a relatively small percentage of the Portfolio's assets. For instance, as of May 31, 2010, the Removed and Replacement Portfolios had invested approximately 1.8% and 3.8%, respectively, in foreign securities. In addition, while the Removed Portfolio is subject to investment style risk because its Advisers primarily utilize growth investing styles, both of the Portfolios seek long-term growth of capital, invest in similar types of securities and generally are classified by third party mutual fund rating organizations as aggressive equity portfolios (
19. As provided in the chart below, the Section 26 Applicants anticipate that the Replacement Portfolio's total annual operating expense ratio (taking into account any expense waivers or reimbursements) will be lower than that of the Removed Portfolio immediately after the Substitution. The chart below compares the advisory fees and total annual operating expenses of the Class A and Class B shares of the Removed Portfolio and the Replacement Portfolio for the fiscal year ended December 31, 2009. Class A shares of each Portfolio are not subject to plans adopted pursuant to Rule 12b–1 under the 1940 Act.
As
20. The Section 26 Applicants currently expect that the proposed Substitution will be carried out on or about August 1, 2010, or as soon as reasonably practicable thereafter (“Substitution Date”) and by supplements to the prospectuses for the Contracts and Separate Accounts, which were delivered to Contract owners and Participants at least thirty (30) days before the proposed Substitution, each Insurance Company will notify all Contract owners and Participants of its intention to take the necessary actions, including seeking the order requested by the application, to substitute shares of the Replacement Portfolio for the Removed Portfolio as described herein. The supplements advised Contract owners and Participants that, from the date of the supplement until the date of the proposed Substitution, Contract owners and Participants are permitted to make transfers of Contract value (or annuity unit value) out of a Removed Portfolio subaccount to one or more other subaccounts without the transfers (or exchanges) being treated as one of a limited number of permitted transfers (or exchanges) or a limited number of transfers (or exchanges) permitted without a transfer charge, as applicable. The supplements also will inform Contract owners and Participants that the Insurance Companies will not exercise any rights reserved under any Contract to impose additional restrictions on transfers until at least 30 days after the proposed Substitution.
21. Each Insurance Company also has sent or will send Contract owners and Participants prospectuses for the Replacement Portfolio prior to the Substitution. The Section 26 Applicants have sent or will send the appropriate prospectus supplement (or other notice, in the case of Contracts no longer actively marketed and for which there are a relatively small number of existing Contract owners or Participants), containing this disclosure to all existing Contract owners and Participants. Prospective purchasers and new purchasers of Contracts will be provided with a Contract prospectus and the supplement containing disclosure regarding the proposed Substitution, as well as a prospectus and supplement for the Replacement Portfolio. The Contract prospectus and supplement, and the prospectus and supplement for the Replacement Portfolio will be delivered to purchasers of new Contracts in accordance with all applicable legal requirements.
22. In addition to the prospectus supplements distributed to Contract owners and Participants, within five business days after the Substitution Date, Contract owners and Participants will be sent a written notice of the Substitution informing them that the Substitution was carried out and that they may transfer all Contract value or cash value under a Contract in a subaccount invested in the Replacement Portfolio on the date of the notice to one or more other subaccounts available under their Contract at no cost and without regard to the usual limit on the frequency of transfers among the variable account options. The notice will also reiterate that (other than with respect to implementing policies and procedures designed to prevent
23. Each Insurance Company also is seeking approval of the proposed Substitution from any state insurance regulators whose approval may be necessary or appropriate. The proposed Substitution will take place at relative net asset value determined on the Substitution Date pursuant to Section 22 of the 1940 Act and Rule 22c–1 thereunder with no change in the amount of any Contract owner's or Participant's Contract value, cash value, or death benefit or in the dollar value of his or her investment in the Separate Accounts. The proposed Substitution will be effected by redeeming shares of the Removed Portfolio in cash and/or in-kind on the Substitution Date at their net asset value and using the proceeds of those redemptions to purchase shares of the Replacement Portfolio at their net asset value on the same date. All in-kind redemptions will be effected in accordance with the conditions set forth in the no-action letter issued by the staff of the Commission to Signature Financial Group, Inc. (pub. avail. Dec. 28, 1999).
24. Moreover, the Section 26 Applicants state that Contract owners and Participants will not incur any fees or charges as a result of the proposed Substitution, nor will their rights or insurance benefits or the Insurance Companies' obligations under the Contracts be altered in any way. Consequently, all expenses incurred in connection with the proposed Substitution, including any brokerage, legal, accounting, and other fees and expenses, will be paid by the Insurance Companies. In addition, the proposed Substitution will not impose any tax liability on Contract owners or Participants. The proposed Substitution will not cause the Contract fees and charges currently being paid by Contract owners and Participants to be greater after the Substitution than before the Substitution; all Contract-level fees will remain the same after the Substitution. In addition, because the Substitution will not be treated as a transfer for purposes of assessing transfer charges or computing the number of permissible transfers under the Contracts, no fees will be charged on the transfers made at the time of the Substitution.
25. The Section 26 Applicants represent that with respect to those Contract owners or Participants on the date of the Substitution, the Insurance Companies will reimburse the subaccounts investing in the Replacement Portfolio for a period of two years after the date of the Substitution, on the last business day of each fiscal period (not to exceed a fiscal quarter), such that the sum of the Replacement Portfolio's total operating expense ratio (taking into account any expense waivers and reimbursements) and subaccount expense ratio (asset-based fees and charges deducted on a daily basis from subaccount assets and reflected in the calculations of subaccount unit value) for such period will not exceed, on an annualized basis, the sum of the Removed Portfolio's total operating expense ratio (taking into account any expense waivers and reimbursements) and subaccount expense ratio for fiscal year 2009.
1. Section 26(c) of the 1940 Act prohibits the depositor of a registered unit investment trust that invests in the securities of a single issuer from substituting the securities of another issuer without Commission approval. Section 26(c) provides that “[t]he Commission shall issue an order approving such substitution if the evidence establishes that it is consistent with the protection of investors and the purposes fairly intended by the policy and provisions of this title.”
2. The Section 26 Applicants assert that the proposed Substitution involves a substitution of securities within the meaning of Section 26(c) of the 1940 Act and therefore request an order from the Commission pursuant to Section 26(c) approving the proposed Substitutions.
3. The Section 26 Applicants state they have reserved the right under the Contracts to substitute shares of another underlying investment option for one of the current underlying investment options offered as a funding option under the Contracts both to protect themselves and their Contract owners and Participants in situations where either might be harmed or disadvantaged by events affecting the issuer of the securities held by a Separate Account and to preserve the opportunity to replace such shares in situations where a substitution could benefit the Insurance Companies and their respective Contract owners and Participants.
4. The Section 26 Applicants argue that the Removed Portfolio and the Replacement Portfolio have identical investment objectives and substantially similar investment policies and risks. In addition, the Section 26 Applicants clarify that the proposed Substitution retains for Contract owners and Participants the investment flexibility that is a central feature of the Contracts. The Section 26 Applicants assert that any impact on the investment programs of affected Contract owners and Participants, including the appropriateness of the available investment options, should therefore be negligible.
5. Furthermore, the Section 26 Applicants claim that the Substitution will permit the Insurance Companies to present information to their Contract owners and Participants in a simpler and more concise manner. It is anticipated that after the Substitution, Contract owners and Participants will be provided with disclosure documents that contain a simpler presentation of the available investment options under their Contracts.
6. In addition, the Section 26 Applicants point out that as a result of the proposed Substitution, Contract owners and Participants with subaccount balances currently invested in the Removed Portfolio will have a lower total operating expense ratio after the Substitution as Contract owners or Participants with subaccount balances invested in the Replacement Portfolio. In this regard, each Insurance Company has agreed to impose certain expense limits, as discussed earlier in the application, to ensure that Contract owners and Participants do not incur higher expenses as a result of the Substitution for a period of two years after the Substitution.
7. In addition to the foregoing, the Section 26 Applicants generally submit that the proposed Substitution meets the standards that the Commission and its staff have applied to similar substitutions that the Commission previously has approved. The Section 26 Applicants also submit that the proposed Substitution is not of the type that Section 26(c) was designed to prevent. Unlike traditional unit investment trusts where a depositor could only substitute investment securities in a manner that permanently affected all the investors in the trust, the Contracts provide each Contract owner or Participant with the right to exercise his or her own judgment, and transfer Contract values and cash values into and among other investment options available to Contract owners or Participants under their Contracts.
8. Moreover, the Section 26 Applicants will offer Contract owners and Participants the opportunity to transfer amounts out of the affected subaccounts without any cost or other penalty (other than those necessary to implement policies and procedures designed to prevent disruptive transfer and other market timing activity) that may otherwise have been imposed for a period beginning on the date of the supplement notifying Contract owners and Participants of the proposed Substitution and ending no earlier than thirty (30) days after the Substitution. The proposed Substitution, therefore, will not result in the type of costly forced redemption that Section 26(c) was designed to prevent.
9. The Section 26 Applicants also note that the proposed Substitution is also unlike the type of substitution that Section 26(c) was designed to prevent in that by purchasing a Contract or participating in a group Contract, Contract owners and Participants select much more than a particular underlying fund in which to invest their Contract values; they also select the specific type of insurance coverage offered by the Section 26 Applicants under the applicable Contract, as well as numerous other rights and privileges set forth in the Contract. Contract owners and Participants also may have considered the Insurance Company's size, financial condition, and its reputation for service in selecting their Contract. These factors will not change as a result of the proposed Substitution, nor will the annuity, life or tax benefits afforded under the Contracts held by any of the affected Contract owners or Participants.
10. The Section 17 Applicants request an order pursuant to Section 17(b) of the 1940 Act exempting them from the provisions of Section 17(a) of the 1940 Act to the extent necessary to permit them to carry out the In-Kind Transactions in connection with the proposed Substitution.
11. Section 17(a)(1) of the 1940 Act, in relevant part, prohibits any affiliated person of a registered investment company, or any affiliated person of such a person, acting as principal, from knowingly selling any security or other property to that company. Section 17(a)(2) of the 1940 Act generally prohibits the same persons, acting as principals, from knowingly purchasing any security or other property from the registered investment company.
12. Section 17(b) of the 1940 Act provides that the Commission may, upon application, issue an order exempting any proposed transaction from the provisions of Section 17(a) if: (i) the terms of the proposed transactions are reasonable and fair and do not involve overreaching on the part of any person concerned; (ii) the proposed transactions are consistent with the policy of each registered investment company concerned; and (iii) the proposed transactions are consistent with the general purposes of the 1940 Act.
13. The Removed Portfolio and the Replacement Portfolio may be deemed to be affiliated persons of one another, or affiliated persons of an affiliated person. Shares held by a separate account of an insurance company are legally owned by the insurance company. Thus, the Insurance Companies and their affiliates collectively own substantially all of the shares of the Trust. Accordingly, the Trust and its respective Portfolios may be deemed to be under the control of the Insurance Companies notwithstanding the fact that the Contract owners and Participants may be considered the beneficial owners of those shares held in the Separate Accounts. If the Trust is under the common control of the Insurance Companies, then each Insurance Company is an affiliated person or an affiliated person of an affiliated person of the Trust and its respective Portfolios. If the Trust and its respective Portfolios are under the control of the Insurance Companies, then the Trust and its respective affiliates are affiliated persons of the Insurance Companies.
14. Regardless of whether the Insurance Companies can be considered to control the Trust and its Portfolios, the Insurance Companies may be deemed to be affiliated persons of the Trust and its Portfolios, including the Removed Portfolio and the Replacement Portfolio, because the Insurance Companies (which are under common control) and their affiliates own of record more than 5% of the outstanding shares. Likewise, each of the Trust's Portfolios may be deemed to be an affiliated person of each Insurance Company. As a result of these relationships, the Removed Portfolio may be deemed to be an affiliated person of an affiliated person (the Insurance Companies or the Separate Accounts) of the Replacement Portfolio, and vice versa.
15. The proposed In-Kind Transactions could be seen as the indirect purchase of shares of the Replacement Portfolio with portfolio securities of the Removed Portfolio and the indirect sale of portfolio securities of the Removed Portfolio for shares of the Replacement Portfolio. Pursuant to this analysis, the proposed In-Kind Transactions also could be categorized as a purchase of shares of the Replacement Portfolio by the Removed Portfolio, acting as principal, and a sale of portfolio securities by the Removed Portfolio, acting as principal, to the Replacement Portfolio. In addition, the proposed In-Kind Transactions could be viewed as a purchase of securities from the Removed Portfolio and a sale of securities to the Replacement Portfolio by each Insurance Company (or the Separate Accounts), acting as principal. If categorized in this manner, the proposed In-Kind Transactions may be deemed to contravene Section 17(a) due to the affiliated status of these participants.
16. The Section 17 Applicants assert that the In-Kind Transactions will be effected at the respective net asset values of the Removed Portfolio and the Replacement Portfolio, as determined in accordance with the procedures disclosed in the registration statement for the Trust and as required by Rule 22c–1 under the 1940 Act. The In-Kind Transactions will not change the dollar value of any Contract owner's or Participant's investment in any of the Separate Accounts, the value of any Contract, the accumulation value or other value credited to any Contract, or the death benefit payable under any Contract. Immediately after the proposed In-Kind Transactions, the value of a Separate Account's investment in the Replacement Portfolio will equal the value of its investments in the Removed Portfolio (together with the value of any pre-existing investments in the Replacement Portfolio) immediately before the In-Kind Transactions.
17. Rule 17a–7 under the 1940 Act exempts from the prohibitions of Section 17(a), subject to certain enumerated conditions, a purchase or sale transaction between registered investment companies or separate series of registered investment companies, which are affiliated persons, or affiliated persons of affiliated persons, of each other, between separate series of a registered investment company, or between a registered investment company or a separate series of a registered investment company and a person which is an affiliated person of such registered investment company (or affiliated person of such person) solely by reason of having a common investment adviser or investment advisers which are affiliated persons of
18. However, one of the conditions enumerated in Rule 17a–7 requires that the transaction be a purchase or sale for no consideration other than cash payment against prompt delivery of a security for which market quotations are readily available. If the proposed In-Kind Transactions are viewed as purchases and sales of securities, the consideration in the proposed redemptions of shares of the Removed Portfolio and the proposed purchases of shares of the Replacement Portfolio would not be cash, but rather, the portfolio securities received from the Removed Portfolio.
19. The Section 17 Applicants will ensure that the Trust will carry out the proposed In-Kind Transactions in conformity with the conditions of Rule 17a–7, except that the consideration paid for the securities being purchased or sold will not be cash.
20. For the reasons stated above, the Section 17 Applicants submit that the terms of the proposed In-Kind Transactions, including the consideration to be paid and received, as described in the application, are reasonable and fair and do not involve overreaching on the part of any person concerned. Furthermore, the Section 17 Applicants represent that the proposed In-Kind Transactions will be consistent with the policies of the Removed and corresponding Replacement Portfolios, as recited in their respective current registration statements, and that the proposed In-Kind Transactions are consistent with the general purposes of the 1940 Act and do not present any conditions or abuses that the 1940 Act was designed to prevent.
For the reasons set forth in the application, the Applicants each respectively request that the Commission issue an order of approval pursuant to Section 26(c) of the 1940 Act and an order of exemption pursuant to Section 17(b) of the 1940 Act.
For the Commission, by the Division of Investment Management, pursuant to delegated authority.
On May 21, 2010, Financial Industry Regulatory Authority, Inc. (“FINRA”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The proposed rule change would amend FINRA's Certificate of Incorporation to specify the quorum required for a meeting of FINRA members and the quorum required to take action on a matter where a separate vote by a class or group is required.
Section 215(c) of the General Corporation Law, as currently in effect, provides that the certificate of incorporation or bylaws of a nonstock corporation may specify the number of members having voting power who shall be present or represented by proxy at any meeting in order to constitute a quorum for the transaction of any business and, that in the absence of such specification, one-third of the members of such corporation shall constitute a quorum at a meeting of such members.
On August 1, 2010, the General Corporation Law will be amended to, among other things, add new Section 215(c)(4), which section will add a new default quorum requirement for instances where a separate vote by a class or group of members is required. Specifically, effective August 1, 2010, unless the certificate of incorporation or bylaws of a nonstock corporation provides otherwise, where a separate vote by a class or group of members is required, a majority of the members of such class or group shall constitute a quorum entitled to take action with respect to the vote on such matter.
In anticipation of the foregoing amendment to the General Corporation Law, FINRA has proposed to amend its Certificate of Incorporation to set forth quorum requirements for its meetings of members, including in instances where a separate vote by a class or group is required. Specifically, FINRA has proposed that, at all meetings of its members, the presence in person or by proxy of one-third of the members entitled to vote at the meeting shall constitute a quorum; provided, however, where a separate vote by a class or group of members is required, the presence in person or by proxy of one-third of the members of such class or group shall constitute a quorum with respect to the vote on that matter. By incorporating these quorum requirements into the Certification of Incorporation, FINRA has represented that the proposed rule change would maintain FINRA's current one-third quorum requirement where a separate vote of classes or groups of members is required instead of resorting to the default requirement in the General Corporation Law.
After careful review, the Commission finds that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a national securities association.
The Commission notes that the proposed rule change would codify FINRA's current quorum requirements. By clearly specifying FINRA's quorum requirements in its Certificate of Incorporation, the Commission believes that the proposed rule change would provide greater transparency about FINRA's deliberative and voting processes, which should facilitate the ability of FINRA's members to conduct business at meetings and exercise their voting rights. Therefore, the Commission believes that the proposed rule change is consistent with the Act.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”)
NASDAQ is filing with the Commission a proposal for the NASDAQ Options Market (“NOM” or “Exchange”) to amend Chapter IV, Supplementary Material .02 to Section 6 (Series of Options Contracts Open for Trading) to expand the Exchange's $1 Strike Price Program (the “$1 Strike Program” or “Program”)
The text of the proposed rule change is available from NASDAQ's Web site at
In its filing with the Commission, NASDAQ included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. NASDAQ has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
This proposed rule change is based on a filing of NASDAQ OMX PHLX, Inc. (“Phlx”) that was recently approved by the Commission.
Currently, the $1 Strike Program allows the Exchange to select a total of 55 individual stocks on which option series may be listed at $1 strike price intervals. In order to be eligible for selection into the Program, the underlying stock must close below $50 in its primary market on the previous trading day. If selected for the Program, the Exchange may list strike prices at $1 intervals from $1 to $50, but no $1 strike price may be listed that is greater than $5 from the underlying stock's closing price in its primary market on the previous day. The Exchange may also list $1 strikes on any other option class designated by another securities exchange that employs a similar Program under their respective rules.
The restrictions in the current $1 Strike Program remain and are not proposed to be modified by this filing. The Exchange may not list $1 strike intervals on any issue where the strike price is greater than $50. The Exchange may not list long-term option series (“LEAPS”)
The $1 Strike Program has been extremely successful since it was initiated as a pilot program in 2008,
The Exchange now proposes to expand the Program to allow the Exchange to select a total of 150 individual stocks on which option series may be listed at $1 strike price intervals. The proposal would expand $1 strike offerings to market participants (
As stated in Commission orders approving the initial $1 strike price pilot programs of options exchanges,
The Exchange notes that, in addition to options classes that are trading pursuant to the $1 strike programs of options exchanges, there are also options trading at $1 strike intervals on approximately 282 Exchange Traded Fund Shares (“ETFs”),
With regard to the impact of this proposal on system capacity, the Exchange has analyzed its capacity and represents that it and OPRA have the necessary systems capacity to handle the potential additional traffic associated with the listing and trading of an expanded number of series in the $1 Strike Program.
The Exchange believes that the $1 Strike Program has provided investors with greater trading opportunities and flexibility and the ability to more closely tailor their investment and risk management strategies and decisions to the movement of the underlying security. Furthermore, the Exchange has not detected any material proliferation of illiquid options series resulting from the narrower strike price intervals. For these reasons, the Exchange requests an expansion of the current Program and the opportunity to provide investors with additional strikes for investment, trading, and risk management purposes.
Finally, the proposal also corrects an internal rule reference in subsection (c) of Chapter IV, Supplementary Material .06 to Section 6, to conform the reference to a re-numbering of Supplementary Material .06 in a previous filing.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act
The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
Written comments were neither solicited nor received.
Because the foregoing proposed rule change does not significantly affect the protection of investors or the public interest, does not impose any significant burden on competition, and, by its terms, does not become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
The Exchange has requested that the Commission waive the 30-day operative delay. The Commission believes that waiver of the operative delay is consistent with the protection of investors and the public interest because the proposal is substantially similar to that of another exchange that has been approved by the Commission.
At any time within 60 days of the filing of the proposed rule change, the Commission may summarily abrogate such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an e-mail to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549–1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”)
The Exchange proposes to modify the CBOE Stock Exchange (“CBSX”) Fee Schedule to expand the application of the fee for any trade that is the stock component of a qualified contingent trade. The text of the proposed rule change is available on the Exchange's Web site (
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant parts of such statements.
The CBSX Fees Schedule currently lists a fee for executions of the stock component of a stock-option cross trade. Stock-option cross trades are only one form of qualified contingent trades. Other forms of qualified contingent trades can include, for example, stock-future trades. CBSX would like to amend its Fees Schedule so that cross trades on CBSX that are the stock component of a larger qualified contingent trade are covered by the $0.0010 per share fee.
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”)
CBOE does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.
No written comments were solicited or received with respect to the proposed rule change.
The proposed rule change is designated by the Exchange as establishing or changing a due, fee, or other charge, thereby qualifying for
At any time within 60 days of the filing of the proposed rule change, the Commission may summarily abrogate such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposal is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an e-mail to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549–1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”)
The Exchange proposes to extend the pilot program that offers liquidity takers a reduced transaction fee structure for certain bond trades executed on the NYSE Bonds
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The New York Stock Exchange LLC (the “Exchange” or the “NYSE”) proposes to extend the pilot program that offers liquidity takers a reduced transaction fee structure for certain bond trades executed on the NYSE Bonds
This pilot program commenced in January 2008
The pilot program reduces transaction fees charged to liquidity takers for transactions executed on NYSE Bonds with a staggered transaction fee schedule based on the number of bonds purchased or sold in excess of ten (10) bonds. The extended fee filing pilot program provides for the following transaction fee schedule: (1) When the liquidity taker purchases or sells from one to ten (10) bonds, the Exchange will charge an execution fee of $0.50 per bond; (2) when the liquidity taker purchases or sells from eleven (11) to twenty five (25) bonds, the Exchange will charge an execution fee of $0.20 per
For example, if a liquidity taker purchases or sells five (5) bonds, the Exchange will charge $.50 per bond, or a total of $2.50 for execution fees. If a liquidity taker purchases or sells twenty (20) bonds, the Exchange will charge $.20 per bond or a total of $4.00 for execution fees. If a liquidity taker purchases or sells thirty (30) bonds, the Exchange will charge $.10 per bond or a total of $3.00 for execution fees.
The Exchange will continue to impose a $100 execution fee cap per transaction.
The Exchange will seek to file with the Commission, a proposal to make this liquidity taker program permanent. Accordingly, the Exchange proposes to extend the pilot program for an additional six (6) months in order to give the Exchange the necessary time to complete the 19b–4 process regarding the program permanency filing.
The Exchange believes that the proposed rule change is consistent with the provisions of Section 6
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
No written comments were solicited or received with respect to the proposed rule change.
The foregoing rule change is effective upon filing pursuant to Section 19(b)(3)(A)
At any time within 60 days of the filing of such proposed rule change, the Commission may summarily abrogate such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an e-mail to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549–1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On May 11, 2010, the Chicago Board Options Exchange, Incorporated (“CBOE” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Recently, the Commission authorized CBOE to list and trade options on the SPDR Gold Trust,
Under current Rule 5.3, only Units (also referred to herein as exchange traded fund (“ETFs”)) representing (i) interests in registered investment companies (or series thereof) organized as open-end management investment companies, unit investment trusts or similar entities that hold portfolios of securities and/or financial instruments including, but not limited to, stock index futures contracts, options on futures, options on securities and indexes, equity caps, collars and floors, swap agreements, forward contracts, repurchase agreements and reverse purchase agreements (the “Financial Instruments”), and money market instruments, including, but not limited to, U.S. government securities and repurchase agreements (the “Money Market Instruments”) comprising or otherwise based on or representing investments in indexes or portfolios of securities and/or Financial Instruments and Money Market Instruments (or that hold securities in one or more other registered investment companies that themselves hold such portfolios of securities and/or Financial Instruments and Money Market Instruments), or (ii) interests in a trust or similar entity that holds a specified non-U.S. currency deposited with the trust or similar entity when aggregated in some specified minimum number may be surrendered to the trust by the beneficial owner to receive the specified non-U.S. currency and pays the beneficial owner interest and other distributions on deposited non-U.S. currency, if any, declared and paid by the trust; or (iii) commodity pool interests principally engaged, directly or indirectly, in holding and/or managing portfolios or baskets of securities, commodity futures contracts, options on commodity futures contracts, swaps, forward contracts and/or options on physical commodities and/or non-U.S. currency (“Commodity Pool Units”), or (iv) represent interests in the streetTRACKS Gold Trust or the iShares COMEX Gold Trust or the iShares Silver Trust or the ETFS Silver Trust or the ETFS Gold Trust or the ETFS Palladium Trust or the ETFS Platinum Trust; or (v) represents an interest in a registered investment company (“Investment Company”) organized as an open-end management investment company or similar entity, that invests in a portfolio of securities selected by the Investment Company's investment adviser consistent with the Investment Company's investment objectives and policies, which is issued in a specified aggregate minimum number in return for a deposit of a specified portfolio of securities and/or a cash amount with a value equal to the next determined net asset value (“NAV”), and when aggregated in the same specified minimum number, may be redeemed at a holder's request, which holder will be paid a specified portfolio of securities and/or cash with a value equal to the next determined NAV (“Managed Fund Share”) are eligible as underlying securities for options traded on the Exchange.
Apart from allowing the Sprott Physical Gold Trust to be an underlying for options traded on the Exchange as described above, the listing standards for ETFs will remain unchanged from those that apply under current Exchange rules. ETFs on which options may be listed and traded must still be listed and traded on a national securities exchange and must satisfy the other listing standards set forth in Interpretation and Policy .06 to Rule 5.3.
Specifically, in addition to satisfying the aforementioned listing requirements, Units must meet either: (1) The criteria and guidelines under Rule 5.3 and Interpretation and Policy .01 to Rule 5.3,
The Exchange states that the current continued listing standards for options on ETFs will apply to options on the Sprott Physical Gold Trust. Specifically, under Interpretation and Policy .08 to Rule 5.4, options on Units may be subject to the suspension of opening transactions as follows: (1) In the case of Units listed pursuant to Interpretation and Policy .06(v)(E)(y) to Rule 5.3, following the initial twelve-month period beginning upon the commencement of trading of the Units, if there are fewer than 50 record and/or beneficial holders of the Units for 30 or more consecutive trading days; or (2) in the case of Units listed pursuant to Interpretation and Policy .06(v)(E)(x) to Rule 5.3, in accordance with the terms of paragraphs (a)–(d) of Interpretation and Policy .01 to Rule 5.4; or (3) the value of the index or portfolio of securities, non-U.S. currency, or portfolio of commodities including commodity futures contracts, options on commodity futures contracts, swaps, forward contracts and/or options on physical commodities and/or Financial Instruments and Money Market Instruments on which Units are based is no longer calculated or available; or (4) such other event occurs or condition exists that in the opinion of the Exchange makes further dealing on the Exchange inadvisable.
Additionally, the Sprott Physical Gold Trust shall not be deemed to meet the requirements for continued approval, and the Exchange shall not open for trading any additional series of option contracts of the class covering the Sprott Physical Gold Trust, if the Sprott Physical Gold Trust ceases to be an “NMS stock” as provided for in paragraph (f) of Interpretation and Policy .01 of Rule 5.4 or the Sprott Physical Gold Trust is halted from trading on its primary market.
The addition of the Sprott Physical Gold Trust to Interpretation and Policy .06 to Rule 5.3 will not have any effect on the rules pertaining to position and exercise limits
The Exchange represents that its surveillance procedures applicable to trading in options on the Sprott Physical Gold Trust will be similar to those applicable to all other options on other Units currently traded on the Exchange. The Exchange represents that its surveillance procedures applicable to trading in options on the Sprott Physical Gold Trust will be similar to those applicable to all other options on other ETFs currently traded on the Exchange. Also, the Exchange may obtain information from the New York Mercantile Exchange, Inc. (“NYMEX”) (a member of the Intermarket Surveillance Group) related to any financial instrument that is based, in whole or in part, upon an interest in or performance of gold.
After careful consideration, the Commission finds that the proposed rule change submitted by CBOE is
As a national securities exchange, the CBOE is required under Section 6(b)(1) of the Act
Sprott Options will trade as options under the trading rules of the CBOE. These rules, among other things, are designed to avoid trading through better displayed prices for Sprott Options available on other exchanges and, thereby, satisfy CBOE's obligation under the Options Order Protection and Locked/Crossed Market Plan.
CBOE has represented that it has surveillance programs in place for the listing and trading of Sprott Options. For example, CBOE may obtain trading information via the ISG from the NYMEX related to any financial instrument traded there that is based, in whole or in part, upon an interest in, or performance of, gold. Additionally, the listing and trading of Sprott Options will be subject to the exchange's rules pertaining to position and exercise limits
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
NASDAQ OMX BX, Inc. (the “Exchange”) proposes to amend the Rules of the Boston Options Exchange Group, LLC (“BOX”) to enable the listing and trading on BOX of options on the ETFS Gold Trust, the ETFS Silver Trust, the ETFS Palladium Trust and the ETFS Platinum Trust. The text of the proposed rule change is available from the principal office of the Exchange, at the Commission's Public Reference Room and also on the Exchange's Internet Web site at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text
Recently, the U.S. Securities and Exchange Commission (“SEC” or “Commission”) authorized the listing and trading on BOX of options on the SPDR Gold Trust
Under current Chapter IV, Section 3(i) of the BOX Rules, only Exchange-Traded Fund Shares, or ETFs, that are traded on a national securities exchange and are defined as an “NMS” stock under Rule 600 of Regulation NMS, and that (i) represent interests in registered investment companies (or series thereof) organized as open-end management investment companies, unit investment trusts or similar entities that hold portfolios of securities and/or financial instruments, including, but not limited to, stock index futures contracts, options on futures, options on securities and indices, equity caps, collars and floors, swap agreements, forward contracts, repurchase agreements and reverse repurchase agreements (the “Financial Instruments”), and money market instruments, including, but not limited to, U.S. government securities and repurchase agreements (the “Money Market Instruments”) comprising or otherwise based on or representing investments in broad based indexes or portfolios of securities and/or Financial Instruments and Money Market Instruments (or that hold securities in one or more other registered investment companies that themselves hold such portfolios of securities and/or Financial Instruments and Money Market Instruments) or (ii) represent interests in a trust that holds a specified non-U.S. currency or currencies deposited with the trust or similar entity when aggregated in some specified minimum number may be surrendered to the trust by the beneficial owner to receive the specified non-U.S. currency or currencies and pays the beneficial owner interest and other distributions on the deposited non-U.S. currency or currencies, if any, declared and paid by the trust (“Currency Trust Shares”) or (iii) represent commodity pool interests principally engaged, directly or indirectly, in holding and/or managing portfolios or baskets of securities, commodity futures contracts, options on commodity futures contracts, swaps, forward contracts and/or options on physical commodities and/or non-U.S. currency (“Commodity Pool ETFs”) or (iv) are issued by the SPDR® Gold Trust or the iShares COMEX Gold Trust or the iShares Silver Trust are eligible as underlying securities for options traded on BOX.
Apart from allowing the ETFS Gold Trust, the ETFS Silver Trust, the ETFS Palladium Trust and the ETFS Platinum Trust to be underlying securities for options traded on BOX, as described above, the listing standards for ETFs will remain unchanged from those that apply under current BOX rules. ETFs on which options may be listed and traded must still be listed and traded on a national securities exchange and must satisfy the other listing standards set forth in Chapter IV, Section 3(i) of the BOX Rules.
Specifically, in addition to satisfying the aforementioned listing requirements, ETFs must either (1) meet the criteria and guidelines set forth in paragraphs (a) and (b) of Chapter IV, Section 3 or (2) be available for creation or redemption each business day from or through the issuing trust, investment company, commodity pool or other entity in cash or in kind at a price related to net asset value, and the issuer must be obligated to issue Exchange-Traded Fund Shares in a specified aggregate number even if some or all of the investment assets and/or cash required to be deposited have not been received by the issuer, subject to the condition that the person obligated to deposit the investment assets has undertaken to deliver them as soon as possible and such undertaking is secured by the delivery and maintenance of collateral consisting of cash or cash equivalents satisfactory to the issuer of the Exchange-Traded Fund Shares, all as provided in the Exchange-Traded Fund Shares' prospectus.
The Exchange states that the current continued listing standards for options on ETFs will apply to options on the ETFS Gold Trust, the ETFS Silver Trust, the ETFS Palladium Trust and the ETFS Platinum Trust. Specifically, under Chapter IV, Section 4(h) of the BOX Rules, options on Exchange-Traded Fund Shares may be subject to the suspension of opening transactions as follows: (1) Following the initial twelve-month period beginning upon the commencement of trading of the Exchange-Traded Fund Shares, there are fewer than 50 record and/or beneficial holders of the Exchange-Traded Fund Shares for 30 or more consecutive trading days; (2) the value of the underlying silver, gold, palladium or platinum, respectively, is no longer calculated or available; or (3) such other event occurs or condition exists that in the opinion of the Exchange makes further dealing in such options on BOX inadvisable. Additionally, the ETFS Gold Trust, the ETFS Silver Trust, the ETFS Palladium Trust and the ETFS Platinum Trust shall not be deemed to meet the requirements for continued approval, and BOX shall not open for trading any additional series of option contracts of the class covering the ETFS Gold Trust, the ETFS Silver Trust, the ETFS Palladium Trust and the ETFS Platinum Trust, respectively, if the ETFS Gold Trust, the ETFS Silver Trust, the ETFS Palladium Trust and the ETFS Platinum Trust ceases to be an “NMS stock” as provided for in Chapter IV, Section 4(b)(vi) of the BOX Rules or the ETFS Gold Trust, the ETFS Silver Trust, the ETFS Palladium Trust and the ETFS Platinum Trust is halted from trading on its primary market. The addition of the ETFS Gold Trust, the ETFS Silver Trust, the ETFS Palladium Trust and the ETFS Platinum Trust to Chapter IV, Section 3(i) of the BOX Rules will not have any effect on the rules pertaining to position and exercise limits
The Exchange represents that its surveillance procedures applicable to trading in options on the ETFS Gold Trust, the ETFS Silver Trust, the ETFS Palladium Trust and the ETFS Platinum Trust will be similar to those applicable to all other options on other ETFs currently traded on BOX. Also, the Exchange may obtain information from the New York Mercantile Exchange, Inc.
The Exchange believes that the proposal is consistent with the requirements of Section 6(b) of the Act,
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.
The Exchange has neither solicited nor received comments on the proposed rule change.
Because the foregoing proposed rule change: (1) Does not significantly affect the protection of investors or the public interest; (2) does not impose any significant burden on competition; and (3) by its terms does not become operative for 30 days after the date of this filing, or such shorter time as the Commission may designate if consistent with the protection of investors and the public interest, the proposed rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed under Rule 19b–4(f)(6) normally does not become operative for 30 days after the date of filing. However, Rule 19b–4(f)(6)(iii) permits the Commission to designate a shorter time if such action is consistent with the protection of investors and the public interest. The Exchange requests that the Commission waive the 30-day operative delay so that the Exchange can list and trade options on the ETFS Gold Trust, the ETFS Silver Trust, the ETFS Palladium Trust, and the ETFS Platinum Trust immediately. The Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest to permit the Exchange to list and trade options on the ETFS Gold Trust, the ETFS Silver Trust, the ETFS Palladium Trust, and the ETFS Platinum Trust without delay.
At any time within 60 days of the filing of the proposed rule change, the Commission may summarily abrogate such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an e-mail to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities Exchange Commission, 100 F Street, NE., Washington, DC 20549–1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange proposes to amend its Schedule of Fees and Charges for Exchange Services (the “Schedule”) effective July 1, 2010. The text of the proposed rule change is available on NYSE Amex's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
Currently, the Exchange aggregates all of an ATP Holder's volume at the trading permit level for purposes of the Firm Proprietary Manual tiers. Recently, certain ATP Holders have requested that the Firm Proprietary Manual tiered pricing be calculated at the initiating firm level. By this filing, the Exchange proposes to allow its ATP Holders to elect to have their Firm Proprietary Manual billing calculated at the initiating firm level. The Exchange's default billing will continue to aggregate volume at the trading permit level, and ATP Holders must elect this new billing option. If elected, this option will allow Joint Back Office operations to pass-through the pricing associated with the tiers at NYSE Amex more effectively. The Exchange believes this proposed elective billing option is reasonable and equitable and applies uniformly to all ATP Holders.
The Exchange believes that the proposed rule change is consistent with the provisions of Section 6 of the Securities Exchange Act of 1934 (the “Act”),
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
No written comments were solicited or received with respect to the proposed rule change.
The foregoing rule change is effective upon filing pursuant to Section 19(b)(3)(A)
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an e-mail to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549–1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”)
The Exchange proposes to amend Rule 903 Commentary .05 to establish strike price intervals for options on Trust Issued Receipts. The text of the proposed rule change is attached as Exhibit 5 to the 19b–4 form. A copy of this filing is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The purpose of this filing is to amend Rule 903 Commentary .05, to establish strike price intervals for options on Trust Issued Receipts (“TIRs”), including Holding Company Depositary Receipts (“HOLDRs”), in $1 or greater strike price intervals, where the strike price is $200 or less, and $5 strike price intervals where the strike price is greater than $200.
Currently, the strike price intervals for options on TIRs are as follows: (1) $2.50 or greater where the strike price is $25.00 or less; (2) $5.00 or greater where the strike price is greater than $25.00; and (3) $10.00 or greater where the strike price is greater than $200.
The Exchange is seeking to permit $1 strikes for options on TIRs where the strike price is less than $200 because TIRS have characteristics similar to exchange traded funds (“ETFs”). Specifically, TIRs are exchange-listed securities representing beneficial ownership of the specific deposited securities represented by the receipts. They are negotiable receipts issued by a trust representing securities of issuers that have been deposited and held on behalf of the holders of the TIRs. TIRs, which trade in round-lots of 100, and multiples thereof, may be issued after their initial offering through a deposit with the trustee of the required number of shares of common stock of the underlying issuers. This characteristic of TIRs is similar to that of ETFs which also may be created on any business day upon receipt of the requisite securities or other investment assets comprising a creation unit. The trust only issues receipts upon the deposit of the shares of the underlying securities that are represented by a round-lot of 100 receipts. Likewise, the trust will cancel, and an investor may obtain, hold, trade or surrender TIRs in a round-lot and round-lot multiples of 100 receipts.
Strike prices for ETF options are permitted in $1 or greater intervals where the strike price is $200 or less and $5 or greater where the strike is greater than $200. Accordingly, the Exchange believes that the rationale for permitting $1 strikes for ETF options equally applies to permitting $1 strikes for options on TIRs.
The Exchange has analyzed its capacity and believes the Exchange and the Options Price Reporting Authority (“OPRA”) have the necessary systems capacity to handle the additional traffic associated with the listing and trading of $1 strikes where the strike price is less than $200 for options on TIRs.
The Exchange believes the proposed rule change is consistent with section 6(b)
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
No written comments were solicited or received with respect to the proposed rule change.
Because the foregoing proposed rule change does not significantly affect the protection of investors or the public interest, does not impose any significant burden on competition, and, by its terms, does not become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to section 19(b)(3)(A) of the Act
The Exchange has requested that the Commission waive the 30-day operative delay. The Commission believes that waiver of the operative delay is consistent with the protection of investors and the public interest because the proposal is substantially similar to a rule of another exchange that has been approved by the Commission.
At any time within 60 days of the filing of the proposed rule change, the Commission may summarily abrogate such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an e-mail to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549–1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange proposes to amend Rule 903 Commentary .06 to expand the Exchange's $1 Strike Price Program (the “$1 Strike Program” or “Program”) to allow the Exchange to select 150 individual stocks on which options may be listed at $1 strike price intervals. The text of the proposed rule change is attached as Exhibit 5 to the 19b–4 form. A copy of this filing is available on the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of these
The purpose of this proposed rule change is to expand the $1 Strike Program.
The $1 Strike Program currently allows NYSE Amex to select a total of 55 individual stocks on which option series may be listed at $1 strike price intervals. In order to be eligible for selection into the Program, the underlying stock must close below $50 in its primary market on the previous trading day. If selected for the Program, the Exchange may list strike prices at $1 intervals from $1 to $50, but no $1 strike price may be listed that is greater than $5 from the underlying stock's closing price in its primary market on the previous day. The Exchange may also list $1 strikes on any other option class designated by another securities exchange that employs a similar Program under their respective rules. The Exchange may not list long-term option series (“LEAPS”)
The Exchange now proposes to expand the Program to allow NYSE Amex to select a total of 150 individual stocks on which option series may be listed at $1 strike price intervals. The existing restrictions on listing $1 strikes would continue, i.e., no $1 strike price may be listed that is greater than $5 from the underlying stock's closing price in its primary market on the previous day, and NYSE Amex is restricted from listing any series that would result in strike prices being $0.50 apart (unless an option class is selected to participate in both the $1 Strike Program and the $0.50 Strike Program).
As stated in the Commission order that initially approved NYSE Amex's Program and in subsequent extensions and expansions of the Program,
During the time that the $1 Strike Program was a pilot, the Exchange submitted three pilot reports to the Commission in which the Exchange discussed, among other things, the strength and efficacy of the Program based upon the steady increase in volume and open interest of options traded on the Exchange at $1 strike price intervals; and that the Program had not and, in the future, should not create capacity problems for NYSE Amex or the Options Price Reporting Authority (“OPRA”) systems.
The Exchange believes that market conditions have led to an increase in the number of securities trading below $50 warranting the proposed expansion of the $1 Strike Program.
The Exchange notes that, in addition to options classes that are trading pursuant to the $1 strike programs of options exchanges, there are also options trading at $1 strike intervals on the Exchange on over 150 exchange-traded fund shares (“ETFs”) and exchange-traded notes (“ETNs”),
With regard to the impact of this proposal on system capacity, NYSE Amex has analyzed its capacity and represents that it and OPRA have the necessary systems capacity to handle the potential additional traffic associated with the listing and trading of an expanded number of series in the $1 Strike Program.
The Exchange believes that the $1 Strike Program has provided investors with greater trading opportunities and flexibility and the ability to more closely tailor their investment and risk management strategies and decisions to the movement of the underlying security. Furthermore, the Exchange has not detected any material proliferation of illiquid options series resulting from the narrower strike price intervals. For these reasons, the Exchange requests an expansion of the current Program and the opportunity to provide investors with additional strikes for investment, trading, and risk management purposes.
The Exchange believes the proposed rule change is consistent with Section
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
No written comments were solicited or received with respect to the proposed rule change.
Because the foregoing proposed rule change does not significantly affect the protection of investors or the public interest, does not impose any significant burden on competition, and, by its terms, does not become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
The Exchange has requested that the Commission waive the 30-day operative delay. The Commission believes that waiver of the operative delay is consistent with the protection of investors and the public interest because the proposal is substantially similar to that of another exchange that has been approved by the Commission.
At any time within 60 days of the filing of the proposed rule change, the Commission may summarily abrogate such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an e-mail to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549–1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Social Security Administration (SSA).
Proposed System of Records and Routine Uses.
In accordance with the Privacy Act (5 U.S.C. 552a(e)(4) and (e)(11)) we are issuing public notice of our intent to establish a system of records and routine use disclosures. The system of records is the
• Determine persons eligible for the one-time payment under provisions of the American Recovery and Reinvestment Act of 2009 (ARRA) or any similar subsequent payments authorized under the ARRA or other legislation;
• Prevent duplicate payments to those who qualify under more than one criterion;
• Record post-payment actions for Title II and Title XVI of the Social Security Act Economic Recovery Payments (ERP); and
• Provide management information (MI) for the Title II and Title XVI ERPs.
We discuss the system of records and routine use disclosures in the
We filed a report of the system of records and routine use disclosures with the Chairman of the Senate Committee on Homeland Security and Governmental Affairs, the Chairman of the House Committee on Oversight and Government Reform, and the Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB) on June 30, 2010. The system of records and routine uses will become effective on August 8, 2010, unless we receive comments before that date that would result in a contrary determination.
Interested persons may comment on this publication by writing to the Executive Director, Office of Privacy and Disclosure, Office of the General Counsel, Social Security Administration, 3–A–6 Operations Building, 6401 Security Boulevard, Baltimore, Maryland 21235–6401, or through the Federal e-Rulemaking Portal at
Matthew Olsen, Senior Analyst, Disclosure Policy Development and Services Division I, Office of Privacy and Disclosure, Office of the General Counsel, Social Security Administration, 3–A–6 Operations Building, 6401 Security Boulevard, Baltimore, Maryland 21235–6401, telephone: (410) 965–6213, e-mail:
A provision of the ARRA of 2009 authorizes a one-time ERP of $250 to persons receiving benefits under Title II or Title XVI of the Social Security Act, as well as persons receiving benefits from the Railroad Retirement Board (RRB) or the Department of Veterans Affairs, Veterans Benefits Administration (VBA). Persons entitled under multiple programs may receive only one payment.
The
Based on the match of the RRB-eligible COSSN file, we will identify the person as eligible for a unique RRB payment, or as duplicating a payment made by either Title II or Title XVI. We will update the
We will use the updated
The
We will collect and maintain information that will be housed in the
We will collect information for Title II and Title XVI beneficiaries such as: SSN; claim account number; beneficiary identification code; reason for non-payment; and post-payment information such as DOT Offset Payment (TOP), returned payment, non-receipt claims, reclamation claims, limited payability data, and the name of an executor or other person qualified to receive payment, tax identification number, and mailing address for reissuance of payment to the estate of the deceased if, between the determination that a person is eligible and the issuance of payment that person has died. For payments made by RRB or VBA, we will collect the SSN in the system. For all payments we will collect in the system the agency that qualified the person to receive the payment. We will retrieve information covered by the system of records by using the beneficiary's SSN, claim account number, or beneficiary identification code. As a result, the
We propose to establish the following routine uses of information that will be covered by the
We will disclose information under this routine use to allow DOT to prepare the checks and payments to those persons receiving an ERP.
We will disclose information under this routine use to allow for the recovery of debt to the Federal government under the Treasury Offset Program, as mandated in the ARRA
We will disclose information under this routine use to the IRS to allow the Service to administer the Make Work Pay credit, specifically to ensure proper offset of the credit when a person also receives an ERP, as mandated by the ARRA
We will disclose information under this routine use only when the Office of the President makes an inquiry relating to information contained in this system of records and indicates that it is requesting the record on behalf of the person
We will disclose information under this routine use only when a member of Congress, or member of his or her staff,
(a) The agency or any of our components; or
(b) Any agency employee in his or her official capacity; or
(c) Any agency employee in his or her individual capacity when DOJ (or the agency when we are authorized to do so) has agreed to represent the employee; or
(d) The United States or any agency thereof when we determine that the litigation is likely to affect our operations or any of its components, is party to the litigation or has an interest in such litigation, and we determine that the use of such records by DOJ, a court, other tribunal, or another party before such court or tribunal is relevant and necessary to the litigation. In each case, however, we must determine that such disclosure is compatible with the purpose for which we collected the records.
We will disclose information under this routine use only as necessary to enable DOJ to defend us, our components, or our employees in litigation when the use of information covered by this system of records is relevant and necessary to the litigation and compatible with the purpose of the information collection. We will also disclose information to ensure that courts, other tribunals, and parties before such courts or tribunals, have appropriate information when relevant and necessary.
We will disclose information under this routine use only in situations where we enter into a contractual agreement or similar agreement with a third party to assist in accomplishing an agency function relating to information covered by the
We will disclose information under this routine use only when we use the services of student volunteers and participants in certain educational, training, employment, and community service programs when they need access to information covered by this system of records to perform their assigned agency duties.
We will disclose information under this routine use to the RRB and VBA so that they have a list of those persons eligible for a payment, and who have not already qualified as a beneficiary of another agency's programs.
(a) We suspect or confirm that the security or confidentiality of information in this system of records has been compromised;
(b) We determine that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, risk of identity theft or fraud, or harm to the security or integrity of this system or our other systems or programs that rely upon the compromised information; and
(c) We determine that disclosing the information to such agencies, entities, and persons is necessary to assist in our efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm. We will use this routine use to respond only to those incidents involving an unintentional release of our records.
We will disclose information under this routine use specifically in connection with response and remediation efforts in the event of an unintentional release of agency information, otherwise known as a “data security breach.” This routine use will protect the interests of the people whose information is at risk by allowing us to take appropriate steps to facilitate a timely and effective response to a data breach. The routine use will also help us improve our ability to prevent, minimize, or remedy any harm that may result from a compromise of data covered by this system of records.
(a) To enable them to ensure the safety of our employees and customers, the security of our workplace, and the operation of our facilities; or
(b) To assist investigations or prosecutions with respect to activities that affect such safety and security or activities that disrupt the operation of our facilities.
We will disclose information under this routine use to law enforcement agencies and private security contractors when information is needed to respond to, investigate, or prevent activities that jeopardize the security and safety of the public, employees, or workplaces, or that otherwise disrupt the operation of our facilities. Information will also be disclosed to assist in the prosecution of persons charged with violating a Federal, State, or local law in connection with such activities.
We will disclose information under this routine use only when it is necessary for GSA and NARA to have access to the information covered by this system of records. The administrator of GSA and the Archivist of NARA are authorized by Title 44 U.S.C. 2904, as amended, to promulgate standards, procedures, and guidelines regarding records management and to conduct records management studies. Title 44 U.S.C. 2906, as amended, provides that GSA and NARA are authorized to inspect Federal agencies' records for records management purposed and that agencies are to cooperate with GSA and NARA.
We can disclose information when the disclosure is required by law (20 CFR 401.120). We can also disclose information when the purpose is compatible with the purpose for which we collect the information and the disclosure is supported by a published routine use (20 CFR 401.150). The disclosures under our routine uses (numbers one through twelve) will ensure that we efficiently perform our functions relating to the purpose and administration of the
We will maintain information in the
We annually provide all our employees and contractors with appropriate security awareness and training that includes reminders about the need to protect personally identifiable information and the criminal penalties that apply to unauthorized access to, or disclosure of, personally identifiable information.
We will maintain information in the
Economic Recovery List (ERL) Database, Social Security Administration.
None.
Social Security Administration, Office of Retirement and Survivors Insurance Systems, 6401 Security Boulevard, Baltimore, Maryland 21235.
Persons receiving benefits under Title II and XVI of the Social Security Act, as well as those covered by the Railroad Retirement Board (RRB) and the Department of Veterans Affairs, Veterans Benefits Administration (VBA). Executors or other persons qualified to receive a decedent's payment in the event that, between when a person is determined eligible and issuance of the payment, that person has died.
This system will contain information regarding the payees and payments made under provisions of the American Recovery and Reinvestment Act of 2009 (ARRA) or other similar legislation. For Title II and Title XVI beneficiaries, this system will contain the person's Social Security number (SSN), claim account number, beneficiary identification code, reason for non-payment, and post-payment information such as the Treasury Offset Payment (TOP), returned payment, non-receipt claims, reclamation claims, limited payability data, and the name of an executor or other person qualified to receive payment, tax identification number, and mailing address for reissuance of payment to the estate of the deceased if, between the determination that a person is eligible and the issuance of payment that person has died. For payments made by RRB and VBA, the system will contain the person's SSN. For all payments the system will contain the agency that qualified the person to receive the payment.
Title II, Section 2201, Subtitle C of the ARRA.
We will use data in this system to determine persons eligible for a one-time payment under the ARRA, or any subsequent payments authorized under an amendment to or legislation similar to the ARRA, and to prevent duplicate payments to those who qualify under more than one criterion.
Routine use disclosures are as indicated below.
1. To the Department of the Treasury (DOT) to prepare checks or payments it will send to those persons eligible for the one-time payment, or similar payments subsequently authorized under the ARRA or other legislation.
2. To the DOT to allow the Department to recover debts to the Federal government under the Treasury Offset Program.
3. To the Internal Revenue Service to allow for administration of the Make Work Pay credit.
4. To the Office of the President in response to an inquiry from that office made at the request of the subject of the record or a third party on that person's behalf.
5. To a congressional office in response to an inquiry from that office made at the request of the subject of a record or a third party on that person's behalf.
6. To the Department of Justice (DOJ), a court, other tribunal, or another party before such court or tribunal when:
(a) The agency or any of our components; or
(b) Any agency employee in his or her official capacity; or
(c) Any agency employee in his or her individual capacity when DOJ (or the agency when we are authorized to do so) has agreed to represent the employee; or
(d) The United States or any agency thereof when we determine that the litigation is likely to affect our operations or any of its components, is party to the litigation or has an interest in such litigation, and we determine that the use of such records by DOJ, a court, other tribunal, or another party before such court or tribunal is relevant and necessary to the litigation. In each case, however, we must determine that such disclosure is compatible with the purpose for which we collected the records.
7. To our contractors and other Federal agencies, as necessary, to assist us in efficiently administering our programs.
8. To student volunteers, persons working under a personal services
9. To the Railroad Retirement Board and Department of Veterans Affairs, Veterans Benefits Administration, to identify persons who qualify for a payment as a beneficiary from more than one agency.
10. To the appropriate Federal, State, and local agencies, entities, and persons when:
(a) We suspect or confirm that the security or confidentiality of information in this system of records has been compromised;
(b) We determine that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, risk of identity theft or fraud, or harm to the security or integrity of this system or our other systems or programs that rely upon the compromised information; and
(c) We determine that disclosing the information to such agencies, entities, and persons is necessary to assist in our efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm. We will use this routine use to respond only to those incidents involving an unintentional release of our records.
11. To Federal, State, and local law enforcement agencies and private security contractors, as appropriate, information necessary:
a. To enable them to ensure the safety of our employees and customers, the security of our workplace, and the operation of our facilities; or
b. To assist investigations or prosecutions with respect to activities that affect such safety, security, or activities that disrupt the operation of our facilities.
12. To the General Services Administration and the National Archives and Records Administration (NARA) under 44 U.S.C. 2904 and 2906, as amended by the NARA Act, information that is not restricted from disclosure by Federal law for their use in conducting records management studies.
We maintain and store records in this system in electronic form.
We retrieve records by beneficiary Social Security number, claim account number, or beneficiary identification code.
We retain electronic files with personal identifiers in secure storage areas accessible only to our authorized employees and contractors who have a need for the information when performing their official duties. Security measures include the use of access codes (personal identification number (PIN) and password) to enter our computer systems that house the data.
We annually provide all our employees and contractors with appropriate security awareness and training that includes reminders about the need to protect personally identifiable information and the criminal penalties that apply to unauthorized access to, or disclosure of, personally identifiable information (5 U.S.C. 552a(i)(l)). Furthermore, employees and contractors with access to databases maintaining personally identifiable information must sign a sanction document annually, acknowledging their accountability for inappropriately accessing or disclosing such information.
We maintain records in SSA headquarters within the Office of Retirement and Survivors Insurance Systems. We will maintain these records for seven years, pending application of an appropriate General Records Schedule, or approval by NARA, of the proposed retention.
Project Manager, Office of Retirement and Survivors Insurance Systems, Social Security Administration, 6401 Security Boulevard, Baltimore, Maryland 21235–6401.
Persons can determine if this system contains a record about them by writing to the system manager at the above address and providing their name, SSN, or other information in this system of records that will identify them. Persons requesting notification by mail must include a notarized statement to us to verify their identity or must certify in the request that they are the person they claim to be and that they understand that the knowing and willful request for, or acquisition of, a record pertaining to another person under false pretenses is a criminal offense.
Persons requesting notification of records in person must provide the same information, as well as provide an identity document, preferably with a photograph, such as a driver's license. Persons lacking identification documents sufficient to establish their identity must certify in writing that they are the person they claim to be and that they understand that the knowing and willful request for, or acquisition of, a record pertaining to another person under false pretenses is a criminal offense.
Persons requesting notification by telephone must verify their identity by providing identifying information that parallels the information in the record about which they are requesting notification. If we determine that the identifying information the person provides by telephone is insufficient, we will require the person to submit a request in writing or in person. If a person requests information by telephone on behalf of another person, the subject person must be on the telephone with the requesting person and us in the same phone call. We will establish the subject person's identity (his or her name, SSN, address, date of birth, and place of birth, along with one other piece of information such as mother's maiden name) and ask for his or her consent to provide information to the requesting person. These procedures are in accordance with our regulations at 20 CFR 401.40 and 401.45.
Same as notification procedures. Persons also should reasonably specify the record contents they are seeking. These procedures are in accordance with our regulations (20 CFR 401.40(c)).
Same as notification procedures. Persons also should reasonably identify the record, specify the information they are contesting, and state the corrective action sought and the reasons for the correction with supporting justification showing how the record is incomplete, untimely, inaccurate, or irrelevant. These procedures are in accordance with our regulations (20 CFR 401.65(a)).
We obtain data covered by this system of records from information in our existing systems of records (
Based upon a review of the Administrative Record assembled in this matter pursuant to Section 219(a)(4)(C) of the Immigration and Nationality Act, as amended (8 U.S.C. 1189(a)(4)(C)) (“INA”), and in consultation with the Attorney General and the Secretary of the Treasury, I conclude that the circumstances that were the basis for the 2004 re-designation of the aforementioned organization as a foreign terrorist organization have not changed in such a manner as to warrant revocation of the designation and that the national security of the United States does not warrant a revocation of the designation.
Therefore, I hereby determine that the designation of the aforementioned organization as a foreign terrorist organization, pursuant to Section 219 of the INA (8 U.S.C. 1189), shall be maintained.
This determination shall be published in the
Office of the United States Trade Representative.
Notice.
This notice announces the results of 2009 GSP Annual Product Review with respect to: (1) Disposition of the product petitions accepted for review, including petitions to add and remove products; (2) waivers of the Competitive Need Limitations (CNL); (3) revocation of CNL waivers; and (4)
Tameka Cooper, GSP Program, Office of the United States Trade Representative, 1724 F Street, NW., Room 601, Washington, DC 20508. The telephone number is (202) 395–6971, the fax number is (202) 395–2961, and the e-mail address is
The GSP program provides for the duty-free importation of designated articles when imported from beneficiary developing countries. The GSP program is authorized by Title V of the Trade Act of 1974 (19 U.S.C. 2461
In the 2009 Annual Review, the Trade Policy Staff Committee reviewed a number of petitions to change product coverage of the GSP, and evaluated the 2009 value of U.S. imports of each GSP-eligible article to determine whether imports of an article from a GSP beneficiary developing country exceeded the CNLs. The results of the 2009 GSP Annual Review, comprising eight lists, are available for public viewing at
Petitions to add certain frozen mixed beans (HTS 0710.22.40) and frozen mixtures of vegetables (HTS 0710.90.91) to the list of products eligible for duty-free treatment under GSP were granted. Petitions to add three other products were denied. Additional information about the disposition of the petitions to add products is described in List I (Decisions on Petitions to Add Products to the List of Eligible Products for the Generalized System of Preferences).
A petition to remove GSP eligibility for gold mixed link necklaces and neck chains (HTS 7113.19.25) from India was granted. These articles are no longer eligible for duty-free treatment under GSP when imported from India. Additional information about the disposition of all requests to remove products is described in List II (Decisions on Petitions to Remove Duty-Free status from a Beneficiary Developing Country for a Product on the List of Eligible Articles for the Generalized System of Preferences).
A petition to grant a waiver of the CNLs for imports of certain pneumatic radial tires (HTS 4011.10.10) from Thailand was denied, as reflected in List III (Decisions on Petitions to Grant a Waiver to the Competitive Need Limitation).
Existing CNL waivers were not revoked for miniature carnations (HTS 0603.12.30) from Columbia and certain silver jewelry articles (HTS 7113.11.50) from Thailand, and revoked for gold mixed link necklaces and neckchains (HTS 7113.19.25) from India, as reflected in List IV (Decisions on Competitive Need Limitation Waiver Revocations).
Articles that exceeded the CNLs in 2009 and that, effective July 1, 2010, are excluded from GSP eligibility when imported from a specific beneficiary country are described in List V (Products Newly Subject to Exclusion by Competitive Need Limitation), and include certain shrimp and prawn products (HTS 1605.20.05) from Thailand, certain pneumatic radial tires (HTS 4011.10.10) from Thailand, certain wood products (HTS 4409.29.05) from Brazil, and gold rope necklaces and neckchains (HTS 7113.19.21) from India.
No products were redesignated as eligible for GSP. List VII (Decisions on Products Eligible for GSP Redesignation) provides the list of the articles and the associated countries reviewed for redesignation.
The status of petitions considered in the 2009 Country Practices Review is described in List VIII. This list includes the status of petitions that had previously been accepted for review, as well petitions where the decision to accept for further review or reject was pending. The beneficiaries that will continue to be under review for GSP eligibility include: Lebanon, Russia and Uzbekistan regarding intellectual
The announcement of the 2010 annual review and solicitation of new petitions for consideration in that review will be announced in a later
Notice and request for comments.
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Comments must be submitted on or before August 12, 2010.
Mr. Robert Brogan, Office of Safety, Planning and Evaluation Division, RRS–21, Federal Railroad Administration, 1200 New Jersey Ave., SE., Mail Stop 17, Washington, DC 20590 (telephone: (202) 493–6292), or Ms. Kimberly Toone, Office of Information Technology, RAD–20, Federal Railroad Administration, 1200 New Jersey Ave., SE., Mail Stop 35, Washington, DC 20590 (telephone: (202) 493–6132). (These telephone numbers are not toll-free.)
The Paperwork Reduction Act of 1995 (PRA), Public Law 104–13, § 2, 109 Stat. 163 (1995) (codified as revised at 44 U.S.C. 3501–3520), and its implementing regulations, 5 CFR part 1320, require Federal agencies to issue two notices seeking public comment on information collection activities before OMB may approve paperwork packages. 44 U.S.C. 3506, 3507; 5 CFR 1320.5, 1320.8(d)(1), 1320.12. On May 4, 2010, FRA published a 60-day notice in the
Before OMB decides whether to approve these proposed collections of information, it must provide 30 days for public comment. 44 U.S.C. 3507(b); 5 CFR 1320.12(d). Federal law requires OMB to approve or disapprove paperwork packages between 30 and 60 days after the 30-day notice is published. 44 U.S.C. 3507 (b)–(c); 5 CFR 1320.12(d);
The summaries below describe the nature of the information collection requirements (ICRs) and the expected burden. The revised requirements are being submitted for clearance by OMB as required by the PRA.
Send comments regarding these information collections to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 Seventeenth Street, NW., Washington, DC 20503, Attention: FRA Desk Officer.
A comment to OMB is best assured of having its full effect if OMB receives it within 30 days of publication of this notice in the
44 U.S.C. 3501–3520.
Federal Railroad Administration, DOT.
Notice.
In accordance with the Paperwork Reduction Act of 1995 and its implementing regulations, the Federal Railroad Administration (FRA) hereby announces that it is seeking renewal of the following information collection activities that were previously approved by OMB. Before submitting these information collection requirements for clearance by the Office of Management and Budget (OMB), FRA is soliciting public comment on specific aspects of the activities identified below.
Comments must be received no later than September 13, 2010.
Submit written comments on any or all of the following proposed activities by mail to either: Mr. Robert Brogan, Office of Safety, RRS–21, Federal Railroad Administration, 1200 New Jersey Ave., SE., Mail Stop 17, Washington, DC 20590, or Ms. Kimberly Toone, Office of Information Technology, RAD–20, Federal Railroad Administration, 1200 New Jersey Ave., SE., Mail Stop 35, Washington, DC 20590. Commenters requesting FRA to acknowledge receipt of their respective comments must include a self-addressed stamped postcard stating, “Comments on OMB control number 2130–____.” Alternatively, comments may be transmitted via facsimile to (202) 493–6216 or (202) 493–6497, or via e-mail to Mr. Brogan at
Mr. Robert Brogan, Office of Safety, RRS–21, Federal Railroad Administration, 1200 New Jersey Ave., SE., Mail Stop 17, Washington, DC 20590 (telephone: (202) 493–6292) or Ms. Kimberly Toone, Office of Information Technology, RAD–20, Federal Railroad Administration, 1200 New Jersey Ave., SE., Mail Stop 35, Washington, DC 20590 (telephone: (202) 493–6132). (These telephone numbers are not toll-free.)
The Paperwork Reduction Act of 1995 (PRA), Public Law 104–13, section 2, 109 Stat. 163 (1995) (codified as revised at 44 U.S.C. 3501–3520), and its implementing regulations, 5 CFR Part 1320, require Federal agencies to provide 60-days notice to the public for comment on information collection activities before seeking approval of such activities by OMB. 44 U.S.C. 3506(c)(2)(A); 5 CFR 1320.8(d)(1), 1320.10(e)(1), 1320.12(a). Specifically, FRA invites interested respondents to comment on the following summary of proposed information collection activities regarding (i) whether the information collection activities are necessary for FRA to properly execute its functions, including whether the activities will have practical utility; (ii) the accuracy of FRA's estimates of the burden of the information collection activities, including the validity of the methodology and assumptions used to determine the estimates; (iii) ways for FRA to enhance the quality, utility, and clarity of the information being collected; and (iv) ways for FRA to minimize the burden of information collection activities on the public by automated, electronic, mechanical, or other technological collection techniques or other forms of information technology (
Below is a brief summary of the information collection activities that FRA will submit for renewed clearance by OMB as required under the PRA:
While railroad companies must report trespass incidents resulting in serious injury or death to the U.S. Federal Railroad Administration (FRA), injuries or deaths that are ruled by a medical examiner or coroner to be intentional are not reported. Preliminary figures from 2006 indicate there were approximately 500 deaths and 360 injuries reported to the FRA—an increase of 100 incidents over the previous year—but suicides are not represented in these numbers. Unverifiable estimates from a number of sources range from 150 to more than 300 suicides per year on the U.S. railways.
Like any other incident on the rail system, a suicide on the tracks results in equipment and facility damage, delays to train schedules, and trauma to railroad personnel involved in the incidents. As a result, FRA last year awarded a grant for the first phase of a 5-year project to reduce suicides on the rail system to the Railroad Research Foundation (part of the Association of American Railroads) and its subcontractor, the American Association of Suicidology (AAS).
In the course of five years, the research project's goals include:
• A prevalence assessment to determine verifiable numbers of suicides on the rail system,
• Development of a standardized reporting tool for industry use,
• A causal analysis and root cause analysis of suicide incidents that occur during the grant cycle, and
• Design and implementation of suicide prevention measures for the nation's rail system to reduce suicide injuries and deaths.
This request to the Office of Management and Budget is for re-approval in order to complete Phase II of the project, the causal analysis. In order to understand as much as possible about people who intend to die by placing themselves in the path of a train, and therefore to design prevention strategies, AAS has been conducting 60 psychological autopsies over the course of two years on people who die by rail-related suicide.
Psychological autopsy is a recognized and accepted method for obtaining information about physical, emotional and circumstantial contributors to a person's death. The 60 psychological autopsies for the FRA project involve interviews with informants to these incidents including family members and friends, employers and co-workers, and rail personnel involved in the incidents.
After conducting a root cause analysis of this data, AAS will then work with the industry to design, pilot test and implement effective countermeasures with the goal of reducing deaths, injuries and psychological trauma.
In recognition of the need for new approaches to improving safety, FRA has instituted the Confidential Close Call Reporting System (C
If C
Program evaluation is an inherently data driven activity. Its basic tenet is that as change is implemented, data can be collected to track the course and consequences of the change. Because of the setting in which C
The current study is a five-year demonstration project to improve rail safety, and is designed to identify safety issues and propose corrective action based on voluntary reports of close calls submitted to the Bureau of Transportation Statistics. Because of the innovative nature of this program, FRA is implementing an evaluation to determine whether the program is succeeding, how it can be improved and, if successful, what is needed to spread the program throughout the railroad industry. Interviews to evaluate the close call reporting system are being conducted with two groups: (1) Key stakeholders to the process (
The confidentiality of the interview data is protected by the Privacy Act of 1974. FRA fully complies with all laws pertaining to confidentiality, including the Privacy Act. Thus, information obtained by or acquired by FRA's contractor, the Volpe Center, from key stakeholders and railroad employees will be used strictly for evaluation purposes. None of the information that might be identifying will be disseminated or disclosed in any way. In addition, the participating railroad sites involved will require Volpe to establish a non-disclosure agreement that prohibits disclosure of company confidential information without the carrier's authorization. Also, the data is protected under the Department of Transportation regulation Title 49 CFR Part 9, which is in part concerned with the Department involvement in proceedings between private litigants. According to this statute, if information is subpoenaed, Volpe and Volpe
Pursuant to 44 U.S.C. 3507(a) and 5 CFR 1320.5(b), 1320.8(b)(3)(vi), FRA informs all interested parties that it may not conduct or sponsor, and a respondent is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
44 U.S.C. 3501–3520.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice; request for comments.
This notice is to inform the public of the Federal Motor Carrier Safety Administration's (FMCSA) anticipated Fiscal Year (FY) 2011 safety grant opportunities. At present, FMCSA is operating under an extension of the Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy of Users (Pub. L. 109–59) which will expire December 31, 2010, unless extended further by Congress. While the Agency expects new authorization to make changes to its grant programs, the Agency is preparing for FY 2011 using the assumption that the following grant programs will continue in the new authorization.
The FMCSA invites comments on the proposed application deadlines for its FY 2011 safety grants programs. The 11 safety programs include the Motor Carrier Safety Assistance Program (MCSAP) Basic grants; MCSAP Incentive grants; MCSAP New Entrant Safety Audit grants; MCSAP High Priority grants; Commercial Motor Vehicle (CMV) Operator Safety Training grants; Border Enforcement grants (BEG); Commercial Driver's License Program Improvement (CDLPI) grants; Commercial Driver's License Information System (CDLIS) Modernization grants; Performance and Registration Information Systems Management (PRISM) grants; Safety Data Improvement Program grants (SaDIP); and the Commercial Vehicle Information Systems and Networks (CVISN) grants. The purpose of this notice is to provide grantees with information well in advance of the Agency's proposed FY 2011 safety grant application deadlines and to request comments on the deadlines and other changes in the Agency's safety grant programs.
Comments must be received on or before September 13, 2010.
You may submit comments identified by Docket Number FMCSA–2010–0212, using any of the following methods:
Comments received after the comment closing date will be included in the docket, and we will consider late comments to the extent practicable. FMCSA may, however, issue a final determination at any time after the close of the comment period.
Please contact the following FMCSA staff with questions or needed information on the Agency's grant programs:
The FMCSA recognizes that State and local governments and other grantees are dependent on its safety grants to develop and maintain important commercial motor vehicle (CMV) safety programs. The FMCSA further acknowledges that delays in awarding grant funds may have an adverse impact on these important safety programs. As a result, FMCSA completed a grants process review to identify ways to streamline the application, award, and grants management processes, and to award grant funds earlier each fiscal year. In addition, FMCSA made changes in the grants application, award and oversight processes to standardize application forms, increase the use of electronic documents, standardize quarterly reports and reduce the number of needed grant amendments.
The FMCSA continues to enter into grant agreements beginning October 1 or as soon thereafter as administratively practicable. FMCSA intends to enter into grant agreements no later than 90 days from the date the application is due.
The FMCSA is using a standard grant application form and a new quarterly reporting process. The FMCSA requires the Standard Form 424 (“Application for Federal Assistance”) and its attachments for all grant program applications. While each grant program may request different data in some of the data fields on the form, the use of the Standard Form 424 is mandatory. FMCSA adopted the Standard Form—Project Progress Report (SF–PPR) as its required form for quarterly reporting. Again, each grant program may, in certain instances, request different data be submitted in some of the fields or boxes on the form but SF–PRR is mandatory for quarterly reporting.
The number of original copies of grant agreements required to be submitted to FMCSA was reduced from three copies to two. In addition, FMCSA will provide most grant agreement documents electronically to its financial processing office. Grantees will, however, be required to submit the completed Automated Clearing House (ACH) Vendor Payment Form (SF–3881) directly to FMCSA's financial processing office by U.S. Postal Service, courier service or secure fax. We request information on any impacts of these proposed changes.
The FMCSA continues to request comments and suggestions from grantees concerning improvement of the application, award and grants management processes. Additional information is provided below for each individual grant program.
Sections 4101 and 4107 of SAFETEA–LU authorize FMCSA's Motor Carrier Safety Grants. MCSAP Basic and Incentive
(1) 1997 road miles (all highways) as defined by the FMCSA;
(2) All vehicle miles traveled (VMT) as defined by the FMCSA;
(3) Population—annual census estimates as issued by the U.S. Census Bureau; and
(4) Special fuel consumption (net after reciprocity adjustment) as defined by the FMCSA.
(1) Reduction in the number of large truck-involved fatal accidents;
(2) Reduction in the rate of large-truck-involved fatal accidents or maintenance of a large-truck-involved fatal accident rate that is among the lowest 10 percent of such rates for MCSAP recipients and is not higher than the rate most recently achieved;
(3) Upload of CMV accident reports in accordance with current FMCSA policy guidelines;
(4) Verification of Commercial Driver's Licenses during all roadside inspections; and
(5) Upload of CMV inspection data in accordance with current FMCSA policy guidelines.
Prior to the start of each fiscal year, FMCSA calculates the amount of Basic and Incentive funding each State is expected to receive. This information is provided to the States and is made available on the Agency's Web site. The FY 2011 information is available at
It should be noted that MCSAP Basic and Incentive formula grants are awarded based on the State's submission of the CVSP. The evaluation factors described in the section below titled “Application Information for FY 2011 Grants” will not be considered. MCSAP Basic and Incentive grant applications must be submitted electronically through grants.gov (
Sections 4101 and 4107 of SAFETEA–LU also authorize the Motor Carrier Safety Grants to enable grant recipients to conduct interstate New Entrant safety audits consistent with 49 CFR Parts 350.321 and 385.301. Eligible recipients are State agencies, local governments, and organizations representing government agencies that use and train qualified officers and employees in coordination with State motor vehicle safety agencies. The FMCSA's share of these grant funds will be 100 percent. New Entrant grant applications must be submitted electronically through grants.gov (
Section 4107 of SAFETEA–LU also authorizes the Motor Carrier Safety Grants to enable recipients to carry out activities and projects that improve CMV safety and compliance with CMV regulations. Funding is available for projects that are national in scope, increase public awareness and education, demonstrate new technologies and reduce the number and rate of CMV accidents. Eligible recipients are State agencies, local governments, and organizations representing government agencies that use and train qualified officers and employees in coordination with State motor vehicle safety agencies.
For grants awarded for public education activities, the Federal share will be 100 percent. For all High Priority grants other than those awarded in support of public education activities, FMCSA will provide reimbursements for no more than 80 percent of all eligible costs, and recipients will be required to provide a 20 percent match. FMCSA may reserve High Priority funding exclusively for innovative traffic enforcement projects, with particular emphasis on work zone enforcement and rural road safety. Also, FMCSA may reserve funding for an innovative traffic enforcement initiative known as “Ticketing Aggressive Cars and Trucks” or TACT. TACT provides a research-based safety model that can be replicated by States when conducting a high-visibility traffic enforcement program to promote safe driving behaviors among car and truck drivers. The objective of this program is to reduce the number of commercial truck and bus related crashes, fatalities and injuries resulting from improper operation of motor vehicles and aggressive driving behavior. More information regarding TACT can be found at
High Priority grant applications must be submitted electronically through grants.gov.
Section 4134 of SAFETEA–LU established a grant program which enables recipients to train current and future drivers in the safe operation of CMVs, as defined in 49 U.S.C. 31301(4). Eligible awardees include State governments, local governments and accredited post-secondary educational institutions (public or private) such as colleges, universities, vocational-technical schools and truck driver training schools. Funding priority for this discretionary grant program will be given to regional or multi-state educational or nonprofit associations serving economically distressed regions of the United States. The Federal share of these funds will be 80 percent, and recipients will be required to provide a 20 percent match. CMV Operator Safety Training grant applications must be submitted electronically through grants.gov.
Section 4110 of SAFETEA–LU established the BEG program. The purpose of this discretionary program is to provide funding for border CMV safety programs and related enforcement activities and projects. An entity or a State that shares a land border with another country is eligible to receive this grant funding. Eligible awardees include State governments, local governments, and entities (i.e., accredited post-secondary public or private educational institutions such as universities). Requests from entities must be coordinated with the State lead CMV inspection agency. Applications must include a Border Enforcement Plan and meet the required maintenance of expenditure requirement. BEG funding decisions take into consideration the State or entity's performance on previous BEG awards; its ability to expend the awarded funds with the BEG performance year; and activities meeting the BEG national criteria established by FMCSA. As established by SAFETEA–LU, the Federal share of these funds will be 100 percent. As a result, there is no matching requirement. BEG grant applications must be submitted electronically through grants.gov.
Section 4124 of SAFETEA–LU established a discretionary grant program that provides funding for improving States' implementation of the Commercial Driver's License (CDL) program, including expenses for computer hardware and software, publications, testing, personnel, and training. Funds may not be used to rent, lease, or buy land or buildings. The agency designated by each State as the primary driver licensing agency responsible for the development, implementation, and maintenance of the CDL program is eligible to apply for grant funding. State grant proposals must include the State's assessment of its CDL program and a detailed budget explaining how the funds will be used. The Federal share of funds for projects awarded under this grant is established by SAFETEA–LU as 100 percent; therefore, there is no State matching requirement. The funding opportunity announcement on grants.gov will provide more detailed information on the application process; national funding priorities for FY 2011; evaluation criteria; required documents and certifications; State maintenance of expenditure requirements; and additional information related to the availability of funds. CLDPI grant applications must be submitted electronically through grants.gov.
Section 4128 of SAFETEA–LU established a Safety Data Improvement Program (SaDIP) grant program to improve the quality of crash and inspection truck and bus data reported by the States to FMCSA, as described 49 U.S.C. 31102. Eligible recipients are State agencies, local governments, and organizations representing government agencies that are involved with highway traffic safety activities and must demonstrate a capacity to work with highway traffic safety stakeholders. The State's SaDIP proposal must focus on a project that enhances the accuracy, timeliness, and completeness of the collection and reporting of Commercial Motor Vehicle crash information in all components of the State's record system. An applicant's proposed SaDIP project must address the seven (7) application requirements plus the overriding indicator established for the State Safety Data Quality (SSDQ) program. The FMCSA will provide reimbursements for no more that 80 percent of all eligible costs and recipients are required to provide a 20 percent match.
Section 4109 of SAFETEA–LU authorizes FMCSA to award financial assistance funds to States to implement the Performance and Registration Information Systems Management (PRISM) requirements that link Federal motor carrier safety information systems with State CMV registration and licensing systems. This program enables a State to determine the safety fitness of a motor carrier or registrant when licensing or registering or while the license or registration is in effect. PRISM grant applications must be submitted electronically through grants.gov. No matching funds are required.
Section 4126 of SAFETEA–LU authorizes FMCSA to award financial assistance to States to deploy, operate, and maintain elements of their Commercial Vehicle Information Systems and Networks (CVISN)
Section 4126 of SAFETEA–LU distinguishes between two types of CVISN projects: Core and Expanded. To be eligible for funding of Core CVISN deployment project(s), a State must have its most current Core CVISN Program Plan and Top-Level Design approved by FMCSA and the proposed project(s) should be consistent with its approved Core CVISN Program Plan and Top-Level Design. If a State does not have a Core CVISN Program Plan and Top-Level Design, it may apply for up to $100,000 in funds to either compile or update a Core CVISN Program Plan and Top-Level Design.
A State may also apply for funds to prepare an Expanded CVISN Program Plan and Top-Level Design if FMCSA acknowledged the State as having completed Core CVISN deployment. In order to be eligible for funding of any Expanded CVISN deployment project(s), a State must have its most current Expanded CVISN Program Plan and Top-Level Design approved by FMCSA and any proposed Expanded CVISN project(s) should be consistent with its Expanded CVISN Program Plan and Top-Level Design. If a State does not have an existing or up-to-date Expanded CVISN Program Plan and Top-Level Design, it may apply for up to $100,000 in funds to either compile or update an Expanded CVISN Program Plan and Top-Level Design.
CVISN grant applications must be submitted electronically through grants.gov. Awards for approved CVISN grant applications are made on a first-come, first-served basis. States must provide a match of 50 percent.
General information about the FMCSA grant programs is available in the Catalog of Federal Domestic Assistance (CFDA) which can be found on the internet at
(1) Prior performance—Completion of identified programs and goals per the project plan.
(2) Effective Use of Prior Grants—Demonstrated timely use and expensing of available funds.
(3) Cost Effectiveness—Applications will be evaluated and prioritized on the basis of expected impact on safety relative to the investment of grant funds. Where appropriate, costs per unit will be calculated and compared with national averages to determine effectiveness. In other areas, proposed costs will be compared with historical information to confirm reasonableness.
(4) Applicability to announced priorities—If national priorities are included in the grants.gov notice, those grants that specifically address these issues will be given priority consideration.
(5) Ability of the applicant to support the strategies and activities in the proposal for the entire project period of performance.
(6) Use of innovative approaches in executing a project plan to address identified safety issues.
(7) Feasibility of overall program coordination and implementation based upon the project plan.
(8) Any grant-specific evaluation factors, such as program balance or geographic diversity, will be included in the grants.gov application information.
Applications submitted after due dates may be considered on a case-by-case basis and are subject to availability of funds.
In accordance with part 211 of Title 49 Code of Federal Regulations (CFR), notice is hereby given that the Federal Railroad Administration (FRA) has received a request for a waiver of compliance from certain requirements of its safety standards. The individual petition is described below, including the party seeking relief, the regulatory provisions involved, the nature of the relief being requested, and the petitioner's arguments in favor of relief.
The City of Mishawaka, IN (City), and the Norfolk Southern Corporation (NS) jointly seek a temporary waiver of compliance from certain provisions of the Use of Locomotive Horns at Highway-Rail Grade Crossings, 49 CFR part 222. The City intends to establish a Pre-Rule Quiet Zone that it had previously continued under the provisions of 49 CFR 222.41(c)(1). The City is seeking a waiver for the requirement to construct and complete a Pre-Rule Quiet Zone by June 24, 2010, as required by 49 CFR 222.41(c)(2), and for an extension of such date to October 31, 2010.
There are 19 crossings in the existing Pre-Rule Quiet Zone extending from Elder Road (MP 429.21) to Russell Avenue (MP 434.21) on the NS Dearborn Division, Chicago Line Subdivision. 3 of these crossings will be treated with Supplementary Safety Measures (SSM) and Alternative Safety Measures (ASM) as follows: 1 crossing closure (SSM), 1 crossing with gates and traffic channelization devices (SSM), and 1 crossing with a modified SSM consisting of gates and channelization (ASM). The 2 SSMs will be completed by June 24, 2010, and the ASM will be completed within 45 working days of receipt of the ASM approval from FRA. In the future, 2 other crossings will be modified as part of an Indiana Department of Transportation project resulting in 1 grade separation and 1 closure. The City requests that the existing Pre-Rule Quiet Zone be allowed to continue until October 31, 2010, by which time the 2 SSMs and 1 ASM improvements will have been completed.
The City states that it has had its pre-rule quiet zone since 1974, and that its residents and others have become accustomed to its existence. It asserts
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested party desires an opportunity for oral comment, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate docket number (
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Communications received within 45 days of the date of this notice will be considered by FRA before final action is taken. Comments received after that date will be considered as far as practicable. All written communications concerning these proceedings are available for examination during regular business hours (9 a.m.–5 p.m.) at the above facility. All documents in the public docket are also available for inspection and copying on the Internet at the docket facility's Web site at
Anyone is able to search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the document (or signing the document, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104–13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning an existing final Regulation, INTL–941–86; INTL–656–87; and INTL–704–87, Treatment of Shareholders of Certain Passive Foreign Investment Companies (§ 1.1291–1, 1.1291–2, 1.1291–3, 1.1291–6, 1.1291–8).
Written comments should be received on or before September 13, 2010 to be assured of consideration.
Direct all written comments to Gerald J. Shields, Internal Revenue Service, room 6129, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for copies of the regulations should be directed to Joel Goldberger at Internal Revenue Service, room 6129, 1111 Constitution Avenue NW., Washington, DC 20224, or at (202) 927–9368, or through the Internet at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Request for Comments: Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. All comments will become a matter of public record.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104–13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 8283–V, Payment Voucher for Filing Fee Under Section 170(f)(13).
Written comments should be received on or before September 13, 2010 to be assured of consideration.
Direct all written comments to Gerald Shields, Internal Revenue Service, Room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224.
Requests for additional information or copies of the form(s) and instructions should be directed to Elaine Christophe, (202) 622–3179, or at Internal Revenue Service, Room 6129, 1111 Constitution Avenue NW., Washington, DC 20224, or through the Internet, at
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104–13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning an existing final regulation. REG–116608–97 EIC Eligibility Requirements (§ 1.32–3).
Written comments should be received on or before September 13, 2010 to be assured of consideration.
Direct all written comments to Gerald Shields, Internal Revenue Service, Room 6129, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for additional information or copies of the form and instructions should be directed to Elaine Christophe, (202) 622–3179, or at Internal Revenue Service, Room 6129, 1111 Constitution Avenue NW., Washington, DC 20224, or through the Internet, at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104–13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Final Regulation REG–128767–04, (T.D. 9289), Treatment of Disregarded Entities Under Section 752.
Written comments should be received on or before September 13, 2010 to be assured of consideration.
Direct all written comments to Gerald J. Shields, Internal Revenue Service, Room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224.
Requests for copies of the regulation should be directed to Joel Goldberger, at (202) 927–9368, or at Internal Revenue Service, Room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224, or through the Internet at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104–13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning an existing final and temporary regulations, EE–113–90 (TD 8324), Employee Business Expenses Reporting and Withholding on Employee Business Expense Reimbursements and Allowances (§ 1.62–2).
Written comments should be received on or before September 13, 2010 to be assured of consideration.
Direct all written comments to Gerald Shields, Internal Revenue Service, Room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224.
Requests for additional information or
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104–13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning an existing final regulation. TD 9168, Optional 10-Year Write-off of Certain Tax Preferences.
Written comments should be received on or before September 13, 2010 to be assured of consideration.
Direct all written comments to Gerald Shields, Internal Revenue Service, Room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224.
Requests for additional information or copies of the form and instructions should be directed to Elaine Christophe, (202) 622–3179, or at Internal Revenue Service, Room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224, or through the Internet, at
The following paragraph applies to all of the collections of information covered by this notice.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104–13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 3800, General Business Credit.
Written comments should be received on or before September 13, 2010 to be assured of consideration.
Direct all written comments to Gerald Shields, Internal Revenue Service, Room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224.
Requests for additional information or copies of the form and instructions should be directed to Elaine Christophe, (202) 622–3179, or at Internal Revenue Service, Room 6129, 1111 Constitution Avenue, NW., Washington DC 20224, or through the internet, at
The following new credits are added:
The following new credits are removed:
1. The Hurricane Katrina housing credit from pass-through entities, because it can no longer be claimed.
We are making this submission to renew the OMB approval:
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104–13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 1023, Application for Recognition of Exemption Under Section 501(c)(3) of the Internal Revenue Code.
Comments must be received by September 13, 2010 to be assured of consideration.
The Department of the Treasury is piloting the collaborative tool,
The information collection expires on January 31, 2011. The collaboration tool will maintain the official comments in which the Internal Revenue Service will use to determine potential changes to the form and/or to the estimated burden and costs associated with the collection. The Department believes the public comments received through the collaboration tool will reduce the paperwork burden on the public for Form 1023.
Submit comments by one of the following methods:
•
• Gerald J. Shields, Internal Revenue Service, Room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224.
Requests for additional information or copies of the form and instructions should be directed to Joseph R. Durbala
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104–13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning an existing final regulation, REG–118926–97 (TD 8817), Notice of Certain Transfers to Foreign Partnerships and Foreign Corporations (§ 1.6038B–1, 1.6038B–2).
Written comments should be received on or before September 13, 2010 to be assured of consideration.
Direct all written comments to Gerald J. Shields, Internal Revenue Service, Room 6129, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for additional information or copies of the regulations should be directed to Joel Goldberger at Internal Revenue Service, Room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224, or at (202) 927–9368, or through the Internet at
The collections of information contained in these final regulations are in § 1.6038B–1(b) and 1.6038B–2. The burden of complying with the collection of information required to be reported on Form 8865 is reflected in the burden for Form 8865. The burden of complying with the collection of information required to be reported on Form 926 is reflected in the burden for Form 926.
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104–13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning an existing final regulation, INTL–45–86 (TD 8125), Foreign Management and Foreign Economic Processes Requirements of a Foreign Sales Corporation (Sec. 1.924).
Written comments should be received on or before September 13, 2010 to be assured of consideration.
Direct all written comments to Gerald J. Shields, Internal Revenue Service, room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224.
Requests for copies of the regulations should be directed to Joel Goldberger at Internal Revenue Service, room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224, or at (202) 927–9368, or through the Internet at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
(a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104–13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Taxpayer Advocacy Panel (TAP) Tax Check Waiver.
Written comments should be received on or before September 13, 2010 to be assured of consideration.
Direct all written comments to Gerald J. Shields, Internal Revenue Service, room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224.
Requests for additional information or copies of the form and instructions should be directed to Joel Goldberger, (202) 927–9368, or at Internal Revenue Service, Room 6129, 1111 Constitution Avenue, NW., Washington, DC 20224, or through the Internet at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Tennessee Valley Authority (TVA).
Issuance of Record of Decision.
This notice is provided in accordance with the Council on Environmental Quality's regulations (40 CFR 1500 to 1508) and TVA's procedures for implementing the National Environmental Policy Act (NEPA). TVA has prepared the Northeastern Tributary Reservoirs Land Management Plan (NTRLMP) for the 4,933 acres of TVA-managed public land on Beaver Creek, Clear Creek, Boone, Fort Patrick Henry, South Holston, Watauga, and Wilbur reservoirs in northeast Tennessee and southwest Virginia. On June 10, 2010, the TVA Board of Directors (TVA Board) approved the NTRLMP, implementing the preferred alternative (Alternative C, Modified Proposed Land Use Alternative) identified in the final environmental impact statement (FEIS). Under the plan adopted by the TVA Board, TVA-managed public land on the seven tributary reservoirs has been allocated into broad use categories or “zones”, including Project Operations (Zone 2), Sensitive Resource Management (Zone 3), Natural Resource Conservation (Zone 4), Industrial (Zone 5), Developed Recreation (Zone 6), and Shoreline Access (Zone 7). Zone 1 is applied to reservoir lands that TVA does not own in fee, typically flowage easements, which are not included in the land planning process. Allocations to zones 2 through 7 were made in a manner consistent with TVA's 2006 Land Policy.
Amy Henry, NEPA Specialist, Environmental Permits and Compliance, Tennessee Valley Authority, 400 West Summit Hill Drive, WT 11D, Knoxville, Tennessee 37902–1499; telephone (865) 632–4045 or e-mail
TVA manages public lands to protect the integrated operation of TVA reservoir and power systems, to provide for appropriate public use and enjoyment of the reservoir system, and to provide for continuing economic growth in the Tennessee Valley.
The seven northeastern tributary reservoirs (NTRs) are located in the northeast corner of Tennessee and southwest corner of Virginia. Boone, Fort Patrick Henry, and South Holston reservoirs are along the South Fork Holston River. Watauga and Wilbur reservoirs are along the Watauga River. Beaver Creek and Clear Creek reservoirs are on tributaries within the South Fork Holston River watershed.
TVA originally acquired nearly 11,000 acres of land on the seven reservoirs. About half of that land has been sold for private use or transferred to State and other federal agencies for public use. TVA presently manages approximately 451 miles of shoreline along these reservoirs. Existing land uses around the reservoirs include TVA project operations, developed and dispersed recreation, private residences, and undeveloped areas. Reservoir properties on Fort Patrick Henry, South Holston, Watauga, and Wilbur reservoirs previously were planned in 1965 utilizing a Forecast System. A reservoir land management plan was prepared for Boone Reservoir in 1999. Beaver Creek and Clear Creek reservoirs have never been planned.
The NTRLMP is designed to guide future decision-making and the management of these reservoir properties in a manner consistent with the 2006 TVA Land Policy and other relevant TVA policies.
TVA published a notice of intent (NOI) to prepare an EIS in the
The notice of availability (NOA) of the NTRLMP draft EIS (DEIS) was published in the
Several individuals expressed appreciation for the opportunity to be involved in the planning process and supported Alternatives B and/or C. Other comments addressed a need for recreation opportunities, various land uses, and questions about water access rights. Comments also included concern about shoreline erosion and trash, interest in public access to the William Bean Historical Monument near Boone Reservoir, and the protection of historic resources. Comments from Federal and
TVA reviewed and prepared responses to all of these comments. In some cases, the FEIS was revised to reflect the information or issues presented. After considering all of the comments, the FEIS was completed and distributed to commenting agencies and the public. In the FEIS, TVA selected Alternative C as the preferred alternative. The NOA of the FEIS was published in the
TVA considered three alternatives for managing 254 parcels of public land, comprising approximately 4,933 acres, under its management around the reservoirs. Under all alternatives, TVA would continue to conduct an environmental review to address site- and project-specific issues prior to the approval of any proposed development or activity on an NTR parcel. Future activities and land uses would be guided by the TVA Land Policy. About 95 percent of NTR lands (4,679 acres) had previous commitments specified in land use agreements (
Under Alternatives B and C, the proportion of lands allocated to each zone is similar. About half of the land would be allocated to Natural Resource Conservation (Zone 4) or Sensitive Resource Management (Zone 3). About one-third would be allocated to Project Operations (Zone 2), and the remainder would be allocated to Developed Recreation (Zone 6), Shoreline Access (Zone 7), or Industrial (Zone 5) uses. Compared to Alternative B, zone allocations under Alternative C differ on 19 of the 254 parcels. Alternative C includes slightly more land in Zone 6, and slightly less land in Zones 3 and 4. Under Alternative C, parcels on Fort Patrick Henry, South Holston, and Watauga reservoirs that contain rare plants and plant communities, cultural resources, and high-quality wetlands would be allocated to Zone 3, which allows the least opportunity for development, and is, therefore, the most protective of sensitive resources. Those parcels would be allocated to Zone 4 under Alternative B. Additionally, six parcels on South Holston and Watauga reservoirs would be allocated to Zone 6 under Alternative C, which would provide additional recreational opportunities.
In the FEIS, TVA considered the environmental consequences of the alternatives on a wide variety of environmental resources. No significant direct, indirect or cumulative impacts are expected to occur to any resource under any of the alternatives. Under any alternative, potential impacts to sensitive resources, such as species Federally listed as endangered or threatened, cultural resources, and wetlands would be identified during project-specific evaluations.
TVA received comments on the FEIS from the U.S. Environmental Protection Agency (USEPA); the U.S. Department of Agriculture, Natural Resources Conservation Service (NRCS); and the Virginia Department of Transportation (VDOT). The Tennessee Department of Transportation and Virginia State Historic Preservation Officer (SHPO) acknowledged receipt of the FEIS but offered no comments.
USEPA expressed preference for Alternative B, based upon a finding that Alternative B would result in a reservoir land plan with minimum opportunity for land disturbance. However, the comments acknowledged that Alternative C incorporates public comments and other scoping information into the planning process and that the differences between Alternatives B and C are small. USEPA rated the FEIS as “Lack of Objections.”
Additionally, USEPA offered comments regarding the Beaver Creek watershed in Knox County, Tennessee. USEPA encouraged TVA to continue coordinating efforts and participating with the Beaver Creek Task Force. USEPA recommended that future TVA watershed activities remain in compliance with all approved Federal Emergency Management Agency flood studies completed within the Beaver Creek watershed. The agency also recommended that TVA coordinate efforts with the Knox County Stormwater Program, the USEPA Region 4 Total Maximum Daily Load Program, and the Tennessee Nonpoint Source Management Program.
While the Knox County Beaver Creek watershed is outside the area addressed in the FEIS, TVA acknowledges USEPA's emphasis on water quality in the Tennessee Valley. Water quality is a major consideration in the management of TVA land and reservoirs. TVA is currently a participating member of the task force and, together with the Beaver Creek Watershed Association, is implementing a grant that addresses pathogens and sediment in the impaired streams. TVA has hosted members of USEPA Region 4 and Washington offices to tour the Beaver Creek watershed. Additionally, TVA is working with the task force to implement a pilot project in the Knox County Beaver Creek watershed.
In other agency comments, the NRCS indicated it had no significant comments on the FEIS, but noted that future land use requests on the reservoirs may require interagency coordination to ensure compliance with the Farmland Protection Policy Act. TVA currently implements the NRCS recommendation as part of standard environmental review procedures. The environmental review conducted by TVA prior to approving a proposed use of reservoir land would include a review of the potential effects on prime or unique farmland and subsequent coordination with the NRCS, as appropriate.
Similarly, VDOT cited a statute and guidance for analyzing and mitigating traffic impacts to the highway system, indicating that any proposed new development on TVA-managed land around NTRs would need to adhere to the statute. The environmental review conducted by TVA prior to approving a proposed use of reservoir lands would include an evaluation of effects to transportation systems.
On June 10, 2010, the TVA Board approved the NTRLMP as described in preferred Alternative C of the FEIS. TVA believes that implementation of Alternative C provides suitable opportunities for developed recreation, conservation of natural resources, and management of sensitive resources. This decision incorporates mitigation measures that would further minimize the potential for adverse impacts to the environment. These measures are listed below.
The environmentally preferred alternative is Alternative C, under which approximately half of NTR lands are allocated to natural resource conservation (Zone 4) and sensitive resource management (Zone 3) uses, and all parcels with identified sensitive resources are allocated to Zone 3, which allows the least opportunity for land disturbance and is, therefore, the most protective land use zone.
• All activities will be conducted in accordance with the stipulations defined in the programmatic agreement (PA) between TVA, the Tennessee SHPO, and the Advisory Council on Historic Preservation. Until a similar PA is executed with the Virginia SHPO, TVA will incorporate the identification, evaluation, and treatment procedures established under Section 106 of the National Historic Preservation Act to effectively mitigate any adverse effects to historic properties.
• Invasive plants listed as Rank 1 (Severe Threat), Rank 2 (Significant Threat), or Rank 3 (Lesser Threat) on the Tennessee Exotic Plant Pest Council list of Invasive Exotic Pest Plants in Tennessee will not be used in landscaping activities on the reservoir lands.
• Revegetation and erosion-control measures will utilize seed mixes comprised of native species or noninvasive nonnative species.
With the implementation of the above measures, TVA has determined that adverse environmental impacts of future land development proposals on the TVA-managed reservoir lands would be substantially reduced. Before taking actions that could result in adverse environmental effects or before authorizing such actions to occur on properties it controls, TVA would perform a site-specific environmental review to determine the need for other necessary mitigation measures or precautions. These protective measures represent all of the practicable measures to avoid or minimize environmental harm associated with the alternative adopted by the TVA Board.
The Department of Veterans Affairs (VA) gives notice under Public Law 92–463 (Federal Advisory Committee Act) that the Advisory Committee on Disability Compensation will meet on July 26–27, 2010, at the St. Regis Washington DC, 923 16th and K Streets, NW., from 8:30 a.m. to 5 p.m. each day. The meeting will be held in the Carlton Ballroom. The meeting is open to the public.
The purpose of the Committee is to advise the Secretary of Veterans Affairs on the maintenance and periodic readjustment of the VA Schedule for Rating Disabilities. The Committee is to assemble and review relevant information relating to the nature and character of disabilities arising from service in the Armed Forces, provide an ongoing assessment of the effectiveness of the rating schedule and give advice on the most appropriate means of responding to the needs of veterans relating to disability compensation.
On both days, the Committee will receive briefings on issues related to compensation for Veterans with service-connected disabilities and other Veteran benefits programs. Time will be allocated for receiving public comments on the afternoon of July 26. Public comments will be limited to three minutes each. Individuals wishing to make oral statements before the Committee will be accommodated on a first-come, first-served basis. Individuals who speak are invited to submit 1–2 page summaries of their comments at the time of the meeting for inclusion in the official meeting record.
The public may submit written statements for the Committee's review to Ms. Ersie Farber, Designated Federal Officer, Department of Veterans Affairs, Veterans Benefits Administration (211A), 810 Vermont Avenue, NW., Washington, DC 20420. Any member of the public wishing to attend the meeting or seeking additional information should contact Ms. Farber at (202) 461–9728 or
By Direction of the Secretary.
The Department of Veterans Affairs gives notice under Public Law 92–463 (Federal Advisory Committee Act) that the Rehabilitation Research and Development Service Scientific Merit Review Board will meet on August 16–18, 2010, at the Hyatt Regency Washington on Capitol Hill, 400 New Jersey Avenue, NW., Washington, DC, and on August 24–26, 2010, at The Fairfax at Embassy Row, 2100 Massachusetts Avenue, NW, Washington, DC, from 8 a.m. to 5:30 p.m. each day. Various subcommittees of the Board will meet. Each subcommittee meeting of the Board will be open to the public the first day for approximately one half hour from 8.a.m. to 8:30 a.m. to cover administrative matters, the general status of the program and the administrative details of the review process. The remaining portion of the meetings will be closed for the Board's review of research and development applications.
The purpose of the Board is to review rehabilitation research and development applications for scientific and technical merit and to make recommendations to the Director, Rehabilitation Research and Development Service, regarding their funding.
The reviews involve oral comments, discussion of site visits, staff and consultant critiques of proposed research protocols, and similar analytical documents that focus on the consideration of the personal qualifications, performance and competence of individual research investigators. Disclosure of such information would constitute a clearly unwarranted invasion of personal privacy. Disclosure would also reveal research proposals and research underway which could lead to the loss of these projects to third parties and thereby frustrate future agency research
Those who plan to attend the open sessions should contact Tiffany Asqueri, Federal Designated Officer, Rehabilitation Research and Development Service (122P), Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420, at (202) 461–1740, or e-mail at
By Direction of the Secretary.
Centers for Medicare & Medicaid Services (CMS), HHS.
Proposed rule.
This proposed rule addresses proposed changes to the physician fee schedule and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. It also addresses, implements or discusses certain provisions of both the Affordable Care Act and the Medicare Improvements for Patients and Providers Act of 2008. In addition, this proposed rule discusses payments under the Ambulance Fee Schedule, Clinical Laboratory Fee Schedule, payments to ESRD facilities, and payments for Part B drugs. Finally, the proposed rule includes a discussion regarding the Chiropractic Services Demonstration program, the Competitive Bidding Program for Durable Medical Equipment and Provider and Supplier Enrollment Issues associated with Air Ambulances. (See the Table of Contents for a listing of the specific issues addressed in this proposed rule.)
To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on August 24, 2010.
In commenting, please refer to file code CMS–1503–P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one of the ways listed):
1.
2.
Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS–1503–P, P.O. Box 8013, Baltimore, MD 21244–8013.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS–1503–P, Mail Stop C4–26–05, 7500 Security Boulevard, Baltimore, MD 21244–1850.
4.
a. For delivery in Washington, DC—Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445–G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201.
(Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)
b. For delivery in Baltimore, MD—Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244–1850.
If you intend to deliver your comments to the Baltimore address, please call telephone number (410) 786–9994 in advance to schedule your arrival with one of our staff members.
Comments mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.
Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1–800–743–3951.
To assist readers in referencing sections contained in this preamble, we are providing a table of contents. Some of the issues discussed in this preamble affect the payment policies, but do not require changes to the regulations in the
In addition, because of the many organizations and terms to which we refer by acronym in this proposed rule, we are listing these acronyms and their corresponding terms in alphabetical order below:
Since January 1, 1992, Medicare has paid for physicians' services under section 1848 of the Social Security Act (the Act), “Payment for Physicians' Services.” The Act requires that payments under the physician fee schedule (PFS) are based on national uniform relative value units (RVUs) based on the relative resources used in furnishing a service. Section 1848(c) of the Act requires that national RVUs be established for physician work, practice expense (PE), and malpractice expense. Before the establishment of the resource-based relative value system, Medicare payment for physicians' services was based on reasonable charges. We note that throughout this proposed rule, unless otherwise noted, the term “practitioner” is used to describe both physicians and eligible nonphysician practitioners (such as physician assistants, nurse practitioners, clinical nurse specialists, certified nurse midwives, psychologists, or social workers) that are permitted to furnish and bill Medicare under the PFS for the services under discussion.
The concepts and methodology underlying the PFS were enacted as part of the Omnibus Budget Reconciliation Act (OBRA) of 1989 (Pub. L. 101–239), and OBRA 1990, (Pub. L. 101–508). The final rule, published on November 25, 1991 (56 FR 59502), set forth the fee schedule for payment for physicians' services beginning January 1, 1992. Initially, only the physician work RVUs were resource-based, and the PE and malpractice RVUs were based on average allowable charges.
The physician work RVUs established for the implementation of the fee schedule in January 1992 were developed with extensive input from the physician community. A research team at the Harvard School of Public Health developed the original physician work RVUs for most codes in a cooperative agreement with the Department of Health and Human Services (DHHS). In constructing the code-specific vignettes for the original physician work RVUs, Harvard worked with panels of experts, both inside and outside the Federal government, and obtained input from numerous physician specialty groups.
Section 1848(b)(2)(B) of the Act specifies that the RVUs for anesthesia services are based on RVUs from a uniform relative value guide, with appropriate adjustment of the
We establish physician work RVUs for new and revised codes based on our review of recommendations received from the American Medical Association's (AMA) Specialty Society Relative Value Update Committee (RUC).
Section 121 of the Social Security Act Amendments of 1994 (Pub. L. 103–432), enacted on October 31, 1994, amended section 1848(c)(2)(C)(ii) of the Act and required us to develop resource-based PE RVUs for each physician's service beginning in 1998. We were to consider general categories of expenses (such as office rent and wages of personnel, but excluding malpractice expenses) comprising PEs.
Section 4505(a) of the Balanced Budget Act of 1997 (BBA) (Pub. L. 105–33), amended section 1848(c)(2)(C)(ii) of the Act to delay implementation of the resource-based PE RVU system until January 1, 1999. In addition, section 4505(b) of the BBA provided for a 4-year transition period from charge-based PE RVUs to resource-based RVUs.
We established the resource-based PE RVUs for each physicians' service in a final rule, published November 2, 1998 (63 FR 58814), effective for services furnished in 1999. Based on the requirement to transition to a resource-based system for PE over a 4-year period, resource-based PE RVUs did not become fully effective until 2002.
This resource-based system was based on two significant sources of actual PE data: the Clinical Practice Expert Panel (CPEP) data; and the AMA's Socioeconomic Monitoring System (SMS) data. The CPEP data were collected from panels of physicians, practice administrators, and nonphysicians (for example, registered nurses (RNs)) nominated by physician specialty societies and other groups. The CPEP panels identified the direct inputs required for each physician's service in both the office setting and out-of-office setting. We have since refined and revised these inputs based on recommendations from the RUC. The AMA's SMS data provided aggregate specialty-specific information on hours worked and PEs.
Separate PE RVUs are established for procedures that can be performed in both a nonfacility setting, such as a physician's office, and a facility setting, such as a hospital outpatient department. The difference between the facility and nonfacility RVUs reflects the fact that a facility typically receives separate payment from Medicare for its costs of providing the service, apart from payment under the PFS. The nonfacility RVUs reflect all of the direct and indirect PEs of providing a particular service.
Section 212 of the Balanced Budget Refinement Act of 1999 (BBRA) (Pub. L. 106–113) directed the Secretary of Health and Human Services (the Secretary) to establish a process under which we accept and use, to the maximum extent practicable and consistent with sound data practices, data collected or developed by entities and organizations to supplement the data we normally collect in determining the PE component. On May 3, 2000, we published the interim final rule (65 FR 25664) that set forth the criteria for the submission of these supplemental PE survey data. The criteria were modified in response to comments received, and published in the
In the calendar year (CY) 2007 PFS final rule with comment period (71 FR 69624), we revised the methodology for calculating direct PE RVUs from the top-down to the bottom-up methodology beginning in CY 2007 and provided for a 4-year transition for the new PE RVUs under this new methodology. This transition ended in CY 2010 and direct PE RVUs are calculated in CY 2011 using this methodology, unless otherwise noted.
In the CY 2010 PFS final rule with comment period, we updated the PE/hour (HR) data that are used in the calculation of PE RVUs for most specialties (74 FR 61749). For this update, we used the Physician Practice Information Survey (PPIS) conducted by the AMA. The PPIS is a multispecialty, nationally representative, PE survey of both physicians and nonphysician practitioners (NPPs) using a survey instrument and methods highly consistent with those of the SMS and the supplemental surveys used prior to CY 2010. We note that in CY 2010, for oncology, clinical laboratories, and independent diagnostic testing facilities (IDTFs), we continued to use the supplemental survey data to determine PE/HR values (74 FR 61752).
Section 4505(f) of the BBA amended section 1848(c) of the Act requiring us to implement resource-based malpractice (MP) RVUs for services furnished on or after 2000. The resource-based MP RVUs were implemented in the PFS final rule published November 2, 1999 (64 FR 59380). The MP RVUs were based on malpractice insurance premium data collected from commercial and physician-owned insurers from all the States, the District of Columbia, and Puerto Rico.
Section 1848(c)(2)(B)(i) of the Act requires that we review all RVUs no less often than every 5 years. The first Five-Year Review of the physician work RVUs was published on November 22, 1996 (61 FR 59489) and was effective in 1997. The second Five-Year Review was published in the CY 2002 PFS final rule with comment period (66 FR 55246) and was effective in 2002. The third Five-Year Review of physician work RVUs was published in the CY 2007 PFS final rule with comment period (71 FR 69624) and was effective on January 1, 2007. (
In 1999, the AMA's RUC established the Practice Expense Advisory Committee (PEAC) for the purpose of refining the direct PE inputs. Through March 2004, the PEAC provided recommendations to CMS for over 7,600 codes (all but a few hundred of the codes currently listed in the AMA's Current Procedural Terminology (CPT) codes). As part of the CY 2007 PFS final rule with comment period (71 FR 69624), we implemented a new bottom-up methodology for determining resource-based PE RVUs and transitioned the new methodology over a 4-year period. A comprehensive review of PE was undertaken prior to the 4-year transition period for the new PE methodology from the top-down to the bottom-up methodology, and this transition was completed in CY 2010. In
In the CY 2005 PFS final rule with comment period (69 FR 66236), we implemented the first Five-Year Review of the MP RVUs (69 FR 66263). Minor modifications to the methodology were addressed in the CY 2006 PFS final rule with comment period (70 FR 70153). The second Five-Year Review and update of resource-based malpractice RVUs was published in the CY 2010 PFS final rule with comment period (74 FR 61758) and was effective in CY 2010.
Section 1848(c)(2)(B)(ii)(II) of the Act provides that adjustments in RVUs for a year may not cause total PFS payments to differ by more than $20 million from what they would have been if the adjustments were not made. In accordance with section 1848(c)(2)(B)(ii)(II) of the Act, if revisions to the RVUs cause expenditures to change by more than $20 million, we make adjustments to ensure that expenditures do not increase or decrease by more than $20 million.
As explained in the CY 2009 PFS final rule with comment period (73FR 69730), as required by section 133(b) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110–275), the separate budget neutrality (BN) adjustor resulting from the third Five-Year Review of physician work RVUs is being applied to the CF beginning in CY 2009 rather than to the work RVUs.
For CY 2010, we adopted a number of new payment policies for which we estimated the potential for a redistributive effect under the PFS, including the use of the new PPIS data to develop the specialty-specific PE/HR used for the PE RVUs (74 FR 61749 through 61752) and the elimination of the reporting of all CPT consultation codes in order to allow for correct and consistent coding and appropriate payment for evaluation and management services under the PFS (74 FR 61767 through 61775). We recognize that clinical experience with these new PFS policies has been growing over the first 6 months of CY 2010 and, as we seek to improve future PFS payment accuracy for services, we are interested in public comments on the perspectives of physicians and nonphysician practitioners caring for Medicare beneficiaries under the current PFS coding and payment methodologies for physicians' services.
To calculate the payment for every physicians' service, the components of the fee schedule (physician work, PE, and MP RVUs) are adjusted by a geographic practice cost index (GPCI). The GPCIs reflect the relative costs of physician work, PE, and malpractice expense in an area compared to the national average costs for each component.
RVUs are converted to dollar amounts through the application of a CF, which is calculated by CMS' Office of the Actuary (OACT).
The formula for calculating the Medicare fee schedule payment amount for a given service and fee schedule area can be expressed as:
The CY 2010 PFS final rule with comment period (74 FR 61738) implemented changes to the PFS and other Medicare Part B payment policies. It also finalized some of the CY 2009 interim RVUs and implemented interim RVUs for new and revised codes for CY 2010 to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. The CY 2010 PFS final rule with comment period also addressed other policies, as well as certain provisions of the MIPPA.
As required by the statute at the time of its issuance on October 30, 2009, the CY 2010 PFS final rule with comment period announced the following for CY 2010: The PFS update of −21.2 percent; the initial estimate for the sustainable growth rate of −8.8 percent; and the CF of $28.4061.
On December 10, 2009, we published a correction notice (74 FR 65449) to correct several technical and typographical errors that occurred in the CY 2010 PFS final rule with comment period. This correction notice announced a revised CF for CY 2010 of $28.3895.
On December 19, 2009, the Department of Defense Appropriations Act, 2010 (Pub. L. 111–118) was signed into law. Section 1011 of Pub. L. 111–118 provided a 2-month zero percent update to the CY 2010 PFS effective only for dates of service from January 1, 2010 through February 28, 2010.
On March 2, 2010, the Temporary Extension Act of 2010 (Pub. L. 111–144) was signed into law. Section 2 of Pub. L. 111–144 extended the zero percent update to the PFS through March 31, 2010 that was in effect for claims with dates of service from January 1, 2010 through February 28, 2010.
In addition, on April 15, 2010, the Continuing Extension Act of 2010 (Pub. L. 111–157) was signed into law. Section 4 of Public Law 111–157 extended through May 31, 2010 the zero percent update to the PFS that was in effect for claims with dates of services from January 1, 2010 through March 31, 2010. The law is retroactive to April 1, 2010.
In the May 11, 2010
Finally, on March 23, 2010 the Patient Protection and Affordable Care Act (Pub. L. 111–148) was signed into law. Shortly thereafter, on March 30, 2010, the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111–152) was signed into law. These two laws are discussed in this proposed rule and are collectively referred to as the “Affordable Care Act” (ACA) throughout this proposed rule.
Practice expense (PE) is the portion of the resources used in furnishing the service that reflects the general categories of physician and practitioner expenses, such as office rent and personnel wages but excluding malpractice expenses, as specified in section 1848(c)(1)(B) of the Act. Section 121 of the Social Security Amendments of 1994 (Pub. L. 103–432), enacted on October 31, 1994, required CMS to develop a methodology for a resource-based system for determining PE RVUs for each physician's service. We develop PE RVUs by looking at the direct and indirect physician practice resources involved in furnishing each service. Direct expense categories include clinical labor, medical supplies and medical equipment. Indirect expenses include administrative labor, office expense, and all other expenses. The sections that follow provide more
We use a bottom-up approach to determine the direct PE by adding the costs of the resources (that is, the clinical staff, equipment, and supplies) typically required to provide each service. The costs of the resources are calculated using the refined direct PE inputs assigned to each CPT code in our PE database, which are based on our review of recommendations received from the American Medical Association's (AMA's) Relative Value Update Committee (RUC). For a detailed explanation of the bottom-up direct PE methodology, including examples, we refer readers to the Five-Year Review of Work Relative Value Units Under the PFS and Proposed Changes to the Practice Expense Methodology proposed notice (71 FR 37242) and the CY 2007 PFS final rule with comment period (71 FR 69629).
We use survey data on indirect practice expenses incurred per hour worked (PE/HR) in developing the indirect portion of the PE RVUs. Prior to CY 2010, we primarily used the practice expense per hour (PE/HR) by specialty that was obtained from the AMA's Socioeconomic Monitoring Surveys (SMS). These surveys were conducted from 1995 through 1999. For several specialties that collected additional PE/HR data through supplemental surveys, we incorporated these data in developing the PE/HR values used annually.
While the SMS was not specifically designed for the purpose of establishing PE RVUs, we found these data to be the best available at the time. The SMS was a multispecialty survey effort conducted using a consistent survey instrument and method across specialties. The survey sample was randomly drawn from the AMA Physician Masterfile to ensure national representativeness. The AMA discontinued the SMS survey in 1999. As required by the Balanced Budget Refinement Act of 1999 (BBRA) (Pub. L. 106–113), we also established a process by which specialty groups could submit supplemental PE data. In the May 3, 2000
Because the SMS data and the supplemental survey data were from different time periods, we historically inflated them by the Medicare Economic Index (MEI) to put them on as comparable a time basis as we could when calculating the PE RVUs. This MEI proxy was necessary in the past due to the lack of contemporaneous, consistently collected, and comprehensive multispecialty survey data.
The AMA administered a new survey in CY 2007 and CY 2008, the Physician Practice Expense Information Survey (PPIS), which was expanded (relative to the SMS) to include nonphysician practitioners (NPPs) paid under the PFS. The PPIS was designed to update the specialty-specific PE/HR data used to develop PE RVUs. The AMA and the CMS contractor, The Lewin Group (Lewin), analyzed the PPIS data and calculated the PE/HR for physician and nonphysician specialties, respectively. The AMA's summary worksheets and Lewin's final report are available on the CMS Web site at
The PPIS is a multispecialty, nationally representative, PE survey of both physicians and NPPs using a consistent survey instrument and methods highly consistent with those used for the SMS and the supplemental surveys. The PPIS gathered information from 3,656 respondents across 51 physician specialty and healthcare professional groups.
We believe the PPIS is the most comprehensive source of PE survey information available to date. Therefore, we used the PPIS data to update the PE/HR data for almost all of the Medicare-recognized specialties that participated in the survey for the CY 2010 PFS. When we changed over to the PPIS data beginning in CY 2010, we did not change the PE RVU methodology itself or the manner in which the PE/HR data are used in that methodology. We only updated the PE/HR data based on the new survey. Furthermore, as we explained in the CY 2010 PFS final rule with comment period (74 FR 61751), because of the magnitude of payment reductions for some specialties resulting from the use of the PPIS data, we finalized a 4-year transition (75/25 for CY 2010, 50/50 for CY 2011, 25/75 for CY 2012, and 0/100 for CY 2013) from the previous PE RVUs to the PE RVUs developed using the new PPIS data.
Section 303 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108–173) added section 1848(c)(2)(H)(i) of the Act, which requires us to use the medical oncology supplemental survey data submitted in 2003 for oncology drug administration services. Therefore, the PE/HR for medical oncology, hematology, and hematology/oncology reflects the continued use of these supplemental survey data.
We do not use the PPIS data for reproductive endocrinology, sleep medicine, and spine surgery since these specialties are not separately recognized by Medicare, and we do not know how to blend these data with Medicare-recognized specialty data.
Supplemental survey data on independent labs, from the College of American Pathologists, were implemented for payments in CY 2005. Supplemental survey data from the National Coalition of Quality Diagnostic Imaging Services (NCQDIS), representing IDTFs, were blended with supplementary survey data from the American College of Radiology (ACR) and implemented for payments in CY 2007. Neither IDTFs nor independent labs participated in the PPIS. Therefore, we continue to use the PE/HR that was
Finally, consistent with our past practice, the previous indirect PE/HR values from the supplemental surveys for medical oncology, independent laboratories, and IDTFs were updated to CY 2006 using the MEI to put them on a comparable basis with the PPIS data. In the CY 2010 PFS final rule with comment period (74 FR 61753), we miscalculated the indirect PE/HR for IDTFs as part of this update process. Therefore, for CY 2011, we are proposing to use a revised indirect PE/HR of $479.81 for IDTFs, consistent with our final policy to update the indirect PE/HR values from prior supplemental survey data that we are continuing to use in order to put these data on a comparable basis with the PPIS data. This revision changes the IDTF indirect percentage from 51 percent to 50 percent.
Previously, CMS has established PE/HR values for various specialties without SMS or supplemental survey data by crosswalking them to other similar specialties to estimate a proxy PE/HR. For specialties that were part of the PPIS for which we previously used a crosswalked PE/HR, we instead use the PPIS-based PE/HR. We continue previous crosswalks for specialties that did not participate in the PPIS. However, beginning in CY 2010 we changed the PE/HR crosswalk for portable x-ray suppliers from radiology to IDTF, a more appropriate crosswalk because these specialties are more similar to each other with respect to physician time.
In the CY 2010 PFS final rule with comment period (74 FR 61752), we agreed that, under the current PE methodology, the PPIS data for registered dieticians should not be used in the calculation of PE RVUs since these dieticians are paid 85 percent of what a physician would be paid for providing the service. To include their survey data in the PE calculation would influence the ratesetting by incorporating what the services would be paid if performed by registered dieticians and not strictly what the payment rates would be if provided by physicians. We further stated that we would utilize the “All Physicians” PE/HR, as derived from the PPIS, in the calculation of resource-based PE RVUs in lieu of the PE/HR associated with registered dieticians. In the resource-based PE methodology for CY 2010, while we removed the specialty of registered dieticians from the ratesetting step we did not assign the “All Physicians” PE/HR to services furnished by registered dieticians. Instead, we allowed the PE/HR for those services to be generated by a weighted average of all the physician specialties that also furnished the services. This method was consistent with our policy to not use the registered dietician PPIS PE/HR in calculating the PE RVUs for services furnished by registered dieticians but we did not actually crosswalk the specialty of registered dietician to the “All Physicians” PE/HR data as we had intended according to the final policy. Nevertheless, we are affirming for CY 2011 that the proposed resource-based PE RVUs have been calculated in accordance with the final policy adopted in the CY 2010 PFS final rule with comment period (74 FR 61752) for registered dietician services that crosswalks the specialty to the “All Physicians” PE/HR data.
As provided in the CY 2010 PFS final rule with comment period (74 FR 61751), CY 2011 is the second year of the 4-year transition to the PE RVUs calculated using the PPIS data. Therefore, in general, the CY 2011 PE RVUs are a 50/50 blend of the previous PE RVUs based on the SMS and supplemental survey data and the new PE RVUS developed using the PPIS data as described above. Note that the reductions in the PE RVUs for expensive diagnostic imaging equipment attributable to the change to an equipment utilization rate assumption of 75 percent (
To establish PE RVUs for specific services, it is necessary to establish the direct and indirect PE associated with each service.
(i)
(ii)
• For a given service, we use the direct portion of the PE RVUs calculated as described above and the average percentage that direct costs represent of total costs (based on survey data) across the specialties that perform the service to determine an initial indirect allocator. For example, if the direct portion of the PE RVUs for a given service were 2.00 and direct costs, on average, represented 25 percent of total costs for the specialties that performed the service, the initial indirect allocator would be 6.00 since 2.00 is 25 percent of 8.00.
• We then add the greater of the work RVUs or clinical labor portion of the direct portion of the PE RVUs to this initial indirect allocator. In our example, if this service had work RVUs of 4.00 and the clinical labor portion of the direct PE RVUs was 1.50, we would add 6.00 plus 4.00 (since the 4.00 work RVUs are greater than the 1.50 clinical labor portion) to get an indirect allocator of 10.00. In the absence of any further use of the survey data, the relative relationship between the indirect cost portions of the PE RVUs for any two services would be determined by the relative relationship between these indirect cost allocators. For example, if one service had an indirect cost allocator of 10.00 and another service had an indirect cost allocator of 5.00, the indirect portion of the PE RVUs of the first service would be twice as great as the indirect portion of the PE RVUs for the second service.
• We next incorporate the specialty-specific indirect PE/HR data into the calculation. As a relatively extreme example for the sake of simplicity, assume in our example above that, based on the survey data, the average indirect cost of the specialties performing the first service with an allocator of 10.00 was half of the average indirect cost of the specialties performing the second service with an indirect allocator of 5.00. In this case, the indirect portion of the PE RVUs of the first service would be equal to that of the second service.
For procedures that can be furnished in a physician's office, as well as in a hospital or facility setting, we establish two PE RVUs: facility and nonfacility.
Diagnostic services are generally comprised of two components: a professional component (PC) and a technical component (TC), each of which may be performed independently or by different providers, or they may be performed together as a “global” service. When services have PC and TC components that can be billed separately, the payment for the global component equals the sum of the payment for the TC and PC. This is a result of using a weighted average of the ratio of indirect to direct costs across all the specialties that furnish the global components, TCs, and PCs; that is, we apply the same weighted average indirect percentage factor to allocate indirect expenses to the global components, PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum to the global under the bottom-up methodology.)
In the CY 2010 PFS final rule with comment period (74 FR 61749 through 61750), we discussed the Medicare Payment Advisory Commission's (MedPAC's) comment that in the future, “CMS should consider alternatives to collecting specialty-specific cost data or options to decrease the reliance on such data.” We agreed with MedPAC that it would be appropriate to consider the future of the PE RVUs moving forward. We sought comments from other stakeholders on the issues raised by MedPAC for the future. In particular, we requested public comments regarding MedPAC's suggestion that we consider alternatives for collecting specialty-specific cost data or options to decrease the reliance on such data. We noted MedPAC's comment that, “CMS should consider if Medicare or provider groups should sponsor future data collection efforts, if participation should be voluntary (such as surveys) or mandatory (such as cost reports), and whether a nationally representative sample of practitioners would be sufficient for either a survey or cost reports.” MedPAC also stated that one option for decreasing the reliance on specialty-specific cost data would be the elimination of the use of indirect PE/HR data in the last step of establishing the indirect cost portion of the PE RVUs as described previously.
Almost all of the commenters on the CY 2010 PFS final rule with comment period that addressed this issue expressed a general willingness to work with CMS on methodological improvements or future data collection efforts. Although no commenters detailed a comprehensive overall alternative methodology, several commenters did provide suggestions regarding future data collection efforts and specific aspects of the current methodology.
The commenters that addressed the issue of surveys supported the use of surveys if they yielded accurate PE information. The few commenters that addressed the issue of cost reports were opposed to physician cost reports. The commenters varied with respect to their opinions regarding whether data collection efforts should be led by organized medicine, individual specialty societies, or CMS. Several commenters that addressed the issue of voluntary versus mandatory data collection efforts supported voluntary data collection efforts and opposed mandatory data collection efforts.
Some commenters recommended no changes to the methodology or PE data in the near future. Other commenters indicated that the methodology and data changes needed to be made for CY 2011. Although most commenters did not directly address the use of the indirect PE/HR data, those that did predominately opposed the elimination of the use of these data.
Many commenters addressed specifics of the PE methodology (as further described in section II.A.2.c. of this proposed rule). Some were opposed to the scaling factor applied in the development of the direct PE portion of the PE RVUs so that in the aggregate the direct portion of the PE RVUs do not exceed the proportion indicated by the survey data (
A few commenters recommended that physician work not be used as an allocator in the development of the indirect portion of the PE RVUs as described earlier in this section. A few indicated that physician time, but not physician work, should be used in the allocation. Other commenters suggested that indirect costs should be allocated solely on the basis of direct costs.
We note that many of the issues raised by commenters on the CY 2010 PFS final rule with comment period are similar to issues raised in the development of the original resource-based PE methodology and in subsequent revisions to the methodology, including the adoption of the bottom-up methodology. While we are not proposing a broad methodological change or broad data collection effort in this CY 2011 PFS proposed rule, we invite comments on our summary of the issues raised by the commenters on the CY 2010 PFS final rule with comment period, as presented above. The complete public comments on that final rule are available for public review at
For a more detailed description of the PE RVU methodology, we refer readers to the CY 2010 PFS final rule with comment period (74 FR 61745 through 61746).
First, we create a setup file for the PE methodology. The setup file contains the direct cost inputs, the utilization for each procedure code at the specialty and facility/nonfacility place of service level, and the specialty-specific PE/HR data from the surveys.
Sum the costs of each direct input.
Create indirect allocators.
For most services the indirect allocator is:
There are two situations where this formula is modified:
• If the service is a global service (that is, a service with global, professional, and technical components), then the indirect allocator is: indirect percentage * (direct PE RVUs/direct percentage) + clinical PE RVUs + work RVUs.
• If the clinical labor PE RVUs exceed the work RVUs (and the service is not a global service), then the indirect allocator is: indirect percentage * (direct PE RVUs/direct percentage) + clinical PE RVUs.
(
For presentation purposes in the examples in the Table 2, the formulas were divided into two parts for each service. The first part does not vary by service and is the: indirect percentage * (direct PE RVUs/direct percentage). The second part is either the work RVUs, clinical PE RVUs, or both depending on whether the service is a global service and whether the clinical PE RVUs exceed the work RVUs (as described earlier in this step).
Apply a scaling adjustment to the indirect allocators.
Calculate the indirect practice cost index.
The final PE BN adjustment is calculated by comparing the results of Step 18 (prior to the MEI rebasing and MPPR adjustments) to the current pool of PE RVUs. This final BN adjustment is required primarily because certain specialties are excluded from the PE RVU calculation for ratesetting purposes, but all specialties are included for purposes of calculating the final BN adjustment. (
As discussed in section II.E.1. of this proposed rule, we are proposing to rebase and revise the Medicare Economic Index (MEI) for CY 2011. As discussed in section II.C.4. of this proposed rule, section 1848(c)(2)(K) of the Act (as added by section 3134 of the ACA) specifies that the Secretary shall identify potentially misvalued codes by examining multiple codes that are frequently billed in conjunction with furnishing a single service. There is inherent duplication in the PE associated with those services which are frequently furnished together, so reducing PFS payment for the second and subsequent services to account for the efficiencies in multiple service sessions may be appropriate. Consistent with this provision of the ACA, we are proposing a limited expansion of the current MPPR policy for imaging services for CY 2011 and a new MPPR policy for therapy services.
• Specialties excluded from ratesetting calculation: For the purposes of calculating the PE RVUs, we exclude certain specialties, such as certain nonphysician practitioners paid at a percentage of the PFS and low volume specialties, from the calculation. These specialties are included for the purposes of calculating the BN adjustment. They are displayed in Table 1.
• Crosswalk certain low volume physician specialties: Crosswalk the utilization of certain specialties with relatively low PFS utilization to the associated specialties.
• Physical therapy utilization: Crosswalk the utilization associated with all physical therapy services to the specialty of physical therapy.
• Identify professional and technical services not identified under the usual TC and 26 modifiers: Flag the services that are PC and TC services, but do not use TC and 26 modifiers (for example, electrocardiograms). This flag associates the PC and TC with the associated global code for use in creating the indirect PE RVUs. For example, the professional service, CPT code 93010 (Electrocardiogram, routine ECG with at least 12 leads; interpretation and report only), is associated with the global service, CPT code 93000 (Electrocardiogram, routine ECG with at least 12 leads; with interpretation and report).
• Payment modifiers: Payment modifiers are accounted for in the creation of the file. For example, services billed with the assistant at surgery modifier are paid 16 percent of the PFS amount for that service; therefore, the utilization file is modified to only account for 16 percent of any service that contains the assistant at surgery modifier.
• Work RVUs: The setup file contains the work RVUs from this proposed rule.
The equipment cost per minute is calculated as:
The use of any particular conversion factor (CF) in Table 2 to illustrate the PE calculation has no effect on the resulting RVUs.
As part of the PE methodology associated with the allocation of equipment costs for calculating PE RVUs, we currently use an equipment utilization rate assumption of 50 percent for most equipment, with the exception of expensive diagnostic imaging equipment (which is equipment priced at over $1 million, for example, computed tomography (CT) and magnetic resonance imaging (MRI) scanners), for which we adopted a 90 percent utilization rate assumption and provided for a 4-year transition beginning in CY 2010 (74 FR 61755). Therefore, CY 2010 is the first transitional payment year. Payment is made in CY 2010 for the diagnostic services listed in Table 3 (those that include expensive diagnostic imaging equipment in their PE inputs) based on 25 percent of the new PE RVUs and 75 percent of the prior PE RVUs for those services.
Section 1848(b)(4)(C) of the Act (as added by section 3135(a) of the ACA) requires that with respect to fee schedules established for CY 2011 and subsequent years, in the methodology for determining PE RVUs for expensive diagnostic imaging equipment under the CY 2010 PFS final rule with comment period, the Secretary shall use a 75 percent assumption instead of the utilization rates otherwise established in that rule. The provision also requires that the reduced expenditures attributable to this change in the utilization rate for CY 2011 and subsequent years shall not be taken into account when applying the budget neutrality limitation on annual adjustments described in section 1848(c)(2)(B)(ii)(II) of the Act.
As a result, the 75 percent equipment utilization rate assumption will be applied to expensive diagnostic imaging equipment in a nonbudget neutral manner for CY 2011, and the changes to PE RVUs will not be transitioned over a period of years. We will apply the 75 percent utilization rate assumption in CY 2011 to all of the services to which we currently apply the transitional 90 percent utilization rate assumption in CY 2010. These services are listed in a file on the CMS Web site that is posted under downloads for the CY 2010 PFS final rule with comment period at: (
Additionally, for CY 2011, we are proposing to expand the list of services to which the higher equipment utilization rate assumption applies to all other diagnostic imaging services that utilize similar expensive CT and MRI scanners. The additional 24 CPT codes (listed in Table 4) to which we are proposing to apply the 75 percent equipment utilization rate assumption also have expensive diagnostic imaging equipment (priced at over $1 million) included in their PE inputs. These services are predominantly diagnostic computed tomographic angiography (CTA) and magnetic resonance angiography (MRA) procedures that include similar expensive CT and MRI scanners in their direct PE inputs. We indicated in the CY 2010 PFS final rule with comment period (74 FR 61754) that we were persuaded by PPIS data on angiography that the extrapolation of MRI and CT data (and their higher equipment utilization rate) may be inappropriate. However, this reference was limited to those procedures that include an angiography room in the direct PE inputs, such as CPT code 93510 (Left heart catheterization, retrograde, from the brachial artery, axillary artery or femoral artery; percutaneous). In contrast, CTA and MRA procedures include a CT room or
Consistent with section 1848(c)(2)(B)(v)(III) of the Act (as amended by section 3135 of the ACA), the reduced expenditures attributable to this change in the utilization rate assumption applicable to CY 2011 shall not be taken into account when applying the budget neutrality limitation on annual adjustments described in section 1848(c)(2)(B)(ii)(III) of the Act.
As provided in the CY 2010 PFS final rule with comment period (74 FR 61751), CY 2011 is the second year of the 4-year transition to the PE RVUs calculated using the PPIS data. The reductions in the PE RVUs for expensive diagnostic imaging equipment attributable to the change to an equipment utilization rate assumption of 75 percent for CY 2011 are not subject to the transition.
In this section, we discuss other specific CY 2011 proposals and changes related to direct PE inputs. The proposed changes that follow are included in the proposed CY 2011 direct PE database, which is available on the CMS Web site under the downloads for the CY 2011 PFS proposed rule at
We have identified 22 codes for which the supply item “biohazard bag” (SM004) is currently considered a direct PE input. The item is already properly accounted for in the indirect PE because it is not attributable to an individual patient service. Therefore, we are proposing to remove the biohazard bag from the CY 2011 direct PE database and the changes in direct PE inputs for the associated services are reflected in the proposed CY 2011 direct PE database.
In the case of selected diagnostic tests, different but related CPT codes are used to describe global, professional, and technical components of a service. These codes are unlike the majority of other diagnostic test CPT codes where modifiers may be used in billing a single CPT code in order to differentiate professional and technical components. When different but related CPT codes are used to report the components of these services, the different CPT codes are referred to as “global only,” “professional (PC) only,” and “technical (TC) only” codes. Medicare payment systems are programmed to ensure that the PE RVUs for global only codes equal the sum of the PE RVUs for the PC and TC only codes. However, it has come to our attention that the direct PE inputs for certain global only codes do not reflect the appropriate summation of their related TC only and PC only component code PE inputs as they appear in the direct PE database. While the PFS payment calculations have been programmed to apply the correct PE RVUs for the global only code based on a summation of component code PE RVUs, the direct PE database has reflected incorrect inputs that are overridden by the payment system. Therefore, we are proposing to correct the direct PE inputs for the global only codes so that the inputs reflect the appropriate summing of the PE inputs for the associated PC only and TC only codes. The proposed CY 2011 direct PE database includes PE corrections to the 14 CPT codes listed in Table 5.
We have recently identified incorrect equipment time inputs for four CPT codes associated with certain diagnostic tests (each is displayed in Table 5):
• CPT code 93225 is the TC only code that includes the connection, recording, and disconnection of the holter monitor (CMS Equipment Code EQ127) used in 24 hour continuous electrocardiographic rhythm derived monitoring. The current equipment time input for the holter monitor is 42 minutes, which parallels the intra-service clinical labor input time for the CPT code. However, the equipment time should reflect the 24 hours of continuous monitoring in which the device is used exclusively by the patient. Therefore, we are proposing to change the monitor equipment time for CPT code 93225 to 1440 minutes, the number of minutes in 24 hours.
• CPT code 93226 is the TC only code that includes the scanning analysis with report. The number of minutes the monitor (CMS Equipment Code EQ127) is used in this service should parallel the intra-service clinical labor input time of 52 minutes during which the monitor is in use, instead of the current equipment time of 1440 minutes, because this code does not represent 24 hours of device use. Therefore, we are proposing to change the monitor equipment time for CPT code 93226 to 52 minutes.
• CPT 93224 is the global only code that includes the connection, recording, and disconnection of the monitor (CMS Equipment Code EQ127) and the scanning analysis with report, as well as the physician review and interpretation. Under our proposal, its direct PE inputs have been appropriately summed to include the 1492 total minutes of time for the holter monitor that are included in CPT codes 93225 and 93226.
• CPT code 93788 is the TC only code that describes the scanning analysis with report for ambulatory blood pressure monitoring. The equipment time input for the blood pressure monitor should parallel the 10 minutes of clinical labor input for the CPT code since that is the time during which the monitor is in use. Currently, the equipment time input for the monitor is 1440 minutes, which is appropriate only for CPT code 93786, the code that describes the 24 hours of ambulatory blood pressure monitoring recording. In this case, CPT code 93786's direct PE inputs are correct. Therefore, we are proposing to correct the equipment time input for the ambulatory blood pressure monitor in CPT code 93788 to 10 minutes.
• CPT code 93784 is the global only code that includes the recording, the scanning analysis with report, and the physician interpretation and report for ambulatory blood pressure monitoring. Under our proposal, its direct PE inputs have been appropriately summed to include the 1450 total minutes of time for the ambulatory blood pressure monitor that are included in CPT codes 93786 and 93788.
We have modified the proposed CY 2011 direct PE database to reflect these changes.
Stakeholders have requested that CMS reevaluate the useful life of the Cobalt-57 flood source (CMS Equipment Code ER001), given their estimate of approximately 271 days for the source's half-life. The current useful life input for the Colbalt-57 flood source is 5 years. Using publicly available catalogs, we found that the Cobalt-57 flood source is marketed with a useful life of 2 years. Therefore, we are proposing to change the useful life input from the current 5 years to 2 years. The Cobalt-57 flood source is included with the revised useful life input for 96 HCPCS codes in the proposed CY 2011 direct PE database.
One stakeholder provided updated price information for the venoms used for the five venom immunology CPT codes, specifically 95145 (Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy (specify number of doses); single stinging insect venom); 95146 (Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy (specify number of doses); 2 single stinging insect venoms); 95147 (Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy (specify number of doses); 3 single stinging insect venoms); 95148 (Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy (specify number of doses); 4 single stinging insect venoms); 95149 (Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy (specify number of doses); 5 single stinging insect venoms).
In the CY 2004 PFS final rule with comment period (68 FR 63206), we
As requested by the stakeholder, we are updating the price inputs for the 1-milliliter dose of venom to $16.67 and for the 3-vespid mix to $30.22 in the proposed CY 2011 direct PE database.
Stakeholders have recently brought to our attention that the ECG, 3-channel (with SpO2, NIBP, temp, resp) (CMS Equipment Code EQ011) incorporates all of the functionality of the pulse oximeter with printer (CMS Equipment Code EQ211). Therefore, in HCPCS codes where CMS Equipment Code EQ011 is present, CMS Equipment Code EQ211 is redundant. On this basis, we are proposing to remove the pulse oximeter with printer (CMS Equipment Code EQ211) as an input for the 118 codes that also contain the ECG, 3-channel (with SpO2, NIBP, temp, resp) (CMS Equipment Code EQ011). We have made these adjustments in the proposed CY 2011 direct PE database.
We recently identified a number of CPT codes with duplicate equipment inputs in the PE database. We are proposing to remove the duplicate equipment items and have modified the proposed CY 2011 direct PE database accordingly as detailed in Table 6.
We have identified minor errors in total price inputs for a number of supply items due to mathematical mistakes in multiplying the item unit price and the quantity used in particular CPT codes for the associated services. We are proposing to modify the direct PE database to appropriately include the overall supply price input for a supply item as the product of the unit price and the quantity of the supply item used in the CPT code. Most of the overall supply price input changes are small, and we have adjusted the proposed CY 2011 direct PE database accordingly. The CPT and Level II HCPCS codes and associated supplies for nonfacility and facility settings that are subject to these corrections are displayed in Tables 7 and 8, respectively.
In a March 2010 letter, the AMA RUC made specific PE recommendations that we consider below. As stated earlier, the proposed changes that follow are included in the proposed CY 2011 direct PE database, which is available on the CMS Web site under the downloads for the CY 2011 PFS proposed rule at
We are accepting the AMA RUC recommendations for the CY 2011 PE inputs for the following CPT codes: 91132 (Electrogastrography, diagnostic, transcutaneous); 91133 (Electrogastrography, diagnostic, transcutaneous; with provocative testing); 91038 (Esophageal function test, gastroesophageal reflux test with nasal catheter intraluminal impedance electrode(s) placement, recording, analysis and interpretation; prolonged (greater than 1 hour, up to 24 hours)). For CPT code 91038, we have assumed a useful life of 5 years for the equipment item “ZEPHR impedance/pH reflux monitoring system with data recorder, software, monitor, workstation and cart,” based on its entry in the AHA's publication, “Estimated Useful Lives of Depreciable Hospital Assets,” which we use as a standard reference. The proposed CY 2011 direct PE database has been changed accordingly.
The AMA RUC submitted an updated recommendation regarding the correct pricing of the 64-slice CT scanner and its accompanying software. Based on the documentation accompanying the recommendation, we are accepting this recommendation and updating the price input for the 64-slice scanner and software. This affects the following four CPT codes that use either the scanner, the software, or both: 75571 (computed tomography, heart, without contrast material, with quantitative evaluation of coronary calcium); 75572 (Computed tomography, heart, with contrast material, for evaluation of cardiac structure and morphology (including 3D image postprocessing, assessment of cardiac function, and evaluation of venous structures, if performed)); 75573 (Computed tomography, heart, with contrast material, for evaluation of cardiac structure and morphology in the setting of congenital heart disease (including 3D image postprocessing, assessment of LV cardiac function, RV structure and function and evaluation of venous structures, if performed)); and 75574 (Computed tomographic angiography, heart, coronary arteries and bypass grafts (when present), with contrast material, including 3D image postprocessing (including evaluation of cardiac structure and morphology, assessment of cardiac function, and evaluation of venous structure, if performed)). The proposed CY 2011 direct PE database has been modified accordingly.
The AMA RUC recently identified a rank order anomaly regarding CPT code 51726 (Complex cystometrogram (i.e., calibrated electronic equipment)). Currently, this procedure has higher PE RVUs, despite being less resource- intensive than the three CPT codes for which it serves as the base: 51727 (Complex cystometrogram
Since usual AMA RUC policy is that CPT codes with a 0-day global period do not have pre-service time associated with the code, the AMA RUC recommended removing the nonfacility pre-service clinical staff time from the PE inputs for 51726. Additionally, the AMA RUC recommended that the nonfacility clinical intra-service staff time for CPT code 51276 be reduced from the 118 minutes of intra-service clinical staff time currently assigned to the code to 85 minutes of intra-service clinical staff time. These changes would resolve the rank order anomaly and bring the PE inputs for CPT code 51726 into alignment with the other three codes. Finally, and for the reasons
The AMA RUC provide recommendations regarding the PE inputs for CPT code 91065 (breath hydrogen test (
A recent AMA RUC review of services that include the radiographic fluoroscopic room (CMS Equipment Code EL014) as a direct PE revealed that the use of the item is no longer typical for certain services in which it is specified within the current direct cost inputs. The AMA RUC recommended to CMS that the radiographic fluoroscopic room be deleted from CPT codes 64420 (Injection, anesthetic agent; intercostal nerve, single); 64421 (Injection, anesthetic agent; intercostal nerves, multiple, regional block); and 64620 (Destruction by neurolytic agent, intercostal nerve).
We are accepting these recommendations and, therefore, these changes are included in the proposed CY 2011 direct PE database.
The AMA RUC also informed us that it has convened a workgroup to examine the inclusion of the fluoroscopic room across a broader range of codes. We will consider any future recommendations from the AMA RUC on this topic when they are submitted.
As part of our review of high cost supplies, we conducted a clinical review of the procedures associated with high cost supplies to confirm that those supplies currently are used in the typical case described by the CPT codes. While we confirmed that most high cost supplies could be used in the procedures for which they are currently direct PE inputs, we noted that one of the high cost supplies, fiducial screws (CMS Supply Code SD073) with a current price of $558, is included as a direct PE input for two CPT codes, specifically 77301 (Intensity modulated radiotherapy plan, including dose-volume histograms for target and critical structure partial tolerance specifications) and 77011 (Computed tomography guidance for stereotactic localization). The documentation used in the current pricing of the supply item describes a kit that includes instructions, skull screws, a drill bit, and a collar for the TALON® System manufactured by Best nomos. Best nomos' literature describes the insertion of the screws into the patient's skull to ensure accurate set-up. When CPT codes 77301 and 77011 were established in CY 2002 and CY 2003, respectively, we accepted the AMA RUC recommendations to include fiducial screws in the PE for these services. Upon further review, while we understand why this supply may be considered a typical PE input for CPT code 77011, we do not now believe that fiducial screws, as described in the Best nomos literature, would typically be used in CPT code 77301, where the most common clinical scenario would be treatment of prostate cancer.
Therefore, in order to ensure that CPT codes 77301 and 77011 are appropriately valued for CY 2011 through the inclusion or exclusion of fiducial screws in their PE, we are asking the AMA RUC to review these CPT codes with respect to the inclusion of fiducial screws in their PE. We are requesting that the AMA RUC make recommendations to us regarding whether this supply should be included in the PE or removed from the PE for CPT codes 77301 and 77011 in a timeframe that would allow us to adopt interim values for these codes for CY 2011, should the AMA RUC recommend a change. If the AMA RUC continues to recommend the inclusion of fiducial screws in the PE for CPT code 77301 and/or 77011 for CY 2011, we are requesting that the AMA RUC provide us with a detailed rationale for the inclusion of this specialized supply in the PE for the typical case reported under the relevant CPT code. We would also request that the AMA RUC furnish updated pricing information for the screws if they continue to recommend the screws as a PE input for one or both of these CPT codes in CY 2011.
Historically, we have periodically received requests to change the PE price inputs for supplies and equipment in the PE database. In the past, we have considered these requests on an
We are proposing to act on public requests to update equipment and supply price inputs annually through rulemaking by following a regular and consistent process as discussed in the following paragraphs. We are proposing to use the annual PFS proposed rule released in the summer and the final rule released on or about November 1 each year as the vehicle for making these changes.
We will accept requests for updating the price inputs for supplies and equipment on an ongoing basis; requests must be received no later than December 31 of each CY to be considered for inclusion in the next proposed rule. In that next proposed rule, we would present our review of submitted requests to update price inputs for specific equipment or supplies and our proposals for the subsequent calendar year. We would then finalize changes in the final rule for the upcoming calendar year. Our review of the issues and consideration of public comments may result in the following outcomes that would be presented in the final rule with comment period:
• Updating the equipment or supply price inputs, as requested.
• Updating the equipment or supply price inputs, with modifications.
• Rejecting the new price inputs.
• Declining to act on the request pending a recommendation from the AMA RUC.
To facilitate our review and preparation of issues for the proposed rule, at a minimum, we would expect that requesters would provide the following information:
• Name and contact information for the requestor.
• The name of the item exactly as it appears in the direct PE file under downloads for the most recent PFS final rule with comment period, available on the CMS Web site at
In order to best evaluate the requests in the context of our goal of utilizing accurate market prices for these items as direct PE inputs, we also would expect requestors to provide multiple invoices from different suppliers/manufacturers. In some cases, multiple sources may not be available, whereupon a detailed explanation should be provided to support the request. When furnishing invoices, requestors should take into consideration the following parameters:
++ May be either print or electronic but should be on supplier and/or manufacturer stationery (for example, letterhead, billing statement,
++ Should be for the typical, common, and customary version of the supply or equipment that is used to furnish the services.
++ Price should be net of typical rebates and/or any discounts available, including information regarding the magnitude and rationale for such rebates or discounts.
++ If multiple items are presented on the same invoice, relevant item(s) should be clearly identified.
We are soliciting public comments on this proposed process, including the information that requestors should furnish to facilitate our full analysis in preparation for the next calendar year's rulemaking cycle.
Section 1848(c) of the Act requires that each service paid under the PFS be comprised of three components: work, PE, and malpractice. From 1992 to 1999, malpractice RVUs were charge-based, using weighted specialty-specific malpractice expense percentages and 1991 average allowed charges. Malpractice RVUs for new codes after 1991 were extrapolated from similar existing codes or as a percentage of the corresponding work RVU. Section 4505(f) of the BBA required us to implement resource-based malpractice RVUs for services furnished beginning in 2000. Therefore, initial implementation of resource-based malpractice RVUs occurred in 2000.
The statute also requires that we review, and if necessary adjust, RVUs no less often than every 5 years. The first review and update of resource-based malpractice RVUs was addressed in the CY 2005 PFS final rule with comment period (69 FR 66263). Minor modifications to the methodology were addressed in the CY 2006 PFS final rule with comment period (70 FR 70153). In the CY 2010 PFS final rule with comment period, we implemented the second review and update of malpractice RVUs. For a discussion of the second review and update of malpractice RVUs see the CY 2010 PFS proposed rule (74 FR 33537) and final rule with comment period (74 FR 61758).
Currently, malpractice RVUs for new and revised codes effective before the next 5-Year Review (for example, effective CY 2011 through CY 2014) are determined by a direct crosswalk to a similar “source” code or a modified crosswalk to account for differences in work RVUs between the new/revised code and the source code. For the modified crosswalk approach, we adjust the malpractice RVUs for the new/revised code to reflect the difference in work RVUs between the source code and the AMA RUC's recommended work value (or the work value we are applying as an interim final value under the PFS) for the new code. For example, if the interim final work RVUs for the new/revised code are 10 percent higher than the work RVUs for the source code, the malpractice RVUs for the new/revised code would be increased by 10 percent over the source code RVUs. This approach presumes the same risk factor for the new/revised code and source code but uses the work RVUs for the new/revised code to adjust for risk-of-service. The assigned malpractice RVUs for new/revised codes effective between updates remain in place until the next 5-Year Review.
We will continue our current approach for determining malpractice RVUs for new/revised codes that become effective before the next 5-Year Review and update. Under this approach we will crosswalk the new/revised code to the RVUs of a similar source code and adjust for differences in work (or, if greater, the clinical labor portion of the fully implemented PE RVUs), between the source code and the new/revised code. Additionally, we will publish a list of new/revised codes and the analytic crosswalk(s) used for determining their malpractice RVUs in the final rule with comment period, which we have not previously done. The CY 2011 malpractice RVUs for new/revised codes will be implemented as interim final values in the CY 2011 PFS final rule with comment period, where they will be subject to public comment. They will then be finalized in the CY 2012 PFS final rule with comment period.
As discussed in the CY 2010 PFS proposed rule (74 FR 33539), we assign malpractice RVUs to each service based upon a weighted average of the risk factors of all specialties that furnish the service. For the CY 2010 review of malpractice RVUs, we used CY 2008 Medicare payment data on allowed services to establish the frequency of a service by specialty. CPT code 22856 (Total disc arthroplasty (artificial disc), anterior approach, including discectomy with end plate preparation (includes osteophytectomy for nerve root or spinal cord decompression and microdissection), single interspace, cervical) had zero allowed services for CY 2008. Therefore, our contractor initially set the level of services to 1, and assigned a risk factor according to the average risk factor for all services that do not explicitly have a separate technical or professional component. We proposed to adopt our contractor's initial malpractice RVUs for CPT code 22856 in the CY 2010 proposed rule. Application of the average physician risk factor would have resulted in a significant decrease in malpractice RVUs for CPT code 22856 in CY 2010.
Several commenters on the CY 2010 PFS proposed rule expressed concern regarding the proposed malpractice RVUs for CPT code 22856, which represented a proposed reduction of more than 77 percent. The commenters stated that this service is predominantly furnished by neurosurgeons and orthopedic surgeons. Given the high risk factors associated with these specialty types and the changes in malpractice RVUs for comparable services, the commenters stated that a reduction in the malpractice RVUs of this magnitude for CPT code 22856 could not be correct.
After consideration of the public comments, for CY 2010, we set the risk factor for CPT code 22856 as the weighted average risk factor of six comparable procedures mentioned by
Since publication of the CY 2010 PFS final rule with comment period, stakeholders have mentioned that we made significant changes to the malpractice RVUs for CPT code 22856 in CY 2010. The commenters also brought to our attention that other services are clinically similar to CPT code 22856 and have similar work RVUs, and therefore, some stakeholders believe these services should all have similar malpractice RVUs. Services mentioned by the stakeholders that are clinically similar to CPT code 22856 include CPT code 22857; CPT code 22861 (Revision including replacement of total disc arthroplasty (artificial disc), anterior approach, single interspace; cervical); CPT code 22862 (Revision including replacement of total disc arthroplasty (artificial disc) anterior approach, lumbar); CPT code 22864 (Removal of total disc arthroplasty (artificial disc), anterior approach, single interspace; cervical); and CPT code 22865 (Removal of total disc arthroplasty (artificial disc), anterior approach, single interspace; lumbar).
After further review of this issue, we are proposing to apply the same risk factor used for CPT code 22856 to certain other services within this family of services (CPT codes 22857 through 22865) for which there were no allowed services in CY 2008. CPT codes 22861 and 22864 had zero allowed services in CY 2008 and our contractor initially set their malpractice RVUs in the same way as it did for CPT code 22856. Therefore, we will assign the weighted average risk factor we use for CPT code 22856 (that is, the weighted average of the risk factors for CPT codes 20931, 22554, 22558, 22845, 22857, and 63075) to CPT codes 22861 and 22864. However, CPT codes 22857, 22862, and 22865 are low volume services (allowed services under 100). Our policy for low volume services is to apply the risk factor of the dominant specialty as indicated by our claims data. We will continue to apply our policy for low volume services to CPT codes 22857, 22862, and 22865.
As discussed in section I. of this proposed rule, in order to value services under the PFS, section 1848(c) of the Act requires the Secretary to determine relative values for physicians' services based on three components: the work, practice expense (PE), and malpractice components. Section 1848(c)(1)(A) of the Act defines the work component to include “the portion of the resources used in furnishing the service that reflects physician time and intensity in furnishing the service.” Additionally, the statute provides that the work component shall include activities that occur before and after direct patient contact. Furthermore, the statute specifies that with respect to surgical procedures, the valuation of the work component for the code would reflect a “global” concept in which pre-operative and post-operative physicians' services related to the procedure would also be included.
In addition, section 1848(c)(2)(C)(i) of the Act specifies that “the Secretary shall determine a number of work relative value units (RVUs) for the service based on the relative resources incorporating physician time and intensity required in furnishing the service.” As discussed in detail in sections I.A.2. and I.A.3 of this proposed rule, the statute also defines the PE and malpractice components and provides specific guidance in the calculation of the RVUs for each of these components. Section 1848(c)(1)(B) of the Act defines the PE component as “the portion of the resources used in furnishing the service that reflects the general categories of expenses (such as office rent and wages of personnel, but excluding malpractice expenses) comprising practice expenses.”
Section 1848(c)(2)(C)(ii) of the Act specifies that the “Secretary shall determine a number of practice expense relative value units for the services for years beginning with 1999 based on the relative practice expense resources involved in furnishing the service.” Furthermore, section 1848(c)(2)(B) of the Act directs the Secretary to conduct a periodic review, not less often than every 5 years, of the RVUs established under the PFS. Finally, on March 23, 2010, the Affordable Care Act was enacted, further requiring the Secretary to periodically review and identify potentially misvalued codes and make appropriate adjustments to the relative values of those services identified as being potentially misvalued. Section 3134(a) of the ACA added a new section 1848(c)(2)(K) of the Act which requires the Secretary to periodically identify potentially misvalued services using certain criteria, and to review and make appropriate adjustments to the relative values for those services. Section 3134(a) of the ACA also added a new section 1848(c)(2)(L) which requires the Secretary to develop a validation process to validate the RVUs of potentially misvalued codes under the PFS and make appropriate adjustments.
As discussed in section I.A.1. of this proposed rule, we establish physician work RVUs for new and revised codes based on our review of recommendations received from the AMA RUC. The AMA RUC also provides recommendations to CMS on the values for codes that have been identified as potentially misvalued. To respond to concerns expressed by MedPAC, the Congress, and other stakeholders regarding accurate valuation of services under the PFS, the AMA RUC created the Five-Year Review Identification Workgroup. In addition to providing recommendations to CMS for work RVUs, the AMA RUC's Practice Expense Subcommittee reviews direct PE (clinical labor, medical supplies, and medical equipment) for individual services and examines the many broad and methodological issues relating to the development of PE RVUs.
In accordance with section 1848(c) of the Act, we determine appropriate adjustments to the RVUs, taking into account the recommendations provided by the AMA RUC and MedPAC, and publish the explanation for the basis of these adjustments in the PFS proposed and final rules. We note that section 1848(c)(2)(A)(ii) of the Act authorizes the use of extrapolation and other techniques to determine the RVUs for physicians' services for which specific data are not available, in addition to taking into account the results of consultations with organizations representing physicians.
In its March 2006 Report to Congress, MedPAC noted that “misvalued services can distort the price signals for physicians' services as well as for other health care services that physicians order, such as hospital services.” In that same report MedPAC postulated that physicians' services under the PFS can become misvalued over time for a number of reasons: “For example, when a new service is added to the physician fee schedule, it may be assigned a relatively high value because of the time, technical skill, and psychological stress that are required to perform it. Over time, skill, and stress involved may decline as physicians become more familiar with the service and more efficient at providing it. The amount of physician work needed to furnish an existing service may decrease when new technologies are incorporated. Services can also become overvalued when practice expenses decline. This can happen when the costs of equipment and supplies fall, or when equipment is used more frequently, reducing its cost per use. Likewise, services can become undervalued when physician work increases or practice expenses rise.” In the ensuing years since MedPAC's 2006 report, additional groups of potentially misvalued services have been identified by Congress, CMS, MedPAC, the AMA RUC, and other stakeholders.
In recent years CMS and the AMA RUC have taken increasingly significant steps to address potentially misvalued codes. As MedPAC noted in its March 2009 Report to Congress, in the intervening years since MedPAC made the initial recommendations, “CMS and the AMA RUC have taken several steps to improve the review process.” Most recently, section 1848(c)(2)(K)(ii) of the Act (as added by section 3134 of the ACA) directed the Secretary to specifically examine potentially misvalued services in seven categories.
(1) Codes and families of codes for which there has been the fastest growth.
(2) Codes or families of codes that have experienced substantial changes in practice expenses.
(3) Codes that are recently established for new technologies or services.
(4) Multiple codes that are frequently billed in conjunction with furnishing a single service.
(5) Codes with low relative values, particularly those that are often billed multiple times for a single treatment.
(6) Codes which have not been subject to review since the implementation of the RBRVS (the so-called ‘Harvard-valued codes').
(7) Other codes determined to be appropriate by the Secretary.
Section 1848(c)(2)(K)(iii) of the Act (as added by section 3134 of the ACA) also specifies that the Secretary may use existing processes to receive recommendations on the review and appropriate adjustment of potentially misvalued services. In addition, the Secretary may conduct surveys, other data collection activities, studies, or other analyses as the Secretary determines to be appropriate to facilitate the review and appropriate adjustment of potentially misvalued services. This section authorizes the use of analytic contractors to identify and analyze potentially misvalued codes, conduct surveys or collect data, and make recommendations on the review and appropriate adjustment of potentially misvalued services. Finally, section 1848(c)(2)(K)(iii)(V) of the Act (as added by section 3134 of the ACA) specifies that the Secretary may make appropriate coding revisions (including using existing processes for consideration of coding changes) which may include consolidation of individual services into bundled codes for payment under the physician fee schedule.
Over the last several years, CMS, in conjunction with the AMA RUC, has identified and reviewed numerous potentially misvalued codes in all seven of the categories specified in section 1848(c)(2)(K)(ii) (as added by section 3134 of the ACA), and we plan to continue our work examining potentially misvalued codes in these areas over the upcoming years, consistent with the new legislative mandate on this issue. In the current process, the AMA RUC reviews potentially misvalued codes that are identified either by CMS or through its own processes and recommends revised work RVUs and/or direct PE inputs for those codes to CMS. CMS then assesses the recommended revised work RVUs and/or direct PE inputs and, in accordance with section 1848(c) of the Act, we determine if the recommendations constitute appropriate adjustments to the RVUs under the PFS. Since CY 2009, CMS and the AMA RUC have identified over 700 potentially misvalued codes.
For example, in regards to the first category (codes and families of codes for which there has been the fastest growth), for CY 2009 CMS identified over 100 potentially misvalued codes for which an analysis of the utilization data showed an annual growth in allowed services of 10 percent (or more) for 3 consecutive years (73 FR 38586). Each of these codes had allowed charges of $1 million or more in CY 2007. We published this list in the CY 2009 proposed rule (73 FR 38586 through 38589) and requested that the AMA RUC immediately begin a review of the codes on this list. Meanwhile, in parallel with CMS' efforts, the AMA RUC also initiated processes to identify and review potentially misvalued codes on an ongoing basis using certain screens, including screens for “CMS fastest growing procedures” and “high volume growth.” Both of these AMA RUC screens are applicable to the first category of potentially misvalued codes specified in ACA. We plan to continue to analyze Medicare claims data over future years to identify additional services that exhibit rapid growth and high Medicare expenditures for referral to the AMA RUC for review as potentially misvalued codes.
Pertaining to the second category specified in section 1848(c)(2)(K)(ii) of the Act (as added by section 3134 of ACA) (codes or families of codes that have experienced substantial changes in practice expenses), in CY 2009 we requested that the AMA RUC continue its review of direct PE inputs, focusing particularly on high-volume codes where the PE payments are increasing significantly under the transition to the new PE methodology (73 FR 38589). The AMA RUC has responded by sending CMS recommendations for revised direct PE inputs for codes identified for PE review on an ongoing basis.
Additionally in CY 2009, we began an initiative to review and update the prices for high-cost supplies in order to ensure the accuracy and completeness of the direct PE inputs. We discuss our most recent efforts in refining the process to update the prices of high-cost supplies in section II.C.5. of this proposed rule.
For the third category of potentially misvalued codes identified in section 1848(c)(2)(K)(ii) (as added by section 3134 of the ACA) (codes that are recently established for new technologies or services), the AMA RUC routinely identifies such codes through a screen based on 3 years of Medicare claims data, and sends CMS recommendations for revised work RVUs and/or direct PE inputs for these codes on an ongoing basis. The AMA RUC may determine that a code for a new service requires reevaluation or does not require reevaluation, or it may conclude, on a case-by-case basis, that more than 3 years of claims data are
We also note that in its June 2008 Report to Congress entitled “Reforming the Health Care System” and in the context of a discussion about primary care, MedPAC acknowledges, “* * * Efficiency can improve more easily for other types of services, such as procedures, with advances in technology, technique, and other factors. Ideally, when such efficiency gains are achieved, the fee schedule's relative value units (RVUs) for the affected services should decline accordingly, while budget neutrality would raise the RVUs for the fee schedule's primary care services.” (page 27). Section III.C.5. of this proposed rule includes a discussion regarding periodic updates to the costs of high cost supplies. This discussion is highly relevant to new technology services, where growth in volume of a service as it diffuses into clinical practice may lead to a decrease in the cost of expensive supplies. We also expect that other efficiencies in physician work and PE may be achieved after an initial period of relative inefficiency that reflects the “learning curve.” We plan to pay particular attention to the work values and direct PE inputs for these new services and the AMA RUC's periodic review process to ensure that any efficiencies are captured under the PFS over time, recognizing that the appropriate timing for revaluing these services needs to be considered on a case-by-case basis depending on the growth rate in service volume.
We have also addressed the fourth category (multiple codes that are frequently billed in conjunction with furnishing a single service) in rulemaking prior to the enactment of the ACA. As discussed in the CY 2009 PFS proposed rule (73 FR 38586), we have a longstanding policy of reducing payment for multiple surgical procedures performed on the same patient, by the same physician, on the same day. Over the ensuing years, the multiple procedure payment reduction (MPPR) policy has been extended to a number of nuclear diagnostic and diagnostic imaging procedures. We continue our work to recognize efficiencies in this area with a proposal to expand the MPPR policy to additional combinations of imaging services and to therapy services for CY 2011 as described in section II.C.4. of this proposed rule.
We note the AMA RUC has also established a screen to identify services performed by the same physician on the same date of service 95 percent of the time or more. Over the past 2 years, the CPT Editorial Panel has established new bundled codes to describe a comprehensive service for certain combinations of these existing services that are commonly furnished together, and the AMA RUC has recommended work values and direct PE inputs to CMS for these comprehensive service codes that recognize the associated efficiencies. CMS looks forward to working with the AMA RUC in this joint effort to examine codes commonly reported together and more appropriately value common combinations services.
We address the fifth category of potentially misvalued codes (codes with low relative values, particularly those that are often billed multiple times for a single treatment) in section II.C.3.b. of this proposed rule. That is, we are providing a list of services with low work RVUs that are commonly reported with multiple units in a single encounter and requesting that the AMA RUC review these codes that we have identified as potentially misvalued.
The sixth category (codes which have not been subject to review since the implementation of the RBRVS (the so-called ‘Harvard-valued codes’)) also continues to be addressed by CMS and the AMA RUC on an ongoing basis. As we noted in the CY 2009 PFS proposed rule (73 FR 38589), there were at that time approximately 2900 codes, representing $5 billion in annual spending, that were originally valued using Harvard data and have not subsequently been evaluated by the AMA RUC. Consequently, in CY 2009, we requested that the AMA RUC engage in an ongoing effort to review the remaining Harvard-valued codes, focusing first on the high-volume, low intensity codes (73 FR 38589). In response to our request, the AMA RUC initially conducted an analysis of Harvard-valued services with utilization above 10,000 services per year, which resulted in a list of 296 distinct services (73 FR 69883). The AMA RUC, in its public comment on the CY 2009 proposed rule, stated that it believes it would be effective to limit any review to these 296 services and also noted that of the 296 services identified, 23 had already been identified by another screen and were in the process of being reviewed (73 FR 69883). To date, the AMA RUC has reviewed and submitted to CMS recommendations for revised work RVUs and/or direct PE inputs for a number of Harvard-valued codes, prioritizing those codes with utilization of over 1 million services. The AMA RUC and CMS intend to continue our ongoing assessment of Harvard-valued codes, next targeting codes with utilization of over 100,000 services.
Finally, the seventh category of potentially misvalued codes mentioned in section 1848(c)(2)(K)(ii) (as added by section 3134 of the ACA) is all other codes determined to be appropriate by the Secretary. In this category, CMS has previously proposed policies and requested that the AMA RUC review codes for which there have been shifts in the site-of-service (site-of-service anomalies), as well as codes that qualify as “23-hour stay” outpatient services. The policies for valuation of both the site-of-service anomaly codes and the “23-hour stay” codes are developed further in sections II.C.3.d. and e., respectively, of this proposed rule. For CY 2011, we are also identifying codes with low work RVUs but are high volume based on claims data as another category of potentially misvalued codes and are referring these codes to the AMA RUC for review, as discussed in section II.C.3.b. of this proposed rule. In addition, for CY 2011 we are newly targeting key codes that the AMA RUC uses as reference services for valuing other services, termed “multispecialty points of comparison” services, and referring these to the AMA RUC for review as potentially misvalued codes as described in section II.C.3.a. of this proposed rule. Finally, we note the AMA RUC has also established screens to identify potentially misvalued codes in additional categories, including codes with a high intra-service work per unit of time (IWPUT) and codes representing services that had been surveyed by one specialty, but are now performed by a different specialty. We will continue to review AMA RUC recommendations for revised work RVUs and/or direct PE inputs for codes that fall into these categories.
As a result of the combined efforts of CMS and the AMA RUC to address potentially misvalued codes, for CY 2009 the AMA RUC recommended revised work values and/or PE inputs for 204 misvalued services (73 FR 69883). For CY 2010, an additional 113 codes were identified as misvalued and the AMA RUC provided new recommendations for revised work RVUs and/or PE inputs to CMS as discussed in the CY 2010 PFS final rule with comment period (74 FR 61778). Upon review of the AMA RUC-recommended work RVUs, CMS accepted the majority of the values as appropriate adjustments to the RVUs under the PFS, in accordance with section 1848(c) of the Act. However, for a number of codes, mainly the site-of-service anomaly codes, we indicated
In addition to identifying and reviewing potentially misvalued codes, section 1848(c)(2)(L) (as added by section 3134 of the ACA) specifies that the Secretary shall establish a formal process to validate relative value units under the PFS. The validation process may include validation of work elements (such as time, mental effort and professional judgment, technical skill and physical effort, and stress due to risk) involved with furnishing a service and may include validation of the pre, post, and intra-service components of work. The Secretary is directed to validate a sampling of the work RVUs of codes identified through any of the seven categories of potentially misvalued codes specified by section 1848(c)(2)(K)(ii) (as added by section 3134 of the ACA). Furthermore, the Secretary may conduct the validation using methods similar to those used to review potentially misvalued codes, including conducting surveys, other data collection activities, studies, or other analyses as the Secretary determines to be appropriate to facilitate the validation of RVUs of services. Currently, while CMS does assess the AMA RUC- recommended work RVUs to determine if the recommendations constitute appropriate adjustments to the RVUs under the PFS, we intend to establish a more extensive validation process of RVUs in the future in accordance with the requirements of section 1848(c)(2)(L) (as added by section 3134 of the ACA). Therefore, we are soliciting public comments on this proposed rule on possible approaches and methodologies that we should consider for a validation process. We are especially interested in public comments regarding approaches, including the use of time and motion studies, to validate estimates of physician time and intensity that are factored into the work RVUs for services with rapid growth in Medicare expenditures, one of the categories that the statute specifically directs CMS to examine. We plan to discuss the validation process in a future PFS rule once we have considered the matter further in conjunction with any public comments and other input from stakeholders that we receive.
In this section, we discuss codes that may be misvalued according to five different criteria:
• Codes on the multi-specialty points of comparison list;
• Codes with low work RVUs commonly billed in multiple units per single encounter;
• Codes with high volume and low work RVUs;
• Codes with site-of-service anomalies; and
• Codes that qualify as “23-hour stay” outpatient services.
The AMA RUC uses a scale referred to as the multispecialty points of comparison (MPC) to evaluate the reasonableness of a specialty society's recommended RVU value for a service. The MPC list contains reference codes of established comparison services that are used in the valuation of new codes. The current MPC list consists of 316 codes which the AMA RUC may use to compare and contrast the relativity of codes under review to existing relative values. Since the AMA RUC may use the values on the MPC list as a basis for relativity when determining the values for new, revised, and newly reviewed codes (including potentially misvalued codes), it is essential that the services on the MPC list be appropriately valued since any codes misvalued on the MPC list could contribute to the misvaluing of other codes under review. While we believe that the entire MPC list should be assessed to ensure that services are paid appropriately under the PFS, we have prioritized the review of the MPC list, ranking the codes by allowed service units and charges based on CY 2009 claims data. We are proposing to refer the codes in Table 9 to the AMA RUC for review.
Consistent with section 1848(c)(2)(K)(ii) (as added by section 3134 of the ACA) which identifies categories of potentially misvalued codes for our review, we believe services with low work RVUs that are commonly billed with multiple units in a single encounter are an additional appropriate category for identifying potentially misvalued codes. An example of a high multiple/low work RVU service is CPT code 95004 (Percutaneous tests (scratch, puncture, prick) with allergenic extracts, immediate type reaction, including test interpretation and report by a physician, specify number of tests). For purposes of compiling a list of the high multiple/low work RVU services, we defined a high multiple service as one that is commonly performed in multiples of 5 or more per day. Then, we selected from high multiple services with work RVUs of less than or equal to 0.5 RVUs. We note that in selecting 5 per day as the minimum threshold for the number of common services performed in a multiple service encounter, we intended to establish a meaningful threshold which, in conjunction with the
We are asking the AMA RUC to review the codes in Table 10.
We believe that codes that have low work RVUs but are high volume based on claims data are another category of potentially misvalued codes. Although these codes have low work RVUs (less than or equal to 0.25 RVUs), the high utilization of these codes represents significant expenditures under the PFS such that their appropriate valuation is especially important. Table 11 contains a list of such codes and we are requesting that the AMA RUC review these codes.
In previous years, we requested that the AMA RUC review codes that, according to the Medicare claims database, have experienced a change in the typical site of service since the original valuation of the code. For example, we have found services that originally were provided in the inpatient setting but for which current claims data show the typical case has shifted to being furnished outside the inpatient setting. Since the procedures were typically performed in the inpatient setting when the codes were originally valued, the work RVUs for these codes would have been valued to include the inpatient physician work provided, as well as to reflect the intensive care and follow-up normally associated with an inpatient procedure. If the typical case for the procedure has shifted from the inpatient setting to an outpatient or physician's office setting, it is reasonable to expect that there have been changes in medical practice, and that such changes would represent a decrease in physician time or intensity or both. The AMA RUC reviewed and recommended to CMS revised work RVUs for 29 codes for CY 2009 and 11 codes for CY 2010 that were identified as having site-of-service anomalies.
In the CY 2010 PFS proposed and final rules with comment period (74 FR 33556 and 74 FR 61777, respectively), we encouraged the AMA RUC to utilize the building block methodology when revaluing services with site-of-service anomalies. Specifically, where the AMA RUC has determined in its review that changes in the inclusion of inpatient hospital days, office visits, and hospital discharge day management services (that is, the “building blocks” of the code) are warranted in the revaluation of the code, we asked the AMA RUC to adjust the site-of-service anomaly code for the work RVUs associated with those changes.
Additionally, we suggested that in cases where the AMA RUC has adjusted the pre-service, intra-service and post-service times of the code under review, the AMA RUC should also make associated work RVU adjustments to account for those changes. However, we remain concerned that in the AMA RUC's recommendations of the work RVUs for the CYs 2009 and 2010 site-of-service anomaly codes, the AMA RUC may have determined that eliminating or reallocating pre-service and post-service times, hospital days, office visits, and hospital discharge day management services was appropriate to reflect the typical case that is now occurring in a different setting, but the work RVUs associated with those changes may not have been systematically extracted or reallocated from the total work RVU value for the service.
In the CYs 2009 and 2010 PFS final rules with comment period (73 FR 69883 and 74 FR 61776 through 61778, respectively), we indicated that although we would accept the AMA RUC valuations for these site-of-service anomaly codes on an interim basis through CY 2010, we had ongoing concerns about the methodology used by the AMA RUC to review these services. We requested that the RUC reexamine the site-of-service anomaly codes and use the building block methodology to revalue the services (74 FR 61777). We also stated that we would continue to examine these codes and consider whether it would be appropriate to propose additional changes in future rulemaking.
Accordingly, in preparation for CY 2011 rulemaking, we conducted a comprehensive analysis of the codes that the AMA RUC reviewed for CYs 2009 and 2010 due to site-of-service anomaly concerns. We systematically applied the reverse building block methodology to the 29 codes from CY 2009 and 11 codes from CY 2010 as follows:
• First, we obtained the original work RVU value assigned to the code (this is the “starting value”) and made a list of the building block services with RVUs that were originally associated with the code (that is, before the AMA RUC reviewed the code for site-of-service anomalies).
• Next, we examined the AMA RUC-recommended changes to the building blocks of the code.
• We then deducted the RVUs associated with the AMA RUC's recommended eliminations from the code's starting RVU value.
Generally, the AMA RUC eliminated inpatient hospital visit building blocks from the value of the code since the site-of-service for the code has shifted from the inpatient setting to another setting. We note in some cases, the AMA RUC left an inpatient hospital visit in the valuation of the code. We believe this is inconsistent with the change in the site of service to non-inpatient settings. Accordingly, we adhered to the methodology and deducted the RVUs associated with all inpatient hospital visits from the starting value. In cases where the AMA RUC recommended adding or substituting outpatient visits, we also added or substituted the RVUs associated with those changes to the starting value. If the AMA RUC recommended changes to the pre-, intra-, or post-service times, we calculated the incremental change in RVUs associated with that time and either added or deducted that RVU amount from the starting value. We note that the RVU values associated with the incremental time change are calculated using the intensity associated with the particular pre-, intra-, or post period. For the intensity of the intra-service period, we utilized the original IWPUT associated with the code. The AMA RUC generally recommended allowing only half of a hospital discharge day management service for the site-of-service anomaly codes. That is, CPT code 99238 (Hospital discharge day management; 30 minutes or less) has a work RVU value of 1.28; therefore, half the value associated with CPT code 99238 is 0.64. Accordingly, if a code had one CPT code 99238 listed as part of the original valuation, we deducted 0.64 RVUs from the starting value.
We standardized the methodology so that each of the site-of-service anomaly codes has half of a hospital discharge day management service value accounted in the valuation. Finally, we note that while we eliminated the RVUs associated with all inpatient hospital visits built into the code's starting value, because the typical case no longer occurs in the inpatient setting, we allowed for the possibility that in some cases, some part of the work which had been performed in the inpatient setting may continue to be provided even in the outpatient setting. Therefore, to be conservative in our deductions of work RVUs associated with the inpatient hospital codes from the starting values, we allowed the intra-time of any inpatient hospital visits included in the original valuation to migrate to the post-service period of the code. Accordingly, while we deducted the full RVUs of an inpatient hospital visit from the starting value, we added the intra-service time of the inpatient hospital visit to the post-service time of the code and accounted for the incremental change in RVUs. The following description provides an example of our methodology.
CPT code 21025 (Excision of bone (
The AMA RUC removed two inpatient hospital visits and reduced the outpatient visits from 6 to 4 visits. Table 13 shows the building blocks that were recommended for CY 2009 by the AMA RUC after its review of the code for site-of-service anomalies.
Next we calculated the RVUs associated with the changes to the building blocks recommended by the AMA RUC. We note that the immediate post-service value of 0.38 RVUs (Table 14) includes 30 minutes of intra-service time from inpatient hospital CPT code 99231 (Level 1 subsequent hospital care, per day). Also, the median intra-service value of 0.44 RVUs (Table 14) was determined using the starting IWPUT value of 0.0145. Additionally, our methodology accounted for a half of a hospital discharge day management service (CPT code 99238) for the site-of-service anomaly code. Table 14 shows the RVU changes to the building blocks that were calculated based on the methodology discussed above.
In the final step, the RVUs associated with the changes to the building blocks recommended by the AMA RUC (Table 14) were deducted from or added to the starting value of 11.07 RVUs, which resulted in the CY 2011 reverse building
The methodology discussed above was applied to each of the site-of-service anomaly codes from CYs 2009 and 2010 and the results are summarized in Tables 15 and 16.
For most codes in Tables 15 and 16, the CY 2011 reverse building block methodology produced a value that is somewhat lower than the AMA RUC-recommended value. While our results suggest that the majority of the codes with site-of-service anomalies continue to be overvalued under the AMA RUC's most recent recommendations, we also found that the methodology may produce a result that is considerably reduced or, in several cases, a negative value. We understand that in previous years, stakeholders have expressed confusion as to why the application of a building block methodology would produce negative values. We believe in some cases, the starting value, that is,
We note the application of the reverse building block methodology is an objective way to account for changes in the resources resulting from the change in the site-of-service in which the typical service is provided. However, because relative values under the PFS are “relative,” that is, where work relative value units for a code are established relative to work relative value units for other codes, the recommended methodology of valuing services based on input building blocks is best applied within the context of the AMA RUC discussion. For example, we recognize that the AMA RUC looks at families of codes and may assign RVUs based on a particular code ranking within the family. This method of valuing services preserves relativity within the relative value scale for that code family. However, we have stated that we believe the relative value scale requires each service to be valued based on the resources used in furnishing the service as specified in section 1848(c)(1)(A) of the Act, which defines the physician work component to include “the portion of the resources used in furnishing the service that reflects physician time and intensity in furnishing the service.” Furthermore, section 1848(c)(2)(C)(i) of the Act specifies that “the Secretary shall determine a number of work relative value units (RVUs) for the service based on the relative resources incorporating physician time and intensity required in furnishing the service.” Read together, these two sections of the statute support our intention to rely on the building block methodology to determine appropriate work RVUs for codes.
We note that we continue to rely on the extensive expertise provided by the AMA RUC to recommend appropriate input building blocks for codes. Additionally, the AMA RUC's unique infrastructure and broad perspective permits the valuation of a code within the context of relativity to the entire relative value system. Therefore, we believe that the recommended methodology of valuing services based on input building blocks is best applied within the context of the AMA RUC discussion.
Accordingly, we are requesting that the AMA RUC review the CPT codes displayed in Tables 15 and 16. In addition, where the application of the CY 2011 reverse building block methodology produces an aberrant result that is clearly not a reflection of physician work for the service, we are requesting that the AMA RUC review the input building blocks and recommend an appropriate RVU value that is both consistent with the building blocks of the code and appropriate relative to the values for other codes in the family. For other codes where the application of the CY 2011 reverse building block methodology produces a result that is consistent with the physician work for the service, we encourage the AMA RUC to confirm the values and recommend these work values for CY 2011. In this way, we would hope to receive new AMA RUC recommendations for all of the codes in Tables 15 and 16 for CY 2011. Furthermore, if the recommendations that we receive from the AMA RUC are not consistent with the building block methodology and not appropriate relative to the values of other services, and the application of the CY 2011 reverse building block methodology produces a result that CMS medical advisors believe is consistent with the work for the service, we are proposing to adopt the CY 2011 reverse building block methodology values that are listed in Tables 15 and 16 for CY 2011. In cases where the reverse building block methodology produces a negative work value, we are suggesting that the AMA RUC review and revise the building blocks of the code so that a new valuation can be determined based on the building block methodology. For such codes, if the revised recommendations that we would hope to receive from the AMA RUC are still not consistent with the building block methodology upon revision, because we cannot pay for these services based on negative work RVUs, we are proposing to modify the AMA RUC-recommended values for these codes as CMS determines clinically appropriate and adopt the CMS-modified RVUs on a interim final basis for CY 2011.
In their future work, we urge the AMA RUC to use the building block methodology when valuing services or provide CMS with extensive rationale for cases where the AMA RUC believes the building block methodology is inappropriate for a specific code. Since section 1848(c)(2)(L) (as added by section 3134 of the ACA) specifies that the Secretary shall establish a process to validate work RVUs of potentially misvalued codes under the PFS, as we have discussed earlier in this section, we believe codes that are valued using the building block methodology would be more likely to meet the standards of a systematic RVU validation process that could be developed in accordance with the requirements of the statute.
In the CY 2010 PFS proposed rule (74 FR 33557), we requested that the AMA RUC review services that are typically performed in the outpatient setting and require a hospital stay of less than 24 hours. We stated in the proposed rule that we believed these to be primarily outpatient services and expressed concern that the value of evaluation and management (E/M) visits for inpatients was inappropriately included in the valuation of codes that qualify as “23-hour stay” outpatient services.
We received a number of comments in response to the discussion in the CY 2010 proposed rule. The AMA RUC stated that it already values stays of less than 23 hours appropriately by reducing the hospital discharge day management service (that is, CPT code 99238), from 1 day to a half day. The AMA RUC also explained that when the AMA RUC refers to 23-hour stay services in discussions at AMA RUC meetings, it is referring primarily to services that are reported in the Medicare claims database as typically outpatient services, but where the patient is kept overnight and, on occasion, even longer in the hospital. Because the AMA RUC believes the patient stays overnight in the hospital, it believes the inclusion of inpatient E/M visits to be appropriate in the valuation of this category of codes.
We believe that the 23-hour stay issue encompasses several scenarios. The typical patient is commonly in the
Currently, the valuation of 23-hour stay services is conducted in a nonuniform manner by the AMA RUC. The AMA RUC has indicated that it currently includes a half hospital discharge day management service and no hospital inpatient visits for outpatient services with expected hospital stays of 23 hours or less. In contrast, for those outpatient services where the AMA RUC believes that the recovery period could be longer than 23 hours, the AMA RUC stated in its comment on the CY 2010 PFS proposed rule that it currently includes a full hospital discharge day management service and one or more inpatient E/M visits in the code's value. However, we note the typical 23-hour stay service is billed as an outpatient service and so long as the typical case continues to be billed as an outpatient service, we believe the code should not incorporate physician work values for services that are typically associated with an inpatient service. In the 2010 PFS proposed and final rule with comment period (74 FR 33556 and 74 FR 61777, respectively), we stated that we believed the use of inpatient E/M visit codes for services rendered in the post-service period for outpatient 23-hour stay procedures would result in overpayment for pre- and post-service work that would not be provided. Accordingly, we proposed in the CY 2010 proposed rule (74 FR 33556 through 33557) not to allow any additional inpatient E/M service to be billed for care furnished during the post-procedure period when care is furnished for an outpatient service requiring less than a 24-hour hospital stay.
However, we find it is plausible that while the patient receiving the 23-hour stay service remains a hospital outpatient, the patient would typically be cared for by the physician furnishing the procedure during that post-procedure period. While we do not believe that post-procedure hospital “visits” would be at the inpatient level since the typical case is an outpatient who would be ready to be discharged from the hospital in 23 hours or less, we agree that the intra-service time of the inpatient hospital visit may be included in the valuation for the 23-hour stay code.
Accordingly, we are modifying our proposed CY 2010 approach and suggesting that in the future, when the AMA RUC reviews new and potentially misvalued codes that are identified as 23-hour stay services, the AMA RUC would apply the following methodology:
(1) Begin with the starting RVU value of the 23-hour stay code under review and decrease the hospital discharge day management service from one day to a half day.
(2) Deduct the RVUs of inpatient hospital visits from the starting RVU value.
(3) Reallocate the time associated with the intra-service portion of the inpatient hospital visits to the immediate post-service time of the 23-hour stay code under review.
• Applying step (1): 15−0.64
• Applying step (2): 14.36−2
• Applying step (3): 12.36 + (30 minutes × 0.0224)
Finally, we note that since work relative value units are established by the Secretary in the context of relativity to other codes in the system, the recommended methodology for the evaluation of 23-hour stay codes is best applied within the context of relativity. We appreciate that the AMA RUC has the ability to assess the 23-hour stay code after application of the recommended methodology to ensure appropriate relativity of this code and other codes within the system. We strongly encourage the AMA RUC to apply the recommended methodology to ensure the consistent and appropriate valuation of the physician work for these services.
Medicare has a longstanding policy to reduce payment by 50 percent for the second and subsequent surgical procedures furnished to the same patient by the same physician on the same day, largely based on the presence of efficiencies in the PE and pre- and post-surgical physician work. Effective January 1, 1995, the multiple procedure payment reduction (MPPR) policy, with the same percentage reduction, was extended to nuclear medicine diagnostic procedures (CPT codes 78306, 78320, 78802, 78803, 78806, and 78807). In the CY 1995 PFS final rule with comment period (59 FR 63410), we indicated that we would consider applying the policy to other diagnostic tests in the future.
Consistent with recommendations of MedPAC in its March 2005 Report to Congress on Medicare Payment Policy, under the CY 2006 PFS, the MPPR policy was extended to the technical component (TC) of certain diagnostic imaging procedures performed on contiguous areas of the body in a single session (70 FR 70261). The reduction recognizes that, for the second and subsequent imaging procedures, there are some efficiencies in clinical labor, supplies, and equipment time. In particular, certain clinical labor activities and supplies are not duplicated for subsequent procedures and, because equipment time and indirect costs are allocated based on clinical labor time, those would also be reduced accordingly.
The imaging MPPR policy currently applies to computed tomography (CT) and computed tomographic angiography (CTA), magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA), and ultrasound services within 11 families of codes based on imaging modality and body region. When we adopted the policy in CY 2007, we stated that we believed efficiencies were most likely to occur when contiguous body areas are the focus of the imaging because the patient and equipment have already been prepared for the second and subsequent procedures, potentially yielding resource savings in areas such as clerical time, technical preparation, and supplies (70 FR 45850). Therefore, the MPPR policy currently applies only to procedures involving contiguous body
Under the current imaging MPPR policy, full payment is made for the TC of the highest-paid procedure, and payment is reduced by 25 percent of the TC for each additional procedure when an MPPR scenario applies. We had originally planned to phase in the MPPR policy over a 2-year period, with a 25 percent reduction in CY 2006 and a 50 percent reduction in CY 2007 (70 FR 70263). However, the Deficit Reduction Act of 2005 (Pub. L. 109–171) (DRA) capped the PFS payment amount for most imaging procedures at the amount paid under the hospital Outpatient Prospective Payment System (OPPS). In view of the DRA, we determined that it would be prudent to retain the MPPR at 25 percent while we continued to examine the appropriate payment levels (71 FR 69659). The DRA also exempted reduced expenditures attributable to the MPPR policy from the PFS budget neutrality provision. Most recently, effective July 1, 2010, section 3135(b) of the ACA increased the MPPR on the TC of imaging services under the policy established in the CY 2006 PFS final rule with comment period from 25 to 50 percent and exempted the reduced expenditures attributable to this further change from the PFS budget neutrality provision.
In the July 2009 GAO report entitled, “Medicare Physician Payments: Fees Could Better Reflect Efficiencies Achieved when Services are Provided Together,” the GAO recommended that we take further steps to ensure that fees for services paid under the PFS reflect efficiencies that occur when services are performed by the same physician on the same beneficiary on the same day. The GAO recommended the following: (1) Expanding the existing MPPR policy to the PC to reflect efficiencies in physician work for certain imaging services; and (2) expanding the MPPR to reflect PE efficiencies that occur when certain nonsurgical, nonimaging services are provided together. The GAO also encouraged us to focus on service pairs that have the most impact on Medicare spending.
In the March 2010 report, MedPAC noted its concerns about mispricing of services under the PFS. MedPAC indicated that it would explore whether expanding the unit of payment through packaging or bundling would improve payment accuracy and encourage more efficient use of services.
In the CYs 2009 and 2010 PFS proposed rules (73 FR 38586 and 74 FR 33554, respectively), we stated that we planned to analyze nonsurgical services commonly furnished together (for example, 60 to 75 percent of the time) to assess whether an expansion of the MPPR policy could be warranted. MedPAC encouraged us to consider duplicative physician work, as well as PE, in any expansion of the MPPR policy.
Over the past 2 years, the AMA RUC has examined several services billed 90 percent or more of the time together as part of the potentially misvalued service initiative and, in several cases, created one code to describe the complete service, with a value that reflects the expected efficiencies. Notwithstanding the bundling work of the RUC, there may be additional imaging and other diagnostic services that are furnished together less than 90 percent of the time where we could still expect efficiencies in the TC, and in some cases in the PC, resulting in potential overpayment for these services under current policy when furnished together.
Section 1848(c)(2)(K) of the Act (as added by section 3134 of the ACA) specifies that the Secretary shall identify potentially misvalued codes by examining multiple codes that are frequently billed in conjunction with furnishing a single service, and review and make appropriate adjustments to their relative values. As a first step in applying this provision, we are proposing a limited expansion of the current imaging MPPR policy for CY 2011. We will continue to review other possible expansions of the MPPR policy to the TC and/or PC of imaging procedures or other diagnostic tests for the future. Any further changes would be addressed in future rulemaking.
In a related policy for hospital outpatient payment of imaging services, in the CY 2009 OPPS/ASC final rule with comment period (73 FR 68559 through 68569), the OPPS adopted a policy to pay for two or more CT and CTA, MRI and MRA, or ultrasound procedures furnished in the same session through a single composite ambulatory payment classification (APC) group. These composite APC payments were based on the 11 families of codes subject to the MPPR under the PFS that were collapsed into 3 imaging families for the OPPS according to their modality—1 for ultrasound, 1 for CT and CTA, and 1 for MRI and MRA services.
At that time, we stated our belief that the contiguous body area concept that was incorporated in the PFS imaging families was not necessary for potential efficiencies to be achieved in an imaging session. We provided examples to illustrate that we would not expect second and subsequent imaging services of the same modality involving noncontiguous body areas to require duplicate facility resources (comparable to the TC under the PFS) for clinical labor activities such as greeting the patient, providing education and obtaining consent, retrieving prior exams, setting up an intravenous infusion, and preparing and cleaning the room, any more than second and subsequent imaging procedures of the same modality involving contiguous body areas. While we noted that multiple imaging claims under the OPPS are generally within the same imaging modality and involve contiguous body areas the vast majority of the time, we estimated that the collapsed 3 families, as opposed to the 11 PFS families, would add 12 percent additional claims to those eligible for a single composite APC payment under the OPPS based on the provision of 2 or more imaging services in a single session, allowing us to capture additional claims with efficiencies.
Taking into consideration the OPPS policy that was adopted in the CY 2009 OPPS/ASC final rule with comment period, in this proposed rule, we are proposing to apply the MPPR regardless of family, that is, the policy would apply to multiple imaging services furnished within the same family of codes or across families. This proposal would simplify the current imaging MPPR policy in a way that is consistent with the standard PFS MPPR policy for surgical procedures that does not group procedures by body region. Therefore, the MPPR would apply to CT and CTA, MRI and MRA, and ultrasound procedures services furnished to the same patient in the same session, regardless of the imaging modality, and not limited to contiguous body areas.
Because of the different pieces of equipment used for CT/CTA, MRI/MRA, and ultrasound procedures, it would be highly unlikely that a single practitioner would furnish more than one imaging procedure involving 2 different modalities to one patient in a single session where the proposed MPPR policy would apply. On the other hand, while most multiple procedures furnished with a single modality in one session would involve procedures currently assigned to one of the 11
The proposed expansion of the imaging MPPR policy to include all of the current codes in a single family to which the standard 50 percent reduction for second and subsequent procedures would apply would reduce payment for 20 percent more services than the current MPPR policy under the PFS. Thus, under the CY 2011 proposal, we would capture additional efficiencies and pay more appropriately in these cases. We note that, as indicated above, section 3135(b)(2) of the ACA specifies that reduced expenditures attributable to the increase in the imaging MPPR from 25 to 50 percent in CY 2011 are excluded from the PFS budget neutrality adjustment. However, the reduced payment for code combinations that would newly be subject to the imaging MPPR policy under this proposal would be made in a budget neutral manner under the PFS, as these new combinations are not included under section 1848(b)(4)(D) (added by section 3135(b) of the ACA), which addresses “single-session imaging to consecutive body parts” under the established imaging MPPR policy.
Finally, we are also proposing to add the codes displayed in Table 17 to the list of imaging services subject to the MPPR policy in CY 2011. These codes were newly created for CY 2010 and are similar to codes currently in imaging family 2, titled CT and CTA (Chest/Thorax/Abdomen/Pelvis).
We further note that new CY 2010 CPT codes 74261 (Computed tomography (CT) colonography, diagnostic, including image postprocessing; without contrast material) and 74262 (Computed tomography (CT) colonography, diagnostic, including image postprocessing; with contrast material(s) including non-contrast images, if performed) were added to the CY 2010 MPPR policy through the July 2010 PFS quarterly update, with a retroactive effective date of January 1, 2010. These codes replaced CPT code 0067T (Computed tomographic (CT) colonography (
As discussed earlier in this section, reduced expenditures attributable to the increase in the MPPR for multiple imaging procedures to consecutive body parts (that is, those previously designated in the same family of codes) are exempt from the budget neutrality provision of the PFS. However, the reduced expenditures attributable to the MPPR for combinations of multiple imaging procedures that we are proposing for CY 2011 (the MPPR for multiple imaging procedures not involving consecutive body parts) would be subject to budget neutrality adjustment under the PFS. We note that this formulation for whether reduced expenditures are exempt from budget neutrality applies both to procedures currently subject to the imaging MPPR and to new codes that are subject to the policy in CY 2011 and in future years. To the extent that imaging procedures described by the new codes are furnished in combination with other procedures that are subject to the imaging MPPR on consecutive body areas, the reduced expenditures attributable to the MPPR for these combinations would be exempt from the PFS budget neutrality adjustment.
The complete list of codes subject to the proposed CY 2011 MPPR policy for diagnostic imaging services is included in Addendum F to this proposed rule.
In the July 2009 GAO report entitled, “Medicare Physician Payments: Fees Could Better Reflect Efficiencies Achieved when Services are Provided Together,” the GAO found efficiencies when multiple physical therapy services were furnished in one session and concluded that an MPPR policy could be appropriate for these services. In the report, the GAO noted that officials from the AMA RUC explained that time spent on pre-service and post-service therapy activities is spread across the number of services in a typical session in order to avoid duplication of the PE for the services. Nevertheless, the GAO found that there was duplication of certain activities in the intra-service period, and provided the example of time spent testing range of motion or muscle flexibility that was duplicated in commonly observed code pairs.
In the typical clinical scenario for therapy services, we believe that therapy services are misvalued for PFS payment when multiple services are furnished to a patient in a single session because duplicate clinical labor and supplies are included in the PE of the services furnished. We believe this duplication should be accounted for under the PFS, as we currently account for efficiencies in multiple surgical and multiple diagnostic imaging procedures furnished in a single session. Over the past 2 years, the AMA RUC has examined several services billed 90 percent or more of the time together as part of its potentially misvalued service initiative and, in several cases, created one code to describe the complete service, with a value that reflects the expected efficiencies. Notwithstanding the AMA RUC's analyses, in most cases it has not created one code to describe a complete therapy service, in part because many of the core therapy CPT codes are timed codes based on increments of treatment time.
Therefore, we are proposing a further step to implement section 1848(c)(2)(K) of the Act (as added by section 3134 of the ACA) that specifies that the Secretary shall identify potentially misvalued codes by examining multiple codes that are frequently billed in conjunction with furnishing a single service. For CY 2011 we are proposing an MPPR policy for the HCPCS codes listed in Table 18, specifically the separately payable “always therapy” services that are only paid by Medicare when furnished under a therapy plan of care. These services are designated “always therapy” services regardless of who furnishes them and always require therapy modifiers to be reported, specifically –GP (Services rendered under outpatient physical therapy plan of care); –GO (Services rendered under outpatient occupational therapy plan of care); or –GN (Services rendered under outpatient speech pathology plan of care). The therapy codes are available in a file on the CMS Web site at:
At this time, we are not proposing an MPPR policy for “sometimes therapy” services, specifically those services that may be furnished under a therapy plan of care or otherwise by physicians or NPPs as medical services. We believe that the care patterns are different for the latter group of services that may sometimes be furnished as therapy services, and note that they are less commonly furnished with multiple services in a single session than the “always therapy” services. In the discussion that follows, our reference to therapy services means those HCPCS codes designated annually as “always therapy” services by CMS.
Based on CY 2009 PFS claims data, we identified over 500 therapy service code pairs billed for the same patient in a single session. We then reviewed a sample of the most common therapy code pairs, specifically those high volume code pairs with more than 250,000 combined services per year, to examine the potential for duplication in the PE. These codes pairs represented more than half of the occurrences of therapy services billed together. While we acknowledge that the PE inputs per service for some therapy services were included in the direct PE database based on one-half of the total PE inputs required for two services provided in a single session, which would account for some duplication, this was not the case for all combinations of therapy services. Of the high volume therapy services examined, approximately one-fourth of the code pairs were not valued based on two services. In addition, we note that the CY 2009 PFS claims data show that when multiple therapy services are billed on a claim for the same date of service, the median number is four services per day. Therefore, even for those clinical labor times that may reflect the allocation of total time across two units of therapy services, we believe that some elements of the current PE inputs are duplicated based on current patterns of therapy service delivery where most multiple service claims involve delivery of more than 2 services in a session.
Duplicate labor activities currently included in the PE for the service period for these high volume pairs of therapy services are as follows: clean room/equipment; education/instruction/counseling/coordinating home care; greet patient/provide gowning; obtain measurements, for example, ROM/strength/edema; and post-treatment patient assistance. The most common duplicate supply item included in the PE was the multispecialty visit pack. Examples of duplicated and unduplicated labor activities and supplies for two sample therapy code pairs and our estimates of potential clinically appropriate time and quantity reductions for multiple service sessions are displayed in Table 19. We note that CY 2009 PFS claims data for these sample code pairs include over 3.4 million pairs of CPT codes 97112 (Therapeutic procedure, 1 or more areas, each 15 minutes; neuromuscular reeducation of movement, balance, coordination, kinesthetic sense, posture, and/or proprioception for sitting and/or standing activities) and 97110 (Therapeutic procedure, 1 or more areas, each 15 minutes; therapeutic exercises to develop strength and endurance, range of motion and flexibility) furnished by the same practitioner on the same day and over 500,000 pairs of CPT codes 97001 (Physical therapy evaluation) and 97140 (Manual therapy techniques (
Example 1: CPT code 97112 (Therapeutic procedure, 1 or more areas, each 15 minutes; neuromuscular reeducation of movement, balance, coordination, kinesthetic sense, posture, and/or proprioception for sitting and/or standing activities) and CPT code 97110 (Therapeutic procedure, 1 or more areas, each 15 minutes; therapeutic exercises to develop strength and endurance, range of motion and flexibility)
Example 2: CPT code 97001 (Physical therapy evaluation) and CPT Code 97140 (Manual therapy techniques (eg, mobilization/manipulation, manual lymphatic drainage, manual traction), 1 or more regions, each 15 minutes)
We did not remove minutes for clinical labor tasks that were not duplicated. For example, for CPT code pair 97001 and 97140 the following tasks were not duplicated: Post treatment patient assistance; prep and position patient; and prepare room, equipment, and supplies. In addition, we did not remove any supply items that would be required for only one of the separate services because these would not be duplicated in the PE applicable to the combination of services. We estimated no reduction for equipment time, even though efficiencies would be expected for equipment that is used in both services when they are furnished together. Finally, a corresponding reduction to the indirect expenses is appropriate since indirect costs are allocated partially based on direct costs. For five high volume therapy code pairs that each occur over 2 million time in PFS claims for multiple therapy services and account for almost half of such claims, we estimated that the resulting reduction in the PE for the lower paying code would range from 28 to 56 percent.
In summary, given the duplicative clinical labor activities and supplies as shown in the code combination examples, we believe it would be appropriate to extend the 50 percent MPPR policy that is currently applied to surgical services and the TC of imaging services, to the PE component of certain therapy services. Specifically, we are proposing to apply a 50 percent payment reduction to the PE component of the second and subsequent therapy services for multiple “always therapy” services furnished to a single patient in a single day. Because it would be difficult to determine the precise beginning and end of therapy sessions and we do not believe that beneficiaries would typically have more than one therapy session in a single day, we are proposing to apply the 50 percent MPPR policy to the PE component of subsequent therapy services provided to the same patient on the same day, rather than in the same session.
We note that many therapy services are time-based CPT codes, so multiple units of a single code may be billed for a single session that lasts for a longer period of time than one unit of the code. The proposed MPPR policy would apply to multiple units of the same therapy service, as well as to multiple different services, when furnished to the same patient on the same day. Full payment would be made for the service or unit with the highest PE and payment would be made at 50 percent of the PE component for the second and subsequent procedures or units of the service. The work and malpractice components of the therapy service payment would not be reduced. For therapy services furnished by a group practice or “incident to” a physician's service, the MPPR would apply to all “always therapy” services furnished to a patient on the same day, regardless of whether the services are provided in one therapy discipline or multiple disciplines, for example, physical therapy, occupational therapy, or speech-language pathology. The proposed CY 2011 MPPR policy would apply to both those services paid under the PFS that are furnished in the office setting and those services paid at the PFS rates that are furnished by outpatient hospitals, home health agencies, comprehensive outpatient rehabilitation facilities (CORFs), and other entities that are paid by Medicare for outpatient therapy services. Table 20 provides a sample calculation of the current and proposed CY 2011 payment for multiple therapy services furnished on the same day. For those services paid under the PFS, the PFS budget neutrality provision would apply so that the estimated reduced expenditures for therapy services would be redistributed to increase payment for other PFS services.
We believe this proposed therapy MPPR policy would provide more appropriate payment for therapy services that are commonly furnished together by taking into account the duplicative clinical labor activities and supplies in the PE that are not furnished more than once in the single therapy session. This approach is consistent with the statutory requirement for the Secretary to identify, review, and adjust the relative values of potentially misvalued services under the PFS as specified by section 3134 of the ACA. We also believe this proposed policy is responsive to Congressional concerns about significant growth in therapy spending and to MedPAC and GAO recommendations regarding the expansion of MPPR policies under the PFS to account for additional efficiencies. We note that paying more appropriately for therapy services based on PE relative values that are adjusted for the clinical scenario under which the services are furnished would result in reduced therapy expenditures, and beneficiaries would be able to receive more medically necessary outpatient therapy services before reaching the therapy cap. For a further discussion of potential alternatives to the therapy caps, we refer readers to section III.A.2. of this proposed rule.
MedPAC and the AMA RUC have long recommended that CMS establish a frequent price update process for high-cost supplies that are direct PE inputs in the PE database for services paid under the PFS because of their speculation that prices for these items may decrease over time as competition increases and new technologies disseminate into medical practice. MedPAC in particular has perennially noted that it is important for CMS to update the prices of high-priced supplies on a regular basis as inaccurate prices can distort PE RVUs over time,
Most of the current prices for high-cost supplies included in the direct PE database are from 2004 or earlier. There are currently 62 unique supplies with prices of $150 or more in the proposed CY 2011 PE database, which is available on the CMS Web site under the supporting data files for the CY 2011 PFS proposed rule at
Accordingly, in the CY 2009 PFS proposed rule (73 FR 38582), we proposed a process to update the prices for high-cost supplies priced at $150 or more that are included in the PE inputs for procedures paid under the PFS PE methodology. The CY 2009 proposed rule described a publicly transparent process in which CMS would publish a list of the high-cost supplies in the PFS proposed rule (65 supplies were included in the CY 2009 PFS proposed rule), and specialty societies or other relevant organizations would provide acceptable documentation supporting the pricing for the supplies during the 60-day public comment period. Furthermore, in that same proposed rule (73 FR 38582), we provided guidance on what constitutes valid, reliable documentation that reflects the typical price of the high-cost item in the marketplace. We outlined examples of acceptable documentation, such as a detailed description (including system components), sources, and current pricing information, confirmed by copies of catalog pages, invoices, and quotes from manufacturers, vendors, or distributors. We indicated that documentation that does not include specific pricing information such as phone numbers and addresses of manufacturers, vendors, or distributors or Web site links without pricing information would not be acceptable. We also noted that if acceptable documentation was not received within the proposed rule's 60-day public comment period, we would use prices from the Internet, retail vendors, and supply catalogs to determine the appropriate cost, and that we would use the lowest price identified by these sources (73 FR 38582). Finally, we solicited public comments on alternatives that could be used to update pricing information in the absence of acceptable documentation provided by specialty societies or other interested organizations.
In the CY 2009 PFS final rule with comment period (73 FR 69882), we indicated that we received many comments on the proposed process and, while some commenters expressed support, others believed the proposed process was flawed and burdensome. Moreover, although we received some data in response to our request for information on the 65 high-cost supplies with prices of $150 or more, much of what we received was not complete or did not represent typical market prices. In particular, we expressed concern that the submitted data often represented manufacturer list prices for the premier models of many supplies, while we believed there were less expensive alternatives. Therefore, we were unable to determine the most appropriate, typical supply prices for our PFS payment methodology that prices the typical service described by a HCPCS code. Rather than finalizing the proposed process for updating high-cost supplies and revising the prices for the 65 supplies based on inadequate pricing information, we stated in the CY 2009 PFS final rule with comment period (73 FR 69882) that we would research the possibility of using an independent contractor to assist us in obtaining accurate pricing information. Furthermore, we informed the public that we planned to study the limitations of available pricing data and determine how to revise our proposed process to elicit better data.
In the CY 2010 PFS proposed rule and final rule with comment period (74 FR 33554 and 61776, respectively), we stated that we were continuing to examine ways to obtain accurate pricing information for high-cost supplies. We noted again in the CY 2010 PFS proposed rule that we would depend upon the cooperation of the medical community to obtain typical prices in the marketplace, and we provided stakeholders with another opportunity to submit public comments on the process. In the CY 2010 PFS final rule with comment period, we acknowledged commenters' general support for an initiative to ensure accurate pricing of high-cost supplies. In general, the commenters strongly preferred a transparent and public process, and we stated that we would consider this perspective as we explore the best way to ensure that accurate supply pricing information is used in the PFS payment methodology.
In working towards refining a process to update the prices of high-cost supplies and consistent with our intention expressed in the CY 2009 PFS final rule with comment period (73 FR 69882), we contracted with an independent contractor during CY 2009 to help us study the availability of accurate pricing information. We requested that the independent contractor, L&M Policy Research, research pricing information for the 65 high-cost supplies listed in the CY 2009 proposed rule (73 FR 38583 through 38585) and determine what, if any, pricing information reflecting typical market prices could be obtained for these high-cost supplies.
We first requested that the contractor explore publicly available sources to obtain typical market prices for these supplies. The contractor utilized supply vendor catalogs and Web sites and directly contacted vendors, manufacturers, group purchasing organizations (GPOs), and any other suppliers that the contractor identified in their research in order to identify prices for each of the supplies. Where more than one version of a supply item appeared to match a description of a high-cost supply and/or more than one possible vendor or manufacturer was identified, the contractor attempted to obtain prices from the multiple sources.
Upon review of the high-cost supply list, the contractor refined the list to 62 unique high-cost items with prices of $150 or more for the study. The original list only consisted of 64 items but included one item inadvertently listed twice (CMS Supply Code SD207 (suture device for vessel closure (Perclose A–T)) and one item (CMS Supply Code SH079 (collagen implant)) that was deleted from the PE database after CY 2007 because it was no longer used as an input for any codes. While the contractor was able to obtain prices for 37 of the 62 unique supplies, the contractor was unable to obtain pricing information for the remaining 25 supplies. Documentation of these prices, a requirement we discussed in the CY 2009 PFS proposed rule (73 FR 38582), was only obtained for 25 of the 36 supplies with new pricing information. For the remainder, while the contractor was given price quotes over the phone, the sales agents or customer service representatives declined to provide any form of written documentation, in some cases because company policies
Next, we directed the contractor to access the United States General Services Administration (GSA) medical supply schedule to augment the results obtained through review of vendor materials and direct contact with vendors, manufacturers, and GPOs. We note that the GSA establishes long-term government-wide contracts with commercial firms for many products, negotiating contracts and determining prices to be fair and reasonable prior to placing them on schedule. Included on the schedule are thousands of medical supplies at prices that, in most cases, are established through competition. The GSA schedule is an open solicitation and a business of any size, if it is stable and financially sound, can request to be included on the schedule. GSA's vendors usually are nationwide vendors with substantial non-government sales, and products on the schedule must be manufactured in the U.S. or in a nation with a trade agreement with the United States. Submissions for the schedule are received 365 days per year, vendor contracts can be of varying lengths, and vendors can add or delete products from the schedule. Depending on the aggregate cost estimate associated with the vendor's supply items, the time to achieve inclusion on the schedule can vary from as short as several months to as long as 2 years. The GSA has delegated authority to the Department of Veterans Affairs (VA) to procure medical supplies under the VA Federal Supply Schedules Program.
Using the GSA general search engine under the category “Laboratory, Scientific, & Medical” available at
Since the GSA medical supply schedule is a source for pricing information that is public and transparent and reflects the best government contract price for a product, we believe it is a desirable resource for us to use in a refined process for updating the prices of high-cost
We further note that public commenters on pricing high-cost supplies have consistently requested that CMS ensure that the pricing information used to update the prices is provided publicly. The commenters have observed that this transparency would enable stakeholders to evaluate and provide feedback to the agency on pricing accuracy (74 FR 61776). We also acknowledge that our past attempts over several years to identify typical market prices for the high-cost supplies have been inhibited by the limited availability of public data that meet the documentation requirements we have previously established. Individual vendors do not always publish their product prices or provide typical discounts. Moreover, discounts may vary depending on suppliers and the volume of supplies purchased. Our understanding of the GSA medical supply schedule is that the publicly listed fair and reasonable prices on the schedule generally do not include volume and or certain other discounts that may be subsequently negotiated by the buyer. Consequently, we would consider the prices available on the GSA schedule to represent the “individual item ceiling” price for a single item purchase, which we believe would be appropriate to estimate the high-cost supply prices for physicians' office purchases. We are soliciting public comments regarding the high-cost supplies in the direct PE database for the CY 2011 PFS proposed rule, available on the CMS Web site as noted earlier in this section, and the corresponding supplies or alternative items that could be used for the same function that are currently on the GSA supply schedule. We encourage commenters to provide a detailed analysis of the current relationships between the items in the PE database and those on the GSA schedule.
At this time, we would like to describe a refined process for regularly updating prices for high-cost supplies under the PFS and solicit comments on how we could improve on this process. The process could occur every 2 years beginning as soon as CY 2013, although we note that we would propose the refined process through rulemaking before revising the prices for any high-cost supply item based on the GSA schedule. We could also consider establishing a different price update period depending on whether a high-cost supply was a new supply in the PE database or had been in use for some time, in which case we might expect that the price would have stabilized and, therefore, could be updated less frequently. In general, we would expect that the periodicity of updating prices for high-cost supplies that we eventually adopted would balance the associated administrative burden with the rate of price changes, to ensure that the associated procedures remain appropriately valued, rather than increasingly misvalued, over time.
We envision that we would base high-cost supply price inputs on the publicly available price listed on the GSA medical supply schedule. Since the medical community would have several years to examine the GSA medical supply schedule before the refined process would be adopted, and we have found no apparent limitations on vendors placing products on the GSA schedule, beyond the schedule's interest in competitive, best value procurements, stakeholders would have the opportunity to ensure that any high-cost direct PE input for a PFS service that may currently be missing from the GSA medical supply schedule would be included before CMS needs to access the publicly available price for the item. If a supply price were not publicly available on the GSA medical supply schedule by the time CMS needs to access the price, we would propose to reduce the current price input for the supply by a percentage that would be based on the relationship between GSA prices at that time and the existing PE database prices for similar supplies (currently an average 23 percent reduction). We believe that this refined process is desirable because it is consistent with commenters' repeated requests for the updating methodology to be transparent and predictable.
Moreover, the VA (with responsibility delegated by the GSA) determines whether prices are fair and reasonable by comparing the prices and discounts that a company offers the government with the prices and discounts that the company offers to commercial customers. Therefore, using the GSA medical supply schedule as a source for publicly available prices would also better account for product-specific market dynamics than the alternative of an across-the-board percentage reduction for supplies not on the GSA schedule based on general price trends for the high-cost supplies on the schedule. That is, if the market price of a particular supply were not to drop according to broad trends for other high-cost supplies, suppliers would have the opportunity to provide their price to the public on the GSA schedule in order to preclude any reduction in Medicare payment for procedures associated with that supply.
Finally, we would like to reiterate that we are interested in receiving detailed public comments on the refined process discussed above, including all aspects of the price update methodology that we have presented. Moreover, we believe a similar approach could potentially be appropriate to update the prices for other supplies in the PE database that would not fall under our definition of high-cost supplies, and we welcome further public comments on that possible extension. We also invite further suggestions for alternative approaches to updating high-cost supply prices, specifically those that would result in a predictable, public, and transparent methodology that would ensure that the prices in the PE database reflect typical market prices. These principles are particularly important in order to ensure that the services that utilize the high-cost supplies when provided in the physician's office are appropriately valued under the PFS and continue to be appropriately valued over time.
Section 1848(e)(1)(A) of the Act requires us to develop separate Geographic Practice Cost Indices (GPCIs) to measure resource cost differences among localities compared to the national average for each of the three fee schedule components (that is, work, PE, and malpractice). While requiring that the PE and malpractice GPCIs reflect the full relative cost differences, section 1848(e)(1)(A)(iii) of the Act requires that the physician work GPCIs reflect only one-quarter of the relative cost differences compared to the national average. In addition, section 1848(e)(1)(G) of the Act sets a
For the CY 2011 PFS proposed rule, we have completed the sixth review of the GPCIs and are proposing new GPCIs. We note that section 1848(e)(1)(E) of the Act (as amended by section 3102(a) of ACA) extends the 1.0 work GPCI floor only through December 31, 2010. Under current statute, the 1.0 work GPCI floor will expire on January 1, 2011. Therefore, the CY 2011 physician work GPCIs and summarized geographic adjustment factors (GAFs) do not reflect the 1.0 work floor. However, section 1848(e)(1)(G) of the Act (as amended by section 134(b) of the MIPPA) set a permanent 1.5 work GPCI floor in Alaska for services furnished beginning January 1, 2009; and, as noted above, section 1848(e)(1)(I) of the Act (as added by section 10324(c) of ACA) provides for a permanent 1.0 PE GPCI floor for frontier States effective January 1, 2011. Therefore, as required by the statute, the 1.5 work GPCI floor for Alaska and the 1.0 PE GPCI floor for frontier States will be in effect for CY 2011. In addition to the limited recognition of certain cost differences for the PE GPCIs, section 1848(e)(1)(H) of the Act (as added by section 3102(b) of ACA) also requires us to complete an analysis of the data sources used and cost share weights assigned to the PE GPCIs. Implementation of ACA provisions related to the CY 2011 PE GPCIs is discussed in more detail in the GPCI update section below.
See Addenda D and E to this proposed rule for the proposed CY 2011 GPCIs and summarized GAFs.
The proposed updated GPCI values were developed by Acumen, LLC (Acumen) under contract to CMS. As mentioned above, there are three GPCI components (physician work, PE, and malpractice), and all GPCIs are developed through comparison to a national average for each component. Additionally, each of the three GPCIs relies on its own data source(s) and methodology for calculating its value as described below.
The physician work GPCIs are designed to capture the relative cost of physician labor by Medicare PFS locality. Previously, the physician work GPCIs were developed using the median hourly earnings from the 2000 Census of workers in seven professional specialty occupation categories which we used as a proxy for physicians' wages and calculated to reflect one-quarter of the relative cost differences for each locality compared to the national average. Physicians' wages are not included in the occupation categories because Medicare payments are a key determinant of physicians' earnings. Including physicians' wages in the physician work GPCIs would, in effect, have made the indices dependent upon Medicare payments.
The physician work GPCIs were updated in CYs 2001, 2003, 2005, and 2008 using professional earnings data from the 2000 Census. However, wage and earnings data are no longer available from the Census long form and the 2000 data are outdated. Therefore, for the proposed sixth GPCI update, we used the 2006 through 2008 Bureau of Labor Statistics (BLS) Occupational Employment Statistics (OES) data as a replacement for the 2000 Census data. The use of BLS OES data as a replacement for the 2000 Census data is discussed in more detail in the update of the PE GPCIs section. As noted above, the 1.0 work GPCI floor is set to expire under current statute on December 31, 2010. Therefore, the CY 2011 proposed physician work GPCIs reflect the removal of this floor.
ACA added a new subparagraph 1848(e)(1)(H) to the Act which revises the methodology for calculating the PE GPCIs for CY 2010 and CY 2011 so that the employee compensation and rent portions of the PE GPCIs reflect only one-half of the relative cost differences for each locality compared to the national average. Additionally, under section 1848(e)(1)(H)(iii) of the Act (as added by section 3102(b) of the ACA), each PFS locality is held harmless so that the PE GPCI will not be reduced as a result of the change in methodology for PE GPCIs. In accordance with section 1848(e)(1)(H)(ii) of the Act (as added by section 3102(b) of ACA), the employee compensation and rent components of the proposed CY 2011 PE GPCIs were calculated to reflect one-half of the cost differences for each PFS locality relative to the national average cost. Additionally, as required by the statute, physicians' services furnished in each PFS locality would be adjusted by the higher of the locality's PE GPCI calculated with the limited recognition of employee compensation and rent cost differences or the PE GPCI calculated without the limited recognition of cost differences.
Section 1848(e)(1)(C) of the Act requires us to phase in GPCI adjustments over 2 years if there was more than 1 year between GPCI adjustments. In accordance with the statute, we are proposing to phase in the updated PE GPCIs using one-half of the CY 2010 values and one-half of the fully implemented values (as described in this section). To apply the phase-in and hold harmless provisions of the Act, we calculated transitional PE GPCIs based on two scenarios. Under the first scenario, we calculated transitional CY 2011 PE GPCIs using the full recognition of employee compensation and rent cost differences for each locality as compared to the national average. The
For the second scenario, we calculated transitional CY 2011 PE GPCIs with the limited recognition of cost differences for the employee compensation and rent components (as required by sections 1848(e)(1)(H)(i) and (ii) of the Act (as added by section 3102(b) of ACA)). The CY 2011 transitional PE GPCI values with the limited recognition of cost differences were calculated using one-half of the CY 2010 PE GPCIs with the limited cost differences and one-half of the updated PE GPCIs with the limited cost differences. The hold harmless provision under section 1848(e)(1)(H)(iii) of the Act (as added by section 3102(b) of ACA) was applied by selecting the greater of the CY 2011 transitional PE GPCI value calculated with the limited recognition of cost differences or the CY 2011 transitional PE GCPI value calculated
Section 1848(e)(1)(H)(iv) of the Act (as added by section 3102(b) of ACA) also requires the Secretary to “analyze current methods of establishing practice expense adjustments under subparagraph (A)(i) and evaluate data that fairly and reliably establishes distinctions in the cost of operating a medical practice in different fee schedule areas.” This section also requires the Secretary to make appropriate adjustments to the PE GPCIs no later than by January 1, 2012. To implement this statutory requirement, we are proposing to implement changes in PE data sources and cost share weights discussed herein effective beginning in CY 2011.
In accordance with section 1848(e)(1)(H)(iv) of the Act (as added by section 3102(b) of ACA), we have analyzed the current methods and data sources used in the establishment of the PE GPCIs. With respect to the method used, we began with a review of the GAO's March 2005 Report entitled, “MEDICARE PHYSICIAN FEES: Geographic Adjustment Indices Are Valid in Design, but Data and Methods Need Refinement” (GAO–05–119). While we have raised concerns in the past about some of the GAO's GPCI recommendations, we note that with respect to the PE GPCIs, the GAO did not indicate any significant issues with the
One key component of the PE GPCI method that our analysis identified involved the office expense portion of the PE GPCIs and the cost share weight assigned to this component. Most significantly, we are proposing that the weight for the office rent component be revised from 12.209 percent to 8.410 percent to reflect our more detailed breakout of the types of office expenses that are determined in local markets instead of national markets. For example, for previous GPCI updates, we used the office expenses cost category as the cost share weight for office rent and, therefore, all individual components previously included in the office expenses category were adjusted for local area cost differences by the GPCIs. As discussed in section II.E.1. of this proposed rule, we are proposing to disaggregate the broader office expenses component into 9 new cost categories as part of the proposed CY 2011 MEI rebasing. The disaggregation of the office expenses category indicates that the fixed capital cost category, for which the consumer price index (CPI) for owner's equivalent rent is the price proxy, is the office expense category applicable to the office rent component of the PE GPCI. Therefore, the fixed cost capital cost category is the only component of office expenses that we are proposing to adjust for local area cost differences beginning in CY 2011. We are proposing to assign other newly defined components of the office expenses category (for example, utilities, chemicals, paper, rubber and plastics, telephone, postage, and moveable capital) to the medical equipment, supplies, and other miscellaneous expenses cost component of the PE GPCIs. As discussed later in this section, the medical equipment, supplies, and other miscellaneous expenses component of the PE GPCIs is assumed to have a national market and, therefore, this component is not adjusted for local area cost differences.
The proposed expense categories for the PE GPCIs, along with their respective cost share weights, are primarily derived from the 2006 American Medical Association (AMA) Physician Practice Information Survey (PPIS) for self-employed physicians and selected self-employed non-medical doctor specialties. The PPIS is the most comprehensive, multispecialty, contemporaneous, and consistently collected PE data source available. It
Moreover, we also examined the feasibility of using the American Community Survey (ACS) and the Bureau of Labor and Statistics (BLS) Occupational Employment Statistics (OES) data for the employee compensation component of the PE GPCI. For previous updates, the employee compensation component was based on the 2000 Decennial Census long form data. Since the Census data are significantly outdated and the 2010 Census no longer includes occupational wage data, we believed the ACS or BLS OES data might be viable alternatives. While the ACS 3-year public use microsample (PUMS) is currently available, it reflects only about 3 percent of households and the data exhibit significant variation due to the small sample. In particular, the ACS PUMS has fewer than 10 observations of pharmacists in the Manhattan, Beaumont Texas, and Southern Maine localities. Therefore, we believe it would be premature to use the ACS data for determining GPCI values. The 2006, 2007, and 2008 panels from the BLS OES represent a larger sample than the ACS PUMS and more recent data than the 2000 Census. As such, we are proposing to use the BLS OES data for updating the GPCIs. We look forward to exploring the use of the full ACS data when they become available.
Additionally, we explored other sources of rent data (including commercial rental data and survey data) for use in calculating the PE GPCIs. We could not identify a reliable alternative rental data source available on a national basis with coverage of non-metropolitan areas.
We do not believe there is a national data source better than the Housing and Urban Development (HUD) data for determining the relative cost differences in office rents. Therefore, based on our review of the available data sources, we are proposing to use the 2010 apartment rental data produced by HUD at the 50th percentile as a proxy for the relative cost difference in physician office rents.
We believe our analysis of the current methods of establishing PE GPCIs and our evaluation of data that fairly and reliably establish distinctions in the cost of operating a medical practice in the different fee schedule areas meet the statutory requirements of section 1848(e)(1)(H)(iv) of the Act (as added by section 3102(b) of ACA). A more detailed discussion of our analysis of current methods of establishing PE GPCIs and evaluation of data sources is included in Acumen's draft report. Acumen's draft report and associated analysis of the sixth GPCI update, including the PE GPCIs, will be posted on the CMS Web site after display of this CY 2011 PFS proposed rule. The draft report may be accessed from the PFS Web site at:
To determine the cost share weights for the proposed CY 2011 GPCIs, we used the proposed 2006-based Medicare Economic Index (MEI) as discussed in section II.E.1. of this proposed rule. The proposed MEI was rebased and revised to reflect the weighted-average annual price change for various inputs needed to provide physicians' services. As discussed in detail in that section, the proposed expense categories in the MEI, along with their respective weights, are primarily derived from data collected in the 2006 AMA PPIS for self-employed physicians and selected self-employed non-medical doctor specialties.
For the cost share weight for the PE GPCIs, we used the 2006-based MEI weight for the PE category of 51.734 percent minus the professional liability insurance category weight of 4.295 percent. Therefore, the proposed cost share weight for the PE GPCIs is 47.439 percent. For the employee compensation portion of the PE GPCIs, we used the nonphysician employee compensation category weight of 19.153 percent. The fixed capital category weight of 8.410, for which the CPI for owner's equivalent rent is the price proxy, was used for the office rent component. To determine the medical equipment, supplies, and other miscellaneous expenses component, we removed professional liability (4.295 percent), nonphysician employee compensation (19.153 percent), and fixed capital (8.410 percent) from the PE category weight (51.734 percent). Therefore, the proposed cost share weight for the medical equipment, supplies, and other miscellaneous expenses component is 19.876 percent.
Furthermore, the physician compensation cost category and its weight of 48.266 percent reflect the proposed work GPCI cost share weight and the professional liability insurance weight of 4.295 percent was used for the malpractice GPCI cost share weight. We believe our analysis and evaluation of the weights assigned to each of the categories within the PE GPCIs meets the statutory requirements of section 1848(e)(1)(H)(iv) of the Act (as added by section 3102(b) of ACA).
The proposed cost share weights for the CY 2011 GPCIs are displayed in Table 22 below.
Section 10324(c) of ACA added a new subparagraph (I) under section 1848(e)(1) of the Act to establish a 1.0 PE GPCI floor for physicians' services furnished in frontier States. In accordance with section 1848(e)(1)(I) of the Act (as added by section 10324(c) of ACA), beginning in CY 2011, we will apply a 1.0 PE GPCI floor for physicians' services furnished in States determined to be frontier States. The statute requires us to define any State as a frontier State if at least 50 percent of the State's counties are determined to be frontier
Consistent with the proposed FY 2011 hospital inpatient prospective payment system (IPPS) 1.0 wage index floor for frontier States (as required by section 10324(a) of the ACA) (75 FR 30920 through 30921), we are proposing to identify frontier counties by analyzing population data and county definitions based upon the most recent annual population estimates published by the U.S. Census Bureau. We divide each county's population total by each county's reported land area (according to the decennial census) in square miles to establish population density. We also are proposing to update this analysis from time to time, such as upon publication of a subsequent decennial census, and if necessary, add or remove qualifying States from the list of frontier States based on the updated analysis.
For a State that qualifies as a frontier State, in accordance with section 1848(e)(1)(I) of the Act (as added by section 10324(c) of the ACA), we are proposing that physicians' services furnished within that State would receive the higher of the applicable PE GPCI value calculated according to the standard CY 2011 methodology or a minimum value of 1.00. Furthermore, in accordance with section 1848(e)(1)(I) of the Act (as added by section 10324(c) of the ACA), the frontier State PE GPCI floor is not subject to budget neutrality and would only be extended to physicians' services furnished within a frontier State.
For determining the proposed CY 2011 PFS PE GPCI values, the frontier States are the following: Montana; Wyoming; North Dakota; Nevada; and South Dakota (as reflected in Table 23).
(2) Summary of CY 2011 Proposed PE GPCIs
The PE GPCIs include three components: employee compensation, office rent, and medical equipment, supplies and miscellaneous expenses as discussed below:
(i) Employee Compensation: We used the 2006 through 2008 BLS OES data to determine the proposed employee compensation component of the PE GPCIs. Employee compensation accounts for 40.4 percent of the total PE GPCIs.
(ii) Office Rents: Consistent with the previous GPCI update, we used the most recent residential apartment rental data produced by HUD (2010) at the 50th percentile as a proxy for the relative cost differences in physician office rents. Office rent accounts for 17.7 percent of the PE GPCIs.
(iii) Medical Equipment, Supplies, and other Miscellaneous Expenses: We assumed that items such as medical equipment and supplies have a national market and that input prices do not vary among geographic areas. As discussed in previous GPCI updates in the CY 2005 and CY 2008 PFS proposed rules, specifically the fourth GPCI update (69 FR 47503) and fifth GPCI update (72 FR 38138), respectively, some price differences may exist, but we believe these differences are more likely to be based on volume discounts rather than on geographic market differences. Medical equipment, supplies, and miscellaneous expenses are factored into the PE GPCIs with a component index of 1.000. The medical equipment, supplies, and other miscellaneous expense component are 41.9 percent of the PE GPCIs.
The malpractice GPCIs are calculated based on insurer rate filings of premium data for $1 million to $3 million mature claims-made policies (policies for claims made rather than services furnished during the policy term). The proposed CY 2011 malpractice GPCI update reflects 2006 and 2007 premium data.
The periodic review and adjustment of GPCIs is mandated by section 1848(e)(1)(C) of the Act. At each update, the proposed GPCIs are published in the PFS proposed rule the year before they would take effect in order to provide an opportunity for public comment and further revisions in response to comments prior to implementation. As mentioned above, the proposed CY 2011 updated GPCIs for the first year of the 2-year transition and summarized GAFs are displayed in Addenda D and E to this proposed rule.
The current PFS locality structure was developed and implemented in 1997. There are currently 89 localities; 34 localities are Statewide areas. There are 52 localities in the other 18 States, with 10 States having 2 localities, 2 States having 3 localities, 1 State having 4 localities, and 3 States having 5 or more localities. The District of Columbia, Maryland, and Virginia suburbs, Puerto Rico, and the Virgin Islands are additional localities that make up the remainder of the total of 89 localities. The development of the current locality structure is described in detail in the CY 1997 PFS proposed rule (61 FR 34615) and the subsequent final rule with comment period (61 FR 59494).
As we have previously noted in the CYs 2008 and 2009 proposed rules (72 FR 38139 and 73 FR 38513), any changes to the locality configuration must be made in a budget neutral manner within a State and can lead to significant redistributions in payments. For many years, we have not considered making changes to localities without the support of a State medical association in order to demonstrate consensus for the change among the professionals whose payments would be affected (with some increasing and some decreasing). However, we have recognized that, over time, changes in demographics or local economic conditions may lead us to conduct a more comprehensive
For the past several years, we have been involved in discussions with physician groups and their representatives about recent shifts in relative demographics and economic conditions, most notably within the current California payment locality structure. We explained in the CY 2008 PFS final rule with comment period that we intended to conduct a thorough analysis of potential approaches to reconfiguring localities and would address this issue again in future rulemaking. For more information, we refer readers to the CY 2008 PFS proposed rule (72 FR 38139) and subsequent final rule with comment period (72 FR 66245).
As a follow-up to the CY 2008 PFS final rule with comment period, we contracted with Acumen to conduct a preliminary study of several options for revising the payment localities on a nationwide basis. The contractor's interim report was posted on the CMS Web site on August 21, 2008, and we requested comments from the public. The report entitled, “Review of Alternative GPCI Payment Locality Structures,” remains accessible from the CMS PFS Web page under the heading “Interim Study of Alternative Payment Localities under the PFS.” The report may also be accessed directly from the following link:
We accepted public comments on the interim report through November 3, 2008. The alternative locality configurations discussed in the report are described briefly below in this section.
This option uses the Office of Management and Budget (OMB's) Metropolitan Statistical Area (MSA) designations for the payment locality configuration. MSAs would be considered as urban CBSAs. Micropolitan Areas (as defined by OMB) and rural areas would be considered as non-urban (rest of State) CBSAs. This approach would be consistent with the IPPS pre-reclassification CBSA assignments and with the geographic payment adjustments used in other Medicare payment systems. This option would increase the number of PFS localities from 89 to 439.
Under this approach, higher cost counties are removed from their existing locality structure and they would each be placed into their own locality. This option would increase the number of PFS localities from 89 to 214, using a 5 percent GAF differential to separate high-cost counties.
This option begins with statewide localities and creates separate localities for higher cost MSAs (rather than removing higher cost counties from their existing locality as described in Option 2). This option would increase the number of PFS localities from 89 to 130, using a 5 percent GAF differential to separate high-cost MSAs.
This option creates tiers of counties (within each State) that may or may not be contiguous but share similar practice costs. This option would increase the number of PFS localities from 89 to 140, using a 5 percent GAF differential to group similar counties into statewide tiers.
As discussed in Acumen's interim report, all four studied alternative locality configurations would increase the number of localities and separate higher cost areas from rural “rest of state” areas. As a result, payments to urban areas would increase, while rural areas would see a decrease in payment because they would no longer be grouped with higher cost “urbanized” areas. A number of public commenters on the draft report expressed support for Option 3 (separate MSAs from Statewide localities) because the commenters believed this alternative would improve payment accuracy over the current locality configuration and could mitigate possible payment reductions to rural areas as compared to Option 1 (CMS CBSAs). Therefore, Acumen is conducting a more in-depth analysis of the dollar impacts that would result from the application of Option 3.
For a detailed discussion of the public comments on the contractor's interim locality study report, we refer readers to the CY 2010 PFS proposed rule (74 FR 33534) and subsequent final rule with comment period (74 FR 61757).
The Medicare Economic Index (MEI) is required by section 1842(b)(3) of the Act, which states that prevailing charge levels beginning after June 30, 1973 may not exceed the level from the previous year except to the extent that the Secretary finds, on the basis of appropriate economic index data, that such higher level is justified by year-to-year economic changes. Beginning July 1, 1975, and continuing through today, the MEI has met this requirement by reflecting the weighted-average annual price change for various inputs needed to provide physicians' services. The MEI is a fixed-weight input price index, with an adjustment for the change in economy-wide, private nonfarm business multifactor productivity. This index is comprised of two broad categories: (1) Physician's own time; and (2) physician's practice expense (PE).
The current form of the MEI was detailed in the November 25, 1992
We are proposing to rebase and revise the MEI and incorporate it into the CY 2011 PFS update. The terms “rebasing” and “revising”, while often used interchangeably, actually denote different activities. Rebasing refers to moving the base year for the structure of costs of an input price index, while revising relates to other types of changes such as changing data sources, cost categories, or price proxies used in the input price index. As is always the case with a rebasing and revising exercise, we have attempted to use the most recently available, relevant, and appropriate information to develop the proposed MEI cost category weights and price proxies. In the following sections
The MEI was last rebased and revised in 2003 in the CY 2004 PFS final rule with comment period (68 FR 63239). The current base year for the MEI is 2000, which means that the cost weights in the index reflect physicians' expenses in 2000. However, we believe it is desirable to periodically rebase and revise the index so that the expense shares and their associated price proxies reflect more current conditions. For this reason, we propose to rebase the MEI to reflect appropriate physicians' expenses in 2006.
We are proposing several changes to the expenses that are eligible to be included in the MEI. For instance, we are proposing to remove all costs related to drug expenses as drugs are not paid for under the PFS nor are they included in the definition of “physicians' services” for purposes of the Sustainable Growth Rate (SGR) system that is used to update the PFS. The details of the decision regarding the removal of physician-administered drugs from the SGR system can be found in the CY 2010 PFS proposed rule and finalized in the CY 2010 final rule with comment period (74 FR 33651 and 74 FR 61961, respectively). Additionally, we are proposing to remove costs associated with separately billable supplies. The rationale for removing the separately billable supplies is discussed further below in section III.E.1.X of this proposed rule.
We are proposing to revise the cost categories in the MEI by expanding the Office Expense category into nine detailed categories with additional price proxies associated with these categories. Additionally, we will continue to adjust the MEI for economy-wide multifactor productivity based on the 10-year moving average of total private nonfarm business multi-factor productivity.
The MEI is used in conjunction with the SGR system to update the PFS and represents the price component of that update. The proposed expense categories in the index, along with their respective weights, are primarily derived from data collected in the 2006 AMA Physician Practice Information Survey (PPIS) for self-employed physicians and selected self-employed non-Medical Doctor (non-MD) specialties. We included data from the following specialties in the MEI cost weight calculations (optometrists, oral surgeons, podiatrists, and chiropractors) consistent with the definition of the term “physician” in section 1861(r) of the Act. In summary, the term “physician” when used in connection with the performance of functions or actions an individual is legally authorized to perform means the following: (1) A doctor of medicine or osteopathy; (2) a doctor of dental surgery or of dental medicine; (3) a doctor of podiatric medicine; (4) a doctor of optometry; or (5) a chiropractor. For a complete definition, please see section 1861(r) of the Act. We weighted the expense data from the above-referenced specialties with the self-employed physician expense data using physician counts by specialty.
The AMA data from the PPIS were used to determine expenditure weights for total expenses, physicians' earnings, physicians' benefits, employed physician payroll, nonphysician compensation, office expenses, professional liability insurance (PLI), medical equipment, medical supplies, and all other expenses. To further disaggregate into subcategories reflecting more detailed expenses, we used data from the 2002 Bureau of Economic Analysis (BEA) Benchmark Input-Output table (I/O), the 2006 Bureau of the Census Current Population Survey (CPS), the 2006 Bureau of Labor Statistics (BLS) Occupational Employment Survey (OES) and Employment Cost for Employee Compensation Survey (ECEC), and the 2006 Internal Revenue Service (IRS) Statistics of Income (SOI) data. The development of each of the cost categories using these sources is described in detail below.
Developing a rebased and revised MEI requires selecting a base year and determining the appropriate expense categories. We are proposing to rebase the MEI to CY 2006. We choose CY 2006 as the base year for two primary reasons: (1) CY 2006 is the most recent year for which data were available; and (2) we believe that the CY 2006 data provide a representative distribution of physicians' compensation and PEs.
Compared to the 2000-based MEI, we are proposing to include 9 new cost categories (along with their respective weights) that disaggregate the costs under the broader Office Expenses cost category. The 2000-based MEI did not break these expenses into individual categories. A more detailed discussion is provided below in this section. In addition, we are proposing to exclude the Pharmaceutical cost category as pharmaceuticals are neither paid for under the PFS nor are they included in the definition of “physicians' services” for purposes of calculating the physician update via the SGR system (for more details see the CY 2010 PFS final rule with comment period (74 FR 61961 through 61962)). Lastly, we are proposing to exclude the expenses associated with separately billable supplies since these items are not paid for under the PFS.
We determined the number and composition of expense categories based on the criteria used to develop the current MEI and other CMS input price index expenditure weights. These criteria are timeliness, reliability, relevance, and public availability. Table 24 lists the set of mutually exclusive and exhaustive cost categories that make up the proposed rebased and revised MEI.
The development of each of the cost categories in the proposed 2006 MEI is described, in detail, below.
The component of the MEI that reflects the physician's own time is represented by the net income portion of business receipts. The proposed 2006 cost weight associated with the physician's own time (otherwise referred to as the Physician's Compensation cost weight) is based on 2006 AMA PPIS data for mean physician net income (physician compensation) for self-employed physicians and for the selected self-employed specialties referenced previously in this rule.
We are proposing to continue to add employed physician compensation to self-employed physician compensation in order to calculate an aggregate Physician Compensation cost weight. By including the compensation of employed physicians in the physician compensation expense category, these expenses will be adjusted by the appropriate price proxies for a physician's own time. The proposed 2006 Physician Compensation cost weight is 48.266 percent as compared to a 52.466 percent share in the 2000-based MEI. We split the physician compensation component into subcategories: Wages & Salaries and Benefits. For Physician Compensation, the ratio for Wages & Salaries and Benefits was calculated using data from the PPIS. Self-employed physician wages & salaries accounted for 92.3 percent of physician earnings while physician benefits accounted for the remaining 7.8 percent. For employed physician payroll, the distribution for wages & salaries and benefits for 2006 was 85.8 percent and 14.2 percent, respectively. This ratio was determined by calculating a weighted average of available SOI data for partnerships, corporations, and S-corporations specific to physicians and outpatient care centers. Based on these proposed methods, the proposed 2006 Physician Wages & Salaries cost weight is 43.880 percent and the proposed 2006
To determine the remaining individual Practice Expenses cost weights, we use mean expense data from the 2006 PPIS survey. The detailed explanations for the derivation of the individual weights under Practice Expenses are listed below.
The cost weight for Nonphysician Employee Compensation was developed using the 2006 AMA PPIS mean expenses for these costs. We further divided this cost share into Wages & Salaries and Benefits using 2006 BLS Employer Costs for Employee Compensation (ECEC) data for the Health Care and Social Assistance (private industry). Although this survey does not contain data specifically for offices of physicians, data are available to help determine the shares associated with wages & salaries and benefits for private industry health care and social assistance services (which include hospitals, nursing homes, offices of physicians, and offices of dentists). We believe these data provide a reasonable estimate of the split between wages and benefits for employees in physicians' offices. Data for 2006 in the ECEC for Health Care and Social Assistance indicate that wages and benefits are 71.8 percent and 28.2 percent of compensation, respectively. The 2000-based MEI included a wage and benefit split of 74.0 percent and 26.0 percent of compensation.
As in the 2000-based MEI, we are proposing to use 2006 Current Population Survey (CPS) data and 2006 BLS Occupational Employment Statistics (OES) data to develop cost weights for wages for nonphysician occupational groups. We determined total annual earnings for offices of physicians using employment data from the CPS and mean annual earnings from the OES. To arrive at a distribution for these separate categories, we determined annual earnings for each of the four categories (which are Professional & Technical workers, Managers, Clerical workers, and Service workers), using the Standard Occupational Classification (SOC) system. We then determined the overall share of the total for each. The proposed distribution, as well as the distribution from the 2000-based MEI are presented in Table 25.
The decrease in the Management expenditure share is directly related to a decrease in the total number of employees in Management occupations in physicians' offices, in particular, “Medical and health service managers.” The decrease in expenditure share may also be due, in part to the methods used in this rebasing. That is, for the 2006-based MEI, we are using data limited to “Offices of physicians.” In the 2000-based version of the index, the only data that were available to inform these estimates were inclusive of physician offices and clinics (“Offices of physicians and clinics”). An examination of 2006 CPS and OES data comparing “Outpatient care centers” to “Offices of physicians” indicates that there is a higher share of management occupations in the “Outpatient care centers” than in “Offices of physicians.”
The increase in the Service Workers expenditures share is attributable to a substantive increase in the number of employees in service occupations, particularly, “Medical assistants and other health care support occupations”.
The aggregate Office Expenses cost weight was derived using the 2006 AMA PPIS and is explained in more detail below in this section. This calculation resulted in a 20.035 percent share of total costs in 2006 compared to a 12.209 percent share in the 2000-based index.
For the 2006-based MEI, we propose to further disaggregate the Office Expenses into more detailed cost categories using the BEA 2002–Benchmark I/O data for Offices of physicians, dentists, and other health practitioners (NAICS 621A00). We used this data to develop the nine detailed 2002 costs weights as a percent of total office expenses, as measured by the BEA I/O data. The total Office Expenses cost category was calculated by matching the BEA I/O data as closely as possible to the AMA survey data, the latter of which defined office expenses as “office (non-medical) equipment and office (non-medical) supplies, as well as rent, mortgage, interest, maintenance, refrigeration, storage, security, janitorial, depreciation on medical buildings used in your practice, utilities, or other office computer systems (including information management systems/electronic medical record systems) and telephone.”
We then aged the 2002 weights forward to 2006 to derive the 2006 detailed office expense cost weights as a percent of total Office Expenses. The methodology we used to age the data forward involved applying the annual price changes from each respective price proxy to the appropriate cost categories. We repeated this practice for each year of the interval. We then applied the resulting 2006 distributions to the aggregate 2006 AMA Office Expenses weight to yield the detailed 2006 Office Expenses' weights as a percent of total expenses.
We are proposing to introduce these new, more detailed weights for the 2006-based index based on our intent to derive an increased level of precision while maintaining appropriate levels of aggregation in the market basket. The proposed proxies are described in section X. of this proposed rule. The following is a description of what is included in each of the detailed cost categories.
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The weight for PLI expense was derived from the 2006 AMA survey and was calculated as the mean PLI expense expressed as a percentage of total expenses. This calculation resulted in a 4.513 percent share of total costs in 2006 compared to a 3.865 percent share in the 2000-based index. The increase in the weight for PLI reflects the current prices of premiums, as well as an update to the level of coverage purchased by physicians in 2006 compared to 2000.
The proposed weight for Medical Equipment was calculated using the 2006 AMA PPIS mean expense data. This calculation resulted in a 1.978 percent share of total costs in 2006 compared to a 2.055 percent share in the 2000-based index. By definition, this category includes the expenses related to depreciation, maintenance contracts, leases/rental of medical equipment used in diagnosis or treatment of patients. The category would also include the tax-deductible portion of the purchase price or replacement value of medical equipment, if not leased.
The proposed weight for Medical Supplies was calculated using the 2006 AMA PPIS mean expense data. This calculation resulted in a 1.760 percent share of total costs in 2006 compared to a 2.011 percent share in the 2000-based index. By definition, this category includes the expenses related to medical supplies such as sterile gloves, needles, bandages, specimen containers, and catheters. Additionally, we are proposing to exclude the expenses related to separately billable supplies as these expenses are not paid for under the PFS. The Medical Supply cost category does not include expenses related to drugs.
The proposed weight for All Other Professional expenses was calculated using the 2006 AMA PPIS mean expense data. This calculation resulted in a 4.513 percent share of total costs in 2006 compared to a 6.433 percent share in the 2000-based index. By definition, this category includes the expenses related to tax-deductible expenses for any other expenses not reported in another category from the PPIS. These expenses would include fees related to legal, marketing, accounting, billing, office management services, professional association memberships, maintenance of certification or licensure, journals and continuing education, professional car upkeep and depreciation, and any other professional expenses not reported elsewhere on the PPIS.
After the proposed 2006 cost weights for the rebased and revised MEI were developed, we reviewed all of the price proxies to evaluate their appropriateness. As was the case in the development of the 2000-based MEI (68 FR 63239), most of the proxy measures we considered are based on BLS data and are grouped into one of the following five categories:
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When choosing wage and price proxies for each expense category, we evaluate the strengths and weaknesses of each proxy variable using the following four criteria.
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The BLS price proxy categories previously described meet the criteria of relevance, reliability, timeliness, and public availability. Below we discuss the proposed price-wage proxies for the rebased and revised MEI (as shown in Table 23).
In the proposed revised and rebased MEI, we are using the AHE for the private nonfarm economy as the proxy for the Physician Wages & Salaries component (BLS series code: CEU0500000008).
As discussed extensively in the November 2, 1998 final rule (63 FR 58848), and again in the December 31, 2002 final rule (67 FR 80019), we believe that this price proxy represents the most appropriate proxy for use in the MEI. The AHE for the nonfarm business economy reflects the impacts of supply, demand, and economy-wide productivity for the average worker in the economy. As such, use of this proxy is consistent with the original legislative intent that the change in the physicians' earnings portion of the MEI follow the change in general earnings for the economy. Since earnings are expressed per hour, a constant quantity of labor input per unit of time is reflected. Finally, the use of the AHE data is also consistent with our using the BLS economy-wide private nonfarm business sector multifactor productivity measures since economy-wide wage increases reflect economy-wide productivity increases.
The current 2000-based MEI uses the ECI for Total Benefits (BLS series code: CIU2030000000000I) for total private industry as the price proxy for Physician Benefits. We are proposing to use the same proxy for the 2006-based MEI. This means that both the wage and benefit proxies for physician earnings are derived from the private nonfarm business sector and are computed on a per-hour basis.
For the 2006-based MEI, we are proposing to use Current Population Survey (CPS) data on employment by occupation and earnings from the BLS Occupational Employment Statistics for NAICS 6211, Office of Physicians, to develop labor cost shares for the nonphysician occupational groups shown in Table 23. The 2000-based MEI was based on CPS data for the Standard Industrial Classification 801 and 803, which included both office of physicians and outpatient care centers. Beginning in 2003, BLS began publishing CPS data on a NAICS basis which provided data for office of physicians (NAICS 6211)and outpatient care centers (NAICS 6214) separately. We believe using data for office of physicians is appropriate for the 2006-based MEI. The BLS maintains an ECI for each selected industry group. We propose to use these ECIs as price proxies for nonphysician employee wages in the same manner they are used in the current MEI.
As described in the CY 2008 PFS proposed rule (72 FR 38190), as a result of the discontinuation of the White Collar Benefit ECI for private workers, we are currently using a composite ECI benefit index. We are proposing to continue to use the composite ECI for nonphysician employees in the proposed rebased and revised MEI; however, we are proposing to revise the weights within that blend in order to reflect the more recent 2006 data. Table 26 lists the four ECI series and corresponding weights used to construct the 2006 composite benefit index.
For the 2006-based MEI, we are proposing to use the CPI for Fuel and Utilities (BLS series code #CUUR0000SAH2) to measure the price growth of this cost category. This cost category was not broken-out separately in the 2000-based MEI.
For the 2006-based MEI, we are proposing to use the PPI for Other Basic Organic Chemical Manufacturing (BLS series code #PCU32519–32519) to measure the price changes of this cost category. We are proposing this industry-based PPI because BEA's 2002 benchmark I/O data show that the majority of the office of physicians' chemical expenses are attributable to Other Basic Organic Chemical Manufacturing (NAICS 32519). This cost category was not broken-out separately in the 2000-based MEI.
For the 2006-based MEI, we are proposing to use the PPI for Converted Paper and Paperboard (BLS series code #WPU0915) to measure the price growth of this cost category. This cost category was not broken-out separately in the 2000-based MEI.
For the 2006-based MEI, we are proposing to use the PPI for Rubber and Plastic Products (BLS series code #WPU07) to measure the price growth of this cost category. This cost category was not broken-out separately in the 2000-based MEI.
For the 2006-based MEI, we are proposing to use the CPI for Telephone Services (BLS series code #CUUR0000SEED) to measure the price growth of this cost category. This cost category was not broken-out separately in the 2000-based MEI.
For the 2006-based MEI, we are proposing to use CPI for Postage (BLS series code #CUUR0000SEEC01) to measure the price growth of this cost category. This cost category was not broken-out separately in the 2000-based MEI.
For the 2006-based MEI, we are proposing to use the ECI for Compensation for Service Occupations (private industry) (BLS series code #CIU2010000300000I) to measure the price growth of this cost category. This cost category was not broken-out separately in the 2000-based MEI.
For the 2006-based MEI, we are proposing to use the CPI for Owner's Equivalent Rent (BLS series code #CUUS0000SEHC) to measure the price growth of this cost category. This price index represents about 50 percent of the CPI for Housing which was used to in the 2000-based MEI to proxy total office expenses.
For the 2006-based MEI, we are proposing to use the PPI for Machinery and Equipment (series code #WPU11) to measure the price growth of this cost category. This cost category was not broken-out separately in the 2000-based MEI.
In order to accurately reflect the price changes associated with PLI, each year, we solicit PLI premium data for physicians from a sample of commercial carriers. This information is not collected through a survey form, but instead is requested directly from, and provided by (on a voluntary basis), several national commercial carriers. As we require for our other price proxies, the professional liability price proxy is intended to reflect the pure price change associated with this particular cost category. Thus, it does not include changes in the mix or level of liability coverage. To accomplish this result, we obtain premium information from a sample of commercial carriers for a fixed level of coverage, currently $1 million per occurrence and a $3 million annual limit. This information is collected for every State by physician specialty and risk class. Finally, the State-level, physician-specialty data are aggregated by effective premium date to compute a national total, using counts of physicians by State and specialty as provided in the AMA publication,
The resulting data provide a quarterly time series, indexed to a base year consistent with the MEI, and reflect the national trend in the average professional liability premium for a given level of coverage, generally $1 million/$3 million of claims-made mature policies. From this series, quarterly and annual percent changes in PLI are estimated for inclusion in the MEI.
The most comprehensive data on professional liability costs are held by the State insurance commissioners, but these data are available only with a substantial time lag and hence, the data currently incorporated into the MEI are much timelier. We believe that, given the limited data available on professional liability premiums, the information and methodology described above adequately reflect the PLI price trends facing physicians.
The Medical Equipment cost category includes depreciation, leases, and rent on medical equipment. We are proposing to use the PPI for Medical Instruments and Equipment (BLS series code: WPU1562) as the price proxy for this category, consistent with the price proxy used in the 2000-based MEI and other CMS input price indexes.
As is used in the 2000-based MEI, we are proposing to use a blended index comprised of 50/50 blend of the PPI Surgical Appliances (BLS series code: WPU156301) and the CPI–U for Medical Equipment and Supplies (BLS series code: CUUR0000SEMG). We believe physicians purchase the types of supplies contained within these proxies, including such items as bandages, dressings, catheters, I.V. equipment, syringes, and other general disposable medical supplies, via wholesale purchase, as well as at the retail level. Consequently, we are proposing to combine the two aforementioned indexes to reflect those modes of purchase.
This category includes the residual subcategory of other professional expenses such as accounting services, legal services, office management services, continuing education, professional association memberships, journals, professional car expenses, and other professional expenses. Given this heterogeneous mix of goods and services, we are proposing to use the CPI–U for All Items Less Food and Energy, consistent with the price proxy used in the 1996 and 2000-based MEI.
The MEI has been adjusted for changes in productivity since its inception. In the CY 2003 PFS final rule (67 FR 80019), we implemented a change in the way the MEI was adjusted to account for those changes in productivity The MEI used for the 2003 physician payment update incorporated changes in the 10-year moving average of private nonfarm business (economy-wide) multifactor productivity that were applied to the entire index. Previously, the index incorporated changes in productivity by adjusting the labor portions of the index by the 10-year moving average of economy-wide private nonfarm business labor productivity.
We are proposing to continue to use the current method for adjusting the full MEI for multifactor productivity in the rebased and revised MEI.
As described in the CY 2003 PFS final rule, we believe this adjustment is appropriate because it explicitly reflects the productivity gains associated with all inputs (both labor and non-labor). We believe that using the 10-year moving average percent change in economy-wide multifactor productivity is appropriate for deriving a stable measure that helps alleviate the influence that the peak (or a trough) of a business cycle may have on the measure. The adjustment will be based on the latest available historical economy-wide nonfarm business multifactor productivity data as measured and published by BLS.
Table 27 illustrates the results of updating the MEI from the following changes to the weights for the Physician Compensation, Practice Expenses (excluding PLI), and PLI.
The rebased and revised MEI has several differences as compared to the 2000-based MEI; these changes have been discussed in detail in prior
As shown in Table 29, the projection of the proposed rebased and revised MEI for the CY 2011 PFS proposed rule is an increase of 0.3 percent, identical to the projected increase using the 2000-based MEI. In the CY 2011 PFS final rule, we will incorporate historical data through the second quarter of 2010; therefore, the current estimated increase of 0.3 percent for 2011 may differ in the final rule.
In addition to the proposed revisions to the MEI mentioned earlier in this section, we are also proposing to convene a technical advisory panel later this year to review all aspects of the MEI, including the inputs, input weights, price-measurement proxies, and productivity adjustment. We will ask the panel to assess the relevance and accuracy of these inputs to current physician practices. The panel's analysis and recommendations will be considered in future rule making to ensure that the MEI accurately and appropriately meets its intended statutory purpose. We are requesting comments from the physician community and other interested members of the public on any other specific issues that should be considered by the technical panel.
As described in the previous section, we are proposing to rebase the MEI for CY 2011 based on the most current data and establish new weights for physician work, PE, and malpractice under the MEI. As stated in the previous section, the MEI was rebased to a CY 1996 base year beginning with the CY 1999 MEI (63 FR 58845), and to a CY 2000 base year beginning with the CY 2004 MEI (68 FR 63239). For both the CY 1999 and CY 2004 rebasing, we made adjustments to ensure that our estimates of aggregate PFS payments for work, PE, and malpractice were in proportion to the weights for these categories in the rebased MEI (63 FR 58829 and 69 FR 1095).
Consistent with our past practice when the MEI has been rebased, we are proposing to make adjustments to ensure that estimates of aggregate CY 2011 PFS payments for work, PE, and malpractice are in proportion to the weights for these categories in the rebased CY 2011 MEI.
Our proposal would necessitate increasing the proportion of aggregate CY 2011 PFS payments for PE and malpractice and decreasing the proportion for work. This could be accomplished by applying adjustments directly to the work, PE, and malpractice RVUs. However, we are cognizant of the public comments made during prior rulemaking on issues related to scaling the work RVUs. Many commenters have indicated a preference for the work RVUs to remain stable over time and for any necessary adjustments that would otherwise be made broadly to the work RVUs to be accomplished in an alternative manner. For example, in past 5-Year Reviews of the work RVUs, many commenters have cited stability in the work RVUs, among other reasons, in their requests that any required budget neutrality adjustments not be made directly to the work RVUs. Given these prior comments, we are proposing to make the necessary MEI rebasing adjustments without adjusting the work RVUs. Instead, we are proposing to increase the PE RVUs by an adjustment factor of 1.168 and the malpractice RVUs by an adjustment factor of 1.413. The RVUs in Addendum B to this proposed rule reflect the application of these adjustment factors. We note that an application of the 1.413 adjustment factor to the malpractice RVUs for services with malpractice RVUs of 0.01 will, due to rounding, result in malpractice RVUs of 0.01.
Section 1848(c)(2)(B)(ii)(II) of the Act requires that changes to RVUs cannot cause the amount of expenditures for a year to differ by more than $20 million from what expenditures would have been in the absence of the changes. Therefore, as required by section 1848(c)(2)(B)(ii) of the Act, we are proposing to make an adjustment of 0.921 to the CY 2011 conversion factor to ensure that the 1.168 adjustment to the PE RVUs and the 1.413 adjustment to the malpractice RVUs do not cause an increase in CY 2011 PFS expenditures. The current law estimate of the CY 2011 CF is $26.6574.
Section 1833(g) of the Act applies an annual, per beneficiary combined cap on expenses incurred for outpatient physical therapy and speech-language pathology services under Medicare Part B. A similar separate cap for outpatient occupational therapy services under Medicare Part B also applies. The caps do not apply to expenses incurred for therapy services furnished in an outpatient hospital setting. The caps were in effect during 1999, from September 1, 2003 through December 7, 2003, and beginning January 1, 2006. The caps are a permanent provision, that is, there is no end date specified in the statute for therapy caps. Beginning January 1, 2006, the Deficit Reduction Act (Pub. L. 109–171) (DRA) provided for exceptions to the therapy caps until December 31, 2006. The exceptions
Section 1833(g)(5) of the Act (as amended by section 3103 of the ACA) extended the exceptions process for therapy caps through December 31, 2010. We will announce the amount of the therapy cap for CY 2011 in the CY 2011 PFS final rule with comment period. The annual change in the therapy cap is computed by multiplying the cap amount for CY 2010, which is $1,860, by the MEI for CY 2011, and rounding to the nearest $10. This amount is added to the CY 2010 cap to obtain the CY 2011 cap. The agency's authority to provide for exceptions to therapy caps (independent of the outpatient hospital exception) will expire on December 31, 2010, unless the Congress acts to extend it. If the current exceptions process expires, the caps will be applicable in accordance with the statute, except for services furnished and billed by outpatient hospitals.
In section 4541 of the Balanced Budget Act of 1997 (Pub. L. 105–33) (BBA), the Congress enacted the financial limitations on outpatient therapy services (the “therapy caps” discussed above for physical therapy, occupational therapy, and speech-language pathology). At the same time, the Congress requested that the Secretary submit a Report to Congress that included recommendations on the establishment of a revised coverage policy for outpatient physical therapy services and outpatient occupational therapy services under the statute. The Balanced Budget Refinement Act of 1999 (Pub. L. 106–113) (BBRA) placed the first of a series of moratoria on implementation of the limits. In addition, it required focused medical review of claims and revised the report requirements in section 4541(d)(2) of the BBA to request a report that included recommendations on the following: (A) The establishment of a mechanism for assuring appropriate utilization of outpatient physical therapy services, outpatient occupational therapy services, and speech-language pathology services; and (B) the establishment of an alternative payment policy for such services based on classification of individuals by diagnostic category, functional status, prior use of services (in both inpatient and outpatient settings), and such other criteria as the Secretary determines appropriate, in place of the limits.
In 1999, therapy services were not defined, but services documented as therapy were billed and reported when furnished by a variety of individuals in many different settings. These services were not identified in a way that would allow analysis of utilization or development of alternative payment policies.
We have studied therapy services with the assistance of a number of contractors over the past 11 years. Reports of these projects are available on the CMS Web site at
Over the past decade, significant progress has been made in identifying the outpatient therapy services that are billed to Medicare, the demographics of the beneficiaries who utilize those services, the types of services, the HCPCS codes used to bill the services, the allowed and paid amounts of the services, and the settings, geographic locations, and provider types where services are furnished.
Some of the information that is necessary to ensure appropriate utilization and develop objective and equitable payment alternatives to therapy caps based on patient condition has proven difficult to develop. The influence of prior use of inpatient services on outpatient use of therapy services was not accessible due to systems issues and differences in the policies, billing, and reporting practices for inpatient and outpatient therapy services. The weakness of the ICD–9–CM diagnostic codes in describing the condition of the rehabilitation patient obscured analyses of claims to assess the need for therapy services. The primary diagnosis on the claim is a poor predictor for the type and duration of therapy services required, which complicates assignment of patient cohorts for analysis. Although changes to the guidance in the Medicare Benefit Policy Manual (Pub. 100–02) on documentation of therapy services in 2005 improved the consistency of records and facilitated chart review, it became increasingly obvious that neither claims analysis nor chart review could serve as a reliable and valid method to determine a patient's need for services or to form the basis for equitable payment. We concluded that in order to develop alternative payment approaches to the therapy caps, we needed a method to identify patients with similar risk-adjusted conditions (cohorts) and then we would identify the therapy services that are necessary for the patients to attain the best outcomes with the most efficient use of resources.
While we studied therapy utilization, a number of proprietary tools were developed by researchers in the professional community to assess the outcomes of therapy. Some tool sponsors collected sufficient information to predict with good reliability the amount or length of treatment that would result in the best expected outcomes. We encouraged the use of these proprietary tools in manual instructions, but proprietary tools do not serve CMS' purposes because modification of proprietary tools may only be done by the tool sponsor. There now are some versions of the tools in the public domain and they are being utilized widely to identify patient conditions and, by some insurers, to pay for efficient and effective treatment. Examples of such tools including the National Outcomes Measurement System (NOMS) by the American Speech-Language Hearing Association and Patient Inquiry by Focus On Therapeutic Outcomes, Inc. (FOTO).
In 2006, Focus on Therapeutic Outcomes, Inc. delivered to CMS a report titled, “Pay for Performance for Physical Therapy and Occupational Therapy,” which is also available on the CMS Web site at
The Tax Relief and Health Care Act of 2006 (TRHCA) extended the therapy cap
The DOTPA project reports are available on the contractor's Web site at
The TRCHA also funded the 2-year project contracted to Computer Sciences Corporation (CSC) titled “Short Term Alternatives for Therapy Services” (STATS). STATS will provide recommendations regarding alternative payment approaches to therapy caps that could be considered before completion of the DOTPA project. The STATS project draws upon the analytical and clinical expertise of contractors and stakeholders to consider policies, measurement tools, and claims data that are currently available to provide further information about patient condition and the outcomes of therapy services. The final report, due in the fall of CY 2010, will include recommended actions we could take within 2 or 3 calendar years to replace the current cap limits on therapy services with a policy that pays appropriately for necessary therapy services.
On June 30, 2009, we received a draft of the CSC report titled “STATS Outpatient Therapy Practice Guidelines,” a summary of expert workgroup discussions, and several short-term payment alternatives for consideration. CSC discussed options based on the assumption that short-term policy changes should facilitate the development of adequate function and/or outcomes reporting tools. In the long-term, CSC recommended that payment be based on function or quality measurements that adequately perform risk adjustment for episode-based payment purposes.
Based on the draft report, additional stakeholder input, and subsequent communications with the contractor, in this proposed rule we are discussing several potential alternatives to the therapy caps that could lead to more appropriate payment for medically necessary and effective therapy services that are furnished efficiently. We are soliciting public comments on this proposed rule regarding all aspects of these alternatives, including the potential associated benefits or problems, clinical concerns, practitioner administrative burden, consistency with other Medicare and private payer payment policies, and claims processing considerations. We are not proposing either short-term or long-term payment alternatives to the therapy caps at this time. However, we refer readers to section II.C.4.(c) of this proposed rule for our CY 2011 proposal to expand the MPPR policy to “always therapy” services furnished in a single session in order to pay more appropriately for therapy services, taking into consideration the expected efficiencies when services are furnished together. While we are not proposing the adoption of an MPPR policy for therapy services specifically as an alternative to the therapy caps, we acknowledge that by paying more appropriately for combinations of therapy services that are commonly furnished in a single session, practitioners would be able to furnish more medically necessary therapy services to a given beneficiary before surpassing the caps. This proposed policy would have the potential to reduce the number of beneficiaries impacted by the therapy caps in a given year.
The three specific short-term options that we are discussing in this proposed rule would not require statutory changes. Some would require moderate reporting changes that would yield more detailed information about patient function and progress to inform future payment approaches and facilitate the medical review of services above the therapy caps at the present time. Others require new coding and bundled per-session payment that would be a first step toward episode-based payment. They are not necessarily independent of each other. Under each of these alternatives, administrative simplification with respect to current policies, such as HCPCS code edits and “ICD–9–CM to HCPCS code” crosswalk edits that serve to limit utilization without regard to the patient's clinical presentation, could be pursued in the context of these options.
The first option would modify the current therapy caps exceptions process to capture additional clinical information regarding therapy patient severity and complexity in order to facilitate medical review. This approach would complement the DOTPA project, which is identifying items to measure patient condition and outcomes. We believe the first option may have the greatest potential for rapid implementation that could yield useful information in the short-term. We are especially interested in detailed public comments on this option that could inform a potential proposal to adopt such an alternative through future rulemaking. The second option would involve introducing additional claims edits regarding medical necessity, in order to reduce overutilization. The third option would be to adopt a per-session bundled payment that would vary based on patient characteristics and the complexity of evaluation and treatment services furnished in the session. Each option would require significant provider and contractor education, and all would necessitate major claims processing systems changes. Moreover, some of the options may affect beneficiaries by changing the type or amount of services covered by Medicare or the beneficiary's cost sharing obligations.
This option would require that clinicians submit beneficiary function-related nonpayable HCPCS codes to replace the –KX modifier (Specific
Six Level II HCPCS G-codes representing functions addressed in the plan of care and 5 (or 7) modifiers representing severity/complexity would be utilized to report information on the claim.
Examples of six new function-related G-codes:
• GXXXU—Impairments to body functions and/or structures—current.
• GXXXV—Impairments to body functions and/or structures—goal.
• GXXXW—Activity limitations and/or participation restrictions—current.
• GXXXX—Activity limitations and/or participation restrictions—goal.
• GXXXY—Environmental barriers—current.
• GXXXZ—Environmental barriers—goal.
Two potential severity/complexity scales have been suggested that would require the adoption of 5 or 7 new severity modifiers, respectively. Under one scenario, modifiers based on the International Classification of Function could identify severity as follows:
• None (0 to 4 percent);
• MILD (5 to 24 percent);
• MODERATE (25 to 49 percent);
• SEVERE (50 to 95 percent); or
• COMPLETE (96 to 100 percent).
Alternatively, a proportional severity/complexity scale would use 7 modifiers to describe impairments, limitations, or barriers:
• 0 percent;
• 1 to 19 percent;
• 20 to 39 percent;
• 40 to 59 percent;
• 50 to 79 percent;
• 80 to 99 percent; or
• 100 percent.
Implementation of this general approach would require 6 months to 2 years to modify claims processing for the current therapy caps and exceptions processing of claims, and to develop, pilot test, and refine coding before applying the approach nationally. While therapists initially would need to learn the new codes and update their billing systems, ultimately their reporting burden would be reduced because the –KX modifier would not be required on each claim line for patients with expenditures approaching or exceeding the therapy caps. This option could potentially result in a small reduction in outpatient therapy expenditures due to increased Medicare contractor scrutiny of episodes where functional severity scores did not change over time, or to other atypical reporting patterns associated with the new codes.
In the long-term, these codes and modifiers could be mapped to reliable and validated measurement tools (either currently available tools in the public domain or newly developed tools from items on the DOTPA instrument or the Continuity Assessment Record and Evaluation (CARE) tool). When statistically robust patient condition information has been collected from claims data, it may be possible to develop Medicare payment approaches for outpatient therapy services that would pay appropriately and similarly for efficient and effective services furnished to beneficiaries with similar conditions who have good potential to benefit from the services furnished. At a minimum, the new codes would allow contractors to more easily identify and limit the claims for beneficiaries that show no improvement over reasonable periods of time.
The existing automatic process for exceptions, and the revised exceptions process described in Option 1 above, pay practitioners indefinitely for services if they attest on the claim by appending a specific modifier to therapy HCPCS codes that the services being furnished are medically necessary and that supporting documentation is included in the medical record. Unless the contractor uses claims edits or does post payment review, these processes do not identify or limit unusually high annual per-beneficiary utilization. High utilization is not limited to beneficiaries with multiple or complex conditions. We could use existing therapy utilization data to develop annual per-beneficiary medical necessity payment edits, such as limits to the number of services per session, per episode, or per diagnostic grouping, for exceptions to the therapy caps which could be set at benchmark payment levels that only a small percentage of beneficiaries would surpass in a single year. Once these levels were reached, additional claims would be denied and practitioners would need to appeal those denials if they wished to challenge Medicare's nonpayment.
This alternative would require 1 to 2 years to implement as an expansion of existing policy, and its effects could be anticipated by analysis of the current utilization of therapy services. Additional practitioner burden would be incurred in the small number of cases exceeding the per-beneficiary expenditure edits when the practitioner chooses to appeal the medical necessity denial.
As discussed in section II.C.4.(c) of this proposed rule, multiple therapy services are often furnished in a single session, and we are proposing to expand the MPPR policy to “always therapy” services in CY 2011 in order to take into consideration the efficiencies that occur when multiple services (the typical therapy scenario) are furnished in one session to a beneficiary. Furthermore, we note that section 1848(c)(2)(K) of the Act (as added by section 3134 of the ACA) regarding potentially misvalued codes under the PFS specifies that the Secretary may make appropriate coding changes, which may include consolidation of individual services into bundled codes for payment under the PFS, as part of her review and adjustment of the relative values for services identified as potentially misvalued.
This option would require that practitioners submit a single new Level II HCPCS code to represent all the therapy services currently reported and paid separately for an outpatient therapy session. Payment for the HCPCS code would be based on patient characteristics (as identified through prior CMS contractor analyses) and the complexity of the evaluation/assessment and intervention services furnished during the session. The new coding requirements would not disrupt the current exceptions process or the revised exceptions process described in Option (1) above. Approximately 12 E&I codes would be needed, taking into consideration the basic algorithm shown in Table 31.
We would need to develop and test operational definitions for each E&I code so that practitioners would be able to properly report services and appropriate relative values could be established for each per-session code. We believe that a pilot study might reveal that the different practice patterns for the three therapy professions (physical therapy, occupational therapy, and speech-language pathology) could necessitate separate relative value determinations for each E&I code by type of therapy service furnished. As a result, up to 36 total new Level II HCPCS codes could be needed (12 per discipline).
We anticipate that the definitions of E&I codes 1 through 3 and 7 through 12 would describe services that may only be furnished by a “clinician” (therapist, physician, or nonphysician practitioner). E&I codes 1 through 3 would be reported for sessions that consisted only of evaluations. In addition, the definitions of E&I codes 4 through 6 would describe services that could be furnished by or under the permissible supervision of all qualified outpatient therapy professionals. Based upon historical therapy utilization patterns, the vast majority of E&I codes submitted would likely fall in the 4 through 9 code range. We would expect the RVUs under the PFS for all E&I codes to take into consideration the efficiencies when multiple services (those that would be currently reported under multiple CPT codes) are furnished.
This option would require 2 to 4 years to add new codes and conduct a short-term pilot study to refine coding and value the 12 new HCPCS codes (or 36 if they are specific to each therapy discipline). There would be significant initial practitioner administrative burden to learn new codes and update billing systems. However, ultimately, with elimination of the practitioner's reporting of 76 different codes and many of the associated claims processing edits, the administrative burden of reporting therapy services to Medicare would be minimized. This bundled approach to reporting and payment could result in more appropriate valuation of therapy services that reflects efficiencies when individually reported services are furnished in the same session. As a result, it could lead to reduced therapy expenditures, as well as a reduction in the number of beneficiaries affected by the therapy caps in a given year.
In conclusion, we emphasize that we continue to be committed to developing alternatives to the therapy caps that would provide appropriate payment for medically necessary and effective therapy services furnished to Medicare beneficiaries based on patient needs, rather than the current therapy caps which establish financial limitations on Medicare payment for therapy services in some settings regardless of medical necessity. The Congress has repeatedly intervened to allow exceptions to these caps for certain time periods, and the current exceptions are automatically processed based on a practitioner's attestation that medical necessity is documented in the chart for an individual patient. We believe that, ultimately, payment for therapy services should incentivize the most effective and efficient care, consistent with Medicare's focus on value in its purchasing.
Therefore, we are soliciting public comments on potential alternatives to the therapy caps, including those discussed in this section of this proposed rule. The STATS contractor has worked closely with a broad variety of clinicians, administrators, scientists, researchers, and other contractors to develop the 3 alternatives presented this discussion. We welcome all public comments on this propose rule from interested stakeholders, including individual therapists from both facility and nonfacility settings treating Part B (outpatient) beneficiaries. Among the topics of interest to us are the following:
• Recommendations for alternative payment policies (options discussed in this proposed rule or others) that address patient needs, while minimizing payment for inefficient services or those of limited patient benefit;
• Assessment of the practitioner burden associated with the recommended policies;
• Likelihood that recommended changes would minimize fraud, abuse, and waste;
• Whether the recommendations could assist CMS in obtaining meaningful information on patient function and how that information could be utilized;
• Whether measurement tools relevant to assessing the need for therapy services exist in the public domain and how they might be utilized;
• What function information should be collected and how it could be utilized to ensure necessary care, while minimizing payment for inefficient services or those of limited patient benefit; and
• How therapist behavior, plans of care, or patient scheduling would be affected by the recommended alternatives.
We are committed to finding alternatives to the current therapy cap limitations on expenditures for outpatient therapy services that will ensure that beneficiaries continue to receive those medically necessary therapy services that maximize their health outcomes. We continue to dedicate our resources to identifying alternatives that would encourage the most efficient and cost-effective treatments. We believe motivated therapists, with attention to the most cost-effective practices, can incorporate practice efficiencies that benefit patients by achieving the best possible results at the lowest cost.
Our STATS and DOTPA projects, which are currently engaged in data collection and analysis to inform short-term and long-term alternatives to the therapy caps, respectively, lay the foundation for future payment alternatives for outpatient therapy services. We are optimistic that the STATS project will identify short-term, feasible alternatives that may be tested in the future. The DOTPA project will create a tool and test its use to collect patient condition information that can then be applied to identify patient need
Section 4105(a) of BBA provided coverage for DSMT in outpatient settings without limiting this coverage to hospital outpatient departments. DSMT services consist of educational and training services furnished to an individual with diabetes by a certified provider in an outpatient setting.
Section 4105(a) of the BBA stipulated that training would be furnished by a “certified provider” which is a physician or other individual or entity that also provides other items or services for which payment may be made under Medicare. This program is intended to educate beneficiaries in the successful self-management of diabetes. The program includes instructions in self-monitoring of blood glucose; education about diet and exercise; an insulin treatment plan developed specifically for the patient who is insulin-dependent; and motivation for patients to use the skills for self-management. DSMT services are reported under HCPCS codes G0108 (Diabetes outpatient self-management training services, individual, per 30 minutes) and G0109 (Diabetes outpatient self-management training services, group session (2 or more), per 30 minutes).
In accordance with section 4105(a) of the BBA, Medicare payment for outpatient DSMT services is made under the PFS as specified in § 414.1 through § 414.48. When we created HCPCS codes G0108 and G0109, the only direct costs included in the PE were registered nurse labor. Section 410.144(a)(4)(a) states that the DSMT team includes at least a registered dietitian and a certified diabetes educator. We did not establish work RVUs for DSMT services because we believed training would typically be performed by individuals other than a physician, such as a registered nurse (65 FR 83130). However, since that time, we have received requests from a number of stakeholders, including the American Association of Clinical Endocrinologists (AACE), the American Association of Diabetes Educators (AADE), and the Juvenile Diabetes Research Foundation, to include physician work in valuing DSMT services that is similar to the physician work that has been included in medical nutrition therapy (MNT) services since CY 2007 and kidney disease education (KDE) services since CY 2010. The stakeholders argued that because physicians coordinate DSMT programs, provide patient instruction, and communicate with referring physicians, physician work should be included in the RVUs for DSMT services. The stakeholders also requested that we reconsider the direct PE inputs for DMST services and include clinical labor for diabetes educators at a higher hourly rate instead of registered nurse labor. In addition, they stated that the supplies and equipment in the PE for DSMT services should be the same as for KDE services, with additional direct PE inputs for a diabetic educator curriculum, data tracking software, and DSMT program accreditation.
For CY 2011, we are proposing to assign physician work RVUs to DSMT services that are comparable, as adjusted for the service times of the HCPCS codes, to the work RVUs for MNT services. We are proposing that HCPCS G0108 for 30 minutes of individual DSMT services would be crosswalked to CPT code 97803 (Medical nutrition therapy; re-assessment and intervention, individual, face-to-face with the patient, each 15 minutes) for purposes of assigning work RVUs, with the physician work RVUs for CPT code 97803 multiplied by two to account for the greater time associated with HCPCS code G0108 (that is, 30 minutes). We are also proposing that HCPCS G0109 for 30 minutes of group DSMT services would be crosswalked to CPT code 97804 (Medical nutrition therapy; group (2 or more individuals(s)), each 30 minutes) for purposes of assigning work RVUs. The rationale for the proposed work RVUs for the DSMT HCPCS G-codes is based on the similarity of DSMT services to MNT services in the individual (CPT code 97803) and group (CPT code 97804) setting.
For CY 2011, we are also proposing to modify the PE inputs for DSMT services to reflect the current equipment and supplies for the KDE HCPCS G-codes implemented in the CY 2010 PFS final rule with comment period (74 FR 61901) (that is, HCPCS codes G0420 (Face-to-face educational services related to the care of chronic kidney disease; individual, per session, per one hour) and G0421 (Face-to-face educational services related to the care of chronic kidney disease; group, per session, per one hour)), based on the similarity in the equipment and supplies necessary for DSMT and KDE services. We have made adjustments to some of the equipment times for the 30 minute DSMT individual and group services as compared to the 1 hour individual and group KDE services. We are also including a diabetic educator curriculum and data tracking software in the PE inputs for DSMT services, but it is our general practice not to include program accreditation costs in those PE inputs. With respect to clinical labor, rather than changing the current labor type for DSMT services, we are proposing to utilize the same approach as we adopted for MNT services when we provided physician work RVUs for those services in CY 2007 (71 FR 69645). Specifically, we are removing all of the clinical labor from the group DSMT code and most of the clinical labor from the individual DSMT code, given that we are proposing work RVUs for both DSMT codes for CY 2011.
We believe these proposals would value DSMT services more consistently with other similar services that are paid under the PFS. As a result of our proposed CY 2011 changes, the proposed work RVUs for HCPCS codes G0108 and G0109 are 0.90 and 0.25, respectively. As described above, we are also proposing to modify the direct PE inputs for these codes for CY 2011.
In the CY 2004 PFS final rule with comment period (68 FR 63216), we established new Level II HCPCS G-codes for end-stage renal disease (ESRD) monthly capitation payment (MCP) services. For center-based patients, payment for the G-codes varied based on the age of the beneficiary and the number of face-to-face visits furnished each month (for example, 1 visit, 2–3 visits and 4 or more visits). Under the MCP methodology, the lowest payment applied when a physician provided one visit per month; a higher payment was provided for two to three visits per month. To receive the highest payment, a physician would have to provide at least four ESRD-related visits per month. However, payment for home dialysis MCP services only varied by the age of beneficiary. Although we did not initially specify a frequency of required
Effective January 1, 2009, the CPT Editorial Panel created new CPT codes to replace the G-codes for monthly ESRD-related services, and we accepted the new codes for use under the PFS in CY 2009. The CPT codes for monthly ESRD-related services for home dialysis patients include the following, as displayed in Table 32: 90963, 90964, 90965, and 90966. In addition, the clinical vignettes used for the valuation of CPT codes 90963, 90964, 90965, and 90966 include scheduled (and unscheduled) examinations of the ESRD patient.
Given that we pay for a physician (or practitioner) to evaluate the ESRD patient over the course of an entire month under the MCP, we believe that it is clinically appropriate for the physician (or practitioner) to have at least one in-person, face-to-face encounter with the patient per month. Therefore, we are proposing to require the MCP physician (or practitioner) to furnish at least one in-person patient visit per month for home dialysis MCP services (as described by CPT codes 90963 through 90966). This requirement would be effective for home dialysis MCP services beginning January 1, 2011. We believe this requirement reflects appropriate, high quality medical care for ESRD patients being dialyzed at home and generally would be consistent with the current standards of medical practice.
In CY 2008, the AMA RUC submitted recommendations for valuing the new CY 2009 CPT codes displayed in Table 32 that replaced the MCP HCPCS G-codes for monthly ESRD-related services. We accepted these codes for use under the PFS.
There are four additional CPT codes for ESRD-related services that are reported on a per-day basis. These daily CPT codes are: 90967 (End-stage renal disease (ESRD) related services for dialysis less than a full month of service, per day; for patients younger than 2 years of age); 90968 (End-stage renal disease (ESRD) related services for dialysis less than a full month of service, per day; for patients 2–11 years of age); 90969 (End-stage renal disease (ESRD) related services for dialysis less than a full month of service, per day; for patients 12–19 years of age); and 90970 (End-stage renal disease (ESRD) related services for dialysis less than a full month of service, per day; for patients 20 years of age and older).
For the MCP codes displayed in Table 32, the AMA RUC initially
In the CY 2009 PFS final rule with comment period (73 FR 69898), we asked the AMA RUC to reconsider their recommended PE inputs in the interest of making certain that they accurately reflected the typical direct PE resources required for these services. In addition, we asked the AMA RUC to review the physician times for CPT codes 90960 and 90961 that are used in the calculation of the PE RVUs. We accepted the work values for the new CPT codes for ESRD-related services that were recommended by the AMA RUC.
Since CY 2009, we have continued to calculate the PE RVUs for the entire series of MCP codes displayed in Table 32 by using the direct PE inputs from the predecessor HCPCS G-codes, except for CPT codes 90952 and 90953 which are contractor-priced. We have also continued to use the physician time associated with the predecessor HCPCS G-codes for CPT codes 90960 and 90961 for purposes of calculating the PE RVUs.
In CY 2009, the AMA RUC submitted new recommendations for CPT codes 90951 and 90954 through 90970. For each of the MCP codes (CPT code 90951 and CPT codes 90954 through 90966), the AMA RUC recommended an increased pre-service clinical staff time of 60 minutes. For each of the daily dialysis service codes (CPT codes 90967 through 90970), the AMA RUC recommended an increased clinical labor time of two minutes, which is the prorated amount of clinical labor included in the monthly codes. The AMA RUC also recommended an additional 38 minutes of physician time for CPT codes 90960 and 90961. This resulted in a total physician time of 128 minutes and 113 minutes, respectively, for these codes. The AMA RUC continued to recommend that CPT codes 90952 and 90953 be contractor-priced.
For CY 2011, we are proposing to accept these AMA RUC recommendations as more accurate reflections of the typical direct PE resources required for these services. Therefore, we are proposing to develop the PE RVUs for CPT code 90951 and CPT codes 90954 through 90970 using the direct PE inputs as recommended by the AMA RUC and reflected in the proposed CY 2011 PE database, which is available on the CMS Web site under the supporting data files for the CY 2011 PFS proposed rule at:
When a portable x-ray is furnished to a single patient, as many as four component HCPCS codes may be billed and paid for the service, including the portable x-ray transportation (HCPCS code R0070 (Transportation of portable x-ray equipment and personnel to home or nursing home, per trip to facility or location, one patient seen)); the portable x-ray set-up (HCPCS code Q0092 (Set-up of portable x-ray equipment)); and the professional and technical components of the x-ray service itself (CPT 70000 series). Currently, the direct PE database contains x-ray equipment in both the radiology codes in the 70000 series of CPT and HCPCS code Q0092, the code for the set-up of a portable x-ray. In the technical component of the x-ray service is the direct PE input of a radiology room which contains x-ray equipment for the various radiology codes in the 70000 series of CPT. In addition, portable x-ray equipment is included as a direct PE input for HCPCS code Q0092. Thus, x-ray equipment currently is recognized within the direct PE values for two of the HCPCS codes that would be reported for the portable x-ray service, resulting in an overvaluation of the comprehensive portable x-ray service.
Therefore, for CY 2011 we are proposing to remove portable x-ray equipment as a direct PE input for HCPCS code Q0092, in order to pay more appropriately for the x-ray equipment used to furnish a portable x-ray service. We believe the resulting payment for the comprehensive portable x-ray service would more appropriately reflect the resources used to furnish portable x-ray services by providing payment for the x-ray equipment solely through payment for the technical component of the x-ray service that is furnished.
In the CY 2010 PFS proposed rule (74 FR 33614), we proposed to create new HCPCS G-code G0424 (Pulmonary rehabilitation, including aerobic exercise (includes monitoring), per session, per day) to describe the services of a pulmonary rehabilitation (PR) program as specified in section 144(a) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). Using CPT code 93797 (Cardiac rehab without telemetry) as a reference code, we proposed to assign 0.18 work RVUs and 0.01 malpractice RVUs to G0424. To establish PE RVUs, we reviewed the PE inputs of similar services, particularly those of the respiratory therapy HCPCS codes G0237 (Therapeutic procedures to increase strength or endurance or respiratory muscles, face to face, one on one, each 15 minutes (includes monitoring)) and G0238 (Therapeutic procedures to improve respiratory function, other than described by G0237, one on one, face to face, per 15 minutes (includes monitoring)), as well as the cardiac rehabilitation codes, CPT codes 93797 and 93798 (Physician services for outpatient cardiac rehabilitation; with continuous ECG monitoring (per session)). In the CY 2010 PFS final rule with comment period (74 FR 61886), we finalized our proposal with modifications to the code descriptor and PE inputs, as recommended by some commenters.
Based on commenters' recommendations from the CY 2010 PFS final rule with comment period and further information furnished by stakeholders, we are proposing to increase the work RVUs for HCPCS code G0424 to 0.28 for CY 2011 to be comparable to the work RVUs for cardiac rehabilitation with monitoring (CPT code 93798) in view of the monitoring required for HCPCS code G0424.
In addition, we are also proposing to increase the clinical labor time for the respiratory therapist from 15 minutes to 30 minutes and to crosswalk the PE equipment inputs for HCPCS code G0424 to those for respiratory treatment services (HCPCS code G0238), which include a 1-channel ECG and a pulse oximeter. We would retain the treadmill currently assigned to HCPCS code G0424 and adjust the equipment time to 45 minutes. While several public commenters recommended this equipment, these commenters also requested a full 60 minutes of respiratory therapist time be included in the PE for HCPCS code G0424, comparable to the 15 minutes of
There are currently two biological products, Apligraf and Dermagraft, which are FDA-approved for the treatment of diabetic foot ulcers. While commonly used by podiatrists for this purpose, these products are also used by other specialists in the treatment of other clinical conditions, such as burns.
Many Medicare contractors have established local coverage determinations specifying the circumstances under which these services are covered. In the case of diabetic foot ulcers, clinical studies of Apligraf weekly application were based on up to 5 treatments over a 12-week period. In contrast, Dermagraft was applied weekly, up to 8 treatments over a 12-week period.
The skin substitute CPT codes were reviewed and new codes were last created by the CPT Editorial Panel for CY 2006. There are currently 2 skin repair CPT codes that describe Apligraf application, one primary code, CPT code 15340 (Tissue cultured allogeneic skin substitute; first 25 sq cm or less) and one add-on code, CPT code 15341 (Tissue cultured allogeneic skin substitute; each additional 25 sq cm, or part thereof (List separately in addition to code for primary procedure)) and 4 codes that describe Dermagraft application, two initial codes based on body area, CPT codes 15360 (Tissue cultured allogeneic dermal substitute, trunk, arms, legs; first 100 sq cm or less, or 1 percent of body area of infants and children) and 15365 (Tissue cultured allogeneic dermal substitute, face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits; first 100 sq cm or less, or 1 percent of body area of infants and children) and two add-on codes, CPT codes 15361 (Tissue cultured allogeneic dermal substitute, trunk, arms, legs; each additional 100 sq cm, or each additional 1 percent of body area of infants and children, or part thereof (List separately in addition to code for primary procedure)) and 15366 (Tissue cultured allogeneic dermal substitute, face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits; each additional 100 sq cm, or each additional 1 percent of body area of infants and children, or part thereof (List separately in addition to code for primary procedure)).
Several stakeholders have expressed concern about the appropriateness and equity of the coding and payment for these services, given their similar uses and the office resources required when the products are applied repeatedly over a number of weeks for treatment of lower extremity ulcers. They are concerned that current coding, with the associated payment policies and relative values, does not provide for appropriate payment for the services based on how they are furnished. In addition, some stakeholders believe that the current coding and payment provides a financial incentive for the selection of one tissue-cultured product over another, rather than facilitating clinical decisionmaking based solely on the most clinically appropriate product for the patient's case. For example, the Dermagraft and Apligraf application codes have 90-day and 10-day global periods, respectively, and their current values include several follow-up office visits. When patients are treated periodically with repeated applications of the products over several weeks, the patients may be seen in follow-up by the physician. However, those encounters would not be evaluation and management visits but, instead, would be procedural encounters that would typically be valued differently under the PFS than the follow-up office visits currently included in the values for the Dermagraft and Apligraf application codes. Furthermore, while different stakeholders have indicated that debridement and site preparation are variably performed when these products are applied, the CPT codes for Dermagraft application allow separate reporting of these preparation services when they are performed, while the Apligraf application codes bundle these services. Since CY 2006, the PFS has accepted the RUC work and PE recommendations for the Dermagraft and Apligraf application codes and has paid accordingly.
With respect to Medicare payment policy, some Medicare contractors allow the use of modifier -58 (Staged or related procedure or service by the same physician during the postoperative period) to be reported with the skin substitute application codes and provide full payment for the service each time it is performed, even if the subsequent application(s) is within the global period of the service. Other contractors do not allow the use of modifier -58, and therefore, provide a single payment for a series of applications over 90 days or 10 days, as applicable to the particular code reported for the product's initial application.
Because of the current inconsistencies in valuing similar skin substitute application services and the common clinical scenarios for their use for Medicare beneficiaries, we believe that it would be appropriate to temporarily create Level II HCPCS G-codes to report application of tissue-cultured skin substitutes applied to the lower extremities in order to provide appropriate and consistent payment for the services as they are commonly furnished. Therefore, we are proposing to create two new HCPCS G-codes for CY 2011, GXXX1 (Application of tissue cultured allogeneic skin substitute or dermal substitute; for use on lower limb, includes the site preparation and debridement if performed; first 25 sq cm or less) and GXXX2 (Application of tissue cultured allogeneic skin or dermal substitute; for use on lower limb, includes the site preparation and debridement if performed; each additional 25 sq cm), that would be recognized for payment under the PFS for the application of Apligraf or Dermagraft to the lower limb. These codes would not allow separate reporting of CPT codes for site preparation or debridement. We emphasize that we would expect that the use of these HCPCS G-codes for payment under Medicare would be temporary, while stakeholders work through the usual channels to establish appropriate coding for these services that reflects the current common clinical scenarios in which the skin substitutes are applied. Furthermore, we would expect to receive recommendations from the AMA RUC for appropriate work values and direct practice expense inputs for the applicable codes, according to the usual process for new or revised codes.
Under the PFS, as a temporary measure, the HCPCS G-codes would be assigned a 0-day global period so payment would be made each a time a covered service was furnished. We are proposing to base payment on the physician work relative values and the direct PE inputs for the existing CPT codes for Apligraf application, with adjustments for the global period differences because the HCPCS G-codes and the Apligraf application CPT codes. These CPT codes resemble the new HCPCS G-codes in terms of wound size description and the inclusion of site preparation and debridement in their current values so we believe they
Our crosswalks and adjustments result in proposed CY 2011 work RVUs of 2.22 for HPCPCS code GXXX1 and 0.50 for HCPCPS GXXX2. The proposed direct PE inputs for HCPCS codes GXXX1 and GXXX2 are included in the direct PE database for the CY 2011 proposed rule that is posted on the CMS Web site at
We note that many Medicare contractors currently have local coverage policies that specify the circumstances under which Medicare covers the application of skin substitutes. The local coverage policies may include diagnostic or prior treatment requirements, as well as frequency limitations on the number and periodicity of treatments. We expect that these policies would be updated in the context of the temporary new HCPCS G-codes that we are proposing for use in CY 2011 to report the application of tissue cultured allogeneic skin or dermal substitutes. We are proposing to establish the HCPCS G-codes for temporary use in CY 2011 in order to improve the consistency and resource-based nature of PFS payments for skin substitute application services that require similar resources. However, we note our continued interest in ensuring that skin substitutes are properly utilized for Medicare beneficiaries who will benefit from that treatment. We will continue to monitor the utilization of these services and plan to identify any concerning trends in utilization that contractors may want to examine further through medical review or other approaches.
For CY 2009, CPT created a new code for canalith repositioning, specifically CPT code 95992 (Canalith repositioning procedure(s) (
Based on further information from stakeholders regarding the distinct and separate nature of this procedure from an E/M service and their request that we recognize this CPT code for payment, similar to our separate payment for most other procedures commonly furnished in association with an E/M service, we are proposing to recognize CPT code 95992 for payment under the CY 2011 PFS, consistent with our typical treatment of most other codes for minor procedures. In doing so, we are proposing to change the code's status to “A” and utilize the CY 2009 RUC recommendations for work RVUs (0.75) and PE inputs for establishing its payment in CY 2011. (That is, status “A” means Active code. These codes are separately payable under the PFS if covered.) Because canalith repositioning (CPT code 95992) can be furnished by physicians or therapists as therapy services under a therapy plan of care or by physicians as physicians' services outside of a therapy plan of care, we would add CPT code 95992 to the “sometimes therapy” list on the therapy code abstract file.
To ensure that the PE RVUs are consistent between the intranasal/oral and injectable immunization administration CPT codes that describe services that utilize similar PE resources, we are proposing to crosswalk the PE values for CPT code 90471 (Immunization administration (includes percutaneous, intradermal, subcutaneous, or intramuscular injections); one vaccine (single or combination vaccine/toxoid)) to CPT codes 90467 (Immunization administration younger than age 8 years (includes intranasal or oral routes of administration) when the physician counsels the patient/family; first administration (single or combination vaccine/toxoid), per day) and 90473 (Immunization administration by intranasal or oral route; one vaccine (single or combination vaccine/toxoid)).
Similarly, we are also proposing to crosswalk the PE values for CPT code 90472 (Immunization administration (includes percutaneous, intradermal, subcutaneous, or intramuscular injections); each additional vaccine (single or combination vaccine/toxoid) (List separately in addition to code for primary procedure)) to CPT codes 90468 (Immunization administration younger than age 8 years (includes intranasal or oral routes of administration) when the physician counsels the patient/family; each additional administration (single or combination vaccine/toxoid), per day (List separately in addition to code for primary procedure)) and 90474 (Immunization administration by intranasal or oral route; each additional vaccine (single or combination vaccine/toxoid) (List separately in addition to code for primary procedure)).
As discussed in the November 25, 1992 PFS final rule (57 FR 55938), we adopted a refinement panel process to assist us in reviewing the public comments on interim physician work RVUs for CPT codes with that status in each year and developing final work values for the subsequent year. Our decision to convene multispecialty panels of physicians was based on our need to balance the interests of those who commented on the work RVUs against the budgetary and redistributive effects that could occur if we accepted extensive increases in work RVUs across a broad range of services. The refinement panel reviews and discusses the work involved in each procedure and then each member individually rates the work of the procedure. Since 1992, the refinement panels' recommendation to change a work value or to retain the interim value has hinged solely on the outcome of a statistical test on the ratings (an F-test).
Depending on the number and range of codes that public commenters, typically specialty societies, request be subject to refinement, we establish refinement panels with representatives from 4 groups of physicians: Clinicians representing the specialty most identified with the procedures in question; physicians with practices in related specialties; primary care physicians; and contractor medical directors (CMDs). Typically the refinement panels meet in the summer prior to the promulgation of the final rule finalizing the RVUs for the codes.
Most recently, section 1848(c)(2)(K) of the Act (as added by section 3134 of the ACA) authorizes the Secretary to review potentially misvalued codes and make appropriate adjustments to the relative values. In addition, MedPAC has encouraged CMS to critically review the values assigned to the services under the PFS. MedPAC has stated its belief that CMS has historically relied too heavily on specialty societies to identify services that are misvalued by accepting so many recommendations of the RUC.
We believe the refinement panel process continues to provide stakeholders with a meaningful opportunity for review and discussion of the interim work RVUs with a clinically diverse group of experts that then provides informed recommendations to CMS. Therefore, we would like to continue the refinement process, including the established composition that includes representatives from the 4 groups of physicians, but with administrative modification and clarification. Specifically, for refinement panels beginning in CY 2011 (that is, for those codes with CY 2011 interim values that would be subject to refinement during CY 2011), we are proposing to eliminate the use of the F-test and instead base revised RVUs on the median work value of the panel members' ratings. We believe this approach will simplify the refinement process administratively, while resulting in a final panel recommendation that reflects the summary opinion of the panel members based on a commonly used measure of central tendency that is not significantly affected by outlier values. In addition, we are clarifying that we have the final authority to set the RVUs, and therefore, may make adjustments to the work RVUs resulting from refinement if policy concerns warrant their modification.
In the CY 2010 PFS final rule with comment period (74 FR 61755), we indicated that we continued to have concerns about the issue of developing PE RVUs for services that are utilized 24 hours a day, 7 days a week (24/7), such as those that require certain monitoring system equipment. The PE equipment methodology was developed for equipment that is in use during standard physician's office business hours and not this type of 24/7 equipment. We stated that we would conduct further analysis of this issue. Services that were contractor-priced in CY 2009 remained contractor-priced in CY 2010. We also indicated that any proposed changes will be communicated through future rulemaking.
Since publication of the CY 2010 PFS final rule with comment period, we have focused our additional analysis on four of the CPT codes that commenters have brought to our attention because they involve concurrent, remote, 24/7 attended monitoring of multiple patients from a central location: CPT code 93012 (Telephonic transmission of post-symptom electrocardiogram rhythm strip(s); 24-hour attended monitoring, per 30 day period of time; tracing only); CPT code 93229 (Wearable mobile cardiovascular telemetry with electrocardiographic recording, concurrent computerized real time data analysis and greater than 24 hours of accessible ECG data storage (retrievable with query) with ECG triggered and patient selected events transmitted to a remote attended surveillance center for up to 30 days; technical support for connection and patient instructions for use, attended surveillance, analysis and physician prescribed transmission of daily and emergent data reports); CPT code 93268 (Wearable patient activated electrocardiographic rhythm derived event recording with presymptom memory loop, 24-hour attended monitoring, per 30 day period of time; includes transmission, physician review and interpretation); and CPT 93271 code (Wearable patient activated electrocardiographic rhythm derived event recording with presymptom memory loop, 24-hour attended monitoring, per 30 day period of time; monitoring, receipt of transmissions, and analysis).
Of these four codes, CPT code 93229 is currently contractor-priced in CY 2010, meaning that the local Medicare contractors determine payment rates for the service within the PFS geographic areas in their jurisdiction. The three services that are currently nationally-priced on the PFS are in the first year of a 4-year transition to lower payment rates based on the use of the PPIS data adopted in the CY 2010 PFS final rule with comment period. We refer readers to section II.A.2. of this proposed rule for a description of the general PFS PE methodology that is the basis for the following discussion of approaches to establishing PE RVUs for these four CPT codes.
We examined several alternative methods for developing PE RVUS upon which PFS payment rates for these four CPT codes could be based. Each of these services involves transmission of information from multiple patients who wear individual monitoring devices that transmit patient-specific information to centralized equipment that is simultaneously in use for multiple patients. We believe it would be most consistent with the principles underlying the PFS PE methodology to classify the centralized monitoring equipment as an indirect cost since it is servicing multiple patients at the same time. After classifying this equipment as an indirect cost, we used our standard methodology to calculate an indirect practice cost index value for each code based on the PE/HR survey data of the historical mix of specialties providing these services. Establishing payment rates for these codes based on this approach would result in decreases in the payment rates for these services, including the typical contractor's price for CPT code 93229. For the three services that are nationally priced, these decreases would be relative to the lower payment rates based on the use of the PPIS data after the 4-year transition.
We also received PE/HR data from the Remote Cardiac Services Provider Group (RCSPG), a group of IDTF suppliers of these types of services. For sensitivity analysis purposes, we substituted these data for the PE/HR data of the specialties performing these services, while continuing to treat the centralized monitoring equipment as an indirect cost. We found that establishing payment rates for these codes based on the approach of using the submitted RCSPG PE/HR data would again result in decreases in the payment rates for these services, including the typical contractor's price for CPT code 93229. As in the prior alternative, the decreases for the nationally priced codes would be relative to the payment rates reflecting the 4-year transition to the PPIS data.
Although we believe that it would be most consistent with the principles underlying the PE methodology to classify the centralized monitoring equipment as an indirect cost, we also performed a sensitivity analysis of the payment rates if the centralized monitoring equipment were classified as a direct cost. In this simulation, we
Finally, we considered proposing contractor-pricing for all four of these services for CY 2011. However, we are cognizant of past public comments on this issue that have requested that all of these services be priced nationally on the PFS, including the one service (CPT code 93229) that is currently contractor-priced.
We also considered that the services currently priced nationally on the PFS are scheduled to receive lower payment rates under the 4-year transition to the PPIS data and that the contractor's price for CPT 93229 was recently reduced in the area where the majority of the billings for this service currently occur.
After taking all these factors into consideration, we are not proposing CY 2011 methodological or direct cost input changes for CPT codes 93012, 93268, or 93271—the services that are currently nationally priced under the PFS. We are also proposing to continue contractor-pricing for CPT 93229 for CY 2011. We continue to be interested in public comments on this issue, including responses to our analysis of alternative approaches to establishing PE RVUs for 24/7 services, and further discussion of the issues we have identified in our alternative pricing methodologies. In addition, while we have focused the 24/7 services analysis to date on developing the PE RVUs for remote cardiac monitoring services, there may be 24/7 services in other areas of medicine, either currently paid under the PFS or in development for the future. Therefore, we are also interested in public comments on these current or emerging 24/7 services, including descriptions of the similarities or differences between these other services and remote cardiac monitoring services, particularly with respect to the issues we have identified in our analysis of alternative approaches to establishing PE RVUs for remote cardiac monitoring services under the PFS.
Prior to January 1, 1999, Medicare coverage for services delivered via a telecommunications system was limited to services that did not require a face-to-face encounter under the traditional model of medical care. Examples of these services included interpretation of an x-ray or electrocardiogram or electroencephalogram tracing, and cardiac pacemaker analysis.
Section 4206 of the BBA provided for coverage of, and payment for, consultation services delivered via a telecommunications system to Medicare beneficiaries residing in rural health professional shortage areas (HPSAs) as defined by the Public Health Service Act. Additionally, the BBA required that a Medicare practitioner (telepresenter) be with the patient at the time of a teleconsultation. Further, the BBA specified that payment for a teleconsultation had to be shared between the consulting practitioner and the referring practitioner and could not exceed the fee schedule payment which would have been made to the consultant for the service provided. The BBA prohibited payment for any telephone line charges or facility fees associated with the teleconsultation. We implemented this provision in the CY 1999 PFS final rule with comment period (63 FR 58814).
Effective October 1, 2001, section 223 of the Medicare, Medicaid and SCHIP Benefits Improvement Protection Act of 2000 (Pub. L. 106–554) (BIPA) added a new section 1834(m) to the Act which significantly expanded Medicare telehealth services. Section 1834(m)(4)(F)(i) of the Act defines Medicare telehealth services to include consultations, office visits, office psychiatry services, and any additional service specified by the Secretary, when delivered via a telecommunications system. We first implemented this provision in the CY 2002 PFS final rule with comment period (66 FR 55246). Section 1834(m)(4)(F)(ii) required the Secretary to establish a process that provides for annual updates to the list of Medicare telehealth services. We established this process in the CY 2003 PFS final rule with comment period (67 FR 79988).
As specified in regulations at § 410.78(b), we generally require that a telehealth service be furnished via an interactive telecommunications system. Under § 410.78(a)(3), an interactive telecommunications system is defined as multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real-time interactive communication between the patient and the practitioner at the distant site. Telephones, facsimile machines, and electronic mail systems do not meet the definition of an interactive telecommunications system. An interactive telecommunications system is generally required as a condition of payment; however, section 1834(m)(1) of the statute does allow the use of asynchronous “store-and-forward” technology in delivering these services when the originating site is a Federal telemedicine demonstration program in Alaska or Hawaii. As specified in regulations at § 410.78(a)(1), store and forward means the asynchronous transmission of medical information from an originating site to be reviewed at a later time by the practitioner at the distant site.
Medicare telehealth services may be provided to an eligible telehealth individual notwithstanding the fact that the individual practitioner providing the telehealth service is not at the same location as the beneficiary. An eligible telehealth individual means an individual enrolled under Part B who receives a telehealth service furnished at an originating site. As specified in BIPA, originating sites are limited under section 1834(m)(3)(C) of the statute to specified medical facilities located in specific geographic areas. The initial list of telehealth originating sites included the office of a practitioner, a critical access hospital (CAH), a rural health clinic (RHC), a federally qualified health center (FQHC) and a hospital. More recently, section 149 of the Medicare Improvements for Patients and Providers Act of 2008 (Pub. L. 110–275) (MIPPA) expanded the list of telehealth originating sites to include hospital-based renal dialysis centers, skilled nursing facilities (SNFs), and community mental health centers (CMHCs). In order to serve as a telehealth originating site, these sites must be located in an area designated as a rural health professional shortage area (HPSA), in a county that is not in a metropolitan statistical area (MSA), or must be an entity that participates in a Federal telemedicine demonstration project that has been approved by (or receives funding from) the Secretary of Health and Human Services as of December 31, 2000. Finally, section 1834(m) of the statute does not require the eligible telehealth individual to be
As noted above, Medicare telehealth services can only be furnished to an eligible telehealth beneficiary in an originating site. An originating site is defined as one of the specified sites where an eligible telehealth individual is located at the time the service is being furnished via a telecommunications system. In general, originating sites must be located in a rural HPSA or in a county outside of an MSA. The originating sites authorized by the statute are as follows:
Currently approved Medicare telehealth services include the following:
In general, the practitioner at the distant site may be any of the following, provided that the practitioner is licensed under State law to furnish the service being furnished via a telecommunications system:
Practitioners furnishing Medicare telehealth services are located at a distant site, and they submit claims for telehealth services to the Medicare contractors that process claims for the service area where their distant site is located. Section 1834(m)(2)(A) of the Act requires that a practitioner who furnishes a telehealth service to an eligible telehealth individual be paid an amount equal to the amount that the practitioner would have been paid if the service had been furnished without the use of a telecommunications system. Distant site practitioners must submit the appropriate HCPCS procedure code for a covered professional telehealth service, appended with the –GT (Via interactive audio and video telecommunications system) or –GQ (Via asynchronous telecommunications system) modifier. By reporting the –GT or –GQ modifier with a covered telehealth procedure code, the distant site practitioner certifies that the beneficiary was present at a telehealth originating site when the telehealth service was furnished. The usual Medicare deductible and coinsurance policies apply to the telehealth services reported by distant site practitioners.
Section 1834(m)(2)(B) of the Act provides for payment of a facility fee to the originating site. To be paid the originating site facility fee, the provider or supplier where the eligible telehealth individual is located must submit a claim with HCPCS code Q3014 (Telehealth originating site facility fee), and the provider or supplier is paid according to the applicable payment methodology for that facility or location. The usual Medicare deductible and coinsurance policies apply to HCPCS code Q3014. By submitting HCPCS code Q3014, the originating site authenticates that it is located in either a rural HPSA or non-MSA county or is an entity that participates in a Federal telemedicine demonstration project that has been approved by (or receives funding from) the Secretary of Health and Human Services as of December 31, 2000 as specified in section 1834(m)(4)(C)(i)(III) of the Act.
As described above, certain professional services that are commonly furnished remotely using telecommunications technology, but that do not require the patient to be present in-person with the practitioner when they are furnished, are covered and paid in the same way as services delivered without the use of telecommunications technology when the practitioner is in-person at the medical facility furnishing care to the patient. Such services typically involve circumstances where a practitioner is able to visualize some aspect of the patient's condition without the patient being present and without the interposition of a third person's judgment. Visualization by the practitioner can be possible by means of x-rays, electrocardiogram or electroencephalogram tracings, tissue samples,
As noted above, in the December 31, 2002
• Category 1: Services that are similar to professional consultations, office visits, and office psychiatry services. In reviewing these requests, we look for similarities between the requested and existing telehealth services for the roles of, and interactions among, the beneficiary, the physician (or other practitioner) at the distant site and, if necessary, the telepresenter. We also look for similarities in the telecommunications system used to deliver the proposed service, for example, the use of interactive audio and video equipment.
• Category 2: Services that are not similar to the current list of telehealth services. Our review of these requests includes an assessment of whether the use of a telecommunications system to deliver the service produces similar diagnostic findings or therapeutic interventions as compared with the in-person delivery of the same service. Requestors should submit evidence showing that the use of a telecommunications system does not affect the diagnosis or treatment plan as compared to in-person delivery of the requested service.
Since establishing the process to add or remove services from the list of approved telehealth services, we have added the following to the list of Medicare telehealth services: Individual HBAI services; psychiatric diagnostic interview examination; ESRD services with 2 to 3 visits per month and 4 or more visits per month (although we require at least 1 visit a month to be furnished in-person by a physician, CNS, NP, or PA in order to examine the vascular access site); individual MNT; neurobehavioral status exam; and initial and follow-up inpatient telehealth consultations for beneficiaries in hospitals and skilled nursing facilities (SNFs).
Requests to add services to the list of Medicare telehealth services must be submitted and received no later than December 31 of each calendar year to be considered for the next rulemaking cycle. For example, requests submitted before the end of CY 2010 are considered for the CY 2012 proposed rule. Each request for adding a service to the list of Medicare telehealth services must include any supporting documentation the requester wishes us to consider as we review the request. Because we use the annual PFS rulemaking process as a vehicle for making changes to the list of Medicare telehealth services, requestors should be advised that any information submitted is subject to public disclosure for this purpose. For more information on submitting a request for an addition to the list of Medicare telehealth services, including where to mail these requests, we refer readers to the CMS Web site at
We received requests in CY 2009 to add the following services as Medicare telehealth services effective for CY 2011: (1) Individual kidney disease education (KDE) services; (2) individual diabetes self-management training (DSMT) services; (3) group KDE, DSMT, MNT, and HBAI services; (4) initial, subsequent, and discharge day management hospital care services; (5) initial, subsequent, discharge day management, and other nursing facility care services; (6) neuropsychological testing services; (7) speech-language pathology services; and (8) home wound care services. The following presents a discussion of these requests, including our proposals for additions to the CY 2011 telehealth list.
The American Society of Nephrology, Dialysis Patient Citizens, AMGEN, and Kidney Care Partners submitted requests to add individual KDE services, reported by HCPCS code G0420 (Face-to-face educational services related to the care of chronic kidney disease; individual, per session, per one hour), to the list of approved telehealth services for CY 2011 on a category 1 basis.
Individual KDE services, covered under the new Medicare KDE benefit effective for services furnished beginning in CY 2010, are defined as face-to-face educational services provided to a patient with stage IV chronic kidney disease (CKD). We believe the interaction between a practitioner and a beneficiary receiving individual KDE services is similar to the education, assessment, and counseling elements of individual MNT services, reported by HCPCS code G0270 (Medical nutrition therapy; reassessment and subsequent intervention(s) following second referral in same year for change in diagnosis, medical condition or treatment regimen (including additional hours needed for renal disease), individual, face to face with the patient, each 15 minutes); CPT code 97802 (Medical nutrition therapy; initial assessment and intervention, individual, face-to-face with the patient, each 15 minutes); and CPT code 97803 (Medical nutrition therapy; re-assessment and intervention, individual, face-to-face with the patient, each 15 minutes), all services that are currently on the telehealth list.
Therefore, we are proposing to add HCPCS code G0420 to the list of telehealth services for CY 2011 on a category 1 basis. Consistent with this proposal, we are also proposing to revise our regulations at § 410.78(b) and § 414.65(a)(1) to include individual KDE as a Medicare telehealth service.
The Tahoe Forest Health System and the Marshfield Clinic submitted requests to add individual DSMT services, reported by HCPCS code G0108 (Diabetes outpatient self-management training services, individual, per 30 minutes), to the list of telehealth services for CY 2011 on a category 1 basis. In the CY 2009 PFS final rule with comment period (73 FR 69743), we stated that we believe individual DSMT services are not analogous to individual MNT services because of the element of skill-based training that is encompassed within individual DSMT services that is not an aspect of individual MNT services (or any other services currently approved for telehealth). Due to the statutory requirement that DSMT services include teaching beneficiaries the skills necessary for the self-administration of injectable drugs, we have stated our belief that DSMT, whether provided to an individual or a group, must be evaluated as a category 2 service as specified in the CY 2009 PFS proposed rule (73 FR 38516). We have considered several previous requests to add DSMT to the list of Medicare telehealth services. We have not added individual DSMT to the list of telehealth services because we believe that skill-based training, such as teaching patients how to inject insulin, would be difficult to accomplish effectively without the physical presence of the teaching practitioner (70 FR 45787 and 70157, and 73 FR 38516 and 69743).
In considering the new request to add individual DSMT services to the list of telehealth services in CY 2011, we have taken into account requestors' argument that individual DSMT services are highly similar to individual MNT services and that injection training constitutes just a small proportion of DSMT services. Except for the component of individual DSMT services that involves instruction in self-administration of injectable drugs for eligible beneficiaries, we agree with the requestors that individual DSMT services are similar to individual MNT services, which are currently on the list of Medicare telehealth services. We note that Medicare coverage of DSMT services was initially authorized in the Balanced Budget Act of 1997. After more than a decade of Medicare coverage, the most recent information shows that DSMT continues to be significantly underutilized in the context of the eligible population of Medicare beneficiaries. While we are uncertain to what extent geographic barriers to care contribute to this underutilization, given the morbidity associated with poorly managed diabetes and the growing evidence-base regarding effective DSMT services, we believe it is very important to facilitate Medicare beneficiary access to these underutilized services. While we have previously been concerned about treating the components of DSMT services differently in the context of considering DSMT services for the telehealth list, we believe that our concern regarding the skill-based injection training component of DSMT services can be addressed by imposing a requirement that a minimum portion of the training be furnished in-person.
Therefore, we are proposing to add HCPCS code G0108 to the list of telehealth services beginning in CY 2011. We are also proposing that, as a condition of payment for individual DSMT services furnished as telehealth services to an eligible telehealth individual, a minimum of 1 hour of in-person instruction in the self-administration of injectable drugs must be furnished to the individual during the year following the initial DSMT service. The injection training may be furnished through either individual or group DSMT services. By reporting the –GT or –GQ modifier with HCPCS code G0108 as a telehealth service, the distant site practitioner would certify that the beneficiary has received or will receive 1 hour of in-person DSMT services for purposes of injection training during the year following the initial DSMT service. Consistent with this proposal, we are proposing to revise our regulations at § 410.78(b) and § 414.65(a)(1) to include individual DSMT services as a Medicare telehealth service, with the exception of 1 hour of in-person instruction in self-administration of injectable drugs which must be furnished to the eligible telehealth individual as individual or group DSMT services during the year following the initial DSMT service.
We note that, as specified in § 410.141(e), individual DSMT services may be furnished by a physician, individual, or entity that furnishes other services for which direct Medicare payment may be made and that submits necessary documentation to, and is accredited by, an accreditation organization approved by CMS. However, consistent with the statutory requirements of section 1834(m)(1) of the Act and as provided in § 410.78(b)(1) and (b)(2) of our regulations, Medicare telehealth services, including individual DSMT furnished as a telehealth service, could only be furnished by a licensed PA, NP, CNS, certified nurse-midwife, clinical psychologist, clinical social worker, or registered dietitian or nutrition professional.
The American Society of Nephrology, Dialysis Patient Citizens, AMGEN, Tahoe Forest Health Systems, Kidney Care Partners, the American Telemedicine Association, and the Marshfield Clinic submitted requests to add one or more of the following group services to the telehealth list for CY 2011:
• Group KDE services, reported by HCPCS code G0421 (Face-to-face educational services related to the care of chronic kidney disease; group, per session, per one hour);
• Group MNT services, reported by CPT code 97804 (Medical nutrition therapy; group (2 or more individual(s)), each 30 minutes);
• Group DSMT services, reported by HCPCS code G0109 (Diabetes outpatient self-management training services, group session (2 or more), per 30 minutes); and/or
• Group HBAI services, reported by CPT code 96153 (Health and behavior intervention, each 15 minutes, face-to-face; group (2 or more patients)) and 96154 (Health and behavior intervention, each 15 minutes, face-to-face; family (with the patient present)).
When furnished as individual services, HBAI and MNT services are currently on the list of Medicare telehealth services. Furthermore, we are proposing to add individual KDE and DSMT services to the list of Medicare telehealth services beginning in CY 2011 as described above.
In the CY 2007 and CY 2010 PFS rulemaking cycles (70 FR 45787 and 70157, and 74 FR 33543 and 61764), we stated that we did not believe that group services could be appropriately delivered through telehealth. We have observed that currently there are no group services approved as Medicare telehealth services and that there is a different interactive dynamic between the practitioner and his or her patients in group services as compared to individual services. We previously have considered requests to add various group services to the list of Medicare telehealth services on a category 2 basis because we have believed that, especially given the interactive dynamic between practitioners and their patients, group services are not similar to other services on the list of Medicare telehealth services. Therefore, we have maintained that it is necessary to evaluate the addition of group services by comparing diagnostic findings or therapeutic interventions when services are furnished via telehealth versus when services are furnished in-person.
We continue to believe that the group dynamic may be a critical and defining element for certain services, and that this characteristic precludes many group services from being considered on a category 1 basis for addition to the list of Medicare telehealth services. For example, we believe that due to the therapeutic nature of the group dynamic that is integral to group psychotherapy, group psychotherapy is fundamentally different from other Medicare telehealth services and, therefore, could not be considered on a category 1 basis for addition to the telehealth services list. For the same reason, in the absence of evidence to the contrary, we do not believe group psychotherapy services could be appropriately delivered through telehealth.
However, upon further consideration, with regard to the particular group education and training services for which we received requests for addition to the Medicare telehealth services list, we believe the group dynamic is not central to the core education and training components of these particular services, specifically DSMT, MNT, KDE, and HBAI services. We believe that these group services are sufficiently similar to the individual, related services that are already on the telehealth services list or are proposed for addition beginning in CY 2011. Specifically, we believe that for these group services, which consist principally of an information exchange for the purpose of education and training, the roles of, and interactions between, the patients and the practitioner are sufficiently similar to the related individual education and training services that the services can be furnished appropriately as a telehealth service.
Therefore, we are proposing to add HCPCS code G0421 for group KDE services, CPT code 97804 for group MNT services, HCPCS code G0109 for group DSMT services, and CPT codes 96153 and 96154 for group HBAI services to the Medicare telehealth services list on a category 1 basis. Furthermore, because the concerns we raised above regarding adequate injection training with the addition of individual DSMT are also present for group DSMT, we are proposing to require the same minimum of 1 hour of in-person instruction for injection training within the year following the initial DSMT service for any beneficiary that receives DSMT services via
As described above for individual DSMT services, we note that group DSMT services may be furnished by a physician, individual, or entity that furnishes other services for which direct Medicare payment may be made and that submits necessary documentation to, and is accredited by, an accreditation organization approved by CMS, as specified in § 410.141(e) for DSMT services. However, consistent with the statutory requirements of section 1834(m)(1) of the Act and as provided in § 410.78(b)(1) and (b)(2) of our regulations, Medicare telehealth services, including group DSMT furnished as a telehealth service, could only be furnished by a licensed PA, NP, CNS, certified nurse-midwife, clinical psychologist, clinical social worker, or registered dietitian or nutrition professional.
The University of Louisville School of Medicine, the American Telemedicine Association, and Mille Lacs Health System submitted various requests to add initial hospital care services (reported by CPT codes 99221 (Level 1 initial hospital care), 99222 (Level 2 initial hospital care), and 99223 (Level 3 initial hospital care)); subsequent hospital care services (reported by CPT codes 99231 (Level 1 subsequent hospital care), 99232 (Level 2 subsequent hospital care), and 99233 (Level 3 subsequent hospital care)); and/or hospital discharge day management services (reported by CPT codes 99238 (Hospital discharge day management; 30 minutes or less) and 99239 (Hospital discharge day management; more than 30 minutes) to the Medicare telehealth services list beginning in CY 2011, generally on a category 1 basis. Some of the requestors also recommended that we limit the delivery of these services through telehealth to the provision of services to patients with a psychiatric diagnosis or to those treated in a psychiatric hospital or licensed psychiatric bed.
We appreciate the recommendations of the requestors to substantially expand the list of Medicare telehealth services. The requestors submitted a number of studies regarding the outcomes of telehealth services in caring for patients with psychiatric diagnoses. However, we note that the CPT codes for hospital care services are used to report care for hospitalized patients with a variety of diagnoses, including psychiatric diagnoses. We do not believe it would be appropriate to add services to the telehealth list only for certain diagnoses because the service described by a HCPCS code is essentially the same service, regardless of the patient's diagnosis. When evaluating the addition of services for telehealth on a category 1 basis, our focus is on the roles of, and interactions among, the beneficiary, the physician or practitioner, and the telepresenter (if applicable), which generally are similar across diagnoses for services that may be reported with the same HCPCS codes. Even in the unique case of certain ESRD services, we limited additions to the list of Medicare telehealth services based on the appropriateness of certain specific codes, taking into consideration the full service descriptions (69 FR 47511). Therefore, we continue to believe that it is most appropriate to consider additions to the list of telehealth services based on the overall suitability of the services described by the relevant HCPCS codes to delivery through telehealth.
In the CY 2005, CY 2008, and CY 2009 PFS rulemakings (69 FR 47510 and 66276, 72 FR 38144 and 66250, and 73 FR 38517 and 69745, respectively), we did not add initial, subsequent, or discharge day management hospital care services to the list of approved telehealth services because of our concern regarding the use of telehealth for the ongoing evaluation and management (E/M) for the generally high acuity of hospital inpatients. While we continue to have some concern in this area, we also share the requestors' interest in improving access for hospitalized patients to care furnished by treating practitioners. Therefore, we have reevaluated these services in the context of the CY 2011 requests, including considering the possibility that these services could be added on a category 1 basis based on their resemblance to services currently on the telehealth list, such as initial and follow-up inpatient telehealth consultations. The following presents a discussion of our review of the subcategories of hospital care services included in these requests.
Currently, one of the three codes for an initial hospital care service (specifically CPT codes 99221, 99222, or 99223) is reported for the first hospital inpatient E/M visit to the patient by the admitting or a consulting practitioner when that visit is furnished in-person. In addition, we note that currently there are several HCPCS G-codes on the Medicare telehealth services list that may be reported for initial and follow-up inpatient consultations through telehealth, specifically HCPCS codes G0406 (Follow-up inpatient telehealth consultation, limited, physicians typically spend 15 minutes communicating with the patient via telehealth); G0407 (Follow-up inpatient telehealth consultation, intermediate, physicians typically spend 25 minutes communicating with the patient via telehealth); G0408 (Follow-up inpatient telehealth consultation, complex, physicians typically spend 35 minutes or more communicating with the patient via telehealth); G0425 (Initial inpatient telehealth consultation, typically 30 minutes communicating with the patient via telehealth); G0426 (Initial inpatient telehealth consultation, typically 50 minutes communicating with the patient via telehealth); and G0427 (Initial inpatient telehealth consultation, typically 70 minutes or more communicating with the patient via telehealth).
While initial inpatient consultation services are currently on the list of approved telehealth services, there are no services on the current list of telehealth services that resemble initial hospital care for an acutely ill patient by the admitting practitioner who has ongoing responsibility for the patient's treatment during the hospital course. Therefore, we are unable to consider initial hospital care services on a category 1 basis for the telehealth list.
We have reviewed the documentation submitted in support of adding the initial hospital care codes to the Medicare telehealth services list as category 2 requests. Most of the studies provided by the requestors were specific to the treatment of patients with particular diagnoses. Additionally, the studies were not specific to initial hospital care visits by admitting practitioners. Finally, most of the studies concluded that more research was required in order to establish medical equivalence between telehealth and in-person services. Therefore, we received no information that provides robust support for the addition of initial hospital care services to the approved telehealth list on a category 2 basis. The
We have again considered adding subsequent hospital care services reported by CPT codes 99231 through 99233 to the telehealth list for CY 2011 on a category 1 basis. In the CY 2005 and CY 2008 PFS proposed rules (69 FR 47511 and 72 FR 38155), we stated that the potential acuity of patients in the hospital setting precludes consideration of subsequent hospital visits as similar to existing telehealth services. However, as stated earlier, we also note that HCPCS codes for initial and follow-up inpatient consultation services are on the list of telehealth services. These E/M services are furnished to high acuity hospitalized patients, although not by the admitting practitioner himself or herself. However, in light of the increasingly prevalent care model that entails multidisciplinary team care for patients with complex medical illnesses that involve multiple body systems, consulting practitioners may often play a key, intensive, and ongoing role in caring for hospitalized patients. Therefore, we believe that subsequent hospital care visits by a patient's admitting practitioner may sufficiently resemble follow-up inpatient consultation services to consider these subsequent hospital care services on a category 1 basis for the telehealth list. While we still believe the potential acuity of hospital inpatients is greater than those patients likely to receive currently approved Medicare telehealth services, we also believe that it would be appropriate to permit some subsequent hospital care services to be furnished through telehealth in order to ensure that hospitalized patients have frequent encounters with their admitting practitioner. However, we also continue to believe that the majority of these visits should be in-person to facilitate the comprehensive, coordinated, and personal care that medically volatile, acutely ill patients require on an ongoing basis.
Therefore, we are proposing that subsequent hospital care services, specifically CPT codes 99231, 99232, and 99233, be added to the list of telehealth services on a category 1 basis for CY 2011, but with some limitations on the frequency that these services may be furnished through telehealth. Because of our concerns regarding the potential acuity of hospital inpatients, we are proposing to limit the provision of subsequent hospital care services through telehealth to once every 3 days. We are confident that admitting practitioners will continue to make appropriate in-person visits to all patients who need such care during their hospitalization. Consulting practitioners should continue to use the inpatient telehealth consultation HCPCS G-codes, specifically G0406, G0407, G0408, G0425, G0426, or G0427 when reporting consultations furnished to inpatients via telehealth.
Consistent with this proposal, we are proposing to revise § 410.78(b) and § 414.65(a)(1) to include subsequent hospital care services as Medicare telehealth services, with the limitation of one telehealth subsequent hospital care service every 3 days.
We also considered adding hospital discharge day management services to the list of telehealth services. These services, reported by CPT codes 99238 and 99239, include the final examination of the patient, discussion of the hospital stay, instructions for continuing care to all relevant caregivers, and preparation of discharge records, prescriptions, and referral forms. These services are furnished when a practitioner deems it medically reasonable and necessary to assess a patient's readiness for discharge and to prepare a patient for discharge from an acute care environment to a less intensive setting. There are no services on the current list of telehealth services that resemble such preparation of a patient for discharge. We believe it is especially important that, if a practitioner furnishes a discharge day management service, the service be furnished in-person in order to allow the practitioner to comprehensively assess the patient's status in preparation for discharge so that the patient will have a higher likelihood of making a successful transition to the less intensive setting. Therefore, we are not considering hospital discharge day management services for addition to the Medicare telehealth services list on a category 1 basis.
We have reviewed the documentation submitted by requestors in support of adding these codes to the Medicare telehealth services list on a category 2 basis. Most of the submitted studies were specific to the treatment of patients with specific diagnoses and were not specific to discharge services. Additionally, most of the studies concluded that more research was required in order to establish medical equivalence between telehealth and in-person services. The submitted documentation did not provide the necessary evidence to alter our previous conclusion that hospital discharge day management services should be provided in-person in light of the acuity of hospitalized patients, their typically complex post-hospitalization care needs, and the importance of patient education by the admitting practitioner who had ongoing responsibility for the patient's treatment during the hospital stay. Therefore, we are not proposing to add hospital discharge day management services to the list of telehealth services for CY 2011.
The American Telemedicine Association and the Marshfield Clinic submitted requests to add nursing facility care codes, covering the spectrum of initial (reported by CPT codes 99304 (Level 1 initial nursing facility care), 99305 (Level 2 initial nursing facility care) and 99306 (Level 3 initial nursing facility care)); subsequent (reported by CPT codes 99307 (Level 1 subsequent nursing facility care), 99308 (Level 2 subsequent nursing facility care), 99309 (Level 3 subsequent nursing facility care), and 99310 (Level 4 subsequent nursing facility care)); discharge day management (reported by CPT codes 99315 (Nursing facility discharge day management; 30 minutes or less) and 99316 (Nursing facility discharge day management; more than 30 minutes)); and other (reported by CPT code 99318 (Evaluation and management of a patient involving an annual nursing facility assessment)) services, to the Medicare telehealth services list beginning in CY 2011. The requests for the addition of these services expressed concerns regarding limited access to care if we do not allow these services to be furnished through telehealth, and requested that CMS acknowledge the recent Congressional inclusion of nursing facilities as telehealth originating sites by adding these codes to the list of Medicare telehealth services.
In the CY 2010 PFS proposed and final rules (74 FR 33544 and 74 FR 61762), we discussed concerns about potential disparities in patient acuity between nursing facility services and the current list of Medicare telehealth
We reviewed the use of telehealth for each of the subcategories of nursing facility services included in the requests for CY 2011. We identified the E/M services that fulfill Federal requirements for personal visits under § 483.40(c), and we are not proposing for CY 2011 to add any HCPCS codes to the Medicare telehealth services list that are used exclusively to describe these Federally-mandated visits. These codes include the CPT codes for initial nursing facility care (CPT codes 99304 through 99306) that are used to report the initial E/M visit that fulfills Federally-mandated requirements under § 483.40(c) and other nursing facility service (CPT code 99318) that is only payable by Medicare if the visit is substituted for a federally-mandated visit under § 483.40(c).
The nursing facility discharge day management services reported under CPT code 99315 and 99316 are E/M visits that prepare a nursing facility resident for discharge from the facility. There are no Medicare requirements that such a service be furnished. If a practitioner chooses to furnish this service, we continue to believe that an in-person visit is most appropriate in order to ensure the resident is prepared for discharge from the nursing facility. These services are furnished when a practitioner deems it medically reasonable and necessary to assess a patient's readiness for and to prepare a patient being discharged from the monitored nursing facility environment to another typically less intensive setting. There are no services on the current list of telehealth services that resemble such preparation of a patient for discharge. As in the case of hospital discharge day management services, we believe it is especially important that, if a practitioner furnishes a nursing facility discharge day management service, the service be furnished in-person. The practitioner must be able to comprehensively assess the patient's status in preparation for discharge so that the patient will have a higher likelihood of making a successful transition from the nursing facility to another setting. Therefore, we are not considering nursing facility discharge day management services for addition to the Medicare telehealth services list on a category 1 basis. When we considered the addition of these services under category 2, we had no evidence that nursing facility discharge services furnished through telehealth are equivalent to in-person discharge services. Therefore, we are not proposing to add nursing facility discharge day management services to the CY 2011 telehealth list.
Subsequent nursing facility services, reported by CPT codes 99307 through 99310, may be used to report either a federally-mandated periodic visit under § 483.40(c) or another E/M visit, prior to or after the initial nursing facility care visit, as long as the subsequent nursing facility care visit is medically reasonable and necessary for the resident's care. While we continue to believe that many SNF residents have complex medical care needs, we believe that it is appropriate to consider the addition of these codes to the telehealth list on a category 1 basis. As we state above in the context of our discussion of subsequent hospital care services, the HCPCS codes for initial and follow-up inpatient consultation services for nursing facility patients are on the list of Medicare telehealth services, and subsequent nursing facility services are similar to those services. These E/M services are furnished to high acuity, complex SNF patients, although not by the admitting practitioner himself or herself. Therefore, we believe that subsequent nursing facility visits by a patient's admitting practitioner sufficiently resemble follow-up inpatient consultation services to consider them on a category 1 basis for the telehealth list. We have concluded that it would be appropriate to permit some subsequent nursing facility care services to be furnished through telehealth to ensure that complex nursing facility patients have frequent encounters with their admitting practitioner, although we continue to believe that the federally-mandated visits should be in-person to facilitate the comprehensive, coordinated, and personal care that these complex patients require on an ongoing basis.
Therefore, we are proposing that subsequent nursing facility care services, specifically CPT codes 99307, 99308, 99309 and 99310, be added to the list of Medicare telehealth services on a category 1 basis beginning in CY 2011, with some limitations on furnishing these services through telehealth. Because of our concerns regarding the potential acuity and complexity of SNF inpatients, we are proposing to limit the provision of subsequent nursing facility care services furnished through telehealth to once every 30 days. We are especially interested in public comments, including any evidence regarding patterns of high quality care and clinical outcomes, regarding this proposal to limit the provision of subsequent nursing facility care services furnished through telehealth to once every 30 days. We remain committed to ensuring that SNF inpatients receive appropriate in-person visits and that Medicare pays only for medically reasonable and necessary care. Currently and continuing in CY 2011, an unlimited number of initial and follow-up consultation services may be furnished through telehealth to these patients so we believe that only a limited number of subsequent nursing facility care services by the admitting practitioner would be appropriate for SNF inpatients. Finally, we are specifying that subsequent nursing facility care services reported for a Federally-mandated periodic visit under § 483.40(c) may not be furnished through telehealth. In light of this proposal for CY 2011, we remain confident that admitting practitioners will continue to make appropriate in-person visits to all patients who need such care during their SNF stay.
Consistent with this proposal, we are proposing to revise § 410.78(b) and § 414.65(a)(1) to include subsequent nursing facility care services as Medicare telehealth services, with the limitation of one telehealth subsequent nursing facility care service every 30 days. Federally-mandated periodic visits may not be furnished through telehealth, as specified currently in § 410.78(e)(2).
The American Telemedicine Association submitted a request to add neuropsychological testing services, described by CPT codes 96119 (Neuropsychological testing (
In the CY 2008 PFS final rule with comment period (72 FR 66251), we stated that we have received conflicting comments and data regarding the appropriateness of furnishing neuropsychological testing via telehealth. While we appreciate the recent request for addition of these same services to the Medicare telehealth services list, we do not believe that these services are similar to services currently on the Medicare telehealth services list and, therefore, we conclude that they would not be appropriate for consideration or addition under category 1. In this year's request for the addition of the these services, we received no information to indicate that the diagnostic findings of neuropsychological testing through telehealth are similar to those based upon in-person testing, and therefore, that testing through telehealth does not affect the patient's diagnosis. Therefore, we are not proposing to add neuropsychological testing services to the list of approved Medicare telehealth services for CY 2011.
The Marshfield Clinic submitted a request to add various speech-language pathology services to the list of approved telehealth services for CY 2011. Speech-language pathologists are not permitted under section 1842(b)(18)(C) of the Act to furnish and receive payment for Medicare telehealth services. Therefore, we are not proposing to add any speech-language pathology services to the list of Medicare telehealth services for CY 2011. For further discussion of these services in the context of telehealth, we refer readers to the CY 2005 and CY 2007 PFS proposed and final rules with comment period (69 FR 47512 and 66276, and 71 FR 48995 and 69657).
Wound Care Associates, LLC, submitted a request to add wound care in the home setting to the list of Medicare telehealth services. A patient's home is not permitted under current statute to serve as an originating site for Medicare telehealth services. Therefore, we are not proposing to add home wound care services to the list of Medicare telehealth services for CY 2011.
In summary, we are proposing to add the following requested services to the list of Medicare telehealth services for CY 2011:
• Individual and group KDE services (HCPCS codes G0420 and G0421, respectively);
• Individual and group DSMT services, with a minimum of 1 hour of in-person instruction to be furnished in the year following the initial DSMT service to ensure effective injection training (HCPCS codes G0108 and G0109, respectively);
• Group MNT and HBAI services (CPT codes 97804, and 96153 and 96154, respectively);
• Subsequent hospital care services, with the limitation for the patient's admitting practitioner of one telehealth visit every 3 days (CPT codes 99231, 99232, and 99233); and
• Subsequent nursing facility care services, with the limitation for the patient's admitting practitioner of one telehealth visit every 30 days (CPT codes 99307, 99308, 99309, and 99310).
Furthermore, we are proposing to revise § 410.78(b) and § 414.65(a)(1) accordingly. Specifically, we are proposing to add individual and group KDE services, individual and group DSMT services, group MNT services, group HBAI services, and subsequent hospital care and nursing facility care services to the list of telehealth services for which payment will be made at the applicable PFS payment amount for the service of the practitioner. In addition, we have reordered the listing of services in these two sections and removed “initial and follow-up inpatient telehealth consultations furnished to beneficiaries in hospitals and SNFs” in § 410.78(b) because these are described by the more general term “professional consultations” that is in the same section. Finally, we are continuing to specify that the physician visits required under § 483.40(c) may not be furnished as telehealth services.
The following section addresses certain provisions of the Patient Protection and Affordable Care Act (Pub. L. 111–148), enacted on March 23, 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111–152) enacted on March 30, 2010 (collectively known as the Affordable Care Act (ACA)).
Section 3002 of ACA makes a number of changes to the Physician Quality Reporting Initiative (PQRI), including authorizing incentive payments through 2014, and requiring a penalty beginning in 2015, for eligible professionals who do not satisfactorily submit quality data. For a more detailed discussion of the provisions of section 3002 of the ACA, please refer to section VI.G.1. of this proposed rule.
As required under section 1848(n) of the Act, as added by section 131(c) of MIPPA, we established and implemented by January 1, 2009, the Physician Resource Use Measurement & Reporting (RUR) Program for purposes of providing confidential reports to physicians that measure the resources involved in furnishing care to Medicare beneficiaries. Section 1848(n) of the Act also authorizes CMS to include information on the quality of care furnished to Medicare beneficiaries by a physician or group of physicians.
We are continuing a phased implementation of the program. Phase I was discussed in the CY 2010 proposed and final rules (74 FR 33589, and 74 FR 61844, respectively), and has been completed. Phase I consisted of several activities including extensive data analysis to inform decisions about topics such as measures, attribution, and risk adjustment and formative testing of report design with practicing physicians. We concluded Phase I by sending to individual practicing physicians in 12 geographic areas
Phase I of the Program focused on providing confidential feedback on resource use measures. Section 1848(n)(1)(A)(iii) of the Act states that the Secretary may also include information on the quality of care
Section 1848(n)(1)(A)(ii) also states that the Secretary may provide reports at the physician group level. Accordingly, as part of Phase II of the program, we will also include reporting to group practices, defined as more than one physician practicing medicine together (74 FR 61846). In addition, we noted that the definition applies to the following types of physician groups: (1) Formally established single or multi-specialty group practices; (2) physicians practicing in defined geographic regions; and (3) physicians practicing within facilities or larger systems of care (74 FR 61846). As we continue with Phase II, we plan to report to both physician group practices and their affiliated practitioners, recognizing that many physicians practice in arrangements other than solo practices. We believe that using both group and individual level reporting will also allow us to gain experience with the sample size issues that arise when individual physicians have too few Medicare beneficiaries with specific conditions to generate reliable information. (
The ACA contains two provisions relevant to the RUR program. Section 3003 continues the confidential feedback program and requires the Secretary, beginning in 2012, to provide reports that compare patterns of resource use of individual physicians to other physicians. In addition, section 3007 of the ACA requires the Secretary to apply a separate, budget-neutral payment modifier to the Fee-For-Service physician fee schedule payment formula. The payment modifier, which will be phased in beginning January 1, 2015 through January 1, 2017, will provide for differential payment under the fee schedule to a physician or groups of physicians, and later, possibly to other eligible professionals, based upon the relative quality and cost of care of their Medicare beneficiaries. Accordingly, our goal is to have Medicare physicians receive a confidential feedback report prior to implementation of the payment modifier. We view these two provisions as complementary, as we expect the work done for the confidential feedback program under section 3003 of the ACA will inform our implementation of the payment modifier under section 3007 of the ACA. The approach used in the confidential feedback reports will serve as the foundation for implementing the payment modifier. Specifically, throughout future phases of reports under the RUR program, we will continue to enhance our measures and methods and improve the content of the reports based on both our research and the feedback of stakeholders before the payment modifier begins to affect physician payments in 2015.
We plan to engage in a large-scale effort to garner widespread stakeholder involvement with regard to how we continue to build and expand the confidential feedback program and transition to implementation of the payment modifier. We recognize that such a payment modifier may have an impact on the delivery of care to Medicare beneficiaries. Reports that will be produced in the future based on changes as a result of section 3003 of the ACA will contain both cost and quality data, and work done to improve these reports with regard to fair and actionable measures in each of these domains will aid our decision making in how to apply the payment modifier. We intend to seek stakeholder input on various aspects of program design, including cost and quality measures, methodologies for compositing measures, and feedback report content and delivery. Such feedback may be gathered through rulemaking, open door forums, or other mechanisms.
We anticipate that reports in Phase II of the RUR Program will be distributed in the fall of 2010. We are proposing, however, several changes to the program parameters for Phase II that were finalized in prior rules. First, we plan to discontinue our use of commercially-available proprietary episode grouping software. In particular, section 3003 of the ACA requires that the Secretary develop a Medicare-specific episode grouper by January 1, 2012, the details of which must be made public. This grouper will address the limitations found in the proprietary software.
We recognize that episode-specific cost information is meaningful and actionable for physicians, and we plan to provide such information in feedback reports after the public grouper software is developed. Prior to that, we may consider other potential interim options for grouping to provide such information. We believe that our use of proprietary episode grouping software in previous phases of the program had limitations. These software products were not intended for use with Medicare claims data, and we discovered several problems with the data outputs. Specifically, the groupers do not work well to create episodes for beneficiaries with multiple chronic conditions, which is a significant portion of Medicare beneficiaries.
For example, when a beneficiary with a chronic disease is hospitalized for an acute condition, that beneficiary most likely also receives treatments unrelated to the condition for which he or she is hospitalized, but related to the chronic disease. The groupers, which are proprietary and often referred to as “black boxes,” do not enable users to understand the coding to determine how to accomodate these issues. Therefore, CMS had to make several decisions about how to pre-process the claims data so that the groupers could recognize and attempt to deal with these issues in the clinical grouping logic. After report production in Phase I, we discovered several problems with the pre-processing, which resulted in inaccurate episode cost information being disseminated.
Until a Medicare-specific episode grouping software is developed, we plan to produce reports for Phase II that contain per capita cost information. More specifically, instead of episode-specific cost information, we plan to provide overall per capita cost information, as well as per capita cost information for those beneficiaries with five common chronic diseases: (1) Diabetes, (2) congestive heart failure, (3) coronary artery disease, (4) chronic obstructive pulmonary disease, and (5) prostate cancer. This information will not be specific to the cost of treating the disease itself, but will provide total Part A/B per capita cost information, as well as service category breakdowns, for treating the subset of attributed beneficiaries with that disease.
Second, while commenters have been generally supportive of including PQRI measures in the reports, we propose not including data from PQRI in the reports. The current support contractor for this program has only 2007 PQRI data. This was the first year of PQRI, and participation was still quite low. Because of the low number of physicians reporting under PQRI, and because providers have the flexibility to choose which measures to report under
Third, we propose to distribute reports electronically in Phase II, by leveraging the infrastructure used to distribute PQRI feedback reports. This infrastructure will enable groups to utilize an electronic portal to download their Phase II reports. Individual practitioners will be able to contact their MACs/fiscal intermediaries to receive an e-mailed copy of their reports. We have received feedback from physicians that the reports distributed in Phase I were too long and cumbersome to manage in hard copy. Our intent is a condensed report with electronic dissemination that allows for easier navigation. We are seeking public comment on the above proposals.
The Affordable Care Act provisions that we mention above contain several important implementation dates. In addition to developing an episode grouper by January 1, 2012, we are required to publish the cost and quality measures we intend to use in determining the payment modifier to be effective on January 1, 2012. We are also required to begin implementing the program parameters through rulemaking in 2013. The payment modifier is effective on January 1, 2015, with a phased implementation so that all physicians paid under the physician fee schedule will be subject to the modifier by January 1, 2017. On or after January 1, 2017, we have the authority to also apply the payment modifier to other eligible professionals.
In anticipation of implementing sections 3003 and 3007 of the ACA, we intend to perform extensive data analysis and research, and to seek stakeholder input on issues related to cost and quality measures so that we can be prepared to publish, by January 1, 2012, those measures we intend to use for the payment modifier. We intend for the work done in determining measures for use in the payment modifier to inform the continued dissemination of confidential feedback reports to both individual physicians and physician groups. Specifically, the measures chosen for use in the payment modifier will be candidates for inclusion in future phases of the confidential feedback reports.
As mentioned above, Phase I included reports to several hundred physicians. In Phase II we anticipate disseminating reports to about 40 large physician groups and the approximately 2,000 physicians affiliated with those groups. We anticipate future phases of the reports to include additional dissemination to increasing numbers of practitioners and groups such that virtually every applicable Medicare practitioner receives a report prior to implementation of the payment modifier.
We recognize that there are many important decisions to be made when implementing a program that compares physicians to their peers, especially when such information can lead to differential payment. Since the inception of the RUR program, all data have been price standardized which includes accounting for geographic adjustments. We have identified important statistical issues in previous rules, and as we have done in previous rules, CMS seeks input on several of these topics as they relate to future phases of reports. These include, but are not limited to: risk adjustment; attribution; benchmarking; peer groups; minimum case sizes; cost and quality measures; and compositing methods. To date, the public comments we have received have not led us to a single methodology to propose for dealing with any of these issues. Therefore, we do not make formal proposals in this proposed rule. Specific parameters of the RUR program are based on the most current information we have available to us. These parameters will continue to evolve and we will continue to evaluate them as the state of the art in these areas continues to improve. Therefore, we seek public comment on these issues.
The cost data used in Phase I will be risk adjusted. For the per capita costs, we used the Hierarchical Condition Categories (HCC) model developed for risk adjustment in Medicare Advantage plans. This model takes into account beneficiary characteristics such as age, sex, and Medicaid status, and then predicts costs for beneficiaries based on their unique mix of health conditions. Several other socioeconomic factors, such as the median income per capita in the county where the physician practices, were used. For the episode costs, we used the risk adjustment/severity levels in the proprietary grouper software.
The cost data in Phase II are risk adjusted using the HCC model, but excluding the additional socioeconomic factors such as the median income per capita in the county where the physician practices, as mentioned above. Regression analyses indicated that these additional socioeconomic factors did little to improve the fit of the model, so we will not include them. And since there are no episode-based costs in Phase II—only annual per capita costs—the HCC model will be the only method used. Other methods of risk adjustment exist that we have not used, such as the CC (complications and comorbidities) and MCC (major complications and comorbidities) indicators implemented in the 2008 MS–DRG system.
The quality data included in Phase II will not be risk adjusted because the GEM measures are all clinical process measures, and it is generally accepted that such measures need not be risk adjusted. Beneficiaries should receive the indicated preventive services (for example, breast cancer screening) regardless of their demographic characteristics or presence or absence of health conditions.
We seek comment on the appropriate method for risk adjusting cost data, as well as our reasoning for not risk adjusting clinical process quality measures.
Deciding which physician(s) is/are responsible for the care of which beneficiaries is an important aspect of measurement. CMS must strike a balance between only attributing cost information to physicians for the services they personally delivered, and attributing costs to physicians based on a more encompassing view of the services provided to each beneficiary so as to encourage better care coordination and accountability for patient outcomes.
There are several methods that are generally used for attributing beneficiaries' costs to physicians for the purposes of measuring and comparing
In Phase II reports, we plan to use the “plurality-minimum” method with a minimum percentage threshold of E&M services of 20 percent for individual physicians and a minimum percentage threshold of E&M services of 30 percent of the E&M services for physician group level reports. These minimum threshold determinations were based on our analysis of the claims data. We recognize that other attribution methods exist, which may be either more or less appropriate given the aspect of care one is measuring. For example, it may be desirable to attribute the entire cost of a surgical episode to the performing surgeon. Another method for attributing costs is referred to as “multiple-even,” in which the entire beneficiary's cost is attributed to multiple physicians who treated the beneficiary.
We seek comment on the topic of attribution methodologies, including both of those we have already used in the program, as well as others that may or may not be mentioned here.
Determining the relevant comparisons to make among physicians is also an important policy aspect of the program. CMS' research conducted in Phase I of the program indicated that physicians prefer to be compared only to those physicians most like them (that is, the narrowest peer group). We recognize the importance of fair comparison, but are also faced with the challenge that very narrow peer groups are most often not large enough to make statistically significant comparisons.
The individual-level reports in both phases of the program have contained, or will contain, two peer group comparisons: (1) Physicians in the same specialty in the same geographic area; and (2) physicians in the same specialty across all 12 geographic areas. In each of these peer groups, a physician is shown where he or she falls on a distribution that specifically identified the 10th, 50th, and 90th percentiles. These benchmarks were finalized on an interim basis in the CY 2010 proposed rule (74 FR 33589).
In determining applicability for episode measures in Phase I, we used a statistical reliability test. For per capita measures in Phase I, a physician had to have 20 or more beneficiaries to be measured and compared. There was no minimum peer group size requirement.
The original MIPPA mandate requires CMS to make comparisons among physicians on cost, and gives the Secretary the authority to include comparisons on quality. The use of quality measures in the program was finalized in the CY 2010 final rule (74 FR 61846). In Phase II, comparisons with appropriate peer groups will be made for both cost and quality. Phase II reports will be provided only to those physicians that have 30 or more patients for each of the cost measures. For the quality measures, we plan to use the measure specifications in the GEM project to define minimum case sizes, which are at least 11 beneficiaries. We also plan to impose a minimum peer group size of 30 in Phase II for both the cost and quality measures. A minimum sample size of 30 is generally accepted in the research community as the minimum sample size to represent a group and make comparisons.
We seek comment on the most appropriate and relevant peer groups for comparison, including the appropriate minimum case sizes and minimum peer group sizes. We are also interested in methodologies that can account for small case sizes.
As mentioned above, and in previous rules, section 1848(n)(1)(A)(ii) of the Act gives the Secretary the authority to include both cost and quality information in the feedback reports. In Phase I, we chose to use only cost information, and used both per capita and episode cost measurements. As mentioned above, we previously finalized the use of quality measures in Phase II (74 FR 61846), but propose to discontinue our use of episode cost measurements. We have yet to include any composite measures of cost or quality in the feedback reports.
Section 3007 of the ACA requires CMS to pay physicians differentially based on a modifier derived with composites of both quality and cost measures. Accordingly, we will need to devise a methodology in the future for compositing cost measures and quality measures, including considering, among other things, possible methodologies to develop a single score. In the future, episode-based cost measures developed using the public Medicare-specific episode grouper software also may be considered in developing a composite score. Other domains of measures that may be considered include patient-level utilization statistics (for example, emergency department visits per 1,000 patients) and structural measures such as whether a provider has adopted an electronic health record. We recognize that measure composites are methodologically and operationally complex and, therefore, we are seeking comment on this topic.
We plan to continue a phased approach in the future. Although we will continue to move from phase-to-phase, any substantive changes to the RUR program will be implemented through rulemaking. We also anticipate continuing to gather feedback from stakeholders about the important data-driven policy topics that affect the feedback reports.
Section 1848(e)(1)(E) of the Act (as amended by section 3102(a) of the ACA) extends application of the 1.0 work GPCI floor for services furnished through December 31, 2010. In addition, section 1848(e)(1) of the Act (as amended by section 3102(b) of the ACA) specifies that for CY 2010 and CY 2011, the employee wage and rent portions of the PE GPCI must reflect only one-half of the relative cost differences for each locality compared to the national average and includes a “hold harmless” provision for any PFS locality that would receive a reduction to its PE GPCI resulting from the limited recognition of cost differences. Section 1848(e)(1) of the Act (as amended by section 3102(b) of the ACA) also requires an analysis of the current methods and data sources used to determine the relative cost differences in office rent and employee wages compared to the national average and the cost share weights assigned to each PE GPCI component: Employee wages, office rent, and supplies. Finally, section 1848(e)(1) of the Act (as amended by section 3102(b) of the ACA) requires the Secretary to make appropriate adjustments to the PE GPCI by no later than January 1, 2012. In addition, section 1848(e)(1) of the Act (as amended by section 10324(c) of the ACA) establishes a 1.0 PE GPCI floor for services furnished in frontier states effective January 1, 2011. The
Section 1833(g)(5) of the Act (as amended by section 3103 of the ACA) extends the exceptions process for therapy caps through December 31, 2010. Therapy caps are discussed in detail in section III.A. of this proposed rule.
Section 542(c) of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106–554), as amended by section 732 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108–173), section 104 of division B of the Tax Relief and Health Care Act of 2006 (MIEA–TRHCA) (Pub. L. 109–432), section 104 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 (MMSEA) (Pub. L. 110–173), and section 136 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110–275) is amended by section 3104 of the ACA to continue payment to independent laboratories for the TC of physician pathology services for fee-for-service Medicare beneficiaries who are inpatients or outpatients of a covered hospital through CY 2010. The technical component (TC) of physician pathology services refers to the preparation of the slide involving tissue or cells that a pathologist interprets. The professional component (PC) of physician pathology services refers to the pathologist's interpretation of the slide.
When the hospital pathologist furnishes the PC service for a hospital patient, the PC service is separately billable by the pathologist. When an independent laboratory's pathologist furnishes the PC service, the PC service is usually billed with the TC service as a combined service.
Historically, any independent laboratory could bill the Medicare contractor under the PFS for the TC of physician pathology services for hospital patients even though the payment for the costs of furnishing the pathology service (but not its interpretation) was already included in the bundled inpatient stay payment to the hospital. In the CY 2000 PFS final rule with comment period (64 FR 59408 through 59409), we stated that this policy has contributed to the Medicare program paying twice for the TC service: (1) To the hospital, through the inpatient prospective payment rate, when the patient is an inpatient; and (2) to the independent laboratory that bills the Medicare contractor, instead of the hospital, for the TC service. While the policy also permits the independent laboratory to bill for the TC of physician pathology services for hospital outpatients, in this case, there generally would not be duplicate payment because we would expect the hospital to not also bill for the pathology service, which would be paid separately to the hospital only if the hospital were to specifically bill for it. We further indicated that we would implement a policy to pay only the hospital for the TC of physician pathology services furnished to its inpatients.
Therefore, in the CY 2000 PFS final rule with comment period, we revised § 415.130(c) to state that for physician pathology services furnished on or after January 1, 2001 by an independent laboratory, payment is made only to the hospital for the TC furnished to a hospital inpatient. Ordinarily, the provisions in the PFS final rule with comment period are implemented in the following year. However, the change to § 415.130 was delayed 1 year (until January 1, 2001), at the request of the industry, to allow independent laboratories and hospitals sufficient time to negotiate arrangements.
Full implementation of § 415.130 was further delayed by section 542 of the BIPA and section 732 of the MMA, which directed us to continue payment to independent laboratories for the TC of physician pathology services for hospital patients for a 2-year period beginning on January 1, 2001 and for CYs 2005 and 2006, respectively.
In the CY 2007 MPFS final rule with comment period (71 FR 69624 and 69788), we amended § 415.130 to provide that, for services furnished after December 31, 2006, an independent laboratory may not bill the carrier for the TC of physician pathology services furnished to a hospital inpatient or outpatient. However, section 104 of the MIEA–TRHCA continued payment to independent laboratories for the TC of physician pathology services for hospital patients through CY 2007, and section 104 of the MMSEA further extended such payment through the first six months of CY 2008.
Section 136 of the MIPPA extended the payment through CY 2009. Most recently, section 3104 of the ACA amended the prior legislation to extend the payment through CY 2010.
Consistent with this legislative change, we are proposing to revise § 415.130(d) to: (1) Amend the effective date of our payment policy to reflect that for services furnished after December 31, 2010, an independent laboratory may not bill the Medicare contractor for the TC of physician pathology services furnished to a hospital inpatient or outpatient; and (2) reformat this subsection into subparagraphs.
Section 146(a) of the MIPPA amended section 1834(l)(13)(A) of the Act to specify that, effective for ground ambulance services furnished on or after July 1, 2008 and before January 1, 2010, the ambulance fee schedule amounts for ground ambulance services shall be increased as follows:
• For covered ground ambulance transports which originate in a rural area or in a rural census tract of a metropolitan statistical area, the fee schedule amounts shall be increased by 3 percent.
• For covered ground ambulance transports which do not originate in a rural area or in a rural census tract of a metropolitan statistical area, the fee schedule amounts shall be increased by 2 percent.
Sections 3105(a) and 10311(a) of the ACA further amend section 1834(l)(13)(A) of the Act to extend the payment add-ons described above for an additional year, such that these add-ons also apply to covered ground ambulance transports furnished on or after January 1, 2010 and before January 1, 2011. We are revising § 414.610(c)(1)(i) to conform the regulations to this statutory requirement. This statutory requirement is self-implementing. A plain reading of the statute requires only a ministerial application of the mandated rate increase, and does not require any substantive exercise of discretion on the part of the Secretary. For further information regarding the extension of these payment add-ons, please see Transmittal 706 (Change Request 6972) dated May 21, 2010.
Section 146(b)(1) of the MIPPA amended the designation of rural areas for payment of air ambulance services. The statute specified that any area that was designated as a rural area for purposes of making payments under the ambulance fee schedule for air ambulance services furnished on December 31, 2006, shall continue to be
Section 414 of the MMA added paragraph (12) to section 1834(l) of the Act, which specified that in the case of ground ambulance services furnished on or after July 1, 2004, and before January 1, 2010, for which transportation originates in a qualified rural area (as described in the statute), the Secretary shall provide for a percent increase in the base rate of the fee schedule for such transports. The statute requires this percent increase to be based on the Secretary's estimate of the average cost per trip for such services (not taking into account mileage) in the lowest quartile of all rural county populations as compared to the average cost per trip for such services (not taking into account mileage) in the highest quartile of rural county populations. Using the methodology specified in the July 1, 2004 interim final rule (69 FR 40288), we determined that this percent increase was equal to 22.6 percent. As required by the MMA, this payment increase was applied to ground ambulance transports that originated in a “qualified rural area”; that is, to transports that originated in a rural area included in those areas comprising the lowest 25th percentile of all rural populations arrayed by population density. For this purpose, rural areas included Goldsmith areas (a type of rural census tract). Sections 3105(c) and 10311(c) of the ACA amend section 1834(l)(12)(A) of the Act to extend this rural bonus for an additional year through December 31, 2010. Therefore, as directed by the ACA, we are continuing to apply the rural bonus described above (in the same manner as in previous years), to ground ambulance services with dates of service on or after January 1, 2010 and before January 1, 2011 where transportation originates in a qualified rural area.
We are revising § 414.610(c)(5)(ii) to conform the regulations to this statutory requirement. This statutory requirement is self-implementing. The statute requires a one-year extension of the rural bonus (which was previously established by the Secretary), and does not require any substantive exercise of discretion on the part of the Secretary. For further information regarding the extension of this rural bonus, please see Transmittal 706 (Change Request 6972) dated May 21, 2010.
Section 3107 of the ACA amends section 138(a)(1) of the MIPPA to continue the 5 percent increase in Medicare payment for specified mental health services through December 31, 2010. This payment increase was originally authorized under section 138 of the MIPPA from July 1, 2008 until December 31, 2009. Accordingly, payment for the 24 psychiatry CPT codes in Table 33, representing “specified services,” remains increased by 5 percent until December 31, 2010.
The ACA included a self-implementing provision relating to SNFs. Section 3108 adds physician assistants (PAs) to the list of practitioners (that is, physicians, nurse practitioners (NPs), and clinical nurse specialists) that can perform the required initial certification and periodic recertifications under section 1814(a)(2)(B) of the Act with respect to the SNF level of care. Accordingly, we are proposing to make appropriate revisions to include PAs in § 424.20(e)(2), in which we refer to NPs, clinical nurse specialists, and PAs collectively as “physician extenders.”
Section 1848(b) of the Act (as amended by section 3111 of the ACA) changes the payment calculation for dual-energy X-ray absorptiometry (DXA) services described by two specified DXA CPT codes for CYs 2010 and 2011. This provision requires payment for these services at 70 percent of the product of the CY 2006 RVUs for these DXA codes, the CY 2006 conversion factor (CF), and the geographic adjustment for the relevant payment year.
Effective January 1, 2007, the CPT codes for DXA services were revised. The former DXA CPT codes 76075 (Dual energy X-ray absorptiometry (DXA), bone density study, one or more sites; axial skeleton (
Section 1848(b) (as amended by section 3111 of the ACA) revises the payment for CPT codes 77080 and 77082 during CY 2010 and CY 2011. We have provided payment in CY 2010 under the PFS for CPT codes 77080 and 77082 at the specified rates. We note that the RVUs included in Addendum B to this proposed rule reflect the RVUs that result from application of this statutory provision and the proposed CY 2011 conversion factor. Because the statute specifies a payment amount for these services as described previously, we imputed RVUs for CY 2011 to include in Addendum B that would provide the specified payment amount for these services when multiplied by the CY 2011 CF. Specifically, we divided the payment amount based on the statutory requirements by the CY
Section 1833(a)(1)(K) of the Act (as amended by section 3114 of the ACA) increases the amount of Medicare payment made under the PFS for certified nurse-midwife (CNM) services. Currently, section 1833(a)(1)(K) of the Act specifies that the payment amount for CNM services is 80 percent of the lesser of the actual charge or 65 percent of the PFS amount. Under section 1833(a)(1)(K) of the Act (as amended by section 3114 of the ACA), effective for services furnished on or after January 1, 2011, Medicare payment for CNM services is increased to 100 percent of the PFS amount (or 80 percent of the actual charge if that is less). We are proposing to revise our regulations at § 414.54 (Payment for certified nurse-midwives' services) accordingly to reflect the increased payment for CNM services effective for services furnished on or after January 1, 2011.
Although CNMs are currently paid under Medicare Part B for their professional services, there is no mention of CNMs under the regulatory provision that lists the providers and suppliers of services to whom payment is made under the Medicare Part B program. Accordingly, we are proposing to make a technical revision to § 410.150 (To whom payment is made) to specify that Medicare Part B pays CNMs for professional services in all settings, as well as services and supplies furnished incident to those services.
CNMs are authorized under the statute to be paid directly for services that they are legally authorized to furnish under State law and that are of the type that would otherwise be covered if furnished by a physician or incident to a physician's services. Additionally, there is no requirement under the CNM benefit for physician oversight or supervision. Accordingly, CNMs are authorized to personally furnish diagnostic tests that fall under their State scope of practice without regard to the levels of physician supervision required under the diagnostic tests benefit. Therefore, we are amending § 410.32(b)(2) (Exceptions to the levels of physician supervision required for diagnostic tests) to include CNMs who furnish diagnostic tests that fall within their State scope of practice.
Section 416 of the MMA established a reasonable cost payment for outpatient clinical diagnostic laboratory tests furnished by hospitals with fewer than 50 beds that are located in qualified rural areas for cost reporting periods beginning during the 2-year period beginning on July 1, 2004.
Section 105 of the Tax Relief and Health Care Act of 2006 (Pub. L. 109–432) (TRHCA) extended the 2-year period in section 416(b) of the MMA for an additional cost-reporting year.
Section 107 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 (Pub. L. 110–173) (MMSEA) extended the time period for cost reporting periods beginning on July 1, 2004, and ending on June 30, 2008. For some hospitals with cost reports that began as late as June 30, 2008, this extension affected services performed as late as June 29, 2009, because this was the date those cost reports would have closed.
Section 3122 of the ACA reinstitutes reasonable cost payment for clinical diagnostic laboratory tests performed by hospitals with fewer than 50 beds that are located in qualified rural areas as part of their outpatient services for cost reporting periods beginning on or after July 1, 2010, through June 30, 2011. For some hospitals with cost reports that begin as late as June 30, 2011, this reinstitution of reasonable cost payment could affect services performed as late as June 29, 2012, because this is the date those cost reports will close.
Section 1848(c)(2)(K) of the Act (as added by section 3134 of the ACA) requires the Secretary to periodically review and identify potentially misvalued codes and make appropriate adjustments to the relative values of those services identified as being potentially misvalued. Section 1848(c)(2)(K) of the Act (as added by section 3134 of the ACA) further specifies that the Secretary may use existing processes to receive recommendations on the review and appropriate adjustment of potentially misvalued services, as well as conduct surveys or implement other data collection activities, studies, or other analyses as the Secretary determines to be appropriate to facilitate the review and appropriate adjustment of the relative values of potentially misvalued codes. Finally, section 1848(c)(2)(L) of the Act (as added by section 3134 of the ACA) provides that the Secretary shall establish a process to validate relative value units under the PFS.
We note that over the past several years, we have been working with the AMA RUC to identify approaches to addressing the issue of potentially misvalued services. Our proposed CY 2011 approaches to categories of potentially misvalued codes are discussed in section II.C. of this proposed rule.
Section 1848(b)(4)(C) of the Act (as added by section 3135(a) of the ACA) adjusts the utilization rate for expensive diagnostic imaging equipment to 75 percent in the methodology for establishing the PE of the associated procedures. As discussed further in section II.A.3.a. of this proposed rule, effective January 1, 2011, we are proposing to assign a 75 percent equipment utilization rate assumption to expensive diagnostic imaging equipment used in services described by the HCPCS codes displayed in Table 4.
In the CY 2010 PFS final rule with comment period (74 FR 61755), we finalized a policy to increase the utilization rate to 90 percent for expensive diagnostic equipment priced at more than $1 million (CT and MRI scanners), providing for a 4-year transition to the 90 percent utilization rate from the CY 2009 utilization rate of 50 percent. Therefore, in CY 2010 we were transitioning to a 90 percent equipment utilization rate assumption, applying a 25/75 blend of the new and old PE RVUs, respectively, for the associated procedures. Section 1848(b)(4)(C) of the Act (as added by section 3135(a) of the ACA) does not provide for any further transition and, therefore, we are assigning a 75 percent equipment utilization rate assumption to CT and MRI scanners, effective January 1, 2011. Under section 1848(b)(4) of the Act (as amended by section 3135(a) of the ACA), this change in the equipment utilization rate assumption from CY 2010 to CY 2011 is not budget neutral under the PFS. The equipment utilization rate assumption remains at 50 percent for all other equipment included in the PFS PE methodology.
Section 1848(b)(4)(D) of the Act (as added by section 3135(a) of the ACA) increases the established PFS multiple procedure payment reduction (MPPR) for the technical component (TC) of certain single-session imaging services to consecutive body areas from 25 to 50 percent, effective July 1, 2010, and section 1848(c)(2)(B)(v)(VI) of the Act (as added by section 3135(b) of the ACA) exempts this change from the PFS budget neutrality provision. This policy is discussed in detail in section II.C.4 of this proposed rule.
Effective January 1, 2006, we adopted an MPPR of 25 percent for the technical component (TC) of certain diagnostic imaging procedures, applied to the second and subsequent services when more than one service in one of 11 imaging families, defined by imaging modality and contiguous body area, is furnished in a single session (70 FR 70261 through 70263). The established imaging MPPR applies to TC-only services and to the TC of global services. It does not apply to professional component (PC) services. Under this policy, full payment was made for the TC of the highest priced procedure, while payment was made at 75 percent of the TC for each additional procedure. As of July 1, 2010, and continuing in CY 2011, payment is made at 50 percent of the TC for each additional procedure, consistent with the statutory provision.
Durable medical equipment (DME) is defined at section 1861(n) of the Act and includes wheelchairs necessary for use in the patient's home. Section 1861(n) provides that wheelchairs included in the definition of DME “may include a power-operated vehicle that may be appropriately used as a wheelchair, but only where the use of such a vehicle is determined to be necessary on the basis of the individual's medical and physical condition.” The general Medicare payment rules for DME are set forth in section 1834(a) of the Act and 42 CFR part 414, subpart D of our regulations. Section 1834(a)(1) of the Act and § 414.210(a) of our regulations establish that the Medicare payment for a DME item is generally equal to 80 percent of either the lower of the actual charge or the fee schedule amount for the item. The beneficiary coinsurance is generally equal to 20 percent of either the lower of the actual charge or the fee schedule amount for the item once the deductible is met.
For Medicare payment purposes, power wheelchairs or power-driven wheelchairs are classified under various codes in the Healthcare Common Procedure Coding System (HCPCS) based on the level of performance and functional characteristics of each power wheelchair that accommodate the specific needs of patients. Power wheelchairs classified under performance Groups 1 through 3 are covered under Medicare for use in the patient's home. Power wheelchair groups were established in 2006 with the release of the Power Mobility Device Coding Guidelines published by the Durable Medical Equipment Regional Carriers (DMERCs) currently called the Durable Medical Equipment Medicare Administrative Contractors (DME MACs). The DMEPOS quality standards define certain power wheelchairs falling as “complex, rehabilitative” power wheelchairs, and these “complex, rehabilitative” power wheelchairs are treated as a separate product category for the purpose of implementing the DMEPOS Competitive Bidding Program (CBP) mandated by section 1847(a) of the Act. In both the quality standards and the DMEPOS competitive bidding program, complex, rehabilitative power wheelchairs are defined or identified as power wheelchairs classified as Group 2 power wheelchairs with power options that can accommodate rehabilitative features (for example, tilt in space) or Group 3 power wheelchairs.
With the exception of power wheelchairs furnished during calendar year 1990, power wheelchairs have been paid under the capped rental category of DME since January 1, 1989. The payment rules for capped rental DME are provided at section 1834(a)(7) of the Act and § 414.229 of our regulations. Payment for these items is generally on a monthly rental basis, with rental payments capped at 13 months. After a 13-month period of continuous use during which rental payments are made, the statute and regulations require that the supplier transfer title to the wheelchair to the beneficiary. In addition, effective for power wheelchairs furnished on or after January 1, 1***, section 1834(a)(7) of the Act, as amended by section 4152(c)(2) (D) of the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101–508), mandates that the supplier of the power wheelchair offer the patient the option to purchase rather than rent the item. Since 1991, over 95 percent of Medicare beneficiaries have exercised this lump-sum purchase option for power wheelchairs.
Consistent with payment for other DMEPOS items, § 414.210(f)(1) permits payment for replacement of capped rental DME if the item has been in continuous use for the equipment's reasonable useful lifetime or is lost, stolen, or irreparably damaged. Section 414.210(f)(1) states the reasonable useful lifetime for equipment is determined through program instructions. In the absence of CMS program instructions, the carrier may determine the reasonable useful lifetime for equipment, but in no case can it be less than 5 years. Computation is based on when the equipment is delivered to the beneficiary, not the age of the equipment. If the beneficiary elects to obtain a new capped rental item after the reasonable useful lifetime, a new 13-month rental payment period would begin for the new equipment in accordance with the requirements of § 414.229.
Section 1834(a)(7)(A) of the Act, § 414.229(b) and (c) set forth the current fee schedule amounts for capped rental items. Pursuant to section 1834(a)(7)(A)(i)(II) of the Act and § 414.229(b), the current rental fee schedule amounts for months 1 thru 3 of the 13-month capped rental period are calculated to pay 10 percent of the average of allowed purchase price for the item. The rental fee schedule amounts for months 4 thru 13 of the 13-month capped rental period are calculated to pay 7.5 percent of the average of allowed purchase price for the item. The purchase price is determined consistent with section 1834(a)(8) of the Act and § 414.229(c) and § 414.220(e) and (f) and is updated by the covered item update, as required by section 1834(a)(14) of the Act and § 414.229(d). The current purchase price amount for power wheelchairs acquired on a lump sum purchase basis is 100 percent of the purchase price calculated for the item when rented, as discussed above.
Section 3136(a) of the ACA made several changes to section 1834(a)(7)(A) of the Act. Section 3136(a)(1) of the ACA amends section 1834(a)(7)(A) of the Act by adding a new subclause (III) to section 1834(a)(7)(A)(i) of the Act. Subclause (III) revises the capped rental fee schedule amounts for all power wheelchairs, modifying the current payment structure of 10 percent of the purchase price for months 1 thru 3 and 7.5 percent of that purchase price for months 4 through 13 that was discussed above. The rental fee schedule amount for months 1 thru 3 of the 13-month
Pursuant to section 3136(c) of the ACA, the changes made by section 3136(a) of the ACA apply to power-driven wheelchairs furnished on or after January 1, 2011.
Furthermore, as discussed above, section 3136(c)(2) of the ACA states that the changes made by section 3136(a), including the new payment structure for power wheelchairs, do not apply to payment made for items and services furnished pursuant to contracts entered into under section 1847 of the Act for the DMEPOS CBP prior to January 1, 2011 which applies to the implementation of the first round of the DMEPOS CBP. As a result, contract suppliers furnishing power wheelchairs in competitive bidding areas (CBA) pursuant to contracts entered into prior to January 1, 2011 as part of Round 1 of the DMEPOS CBP will continue to be paid based under the current regulations using 10 percent of the purchase price for months 1 through 3 and 7.5 percent for each of the remaining months. As a result, we are proposing to make changes to §§ 414.202, 414.229 and 414.408 to reflect these statutory requirements.
Section 3136(a)(2) of the ACA further amends section 1834(a)(7)(A)(iii) by inserting the term “complex rehabilitative” before the term “power-driven wheelchairs.” As a result, section 1834(a)(7)(A)(iii) of the Act now extends the lump sum purchase option only to complex rehabilitative power wheelchairs. As discussed above, “complex rehabilitative power wheelchairs are power wheelchairs that are classified as: (1) Group 2 power wheelchairs with power options that can accommodate rehabilitative features (for example, tilt in space), or (2) Group 3 power wheelchairs. We consider all other power wheelchairs to be standard power wheelchairs. Therefore, we propose to interpret the language “complex rehabilitative” in section 1834(a)(7)(A) of the Act consistent with this longstanding classification. As a result, the changes made by section 3136 to section 1834(a)(7)(A)(iii) eliminate the lump sum purchase option for standard power wheelchairs.
Pursuant to section 3136(c) of the ACA, the changes made to section 1834(a)(7)(A)(iii) of the Act apply to power-driven wheelchairs furnished on or after January 1, 2011. The lump sum purchase payment option will no longer extend to standard power driven wheelchairs furnished on or after January 1, 2011.
Furthermore, section 3136(c)(2) of the ACA states that the changes made by section 3136(a), including the limitation of the lump sum purchase payment option to complex, rehabilitative power wheelchairs, do not apply to payment made for items and services furnished pursuant to contracts entered into under section 1847 of the Act for the DMEPOS CBP prior to January 1, 2011 pursuant to the implementation of the first round of the DMEPOS CBP. As a result, contract suppliers furnishing power wheelchairs in CBAs pursuant to contracts entered into prior to January 1, 2011 as part of Round 1 of the DMEPOS CBP must continue to offer beneficiaries the lump sum purchase option for all power wheelchairs.
We are proposing changes to §§ 414.229 and 414.408 to reflect our interpretation of these statutory requirements.
Section 3139 of the ACA amends section 1847A of the Act to provide for Medicare payment of biosimilar biological products using the average sale price (ASP) methodology.
Section 1847A of the Act, as amended by the ACA, defines a biosimilar biological product as a biological product approved under an abbreviated application for a license of a biological product that relies in part on data or information in an application for another biological product licensed under section 351 of the Public Health Service Act (PHSA). The reference biological product for a biosimilar biological product is defined by the statute as the biological product licensed under such section 351 of the PHSA that is referred to in the application of the biosimilar biological product.
The ACAct also amends section 1847A of the Act to specify that the payment amount for a biosimilar biological product will be the sum of the following two amounts: the ASP of all NDCs assigned to the biosimilar biological drug product determined using the methodology in section 1847A(b)(6) of the Act, and 6 percent of the payment amount determined using the methodology in section 1847A(b)(4) of the Act for the corresponding reference biological product. Sections 7001 to 7003 of the ACA also established a licensing pathway for biosimilar biological products, and in accordance with the statute, the effective date for Medicare ASP statutory provisions is July 1, 2010. We are proposing conforming regulation text changes at § 414.902 and § 414.904 and we welcome comments on these conforming changes.
We anticipate that as biosimilar biological drug products are approved, we will receive ASP sales data through the ASP data submission process and publish national payment amounts in a manner that is consistent with our current approach to other drugs and biologicals that are paid under section 1847A of the Act and set forth in 42 CFR part 414 subpart J. Until we have collected sufficient sales data, as reported by manufacturers, payment limits will be determined in accordance with the provisions in section 1847A(c)(4) of the Act. If no manufacturer data is collected, prices will be determined by local contractors using any available pricing information, including provider invoices. More information about the ASP payment methodology and the data submission process may be found on the CMS Web site at
Section 3401(h) of the ACA amended section 1881(b)(14)(F) of the Act and directs the Secretary to annually increase payment amounts established under the ESRD market basket. Please see section VI.E. of this proposed rule for a detailed description of these provisions.
Section 3401 of the ACA requires that the update factor under certain payment systems be annually adjusted by changes in economy-wide productivity.
The projection of MFP will be produced by an economic forecasting firm, currently HIS Global Insight (IGI). In order to generate a forecast of MFP, IGI would replicate the MFP measure calculated by the BLS using a series of proxy variables derived from the IGI US Macro-economic models. These models take into account a very broad range of factors that influence the total US economy. IGI forecasts the underlying proxy components such as Gross Domestic Product (GDP), capital, and labor inputs required to estimate MFP, and will combine those projections according to the BLS methodology. For more information on the BLS measure of MFP, including technical notes, visit:
To identify the appropriate proxy variables, IGI compared the historical growth rates of the BLS and IGI components listed above and found they were consistent across all series and therefore suitable proxies for calculating MFP. IGI would use the growth rates of the forecasted IGI concepts to project BLS' components of MFP, and derive the MFP adjustment that would be used under section 3401 to adjust the updates for the ASC payment system, the AFS, and the CLFS.
As discussed below, for each of these payment systems, the update factor is the percentage increase (or percentage decrease for the CLFS) in the consumer price index for all urban consumers (CPI–U) (referred to as the “CPI–U update factor”).
The statute for all three payment systems generally states that the Secretary shall reduce the CPI–U adjustment by the MFP adjustment. In order to calculate the MFP-adjusted updates to these payment systems, the MFP percentage adjustment would be subtracted from the CPI–U update factor (for the most recent 12-month period beginning with July 1 of the previous year and ending with June 30 of the current year). For example, if the update factor (CPI–U) is 4.0 percent, and the projected MFP is 1.3 percent, the MFP–Adjusted update factor (or MFP–Adjusted CPI–U for these payment systems) would be a 2.7 percent increase.
The period on which the CPI–U is calculated is for the most recent 12-month period beginning with July 1 of the previous year and ending with June 30 of the current year, and we propose that the end of the 10-year moving average of changes in the MFP should coincide with the end of this CPI–U timeframe. Since the CPI–U update factor is reduced by the MFP adjustment to determine the annual update for these payment systems, we believe it is appropriate for the numbers associated with both parts of the calculation to be projected as of the same end date (in this case, the end date of the time frame for both estimates would be June 30th of the year preceding the update year itself). In this way, changes in market conditions are aligned. We will round the final annual adjustment to the one-tenth of one percentage point level up or down as applicable according to conventional rounding rules (that is, if the number we are rounding is followed by 5, 6, 7, 8, or 9, we will round the number up; if the number we are rounding is followed by 0, 1, 2, 3, or 4, we will round the number down).
Below, we provide more information on the statutory requirements and proposals for each of the three payment systems. The statutory requirements for the ASC payment system will also be addressed in the CY 2011 OPPS/ASC proposed rule. We note that, in this proposed rule, we are describing the legislative provision and outlining the methodology we propose to use to calculate and apply the MFP adjustment to determine the annual updates for ASCs, the AFS, and the CLFS for CY 2011 and each subsequent year. We will set forth the final MFP adjustment for CY 2011 in the CY 2011 PFS final rule. Once we finalize the methodology for determining and applying the MFP adjustment to the CPI–U update factors for these payment systems, for subsequent calendar years, as we have done in the past, we intend to notify the general public of the annual update to the AFS and CLFS via CMS instruction and on the CMS Web site. These notifications would set forth both the CPI–U percentage increase or decrease and the MFP adjustment for the applicable year. For ASCs, for subsequent calendar years, as we have done in the past, we would continue to notify the general public of the annual update to the ASC payment amount via OPPS/ASC rulemaking.
We welcome comments on these proposals.
Section 1833(i)(2)(C) of the Act requires that, if the Secretary has not updated the ASC payment amounts in a calendar year, the payment amounts shall be increased by the percentage increase in the CPI–U as estimated by the Secretary for the 12-month period ending with the midpoint of the year involved. Because the Secretary does update the ASC payment amounts annually, we adopted a policy, which we codified at § 416.171(a)(2)(ii), to update the ASC conversion factor using the CPI–U for CY 2010 and subsequent calendar years. Therefore, the annual
In accordance with section 1833(i)(2)(C)(i) of the Act, before applying the MFP adjustment, the Secretary first determines the “percentage increase” in the CPI–U, which we interpret cannot be a negative number. Thus, in the instance where the percentage change in the CPI–U for a year is negative, we propose to hold the CPI–U update factor for the ASC payment system to zero. Section 1833(i)(2)(D)(v) of the Act, as added by section 3401(k) of the ACA, then requires that the Secretary reduce the CPI–U update factor (which would be held to zero if the CPI–U percentage change is negative) by the MFP adjustment, and states that application of the MFP adjustment may reduce this percentage change below zero. If the application of the MFP adjustment to the CPI–U percentage increase would result in a MFP-adjusted CPI–U update factor that is less than zero, then the annual update to the ASC payment rates would be negative and payments would decrease relative to the prior year.
Table 35 provides illustrative examples of how the MFP would be applied to the ASC payment system. These examples show the implication of a positive CPI–U update factor with a smaller MFP, a positive CPI–U update factor with a large MFP, and a CPI–U update factor of 0. We discuss the application of the MFP to the CPI–U update factor for the ASC payment system under the OPPS/ASC CY 2001 proposed rule (1504–P), which will be published around the same time as this proposed rule. Comments on the specific mathematical calculation of the MFP should be made to this PFS proposed rule. Comments on the application of the MFP to the CPI–U update factor under the ASC payment system should be made to the OPPS/ASC CY 2011 proposed rule (1504–P).
In accordance with section 1834(l)(3)(B) of the Act, the AFS is required to be increased each year by the percentage increase in the CPI–U (U.S. city average) for the 12-month period ending with June of the previous year. We refer to this update as the Ambulance Inflation Factor (AIF). Section 3401(j) of the ACA amends section 1834(l)(3) of the Act to add a new subparagraph (C) which states that, for CY 2011 and each subsequent year, after determining the percentage increase under section 1834(l)(3)(B) (that is, the CPI–U percentage increase, or AIF), the Secretary shall reduce such percentage increase by the MFP adjustment described in section 1886(b)(3)(B)(xi)(II) (as discussed above). Section 3401(j) further amends section 1834(l)(3) to state that the application of subparagraph (C) (that is, the reduction of the CPI–U percentage increase by the MFP adjustment) may result in that percentage increase being less than zero for a year, and may result in payment rates for a year being less than such payment rates for the preceding year.
In accordance with section 1834(l)(3) of the Act as amended by section 3401(j) of the ACA, before applying the MFP adjustment, the Secretary first determines the “percentage increase” in the CPI–U, which we interpret cannot be a negative number. Thus, in the instance where the percentage change in the CPI–U for a year is negative, we propose to hold the AIF to zero. The statute then requires that the Secretary reduce the CPI–U percentage increase (which would be held to zero if the CPI–U percentage change is negative) by the MFP adjustment, and states that application of the MFP adjustment may reduce this percentage increase below zero. If the application of the MFP adjustment to the CPI–U percentage increase would result in an MFP-adjusted AIF that is less than zero, then the annual update to the AFS would be negative and payments would decrease relative to the prior year.
Table 36 provides illustrative examples of how the MFP would be applied to the AFS. Finally, we propose to revise § 414.610(f) to require that the AIF be reduced by the MFP adjustment as required by the statute in determining the annual update under the ambulance fee schedule for CY 2011 and each subsequent year, and to revise § 414.620 to state that changes in payment rates resulting from the incorporation of the AIF and the MFP adjustment will be announced by CMS by instruction and on the CMS Web site, as we discussed above.
Section 1833(h)(2)(A)(i) of the Act, as amended by section 3401(l) of the ACA, requires the Secretary to annually adjust the CLFS “by a percentage increase or decrease equal to the percentage increase or decrease in the Consumer Price Index for All Urban Consumers (United States city average minus, for each of the years 2009 through 2010, 0.5 percentage points.” Therefore, the
Section 3401(l) of the ACA also adds new clause (iv) that applies in CY 2011 and each subsequent year. This clause requires the Secretary to reduce the adjustment in clause (i): (1) By the MFP adjustment described in section 1886(b)(3)(B)(xi)(II) for 2011 and each subsequent year and (2) by 1.75 percentage points for each of 2011 through 2015 (the “percentage adjustment”). However, section 3401(l) of the ACA states that the MFP adjustment will not apply in a year where the adjustment to the fee schedule determined under clause (i) is zero or a percentage decrease for a year. Further, the application of the MFP adjustment may not result in an adjustment to the fee schedule under clause (i) of less than zero for a year.
Therefore, we are proposing to apply the MFP adjustment as follows:
• If the CPI–U update factor is positive, it would be reduced by the MFP. However, if application of the MFP would result in a negative update, the update would be held to zero.
• If the CPI–U update factor is zero or negative, the MFP adjustment would not be applied.
Section 3401(l) of the ACA also states that the application of the percentage adjustment may result in an adjustment to the fee schedule under clause (i) being less than zero for a year and may result in payment rates for a year being less than such payment rates for the preceding year. Therefore, we are proposing to apply the percentage reduction of 1.75 percentage points to any adjustment to the fee schedule under the CLFS as directed by Section 3401(l) of the ACA.
Table 37 provides illustrative examples of how these adjustments would be applied to fees under the CLFS.
Sections 1834(a)(14), 1834(h)(4), and 1842(s)(1) of the Act mandate annual updates to the fee schedule amounts established in accordance with these respective sections for covered items of durable medical equipment defined in section 1834(a)(13) of the Act, prosthetic devices, orthotics, and prosthetics defined in section 1834(h)(4)(B) and (C) of the Act, and parenteral and enteral nutrients, equipment, and supplies described in section 1842(s)(2)(D) of the Act. The annual updates for 2011 for these sections are based on the percentage increase in the CPI–U for the 12-month period ending with June 2010. The annual updates for years subsequent to 2011 are based on the percentage increase in the CPI–U for the 12-month period ending with June of the previous year (that is, June 2011 for 2012, June 2011 for 2013,
Section 3401(m) of the ACA amends section 1834(a)(14) of the Act to add a new subparagraph (L) which provides that, for CY 2011 and each subsequent year, the fee schedule update factor based on the CPI–U for the 12-month period ending with June of the previous year is to be reduced by the MFP adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act (as discussed above). Section 3401(m) of the ACA further amends section 1834(a)(14) of the Act to state that the application of subparagraph (L) (that is, the reduction of the CPI–U percentage increase by the MFP adjustment) may result in that percentage increase being less than zero for a year, and may result in payment rates for a year being less than such payment rates for the preceding year.
Section 3401(n) of ACA amends section 1834(h)(4)(A) of the Act to add a new clause (xi) which provides that, for CY 2011 and each subsequent year, the fee schedule update factor based on the CPI–U for the 12-month period ending with June of the previous year is to be reduced by the MFP adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act (as discussed above). Section 3401(n) of the ACA further amends section 1834(h)(4) of the Act to state that the application of subparagraph (A)(xi) (that is, the reduction of the CPI–U percentage increase by the MFP adjustment) may result in that percentage increase being less than zero for a year, and may result in payment rates for a year being less than such payment rates for the preceding year.
Section 3401(o) of ACA amends section 1842(s)(1) of the Act to add a new subparagraph (B) and clause (ii) which provides that, for CY 2011 and each subsequent year, the fee schedule update factor based on the CPI–U for the 12-month period ending with June of the previous year is to be reduced by the MFP adjustment described in section 1886(b)(3)(B)(xi)(II) (as discussed above). Section 3401(o) further amends section 1842(s)(1) to state that the application of subparagraph (B)(ii) (that is, the reduction of the CPI–U percentage increase by the MFP adjustment) may result in that percentage increase being less than zero for a year, and may result in payment rates for a year being less than such payment rates for the preceding year.
The MFP adjustments to the CPI–U percentage increases used in calculating the fee schedule adjustment factors for these DMEPOS items and services as mandated by sections 3401(m), (n), and (o) of ACA are simple mathematical calculations and are ministerial in nature. Therefore, we plan to implement these adjustments for 2011 and subsequent years as part of the annual program instructions related to the DMEPOS fees schedule updates.
Section 1862(a)(7) of the Act explicitly prohibits Medicare payment for routine physical checkups with certain exceptions. One exception is for the Initial Preventive Physical Exam (also referred to as the “Welcome to Medicare” exam) established for new beneficiaries effective for services furnished on or after January 1, 2005. Section 4103 of the ACA has provided another exception to section 1862(a)(7). Congress has expanded Medicare coverage under part B to include an Annual Wellness Visit Providing Personalized Prevention Plan Services (hereinafter referred to as the annual wellness visit) in sections 1861(s)(2)(FF) and 1861(hhh) of the Act. This expanded benefit will be effective on January 1, 2011. Preventive care has become an increasing focus of the Medicare program. For instance, section 101 of the MIPPA expanded Medicare's authority to establish coverage for preventive services that meet specified criteria. Among other things, the annual wellness visit will encourage beneficiaries to obtain the preventive services already covered by Medicare, and that are appropriate for each individual beneficiary.
Section 4103 of the ACA provides for coverage of an annual wellness visit, which includes and/or takes into account a health risk assessment (HRA), and creates a personalized prevention plan for beneficiaries, subject to certain eligibility and other limitations. Section 4103 of the ACA also requires the identification of elements that must be provided to a beneficiary as part of the first visit for personalized prevention plan services and requires the establishment of a yearly schedule for appropriate provision of such elements thereafter.
The Affordable Care Act specifies elements that may be included in a personalized prevention plan, including establishment of, or update to, the individual's medical and family history, a list of the individual's current providers and suppliers and medications prescribed for the individual; measurement of height, weight, body-mass index (BMI) or waist circumference, and blood pressure; detection of any cognitive impairment; establishment or update of an appropriate screening schedule for the next 5 to 10 years; establishment or update of a list of risk factors and conditions (including any mental health conditions) for which interventions are recommended or underway; and furnishing of personalized health advice and referral, as appropriate, to health education or preventive counseling services or programs. The Affordable Care Act also permits the Secretary to add other elements to the annual wellness visit determined to be appropriate.
To conform the regulations to the statutory requirements of the ACA, we are proposing to revise § 411.15 by specifying an exception to the routine physical checkups exclusion from coverage in § 411.15(a)(1) and modifying § 411.15(k)(15). We would add a provision to permit coverage of annual wellness visits that meet the eligibility limitation and the conditions for coverage we are specifying in § 410.15 (Annual Wellness Visit Providing Personalized Prevention Plan Services). Coverage of the annual wellness visit is furnished under Medicare Part B only. As provided in the statute, this new coverage allows payment for an annual wellness visit if provided after January 1, 2011 for an individual who is no longer within 12 months after the effective date of his or her first Medicare Part B coverage period, and has not received either an IPPE or an annual wellness visit within the past 12 months.
We propose to add § 410.15(a), Condition for Coverage of Annual Wellness Visits Providing Personalized Prevention Plan Services, and § 410.15(b), Limitation on Coverage of Annual Wellness Visits Providing Personalized Prevention Plan Services, to codify the coverage of the annual wellness visit providing personalized prevention plan services.
We are proposing to define several terms in § 410.15. These include the following terms: (1) Detection of any cognitive impairment; (2) Review of the individual's functional ability and level of safety; (3) Health professional; (4) Establishment of, or update to the individual's medical and family history; (5) Eligible beneficiary; (6) First annual wellness visit providing personalized prevention plan services; and (7) Subsequent annual wellness visit providing personalized prevention plan services.
Further, the ACA allows the addition of any other element determined appropriate by the Secretary for inclusion in an annual wellness visit. We reviewed the relevant medical literature, current clinical practice guidelines, and the recommendations of the United States Preventive Services Task Force (USPSTF). Pursuant to that review, we propose to add depression screening and functional status screening as elements of the first annual wellness visit only. In their December 2009 Recommendation Statement, the U.S. Preventive Services Task Force (USPSTF) recommends screening adults for depression when staff-assisted depression care supports are in place to assure accurate diagnosis, effective treatment and follow-up (Grade: B recommendation). That is, the USPSTF recommends the service; and there is high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial.
The USPSTF is currently updating its 1996 recommendation regarding screening for hearing impairment in older adults as well as its recommendation on falls in the elderly. Until those recommendations can be published, functional status screening (including assessment of hearing impairment, ability to successfully perform activities of daily living, fall risk and home safety) appears supportable by evidence only for the first annual wellness visit.
We also are proposing that the definition of the term “Establishment of, or an update to the individual's medical and family history” include more than a list of all of an individual's prescribed medications as provided in the statute, but also supplements such as vitamins and calcium that an individual may use or be exposed to. Supplements such as these are commonly used by many beneficiaries and the medical literature supports that their use be closely monitored by health professionals because they can interact with prescribed medications and may result in unintended medical problems in individual cases. The statute expressly permits the Secretary to add other elements such as this to the annual wellness visits.
We are proposing to add the following definitions to § 410.15:
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We are proposing that the first annual wellness visit for purposes of this benefit include the following:
• Establishment of the individual's medical and family history;
• Establishment of a list of current providers and suppliers that are regularly involved in providing medical care to the individual;
• Measurement of the individual's height, weight, body mass index (or waist circumference, if appropriate), blood pressure, and other routine measurements as deemed appropriate, based on the individual's medical and family history;
• Detection of any cognitive impairment that the individual may have;
• Review of the individual's potential (risk factors) for depression, including current or past experiences with depression or other mood disorders, based on the use of an appropriate screening instrument for persons without a current diagnosis of depression, which the health professional as defined in this section may select from various available screening questions or standardized questionnaires designed for this purpose and recognized by national professional medical organizations;
• Review of the individual's functional ability and level of safety, based on direct observation or the use of appropriate screening questions or a screening questionnaire, which the health professional as defined in this section may select from various available screening questions or standardized questionnaires designed for this purpose and recognized by national professional medical organizations;
• Establishment of the following:
• Furnishing of personalized health advice and a referral, as appropriate, to health education or preventive counseling services or programs aimed at reducing identified risk factors and improving self management, or community-based lifestyle interventions to reduce health risks and promote self-management and wellness, including weight loss, physical activity, smoking cessation, fall prevention, and nutrition; and
• Any other element determined appropriate by the Secretary through the National Coverage Determination process.
We are proposing that subsequent annual wellness visits providing personalized prevention plan services for purposes of this benefit include the following:
• An update of the individual's medical and family history;
• An update of the list of current providers and suppliers that are regularly involved in providing medical care to the individual, as that list was developed for the first annual wellness visit providing personalized prevention plan services;
• Measurement of an individual's weight, blood pressure, and other routine measurements as deemed appropriate, based on the individual's medical and family history;
• Detection of any cognitive impairment, as that term is defined in this section, that the individual may have;
• An update to the following:
• Furnishing of personalized health advice to the individual and a referral, as appropriate, to health education or preventive counseling services or programs as that advice and related services are defined in paragraph (a) of this section;
• Any other element determined appropriate by the Secretary through the National Coverage Determination process. Body-mass index (BMI) should be calculated at the first annual wellness visit and may be recalculated at subsequent visits, if indicated. Given
We are proposing to add two distinct elements to the definition of the first annual wellness visit only: depression screening and functional status assessment. Our review of the medical literature and the USPSTF recommendations indicates that the optimum frequency for those services is unknown. Thus we believe it would be premature and beyond the current evidence to require that they be included in the definition of subsequent visits, but they may be performed at these visits, if indicated.
In addition, to facilitate future consideration of coverage of additional elements in the definitions of the first and subsequent annual wellness visits in § 410.15(a), we are proposing that the determination of other required elements for those purposes will be made through the National Coverage Determination (NCD) process. The NCD process is evidence based, transparent and furnishes the opportunity for public comment, and is described in sections 1862(l) of the Act.
While section 4103 of the ACA ultimately requires that an HRA be included in the new annual wellness visit benefit beginning January 1, 2011, the HRA guidelines (with standards for interactive telephonic and web-based HRAs) and the model HRA tool also required by section 4103 are not yet available. As a result, we have not included requirements related to the HRA in this proposed rule. When HRA guidelines and standards have been established, and a model HRA instrument is available and determined by the Secretary to be appropriate for the Medicare population, we will revise these regulations to include the HRA as an element in the definition of the annual wellness visit.
We are requesting public comments on the components of both the first and subsequent annual wellness visits, as well as the definitions of related terms in the document. We ask that commenters making specific recommendations on this or any related issue provide documentation from the medical literature, current clinical practice guidelines, or the USPSTF or Advisory Committee on Immunization Practices recommendations.
Section 4103 of the ACA created a new benefit for the “annual wellness visit” with personalized prevention plan services. The Affordable Care Act amends section 1861(s)(2) of the Act by adding a new subsection (FF) to provide for coverage of the annual wellness visit beginning January 1, 2011. Section 4103 also adds new subsection (hhh) to section 1861 of the Act to define “personalized prevention plan services” and to specify who may furnish these services. Finally, section 4103 amends section 1848(j)(3) of the Act to provide for payment of annual wellness visits under the PFS, and specifically excludes the annual wellness visit from the hospital outpatient prospective payment system (OPPS). Therefore, a single payment under the PFS will be made when an annual wellness visit is furnished by a physician, physician assistant, nurse practitioner, or clinical nurse specialist, or by a medical professional or team of medical professionals, as determined appropriate by the Secretary, under the supervision of a physician.
To allow for Medicare reporting and payment of the annual wellness visit, we are proposing to create two new HCPCS G-codes for reporting the first wellness visit and creation of the PPPS and the subsequent visits available to the beneficiary every 12 months. Specifically, we are proposing to establish the following two new HCPCS codes for CY 2011: GXXXA (Annual wellness visit; includes a personalized prevention plan of service (PPPS), first visit) and GXXXB (Annual wellness visit; includes a personalized prevention plan of service (PPPS), subsequent visit). A beneficiary's first annual wellness visit to a practitioner would be reported to Medicare under HCPCS code GXXXA, even if the beneficiary had previously received an initial preventive physical examination (IPPE) that was covered by Medicare. Beneficiaries, in their first 12 months of Part B coverage, will continue to be eligible only for an IPPE. After the first 12 months of Part B coverage, on and after January 1, 2011, beneficiaries will be eligible for an annual wellness visit described by HCPCS code GXXXA or GXXXB, provided that the beneficiary has not received an IPPE or annual wellness visit within the preceding 12-month period.
A beneficiary would be eligible for one initial annual wellness visit covered by Medicare that must include all of the required elements that we are proposing for the first visit as described in the preceding section. All other annual wellness visits that would include the required elements for those visits would be reported as subsequent visits, even if a different practitioner furnished the subsequent annual wellness visit. We would expect there to be continuity and communication among the practitioners caring for beneficiaries over time with respect to the PPPS, and that would include the case where a different practitioner furnishing a subsequent annual wellness visit would update the information in the patient's medical record based on the patient's interval history since the previous annual wellness visit.
The first wellness visit described by HCPCS code GXXXA is similar to the IPPE that is currently reported with HCPCS code G0402 (Initial preventive physical examination; face-to-face visit, services limited to new beneficiary during the first 12 months of Medicare enrollment). We believe that the physician work and nonfacility PE of the IPPE and the first annual wellness visit are very similar, given that both represent an initial beneficiary visit focused on prevention. In the CY 2010 PFS final rule with comment period discussion of payment for the IPPE (74 FR 61767), we noted that in the context of physician work and intensity, HCPCS code G0402 was most equivalent to CPT code 99204 (Level 4 new patient office or other outpatient visit). Therefore, for CY 2011, we are proposing to crosswalk the same physician work RVUs of 2.43 from CPT code 99204 to HCPCS codes G0402 and GXXXA. Similarly, we believe the direct PE inputs for all of these services are similar and, therefore, we are proposing to assign the same direct PE inputs to HCPCS codes G0402 and GXXXA as are included for CPT code 99204. We note that currently, the direct PE inputs for HCPCS code G0402 also include preventive assessment forms, and we are proposing to add this supply to the PE for HCPCS code GXXXA as well because we believe it would be used in the first wellness visit. The proposed CY 2011 PE and malpractice RVUs for HCPCS code GXXXA are displayed in Addendum B to this proposed rule. We also note that we are proposing no facility PE RVUs for HCPCS code GXXXA because only a single payment will be made under the PFS when this service is furnished. There is no separate facility payment for GXXXA when a practitioner furnishes this service in the facility setting.
Moreover, we believe that a subsequent annual wellness visit described by HCPCS code GXXXB is most similar, from the perspectives of
While we believe there could be overlap in the direct PE, malpractice expense, and physician work in both history taking and examination of the patient in the context of the initial or subsequent wellness visit and another E/M service, we are not proposing to limit the level of a medically necessary E/M visit when furnished and billed with a wellness visit. As we stated in the CY 2005 PFS final rule with comment period with respect to the IPPE (69 FR 66289 through 66290), we do not want to prohibit the reporting of an appropriate level of service when it is necessary to evaluate and treat the beneficiary for acute and chronic conditions. However, at the same time, we believe the practitioner is better able to discuss health promotion, disease prevention, and the educational opportunities available with beneficiaries when their health status has been stabilized and the beneficiary is physically receptive. Therefore, depending on the clinical circumstances, a CPT code for a medically necessary E/M visit may be reported and appended with CPT modifier -25 (significant, separately identifiable evaluation and management service by the same physician on the same day of the procedure or other service) to designate the E/M visit as a separately identifiable service from the initial or subsequent wellness visit. However, we believe this scenario would be uncommon, and we expect that no components of an encounter attributable to the annual wellness visit would be used in determining the level of a separate E/M visit that would also be reported.
With respect to beneficiary cost-sharing, section 4103(c) of the ACA amends section 1833(a)(1) of the Act by adding subparagraph (X), referring to the PPPS to state that the amount paid shall be 100 percent of the lesser of the actual charge for the services or the amount determined under the payment basis determined under section 1848 of the Act, thereby eliminating coinsurance for the annual wellness visit. Finally, section 4103(b)(4) of the ACA amends section 1833(b) of the Act to specify that the Part B deductible does not apply to the annual wellness visit. We expect that practitioners will work to ensure that this valuable new Medicare benefit is furnished to the beneficiaries that they care for in their practices, effective January 1, 2011.
Section 4104 of the ACA revises section 1861(ddd) of the Act to add paragraph (3), which defines the term “preventive services” as follows:
• The specific services currently listed in section 1861(ww)(2) of the Act with the explicit exclusion of electrocardiograms (as specified in section 1861(ww)(2)(M) of the Act);
• The initial preventive physical examination (IPPE) established by section 611 of the MMA and defined in section 1861(ww)(1) of the Act; and
• The annual wellness visit, as specified by section 1861(hhh) of the Act as added by section 4103 of the ACA. We refer readers to section V.Q. of this proposed rule for the proposed provisions related to the coverage of and payment for the annual wellness visit. The regulations regarding coverage of the IPPE are specified in § 410.16 and remain unchanged by the ACA.
The specific preventive services included in the definition of “preventive services” in section 1861(ddd)(3)(A) of the Act as cross-referenced to section 1861(ww)(2) of the Act, excluding electrocardiograms, include the following:
• Pneumococcal, influenza, and hepatitis B vaccine and administration.
• Screening mammography.
• Screening pap smear and screening pelvic exam.
• Prostate cancer screening tests.
• Colorectal cancer screening tests.
• Outpatient diabetes self-management training (DSMT).
• Bone mass measurement.
• Screening for glaucoma.
• Medical nutrition therapy (MNT) services.
• Cardiovascular screening blood tests.
• Diabetes screening tests.
• Ultrasound screening for abdominal aortic aneurysm (AAA).
• Additional preventive services identified for coverage through the national coverage determination (NCD) process.
We note that currently the only additional preventive service identified for coverage through the NCD process is HIV testing. A proposed NCD for smoking cessation services for asymptomatic patients was released in May 2010 on the CMS Web site at:
We are proposing to add the definition of “preventive services” in § 410.2 to implement the provisions of section 1861(ddd)(3) of the Act (as amended by section 4104 of the ACA).
Section 4104(b)(4) of the ACA amends section 1833(a)(1) of the Act by requiring 100 percent Medicare
Section 4104(c) of the ACA amends section 1833(b)(1) of the Act to waive the Part B deductible for preventive services described in subparagraph (A) of section 1861(ddd)(3) of the Act that have a grade of A or B from the USPSTF. In addition, section 1833(b)(1) of the Act (as amended by section 4103(c)(4) of the ACA) waives the Part B deductible for the annual wellness visit. These provisions are effective for services furnished on and after January 1, 2011. Section 101(b)(2) of the MIPPA amended section 1833(b) of the Act to waive the deductible for the IPPE effective January 1, 2009.
Not all preventive services described in subparagraph (A) of section 1861(ddd)(3) are recommended by the USPSTF with a grade of A or B and, therefore, some of the preventive services do not meet the criteria in sections 1833(a)(1) and (b)(1) of the Act for the waiver of the deductible and coinsurance. However, with certain exceptions noted below, the changes made by section 4104 of the ACA do not affect most of the preexisting specific provisions in sections 1833(a) and 1833(b) of the Act (that are codified in regulations in § 410.160(b) and § 410.152) that waive the deductible and coinsurance for specific services. For example, section 1833(a)(1)(D) of the Act already waives the coinsurance and section 1833(b)(3) of the Act waives the deductible for clinical laboratory tests (including tests furnished for screening purposes). Section 4104 of the ACA does not change this provision and, therefore, the waiver of both the deductible and coinsurance remains in place for all laboratory tests, regardless of whether the particular clinical laboratory test meets the USPSTF grading criteria specified in sections 1833(a)(1) and 1833(b)(1) of the Act (as amended by section 4104 of the ACA) for waiver of the deductible and coinsurance as a preventive service.
The following preventive services listed in section 1833(ddd)(3)(A) of the Act are not recommended by the USPSTF with a grade of A or B for any indication or population: digital rectal examination furnished as a prostate cancer screening service; glaucoma screening; DSMT services; and barium enema furnished as a colorectal cancer screening service.
Specifically, HCPCS code G0102 (Prostate cancer screening; digital rectal exam), which does not have a grade of A or B from the USPSTF for any indication or population, will continue to be subject to the deductible and coinsurance as there is no statutory provision to the contrary. However, the deductible and coinsurance for HCPCS code G0103 (Prostate cancer screening; prostate specific antigen test (PSA)) will continue to be waived in accordance with section 1833(a)(1)(D) of the Act, even though this service also does not have a grade of A or B from the USPSTF.
Glaucoma screening services, described by HCPCS codes G0117 (Glaucoma screening for high risk patients furnished by an optometrist or ophthalmologist) and G0118 (Glaucoma screening for high risk patient furnished under the direct supervision of an optometrist or ophthalmologist), will continue to be subject to the deductible and coinsurance because these services are not recommended with a grade of A or B by the USPSTF for any indication or population and there is no other statutory provision to except them. Similarly, DSMT services are currently not rated by the USPSTF, and there is no other statutory provision to except them from applicability of the deductible and coinsurance. Therefore the deductible and coinsurance requirements will continue to apply.
Barium enemas furnished as colorectal cancer screening tests, described by HCPCS codes G0106 (Colorectal cancer screening; alternative to G0104, screening sigmoidoscopy, barium enema) and G0120 (Colorectal cancer screening; alternative to G0105, screening colonoscopy, barium enema), do not have a grade of A or B from the USPSTF for any indication or population. However, the deductible does not apply to barium enemas furnished as colorectal cancer screening tests, because colorectal cancer screening tests are explicitly excluded from the deductible in section 1833(b)(8) of the Act. However, there is no specific exclusion of barium enemas from the coinsurance requirement in section 1833(b)(1) of the Act and, therefore, this requirement, as applicable, continues to apply to barium enemas. We note that the USPSTF has given a grade of A to screening colonoscopy, screening flexible sigmoidoscopy, and fecal occult blood screening tests, and that, as a result, these colorectal cancer screening tests are subject to the statutory waiver of both the deductible and coinsurance.
We note also that the USPSTF ceased to make recommendations with regard to vaccines and vaccine administration after CY 1996, so as not to conflict with the recommendations of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices. However, the USPSTF's most recent vaccine recommendations gave a grade of B to influenza and pneumococcal vaccines and their administration and a grade of A to hepatitis B vaccine and its administration. While sections 1833(a)(1) and 1833(b)(1) of the Act require that the preventive services receive a grade of A or B from the USPSTF for the coinsurance and deductible to be waived, the statute does not specify that the recommended grade must be furnished by the USPSTF within any given timeframe. The USPSTF grades for these preventive services are the most current USPSTF grade and have never been withdrawn. Therefore, we believe that these preventive services meet the requirements of the statute for the waiver of the deductible and coinsurance. We also note that the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices currently recommends influenza, pneumococcal, and hepatitis B vaccines.
We are proposing to update § 410.160(b), which lists the services for which expenses incurred are not subject to the Part B annual deductible and do not count toward meeting that deductible. Specifically, we are proposing to revise § 410.160(b)(2) to include influenza and hepatitis B
In § 410.152, we are proposing to revise paragraph (l) to establish the amount of payment under the applicable payment system for providers and suppliers of the services listed in the paragraph and displayed in Table 38. Table 38 displays the HCPCS codes that we are proposing as “preventive services” under section 1861(ddd)(3)(A) of the Act and identifies the HCPCS codes for the IPPE and the annual wellness visit. Table 38 also indicates the most recent USPSTF grade, if any, that is the basis for our proposed policy with regard to waiver of the deductible and coinsurance, as applicable, and the Medicare payment system under which the HCPCS code would be paid when furnished outside of the facility setting. We note that the changes made by section 4104 of the ACA with respect to the deductible and coinsurance apply in all settings in which the services are furnished.
In developing recommendations regarding preventive services, we recognize that the USPSTF may make recommendations that are specific to an indication or population, at times including characteristics such as gender and age in its recommendations. While we are proposing to waive the deductible and coinsurance for any Medicare covered preventive service recommended with a grade of A or B for any indication or population, with no limits on the indication or population as long as the USPSTF has recommended the preventive service for at least one indication and/or population with a grade of A or B, we note that all existing Medicare coverage policies for such services, including any limitations based on indication or population, continue to apply. In some cases, national coverage policies may currently limit Medicare coverage based on the indication or population, consistent with the USPSTF recommendations with a grade of A or B for the indication or population. In other cases where Medicare does not explicitly noncover preventive services for a specific population or indication, we would expect that, particularly in those cases where the USPSTF recommendation grade is a D (that is, the USPSTF recommends against the service because there is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits), practitioners would only order those preventive services that are clinically appropriate for the beneficiary. If we have concerns in the future about the appropriateness of preventive services for an indication or population in light of the USPSTF's recommendations, we may consider using our authority under section 1834(n)(1) of the Act (as added by section 4105 of the ACA) to modify Medicare coverage of any preventive service to be consistent with the recommendations of the USPSTF.
Section 10501(i)(2) of the ACA amended the definition of Federally Qualified Health Center (FQHC) services as defined in section 1861(aa)(3)(A) of the Act by replacing the specific references to services provided under section 1861(qq) and (vv) of the Act (diabetes outpatient self-management training services and medical nutrition therapy services, respectively) with preventive services as defined in section 1861(ddd)(3) of the Act, as established by section 4014(a)(3) of the ACA. These changes are effective for services provided on or after January 1, 2011. Accordingly, we are proposing to conform the regulations to the new statutory requirement by adding a new section § 405.2449 which would add the new preventive services definition to the definition of FQHC services effective for services provided on or after January 1, 2011.
Section 1861(ddd)(3) of the Act defines “preventive services” as consisting of the following three components:
• Screening and preventive services described in section 1861(ww)(2) of the Act (other than electrocardiograms described in subparagraph (M) of that same subsection).
• An initial preventive physical examination, as defined in section 1861(ww) of the Act.
• Personalized prevention plan services as defined in section 1861(hhh)(1) of the Act.
We are proposing to add each of these three components into the new Medicare FQHC preventive services definition in a new § 405.2449.
Section 4104(b)(1) of the ACA, as amended by section 10406 of the same Act, waives coinsurance for preventive services by adding section 1833(a)(1)(Y) to the Act to require, essentially, waiver of coinsurance for preventive services that are recommended with a grade of A or B by the USPSTF for any indication or population. This provision is specifically designed to remove barriers to affording and obtaining such preventive services under Medicare.
In addition, section 10501(i)(3)(B)(ii) of the ACA added section 1833(a)(1)(Z) to the Act to require a 20-percent copay on all FQHC services after implementation of the FQHC prospective payment system. We believe we can give both section 1833(a)(1)(Y) and (Z) of the Act, and the definition of FQHC services (revised to include the broader scope of preventive services) their best effect by permitting a 100 percent reimbursement rate for preventive services as defined at section 1861 (ddd)(3) of Act, effective January 1, 2011.
Section 1833(b)(4) of the Act stipulates that the Medicare Part B deductible shall not apply to Federally qualified health center services. The ACA makes no change to this provision, therefore Medicare shall continue to waive the Part B deductible for all federally qualified health center services, including preventive services added by the ACA.
Section 4104(c) of the ACA amends section 1833(b) of the Act to waive the Part B deductible for colorectal cancer screening tests that become diagnostic. Specifically, section 1833(b)(1) of the Act (as amended by section 4104(c)(2) of the ACA) waives the deductible with respect to a colorectal cancer screening test regardless of the code that is billed for the establishment of a diagnosis as a result of the test, or for the removal of tissue or other matter or other procedure that is furnished in connection with, as a result of, and in the same clinical encounter as a screening test. We are proposing that all surgical services furnished on the same date as a planned screening colonoscopy, planned flexible sigmoidoscopy, or barium enema be considered to be furnished in connection with, as a result of, and in the same clinical encounter as the screening test. In the event of a legislative change to this policy (for example, a statutory change that would waive the coinsurance for these related services in addition to the deductible), we would reassess the appropriateness of this proposed definition of services that are furnished in connection with, as a result of, and in the same clinical encounter as the colorectal cancer screening test that becomes diagnostic. We also note that the beneficiary's annual deductible would likely be met when any surgical procedure (related or not) is furnished on the same day as the scheduled screening test.
We are proposing to implement this provision by creating a HCPCS modifier that providers and practitioners would append to the diagnostic procedure code that is reported instead of the screening colonoscopy or screening flexible sigmoidoscopy HCPCS code or as a result of the barium enema when the screening test becomes a diagnostic service. The claims processing system would respond to the modifier by waiving the deductible for all surgical services on the same date as the diagnostic test. Coinsurance would continue to apply to the diagnostic test and to other services furnished in connection with, as a result of, and in the same clinical encounter as the screening test.
Section 5501(a) of the ACA revises section 1833 of the Act by adding a new paragraph (x), “Incentive Payments for Primary Care Services.” Section 1833(x) of the Act states that in the case of primary care services furnished on or after January 1, 2011 and before January 1, 2016 by a primary care practitioner, there shall also be paid on a monthly or quarterly basis an amount equal to 10 percent of the payment amount for such services under Part B.
Section 1833(x)(2)(A) of the Act (as added by section 5501(a) of the ACA) defines a primary care practitioner as: (1) A physician, as described in section 1861(r)(1) of the Act, who has a primary specialty designation of family medicine, internal medicine, geriatric medicine, or pediatric medicine; or (2) a nurse practitioner, clinical nurse specialist, or physician assistant as defined in section 1861(aa)(5) of the Act, and in all cases, for whom primary care services accounted for at least 60 percent of the allowed charges under Part B for the practitioner in a prior period as determined appropriate by the Secretary.
Section 1833(x)(2)(B) (as added by section 5501(a)(2)(B) of the ACA) defines primary care services as those services identified by the following HCPCS codes as of January 1, 2009 (and as subsequently modified by the Secretary, as applicable):
• 99201 through 99215 for new and established patient office or other outpatient evaluation and management (E/M) visits;
• 99304 through 99340 for initial, subsequent, discharge, and other nursing facility E/M services; new and established patient domiciliary, rest home (
• 99341 through 99350 for new and established patient home E/M visits.
These codes are displayed in Table 39. All of these codes remain active in CY 2010 and there are no other codes used to describe these services.
For primary care services furnished on or after January 1, 2011 and before January 1, 2016, we are proposing to provide a 10 percent incentive payment to primary care practitioners, identified as the following: (1) In the case of physicians, enrolled in Medicare with a primary specialty designation of 08—family practice, 11—internal medicine, 37—pediatrics, or 38—geriatrics; or (2) in the case of nonphysician practitioners (NPPs), enrolled in Medicare with a primary care specialty designation of 50—nurse practitioner, 89—certified clinical nurse specialist, or 97—physician assistant; and (3) for whom the primary care services displayed in Table 39 accounted for at least 60 percent of the allowed charges under Part B for such practitioner during the time period that is specified by the Secretary, and proposed in this section.
We are proposing to use the most current full year of claims data to identify primary care practitioners eligible for the PCIP for a CY based on the practitioner's primary specialty (as identified on claims) and the practitioner's percentage of all allowed charges for the primary care services displayed in Table 39. We commonly use the most recent full year of claims data for purposes of establishing annual payment amounts under a number of Medicare's fee-for-service programs. A practitioner with a primary care specialty designation would be eligible for the PCIP in a CY if the percentage of his or her allowed charges for primary care services (identified in Table 39) on claims where the practitioner is identified as one of the primary care specialties described above meets or exceeds the 60 percent threshold. We note that the practitioner's specialty is applied to the claim by the claims processing system and reflects the physician's primary specialty designation for purposes of Medicare enrollment on the date the claim is processed, which would usually be close to the date on which the service was actually furnished to the beneficiary. We would identify primary care practitioners eligible for the PCIP for a year by the individual physician/practitioner national provider identifier (NPI) number using the most current full year of claims data available.
Therefore, for determining PCIP practitioner eligibility for CY 2011, we would use CY 2009 PFS claims data, processed through June 30, 2010. This would ensure analysis of about 99 percent of CY 2009 claims to determine practitioner eligibility for PCIP payment beginning January 2011. We note that the MMA changed the requirements for critical access hospital (CAH) billing for practitioners' professional services and, therefore, modifications were made to the Medicare claims processing system to require CAHs to identify the practitioner furnishing a service on the CAH claim for that professional service. However, because the rendering practitioner has only been identified on CAH claims since July 1, 2009, for the first year of the PCIP we are proposing to identify eligible practitioners using only 6 months of CAH data for those CAHs paid under the optional method. Thereafter, we would update the list of practitioners eligible for the PCIP annually based on the most recent available full year of PFS and CAH claims data.
To the extent practitioners were paid under the PFS during the historical claims data year for some primary services and, for other services, CAHs were paid under the optional method for those same practitioners' professional services, we would aggregate the historical claims data from all settings by the practitioner's NPI in order to determine whether the practitioner is eligible for PCIP payments. We note that for all practitioners (both practitioners paid under the PFS and practitioners for whose professional services CAHs are paid under the optional method), the period of claims data used for the annual determination of the primary care service percentage of allowed charges with a practitioner specialty of primary care would lag the PCIP payment year by 2 years (for example, CY 2010 claims data would be used for the CY 2012 PCIP). This 2-year lag is consistent with other areas of the Medicare program where we rely on information from claims data to inform payment in a future year, such as the use of CY 2009 PFS utilization data in the establishment of certain aspects of CY 2011 PFS payment rates.
Under the proposed PCIP eligibility determination method, it would be necessary to revise the list of eligible practitioners based on updated claims data regarding primary specialty designation and the percentage of a practitioner's allowed charges for primary care services each year. The
We plan to monitor changes in the primary specialties of enrolled practitioners over time and would expect not to see significant changes in the specialties of currently enrolled practitioners as a result of the PCIP payments. We would expect that physicians changing their primary specialty to one of the primary care specialties of family medicine, internal medicine, geriatric medicine, or pediatric medicine and who would be newly eligible for the PCIP would be furnishing primary care services to the patients in their practices. Consistent with our past policies, we would expect that physicians changing their primary specialty designation under Medicare would make such changes only so that their primary specialty designation is fully consistent with the specific or unique type of medicine they practice. If we find that physicians are changing their specialty designations (for example, cardiologists who designate their primary specialty as internal medicine, although they practice cardiology) in order to take advantage of the PCIP payments, we would considering making future revisions to eliminate such an outcome.
Consistent with the established Medicare HPSA physician bonus program (Medicare Claims Processing Manual, Pub. 100–04, Chapter 12, Section 90.4.4) and the proposed Health Professional Shortage Area Surgical Incentive Payment Program (HSIP) described in section III.S.2. of this proposed rule, we are proposing that PCIP payments would be calculated by the Medicare contractors and made quarterly on behalf of the eligible primary care practitioner for the primary care services furnished by the practitioner in that quarter. The primary care practitioners' professional services may be paid under the PFS based on a claim for professional services or, where the practitioner has reassigned his or her benefits to a CAH paid under the optional method, to the CAH based on an institutional claim.
As discussed above, eligible primary care practitioners would be identified on a claim based on the NPI of the rendering practitioner. If the claim is submitted by a practitioner's group practice or a CAH, the rendering practitioner's NPI must be included on the line-item for the primary care service (identified in Table 39 above) in order for a determination to be made regarding whether or not the service is eligible for payment of the PCIP. We note that, in order to be eligible for the PCIP, physician assistants, clinical nurse specialists, and nurse practitioners must be billing for their services under their own NPI and not furnishing services incident to physicians' services. Regardless of the specialty area in which they may be practicing, these specific NPPs would be eligible for the PCIP based on their specialty if their historical percentage of allowed charges for primary care services equals or exceeds the 60 percent threshold.
We note that section 1833(x)(4) of the Act (as added by section 5501(a) of the ACA) specifies “there shall be no administrative or judicial review under section 1869, 1878, or otherwise, respecting the identification of primary care practitioners.” We believe that the inclusion of this language is intended to provide a means for the practical implementation of this provision. That is, because we must develop a process and identify primary care practitioners before we can make payment under the PCIP to the eligible primary care practitioners, the statute gives CMS the authority to make final determinations of eligible primary care practitioners that are not subject to appeal through the various channels normally available to practitioners, in order for the timely payments under the PCIP to occur. In contrast, if the determinations that CMS must make under this provision were subject to appeal, the timely implementation of this provision could be jeopardized and payments under the PCIP could be significantly delayed. However, we do not believe that the “no administrative or judicial review” clause precludes CMS from correcting errors resulting from clerical or mathematical mistakes. Therefore, we note that practitioners would have the opportunity to notify CMS of clerical or mathematical errors that may have occurred during the process of identifying eligible primary care practitioners for PCIP payment, and which could result in a mistaken eligibility determination for the PCIP.
In summary, under the PCIP beginning in CY 2011, we are proposing to identify primary care practitioners based on their primary specialty and percentage of allowed charges for primary care services that equals or exceeds the 60 percent threshold based upon the most current full year of Medicare claims data, which would be the claims data for 2 years prior to the incentive payment year (for example, CY 2009 claims data processed through June 2010 would be used to identify primary care practitioners for the CY 2011 PCIP). Practitioners identified as eligible for the PCIP immediately prior to the PCIP payment year would then receive quarterly incentive payments during the PCIP year equal to 10 percent of the payment amount for their primary care services under Part B, in addition to the amount the primary care practitioner would otherwise be paid for their professional services under Part B for furnishing the primary care services. For example, primary care practitioners identified in late CY 2010 for the CY 2011 PCIP would receive quarterly PCIP payments in CY 2011 that equal 10 percent of the Part B payment for the primary care services those practitioners furnish during CY 2011.
We further note that section 1833(x)(3) of the Act (as added by section 5501(a) of the ACA) authorizes
Accordingly, for CY 2011, we are proposing to add a new § 414.80 to our regulations to specify the requirements of the PCIP. Proposed § 414.80(a) would define primary care practitioners and primary care services. Proposed § 414.80(b) would provide eligible primary care practitioners a 10 percent incentive payment with respect to primary care services, in addition to the amount that would otherwise be paid for their professional services under Part B. Quarterly PCIP payments would be made to eligible practitioners or to CAHs paid under the optional method that are billing on behalf of practitioners for their professional services for identified primary care services.
Section 1833(m) of the Act provides for an additional 10 percent incentive payment for physicians' services furnished to a covered individual in an area that is designated as a geographic Health Professional Shortage Area (HPSA) as identified by the Secretary prior to the beginning of such year. Section 5501(b) of the ACA revises section 1833 of the Act by adding the new subparagraph (y), “Incentive Payments for Major Surgical Procedures Furnished in Health Professional Shortage Areas.”
In the case of major surgical procedures furnished by a general surgeon on or after January 1, 2011 and before January 1, 2016, in an area designated under section 332(a)(1)(A) of the Public Health Service Act as a geographic HPSA, there shall be paid on a monthly or quarterly basis, an amount equal to 10 percent of the payment amount for eligible services under Part B. Section 1833(y)(2)(A) of the Act (as added by section 5501(b) of the ACA) defines a general surgeon as a physician who is described in section 1861(r)(1) of the Act and who has designated a CMS specialty code of 02—General Surgery as his or her primary specialty code in the physician enrollment under section 1866(j) of the Act.
Section 1833(y)(2)(B) of the Act (as added by section 5501(b) of the ACA) defines major surgical procedures as surgical procedures for which a 10-day or 90-day global period is used for payment under the PFS in section 1848(b) of the Act. In Addendum B to the CY 2010 PFS final rule with comment period (74 FR 62017 through 62143), as corrected in the correction notice (74 FR 65455 through 65457), we identified 489 10-day global procedure codes and 3,796 90-day global procedure codes for a total of 4,285 surgical procedure codes that would have met the surgical procedure criteria for the incentive payment if it were applicable in CY 2010.
For services furnished on or after January 1, 2011 and before January 1, 2016, we are proposing to provide a 10 percent incentive payment to general surgeons, identified by their enrollment in Medicare with a primary specialty code of 02—general surgery, in addition to the amount they would otherwise be paid for their professional services under Part B, when they furnish a major surgical procedure in a location that was defined by the Secretary as of December 31 of the prior year as a geographic HPSA. As with the PCIP described above, we do not believe that surgeons will change their Medicare specialty designation in order to take advantage of the HSIP payments. However, we will monitor the specialty designations of enrolled physicians, and if we find that surgeons are changing their primary specialty designation to general surgery in order to take advantage of the HSIP payments, we would consider making future revisions to eliminate such an outcome.
Consistent with the established Medicare HPSA physician bonus program, we are proposing that these HSIP payments would be calculated by the Medicare contractors based on the criteria for payment that we have established as discussed earlier in this section, and payments would be made quarterly on behalf of the qualifying general surgeon for the qualifying major surgical procedures. The surgeons' professional services may be paid under the PFS based on a claim for professional services or, where the physician has reassigned his or her benefits to a critical access hospital (CAH) paid under the optional method, to the CAH based on an institutional claim.
Qualifying general surgeons would be identified on a claim for a major surgical procedure based on the primary specialty of the rendering physician, identified by his or her NPI, of 02—general surgery. If the claim is submitted by a physician's group practice or a CAH, the rendering physician's NPI must be included on the line-item for the major surgical procedure in order for a determination to be made regarding whether or not the procedure is eligible for payment under the HSIP.
For HSIP payment to be applicable, the major surgical procedure must be furnished in an area designated by the Secretary as of December 31 of the prior year as a geographic HPSA. We would provide HSIP payments for major surgical procedures furnished by general surgeons in the same HPSAs as we currently recognize for purposes of payment of all physicians under the established Medicare HPSA physician bonus program under section 1833(m) of the Act.
Each year, we publish a list of zip codes eligible for automatic payment of the HPSA physician bonus payment at:
Consistent with the statutory requirement, we are proposing to define major surgical procedures as those for which a 10-day or 90-day global period is used for payment under the PFS. For CY 2011, approximately 4,300 10-day and 90-day global surgical procedures codes are identified in Addendum B to this proposed rule under the far right column labeled “Global” and designated with “010” or “090,” respectively.
We further note that section 1833(y)(3) of the Act (as added by section 5501(b)(1) of the ACA) authorizes payment under the HSIP as an additional payment amount for specified surgical services without regard to any additional payment for the service under section 1833(m) of the Act. Therefore, a general surgeon may receive both a HPSA physician bonus payment under the established Medicare HPSA physician bonus program and an HSIP payment under the new program beginning in CY 2011, but the HSIP payment is made without regarding to the HPSA physician bonus payment amount. In addition, payments for outpatient CAH services under section 1834(g)(2)(B) of the Act (as amended by section 5501(b) of the ACA) are not affected by the HSIP payment amounts made to the CAH on behalf of the general surgeon.
Accordingly, for CY 2011, we are proposing to amend § 414.2 by adding the definitions of “HPSA” and “major surgical procedure.” We are also proposing to revise § 414.67 to move the existing provisions to paragraph (a) to be grouped as the “Health Professional Shortage Area (HPSA) physician bonus program” and adding a new paragraph (b) for the “HPSA surgical incentive payment program” provisions. Proposed § 414.67(b) would state that general surgeons who furnish identified 10-day and 90-day global period surgical procedures in an area designated by the Secretary as of December 31 of the prior year as a geographic HPSA that is recognized by Medicare for the HPSA physician bonus program as specified under renumbered § 414.67(a)(1) would receive a 10 percent incentive payment in addition to the amount that would otherwise be paid for their professional services under Part B. Physicians furnishing services in areas that are designated as geographic HPSAs prior to the beginning of the year but not included on the published list of zip codes for which automated HPSA surgical bonus payments are made should report a specified HCPCS code modifier to receive the HSIP payment. Quarterly incentive payments would be made to physicians or to CAHs paid under the optional method that are billing on behalf of physicians for their professional services.
Section 1834(g) of the Act establishes the payment rules for outpatient services furnished by a CAH. In 1999, section 403(d) of the Balanced Budget Refinement Act of 1999 (Pub. L. 106–113) (BBRA) amended section 1834(g) of the Act to provide for two methods of payment for outpatient services furnished by a CAH. Specifically, section 1834(g)(1) of the Act, as amended by the BBRA, specifies that the amount of payment for outpatient services furnished by a CAH is equal to the reasonable costs of the CAH in furnishing such services. (The physician or other practitioner furnishing the professional service receives payment under the PFS.) In the alternative, the CAH may make an election, under section 1834(g)(2) of the Act, to receive amounts that are equal to “the reasonable costs” of the CAH for facility services plus, with respect to the professional services, the amount otherwise paid for professional services under Medicare, less the applicable Medicare deductible and coinsurance amount. The election made under section 1834(g)(2) of the Act is sometimes referred to as “method II” or “the optional method.” Throughout this section of this preamble, we refer to this election as “the optional method.”
In 2000, section 202 of the Medicare, Medicaid and SCHIP Benefits Improvement and Protection Act of 2000) (Pub. L. 106–554) (BIPA) amended section 1834(g)(2)(B) of the Act to increase the payment for professional services under the optional method to 115 percent of the amount otherwise paid for professional services under Medicare. In addition, in 2003 section 405(a)(1) of the MMA amended section 1834(g)(l) of the Act by inserting the phrase “equal to 101 percent of” before the phrase “the reasonable costs.” However, section 405 of the MMA did not make a corresponding change to section 1834(g)(2)(A) of the Act regarding the amount of payment for facility services under the optional method. In 2010, Section 3128 of the ACA amended section 1834(g)(2)(A) of the Act by inserting the phrase “101 percent of” before “the reasonable costs.”
Section 5501(a) of the ACA amends section 1833 of the Act by adding a new paragraph (x), “Incentive Payments for Primary Care Services,” that authorizes additional Part B payments to primary care practitioners for primary care services. Section 5501(b) of the ACA further amends section 1833 of the Act by adding new paragraph (y), “Incentive Payments for Major Surgical Procedures Furnished in Health Professional Shortage Areas,” that authorizes additional Part B payments for major surgical procedures furnished by general surgeons in HPSAs. Sections 5501(a)(3) and 5501(b)(3) of the ACA make conforming amendments to section 1834(g)(2)(B) of the Act, which refers to payment to the CAH for professional services under the optional method, by adding at the end of section 1834(g)(2)(B) the following phrase, “Subsections (x) and (y) of 1833 shall not be taken into account in determining the amounts that would otherwise be paid pursuant to the preceding sentence.” As such, section 1834(g)(2)(B) of the Act (as amended by sections 5501(a)(2) and 5501(b)(2) of the ACA) requires that under the optional method, the 115 percent adjustment payment to the CAH for professional services is calculated without considering the incentive payments for primary care services furnished by primary care practitioners and major surgical procedures furnished by general surgeons in HPSAs as these terms are defined under sections 1833(x) and (y) of the Act.
The regulations implementing section 1834(g)(2)(B) of the Act, payment to the CAH for professional services under the optional method, are in § 413.70(b)(3)(ii)(B). In order to implement the amendments to section 1834(g)(2)(B) of the Act as specified by sections 5501(a)(2) and 5501(b)(2) of the ACA, we are proposing to amend the regulations in § 413.70(b)(3)(ii)(B) to state that, effective for primary care services furnished by primary care practitioners and major surgical procedures furnished by general surgeons in HPSAs on or after January 1, 2011 and before January 1, 2016, the additional incentive payment amounts as specified in § 414.67 and § 414.80 are not included in the determination of the payment for professional services made to the CAH under the optional method. Accordingly, we are proposing that payment for professional services to the CAH at 115 percent of the PFS amount under the optional method would not take into account the additional Part B incentive payments for primary services furnished by primary care practitioners and major surgical procedures furnished by general surgeons in HPSAs as provided in § 414.67 and § 414.80.
Section 1877 of the Act also known as the physician self-referral law: (1) Prohibits a physician from making referrals for certain “designated health services” (DHS) payable by Medicare to an entity with which he or she (or an immediate family member) has a
Section 1877(b)(2) of the Act, entitled “In-office Ancillary Services” sets forth the exception that permits a physician in a solo or group practice to order and provide designated health services (DHS), other than most durable medical equipment and pretrial and enteral nutrients, in the office of the physician or group practice, provided that certain specific criteria are met. Under this exception, the statute limits who can furnish the service, designates where the service must be performed, and limits who can bill for the service. As explained at the end of the statutory exception, the service may also be subject to “such other requirements as the Secretary may impose by regulation as needed to protect against program or patient abuse.” The in-office ancillary services exception is interpreted at § 411.355(b).
Section 6003 of the ACA amends section 1877(b)(2) of the Act by creating a new disclosure requirement for the in-office ancillary services exception to the prohibition on physician self-referral. Specifically, section 6003 provides that, with respect to referrals for magnetic resonance imaging (MRI), computed topography (CT), positron emission topography (PET), and any other DHS specified under section 1877(h)(6)(D) that the Secretary determines appropriate, we must promulgate a requirement that the referring physician inform a patient in writing at the time of the referral that the patient may obtain the service from a person other than the referring physician or someone in the physician's group practice and provide the patient with a list of suppliers who furnish the service in the area in which the patient resides.
We are proposing to implement section 6003 of the ACA by amending § 411.355(b) to add new paragraph (b)(7). We describe below our proposal for the new disclosure requirement.
Section 6003(a) of the ACA requires that the new disclosure requirement apply to MRI, CT, and PET services as well as such other radiology or imaging services included in the DHS category specified in section 1877(h)(6)(D) of the Act that the Secretary determines appropriate. We are considering whether to expand this disclosure requirement to other radiology and imaging services. We are not inclined to expand the disclosure requirement but we solicit comments regarding whether other radiology or imaging services that fall under section 1877(h)(6)(D) of the Act should be included in this requirement, and if so, which services, and the purpose served by extending the disclosure requirement to additional radiology or imaging services.
In § 411.355(b)(7), we are proposing that the disclosure notice should be written in a manner sufficient to be reasonably understood by all patients and must, as the ACA requires, be given to the patient at the time of the referral. This notice must indicate to the patient that the services may be obtained from a person other than the referring physician or his or her group practice and include a list of other suppliers who provide the service being referred (MRI, CT, or PET).
We believe one purpose of the disclosure requirement is to inform a patient's decision-making regarding his or her own care. The list of suppliers provided to the patient by the physician is meant to serve as a resource for the patient. Nothing on the disclosure notice or list of suppliers may indicate to the patient that he or she must receive imaging from a supplier on the list if not receiving the service from the referring physician. The patient may receive the imaging service from the referring physician, from a supplier identified on the notice, or from another supplier of the patient's choice. The patient is free to choose the supplier of the service.
Section 6003(a) of the ACA specifies that the referring physician must provide a written list of “suppliers (as defined in section 1861(d)).” Section 1861(d) of the Act defines supplier as “a physician or other practitioner, a facility, or other entity (other than a provider of services) that furnishes items or services under this title.” We are proposing that only suppliers be included on the written list. We are not proposing to permit or require the list to include “providers of services”, which is defined in section 1861(u) of the Act to include hospitals and critical access hospitals, among other facilities. We are soliciting comments regarding whether inclusion of providers of services on the written notice would benefit patients in choosing an alternate entity for an imaging service by providing more, and varied, options.
Section 6003(a) of the ACA also requires that the alternate suppliers specified in the notice provided to the patient must furnish the relevant services “in the area in which [the patient] resides.” We are aware that a patient may travel outside the area in which he or she resides in order to receive medical care. We believe that requiring an original written notice for each patient based upon a certain distance from the patient's residence could place a significant administrative burden on physicians practicing in a solo or group practice. It would be impractical for a physician to prepare a separate list for every area in which his or her patients reside. Additionally, we believe that if a patient has traveled to see the referring physician, the physician is located in an area convenient to the patient and therefore, a referral within a certain distance of this location would also be convenient for the patient.
In order to ease the administrative burden of creating multiple lists while still implementing the requirements of the statute, we are proposing that the suppliers included in this notice should be located within a 25-mile radius of the physician's office location at the time of the referral. We believe that a 25-mile radius is large enough in most areas to generate a list of suppliers that will be useful to patients. We note that we have used a 25-mile radius in other physician self-referral exceptions, including the intra-family rural referrals exception (§ 411.355(j)) and the physician recruitment exception (§ 411.357(e)). Even if a patient resides more than 25 miles away, we are proposing that it will be sufficient to provide a list of suppliers located within a 25-mile radius of the physician's office location at the time the referral is made. As discussed above, we believe that measuring the distance from the physician's office location will better serve patients who have perhaps traveled from long distances to receive specialized treatment.
We are soliciting comments regarding the proposed 25-mile radius requirement. In attempting to minimize confusion and burden related to implementing this provision, we have proposed the same standard for both urban and rural areas. We realize that in some areas 25 miles may be too small to generate a sufficient list of other suppliers. We are interested in hearing whether an alternative distance may be
In order to help a patient make an informed decision regarding other options for the recommended imaging services, we propose that the written notice include no fewer than 10 other suppliers. We considered proposing that the list include the 10 closest suppliers, but we want to allow physicians some flexibility in drafting the list of suppliers. On the other hand, we are concerned that physicians located in large metropolitan areas will draft a list that includes suppliers located mostly at the edges of the 25-mile radius, thereby increasing the chances that the patient will choose to receive imaging services from the referring physician's practice. We are soliciting comments regarding whether providing a list of 10 suppliers is sufficient or too burdensome or susceptible to abuse and whether there are alternate criteria we should use that would result in an adequate list of convenient suppliers that does not impose an undue burden on physician practices or a risk of abuse.
We recognize that there may be fewer than 10 other suppliers within a 25-mile radius of the referring physician's office location. We propose that, under these circumstances, the physician shall list all of the other suppliers of the particular imaging service that are present within a 25-mile radius of the referring physician's office location, including up to 10 suppliers as required by these regulations. If no other suppliers of the imaging services ordered exist within the 25-mile radius of the physician's office location, the physician need not provide a list of alternative suppliers, but must still disclose to his or her patients that the patients may receive the imaging services from another supplier. In this last situation, simply providing this disclosure statement will satisfy the disclosure requirement of this provision even though alternative suppliers are not listed. The physician must maintain documentation of the disclosure.
We are proposing that the written notice be required to include certain information about the listed suppliers in order to satisfy this disclosure requirement. The list must include the name, address, phone number, and distance from the physician's office location at the time of the referral. We propose to require inclusion of the distance from the physician's location to the other suppliers in order to emphasize to the patient the relative convenience of the listed suppliers.
We are not proposing an exception to the disclosure requirement for MRI, CT, or PET services furnished on an emergency or time-sensitive basis. We are soliciting comments related to whether there are other procedures or circumstances in which it may be difficult or impractical to provide the written disclosure prior to provision of the imaging services.
This proposal sets forth criteria that apply to the disclosure requirement and list of alternative suppliers. These criteria are intended to provide clear guidance as to how physicians may comply with the new requirement of the in-office ancillary services exception. We understand that there may be alternative ways to implement these statutory requirements. One possible alternative is to only require a “reasonable” list of other suppliers with general requirements for the disclosure to patients, while providing that if the physician meets the more specific requirements set forth in this proposal, he or she will be deemed to have a “reasonable” disclosure. We seek comments on this specific alternative and any other alternative methods of compliance that still satisfy the statutory requirements.
In order to document that this disclosure requirement has been satisfied, we propose that a record of the patient's signature on the disclosure notification must be maintained as an element of the patient's medical record. We are soliciting comments regarding the burden of this recordkeeping requirement. We are also interested in comments that suggest alternative means of recording that the disclosure was made to the patient at the time of referral.
As discussed above, section 6003(a) of the ACA amends section 1877(b)(2) of the Act by instructing that the new disclosure requirement be added as one of the additional requirements of the in-office ancillary services exception. The last sentence of the statutory exception preceding this amendment authorizes the Secretary to impose “such other requirements * * *
We considered whether, pursuant to section 6003 of the ACA, the final rule setting forth the disclosure requirement should apply retroactively to all services furnished on or after January 1, 2010. Given the structure of the amended in-office ancillary services exception and the statute as a whole, however, we believe that retroactive rulemaking is not required. Therefore, we are proposing that the new disclosure requirement shall apply only to services furnished on or after the effective date of the final regulation implementing section 6003 of the ACA. We are proposing an effective date of January 1, 2011 for the regulation implementing this provision.
Sections 1814(a)(1), 1835(a), and 1842(b)(3)(B) of the Act establish time limits for filing Medicare Part A and B claims. Prior to the enactment of the ACA, under sections 1814(a)(1) and 1835(a) of the Act, providers could file for Part A and Part B claims, respectively, “* * * no later than the close of the period of 3 calendar years following the year in which such services are furnished (deeming any services furnished in the last 3 calendar months of any calendar year to have been furnished in the succeeding calendar year) except that, where the Secretary deems that efficient administration so requires, such period may be reduced to not less than 1 calendar year * * *”. Prior to the enactment of the ACA, CMS was authorized to establish a minimum time limit for provider-submitted Part A and Part B claims of at least 1 calendar year from the date of service, and a maximum time limit not to exceed 4 years and 3 months after the date of service.
Additionally, prior to the enactment of the ACA, under section 1842(b)(3)(B) of the Act, Part B claims for physician and other supplier services could be filed with Medicare “* * * no later than the close of the calendar year following the year in which such service is furnished (deeming any service furnished in the last 3 months of any calendar year to have been furnished in
Section 424.44 implements sections 1814(a)(1), 1835(a), and 1842(b)(3)(B) of the Act. In order to effectively administer the Medicare Program, CMS, through regulations, modified the potential minimum and maximum time periods for filing Part A claims so that Part A claims would have the same time limits as Part B claims. At § 424.44(a), CMS adopted the minimum time limit of 15 months and potential maximum of 27 months after the service was furnished that was permitted under section 1842(b)(3)(B) of the Act for Part B claims and uniformly applied that 15 to 27 month time limit to both Part A and B claims. Also, under § 424.44(b), CMS allowed providers and suppliers the opportunity to file claims after the 15 to 27 month deadline for filing claims expired when the failure to file “* * * was caused by error or misrepresentation of an employee, intermediary, carrier, or agent of the Department that was performing Medicare functions and acting within the scope of its authority.”
Section 6404 of the ACA amended sections 1814(a)(1), 1835(a), and 1842(b)(3)(B) of the Act regarding Medicare fee-for-service (FFS) claims for services furnished on or after January 1, 2010. Under section 6404(b)(1) of the ACA, all claims for services furnished on or after January 1, 2010 must be filed within 1 calendar year after the date of service. The provisions of the ACA did not amend these sections of the Act for services furnished before January 1, 2010. However, section 6404(b)(2) of the ACA created a new requirement that claims for services furnished before January 1, 2010 must be filed on or before December 31, 2010. Thus, the statutory provisions prior to the enactment of the ACA remain in effect for pre-2010 services, subject to this new requirement. The practical effect of this change is that any claims for services furnished before October 1, 2009 will follow the current existing regulations. But for any services furnished during the last three months of 2009, those claims must be filed no later than December 31, 2010. For services furnished between October 1, 2009 and December 31, 2009, providers and suppliers will only have 12–15 months to file a claim, whereas before the ACA amendments, they would have had an additional year to file their claims, or 24 to 27 months. Therefore, in order to effectuate the changes made by the ACA, we are proposing to amend § 424.44 so that it is consistent with the amended statutory provisions.
We are proposing to amend § 424.44(a) by replacing the current text with the requirement that claims for services provided on or after January 1, 2010 must be submitted no later than the close of the period ending 1 calendar year after the date of service. As noted above, any services furnished before January 1, 2010 will still be subject to the pre-existing statutory provisions. Therefore, we are proposing that for pre-2010 services, the pre-existing regulatory structure will continue to apply. For those services furnished before January 1, 2010, claims must be filed on or before December 31 of the following year for services that were furnished during the first 9 months of a calendar year, and on or before December 31st of the second following year for services that were furnished during the last 3 months of the calendar year. However, for those services provided in the last three months of 2009, we propose that all claims for those services must be filed no later than December 31, 2010.
Section 6404 of the ACA also gives the Secretary authority to create exceptions to the 1 year timely filing period. In addition to the existing exception to the timely filing requirement due to error or misrepresentation by CMS, our contractors or agents, we propose to create two new exceptions. First, we are proposing to create an exception for those situations where a beneficiary becomes retroactively entitled to Medicare benefits, but was not entitled at the time the services were furnished. Second, we are proposing to permit providers and suppliers to file claims after the time limit for filing claims has expired in limited dual eligible Medicare/Medicaid beneficiary situations.
The first new proposed exception at § 424.44(b)(2) will permit providers and suppliers to file claims after the time limit for filing claims expires when CMS or our contractors determines that the following conditions have been met:
• At the time the service was furnished the beneficiary was not entitled to Medicare; and
• The beneficiary subsequently received notification of Medicare entitlement effective retroactively to or before the date of the furnished service.
In these situations, if CMS or one of our contractors determines that both of the conditions in § 424.44(b)(2) are met, then the time to file a claim will be extended through the last day of the 6th calendar month following the month in which the beneficiary received notification of Medicare entitlement effective retroactively to or before the date of the furnished service. Therefore, instead of the beneficiary having to pay out of his or her own pocket for the service or instead of the beneficiary's other insurance or some other payer that is secondary to Medicare having to pay primary for the service, Medicare may pay primary (or secondary or tertiary) for the service since the beneficiary was entitled to Medicare (although retroactively) at the time the service was furnished. All of Medicare's payment rules including Medicare's Secondary Payer rules still apply in these retroactive entitlement situations.
The second proposed new exception at § 424.44(b)(3) will permit providers and suppliers to file claims for dually-eligible beneficiaries after the time limit for filing claims expires when CMS or our contractors determine that all of the following conditions have been met:
• At the time the service was furnished the beneficiary was not entitled to Medicare;
• The beneficiary subsequently received notification of Medicare entitlement effective retroactively to or before the date of the furnished service; and
• A State Medicaid agency recovered the Medicaid payment for the furnished service from the provider or supplier 11 months or more after the date of service.
This proposed exception applies to situations where a provider or supplier bills (and receives payment from) Medicaid for the services that a dual eligible Medicare/Medicaid beneficiary receives from the provider or supplier. However, at the time the services were furnished, the patient was not a dual eligible Medicare/Medicaid beneficiary yet because Medicare entitlement was granted to the individual retroactively after the service was actually furnished to the individual. In addition, after the State Medicaid Program discovers that the individual was granted Medicare entitlement retroactively, the State Medicaid Program recovers its payments from the provider or supplier for that individual's services instructing the provider or supplier that Medicare should be billed for the services (not Medicaid). If all three of the conditions outlined above occur within 11 months of the date the service was furnished, then the provider or supplier will have enough time to bill Medicare for the
We are proposing that for the one existing exception due to error or misrepresentation by CMS, our contractors or agents (
CMS is not proposing a definition of the term “date of service” in this regulation. Yet we recognize that the definition of this term is very important to providers, suppliers, and beneficiaries because the “date of service” will ultimately determine when the claim has to be filed in order to meet the new 1 calendar year requirement. In most cases the “date of service” will be the date that the item or service is actually furnished to the beneficiary; however, we recognize that for many Part A and B services it is difficult to craft a uniform rule that will apply a consistent date of service standard. It is our intention to provide sub-regulatory guidance on what constitutes the date of service for different Part A and B services. We are soliciting comments regarding whether CMS should provide a regulatory definition of “date of service” and, if so, how should it define this term.
We are also clarifying the exception that appears at § 424.44(e). We are making clear that this regulation does not supersede the restriction on retrospective billing that appears in §§ 424.520 and 424.521. Under these provisions certain newly-enrolled suppliers, such as physicians, non-physician practitioners, physician or non-physician practitioner organizations and IDTFs, have only a limited ability to submit claims for items or services furnished prior to the effective date of their Medicare billing privileges even if these claims would otherwise be considered timely. In addition, we want to make clear that the one calendar year timely filing limit in section 424.44(a) does apply to any retrospective claims permitted by sections 424.520 and 424.521 and to claims for items or services furnished after the effective date of the supplier's billing privileges.
We are proposing a number of revisions to the DMEPOS CBP as a result of changes to the statute made by both the Medicare Improvements for Patients and Provider Act of 2008 (MIPPA) and the ACA. Since both MIPPA and the ACA specify requirements for MSA selection for round 2 and beyond we are outlining our proposals for implementing the statutory requirements related to MSA selection in both MIPPA and the ACA in this section. First, we propose to use the authority provided by the statute at section 1847(a)(1)(D)(ii) of the Act, as amended by MIPPA to subdivide Metropolitan Statistical Areas (MSAs) with populations of greater than 8,000,000 under Round 2 of the DMEPOS CBP. Second, we propose to exclude certain areas from competitive bidding after round 2 as mandated by section 1847(a)(1)(D)(iii) of the Act, as amended by MIPPA. Third, we propose to implement the requirement of section 6410 of the ACA to expand Round 2 of the program by adding 21 of the largest MSAs based on total population to the original 70 already selected for round 2.
Section VI.H of this proposed rule provides background on the DMEPOS CBP, including a description of many of the changes made to the program by section 154 of MIPPA. In this section, we provide additional information regarding changes made by both MIPPA and Section 6410 of the ACA. In addition to the changes discussed previously in this proposed rule, MIPPA also added subparagraph (D) to section 1847(a)(1) of the Act. Section 1847(a)(1)(D)(ii), as added by MIPPA, addresses Round 2 of the DMEPOS CBP, and section 1847(a)(1)(D)(iii) addresses subsequent rounds of the Program.
Section 1847(a)(1)(D)(ii)(II) of the Act specifies that the Secretary shall implement DMEPOS competitive bidding in the areas previously selected for round 2 of the program and also allows the Secretary, in implementing round 2 of the program, to subdivide metropolitan statistical areas (MSAs) with populations of greater than 8,000,000 into separate CBAs. Previously, we believe the statute could have been interpreted to allow CMS to subdivide large MSAs but MIPPA gave CMS the explicit authority to subdivide large MSAs. Section 1847(a)(1)(D)(iii) imposes new requirements on the Secretary for competitions occurring before 2015 in subsequent rounds of the program. For such competitions (other than national mail order), the following areas are to be excluded from the program: (I) Rural areas; (II) MSAs not selected under Round 1 or 2 with a population of less than 250,000; and (III) certain areas with low population density within a selected MSA. These requirements do not apply to a national mail order program.
Finally, MIPPA required that we implement Round 2 of the DMEPOS CBP in the same MSAs that were designated as of June 1, 2008. In 2010, section 6410(a) of the ACA amended sections 1847(a)(1)(B)(i)(II) and (D)(ii) of the Act to expand Round 2 of the program from 70 MSAs to 91 MSAs by adding the next 21 largest MSAs by total population not already selected for Rounds 1 or 2.
We have selected MSAs for Round 1 and for Round 2 consistent with MIPPA's requirement. For round 1 CBAs generally were comparable to MSAs, however, for round 2 we are proposing to subdivide MSAs of 8,000,000 or more in population. The authority to subdivide MSAs into separate areas for competitive bidding
We considered certain factors when considering whether to propose subdividing the MSAs with populations of at least 8,000,000. We considered the geographic, social, and economic integration of each of the MSAs. We apply all of these factors when grouping counties into CBAs considered at a county level in each MSA and we believe it is also appropriate to use these factors to determine: (1) Whether or not to subdivide an MSA into separate CBAs, and (2) once the decision is made to subdivide the MSA, how to subdivide the MSA. We considered the following factors, generally in the order in which they are listed:
• Geographic size of the MSA and the location of the counties within each MSA compared to neighboring counties;
• The driving distances from north to south and east to west within each MSA and county;
• The total population and the population of FFS Medicare beneficiaries using DMEPOS items subject to competitive bidding;
• The DMPOS allowed charges for items subject to competitive bidding;
• Comparably sized Round 1 and Round 2 MSAs based on beneficiary counts and allowed charges for competitive bid items;
• The interstate highway infrastructures of the MSAs; and
• The current service patterns of suppliers in each county of the MSA.
We used each of the factors to the extent practical to develop initial proposals for reasonable and workable subdivisions of these highly and densely populated MSAs. We believe consideration of these factors will help us meet our goal of subdividing large and densely populated MSAs and creating CBAs that are attractive to suppliers and incentivize them to bid competitively for a contract. With this goal in mind, we are trying to establish CBAs that provide for a good volume of DMEPOS business for winning bidders, avoid obvious geographic obstacles, mimic existing supplier service patterns, and, to the extent possible, do not cross State lines. We believe the factors we have selected will achieve those objectives.
We found that counties clearly delineate areas within a MSA, and as we have done for Round 1 by identifying CBAs by counties and zip codes, we are proposing to subdivide the MSAs at a county level. Since the Office of Management and Budget (OMB) defines the MSAs by counties and county-based subdivisions are stable, we use counties to subdivide CBAs. When subdividing an MSA into counties, we consider counties that share social, economic and geographic integration. The Chicago-Naperville-Joliet IL-IN-WI MSA comprises 14 counties within 3 States: Illinois, Indiana, and Wisconsin. This MSA has 207,106 beneficiaries and $218,161,562 of DMEPOS allowed charges subject to the DMEPOS CBP. Using the factors that we indentified, we would subdivide the Chicago-Naperville-Joliet, IL-IN-WI MSA into four separate CBAs: Indiana-Chicago Metro CBA; South-West-Chicago-Metro CBA; Central-Chicago Metro CBA; and Northern-Chicago Metro CBA. The counties, DMEPOS allowed charges, and the number of beneficiaries subject to competitive bidding, and the general population that comprise each of these proposed CBAs are shown in Table 40.
Figure 1 shows the boundaries of each proposed CBA.
The Indiana-Chicago Metro CBA would include all four of the Indiana counties that are part of the MSA. The other CBAs in the MSA would be as follows:
• The South-West-Chicago Metro CBA would include counties in Illinois located to the south and west of the Central-Chicago Metro CBA.
• The Central-Chicago Metro CBA would include the city of Chicago covering both Cook and DuPage counties.
• The Northern-Chicago Metro CBA which is north of the Central-Chicago Metro CBA subdivision that encompasses the city of Chicago.
The Los Angeles-Long Beach-Santa Ana, CA MSA comprises two counties: Los Angeles County and Orange County. The MSA has 173,631 fee-for-service beneficiaries receiving DMEPOS subject to competitive bidding and $244,523,957 in DMEPOS allowed charges subject to the DMEPOS CBP. We propose to subdivide the Los Angeles-Long Beach-Santa Ana, CA MSA into two CBAs: Los Angeles County CBA and Orange County CBA. The DMEPOS allowed amount and beneficiary count subject to competitive bidding, and the general population that comprises these two proposed CBAs are shown in Table 41.
Figure 2 shows the boundaries of each proposed CBA.
As mentioned earlier, we propose to subdivide MSAs using counties, and since the Los Angeles-Long Beach-Santa Ana, CA MSA only has two counties, it offers only one subdivision along the county lines. Hence, we have proposed to divide the MSA by the two counties creating two CBAs.
We also propose to use the authority in section 1847(a)(3)(A) of the Act to exclude certain areas within the Los Angeles-Long Beach-Santa Ana, CA MSA. We believe these areas meet the requirement of section 1847(a)(3)(A); they are rural areas with a low population density within an urban area that are not competitive. In the final rule CMS–1270 F § 414.410(c) published in April 2007, we defined the factors we consider when determining an area is considered a low population density area or an area that would not be competitive. Based on our review of the County Subdivision Population from the 2000 Census from the U.S. Census Bureau, and using the factors set forth in the April 2007 proposed rule, we propose to exclude the area of Los Angeles County north of the San Gabriel mountains. This large geographic area has a population of about 357,000, which is only 4 percent of the total population of Los Angeles County, and is separated from the rest of the county by the San Gabriel Mountains. The area north of the San Gabriel Mountains has one major road and many terrains which make this area remote. The majority of the population in LA County lives south of the San Gabriel Mountains.
We believe that excluding this area will create a more manageable CBA that still provides sufficient volume of DMEPOS items while avoiding the geographic obstacle of the mountains. We believe including this area in the DMEPOS CBP would result in fewer small suppliers being considered for participation under the program, because we would not expect small suppliers to have the resources to serve these more remote areas. As a result, we expect that if this proposal is finalized it will increase the number of bids submitted for the CBAs within the Los Angeles-Long Beach-Santa Ana, CA MSA.
The Los Angeles County includes the two islands of Santa Catalina and San Clemente off the west coast. We are proposing that the two islands be included as a part of the Los Angeles County CBA in order to ensure that
We also propose to subdivide the New York-Northern New Jersey-Long Island, NY–NJ–PA MSA into five CBAs. This MSA comprises 23 counties in three States: New York, New Jersey and Pennsylvania. The MSA has 344,879 FFS beneficiaries receiving DMEPOS subject to the DMEPOS CBP and $350,449,795 in allowed charges for DMEPOS items subject to competitive bidding. The counties, DMEPOS allowed amount and beneficiary count subject to competitive bidding and the general populations that comprise each of these proposed CBAs are shown in Table 42.
Figure 3 shows the boundaries of each proposed CBA.
The Nassau-Brooklyn-Queens CBA would be contiguous to Suffolk County and would consist of the western part of Long Island and extend to the eastern part of New York City. The Suffolk County CBA would consist of the eastern part of Long Island and would encompass most of Long Island. The Bronx-Manhattan NY CBA would include the entire area of Manhattan and the Bronx. The North-West NY Metro CBA would be situated north and west of New York City and would extend into New Jersey and Pennsylvania. The Southern NY Metro CBA would include Staten Island and would extend south to Ocean County, New Jersey.
At the March 17, 2010 meeting of the Program Advisory and Oversight Committee (PAOC), we presented these proposals for subdividing these three large MSAs. Various members of the PAOC had the following suggestions for subdividing these MSAs:
• Draw the boundaries of CBAs using the interstate highways rather than the divisions by County;
• Determine the current servicing areas of suppliers by MSA and product category by using a scatter plot;
• Use the Hudson River to divide the CBAs for the New York MSA;
• Carve out Pike and Putnam Counties from the New York MSA due to their location and their low population density;
• Include Manhattan as a separate CBA, due to its unique nature as a self contained area;
• Consider State licensure requirements when we divide the MSAs into CBAs;
• In the LA County CBA, exclude the area north of the San Gabriel Mountains from the CBA; and
• Consider traffic patterns when dividing the Los Angeles MSAs into CBAs.
We are considering the PAOC's advice and recommendations and invite further comments on the proposed subdivisions and PAOC's advice of these three MSAs.
The MIPPA amended the statute by requiring that competition under Round 2 takes place in 2011 and by adding section 1847(a)(1)(D)(iii) that requires CMS to exclude the following areas from the competitive bid program for competitions after Round 2 of the program and before 2015:
• Rural Areas;
• Metropolitan Statistical Areas not selected under Round 1 or Round 2 with a population of less than 250,000; and
• Areas with a low population density within a MSA that is otherwise selected consistent with section 1847(a)(3)(A).
We propose to incorporate these requirements and timeframes in proposed § 414.410(c).
Section 6410(a) of the ACA expanded the areas to be included in Round 2 of the program. As amended by section 6410(a) of the ACA, section 1847(a)(1)(B)(i)(II) requires that the competition for Round 2 of the program occur in 91 of the largest MSAs in 2011. Prior to this change, Round 2 was to include 70 MSAs. Section 1847(a)(1)(D)(ii)(II), as added by section 6410(a), specifies that the additional 21 MSAs to be included in Round 2 “include the next 21 largest metropolitan statistical areas by total population” (after those already selected Round 2). The 2009 annual population estimates from the U.S. Census Bureau
The Omnibus Budget Reconciliation Act (OBRA) of 1989 amended the Social Security Act by creating new FQHC benefit programs under both Medicare and Medicaid. The Medicare FQHC benefit provides coverage for a full range of primary care services, including physician and certain nonphysician services (PAs, NPs), clinical social worker, psychologist services, and preventive services. FQHCs are “safety net” providers (for example, community health centers and programs serving migrants, the homeless, public housing centers, and tribal groups). The main purpose of the FQHC program is to enhance the provision of primary care services in underserved urban and rural communities. FQHCs typically enhance the availability of care to vulnerable populations, including Medicare, Medicaid, SCHIP, and the uninsured. Most of these health centers receive HRSA grants for services to the uninsured.
Medicare pays FQHCs on the basis of reasonable cost, subject to an upper payment limit on the reasonableness of incurred cost. Actual Medicare reasonable cost is determined based upon a Medicare cost report filed by the FQHC after the end of its fiscal year. Prior to the start of the year, an interim all-inclusive per-visit payment amount, based upon an estimate of Medicare reasonable costs, is calculated for each Medicare FQHC. During the year, this interim all-inclusive per-visit payment amount is paid for each covered visit between a Medicare beneficiary and an FQHC health professional. After the end of the Medicare FQHC's cost reporting year, interim per-visit payments are reconciled to actual Medicare reasonable costs based upon the Medicare cost report filed by the FQHC. Section 10501(i)(3) of the ACA now amends this current Medicare FQHC payment policy with an entirely different payment system, effective with cost reporting periods beginning on or after October 1, 2014.
Section 10501(i)(3)(A) of the ACA amended section 1834 of the Act by adding a new subsection (o), Development and Implementation of Prospective Payment System. This subsection provides the statutory framework for development and implementation of a prospective payment system for Medicare FQHCs. Section 1834(o)(1)(B) of the Act, as established by the ACA, addresses collection of data necessary to develop and implement the new Medicare FQHC prospective payment system. Specifically, section 1834(o)(1)(B) of the Act, Collection of Data and Evaluation, grants the Secretary of HHS the authority to require FQHCs to submit such information as may be required in order to develop and implement the Medicare FQHC prospective payment system, including the reporting of services using HCPCS codes. Section 1834(o)(1)(B) of the Act requires that the Secretary impose this data collection submission requirement no later than January 1, 2011. Accordingly, we are proposing to add a new paragraph (d) to § 405.2470 to require Medicare FQHCs to begin reporting all services furnished and using HCPCS codes for these services starting January 1, 2011. Beginning January 1, 2011, the Medicare FQHC would be required to report on Medicare FQHC claims all pertinent service(s) provided for each Medicare FQHC visit (defined in § 405.2463). This additional reporting would include the information needed to develop and implement a PPS for FQHCs. For example, corresponding HCPCS code(s) would be required to be reported along with the presently required Medicare revenue code(s) for the Medicare FQHC visit(s). CMS' Medicare FQHC claims processing system would be revised to accept the addition of the new reporting requirements effective January 1, 2011. The proposed new data collection effort would be for informational and data gathering purposes only, and would not be utilized to determine Medicare payment to the FQHC. Until the FQHC prospective payment system is implemented in 2014 and the Medicare claims processing system is revised to reflect such a system, Medicare FQHC
We further note that Medicare FQHCs would be required to adhere to the information collection requirements in accordance with the content and terms of their Medicare agreement as stipulated at § 405.2434. Failure to do so could result in the termination of the FQHC's Medicare agreement in accordance with § 405.2436 of the Medicare FQHC regulations.
At this time, we do not foresee additional claims or other information collection needs beyond collection of HCPCS codes. Accordingly, we are not proposing additional information collection requirements at this time. However, we invite public comment on any additional information FQHCs believe may be necessary in order to develop and implement a prospective payment system for Medicare FQHCs.
The ASP payment methodology is authorized under section 303(c) of the MMA which amends Title XVIII of the Act by adding section 1847A of the Act. This section establishes the use of the ASP methodology for payment for drugs and biologicals described in section 1842(o)(1)(C) of the Act furnished on or after January 1, 2005. For purposes of this part, the term “drugs” will hereafter refer to both drugs and biologicals. The ASP methodology applies to most drugs furnished incident to a physician's service, drugs furnished under the durable medical equipment (DME) benefit, certain oral anti-cancer drugs, and oral immunosuppressive drugs.
Sections 1847A and 1927(b) of the Act specify quarterly ASP data reporting requirements for manufacturers. Specific ASP reporting requirements are set forth in section 1927(b) of the Act. Although delays in reporting have been uncommon, they create a risk that: (1) Could result in the publication of payment limits which do not reflect prices for drug products, and (2) could result in inaccurate payments, the need for correction of files and unintentional ASP payment limit variability.
As a result of these concerns, we are seeking to establish a process for addressing situations where manufacturers fail to report manufacturer ASP data in a timely fashion. This proposal is intended to allow us to calculate and report ASP payment limits for a given quarter within the existing timelines and does not affect the CMS or OIG's authority to assess civil monetary penalties associated with untimely or false ASP reporting. Manufacturers who misrepresent or fail to report manufacturer ASP data will remain subject to civil monetary penalties, as applicable and described in sections 1847A and 1927(b) of the Act.
For the purposes of reporting under section 1847A of the Act, the term manufacturer is defined in section 1927(k)(5) of the Act and means any entity engaged in the following: production, preparation, propagation, compounding, conversion or processing of prescription drug product, either directly or indirectly by extraction from substances of natural origin, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis; or packaging, repackaging, labeling, relabeling, or distribution of prescription drug products. The term manufacturer does not include a wholesale distributor of drugs or a retail pharmacy licensed under State law. However, manufacturers that also engage in certain wholesaler activities are required to report ASP data for those drugs that they manufacture. Note that the definition of manufacturers for the purposes of ASP data reporting includes repackagers.
In accordance with section 1847A of the Act, manufacturers are required to report data on the NDC level, which include the following elements: the manufacturer ASP for drugs; the Wholesale Acquisition Cost (WAC) in effect on the last day of the reporting period; the number of ASP units sold; and the NDC. Currently, when manufacturer ASP data or specific data elements are not available, we calculate an ASP price for a billing code based on other applicable and available pricing data from manufacturers for that drug. This includes WAC prices from compendia if manufacturer data are not available for a billing code. WAC prices tend to be higher than manufacturer ASP prices.
Although problems with reporting have been uncommon, we have recently encountered situations where delays in manufacturer ASP reporting could have led to significant ASP payment limit fluctuations for highly utilized HCPCS codes. The greatest potential impact occurs when data for high volume drug products within a HCPCS code that is represented by a limited number of NDCs have not been reported and cannot be included in the ASP volume weighted calculations described in section 1847A(b) of the Act. For multisource drugs, such a situation is likely to artificially increase or decrease Medicare ASP payment limits, which in turn would affect beneficiary cost sharing amounts. Such artificial fluctuations of the ASP payment limit could provide the appearance of instability unrelated to market forces and could also create access issues for providers and beneficiaries and confusion that could ultimately affect product demand in the marketplace.
In order to minimize the possibility of ASP payment limit fluctuations due to missing data, we are proposing a process, consistent with our authority in section 1847A(c)(5)(B), to update ASPs, based on the manufacturer's ASP calculated for the most recent quarter for which data is available. Specifically, we are proposing to carry over the previously reported manufacturer ASP for an NDC(s) when missing manufacturer ASP and/or WAC data could cause significant changes or fluctuations in ASP payment limits, and efforts by us to obtain manufacturer reported ASP before Medicare ASP payment limits publication deadlines have not been successful. For example, the most recently reported manufacturer ASP prices for products on the market would be carried over to the next quarter if an entire manufacturer's submission was not received, manufacturer ASP price data for specific NDCs has not been reported, or only WAC data has been reported; however, NDCs that have zero sales or are no longer being manufactured will not be subjected to this process. Also, we are proposing to apply the carryover process only in cases where missing data results in a 10 percent or greater change in the ASP payment limit compared to the previous quarter. Based on experience with ASP methodology since 2006, we believe that this percentage threshold meets the definition of significant. We are specifically seeking comments on our use of 10 percent as the threshold amount. In order to better represent actual market trends, that is actual increases or decreases in manufacturer reported ASP for the group of NDCs that represent the HCPCS code, we are proposing that the manufacturer ASP payment amounts for the individual NDCs that are carried over will be adjusted by the weighted average of the change in the manufacturer ASP for the NDCs that were reported during both the most recently available quarter and the current quarter. We would appreciate comments about whether other methods to account for
We propose to apply this process to both single source drugs and multiple source drugs. However, we are concerned that including single source drugs in the carry over process could create an incentive for non-reporting in situations where ASP prices for a single source drug are falling and the manufacturer stops reporting ASP in an effort to preserve a higher payment amount despite the risk of significant statutory penalties for such an action. Therefore, we are specifically requesting comments on this option and the effect of limiting this proposal to multiple source drugs only. We will consider these comments carefully before including both single source and multisource drugs in this process.
Our proposed approach is intended to establish a straightforward and transparent solution that minimizes the effect of missing manufacturer ASP data on Medicare ASP payment limits. We believe that the availability of a mechanism to minimize non-market related price fluctuations is desirable when efforts to obtain manufacturer's ASP data by deadlines have not been successful. Our proposed mechanism is not intended to alter or adjust reported prices and will not be used to do so, but instead is intended to more accurately represent prices in the marketplace if manufacturer ASP data for particular drug product(s) is missing. Based on our experience with ASP reporting since 2004, we do not believe that this process will be used frequently. However, as we stated previously, recent concerns with delays in reporting of manufacturer ASP data have led to this proposal.
We also remind manufacturers that significant civil monetary penalties for not reporting or misrepresenting manufacturer ASP data are authorized under sections 1847A(d)(4) and 1927(b)(3)(C) of the Act and codified in regulations at § 414.806. This proposal should not be interpreted to mean that CMS and the OIG will refrain from collecting such penalties for ASP reporting violations. Late or missing reports will not be tolerated. This proposed policy would be implemented regardless of any efforts by the OIG to enforce Civil Monetary Penalties for non-reporting.
We would also like to remind manufacturers that additional specific information about reporting ASP data to us is available. (See for example.: 69 FR 17936, 69 FR 66299, 70 FR 70215, 71 FR 69665, 72 FR 66256, 73 FR 69751, and 74 FR 61904.) Also, Frequently Asked Questions are posted in the Related Links Inside CMS Section of the ASP Overview Web page at
In summary, in situations where any current quarter's manufacturer ASP data is unavailable, we are proposing, consistent with our authority in section 1847A(c)(5)(B), to use the most recent data available in the ASP payment limit calculation for single source and multiple source drugs. We look forward to comments on this proposal and the proposed changes to § 414.904(i).
Section 1847A(c)(4) of the Act states that “In the case of a drug or biological during an initial period (not to exceed a full calendar quarter) in which data on the prices for sales for the drug or biological is not sufficiently available from the manufacturer to compute an average sales price for the drug or biological, the Secretary may determine the amount payable under this section for the drug or biological based on— (A) the wholesale acquisition cost; or (B) the methodologies in effect under this part on November 1, 2003, to determine payment amounts for drugs or biological.”
When a new drug product enters the market, the first date of sale rarely coincides with the beginning of a calendar quarter. Therefore, the ASP data for many new drug products falls into partial quarter status during the first quarter of sales. We are taking this opportunity to describe our policy regarding how reported data is used in the calculation of ASP payment limits during the first quarter of sales for single source and multiple source drugs.
In accordance with section 1847A(c)(4)(A) of the Act, it has been our policy to price new single source drugs at WAC for the first quarter (unless the date of first sale is on the first day of the quarter), and to add new
We believe that the approaches for both single source and multi source drugs are consistent with the statute, particularly section 1847A(c)(4) of the Act, and we intend to continue this policy.
The methodology for developing Medicare drug payment allowances based on the manufacturers' submitted ASP data is specified in 42 CFR part 414, subpart K. We initially established this regulatory text in the CY 2005 PFS final rule with comment period (69 FR 66424). We further described the formula we use to calculate the payment amount for each HCPCS billing code in the CY 2006 PFS proposed rule (70 FR 45844) and final rule with comment period (70 FR 70217). With the enactment of the Medicare, Medicaid and SCHIP Extension Act (MMSEA) (Pub. L. 110–173), the formula we use changed beginning April 1, 2008. Section 112(a) of the MMSEA requires us to calculate payment amounts using a specified volume-weighting methodology. In addition, section 112(b) of the MMSEA sets forth a special rule for determining the payment amount for certain drugs and biological. We addressed these changes in the CY 2009 PFS proposed and final rules (73 FR 38520 and 69571, respectively). For each billing code, we calculate a volume-weighted, ASP-based payment amount using the ASP data submitted by manufacturers. Manufacturers submit ASP data to us at the 11-digit National Drug Code (NDC) level, including the number of units of the 11-digit NDC sold and the ASP for those units. We determine the number of billing units in an NDC based on the amount of drug in the package.
For example: A manufacturer sells a box of 4 vials of a drug. Each vial contains 20 milligrams (mg); the billing code is per 10 MG. The number of billing units in this NDC for this billing code is (4 vials × 20mg)/10mg = 8 billable units.
Beginning April 1, 2008, we use a two-step formula to calculate the payment amount for each billing code. We sum the product of the manufacturer's ASP and the number of units of the 11-digit NDC sold for each NDC assigned to the billing and payment code, and then divide this total by the sum of the product of the number of units of the 11-digit NDC sold and the number of billing units in that NDC for each NDC assigned to the billing and payment code.
The provisions in section 112 of the MMSEA were self-implementing for services on and after April 1, 2008. Because of the limited time between enactment and the implementation date, it was not practical to undertake and complete rulemaking on this issue prior to implementing the required changes. As a result of the legislation, we revised § 414.904 to codify the changes to the determination of payment amounts consistent with section 112 of the MMSEA.
Since that time, we have become aware of situations where manufacturers, by design, include a small amount of “intentional overfill” in containers of drugs. We understand that this “intentional overfill” is intended to compensate for loss of product when a dose is prepared and administered properly. For instance, a hypothetical drug is intended to be delivered at a 0.5 mg dose which must be drawn into a syringe from a vial labeled for single use only. The vial is labeled to contain 0.5 mg of product but actually contains 1.5 mg of product. The additional 1.0 mg of product is included, by design, and is intended to be available to the provider so as to ensure a full 0.5 mg dose is administered to the patient.
Our ASP payment calculations are based on data reported to us by manufacturers. This data includes the “volume per item.” In our “Appendix A—Average Sales Price Reporting Data Elements” available on our Web site at
It has been longstanding Medicare policy that in order to meet the general requirements for coverage under the “incident to” provision, services or supplies should represent an expense incurred by the physician or entity billing for the services or supplies (See Medicare Benefit Policy Manual (Publication #100–02), Chapter 15, Sections 50.3, 60.1.A). Such physicians' services and supplies include drugs and biological under section 1861(s)(2)(A). In accordance with this policy, providers may only bill for the amount of drug product actually purchased and that the cost of the product must represent an expense to the physician.
We further understand that when a provider purchases a vial or container of product, the provider is purchasing an amount of drug defined by the product packaging or label. Any excess, free product (that is, overfill) is provided without charge to the provider. In accordance with our policy, providers may not bill Medicare for overfill harvested from containers, including overfill amounts pooled from more than one container, because that overfill does not represent a cost to the provider. Claims for drugs and biological that do not represent a cost to the provider are not reimbursable, and providers who submit such claims may be subject to scrutiny and follow up action by CMS, its contractors, and OIG.
Because such overfill is not included in the calculation of payment limits under the methodology in section 1847A of the Act and does not represent an incurred cost to a provider, we are proposing to update our regulations at 42 CFR part 414 subpart J to clearly state that Medicare ASP payment limits are based on the amount of product in the vial or container as reflected on the FDA-approved label. We are also proposing to update our regulations to clearly state that payment for amounts of free product, or product in excess of the amount reflected on the FDA-approved label, will not be made under Medicare.
Section 1847A(d)(1) of the Act states that “the Inspector General of HHS shall conduct studies, which may include surveys to determine the widely available market prices (WAMP) of drugs and biologicals to which this section applies, as the Inspector General, in consultation with the Secretary, determines to be appropriate.” Section 1847A (d)(2) of the Act states that, “Based upon such studies and other data for drugs and biologicals, the Inspector General shall compare the ASP under this section for drugs and biologicals with—
• The widely available market price (WAMP) for these drugs and biologicals (if any); and
• The average manufacturer price (AMP) (as determined under section 1927(k)(1) of the Act) for such drugs and biologicals.”
Section 1847A(d)(3)(A) of the Act states that, “The Secretary may disregard the ASP for a drug or biological that exceeds the WAMP or the AMP for such drug or biological by the applicable
The applicable threshold percentage is specified in section 1847A(d)(3)(B)(i) of the Act as 5 percent for CY 2005. For CY 2006 and subsequent years, section 1847A(d)(3)(B)(ii) of the Act establishes that the applicable threshold percentage is “the percentage applied under this subparagraph subject to such adjustment as the Secretary may specify for the WAMP or the AMP, or both.” In the CY 2006 (70 FR 70222), CY 2007 (71 FR 69680), CY 2008 (72 FR 66258), CY 2009 (73 FR 69752), and CY 2010 (74 FR 61904) PFS final rules with comment period, we specified an applicable threshold percentage of 5 percent for both the WAMP and AMP. We based this decision on the fact that data was too limited to support an adjustment to the current applicable threshold percentage.
For CY 2011, we are proposing to specify two separate adjustments to the applicable threshold percentages. When making comparisons to the WAMP, we propose the applicable threshold percentage to remain at 5 percent. The applicable threshold percentage for the AMP is addressed below in this section of the preamble. Although the latest WAMP comparison was published in 2008, the OIG is continuing to perform studies comparing ASP to WAMP. Based on available OIG reports that have been published comparing WAMP to ASP, we do not have sufficient information to determine that the 5 percent threshold percentage is inappropriate. As a result, we believe that continuing the 5 percent applicable threshold percentage for the WAMP is appropriate for CY 2011. Therefore we are proposing to revise § 414.904(d)(3) to include the CY 2011 date.
As we noted in the CY 2010 PFS final rule with comment period (74 FR 61904), we understand that there are complicated operational issues associated with this policy. We continue to proceed cautiously in this area. We remain committed to providing stakeholders, including providers and manufacturers of drugs impacted by potential price substitutions with adequate notice of our intentions regarding such, including the opportunity to provide input with regard to the processes for substituting the WAMP for the ASP.
We welcome comments on our proposal to continue the applicable threshold percentage at 5 percent for the WAMP for 2011.
As mentioned elsewhere in this proposal, when making comparisons of ASP to AMP, the applicable threshold percentage for CY 2005 was specified in statute as 5 percent. Section 1847A(d)(3) of the Act allows the Secretary to specify adjustments to this threshold percentage for years subsequent to 2005, and to specify the timing for any price substitution. For CY 2006 (70 FR 70222), CY 2007 (71 FR 69680), CY 2008 (72 FR 66258), CY 2009 (73 FR 69752), and CY 2010 (74 FR 61904), the Secretary made no adjustments to the threshold percentage; it remained at 5 percent.
For CY 2011, we are proposing with respect to AMP substitution to apply the applicable percentage subject to certain adjustment such that comparisons of ASP to AMP will only be made when the ASP exceeds the AMP by 5 percent in two consecutive quarters immediately prior to the current pricing quarter, or three of the previous four quarters immediately prior to the current quarter.
In general, the ASP methodology reflects average market prices for Part B drugs for a quarter. The ASP is based, in part, on the average sales price to all purchasers for a calendar quarter; the AMP, in turn, represents the average price paid by certain wholesalers. Accordingly, while the ASP payment amount for a billing code may exceed its AMP for that billing code for any given quarter, this may only reflect a temporary fluctuation in market prices that would be otherwise corrected in a subsequent quarter. We believe this fluctuation is demonstrated by how few billing codes exceed the applicable threshold percentage over multiple quarters. For example, in the Inspector General's report “Comparison of Average Sales Prices and Average manufacturer Prices: An Overview of 2008”, only 33 of 482 examined billing codes exceeded the applicable threshold percentage over multiple quarters. This figure also included billing codes that exceeded the threshold based on partial price comparisons (OEI–03–09–00350). We are concerned that comparisons of a single quarter's ASP to AMP will not adequately account for these temporary fluctuations and underlying market trends. We believe that applying this threshold percentage adjusted to reflect data from multiple quarters will account for continuing differences between ASP and AMP, and allow us to better identify those drugs that consistently trigger the substitution threshold.
We further propose to apply the applicable AMP threshold percentage only for those situations where AMP and ASP comparisons are based on the same set of NDCs for a billing code (that is, “complete” AMP data). Prior to 2008, the OIG calculated a volume-weighted AMP and made ASP and AMP comparisons for only billing codes with such “complete” AMP data. In such comparisons, a volume-weighted AMP for a billing code was calculated when NDC-level AMP data was available for the same NDCs used by us to calculate the volume-weighted ASP. Beginning in the first quarter of 2008, the OIG also began to make ASP and AMP comparisons based on “partial” AMP data (that is, AMP data for some, but not all NDCs in a billing code). For these comparisons, the volume-weighted AMP for a billing code is calculated even when only such limited AMP data is available. That is, the volume-weighted AMP calculated by the Inspector General is based on fewer NDCs than the volume-weighted ASP calculated by CMS. Moreover, volume-weighted ASPs are not adjusted by the Inspector General to reflect the fewer number of NDCs in the volume-weighted AMP.
Because the OIG's partial AMP data comparison does not reflect all the NDCs used in our volume-weighted ASP calculations, we have some concerns using the volume-weighted AMP. We believe that such AMP data may not adequately account for market-related drug price changes and may lead to the substitution of incomplete and inaccurate volume-weighted prices. Such substitutions may impact physician and beneficiary access to drugs. Therefore, in accordance with our authority as set forth in section 1847A(d)(1) and (3) of the Act, we are proposing the substitution of 103 percent of AMP for 106 percent of ASP should be limited to only those drugs with ASP and AMP comparisons based on the same set of NDCs. We are proposing to revise § 414.904(d)(3) to reflect corresponding regulatory text changes, and we welcome comments on all aspects of this proposal.
Section 1847A(d) of the Act requires the Inspector General to conduct studies of the widely available market price for drugs and biological to which section 1847A of the Act applies. However, it does not specify the frequency of when such studies should be conducted. The Inspector General has conducted studies comparing AMP to ASP for essentially each quarter since the ASP system has been implemented. Since 2005, the OIG has published 18 reports pertaining to the price substitution issue (see Table 45), of which 16 have identified billing codes with volume-weighted ASPs that have exceeded their volume-weighted AMPs by the applicable threshold percentage.
For example, in their latest report comparing AMP to ASP entitled “Comparison of Third-Quarter 2009 Average Sales Price and Average Manufacturer Prices: Impact on Medicare Reimbursement for First Quarter 2010” (OEI–03–10–00150), the Inspector General found that of 356 billing codes with complete AMP data in the third quarter of 2009, 16 met the 5 percent threshold, that is, ASP exceeded AMP by at least 5 percent. Eight of these 16 billing codes were also eligible for price adjustments in one or more of the previous four quarters, with three drugs meeting the 5-percent threshold in all five quarters under review. This Inspector General report further indicates that, “If reimbursement amounts for all 16 drugs had been based on 103 percent of the AMPs, we estimate that Medicare expenditures would have been reduced by over half a million dollars in the first quarter of 2010.” These drugs and the savings found by the Inspector General constitute potential savings for the Medicare program and beneficiaries.
Since 2005, regulatory and legislative changes, as well as litigation, have had a direct impact on this price substitution issue. In 2007, we published a final rule that, in accordance with section 6001(c) of the Deficit Reduction Act, was designed to clarify the definition of AMP (72 FR 39142). On December 19, 2007, the United States District Court for the District of Columbia issued a preliminary injunction in
In 2010, section 2503 of ACA amended the definition of AMP, in part, to reflect the average price paid for covered outpatient drugs: (1) By wholesalers for drugs distributed to retail community pharmacies; and (2) by retail community pharmacies that purchase drugs directly from the manufacturer. The statute defines retail community pharmacies, in part, as independent, chain, and supermarket pharmacies.
Overall, we are cognizant that any policy must reflect market-related pricing changes. Additionally, we continue to recognize the need, in light of the statute, to implement a price substitution policy.
As discussed previously, section 1847A(d)(3) of the Act provides authority for us to determine the applicable percentage subject to “such adjustment as the Secretary may specify for the widely available market price or the average manufacturer price, or both.” We also have authority to specify the timing of any ASP substitution. Consistent with this authority, we are proposing a policy to substitute 103 percent of AMP for 106 percent of ASP where the applicable percentage has been satisfied for a number of calendar quarters, as discussed elsewhere in this rule. This policy would apply to both single source and multiple source drugs and biologicals as defined respectively at section 1847A(c)(6)(C) and (D) of the Act.
We acknowledge the limitation of the preliminary injunction on our ability to publicly disclose AMP data and until that injunction is modified, we will not implement this price substitution policy.
Because of the lack of data regarding WAMP to ASP comparisons, we are explicitly excluding WAMP from this price substitution proposal though we are proposing to maintain the WAMP threshold at 5 percent for CY 2011 in a separate section of this rule. Overall, we are interested in implementing a price substitution policy that reflects market-related pricing changes and which focuses on those drugs that consistently exceed the price substitution threshold over multiple quarters. Unlike the OIG's AMP studies, the published WAMP studies have recommended price substitutions based on specific timeframes that do not illustrate whether such pricing discrepancies are singular or consistent across multiple quarters. We will reconsider proposing a policy for the substitution of WAMP at a later date.
As stated in § 414.804(a)(5), a manufacturer's average sales price must be submitted to CMS within 30 days of the close of the quarter. We then calculate an ASP for each billing code as per the process outlined at § 414.904. Then, as per our CY 2005 PFS final rule (69 FR 66300), we implement these new prices through program instructions or otherwise at the first opportunity after we receive the data, which is the calendar quarter after receipt.
Section 1847A(d)(3)(C) of the Act indicates that a price substitution would be implemented “effective as of the next quarter” after the OIG has informed us that the ASP for a drug or biological exceeds its AMP by the applicable percentage threshold. The OIG does not receive new ASP prices for a given quarter until after we have finalized them. Also, the results of their pricing comparisons are not available until after the ASP prices for a given quarter have gone into effect. Therefore, we anticipate that there will be a three quarter lag for substituted prices from the quarter in which manufacturer sales occurred, though this will depend in great part upon the timeframe in which we obtain comparison data from the OIG. Table 46 provides an example of this timeframe.
Given this lag in time, the ASP price for a billing code may have decreased since the OIG's comparison. Therefore, consistent with our authorities in section 1847A(d)(3) of the Act and our desire to provide accurate payments consistent with these provisions, we believe that the timing of any substitution policy should permit a final comparison between the OIG's volume-weighted 103 percent AMP for a billing code (calculated from the prior quarter's data) and the billing code's volume-weighted 106 percent ASP, as calculated by CMS, for the current quarter. This final comparison would assure the Secretary that the 106 percent ASP payment limit continues to exceed 103 percent of the OIG's calculated AMP in order to avoid a situation in which the Secretary would inadvertently raise the Medicare payment limit through this price substitution policy. We specifically request comments on this proposal.
ASP payment limits are calculated on a quarterly basis as per section 1847A(c)(5)(A) of the Act, and we are particularly mindful that the ASP-based payment allowance for a billing code may change from quarter to quarter. As such, we propose that any price substitution would last for one quarter.
Overall, we believe that our proposal as outlined above to substitute 103 percent of AMP for 106 percent of ASP provides us with a viable mechanism for generating savings for the Medicare program and its beneficiaries since it will allow Medicare to pay based off lower market prices for those drugs and biologicals that consistently exceed the applicable threshold percentage. Moreover, it will enable us to address a programmatic vulnerability identified by the OIG. We welcome comments on all aspects of our proposal.
We are also seeking comment on other issues related to the comparison between ASP and AMP, such as—
• Any effect of definitional differences between AMP and ASP, particularly in light of the revised definition of AMP per ACA;
• The impact of any differences in AMP and ASP reporting by manufacturers on price substitution comparisons; and
• Whether and/or how general differences and similarities between AMP and manufacturer's ASP would affect comparisons between these two.
Under the ambulance fee schedule, the Medicare program pays for transportation services for Medicare beneficiaries when other means of transportation are contraindicated and all other applicable medical necessity requirements are met. Ambulance services are classified into different levels of ground (including water) and air ambulance services based on the medically necessary treatment provided during transport. These services include the following levels of service:
• For Ground—
++ Basic Life Support (BLS) (emergency and nonemergency).
++ Advanced Life Support, Level 1 (ALS1) (emergency and nonemergency).
++ Advanced Life Support, Level 2 (ALS2).
++ Specialty Care Transport (SCT).
++ Paramedic ALS Intercept (PI).
• For Air—
++ Fixed Wing Air Ambulance (FW).
++ Rotary Wing Air Ambulance (RW).
Under sections 1834(l) and 1861(s)(7) of the Act, Medicare Part B (Supplementary Medical Insurance) covers and pays for ambulance services, to the extent prescribed in regulations, when the use of other methods of transportation would be contraindicated by the beneficiary's medical condition. The House Ways and Means Committee and Senate Finance Committee Reports that accompanied the 1965 Social Security Amendments suggest that the Congress intended that—
• The ambulance benefit cover transportation services only if other means of transportation are contraindicated by the beneficiary's medical condition; and
• Only ambulance service to local facilities be covered unless necessary services are not available locally, in which case, transportation to the nearest facility furnishing those services is covered (H.R. Rep. No. 213, 89th Cong., 1st Sess. 37 and Rep. No. 404, 89th Cong., 1st Sess. Pt 1, 43 (1965)).
The reports indicate that transportation may also be provided from one hospital to another, to the beneficiary's home, or to an extended care facility.
Our regulations relating to ambulance services are set forth at 42 CFR part 410, subpart B, and 42 CFR part 414, subpart H. Section 410.10(i) lists ambulance services as one of the covered medical and other health services under Medicare Part B. Therefore, ambulance services are subject to basic conditions and limitations set forth at § 410.12 and to specific conditions and limitations as specified in § 410.40 and § 410.41. Part 414, subpart H, describes how payment is made for ambulance services covered by Medicare.
Historically, the Medicare fee-for-service (FFS) claims processing system lacked the capability to accept and process fractional unit amounts reported in any claim format. Therefore, the standard for reporting units for ambulance mileage was to bill in whole number increments. Thus, if the total units of service for ambulance mileage included a fractional amount, providers and suppliers of ambulance services (hereafter referred to collectively as “providers and suppliers”) were instructed to round the fraction up to the next whole number. Claims billed with fractional units of service were, at that time, returned as unprocessable as CMS' claims processing systems could not accept nor adjudicate fractional unit amounts properly.
Consequently, in Change Request (CR) 1281 (Transmittal AB–00–88, issued on September 18, 2000), we instituted an operational procedure requiring whole-unit reporting of mileage on ambulance claims. Specifically, we instructed providers and suppliers that “If mileage is billed, the miles must be whole numbers. If a trip has a fraction of a mile, round up to the nearest whole number.” Our instructions also stated that “1” should be reported for trips totaling less than a single mile. This was an operational instruction based on Medicare's FFS system limitations and capabilities at the time, as our claims processing systems were not capable of accepting and processing claims submitted with fractional units of service. Since then, our claims processing system functionality has evolved to the point where this rounding process is no longer necessary for most ambulance transports, as it is now possible for our FFS systems to capture and accurately process fractional units on both paper and electronic forms.
Under our current instructions, providers and suppliers continue to report loaded mileage as whole-number units on both paper and electronic claims. Providers and suppliers utilize the appropriate Healthcare Common Procedure Coding System (HCPCS) code for ambulance mileage to report the number of miles traveled during a Medicare-covered trip rounded up to the nearest whole mile at a minimum of 1 unit for the purpose of determining payment for mileage. Transmittal AB–00–88 established a list of HCPCS codes accepted by Medicare for the purpose of billing mileage. Providers and suppliers were instructed to use these specific HCPCS codes and enter the total number of covered miles in the “units” field of the claim form. For example, if a covered trip from the point of pickup (POP) to the Medicare-approved destination (see § 414.40 for a list of approved destinations) totaled 9.1 miles, the provider would enter the appropriate HCPCS code for covered mileage and a “10” in the units field. Providers and suppliers billing for trips totaling, for example, 0.5 covered miles, would enter “1” in the units field along with the appropriate HCPCS code for mileage.
Often an ambulance provider will transport a distance that is either not an exact whole number of miles or less than one whole mile during a covered trip. Currently, providers and suppliers billing for ambulance services must round up the total billable mileage to the nearest whole mile for trips that include a fraction of a mile or less than one whole mile. Under our current instructions, a provider or supplier is required to bill as much as .9 of a mile more than what was actually traveled.
We have been contacted by suppliers on several occasions with concerns regarding our current instructions for reporting ambulance mileage. Certain suppliers believe that our instructions require them to bill inaccurately. One company in particular stated that they routinely need to bill for trips totaling less than 1 mile. The beneficiaries that are being transported by this company live in the immediate vicinity of the facility to which they are being transported, and therefore, the number of loaded miles for each trip totals approximately one half of a mile. The company was concerned that since Medicare requires that they enter a “1” in the units field of their claims for mileage, they are being overpaid by
However, the company's main concern revolved around the risk of creating an appearance of impropriety. Although our instructions clearly state that providers and suppliers should, as a matter of procedure, round up fractional mileage amounts to the nearest whole mile, some providers and suppliers indicated that they wanted to bill as accurately as possible and that they only wanted to be paid for the service they actually provided. We thoroughly considered these concerns while reevaluating the procedure for reporting units for fractional mileage amounts.
Our first priority in considering the issues raised by ambulance providers and suppliers was to ascertain the basis for the current mileage reporting instructions. As previously discussed, the original instructions for reporting fractional mileage were published in Transmittal AB–00–88, issued on September 18, 2000. We instructed providers and suppliers to round fractional mileage amounts “up to the nearest whole mile” and to enter “1” for fractional mileage totaling less than one mile. This particular process had also been in place prior to issuance of the transmittal. The reason for the procedure was that our claims processing systems were not capable of accepting and processing claims submitted with fractional units of service—even if the service was commonly measured in fractional amounts, as with ambulance mileage.
We then explored whether a change in our procedure would be: (a) Appropriate, (b) possible considering our current system capabilities and industry standards of measurement, and (c) applicable to any service other than ambulance mileage. As to the appropriateness of changing the procedure for reporting units of service on provider claims for fractional ambulance mileage, we believe that we should make every effort to create and implement policies and processes that create the best opportunity for accuracy in billing. It is not our intention to put providers and suppliers in a position where they are required to bill inaccurately for the service they provide. We continue to strive toward ensuring that providers and suppliers bill and are paid only for services actually provided. We believe that changing our current procedure for reporting units of service to require reporting of fractional mileage will help to ensure that providers and suppliers can submit claims that more precisely reflect actual mileage, and are reimbursed more accurately for the services they actually provided. We originally instituted a policy of accepting and processing only whole units because at that time, system limitations prevented us from accepting and processing fractional ambulance mileage.
Second, we considered whether it is currently possible for our claims processing systems to accept and process fractional unit amounts on both paper and electronic claims. Upon reevaluating our system capabilities, we found that technological advancements in Optical Character Recognition (OCR) and electronic claim submission have made it possible for our FFS systems to capture and accurately process fractional units on both paper and electronic claims. We note that our systems currently have the capability to accept fractional units with accuracy up to as much as one thousandth of a unit (that is, to 3 decimal places).
We also considered whether ambulance providers and suppliers have the capability to measure fractional mileage. This was an important point because if providers and suppliers are not able to measure mileage with any more specificity than the nearest whole number mile, then there would be no need to modify the current procedure for billing fractional mileage. In that case, providers and suppliers would continue to report mileage as whole numbers since they could measure no more accurately than that. However, both analog and digital motor vehicle odometers are designed to measure mileage accurately to within a minimum of a tenth of a mile. While we found that some vehicle odometers measure mileage more accurately than a tenth of a mile, most odometers are accurate to the nearest tenth of a mile. Additionally, aircraft geographic positioning system (GPS) technology provides the means to accurately determine billable mileage to the tenth of a mile.
Third, we considered whether a policy of billing fractional units would be applicable to any other service besides ambulance mileage. The units of service field on both the electronic and paper claim is used to report the quantity of services or supplies provided to Medicare beneficiaries and is used to report a wide range of services and supplies including, but not limited to: Number of office visits; anesthesia minutes; quantity of drugs administered; covered miles. Although Medicare currently makes payment based on fractional units for some services (for example, calculation of payment after conversion of anesthesia time reported in minutes to time units), there is currently no requirement that providers bill fractional units on the claim. If we were to implement a policy of requiring reporting of fractional units for other types of services or supplies we would first need to evaluate whether it is possible to do so considering industry standards of measurement. As previously discussed, providers and suppliers of ambulance services have the capability to determine fractional mileage using standard onboard equipment, that is, an odometer, GPS, and/or other similar equipment used to measure distance traveled. This would enable us to readily implement a fractional unit billing policy for ambulance mileage; whereas applicability to other areas (such as anesthesia, drugs,
Finally, and perhaps most importantly, we considered that our claims processing system should be configured to process claims as accurately as possible so as to provide for more accurate payments and to safeguard Medicare dollars. As previously discussed, ambulance providers and suppliers currently have the capability to measure mileage accurately to within a minimum of a tenth of a mile using devices (for example, odometers, GPS technology, etc.) already equipped onboard their vehicles. We believe that requiring ambulance providers and suppliers to round (and report) fractional ambulance mileage up to the next tenth of a mile strikes a proper balance between ensuring that the claims processing system adjudicates a claim as accurately as the system will permit without unduly burdening the ambulance community.
Based on all of the above considerations, we have decided that our claims processing instructions for submission of claims for ambulance mileage should be revised to reflect the current functionality of our claims processing systems so as to maximize the accuracy of claims payment, as further discussed below in this section.
It is both reasonable and prudent that, in order to ensure accuracy of payment, we facilitate and allow submission of the most accurate information on all Medicare ambulance claims. Furthermore, since our claims processing systems are currently capable of accepting and processing fractional units of service, we believe that ambulance mileage should be billed to and paid by Medicare in fractional amounts to enhance payment accuracy. Based on all the considerations discussed above, we are proposing to require that claims for mileage submitted by ambulance providers and suppliers for an ambulance transport (ground and air) be billed in fractional units, by rounding up to the nearest tenth of a mile (with the exception discussed below). As discussed above, we believe that requiring ambulance providers and suppliers to round (and report) fractional mileage up to the next tenth of a mile would allow us to provide for more accurate claims payment without unduly burdening the ambulance community.
Therefore, we are proposing that, effective for claims with dates of service on and after January 1, 2011, ambulance providers and suppliers would be required to report mileage rounded up to the nearest tenth of a mile for all claims for mileage totaling up to 100 covered miles. Providers and suppliers would submit fractional mileage using a decimal in the appropriate place (for example, 99.9). Since standard vehicle mileage (analog, digital, and GPS) is or can be calculated accurately to the nearest tenth of a mile, we are proposing that the mileage billed to Medicare by ambulance providers and suppliers be reported by rounding up to the next tenth of a mile.
Although the electronic claim formats can accommodate fractional mileage when mileage is equal to or greater than 100 covered miles (for example, 100.0), the paper claim cannot. Because the Form CMS–1500 paper claim currently only supports four characters (including the decimal point) in the units field (Item 24G), we also propose that mileage equal to or greater than 100 covered miles continue to be reported in whole number miles on both paper and electronic claims. We propose that providers and suppliers would round up fractional mileage to the next whole number for mileage that exceeds 100 covered miles and report the resulting whole number in the units' field. We would revise the instructions set forth in our Claims Processing Manual to reflect the revised procedures for submitting and paying claims for fractional ambulance.
In the March 10, 2000
On March 5, 2002, we published a program transmittal implementing the administrative policies set forth in the final rule, including the following instruction: “Medicare does not require the signature of the ordering physician on a laboratory service requisition. While the signature of a physician on a requisition is one way of documenting that the treating physician ordered the service, it is not the only permissible way of documenting that the service has been ordered. For example, the physician may document the ordering of specific services in the patient's medical record.” (Transmittal AB–02–030, Change Request 1998, dated March 5, 2002).
On January 24, 2003, we published a program transmittal in order to manualize the March 5, 2002 Transmittal. (Transmittal 1787, Change Request 2410, dated January 24, 2003). The cover note to the transmittal states, “Section 15021, Ordering Diagnostic Tests, manualizes Transmittal AB–02–030, dated March 5, 2002. In accordance with negotiated rulemaking for outpatient clinical diagnostic laboratory services, no signature is required for the ordering of such services or for physician pathology services.” In the manual instructions in that transmittal in a note, we stated: “No signature is required on orders for clinical diagnostic services paid on the basis of the physician fee schedule or for physician pathology services.” The manual instructions did not explicitly reference clinical diagnostic laboratory tests as the cover note did. Rather, the transmittal seemed to extend the policy set forth in the
When we transitioned from paper manuals to the current electronic Internet Only Manual system, these manual instructions were inadvertently omitted from the new Benefit Policy Manual (BPM).
In August 2008, we issued a program transmittal (Transmittal 94, Change Request 6100, dated August 29, 2008) to update the BPM to incorporate language that was previously contained in section 15021 of the Medicare Carriers Manual. The reissued language states, “No signature is required on orders for clinical diagnostic tests paid on the basis of the clinical laboratory fee schedule, the physician fee schedule, or
To resolve any existing confusion surrounding the implementation of the policy in 2001 and subsequent transmittals, we restated and solicited public comments on our policy in the CY 2010 PFS proposed rule (74 FR 33641). Our current policy is that a physician's signature is not required on a requisition for clinical diagnostic laboratory tests paid on the basis of the CLFS; however, it must be evident, in accordance with our regulations at § 410.32(d)(2) and (3), that the physician ordered the services.
We note that we solicited and received comments on this signature requirement during the notice and comment period for the March 10, 2000 proposed rule in the context of our proposal to add paragraph (d)(2)(i) to § 410.32 to require that the practitioner who orders a diagnostic laboratory test must maintain documentation of medical necessity in the beneficiary's medical record. The majority of comments supported the adoption of a policy that the signature of the practitioner on a requisition for a clinical diagnostic laboratory test paid under the CLFS is not the only way of documenting that the test has been ordered and, thus, should not be required provided such documentation exists in an alternate form.
This policy regarding requisitions for clinical diagnostic laboratory tests does not supersede other applicable Medicare requirements (such as those related to hospital Conditions of Participation (CoPs)) which require the medical record to include an order signed by the physician who is treating the beneficiary. Nor do we believe that anything in our policy regarding signatures on requisitions for clinical diagnostic laboratory tests supersedes other requirements mandated by professional standards of practice or obligations regarding orders and medical records promulgated by Medicare, the Joint Commission, or State law; nor do we believe the policy would require providers to change their business practices.
We also restated and solicited public comment on our long-standing policy consistent with the principle in § 410.32(a) that a written order for diagnostic tests including those paid under the CLFS and those that are not paid under the CLFS (for example, that are paid under the PFS or under the OPPS), such as X-rays, MRIs, and the TC of physician pathology services, must be signed by the ordering physician or NPP. That is, the policy that signatures are not required on requisitions for clinical diagnostic laboratory tests paid based on the CLFS applies only to requisitions (as opposed to written orders) (74 FR 33642).
Additionally, we solicited public comments about the distinction between an order and a requisition (74 FR 33642). We note that an “order” as defined in our IOM, 100–02, Chapter 15, Section 80.6.1, is a communication from the treating physician/practitioner requesting that a diagnostic test be performed for a beneficiary. The order may conditionally request an additional diagnostic test for a particular beneficiary if the result of the initial diagnostic test ordered yields to a certain value determined by the treating physician/practitioner (for example, if test X is negative, then perform test Y). As set forth in the CY 2010 MPFS final rule (FR 74 61930), an order may be delivered via any of the following forms of communication:
• A written document signed by the treating physician/practitioner, which is hand-delivered, mailed, or faxed to the testing facility.
• A telephone call by the treating physician/practitioner or his or her office to the testing facility.
• An electronic mail, or other electronic means, by the treating physician/practitioner or his or her office to the testing facility.
If the order is communicated via telephone, both the treating physician/practitioner, or his or her office, and the testing facility must document the telephone call in their respective copies of the beneficiary's medical records.
In the proposed rule (74 FR 33642), we defined a “requisition” as the actual paperwork, such as a form, which is provided to a clinical diagnostic laboratory that identifies the test or tests to be performed for a patient. It may contain patient information, ordering physician information, referring institution information, information about where to send reports, billing information, specimen information, shipping addresses for specimens or tissue samples, and checkboxes for test selection. We believe it is ministerial in nature, assisting laboratories with billing and handling of results, and serves as an administrative convenience to providers and patients. We believe that a written order, which may be part of the medical record, and the requisition are two different documents, although a requisition that is signed may serve as an order. We welcomed comments from the public about the distinction between requisitions and orders.
During the proposed and final rulemaking process for CY 2010, we received numerous comments on these issues, including, among others: Expressions of continued confusion over the difference between an “order” and a “requisition”; requests that CMS develop a single policy for all outpatient laboratory services, without the distinction for those paid under the CLFS or the PFS; and concerns about reference laboratory technicians who felt compelled to perform a test in order to protect the viability of the specimen although they did not have the proper documentation. See 74 FR 61930–32 for a complete discussion of the comments received and responses to these issues. In the CY 2010 PFS final rule with comment period (74 FR 61931), we stated that, in light of the issues and concerns raised during the comment period, and our desire to create policy that will address the concerns in a meaningful, clear and thoughtful way, we would continue to carefully consider the issues of physician signatures on requisitions and orders and that we plan to revisit these issues in the future paying particular attention to the definitions of order and requisition.
Since the publication of the CY 2010 PFS final rule with comment period, we have considered an approach that would address the concerns raised. We are proposing to require a physician's or NPP's signature on requisitions for clinical diagnostic laboratory tests paid on the basis of the CLFS.
We believe that this policy would result in a less confusing process. We believe that it would be less confusing because a physician's signature would then be required for all requisitions and orders, eliminating uncertainty over whether the documentation is a requisition or an order, whether the type of test being ordered requires a signature, or which payment system does or does not require a physician or NPP signature. We also believe that it would not increase the burden on physicians because it is our understanding that, in most instances, physicians are annotating the patient's medical record with either a signature or an initial (the “order”), as well as providing a signature on the paperwork that is provided to the clinical diagnostic laboratory that identifies the
We welcome comments on this proposal.
Section 651 of MMA requires the Secretary to conduct a 2-year demonstration to evaluate the feasibility and advisability of expanding coverage for chiropractic services under Medicare. Medicare coverage for chiropractic services is limited to manual manipulation of the spine to correct a subluxation described in section 1861(r)(5) of the Act. The demonstration expanded current Medicare coverage to include “care for neuromusculoskeletal conditions typical among eligible beneficiaries and diagnostic and other services that a chiropractor is legally authorized to perform by the State or jurisdiction in which such treatment is provided” and was conducted in four geographically diverse sites, two rural and two urban regions, with each type including a Health Professional Shortage Area (HPSA). The two urban sites were 26 counties in Illinois and Scott County, Iowa, and 17 counties in Virginia. The two rural sites were the States of Maine and New Mexico. The demonstration, which ended on March 31, 2007, was required to be budget neutral as section 651(f)(1)(B) of MMA mandates the Secretary to ensure that “the aggregate payments made by the Secretary under the Medicare program do not exceed the amount which the Secretary would have paid under the Medicare program if the demonstration projects under this section were not implemented.”
In the CY 2006, 2007, and 2008 PFS final rules with comment period (70 FR 70266, 71 FR 69707, 72 FR 66325, respectively), we included a discussion of the strategy that would be used to assess budget neutrality (BN) and the method for adjusting chiropractor fees in the event the demonstration resulted in costs higher than those that would occur in the absence of the demonstration. We stated BN would be assessed by determining the change in costs based on a pre-post comparison of Medicare costs for beneficiaries in the demonstration and their counterparts in the control groups and the rate of change for specific diagnoses that are treated by chiropractors and physicians in the demonstration sites and control sites. We also stated that our analysis would not be limited to only review of chiropractor claims because the costs of the expanded chiropractor services may have an impact on other Medicare costs.
In the CY 2010 PFS final rule with comment period (74 FR 61926), we discussed the evaluation of this demonstration conducted by Brandeis University and the two sets of analyses used to evaluate budget neutrality. In the “All Neuromusculoskeletal Analysis,” which compared the Medicare costs of
As explained in the CY 2010 PFS final rule, we based the BN estimate on the “Chiropractic User Analysis” because of its focus on users of chiropractic services rather than all Medicare beneficiaries with neuromusculoskeletal conditions, including those who did not use chiropractic services and who would not have become users of chiropractic services even with expanded coverage for them (74 FR 61926 through 61927). Users of chiropractic services are most likely to have been affected by the expanded coverage provided by this demonstration. Cost increases and offsets, such as reductions in hospitalizations or other types of ambulatory care, are more likely to be observed in this group.
As explained in the CY 2010 PFS final rule (74 FR 61927), because the costs of this demonstration were higher than expected and we did not anticipate a reduction to the PFS of greater than 2 percent per year, we finalized a policy to recoup $50 million in expenditures from this demonstration over a 5-year period, that is, CYs 2010 through 2014 (74 FR 61927). Specifically, we are recouping $10 million for each such year through adjustments to the chiropractic CPT codes. Payment under the PFS for these codes will be reduced by approximately 2 percent. We believe that spreading this adjustment over a longer period of time will minimize its potential negative impact on chiropractic practices.
We are continuing the implementation of the required budget neutrality adjustment by recouping $10 million in CY 2011. Our Office of the Actuary estimates chiropractic expenditures in CY 2011 to be approximately $524 million based on actual Medicare spending for chiropractic services for the most recent available year. To recoup $10 million in CY 2011, the payment amount under the PFS for the chiropractic CPT codes (that is, CPT codes 98940, 98941, and 98942) will be reduced by approximately 2 percent. We are reflecting this reduction only in the payment files used by the Medicare contractors to process Medicare claims rather than through adjusting the RVUs. Avoiding an adjustment to the RVUs would preserve the integrity of the PFS, particularly since many private payers also base payment on the RVUs.
Since August 1, 1983, payment for dialysis services furnished by ESRD facilities has been based on a composite rate payment system that provides a fixed, prospectively determined amount per dialysis treatment, adjusted for geographic differences in area wage levels. The composite rate is designed to cover a package of goods and services needed to furnish dialysis treatments that include, but not be limited to, certain routinely provided drugs, laboratory tests, supplies, and equipment. Unless specifically included in the composite rate, other injectable drugs and laboratory tests medically necessary for the care of patients on dialysis are separately billable.
Other than periodic updates, there were no significant changes to the composite rate payment system until the implementation of the basic case-mix adjusted composite rate payment system beginning January 1, 2005. The Congress has enacted a number of adjustments to the composite rate since that time. As a result of the July 15, 2008 enactment of MIPPA, we are required to implement an end-stage renal disease (ESRD)
On September 29, 2009, we published in the
As explained in the ESRD PPS proposed rule (74 FR 50019), section 1881(b)(14)(E)(i) of the Act requires a 4-year transition (phase-in) from the current composite payment system to the ESRD PPS, and section 1881(b)(14)(E)(ii) of the Act allows ESRD facilities to make a one-time election to be excluded from the transition. Electing to be excluded from the 4-year transition means that the ESRD facility receives payment for renal dialysis services based on 100 percent of the payment rate established under the ESRD PPS, rather than a blended rate under each year of the transition based in part on the payment rate under the current payment system and in part on the payment rate under the ESRD PPS. As of January 1, 2011, ESRD facilities that elect to go through the transition would be paid in the first year a blended amount that will consist of 75 percent of the basic case-mix adjusted composite payment system and the remaining 25 percent would be based on the ESRD PPS payment. Thus, we must continue to update the basic case-mix composite payment system for purposes of determining the composite rate portion of the blended payment amount during the ESRD PPS 4-year transition (CYs 2011 through 2013.) Accordingly, in this proposed rule, we are proposing the composite rate portion of the blend, which includes an update to the drug add-on and the application of the wage index, as well as the payment amount for the first-year (CY 2011) of the ESRD PPS transition. We anticipate that the final rule for the ESRD PPS will be published this summer.
Section 623 of the MMA amended section 1881 of the Act to require changes to the composite rate payment methodology, as well as to the pricing methodology for separately billable drugs and biologicals furnished by ESRD facilities. Section 1881(b)(12) of the Act, as added by section 623(d) of the MMA, requires the establishment of a basic case-mix adjusted composite payment system that includes services comprising the composite rate and an add-on to the composite rate component to account for the difference between current payments for separately billed drugs and the revised drug pricing specified in the statute. In addition, section 1881(b)(12)(A) of the Act requires that the composite rate be adjusted for a number of patient characteristics (case-mix) and section 1881(b)(12)(D) of the Act gives the Secretary discretion to revise the wage indices and the urban and rural definitions used to develop them. Finally, section 1881(b)(12)(E) of the Act imposed a budget neutrality (BN) requirement, so that aggregate payments under the basic case-mix adjusted composite payment system equal the aggregate payments for the same period if section 1881(b)(12) of the Act did not apply.
In the CY 2005 PFS final rule with comment period (69 FR 66319 through 66334), we implemented section 1881(b)(12) of the Act, as added by section 623 of the MMA, and revised payments to ESRD facilities. These revisions that were effective January 1, 2005, included an update of 1.6 percent to the composite rate component of the payment system; a drug add-on adjustment of 8.7 percent to the composite rate to account for the difference between pre-MMA payments for separately billable drugs and payments based on revised drug pricing for 2005 which used acquisition costs.
Also, to implement section 1881(b)(13) of the Act, we revised payments for drugs billed separately by independent ESRD facilities, paying for the top 10 ESRD drugs based on acquisition costs (as determined by the OIG) and for other separately billed drugs at the average sales price +6 percent (ASP+6).
In addition, effective April 1, 2005, we implemented the case-mix adjustments to the composite rate for certain patient characteristics (that is, age, low body mass index, and body surface area). For further explanation of the development of the basic case-mix adjusted composite payment system, see the CY 2005 PFS final rule with comment period (69 FR 66319 through 66334).
In the CY 2006 PFS final rule with comment, we implemented additional revisions to payments to ESRD facilities required under section 623 of the MMA. We revised the drug payment methodology applicable to drugs furnished by ESRD facilities. Effective January 1, 2006, all separately billed drugs and biologicals furnished by both hospital-based and independent ESRD facilities were paid based on ASP+6 percent. The drug add-on adjustment was updated to 14.5 percent to reflect the expected growth in expenditures for separately billable drugs in CY 2006.
We also implemented a revised geographic adjustment authorized by section 1881(b)(12)(D) of the Act. This adjustment revised the labor market areas to incorporate the Core-Based Statistical Area (CBSA) designations established by the Office of Management and Budget (OMB) by providing a 4-year transition from the previous wage-adjusted composite rates. Effective January 1, 2006, 25 percent of the payment was based on the revised geographic adjustments, and the remaining 75 percent of payment was based on the metropolitan statistical area-based (MSA-based) adjustments. Other adjustments included the elimination of the wage index ceiling, and reducing the wage index floor to 0.8500, as well as a revised labor portion of the composite rate to which the geographic adjustment is applied.
In addition, section 5106 of the DRA (Pub. L. 109–171) provided for a 1.6 percent update to the composite rate component of the basic case-mix adjusted composite payment system, effective January 1, 2006. For further explanation of the revisions to the basic case-mix adjusted composite payment system, see the CY 2006 PFS final rule with comment period (70 FR 70161 through 70771).
In the CY 2007 PFS final rule with comment period, we implemented a method to annually calculate the growth update to the drug add-on adjustment required by section 1881(b)(12) of the Act, as well as a growth update of 0.5 percent to the drug add-on adjustment. Also, section 103 of the MIEA–TRHCA (Pub. L. 109–432) established a 1.6 percent update to the composite rate portion of the payment system, effective
We provided an update to the wage index adjustments to reflect the latest hospital wage data, including a BN adjustment factor. We also implemented the second year of the transition to the CBSA-based wage index, where 50 percent of the payment was based on the CBSA-based geographic adjustments, and the remaining 50 percent of payment was based on the MSA-based adjustments. In addition, we reduced the wage index floor 0.85 to 0.80.
For further explanation of the development of the basic case-mix adjusted composite payment system, see the CY 2007 PFS final rule with comment period (71 FR 69681 through 69688).
In the CY 2008 PFS final rule with comment period (72 FR 66280), we implemented a growth update to the drug add-on adjustment of 0.5 percent. As a result, the drug add-on adjustment to the composite payment rate increased from 14.9 percent to 15.5 percent. In addition, we updated the wage index adjustments to reflect the latest hospital wage data, including a wage index BN adjustment of 1.055473 to the wage index for CY 2008, and finally, for CY 2008, we implemented the third year of the transition to the CBSA-based wage index, where 75 percent of the payment was based on the the CBSA-based adjustments and the remaining 25 percent of payment was based on the MSA-based adjustments. In addition, we reduced the wage index floor from 0.80 to 0.75.
For CY 2009, section 153(a) of the MIPPA updated sections 1881(b)(12)(G) and 1881(b)(12)(A) of the Act to revise payments to ESRD facilities effective for services furnished on or after January 1, 2009 and January 1, 2010. The revisions included an update of 1 percent to the composite rate, and the establishment of a site neutral composite rate to both hospital-based and independent dialysis facilities that reflects the labor share applicable to independent dialysis facilities (53.711). The 1 percent increase to the independent dialysis facility's CY 2008 composite rate of $132.49 resulted in a CY 2009 base composite rate for hospital-based and independent dialysis facilities of $133.81. The one percent increase in the composite rate portion of the payment system effective January 1, 2009, reduced the drug add-on adjustment from 15.5 to 15.2 percent.
Also, we updated the wage index adjustments to reflect the latest available wage data, including a wage index BN adjustment of 1.056672 to the wage index for CY 2009. Finally, we completed the 4-year transition to the CBSA-based geographic adjustments and reduced the wage index floor from 0.7500 to 0.700. For further detail, regarding the ESRD provisions, see the 2008 PFS final rule with comment period (73 FR 61921 through 61926).
For CY 2010, we updated the case-mix adjusted composite rate payment system by updating the drug add-on component of the composite rate system, as well as the wage index values used to adjust the labor component of the composite rate. Specifically, to update the drug add-on adjustment, we conducted a trend analysis of CY 2006 through 2008, we implemented a zero growth update to the drug add-on adjustment to the composite rates for 2010 required by section 1881(b)(12)(F) of the Act.
Also, section 1881(b)(12)(G)(iv) of the Act, as added by section 153(a)(1) of the MIPPA, increased the composite rate by 1.0 percent for ESRD services furnished on or after January 1, 2010. The 1.0 percent increase resulted in a base composite rate of $135.15 per treatment and reduced the drug add-on adjustment from 15.2 to 15.0 percent.
Lastly, we updated the wage index to reflect the latest available wage data, including a revised BN adjustment factor of 1.057888. We applied a reduction to the wage index floor from 0.700 to 0.6500.
For further detail, regarding the ESRD provisions, see the 2009 final rule with comment period (74 FR 33634 through 33639).
For purposes of establishing the composite rate portion of the blended payments under the ESRD PPS for those facilities electing to go through the transition in CY 2011, CMS is proposing the following:
• An update to the drug add-on adjustment to the composite rate, using a refined methodology for projecting growth in drug expenditures; and
• An update to the wage index adjustment to reflect the latest available wage data, including a revised BN adjustment.
• A reduction in the ESRD wage index floor from 0.6500 to 0.600.
Section 1881(b)(14)(F) of the Act, as added by section 153(b) of MIPPA and amended by section 3401(h) of ACA, governs the ESRD market basket increase factor (that is, the ESRD market basket). As explained in the ESRD PPS proposed rule (74 FR 4997), we described how the ESRD Bundled market basket would be used to update the composite rate portion of the ESRD payments during the PPS transition.
Ordinarily in updating the composite payment system, we discuss any updates to the composite rate. However, beginning in 2011, the composite payment would be used as part of the blended payments during the ESRD PPS transition. Since the publication of the ESRD PPS proposed rule, and as explained in the ESRD PPS final rule, which we anticipate will be published this summer, we interpret this provision as requiring that the composite rate portion of the blended payment amount be increased in CY 2011 by the ESRD market basket percentage increase factor (the “ESRD market basket”).
For purposes of this proposed rule, for CY 2011, we anticipate an estimate of a 2.5 percent increase to the ESRD composite rate portion of the blended payment amount, resulting in a CY 2011 composite rate of $138.53 ($135.15*1.025). This 2.5 percent increase does not apply to the drug add-on adjustment to the composite rate. Also, we note that the drug add-on percentage would be reduced from 15.0 to 14.7 as a result of the proposed increase to the composite rate in CY 2011. (A detailed explanation of the reduction to the drug add-on adjustment is discussed below).
Section 1881(b)(12)(F) of the Act specifies that the drug add-on increase must reflect “the estimated growth in expenditures for drugs and biologicals (including erythropoietin) that are separately billable * * *.” By referring to “expenditures,” we believe the statute contemplates that the update would account for both increases in drug prices, as well as increases in utilization of those drugs.
Since we now have 4 years of drug expenditure data based on ASP pricing,
We further propose to use the per patient growth update to the drug add-on adjustment for CY 2011. To estimate drug expenditure growth using trend analysis, we looked at the average annual growth in total drug expenditures between 2006 and 2009. First, we estimated the total drug expenditures for all ESRD facilities in CY 2009. For this proposed rule, we used the final CY 2006, through CY 2008 ESRD claims data and the latest available CY 2009 ESRD facility claims, updated through December 31, 2009 (that is, claims with dates of service from January 1 through December 31, 2009, that were received, processed, paid, and passed to the National Claims History File as of December 31, 2009). For the CY 2011 PFS final rule, we plan to use additional updated CY 2009 claims with dates of service for the same timeframe. This updated CY 2009 data file will include claims received, processed, paid, and passed to the National Claims History File as of June 30, 2010.
While the CY 2009 claims file used in this proposed rule is the most current available, we recognize that it does not reflect a complete year, as claims with dates of service towards the end of the year have not all been processed. To more accurately estimate the update to the drug add-on, aggregate drug expenditures are required. Based on an analysis of the 2008 claims data, we are proposing to inflate the CY 2009 drug expenditures to estimate the June 30, 2010 update of the 2009 claims file. We used the relationship between the December 2008 and the June 2009 versions of 2008 claims to estimate the more complete 2009 claims that will be available in June 2010 and applied that ratio to the 2009 claims data from the December 2009 claims file. The net adjustment to the CY 2009 claims data is an increase of 12.22 percent to the 2009 expenditure data. This adjustment allows us to more accurately compare the 2008 and 2009 drug expenditure data to estimate per patient growth. As stated earlier in this section, we plan to use additional updated CY 2009 claims in the CY 2011 PFS final rule.
Using the full-year 2009 drug expenditure figure, we calculated the average annual change in drug expenditures from 2006 through 2009. This average annual change showed an increase of 2.1 percent for this timeframe. We propose to use this 2.1 percent increase to project drug expenditures for both 2010 and 2011.
Once we had the projected growth in drug expenditures from 2010 to 2011, which is what we believe that section 1881(b)(12)(F) of the Act requires us to use to update the drug add-on adjustment. To calculate the per patient growth between CYs 2010 and 2011, we removed the enrollment component by using the estimated growth in enrollment data between CY 2010 and CY 2011. This was approximately 3.6 percent. To do this, we divided the total drug expenditure change between 2010 and 2011 (1.021) by enrollment growth of 3.6 percent (1.036) for the same timeframe. The result is a per patient growth factor equal to 0.986 (1.021/1.036 = 0.986). Thus, we are projecting a 1.4 percent decrease in per patient growth in drug expenditures between 2010 and 2011.
In CY 2006, we applied the projected growth update percentage to the total amount of drug add-on dollars established for CY 2005 to establish a dollar amount for the CY 2006 growth update. In addition, we projected the growth in dialysis treatments for CY 2006 based on the projected growth in ESRD enrollment. We divided the projected total dollar amount of the CY 2006 growth by the projected growth in total dialysis treatments to develop the per treatment growth update amount. This growth update amount, combined with the CY 2005 per treatment drug add-on amount, resulted in an average drug add-on amount per treatment of $18.88 (or a 14.5 percent adjustment to the composite rate) for CY 2006.
In the CY 2007 PFS final rule with comment period (71 FR 69684), we revised our update methodology by applying the growth update to the per treatment drug add-on amount. That is, for CY 2007, we applied the growth update factor of 4.03 percent to the $18.88 per treatment drug add-on amount for an updated amount of $19.64 per treatment (71 FR 69684). For CY 2008, the per treatment drug add-on amount was updated to $20.33. In the CY 2009 and 2010 PFS final rule with comment period (73 FR 69755 through 69757 and 74 FR 61923), we applied a zero update to per treatment drug add-on amount which left it at $20.33. As discussed in detail below, for CY 2011, we are again proposing no update to the per treatment drug add-on amount of $20.33 established in CY 2008.
As discussed previously in this section, we estimate a 2.1 percent increase in drug expenditures between CY 2010 and CY 2011. Combining this reduction with a 3.6 percent increase in enrollment, as described above, we are projecting a 1.4 percent decrease in per patient growth of drug expenditures between CY 2010 and CY 2011. Therefore, we are projecting that the combined growth in per patient utilization and pricing for CY 2011 would result in a negative update equal to 0.2 percent. However, similar to last year and as indicated above, we are proposing a zero update to the drug add-on adjustment. We believe this approach is consistent with the language under section 1881(b)(12)(F) of the Act which states in part that “the Secretary shall annually increase” the drug add-on amount based on the growth in expenditures for separately billed ESRD drugs. Our understanding of the statute contemplates “annually increase” to mean a positive or zero update to the drug add-on. Therefore, we propose to apply a zero update, and to maintain the $20.33 per treatment drug add-on amount for CY 2011.
The purpose of the wage index is to adjust the composite rates for differing wage levels covering the areas in which ESRD facilities are located. The wage indexes are calculated for each urban and rural area.
In addition, we generally have followed wage index policies related to these definitions as used under the inpatient hospital prospective payment system (IPPS), but without regard to any approved geographic reclassification authorized under sections 1886(d)(8) and (d)(10) of the Act or other provisions that only apply to hospitals paid under the IPPS (70 FR 70167). For purposes of the ESRD wage index methodology, the hospital wage data we use is pre-classified, pre-floor hospital data and unadjusted for occupational mix.
In the CY 2006 PFS final rule with comment period (70 FR 70167), we announced our adoption of the OMB's
In the CY 2007 PFS final rule with comment period (71 FR 69685), we stated that we intended to update the ESRD wage index values annually. The ESRD wage index values for CY 2011 were developed from FY 2007 wage and employment data obtained from the Medicare hospital cost reports. As we indicated, the ESRD wage index values are calculated without regard to geographic classifications authorized under sections 1886(d)(8) and (d)(10) of the Act and utilize pre-floor hospital data that is unadjusted for occupational mix. We propose to use the same methodology for CY 2011, with the exception that FY 2007 hospital data would be used to develop the CY 2011 wage index values. For a detailed description of the development of the proposed CY 2011 wage index values based on FY 2007 hospital data, see the FY 2011 IPPS proposed rule (75 FR 23944). Section III.G, of the preamble to the FY 2011 IPPS proposed rule, “Method for Computing the Proposed FY 2011 Unadjusted Wage Index,” describes the cost report schedules, line items, data elements, adjustments, and wage index computations. The wage index data affecting the ESRD composite rate for each urban and rural locale may also be accessed on the CMS Web site at
In the CY 2010 PFS final rule with comment period, we stated our intention to continue to reassess the need for a wage index floor (74 FR 61924). We also stated that a gradual reduction in the floor is needed to support continuing patient access to dialysis in areas that have low wage index values, especially in Puerto Rico where the wage index values are below the current wage index floor.
In the ESRD PPS proposed rule (74 FR 49968), we stated our intent to continue to reduce the wage index floor to the composite rate during the transition. For CY 2011, we propose that the ESRD wage index floor would be reduced from 0.65 to 0.60.
As discussed in the CY 2010 PFS final rule (74 FR 61925), and the ESRD PPS proposed rule (74 FR 49969) we have a methodology for identifying the small number of ESRD facilities in both urban and rural geographic areas where there are no hospital wage data from which to calculate ESRD wage index values. At that time those rules were published, the affected areas were rural Puerto Rico, and the urban area Hinesville-Fort Stewart, GA (CBSA 25980), and rural Massachusetts.
In the case of Massachusetts, the entire rural area consists of Dukes and Nantucket Counties. We determined that the borders of Dukes and Nantucket counties are contiguous with CBSA 12700, Barnstable Town, MA, and CBSA 39300, Providence-New Bedford-Fall River, RI–MA. We intend to use the same methodology for CY 2011. Under this methodology, this results in a proposed CY 2011 wage index value of 1.3577 for the composite rate portion of the blend, and a wage index value of 1.2844 for the ESRD PPS portion of the blend for Barnstable Town, MA (CBSA 12700) and also results in a proposed CY 2011 wage index value of 1.1343 for the composite rate portion of the blend, and a wage index value of 1.0731 for the ESRD PPS portion of the blend for (Providence-New Bedford-Fall River, RI–MA (CBSA 39300). These averages result in an imputed proposed wage index value of 1.2460 for rural Massachusetts in CY 2011, for the composite rate portion of the blend, and a wage index value of 1.1788 for the ESRD PPS portion of the blend.
For Hinesville-Fort Stewart, GA (CBSA 25980), which is an urban area without specific hospital wage data, we propose to apply the same methodology used to impute a wage index value that we used in CYs 2006 through 2010. Specifically, we compute the average wage index value of all urban areas within the State of Georgia. This results in a CY 2011 wage index value of 0.9465 for the composite rate portion of the blend, and a wage index value of 0.8954 for the ESRD PPS portion of the blend for Hinesville-Fort Stewart, GA (CBSA 25980).
For CY 2011, there is an additional urban area—Anderson, SC—with no hospital data. For this urban area, Anderson, SC (CBSA 11340), we propose to use the same methodology we have used for the other urban area with no hospital data, that is, Hinesville-Fort Stewart, GA (CBSA 25980). Under the methodology used for that area, we compute the average of all urban areas within the State of South Carolina. This approach would result in a CY 2011 wage index value of 0.9480 for the composite rate portion of the blend, and a wage index value of 0.8839 for the ESRD PPS portion of the blend for the Anderson, SC CBSA (CBSA 11340).
For Puerto Rico, because all geographic areas in Puerto Rico were subject to the wage index floor in CYs 2006 through 2010, we applied the ESRD wage index floor to rural Puerto Rico as well. Therefore, for CY 2011, all urban areas in Puerto Rico that have a wage index are eligible for the ESRD wage index floor of 0.60. Currently there are no ESRD facilities located in rural Puerto Rico, however, should any facilities open in rural Puerto Rico, we intend to apply the CY 2011 proposed wage index floor of 0.60 to facilities that are located in rural Puerto Rico. The proposed reduction to the wage index floor of 0.60 remains higher than the actual wage index values for ESRD facilities located in Puerto Rico, which currently range from 0.3674 to 0.4828. Also, in the CY 2010 PFS final rule with comment period (74 FR 61925), we stated that we would continue to evaluate existing hospital wage data and possibly wage data from other sources such as the Bureau of Labor Statistics, to determine if other methodologies might be appropriate for imputing wage index values for areas without hospital wage data for CY 2011 and subsequent years. To date, no data from other sources, superior to that currently used in connection with the IPPS wage index has emerged. For ESRD purposes, we continue to believe this is an appropriate policy.
Finally, for CY 2011, we are proposing to use the FY 2011 wage index data (collected from cost reports submitted by hospitals for cost reporting
We have previously interpreted the statute as requiring that the geographic adjustment be made in a budget neutral manner. Given our application of the ESRD wage index, this means that aggregate payments to ESRD facilities in CY 2011 would be the same as aggregate payments that would have been made if we had not made any changes to the geographic adjusters. We note that this BN adjustment only addresses the impact of changes in the geographic adjustments. A separate BN adjustment was developed for the case-mix adjustments required by the MMA.
As we are not proposing any changes to the case-mix measures for CY 2011, the current case-mix BN adjustment of 0.9116 would remain in effect for CY 2011. Consistent with prior rulemaking, For CY 2011, we propose to apply the wage-index BN adjustment factor of 1.057057 directly to the ESRD wage index values to the composite rate portion of the blend. Because the ESRD wage index is only applied to the labor-related portion of the composite rate, we computed the BN adjustment factor based on that proportion (53.711 percent).
To compute the proposed CY 2011 wage index BN adjustment factor (1.057057), we used the FY 2007 pre-floor, pre-reclassified, non-occupational mix-adjusted hospital data to compute the wage index values, 2009 outpatient claims (paid and processed as of December 31, 2009), and geographic location information for each facility which may be found through Dialysis Facility Compare Web page on the CMS Web site at
Using treatment counts from the 2009 claims and facility-specific CY 2010 composite rates, we computed the estimated total dollar amount each ESRD provider would have received in CY 2010. The total of these payments became the target amount of expenditures for all ESRD facilities for CY 2011. Next, we computed the estimated dollar amount that would have been paid for the same ESRD facilities using the proposed ESRD wage index for CY 2011. The total of these payments becomes the new CY 2011 amount of wage-adjusted composite rate expenditures for all ESRD facilities.
After comparing these two dollar amounts (target amount divided by the new CY 2011 amount), we calculated an adjustment factor that, when multiplied by the applicable CY 2011 ESRD wage index value, would result in aggregate payments to ESRD facilities that would remain within the target amount of composite rate expenditures. When making this calculation, the ESRD wage index floor value of 0.6000 is applied whenever appropriate. The proposed wage BN adjustment factor for CY 2011 is 1.057057.
To ensure BN, we also must apply the BN adjustment factor to the wage index floor of 1.057057 which results in an adjusted wage index floor of 0.6343 (0.6000 x 1.057057) for CY 2011. This budget neutrality factor is not applied to the wage index values for the ESRD PPS portion of the blend.
The CY 2011 ESRD proposed wage index tables are located in Addenda K and L of this proposed rule. The wage index tables lists two separate columns of wage index values. The first column lists the wage index values will be applied under the composite rate portion and includes the budget neutrality adjustment of 1057057. The second column lists the wage index values that will be applied under the ESRD PPS.
The Physician Quality Reporting Initiative (PQRI) is a voluntary reporting program, first implemented in 2007, that provides an incentive payment to identified EPs (EPs) who satisfactorily report data on quality measures for covered professional services furnished during a specified reporting period. We propose to add § 414.90 to title 42 of the Code of Federal Regulations to implement the provisions of the PQRI discussed in this section of the proposed rule.
Under section 1848(k)(3)(B) of the Act, the term “EP” means any of the following: (1) A physician; (2) a practitioner described in section 1842(b)(18)(C); (3) a physical or occupational therapist or a qualified speech-language pathologist; or (4) a qualified audiologist. The PQRI was first implemented in 2007 as a result of section 101 of Division B of the Tax Relief and Health Care Act of 2006—the Medicare Improvements and Extension Act of 2006 (Pub.L. 109–432) (MIEA–TRHCA), which was enacted on December 20, 2006. The PQRI was extended and further enhanced as a result of the Medicare, Medicaid, and SCHIP Extension Act of 2007 (Pub. L. 110–173) (MMSEA), which was enacted on December 29, 2007, and the MIPPA, which was enacted on July 15, 2008. Changes to the PQRI as a result of these laws, as well as information about the PQRI in 2007, 2008, 2009, and 2010 are discussed in detail in the CY 2008 PFS proposed and final rules (72 FR 38196 through 38204 and 72 FR 66336 through 66353, respectively), CY 2009 PFS proposed and final rules (73 FR 38558 through 38575 and 73 FR 69817 through 69847, respectively), and CY 2010 PFS proposed and final rules (74 FR 33559 through 33600 and 74 FR 61788 through 61861, respectively). Further detailed information, about the PQRI program, related laws, and help desk resources, is available on the CMS Web site at
The ACA makes a number of changes to the PQRI, including authorizing incentive payments through 2014, and requiring a penalty beginning in 2015 for EPs who do not satisfactorily report data on quality measures in the applicable reporting period for the year. The various provisions of the ACA, with respect to PQRI, are further discussed in sections VI.F.1.b., VI.F.1.k., and VI.F.1.l. of this proposed rule.
Prior to the enactment of the ACA, PQRI incentive payments were only authorized through 2010. As discussed further in sections VI.F.1.b. and VI.F.1.l. below, under section 1848(m)(1)(A) of the Act, as amended by section 3002(a) of the ACA, PQRI incentive payments are extended through 2014 for EPs that satisfactorily report data on PQRI quality measures for the applicable reporting period. Section 1848(m)(1)(B) of the Act, as amended by section 3002(a) of the ACA, authorizes a 1.0 percent incentive payment for program year 2011 and a 0.5 percent incentive payment for program years 2012 through 2014 for qualified EPs who satisfactorily submit PQRI quality measures data. Beginning in 2015, an incentive payment adjustment will be implemented for EPs who do not satisfactorily report quality measures as required by section 1848(a)(8) of the Act
Section 3002(e) of the ACA amends section 1848(m)(5) of the Act to require the Secretary to provide timely feedback to EPs on the performance of the EP with respect to satisfactorily submitting data on quality measures. This is discussed further in section VI.F.1.l.(4) below.
Section 3002(f)(2) amends section 1848(m)(5) of the Act by adding a requirement with respect to an informal appeals process. Specifically, section 1848(m)(5)(I) of the Act, as discussed further in section VI.F.1.l.(5) below, requries that the Secretary establish and have in place an informal process by January 1, 2011, whereby EPs may seek a review of the determination that an EP did not satisfactorily submit data on quality measures for purposes of qualifying for a PQRI incentive payment.
Section 1848(m)(7) of the Act (“Additional Incentive Payment”), as added by section 10327(a) of the ACA, provides that for years 2011 through 2014, the applicable quality percent under PQRI for EPs satisfactorily reporting PQRI quality measures data will be increased by 0.5 percentage points, if the EP also meets certain requirements, including satisfactorily reporting data on quality measures for a year and having such data submitted on their behalf through a Maintenance of Certification Program (MOCP) (as defined under section 1848(m)(7) of the Act) and participating in an MOCP practice assessment more frequently than is required to qualify for or maintain board certification status. Section 1848(m)(7) of the Act (“Additional Incentive Payment”) is discussed in more detail in section VI.F.1.l.(2). Furthermore, section 3002(c) of the ACA, as amended by section 10327(b) of the ACA authorizes the Secretary to incorporate participation and successful completion in an MOCP and successful completion of a qualified MOCP practice assessment into the composite of measures of quality of care furnished under the PFS payment modifier.
Also discussed further in section VI.F.1.k. below, section 10331 of the ACA requires the Secretary to develop a Physician Compare Internet web site by January 1, 2011, on which information on physicians enrolled in the Medicare program and other EPs who participate in the PQRI program would be posted. With respect to measures collected under the PQRI program, to the extent practicable, the Secretary will implement a plan by January 1, 2013, to report 2012 PQRI information on the Physician Compare Web site.
Finally, section 1848(m)(7) of the Act (“Integration of Physician Quality Reporting and EHR Reporting”), as added by section 3002 of the ACA requires that not later than January 1, 2012, the Secretary shall develop a plan to integrate reporting on quality measures under subsection (o) relating to the meaningful use of electronic health records (EHRs), as discussed further in section VI.F.1.l.(3) below.
As stated above, for years 2011 through 2014, section 3002(a) of the ACA extends the opportunity for EPs to earn a PQRI incentive payment for satisfactorily reporting PQRI quality measures. For 2011 PQRI, section 1848(m)(2)(B) of the Act, as amended by section 3002(a) of the ACA, authorizes a 1.0 percent incentive, and for 2012 through 2014, a 0.5 percent incentive, for qualified EPs who satisfactorily submit PQRI quality measures data. Regardless of the reporting mechanism, and/or the associated reporting period (both discussed in detail below) an EP chooses to report quality data for purposes of PQRI, if the EP meets the respective criteria for satisfactory reporting, the EP may receive a 1.0 percent incentive.
The PQRI incentive payment amount is calculated using estimated Medicare Part B PFS allowed charges for all covered professional services, not just those charges associated with the reported quality measures. “Allowed charges” refers to total charges, including the beneficiary deductible and coinsurance, and is not limited to the 80 percent paid by Medicare or the portion covered by Medicare where Medicare is secondary payer. Amounts billed above the PFS amounts for assigned and non-assigned claims will not be included in the calculation of the incentive payment amount. In addition, since, by definition under section 1848(k)(3)(A) of the Act, “covered professional services” are limited to services for which payment is made under, or is based on, the PFS and which are furnished by an EP, other Part B services and items that may be billed by EPs, but are not paid under or based upon the Medicare Part B PFS, are not included in the calculation of the incentive payment amount.
As mentioned above, we are proposing a number of reporting mechanisms that EPs may choose in order to participate in PQRI. Our proposals for claims-based reporting, registry-based reporting, and EHR-based reporting are discussed below with respect to the opportunity for individual EPs to participate in PQRI. For satisfactory reporting at the individual level in 2011, 1.0 percent of qualified charges would be paid at the TIN/NPI level. These proposed reporting mechanisms are addressed in section G.1.d. below. Our proposed criteria for satisfactorily reporting using the various reporting mechanisms are discussed in further detail in sections VI.F.1.e. and VI.F.1.f. below. Our proposals with respect to the reporting mechanisms and criteria for satisfactorily reporting for group practices are also addressed below, in section VI.F.1.g. Those group practices that satisfactorily report will also be paid a 1.0 percent incentive payment based upon the qualified charges for the group practice TIN.
Under section 1848(m)(6)(C) of the Act, the “reporting period” for the 2008 PQRI and subsequent years is defined to be the entire year, but the Secretary is authorized to revise the reporting period for years after 2009 if the Secretary determines such revision is appropriate, produces valid results on measures reported, and is consistent with the goals of maximizing scientific validity and reducing administrative burden. For the 2011 PQRI, we propose the following reporting periods: (1) 12-month reporting period for claims-based reporting and registry-based reporting (that is, January 1, 2011 through December 31, 2011); (2) 12-month reporting period for EHR-based reporting (that is, January 1, 2011 through December 31, 2011; and (3) 6-month reporting period for claims-based reporting and registry-based reporting (that is, July 1, 2011 through December 31, 2011). Additionally, as discussed further below in their respective sections, we propose the 12-month reporting period for the group practice reporting option (GPRO) for both PQRI and the eRx Prescribing Incentive Program (January 1, 2011 through December 31, 2011).
The proposed 2011 PQRI reporting periods are consistent with the 2010 reporting periods. In addition, in prior program years, we received input from stakeholders in support of partial year reporting for all reporting mechanisms, to give more EPs the opportunity to begin reporting later in the year. We agree that having the same reporting periods for all mechanisms may be less complex, and may facilitate participation in 2011 PQRI for certain EPs. In an effort to be consistent with prior program years, and move in the direction of maintaining program
When the PQRI was first implemented in 2007, there was only 1 reporting mechanism available to submit data on PQRI quality measures. For the 2007 PQRI, EPs had to submit quality data codes (QDCs) on Medicare Part B claims (claims-based reporting). QDCs are Current Procedural Terminology (CPT) Category II codes or G-codes (where CPT Category II codes are not yet available). CPT Category II codes and G-codes are Healthcare Common Procedure Coding System (HCPCS) codes for reporting quality data. For the 2008 PQRI, we added registry-based reporting as an alternative reporting mechanism as required by section 1848(k)(4) of the Act. Under this option, EPs may submit data on PQRI quality measures to a qualified PQRI registry and request the registry to submit PQRI quality measures results and numerator and denominator data on the 2008 PQRI quality measures or measures groups. For the 2009 PQRI, we retained the 2 reporting mechanisms used in the 2008 PQRI (that is, claims-based reporting and registry-based reporting) for reporting individual PQRI quality measures and for reporting measures groups.
Finally, to promote the adoption of EHRs, and to facilitate quality measure data reporting, we sought to establish an EHR reporting option by conducting limited testing of EHR reporting for the 2008 and 2009 PQRI. This involved the submission of clinical quality data extracted from an EHR, or the EHR-based reporting mechanism. No incentive payment was available to those EPs who participated in testing the EHR-based reporting mechanism.
For the 2010 PQRI, we retained the claims-based reporting mechanism, the registry-based reporting mechanism, and established EHR reporting for a limited subset of the 2010 PQRI quality measures, as identified in Table 14 of the CY 2010 PFS final rule with comment period (74 FR 61831), contingent upon the successful completion of our 2009 EHR data submission testing process and a determination based on that testing process that accepting data from EHRs on quality measures for the 2010 PQRI was practical and feasible. In the 2010 PQRI, following the successful completion of the 2009 EHR data submission testing process, it was determined that it is practical and feasible to accept data from EHRs on quality measures for the 2010 PQRI.
For the 2011 PQRI, we are proposing to retain the claims-based reporting mechanism and the registry-based reporting mechanism. We also propose to retain the 2010 EHR-based reporting mechanism, by which we will continue to accept quality measures data extracted from a qualified EHR product for a limited subset of the proposed 2011 PQRI quality measures, as identified in Tables 55 and 56. Under the 2011 PQRI, we propose that the EHR submission is optional.
For the 2011 PQRI, we are not proposing to offer additional reporting options for individual EPs beyond those discussed above. In contrast to prior program years (2008 PQRI, 2009 PQRI, and 2010 PQRI), we believe that other options would not facilitate reporting of quality data for PQRI by EPs. However, we seek public comment on these proposals and invite suggestions as to other options that could be included in the PQRI.
We recognize that there continues to be a number of limitations associated with claims-based reporting since the claims processing system was developed for billing purposes and not for the submission of quality data. Claims submission, however, is available to all EPs. We have observed that only about half of those EPs who participated in PQRI via the claims-based reporting mechanism satisfied the criteria for satisfactory reporting (that is, reported at least 3 PQRI measures or 1–2 measures if there were fewer than 3 applicable measures, for at least 80 percent of the EP's Medicare Part B FFS patients for whom services were furnished during the reporting period to which the measure applies) and qualified for the incentive. We have also found that measures with complex specifications, such as those that require multiple diagnosis codes are not as conducive to claims-based reporting and may be associated with a greater number of invalidly reported QDCs. Similarly, when multiple measures share the same codes it may be difficult to determine which measure(s) the EP intended to report through claims. Finally, for pragmatic efficiency it is not practical to allow resubmission of claims for the sole purpose of adding QDCs. This means that claims-based reporting must be concurrent with billing.
By contrast, our experience with the registry-based reporting mechanism continues to be a favorable option, as the drawbacks discussed above do not apply. Data has shown that not only have the participation rates for registry-based reporting increased, but also satisfactory reporting, resulting in an incentive payment for EPs, has also increased. Furthermore, the available number of qualified registries has also increased since 2008, and we expect additional registries to become qualified in future years. For these reasons, we maintain that the registry-based reporting option remains viable, and furthermore, we anticipate continuing to expand this option in future years.
We also believe that EHR-based reporting continues to be a viable option for overcoming the limitations associated with claims-based reporting of quality measures, as clinical quality data is extracted from the EHR for submission. We believe further that retaining the EHR-based reporting mechanism for 2011 PQRI will continue to promote the adoption and use of EHRs and further align with the provision in the ACA related to the integration of PQRI EHR measures and the EHR incentive program measures in years after 2011, which is discussed in further detail in section VI.F.1.l.(3) below.
In summary, we propose that for 2011, an EP may choose to report data on PQRI quality measures through claims, a qualified registry (for the proposed qualification requirements for registries, see section VI.F.1.d.(4) of this proposed rule), or through a qualified EHR product (for the proposed qualification requirements for the EHR vendors and their products, see section VI.F.1.d.(5) of this proposed rule). As in previous years, depending on which PQRI individual quality measures or measures groups an EP selects, one or more of the proposed reporting mechanisms may not be available for reporting a particular 2011 PQRI individual quality measure or measures group. For example, the EHR reporting mechanism currently is not available for reporting measures groups and specifications for the electronic transmission of a measure via an EHR are not available for all of the individual PQRI measures. In addition, as discussed previously the specifications for some measures are too complex for claims-based reporting. The proposed 2011 reporting mechanisms through which each proposed 2011 PQRI individual quality measure and measures group could be reported are identified in Tables 47 and 48. We invite comments on our proposal for the 2011 reporting mechanisms.
While we propose to retain the claims-based reporting mechanism for 2011, we note that we continue to
Continuing to reduce our reliance on the claims-based reporting mechanism after 2011 would allow us and EPs to continue to devote available resources towards maximizing the potential of registries and EHRs for quality measurement reporting. Both mechanisms hold the promise of more sophisticated and timely reporting of clinical quality measures. Clinical data registries allow the collection of more detailed data, including outcomes, without the necessity of a single submission contemporaneously with claims billing, which overcomes some of the limitations of the claims-based reporting mechanism. Registries can also provide feedback and quality improvement information based on reported data. Finally, clinical data registries can also receive data from EHRs, and therefore, serve as an alternative means to reporting clinical quality data extracted from an EHR. As we continue to qualify additional registries (qualified registries are listed on the CMS PQRI Web site
As in previous years, regardless of the reporting mechanism chosen by an EP, there is no requirement for the EP to sign up or register to participate in the PQRI. However, there may be some requirements for participation through a specific reporting mechanism that are unique to that particular reporting mechanism. In addition to the proposed criteria for satisfactory reporting of individual measures and measures groups described in section VI.F.1.e. and section VI.F.1.f., respectively, of this proposed rule, EPs must ensure that they meet all requirements for their chosen reporting mechanism for 2011.
For EPs who choose to participate in the 2011 PQRI by submitting data on individual quality measures or measures groups through the claims-based reporting mechanism, we propose the EP would be required to submit the appropriate PQRI QDCs on the professionals' Medicare Part B claims. QDCs for the EP's selected individual PQRI quality measures or measures group may be submitted to CMS at any time during 2011. Please note, however, that as required by section 1848(m)(1)(A) of the Act, all claims for services furnished between January 1, 2011 and December 31, 2011, would need to be processed by no later than February 28, 2012, to be included in the 2011 PQRI analysis.
We propose that in order to report quality data on the 2011 PQRI individual quality measures, or measures groups, through a qualified clinical registry, an EP must enter into and maintain an appropriate legal arrangement with a qualified 2011 PQRI registry. Such arrangements would provide for the registry's receipt of patient-specific data from the EP and the registry's disclosure of quality measures results and numerator and denominator data on PQRI quality measures or measures groups on behalf of the EP to CMS. Thus, the registry would act as a Health Insurance Portability and Accountability Act of 1996 (Pub. L. 104–191) (HIPAA) Business Associate and agent of the EP. Such agents are referred to as “data submission vendors.” The “data submission vendors” would have the requisite legal authority to provide clinical quality measures results and numerator and denominator data on individual quality measures or measures groups on behalf of the EP for the PQRI. We propose that the registry, acting as a data submission vendor, would submit CMS-defined registry-derived measures information to our designated database for the PQRI, using a CMS-specified record layout, which would be provided to the registry by CMS.
To maintain compliance with applicable statutes and regulations, our program and our data system must maintain compliance with the HIPAA requirements for requesting, processing, storing, and transmitting data. EPs that conduct HIPAA covered transactions also would need to maintain compliance with the HIPAA requirements.
We propose that EPs choosing to participate in PQRI through the registry-based reporting mechanism for 2011 would need to select a qualified PQRI registry and submit information on PQRI individual quality measures or measures groups to the selected registry in the form and manner and by the deadline specified by the registry.
We propose to post on the PQRI section of the CMS Web site at
In the first phase, we propose to post, by December 31, 2010, a list of those registries qualified for the 2011 PQRI based on the following: (1) Being a qualified registry for a prior PQRI program year that successfully submitted 2008 and/or 2009 PQRI quality measures results and numerator and denominator data on the quality measures; (2) having received a letter indicating their continued interest in being a PQRI registry for 2011 by October 31, 2010; and (3) the registry's compliance with the 2011 PQRI registry requirements. This list may be modified if any given registry fails to meet any new requirement(s) proposed for 2011. The testing of any additional requirements will be completed as soon as possible but by the end of the first quarter of 2011 at the latest. By posting this first list of qualified registries for the 2011 PQRI, we seek to make available the names of registries that can be used at the start of the 2011 reporting period.
We propose in the second phase, to add the names of the registries that were initially qualified in 2010 and submitted actual quality data on behalf of their EPs to CMS for the first time in early 2011. Successful submission of data to CMS
In the third phase, we propose to complete posting of the list of qualified 2011 registries as soon as we have completed vetting the additional registries interested in and capable of participating in the 2011 PQRI. We anticipate this will be completed no later than the summer of 2011. An EP's ability to report PQRI quality measures data and numerator and denominator data on PQRI quality measures or measures groups using the registry-based reporting mechanism should not be impacted by the complete list of qualified registries for the 2011 PQRI being made available after the start of the reporting period. First, registries would not begin submitting EPs' PQRI quality measures results and numerator and denominator data on the quality measures or measures groups to CMS until 2012. Second, if an EP decides that he or she is no longer interested in submitting quality measures data and numerator and denominator data on PQRI individual quality measures or measures group through the registry-based reporting mechanism after the complete list of qualified registries becomes available, this would not preclude the EP from attempting to meet the criteria for satisfactory reporting through another 2011 PQRI reporting mechanism, such as claims or EHR-based data submission.
In addition to meeting the above proposed requirements specific to registry-based reporting, we propose that EPs who choose to participate in PQRI through the registry-based reporting mechanism would need to meet the relevant criteria proposed for satisfactory reporting of individual measures or measures groups that all EPs must meet in order to satisfactorily report for PQRI 2011. However, in 2011, we propose not to count measures that are reported through a registry or EHR that have a zero percent performance rate. That is, if the recommended clinical quality action is not performed on at least 1 patient for a particular measure or measures group reported by the EP via a registry or EHR, we will not count the measure (or measures groups) as a measure (or measures group) reported by an EP. We propose to disregard measures (or measures groups) that are reported through a registry or EHR that have a zero percent performance rate in the 2011 PQRI because we are assuming that the measure was not applicable to the EP and was likely reported from EHR-derived data (or from data mining) and was unintentionally submitted from the registry or EHR to CMS. We also seek to avoid the possibility of intentional submission of spurious data solely for the purpose of receiving an incentive payment for reporting.
For 2011, in addition to meeting the criteria for satisfactory reporting of at least 3 individual measures, we propose the following requirements associated with EHR-based reporting: (1) Selection of a PQRI qualified EHR product; and (2) submission of clinical quality data extracted from the EHR to a CMS clinical data warehouse in the CMS-specified manner and format. These proposed requirements are identical to the 2010 requirements for individual EPs who choose the EHR-based requirements. We are proposing to retain the 2010 requirements because results from 2010 EHR data submission will not be available until 2011. A test of quality data submission from EPs who wish to report 2010 quality measure data directly from their qualified EHR product will be required and occur in early 2011 immediately followed by the submission of the EP's actual 2010 PQRI data. This entire final test/production 2010 data submission timeframe is expected to be January 2011 through March 2011. As discussed in the CY 2010 PFS final rule with comment period (74 FR 61800), throughout most of 2010, we will continue to vet newly self-nominated EHR vendor products for possible qualification for the 2011 PQRI program year. We expect to list any additional PQRI qualified EHR products by January 2011. It is expected that these newly qualified products would be able to submit 2011 PQRI data in early 2012.
Measures group reporting is not an option for EHR based quality measure reporting for 2010. We propose to continue this policy for 2011 and therefore, propose not to include measures group reporting via EHRs for the 2011 PQRI. We will receive 2010 production data in early 2011 and since this will be the first time we have an opportunity to receive direct EHR data submission for quality reporting and to calculate the results, we believe it is best not to add another reporting option using EHRs at this time. We propose that EPs who choose the EHR-based reporting mechanism for the 2011 PQRI would be required to (in addition to meeting the criteria for satisfactory reporting of individual measures)—
• Have a qualified EHR product;
• Have an active Individuals Authorized Access to CMS Computer Services (IACS) user account with a data submission role or be able to use the surrogate data submission method (if one exists) that will be used to submit clinical quality data extracted from the EHR to a CMS clinical data warehouse or another CMS approved means of securely transmitting the quality measures data to CMS such as a CMS/OCSQ approved HIE (health information exchange) if we are able to collect data from HIEs in 2012 using the NHIN (national health information network) or NHIN direct network;
• Submit a test file containing real or test clinical quality data extracted from the EHR to a CMS clinical data warehouse via an approved data submission method such as IACS, an HIE, or the NHIN between July 1, 2011 and September 30, 2011 (if technically feasible); and
• Submit a file containing the EP's 2011 PQRI clinical quality data extracted from the EHR for the entire reporting period (that is January 1, 2011 through December 31, 2011) via IACS or an acceptable surrogate (if technically feasible) between January 1, 2012, through February 28, 2012.
However, as stated above, the 2010 EHR Testing Program is still ongoing. Since we are proposing that only EHR vendors that self-nominated to participate in the 2011 EHR Testing Program and successfully complete the 2011 EHR Testing Program would be considered qualified EHR vendors for the 2011 PQRI, there is no guarantee that there will be any additionally qualified EHR vendors available for the 2011 PQRI. In addition, as we complete the 2010 EHR Testing Program and are better able to determine what is technically feasible, the actual dates on which EPs are required to submit their test files and/or to begin submitting their actual 2011 PQRI data are subject to change.
We cannot assume responsibility for the successful submission of data from an EP's EHR. Any EP who chooses to submit PQRI data extracted from an EHR should contact the EHR product's vendor to determine if the product is qualified and has been updated to facilitate PQRI quality measures data submission. Such professionals also should begin attempting submission soon after the opening of the clinical data warehouse in order to assure the
The specifications for the electronic transmission of the 2011 PQRI measures, identified in Tables 55 and 56 of this proposed rule as being available for EHR-based reporting in 2011, will be posted on the Alternative Reporting Mechanisms page of the PQRI section of the CMS Web site during the summer of 2010.
In order to be “qualified” to submit quality measures results and numerator and denominator data on PQRI quality measures and measures groups on behalf of EPs pursuing a PQRI incentive for the 2008, 2009, and 2010 PQRI, we required registries to complete a self-nomination process and to meet certain technical and other requirements. For the 2010 PQRI, registries that were qualified for 2009 did not need to be “re-qualified” for 2010 unless they were unsuccessful at submitting 2009 PQRI data (that is, failed to submit 2009 PQRI data per the 2009 PQRI registry requirements). Registries that were “qualified” for 2009 and wished to continue to participate in 2010 were only required to communicate their desire to continue participation for 2010 by submitting a letter to CMS indicating their continued interest in being a PQRI registry for 2010 and their compliance with the 2010 PQRI registry requirements by March 31, 2010.
For the 2011 PQRI, we are proposing to require a self-nomination process for registries wishing to submit 2011 PQRI quality measures or measures groups on behalf of EPs for services furnished during the applicable reporting periods in 2011. We propose that the registry self-nomination process for the 2011 PQRI would be based on a registry meeting specific technical and other requirements, as discussed below.
To be considered a qualified registry for purposes of submitting individual quality measures and measures groups on behalf of EPs who choose to report using this reporting mechanism under the 2011 PQRI, we propose that all registries (new to PQRI and those previously qualified) must:
• Be in existence as of January 1, 2011;
• Have at least 25 participants by January 1, 2011;
• Provide at least 1 feedback report per year to participating EPs;
• Not be owned and managed by an individual locally-owned single-specialty group (in other words, single-specialty practices with only 1 practice location or solo practitioner practices would be prohibited from self-nominating to become a qualified PQRI registry);
• Participate in ongoing 2011 PQRI mandatory support conference calls hosted by CMS (approximately 1 call per month), including an in-person registry kick-off meeting to be held at CMS headquarters in Baltimore, MD. Registries that miss more than one meeting will be precluded from submitting PQRI data for the reporting year (2011);
• Be able to collect all needed data elements and transmit to CMS the data at the TIN/NPI level for at least 3 measures in the 2011 PQRI program (according to the posted 2011 PQRI Measure Specifications);
• Be able to calculate and submit measure-level reporting rates or the data elements needed to calculate the reporting rates by TIN/NPI;
• Be able to calculate and submit, by TIN/NPI, a performance rate (that is, the percentage of a defined population who receive a particular process of care or achieve a particular outcome) for each measure on which the TIN/NPI reports or the data elements needed to calculate the reporting rates;
• Be able to separate out and report on Medicare Part B FFS patients;
• Provide the name of the registry;
• Provide the reporting period start date the registry will cover;
• Provide the reporting period end date the registry will cover;
• Provide the measure numbers for the PQRI quality measures on which the registry is reporting;
• Provide the measure title for the PQRI quality measures on which the registry is reporting;
• Report the number of eligible instances (reporting denominator);
• Report the number of instances of quality service performed (numerator);
• Report the number of performance exclusions;
• Report the number of reported instances, performance not met (EP receives credit for reporting, not for performance);
• Be able to transmit this data in a CMS-approved XML format. We expect that this CMS-specified record layout will be substantially the same as for the 2008, 2009, and 2010 PQRI if aggregate level data is continued but will likely change if individual data elements are required, as discussed below. This layout will be provided to registries in 2011;
• Comply with a CMS-specified secure method for data submission, such as submitting the registry's data in an XML file through an IACS user account or another approved method such as over the NHIN (national health information network) if technically feasible;
• Submit an acceptable “validation strategy” to CMS by March 31, 2011. A validation strategy ascertains whether EPs have submitted accurately and on at least the minimum number (80 percent) of their eligible patients, visits, procedures, or episodes for a given measure. Acceptable validation strategies often include such provisions as the registry being able to conduct random sampling of their participant's data, but may also be based on other credible means of verifying the accuracy of data content and completeness of reporting or adherence to a required sampling method;
• Perform the validation outlined in the strategy and send the results to CMS by June 30, 2012 for the 2011 reporting year's data;
• Enter into and maintain with its participating professionals an appropriate Business Associate agreement that provides for the registry's receipt of patient-specific data from the EPs, as well as the registry's disclosure of quality measure results and numerator and denominator data on behalf of EPs who wish to participate in the PQRI program;
• Obtain and keep on file signed documentation that each holder of an NPI whose data are submitted to the registry has authorized the registry to submit quality measures and numerator and denominator data to CMS for the purpose of PQRI participation. This documentation must be obtained at the time the EP signs up with the registry to submit PQRI quality measures data to the registry and must meet any applicable laws, regulations, and contractual business associate agreements;
• Provide CMS access (if requested for validation purposes) to review the Medicare beneficiary data on which 2011 PQRI registry-based submissions are founded or provide to CMS a copy of the actual data (if requested);
• Provide the reporting option (reporting period and reporting criteria) that the EP has satisfied or chosen;
• Provide CMS a signed, written attestation statement via mail or e-mail which states that the quality measure results and any and all data including numerator and denominator data
• Indicate the reporting period chosen for each EP who chooses to submit data on measures groups;
• Base reported information on measures groups only on patients to whom services were furnished during the 12-month reporting period of January through December 2011 or the 6-month reporting period of July 1, 2011 through December 31, 2011;
• Agree that the registry's data may be inspected or a copy requested by CMS and provided to CMS under our oversight authority;
• Be able to report data on all applicable measures in a given measures group on either 30 or more Medicare Part B FFS patients from January 1, 2011 through December 31, 2011, or on 80 percent of applicable Medicare Part B FFS patients for each EP (with a minimum of 15 patients during the January 1, 2011, through December 31, 2011, reporting period or a minimum of 8 patients during the July 1, 2011, through December 31, 2011, reporting period).
These proposed qualification requirements for 2011 registries are similar to the PQRI qualification requirements for registries for previous years. However, we note, that registries would no longer be permitted to include non-Medicare patients for measures group reporting (
In addition, in prior years registries were permitted to develop their own algorithms to calculate measure results (that is, reporting and performance rates) from the data provided to them from their EP members. For the 2011 PQRI, we propose that all current and future registries would have to meet the following new requirements proposed for 2011:
• Use PQRI measure specifications and the CMS provided measure calculation algorithm to calculate reporting rates or performance rates unless otherwise stated if aggregated measures data is continued for 2011 PQRI registry reporting. CMS will provide registries a calculation algorithm for each measure and/or measures group they intend to report in 2011.
• Provide a calculated result using the CMS supplied algorithm and XML file for each measure that the registry intends to calculate (as described below). This applies to all registries; those that are new to the program, and those that were previously qualified. The registries will be required to show that they can calculate the proper measure results (that is, reporting and performance rates) using the CMS-supplied algorithm and send the
• Provide us the individual data elements used to calculate the measures if so requested by CMS for validation purposes, if aggregated data submission is still the selected method of data collection. Registries that are subject to validation will be asked to send discrete data elements for a measure (determined by CMS) in the required data format for us to recalculate the registries' reported results. Validation will be conducted for several measures at a randomly selected sample of registries in order to validate their data submissions.
While registries allow EPs to collect data over a broader timeframe enabling us to implement more sophisticated measures in PQRI and despite their apparent success as a vehicle for quality reporting (over 90.0 percent of EPs who participated in the 2008 PQRI through registry-based reporting were incentive eligible), registry data results have been inconsistent when we have validated the registry data against claims. Even though qualified registries go through a thorough vetting and testing process, we have found differences in measure results (that is, performance rates) reported by the registries when compared to measure results calculated from claims data for the same EP. This makes it difficult for EPs to analyze their performance results for practice improvement in that the information may not be reliable and reproducible from registry to registry. This also makes possible physician comparison difficult and inconsistent. We believe there are likely several reasons for these inconsistencies, including the fact that some registries are getting their data from an EP's EHR, the use of non-Medicare patients by registries for measures groups, and the use of different algorithms by registries to calculate measures. We believe the proposed new requirements for registries discussed above will help us in validating the registry data we receive by addressing some of the reasons leading to the inconsistencies. The proposal for 2011 to retain many of the 2010 requirements while introducing some new requirements is intended to improve the registry-based reporting mechanism by capitalizing on some of the registry's existing quality improvement functions, maximizing the registry's ability to successfully submit EP's quality measure results and numerator and denominator data on PQRI individual quality measures or measures groups to CMS, and discouraging small physicians' offices or an individual EP from self-nominating to become a qualified registry. We continue to be concerned that an individual EP or a small practice does not have either the resources, or the capabilities, to successfully submit quality measures results and numerator and denominator data on PQRI individual measures or measures groups through the registry data submission process. We invite comments on the process and requirements that we propose to use to determine whether a registry is qualified to submit quality measures results (performance rates and reporting rates) and numerator and denominator data on PQRI quality measures or measures groups on an EP's behalf.
As stated previously, registries currently calculate the measure results (that is reporting and performance rates) from the data submitted to them by their EP members and send us the measure results for each participating EP, which are aggregated, nonpatient identifiable data. An advantage of this approach is that less data will need to be transmitted to CMS (since we only receive aggregated data), which means there is less data for CMS to analyze.
Another option that we considered was changing the requirements with respect to the type of data that registries send us. For 2011, we considered requiring registries, instead, to send discrete data elements for a measure (as determined by CMS) in the required data format for us to calculate the EP's measure results. Thus, the registry would be required to send CMS beneficiary-level data provided to the registry by the EP and CMS would use the data to calculate the EP's measure results (that is, reporting and performance rates). This approach is similar to the approach that was contemplated when registry data submission began in 2008 and was referred to as “Option 2” in the CY 2008 PFS proposed rule (72 FR 38203). An advantage of this approach is that it allows us to calculate the measure results and reduces the variation that occurs when registries try to aggregate their data and calculate the measure results themselves. Reducing the variation would facilitate comparison of EPs' results should we move towards public reporting of performance results in the future. Also, if the measure specifications change from year to year, this approach would require the registry to make fewer systems changes. The registry would not need to update the algorithms used to calculate the
We propose to post the final 2011 PQRI registry requirements, including the exact date by which registries that wish to qualify for 2011 must submit a self-nomination letter and instructions for submitting the self-nomination letter, on the PQRI section of the CMS Web site at
Similar to 2010 PQRI, we propose that registries that were “qualified” for 2010 and wish to continue to participate in 2011 will not need to be “re-qualified” for 2011 except to the extent that the requirements change for 2011 (as proposed above). If this occurs, we propose that all previously qualified registries would need to demonstrate that they can meet the new 2011 data submission requirements. Additionally, we propose that registries that are unsuccessful submitting 2010 PQRI data (that is, fail to submit 2010 PQRI data per the 2010 PQRI registry requirements) will need to go through a full self-nomination vetting process for 2011. Successful 2010 PQRI registries that choose to report on new or different 2011 PQRI measures would also need to qualify for these additional measures and/or methods. We also propose that registries that are “qualified” for 2010, who were successful in submitting 2010 PQRI data, and wish to continue to participate in 2011 would need to indicate their desire to continue participation for 2011 by submitting a letter to CMS indicating their continued interest in being a PQRI registry for 2011 and their compliance with the 2011 PQRI registry requirements by no later than October 31, 2010. Instructions regarding the procedures for submitting this letter will be provided to qualified 2010 PQRI registries on the 2010 PQRI registry support conference calls.
Similar to 2010 PQRI, we propose that if a qualified 2010 PQRI registry fails to submit 2010 PQRI data per the 2010 PQRI registry requirements, the registry would be considered unsuccessful at submitting 2010 PQRI data and would need to go through the full self-nomination process again to participate in the 2011 PQRI. By March 31, 2011, registries that are unsuccessful at submitting quality measures results and numerator and denominator data for 2010 would need to be able to meet the 2011 PQRI registry requirements and go through the full vetting process again. This would include CMS receiving the registry's self-nomination by March 31, 2011. As discussed further under section VI.F.2. of this proposed rule, we propose that the above registry requirements would apply not only for the purpose of a registry qualifying to report 2011 PQRI quality measure results and numerator and denominator data on PQRI individual quality measures or measures groups, but also for the purpose of a registry qualifying to submit the proposed electronic prescribing measure for the 2011 Electronic Prescribing Incentive Program. We invite comments on the proposed qualification requirements for registries for the 2011 PQRI.
In 2010 PQRI, EHR products were listed on the PQRI section of the CMS Web site at
Vendors' EHR products that were listed as “qualified” products for the 2010 PQRI were selected because the vendor self-nominated to participate in the 2009 EHR Testing Program and demonstrated that their products met the “Requirements for Electronic Health Record (EHR) Vendors to Participate in the 2009 PQRI EHR Testing Program” that were posted on the Alternative Reporting Mechanisms page of the PQRI section of the CMS Web site at
The EHR vendor qualification process for the 2011 PQRI was finalized in the 2010 PFS final rule with comment period (74 FR 61800 through 61802) and is currently underway. We anticipate the EHR vendor vetting process for the 2011 PQRI will be complete in early 2011. At the conclusion of the 2011 PQRI EHR vendor vetting process, those EHR products that meet all of the 2011 EHR vendor requirements will be listed on the PQRI section of the CMS Web site as a “qualified” PQRI EHR product, which indicates that the product's users may submit quality data to CMS for the 2011 PQRI. We continue to caution there is no guarantee that there will be any qualified EHR vendors available for the 2011 PQRI. However, since seven EHR vendors and their programs were “qualified” to submit quality data to CMS directly from their EPs for 2010 PQRI reporting, we are optimistic that for 2011 PQRI and subsequent years there will continue to be multiple “qualified” EHR vendors available for EPs.
During 2011, we propose to use the same self-nomination process described in the “Requirements for Electronic Health Record (EHR) Vendors to Participate in the 2011 PQRI EHR Testing Program” posted on the PQRI section of the CMS Web site at
• Be able to collect and transmit all required data elements according to the 2012 EHR Specifications.
• Be able to separate out and report on Medicare Part B FFS patients only.
• Be able to include TIN/NPI information submitted with an EP's quality data.
• Be able to transmit this data in the CMS-approved format.
• Comply with a secure method for data submission.
• Not be in a beta test form.
• Have at least 25 active users.
Additionally, we propose that previously qualified PQRI EHR vendors and 2012 EHR test vendors must also
We propose that previously qualified vendors and new vendors will need to incorporate any new EHR measures (measures electronically-specified) added to PQRI for the reporting year they wish to maintain their PQRI qualification, as well as update their electronic measure specifications and data transmission schema should either or both change. This proposed requirement ensures that all PQRI qualified EHR products can be used by EPs to report any PQRI EHR measure. We invite comments on the proposed qualification requirements for EHR Vendors and their products for the 2012 PQRI.
Section 1848(m)(3)(A) of the Act established the criteria for satisfactorily submitting data on individual quality measures as at least 3 measures in at least 80 percent of the cases in which the measure is applicable. If fewer than 3 measures are applicable to the services of the professional, the professional may meet the criteria by submitting data on 1 or 2 measures for at least 80 percent of applicable cases where the measures are reportable. This section establishes the presumption that if an EP submits quality data codes for a particular measure the measure applies to the EP.
For years after 2009, section 1848(m)(3)(D) of the Act provides additional authority to the Secretary, in consultation with stakeholders and experts, to revise the criteria for satisfactorily reporting data on quality measures. Based on this authority and the input we have previously received from stakeholders, we propose, for 2011, the following 2 criteria for claims-based reporting of individual measures by individual EPs:
• Report on at least 3 measures that apply to the services furnished by the professional; and
• Report each measure for at least 50 percent of the EP's Medicare Part B FFS patients for whom services were furnished during the reporting period to which the measure applies.
To the extent that an EP has fewer than 3 PQRI measures that apply to the EP's services, then we propose the EP would be able to meet the criteria for satisfactorily reporting data on individual quality measures by meeting the following 2 criteria:
• Report on all measures that apply to the services furnished by the professional (that is 1 to 2 measures); and
• Report each measure for at least 50 percent of the EP's Medicare Part B FFS patients for whom services were furnished during the reporting period to which the measure applies.
We also propose for 2011 the requirement that an EP who reports on fewer than 3 measures through the claims-based reporting mechanism may be subject to the Measure Applicability Validation (MAV) process, which would allow us to determine whether an EP should have reported quality data codes for additional measures. This process was applied in prior years. Under the proposed MAV process, when an EP reports on fewer than 3 measures, we propose to review whether there are other closely related measures (such as those that share a common diagnosis or those that are representative of services typically provided by a particular type of EP). We further propose that if an EP who reports on fewer than 3 measures in 2011 reports on a measure that is part of an identified cluster of closely related measures and did not report on any other measure that is part of that identified cluster of closely related measures, then the EP would not qualify as a satisfactory reporter in 2011 PQRI or earn an incentive payment. In 2011, we propose that these criteria for satisfactorily reporting data on fewer than 3 individual quality measures would apply for the claims-based reporting mechanism only.
We note that the proposed 2011 criteria for satisfactory reporting of individual quality measures through claims submission are different from the 2010 criteria, which required reporting on at least 80 percent of the EP's Medicare Part B FFS patients for whom services were furnished during the reporting period to which the measure applies.
The rationale for an 80 percent reporting rate is that this sample size would prevent selective reporting to achieve higher performance rates. However, we now have experience with claims based reporting, which has proved challenging for EPs, as discussed above. In 2007, approximately half of PQRI participants (defined as submitting at least one QDC), qualified for the PQRI incentive payment. Following the 2007 program completion, we performed an extensive review and made a number of analytic changes that we detailed in our 2007 PQRI Experience Report. For 2008, the analytic changes that we made following the completion of the 2007 program resulted in substantial increases in valid QDC reporting and the number of professionals qualifying for an incentive payment. However, the number who qualified for the incentive for the 2008 program year remained at about half of those who participated. A major reason for this was reporting at less than the required 80 percent reporting requirement. As a result of our review of the 2007 and 2008 program results, we believe that we can reduce the reporting sample requirement to 50 percent for claims-based submission without increasing the likelihood that professionals will selectively report based on whether the performance expectation of a measure is met for that particular patient. Inasmuch as we do not allow resubmission of a claim solely for the purpose of resubmission of a QDC, EPs will still need to submit QDCs contemporaneously with the claim. Therefore, we believe that even at a 50 percent reporting it would be difficult to selectively report for the purpose of better performance. Based on our review, we further believe that by reducing the reporting sample, there will be substantial increases in the portion of participating professionals who qualify for the PQRI incentive. Thus, we believe we can encourage significantly broader participation which otherwise might be deterred if physicians and other EPs do not believe that they are likely to qualify for the incentive.
As previously stated, we propose that the 50 percent reporting sample would apply only to the 2011 PQRI claims-based reporting mechanism available for reporting individual PQRI quality measures and not registry-based reporting or EHR-based reporting.
For the 2011 PQRI, we propose the following 2 criteria for satisfactory reporting of data on individual PQRI quality measures for registry-based and EHR-based reporting:
• Report on at least 3 measures that apply to the services furnished by the professional; and
• Report each measure for at least 80 percent of the EP's Medicare Part B FFS patients for whom services were furnished during the reporting period to which the measure applies.
We do not believe that reducing the reporting sample to 50 percent for registry-based reporting or EHR-based reporting would substantially impact the portion of participating professionals who qualify for the PQRI incentive. As stated previously, over 90.0 percent of EPs submitting data through registries were incentive eligible.
The proposed 2011 criteria for satisfactory reporting of data on individual PQRI quality measures are summarized in Table 47 and are arranged by reporting mechanism and reporting period. We seek public comment on these proposed reporting criteria. We are particularly interested in receiving comments on our proposal to lower the reporting criteria for claims-based reporting of individual measures from 80 percent to 50 percent. We seek input on whether 50 percent is an appropriate threshold or if another threshold would be more appropriate. We had considered lowering the reporting criteria to a higher threshold (such as 60 percent or 75 percent) but we found that differences in the performance rates at 50 percent and 80 percent reporting were not substantial while differences in the proportion of EPs satisfactorily reporting at the two different thresholds were substantial.
Table 47 illustrates that there are a total of 5 proposed reporting options for 2011, or ways in which an EP may meet the criteria for satisfactorily reporting on individual quality measures for the 2011 PQRI. Each proposed reporting option consists of the criteria for satisfactorily reporting such data and results on individual quality measures relevant to a given reporting mechanism and reporting period. EPs may potentially qualify for an incentive as satisfactorily reporting individual quality measures under more than one of the proposed reporting criteria, proposed reporting mechanism, and or for more than one proposed reporting period; however, only one incentive payment will be made to an EP based on the longest reporting period for which the EP satisfactorily reports.
We also propose that individual EPs have the option to report measures groups instead of individual quality measures to qualify for the 2011 PQRI incentive, using claims or registries. As stated previously, we do not propose to make the EHR-based reporting mechanism available for reporting on measures groups in 2011. The criteria that we propose for 2011 for satisfactory reporting of measures groups through claims-based or registry-based reporting for either the 12-month or 6-month reporting period are as follows: (1) For claims-based reporting, the reporting of at least 1 measures group for at least 50 percent of patients to whom the measures group applies, during the reporting period; or (2) for registry-based reporting, the reporting of at least 1 measures group for at least 80 percent of patients to whom the measures group applies during the reporting period. EPs, for both claims-based and registry-based reporting under these criteria, would be required to submit data on a minimum of 15 unique Medicare Part B FFS patients for the 12-month reporting period and a minimum of 8 Medicare Part B FFS patients for the 6-month reporting period. We note that the proposed criteria for 2011 are the same criteria as for 2010 PQRI reporting on measures groups, with the exception of our reducing the reporting sample from 80 percent to 50 percent for claims-based submission of measures groups. We propose to reduce the reporting sample requirement for claims-based submission of measures groups for the same reasons discussed in section VI.F.1.e. of this proposed rule for claims-based submission of individual measures. In other words, we believe that reducing the reporting sample from 80 percent to 50 percent will substantially increase the portion of participating EPs who qualify for a 2011 PQRI incentive without encouraging EPs to selectively report only those cases that will increase their performance rates. Additionally for 2011, we propose to retain the criteria, available only for the 12-month reporting period, based on reporting on at least 1 measures group for at least 30 patients for whom
Finally, for registry-based reporting in 2011, in contrast to prior program years, we propose to require that the minimum patient numbers or percentages must be met by Medicare Part B FFS patients exclusively and not non-Medicare Part B FFS patients. The reason for this is the difficulty of analyzing data we receive from registries, where patients other than Medicare Part B FFS patients are included. For example, under our proposal we would be able to compare claims data with registry submitted data to compare patients in the denominator of the measure for validation. The proposed 2011 criteria for satisfactory reporting of data on measures groups are summarized in Table 48 and are arranged by reporting mechanism and reporting period.
As illustrated in Table 48, there are a total of 6 proposed reporting options, or ways in which EPs may meet the criteria for satisfactory reporting of measures groups for the 2011 PQRI. Each proposed reporting option consists of the criteria for satisfactory reporting relevant to a given reporting mechanism and reporting period. As stated previously, EPs may potentially qualify as satisfactorily reporting for 2011 PQRI on measures groups under more than one of the reporting criteria, reporting mechanisms, and/or for more than one reporting period; however, only one incentive payment will be made to an EP based on the longest reporting period for which the EP satisfactorily reports. Similarly, an EP could also potentially qualify for the PQRI incentive payment by satisfactorily reporting both individual measures and measures groups. However, only one incentive payment will be made to the EP based on the longest reporting period for which the EP satisfactorily reports. We invite comments on the proposed criteria for satisfactory reporting measures groups for individual EPs.
Section 1848(m)(3)(C)(i) of the Act requires the Secretary to establish and have in place a process by January 1, 2010 under which EPs in a group practice (as defined by the Secretary) shall be treated as satisfactorily submitting data on quality measures
In addition, payments to a group practice under section 1848(m) of the Act by reason of the process proposed herein shall be in lieu of the PQRI incentive payments that would otherwise be made to EPs in the group practice for satisfactorily submitting data on quality measures (that is, prohibits double payments). Therefore, for the 2011 PQRI, we propose to continue to allow a group practice, as a whole (that is, for the TIN(s)), to participate in 2011 PQRI and to submit PQRI quality measures for 2011 and qualify to earn an incentive. If, however, an individual EP is affiliated with a group practice participating in the GPRO and the group practice satisfactorily reports under the GPRO, the EP will be considered as satisfactorily reporting PQRI quality measures data at the individual level under that same TIN(s) (that is, for the same TIN/NPI combination).
As stated above, section 1848(m)(3)(C)(i) of the Act authorizes the Secretary to define “group practice.” For purposes of determining whether a group practice satisfactorily submits PQRI quality measures data, we propose that for the 2011 PQRI a “group practice” would consist of a physician group practice, as defined by a TIN, with 2 or more individual EPs (or, as identified by NPIs) who have reassigned their billing rights to the TIN. This proposed definition for group practice is different from the 2010 PQRI definition of group practice in that we propose to change the minimum group size from 200 to 2 to enable more group practices to participate in the PQRI GPRO in 2011.
Generally, our intent continues to be to build on an existing quality reporting program that group practices may already be familiar with by modeling some aspects of the the PQRI GPRO after the PGP demonstration while concurrently expanding the availability of the GPRO to more group practices. Since the PGP demonstration is a demonstration program for large group practices, one of the requirements for group practices participating in the PGP demonstration is for each practice to have 200 or more members. To be consistent with the PGP demonstration, we propose one GPRO process, which we refer to as “GPRO I” that would be available only to similar large group practices. For group practices that have fewer than 200 members, we propose, if technically feasible, an alternative GPRO process which we refer to as “GPRO II”. We invite comments on the proposed definition of “group practice” and our proposal to expand the definition of group practice to include groups with 2 or more members.
In order to participate in the 2011 PQRI through the GPRO, we propose to require group practices to complete a self-nomination process and to meet certain technical and other requirements. The proposed self-nomination process and participation requirements for GPRO I and GPRO II are separately discussed below.
As discussed further in section VI.F.2. of this proposed rule, participation in the Electronic Prescribing (eRx) Incentive Program is voluntary for group practices selected to participate in the PQRI group practice reporting option. However, for 2011, we propose that group practices must participate in the PQRI group practice reporting option in order to be eligible to participate in the eRx group practice reporting option for 2011 PQRI. This is the current requirement under the 2010 PQRI and ERx Incentive programs. Therefore, we propose that a group practice that wishes to participate in both the PQRI group practice reporting option and the electronic prescribing group practice reporting option must notify CMS of its desire to do so at the time that it self-nominates to participate in the PQRI group practice reporting option.
In addition, we propose that group practices that are participating in Medicare demonstration projects, as approved by the Secretary, would also be considered group practices for purposes of the 2011 PQRI GPRO. Specifically, for the 2011 PQRI we propose to deem group practices participating in the PGP, Medicare Care Management Performance (MCMP), and EHR demonstrations to be participating in the PQRI GPRO since many of the measures being reported under these demonstration programs are similar to PQRI measures. As a result, such practices do not need to separately self-nominate to participate in the PQRI GPRO, although it would be necessary for such groups to meet the requirements for incentive qualification under their respective approved demonstration project. For example, the MCMP demonstration sites would be required to meet the requirements for earning a PQRI incentive specified under the MCMP demonstration.
For purposes of the 2011 eRx Incentive Program, however, we propose that group practices participating in CMS-approved demonstration projects discussed above would be required to meet the proposed 2011 eRx Incentive Program GPRO requirements or the proposed 2011 eRx Incentive Program requirements for individual EPs in order to qualify for a 2011 eRx incentive. Such group practices would not be able to qualify for a 2011 eRx incentive via participation in an approved demonstration project since there is no eRx requirement under these demonstrations.
(3) Proposed Process for Physician Group Practices To Participate as Group Practices and Criteria for Satisfactory Reporting
As stated above, we propose that group practices interested in participating in GPRO I must self-nominate to do so. Specifically, we propose that the 2011 PQRI self-nomination letter for group practices interested in participating in the 2011 PQRI through the GPRO I must be accompanied by an electronic file submitted in a format specified by CMS (such as, a Microsoft Excel file) that includes the group practice's TIN(s) and name of the group practice, the name and e-mail address of a single point of contact for handling administrative issues, as well as the name and e-mail address of a single point of contact for technical support purposes. This information was also required as part of the self-nomination process for the 2010 PQRI GPRO.
One change that we propose from the 2010 PQRI GPRO is that we propose for 2011 PQRI GPRO I to validate that the group practice consists of a minimum of 200 NPIs and we will supply group practices with this list. We invite comment on this proposed change for self nomination criteria. In addition, we propose that the self-nomination letter must also indicate the group practice's compliance with the following requirements:
• Have an active IACS user account;
• Agree to attend and participate in all mandatory GPRO training sessions; and
• Have billed Medicare Part B on or after January 1, 2010 and prior to October 29, 2010.
We propose to post the final 2011 PQRI participation requirements for group practices, including instructions for submitting the self-nomination letter and other requested information, on the PQRI section of the CMS Web site at
For physician groups selected to participate in the PQRI GPRO I for 2011, we propose to retain the existing 12-month reporting period beginning January 1, 2011. We propose that group practices participating in GPRO I submit information on these measures using a data collection tool based on the GPRO Tool used in 2010 PQRI GPRO by 36 participating group practices to report quality measures under PQRI. The 2010 PQRI GPRO Tool will be updated as needed to include the 2011 PQRI GPRO I measures. We believe that use of the GPRO data collection tool allows group practices the opportunity to calculate their own performance rates for reporting quality measures. We propose that physician groups selected to participate in the 2011 PQRI through the GPRO I report on a proposed common set of 26 NQF-endorsed quality measures that are based on measures currently used for 2010 PQRI GPRO. We believe these measures target high-cost chronic conditions and preventive care. The proposed quality measures are identified in Table 71.
The proposed 2011 PQRI GPRO I quality measures are based on a subset of the Doctor's Office Quality (DOQ) quality measures set developed under the direction of CMS and were used in the PGP and/or MCMP demonstration programs, and have subsequently been used in 2010 PQRI GPRO. Contributors to the development of the DOQ measures set included the American Medical Association's Physician Consortium for Performances Improvement (AMA–PCPI), the American College of Cardiology (ACC), the American Heart Association (AHA), the National Diabetes Quality Improvement Alliance, the National Committee for Quality Assurance (NCQA), and the Veterans Health Administration (VA). In most instances, these measures overlap with the proposed 2011 PQRI measures for reporting by individual EPs, however, there are some measures proposed for GPRO I that are not proposed for individual EPs.
These quality measures are grouped into four disease modules: coronary artery disease; diabetes; heart failure; and preventive care services. On February 2, 2010, we hosted a 2011 PQRI listening session to solicit input on a number of aspects of the PQRI, including measures for the 2011 PQRI GPRO. Since we received no suggestions for additional disease modules for the GPRO I from this listening session, we are not proposing any additional measures for the 2011 PQRI GPRO I. We invite comments on our proposal to use the 26 measures identified in Table 71 for inclusion in 2011 PQRI GPRO I. We specifically request comments on whether these measures can and/or should be expanded for the group practice reporting option for future program years. Disease modules and measures should address high cost conditions and/or a gap in care. Further detail on criteria for measure selection can be found in section VI.F.1.h. below.
The proposed process that group practices will be required to use to report data on quality measures for the 2011 PQRI GPRO I and the proposed associated criteria for satisfactory reporting of data on quality measures by group practices, are summarized in Table 49. Under our proposed 2011 program, group practices participating in PQRI GPRO I as a group practice would be required to report on all of the measures listed in Table 71.
As part of the data submission process for 2011 GPRO I, we propose that during 2012, each group practice would be required to report quality measures with respect to services furnished during the 2011 reporting period (that is, January 1, 2011, through December 31, 2011) on an assigned sample of Medicare beneficiaries. We propose to analyze the January 1, 2011 through October 31, 2011 (that is, the last business day of October 2011) National Claims History (NCH) file to assign Medicare beneficiaries to each physician group practice using a patient assignment methodology modeled after the patient assignment methodology used in the PGP demonstration. Based on our desire to model the PQRI GPRO I after the PGP demonstration, we will also consider applying any refinements made to the patient assignment methodology used in the PGP demonstration prior to January 1, 2011 to the 2011 PQRI GPRO I. Assigned beneficiaries would be limited to those Medicare FFS beneficiaries with Medicare Parts A and B for whom Medicare is the primary payer. Assigned beneficiaries would not include Medicare Advantage enrollees. A beneficiary would be assigned to the physician group that provides the plurality of a beneficiary's office or other outpatient evaluation and management allowed charges (based on Medicare Part B claims submitted for the beneficiary for dates of services between January 1, 2011, and October 31, 2011). Beneficiaries with only 1 visit to the group practice between January 1, 2011 and October 31, 2011, would be eliminated from the group practice's assigned patient sample for purposes of 2011 PQRI GPRO I. For inclusion in the sample, assigned beneficiaries would be required to have at least 2 visits to the group practice between January 1, 2011, and October 31, 2011.
Once the beneficiary assignment has been made for each physician group during the fourth quarter of 2011, we propose to provide each physician group selected to participate in the PQRI GPRO I with access to a database (that is, a data collection tool) that will include the group's assigned beneficiary samples and the quality measures listed in Table 71. We propose to pre-populate the data collection tool with the assigned beneficiaries' demographic and utilization information based on all of their Medicare claims data. We intend to provide the selected physician groups with access to this pre-populated database by no later than the first quarter of 2012. The physician group would be required to populate the remaining data fields necessary for capturing quality measure information on each of the assigned beneficiaries. Numerators for each of the quality measures would include all
For 2011, we propose an exclusive reporting mechanism for EPs identified as part of the group practice with respect to the group as identified by the TIN. However, EPs who are part of the group practice, and who separately practice with respect to another TIN to which the EP has reassigned benefits, could separately qualify as individual EPs with respect to the other practice (TIN). As discussed above, we propose that each physician group selected to participate in the PQRI GPRO I would have access to a data base (that is a data collection tool) that would include the assigned beneficiary sample and the quality measures. This data collection tool was originally developed for use in the PGP demonstration, updated for use in the MCMP demonstration, and will continue to be updated as needed for use in the PQRI. The assigned beneficiaries' demographic and utilization information is pre-populated based on claims data. We anticipate being able to provide the selected physician groups with access to this pre-populated database by the first quarter of 2012. The physician group would be required to populate the remaining data fields necessary for capturing quality measure information on each of the assigned beneficiaries. Numerators for each of the quality measures would include all beneficiaries in the denominator population who also satisfy the quality performance criteria for that measure. Denominators for each quality measure would include a sample of the assigned beneficiaries who meet the eligibility criteria for that quality measure module or preventive care measure.
We expect that use of the PQRI GPRO I data collection tool allows group practices the opportunity to calculate their own performance rates for reporting quality measures. This provides group practices with the chance to preview their information prior to the public posting of performance data should we choose to do so in future program years.
We invite comment on our proposal for 2011 to retain 200 as the number of NPIs for a TIN required for each group practice under the GPRO I. We also invite comment on our proposal to allow those “qualified” for 2010 GPRO to be rolled over for automatic qualification for 2011 GPRO I.
As discussed previously, section 1848(m)(3)(C) of the Act authorizes us to define the term “group practice” and requires us to establish a process under which EPs in group practices shall be treated as satisfactorily submitting data on PQRI quality measures, but is not prescriptive with regard to the characteristics of this process. Although for 2010 we did not provide a process for groups of less than 200 NPIs to report under the GPRO, we believe that there are significant potential benefits to allowing reporting at the group level generally. At present, for example, where more than one individual professional sees the same patient, each may have to report separately with respect to the patient even for processes of care that do not need to be repeated at each visit. Thus, there is significant duplication of reporting. Additionally, while we are not proposing to report performance information with respect to the 2011 PQRI GPRO, the public reporting of performance information at the group level raises substantially fewer issues, such as privacy, and the potential adverse impact of public reporting on the individual physician, and the lack of sufficient numbers of patients for any one physician to meaningfully differentiate performance results. Finally, we believe that many process-of-care measures depend on general functioning of the practice, such as in coordinating and tracking care, as opposed to a quality of a particular professional in the group, particularly for measures related to prevention and care of chronic illnesses.
As a result, based on our authority under section 1848(m)(3)(C) of the Act to establish a process for group practices and our discretion to define “group practice” under this section we are proposing multiple processes for reporting at the group level for groups of EPs of all sizes for purposes of qualifying for a PQRI incentive payment. The proposed process for groups of 200 or more EPs, known as GPRO I, was discussed above. If technically feasible, we propose a new group practice reporting option (GPRO
We also propose that self-nominating groups would need to indicate in this letter if the group intends to report as a group for the eRx Incentive Program and the reporting mechanism the group intends to use to report as a group for the eRx Incentive Program. We would require that this information be sent to: GPRO II, c/o CMS, 7500 Security Blvd., Mail Stop S3–02–01, Baltimore, MD 21244, and must be postmarked by January 31, 2011, for consideration in the program.
Since GPRO II would be a new process available to groups in 2011, we propose to initially pilot the GPRO II process with a limited number of groups. We propose to select the first 500 groups that meet the proposed eligibility requirements to participate in the 2011 GPRO II. We propose to use the postmark to determine the order in which groups self-nominated for GPRO II. We propose to consider only self-nomination letters postmarked between January 3, 2011 and January 31, 2011. We do not propose to consider letters postmarked prior to January 3, 2011 to prevent groups from self-nominating before the GPRO II requirements are finalized and to discourage groups from self-nominating for GPRO II prior to reviewing the final GPRO II requirements.
For purposes of quality data submission, we propose, for the GPRO II, to allow EPs to submit their data through claims or through a qualified GPRO registry to the extent registries are technically capable of collecting, calculating and transmitting the required data to CMS and that we are able to accept such data from registries.
For GPRO II, as discussed in greater detail below, we propose that in addition to reporting a specific number of individual measures, the group would have to report one or more proposed 2011 PQRI measures groups identified in Tables 57 through 70 of this proposed rule depending on the size of the group practice. In this way we seek to address a concern expressed regarding PQRI for individual reporting that EPs are able to select any three of a large array of measures making comparison data difficult whether for the same individual or among professionals. We believe that by having a smaller set of measures to choose from, we hope to focus on topics of major significance, and make the information obtained with respect to quality more meaningful.
For purposes of satisfying the requirements under section 1848(m)(3)(C)(i) of the Act for groups of 2–199 NPIs, we propose that in order to be treated as satisfactorily reporting under GPRO II, the group practice would be required to report on 50 percent or more (if submitting through claims) of all Medicare Part B patients who fit into the measures group denominator or 80 percent or more of Medicare patients if using a registry to report.
Additionally, to earn a PQRI incentive payment for all allowed Medicare Part B services that are provided by the TIN, we propose that a group practice must report on three to six individual 2011 PQRI measures, depending on the size of the group. We propose that the group practice may select from among any of the 2011 PQRI measures on which to submit data, provided the measures selected are not duplicated in the measures group(s) reported.
We propose that, to satisfactorily report individual PQRI measures, a group must report each measure at the same rate (percentage) as determined by the method of submission as individual EPs. For example, if reporting via claims, to satisfactorily report individual measures, each measure would need to be reported on at least 50 percent of eligible Medicare Part B FFS patients.
An alternative which we considered was to require that the individual measures be selected from a more limited set of measures, such as measures closely linked to improved population health, or other measures perceived to address the greatest potential benefit from improved performance. While there are potential benefits to this approach of encouraging broad reporting of a more limited set of measures, we are concerned that any limited measures set may not be applicable to all groups, such as single specialty groups. Further we are concerned that this would diminish an important strength of the overall PQRI measures set, which is its broad applicability. We invite comments on the potential benefits of a core measures set, as opposed to allowing groups to select from among the array of PQRI measures, what measures should be included in that set, whether there are any PQRI measures that all professionals in group practices should report, where the measure applies to patients of the group.
A second alternative that we considered was to require group practices, as part of the self-nomination process, to designate whether they were a multispecialty group with primary care, a multispecialty group without primary care, or a single specialty group, and if so, the specialty. Depending on what type of specialty the group is, we would identify a set of PQRI measures pertaining to the group's specialty and require the group practice to report on the identified set of specialty-specific PQRI measures. We invite comments on the potential benefits of this approach as opposed to allowing groups to select from among the array of PQRI measures or requiring all groups, regardless of specialty, to report on the same core set of measures.
Table 50 sets forth the proposed criteria for satisfactory reporting under the 2011 PQRI GPRO II and requirements for each group based on their respective group size (number of EPs).
If a group does not satisfactorily report as a GPRO II group, we propose to analyze the individual professional's data to see if they satisfactorily reported at the individual TIN/NPI level. If the EP satisfactorily reported at the individual level, he or she would receive a PQRI incentive, which is calculated using the EP's TIN/NPI Medicare Part B allowed charges.
If a group practice participating in the 2011 PQRI GPRO II wants to also participate in the 2011 eRx Incentive Program as a small group, we propose that the group would need to indicate that preference in their self-nomination letter and would need to report on the number of unique encounters based on their group size as listed in Table 50 below. For the 2011 eRx reporting for GPRO II, we propose the following reporting mechanisms: claims, a GPRO eRx qualified registry or a GPRO qualified EHR. As with the 2011 eRx Incentive Program for individual EPs and the 2011 eRx GPRO I, at least 10 percent of a GPRO II group's charges would need to be comprised of codes in the denominator of the electronic
The required number of unique visits where an electronic prescription was generated to be a successful electronic prescriber was determined by taking the midpoint of the group size range and multiplying the number by 12.5 and then rounding this number to the nearest multiple of 5. This is consistent with how the 2010 eRx GPRO requirements, which requires that the group practice report that at least 1 prescription during an encounter was generated and transmitted using a qualified electronic prescribing system in at least 2,500 instances during the reporting period, were derived. For the 2010 eRx Incentive Program, we assumed that half the members of an average sized-group (which we assumed to be 200 EPs) do not furnish the services represented by the electronic prescribing measure's denominator codes, and thus, would not have an opportunity to report the electronic prescribing measure. For the remaining EPs within the group who do have an opportunity to report the electronic prescribing measure, we sought to hold those EPs to the same standard as individual EPs. Thus, for an average 200 EP group, each of the 100 EPs with an opportunity to report the electronic prescribing measure would be expected to have 25 unique electronic prescribing events for a total of 2,500 unique electronic prescribing events for the group.
We propose posting the information required by section 1848(m)(5)(G) of the Act for those group practices that are selected to participate in the 2011 PQRI under the GPRO II. That is, we propose to post the names of group practices that satisfactorily report under GPRO II as we propose to do for group practices that satisfactorily report under the 2011 PQRI GPRO I.
We invite comment on our proposal to add this second option (GPRO II) for group practices to report PQRI quality data measures and the GPRO II process. We also invite comments regarding our proposal to publicly report GPRO II information with respect to satisfactory PQRI participation.
In addition to the GPRO II, another option that we considered for expanding the GPRO for 2011 was to expand GPRO I to include smaller group practices. Specifically, we considered allowing groups of 100 or more EPs to participate in the PQRI under GPRO using the same reporting mechanism and reporting criteria required under the 2010 PQRI GPRO and proposed for the 2011 PQRI GPRO I. We also considered modifying the definition of “group practice” to include groups that have and use multiple TINs. We invite comments on these alternatives.
Under section 1848(k)(2)(C)(i) of the Act, the PQRI quality measures shall be such measures selected by the Secretary from measures that have been endorsed by the entity with a contract with the Secretary under subsection 1890(a) of the Act (that is, the National Quality Forum, or NQF). However, in the case of a specified area or medical topic determined appropriate by the Secretary for which a feasible and practical measure has not been endorsed by the NQF, section 1848(k)(2)(C)(ii) of the Act authorizes the Secretary to specify a measure that is not so endorsed as long as due consideration is given to measures that have been endorsed or adopted by a consensus organization identified by the Secretary, such as the AQA alliance. In light of these statutory requirements, we believe that, except in the circumstances specified in the statute, each proposed 2011 PQRI quality measure would need to be endorsed by the NQF. The NQF endorsement status of each of the proposed measures is identified for each measure. The basis for including certain measures that are not endorsed by NQF is discussed further below.
Additionally, section 1848(k)(2)(D) of the Act requires that for each 2011 PQRI quality measure, “the Secretary shall ensure that EPs have the opportunity to provide input during the development, endorsement, or selection of measures applicable to services they furnish.” We believe that this requirement is met for all proposed measures in several ways. Measure developers generally include a public comment phase in their measure development process. As part of the measures development process, measures developers typically solicit public comments on measures that they are testing in order to determine whether additional refinement of the measure(s) is needed prior to submission for consensus endorsement. For example, information on the measure development process, employed by us when CMS or our contractor is the measure developer, is available in the “Measures Management System Blueprint” found on the CMS Web site at
The statutory requirements under section 1848(k)(2)(C) of the Act, subject to the exception noted above, require only that the measures be selected from measures that have been endorsed by the entity with a contract with the Secretary under section 1890(a) (that is, the NQF) and are silent with respect to how the measures that are submitted to the NQF for endorsement were developed. The basic steps for developing measures applicable to physicians and other EPs prior to submission of the measures for endorsement may be carried out by a variety of different organizations. We do not believe there needs to be any special restrictions on the type or make up of the organizations carrying out this basic development of physician measures, such as restricting the initial development to physician-controlled organizations. Any such restriction would unduly limit the basic development of quality measures and the scope and utility of measures that may be considered for endorsement as voluntary consensus standards.
As stated previously, in addition to reviewing the 2010 PQRI measures for purposes of developing the proposed 2011 PQRI measures, we reviewed and considered measure suggestions including comments received in response to the CY 2010 PFS proposed rule and final rule with comment period. Additionally, suggestions and input received through other venues, such as an invitation for measures suggestions via the Listening Session held February 2, 2010, were also reviewed and considered for purposes of our development of the list of proposed 2011 PQRI quality measures. A summary of the measures suggestions received via the Listening Session is included in the background paper that was provided to Listening Session participants. The Listening Session background paper is posted on CMS Sponsored Calls page of the PQRI section of the CMS Web site at:
With respect to the selection of new measures (that is, measures that have never been selected as part of a PQRI quality measure set for 2010 or any prior year), we propose to apply the following considerations, which include many of the same considerations applied to the selection of 2009 and 2010 PQRI quality measures for inclusion in the 2011 PQRI quality measure set described above:
• High Impact on Healthcare.
• Measures that are included in, or facilitate alignment with, other Medicare, Medicaid, and CHIP programs in furtherance of overarching healthcare goals.
• NQF Endorsement.
• Address Gaps in PQRI Measure Set.
• Measures of various aspects of clinical quality including outcome measures, where appropriate and feasible, process measures, structural measures, efficiency measures, and measures of patient experience of care.
Other considerations that we propose to apply to the selection of measures for 2011, regardless of whether the measure was a 2010 PQRI measure or not, were:
• Measures that are functional, which is to say measures that can be technically implemented within the capacity of the CMS infrastructure for data collection, analysis, and calculation of reporting and performance rates. This leads to preference for measures that reflect readiness for implementation, such as those that are currently in the 2010 PQRI program or have been through testing. The purpose of measure testing is to reveal the measure's strengths and weaknesses so that the limitations can be addressed and the measure refined and strengthened prior to implementation. For any new measures considered for 2011 PQRI, preference is given to those that can be most efficiently implemented for data collection and submission. Therefore, any measures that have previously been found to be technically impractical to report because they are analytically challenging due to any number of factors, including those that are claims-based, will again not been included for 2011 PQRI. For example, in some cases, we are proposing to replace existing 2010 PQRI measures with updated and improved measures that are less technically challenging to report. For example, we are proposing to replace existing 2010 PQRI measures #114 and #115 with updated and improved measure #TBD (Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention), which is less technically challenging to report.
• In 2011 PQRI, as in 2010 PQRI, for some measures that are useful, but where data submission is not feasible through all otherwise available PQRI reporting mechanisms, a measure may be included for reporting solely through specific reporting mechanism(s) in which its submission is feasible. For the 2011 PQRI, we propose to retain those measures that had previously been available for claims-based reporting and registry-based reporting, which were changed for 2010 PQRI to registry-based reporting only because they were technically challenging to report and/or analyze through the claims-based reporting mechanism.
We welcome comments on the implication of including or excluding any given measure or measures for our proposed 2011 PQRI quality measure set, as well as feedback relative to our proposed approach in selecting measures. We recognize that some commenters may also wish to recommend additional measures for inclusion in the 2011 PQRI measures that we are not proposing. While we welcome all constructive comments and suggestions, and may consider such recommended measures for inclusion in future measure sets for PQRI and/or other programs to which such measures may be relevant, we will not be able to consider such additional measures for inclusion in the final 2011 measure set.
As discussed above, section 1848(k)(2)(D) of the Act requires that the public have the opportunity to provide input during the selection of measures. We also are required by other applicable statutes to provide opportunity for public comment on provisions of policy or regulation that are established via notice and comment rulemaking. Measures that were not included in this proposed rule for inclusion in the 2011 PQRI that are recommended to CMS via comments on this proposed rule cannot be included in the 2011 measure set.
As discussed above, section 1848(k)(2)(D) of the Act requires that the public have the opportunity to provide input during the selection of measures. We also are required by other applicable statutes to provide opportunity for public comment on provisions of policy or regulation that are established via notice and comment rulemaking. Measures that were not included in this proposed rule for inclusion in the 2011 PQRI that are recommended to CMS via comments on this proposed rule have not been placed before the public to comment on the selection of those measures within the rulemaking process. Even when measures have been published in the
In addition, as in prior years, we again note that we do not use notice and comment rulemaking as a means to update or modify measure specifications. Quality measures that have completed the consensus process have a designated party (usually, the measure developer/owner) who has accepted responsibility for maintaining the measure. In general, it is the role of the measure owner, developer, or maintainer to make changes to a measure. Therefore, comments requesting changes to a specific proposed PQRI measure's title, definition, and detailed specifications or coding should be directed to the measure developer identified in Tables 52 through 70. Contact information for the 2010 PQRI measure developers is listed in the “2010 PQRI Quality Measures List,” which is available on the PQRI section of the CMS Web site at
However, we stress that inclusion of measures that are not NQF endorsed or AQA adopted is an exception to the requirement under section 1848(k)(2)(C)(i) of the Act that measures be endorsed by the NQF. We may exercise this exception authority in a specified area or medical topic for which a feasible and practical measure has not been endorsed by NQF, so long as due consideration is given to measures that have been endorsed by the NQF.
As in 2010 PQRI, individual EPs have the choice of reporting PQRI quality measures data on either individual quality measures or on measures groups for 2011 PQRI.
Consistent with statutory requirements for identifying and including measures for 2011 PQRI, the individual quality measures identified for use in the 2011 PQRI will be selected from those we propose in this rule and will ultimately be finalized as of the date the CY 2011 PFS final rule with comment period is available for public inspection at the Office of the Federal Register. No changes (that is, additions or deletions of measures) will be made after publication of the CY 2011 PFS final rule with comment period. However, as was the case in previous program years, we may make modifications or refinements, such as revisions to measures titles and code additions, corrections, or revisions to the detailed specifications for the 2011 measures until the beginning of the reporting period. The 2011 measures specifications for individual quality measures will be available on the PQRI section of the CMS Web site at
In response to the February 2, 2010 Listening Session, CMS received 146 individual measure suggestions and 9 measures groups suggestions, one of which included modifications to an existing measures group, for possible inclusion in the 2011 PQRI.
We propose to include a total of 198 measures (this includes both individual measures and measures that are part of a proposed 2011 measures group) on which individual EPs can report for the 2011 PQRI. The individual PQRI quality measures proposed for the 2011 PQRI are listed in Tables 52 through 56 and fall into four broad categories as set forth below. The four categories are the following:
• Proposed 2011 Individual Quality Measures Selected From the 2010 PQRI Quality Measures Set Available for Claims-Based Reporting and Registry-Based Reporting;
• Proposed 2011 Individual Quality Measures Selected From the 2010 PQRI Quality Measures Set Available for Registry-Based Reporting Only;
• New Individual Quality Measures Proposed for 2011; and
• Proposed 2011 Measures Available for EHR-Based Reporting.
In addition, we are also proposing the inclusion of 1 new measures group for 2011 PQRI. The measures proposed for 2011 measures groups are listed in Tables 57 through 70. Please note Table 51 includes 2010 PQRI measures that are not proposed for inclusion in 2011 PQRI.
After careful consideration of 2010 PQRI measures, we propose to retire these 5 measures because they did not meet one or more of the considerations for selection of proposed 2011 measures discussed in section VI.F.1.h. above. Specifically, we are proposing to retire PQRI measures #135, #136, and #139, for 2011 because they have been considered by NQF for possible endorsement but ultimately were not NQF-endorsed. In addition we propose to replace existing 2010 PQRI measures #114 and #115 with an updated and improved measure (#TBD “Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention”), which is less technically challenging to report. We invite comments on our proposal to retire the 2010 measures listed in Table 51 for the 2011 PQRI.
For 2011, we propose to retain 170 measures currently used in the 2010 PQRI. These 170 proposed measures include 45 registry-only measures currently used in the 2010 PQRI, but do not include any measures that are proposed to be included as part of the 2011 Back Pain measures group (
The 125 individual 2010 PQRI measures proposed for inclusion in the 2011 PQRI quality measure set as individual quality measures for either claims-based reporting or registry-based reporting are listed by their Measure Number and Title in Table 52, along with the name of the measure's developer/owner, and the NQF measure number, if applicable. The PQRI Measure Number is a unique identifier assigned by CMS to all measures in the PQRI measure set. Once a PQRI Measure Number is assigned to a measure, it will not be used again to identify a different measure, even if the original measure to which the number was assigned is subsequently retired from the PQRI measure set. A description of the measures listed in Table 52 can be found in the “2010 PQRI Quality Measures List,” which is available on the Measures and Codes page of the PQRI section of the CMS Web site at
The 2010 measures that are proposed to be available for registry-based reporting only for the 2011 PQRI are discussed and identified in section VI.F.1.i.(2) of this proposed rule.
It is our understanding that measures #188, #189, and #190 were considered by NQF for possible endorsement but were not ultimately NQF-endorsed. However, since we are not aware of any other NQF-endorsed measures that are available to audiologists, we propose to exercise our exception authority under section 1848(k)(2)(C)(ii) of the Act. Therefore, we propose to use measures #188, #189, and #190 for the 2011 PQRI despite the fact that they are neither NQF-endorsed nor AQA adopted.
Please note that detailed measure specifications, including the measure's title, for 2010 individual PQRI quality measures may have been updated or modified during the NQF endorsement process or for other reasons prior to 2011. The 2011 PQRI quality measure specifications for any given individual quality measure may, therefore, be different from specifications for the same quality measure used for 2010. Specifications for all 2011 individual PQRI quality measures, whether or not included in the 2010 PQRI program, must be obtained from the specifications document for 2011 individual PQRI quality measures, which will be available on the PQRI section of the CMS Web site on or before December 31, 2010.
For the 2011 PQRI, we propose to include 45 registry-only individual measures from the 2010 PQRI. As in 2010 PQRI, we are proposing to designate these measures as registry-only measures for 2011 to relieve ongoing analytical difficulties encountered with claims-based reporting of these measures in prior program years. We encourage comments on our proposal to designate these 45 2010 measures as registry-only measures for the 2011 PQRI.
Although we are proposing to designate certain measures as registry-only measures for 2011, we cannot guarantee that there will be a registry qualified to submit each registry-only measure for 2011. We rely on registries to self-nominate and identify the types of measures for which they would like to be qualified to submit quality measures results and numerator and denominator data on quality measures. If no registry self-nominates to submit measure results and numerator and denominator data on a particular type of measure for 2011, then an EP would not be able to report that particular measure type via a registry. The Measure Number and Measure Title for these proposed registry-only measures are listed in Table 53 along with the NQF measure number, if applicable, and the name of the measure's developer/owner. As mentioned above, a description of the measures listed in Table 53 can be found in the “2010 PQRI Quality Measures List,” which is available on the Measures and Codes page of the PQRI section of the CMS Web site at
Please note, as previously discussed above, detailed measure specifications, including a measure's title, for 2010 PQRI quality measures may be updated or modified during the NQF endorsement process or for other reasons during 2010. Therefore, the 2011 PQRI quality measure specifications for any given quality measure may be different from specifications for the same quality measure used for 2010. Specifications
We propose to include in the 2011 PQRI quality measure set 20 measures that were not included in the 2010 PQRI quality measures set provided that each measure obtains NQF endorsement by June 1, 2010 and its detailed specifications are completed and ready for implementation in PQRI by August 15, 2010. Besides having NQF endorsement, we again propose that the development of a measure is considered complete for the purposes of the 2011 PQRI if by August 15, 2010: (1) The final, detailed specifications for use in data collection for PQRI have been completed and are ready for implementation, and (2) all of the Category II Current Procedural Terminology (CPT II) codes required for the measure have been established and will be effective for CMS claims data submission on or before January 1, 2011. The titles of these proposed additional, or new, measures are listed in Table 54 along with the name of the measure developer and the proposed reporting mechanism (that is, whether the measure is proposed to be reportable using claims, registries, or both). For these 20 proposed measures, a PQRI Measure Number will be assigned to a measure if and when the measure is included in the final set of 2011 PQRI measures.
Due to the complexity of their measure specifications, we propose that 8 of these 20 measures would be available as registry-only measures for the 2011 PQRI. The remaining 15 measures are proposed to be available for reporting through either claims-based reporting or registry-based reporting.
For 2011, we propose to again accept PQRI data from EHRs for a limited subset of the proposed 2011 PQRI quality measures, contingent upon the successful completion of our 2010 EHR data submission process and a determination that accepting data from EHRs on quality measures for the 2011 PQRI continues to be practical and feasible.
We propose to make a total of 22 measures available for EHR-based reporting in the 2010 PQRI. These include the 10 measures available for EHR-based reporting in the 2010 PQRI, which are identified in Table 55 and 12 additional measures identified in Table 56 that overlap with the clinical quality measures used in the EHR incentive program established by the American Recovery and Reinvestment Act (ARRA). Again, this year, we propose to make these measures available for electronic submission via an EHR because these measures target preventive care or common chronic and high-cost conditions.
We propose to retain the following 13 2010 PQRI measures groups for the 2011 PQRI: (1) Diabetes Mellitus; (2) CKD; (3) Preventive Care; (4) CABG; (5) Rheumatoid Arthritis; (6) Perioperative Care; (7) Back Pain; (8) CAD; (9) Heart Failure; (10) IVD; (11) Hepatitis C; (12) HIV/AIDS; and (13) CAP. We are proposing to include these measures groups in 2011 PQRI because they each contain at least 4 PQRI quality measures that share a common denominator definition.
For 2011, we propose that the CABG, CAD, Heart Failure, HIV/AIDS measures groups continue to be reportable through the registry-based reporting mechanism only, while the remaining Diabetes Mellitus, CKD, Preventive Care, Rheumatoid Arthritis, Perioperative Care, Back Pain, IVD, Hepatitis C, and CAP measures groups will continue to be reportable through either claims-based reporting or registry-based reporting for the 2011 PQRI. The 4 2011 proposed measures groups reportable via registry-based reporting only are identified with an asterisk (*) below.
For 2010, the 13 measures groups that we propose to retain in the 2011 PQRI, combined with the one additional measures group we are proposing for 2011, makes a total of 14 measures groups for the 2011 PQRI. The 1 additional measures group we propose for the 2011 PQRI, identified in Table 70, is an Asthma Measures Group. The Asthma Measures Group is proposed to be reportable through either claims-based reporting or registry-based reporting.
We believe that the measure groups proposed for the 2011 PQRI address gaps in quality reporting and are those that have a high impact on HHS and CMS priority topics for improved quality and efficiency for Medicare beneficiaries (such as prevention, chronic conditions, improved care coordination, improved efficiency, improved patient and family experience of care, and effective management of acute and chronic episodes).
Finally, as in previous program years, for 2011, we continue to propose that except for the measures included in the Back Pain measures group, the measures included in any proposed 2011 measures group be reportable either as individual measures or as part of a measures group. For 2011, we propose that the measures proposed for inclusion in the Back Pain measures group will continue to be reportable only as part of a measures group and not as individual measures in 2011. We propose that measures selected for inclusion in all 2011 PQRI measures groups (except for the Back Pain measures group) are reportable either as individual measures or as part of a measures group.
The measures proposed for inclusion in each of the 2011 measures groups are identified in Tables 57 through 70. As stated previously, the PQRI Measure Number is a unique identifier assigned by CMS to all measures in the PQRI measure set. Once a PQRI Measure Number is assigned to a measure, it will not be used again, even if the measure is subsequently retired from the PQRI measure set. Measures that are not preceded by a number (in other words, those preceded by “TBD”) in Tables 57 through 71 were never part of a PQRI measure set prior to 2011. A number will be assigned to such measures for 2011, if we finalize inclusion of the measures in the 2011 PQRI.
As with measures group reporting in the 2008, 2009, and 2010 PQRI, we propose that each EP electing to report a group of measures for 2011 must report all measures in the group that are applicable to each patient or encounter to which the measures group applies at least up to the minimum number of patients required by the applicable reporting criteria.
We note that the specifications for measures groups do not necessarily contain all the specification elements of each individual measure making up the measures group. This is based on the need for a common set of denominator specifications for all the measures making up a measures group in order to define the applicability of the measures group. Therefore, the specifications and instructions for measures groups will again be provided separately from the specifications and instructions for the individual 2011 PQRI measures. We will post the detailed specifications and specific instructions for reporting measures groups on the PQRI section of the CMS Web site at
Additionally, the detailed measure specifications and instructions for submitting data on those 2011 measures groups that were also included as 2010 PQRI measures groups may be updated or modified prior to 2011. Therefore, the 2011 PQRI measure specifications for any given measures group could be different from specifications and submission instructions for the same measures group used for 2010. These measure specification changes are not expected to materially impact the intended meaning of the measures or the strength of the measures.
As discussed in section VI.F.1.g.(3).(i) of this proposed rule, we propose that physician groups selected to participate in the 2011 PQRI GPRO I would be required to report on 26 proposed measures. We are proposing these measures because they are NQF-endorsed measures currently collected as part of the PGP and/or MCMP demonstrations and in the 2010 PQRI GPRO. These proposed measures are listed in Table 71. To the extent that a measure is an existing PQRI measure available for reporting by individual EPs, the Measure Title is preceded by the measure's PQRI Measure Number. If there is no number in the PQRI Measure Number column of the table, then the measure is not an existing PQRI measure and will be added to the 2011 PQRI for purposes of the GPRO I. Measures proposed for GPRO II are discussed in section VI.F.1.g.(3).(ii) of this proposed rule.
As in the 2010 PQRI, a separate measures specifications manual and other supporting documents will be available for group practices participating in the 2011 PQRI GPRO I. We anticipate that the group practice measures specifications manual will be available by November 15, 2010 on the PQRI section of the CMS Web site at
Section 1848(m)(5)(G) of the Act requires the Secretary to post on the CMS Web site, in an easily understandable format, a list of the names of EPs (or group practices) who satisfactorily submitted data on quality measures for the PQRI and the names of the EPs (or group practices) who are successful electronic prescribers. In addition, section 10331(a)(1) of the ACA, requires the Secretary to develop a Physician Compare Internet Web site by January 1, 2011, on which information on physicians enrolled in the Medicare program and other EPs who participate in the PQRI program would be posted.
To meet the ACA deadline of January 1, 2011, with respect to establishing the Physician Compare Web site, we propose, for 2011 PQRI, to use the current Physician and Other Health Care Professional Directory as a foundation for the Physician Compare Web site. As in 2010 PQRI, we propose to continue to make public the names of EPs and group practices that satisfactorily submit quality data for the 2011 PQRI. Previously, this was posted on the Physician and Other Health Care Professionals Directory. Our intent for the 2011 PQRI is to post the information on the Physician Compare Web site that must be developed by January 1, 2011. Specifically, we propose to post the names of EPs who: (1) Submit data on the 2011 PQRI quality measures through one of the reporting mechanisms available for the 2011 PQRI; (2) meet one of the proposed satisfactory reporting criteria of individual measures or measures groups for the 2011 PQRI as described above; and (3) qualify to earn a PQRI incentive payment for covered professional services furnished during the applicable 2011 PQRI reporting period, for purposes of satisfying the requirements under section 1848(m)(5)(G)(i) of the Act, on the Physician Compare Web site.
Similarly, for purposes of publicly reporting the names of group practices, on the Physician Compare Web site, for 2011, we propose to post the names of group practices that: (1) Submit data on the 2011 PQRI quality measures through one of the proposed group practice reporting options; (2) meet the proposed criteria for satisfactory reporting under the respective group practice reporting option; and (3) qualify to earn a PQRI incentive payment for covered professional services furnished during the applicable 2011 PQRI reporting period for purposes of satisfying the requirements under section 1848(m)(5)(G)(i) of the Act.
We do not propose to require as a condition of participation in the 2011 PQRI that performance information be made publicly available at either the group practice or individual level for 2011 PQRI. However, we note that section 10331 of the ACA requires that not later than January 1, 2013, and with respect to reporting periods that begin no earlier than January 1, 2012, we implement a plan for making publicly available through Physician Compare, information on physician performance, including measures collected under PQRI. Consistent with section 10331 of the ACA, we expect, in the future, to publicly report performance information based on PQRI.
We will be working on a plan to expand the information that is publicly posted on the Physician Compare in future years. This will be further described in future rulemaking. We solicit comments on our plan for implementation of a Physician Compare Web site for 2011.
Beginning 2015, a payment adjustment will apply under the PQRI. Specifically, under section 1848(a)(8) of the Act, as added by section 3002(b) of the ACA, with respect to covered professional services furnished by an EP during 2015 or any subsequent year, if the EP does not satisfactorily submit data on quality measures for covered professional services for the quality reporting period for the year, the fee schedule amount for services furnished by such professionals during the year shall be equal to the applicable percent of the fee schedule amount that would otherwise apply to such services. The applicable percent for 2015 is 98.5 percent and for 2016 and each subsequent year it is 98.0 percent.
We will address this provision of the ACA in future notice and comment rulemaking.
Section 3002(c) of the ACA amends section 1848(k)(4) of the Act to require a mechanism whereby an EP may provide data on quality measures through an MOCP operated by a specialty body of the American Board of Medical Specialties (ABMS). In addition, section 1848(m)(7)of the Act (“Additional Incentive Payment”), as added by section 10327(a) of the ACA, provides for an additional 0.5 percent incentive payment for years 2011 through 2014 if certain requirements are met. In accordance with section 1848(m)(7)(B) of the Act, in order to qualify for the additional incentive payment, an EP must—
• Satisfactorily submit data on quality measures under PQRI for a year and have such data submitted—
• More frequently than is required to qualify for or maintain board certification status—
Section 1848(m)(7)(C)(i) of the Act defines “Maintenance of Certification Program” as a continuous assessment program, such as a qualified ABMS MOCP, or an equivalent program (as determined by the Secretary), that advances quality and the lifelong learning and self-assessment of board certified specialty physicians by focusing on the competencies of patient care, medical knowledge, practice-based learning, interpersonal and communications skills and professionalism. Such a program shall require a physician to do the following:
• Maintain a valid, unrestricted medical license in the United States.
• Participate in educational and self-assessment programs that require an assessment of what was learned.
• Demonstrate, through a formalized, secure examination, that the physician has the fundamental diagnostic skills, medical knowledge, and clinical judgment to provide quality care in their respective specialty.
• Successful completion of a qualified MOCP practice assessment.
As defined in section 1848(m)(7)(C)(ii) of the Act, a “qualified Maintenance of Certification Program practice assessment” means an assessment of a physician's practice that—
(1) Includes an initial assessment of an EP's practice that is designed to demonstrate the physician's use of evidence-based medicine;
(2) Includes a survey of patient experience with care; and
(3) Requires a physician to implement a quality improvement intervention to address a practice weakness identified in the initial assessment and then to remeasure to assess performance after such intervention.
To qualify for the additional incentive payment, section 1848(m)(7)(B)(iii) of the Act also requires the MOCP Program to submit to CMS, on behalf of the EP, information:
(1) In a form and manner specified by the Secretary, that the EP has successfully completed a qualified MOCP practice assessment for such year;
(2) If requested by the Secretary, information on the survey of patient experience with care; and
(3) As the Secretary may require, on the methods, measures, and data used under the MOCP and the qualified MOCP practice assessment.
Section 10327(b) of the ACA amends section 3002(c) of the ACA further to specify that the additional 0.5 percent incentive payment is available only for years 2011, 2012, 2013, and 2014. For years after 2014, if the Secretary determines it to be appropriate, the Secretary may incorporate participation in an MOCP and successful completion of a qualified MOCP practice assessment into the composite of measures of quality for care furnished pursuant to the physician fee schedule payment modifier.
To implement the provisions under sections 3002(c) and 10327 of the ACA, CMS proposes for 2011 to require the following:
• An EP wishing to be eligible for the additional PQRI incentive payment of 0.5 percent must meet the proposed requirements for satisfactory PQRI reporting, for program year 2011, based on the 12-month reporting period. We propose to require that EPs seeking the additional PQRI incentive payment satisfactorily report for a 12-month reporting period rather than only a 6 month reporting period, based on the statutory language that the EP must satisfactorily report “for a year.” For purposes of satisfactory reporting under PQRI, we propose that the EP may participate as an individual EP using either individual PQRI measures or measures groups and submitting the PQRI data via claims, a registry, or an her or participate under one of the GPRO options (I or II),. Alternatively, EPs may satisfactorily report under PQRI based on submission of PQRI data by an MOCP, provided that the MOCP has qualified as a PQRI registry for 2011. As indicated previously, an EP would not necessarily have to qualify for PQRI through an MOCP serving as a registry. Rather, we propose that an EP may qualify for the additional incentive, without reqard to the method by which the EP has met the basic requirement of satisfactory reporting under PQRI.
• In addition to meeting the proposed requirements for satisfactory reporting under PQRI for program year 2011, the EP must have data submitted on his or her behalf through an MOCP, for the MOCP in which the EP participates. Although the MOCP need not become a qualified registry for data submission for PQRI purposes, the MOCP must meet the criteria for a registry for submission of the MOCP data as specified below.
• An EP must, more frequently than is required to qualify for or maintain board certification, participate in an MOCP for a year and successfully complete a qualified MOCP practice assessment for such year. We believe that the “more frequently” requirement applies both to the elements of the MOCP itself and the requirement to successfully complete a qualified MOCP practice assessment. With regard to the elements other than completing a qualified MOCP practice assessment, we propose to require that the MOCP certify that the EP has “more frequently” than is required to qualify for or maintain
With respect to the MOCP practice assessment, which is specifically delineated in section 1848(m)(7)(B)(ii) of the Act as being required more often than is necessary to qualify for or maintain board certification, we believe we need to be more specific regarding our interpretation of the phrase “more frequently.” Additionally, we are aware that some specialty boards have varying MOCP requirements for physicians to maintain board certification, based on the date of original certification. Some, we believe, may not be required to participate in an MOCP program at all in order to maintain board certifications. Accordingly, we recognize that “more often” may vary among physicians certified by the same specialty board. We interpret the statutory provisions as requiring participation in and successful completion of at least one MOCP practice assessment. Therefore, we propose, as a basic requirement, participation in and successful completion in at least one MOCP practice assessment. For physicians who are not required to participate in an MOCP to maintain board certification, “more often” would be more than 0, and therefore only once. For physicians, however, who are otherwise required by the specialty board to participate in an MOCP to maintain board certification status, these physicians would need to complete the MOCP practice assessment a second time in order to qualify for the additional incentive payment. If an MOCP practice assessment were required more than once during a particular cycle, the EP would be required to complete the MOCP practice assessment a third time in order to qualify for the additional incentive.
We are also aware that ABMS boards are at various stages in implementing the practice assessment modules, and some may not have such assessment modules in place. However, inasmuch as we interpret the statute to require an MOCP practice assessment at least once as part of the MOCP, EPs who do not have available, through their boards or otherwise, an MOCP practice assessment are not eligible for the 0.5 percent incentive.
• We believe that the experience of care survey provides particularly valuable information and propose that a qualified MOCP practice assessment must include a survey of patient experience with care. The Secretary may request information on the survey of patient experience with care, under section 1848(m)(7)(B)(iii) of the Act. In view of the importance of this information, and the lack of readily available alternative sources, we propose to require that MOCPs submit information as to the survey of patient experience with care for the EP regarding whom information is being submitted by the MOCP.
We propose that MOCPs, who wish to enable their members to be eligible for an additional PQRI incentive payment for the 2011 PQRI, will need to go through a self-nomination process by January 31, 2011. We propose the board will need to include all of the following information in their self-nomination letter to CMS:
• Provide detailed information regarding the MOCP with reference to the statutory requirements for such program.
• Indicate the organization sponsoring the MOCP, and whether the MOCP is sponsored by an ABMS board. If not an ABMS board, indicate whether the program is substantially equivalent to the ABMS MOCP process.
• The frequency of a cycle of MOC for the specific MOCP of the sponsoring organization; including what constitutes “more frequently” for the MOCP practice assessment for the specific MOCP of the sponsoring organization.
• What was, is, or will be the first year of availability of the MOCP practice assessment for completion by an EP.
• What data is collected under the patient experience of care survey and how this information would be provided to CMS.
• How the MOCP monitors that an EP has implemented a quality improvement process for their practice.
• Describe the methods, and data used under the MOCP, and provide a list of all measures used in the MOCP for 2010 and to be used for 2011, including the title and descriptions of each measure, the owner of the measure, whether the measure is NQF endorsed, and a link to a Web site containing the detailed specifications of the measures, or an electronic file containing the detailed specifications of the measures.
We propose that sponsoring organizations who desire to participate as an MOCP will need to be able to provide CMS the following information in a CMS-specified file format by no later than the end of the first quarter of 2012:
• The name, NPI and applicable TIN(s) of the EP who would like to participate in this process;
• Attestation from the board that the information provided to CMS is accurate and complete;
• The board has signed documentation from the EP that the EP wishes to have their information released to CMS; Information from the experience of care survey;
• Information certifying that the EP has participated in an MOCP for a year, more frequently than is required to qualify for or maintain board certification status, including the year that the physician met the board certification requirements for the MOCP, and the year the EP participated in an MOCP “more frequently” than is required to maintain or qualify for board certification; and
• Information certifying that the EP has completed the MOCP practice assessment one additional time more than is required to qualify for or maintain board certification, including the year of the original MOCP practice assessment or that an MOCP practice assessment is not required for the EP, and the year of the additional MOCP practice assessment completion.
We propose that specialty boards that also desire to send PQRI information to CMS on behalf of their EP should be able to meet the requirements for registry data submission proposed in section VI.F.1.d.(4) of this rule and should follow the directions for self-nomination to become a qualified registry. Boards may also participate as registries for PQRI data provided that they meet the registry requirements.
As an alternative to requiring boards to either operate a qualified PQRI registry or to self-nominate to submit MOCP data to CMS on behalf of their members, we also considered having the
Section 1848(m)(7) of the Act (“Integration of Physician Quality Reporting and EHR Reporting), as added by section 3002(d) of the ACA requires us to move towards the integration of EHR measures with respect to the PQRI program. Section 1848(m)(7) of the Act specifies that by no later than January 1, 2012, the Secretary shall develop a plan to integrate reporting on quality measures under PQRI with reporting requirements under subsection (o) relating to the meaningful use of EHRs. Such integration shall consist of the following:
(A) The selection of measures, the reporting of which would both demonstrate—
(i) Meaningful use of an EHR for purposes of the EHR incentive program; and
(ii) Quality of care furnished to an individual; and
(B) Such other activities as specified by the Secretary.
In an effort to align PQRI with the EHR incentive program, we propose to include many ARRA core clinical quality measures in the PQRI program, to demonstrate meaningful use of EHR and quality of care furnished to individuals. We propose the selection of these measures to meet the requirements of planning the integration of PQRI and EHR reporting. We are working towards a plan to integrate reporting on quality measures to make available by January 1, 2012.
We solicit comments on this approach to integrate PQRI EHR measures with the clinical quality measures adopted for the EHR incentive program. Specifically, we encourage comments on how CMS plans to align the measures, and how the plan for integration will optimally improve quality of care for individuals and provide meaningful use of EHRs.
Section 3002 (e) of the ACA amends section 1848(m)(5) of the Act by adding subparagraph (H), which requires the Secretary to provide timely feedback to EPs on the performance of the EP with respect to satisfactorily submitting data on quality measures. Since the inception of the program in 2007, the PQRI program has provided EPs who have reported PQRI data on quality measures feedback reports at the TIN/NPI level detailing participation in PQRI, including reporting rate and performance rate information. For 2008, we improved the format and content of feedback reports based on stakeholder input. We also developed an alternate report distribution method whereby each EP can directly request and receive a feedback report. We will continue to provide feedback reports to individuals and group practices that satisfactorily submit PQRI quality measure and thus qualify to earn a PQRI incentive.
We believe that the requirements under section 1848(m)(5)(H) of the Act, as added by section 3002(e) of the ACA, for “timely” feedback reports with respect to satisfactorily submitting data on quality measures is met by providing the feedback reports on or about the time of issuance of the incentive payments. Thus, we propose to provide 2011 feedback reports on or about the time of issuance of the 2011 incentive payments, consistent with our current practice.
In addition, we also propose to provide interim feedback reports for EPs reporting 2011 measures groups through the claims-based reporting mechanism. Specifically, we propose to develop interim feedback reports that are similar in content and format to the reports that we currently provide for such EPs using claims for dates of service between January 1, 2011 and February 28, 2011. We expect that we would be able to make these interim feedback reports available to EPs in June 2011. We believe interim feedback reports would be particularly valuable to EPs reporting measures group because, unlike with individual measures reporting, EPs would not be required to report on a certain percentage of eligible cases to satisfactorily report the 2011 PQRI measures groups. EPs could just report on 30 eligible cases to satisfactorily report using measures groups. Interim feedback regarding the number of cases reported as of February 28, 2011 would be valuable since an EP would know how many more cases he or she needs to report to satisfy the criteria for satisfactory reporting for claims-based reporting of measures groups.
We also intend to continue to explore methods to facilitate PQRI feedback report distribution. Additionally, based on feedback from the 2011 PQRI Listening Session that was held on February 2, 2010, we are considering a process by which we could respond to interim feedback report requests at the individual level for claims-based submission, based upon first quarter claims data for the applicable program year. The goal of this would be to provide information to EPs as to errors in claims-based QDC submission while the reporting period is ongoing and prior to the start of the 6-month reporting period. We welcome comments with respect to our proposal to provide timely feedback reports for PQRI.
Section 1848(m)(5)(I) of the Act, as amended and added by section 3002(f)(2) of the ACA, requires an informal review process. Specifically, the statute requires that the Secretary establish and have in place, no later than January 1, 2011, an informal process for EPs to seek a review of the determination that an EP did not satisfactorily submit data on quality measures under the PQRI.
We note that except as provided under the informal process under section 1848(m)(5)(I) of the Act, section 1848(m)(5)(E) of the Act, as amended by section 3002(f) of the ACA, specifies that, with respect to the PQRI, there shall be no administrative or judicial review under section 1869, section 1878, or otherwise, of:
(1) The determination of measures applicable to services furnished by EPs under PQRI;
(2) The determination of satisfactory reporting under PQRI; and
(3) The determination of any PQRI incentive payment and PQRI payment adjustment.
We propose to base the informal process on our current inquiry process whereby an EP can contact the Quality Net Help Desk (via phone or e-mail) for general PQRI and eRx Incentive Program information, information on PQRI feedback report availability and access, and/or information on PQRI Portal password issues. We believe that the current inquiry process provides a good basis for an informal review process because EPs currently can utilize the inquiry process if they have questions on whether they qualified for an incentive. However, the current inquiry process does not have timelines nor is it restricted to questions solely on whether the EP qualified for an incentive. Thus, for purposes of the informal process required under section 1848(m)(5)(E) of the Act, we propose the following process:
• An EP electing to utilize the informal process must request an informal review within 90 days of the release of his or her feedback report.
• An EP can request the informal review by notifying the Quality Net Help Desk via e-mail at
• We propose to provide the EP with a response to his or her request for an informal review within 60 days of receiving the original request.
• As this process is informal and the statute does not require a formal appeals process, we will not include a hearing or evidence submission process, although the EP may submit information to assist in the review.
• Based on our informal review, we will provide a written response. Where we find that the EP did satisfactorily report, we propose to provide the applicable incentive payment.
• Given that this is an informal review process and given the limitations on review under section 1848(m)(5)(E) of the Act, decisions based on the informal review will be final, and there will be no further review or appeal.
• By December 31, 2011, we propose to post on the CMS PQRI Web site, further information regarding the operational aspects of the informal review process for 2011 PQRI. We invite public comment on this proposed process.
As defined in § 423.159(a), eRx is the transmission using electronic media, of prescription or prescription-related information between prescriber, dispenser, pharmacy benefit manager (PBM), or health plan, either directly or through an intermediary, including an eRx network. Included in eRx, but not limited to, are two-way transmissions between the point of care and the dispenser.
Section 1848(m)(2) of the Act promotes the use of electronic prescribing by authorizing incentive payments to EPs or group practices who are “successful electronic prescribers.” The intention of the 2011 eRx Incentive Program, which is separate from, and in addition to, any incentive payment that EPs may earn through the PQRI program, is to continue to encourage significant expansion of the use of electronic prescribing by authorizing a combination of financial incentives and payment adjustments. Individual EPs do not have to participate in PQRI in order to participate in the eRx Incentive Program (and vice versa). We propose to add § 414.92 to title 42 of the Code of Federal Regulations to implement the provisions of the eRx Incentive Program discussed in this section of the proposed rule.
For 2011, which is the third year of the eRx Incentive Program, the Secretary is authorized to provide successful electronic prescribers, as defined in section 1848(m)(3)(B) of the Act and further discussed below in this section, an incentive payment equal to 1.0 percent of the total estimated Medicare Part B PFS allowed charges (based on claims submitted not later than 2 months after the end of the reporting period) for all covered professional services furnished during the 2011 reporting period. Covered professional services are defined under the statute to be services for which payment is made under, or is based on, the PFS and which are furnished by an EP. The applicable electronic prescribing percent (1.0 percent) authorized for the 2011 eRx Incentive Program is different from that authorized for the 2009 and 2010 eRx Incentive Program.
Under section 1848(m)(2)(C) of the Act, the incentive payments for successful electronic prescribers for future years are authorized as follows:
• 1.0 percent for 2012.
• 0.5 percent for 2013.
However, section 1848(m)(2)(D) of the Act, as added by section 4101(f)(2)(B) of Title IV of Division B of the American Recovery and Reinvestment Act of 2009 (Pub.L. 111–5) (ARRA–HITECH), specifies that the eRx incentive does not apply to an EP (or group practice), if, for the EHR reporting period, the EP (or group practice) earns an incentive payment under the Medicare EHR incentive program. The Medicare EHR incentive program begins in 2011. Therefore, EPs who earn an incentive under the Medicare EHR Incentive Program, with respect to certified EHR technology that has eRx capabilities, will not be eligible to earn a separate incentive payment for being a successful electronic prescriber under the eRx Incentive Program.
For eRx, when reporting any of the G-codes for purposes of qualifying for the incentive payment for electronic prescribing in 2011, we propose that the professional must have and regularly use a “qualified” electronic prescribing system, as defined in the electronic prescribing measure specifications. If the professional does not have general access to an eRx system in the practice setting, as cited in the hardship exception as stated by the secretary, there is nothing to report.
In addition, under section 1848(a)(5)(A) of the Act, a PFS payment adjustment applies beginning in 2012 to those who are not successful electronic prescribers. Specifically, for 2012, 2013, and 2014, if the EP is not a successful electronic prescriber for the reporting period for the year, the PFS amount for covered professional services furnished by such professionals during the year as referenced above shall be less than the PFS amount that would otherwise apply over the next several years by:
• 1.0 percent for 2012.
• 1.5 percent for 2013.
• 2.0 percent for 2014.
We believe that the criteria for determination of successful electronic prescriber proposed herein for the eRx incentive payment are not required to be identical to the criteria that will be used to determine the applicability of the payment adjustment that begins in 2012. Policy considerations underlying the application of the incentive payment are not necessarily the same as those in applying a payment adjustment. In general, we believe that an incentive should be broadly available to encourage the widest possible adoption of eRx, even for low volume prescribers. On the other hand, we believe that a payment adjustment should be applied primarily to assure that those who have a large volume of prescribing do so electronically, without penalizing those for whom the adoption and use of an electronic prescribing system may be impractical given the low volume of prescribing. The 2011 eRx incentive and the application of the payment adjustment for 2012 will be addressed separately below.
Under section 1848(m)(6)(A) of the Act, the definition of “EP” for purposes of eligibility for the eRx Incentive Program is identical to the definition of “EP” for the PQRI under section 1848(k)(3)(B) of the Act. In other words, EPs include physicians, other practitioners as described in section 1842(b)(18)(C) of the Act, physical and occupational therapists, qualified speech-language pathologists, and qualified audiologists. However, as we have noted in prior years, for purposes of the eRx Incentive Program, eligibility is further restricted by scope of practice to those professionals who have prescribing authority. Detailed information about the types of professionals that are eligible to participate in the eRx Incentive Program is available on the Electronic Prescribing Incentive Program section of the CMS Web site at
As in the 2010 eRx Incentive Program, we propose in 2011 that the eRx Incentive Program continue to be an incentive program in which determination of whether an EP is a
Section 1848(m)(6)(C)(i)(II) of the Act defines “reporting period” for the 2011 eRx Incentive Program to be the entire year. Section 1848(m)(6)(C)(ii) of the Act, however, authorizes the Secretary to revise the reporting period if the Secretary determines such revision is appropriate, produces valid results on measures reported, and is consistent with the goals of maximizing scientific validity and reducing administrative burden. We propose the 2011 eRx Incentive Program reporting period to be the entire calendar year (January 1, 2011 through December 31, 2011) based on the definition of “reporting period” specified under section 1848(m)(6)(C)(i)(II) of the Act. We believe that keeping the 2011 eRx Incentive Program reporting period consistent with 2009 and 2010 eRx Incentive Program reporting periods will help to further maintain program stability and be less confusing for EPs.
Accordingly, we propose that successful electronic prescribers would be eligible to receive an incentive payment equal to 1.0 percent of the total estimated allowed Medicare Part B charges (based on claims submitted by no later than February 28, 2012) for all covered professional services furnished January 1, 2011 through December 31, 2011.
Under section 1848(m)(3)(B) of the Act, in order to qualify for the incentive payment, an EP must be a “successful electronic prescriber,” which the Secretary is authorized to identify using 1 of 2 possible criteria. One criterion, under section 1848(m)(3)(B)(ii) of the Act, is based on the EP's reporting, in at least 50 percent of the reportable cases, on any electronic prescribing quality measures that have been established under the physician reporting system, under subsection 1848(k) of the Act (which, as noted previously, we have named “PQRI” for ease of reference) and are applicable to services furnished by the EP during a reporting period. We applied this criterion in 2009. However, for years after 2009, section 1848(m)(3)(D) of the Act permits the Secretary in consultation with stakeholders and experts to revise the criteria for submitting data on electronic prescribing measures under section 1848(m)(3)(B)(ii) of the Act.
The second criterion, under section 1848(m)(3)(B)(iii) of the Act, is based on the electronic submission by the EP of a sufficient number (as determined by the Secretary) of prescriptions under Part D during the reporting period. If the Secretary decides to use the latter standard, then, in accordance with section 1848(m)(3)(B)(iv) of the Act, the Secretary is authorized to use Part D drug claims data to assess whether a “sufficient” number of prescriptions have been submitted by EPs. However, under section 1848(m)(3)(B)(i) of the Act, if the standard based on a sufficient number (as determined by the Secretary) of electronic Part D prescriptions is applied for a particular reporting period, then the standard based on the reporting on electronic prescribing measures would no longer apply.
For 2011, we propose to continue to require EPs to report on the electronic prescribing measure used in the 2009 and 2010 eRx Incentive Program to determine whether an EP is a successful electronic prescriber, but we are proposing to again use modified measure specifications and to use modified reporting criteria based on the authority provided under section 1848(m)(3)(D) of Act, as discussed below.
As we stated in prior years, we are still considering the use of a certain number of Part D prescribing events as the basis for the incentive payment. We propose to continue to require EPs to report on the electronic prescribing measure used in the 2009 and 2010 eRx Incentive Program because we believe that the accuracy and completeness of the Part D data with respect to whether a prescription was submitted electronically is unknown. In 2010, information on whether a prescription was submitted electronically by an individual EP began to be collected on the Part D claims and/or Prescription Drug Event (PDE) data. Also, since April 1, 2009, prescription drug plan sponsors are required to send PDE data with an individual prescriber's NPI. We currently have limited information on the accuracy and completeness of NPI data that is submitted with the PDE data. The NPI is needed in order for CMS to be able to link an EP's PDE data to his or her Medicare Part B claims to calculate the incentive payment amount. During 2010, we continue to evaluate the adequacy of Part D data to determine the feasibility of its use for determining whether an EP qualifies as a successful electronic prescriber. The use of Part D data for correlation has not yet shown to be possible due to NPI and other issues. Part D data is supplied by the pharmacy and not the EP. We are in the process of writing and will publish an evaluation of the PQRI reporting experience. The experience report will include an evaluation of the eRx Incentive Program.
For 2011, we propose to retain the 3 reporting mechanisms available to individual EPs to report the electronic prescribing measure in 2010 to maintain program stability. First, we propose to again retain the claims-based reporting mechanism that is used in the 2009 and 2010 eRx Incentive Program. In addition, similar to the PQRI, for the eRx Incentive Program, we propose to continue the registry-based reporting mechanism and, we also propose that the EHR-based reporting mechanism be available for the electronic prescribing measure for 2011.
We propose that only registries qualified to submit quality measure results and numerator and denominator data on quality measures on behalf of EPs for the 2011 PQRI would be qualified to submit measure results and numerator and denominator data on the electronic prescribing measure on behalf of EPs for the 2011 eRx Incentive Program. As in 2010, not all registries qualified to submit quality measures on behalf of EPs for the 2011 PQRI would be qualified to submit quality measures results and numerator and denominator data on the eRx measure. The electronic prescribing measure is reportable by an EP any time he or she bills for one of the procedure codes for Part B services included in the measure's denominator. Some registries who self-nominate to become a qualified registry for PQRI may not choose to self-nominate to become a qualified registry for submitting measures that require reporting at each eligible visit. Registries need to indicate their desire to qualify to submit measure results and numerator and denominator data on the electronic prescribing measure for the 2011 eRx Incentive program at the time that they submit their self-nomination letter for the 2011 PQRI. In addition, we propose that registries that want to be qualified to submit measure results and numerator and denominator data on the electronic prescribing measure for the 2011 eRx Incentive Program would be required to transmit 2011 eRx measure results and numerator and denominator data on the electronic prescribing measure to CMS in two separate transmissions. In addition to submitting 2011 measure results and numerator data on the electronic prescribing measure in 2012 as described in section VI.F.1. above, such registries would need to submit 2011 measure results and numerator and denominator data on the electronic prescribing measure between July 1, 2011 and August 19, 2011 for purposes of the eRx penalty described in section VI.F.2.c. below. The self-nomination process and requirements for registries for the PQRI, which also would apply to the registries for the 2011 eRx Incentive Program, are discussed previously in section VI.F.1. of this proposed rule. We will post a final list of qualified registries for the 2011 eRx Incentive Program on the Electronic Prescribing Incentive Program section of the CMS Web site at
Similarly, we continue to propose that only EHR products “qualified” to potentially be able to submit clinical quality data extracted from the EHR to CMS for the 2011 PQRI would be considered “qualified” for the purpose of an EP potentially being able to submit data on the electronic prescribing measure for the 2011 eRx Incentive Program. The self-nomination process and requirements for EHR vendors for the PQRI, which would apply to the EHR vendors for the 2011 eRx Incentive Program were discussed in the CY 2010 PFS final rule with comment period (74 FR 61801 through 61802). EHR vendors were required to indicate their desire to have one or more of their EHR products qualified for the purpose of an EP potentially being able to submit data on the electronic prescribing measure for the 2011 eRx Incentive Program at the time that they submitted their self-nomination letter for the 2011 PQRI. A list of qualified EHR vendors and their products (including the version that is qualified) for the 2011 eRx Incentive Program will be posted on the eRx Incentive Program section of the CMS Web site at
The electronic prescribing measure, similar to the PQRI measures, has 2 basic elements, which include: (1) A reporting denominator that defines the circumstances when the measure is reportable; and (2) a reporting numerator.
The denominator for the electronic prescribing measure consists of specific billing codes for covered professional services. The measure becomes reportable when any one of these procedure codes is billed by an EP for Part B covered professional services. As initially required under section 1848(k)(2)(A)(ii) of the Act, and further established through rulemaking and under section 1848(m)(2)(B) of the Act, we may modify the codes making up the denominator of the electronic prescribing measure. As such, we expanded the scope of the denominator codes for 2010 to covered professional services outside the professional office and outpatient setting, such as professional services furnished in skilled nursing facilities or the home care setting.
We propose to retain the following CPT codes in the denominator of the electronic prescribing measure for 2011: 90801, 90802, 90804, 90805, 90806, 90807, 90808, 90809, 90862, 92002, 92004, 92012, 92014, 96150, 96151, 96152, 99201, 99202, 99203, 99204, 99205, 99211, 99212, 99213, 99214, 99215, 99304, 99305, 99306, 99307, 99308, 99309, 99310, 99315, 99316, 99324, 99325, 99326, 99327, 99328, 99334, 99335, 99336, 99337, 99341, 99342, 99343, 99344, 99345, 99347, 99348, 99349, 99350, G0101, G0108, G0109. In 2010, the expansion of the electronic prescribing measure denominator was expected to provide more EPs the opportunity to report the measure, and thus, provide more opportunities for EPs to participate in the eRx Incentive Program. Thus far, our experience in the 2010 eRx Incentive Program has been positive and we do not see a need to change the denominator codes for 2011. We invite comments on our proposal to retain the denominator codes from the 2010 electronic prescribing measure denominator.
There are no diagnosis codes in the measure's denominator and there are no age/gender requirements in order for a patient to be included in the measure's denominator (that is, reporting of the electronic prescribing measure is not further limited to certain ages or a specific gender). EPs are not required to report this measure in all cases in which the measure is reportable. EPs who do not bill for one of the procedure codes for Part B covered professional services included in the measure's denominator will have no occasion to report the electronic prescribing measure.
We further propose that by December 31, 2010, we will post the final specifications of the measure on the “eRx Measure” page of the eRx Incentive Program section of the CMS Web site at
To report the electronic prescribing measure in 2011, we again propose that the EP must report one of the measure's numerator “G” codes, as will be discussed below. However, when reporting any of the G-codes for purposes of qualifying for the incentive
For 2011, we propose to retain what constitutes a “qualified” electronic prescribing system as a system based upon certain required functionalities that the system can perform. We propose that for 2011, a “qualified” electronic prescribing system would be one that can—
• Generate a complete active medication list incorporating electronic data received from applicable pharmacies and PBMs, if available.
• Allow EPs to select medications, print prescriptions, electronically transmit prescriptions, and conduct alerts (written or acoustic signals to warn the prescriber of possible undesirable or unsafe situations including potentially inappropriate dose or route of administration of a drug, drug-drug interactions, allergy concerns, or warnings and cautions). This functionality must be enabled.
• Provide information related to lower cost, therapeutically appropriate alternatives (if any). The ability of an electronic prescribing system to receive tiered formulary information, if available, would again suffice for this requirement for 2011 and until this function is more widely available in the marketplace.
• Provide information on formulary or tiered formulary medications, patient eligibility, and authorization requirements received electronically from the patient's drug plan (if available).
To ensure that EPs utilize electronic prescribing systems that meet these requirements, the electronic prescribing measure requires that those functionalities required for a “qualified” electronic prescribing system utilize the adopted Part D electronic prescribing standards. The Part D electronic prescribing standards relevant to the four functionalities for a “qualified” system in the electronic prescribing measure described above and listed as (a), (b), (c), and (d), currently are as follows:
(a) Generate medication list—Use the National Council for Prescription Drug Programs (NCPDP) Prescriber/Pharmacist Interface SCRIPT Standard, Implementation Guide, Version 8, Release 1, October 2005 (hereinafter “NCPDP SCRIPT 8.1”) Medication History Standard.
(b) Transmit prescriptions electronically—Use the NCPDP SCRIPT 8.1 for the transactions listed at § 423.160(b)(2).
(c) Provide information on lower cost alternatives—Use the NCPDP Formulary and Benefits Standard, Implementation Guide, Version 1, Release 0 (Version 1.0), October 2005 (hereinafter “NCPDP Formulary and Benefits 1.0”).
(d) Provide information on formulary or tiered formulary medications, patient eligibility, and authorization requirements received electronically from the patient's drug plan—use—
(1) NCPDP Formulary and Benefits 1.0 for communicating formulary and benefits information between prescribers and plans;
(2) Accredited Standards Committee (ASC) X12N 270/271–Health Care Eligibility Benefit Inquiry and Response, Version 4010, May 2000, Washington Publishing Company, 004010X092 and Addenda to Health Care Eligibility Benefit Inquiry and Response, Version 4010A1, October 2002, Washington Publishing Company, 004010X092A1 for communicating eligibility information between the plan and prescribers; and
(3) NCPDP Telecommunication Standard Specification, Version 5, Release 1 (Version 5.1), September 1999, and equivalent NCPDP Batch Standard Batch Implementation Guide, Version 1, Release 1 (Version 1.1), January 2000 for communicating eligibility information between the plan and dispensers.
However, there are Part D electronic prescribing standards that are in effect for functionalities that are not commonly utilized at this time. Such functionalities are not currently required for a “qualified” system under the eRx Incentive Program. One example is Rx Fill Notification, which is discussed in the Part D electronic prescribing final rule (73 FR 18918, 18926). For purposes of the 2011 Electronic Prescribing Program, we again are not proposing to require that an electronic prescribing system contain all functionalities for which there are available Part D electronic prescribing standards. For those required functionalities described above, we propose that a “qualified” system must use the adopted Part D electronic prescribing standards for electronic messaging.
There are other aspects of the functionalities for a “qualified” system that are not dependent on electronic messaging and are part of the software of the electronic prescribing system, for which Part D standards for electronic prescribing do not pertain and are not required for purposes of the eRx Incentive Program. For example, the requirements in qualification (b) listed above that require the system to allow professionals to select medications, print prescriptions, and conduct alerts are functions included in the particular software, for which Part D standards for electronic messaging do not apply.
We are aware that there are significant numbers of EPs who are interested in participating in the eRx Incentive Program, but currently do not have an electronic prescribing system. The electronic prescribing measure does not require the use of any particular system or transmission network; only that the system be a “qualified” system having the functionalities described above based on Part D electronic prescribing standards. As in 2010, if the professional does not have general access to an electronic prescribing system in the practice setting, the EP does not have any data to report for purposes of the incentive payment and would not be able to participate in the 2011 eRx Incentive Program. If an EP does not participate in the 2011 eRx Incentive Program he or she may be subject to the 2012 eRx penalty
The proposed criteria for reporting for purposes of being a 2011 successful electronic prescriber are designed to reward those EPs who demonstrate that they have adopted a qualified electronic prescribing system and actually used the system in a substantial way to electronically prescribe. In this context, the reporting of information in circumstances where a professional did not electronically prescribe is not pertinent. Additionally, although it may be of interest to measure the proportion of prescribing events that are electronic, we do not believe such detail at the individual or group practice level is of sufficient value to warrant the high burden of reporting such information. We do note that in the future the use of Part D claims data may allow this information to be collected without the necessity for professionals to specifically report such details.
Accordingly, for the 2011 electronic prescribing measure, we propose to retain the following numerator G-code from the 2010 electronic prescribing measure's numerator: G8553 (At least 1 prescription created during the encounter was generated and transmitted electronically using a qualified electronic prescribing system.)
We propose to post the final 2011 electronic prescribing measure specifications on the “eRx Measure” page of the eRx Incentive Program section of the CMS Web site at
Because the electronic prescribing quality measure will apply only when an EP furnishes services indicated by one of the codes included in the measure's denominator, for claims-based reporting, for example, it will not be necessary for an EP to report G-codes for the electronic prescribing measure on claims not containing one of the denominator codes. However, if reporting a G-code, the G-code data submission will only be considered valid if it appears on the same Medicare Part B claim containing one of the electronic prescribing quality measure's denominator codes.
In addition, if the EP submits a Medicare Part B claim containing one of the electronic prescribing measure's denominator codes, he or she can report the numerator G-code only when the EP furnishes services indicated by the G-code included in the measure's numerator. That is, only when at least 1 prescription created during the encounter is generated and transmitted electronically using a qualified electronic prescribing system.
As discussed above, section 1848(m)(3)(D) of the Act authorizes the Secretary to revise the criteria for submitting data on the electronic prescribing measure from the criteria specified under section 1848(m)(3)(B)(ii) of the Act, which requires the measure to be reported in at least 50 percent of the cases in which the measure is reportable. In 2010, we revised the criteria for successful electronic prescriber such that an EP shall be treated as a successful electronic prescriber for a reporting period based on the EP's reporting of the electronic prescribing measure by generating and reporting one or more prescriptions associated with a patient visit electronically, a minimum of 25 unique visits per year in 2010 of applicable cases in the denominator of the eRx measure. For 2011, we again propose to make the determination of whether an EP is a successful electronic prescriber based on a count of the number of times (minimum threshold of 25) an EP reports that at least one prescription created during the encounter is generated using a qualified electronic prescribing system (that is, reports the G8553 code).
As in 2010, we believe these criteria will bring us closer to our intention to transition to using a certain number of electronic Part D prescribing events as the basis for the incentive payment in future years. In proposing these criteria again for 2011 eRx, we continue to assume that once an EP has invested in an eRx system, integrated the use of the eRx system into the practice's work flows, and has used the system to some extent, he or she is likely to continue to use the eRx system for most of the prescriptions he or she generates.
For structural measures such as the electronic prescribing measure, once an EP has demonstrated that he or she has integrated use of an eRx system into his or her practice's work flow, we believe that requiring the EP to continue to report the measure represents an administrative burden with little added benefit to the reliability and validity of the data being reporting. In contrast, for clinical quality measures, we believe that the reliability and validity of the performance rates depends on the adequacy of the sample. Therefore, we propose that an EP would be required to report that at least 1 prescription for a Medicare Part B FFS patient created during an encounter that is represented by 1 of the codes in the denominator of the electronic prescribing measure was generated and transmitted electronically using a qualified eRx system for at least 25 times during the 2011 reporting period.
The reporting threshold of 25 also takes into consideration that prescriptions are not generated with every Medicare Part B FFS patient encounter, some prescriptions, such as narcotics, cannot be prescribed electronically, and that not all Medicare Part B FFS encounters are represented by the electronic prescribing measure's denominator codes.
As stated previously, we propose that by December 31, 2010, we will post the final specifications of the measure on the “eRx Measure” page of the eRx Incentive Program section of the CMS Web site at
Section 1848(m)(2)(B) of the Act imposes a limitation on the electronic prescribing incentive payment. The Secretary is authorized to choose 1 of 2 possible criteria for determining whether or not the limitation applies to a successful electronic prescriber. The first criterion, under section 1848(m)(2)(B)(i) of the Act, is based upon whether the Medicare Part B allowed charges for covered professional services to which the electronic prescribing quality measure applies are less than 10 percent of the total Medicare Part B PFS allowed charges for all covered professional services furnished by the EP during the reporting period. The second criterion, under section 1848(m)(2)(B)(ii) of the Act, is based on whether the EP submits (both electronically and non-electronically) a sufficient number (as determined by the Secretary) of prescriptions under Part D (which can, again, be assessed using Part D drug claims data). If the Secretary decides to use the latter criterion, then, in accordance with section 1848(m)(2)(B) of the Act, the criterion based on the reporting on electronic prescribing measures would no longer apply. The statutory limitation also applies with regard to the application of the payment adjustment.
Based on our proposal to make the determination of whether an EP is a “successful electronic prescriber” based on submission of the electronic prescribing measure, we propose to
Since, as discussed above, we are retaining for 2011 our proposal to make the determination of whether an EP is a “successful electronic prescriber” based on submission of the electronic prescribing measure, we also are proposing to retain the requirement to analyze the claims submitted by the EP at the TIN/NPI level to determine whether the 10 percent threshold is met in determining the receipt of an electronic prescribing incentive payment for 2011 by an EP. This calculation is expected to take place in the first quarter of 2012 and will be performed by dividing the EP's total 2011 Medicare Part B PFS allowed charges for all such covered professional services submitted for the measure's denominator codes by the EP's total Medicare Part B PFS allowed charges for all covered professional services (as assessed at the TIN/NPI level). If the result is 10 percent or more, then the statutory limitation will not apply and a successful electronic prescriber will qualify to earn the electronic prescribing incentive payment. If the result is less than 10 percent, then the statutory limitation will apply and the EP will not earn an electronic prescribing incentive payment even if he or she electronically prescribes and reports a G-code indicating that he or she generated and transmitted a prescription electronically at least 25 times for those eligible cases that occur during the 2011 reporting period. Although an individual EP may decide to conduct his or her own assessment of how likely this statutory limitation is expected to apply to him or her before deciding whether or not to report the electronic prescribing measure, an individual EP may report the electronic prescribing measure without regard to the statutory limitation for the incentive payment.
In 2010 eRx Incentive Program, we were required by section 1848(m)(3)(C) of the Act to establish a process under which EPs in a group practice shall be treated as a successful electronic prescriber. In addition, section 1848(m)(3)(C)(iii) of the Act requires that payments to a group practice by reason of the process established under section 1848(m)(3)(C)(i) of the Act shall be in lieu of the payments that would otherwise be made under this subsection to EPs in the group practice for being a successful electronic prescriber. In 2011, we propose to retain the requirements from 2010 eRx Incentive Program with respect to making incentive payments to group practices based on the determination that the group practice, as a whole, is a successful electronic prescriber for 2011. An individual EP who is affiliated with a group practice participating in the group practice reporting option that successfully meets the proposed requirements for group practices would not be eligible to earn a separate eRx incentive payment for 2011 on the basis of his or her successfully reporting the electronic prescribing measure at the individual level.
Section 1848(m)(3)(C)(i) of the Act authorizes the Secretary to define “group practice.” For purposes of determining whether a group practice is a successful electronic prescriber for 2011, we propose that consistent with the definition of group practice proposed for the PQRI group practice reporting option (GPRO) discussed in section VI.F.1. of this proposed rule, a “group practice” would be defined as a single Taxpayer Identification Number (TIN) with 2 or more EPs, as identified by their individual National Provider Identifier (NPI), who have reassigned their Medicare billing rights to the TIN. “Group practice” would also include group practices participating in Medicare demonstration projects approved by the Secretary, as described in section VI.F.1.g.(2) of this proposed rule.
In addition, we propose to restrict participation in the 2011 eRx GPRO to group practices participating in the 2011 PQRI GPRO (either through GPRO I or GPRO II) or group practices that are deemed to be participating in the 2011 PQRI GPRO (that is, group practices participating in a CMS-approved Medicare demonstration) that have indicated their desire to participate in the 2011 eRx GPRO.
Therefore, unlike individual EPs who are not required to participate in the PQRI, to be eligible to earn an electronic prescribing incentive in 2011, group practices that wish to participate in the electronic prescribing group practice reporting option will be required to participate in the PQRI group practice reporting option or be deemed to be participating in the PQRI group practice reporting option based on the practice's participation in an approved Medicare demonstration project. Participation in the eRx Incentive Program, including participation in the electronic prescribing group practice reporting option is, however, optional for group practices that are participating in PQRI under the group practice reporting option. If a group practice wishes to participate in the 2011 eRx Incentive Program under the group practice reporting option, it must indicate its desire to do so at the time that the group practice self-nominates to participate in the 2011 PQRI group practice reporting option. There is no need for group practices to indicate their intent to participate in the 2011 eRx Incentive Program as individual EPs when the group practice self-nominates to participate in the 2011 PQRI group practice reporting option.
Group practices interested in participating in the 2011 PQRI through the group practice reporting option will be required to submit a self-nomination letter to CMS, requesting to participate in the 2011 PQRI group practice reporting option. Instructions for submitting the self-nomination letter will be posted on the PQRI section of the CMS Web site by November 15, 2010. A group practice that wishes to participate in the eRx Incentive Program group practice reporting option will be notified of the selection decision to participate in the eRx Incentive Program at the same time that it is notified of the selection decision for the PQRI group practice reporting option.
In addition to meeting the proposed eligibility requirements discussed in section VI.F.1.g. of this proposed rule, we propose that a group practice that wishes to participate in the 2011 eRx Incentive Program under the group practice reporting option will also have to indicate how it intends to report the electronic prescribing measure. That is, the group practice will need to indicate in its self-nomination letter which reporting mechanism the group practice intends to use for purposes of participating in the 2011 eRx Incentive Program group practice reporting option.
For group practices selected to participate in the electronic prescribing group practice reporting option for 2011, we propose the reporting period would be January 1, 2011, to December 31, 2011.
We propose that physician groups selected to participate in the 2011 eRx Incentive Program through the group practice reporting option would be able to choose to report the electronic prescribing measure through the claims-
In order for a group practice participating in the PQRI GPRO I to be considered a successful electronic prescriber, we propose that the group practice would have to report that at least 1 prescription during an encounter was generated and transmitted electronically using a qualified electronic prescribing system in at least 2,500 instances during the reporting period. In order for a group practice participating in the PQRI GPRO II to be considered a successful electronic prescriber, we propose that the group practice would have to report that at least 1 prescription during an encounter was generated and transmitted electronically using a qualified electronic prescribing system for the number of instances specified in Table 50 (see section VI.F.1.g.(3).(ii). of this proposed rule). In other words, a group of 2–10 NPIs would need to report the 2011 electronic prescribing measure for at least 75 denominator eligible patient encounters during 2011, 225 instances for groups of 11–25 NPIs, 475 instances for groups of 26–50 NPIs, 925 instances for groups of 51–100, and 1,875 instances for groups of 101–199.
Section 1848(m)(2)(B) of the Act specifies that the limitation on the applicability of the electronic prescribing incentive applies to group practices as well as individual EPs. Therefore, in determining whether a group practice will receive an electronic prescribing incentive payment for 2011 by meeting the proposed reporting criteria described above, we would determine whether the 10 percent threshold is met based on the claims submitted by the group practice.
This calculation is expected to take place in the first quarter of 2012 and will be determined by dividing the group practice's total 2011 Medicare Part B PFS allowed charges for all covered professional services submitted for the measure's denominator codes by the group practice's total Medicare Part B PFS allowed charges for all covered professional services. If the result is 10 percent or more, then the statutory limitation would not apply and a group practice that is determined to be a successful electronic prescriber would qualify to earn the electronic prescribing incentive payment. If the result is less than 10 percent, then the statutory limitation would apply and the group practice would not qualify to earn the electronic prescribing incentive payment.
As stated previously, section 1848(a)(5) of the Act requires that beginning with respect to covered professional services furnished by an EP in 2012, if the EP is not a successful electronic prescriber for the reporting period for the year, the fee schedule amount for such services furnished by such professional during 2012 shall be equal to 99 percent of the fee schedule amount that would otherwise apply to such PFS services. As noted previously, we do not believe that the criteria that will be used to determine the applicability of the payment adjustment, or penalty, for 2012 need to be identical to the criteria for determination of successful electronic prescriber.
We note also that although earning an incentive payment under the EHR incentive payment program precludes an EP from earning an eRx incentive payment, it does not preclude the EP from being subject to the eRx penalty. In order to avoid the eRx penalty, an EP participating in the Medicare EHR incentive program still must meet the relevant eRx penalty criteria for being a successful electronic prescriber.
For purposes of the 2012 eRx penalty, we propose to make a determination of whether an EP or a group practice is a successful electronic prescriber based on the reporting period that begins January 1, 2011 through June 30, 2011. We are proposing a 6-month reporting period for the 2012 penalty rather than a 12-month reporting period so that we may be able to complete the analysis of 2011 data to determine whether an EP or group practice is a successful electronic prescriber prior to January 1, 2012. In order to apply the penalty in 2012 concurrently with claims submission, we will need to make a determination of whether the penalty applies sufficiently in advance of 2012. We believe that establishing a 6-month reporting period for the first year of the penalty will provide administrative efficiencies and avoid the need to apply a retroactive penalty or to make retroactive payments based on application of a penalty.
For EPs and group practices using the claims-based reporting mechanism, we propose that all claims for services furnished between January 1, 2011 and June 30, 2011 must be processed by no later than July 31, 2011 for the claim to be included in our data analysis. This is in contrast to the incentive, where we allow 2 months for claims to be processed. In order to be able to make a determination of whether the penalty applies sufficiently in advance of 2012, we will need to begin our analysis of the claims shortly after June 30, 2011. We invite comments on the proposed reporting period for the 2012 penalty and our proposal to require claims to be submitted by no later than 1 month after the reporting period.
Based on the authority under section 1848(m)(3)(D) of the Act, we propose that the 2012 eRx penalty would apply to an individual EP unless one of the following conditions is met:
• The EP is not a physician (includes MDs, DOs, and podiatrists), nurse practitioner, or physician assistant as of June 30, 2011. We believe that it is appropriate to limit the application of the penalty to those professionals who generally have prescribing privileges nationwide. Other EPs not listed above may have prescribing privileges in some states but not others. Therefore, we propose to exempt EPs who do not generally have prescribing privileges from being subject to the penalty.
• The EP does not have at least 100 cases (that is, claims for patient services) containing an encounter code that falls within the denominator of the eRx measure for dates of service between January 1, 2011 through June 30, 2011. We seek to apply the penalty only to EPs who have a sufficient number of cases between January 1, 2011 and June 30, 2011 to meet the criteria for successful electronic prescribing for purposes of the penalty. We believe that, on average, for every 10 eligible cases, there will be at least one electronic prescribing opportunity, which provides a sufficient number of cases to allow EPs to meet the criteria for being a successful electronic prescriber. In addition, we seek to prevent EPs who are new to Medicare from being subject to the eRx penalty.
• The EP is a successful electronic prescriber for the January 1, 2011 through June 30, 2011 reporting period. Specifically, we propose that the EP must report that at least 1 prescription for Medicare Part B FFS patients created during an encounter that is represented by 1 of the codes in the denominator of the 2011 electronic prescribing measure was generated and transmitted electronically using a qualified eRx system at least 10 times during the 2012 eRx penalty reporting period (that is, January 1, 2011 through June 30, 2011). We propose reporting criteria that are lower for the 2012 eRx penalty than for the 2011 eRx incentive because EPs will only have 6 months to satisfy the
The limitation with respect to the electronic prescribing measures required under section 1848(m)(2)(B)(i) of the Act also applies to the penalty. Therefore, we propose that if less than 10 percent of the EP's estimated total allowed charges for the January 1, 2011 through June 30,2011 reporting period are comprised of services which appear in the denominator of the 2011 electronic prescribing measure, then the EP would not be subject to the eRx penalty.
We invite comments on the proposed conditions under which we would prospectively apply the 1.0 percent reduction in PFS charges for services furnished January 1, 2012 through December 31, 2012. We specifically invite comments on our proposals to exempt certain types of EPs and EPs who do not have a certain number of cases from the penalty as well as the proposed criteria for successful reporting of the electronic prescribing measure for individual EPs with respect to the penalty.
As with the 2011 incentive payment, we propose that the determination of whether an EP is subject to the penalty will be made at the individual professional level, based on the NPI and for each unique TIN/NPI combination.
As required by section 1848(m)(3)(C) of the Act, we are also required to establish and have in place a process under which EPs in a group practice shall be treated as a successful electronic prescriber for purposes of the eRx penalty. Thus, we propose that for purposes of the 2012 eRx penalty, a payment adjustment would not be applied to a a group practice participating in the 2011 eRx GPRO if the group practice is participating in either the 2011 PQRI GPRO I or the 2011 PQRI GPRO II and meets the proposed 2011 criteria for successful electronic prescribing described in sections VI.F.2.b.(4).(ii). (with respect to the eRx requirements for GPRO I participants who wish to participate in the 2011 eRx GPRO) and VI.F.1.g.(3).(ii). of the preamble to this proposed rule (with respect to the eRx requirements for GPRO II participants who wish to participate in the 2011 eRx GPRO) for the 2011 eRx incentive.
For purposes of the 2012 eRx penalty, we propose that the proposed 2011 criteria for successful electronic prescribing would need to be satisfied during the 2012 eRx penalty reporting period of January 1, 2011 through June 30, 2011 for the same operational reasons that we are proposing a 6-month reporting period for the penalty for individual EPs. Furthermore, we do not believe that group practices would be disadvantaged by having to satisfy the proposed criteria for being a successful electronic prescriber for the 2011 incentive in 6 months rather than 12 months to avoid the penalty. When compared to the criteria for individual EPs, the proposed criteria for being a successful electronic prescriber for the 2011 eRx incentive payment for group practices enable group practices, on average, to earn the incentive by electronically prescribing a fewer number of prescriptions per EP than what individual EPs are required to do.
For purposes of determining whether the eRx penalty applies to a group practice, we propose to conduct our analysis for each unique TIN/NPI combination so as not to disadvantage EPs who may have joined the group practice after January 1, 2011.
In addition, in accordance with section 1848(m)(2)(B)(i) of the Act, we also propose that the 2012 eRx penalty would not apply to an eRx GPRO in which less than 10 percent of the group practice's estimated total allowed charges for the January 1, 2011 through June 30, 2011 reporting period are comprised of services which appear in the denominator of the 2011 electronic prescribing measure. To be consistent with how this limitation is applied to group practices for purposes of the incentive, we propose to determine whether this limitation applies to a group practice for the penalty at the TIN level.
For the same reasons that we are proposing a 6-month reporting period for the 2012 eRx penalty for group practices, we also propose that we will use only claims processed by July 31, 2011 in our analysis. This is consistent with our proposed approach for analyzing individual EP claims. Similarly, we propose that registries would need to submit eRx data for services furnished January 1, 2011 through June 30, 2011 to CMS between July 1, 2011 and August 19, 2011 so that we may include registry data in our analysis. We propose also that group practices participating in the eRx group practice reporting option via EHR-based reporting would be required to submit eRx data for services furnished January 1, 2011 through June 30, 2011 to CMS between July 1, 2011 and August 19, 2011.
We invite comments on the proposed criteria for determining applicability of the 2012 eRx penalty to group practices, including the proposed criteria for successful reporting of the electronic prescribing measure for group practices, and our proposed analytical approach.
Section 1848(a)(5)(B) of the Act provides that the Secretary may, on a case-by-case basis, exempt an EP from the application of the payment adjustment, or penalty, if the Secretary determines, subject to annual renewal, that compliance with the requirement for being a successful electronic prescriber would result in a significant hardship, such in the case of an EP who practices in a rural area without sufficient Internet access. Therefore, we propose that in addition to meeting the criteria for successful electronic prescriber described in sections VI.F.2.(c).(2) and VI.F.2.(c).(3) of the preamble to this proposed rule, an EP or group practice may also be exempt from application of the 2012 eRx penalty, if during the 2012 eRx penalty reporting period (that is, January 1, 2011 through June 30, 2011), one of the following circumstances applies to the EP or group practice:
• The EP or group practice practices in a rural area with limited high speed Internet access.
• The EP or group practice practices in an area with limited available pharmacies for electronic prescribing.
We propose to add two additional “G” codes to the 2011 electronic prescribing measure's specifications describing these 2 circumstances. EPs or group practices to whom one or more of these circumstances apply would be required to report the appropriate G-code at least once between January 1, 2011 and June 30, 2011 using their selected 2011 eRx reporting mechanism. Reporting of one of these two G-codes prior to June 30, 2011 will indicate to us that the EP or group practice would like to be considered for an exemption from the 2012 penalty under the significant hardship exception. We invite comments on the proposed process for the significant hardship exception as well as comments regarding other circumstances that should be considered a significant hardship.
Section 1848(a)(5) of the Act also requires that with respect to covered professional services furnished by an EP in 2013, if the EP is not a successful electronic prescriber for the reporting period for the year, the fee schedule amount for such services furnished by such professional during 2013 shall be equal to 98.5 percent of the fee schedule
For purposes of the 2013 eRx penalty, we propose to use the proposed 2011 criteria for successful electronic prescriber to determine whether an EP or a group practice is a successful electronic prescriber for purposes of the 2013 eRx penalty. In addition, we propose that the reporting period for the 2013 eRx penalty would be the 2011 eRx incentive reporting period of January 1, 2011 through December 31, 2011. We believe that matching the criteria that will be applied for the 2013 penalty with the criteria that will be applied for the incentive in an earlier year would be the most effective means of encouraging EPs and group practices to adopt and use electronic prescribing systems since anyone who does not qualify for an incentive in 2011 would be subject to a payment adjustment in 2013. We invite comments on this proposal.
Section 1848(m)(5)(G) of the Act requires the Secretary to post on the CMS Web site, in an easily understandable format, a list of the names of EPs (or group practices) who satisfactorily submit data on quality measures for the PQRI and the names of the EPs (or group practices) who are successful electronic prescribers. As required by section 1848(m)(5)(G) of the Act, we are proposing to make public the names of EPs and group practices who are successful electronic prescribers for the 2011 eRx Incentive Program on the Physician Compare Web site that we are required to establish by January 1, 2011 under section 10331 of the ACA. As stated under section VI.F.1.k. of this proposed rule, we plan to use the existing Physician and Other Health Care Professionals directory as the foundation for the Physician Compare Web site.
We anticipate that the names of individual EPs and group practices who are successful electronic prescribers for the 2011 eRx Incentive Program will be available in 2012 after the 2011 incentive payments are paid.
To comply with section 1848(m)(5)(G) of the Act, we specifically propose to post the names of individual EPs who report the electronic prescribing measure at least 25 times during the 2011 reporting period for patient encounters included in the measure's denominator, without regard to whether the limitation under section 1848(m)(2)(B) of the Act applies to the EP and without regard to whether the EP actually qualifies to earn an incentive payment. In addition, since the PQRI and the eRx Incentive Program are two separate incentive programs and individual EPs are not required to participate in both programs to earn an incentive under either program, we point out that it is possible for an EP who participates in both incentive programs to be listed both as an individual EP who satisfactorily submits data on quality measures for the PQRI and is a successful electronic prescriber under the eRx Incentive Program. Likewise, an individual EP may be listed as an individual EP who satisfactorily submits data on quality measures for the PQRI but not as a successful electronic prescriber under the eRx Incentive Program (or vice versa) even if he or she participated in both incentive programs.
Similarly, for purposes of publicly reporting the names of group practices, on the Physician Compare Web site, we intend to post the names of group practices that report the electronic prescribing measure the required number of times during the 2011 reporting period for patient encounters included in the measure's denominator without regard to whether the limitation under section 1848(m)(2)(B) of the Act applies to the group practice or whether the group practice actually qualifies to earn an incentive payment. Although any group practice participating in the eRx Incentive Program under the group practice reporting option would also have to participate in a PQRI group practice reporting option, the criteria for satisfactory reporting of PQRI measures for group practices are different from the criteria for successful reporting of the electronic prescribing measure by group practices. Therefore, it is possible for a group practice to be listed as a group practice that satisfactorily submits data on quality measures for the PQRI but not as a successful electronic prescriber under the eRx Incentive Program, or vice versa.
Medicare pays for most DMEPOS furnished after January 1, 1989 pursuant to fee schedule methodologies set forth in section 1834 of the Act, as added by section 4062 of the Omnibus Budget Reconciliation Act of 1987 (OBRA '87) (Pub. L. 100–203). Specifically, sections 1834(a)(1)(A) and (B), and 1834 (h)(1)(A) of the Act provide that Medicare payment for these items is equal to 80 percent of the lesser of the actual charge for the item or the fee schedule amount for the item. We implemented this payment methodology at 42 CFR part 414, subpart D of our regulations. Sections 1834(a)(2) through (a)(5) and 1834(a)(7) of the Act, and implementing regulations at § 414.200 through § 414.232 (with the exception of § 414.228), set forth separate payment categories of durable medical equipment (DME) and describe how the fee schedule for each of the following categories is established:
• Inexpensive or other routinely purchased items (section 1834(a)(2) of the Act and § 414.220 of the regulations);
• Items requiring frequent and substantial servicing (sections 1834(a)(3) of the Act and § 414.222 of the regulations);
• Customized items (section 1834(a)(4) of the Act and § 414.224 of the regulations);
• Oxygen and oxygen equipment (section 1834(a)(5) of the Act and § 414.226 of the regulations);
• Other items of DME (section 1834(a)(7) of the Act and § 414.229 of the regulations).
For a detailed discussion of payment for DMEPOS under fee schedules, see the final rule published in the April 10, 2007
Blood glucose testing strips or diabetic testing strips are covered under the Medicare DME benefit in accordance with section 1861(n) of the Act. Other supplies that are necessary for the effective use of DME are also covered under the Medicare DME benefit in accordance with longstanding program instructions at section 110.3 of chapter 15 of the Medicare Benefit Policy Manual.
Section 1847 of the Act, as amended by section 302(b)(1) of the MMA, requires the Secretary to establish and implement a DMEPOS CBP. Under the DMEPOS CBP, Medicare sets payment amounts for selected DMEPOS items and services furnished to beneficiaries in competitive bidding areas (CBAs) based on bids submitted by qualified suppliers and accepted by Medicare. For competitively bid items, these new payment amounts, referred to as “single payment amounts (SPA),” replace the fee schedule payment methodology. Section 1847(b)(5) of the Act provides that Medicare payment for these
When first enacted by the Congress, section 1847(a)(1)(B) of the Act required the Secretary to phase in the DMEPOS CBP in a manner so that the competition under the program occurred in 10 of the largest metropolitan statistical areas (MSAs) in 2007. The program was to be expanded into 70 additional MSAs in 2009, and then into additional areas after 2009.
In the May 1, 2006
Consistent with the requirements of section 1847 of the Act and the competitive bidding regulations, we began implementation of the program by conducting the first round of competition in 10 of the largest MSAs in 2007. We limited competition during this first round of the program to DMEPOS items and services included in 10 selected product categories, including mail order diabetic supplies. The bidding window opened on May 15, 2007 and was extended to allow bidders adequate time to prepare and submit their bids. We then evaluated each submission and awarded contracts consistent with the requirements of section 1847(b)(2) of the Act and § 414.414. Following the bid evaluation process, we awarded over 329 contracts to qualified suppliers.
The DMEPOS CBP was effective on July 1, 2008. Beginning on that date, Medicare coverage for competitively bid DMEPOS items and services furnished in the first 10 CBAs was limited to items and services furnished by contract and grandfathered suppliers of oxygen and oxygen equipment and rented DME, and payment to these suppliers was based on the SPA, as determined under the competitive bidding regulations. For further discussion of the DMEPOS CBP and the bid evaluation process, see the final rule published in the April 10, 2007
On July 15, 2008, the MIPPA was enacted. Section 154 of the MIPPA amended section 1847 of the Act to make certain limited changes to the DMEPOS CBP. Section 154(a) of the MIPPA delayed competition under the program and amended section 1847(a)(1)(D)(i) of the Act to terminate the competitive bidding contracts effective June 30, 2008 and prohibit payment based on the contracts.
Section 154(a) of the MIPPA required the Secretary to conduct a second competition to select suppliers for Round 1 in 2009 (“Round 1 Rebid”). The Round 1 Rebid includes the “same items and services” and is to be conducted in the “same areas” as the 2007 Round 1 competition, with certain limited exceptions. Specifically, we were required to exclude the product category of negative pressure wound therapy (NPWT) items and services and the San Juan, Puerto Rico CBA from the Round 1 Rebid. In addition, section 154(a) of the MIPPA permanently excluded group 3 complex rehabilitative wheelchairs from the DMEPOS CBP by amending the definition of “items and services” in section 1847(a)(2) of the Act. Section 154(a) of the MIPPA delayed competition for Round 2 of the DMEPOS CBP from 2009 to 2011, and subsequent competitions under the program to after 2011. Finally, section 154(a) of the MIPPA specifically addresses the phase in of a competition for national mail order items and services by specifying that such competitions may be phased in after 2010.
We conducted competitions for mail order diabetic testing supplies in the 10 CBAs selected for Round 1. In the Round 1 rebid we conducted competition for mail order diabetic testing supplies in 9 of the 10 CBAs selected in Round 1. These competitions were limited to diabetic testing supplies furnished by mail order contract suppliers, as defined in the April 10, 2007 DMEPOS Competitive Bidding final rule (72 FR 17992) to individuals located in those CBAs. As defined in the final rule, a mail order contract supplier is “a contract supplier that furnishes items through the mail to beneficiaries who maintain a permanent residence in a CBA”. We clarified in program instructions that “mail order” means items ordered remotely (that is, by phone, e-mail, Internet, or mail) and delivered to a beneficiary's residence by common carriers (for example, U.S. Postal Service, Federal Express, United Parcel Service, or other shipping or courier service companies) but not items obtained by beneficiaries from local retail storefronts.
Due to the inclusion of mail order diabetic supplies as a product category in Round 1 of the program, Medicare beneficiaries in a CBA who obtain diabetic testing supplies through mail order must purchase these supplies from a mail order contract supplier in order for Medicare to pay for these items. Payment for these items will be at the SPA determined consistent with the program's regulations. Beneficiaries who do not obtain their testing supplies through mail order may purchase these products from any enrolled Medicare supplier and Medicare payment for these items will be at the fee schedule amount. The home blood glucose monitor (diabetic testing equipment) itself is not included in the Round 1 DMEPOS CBP for mail order diabetic supplies. This allows the beneficiary to go to any enrolled supplier to obtain the glucose monitor that the beneficiary and their clinician believes best meets their medical needs. The supplier of the glucose monitor is responsible for training the beneficiary on how to use the monitor and for answering all follow up questions and providing all services required by the DMEPOS quality standards and supplier standards, found in § 424.57, related to the glucose monitoring system selected by the beneficiary and their clinician. The beneficiary then has the choice of obtaining the replacement diabetic testing supplies that work with their purchased monitoring system from any local, non-mail order supplier (typically a pharmacy) or from a mail order supplier whose contract requires them to ship the replacement diabetic supplies directly to the beneficiary's home. If the beneficiary wants to continue receiving their replacement
The SPA was on average 43 percent lower than the fee schedule amount for diabetic testing supplies during the Round 1 of DMEPOS CBP. This reduction in payment would have resulted in a reduction of the beneficiary's co-insurance payment. The contracts and SPAs for the Round 1 Rebid for mail order diabetic testing supplies are scheduled to be effective for diabetic supplies furnished on a mail order basis to beneficiaries in the 9 CBAs from January 1, 2011, through December 31, 2012.
As part of our rulemaking implementing the DMEPOS CBP, we established regulations to implement competitions on a regional or national level for certain items such as diabetic testing supplies that are furnished on a mail order basis. We explained our rationale for establishing a national DMEPOS CBP for items furnished on a mail order basis in the
In the January 16, 2009
As part of the phase in of the DMEPOS CBP, we are proposing to implement a national mail order DMEPOS CBP for diabetic testing supplies. Under the proposed mail order DMEPOS CBP, we would award contracts to suppliers to furnish these items across the nation to beneficiaries who elect to have replacement diabetic testing supplies delivered to their residence. Suppliers wishing to furnish these items through mail order to Medicare beneficiaries would be required to submit bids to participate in any DMEPOS CBP implemented for the furnishing of mail order items. In accordance with the DMEPOS CBP final rule, payment for mail order diabetic supplies would be based on the SPA determined from the bids submitted and accepted for the furnishing of diabetic testing supplies by mail order throughout the national CBA.
As part of our proposal to implement the national mail order DMEPOS CBP, we are also proposing a revised definition in regulation of “mail order” so that there would be a clear distinction between mail order items and non-mail order items. This revised definition would apply to all future competitions for mail order items and services. We are also proposing to implement the special rule mandated by section 1847(b)(10)(A) of the Act for competitions for diabetic testing strips following the Round 1 Rebid. Section 1847(b)(10)(A) requires suppliers bidding in competitions to furnish diabetic testing strips after the Round 1 Rebid to demonstrate that their bid covers at least 50 percent of all types of diabetic testing strips furnished by suppliers. If the supplier is not able to satisfy this requirement, the Secretary must reject that bid. Finally, we are proposing to include an additional term in contracts of mail order suppliers of diabetic testing supplies following the Round 1 Rebid. The proposed term would prohibit suppliers from influencing or incentivizing beneficiaries to change their brand of glucose monitor and test strips.
Section 1847(a)(1)(A) of the Act mandates the establishment of DMEPOS CBP for items described in section 1847(a)(2)(A) of the Act, including diabetic testing supplies. Section 1847(a)(1)(B)(ii) of the Act authorizes the phase in of items and services under these programs beginning with the highest cost and highest volume items and services or those items and services that are determined to have the largest savings potential. Current Medicare claims data from fiscal year 2009 shows that over 62 percent of beneficiaries currently receive their replacement diabetic testing supplies from mail order suppliers. Mail order diabetic testing supplies account for approximately one billion dollars in allowed charges per year and are therefore high volume items. We believe that a national mail order CBP for diabetic testing supplies would result in large savings as a result of competition between entities that would factor into their bids savings from volume discount purchasing of quantities of supplies needed on a national rather than local basis. Therefore, we believe that implementing a national mail order DMEPOS CBP for diabetic testing supplies is the best option for meeting the requirements of the statute referenced above as long as certain refinements discussed below are made to the program to address concerns about the mail order/non-mail order bifurcation.
We have heard from industry groups and suppliers that furnish diabetic testing supplies on a national mail order
We considered other alternatives for establishing DMEPOS CBP for diabetic testing supplies that would eliminate the mail order/non-mail order bifurcation and associated concerns. These alternatives include:
• A national competition among all types of suppliers for all replacement diabetic supplies. Under this alternative, all beneficiaries would receive their replacement diabetic supplies from contract suppliers responsible for furnishing diabetic supplies throughout the nation using any method of delivery as long as the supplies are delivered on a timely basis.
• Competitions in regional CBAs among all types of suppliers for all replacement diabetic supplies. Under this alternative, all beneficiaries would receive their replacement diabetic supplies from contract suppliers responsible for furnishing diabetic supplies throughout a designated region of the country using any method of delivery to a beneficiary home as long as the supplies are delivered on a timely basis.
• Competitions in local CBAs among all types of suppliers for all replacement diabetic supplies. Under this alternative, all beneficiaries would receive their replacement diabetic supplies from contract suppliers responsible for furnishing diabetic supplies throughout the local area using any method of delivery to a beneficiary as long as the supplies are delivered on a timely basis.
We believe that the first option to bid on a national basis for all diabetic supplies, would result in most beneficiaries using mail order and might generate more savings than a national competition for diabetic supplies furnished on a mail order basis only. However, this first option would likely eliminate the beneficiary choice to obtain replacement diabetic supplies on a non-mail order basis from any enrolled supplier that is a pharmacy or other local supplier storefront where a licensed pharmacist is on hand to offer guidance and consultation to the beneficiary. We believe the other two options would also diminish this choice. In addition, the alternatives of regional or local competitions are not likely to result in savings at or above the level that can be generated from a national competition for mail order supplies. Suppliers participating in a national program may be able to obtain volume purchasing discounts for the quantities of supplies needed nationwide. Therefore, we are not proposing any of these alternatives at this time. However, we are specifically requesting public comments on these and other alternatives for establishing DMEPOS CBP for diabetic supplies.
In § 414.411, we are proposing to establish a national mail order DMEPOS CBP with competitions taking place after 2010 for the purpose of awarding contracts to suppliers to furnish replacement diabetic testing supplies across the nation, with additional program refinements described below. We note that the decision to proceed with a national mail order competition after 2010 does not prevent us from phasing in competitions for non-mail order diabetic supplies or from conducting competitions for diabetic supplies in general in the future consistent with section 1847(a)(1) of the Act.
We are proposing to define “mail order item” in 42 CFR 414.402 to mean any item (for example, diabetic testing supplies) shipped or delivered to the beneficiary's home, regardless of the method of delivery. We are also proposing to define “non-mail order item” as any item (for example, diabetic testing supplies) that a beneficiary or caregiver picks up in person at a local pharmacy or supplier storefront. Therefore, the only items excluded from the mail order definition and mail order competition would be those that a beneficiary or caregiver picks up in person at a local pharmacy or other local supplier storefront. These revised definitions of mail order item and non-mail order item are intended to clearly identify which items are truly mail order. In addition, we believe this definition will preserve the choice of the beneficiary to obtain replacement diabetic supplies in person from a local pharmacy and eliminate the circumvention of the mail order program.
As discussed above, for Round 1 and the Round 1 Rebid of the DMEPOS CBP, we defined mail order contract supplier in our regulations at § 414.402 to mean a contract supplier that furnishes items through the mail. We further defined mail order in program instructions to mean “items ordered remotely (that is, by telephone, e-mail, Internet or mail) and delivered to beneficiary's residence by common carriers (for example, U.S. Postal Service, Federal Express, United Parcel Service) and does not include items obtained by beneficiaries from local storefronts.” The intent of the Round 1 definition was to distinguish between mail order supplies (supplies furnished directly to the beneficiary's home) and non-mail order supplies (supplies picked up at a local pharmacy). Manufacturers and suppliers of blood glucose monitors and test strips have expressed on numerous occasions the importance of maintaining the patient option of obtaining diabetic testing supplies from a local pharmacy that provides full time access to a licensed pharmacist who can provide instructions and guidance to the beneficiary or caregiver related to the use of the diabetic supplies (the
During implementation of Round 1 of the program, we discovered that suppliers that did not successfully compete and win a contract under the program tried to adopt certain approaches to circumvent the mail order definition. In the first round of competitive bidding, suppliers that lost their bid to be a contract supplier for mail order diabetic testing supplies considered ways to change their delivery methods to circumvent the mail order DMEPOS CBP. For example, some mail order suppliers considered purchasing a fleet of cars to deliver these items to the beneficiary's home so as not to be considered a mail order supplier. Other suppliers attempted to enter into special “private” arrangements with well known delivery services and claimed that because of such arrangements they should not be considered mail order suppliers. These alternative home delivery methods do not provide any benefits to the patient beyond what the traditional mail order home delivery method offers. They are simply ways to continue furnishing diabetic supplies on a home delivery basis after submitting a bid for mail order that does not result in the award of a contract under the DMEPOS CBP. Without a clear distinction between mail order (home delivery option) and non-mail order (pharmacy pickup option), suppliers could continue to attempt to make arrangements as they did in the initial Round 1 competition to circumvent the DMEPOS CBP. We consider these practices to be inconsistent with the DMEPOS CBP statute and regulations currently in effect, and our proposal is intended to further clarify the existing definition of mail order. Such arrangements prevent beneficiaries and the Medicare program from realizing savings afforded by the mail order DMEPOS CBP and is unfair to winning suppliers who bid in good faith for a contract for furnishing supplies to the home delivery market.
This proposed definition of mail order item would not apply to the Round 1 competition because of the specific requirement of MIPPA to rebid Round 1 in 2009 for the same items and services included in the initial Round 1 competition. However, for a national competition, it is imperative that the new definition of mail order item be in place because of the implications such a program would have on the entire mail order delivery market in the United States. In these future competitions, we would continue to emphasize in our educational efforts the basic distinction between mail order (home delivery) and non-mail order (pharmacy pickup). In addition, we will continue to take appropriate and necessary action against suppliers that do not comply with the revised definition.
As mentioned above, an alternative DMEPOS CBP for replacement diabetic supplies would be to hold a national competition among all types of suppliers for all replacement diabetic supplies. One benefit to this approach is that it would eliminate the need to differentiate between mail order and non-mail order supplies; however, it would likely eliminate the pharmacy pickup choice since most local pharmacies would not be able to service the entire CBA if they did not also operate a national mail order service.
We invite comments on our proposed definition of “mail order” and its impact on future rounds of bidding.
Following Round 1 of the program, any competition for diabetic testing strips, such as the national mail order program for diabetic testing supplies proposed in this rule, must include the special rule set forth in section 1847(b)(10)(A) of the Act. Under that section, a supplier must demonstrate that their bid to furnish diabetic testing strips covers the furnishing of a sufficient number of different types of diabetic testing strip products that, in the aggregate and taking into account volume for the different products, to account for at least 50 percent of all such types of products on the market. Section 1847(a)(10)(A) also specifies that the volume for the different products may be determined in accordance with data (which may include market based data) recognized by the Secretary. When a beneficiary needs to obtain replacement test strips, they must obtain the specific brand of test strips products that work with their brand and model of blood glucose monitor. The test strips are not manufactured in a way that allows use of different brands of test strips in different brands of monitors. Therefore, when replacement test strips are furnished, the supplier must ensure that the specific brand and model of test strips that the patient requires for use with their purchased monitor is furnished.
Section 1847(b)(10)(B) of the Act mandates the Office of Inspector General (OIG) of the Department to conduct a study before 2011 to generate volume data for the various products that could be used for this purpose.
Under the DMEPOS CBP, bidding suppliers are required to provide information on the products they plan to furnish if awarded a contract. We propose to use this information and information on the market share (volume) of the various diabetic testing strip products to educate suppliers on meeting the requirements of this special rule. In addition, it may be necessary to obtain additional information from suppliers such as invoices or purchase orders to verify that the requirements in the statute have been met.
We are proposing that suppliers be required to demonstrate that its bid covers the minimum 50 percent threshold provided in the statute, but we invite comments on whether a higher threshold should be used. We have proposed the 50 percent threshold in part because we believe that all suppliers have an inherent incentive to furnish a wide variety of types of diabetic testing products to generate a wider customer referral base. The 50 percent threshold would ensure that beneficiaries have access to mail order delivery of the top-selling diabetic test strip products. In addition, as explained below, we are proposing an “anti-switching provision” that we believe should obviate the need to establish a threshold of greater than 50 percent for the purpose of implementing this special rule because the contract suppliers would not be able to carry a limited variety of products and switch beneficiaries to those products.
For purposes of implementing the special rule in section 1847(b)(10)(A), we are proposing to define “diabetic testing strip product” as a specific brand and model of test strip, as that is the best way to distinguish among different products. Therefore, we plan to use market based data for specific brands and models of diabetic test strips to determine the relative market share or volume of the various products on the market that are available to Medicare beneficiaries. We plan to review a variety of data, including but not limited to data furnished in the OIG report, to determine the market share of the various products. The special rule mandated by section 1847(b)(10)(A) of the Act applies to all competitions for diabetic testing strips after the first round of the DMEPOS CBP. Therefore, we would apply this rule to non-mail order competitions and/or local competitions conducted for diabetic testing strips after Round 1 of the DMEPOS CBP.
We do not believe that we can effectively apply the 50 percent rule, as required by section 1847(b)(10)(A) of the Act, if we do not establish an anti-switching rule to prevent suppliers from influencing beneficiaries to switch monitors. We have heard concerns from beneficiary advocacy groups, as well as industry representatives, that contract suppliers furnishing diabetic testing supplies in the first round encouraged beneficiaries to switch to a different brand of blood glucose monitor and testing supplies than they and/or their physician or clinician previously selected. Suppliers attempted to switch beneficiaries to the less expensive monitor or the monitor that provided them with the most profit rather than the monitor that was most suitable for them. Without the anti-switching rule, suppliers may offer 50 percent of the brands on the market but continue to switch beneficiaries to the least expensive brands so that the requirement to offer at least 50 percent of the brands on the market rather than a few specific brands becomes meaningless.
We are proposing to prohibit suppliers awarded contracts for diabetic testing supplies from influencing or incentivizing the beneficiary in any way to switch the brand of glucose monitor and testing supplies they are currently using. We would propose that contract suppliers continue to furnish the brand of testing supplies that work with the monitor currently in use by the beneficiary. In the case where the beneficiary is receiving a monitor for the first time or a replacement monitor, the contract supplier would be subject to the requirements of § 414.420 in order to protect beneficiaries from feeling forced or incentivized to use a particular type or brand of monitor We continue to believe the proper role of the contract supplier is to furnish diabetic testing strips and other supplies to beneficiaries, not to interfere with the beneficiary's selection of the type of monitor and supplies. This requires the supplier to furnish the brand of testing supplies that work with the blood glucose monitor product that the beneficiary and/or clinician, and not the supplier of the testing supplies, selects. If the beneficiary needs a blood glucose monitor for the first time, or needs to replace their existing blood glucose monitor, and neither the beneficiary nor their physician has determined which brand or type of monitor to obtain, the beneficiary may continue to ask for assistance from the supplier to select a monitor and the supplier should show them the full range of products. However, if the beneficiary has already selected a monitor and simply needs replacement diabetic testing supplies, the supplier must furnish the brands of testing supplies that work with the brand monitor that the beneficiary has selected. We believe this proposal would preserve the integrity of the clinical decision regarding choice of glucose monitoring system and would result in contract suppliers offering a wide variety of diabetic testing supply products.
We are proposing to amend § 414.422 to add the anti-switching requirement to the terms of the contract for a supplier of diabetic testing supplies. A supplier would be in breach of their contract and subject to the sanctions set forth under § 414.423(g), including termination, if they violate this term. We welcome comments on this proposal.
In the April 10, 2007 final rule (72 FR 17992), we established § 414.404(b)(1), which sets forth several exemptions to the DMEPOS CBP. These exceptions are applicable to providers, physicians, and treating practitioners that furnish certain DMEPOS items under Medicare Part B. The exempted items are limited to crutches, canes, walkers, folding manual wheelchairs, blood glucose monitors, and infusion pumps that are DME. For an explanation as to why these items were exempt see the DMEPOS Competitive Bidding final rule (CMS–1270–F) published April 10, 2007, (72 FR 17992). For the exemptions to apply, the items must be furnished by a physician or treating practitioner to his or her own patients as part of his or her professional service. The items are to be billed under a billing number assigned to the physician, the treating practitioner (if possible), or a group practice to which the physician or treating practitioner has reassigned the right to receive Medicare payment.
The April 10, 2007 final rule also established an exemption for a physical therapist in private practice (as defined in § 410.60(c)) or an occupational therapist in private practice (as defined in § 410.59(c)) to furnish competitively bid OTS orthotics without submitting a bid and being awarded a contract under the DMEPOS CBP, provided that the items are furnished only to the therapist's own patients as part of a physical or occupational therapy service.
Section 154(d) of MIPPA amended section 1847(a) of the Act by adding paragraph (7), which expands the exemptions from the DMEPOS CBP for certain OTS orthotics to physicians or other practitioners (as defined by the Secretary) if furnished to their own patients as part of their professional service. Section 1847(a)(7) of the Act, as added by MIPPA, also expanded the exemption from the program to hospitals for certain OTS orthotics, crutches, canes, walkers, folding manual wheelchairs, blood glucose monitors, and infusion pumps if these items are furnished to the hospital's own patients during an admission or on the date of discharge.
The DMEPOS CBP Round 1 Rebid interim final rule with comment period (IFC) included the expanded exemption for certain DMEPOS items as provided by MIPPA for hospitals. We noted in the IFC that we would address the expanded exemption of OTS orthotics for hospitals, physicians and other practitioners in future rulemaking.
In this proposed rule, we are proposing to revise current provisions at § 414.404(b)(1)(i) to incorporate the provision of section 1847(a)(7)(A)(i) and (ii) of the Act that exempts from the program OTS orthotics furnished by physicians and other practitioners to their own patients as part of their professional service or by hospitals to the hospital's own patients during an admission or on the date of discharge.
Section 1847(a)(4) of the Act requires that in the case of rented DME and oxygen and oxygen equipment, the Secretary shall establish a “grandfathering” process. This requirement was implemented through regulations at § 414.408(j) that were published in the April 10, 2007
At the time these rules were developed, the supplier was mandated by the statute to transfer title to the equipment to the beneficiary after the both the 13-month cap for capped rental items and the 36-month cap for oxygen equipment. Section 144(b) of the MIPPA repealed the transfer of title requirement for oxygen equipment, as established by Deficit Reduction Act of 2005, replacing that requirement with the 36-month rental cap. Under the revised oxygen payment provisions, suppliers now get the equipment back when the beneficiary no longer needs it. Also, at the time these rules were developed, the beneficiary had the option to acquire standard power wheelchairs on a lump sum purchase basis, an option which greater than 95% of the beneficiaries selected, based upon historic claims data. Therefore, those items generally would not be affected by the grandfathering rules. However, as discussed in section 3136 of this proposed rule, section 3136 of the ACA eliminates the lump sum purchase option for standard power wheelchairs. This new policy applies to items furnished under the DMEPOS CBP beginning with Round 2 of the program. Over 200,000 beneficiaries received standard power wheelchairs nationwide in 2009, and the Medicare allowed charges for these wheelchairs was over $650 million, including both rental and purchase options. Therefore, this large volume of capped rental items will be subject to the grandfathering rules effective with Round 2 of the DMEPOS CBP, thus increasing the overall magnitude of the effect these rules have on the program and beneficiaries.
In some cases, the grandfathering rules described above place a financial burden on beneficiaries who are near the end of the 13 or 36-month rental cap periods. If a beneficiary's existing supplier chooses not to be a grandfathered supplier, the beneficiary will be required to switch to a contract supplier in order for Medicare to continue to pay for the furnishing of the rental equipment. In such cases, the beneficiary will be responsible for additional co-insurance amounts. Based on experience from the initial Round 1 competition in 2008, we believe that most suppliers will choose to grandfather and therefore these rules will have no impact on these situations. However, in those limited situations in which the beneficiary does not use a grandfathered supplier and the beneficiary is near the end of the 13 or 36-month rental cap period, the impact on the beneficiary could be significant. As mentioned above, our current grandfathering rules will result in a limited number of beneficiaries facing additional co-insurance payments. To illustrate the impact some beneficiaries may face as a result of these rules, a beneficiary who has already made 12 coinsurance payments for a capped rental item could make as many as 12 additional copayments as a result of restarting the capped rental period when they transition from a noncontract supplier to a contract supplier at the beginning of a DMEPOS CBP. In another example, a beneficiary who has already made 35 coinsurance payments for oxygen and oxygen equipment could make as many as 9 additional copayments as a result of the rule that provides a minimum of 10 monthly payments when they transition from a noncontract supplier to a contract supplier at the beginning of a DMEPOS CBP. As stated above, we expect that most noncontract suppliers will choose to become grandfathered suppliers, therefore limiting the number of instances where these rules would apply. However, in light of the beneficiary impact in the those extreme cases illustrated above, and in light of the recent legislative changes by the MIPPA and the ACA as explained above, we are reevaluating whether or not changes to these grandfathering rules are necessary. As discussed above, as a result of the MIPPA, suppliers of oxygen equipment no longer lose title to the equipment after receiving the 36th payment and this may warrant reconsideration of the minimum number of payments they should receive as contract suppliers when a beneficiary transitions to them from a noncontract supplier at the beginning of a DMEPOS CBP. In addition, we believe it is important to reevaluate the policy that restarts the 13-month capped rental period in situations where a beneficiary transitions from a noncontract supplier to a contract supplier at the beginning of a DMEPOS CBP. Therefore, we are soliciting public comments on whether or not the current rules should be changed to reduce the number of payments the contract supplier would receive in these situations above the 13 and 36-month limits set forth under the standard payment rules in section 1834(a) of the Act. We also plan to solicit advice from the PAOC on this subject at a future committee meeting.
The DMEPOS CBP final rule issued on April 10, 2007 includes § 414.422(g)(1), which states that “any deviation from contract requirements, including a failure to comply with governmental agency or licensing organization requirements, constitutes a breach of contract.” In the event we determine that a contract supplier's actions constitute a breach of contract, § 414.422(g)(2) authorizes us to take one or more of the following actions:
• Require the contract supplier to submit a corrective action plan;
• Suspend the contract supplier's contract;
• Terminate the contract;
• Preclude the contract supplier from participating in the DMEPOS CBP;
• Revoke the supplier number of the contract supplier; or
• Avail itself of other remedies allowed by the statute.
We are proposing to add a new § 414.423 to establish an appeals process for contracts terminated under section 1847(a) and (b) of the Act. Section § 414.423, as proposed in this rule, would set forth policies and procedures relating to our determinations of a breach of contract and the appeals process for contract suppliers that are considered to be in breach of contract. In addition, we are proposing to add new definitions to § 414.402 that are used in the proposed § 414.423.
Given the impact that termination has on a contract supplier, we believe it is appropriate for contract suppliers whose contract(s) may be terminated due to a breach of contract to have access to an appeal process that will reconsider that termination. In establishing this process we reviewed other appeals processes, such as the appeals process under Part D located at 42 CFR 423.641 through 423.668, Subpart N—Medicare Contract Determinations and Appeals, to consider essential steps to ensure suppliers have access to an appropriate review of certain CMS decisions. We chose to propose a simplified process that would not result in disruption to the program by having suppliers going in and out of the program. For this reason, we propose a process for review and reconsideration before the contract is actually terminated. This proposal would avoid the necessity to reinstate
We are proposing to amend § 414.402 to define the following terms:
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The appeals process proposed in this regulation would allow contract suppliers the opportunity for a review of the following:
• A CMS determination under § 414.422(g)(1) that the contract supplier breached its contract entered into as part of the DMEPOS CBP; and
• Certain agency actions taken under § 414.422(g)(2).
The proposed appeals process would not apply to any other actions made by CMS, nor would the existence of other appeals processes preclude us from terminating a DMEPOS CBP contract. In other words, the proposed appeals process would be in addition to—and would not replace—existing CMS regulations regarding other appeals mechanisms. For example, a contract may be terminated because a supplier's National Supplier Clearinghouse (NSC) number has been revoked or inactivated. In this case, the supplier would not appeal the decision to inactive or revoke its number through this appeals process. Instead, the supplier would continue to appeal the inactivation or revocation of its supplier number through the NSC's appeals process, and we would postpone the termination decision until the supplier completes the NSC appeals process.
Under our proposal, when we issue a termination decision, it would be final and binding unless a postponement of the termination decision is allowed by proposed § 414.423. We welcome comments on the scope of the proposed appeals process.
We are proposing that this appeals process applies in situations where the supplier has received a notice that we have determined that they are in breach of contract and that their contract is therefore subject to termination. A contract may be terminated for any violation of the terms of the contract. Examples of violations include, but are not limited to, situations where the contract supplier—
• Has committed or participated in false, fraudulent, or abusive activities affecting the Medicare program, including the submission of false or fraudulent data or claims;
• Experiences financial difficulties so that they are unable to effectively provide the necessary services to a Medicare beneficiary; or
• Fails to meet the non-discrimination policy and provides different items to beneficiaries located in a competitive bidding area (CBA) than it provides to its non-Medicare beneficiaries at § 414.422(c).
We welcome comments on our proposed termination process.
Under the proposed rule, the CBIC would work with suppliers to informally resolve performance deficiencies under its DMEPOS CBP contract prior to sending a recommendation to CMS that the supplier's contract be terminated. If the CBIC cannot informally resolve the supplier's deficiencies and recommends that we terminate the contract, we would review the CBIC's recommendation to terminate the supplier's contract. If we find that a breach occurred, we would begin the contract termination process by sending out a notice of termination to the supplier.
We also propose requirements for the notice of termination so that suppliers are informed of the basis for CMS's action as well as their options to respond to this action. The notice would explain all actions we plan to take in response to the supplier's breach, such as the ability to submit a CAP or our determination to preclude a supplier from participating in future rounds of competitive bidding if found in breach of contract. If the supplier decides to appeal any of these decisions the supplier would submit an appeal in response to the notice to terminate. If we consider a supplier to be in breach of its contract, either in part or in whole, we would notify the contract supplier of the termination by certified mail. The notice would indicate that the contract supplier has been found to be in breach of contract and that the supplier's contract would be terminated within 45 calendar days of the date of the notification of termination. The notice would be sent by the CBIC using certified mail on the same date as the date on the notification of termination. The date of the notification of termination is the date that the notification is signed. The notification will be mailed on the date that it is signed. This date will be indicated on the notification.
The proposed rule requires the notice to include, at a minimum, the following information:
• The reasons for the termination in sufficient detail to allow the contract supplier to understand the nature of its breach of contract;
• Depending on the nature of the breach, whether the supplier may be allowed to submit a CAP in lieu of requesting a hearing by the HO;
• The right to request a hearing by the HO;
• The address to which the written request for a hearing must be mailed;
• The address to which the CAP must be mailed; and
• The effective date of the termination of the contract, if a CAP is not submitted or if a request for a hearing has not been filed timely.
We believe that this information would be sufficient to provide the supplier with the basis for CMS's action, as well as their options in responding to our decision. We welcome comments on our proposal regarding the contents of the notice.
In addition, our proposed rule requires the notice to indicate any additional penalties that may result from the termination, such as not being eligible to bid in future rounds of competitive bidding. An appeal of the termination would include the appeal of
We are also proposing a process by which a contract supplier may be able to submit a CAP to address the breach of contract. Depending on the nature of the breach of contract, we propose that the notice to the supplier would indicate whether a contract supplier would be allowed to provide the CBIC with a written CAP instead of submitting a request for a hearing by a HO. For example, under this proposal we would not allow a CAP if the supplier has been excluded, debarred or convicted of a health care related crime. We may also not allow a CAP that would result in negative consequences to the beneficiaries or the program caused by delaying the termination of the contract.
We are proposing timelines related to the CAP. Under the proposed rule, if the supplier decides to submit a CAP, the CAP must be received by the CBIC within 30 calendar days from the date on the notice of termination. If the supplier decides not to submit a CAP, the supplier retains the right to request a review by a HO within 30 days from the date of the notice for termination. While the CAP is being evaluated, the termination determination would be postponed. We believe that 30 days is a sufficient amount of time for suppliers to prepare and submit a CAP and this would also ensure that there are no unnecessary delays in the appeals process.
Under the proposed rule, we would require the CAP to demonstrate that the contract supplier has a plan to remedy all of the deficiencies that were identified in its notice of termination and must specify the timeframes for correcting these deficiencies. The CBIC would review the CAP to ensure that the contract supplier would be taking the appropriate measures in a timely manner to remedy the breach of contract. What constitutes a timely manner is dependent on the type of deficiency that is being corrected. Once the nature of the deficiency is identified the CBIC and CMS would make a case-by-case determination concerning what constitutes a timely manner for correcting the deficiency. However, we expect most deficiencies to be corrected within 90 days or less. Further guidance of what constitutes a timely manner would be communicated to the contract supplier by the CBIC as part of the review process.
As part of the review process, the CBIC would provide guidance, in accordance with CMS instructions, regarding the type of documentation that the CAP and the follow-up report must provide to substantiate that the deficiencies have been corrected. To make a determination if a CAP would be considered acceptable, we may discuss the CAP with the supplier, and as a result of these discussions, the CBIC will allow a supplier to make revisions to its CAP during the review process. Suppliers may only revise their CAP one time during the review process. The timeframe for the review process would vary upon the circumstances for each case. If the supplier does not submit an acceptable CAP during the review process, the supplier would receive a new notice that their CAP is not acceptable or has not been implemented consistent with the supplier's original submission and its contract would be terminated within 45 calendar days. Every supplier would have a one time opportunity to revise their CAP based upon deficiencies identified by the CBIC. Failure to develop and implement an approved CAP would result in a new notice to the supplier of the termination of the DMEPOS CBP contract and provide notice that the supplier may request a hearing on this termination. Under the proposed rule, once an acceptable CAP has been completed the contract supplier must provide a follow-up report within 5 days of the agreed upon date for the completion of the CAP to verify that all of the deficiencies identified in the CAP have been corrected consistent with the timeframes specified in the CAP, as approved by the CMS. We believe that 5 days is sufficient time for a supplier to submit a report to CBIC outlining all steps that have been completed to correct the identified deficiencies.
We welcome comments on our proposals relating to the option for a CAP.
We propose that a contract supplier that has received a notice that we consider the supplier in breach of contract has the right to request a hearing before a HO who was not involved with the original breach of contract determination. We consider this process to be a reconsideration of the original decision, and consistent with other Medicare appeals provisions, we believe it is important that an individual not involved in making the initial recommendation conduct the reconsideration of the initial decision. As mentioned previously, the HO would be an individual who is designated by CMS to review and to make an unbiased and independent recommendation of whether to terminate the supplier's DMEPOS CBP contract. The notice to the contract supplier would also identify the location to which a request for hearing must be sent.
Under the proposed rule, a contract supplier may appeal the notice of termination by submitting a written request to the CBIC for a hearing by a HO. The written request should include any evidence to support its appeal. The HO is not required to allow evidence submitted in addition to the evidence submitted along with the written request. The hearing request must be received by the CBIC within 30 calendar days from the date of the termination letter. A request for a hearing must be sent to the address identified on the notice. Failure to request a hearing within the allotted 30 calendar days would result in a termination of the supplier's contract, as of the effective date of termination identified in the notice to the supplier. There would be no extensions to this 30-day timeframe. We believe suppliers have sufficient time to decide whether or not to request a hearing and the deficiencies identified in the notice may pose a risk to the DMEPOS CBP. The date the request is received by the CBIC determines if the hearing request was timely filed.
We would require that the request for hearing be filed by a supplier's authorized official, because an authorized official of the company signed the contract and this ensures the validity of the request. The authorized official must be an official of the company who is identified on the supplier's CMS 855–S form as an authorized official of the supplier. A supplier may appoint someone other than the authorized official to be a representative for them at the hearing. However, the representative may not be an individual who has been disqualified or suspended from acting as a representative by the Secretary or otherwise prohibited by law. The request for a hearing must be filed with the CBIC at the address identified on the notice of termination.
We welcome comments on our proposed process for requesting a hearing by a HO.
The proposed rule also addresses scheduling the hearing. We propose that within 30 calendar days from the receipt of a supplier's timely hearing request the HO would contact the parties to
The proposed rule would require that the HO's notice scheduling the hearing must provide, at a minimum, the following information:
• Date, time, and location of the scheduled hearing;
• Description of the hearing procedure;
• Issues to be resolved;
• Requirement that the contract supplier bears the burden of proof to demonstrate that it is not in breach of contract; and
• Provide an opportunity for the supplier to submit evidence to support its appeal. We believe this information provides the supplier with sufficient information regarding the hearing date, time, and matters that would be addressed at that time. We welcome comments on the content of this notice and the procedures for scheduling a hearing.
We propose that the contract supplier would present to the HO the basis for its disagreement with the termination notice and would have the burden of proof to demonstrate to the HO with supporting evidence that it is not in breach of its contract and that the termination action is not appropriate. The supplier's supporting evidence must be submitted with its request for a hearing. The supporting evidence and the request for a hearing must be submitted together and received by the HO within 30 calendar days from the date identified on the notice of termination. In the absence of good cause, the HO may not allow evidence to be submitted in addition to the evidence submitted along with the written request. We also have the opportunity to submit evidence to the HO within 30 days of receiving the notice announcing the hearing. The HO will share all evidence submitted, both from the supplier and CMS, in preparation for the hearing with all affected parties within 15 days prior to the scheduled date of the hearing.
We welcome comments on our proposal regarding the burden of proof.
Our proposal requires that the HO conduct a thorough and independent review. Such a review requires the consideration of all information and documentation relevant to the hearing and submitted consistent with this proposal. Consistent with this goal, we propose that the HO is responsible for all of the following:
• Sharing all evidence submitted, both from supplier and CMS, in preparation for the hearing with all affected parties within 15 days prior to the scheduled date of the hearing.
• Conducting the hearing and deciding the order in which the evidence and the arguments of the parties would be presented.
• Determining the rules on admissibility of the evidence.
• Examining the witnesses, in addition to the examinations conducted by CMS and the contract supplier.
• Determining the rules for requesting documents and other evidence from other parties.
• Ensuring a complete recording of the hearing is available and provided to all parties to the hearing and the CBIC.
• Preparing a file of the record of the hearing which includes all evidence submitted as well as any relevant documents identified by the HO and considered as part of the hearing.
• Complying with all applicable provisions of 42 U.S.C. Title 18 and related provisions of the Act, the applicable regulations issued by the Secretary, and manual instructions issued by CMS.
The HO would make a recommendation based on the information presented and submitted. The HO would issue a written recommendation to CMS within 30 days of the close of the hearing, unless the HO requests an extension from CMS and demonstrates to CMS that he or she needs an extension due to complexity of the matter or heavy work load. The HO's recommendation would include the rationale for his or her recommendation regarding the termination of the supplier's contract and the HO would submit this recommendation to CMS for its determination.
We welcome comments on the role of the CBIC HO in our proposed rule.
Under the proposed rule, the HO's recommendation is submitted to CMS, and the agency would make the final determination regarding whether the supplier's contract would be terminated. Our determination would be based upon on the record of the hearing, evidence, and documents considered by the HO as part of the HO recommendation. Information submitted after the hearing would not be considered. Our decision would be made within 30 days of the receipt of the HO's recommendation. If our decision is to terminate the contract, the supplier would be notified of the effective date of termination by certified mail. Our decision regarding the termination of the contract is final and binding.
We welcome comments on our proposal relating to CMS's final determination of a supplier's contract termination.
Under the proposed rule, suppliers who submit a CAP or request a hearing would have the termination date identified on the notice delayed. The only exception to this rule is when a supplier has been excluded, debarred or convicted of a health care related crime; in that situation the contract would be terminated immediately. For terminations that do not meet these exceptions, the effective date of a final termination would be determined as follows:
• The termination of a supplier's DMEPOS CBP contract is effective on the date specified in the initial notice of termination, which will be 45 days from the date of the notice, unless the supplier request a hearing with the HO or the supplier submits an acceptable CAP.
• After reviewing the HO recommendation, if we terminate a supplier's contract the effective date of the termination would be the date specified in the post-hearing notice sent to the supplier indicating CMS's final determination to terminate the contract.
We welcome comments on our proposals related to the effective date of contract termination.
Under our proposal, once a supplier's contract is terminated for breach of contract under the DMEPOS CBP, the contract supplier is no longer a DMEPOS CBP contract supplier for any DMEPOS CBP product category for which it was awarded a contract. This termination applies to all areas and
We recognize that a supplier's termination would impact beneficiaries within the CBA. Therefore, we therefore propose that terminated suppliers must notify all beneficiaries within the CBA who are receiving rented competitively bid items of the termination of their contract status so that the beneficiaries can make arrangements to receive equipment and suppliers through other contract suppliers. After we have made our final determination and sent notification to the supplier, the supplier must notify beneficiaries within 5 days of receipt of the contract supplier's final notice of termination. This notice must inform beneficiaries that they would have to select a new contract supplier to furnish their DMEPOS items in order for Medicare to pay for these items. For beneficiary protection, we also propose that contract suppliers who fail to give proper notification to beneficiaries may be prevented from participating in future rounds of DMEPOS CBP. We also propose that rental items may not be picked up from the beneficiary's home until after the last day of the rental month for which the supplier has already received payment. We are proposing both of these policies to protect the beneficiary and to ensure that suppliers do not pick up equipment from a beneficiary for a time period for which they have already been paid to provide the service.
The general Medicare payment rules for DME are set forth in section 1834(a) of the Act and 42 CFR part 414, subpart D of our regulations. Section 1834(a)(1) of the Act and § 414.210(a) of our regulations establish the Medicare payment for a DME item as equal to 80 percent of either the lower of the actual charge or the fee schedule amount for the item. The beneficiary coinsurance is equal to 20 percent of either the lower of the actual charge or the fee schedule amount for the item once the deductible is met.
The specific payment rules for oxygen and oxygen equipment under the existing fee schedules are set forth in section 1834(a)(5) of the Act and § 414.226 of our regulations. Suppliers are paid a monthly payment amount for furnishing medically necessary oxygen contents (for both stationary and portable) and stationary oxygen equipment described under the class described in § 414.226(c)(1)(i). Equipment in the stationary class includes stationary oxygen concentrators, which concentrate oxygen from room air; stationary liquid oxygen systems, which use oxygen stored as a very cold liquid in cylinders and tanks; and gaseous oxygen systems, which administer compressed oxygen directly from cylinders.
A monthly add-on payment is also made to suppliers furnishing medically necessary portable oxygen equipment falling under one of two classes described in § 414.226(c)(1)(ii) and (iii). Equipment in these classes includes traditional portable equipment, that is, portable liquid oxygen systems and portable gaseous oxygen systems, and oxygen generating portable equipment (OGPE), that is, portable oxygen concentrators and oxygen transfilling equipment used to fill portable tanks or cylinders in the home. Both the liquid and gaseous oxygen systems (for stationary and traditional portable systems) require on-going delivery of oxygen contents.
Section 1834(a)(5)(F) of the Act, as amended by section 144(b) of MIPPA, limits the monthly rental payments to suppliers for oxygen equipment to 36 months of continuous use, although monthly payments for furnishing gaseous or liquid oxygen contents continue after the 36-month equipment rental cap is reached for gaseous or liquid systems. In the CY 2009 PFS final rule with comment period (73 FR 69875 through 69876), we discussed section 144(b) of MIPPA and included a detailed discussion of how section 5101(b) of the Deficit Reduction Act of 2005 (DRA) previously required suppliers to transfer title to oxygen equipment to the beneficiary at the end of the 36-month rental period. Section 144(b) of the MIPPA repealed this requirement to transfer title to the oxygen equipment to the beneficiary and allows suppliers to retain title to the oxygen equipment after 36 monthly rental payments are made for the equipment.
Section 414.210 establishes the requirements for the replacement of DME, including oxygen equipment. Section 414.210(f)(1) states that if an item of DME, which includes oxygen equipment, has been in continuous use by the patient for the equipment's reasonable useful lifetime or if the original equipment is lost, stolen, or irreparably damaged, the patient may elect to obtain a new piece of equipment. In such circumstances, § 414.420(f)(2) authorizes payment for the new oxygen equipment in accordance with § 414.226(a). Section 414.210(f)(1) states that the reasonable useful lifetime for DME, which includes oxygen equipment, is determined through program instructions. In the absence of CMS program instructions, the carrier may determine the reasonable useful lifetime for equipment, but in no case can it be less than 5 years. Computation is based on when the equipment is delivered to the beneficiary, not the age of the equipment. If the beneficiary elects to obtain new oxygen equipment after the reasonable useful lifetime, the payment is made for a new 36-month rental period in accordance with § 414.226(a).
We are proposing to revise the payment rule for oxygen and oxygen equipment at § 414.226(g)(1) to address situations where beneficiaries relocate outside the service area of a supplier during the 36-month rental payment cap period for the oxygen equipment. Beneficiaries are experiencing great difficulties in finding suppliers willing to furnish oxygen equipment in situations where only a few months are left in the 36-month rental payment period at the time they relocate. For example, if a beneficiary is in the 30th rental month, the new supplier would be entitled to only 6 months of rental payments and then would have to continue to furnish the oxygen and oxygen equipment during any period of medical need for the remainder of the reasonable useful lifetime of the equipment. This creates a financial disincentive for oxygen suppliers to furnish oxygen and oxygen equipment to beneficiaries in these situations.
The proposed changes to the payment rules for oxygen and oxygen equipment would apply to oxygen and oxygen equipment furnished under Part B and would also apply to oxygen and oxygen equipment furnished under programs implemented in accordance with section 1847(a) of the Act.
In the CY 2010 PFS final rule with comment period (74 FR 61887 through 61890), we finalized § 414.226(g)(1) which, in accordance with section 1834(a)(5)(F)(ii)(I) of the Act, requires the supplier that furnishes oxygen equipment during the 36-month rental period to continue furnishing the oxygen equipment after the 36-month rental period. The supplier is required
We revised § 414.226(f) to conform our regulations to this new MIPPA requirement. We deleted the transfer of ownership requirement and added the new requirement that the supplier must continue furnishing the oxygen equipment after the 36-month rental period during any period of medical need for the remainder of the reasonable useful lifetime of the equipment. It is important to note that § 414.226(g)(1)(ii) does not apply this same requirement in situations where the beneficiary relocates outside of the supplier's normal service area during the 36-month rental period.
Section § 414.226(g)(1) contains the requirement that the supplier that furnishes oxygen and oxygen equipment for the first month of the 36th month of the rental cap period must continue to furnish the equipment for the entire 36-month period of continuous use, with limited exceptions. One exception at § 414.226(g)(1)(ii) applies when a beneficiary permanently relocates his or her residence during the 36-month rental period outside of the current supplier's normal service area. This exception was proposed in the “Home Health Prospective Payment System Rate Update for Calendar Year 2007 and Deficit Reduction Act of 2005 Changes to Medicare Payment for Oxygen Equipment and Capped Rental Durable Medical Equipment; Proposed Rule” published in the August 3, 2006
For this reason, we believed that beneficiaries would not encounter problems obtaining access to oxygen and oxygen equipment in similar situations, that is, following the 36-month cap imposed by section 144(b) of MIPPA. However, since the changes to the payment rules for oxygen and oxygen equipment mandated by the DRA became effective in 2006 and the 36-month rental cap imposed by MIPPA was reached for the first time in January 2009, we have received many reports of beneficiaries relocating prior to the end of the 36-month rental payment cap period and having difficulty finding an oxygen supplier in the new location. We have learned that many suppliers are unwilling to provide services in situations where there are a few number of months left in the 36-month rental payment period.
We do not believe that beneficiaries have encountered similar issues following the 36-month rental cap, which most likely is the result of different statutory requirements for these two periods (that is, during and after the 36-month rental period). Section 1834(a)(5)(F)(ii) of the Act requires the supplier that furnishes the oxygen equipment during the 36-month rental payment period to continue furnishing the equipment after the 36-month rental payment period. Consistent with this requirement, we established regulations at § 414.226(f)(1) that require the supplier to furnish the equipment or make arrangements for furnishing the equipment in situations where the beneficiary relocates outside the supplier's normal service area. Since no such requirement currently applies in situations where the beneficiary relocates prior to the end of the 36-month rental payment period, and in fact current regulations at § 414.226(g)(1)(ii) absolve the supplier of the obligation to continue furnishing oxygen equipment in these situations, beneficiaries are experiencing difficulties finding suppliers of oxygen equipment in their new locations that are willing to accommodate them. As noted above, we have not seen this problem in the capped rental DME context. The requirement at § 414.226(g)(1) to furnish oxygen equipment for the entire 36 month rental cap period was established in the course of implementing section 5101(b) of the DRA in order to safeguard the beneficiary from situations where suppliers might discontinue service and pick up oxygen equipment prior to the end of the 36-month rental cap in order to avoid losing title to the equipment. As mentioned earlier, the transfer of title of oxygen and oxygen equipment after the 36th paid rental month was repealed. The exception to this rule at § 414.226(g)(1)(ii) was established based on our experience that suppliers of capped rental DME have accommodated beneficiaries in these situations, which, unfortunately, has not been our experience in the context of oxygen equipment.
In order to address this vulnerability facing beneficiaries as a result of regulations currently in effect, we are proposing to revise the exception at § 414.226(g)(1)(ii) to apply only to situations where the beneficiary relocates before the 18th paid rental month to an area that is outside the normal service area of the supplier that initially furnished the equipment. We are proposing to revise the regulation to require the supplier that furnishes the oxygen equipment and receives payment for month 18 or later to either furnish the equipment for the remainder of the 36-month rental payment period or, in the case where the beneficiary has relocated outside the service area of the supplier, make arrangements for furnishing the oxygen equipment with another supplier for the remainder of the 36-month rental payment period. The supplier that is required to furnish the equipment on the basis of this requirement must also furnish the equipment after the 36-month rental payment period in accordance with the requirements of section 1834(a)(5)(F)(ii) and § 414.226(f).
The proposed revision would mean that a supplier does not have to continue to furnish the oxygen equipment if the beneficiary relocates outside the normal service area before the 18th paid rental month during a period of continuous use. Under the current rule, a supplier does not have to furnish the oxygen equipment if the beneficiary relocated before the 36th paid rental month during a period of continuous use. The current rule was established based on the long term, demonstrated ability of suppliers of capped rental DME to accommodate
The National Transportation Safety Board (NTSB) is an independent Federal agency charged by the Congress with investigating transportation accidents, determining their probable cause and making recommendations to prevent similar accidents from occurring. Based on information derived from testimony provided at the NSTB public hearing and investigations into recent Helicopter Emergency Medical Services (HEMS) accidents, the NTSB made several specific recommendations to the Secretary of Health and Human Services on September 24, 2009.
Specifically, the NTSB recommended that the Secretary develop minimum safety accreditation standards for HEMS operators that augment the operating standards of 14 CFR part 135 by including for all fights with medical personnel on board: (a) Scenario-based pilot training; (b) implementation of preflight risk evaluation programs; and (c) the installation of FAA-approved terrain awareness warning systems, night vision imaging systems, flight data recording systems for monitoring and autopilots if a second pilot is not used.
In response to the NTSB concerns, the Secretary noted that the recommendations to CMS were similar to those being made to the Federal Aviation Administration (FAA). While we have expertise to regulate health and safety requirements that suppliers and providers of healthcare should meet, we do not have the expertise to determine aircraft safety requirements. The Secretary stated that, “we believe the FAA should determine the minimum level of safety that HEMS operators should meet and CMS should adopt regulations that require any HEMS operator that enrolls in Medicare to meet those requirements.” The Secretary also added that, “while we do not believe CMS should augment FAA regulations, we do believe that CMS' regulations should ensure that only those HEMS operators that maintain the minimum level of requirements established by the FAA through its regulations are enrolled or maintain enrollment in the Medicare program.”
In the April 21, 2006
While the Airline Deregulation Act (Pub. L. 95–504) preempts a State, political subdivision of a State, or political authority of at least 2 States from enacting or enforcing a law, regulation, or other provision having the force and effect of law related to a price, route, or service of an air carrier that may provide air transportation, air ambulances remain subject to Federal laws and regulations. In accordance with § 424.516(a)(2), providers and suppliers must adhere to all Federal regulations and State laws and regulations, as required, based on the type of services or supplies the provider or supplier type will furnish and bill Medicare.
In § 424.510(d)(iii), we are proposing to clarify that ambulance suppliers and other providers and suppliers include documentation regarding all applicable Federal and State certifications. Accordingly we are propsing to revise § 424.510(d)(iii) from “Submission of all documentation, including all applicable Federal and State licenses and regulatory requirements that apply to the specific provider or supplier type that relate to providing health care service, required by CMS under this or other statutory or regulatory authority, or under the Paperwork Reduction Act of 1995, to establish the provider or supplier's eligibility to furnish Medicare covered items or services to beneficiaries in the Medicare program,” to “Submission of all documentation, including all applicable Federal and State licenses, certifications (including, but not limited to Federal Aviation Administration and Clinical Laboratory Improvement Act certifications), and regulatory requirements that apply to the specific provider or supplier type that relate to providing health care service, required by CMS under this or other statutory or regulatory authority, or under the Paperwork Reduction Act of 1995, to establish the provider or supplier's eligibility to furnish Medicare covered items or services to beneficiaries in the Medicare program.”
We are also proposing to revise § 424.516(e)(2) and add new paragraph
We believe that requiring fixed-wing ambulance and HEMS operators to notify their Medicare contractor of a suspension or revocation of a license or certification will ensure that any action taken by the FAA or other regulating authority will have a direct linkage to the operator's ability to maintain their Medicare enrollment. We believe that such a policy will help improve aircraft safety for operators that are enrolled in Medicare and providing services to Medicare beneficiaries. In addition, since the FAA is responsible for the issuance and enforcement of regulations and minimum standards covering manufacturing, operating, and maintaining aircraft, we will work with the FAA to confirm that fixed-wing ambulance operators and HEMS operators remain in compliance with FAA safety regulations (including, but not limited to Federal Aviation Administration and certifications) to the Medicare contractor within 30 days of the revocation or suspension of the license or certification, the provider or supplier is making the decision to voluntarily terminate its Medicare billing privileges because the provider or supplier is no longer in compliance with the applicable licensing or certification requirements for their provider or supplier type. We believe that allowing providers and suppliers to self-report licensure or certification revocations and suspensions within a 30 day period via the Medicare enrollment application (such as, the Internet-based Provider Enrollment Chain and Ownership System (PECOS) or the paper CMS–855) promotes compliance with the Medciare reporting requirements found in § 424.516. In addition, by reporting a licensure or certification revocation or suspension within 30 days, the provider or supplier avoids the Medicare contractor bringing an action to revoke its Medicare billing privileges and establishing and Medicare enrollment bar, see § 424.535(c). Thus, by complying with the reporting responsibilities found in § 424.516 and voluntarily terminating from the Medicare program, the air ambulance supplier can submit an initial application to enroll in the Medicare program as soon as the licensure or certification revocation or suspension action is resolved with the applicable licensing or certification organization.
In § 424.502, we are proposing to define the term, “voluntary termination” as it is currently used in the Medicare program and throughout this regulation in the context of the provider enrollment requirements: We are proposing that the term, “voluntary termination” to mean an air ambulance supplier, that submits written confirmation to CMS of its decision to discontinue enrollment in the Medicare program.
Futhermore, we belive that an air ambulance supplier, can make the decision to voluntary terminate their business relationship with the Medicare program at any time, including when the provider or supplier makes the decision that they will no longer furnish services to Medicare beneficiaries.
In those situations, where an air ambulance supplier does not meet their reporting responsibilities and notify the Medicare program of a Federal or State licensure or certification revocation or suspension within 30 days of the reportable event, we believe that it is appropriate to that CMS or the Medicare contractor revoke the supplier's Medicare billing privileges using § 424.535(a)(1). We believe that this change will clarify that CMS or our Medicare contractor may revoke Medicare billing privileges when these types of suppliers do not report a revocation or suspension of a Federal or State license or certification.
We are proposing to revise § 409.23(c) by making a minor technical correction to remove an extraneous cross-reference which was initially proposed in the CY 2008 PFS proposed rule (72 FR 38122, 72 FR 38193, and 72 FR 38221). This cross-reference refers the reader to “paragraph (c)(1)(ii) of this section,” a paragraph also proposed in the CY 2008 PFS proposed rule, but never finalized. In the CY 2008 PFS final rule with comment period, we inadvertently neglected to remove the associated cross-reference from the regulations text. Accordingly, we now propose to rectify that oversight by making an appropriate correction in the regulations text, along with other minor formatting revisions. We are also proposing to make a minor clarification to the section heading and introductory text of § 409.23 (along with a conforming revision to the corresponding regulations text at § 409.20(a)(3)) by revising the existing phrase “speech therapy” to read “speech-language pathology services,” so that it more accurately reflects the currently used terminology for this type of therapeutic treatment.
In addition, we are also proposing to make a minor wording change in the provision at § 409.17(d) (which is incorporated by reference in § 409.23(c)(2)), in order to clarify that the former provision's reference to “hospital” policies and procedures can alternatively refer, depending on the particular context, to SNF policies and procedures.
In § 410.3, we are proposing a technical correction to paragraph (b)(2). Currently, § 410.3(b)(2) states that the specific rules on payment are set forth in subpart E of part 410. However, the specific payment rules are actually listed in subpart I of part 410. Therefore, we are proposing to correct § 410.3(b)(2) in this proposed rule.
Under the Paperwork Reduction Act of 1995, we are required to provide 60-day notice in the
• The need for the information collection and its usefulness in carrying out the proper functions of our agency.
• The accuracy of our estimate of the information collection burden.
• The quality, utility, and clarity of the information to be collected.
• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.
We are soliciting public comment on each of these issues for the following sections of this document that contain information collection requirements (ICRs):
Proposed § 410.32(d)(2)(i) would require the physician or qualified non physician practitioner (as defined in § 410.32(a)(2)) who orders the service must maintain documentation of medical necessity in the beneficiary's medical record. In addition, both the medical record and the laboratory requisition (or order) would be required to be signed by the physician or qualified non physician practitioner (as defined in § 410.32(a)(2) of this section) who orders the service. The burden associated with these requirements would be the time and effort necessary for a physician or qualified nonphysician practitioner to sign the medical record or laboratory requisition (or order). There would also be a recordkeeping requirement associated with maintaining the documentation of medical necessity in the beneficiary medical record. While these requirements are subject to the PRA, we believe the associated burden is exempt from the PRA in accordance with 5 CFR 1320.3(b)(2). We believe that the time, effort, and financial resources necessary to comply with the aforementioned information collection requirements would be incurred by persons in the normal course of their activities and therefore considered to be usual and customary business practices.
Proposed § 411.355(b)(7)(i) states that with respect to magnetic resonance imaging, computed tomography, and positron emission tomography, the referring physician shall provide written notice to the patient at the time of the referral that the patient may receive the same services from a person other than one described in § 411.355(b)(1). The written notice shall include a list of other suppliers (as defined in § 400.202 of this title) that provide the services for which the individual is being referred. The list shall include a minimum of 10 suppliers within a 25-mile radius of the referring physician's office location at the time of the referral. The notice should be written in a manner sufficient to be reasonably understood by all patients and should include for each supplier on the list, at a minimum, the supplier's name, address, telephone number, and distance from the referring physician's office. A record of the disclosure notification, signed by the patient, shall be maintained as a part of the patient's medical record.
Section 411.355(b)(7)(ii) proposes that if the referring physician makes a referral within an area with fewer than 10 other suppliers within the 25-mile radius of the physician's office location at the time of the referral, the physician shall list all of the other suppliers of the imaging service that are present within a 25-mile radius of the referring physician's office location, including up to 10 suppliers. Provision of the written list of alternate suppliers will not be required if no other suppliers provide the services for which the individual is being referred within the 25-mile radius. These physicians must still disclose to the patient that the patient may receive these services from a person other than one described in § 411.355(b)(1) in a manner sufficient to reasonably be understood by all patients. A record of the disclosure notification, signed by the patient and the referring physician, shall be maintained as a part of the patient's medical record.
The burden associated with the requirements contained in this section would be the time and effort necessary for a physician to develop a standard disclosure. There would also be burden associated with the time and effort necessary for a physician to provide the disclosure to the patient, to obtain the patient's signature, and to record the paper as part of the patient's medical record. We estimate that it would take 1 hour for a physician's office to develop a standard disclosure. We further estimate that 71,000 physicians will be required to comply with these requirements. The total burden associated with the development of the standard disclosure is 71,000 hours at a cost of $1,042,280. Similarly, we estimate that it will take each physician 1 minute to provide the disclosure to the patient, to obtain the patient's signature, and to record the paper as part of the patient's medical record. We believe that each provider will make approximately 106 disclosures. The total estimated annual for this requirement is 125,433 hours at a cost of $10,536,400.
Proposed § 414.423(c)(1)(i) states that CMS has the option to allow a DMEPOS supplier to provide a written CAP to remedy the deficiencies identified in the notice, when CMS determines that the delay in the termination date caused by allowing a CAP will not cause harm to beneficiaries. As stated in proposed § 414.423(c)(2)(i) a CAP must be submitted within 30 calendar days from the date on the notification letter. If the supplier decides not to submit a CAP the supplier may within 30 days of the date on the termination letter request a hearing by a CBIC hearing officer.
The burden associated with this requirement is the time and effort necessary for a supplier that has received a termination notice to develop and submit a CAP. We estimate that 10 suppliers will need to comply with this requirement annually. Similarly, we estimate that it will take a supplier an average of 3 hours to develop a CAP. The total estimated annual burden associated with this requirement is 30 hours at a cost of $2,250.
Proposed § 414.423(e)(2) would require that if CMS accepts the CAP, including supplier's designated timeframe for its completion, the supplier must provide a follow-up report within 5 days after the supplier has fully implemented the CAP that verifies that all of the deficiencies identified in the CAP have been corrected in accordance with the timeframes accepted by CMS. The burden associated with this requirement is the time and effort necessary for a supplier to develop and submit a follow-up report. While this requirement is subject to the PRA, we believe the associated burden is exempt under 5 CFR 1320.3(h)(6). In accordance with 5 CFR 1320.3(h)(6), a request for facts or opinions addressed to a single person is not defined as information collection requirements and is therefore exempt from the PRA.
Proposed § 414.423(f)(1) states that a supplier who has received a notice that CMS considers them in breach of contract or that their CAP is not acceptable has the right to request a hearing before a CBIC HO who was not involved with the original determination. Section 414.423(f)(2) further proposes that a supplier who wishes to appeal the termination notice must submit a written request to the CBIC. The request for a hearing must be received by the CBIC within 30 calendar days from the date of the notice to terminate.
The burden associated with this section is the time and effort necessary for a supplier to develop and submit a written request for a hearing by a CBIC Hearing Officer. We estimate that it will take a supplier 8 hours to develop and submit a request for a hearing. We believe 5 suppliers will be subject to this requirement on an annual basis. The total estimated annual burden associated with developing and submitting a written request for a
Proposed § 414.423 would require a contract suppliers whose contract has been terminated to notify all beneficiaries who are receiving rented competitive bid items or competitive bid items received on a recurring basis, of the termination of their contract. The notice to the beneficiary from the supplier whose contract was terminated must be provided within 5 days of receipt of the notice of termination. The notification to the beneficiaries must inform the beneficiaries that they are going to have to select a new contract supplier for these items.
The burden associated with this section is the time and effort necessary for a supplier to develop and distribute notification of its termination to all beneficiaries receiving rented competitive bid items or competitive bid items received on a recurring basis. We estimate that it will take a supplier 3 hours to develop and distribute a notice announcing its termination to all of its beneficiaries receiving rented competitive bid items or competitive bid items received on a recurring basis. We believe 2 suppliers will be subject to this requirement on an annual basis. The total estimated annual burden associated with this requirement is 6 hours at a cost of $450.
Proposed § 424.516(e)(2) would require a provider or supplier to report a revocation or suspension to the applicable Medicare contractor within 30 days any revocation or suspension of a Federal or State license or certification. Similarly, proposed § 424.516(e)(2) states that within 30 days of voluntary withdrawal or involuntary termination from the Medicare program, the provider or supplier must report voluntary withdraw or involuntary termination to the applicable Medicare contractor. The burden associated with the requirements in § 424.516(e)(2) and (3) is the time and effort necessary for a provider or supplier to report the required information to the applicable Medicare contractor. While these requirements are subject to the PRA, each submission will be evaluated on a case-by-case basis.
Proposed § 424.516(e)(2) would require a provider or supplier to report a revocation or suspension to the applicable Medicare contractor within 30 days any revocation or suspension of a Federal or State license or certification. Similarly, proposed § 424.516(e)(2) states that within 30 days of voluntary withdrawal or involuntary termination from the Medicare program, the provider or supplier must report voluntary withdraw or involuntary termination to the applicable Medicare contractor. The burden associated with the requirements in § 424.516(e)(2) and (3) is the time and effort necessary for a provider or supplier to report the required information to the applicable Medicare contractor. While these requirements are subject to the PRA, each submission will be evaluated on a case-by-case basis.
If you comment on these information collection and recordkeeping requirements, please do either of the following:
1. Submit your comments electronically as specified in the
2. Submit your comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: CMS Desk Officer, [CMS–1503–P] Fax: (202) 395–6974; or E-mail:
This proposed rule imposes collection of information requirements as outlined in the regulation text and specified above. However, this proposed rule also makes reference to several associated information collections that are not discussed in the regulation text contained in this document. The following is a discussion of these information collections, some of which have already received OMB approval.
The discussion of average sales price (ASP) issues in section VI.A.1 of this proposed rule does not contain any new information collection requirements with respect to payment for Medicare Part B drugs and biologicals under the ASP methodology. Drug manufacturers are required to submit ASP data to us on a quarterly basis. The ASP reporting requirements are set forth in section 1927(b) of the Act. The burden associated with this requirement is the time and effort required by manufacturers of Medicare Part B drugs and biologicals to calculate, record, and submit the required data to CMS. While the burden associated with this requirement is subject to the PRA, it is currently approved under OMB control number 0938–0921.
Section VI.F.1. of this proposed rule discusses the background of the PQRI, provides information about the proposed measures and reporting mechanisms to be available to eligible professionals (EPs) and group practices who choose to participate in the 2011 PQRI, and the proposed criteria for satisfactory reporting in 2011.
With respect to satisfactory submission of data on quality measures by EPs, EPs include physicians, other practitioners as described in section 1842(b)(18)(c) of the Act, physical and occupational therapists, qualified speech-language pathologists, and qualified audiologists. EPs may choose whether to participate and, to the extent they satisfactorily submit data on quality measures for covered professional services, they can qualify to receive an incentive payment. To qualify to receive an incentive payment for 2011, the EP (or group practice) must meet one of the proposed criteria for satisfactory reporting described in sections VI.F.1.e. or VI.F.1.f. of this proposed rule (or section VI.F.1.g. for group practices).
Because this is a voluntary program, it is difficult to accurately estimate how many EPs will opt to participate in the PQRI in CY 2011. Information from the “PQRI 2007 Reporting Experience Report,” which is available on the PQRI section of the CMS Web site at
For individual EPs, the burden associated with the requirements of this reporting initiative is the time and effort associated with EPs identifying applicable PQRI quality measures for which they can report the necessary information, collecting the necessary information, and reporting the information needed to report the EP's or group practice's measures. We believe it is difficult to accurately quantify the burden because EPs may have different processes for integrating the PQRI into their practice's work flows. Moreover, the time needed for an EP to review the quality measures and other information, select measures applicable to his or her patients and the services he or she furnishes to them, and incorporate the use of quality data codes into the office work flows is expected to vary along with the number of measures that are potentially applicable to a given professional's practice. Since EPs are generally required to report on at least 3 measures to earn a PQRI incentive, we will assume that each EP who attempts to submit PQRI quality measures data is attempting to earn a PQRI incentive payment and reports on an average of 3 measures for this burden analysis.
Because we anticipate even greater participation in the 2011 PQRI than in previous years, including participation by EPs who are participating in PQRI for the first time in 2011, we will assign 5 hours as the amount of time needed for EPs to review the 2011 PQRI Measures List, review the various reporting options, select the most appropriate reporting option, identify the applicable measures or measures groups for which they can report the necessary information, review the measure specifications for the selected measures or measures groups, and incorporate reporting of the selected measures or measures groups into the office work flows. This estimate is based on our assumption that an EP will need up to 2 hours to review the 2011 PQRI Measures List, review the reporting options, and select a reporting option and measures on which to report and 3 hours to review the measure specifications for up to 3 selected measures or up to 1 selected measures group and to develop a mechanism for incorporating reporting of the selected measures or measures group into the office work flows.
Information from the Physician Voluntary Reporting Program (PVRP), which was a predecessor to the PQRI, indicated an average labor cost of $50 per hour. To account for salary increases over time, we will use an average practice labor cost of $58 per hour in our estimates based on an assumption of an average annual increase of approximately 3 percent. Thus, we estimate the cost for EP associated with preparing to report PQRI quality measures would be approximately $290 per EP ($58 per hour x 5 hours).
We continue to expect the ongoing costs associated with PQRI participation to decline based on an EP's familiarity with and understanding of the PQRI, experience with participating in the PQRI, and increased efforts by CMS and stakeholders to disseminate useful educational resources and best practices.
We believe the burden associated with actually reporting the PQRI quality measures will vary depending on the reporting mechanism selected by the EP. For claims-based reporting, EPs must gather the required information, select the appropriate quality data codes (QDCs), and include the appropriate QDCs on the claims they submit for payment. The PQRI will collect QDCs as additional (optional) line items on the existing HIPAA transaction 837–P and/or CMS Form 1500 (OCN: 0938–0999). We do not anticipate any new forms and no modifications to the existing transaction or form. We also do not anticipate changes to the 837–P or CMS Form 1500 for CY 2011.
Based on our experience with the PVRP, we continue to estimate that the time needed to perform all the steps necessary to report each measure (that is, reporting the relevant quality data code(s) for a measure) on claims ranges from 15 seconds (0.25 minutes) to over 12 minutes for complicated cases and/or measures, with the median time being 1.75 minutes. At an average labor cost of $58 per hour per practice, the cost associated with this burden ranges from $0.24 in labor to about $11.60 in labor time for more complicated cases and/or measures, with the cost for the median practice being $1.69.
The total estimated annual burden for this requirement will also vary along with the volume of claims on which quality data is reported. In previous years, when we required reporting on 80 percent of eligible cases for claims-based reporting, we found that on average, the median number of reporting instances for each of the PQRI measures was 9. Since we propose to reduce the required reporting rate by over one-third to 50 percent, then for purposes of this burden analysis we will assume that an EP will need to report each selected measure for 6 reporting instances. The actual number of cases on which an eligible professional would be required to report quality measures data will vary, however, with the EP's patient population and the types of measures on which the EP chooses to report (each measure's specifications includes a required reporting frequency).
Based on the assumptions discussed above, we estimate the total annual reporting burden per EP associated with claims-based reporting to range from 4.5 minutes (0.25 minutes per measure × 3 measures × 6 cases per measure) to 180 minutes (12 minutes per measure × 3 measures × 6 cases per measure), with the burden to the median practice being 31.5 minutes (1.75 minutes per measure × 3 measures × 6 cases). We estimate the total annual reporting cost per EP associated with claims-based reporting to range from $4.32 ($0.24 per measure × 3 measures × 6 cases per measure) to $208.80 ($11.60 per measure × 3 measures × 6 cases per measure), with the cost to the median practice being $30.42 per EP ($1.69 per measure × 3 measures × 6 cases per measure).
For registry-based reporting, there would be no additional time burden for EP to report data to a registry as EP
Registries interested in submitting quality measures results and numerator and denominator data on quality measures to CMS on their participants' behalf in 2011 would need to complete a self-nomination process in order to be considered “qualified” to submit on behalf of EPs unless the registry was qualified to submit on behalf of EPs for prior years and did so successfully. We estimate that the self-nomination process for qualifying additional registries to submit on behalf of EPs for the 2011 PQRI involves approximately 1 hour per registry to draft the letter of intent for self-nomination. It is estimated that each self-nominated entity will also spend 2 hours for the interview with CMS officials and 2 hours calculating numerators, denominators, and measure results for each measure the registry wishes to report using a CMS-provided measure flow. However, the time it takes to complete the measure flow could vary depending on the registry's experience and the number and type of measures for which the registry wishes to submit on behalf of EPs. Additionally, part of the self-nomination process involves the completion of an XML submission by the registry, which is estimated to take approximately 5 hours, but may vary depending on the registry's experience. We estimate that the registry staff involved in the registry self-nomination process have an average labor cost of $50 per hour. Therefore, assuming the total burden hours per registry associated with the registry self-nomination process is 10 hours, we estimate the total cost to a registry associated with the registry self-nomination process to be approximately $500 ($50 per hour × 10 hours per registry).
The burden associated with the registry-based reporting requirements of this voluntary reporting initiative is the time and effort associated with the registry calculating quality measure results from the data submitted to the registry by its participants and submitting the quality measures results and numerator and denominator data on quality measures to CMS on behalf of their participants. The time needed for a registry to review the quality measures and other information, calculate the measures results, and submit the measures results and numerator and denominator data on the quality measures on their participants behalf is expected to vary along with the number of EPs reporting data to the registry and the number of applicable measures. However, we believe that registries already perform many of these activities for their participants. The number of measures that the registry intends to report to CMS and how similar the registry's measures are to CMS' PQRI measures will determine the time burden to the registry.
For EHR-based reporting, the EP must have an IACS account, which we believe takes less than 1 hour to obtain. Once an EP has an IACS account, he or she must extract the necessary clinical data from his or her EHR, and submit the necessary data to the CMS-designated clinical data warehouse. With respect to our proposal to require an EP to submit a test file, we believe that doing so would take less than 1 hour. With respect to submitting the actual 2011 data file in 2012, we believe that this would take an EP no more than 2 hours, depending on the number of patients on which the EP is submitting. We believe that once the EHR is programmed by the vendor to allow data submission to CMS, the burden to the EP associated with submission of data on PQRI quality measures should be minimal. Because this manner of reporting quality data to CMS was new to PQRI for 2010 and no EHR data submissions have taken place yet, it is difficult to estimate how many EPs will opt to participate in the PQRI through the EHR mechanism in CY 2011.
An EHR vendor interested in having their product(s) be used by EPs to submit PQRI quality measures data to CMS were required to complete a self-nomination process in order for the vendor's product(s) to be considered “qualified” for 2011. It is difficult to accurately quantify the burden associated with the EHR self-nomination process as there is variation regarding the technical capabilities and experience among vendors. For purposes of this burden analysis, however, we estimate that the time required for an EHR vendor to complete the self-nomination process will be similar to the time required for registries to self-nominate that is approximately 10 hours at $50 per hour for a total of $500 per EHR vendor ($50 per hour x 10 hours per EHR vendor).
The burden associated with the EHR vendor programming its EHR product(s) to extract the clinical data that the EP needs to submit to CMS for purposes of reporting 2010 PQRI quality measures will be dependent on the EHR vendor's familiarity with PQRI, the vendor's system capabilities, as well as the vendor's programming capabilities. Some vendors already have these necessary capabilities and for such vendors, we estimate the total burden hours to be 40 hours at a rate of $50 per hour for a total burden estimate of $2,000 ($50 per hour x 40 hours per vendor). However, given the variability in the capabilities of the vendors, those vendors with minimal experience would have a burden of approximately 200 hours at $50 per hour, for a total estimate of $10,000 per vendor ($50 per hour x 200 hours per EHR vendor).
With respect to the process for group practices to be treated as satisfactorily submitting quality measures data under the 2011 PQRI discussed in section VI.F.1. of this proposed rule, group practices interested in participating in the 2011 PQRI through one of the proposed group practice reporting options would need to complete a self-nomination process similar to the self-nomination process required of registries and EHR vendors. Therefore, assuming 2 hours for a group practice to decide whether to participate as a group or individually, approximately 2 hours per group practice to draft the letter of intent for self-nomination, gather the requested information, and provide this requested information, and an additional 2 hours undergoing the vetting process with CMS officials, we estimate a total of 6 hours associated with the self-nomination process. Assuming that the group practice staff involved in the group practice self-nomination process have the same average practice labor cost as the average practice labor cost estimates we used for individual EPs of $58 per hour, we estimate the total cost to a group practice associated with the group practice self-nomination process to be approximately $348 ($58 per hour x 6 hours per group practice).
The burden associated with the group practice reporting requirements of this voluntary reporting initiative is the time and effort associated with the group practice submitting the quality measures data. For practices participating under the proposed GPRO I process, this would be the time associated with the physician group completing the data collection tool. The information collection components of this data collection tool have been reviewed by OMB and are currently approved under
For group practices participating under the proposed GPRO II process, the burden associated with submitting the PQRI quality measures data would be the time associated with the group practice submitting the required data to CMS via claims or a registry. We would expect that data submission under GPRO II would take no more time than the time it would take an individual EP to submit via claims or registry. We believe it would be appropriate to multiply the appropriate burden estimates for each reporting mechanism for individual EPs by the number of EPs in a group to obtain the burden estimates for data submission under GPRO II. For example, based on our estimate of 15.75 minutes per EP under claims-based reporting, we would expect that a 2-person group would have a burden of 31.50 minutes for claims-based submission under GPRO II.
We invite comments on this burden analysis, including the underlying assumptions used in developing our burden estimates.
We believe it is difficult to accurately estimate how many EPs will opt to participate in the eRx Incentive Program in CY 2011. Final participation numbers from the first year of the eRx Incentive Program (2009) are not available. Information from the “PQRI 2007 Reporting Experience Report,” which is available on the PQRI section of the CMS Web site at
Section VI.F.2 of this proposed rule discusses the background of the eRx Incentive Program. Section VI.F.2.b.(2) of this proposed rule provides information on how we propose EPs and group practices can qualify to be considered a successful electronic prescriber in 2011 in order to earn an incentive payment. For 2011, EPs and group practices may choose whether to participate and, to the extent they meet— (1) certain thresholds with respect to the volume of covered professional services furnished; and (2) the criteria to be considered a successful electronic prescriber described in section VI.F.2.b.(2) of this proposed rule, they can qualify to receive an incentive payment for 2011 and/or avoid being subject to a penalty that goes into effect in 2012.
For the 2011 eRx Incentive Program, as discussed in section VI.F.2. of this proposed rule, we propose that each EP would need to report the G-code indicating that at least one prescription generated during an encounter was electronically submitted at least 25 instances during the reporting period. We expect the ongoing costs associated with participation in the eRx Incentive Program to decline based on an EP's familiarity with and understanding of the eRx Incentive Program, experience with participating in the eRx Incentive Program, and increased efforts by CMS and stakeholders to disseminate useful educational resources and best practices.
Similar to PQRI, one factor in the burden to individual EPs would be the time and effort associated with individual EPs reviewing the electronic prescribing measure to determine whether it is applicable to them, reviewing the available reporting options (we propose this measure would be reportable through claims-based reporting, registry-based reporting, or through EHRs) and selecting one, gathering the required information, and incorporating reporting of the measure into their office work flows. Since the eRx Incentive Program consists of only 1 measure to report, we estimate 2 hours as the amount of time needed for individual EPs to prepare for participation in the eRx Incentive Program. At an average cost of approximately $58 per hour per practice, we estimate the total preparation costs to individual EPs to be approximately $116 (2 hours × $58 per hour).
Another factor that influences the burden to EPs is how they choose to report the electronic prescribing measure. For EPs who choose to do so via claims, we estimate that the burden associated with the requirements of this incentive program is the time and effort associated with gathering the required information, selecting the appropriate quality data codes (QDCs), and including the appropriate QDCs on the claims they submit for payment. For claims-based reporting, the QDCs will be collected as additional (optional) line items on the existing HIPAA transaction 837–P and/or CMS Form 1500. We do not anticipate any new forms and no modifications to the existing transaction or form. We also do not anticipate changes to the 837–P or CMS Form 1500 for CY 201.
Based on the information from the PVRP described above for the amount of time it takes a median practice to report one measure one time on claims (1.75 minutes) and our proposal to require EPs to report the measure 25 times, we estimate the burden associated with claims-based data submission to be 43.75 minutes (1.75 minutes per case × 1 measure × 25 cases per measure). This equates to a cost of approximately $42.29 (1.75 minutes per case × 1 measure × 25 cases per measure × $58 per hour) per individual EP.
Because registry-based reporting of the electronic prescribing measure to CMS was added to the eRx Incentive Program for 2010 and EPs are not required to indicate to us how they plan to report the electronic prescribing measure each year, it is difficult to accurately estimate how many EPs will opt to participate in the eRx Incentive Program through the registry-based reporting mechanism in CY 2011. We do not anticipate, however, any additional burden for EPs to report data to a registry as EPs opting for registry-based reporting would more than likely already be reporting data to the registry for other purposes. Little, if any, additional data would need to be reported to the registry for purposes of participation in the 2011 eRx Incentive Program. However, EPs would need to authorize or instruct the registry to submit quality measures results and numerator and denominator data on the electronic prescribing measure to CMS on their behalf. We estimate that the time and effort associated with this would be approximately 5 minutes for each EP that wishes to authorize or instruct the registry to submit quality measures results and numerator and denominator data on the electronic
Based on our proposal to consider only registries qualified to submit PQRI quality measures results and numerator and denominator data on quality measures to CMS on their participants' behalf for the 2010 PQRI to be qualified to submit results and numerator and denominator data on the electronic prescribing measure for the 2010 eRx Incentive Program, there would be no need for a registry to undergo a separate self-nomination process for the eRx Incentive Program and therefore, no additional burden associated with the registry self-nomination process.
There would also be a burden to the registry associated with the registry calculating results for the electronic prescribing measure from the data submitted to the registry by its participants and submitting the quality measures results and numerator and denominator data on the electronic prescribing quality measure to CMS on behalf of their participants. The time needed for a registry to review the electronic prescribing measure and other information, calculate the measure's results, and submit the measure's results and numerator and denominator data on the measure on their participants behalf is expected to vary along with the number of EPs reporting data to whom the measure applies. However, we believe that registries already perform many of these activities for their participants. Since the E–Prescribing Incentive Program consists of only one measure, we believe that the burden associated with the registry reporting the measure's results and numerator and denominator to CMS on behalf of their participants would be minimal.
For EHR-based reporting, the EP must extract the necessary clinical data from his or her EHR and submit the necessary data to the CMS-designated clinical data warehouse. Because this manner of reporting quality data to CMS was first added to the eRx Incentive Program in 2010 and EPs are not required to indicate to us how they intend to report the electronic prescribing measure, it is difficult to estimate how many EPs will opt to participate in the eRx Incentive Program through the EHR-based reporting mechanism in CY 2011. We believe that once an EP's EHR is programmed by the vendor to allow data submission to CMS, the burden to the EP associated with submission of data on the electronic prescribing measure should be minimal.
Since we are considering only EHR products qualified for the 2010 PQRI to be qualified for the 2011 eRx Incentive Program, there would be no need for EHR vendors to undergo a separate self-nomination process for the 2011 eRx Incentive Program and therefore, no additional burden associated with the self-nomination process.
There would also be a burden to the EHR vendor associated with the EHR vendor programming its EHR product(s) to extract the clinical data that the EP needs to submit to CMS for purposes of reporting the proposed 2011 electronic prescribing measure. The time needed for an EHR vendor to review the measure and other information and program each qualified EHR product to enable EPs to submit data on the measure to the CMS-designated clinical data warehouse will be dependent on the EHR vendor's familiarity with the electronic prescribing measure, the vendor's system capabilities, as well as the vendor's programming capabilities. Since only EHR products qualified for the 2011 PQRI would be qualified for the 2011 eRx Incentive Program and the eRx Incentive Program consists of only one measure, we believe that any burden associated with the EHR vendor to program its product(s) to enable EPs to submit data on the electronic prescribing measure to the CMS-designated clinical data warehouse would be minimal.
Finally, with respect to the process for group practices to be treated as successful electronic prescribers under the 2011 eRx Incentive Program discussed in section VI.F.2. of this proposed rule, we propose that group practices would have the same options as individual EPs in terms of the form and manner for reporting the electronic prescribing measure (that is, group practices would have the option of reporting the measure through claims, a qualified registry, or a qualified EHR product). There are only 2 differences between the proposed requirements for an individual EP and a group practice: (1) The fact that a group practice would have to self-nominate; and(2) the number of times that a group practice would be required to report the electronic prescribing measure.
We do not anticipate any additional burden associated with the group practice self-nomination practice since we propose to limit the group practices to those selected to participate in the 2011 PQRI GPRO I or PQRI GPRO II. The practice only would need to indicate their desire to participate in the eRx GPRO at the same time they self-nominate for either PQRI GPRO I or PQRI GPRO II and indicate how they intend to report the electronic prescribing measure.
In terms of the burden to group practices associated with submission of the electronic prescribing measure, we believe that this would be similar to the burden to individual EPs for submitting the electronic prescribing measure. In fact, overall, there could be less burden associated with a practice participating as a group rather than as individual EPs because the total number of reporting instances required by the group could be less than the total number of reporting instances that would be required if each member of the group separately reported the electronic prescribing measure. Thus, we believe that the burden to a group practice associated with reporting the electronic prescribing measure could range from almost no burden (for groups who choose to do so through a qualified EHR or registry) to 72.92 hours (1.75 minutes per measure × 1 measure × 2,500 cases per measure) for a GPRO I group who chooses to report the electronic prescribing measures through claims submission. Consequently, the total estimated cost per group practice to report the electronic prescribing measure could be as high as $4,225 ($1.69 per measure × 1 measure × 2,500 cases per measure).
As with individual EPs, we believe that group practices that choose to participate in the 2011 eRx GPRO through registry-based reporting of the electronic prescribing measure would more than likely already be reporting data to the registry. Little, if any, additional data would need to be reported to the registry for purposes of participation in the 2011 eRx Incentive Program beyond authorizing or instructing the registry to submit quality measures results and numerator and denominator data on the electronic prescribing measure to CMS on their behalf. We estimate that the time and effort associated with this would be approximately 5 minutes for each group practice that wishes to authorize or instruct the registry to submit quality measures results and numerator and denominator data on the electronic prescribing measure to CMS on their behalf.
For group practices that choose to participate in the 2011 eRx Incentive Program through EHR-based reporting of the electronic prescribing measure, once the EHR is programmed by the vendor to allow data submission to CMS, the burden to the group practice associated with submission of data on the electronic prescribing measure should be minimal.
We invite comments on this burden analysis, including the underlying
Because of the large number of public comments we normally receive on
We have examined the impacts of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96–354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4), Executive Order 13132 on Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C. 804(2)).
Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). We estimate, as discussed below in this section, that the PFS provisions included in this proposed rule will redistribute more than $100 million in 1 year. Therefore, we estimate that this rulemaking is “economically significant” as measured by the $100 million threshold, and hence also a major rule under the Congressional Review Act. Accordingly, we have prepared a Regulatory Impact Analysis that to the best of our ability presents the costs and benefits of the rulemaking.
The RFA requires agencies to analyze options for regulatory relief of small businesses, if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, we estimate that most hospitals and most other providers are small entities as that term is used in the RFA (including small businesses, nonprofit organizations, and small governmental jurisdictions). The great majority of hospitals and most other health care providers and suppliers are small entities, either by being nonprofit organizations or by meeting the SBA definition of a small business (having revenues of less than $34.5 million in any 1 year) (for details see the SBA's Web site at
For purposes of the RFA, physicians, NPPs, and suppliers including IDTFs are considered small businesses if they generate revenues of $10 million or less based on SBA size standards. Approximately 95 percent of physicians are considered to be small entities. There are over 1 million physicians, other practitioners, and medical suppliers that receive Medicare payment under the PFS.
For purposes of the RFA approximately 85 percent of suppliers of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) are considered small businesses according to the SBA size standards. Our most recent claims information includes 47,000 entities billing Medicare for DMEPOS each year. Total annual estimated Medicare expenditures for DMEPOS suppliers are approximately $10.1 billion in CY 2009, for which $8.1 billion was fee-for-service (FFS) and $2 billion was for managed care.
For purposes of the RFA, approximately 80 percent of clinical diagnostic laboratories are considered small businesses according to the SBA size standards.
Ambulance providers and suppliers for purposes of the RFA are also considered to be small entities.
In addition, most ESRD facilities are considered small entities for purposes of the RFA, either based on nonprofit status or by having revenues of $34.5 million or less in any year. We note that a considerable number of ESRD facilities are owned and operated by large dialysis organizations (LDOs) or regional chains, which would have total revenues more than $34.5 million in any year if revenues from all locations are combined. However, the claims data we use to estimate payments for this RFA and RIA does not identify which dialysis facilities are parts of an LDO, regional chain, or other type of ownership. Each individual dialysis facility has its own provider number and bills Medicare using this number. Therefore, we consider each ESRD facility to be a small entity for purposes of the RFA. We consider a substantial number of entities to be significantly affected if the proposed rule has an annual average impact on small entities of 3 to 5 percent or more. The majority of ESRD facilities will experience impacts of approximately 2 percent of total revenues. There are 954 nonprofit ESRD facilities with a combined increase of 2.1 percent in overall payments relative to current overall payments. We note that although the overall effect of the wage index changes is budget neutral, there are increases and decreases based on the location of individual facilities. The analysis and discussion provided in this section and elsewhere in this proposed rule complies with the RFA requirements.
Because we acknowledge that many of the affected entities are small entities, the analysis discussed throughout the preamble of this proposed rule constitutes our regulatory flexibility analysis for the remaining provisions and addresses comments received on these issues.
In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis, if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. Any such regulatory impact analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100 beds. We do not believe this proposed rule has impact on significant operations of a substantial number of small rural hospitals because most dialysis facilities are freestanding. While there are 184 rural hospital-based dialysis facilities, we do not know how many of them are based at hospitals with fewer than 100 beds. However, overall, the 184 rural hospital-based dialysis facilities will experience an estimated 2.1 percent increase in payments. As a result, this rule will not have a significant impact on small rural hospitals. Therefore, the Secretary has determined that this proposed rule will not have a significant impact on the operations of a substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2010, that threshold is approximately $135 million. This proposed rule will not mandate any requirements for State, local, or tribal governments in the aggregate, or by the private sector, of $135 million. Medicare beneficiaries are considered to be part of the private sector and as a result a more detailed discussion is presented on the Impact of Beneficiaries in section IX.G. of this regulatory impact analysis.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. We have examined this proposed rule in accordance with Executive Order 13132 and have determined that this regulation would not have any substantial direct effect on State or local governments, preempt States, or otherwise have a Federalism implication.
We have prepared the following analysis, which together with the information provided in the rest of this preamble, meets all assessment requirements. The analysis explains the rationale for and purposes of this proposed rule; details the costs and benefits of the rule; analyzes alternatives; and presents the measures we will use to minimize the burden on small entities. As indicated elsewhere in this rule, we are implementing a variety of changes to our regulations, payments, or payment policies to ensure that our payment systems reflect changes in medical practice and the relative value of services. We provide information for each of the policy changes in the relevant sections of this proposed rule. We are unaware of any relevant Federal rules that duplicate, overlap, or conflict with this proposed rule. The relevant sections of this rule contain a description of significant alternatives if applicable.
Section 1848(c)(2)(B)(ii) of the Act requires that increases or decreases in RVUs may not cause the amount of expenditures for the year to differ by more than $20 million from what expenditures would have been in the absence of these changes. If this threshold is exceeded, we make adjustments to preserve budget neutrality.
Our estimates of changes in Medicare revenues for PFS services compare payment rates for CY 2010 with proposed payment rates for CY 2011 using CY 2009 Medicare utilization for all years. To the extent that there are year-to-year changes in the volume and mix of services provided by physicians, the actual impact on total Medicare revenues will be different than those shown in Table 73. The payment impacts reflect averages for each specialty based on Medicare utilization. The payment impact for an individual physician would be different from the average, based on the mix of services the physician furnishes. The average change in total revenues would be less than the impact displayed here because physicians furnish services to both Medicare and non-Medicare patients and specialties may receive substantial Medicare revenues for services that are not paid under the PFS. For instance, independent laboratories receive approximately 85 percent of their Medicare revenues from clinical laboratory services that are not paid under the PFS.
Table 73 shows only the payment impact on PFS services. We note that these impacts do not include the effect of the current law −6.1 percent CY 2011 PFS update. The following is an explanation of the information represented in Table 73:
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The most widespread specialty impacts of the RVU changes are generally related to two factors. First, as discussed in section II.A.2. of this proposed rule, we are currently implementing the second year of the 4-year transition to new PE RVUs using the new PPIS data that were adopted in the CY 2010 PFS final rule with comment period (74 FR 61751). The impacts of using the new PPIS data are generally consistent with the impacts discussed in the CY 2010 PFS final rule with comment period (74 FR 61983 through 61984).
The second general factor contributing to the CY 2011 impacts shown in Table 73 is the proposed CY 2011 rescaling of the RVUs so that in the aggregate they match the proposed work, PE, and malpractice proportions in the rebased CY 2006 MEI. That is, as discussed in section II.E.1. of this proposed rule, the proposed rebased MEI has a greater proportion attributable to malpractice and PE and, correspondingly, a lesser proportion attributable to work. Specialties that have a high proportion of total RVUs attributable to work, such as anesthesiology, are estimated to experience a decrease in aggregate payments as a result of this rescaling, while specialties that have a high proportion attributable to PE, such as radiation oncology, are estimated to experience an increase in aggregate payments. Malpractice generally represents a small proportion of total payments and the rescaling of the malpractice RVUs is not the primary driver of the specialty impacts. As discussed in section II.E.1. of this proposed rule, the proposed rescaling of the RVUs to match the proposed rebased MEI is budget neutral overall.
Table 73 also includes the impacts resulting from our proposed regulatory change to apply the current 50 percent MPPR policy to therapy services. Under the PFS, we estimate that this change would primarily reduce payments to the specialties of physical therapy and occupational therapy. In order to maintain budget neutrality, we are proposing to redistribute the PFS savings back into other services paid under the PFS by increasing all PE RVUs by approximately 1 percent.
Because providers in settings outside of the PFS, such as outpatient hospital departments, are also paid using the PFS payment rates and policies for physical therapy services, we estimate that this proposal would reduce (not redistribute) payments in those settings for therapy services by approximately 13 percent in CY 2011.
In addition, Table 73 includes the impacts resulting from the proposed regulatory change to the scope of the current contiguous body area MPPR policy for imaging services from contiguous body areas to include noncontiguous body areas. We estimate that this change would primarily reduce payments to the specialties of IDTF and radiology. In order to maintain budget neutrality, we are proposing to redistribute these savings back into other services paid under the PFS by increasing all PE RVUs by approximately 0.1 percent.
Table 73 also reflects the impacts resulting from certain ACA provisions, including section 3135 that amends section 1848(b)(4) of the Act to reduce the payment for expensive diagnostic imaging equipment, and, effective July 1, 2010, increases the level of the MPPR for contiguous body areas from 25 percent to 50 percent. The proposed expansion of the MPPR policy is further discussed in section II.C.4. of this proposed rule, while the discussions of the provisions of section 3135 of the ACA are found in sections V.M. and II.A.3.a. of this proposed rule. As required by sections 1848(c)(2)(B)(v)(V) and (VI) of the Act (as added by sections 3135(a) and (b) of the ACA), these changes are not budget neutral and result in program savings. See section IX.D below for a discussion of the budget impacts of the ACA provisions.
We note that the payment impact for an individual physician may be different from the average, based on the mix of services the physician furnishes.
Column H of Table 73 displays the estimated CY 2011 combined impact on total allowed charges by specialty of all the proposed RVU and MPPR changes. These impacts range from an increase of 8 percent for portable x-ray suppliers, to a decrease of 12 percent for physical/occupational therapy. There is generally a slightly positive net effect of our proposals on primary care specialties, such as family practice, internal medicine, and geriatrics. Again, these impacts are estimated prior to the application of the negative CY 2011 CF update specified under the current statute.
Table 74 shows the estimated impact on total payments for selected high-volume procedures of all of the changes discussed previously, including the effect of the CY 2011 negative PFS CF update. We selected these procedures because they are the most commonly furnished by a broad spectrum of physician specialties. There are separate columns that show the change in the facility rates and the nonfacility rates. For an explanation of facility and nonfacility PE, we refer readers to Addendum A of this proposed rule.
As discussed in section II.D. of this proposed rule, we are required to update the GPCI values at least every 3 years and phase in the adjustment over 2 years (if there has not been an adjustment in the past year). For CY 2011, we are proposing new GPCIs for each Medicare locality. The updated GPCIs reflect the first year of the 2-year phase in. The new GPCIs rely upon the 2010 HUD data for determining the relative cost differences in the office rent component of the PE GPCIs, as well as the 2006 through 2007 professional malpractice premium data for determining the malpractice GPCIs. The 2006 through 2008 Bureau of Labor and Statistics (BLS) Occupational Employment Statistics (OES) data were used as a replacement for 2000 Census data for determining the physician work GPCIs and the employee compensation component of the PE GPCIs. As discussed in section II.D. of this proposed rule, the cost share weights for each GPCI value, that is, work, PE, and malpractice, reflect the same proportions determined for the proposed 2006-based MEI.
Additionally, the proposed GPCIs reflect several provisions required by the ACA. Section 1848(e)(1)(H) of the Act (as added by section 3102(b) of the ACA) specifies that for CY 2010 and CY 2011, the employee wage and rent portions of the PE GPCIs reflect only one-half of the relative cost differences for each locality compared to the national average and includes a “hold harmless” provision for any PFS locality that would receive a reduction to its PE GPCI resulting from the limited recognition of cost differences. Section 1848(e)(1)(E) of the Act (as amended by section 3102(a) of the ACA) extends the 1.000 work GPCI floor only through December 31, 2010. Therefore, the proposed CY 2011 GPCIs reflect the sunset of the 1.000 work GPCI floor. Section 1848(e)(1)(G) of the Act (as amended by section 134(b) of the MIPPA) established a permanent 1.500 work GPCI floor in Alaska, beginning January 1, 2009 and, therefore, the 1.500 work GPCI floor in Alaska will remain in place for CY 2011. Moreover, section 1848(e)(1)(I) of the Act (as added by section 10324(c) of the ACA) establishes a 1.000 PE GPCI floor for services furnished in frontier states effective January 1, 2011. OACT estimates the combined impact of these provisions on a fiscal year cash basis as $580 million for FY 2011.
As required by the statute, the updated GPCIs would be phased in over a 2-year period. Addendum D to this proposed rule shows the estimated effects of the revised GPCIs on locality
As discussed in section II.E.1. of this proposed rule, we are proposing to rebase and revise the MEI for the CY 2011 PFS. Substituting the proposed 2006 MEI weights in place of the 2000 weights and implementing the proposed revisions to the MEI has no impact on the projected MEI increase for CY 2011. The projected MEI update for CY 2011 is 0.3 percent under both the 2000-based and 2006-based MEI. After CY 2011, the MEI updates are slightly higher (0.1 percentage point) in the early part of the forecast, unchanged in the medium term, and slightly lower in the long term (between 0.1 to 0.2 percentage points).
This provision extends the exceptions process for therapy caps through December 31, 2010. Therapy caps are discussed in detail in section III.A.1. of this proposed rule. OACT estimates the impact on a fiscal year cash basis as $1.16 billion for FY 2011.
As discussed in section V.E. of this proposed rule, this provision continues payment to independent laboratories for the TC of physician pathology services for fee-for-service Medicare beneficiaries who are inpatients or outpatients of a covered hospital through CY 2010. OACT estimates the impact on a fiscal year cash basis as $80 million for FY 2011.
As discussed in section V.F. of this proposed rule, these provisions require the extension of certain add-on payments for ground ambulance services, and the extension of certain rural area designations for purposes of air ambulance payment. As further discussed in section V.F., we are amending the Medicare program regulations to conform the regulations to these provisions of the ACA. These statutory provisions are essentially prescriptive and do not allow for discretionary alternatives on the part of the Secretary.
As discussed in the July 1, 2004 interim final rule (69 FR 40288), in determining the super-rural bonus amount under section 1834(l)(12) of Act, we followed the statutory guidance of using the data from the Comptroller General (GAO) of the U.S. We obtained the same data as the data that were used in the GAO's September 2003 Report titled “Ambulance Services: Medicare Payments Can Be Better Targeted to Trips in Less Densely Populated Rural Areas” (GAO report number GAO–03–986) and used the same general methodology in a regression analysis as was used in that report. The result was that the average cost per trip in the lowest quartile of rural county populations was 22.6 percent higher than the average cost per trip in the highest quartile. As required by section 1834(l)(12) of the Act, this percent increase is applied to the base rate for ground ambulance transports that originate in qualified rural areas, which were identified using the methodology set forth in the statute. Payments for ambulance services under Medicare are determined by the point of pick-up (by zip code area) where the beneficiary is loaded on board the ambulance. We determined that ground ambulance transports originating in 7,842 zip code areas (which were determined to be in “qualified rural areas”) out of 42,879 zip code areas, according to the July 2010 zip code file, will realize increased base rate payments under this provision; however, the number and level of services that might occur in these areas for CY 2011 is unknown at this time. While many elements may factor into the final impact of sections 3105(a), (b), and (c) and 10311(a), (b), and (c) of the ACA, our Office of the Actuary (OACT) estimates the impact of all these provisions to be $10 million for FY 2011.
As discussed in section V.G. of this proposed rule, this provision extends the period of time for the five percent increase in Medicare payment for specified mental health services through CY 2010. OACT estimates the impact on a fiscal year cash basis as $20 million for FY 2011.
As discussed in section V.I. of this proposed rule, this provision restores payment for dual-energy x-ray absorptiometry (DXA) services furnished during CYs 2010 and 2011 to 70 percent of the Medicare rate paid in CY 2006. OACT estimates the impact on a fiscal year cash basis as $60 million for FY 2011.
As discussed in section V.K. of this proposed rule, this provision reinstitutes reasonable cost payment for clinical diagnostic laboratory tests performed by hospitals with fewer than 50 beds that are located in qualified rural areas as part of their outpatient services for cost reporting periods beginning on or after July 1, 2010 through June 30, 2011. For some hospitals with cost reports that begin as late as June 30, 2011, this reinstitution of reasonable cost payment could affect services performed as late as June 29, 2012, because this is the date those cost reports will close.
As discussed in section V.M. of this proposed rule, for services furnished on or after July 1, 2010, section 1848(b)(4)(D) of the Act (as added by section 3135(b) of the ACA) adjusts the technical component MPPR for multiple imaging studies provided in a single imaging session on contiguous body parts within families of codes from 25 percent to 50 percent as of July 1, 2010. For services furnished on or after January 1, 2011, section 1848(b)(4)(C) of the Act (as added by section 3135(a) of the ACA) increases the equipment utilization rate to 75 percent for expensive diagnostic imaging equipment, changing the CY 2011 transitional utilization rate adopted in
As discussed in section V.N. of this proposed rule, this provision requires the Secretary to revise the capped rental fee schedule amounts for all power wheelchairs effective for power wheelchairs furnished on or after January 1, 2011. Under the monthly capped rental payment structure, the fee schedule will pay 15 percent (instead of 10 percent) of the purchase price for the first three months and 6 percent (instead of 7.5 percent) for the remaining rental months not to exceed 13 months. In addition, the lump sum (up front) purchase payment will be eliminated for standard power-driven wheelchairs. For complex rehabilitative power-driven wheelchairs, the provision permits payment to be made on a lump sum purchase method or a monthly rental method. These changes are prescriptive in the statute and does not allow for discretionary alternatives.
We expect the changes mandated by section 3136 of the ACA as a whole to achieve program savings as a result of total payments per standard power wheelchair being less than 100 percent of the purchase fee schedule amount. This decrease in expenditures is expected for two reasons. Primarily, the provision will eliminate the lump sum payment method for standard power-driven wheelchairs and instead payment will be made under the monthly rental method resulting in lower aggregate payments because many beneficiaries who use standard power wheelchairs do not use them for as long as 13 months. In addition, we note that currently a significantly lower volume of power-driven wheelchairs are paid under the monthly payment method. The payment impact of increasing monthly rental payments in the initial 3 months will be offset both by the savings achieved from eliminating the lump sum payment method for standard power-driven wheelchairs and by decreasing payments for the remaining months of rental from 7.5 percent to 6 percent of the purchase price for all power-driven wheelchairs. We compared the estimates of current payments for power-driven wheelchairs to estimates of payments resulting from the changes which showed an estimated payment impact of a decrease in expenditures of approximately $780 million over a 5-year period. The FY 2011 cash savings was $120 million.
As discussed in section V.P. of this proposed rule, section 3401 of the ACA incorporates a productivity adjustment into the update factors for certain payment systems. Specifically, section 3401 requires that in CY 2011 (and in subsequent years), update factors under the ambulatory surgical center payment system, the ambulance fee schedule, and the clinical laboratory fee schedule be adjusted by the productivity adjustment. OACT estimates the impact to be savings to the Medicare program of $20 million, $30 million, and $50 million for the ambulatory surgical center payment system, the ambulance fee schedule, and the clinical laboratory fee schedule, respectively, for FY 2011. Furthermore section 3401 changed the 2011 ESRD composite rate Market Basket minus one increase to a Market Basket increase. This provision would be a cost to the Medicare program of $40 million (does not include coinsurance).
As discussed in section V.Q. of this proposed rule, for services furnished on or after January 1, 2011, section 1861(s)(2)(FF) of the Act (as added by section 4103 of the ACA) provides Medicare coverage, with no coinsurance or deductible, for an annual wellness visit. The annual wellness visit entails the creation of a personalized prevention plan for an individual that includes a health risk assessment and may include other elements, such as updating the family history, identifying providers that regularly provide medical care to the individual, body mass index measurement, development of a screening service schedule, and identification of risk factors. OACT estimates the impact on a fiscal year cash basis to be $110 million for FY 2011.
As discussed in section V.R. of this proposed rule, for services furnished on or after January 1, 2011, sections 1833(a)(1) and 1833(b) of the Act (as amended by section 4104 of the ACA) waive the deductible and coinsurance requirements for most preventive services, and waive the deductible for colorectal cancer screening tests that are reported with other codes. Services to which no coinsurance or deductible would be applied are the annual wellness visit, the initial preventive physical examination, and any covered preventive service if it is recommended with a grade of A or B by the United States Preventive Services Task Force. We estimate that this new benefit will result in an increase in Medicare payments. OACT estimates the impact on a fiscal year cash basis to be $110 million for FY 2011.
As discussed in section V.S. of this proposed rule, for services furnished on or after January 1, 2011 and before January 1, 2016, sections 1833(x) and (y) of the Act (as added by section 5501 of the ACA) provide primary care practitioners, as well as general surgeons practicing in geographic health professional shortage areas, with 10 percent incentive payments based on their provision of primary care or major surgical services, respectively. OACT estimates the impact on a fiscal year cash basis to be $170 million for FY 2011.
In section V.T of the preamble of this proposed rule, we propose to amend § 411.355(b)(2) to include a new disclosure requirement created by section 6003 of the ACA and related to the in-office ancillary services exception to the physician self-referral prohibition. Specifically, the statute requires that, with respect to magnetic resonance imaging, computed tomography, and positron emission tomography, the referring physician must inform the patient in writing at the time of the referral that the patient may obtain the same imaging services from another supplier. In addition, the statute requires physicians to provide a written list of other suppliers who furnish the same imaging services in the area in which the patient resides.
We propose that the written notice shall include a list of at least 10 other suppliers who provide the services for which the individual is being referred and which are located within a 25-mile radius of the referring physician's office location. If there are fewer than 10 other suppliers located within a 25-mile radius of the physician's office location, the physician shall list all of the other suppliers of the imaging service that are present within a 25-mile radius of the
Our proposal minimizes the administrative burden for the physician by requiring the development of only one list of alternative suppliers for each office location, rather than multiple lists targeting the various areas in which the physician's patients reside.
We do not anticipate that our proposals in section V.T. of the preamble of this proposed rule would have a significant economic impact on a substantial number of physicians, other health care providers and suppliers, or the Medicare or Medicaid programs and their beneficiaries. Specifically, we believe that this proposed rule would affect only those physicians who provide MRI, CT, PET services under the in-office ancillary services exception and beneficiaries receiving those services. We are uncertain of the number of physicians who will have to comply with this disclosure requirement. Using data from the 2009 CMS Statistics booklet, we propose an estimate of 71,000 Medicare enrolled physicians would have to comply with this new requirement. This figure represents 20 percent of primary care and medical specialty physicians enrolled in Medicare Part B. In order to ensure accuracy of the effect of this provision on physician practices, we are soliciting comments regarding the appropriateness of this estimate. The burden associated with disclosing the information, receiving the patient's signature on the form and maintaining a record of such disclosure will be de minimis for the individual physician.
Our proposed criteria for the new disclosure requirement would present a negligible economic impact on the physician or group practice required to create the disclosure notice. The physician or group practice would incur only a one-time cost associated with developing a disclosure notice that informs patients that they may receive the same imaging services from another supplier and also lists other suppliers located within a 25-mile radius of the physician's office location at the time of the referral. We believe it would take an individual 1 hour to create the notice informing patients that they may receive imaging services from another supplier as well as to compile the list of 10 other suppliers. In addition, we believe it would require a negligible amount of time to provide the notice and list of suppliers to the patient and to maintain a copy of the notice in the patient's medical record.
We believe that beneficiaries would be impacted positively by this new provision. The disclosure that the patient may receive the referred imaging services from another supplier contributes to informed decision-making about the availability of such imaging services from other suppliers. We also believe that furnishing a list of other suppliers who provide the same services in the vicinity of the referring physician serves patient convenience. The proposed regulation makes no significant changes that would impede patient access to health care services, and it will likely improve patients' awareness of options in deciding where to receive imaging services.
As discussed in section V.U. of this proposed rule, section 6404 of the ACA reduces the maximum time period for filing Medicare claims to no more than 12 months after the date of service. Under the new law, claims for services furnished on or after January 1, 2010, must be filed within 1 calendar year after the date of service. In addition, section 6404 of the ACA provides that claims for services furnished before January 1, 2010, must be filed no later than December 31, 2010.
Section 6404 of the ACA also permits the Secretary to make certain exceptions to the 1-year filing deadline. This proposed rule would create two new exceptions to the 1-year filing deadline.
The first exception would permit the time limits for filing claims to be extended where a beneficiary becomes retroactively entitled to Medicare benefits, but was not entitled to Medicare benefits at the time the services were furnished. Under this exception, the time to file a claim would be extended through the last day of the sixth month following the month in which the beneficiary received notification of the retroactive Medicare entitlement to the date of the furnished service.
The second exception would permit the time limits for filing claims to be extended where: (1) At the time the service was furnished, the beneficiary was not entitled to Medicare; (2) subsequently, the beneficiary received notification of Medicare entitlement, retroactively effective to the date of the furnished service; and (3) subsequently the State Medicaid agency recovered the Medicaid payment for the furnished service from a provider or supplier 11 months or more after date the service was furnished. Under this exception, the time to file a claim would be extended through the last day of the sixth month following the month in which the State recovered the Medicaid payment from the provider or supplier.
The budgetary impact related to this provision is significant as future payment of claims for services incurred will now be made at an earlier date, relative to the 12-month submission expiration. This is reflected by the Part A and Part B payment amounts of $60 and $50 million for FY 2011. However, for purposes of the Regulatory Impact Analysis, the economic impact of this provision is non-economically significant, as to the interest lost on money now required to pay claims prior to the 12-month submission expiration is minimal.
Providers and suppliers have established billing practices for the submission of claims for payment to the Medicare program. Although this proposed rule would require providers and suppliers to submit Medicare fee-for-service claims within 12 months from the date of service, we believe providers and suppliers would easily revise their billing practices on a one-time basis, and suffer no economic impact. In fact, analysis of Medicare claims data shows that more than 99 percent of Part A and Part B claims are filed in 12 months or less. In addition, some providers and suppliers will receive payment and interest on claims that are filed at an earlier date.
Lastly, providers, suppliers, or the small number of beneficiaries that occasionally submit claims may benefit from the availability of the two proposed new exceptions to the timely filing rule; however, we believe the impact on program costs would be negligible.
Application of our proposed policies for “Carry Over ASP” and “Partial Quarter ASP Data,” as discussed in section VI.A. of this proposed rule, are dependent on the status and quality of quarterly manufacturer data
Furthermore, we do not expect that our proposed policy for determining the payment amount for drugs and biologicals which include intentional overfill, as discussed in section VI.A of this proposed rule, will impact payments made by the Medicare program.
Finally, as discussed in section VI.A of this proposed rule, we are proposing to provide for appropriate price substitutions that account for market-related pricing changes and would allow Medicare to pay based off lower market prices for those drugs and biologicals that consistently exceed the applicable threshold percentage. We believe that this proposal will generate some savings for the Medicare program and its beneficiaries since any substituted prices would be for amounts less than the calculated 106 percent of the ASP.
As discussed in section VI.B. of this proposed rule, we are proposing to implement fractional mileage billing for all providers and suppliers of ambulance services. For all claims for mileage totaling up to 100 covered miles, we are proposing to require all providers and suppliers of ambulance services to bill mileage rounded up to the nearest tenth of a mile rather than the nearest whole mile and are proposing to pay based on that amount. By requiring that providers and suppliers round up to the nearest tenth of a mile rather than the nearest whole mile, providers and suppliers would be submitting claims for anywhere between 0.1 and 0.9 of a mile less per claim and Medicare would pay based on that amount. We anticipate that requiring greater accuracy in billing for ambulance mileage will generate modest cost savings for the Medicare program. Based on our rough estimates using CY 2008 claims data, Medicare could potentially save at least $45 million per year in payments for base mileage billed by suppliers, and perhaps as much as $80 million per year when considering other types of ambulance mileage payments such as those for rural mileage and those made to institutional providers.
As discussed in section VI.D. of this proposed rule, we are continuing the recoupment of the $50 million in expenditures from this demonstration in order to satisfy the budget neutrality requirement in section 651(f)(1)(b) of the MMA. We initiated this recoupment in CY 2010 and this will be the second year. As discussed in the CY 2010 PFS final rule with comment period, we finalized a policy to recoup $10 million each year through adjustments to the PFS for all chiropractors in CYs 2010 through 2014. To implement this required budget neutrality adjustment, we are recouping $10 million in CY 2011 by reducing the payment amount under the PFS for the chiropractic CPT codes (that is, CPT codes 98940, 98941, and 98942) by approximately 2 percent.
The ESRD related provisions are discussed in sections V.P. and VI.E. of this proposed rule. To understand the impact of the changes affecting payments to different categories of ESRD facilities, it is necessary to compare estimated payments under the current year (CY 2010 payments) to estimated payments under the revisions to the composite rate payment system (CY 2011 payments) as discussed in section VI.E. of this proposed rule. To estimate the impact among various classes of ESRD facilities, it is imperative that the estimates of current payments and estimates of proposed payments contain similar inputs. Therefore, we simulated payments only for those ESRD facilities for which we are able to calculate both current CY 2010 payments and proposed CY 2011 payments.
Also, as explained in the ESRD PPS proposed rule (74 FR 50019), section 1881(b)(14)(E)(i) of the Act requires a 4-year transition (phase-in) from the current composite payment system to the ESRD PPS, and section 1881(b)(14)(E)(ii) allows ESRD facilities to make a one-time election to be excluded from the transition. As of January 1, 2011, ESRD facilities that elect to go through the transition would be paid a blended amount that will consist of 75 percent of the basic case-mix adjusted composite payment system and the remaining 25 percent would be based on the ESRD PPS payment. Therefore, these proposed rates listed in the impact table below reflect only the composite rate portion of the blended payment amounts for facilities going through the first year of the 4-year transition under the new ESRD PPS. A full analysis of the projected impact of the ESRD PPS will be addressed in the ESRD PPS final rule which will be published in the summer.
ESRD providers were grouped into the categories based on characteristics provided in the Online Survey and Certification and Reporting (OSCAR) file and the most recent cost report data from the Healthcare Cost Report Information System (HCRIS). We also used the December 2009 update of CY 2009 National Claims History file as a basis for Medicare dialysis treatments and separately billable drugs and biologicals. Since the December 2009 update of the CY 2009 National Claims History File is incomplete, we updated the data. The description of the updates for the separately billable drugs is described in section IV.E. of this proposed rule. To update the treatment counts we used the ratio of the June 2009 to the December 2008 updates of the CY 2008 National Claims History File figure for treatments. This was an increase of 12.4 percent. Due to data limitations, we are unable to estimate current and proposed payments for 32 of the 5318 ESRD facilities that bill for ESRD dialysis treatments.
Table 75 shows the impact of this year's proposed changes to CY 2011 payments to hospital-based and independent ESRD facilities. The first column of Table 75 identifies the type of ESRD provider, the second column indicates the number of ESRD facilities for each type, and the third column indicates the number of dialysis treatments. The fourth column shows the effect of all proposed changes to the ESRD wage index for CY 2011 as it affects the composite rate payments to ESRD facilities. The fourth column compares aggregate ESRD wage-adjusted composite rate payments in CY 2011 to aggregate ESRD wage-adjusted composite rate payments in CY 2010. In CY 2010, ESRD facilities receive 100 percent of the CBSA wage-adjusted composite rate. The overall effect to all ESRD providers in aggregate is zero because the CY 2011 ESRD wage index has been multiplied by a budget neutrality adjustment factor to comply with the statutory requirement that any wage index revisions be done in a manner that results in the same aggregate amount of expenditures as would have been made without any changes in the wage index. The fifth column shows the effect of proposed changes to the ESRD wage index in CY 2011 and the effect of section 3401(h) of the ACA, which amends section 1881(b)(14)(F) of the Act to revise the ESRD market basket increase factor. Effective January 1, 2011, there is a full ESRD bundled market basket update to the composite rate component of the blended payment amount under the payment system. We anticipate an estimated ESRD market basket increase factor of 2.5 percent for those facilities
The overall impact to ESRD providers in aggregate is 2.2 percent as shown in Table 75. Most ESRD facilities will see an increase in payments as a result of the ACA provision. While section 3401(h) of the ACA modifies the ESRD bundled market basket, which we anticipate will be a 2.5 percent increase to the ESRD composite rate portion of the blended payment amount, this 2.5 percent increase does not apply to the drug add-on to the composite rate. For this reason, the impact of all changes in this proposed rule is a 2.2 percent increase for all ESRD providers. Overall, payments to independent ESRD facilities will increase by 2.2 percent and payments to hospital-based ESRD facilities will increase by 2.1 percent.
As discussed in section VI.F.1 of this proposed rule, we propose several different reporting options for EPs who wish to participate in the 2011 PQRI. Although there may be some cost incurred in the PQRI and their associated code sets, and for expanding an existing clinical data warehouse to accommodate registry-based reporting and EHR-based reporting for the PQRI, we do not anticipate a significant cost impact on the Medicare program.
Participation in the CY 2011 PQRI by individual EPs is voluntary and individual EPs and group practices may have different processes for integrating the PQRI into their practice's work flows. Given this variability and the multiple reporting options that we propose to provide, it is difficult to accurately estimate the impact of the PQRI on providers. Furthermore, we believe that costs for EPs who are
With respect to the potential incentive payment that will be made for the 2011 PQRI, we estimate this amount to be approximately $100 million. This estimate is derived from looking at our 2008 incentive payment of more than $93 million and then accounting for the fact that the 2008 incentive payment was 1.5 percent of an EP's total estimated Medicare Part B PFS allowed charges for all covered professional services furnished during the 2008 reporting period. For 2011, the incentive payment is 1.0 percent of an EP's total estimated Medicare Part B PFS allowed charges for all covered professional services furnished during the 2011 reporting period. Although we expect that the lower incentive payment amount for 2011 would reduce the total outlay by approximately one-third, we also expect more EPs to participate in the 2011 PQRI as there are more methods of data submission and additional alternative reporting periods.
One factor that influences the cost to individual EPs is the time and effort associated with individual EPs identifying applicable PQRI quality measures and reviewing and selecting a reporting option. This burden will vary with each individual EP by the number of applicable measures, the EP's familiarity and understanding of the PQRI, experience with PQRI participation, and the method(s) selected by the EP for reporting of the measures, and incorporating the reporting of the measures into the office work flows. Information obtained from the Physician Voluntary Reporting Program (PVRP), which was a predecessor to the PQRI and was the first step for the reporting of physician quality of care through certain quality metrics, indicated an average labor cost per practice of approximately $50 per hour. To account for salary increases over time, we will use an average practice labor cost of $58 per hour for our estimates, based on an assumption of an average annual increase of approximately 3 percent. Therefore, assuming that it takes an individual EP approximately 5 hours to review the PQRI quality measures, review the various reporting options, select the most appropriate reporting option, identify the applicable measures for which they can report the necessary information, and incorporate reporting of the selected measures into their office work flows, we estimate that the cost to EPs associated with preparing to report PQRI quality measures would be approximately $290 per individual EP ($58 per hour × 5 hours).
Another factor that influences the cost to individual EPs is how they choose to report the PQRI measures (that is, whether they select the claims-based, registry-based or EHR-based reporting mechanism). For claims-based PQRI reporting, estimates from the PVRP indicate the time needed to perform all the steps necessary to report quality data codes (QDCs) for 1 measure on a claim ranges from 15 seconds (0.25 minutes) to 12 minutes for complicated cases or measures. In previous years, when we required reporting on 80 percent of eligible cases for claims-based reporting, we found that on average, the median number of reporting instances for each of the PQRI measures was 9. Since we propose to reduce the required reporting rate by over one-third to 50 percent, then for purposes of this impact analysis we will assume that an EP will need to report each selected measure for 6 reporting instances, or 6 cases. Assuming that an EP, on average, will report 3 measures and that an EP reports on an average of 6 reporting instances per measure, we estimate that the cost to an individual EP associated with claims-based reporting of PQRI measures would range from approximately $4.35 (0.25 min per reporting instance × 6 reporting instances per measure × 3 measures × $58 per hour) to $208.80 (12 min per reporting instance × 6 reporting instances per measure × 3 measures × $58 per hour). If an EP satisfactorily reports, these costs will more than likely be negated by the incentive earned. For the 2007 PQRI, which had a 1.5 percent incentive for a 6-month reporting period, the mean incentive amount was close to $700 for an individual EP and the median incentive payment amount was over $300.
For registry-based reporting, individual EPs must generally incur a cost to submit data to registries. Estimated fees for using a qualified registry range from no charge, or a nominal charge, for an individual EP to use a registry to several thousand dollars, with a majority of registries charging fees ranging from $500–$1000. However, our impact analysis should be limited to the incremental costs associated with PQRI reporting, which we believe are minimal. Many EPs who select registry-based reporting were already utilizing the registry for other purposes and would not need to report additional data to the registry specifically for PQRI. The registries also often provide the EP services above and beyond what is required for PQRI.
For EHR-based reporting, an individual EP generally would incur a cost associated with purchasing an EHR product. Although we do not believe that the majority of EPs would purchase an EHR solely for the purpose of participating in PQRI, we estimate that an individual EP who chooses to do so would have to spend anywhere from $25,000–$54,000 to purchase and implement a certified EHR and $10,000 annually for ongoing maintenance.
Although we believe that the majority of EPs attempting to qualify for the additional 0.5 percent incentive payment authorized by section 1848(m)(7) of the Act would be those who are already required by their Boards to participate in an MOCP, individual EPs who wish to qualify for the additional 0.5 percent incentive payment and are not currently participating in an MOCP would also have to incur a cost for participating in an MOCP. The manner in which fees are charged for participating in an MOCP vary by specialty. Some Boards charge a single fee for participation in the full cycle of MOC. Such fees appear to range anywhere from over $1,100 to nearly $1,800 per cycle. Some Boards have annual fees that are paid by their diplomates. On average, ABMS diplomates pay approximately $200.00 per year for participating in MOC. Some Boards have an additional fee for the MOC Part III secure examination, but most Boards do not have additional charges for participation in the Part IV practice/quality improvement activities.
With respect to the proposed process for group practices to be treated as satisfactorily submitting quality measures data for the CY 2011 PQRI discussed in section VI.F.1 of this proposed rule, group practices interested in participating in the CY 2011 PQRI through the group practice reporting option (GPRO) I or GPRO II may also incur a cost. However, for groups that satisfactorily report for 2011 PQRI, we believe these costs would be completely offset by the incentive payment earned since the group practice would be eligible for an incentive payment equal to 1 percent of the entire group's total estimated Medicare Part B PFS allowed charges for covered professional services furnished during the reporting period.
One factor in the cost to group practices would be the costs associated with the self-nomination process. Similar to our estimates for staff involved with the claims-based reporting option for individual EPs, we also estimate that the group practice
For groups participating under the proposed GPRO I process, another factor in the cost to the group would be the time and effort associated with the group practice completing and submitting the proposed data collection tool. The information collection components of this data collection tool have been reviewed by OMB and are currently approved under OMB control number 0938–0941, with an expiration date of December 31, 2011. Based on the Physician Group Practice (PGP) demonstration's estimate that it takes approximately 79 hours for a group practice to complete the data collection tool, which uses the same data submission methods as those we have proposed, we estimate the cost associated with a physician group completing the data collection tool would be approximately $4,582 ($58 per hour × 79 hours per group practice).
For group practices participating under the proposed GPRO II process, the costs associated with submitting the PQRI quality measures data would be the time associated with the group practice submitting the required data to CMS via claims or a registry. The costs for a group practice reporting to a registry should be similar to the costs associated with registry reporting for an individual EP, as the process is the same with the exception that more patients and more measures must be reported in GPRO II compared to an individual EP. For similar reasons, the costs for a group practice reporting via claims should also be similar to the costs associated with claims-based reporting for an individual EP. Overall, there is significantly less burden associated with a group practice participating in PQRI via GPRO II than doing so as individual EPs. Participation in GPRO II requires the group practice as a whole to report a fewer number of measures on a fewer number of people since EPs within a group who share patients would not be required to separately report measures for those shared patients. Therefore, assuming that an average group practice would spend 20 hours for data submission, we estimate the cost of data submission under GPRO II would be approximately $1,160 (20 hours for data submission × $58 per hour). Smaller groups may need less time for data submission as they would be required to report fewer measures and presumably have a smaller patient population while larger groups may need more time for data submission since they would be required to report more measures and presumably have a larger patient population.
In addition to costs incurred by EPs and group practices, registries and EHR vendors may also incur some costs related to the PQRI. Registries interested in becoming “qualified” to submit on behalf of individual EPs would also have to incur a cost associated with the vetting process and with calculating quality measures results from the data submitted to the registry by its participants and submitting the quality measures results and numerator and denominator data on quality measures to CMS on behalf of their participants. We estimate the registry self-nomination process would cost approximately $500 per registry ($50 per hour × 10 hours per registry). This cost estimate includes the cost of submitting the self-nomination letter to CMS and completing the CMS vetting process. Our estimate of $50 per hour average labor cost for registries is based on the assumption that registry staff include IT professionals whose average hourly rates range from $36 to $84 per hour depending on experience, with an average rate of nearly $50 per hour for a mid-level programmer. However, the 2010 qualified registries would not incur any costs associated with the self-nomination process unless they are unsuccessful at submitting 2010 PQRI results, they wish to be qualified to submit additional measures or for additional methods, or we finalize new requirements for 2011. We do not believe that there are any additional costs for registries associated with a registry calculating quality measures results from the data submitted to the registry by its participants and submitting the quality measures results and numerator and denominator data on quality measures to CMS on behalf of their participants. We believe that the majority of registries already perform these functions for their participants.
An EHR vendor interested in having its product(s) be used by individual EPs to submit PQRI measures to CMS for 2012 would have to complete a vetting process during 2011 and program its EHR product(s) to extract the clinical data that the EP needs to submit to CMS for purposes of reporting 2012 quality measures as well. We propose that previously qualified vendors would need to only update their electronic measure specifications and data transmission schema to incorporate any new EHR measures to maintain their qualification for the 2012 PQRI. Therefore, for EHR vendors that were not previously qualified, the cost associated with completing the self-nomination process, including the vetting process with CMS officials, is estimated to be $500 ($50 per hour × 10 hours per EHR vendor). Our estimate of a $50 per hour average labor cost for EHR vendors is based on the assumption that vendor staff include IT professionals whose average hourly rates range from $36 to $84 per hour depending on experience, with an average rate of nearly $50 per hour for a mid-level programmer. We believe that the cost associated with the time and effort needed for an EHR vendor to review the quality measures and other information and program the EHR product to enable individual EPs to submit PQRI quality measures data to the CMS-designated clinical warehouse will be dependent on the EHR vendor's familiarity with PQRI, the vendor's system's capabilities, as well as the vendor's programming capabilities. Some vendors already have the necessary capabilities and for such vendors, we estimate the total cost to be approximately $2,000 ($50 per hour × 40 hours per vendor). However, given the variability in the capabilities of the vendors, we believe an estimate for those vendors with minimal experience would be approximately $10,000 per vendor ($50 per hour × 200 hours per EHR vendor).
Section VI.F.2. of this proposed rule describes the proposed 2011 Electronic Prescribing (eRx) Incentive Program. To be considered a successful electronic prescriber in CY 2011, an individual EP would need to meet the requirements proposed in section VI.F.2. of this proposed rule.
We anticipate that the cost impact of the eRx Incentive Program on the Medicare program would be the cost incurred for maintaining the electronic prescribing measure and its associated code set, and for maintaining the existing clinical data warehouse to accommodate registry-based reporting and EHR-based reporting for the electronic prescribing measure. However, we do not anticipate a significant cost impact on the Medicare program since much of this infrastructure has already been established for the PQRI program.
Individual EPs and group practices may have different processes for
At this time, no eRx incentive payments have been made yet. We are currently analyzing 2009 eRx data, which was the first year of the program, and anticipate making the 2009 incentive payments later this year. We estimate that the incentive payments for the 2011 eRx Incentive Program (which will be paid in 2012) will be approximately $81 million. This estimate is based on preliminary participation numbers from the early part of 2010 and incentive payments that have been made for PQRI. We anticipate that despite a decrease in the incentive payment amount from 2 percent in 2010 to 1 percent of total estimated Medicare Part B allowed charges for covered professional services in 2011, more EPs (and groups) will choose to participate in the 2011 eRx Incentive Program to avoid a prospective 1 percent payment penalty in 2012 for not demonstrating that they are successful electronic prescribers. Even though the incentive payment amount for the 2011 eRx Incentive Program is equal to the incentive payment amount for the 2011 PQRI, we believe that the total incentive amount that will be paid for the 2011 eRx Incentive Program will be less than the total incentive payment amount that will be paid for the PQRI discussed above. The eRx Incentive Program does not apply to all EPs. For example, EPs who do not have prescribing privileges or EPs who do not practice in a particular care setting would not be able to participate in the eRx Incentive Program even though they can participate in PQRI.
Any EP who wishes to participate in the eRx Incentive Program must have a qualified electronic prescribing system in order to participate. Therefore, a one-time potential cost to some individual EPs would be the cost of purchasing and using an eRx system, which varies by the commercial software package selected, the level at which the professional currently employs information technology in his or her practice and the training needed. One study indicated that a midrange complete electronic medical record with electronic prescribing functionality costs $2,500 per license with an annual fee of $90 per license for quarterly updates of the drug database after setup costs while standalone prescribing, messaging, and problem list system may cost $1,200 per physician per year after setup costs. Hardware costs and setup fees substantially add to the final cost of any software package. (Corley, S.T. (2003). “Electronic prescribing: a review of costs and benefits.” Topics in Health Information Management 24(1):29–38.). These are the estimates that we propose to use for our impact analysis.
Similar to PQRI, one factor in the cost to individual EPs is the time and effort associated with individual EPs reviewing the electronic prescribing measure to determine whether it is applicable to them, reviewing the available reporting options and selecting one, gathering the required information, and incorporating reporting of the measure into their office work flows. Since the eRx Incentive Program consists of only 1 quality measure, we propose to estimate 2 hours as the amount of time needed for individual EPs to prepare for participation in the eRx Incentive Program. Information obtained from the Physician Voluntary Reporting Program (PVRP), which was a predecessor to the PQRI and was the first step for the reporting of physician quality of care through certain quality metrics, indicated an average labor cost per practice of approximately $50 per hour. To account for salary increases over time, we will use an average practice labor cost of $58 per hour for our estimates, based on an assumption of an average annual increase of approximately 3 percent. At an average cost of approximately $58 per hour, we estimate the total preparation costs to individual EPs to be approximately $116 ($58 per hour × 2 hours).
Another factor that influences the cost to individual EPs is how they choose to report the electronic prescribing measure (that is, whether they select the claims-based, registry-based or EHR-based reporting mechanism). For claims-based reporting, there would be a cost associated with reporting the appropriate QDC on the claims an individual EP submits for payment. Based on the information from the PVRP described above for the amount of time it takes a median practice to report one measure one time (1.75 min) and the proposed requirement to report 25 electronic prescribing events during 2011, we estimate the annual estimated cost per individual EP to report the electronic prescribing measure via claims-submission to be $42.29 (1.75 min per case × 1 measure × 25 cases per measure × $58 per hour). Assuming that the mean and median incentive payment amounts per individual EP would be comparable to those for the PQRI since the incentive payments are calculated in the same manner, we believe that for most successful electronic prescribers who earn an incentive, these costs would be negated by the incentive payment received.
For EPs who select the registry-based reporting mechanism, we do not anticipate any additional cost for individual EPs to report data to a registry, as individual EPs opting for registry-based reporting are more than likely already reporting data to the registry. Little if any, additional data would need to be reported to the registry for purposes of participation in the CY 2011 eRx Incentive Program. Individual EPs using registries for PQRI will likely experience minimal, if any, increased costs charged by the registry to report this 1 additional measure.
For EHR-based reporting, the EP must extract the necessary clinical data from his or her EHR, and submit the necessary data to the CMS-designated clinical data warehouse. Once the EHR is programmed by the vendor to allow data submission to CMS, the cost to the individual EP associated with the time and effort to submit data on the electronic prescribing measure should be minimal.
With respect to the proposed process for group practices to be treated as successful electronic prescribers under the CY 2011 eRx Incentive Program discussed in section VI.F.2 of this proposed rule, group practices have the same option as individual eligible professionals in terms of the form and manner for reporting the eRx measure (that is, group practices have the option of reporting the measure through claims, a qualified registry, or a qualified EHR product). There are only 2 differences between the requirements for an individual EP and a group practice: (1) The fact that a group practice would have to self-nominate; and (2) the number of times a group practice would be required to report the eRx measure. Overall, there could be less cost associated with a practice participating in the eRx Incentive Program as a group rather than the individual members of the group separately participating. We do not anticipate any additional costs associated with the group practice self-nomination process since we propose to
The costs for a group practice reporting to an EHR or registry should be similar to the costs associated with registry and EHR reporting for an individual EP, as the process is the same with the exception that more electronic prescribing events must be reported by the group. For similar reasons, the costs for a group practice reporting via claims should also be similar to the costs associated with claims-based reporting for an individual EP. Therefore, we estimate that the costs for group practices who are selected to participate in the CY 2011 eRx Incentive Program as a group would range from $126.88 (1.75 min per case × 1 measure × 75 cases per measure × $58 per hour) for the smallest groups participating under GPRO II to $4,229.17 (1.75 min per case × 2500 cases per measure × $58 per hour) for the groups participating under GPRO I.
We believe that the costs to individual EPs and group practices associated with avoiding the eRx penalty that goes into effect in 2012 would be similar to the costs of an EP or group practice reporting the electronic prescribing measure for purposes of the 2011 eRx incentive. The proposed requirements for avoiding the 2012 eRx penalty, including the reporting period, essentially overlaps with the proposed requirements for the 2011 eRx incentive.
Based on our proposal to consider only registries qualified to submit quality measures results and numerator and denominator data on quality measures to CMS on their participant's behalf for the 2011 PQRI to be qualified to submit results and numerator and denominator data on the eRx measure for the CY 2011 eRx Incentive Program, we do not anticipate any cost to the registry associated with becoming a registry qualified to submit the eRx measure for CY 2011.
The cost for the registry would be the time and effort associated with the registry calculating results for the eRx measure from the data submitted to the registry by its participants and submitting the quality measures results and numerator and denominator data on the eRx quality measure to CMS on behalf of their participants. We believe such costs would be minimal as registries would already be required to perform these activities for PQRI.
Likewise, based on our proposal to consider only EHR products qualified for the CY 2011 PQRI to be qualified to submit results and numerator and denominator data on the electronic prescribing measure for the CY 2011 eRx Incentive Program, there would be no need for EHR vendors to undergo a separate self-nomination process for the eRx Incentive Program. Therefore, there would be no additional cost associated with the self-nomination process.
The cost to the EHR vendor associated with the EHR-based reporting requirements of this reporting initiative is the time and effort associated with the EHR vendor programming its EHR product(s) to extract the clinical data that the individual EP needs to submit to CMS for purposes of reporting the CY 2011 eRx measure. Since we propose that only EHR products qualified for the 2011 PQRI would be qualified for the CY 2011 eRx Incentive Program, and the eRx Incentive Program consists of only one measure, we believe that any burden associated with the EHR vendor to program its product(s) to enable individual EPs to submit data on the eRx measure to the CMS-designated clinical data warehouse would be minimal.
In section VI.G. of this proposed rule, we are proposing to expand the exemptions from the Competitive Bidding Program (CBP) for certain OTS orthotics to physicians or other practitioners (as defined by the Secretary) if furnished to their own patients as part of their professional service.
The proposed exemption is a self-implementing mandate required by section 154(d) of MIPPA, which added section 1847(a)(7) of the Act. Section 1847(a)(7)(A) of the Act expanded the exemptions from the CBP for certain OTS orthotics to physicians or other practitioners (as defined by the Secretary) if furnished to their own patients as part of their professional service. Section 1847(a)(7)(B) of the Act, as added by section 154(d) of MIPPA, also expanded the exemption from CBP for certain OTS DME items (crutches, canes, walkers, folding manual wheelchairs, blood glucose monitors, and infusion pumps) when furnished by hospitals to the hospital's own patients during an admission or on the date of discharge.
We believe this exemption would have a negligible impact on physicians and other providers. The exemption will allow physicians to continue to provide these items to their own patients without submitting a bid and becoming a contract supplier. This will also allow continued access to OTS items for beneficiaries while being seen in their physician's office.
The revisions pertaining to oxygen and oxygen equipment in section VI.G. of this proposed rule reflect changes made by section 144(b) of MIPPA and regulations implementing that provision. In § 414.226(g), exceptions are listed to the requirement that the supplier that furnishes oxygen equipment in the 1st month of the 36-month period must continue to furnish it until medical necessity ends or the 36-month of continuous use ends. Section VI.G. changes one exception (§ 414.226(g)(1)(ii)) to read that if a beneficiary relocates to an area that is outside the normal service area of the supplier before the 18th month, then the supplier does not have to continue to furnish the item or make arrangements.
We expect that revising § 414.226(g)(1)(ii) so that only suppliers that have received at least 18 months of rental payments must continue to furnish the oxygen equipment until medical necessity ends or the end of the reasonable useful lifetime should have a minor impact on the supplier, but should provide protection to beneficiaries. The reason that we expect the revised exception will have little impact has foremost to do with the fact that it applies in cases that are the exception to the normal circumstances. Only 38 percent of the beneficiaries are still renting by the 18th month of the rental period; only suppliers furnishing oxygen equipment to this subgroup of beneficiaries will be affected by this proposed change. Further, relocation between the 18th to the 36th month is not a common occurrence. Such relocation happens with less than 0.5 percent of the beneficiaries using oxygen equipment. In addition, between the 32nd and 35th month, relocation happens with the beneficiaries in about 0.06 percent of the time on average.
We are establishing requirements for conducting a national competition for furnishing diabetic supplies on a mail order basis. Specifically this proposed rule will establish 3 requirements: A new definition for what constitutes mail order; a rule that requires contract suppliers to provide at a minimum 50 percent of all of the different types of diabetic testing products on the market by brand and model name; and a
Currently based on claims data from fiscal year 2009 over 62 percent of beneficiaries receive their replacement diabetic testing supplies from mail order suppliers. This definition will not impact these beneficiaries because they can continue to obtain their items through mail order. The remaining 38 percent of beneficiaries may continue to obtain these items from a local storefront. We do not expect this rule to have any adverse affects on beneficiaries because the new definition of mail order is reflective of the way that beneficiaries currently get their testing supplies. However, we believe that by clarifying this definition we will protect beneficiaries from paying higher co-payment amounts and we anticipate program savings that would have been eroded by suppliers circumventing our definition to continue to provide items, even if not awarded a contract under competitive bidding and to obtain the higher fee schedule payment amount. This definition is also consistent with the way that suppliers currently do business by either providing items through mail order or at a local storefront. For these reasons we believe this new definition will have minimal impact.
Also, we considered the option to not bifurcate bidding based on delivery method and to bid for diabetic testing suppliers regardless of how the items were obtained. We rejected this approach because it would force companies with different business models to compete against each other, by requiring local pharmacies to compete with national mail order suppliers in order to win a contract to be able to furnish testing supplies.
In order to implement a national mail order competition for diabetic supplies, we are also proposing to implement the special “50 percent rule” mandated by MIPPA. This rule requires a bidder to demonstrate that its bid “covers types of diabetic testing strip products that, in the aggregate and taking into account volume for the different products, cover 50 percent (or such higher percentage as the Secretary may specify) of all such types of products.” The 50 percent threshold would ensure that beneficiaries have access to mail order delivery of the top-selling diabetic test strip products from every contract supplier. We plan to use the information that bidding suppliers provide on their bidding Form B where suppliers list the products they plan to furnish. We believe this requirement will have a minimal impact on suppliers because most suppliers currently provide a wide range of the brands and models in order to gain market share. The statute states that suppliers are required to carry at least 50 percent of all brands on the market. However, the Secretary can establish suppliers to carry a higher percentage of brands. We have adopted 50 percent criteria because we believe this is reflective of what suppliers are currently doing and ensures appropriate access for beneficiaries.
In addition to the 50 percent rule, we are also proposing to establish an anti-switching requirement. This provision would prevent contract suppliers from switching beneficiaries from their current brand to a brand provided by the supplier. We believe this requirement will protect the beneficiary and physician choice of glucose monitoring systems. The decision concerning the type of monitor and testing supplies that a beneficiary chooses should not be made by the supplier but rather by the beneficiary and their physician. We believe that this provision will have a minimal impact on suppliers because suppliers currently offer a variety of products and generally do require beneficiaries to switch from the brands they are familiar with and customarily use.
We believe that the provisions pertaining to subdividing metropolitan statistical areas (MSAs) with populations of at least 8,000,000 for the purpose of establishing competitive bidding areas (CBAs) under Round 2 of the DMEPOS Competitive Bidding Program will have a positive impact on most suppliers, particularly small suppliers. The authority provided by section 1847(a)(1)(D)(ii)(II) of the Act would be used to create CBAs that are smaller than the highly and densely populated MSAs of: Chicago-Naperville-Joliet, IL–IN–WI; Los Angeles-Long Beach-Santa Ana, CA; and New York-Northern New Jersey-Long Island, NY–NJ–PA. This should result in more manageable service areas for suppliers to navigate when furnishing items. More importantly, it should ensure more timely delivery of items and services to beneficiaries located throughout each of the MSAs. It should also benefit small suppliers because they would have smaller geographic areas to cover as contract suppliers than the large MSAs, which in some cases, might prevent them from being considered for participation under the program. The larger suppliers would still have the opportunity to bid in all of the CBAs within each MSA. We expect that subdividing the large MSAs of Chicago, Los Angeles, and New York would not have a negative impact on program savings, as long as each CBA is large enough to be attractive to suppliers for bidding purposes.
Table 76 considers FY cash impact on the entire Medicare program, including Medicare Advantage for FYs 2011 thru 2015 of the provisions of this proposed rule related to the establishment of CBAs during Round 2 and prior to calendar year 2015. The FY–CY distinction is an important one when comparing savings. For example, the savings for the Medicare DMEPOS Competitive Bidding Program will be for 9 months of FY 2013, but for 12 months of CY 2013. Table 76 considers the impact on program expenditures, and does not include beneficiary coinsurance. Finally, the estimates in Table 76 incorporate spillover effects from the competitive acquisition program onto the Medicare Advantage program. The expectation is that the 21 additional MSAs added to the Medicare DMEPOS Competitive Bidding Program would lower prices for DME products in FFS would lead to lower prices in the Medicare Advantage market. The table below considers FY cash impact of the above provisions on the entire Medicare program, including Medicare Advantage for the FY.
In section VI.G. of this proposed rule, we present our proposals regarding air ambulance and provider and supplier enrollment. We note that this proposal is an administrative initiative that may result in Medicare program savings but at this time those savings are inestimable. We believe the probable
This proposed rule contains a range of policies, including some provisions related to specific MIPPA and ACA provisions. The preceding preamble provides descriptions of the statutory provisions that are addressed, identifies those policies when discretion has been exercised, presents rationale for our proposals and, where relevant, alternatives that were considered.
There are a number of changes in this proposed rule that would have an effect on beneficiaries. In general, we believe that many of the proposed changes, including the refinements of the PQRI with its focus on measuring, submitting, and analyzing quality data, the expansion of the list of Medicare-approved telehealth services, the incentive payments for primary care services furnished by primary care practitioners in any location and major surgical procedures furnished by general surgeons in HPSAs, the waiver of beneficiary cost-sharing for most preventive services, and the annual wellness visit proposals, will have a positive impact and improve the quality and value of care provided to Medicare beneficiaries.
The regulatory provisions may affect beneficiary liability in some cases. For example, the waiver of the deductible and coinsurance for the annual wellness visit, the IPPE, and preventive services with a grade of A or B from the USPSTF would reduce beneficiary liability for these services. Most changes in aggregate beneficiary liability due to a particular provision would be a function of the coinsurance (20 percent if applicable for the particular provision after the beneficiary has met the deductible). To illustrate this point, as shown in Table 74, the CY 2010 national payment amount in the nonfacility setting for CPT code 99203 (Office/outpatient visit, new) under the conversion factor that was consistent with the statute as of October 30, 2009 and that would be in effect on December 31, 2010 under current law, is $76.93 which means that in CY 2010 a beneficiary would be responsible for 20 percent of this amount, or $15.39. Based on this proposed rule, the CY 2011 national payment amount in the nonfacility setting for CPT code 99203, as shown in Table 74, is $72.67, which means that, in CY 2011, the beneficiary coinsurance for this service would be $14.53.
Additionally, beneficiary liability would also be impacted by the effect of the aggregate cost (savings) of the provisions on the standard calculation of the Medicare Part B premium rate (generally 25 percent of the provision's cost or savings).
Most policies discussed in this rule that impact payment rates, such as the expansion of the MPPR to therapy services and the increased discount on the TC of multiple imaging procedures from 25 percent to 50 percent, would similarly impact beneficiaries' coinsurance.
As required by OMB Circular A–4 (available at
In accordance with the provisions of Executive Order 12866, this proposed rule was reviewed by the Office of Management and Budget.
Administrative practice and procedure, Health facilities, Health professions, Kidney diseases, Medical devices, Medicare, Reporting and recordkeeping requirements, Rural areas, X-rays.
Health facilities, Medicare.
Health facilities, Health professions, Kidney diseases, Laboratories, Medicare, Reporting and recordkeeping requirements, Rural areas, X-rays.
Kidney diseases, Medicare, Physician Referral, Reporting and record keeping requirements.
Health facilities, Kidney diseases, Medicare Reporting and recordkeeping requirements.
Administrative practice and procedure, Health facilities, Health professions, Kidney diseases, Medicare, Reporting and recordkeeping.
Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements.
Emergency medical services, Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services proposes to amend 42 CFR chapter IV as set forth below:
1. The authority citation for part 405 continues to read as follows:
Secs. 1102, 1861, 1862(a), 1871, 1874, 1881, and 1886(k) of the Social Security Act (42 U.S.C. 1302, 1395x, 1395y(a), 1395hh, 1395kk, 1395rr and 1395ww(k)), and sec. 353 of the Public Health Service Act (42 U.S.C. 263a).
2. A new § 405.2449 is added to read as follows.
For services furnished on or after January 1, 2011, preventive services covered under the Medicare Federally qualified health center benefit are those preventive services defined in section 1861(ddd)(3) of the Act, and § 410.2 of this chapter. Specifically, these include the following:
(a) The specific services currently listed in section 1861(ww)(2) of the Act, with the explicit exclusion of electrocardiograms;
(b) The Initial Preventive Physical Examination (IPPE) (as specified by section 1861(ww)(1) of the Act as added by section 611 of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (Pub. L. 108–173) and § 410.16 of this chapter); and
(c) The Personalized Prevention Plan Services (PPPS), also known as the “Annual Wellness Visit” (as specified by section 1861(hhh) of the Act as added by section 4103 of the Affordable Care Act (Pub. L. 111–148) and part 410, subpart B, § 410.15 of this chapter).
3. Section 405.2470 is amended by adding a new paragraph (d) to read as follows:
(d)
4. The authority citation for part 409 continues to read as follows:
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
5. Amend § 409.17(d) by removing the phrase “hospital policies and procedures” and adding in its place the phrase “the provider's policies and procedures.”
6. Section 409.20 is amended by revising paragraph (a)(3) to read as follows:
(a) * * *
(3) Physical therapy, occupational therapy, and speech-language pathology services.
7. Section 409.23 is revised to read as follows:
Medicare pays for physical therapy, occupational therapy, or speech-language pathology services as posthospital SNF care if they are furnished—
(a) By (or under arrangements made by) the facility and billed by (or through) the facility;
(b) By qualified physical therapists, physical therapist assistants, occupational therapists, occupational therapy assistants, or speech-language pathologists as defined in part 484 of this chapter; and
(c) In accordance with a plan that meets the requirements of § 409.17(b) through (d) of this part.
8. The authority citation for part 410 continues to read as follows:
Secs. 1102, 1834, 1871, and 1893 of the Social Security Act (42 U.S.C. 1302, 1395m, 1395hh, and 1395ddd).
9. Section 410.2 is amended by adding the definition of “Preventive services” in alphabetical order to read as follows:
(1) The specific services listed in section 1861(ww)(2) of the Act, with the explicit exclusion of electrocardiograms;
(2) The Initial Preventive Physical Examination (IPPE) (as specified by section 1861(ww)(1) of the Act); and
(3) The Personalized Prevention Plan Services (PPPS), also known as the “Annual Wellness Visit” (as specified by section 1861(hhh) of the Act)
10. Amend § 410.3(b)(2) by removing the reference “subpart E” and adding in its place the reference “subpart I.”
11. Section 410.15 is added to read as follows:
(a)
(i) Past medical and surgical history, including experiences with illnesses, hospital stays, operations, allergies, injuries and treatments.
(ii) Use or exposure to medications and supplements, including calcium and vitamins.
(iii) Medical events in the beneficiary's parents and any siblings and children, including diseases that may be hereditary or place the individual at increased risk.
(i) Establishment of an individual's medical and family history.
(ii) Establishment of a list of current providers and suppliers that are regularly involved in providing medical care to the individual.
(iii) Measurement of an individual's height, weight, body-mass index (or waist circumference, if appropriate), blood pressure, and other routine measurements as deemed appropriate, based on the beneficiary's medical and family history.
(iv) Detection of any cognitive impairment that the individual may have, as that term is defined in this section.
(v) Review of the individual's potential (risk factors) for depression, including current or past experiences with depression or other mood disorders, based on the use of an appropriate screening instrument for persons without a current diagnosis of depression, which the health professional may select from various available standardized screening tests designed for this purpose and recognized by national medical professional organizations.
(vi) Review of the individual's functional ability and level of safety, based on direct observation or the use of appropriate screening questions or a screening questionnaire, which the health professional as defined in this section may select from various available screening questions or standardized questionnaires designed for this purpose and recognized by national professional medical organizations.
(vii) Establishment of the following:
(A) A written screening schedule for the individual such as a checklist for the next 5 to 10 years, as appropriate, based on recommendations of the United States Preventive Services Task Force and the Advisory Committee on Immunization Practices, and the individual's health status, screening history, and age-appropriate preventive services covered by Medicare.
(B) A list of risk factors and conditions for which primary, secondary or tertiary interventions are recommended or are underway for the individual, including any mental health conditions or any such risk factors or conditions that have been identified through an initial preventive physical examination (as described under § 410.16 of this subpart), and a list of treatment options and their associated risks and benefits.
(viii) Furnishing of personalized health advice and a referral, as appropriate, to health education or preventive counseling services or programs aimed at reducing identified risk factors and improving self-management, or community-based lifestyle interventions to reduce health risks and promote self-management and wellness, including weight loss, physical activity, smoking cessation, fall prevention and nutrition.
(ix) Any other element determined appropriate through the National Coverage Determination process.
(i) A physician who is a doctor of medicine or osteopathy (as defined in section 1861(r)(1) of the Social Security Act); or
(ii) A physician assistant, nurse practitioner, or clinical nurse specialist (as defined in section 1861(aa)(5) of the Act; or
(iii) A medical professional (including a health educator, registered dietitian or nutritionist) or a team of medical professionals, who are working under the supervision of a physician as defined in paragraph (i) of this definition.
(i) Hearing impairment,
(ii) Ability to successfully perform activities of daily living,
(iii) Fall risk and
(iv) Home safety.
(i) An update of the individual's medical and family history.
(ii) An update of the list of current providers and suppliers that are regularly involved in providing medical care to the individual as that list was developed for the first annual wellness visit providing personalized prevention plan services.
(iii) Measurement of an individual's weight (or waist circumference), blood pressure and other routine measurements as deemed appropriate, based on the individual's medical and family history.
(iv) Detection of any cognitive impairment that the individual may have, as that term is defined in this section.
(v) An update to the following:
(A) The written screening schedule for the individual as that schedule is defined in paragraph (a) of this section for the first annual wellness visit providing personalized prevention plan services.
(B) The list of risk factors and conditions for which primary, secondary or tertiary interventions are recommended or are underway for the individual as that list was developed at the first annual wellness visit providing personalized prevention plan services.
(vi) Furnishing of personalized health advice to the individual and a referral, as appropriate, to health education or preventive counseling services or programs as that advice and related services are defined in paragraph (a) of this section.
(vii) Any other element determined appropriate through the National Coverage Determination process.
(b)
(c)
(1) Payment may not be made for either a first or a subsequent annual wellness visit providing personalized prevention plan services that is performed for an individual who is not an eligible beneficiary as described in this section.
(2) Payment may not be made for either a first or a subsequent annual wellness visit providing personalized prevention plan services that is performed for an individual who is an eligible beneficiary as described in this section and who has had either an initial preventive physical examination as specified in section 410.16 of this subpart or either a first or a subsequent annual wellness visit providing personalized prevention plan services performed within the past 12 months.
(d)
12. Section 410.32 is amended by adding paragraph (b)(2)(vii) to read as follows:
(b) * * *
(2) * * *
(vii) Diagnostic tests performed by a certified nurse-midwife authorized to perform the tests under applicable State laws.
13. Section 410.78 is amended by revising the introductory text of paragraph (b) to read as follows:
(b)
14. Section 410.150 is amended by adding paragraph (a)(20) to read as follows:
(a) * * *
(20) To a certified nurse-midwife for professional services furnished by the certified nurse-midwife in all settings and for services and supplies furnished incident to those services. Payment is made only if no facility or other provider charges or is paid any amount for the furnishing of the professional services of the certified nurse-midwife.
15. Section 410.152 is amended by revising paragraph (l) to read as follows:
(l)
(1) Pneumococcal (as specified in paragraph (h) of this section), influenza, and hepatitis B vaccine and administration.
(2) Screening mammography.
(3) Screening pap tests and screening pelvic exam.
(4) Prostate cancer screening tests (excluding digital rectal examinations).
(5) Colorectal cancer screening tests (excluding barium enemas).
(6) Bone mass measurement.
(7) Medical nutrition therapy (MNT) services.
(8) Cardiovascular screening blood tests.
(9) Diabetes screening tests.
(10) Ultrasound screening for abdominal aortic aneurysm (AAA).
(11) Additional preventive services identified for coverage through the national coverage determination (NCD) process.
(12) Initial Preventive Physical Examination (IPPE).
(13) Personalized Prevention Plan Services (PPPS).
16. Section 410.160 is amended by—
A. Revising paragraph (b)(2).
B. Adding paragraphs (b)(10), (11), (12), and (13).
The revisions and additions read as follows:
(b) * * *
(2) Pneumococcal, influenza, and hepatitis b vaccines and their administration.
(10) Bone mass measurement.
(11) Medical nutrition therapy (MNT) services.
(12) Personalized prevention plan services (PPPS).
(13) Additional preventive services identified for coverage through the national coverage determination (NCD) process.
17. The authority citation for part 411 continues to read as follows:
Secs. 1102, 1860D–1 through 1860D–42, 1871, and 1877 of the Social Security Act (42 U.S.C. 1302, 1395w–101 through 1395w–152, 1395hh, and 1395nn).
18. Section 411.15 is amended by—
A. Republishing the introductory text.
B. Revising paragraph (a)(1).
C. Adding new paragraph (k)(16).
The revision and addition read as follows:
The following services are excluded from coverage.
(a) * * *
(1) Examinations performed for a purpose other than treatment or diagnosis of a specific illness, symptoms, complaint, or injury, except for screening mammography, colorectal cancer screening tests, screening pelvic exams, prostate cancer screening tests, glaucoma screening exams, ultrasound screening for abdominal aortic screening for abdominal aortic aneurysms (AAA), cardiovascular disease screening tests, diabetes screening tests, a screening electrocardiogram, initial preventive physical examinations that meet the criteria specified in paragraphs (k)(6) through (k)(15) of this section, additional preventive services that meet the criteria in § 410.64 of this chapter, or annual wellness visits providing personalized prevention plan services
(k) * * *
(16) In the case of an annual wellness visit providing a personalized prevention plan, subject to the conditions and limitations specified in § 410.15 of this chapter.
19. Section 411.355 is amended by adding paragraph (b)(7) to read as follows:
(b) * * *
(7)
(i) With respect to magnetic resonance imaging, computed tomography, and positron emission tomography, the referring physician shall provide written notice to the patient at the time of the referral that the patient may receive the same services from a person other than one described in paragraph (b)(1) of this section. Except as set forth in paragraph (b)(7)(ii) of this section, the written notice shall include a list of at least 10 other suppliers (as defined in § 400.202 of this chapter) that provide the services for which the individual is being referred and which are located within a 25-mile radius of the referring physician's office location at the time of the referral. The notice should be written in a manner sufficient to be reasonably understood by all patients and should include for each supplier on the list, at a minimum, the supplier's name, address, telephone number, and distance from the referring physician's
(ii) If there are fewer than 10 other suppliers located within a 25-mile radius of the physician's office location at the time of the referral, the physician shall list all of the other suppliers of the imaging service that are present within a 25-mile radius of the referring physician's office location, including up to 10 suppliers. Provision of the written list of alternate suppliers will not be required if no other suppliers provide the services for which the individual is being referred within the 25-mile radius.
20. The authority citation for part 413 continues to read as follows:
Secs. 1102, 1812(d), 1814(b), 1815, 1833(a), (i), and (n), 1861(v), 1871, 1881, 1883, and 1886 of the Social Security Act (42 U.S.C. 1302, 1395d(d), 1395f(b), 1395g, 1395l(a), (i), and (n), 1395x(v), 1395hh, 1395rr, 1395tt, and 1395ww); and sec. 124 of Public Law 106–133 (113 Stat. 1501A–332).
21. Section 413.70 is amended by adding a sentence at the end of paragraph (b)(3)(ii)(B) to read as follows:
(b) * * *
(3) * * *
(ii) * * *
(B) * * * Effective for primary care services furnished by primary care practitioners (as defined in § 414.80(a)) and major surgical procedures furnished by general surgeons in health professional shortage areas (as defined in § 414.2) furnished on or after January 1, 2011 and before January 1, 2016, incentive payments specified under § 414.80 and § 414.67(b), respectively, of this chapter shall not be included in determining payment made under this paragraph.
22. The authority citation for part 414 continues to read as follows:
Secs. 1102, 1871, and 1881(b)(l) of the Social Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(l)).
23. Section 414.2 is amended by adding the definitions of “Health Professional Shortage Area” and “Major surgical procedure” in alphabetical order to read as follows:
24. Section 414.26 is amended by—
A. Redesignating paragraph (c) as paragraph (d).
B. Adding a new paragraph (c).
The addition reads as follows:
(c)
(i) At least 50 percent of counties located within the State have a population density less than 6 persons per square mile.
(ii) The State does not receive a non-labor related share adjustment determined by the Secretary to take into account the unique circumstances of hospitals located in Alaska and Hawaii.
(2)
(3)
(ii) CMS will publish annually a listing of qualifying Frontier States receiving a practice expense index floor attributable to this provision.
25. Section 414.54 is revised to read as follows:
(a) For services furnished after December 31, 1991, allowed amounts under the fee schedule established under section 1833(a)(1)(K) of the Act for the payment of certified nurse-midwife services may not exceed 65 percent of the physician fee schedule amount for the service.
(b) For certified nurse midwife services furnished on or after January 1, 2011, allowed amounts may not exceed 100 percent of the physician fee schedule amount for the services.
26. Section 414.65 is amended by revising the introductory text of paragraph (a)(1) to read as follows:
(a) * * *
(1) The Medicare payment amount for office or other outpatient visits, subsequent hospital care services (with the limitation of one telehealth subsequent hospital care service every 3 days), subsequent nursing facility care services (not including the Federally-mandated periodic visits under § 483.40(c) and with the limitation of one telehealth nursing facility care service every 30 days), professional consultations, psychiatric diagnostic interview examination, neurobehavioral status exam, individual psychotherapy, pharmacologic management, end-stage renal disease-related services included in the monthly capitation payment (except for one “hands on” visit per month to examine the access site), individual and group medical nutrition therapy services, individual and group kidney disease education services, individual and group diabetes self-management training (DSMT) services (except for 1 hour of in-person DSMT services to be furnished in the year following the initial DSMT service to ensure effective injection training), and individual and group health and behavior assessment and intervention furnished via an interactive telecommunications system is equal to the current fee schedule amount applicable for the service of the physician or practitioner.
27. Section 414.67 is revised to read as follows:
(a)
(1) HPSA bonuses are payable for services furnished by physicians as defined in section 1861(r) of the Act in areas designated as of December 31 of the prior year as geographic primary medical care HPSAs as defined in section 332(a)(1)(A) of the Public Health Service Act.
(2) HPSA bonuses are payable for services furnished by psychiatrists in areas designated as of December 31 of the prior year as geographic mental health HPSAs if the services are not already eligible for the bonus based on being in a geographic primary care HPSA.
(3) Physicians eligible for the HPSA physician bonus are entitled to a 10 percent incentive payment above the amount paid for their professional services under the physician fee schedule.
(4) Physicians furnishing services in areas that are designated as geographic HPSAs prior to the beginning of the year but not included on the published list of zip codes for which automated HPSA bonus payments are made should use the AQ modifier to receive the HPSA physician bonus payment.
(b)
(1) A major surgical procedure as defined in § 414.2 of this part is furnished by a general surgeon on or after January 1, 2011 and before January 1, 2016 in an area recognized for the HPSA physician bonus program under paragraph (a)(1) of this section.
(2) Payment will be made on a quarterly basis in an amount equal to 10 percent of the Part B payment amount for major surgical procedures furnished as described in paragraph (1), in addition to the amount the physician would otherwise be paid.
(3) Physicians furnishing services in areas that are designated as geographic HPSAs eligible for the HPSA physician bonus program under paragraph (a)(1) of this section prior to the beginning of the year but not included on the published list of zip codes for which automated HPSA surgical bonus payments are made should report a specified HCPCS code modifier to receive the HPSA surgical bonus payment.
(4) The payment described in paragraph (b)(2) of this section is made to the surgeon or, where the surgeon has reassigned his or her benefits to a critical access hospital (CAH) paid under the optional method, to the CAH based on an institutional claim.
28. Section 414.80 is added to subpart B to read as follows:
(a)
(i) A physician (as defined in section 1861(r)(1)) who meets all of the following criteria:
(A) Enrolled in Medicare with a primary specialty designation of 08-family practice, 11-internal medicine, 37-pediatrics, or 38-geriatrics.
(B) At least 60 percent of the physician's allowed charges during a reference period specified by the Secretary are for primary care services.
(ii) A nurse practitioner, clinical nurse specialist, or physician assistant (as defined in section 1861(aa)(5)) who meets all of the following criteria:
(A) Enrolled in Medicare with a primary specialty designation of 50-nurse practitioner, 89-certified clinical nurse, or 97-physician assistant.
(B) At least 60 percent of the practitioner's allowed charges during a reference period specified by the Secretary are for primary care services.
(1) For primary care services furnished by an eligible primary care practitioner on or after January 1, 2011 and before January 1, 2016, payment is made on a quarterly basis in an amount equal to 10 percent of the payment amount for the primary care services under Part B, in addition to the amount the primary care practitioner would otherwise be paid for the primary care services under Part B.
(2) The payment described in paragraph (b)(1) of this section is made to the eligible primary care practitioner or, where the physician has reassigned his or her benefits to a critical access hospital (CAH) paid under the optional method, to the CAH based on an institutional claim.
29. A new § 414.90 is added to subpart B to read as follows:
(a)
(1) 1848(a)—Payment Based on Fee Schedule.
(2) 1848(k)—Quality Reporting System.
(3) 1848(m)—Incentive Payments for Quality Reporting.
(b)
(i) A physician.
(ii) A practitioner described in section 1842(b)(18)(C) of the Act.
(iii) A physical or occupational therapist or a qualified speech-language pathologist.
(iv) A qualified audiologist (as defined in section 1861(ll)(3)(B) of the Act).
(i) The program requires the physician to maintain a valid unrestricted license in the United States.
(ii) The program requires a physician to participate in educational and self-assessment programs that require an assessment of what was learned.
(iii) The program requires a physician to demonstrate, through a formalized secure examination, that the physician
(iv) The program requires successful completion of a qualified Maintenance of Certification Program practice assessment.
(i) Includes an initial assessment of an eligible professional's practice that is designed to demonstrate the physician's use of evidence-based medicine;
(ii) Includes a survey of patient experience with care; and
(iii) Requires a physician to implement a quality improvement intervention to address a practice weakness identified in the initial assessment under paragraph (i) and then to remeasure to assess performance improvement after such intervention.
(c)
(1) There are any quality measures that have been established under the PQRI that are applicable to any such services furnished by such professional (or in the case of a group practice under paragraph (h) of this section, such group practice) for such reporting period; and
(2) The eligible professional (or in the case of a group practice under paragraph (h) of this section, the group practice) satisfactorily submits (as determined under paragraph (g) of this section for eligible professionals and paragraph (h) of this section for group practices) to the Secretary data on such quality measures in accordance with the PQRI for such reporting period, in addition to the amount otherwise paid under section 1848 of the Act, there also shall be paid to the eligible professional (or to an employer or facility in the cases described in section 1842(b)(6)(A) of the Act or, in the case of a group practice) under paragraph (h) of this section, to the group practice, from the Federal Supplementary Medical Insurance Trust Fund established under section 1841 an amount equal to the applicable quality percent (as specified in paragraph (c)(3) of this section) of the eligible professional's (or, in the case of a group practice under paragraph (h) of this section, the group practice's) total estimated allowed charges for all covered professional services furnished by the eligible professional (or, in the case of a group practice under paragraph (h) of this section, by the group practice) during the applicable reporting period. For purposes of this paragraph,
(i) The eligible professional's (or, in the case of a group practice under paragraph (h) of this section, the group practice's) total estimated allowed charges for covered professional services furnished during a reporting period are determined based on claims processed in the National Claims History (NCH) no later than 2 months after the end of the applicable reporting period;
(ii) In the case of an eligible professional who furnishes covered professional services in more than one practice, incentive payments are separately determined for each practice based on claims submitted for the eligible professional for each practice;
(iii) Incentive payments earned by an eligible professional (or in the case of a group practice under paragraph (h) of this section, by a group practice) for a particular program year will be paid as a single consolidated payment to the TIN holder of record.
(3)
(i) For 2011, 1.0 percent; and
(ii) For 2012, 2013, and 2014, 0.5 percent;
(d)
(2) In order to qualify for the additional incentive payment described in paragraph (d)(1) of this section, an eligible professional shall meet the following requirements:
(i) The eligible professional must—
(A) Satisfactorily submit data on quality measures for purposes of this section for a year; and
(B) Have such data submitted on their behalf through a Maintenance of Certification program (as defined in paragraph (b) of this section) that meets:
(
(
(ii) The eligible professional, more frequently than is required to qualify for or maintain board certification status—
(A) Participates in such a Maintenance of Certification Program for a year; and
(B) Sucessfully completes a qualified Maintenance of Certification Program practice assessment (as defined in paragraph (b) of this section) for such year.
(iii) A Maintenance of Certification program submits to the Secretary, on behalf of the eligible professional, information —
(A) In a form and manner specified by the Secretary, that the eligible professional has successfully met the requirements of paragraph (d)(2)(ii) of this section which may be in the form of a structural measure);
(B) If requested by the Secretary, on the survey of patient experience with care (as described in paragraph (b) of this section); and
(C) As the Secretary may require, on the methods, measures, and data used
(e)
(2)
(i) For 2015, 98.5 percent; and
(ii) For 2016 and each subsequent year, 98 percent.
(f)
(1) Subject to paragraph (f)(2) of this section, for purposes of reporting data on quality measures for covered professional services furnished during a year, subject to paragraph (g) of this section, the quality measures specified under this paragraph must be such measures selected by the Secretary from measures that have been endorsed by the entity with a contract with the Secretary under section 1890(a) of the Act.
(2)
(3)
(g)
(1)
(i) The 12-month period from January 1 through December 31 of each program year; or
(ii) The 6-month period from July 1 through December 31 of each program year.
(iii)
(2)
(i) Reporting the individual PQRI quality measures or PQRI measures groups to CMS, by no later than 2 months after the end of the applicable reporting period, on the eligible professional's Medicare Part B claims for covered professional services furnished during the applicable reporting period;
(ii) Reporting the individual PQRI quality measures or PQRI measures groups to a qualified registry (as specified in paragraph (b) of this section) in the form and manner and by the deadline specified by the qualified registry selected by the eligible professional. The selected registry will submit information, as required by CMS, for covered professional services furnished by the eligible professional during the applicable reporting period to CMS on the eligible professional's behalf; or
(iii) Reporting the individual PQRI quality measures to CMS by extracting clinical data using a secure data submission method, as required by CMS, from a qualified EHR product (as defined in paragraph (b) of this section) by the deadline specified by CMS for covered professional services furnished by the eligible professional during the applicable reporting period. Prior to actual data submission for a given program year and by a date specified by CMS, the eligible professional must submit a test file containing real or dummy clinical quality data extracted from the qualified EHR product selected by the eligible professional using a secure data submission method, as required by CMS.
(h)
(1) Meets the participation requirements specified by CMS for the PQRI group practice reporting option (GPRO);
(2) Is selected by CMS to participate in the PQRI GPRO;
(3) Reports measures specified by CMS in the form and manner, and at a time specified by CMS; and
(4) Meets the criteria for satisfactory reporting specified by CMS.
(5)
(i) If an eligible professional, as identified by an individual NPI, has reassigned his or her Medicare billing rights to a TIN selected to participate in the PQRI GPRO for a program year, then for that program year the eligible professional must participate in the PQRI via the GPRO. For any program year in which the TIN is selected to
(ii) If, for the program year, the eligible professional participates in the PQRI under another TIN that is not selected to participate in the PQRI GPRO for that program year, then the eligible professional may individually qualify for a PQRI incentive by meeting the requirements specified in paragraph (g) of this section under that TIN.
(i)
(i) The determination of measures applicable to services furnished by eligible professionals under PQRI;
(ii) The determination of the payment limitation; and
(iii) The determination of any PQRI incentive payment and the PQRI payment adjustment.
(j)
(1) To request an informal review, an eligible professional (or in the case of reporting under paragraph (h) of this section, group practices) must submit a written request to CMS within 90 days of the release of the feedback reports. The request must summarize the concern(s) and reasons for requesting an informal review and may also include information to assist in the review.
(2) CMS will provide a written response within 60 days of the receipt of the original request. All decisions based on the informal review will be final. There will be no further review or appeal.
(k)
30. A new § 414.92 is added to subpart B to read as follows:
(a)
(1) Section 1848(a)—Payment Based on Fee Schedule.
(2) Section 1848(m)—Incentive Payments for Quality Reporting.
(b)
(i) A physician.
(ii) A practitioner described in section 1842(b)(18)(C) of the Act.
(iii) A physical or occupational therapist or a qualified speech-language pathologist.
(iv) A qualified audiologist (as defined in section 1861(ll)(3)(B) of the Act).
(i) Is or is deemed to be participating in the Physician Quality Reporting Initiative (PQRI) group practice reporting option (GPRO) under § 414.90; and
(ii) Has indicated its desire to participate in the eRx GPRO.
(c)
(i) For purposes of this paragraph,
(A) The eligible professional's (or, in the case of a group practice under paragraph (e) of this section, the group practice's) total estimated allowed charges for covered professional services furnished during a reporting period are determined based on claims processed in the National Claims History (NCH) no later than 2 months after the end of the applicable reporting period;
(B) In the case of an eligible professional who furnishes covered professional services in more than one practice, incentive payments are separately determined for each practice based on claims submitted for the eligible professional for each practice;
(C) Incentive payments earned by an eligible professional (or in the case of a group practice under paragraph (e) of this section, by a group practice) for a particular program year will be paid as a single consolidated payment to the TIN holder of record.
(ii)
(A) For the 2011 and 2012 program years, 1.0 percent; and
(B) For the 2013 program year, 0.5 percent.
(iii)
(2)
(i)
(A) For 2012, 99 percent;
(B) For 2013, 98.5 percent; and
(C) For 2014, 98 percent.
(ii)
(A) An eligible professional (or group practice) who practices in a rural area with limited high speed Internet access.
(B) An eligible professional (or group practice) who practices in an area with limited available pharmacies for electronic prescribing.
(C) Other circumstances identified by CMS.
(3)
(d)
(1)
(2)
(i) CMS, by no later than 2 months after the end of the applicable reporting period, on the eligible professional's Medicare Part B claims for covered professional services furnished by the eligible professional during the reporting period specified in paragraph (d)(1) of this section;
(ii) A qualified registry (as defined in paragraph (b)) in the form and manner and by the deadline specified by the qualified registry selected by the eligible professional. The selected registry will submit information, as required by CMS, for covered professional services furnished by the eligible professional during the reporting period specified in paragraph (d)(1) of this section to CMS on the eligible professional's behalf; or
(iii) CMS by extracting clinical data using a secure data submission method, as required by CMS, from a qualified EHR product (as defined in paragraph (b) of this section) by the deadline specified by CMS for covered professional services furnished by the eligible professional during the reporting period specified in paragraph (d)(1) of this section. Prior to actual data submission for a given program year and by a date specified by CMS, the eligible professional must submit a test file containing real or dummy clinical quality data extracted from the qualified EHR product selected by the eligible professional using a secure data submission method, as required by CMS.
(e)
(1) A group practice (as defined in paragraph (b) of this section) will be treated as a successful electronic prescriber for covered professional services for a reporting period if the group practice meets the criteria for successful electronic prescriber specified by CMS in the form and manner and at the time specified by CMS.
(2)
(i) If an eligible professional, as identified by an individual NPI, has reassigned his or her Medicare billing rights to a TIN selected to participate in the eRx GPRO for a program year, then for that program year the eligible professional must participate in the eRx Incentive Program via the GPRO. For any program year in which the TIN is selected to participate in the eRx Incentive Program GPRO, the eligible professional cannot individually qualify for an eRx incentive payment by meeting the requirements specified in paragraph (d) of this section.
(ii) If, for the program year, the eligible professional participates in the eRx Incentive Program under another TIN that is not selected to participate in the eRx Incentive Program GPRO for that program year, then the eligible professional may individually qualify for an eRx incentive by meeting the requirements specified in paragraph (d) of this section under that TIN.
(f)
31. Section 414.202 is amended by adding a definition of “complex rehabilitative power-driven wheelchair” in alphabetical order to read as follows:
(1) Group 2 power wheelchair with power options that can accommodate rehabilitative features (for example, tilt in space); or
(2) Group 3 power wheelchair.
32. Section 414.226 is amended by revising paragraph (g)(1) to read as follows:
(g) * * *
(1) The supplier that furnishes oxygen equipment for the first month during which payment is made under this section must continue to furnish the equipment until medical necessity ends, or the 36-month period of continuous use ends, whichever is earlier, unless—
(i) The item becomes subject to a competitive acquisition program implemented in accordance with section 1847(a) of the Act;
(ii) Before the 18th month of continuous use, the beneficiary relocates to an area that is outside the normal service area of the supplier that initially furnished the equipment;
(iii) The beneficiary elects to obtain oxygen equipment from a different supplier prior to the expiration of the 36-month rental period; or
(iv) CMS or the carrier determines that an exception should apply in an individual case based on the circumstances.
33. Section 414.229 is amended by—
A. Revising paragraphs (a)(3), (d)(1), and (h).
B. Adding paragraphs (a)(4), (a)(5), and (b)(3).
The revisions and additions read as follows:
(a) * * *
(3) For power-driven wheelchairs furnished on or after January 1, 2006 through December 31, 2010, payment is made in accordance with the rules set forth in paragraphs (f) or (h) of this section.
(4) For power-driven wheelchairs that are not classified as complex rehabilitative power-driven wheelchairs, furnished on or after January 1, 2011, payment is made in accordance with the rules set forth in paragraph (f) of this section.
(5) For power-driven wheelchairs classified as complex rehabilitative power-driven wheelchairs, furnished on or after January 1, 2011, payment is made in accordance with the rules set forth in paragraphs (f) or (h) of this section.
(b) * * *
(3) For power-driven wheelchairs furnished on or after January 1, 2011, the monthly fee schedule amount for rental equipment equals 15 percent of the purchase price recognized as determined under paragraph (c) of this section for each of the first 3 months and 6 percent of the purchase price for each of the remaining months.
(d) * * *
(1) Suppliers must offer beneficiaries the option of purchasing power-driven wheelchairs at the time the supplier first furnishes the item. On or after January 1, 2011, this option is available only for complex rehabilitative power-driven wheelchairs. Payment must be on a lump-sum fee schedule purchase basis if the beneficiary chooses the purchase option. The purchase fee is the amount established in paragraph (c) of this section.
(h)
(1) Suppliers must offer beneficiaries the option to purchase power-driven wheelchairs at the time the equipment is initially furnished.
(2) Payment is made on a lump-sum purchase basis if the beneficiary chooses this option.
(3) On or after January 1, 2011, this option is available only for complex rehabilitative power-driven wheelchairs.
34. Section 414.402 is amended by adding the definitions of “Affected party,” “Breach of contract,” “Corrective Action Plan,” “Hearing Officer,” “Mail order item,” “National mail order competitive bidding program,” “Nonmail order item” and “Parties to the hearing” in alphabetical order to read as follows:
35. Section 414.404 is amended by revising paragraph (b)(1)(i) to read as follows:
(b) * * *
(1) * * *
(i) The items furnished are limited to crutches, canes, walkers, folding manual wheelchairs, blood glucose monitors, and infusion pumps that are DME, and,
36. Section 414.408 is amended by-–
A. Revising paragraph (f)(1).
B. Redesignating paragraphs (h)(2) through (h)(7) as paragraphs (h)(3) through (h)(8) respectively.
C. Adding new paragraph (h)(2).
D. In newly designated paragraphs (h)(3)(i) and (ii), remove the phrase “(h)(2)” and add in its place the phrase “(h)(3).”
The revision and addition reads as follows:
(f) * * *
(1) The single payment amounts for new purchased durable medical equipment, including power wheelchairs that are purchased when the equipment is initially furnished, and enteral nutrition equipment are calculated based on the bids submitted and accepted for these items. For contracts entered into beginning on or after January 1, 2011, payment on a lump sum purchase basis is only available for power wheelchairs classified as complex rehabilitative power wheelchairs.
(h) * * *
(2) For contracts entered into beginning on or after January 1, 2011, the monthly fee schedule amount for rental of power wheelchairs equals 15 percent of the single payment amounts calculated for new durable medical equipment under paragraph (f)(1) of this section for each of the first 3 months, and 6 percent of the single payment amounts calculated for these items for each of the remaining months 4 through 13.
37. Section 414.410 is amended as follows:
A. Revising paragraphs (a)(2) and (a)(3).
B. Adding a new paragraph (a)(4).
The revisions and addition read as follows:
(a) * * *
(2) In CY 2011, in an additional 91 MSAs (the additional 70 MSAs selected by CMS as of June 1, 2008, and the next 21 largest MSAs by total population based on 2009 population estimates, and not already phased in as of June 1, 2008). CMS may subdivide any of the 91 MSAs with a population of greater than 8,000,000 into separate CBAs, thereby resulting in more than 91 CBAs.
(3) After CY 2011, additional CBAs (or, in the case of national mail order for items and services, after CY 2010).
(4) For competitions (other than for national mail order items and services) after CY 2011 and prior to CY 2015, the following areas are excluded:
(i) Rural areas.
(ii) MSAs not selected under paragraphs (a)(1) or (a)(2) of this section with a population of less than 250,000.
(iii) An area with low population density within an MSA not selected under paragraphs (a)(1) or (a)(2) of this section.
38. Section 414.411 is added to read as follows:
(a)
(b)
39. Section 414.422 is amended by adding paragraph (e)(3) to read as follows:
(e) * * *
(3) Contract suppliers for diabetic testing supplies must furnish the brand of diabetic testing supplies that works with the home blood glucose monitor selected by the beneficiary. The contract supplier is prohibited from influencing or incentivizing the beneficiary by persuading, pressuring, or advising them to switch from their current brand or for new beneficiaries from their preferred brand of glucose monitor and testing supplies. The contract supplier may not furnish information about alternative brands to the beneficiary unless the beneficiary requests such information.
40. Section 414.423 is added to read as follows:
This section implements an appeals process for suppliers that CMS has determined are in breach of their Medicare DMEPOS Competitive Bidding Program contracts and where CMS has taken action to terminate the supplier's contract. Except as specified in this regulation termination decisions made under this section are final and binding.
(a)
(b)
(2)
(i) The reasons for the termination.
(ii) The right to request a hearing by a CBIC Hearing Officer, and depending on the nature of the breach, the supplier may also be allowed to submit a CAP in lieu of requesting a hearing by a CBIC Hearing Officer, as specified in paragraph (c)(1)(i) of this section.
(iii) The address to which the written request for a hearing must be mailed.
(iv) The address to which the CAP must be mailed, if applicable.
(v) Penalties that will accompany the termination, such as not being eligible to bid in future rounds of competitive bidding.
(vi) The effective date of termination is 45 days from the date of the notification letter unless a timely hearing request has been filed or a Corrective Action Plan (CAP) has been submitted within 30 days of the date on the notification letter.
(c)
(1)
(i) CMS has the option to allow a DMEPOS supplier to provide a written Corrective Action Plan (CAP) to remedy the deficiencies identified in the notice, when CMS determines that the delay in the termination date caused by allowing a CAP will not cause harm to beneficiaries, for example, we would not allow a CAP if the supplier has been excluded, debarred, or convicted of a healthcare related crime.
(ii) If a supplier chooses not to submit a CAP or if CMS determines that a supplier's CAP is insufficient, the supplier may request a hearing on the termination.
(2)
(i) A Corrective Action Plan must be submitted within 30 calendar days from the date on the notification letter. If the supplier decides not to submit a Corrective Action Plan the supplier may within 30 days of the date on the termination letter may request a hearing by a CBIC hearing officer.
(ii) Suppliers will only have the opportunity to submit a CAP when they are first notified that they have been determined to be in breach of contract. If the CAP is not acceptable or properly implemented, suppliers will receive a termination notice.
(d)
(1) For the supplier to eliminate all of the deficiencies that were identified in the CBIC notice to terminate its contract to avoid contract termination.
(2) To identify the timeframes by which the supplier will implement each of the components of the CAP.
(e)
(1) The CBIC will review the CAP and submit a recommendation to CMS concerning whether the CAP includes the steps necessary to remedy the contract deficiencies as identified in the notice.
(2) If CMS accepts the CAP, including supplier's designated timeframe for its completion; the supplier must provide a follow-up report within 5 days after the supplier has fully implemented the CAP that verifies that all of the deficiencies identified in the CAP have been corrected in accordance with the timeframes accepted by CMS.
(3) If the supplier does not implement an acceptable CAP the supplier will receive a new notice that their contract will be terminated within 45 calendar days of the date on the notice to terminate.
(f)
(1) A supplier who has received a notice that CMS considers the supplier in breach of contract or that the supplier's CAP is not acceptable has the right to request a hearing before a HO who was not involved with the original determination.
(2) A supplier who wishes to appeal the termination notice must submit a written request to the CBIC. The request for a hearing must be received by the CBIC within 30 calendar days from the date of the notice to terminate.
(3) A request for hearing must be in writing and submitted by an authorized official of the supplier.
(4) The appeals process for the Medicare DMEPOS Competitive Bidding Program is not to be used in place of other existing appeals processes that apply to other parts of Medicare.
(5) In the absence of submitting a CAP when the supplier is offered the opportunity to submit a CAP within 30 days of the notice in accordance with paragraph (c)(1) of this section, a supplier's failure to timely request a hearing will result in a termination of the supplier's DMEPOS Competitive Bidding Program contract effective 45 days from the date on the notice to terminate.
(g)
(1) Within 30 calendar days from the receipt of the supplier's timely request for a hearing the hearing officer will contact the parties to schedule the hearing.
(2) The hearing may be held in person or by telephone at the supplier's request.
(3) The scheduling notice to the parties must indicate the time and place for the hearing and must be sent to the supplier 30 days before the date of the hearing.
(4) The HO may, on his or her own motion, or at the request of a party, change the time and place for the hearing, but must give the parties to the hearing 30 day notice of the change.
(5) The HO's scheduling notice must provide the parties to the hearing and the CBIC the following information:
(i) Description of the hearing procedure.
(ii) The general and specific issues to be resolved.
(iii) The supplier has the burden to prove it is not in violation of the contract.
(iv) The opportunity for parties to the hearing to submit evidence to support their positions.
(v) All evidence submitted, both from the supplier and CMS, in preparation for the hearing with all affected parties within 15 days prior to the scheduled dated of the hearing.
(h)
(1) The burden of proof is on the Competitive Bidding Program contract supplier to demonstrate to the HO with convincing evidence that it has not breached its contract or that termination is not appropriate.
(2) The supplier's supporting evidence must be submitted with its request for a hearing.
(3) If the Medicare DMEPOS supplier fails to submit this evidence at the time of its submission, the Medicare DMEPOS supplier is precluded from introducing new evidence later during the hearing process, unless permitted by the hearing officer.
(4) The CBIC and CMS also have the opportunity to submit evidence to the HO within 10 days of receiving a notice announcing the hearing.
(5) The HO will share all evidence submitted, both from the supplier and/or CMS, in preparation for the hearing with all affected parties within 15 days prior to the scheduled date of the hearing.
(i)
(1) Conducts the hearing and decides the order in which the evidence and the arguments of the parties are presented;
(2) Determine the rules on admissibility of the evidence;
(3) Examines the witnesses, in addition to the examinations conducted by CMS, CBIC and the contract supplier;
(4) The CBIC may assist CMS in the appeals process including being present at the hearing, testifying as a witness, or performing other, related ministerial duties.
(5) Determines the rules for requesting documents and other evidence from other parties;
(6) Ensures a complete record of the hearing is made available to all parties to the hearing;
(7) Prepares a file of the record of the hearing which includes all evidence submitted as well as any relevant documents identified by the HO and considered as part of the hearing; and
(8) Complies with all applicable provisions of 42 U.S.C. Title 18 and related provisions of the Act, the applicable regulations issued by the Secretary, and manual instructions issued by CMS.
(j)
(1) The HO will issue a written recommendation to CMS within 30 days of the close of the hearing or as soon as practical after the hearing.
(2) The recommendation will explain the basis and the rationale for the HO's recommendation.
(3) The hearing officer must include the record of the hearing, along with evidence and documents produced during the hearing along with its recommendation.
(k)
(1) CMS' review of the HO recommendation will not allow the supplier to submit new information.
(2) After reviewing the HO recommendation, CMS' decision will be made within 30 days from the date of receipt of the HO's recommendation.
(3) A CMS decision to terminate will indicate the effective date of the termination.
(4) This decision is final and binding.
(l)
(1) A contract supplier whose contract has been terminated may no longer furnish competitive bid items to beneficiaries within a CBA and be reimbursed by Medicare for these items after the effective date of the termination.
(2) A contract supplier whose contract has been terminated must notify all beneficiaries who are receiving rented competitive bid items or competitive bid items received on a recurring basis, of the termination of their contract. The notice to the beneficiary from the supplier whose contract was terminated must be provided within 5 days of receipt of the final notice of termination. The notification to the beneficiaries must inform the beneficiaries that they are going to have to select a new contract supplier to furnish these items in order for Medicare to pay these items.
(m)
(1) A supplier's DMEPOS CBP contract is terminated effective on the termination date specified in the CBIC notice to the supplier, unless the supplier timely requests a hearing with the HO or the supplier has submitted a CAP under paragraph (x) of this section.
(2) If a supplier requests an HO review of the CMS decision to terminate its contract, and CMS based upon on the HO recommendation terminates the supplier's contract, the effective date of the termination will be the date specified in the CBIC notice to the supplier.
(3) For violations of the terms of the supplier's DMEPOS CBP contract that may harm beneficiaries, such as a supplier providing an inferior product that causes harm to the beneficiary, no delays of the effective date of the termination will be allowed.
39. Section 414.610 is amended by revising paragraphs (c)(1)(i), (c)(5)(ii), (f), and (h) to read as follows:
(c) * * *
(1)
(5) * * *
(ii) For services furnished during the period July 1, 2004 through December 31, 2010, the payment amount for the ground ambulance base rate is increased by 22.6 percent where the point of pickup is in a rural area determined to be in the lowest 25 percent of rural population arrayed by population density. The amount of this increase is based on CMS's estimate of the ratio of the average cost per trip for the rural areas in the lowest quartile of population compared to the average cost per trip for the rural areas in the highest quartile of population. In making this estimate, CMS may use data provided by the GAO.
(f)
(h)
40. Section 414.620 is revised to read as follows:
(a) Changes in payment rates resulting from incorporation of the annual inflation factor and the multi-factor productivity adjustment as described in § 414.610(f) will be announced by CMS by instruction and on the CMS Web site.
(b) CMS will follow applicable rulemaking procedures in publishing revisions to the fee schedule for ambulance services that result from any factors other than those described in § 414.610(f).
41. Section 414.804 is amended by—
A. Redesignating paragraph (a)(6) as (a)(7).
B. Adding new paragraph (a)(6).
The addition reads as follows:
(a) * * *
(6) The manufacturer's average sales price must be calculated based on the amount of product in a vial or other container as conspicuously reflected on the FDA approved label as defined by section 201(k) of the Food, Drug, and Cosmetic Act.
42. Section 414.902 is amended by adding the definitions of “Biosimilar biological product” and “Reference biological product” in alphabetical order to read as follows:
43. Section 414.904 is amended by—
A. Adding paragraphs (a)(3), (i), and (j).
B. Revising paragraph (d)(3).
The revisions and additions read as follows:
(a) * * *
(3) For purposes of this section—
(i) CMS calculates an average sales price payment limit based on the amount of product included in a vial or other container as reflected on the FDA-approved label.
(ii) Additional product contained in the vial or other container does not represent a cost to providers and is not incorporated into the ASP payment limit.
(iii) No payment shall be made for amounts of product in excess of that reflected on the FDA-approved label.
(d) * * *
(3)
(i) The payment amount substitution will be applied at the next ASP payment amount calculation period after the Inspector General informs the Secretary (at such times specified by the Secretary) about drugs or biologicals that have exceeded the applicable threshold percentage, and will remain in effect for one quarter after publication.
(ii) Payment at 103 percent of the average manufacturer price for a billing code will be applied at such times when:
(A) The threshold for making price substitutions, as defined in section (iii) is met; and,
(B) When 103 percent of the AMP is less than the 106 percent of the ASP during the quarter in which the average manufacturer price would be applied.
(iii) The applicable threshold for AMP comparisons for calendar years 2005, 2006, 2007, 2008, 2009, 2010, is 5 percent. For CY 2011, the threshold for ASP comparisons is reached when:
(A) The ASP for the billing code has exceeded the AMP for the billing code by 5 percent or more in two consecutive quarters, or three of the last four quarters; immediately preceding the quarter to which the price substitution recommendation would apply; and,
(B) The average manufacturer price for the billing code is calculated using the same set of NDCs used for the average sales price calculation as per this section for the billing code;
(iv) The applicable threshold for WAMP comparisons for calendar years 2005 through 2011 is 5 percent.
(v) No payment amount substitutions will occur before the preliminary injunction issued on December 19, 2007, by the United States District of Columbia in
(i) If manufacturer ASP data is not available prior to the publication deadline for quarterly payment limits, the payment limit is calculated by carrying over the most recent available manufacturer ASP price from a previous quarter for an NDC, adjusted by the weighted average of the change in the manufacturer ASPs for the NDCs that were reported during both the most recently available quarter and the current quarter.
(j)
44. The authority citation for part 415 continues to read as follows:
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
45. Section 415.130 is amended by revising paragraph (d) to read as follows:
(d)
(1) The technical component of physician pathology services furnished by an independent laboratory to a hospital inpatient or outpatient on or before December 31, 2010, may be paid to the laboratory by the contractor under the physician fee schedule if the Medicare beneficiary is a patient of a covered hospital as defined in paragraph (a)(1) of this section.
(2) For services furnished after December 31, 2010, an independent laboratory may not bill the Medicare contractor for the technical component of physician pathology services furnished to a hospital inpatient or outpatient.
(3) For services furnished on or after January 1, 2008, the date of service policy in § 414.510 of this chapter applies to the TC of specimens for physician pathology services.
46. The authority citation for part 424 continues to read as follows:
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
47. Section 424.20 is amended by revising paragraph (e)(2) to read as follows:
(e) * * *
(2) A physician extender (that is, a nurse practitioner, a clinical nurse specialist, or a physician assistant as those terms are defined in section 1861(aa)(5) of the Act) who does not have a direct or indirect employment relationship with the facility but who is working in collaboration with a physician. For purposes of this section—
(i)
(A) Collaboration means a process whereby a physician extender works with a doctor of medicine or osteopathy to deliver health care services.
(B) The services are delivered within the scope of the physician extender's professional expertise, with medical direction and appropriate supervision as provided for in guidelines jointly developed by the physician extender and the physician or other mechanisms defined by Federal regulations and the law of the State in which the services are performed.
(ii)
(A)
(B)
(
48. Section 424.44 is amended by revising paragraphs (a), (b), and (e) to read as follows:
(a)
(1) For services furnished on or after January 1, 2010, except as provided in paragraphs (b) and (e) of this section, the claim must be filed no later than the close of the period ending 1 calendar year after the date of service.
(2) For services furnished before January 1, 2010, except as provided in paragraphs (b) and (e) of this section, the claim must be filed on or before December 31 of the following year for services that were furnished during the first 9 months of a calendar year, and on or before December 31st of the second following year for services that were furnished during the last 3 months of the calendar year, except that for services furnished during the last 3 months of 2009 all claims must be filed no later than December 31, 2010.
(b)
(1) The time for filing a claim will be extended if CMS or one of its contractors determines that a failure to meet the deadline in paragraph (a) of this section was caused by error or misrepresentation of an employee, Medicare contractor (including Medicare Administrative Contractor, intermediary, or carrier), or agent of the Department that was performing Medicare functions and acting within the scope of its authority.
(2) The time for filing a claim will be extended if CMS or one of its contractors determines that a failure to meet the deadline in paragraph (a) of this section is caused by all of the following conditions:
(i) At the time the service was furnished the beneficiary was not entitled to Medicare.
(ii) The beneficiary subsequently received notification of Medicare entitlement effective retroactively to or before the date of the furnished service.
(3) The time for filing a claim will be extended if CMS or one of its contractors determines that a failure to meet the deadline in paragraph (a) of this section is caused by all of the following conditions:
(i) At the time the service was furnished the beneficiary was not entitled to Medicare.
(ii) The beneficiary subsequently received notification of Medicare entitlement effective retroactively to or before the date of the furnished service.
(iii) A State Medicaid agency recovered the Medicaid payment for the furnished service from a provider or supplier 11 months or more after the service was furnished.
(4)
(ii) If CMS or one of its contractors determines that both of the conditions are met in paragraph (b)(2) of this section but that all of the conditions in paragraph (b)(3) are not satisfied, the time to file a claim will be extended through the last day of the 6th calendar month following the month in which the beneficiary received notification of Medicare entitlement effective retroactively to or before the date of the furnished service.
(iii) If CMS or one of its contractors determines that all of the conditions are met in paragraph (b)(3) of this section, the time to file a claim will be extended through the last day of the 6th calendar month following the month in which the State Medicaid agency recovered the Medicaid payment for the furnished service from the provider or supplier.
(e) As specified in §§ 424.520 and 424.521 of this subpart, there are restrictions on the ability of the following newly-enrolled suppliers to submit claims for items or services furnished prior to the effective date of their Medicare billing privileges:
(1) Physician or non-physician practitioner organizations.
(2) Physicians.
(3) Nonphysician practitioners.
(4) Independent diagnostic testing facilities.
49. Section 424.502 is amended by adding a definition of “Voluntary termination” in alphabetical order to read as follows:
50. Section 424.510 is amended by revising paragraph (d)(1)(iii) to read as follows:
(d) * * *
(1) * * *
(iii) Submission of all documentation, including all applicable Federal and State licenses, certifications (including, but not limited to Federal Aviation Administration and Clinical Laboratory Improvement Act certifications), and regulatory requirements that apply to the specific provider or supplier type that relate to providing health care service, required by CMS under this or other statutory or regulatory authority, or under the Paperwork Reduction Act of 1995, to establish the provider or supplier's eligibility to furnish Medicare covered items or services to beneficiaries in the Medicare program.
51. Section 424.516 is amended by adding paragraph (e)(3) to read as follows:
(e) * * *
(3) Within 30 days any revocation or suspension of a Federal or State license or certification (including Federal Aviation Administration and Clinical Laboratory Improvement Act certifications), an air ambulance supplier must report a revocation or suspension of its license or certification to the applicable Medicare contractor.
(Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program).
The Addenda on the following pages provide various data pertaining to the Medicare fee schedule for physicians' services furnished in CY 2011. Addendum B contains the RVUs for work, nonfacility PE, facility PE, and malpractice expense, and other information for all services included in the PFS.
In previous years, we have listed many services in Addendum B that are not paid under the PFS. To avoid publishing as many pages of codes for these services, we are not including clinical laboratory codes or the alpha-numeric codes (Healthcare Common Procedure Coding System (HCPCS) codes not included in CPT) not paid under the PFS in Addendum B.
Addendum B contains the following information for each CPT code and alpha-numeric HCPCS code, except for: Alpha-numeric codes beginning with B (enteral and parenteral therapy); “E” (durable medical equipment); “K” (temporary codes for nonphysicians' services or items); or “L” (orthotics); and codes for anesthesiology. Please also note the following:
• An “NA” in the “Nonfacility PE RVUs” column of Addendum B means that CMS has not developed PE RVUs in the nonfacility setting for the service because it is typically performed in the hospital (for example, an open heart surgery is generally performed in the hospital setting and not a physician's office). If there is an “NA” in the nonfacility PE RVU column, and the contractor determines that this service can be performed in the nonfacility setting, the service will be paid at the facility PE RVU rate.
• Services that have an “NA” in the “Facility PE RVUs” column of Addendum B are typically not paid under the PFS when provided in a facility setting. These services (which include “incident to” services and the technical portion of diagnostic tests) are generally paid under either the hospital outpatient prospective payment system or bundled into the hospital inpatient prospective payment system payment. In some cases, these services may be paid in a facility setting at the PFS rate (for example, therapy services), but there would be no payment made to the practitioner under the PFS in these situations.
The BN reduction resulting from the chiropractic demonstration is
MMM = Code describes a service furnished in uncomplicated maternity cases, including antepartum care, delivery, and postpartum care. The usual global surgical concept does not apply. See the Physicians' Current Procedural Terminology for specific definitions.
XXX = The global concept does not apply.
YYY = The global period is to be set by the contractor (for example, unlisted surgery codes).
ZZZ = Code related to another service that is always included in the global period of the other service. (Note: Physician work and PE are associated with intra-service time and, in some instances, with the post-service time.)
Defense Acquisition Regulations System, Department of Defense (DoD).
Interim rule with request for comments.
DoD is issuing an interim rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to bring DoD into compliance with OMB implementation of the Prompt Payment Act by exempting military contingencies, and certain payments related to emergencies and the release or threatened release of hazardous substances.
You may submit comments, identified by DFARS Case 2009–D020, using any of the following methods:
Comments received generally will be posted without change to
Mr. Julian E. Thrash, 703–602–0310.
This rule implements the full authority granted by 5 CFR 1315.1 for payments covered by 5 CFR 1315.1(b)(2) that are either certified for payment in an operational area, or are contingent upon the receipt of necessary supporting documentation (
5 CFR part 1315 exempts Prompt Payment Act compliance for payments related to emergencies (defined in the Disaster Relief Act of 1974, Pub. L. 93–288, as amended (42 U.S.C. 5121,
This DFARS change will provide DoD needed flexibility in limited circumstances. The head of the contracting activity shall make subsequent determinations, after consultation with the cognizant comptroller, as the operational area evolves into a more stable business environment to enable the provisions of FAR 32.9 to apply.
This DFARS change adds section 232.901, Applicability, which provides criteria that the head of the contracting activity will use in determining when conditions exist that limit normal business operations during emergencies and contingency operations. It also adds DFARS 232.908, Contract clauses, which prescribes the use of the new clause 252.232–7011, Payments in Support of Emergencies and Contingency Operations. A conforming change is also required to 212.301, Solicitation provisions and contract clauses for the acquisition of commercial items.
This rule was subject to review under Section 6(b) of Executive Order 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.
DoD does not expect this rule to have a significant economic impact on small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601,
This initial regulatory flexibility analysis has been prepared consistent with 5 U.S.C. 604.
On May 22, 2008, the Department of Defense Inspector General (DoD IG) issued the results of an audit, Report No. D–2008–098, entitled “Internal Controls Over Payments Made in Iraq, Kuwait, and Egypt.” The audit report cited inconsistencies in FAR 32.9, DFARS 232.9, and 5 CFR in regard to compliance with the Prompt Payment Act for military contingency operations. The report further recommended that DoD establish procedures to address contingency operations.
During emergencies and contingency operations, the operational area can be so fluid and dynamic that carrying out normal business practices can be extremely challenging. It is necessary for the head of the contracting activity (HCA) to have the authority to appropriately respond to emergency and contingency operations accordingly whenever limited operational conditions exist. This includes the payment of contractors.
This interim rule will bring DoD into compliance with OMB implementation of the Prompt Payment Act, which exempts military contingencies.
The objectives of this rule allow the HCA to make a determination of whether stable business operations exist in theater, which allows the Prompt Payment Act to apply in an emergency and contingency operation. If stable conditions don't exist, then the HCA is authorized to apply the clause at 252.232–7011. When this clause is used, it will be used instead of the appropriate payment clause at FAR 52.232–25, 52.232–26, or 52.232–27. DFARS 232.901 will require the HCA to make subsequent determinations as the operational area evolves into a more stable environment to enable the provisions of the Prompt Payment Act to apply. It will also require the contracting officer to notify, by contract modification, each contractor that has a contract containing DFARS clause 252.232.7011, that it is no longer applicable, and the applicable FAR Prompt Payment clause in the contract applies.
This interim rule will have an economic impact on small entities. It is expected the rule will initially be applied to contracts supporting Afghanistan. Currently, normal business operations are hindered in Afghanistan due to the uncertain environment and instability in the region. It may be impractical for U.S. forces to adequately match receipt of necessary supporting documentation (
A review of Federal Procurement Data System (FPDS) data for FY08 shows that of the 140 awards made to U.S. firms, only 21 were made to small business entities. This total represents 15% of all awards made during this time period. Therefore, the overall impact of this rule is not expected to have a significant aggregate economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601,
There is no reporting requirement established by this rule. See preceding item 3 regarding an estimate of the effect on small entities that will be subject to this requirement.
This rule does not duplicate, overlap, or conflict with any other Federal rules.
There are no significant alternatives which accomplish the stated objectives. This rule will bring DoD into compliance with OMB implementation of the Prompt Payment Act, which exempts military contingencies.
DoD invites comments from small businesses and other interested parties on the expected impact of this rule on small entities.
DoD will also consider comments from small entities concerning the existing regulations in subparts affected by this rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C 610 (DFARS case 2009–D020), in correspondence.
The Paperwork Reduction Act does not apply, because the rule does not impose any information collection requirements that require the approval of the Office of Management and Budget under 44 U.S.C. 3501,
A determination has been made under the authority of the Secretary of Defense that urgent and compelling reasons exist to publish an interim rule prior to affording the public an opportunity to comment. Specifically, during emergencies and contingency operations, the operational area can be so fluid and dynamic that carrying out normal business practices can become impractical. It is necessary for the head of the contracting activity to have the authority to incorporate the Payments in Support of Emergencies and Contingency Operations clause provided by 252.232–7011, when an unstable business environment exists. This case brings DoD into compliance with OMB implementation of the Prompt Payment Act, which exempts military contingencies under 5 CFR 1315.1(b)(2).
Government procurement.
41 U.S.C. 421 and 48 CFR chapter 1.
(f) * * *
(xiv) Use the clause at 252.232–7011, Payments in Support of Emergencies and Contingency Operations, as prescribed in 232.908.
(1) FAR subpart 32.9, Prompt Payment, does not apply when—
(i) There is—
(A) An emergency, as defined in the Disaster Relief Act of 1974;
(B) A contingency operation (
(C) The release or threatened release of hazardous substances (as defined in 4 U.S.C. 9606, Section 106); and
(ii) The head of the contracting activity has made a determination, after consultation with the cognizant comptroller, that conditions exist that limit normal business operations; and
(iii) Payments will be made in the operational area or made contingent upon receiving supporting documentation (
(2) Criteria limiting normal business operations during emergencies and contingency operations that restrict the use of FAR 32.9 may include such conditions as—
(i) Support infrastructure, hardware, communications capabilities, and bandwidth are not consistently available such that normal business operations can be carried out;
(ii) Support resources, facilities, and banking needs are not consistently available for use as necessary in carrying out normal business operations;
(iii) Military mission priorities override the availability of appropriately skilled personnel in support of back-office operations;
(iv) Mobility impairments and security concerns restrict free movement of personnel and documents necessary for timely processing;
(v) Foreign vendors are not familiar with or do not understand DoD contract requirements (
(vi) Documents received in support of payment requests and shipments require language translations that cannot be performed and documented within normal business processing times.
(3)
(i) If the head of the contracting activity determines that the operational area has evolved into a more stable environment, the contracting officer shall notify, by issuance of a contract modification, each contractor performing in the operational area under review. The modification deactivates clause 252.232–7011 and activates the applicable FAR Prompt Payment clause in the contract.
(ii) If after deactivation of clause 252.232–7011, the head of the
Use the clause at 252.232–7011, Payments in Support of Emergencies and Contingency Operations, in solicitations and contracts in addition to the approved clause prescribed in FAR 32.908 in acquisitions that meet the applicability criteria at 232.901(1).
As prescribed in section 232.908, use the following clause:
(a) Definitions of pertinent terms are set forth in sections 2.101, 32.001, and 32.902 of the Federal Acquisition Regulation.
(b) Notwithstanding any other payment clause in this contract, the Government will make invoice payments under the terms and conditions specified in this clause. The Government considers payment as being made on the day a check is dated or the date of an electronic funds transfer
(c)
(1)
(i) Payment will be made as soon as possible once a proper invoice is received and matched with the contract and the receiving/acceptance report.
(ii) If the contract does not require submission of an invoice for payment (
(2)
(i) Name and address of the Contractor.
(ii) Invoice date and invoice number. (The Contractor should date invoices as close as possible to the date of the mailing or transmission.)
(iii) Contract number or other authorization for supplies delivered or services performed (including order number and contract line item number).
(iv) Description, quantity, unit of measure, unit price, and extended price of supplies delivered or services performed.
(v) Shipping and payment terms (
(vi) Name and address of Contractor official to whom payment is to be sent (must be the same as that in the contract or in a proper notice of assignment).
(vii) Name (where practicable), title, phone number, and mailing address of person to notify in the event of a defective invoice.
(viii) Taxpayer Identification Number (when required). The taxpayer identification number is required for all payees subject to the U.S. Internal Revenue Code.
(ix) Electronic funds transfer banking information.
(A) The Contractor shall include electronic funds transfer banking information on the invoice only if required elsewhere in this contract.
(B) If electronic funds transfer banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct electronic funds transfer banking information in accordance with the applicable solicitation provision (
(C) Electronic funds transfer banking information is not required if the Government waived the requirement to pay by electronic funds transfer.
(x) Any other information or documentation required by the contract (
(3)
(4)
(5)
(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment, including the—
(A) Circumstances of the overpayment (
(B) Affected contract number and delivery order number, if applicable;
(C) Affected contract line item or subline item, if applicable; and
(D) Contractor point of contact; and
(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.
(d) This clause is applicable until otherwise notified by the Contracting Officer. Upon notification by issuance of a contract modification, the appropriate FAR Prompt Payment clause in the contract becomes applicable.
Defense Acquisition Regulations System, Department of Defense (DoD).
Interim rule with request for comments.
DoD is issuing an interim rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement section 820 of the National Defense Authorization Act for Fiscal Year 2010 (Pub. L. 111–84, enacted October 28, 2009).
Submit comments identified by DFARS Case 2009–D033, using any of the following methods:
○
○
○
○
Comments received generally will be posted without change to
Meredith Murphy, Defense Acquisition Regulations System, OUSD(AT&L)DPAP(DARS), Room 3B855, 3060 Defense Pentagon, Washington, DC 20301–3060. Telephone 703–602–1302; facsimile 703–602–0350.
This DFARS case implements section 820 of the National Defense Authorization Act for Fiscal Year 2010. Section 820 is entitled “Publication of Notification of Bundling of Contracts of the Department of Defense.”
The new statute requires DoD contracting officers to publish a notification “consistent with the requirements” of FAR 10.001(c)(2) on FedBizOpps.gov, or any successor site, at least 30 days prior to the release of a solicitation for a bundled acquisition. In addition, if the DoD agency has determined that “measurably substantial benefits are expected to be derived as a result of bundling,” the notification must include a brief description of those benefits. The acquisitions covered by section 820 are defined at 820(b) as those that are funded entirely by DoD funds and covered by FAR 7.107, entitled “Additional requirements for acquisitions involving bundling.”
The statute, at section 820(c), provides that nothing in the new requirement shall be construed to—
(a) Alter any other publication or synopsis requirement;
(b) Require the public availability of information that is protected by the FOIA (5 U.S.C. 552(b)); or
(c) Require contracting officers to delay the issuance of a solicitation in order to meet the 30-day period (between the notification and the release of the solicitation) if the expedited issuance of the solicitation is otherwise authorized under any other requirement of law or regulation.
The FAR, at 10.001(c), addresses the market research requirements for agencies contemplating a bundled contract award. Currently, FAR 10.001(c)(2) requires that the agency, at least 30 days before release of a solicitation for a potential bundled procurement or 30 days prior to placing a bundled order without a solicitation, must notify any affected incumbent small businesses of (a) the intention to bundle the requirement and (b) how the small businesses can contact the appropriate SBA representative. This requirement is somewhat different from that in section 820. Therefore, a cross-reference to the section 820 requirement has been added at DFARS 210.001(c)(2).
The notification requirement is added as a new DFARS 205.205–70. FAR 5.205 addresses special synopsis situations. It currently covers R&D advance notices, public-private competitions under OMB–Circular A–76, and other requirements that differ somewhat from the general synopsis requirement at FAR 5.201. Therefore, this appears to be the proper location for the bundling notification. However, because the new requirement applies only when using DoD funds, it is proposed as a new DFARS section 205.205–70, entitled “Notification of bundling of DoD contracts.” The basic publication requirement is established here, but it was not deemed necessary to repeat the limitations and exclusions at section 820(c) of the statute because nothing in the new language states or implies that the opposite is, or could be, the case.
This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of Executive Order 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.
DoD does not expect that this interim rule will have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601,
DoD invites comments from small business concerns and other interested parties on the expected impact of this rule on small entities.
DoD will also consider comments from small entities concerning the existing regulations in subparts affected by this rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (DFARS Case 2009–D033) in correspondence.
The Paperwork Reduction Act does not apply because the interim rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under 44 U.S.C. chapter 35,
A determination has been made under the authority of the Secretary of Defense (DoD) that urgent and compelling circumstances exist to promulgate this interim rule without prior opportunity for public comments pursuant to 41 U.S.C. 418b and FAR 1.501–3(b). This action is necessary because section 820 of the National Defense Authorization Act for Fiscal Year 2010 became effective upon enactment, October 28, 2009. The rule implements section 820's requirement for contracting officers to publish a notification on FedBizOpps.gov at least 30 days prior to the release of a solicitation for a bundled acquisition. It is imperative that DoD contracting officers be made aware of this requirement as quickly as possible so that small businesses may have the benefit of the procurement planning information and the agency can comply with the statutory requirement. DoD will consider public comments received in response to this interim rule in the formation of the final rule.
Government procurement.
41 U.S.C. 421 and 48 CFR chapter 1.
(a) When a proposed acquisition is funded entirely using DoD funds and potentially involves bundling, the contracting officer shall, at least 30 days prior to the release of a solicitation or 30 days prior to placing an order without a solicitation, publish in FedBizOpps.gov (or any successor site) a notification of the intent to bundle the requirement. In addition, if the agency has determined that measurably substantial benefits are expected to be derived as a result of bundling, the notification shall include a brief description of those benefits (
(b) This requirement is in addition to the notification requirements at FAR 10.001(c)(2)(i) and (ii).
(c)(2) In addition to the notification requirements at FAR 10.001(c)(2)(i) and (ii), see 205.205–70 for the bundling notification publication requirement.
Defense Acquisition Regulations System, Department of Defense (DoD).
Interim rule with request for comments.
DoD is issuing an interim rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement section 814 of the National Defense Authorization Act for Fiscal Year 2010.
Submit comments identified by DFARS Case 2009–D036, using any of the following methods:
○
○
○
○
Comments received generally will be posted without change to
Meredith Murphy, Defense Acquisition Regulations System, OUSD (AT&L) DPAP (DARS), Room 3B855, 3060 Defense Pentagon, Washington, DC 20301–3060. Telephone 703–602–1302; facsimile 703–602–0350.
This DFARS rule implements section 814 of the National Defense Authorization Act for Fiscal Year 2010 (Pub. L. 111–84), enacted October 28, 2009. Section 814 is entitled “Amendment to Notification Requirements for Awards of Single-Source Task or Delivery Orders.” 10 U.S.C. 2304a(d)(3)(A) prohibits the award of a sole-source task or delivery order that is estimated to exceed $100 million (including all options) unless the head of the agency determines in writing that—
(1) The task or delivery orders expected under the contract are so integrally related that only a single source can reasonably perform the work;
(2) The contract provides only for firm-fixed-price task orders or delivery orders for products for which unit prices are established in the contract or services for which prices are established in the contract for the specific tasks to be performed;
(3) Only one source is qualified and capable of performing the work at a reasonable price to the government; or
(4) Because of exceptional circumstances, it is necessary in the public interest to award the contract to a single source.
Section 814 requires agency heads to notify the congressional defense committees within 30 days after making any determination for the reasons in (1) through (4) previously cited. In addition, if the task or delivery order concerns intelligence activities of the Department of Defense, the agency head also is required to provide notification within 30 days of the determination to the Permanent Select Committee on Intelligence of the House of Representatives if the order relates to tactical intelligence and intelligence-related activities, and to the Select Committee on Intelligence of the Senate and the Permanent Select Committee on Intelligence of the House of Representatives if the order relates to intelligence and intelligence-related activities other than those activities previously mentioned.
Given the need for consistency of content and format in the information provided to the Congress and the necessity for meeting the 30-day deadline for reporting the determinations to the Congress, agency heads are being asked to provide the determinations, not directly to the congressional committees, but to the Office of the Under Secretary of Defense (Acquisition, Technology, and Logistics) Defense Procurement and Acquisition Policy, Contract Policy and International Contracting. This will also enable a single office to oversee and manage the DoD picture for single-source task and delivery orders. The new reporting requirement is located at DFARS 216.504(c)(1)(ii)(D)(
This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of Executive Order 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 604.
DoD does not expect that this interim rule will have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601,
DoD will also consider comments from small entities concerning the existing regulations in subparts affected by this rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (DFARS Case 2009–D036) in correspondence.
The Paperwork Reduction Act does not apply because the interim rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under 44 U.S.C.,
A determination has been made under the authority of the Secretary of Defense (DoD) that urgent and compelling circumstances exist to promulgate this interim rule without prior opportunity for public comments pursuant to 41 U.S.C. 418b and FAR 1.501–3(b). This interim rule implements section 814 of the National Defense Authorization Act for FY 2010, which prohibits the award of a sole-source task or delivery order that is estimated to exceed $100 million (including all options) unless the head of the agency determines that one of four exceptions applies, and notifies appropriate congressional defense committees (and intelligence activities, if the order concerns intelligence activities) within 30 days of the determination. An interim rule is necessary because the statute became effective upon enactment on October 28, 2009, and it is imperative that DoD contracting officers be aware of additional congressional notification requirements as soon as possible in order to enable them to comply with the law. DoD will consider public comments received in response to this interim rule in the formation of the final rule.
Government procurement.
41 U.S.C. 421 and 48 CFR chapter 1.
(c)(1)(ii)(D)
Defense Acquisition Regulations System. Department of Defense (DoD).
Final rule.
DoD is making a technical amendment to the Defense Federal Acquisition Regulation Supplement (DFARS) to correct the date of DFARS clause 252.222–7006.
Ms. Ynette R. Shelkin, Defense Acquisition Regulations System, OUSD (AT&L) DPAP/DARS, Room 3B855, 3060 Defense Pentagon, Washington, DC 20301–3060. Telephone 703–602–8384; facsimile 703–602–0350.
This final rule amends the revision date of DFARS clause 252.222–7006. DoD published an interim rule at 75 FR 27946 on May 19, 2010, for DFARS Case 2010–D004, Restrictions on the Use of Mandatory Arbitration Agreements, in which it failed to cite a date for DFARS clause 252.222–7006. The date for the clause should have been May 19, 2010, the date the interim rule was published.
Government Procurement.
41 U.S.C. 421 and 48 CFR chapter 1.