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Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule; request for comments.
We are adopting a new airworthiness directive (AD) for the products listed above that would revise an existing AD. 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:
Bombardier Aerospace has completed a system safety review of the aircraft fuel system against fuel tank safety standards introduced in Chapter 525 of the Airworthiness Manual through Notice of Proposed Amendment (NPA) 2002–043. The identified non-compliances were then assessed using Transport Canada Policy Letter No. 525–001, to determine if mandatory corrective action is required.
The assessment showed that it is necessary to introduce Critical Design Configuration Control Limitations (CDCCL), in order to preserve critical fuel tank system ignition source prevention features during configuration changes such as modifications and repairs, or during maintenance actions. Failure to preserve critical fuel tank system ignition source prevention features could result in a fuel tank explosion. * * *
This AD becomes effective December 10, 2009.
On June 6, 2008 (73 FR 24157, May 2, 2008), the Director of the Federal Register approved the incorporation by reference of certain publications listed in the AD.
We must receive comments on this AD by January 11, 2010.
You may send comments by any of the following methods:
•
•
•
•
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
You may examine the AD docket on the Internet at
Mazdak Hobbi, 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) 228–7330; fax (516) 794–5531.
On April 24, 2008, we issued AD 2008–09–25, Amendment 39–15506 (73 FR 24157, May 2, 2008). That AD applied to all Bombardier Model DHC–8–102, DHC–8–103, DHC–8–106, DHC–8–201, DHC–8–202, DHC–8–301, DHC–8–311, and DHC–8–315 airplanes. That AD required revising the Airworthiness Limitations section (ALS) of the Instructions for Continued Airworthiness to incorporate the critical design configuration control limitations (CDCCL) data specified in the applicable temporary revision (TR) to the applicable maintenance program manual (MPM).
CDCCLs are limitation requirements to preserve a critical ignition source prevention feature of the fuel tank system design that is necessary to prevent the occurrence of an unsafe condition. The purpose of a CDCCL is to provide instruction to retain the critical ignition source prevention feature during configuration change that may be caused by alterations, repairs, or maintenance actions. A CDCCL is not a periodic inspection.
Since we issued that AD, we have determined that it is necessary to clarify the AD's intended effect on spare and on-airplane fuel tank system components, regarding the use of maintenance manuals and instructions for continued airworthiness.
Section 91.403(c) of the Federal Aviation Regulations (14 CFR 91.403(c)) specifies the following:
No person may operate an aircraft for which a manufacturer's maintenance manual or instructions for continued airworthiness has been issued that contains an airworthiness limitation section unless the mandatory * * * procedures * * * have been complied with.
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. This new AD retains the requirements of the existing AD, and adds a new note to clarify the intended effect of the AD on spare and on-airplane fuel tank system components.
AD 2008–09–25 allowed the use of later revisions of the ALS. That provision has been removed from this AD. Allowing the use of “a later revision” of specific service documents violates Office of the Federal Register policies for approving materials that are incorporated by reference. Affected operators, however, may request approval to use a later revision of the referenced service documents as an alternative method of compliance, under the provisions of paragraph (g)(1) of this 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 FAA policies. Any such differences are highlighted in a Note within the AD.
This revision imposes no additional economic burden. The current costs for this AD are repeated for the convenience of affected operators, as follows:
We estimate that this AD will affect about 118 products of U.S. registry. We also estimate that it will take about 1 work-hour per product to comply with the basic requirements of this AD. The average labor rate is $80 per work-hour. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $9,440, or $80 per product.
This revision merely clarifies the intended effect on spare and on-airplane fuel tank system components, and makes no substantive change to the AD's requirements. For this reason, it is found that notice and opportunity for prior public comment for this action are unnecessary, and good cause exists for making this amendment effective in less 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 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.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
49 U.S.C. 106(g), 40113, 44701.
(a) This airworthiness directive (AD) becomes effective December 10, 2009.
(b) This AD revises AD 2008–09–25, Amendment 39–15506.
(c) This AD applies to all Bombardier Model DHC–8–102, DHC–8–103, DHC–8–106, DHC–8–201, DHC–8–202, DHC–8–301, DHC–8–311, and DHC–8–315 airplanes, certificated in any category, all serial numbers.
(d) Air Transport Association (ATA) of America Code 28: Fuel.
(e) The mandatory continuing airworthiness information (MCAI) states:
Bombardier Aerospace has completed a system safety review of the aircraft fuel system against fuel tank safety standards introduced in Chapter 525 of the Airworthiness Manual through Notice of Proposed Amendment (NPA) 2002–043. The identified non-compliances were then assessed using Transport Canada Policy Letter No. 525–001, to determine if mandatory corrective action is required.
The assessment showed that it is necessary to introduce Critical Design Configuration Control Limitations (CDCCL), in order to preserve critical fuel tank system ignition source prevention features during configuration changes such as modifications and repairs, or during maintenance actions. Failure to preserve critical fuel tank system ignition source prevention features could result in a fuel tank explosion. Revisions have been made to Part 2 “Airworthiness Limitations List” of the Maintenance Program Manuals of the affected aircraft models to introduce the required CDCCL.
(f) Unless already done, do the following actions.
(1) For all airplanes: Within 60 days after June 6, 2008 (the effective date of AD 2008–09–25), revise the Airworthiness Limitations section of the Instructions for Continued Airworthiness to incorporate the CDCCL data specified in the applicable temporary revision (TR) to the applicable maintenance program manual (MPM). The TRs are listed in Table 1 of this AD.
The revisions required by paragraph (f)(1) of this AD may be done by inserting a copy of the applicable TR into the applicable maintenance program manual. When the TR has been included in the general revision of the maintenance program, the general revision may be inserted into the maintenance program manual, provided the relevant information in the general revision is identical to that in the applicable TR, and the temporary revision may be removed.
(2) After accomplishing the actions specified in paragraph (f)(1) of this AD, no alternative CDCCLs may be used unless the CDCCLs are approved as an alternative method of compliance (AMOC) in accordance with the procedures specified in paragraph (g)(1) of this AD.
Notwithstanding any other maintenance or operational requirements, components that have been identified as airworthy or installed on the affected airplanes before the revision of the ALS, as required by paragraph (f)(1) of this AD, do not need to be reworked in accordance with the CDCCLs. However, once the ALS has been revised, future maintenance actions on these components must be done in accordance with the CDCCLs.
This AD differs from the MCAI and/or service information as follows: No differences.
(g) The following provisions also apply to this AD:
(1)
(2)
(3)
(h) Refer to MCAI Canadian Airworthiness Directive CF–2008–03, dated January 3, 2008, and the TRs specified in Table 1 of this AD, for related information.
(i) You must use the service information contained in Table 2 of this AD to do the actions required by this AD, unless the AD specifies otherwise.
(1) The Director of the Federal Register previously approved the incorporation by reference of this service information on June 6, 2008 (73 FR 24157, May 2, 2008).
(2) 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
(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 or 425–227–1152.
(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; request for comments.
The FAA is revising an existing airworthiness directive (AD), which applies to all McDonnell Douglas Corporation airplane models identified above. That AD currently requires revising the FAA-approved maintenance program, or the Airworthiness Limitations (AWLs) section of the Instructions for Continued Airworthiness, as applicable, to incorporate new AWLs for fuel tank systems to satisfy Special Federal Aviation Regulation No. 88 requirements. For certain airplanes, this AD also requires the initial accomplishment of a certain repetitive AWL inspection to phase in that inspection, and repair if necessary. This AD clarifies the intended effect of the AD on spare and on-airplane fuel tank system components. This AD results from a design review of the fuel tank system. We are issuing this AD to prevent the potential for ignition sources inside fuel tanks caused by latent failures, alterations, repairs, or maintenance actions, which, in combination with flammable fuel vapors, could result in a fuel tank explosion and consequent loss of the airplane.
This AD is effective December 10, 2009.
On April 23, 2008 (73 FR 14673, March 19, 2008), the Director of the Federal Register approved the incorporation by reference of a certain publication listed in the AD.
We must receive any comments on this AD by January 25, 2010.
You may send comments by any of the following methods:
•
•
•
•
For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, 3855 Lakewood Boulevard, MC D800 0019, Long Beach, California 90846–0001; telephone 206–544–5000, extension 2; fax 206–766–5683; e-mail
You may examine the AD docket on the Internet at
Philip C. Kush, Aerospace Engineer, Propulsion Branch, ANM–140L, Los Angeles Aircraft Certification Office, FAA, 3960 Paramount Boulevard, Lakewood, California 90712–4137; telephone (562) 627–5263; fax (562) 627–5210.
On March 9, 2008, we issued AD 2008–06–21, Amendment 39–15433 (73 FR 14673, March 19, 2008). That AD applied to all McDonnell Douglas Model DC–10–10 and DC–10–10F airplanes, Model DC–10–15 airplanes, Model DC–10–30 and DC–10–30F (KC–10A and KDC–10) airplanes, Model DC–10–40 and DC–10–40F airplanes, Model MD–10–10F and MD–10–30F airplanes, and Model MD–11 and MD–11F airplanes. That AD required revising the FAA-approved maintenance program, or the Airworthiness Limitations (AWLs) section of the Instructions for Continued Airworthiness, as applicable, to incorporate new AWLs for fuel tank systems to satisfy Special Federal Aviation Regulation No. 88 requirements. For certain airplanes, that AD also required the initial accomplishment of a certain repetitive AWL inspection to phase in that inspection, and repair if necessary. That AD resulted from a design review of the fuel tank systems. The actions specified in that AD are intended to prevent the potential for ignition sources inside fuel tanks caused by latent failures, alterations, repairs, or maintenance actions, which, in combination with flammable fuel vapors, could result in a fuel tank explosion and consequent loss of the airplane.
Critical design configuration control limitations (CDCCLs) are limitation requirements to preserve a critical ignition source prevention feature of the fuel tank system design that is necessary to prevent the occurrence of an unsafe condition. The purpose of a CDCCL is to provide instruction to retain the critical ignition source prevention feature during configuration change that may be caused by alterations, repairs, or maintenance actions. A CDCCL is not a periodic inspection.
Since we issued that AD, we have determined that it is necessary to clarify the AD's intended effect on spare and
Section 91.403(c) of the Federal Aviation Regulations (14 CFR 91.403(c)) specifies the following:
No person may operate an aircraft for which a manufacturer's maintenance manual or instructions for continued airworthiness has been issued that contains an airworthiness limitation section unless the mandatory * * * procedures * * * have been complied with.
The unsafe condition described previously is likely to exist or develop on other airplanes of the same type design. For this reason, we are issuing this AD to revise AD 2008–06–21. This new AD retains the requirements of the existing AD, and adds a new note to clarify the intended effect of the AD on spare and on-airplane fuel tank system components.
AD 2008–06–21 allowed the use of later revisions of Appendixes B, C, and D of Report MDC–02K1003. That provision has been removed from this AD. Allowing the use of “a later revision” of specific service documents violates Office of the Federal Register policies for approving materials that are incorporated by reference. Affected operators, however, may request approval to use an alternative CDCCL that is part of a later revision of the referenced service documents as an alternative method of compliance, under the provisions of paragraph (l) of this AD.
This revision imposes no additional economic burden. The current costs for this AD are repeated for the convenience of affected operators, as follows:
There are about 300 airplanes of the affected design in the worldwide fleet. This AD affects about 180 airplanes of U.S. registry. The required actions take about 1 work hour per airplane, at an average labor rate of $80 per work hour. Based on these figures, the estimated cost of the AD for U.S. operators is $14,400, or $80 per airplane.
This revision merely clarifies the intended effect on spare and on-airplane fuel tank system components, and makes no substantive change to the AD's requirements. For this reason, it is found that notice and opportunity for prior public comment for this action are unnecessary, and good cause exists for making this amendment effective in less than 30 days.
This AD is a final rule that involves requirements affecting flight safety, and we did not provide you with notice and an opportunity to provide your comments before it becomes effective. However, we invite you to send any written 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 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 the 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 AD and placed it in the AD docket. See the
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
49 U.S.C. 106(g), 40113, 44701.
(a) This airworthiness directive (AD) is effective December 10, 2009.
(b) This AD revises AD 2008–06–21, Amendment 39–15433.
(c) This AD applies to all McDonnell Douglas Corporation Model DC–10–10 and DC–10–10F airplanes, Model DC–10–15 airplanes, Model DC–10–30 and DC–10–30F (KC–10A and KDC–10) airplanes, Model DC–10–40 and DC–10–40F airplanes, Model MD–10–10F and MD–10–30F airplanes, and Model MD–11 and MD–11F airplanes; 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 (AMOC) in accordance with paragraph (l) of this AD. The request should include a description of changes to the required inspections that will ensure the continued operational safety of the airplane.
(d) This AD results from a design review of the fuel tank systems. We are issuing this AD to prevent the potential for ignition sources inside fuel tanks caused by latent failures, alterations, repairs, or maintenance actions, which, in combination with flammable fuel vapors, could result in a fuel tank explosion and consequent loss 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) The term “Report MDC–02K1003” as used in this AD, means the Boeing Trijet Special Compliance Item Report, MDC–02K1003, Revision C, dated July 24, 2007.
(g) For Model DC–10–10 and DC–10–10F airplanes, Model DC–10–15 airplanes, Model DC–10–30 and DC–10–30F (KC–10A and KDC–10) airplanes, and Model DC–10–40 and DC–10–40F airplanes: Before December 16, 2008, revise the FAA-approved maintenance program to incorporate the information specified in Appendixes B, C, and D of Report MDC–02K1003.
(h) For Model MD–10–10F and MD–10–30F airplanes, and Model MD–11 and MD–11F airplanes: Before December 16, 2008, revise the AWLs section of the Instructions for Continued Airworthiness to incorporate the information specified in Appendixes B, C, and D of Report MDC–02K1003, except that the initial inspection required by paragraph (i) of this AD must be done at the applicable compliance time specified in that paragraph.
(i) For Model MD–11 and MD–11F airplanes: Within 60 months after April 23, 2008 (the effective date AD 2008–06–21), do a detailed inspection of the metallic overbraiding and red-wrap tape installed on the tail tank fuel quantity indication system (FQIS) wiring to verify if the metallic overbraiding or red-wrap tape is damaged or shows signs of deterioration, in accordance with ALI 20–2 of Appendix C of Report MDC–02K1003. If any discrepancy is found during the inspection, repair the discrepancy before further flight in accordance with ALI 20–2 of Appendix C of Report MDC–02K1003.
: For the purposes of this AD, a detailed inspection is: “An intensive examination of a specific item, installation, or assembly to detect damage, failure, or irregularity. Available lighting is normally supplemented with a direct source of good lighting at an intensity deemed appropriate. Inspection aids such as mirror, magnifying lenses, etc., may be necessary. Surface cleaning and elaborate procedures may be required.”
(j) Although Report MDC–02K1003 specifies to submit certain information to the manufacturer, this AD does not require that action.
(k) After accomplishing the applicable actions specified in paragraphs (g), (h), and (i) of this AD, no alternative inspections, inspection intervals, or CDCCLs may be used unless the inspections, intervals, or CDCCLs are approved as an AMOC in accordance with the procedures specified in paragraph (l) of this AD.
Notwithstanding any other maintenance or operational requirements, components that have been identified as airworthy or installed on the affected airplanes before the revision of the FAA-approved maintenance program, or the AWLs section, as required by paragraphs (g) and (h) of this AD, do not need to be reworked in accordance with the CDCCLs. However, once the FAA-approved maintenance program, or the AWLs section, as applicable, has been revised, future maintenance actions on these components must be done in accordance with the CDCCLs.
(l)(1) The Manager, Los Angeles 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: Philip C. Kush, Aerospace Engineer, Propulsion Branch, ANM–140L, FAA, Los Angeles ACO, 3960 Paramount Boulevard, Lakewood, California 90712–4137; telephone (562) 627–5263; fax (562) 627–5210.
(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) AMOCs approved previously in accordance with AD 2008–06–21, Amendment 39–15433, are approved as AMOCs for the corresponding provisions of this AD.
(m) You must use Boeing Trijet Special Compliance Item Report, MDC–02K1003, Revision C, dated July 24, 2007, to do the actions required by this AD, unless the AD specifies otherwise.
(1) The Director of the Federal Register previously approved the incorporation by reference of Boeing Trijet Special Compliance Item Report, MDC–02K1003, Revision C, dated July 24, 2007, on April 23, 2008 (73 FR 14673, March 19, 2008).
(2) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, 3855 Lakewood Boulevard, MC D800 0019, Long Beach, California 90846–0001; telephone 206–544–5000, extension 2; fax 206–766–5683; 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 or 425–227–1152.
(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.
This action amends the Class D and E Airspace at Fort Stewart (Hinesville), GA, by changing the airport name from Fort Stewart, Wright AAF, to Wright AAF (Fort Stewart)/Midcoast Regional, Fort Stewart (Hinesville), GA. This is an administrative change and does not affect the boundaries or operating requirements of the airspace.
Effective 0901 UTC, February 11, 2010. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.
Melinda Giddens, Operations Support Group, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636, Atlanta, Georgia 30320; telephone (404) 305–5610.
The Liberty County Airport in Hinesville, GA has closed and the associated Class E5 airspace has been removed. As a result, Wright AAF (Fort Stewart)/MidCoast Regional has become a joint use facility and the name of the airport will be amended to reflect this change. This rule will become effective on the date specified in the
This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 changes the airport name from Fort Stewart, Wright AAF, to Wright AAF (Fort Stewart)/Midcoast Regional, Fort Stewart, Hinesville, GA.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore, (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) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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.
This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends controlled airspace at Wright AAF (Fort Stewart)/Midcoast Regional, Fort Stewart (Hinesville), GA.
Airspace, Incorporation by reference, Navigation (Air).
49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–1963 Comp., p. 389.
That airspace extending upward from the surface up to and including 2,500 feet MSL within a 4.4-mile radius of Wright AAF (Fort Stewart)/Midcoast Regional. This Class D airspace area is effective during the specific dates and times established in advance by Notice to Airmen. The effective days and times will thereafter be continuously published in the Airport/Facility Directory.
That airspace extending upward from 700 feet above the surface within a 6.6-mile radius of Wright AAF (Fort Stewart)/Midcoast Regional.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action removes the Class E5 Airspace at Liberty County Airport, Hinesville, GA, as the airport has closed, eliminating the need for controlled airspace.
Effective 0901 UTC, February 22, 2010. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.
Melinda Giddens, Operations Support Group, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636, Atlanta, Georgia 30320; telephone (404) 305–5610.
The Liberty County Airport has closed and as a result, the associated Standard Instrument Approach Procedures (SIAPs) were withdrawn and cancelled removing the Class E5 airspace requirement at Liberty County Airport. This rule will become effective on the date specified in the
This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 removes Class E5 airspace at Liberty County Airport, Hinesville, GA. Controlled airspace is no longer needed as the airport has closed.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore, (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) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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.
This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it removes controlled airspace at Liberty County Airport, Hinesville, GA.
Airspace, Incorporation by reference, Navigation (Air).
49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–1963 Comp., p. 389.
Federal Aviation Administration (FAA), DOT.
Final rule.
This amendment adopts miscellaneous amendments to the required IFR (instrument flight rules) altitudes and changeover points for certain Federal airways, jet routes, or direct routes for which a minimum or maximum en route authorized IFR altitude is prescribed. This regulatory action is needed because of changes occurring in the National Airspace System. These changes are designed to provide for the safe and efficient use of the navigable airspace under instrument conditions in the affected areas.
Harry Hodges, Flight Procedure Standards Branch (AMCAFS–420), Flight Technologies and Programs Division, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125) telephone: (405) 954–4164.
This amendment to part 95 of the Federal Aviation Regulations (14 CFR part 95) amends, suspends, or revokes IFR altitudes governing the operation of all aircraft in flight over a specified route or any portion of that route, as well as the changeover points (COPs) for Federal airways, jet routes, or direct routes as prescribed in part 95.
The specified IFR altitudes, when used in conjunction with the prescribed changeover points for those routes, ensure navigation aid coverage that is adequate for safe flight operations and free of frequency interference. The reasons and circumstances that create the need for this amendment involve matters of flight safety and operational efficiency in the National Airspace System, are related to published aeronautical charts that are essential to the user, and provide for the safe and efficient use of the navigable airspace. In addition, those various reasons or
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(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) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Airspace, Navigation (air).
49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44719, 44721.
Federal Energy Regulatory Commission, Energy.
Order on Clarification.
The Federal Energy Regulatory Commission affirms its basic determinations in Order Nos. 890, 890–A, 890–B, and 890–C, granting clarification regarding certain revisions to its regulations and the
Christina Hayes, Office of the General Counsel—Energy Markets, Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426. (202) 502–6194.
1. On February 16, 2007, the Commission issued Order No. 890,
2. In Order Nos. 890–A, 890–B, and 890–C, the Commission largely affirmed the reforms adopted in Order No. 890. The Commission concluded that, taken together, these reforms will better enable the
3. In Order No. 890–C, the Commission affirmed the requirement that network resources used to supply sales of system power off-system must first be undesignated.
4. Duke argues that the Commission's determination in Order No. 890–C is inconsistent with the
5. If the Commission confirms that an off-system buyer is permitted to take network service from both transmission providers, Duke questions whether the seller needs to undesignate specific generating resources or whether it can undesignate a slice of its system. Duke contends that resource-specific undesignations are needed only if the buyer is using point-to-point service on the transmission system on which the seller is located for delivery, not if the off-system buyer takes network service on that system.
6. We confirm that, where an off-system buyer is buying system power from a seller that is a network customer on an adjacent transmission system, the buyer needs transmission service on both the system on which the seller is located and the system on which buyer is located, but that it remains the buyer's choice as to whether to procure network or point-to-point service. The Commission's reference in Order No. 890–C to the use of point-to-point service to take delivery of system power was not intended to restrict the buyer's choice to instead use network service. As Duke notes, there may be a situation in which a buyer and seller of capacity from a network resource both take network service on the same transmission system and the power is delivered under section 31.3 of the
7. In Order No. 890–C, the Commission noted that the Reliability Standards governing the calculation of ATC were pending Commission review. Concurrent with this order, the Commission in Docket No. RM08–19–000 is directing the North American Electric Reliability Corporation (NERC) to develop modifications to certain of these Reliability Standards to address the modeling of network resources and its impact on the calculation of ATC. To the extent Duke or other parties have concerns regarding the appropriate modeling of network resource designations on the calculation of ATC, the Commission encourages those parties to raise their concerns in NERC's standards development process.
8. The Office of Management and Budget (OMB) regulations require that OMB approve certain information collection requirements imposed by an agency.
9. In addition to publishing the full text of this document in the
10. From FERC's Home Page on the Internet, this information is available on eLibrary. The full text of this document is available on eLibrary in PDF and Microsoft Word format for viewing, printing, and/or downloading. To access this document in eLibrary, type the docket number excluding the last three digits of this document in the docket number field.
11. User assistance is available for eLibrary and the FERC's Web site during normal business hours from FERC Online Support at 202–502–6652 (toll free at 1–866–208–3676) or e-mail at
12. This order does not substantively alter the requirements of Order Nos. 890, 890–A, 890–B or 890–C and, therefore, will become effective as of the date of publication in the
By the Commission.
Food and Drug Administration, HHS.
Final rule; technical amendment.
The Food and Drug Administration (FDA) is amending a final rule that appeared in the
Arlene Solbeck, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 5411, Silver Spring, MD 20993–0002, 301–796–2090.
FDA is amending the final rule that was published in the
Publication of this document constitutes final action on the change under the Administrative Procedures Act (5 U.S.C. 553). This technical amendment merely clarifies the intent of the final rule with respect to the three minor issues raised in the submissions. FDA therefore, for good cause shown, has determined that notice and public comment are unnecessary under 5 U.S.C. 553(b)(3)(B).
In the final rule, we require that the new liver injury and stomach bleeding warnings appear on the outer and the immediate container of the retail packaging, where applicable (§ 201.326(a)(1)(iii)(A), (a)(1)(iv)(A)(
We also received feedback that certain immediate containers, such as stick packs and sachets, also present space limitations for labeling and that we should not require the liver injury and stomach bleeding warnings to appear on these immediate container packages (Ref 1). We do not agree that these types of immediate containers should be exempt from the requirements in the final rule. Although these packages have limited labeling space, we believe that there is adequate space to accommodate the required warnings on these types of packages. We are also concerned that consumers may routinely remove these packages from the outer carton and, therefore, fail to see the liver injury and stomach bleeding warnings if they are only printed on the carton. For these reasons, we are not exempting these types of immediate containers from the final rule requirements.
In the April 29, 2009, final rule, we require a “See new warnings” flag on the PDP of all OTC drug products containing acetaminophen or NSAIDs to advise consumers of the new required warnings. In the final rule, we state that “we will require that the ‘See New Warnings’ flag appear on the PDP for one year after the final rule is published, rather than for the 6 or 9 months suggested by the submission” (74 FR 19385 at 19388). We explained that “we continue to believe that educating consumers about the risks associated with OTC IAAA drug products is very important and more likely to be successful if the flag remains on products for 1 year” (74 FR 19385 at 19388 through 19389). In § 201.326(b) (21 CFR 201.326(b)), the final rule states: “The labeling of any drug product subject to this section that is initially introduced or initially delivered for introduction into interstate commerce before the effective date and within 12 months after the effective date of the final rule must bear on its PDP, as defined in § 201.60, the statement ‘See new warnings information.’”
We intended this provision to require that the “See new warnings” statement appear on the PDPs of all OTC drug products containing acetaminophen or NSAIDs that are introduced into interstate commerce by the effective date of the final rule (i.e., by April 29, 2010). We did not intend to require the “See new warnings” statement for those products that are introduced into interstate commerce after the final rule effective date. We also intended the provision to require that the statement remain on the label for at least 1 year from the time the product is introduced into interstate commerce. We did not intend to require that the statement remain on the label for any longer than the 1-year period from the time of introduction into interstate commerce. For example, if the “See new warnings” flag is included on the PDP of a product introduced into interstate commerce 6 months after publication of the final rule (i.e., October 29, 2009), then the flag must remain on the PDP for a full year (i.e., until October 29, 2010). To make this requirement clear, we are modifying § 201.326(b) in the regulatory text of this document.
In the April 29, 2009, final rule, we require a liver injury warning for all OTC drug products containing acetaminophen. The introductory sentence and first bulleted statement of this warning state: “This product contains acetaminophen. Severe liver damage may occur if you take [bullet] more than the [insert maximum number of daily dosage units] in 24 hours, which is the maximum daily amount * * *”. Our intention was that the warning would prevent consumers from taking more than 4 grams (g) of an OTC acetaminophen product daily, the proposed maximum safe daily dose for OTC acetaminophen. After the final rule was published, we received feedback from manufacturers of OTC acetaminophen products who were concerned that consumers may be confused about the warning on OTC acetaminophen containing multiple active ingredients (e.g., cold-cold/analgesic combination products) (Refs. 1 and 2). For some combination products, the maximum number of daily dosage units may be limited by an active ingredient other than acetaminophen in the products. In such cases, the maximum number of daily dosage units result in a maximum daily dose of acetaminophen which is significantly below 4 g. To clarify that the maximum number of daily dosage units may not be the maximal daily dose of acetaminophen, we are allowing the optional statement “for this product” at the end of the first bulleted statement: “more than [insert maximum number of daily dosage units] in 24 hours, which
We received feedback requesting that we exercise enforcement discretion for manufacturers of OTC combination acetaminophen products so that they could revise the first bulleted statement of the liver injury warning to clarify that the maximum number of daily dosage units may not be the maximal daily dose of acetaminophen for those products (Ref. 2). As discussed in section II.C of this document, we are allowing the optional statement “for this product” at the end of the first bulleted statement: “more than [insert maximum number of daily dosage units] in 24 hours, which is the maximum daily amount.” The request asked us to exercise enforcement discretion until we revise this bulleted statement in the final rule. Because we are amending this bulleted statement in this document, the request that we exercise enforcement discretion is no longer applicable.
We have examined the impacts of this rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601–612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104–4). 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). We believe that this rule is not a significant regulatory action under the Executive order.
The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Our April 29, 2009, final rule requires important new organ-specific warnings (i.e., liver injury and stomach bleeding warnings) and related labeling for OTC drug products containing acetaminophen and NSAIDs to advise consumers of potential risks and when to consult a doctor (74 FR 19385). We are amending the final rule in this document to clarify some of the labeling requirements specified in the final rule. Three amendments are being made. One amendment specifies that manufacturers of OTC acetaminophen and NSAID drug products are not required to put the liver injury or stomach bleeding warning on each blister unit of a blister card as long as the appropriate warning appears on the blister card and remains intact and readable when drug is removed from the blister card (§ 201.326(a)(1)(iii)(A), (a)(1)(iv)(A)(
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $133 million, using the most current (2008) Implicit Price Deflator for the Gross Domestic Product. We do not expect the final rule as amended to result in any 1-year expenditure that would meet or exceed this amount.
We conclude that the labeling requirements in this document are not subject to review by the Office of Management and Budget because they do not constitute a “collection of information” under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
We have determined under 21 CFR 25.31(a) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. Section 4(a) of the Executive order requires agencies to “construe * * * a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.” The sole statutory provision giving preemptive effect to the final rule is section 751 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379r).
We believe that we have complied with all of the applicable requirements under the Executive order and have determined that the preemptive effects of this rule are consistent with Executive Order 13132.
The following references have been placed on display in the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852 and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. FDA–1977–N–0013–0039.
2. FDA–1977–N–0013–0040.
Drugs, Labeling, Reporting and recordkeeping requirements.
21 U.S.C. 321, 331, 351, 352, 353, 355, 358, 360, 360b, 360gg–360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.
(a) * * *
(1) * * *
(iii) * * *
(A) The liver warning states “Liver warning [heading in bold type]: This product contains acetaminophen. Severe liver damage may occur if you take [bullet] more than [insert maximum number of daily dosage units] in 24 hours, which is the maximum daily amount [optional: ‘for this product’] [bullet] with other drugs containing acetaminophen [bullet] 3 or more alcoholic drinks every day while using this product”. This “Liver” warning must be the first warning under the “Warnings” heading. For products that contain both acetaminophen and aspirin, this “Liver” warning must appear after the “Reye's syndrome” and “Allergy alert” warnings in § 201.66(c)(5)(ii)(A) and (c)(5)(ii)(B) and before the “Stomach bleeding” warning in paragraph (a)(2)(iii)(A) of this section. If there is an outer and immediate container of a retail package, this warning must appear on both the outer and immediate containers. If the immediate container is a blister card, the warning must appear on the blister card and remain intact and readable when drug product is removed from the blister card. The warning does not need to be included on each blister unit.
(iv) * * *
(A) * * *
(
(v) * * *
(A) The liver warning states “Liver warning [heading in bold type]: This product contains acetaminophen. Severe liver damage may occur if [bullet] adult takes more than [insert maximum number of daily dosage units] in 24 hours, which is the maximum daily amount [optional: ‘for this product’] [bullet] child takes more than 5 doses in 24 hours [bullet] taken with other drugs containing acetaminophen [bullet] adult has 3 or more alcoholic drinks everyday while using this product.” If there is an outer and immediate container of a retail package, this warning must appear on both the outer and immediate containers. If the immediate container is a blister card, the warning must appear on the blister card and remain intact and readable when drug product is removed from the blister card. The warning is not required to be included on each blister unit.
(2) * * *
(iii) * * *
(A) The stomach bleeding warning states “Stomach bleeding warning [heading in bold type]: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you [bullet] are age 60 or older [bullet] have had stomach ulcers or bleeding problems [bullet] take a blood thinning (anticoagulant) or steroid drug [bullet] take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) [bullet] have 3 or more alcoholic drinks every day while using this product [bullet] take more or for a longer time than directed”. This “Stomach bleeding” warning must appear after the “Reye's syndrome” and “Allergy alert” warnings in § 201.66(c)(5)(ii)(A) and (c)(5)(ii)(B). For products that contain both acetaminophen and aspirin, the acetaminophen “Liver” warning in paragraph (a)(1)(iii) of this section must appear before the “Stomach bleeding” warning in this paragraph. If there is an outer and immediate container of a retail package, this warning must appear on both the outer and immediate containers. If the immediate container is a blister card, the warning must appear on the blister card and remain intact and readable when drug product is removed from the blister card. The warning is not required to be included on each blister unit.
(iv) * * *
(A) * * *
(
(v) * * *
(A) The Stomach bleeding warning states “Stomach bleeding warning [heading in bold type]: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if the user [bullet] has had stomach ulcers or bleeding problems [bullet] takes a blood thinning (anticoagulant) or steroid drug [bullet] takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) [bullet] takes more or for a longer time than directed [bullet] is age 60 or older [bullet] has 3 or more alcoholic drinks everyday while using this product”. The “Stomach bleeding” warning must appear after the “Reye's syndrome“ and “Allergy alert” warnings in § 201.66(c)(5)(ii)(A) and (c)(5)(ii)(B). If there is an outer and immediate container of a retail package, this warning must appear on both the outer and immediate containers. If the immediate container is a blister card, the warning must appear on the blister card and remain intact and readable when drug product is removed from the blister card. The warning is not required to be included on each blister unit.
(b)
(1) At least one-quarter as large as the size of the most prominent printed matter on the PDP, or
(2) At least as large as the size of the “Drug Facts” title, as required in § 201.66(d)(2). The new warnings information statement must remain on the PDP of the drug product for at least 1 year from the date the product is initially introduced into interstate commerce.
Food and Drug Administration, HHS.
Final rule.
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 29 new animal drug applications (NADAs) and 2 abbreviated new animal drug applications (ANADAs) from Intervet, Inc., to Schering-Plough Animal Health Corp.
This rule is effective November 25, 2009.
David R. Newkirk, Center for Veterinary Medicine (HFV–100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240–276–8307, e-mail:
Intervet, Inc., P.O. Box 318, 29160 Intervet Lane, Millsboro, DE 19966, has informed FDA that it has transferred ownership of, and all rights and interest in, the following 29 approved NADAs and 2 approved ANADAs to Schering-Plough Animal Health Corp., 556 Morris Ave., Summit, NJ 07901: NADA 034–478, 034–621, 045–188, 102–380, 104–494, 111–278, 120–648, 121–473, 128–620, 131–310, 131–675, 132–872, 137–600, 138–612, 139–189, 140–856, 140–897, 140–927, 140–954, 140–992, 141–222, 141–236, 141–258, 141–269, 141–276, 141–278, 141–280, 141–282, 141–286; ANADA 200–134 and 200–239. Accordingly, the agency is amending the regulations in 21 CFR parts 520, 522 (21 CFR part 522), and 558 to reflect the transfer of ownership. In addition, § 522.1081 is being revised to reflect a current format.
Following these changes of sponsorship, Intervet, Inc., is no longer the sponsor of an approved application. Accordingly, 21 CFR 510.600(c) is being amended to remove the entries for Intervet, Inc.
This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801–808.
Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements.
Animal drugs.
Animal drugs, Animal feeds.
21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
21 U.S.C. 360b.
21 U.S.C. 360b.
(a)
(b)
(1) Nos. 000402 and 053501 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(B) and (d)(1)(i)(C) of this section.
(2) Nos. 058639 and 063323 for use as in paragraphs (d)(1)(i)(A) and (d)(1)(i)(B) of this section.
(3) No. 000061 for use as in paragraphs (d)(1)(i)(A) and (d)(2) of this section.
(c)
(d)
(A) 10,000 USP units by intramuscular injection.
(B) 500 to 2,500 USP units by intrafollicular injection.
(C) 2,500 to 5,000 USP units by intravenous injection.
(ii)
(iii)
(2)
(ii)
(iii)
21 U.S.C. 360b, 371.
State Department.
Final rule.
The Department is amending its regulations to add new classification symbols to the immigrant and nonimmigrant classification tables. This amendment is necessary to implement legislation that created additional immigrant and nonimmigrant classifications as described herein. Additionally, the Department is amending or removing existing classifications that have changed as a result of new legislation or the expiration of legislative provisions that had temporarily authorized them.
This rule is effective November 25, 2009.
Emily C. Cooperman, Legislation and Regulations Division, Visa Services, U.S. Department of State, Washington, DC 20520–0106, phone (202) 663–1203.
A new immigrant classification for qualifying family members of U1 Nonimmigrant Victim of Criminal Activity, adjustment of status cases for: Spouse, SU2; Child, SU3; and Parent, SU5.
Under INA 245(m)(3), upon approval of adjustment of the status of a U1 principal alien, the Secretary of Homeland Security may approve a petition for an immigrant visa for a spouse (SU2), a child (SU3), or in the case of an alien child, a parent (SU5) who did not receive a nonimmigrant visa under section 101(a)(15)(U)(ii) if the Secretary of Homeland Security considers such approval necessary to avoid extreme hardship. To request approval of immigrant visa status for such a relative, the principal alien must file with U.S. Citizenship and Immigration Services (USCIS) a Form I–929, Petition for Qualifying Family Member of a U1 Nonimmigrant. Upon approval of the petition, beneficiaries may apply for an immigrant visa at a visa processing post overseas.
Certain Iraqis (and Afghanis) employed by or on behalf of the United States Government in Iraq (and Afghanistan), SQ1; Spouse SQ2 and Child SQ3.
In addition to Iraqis employed by or on behalf of the United States Government in Iraq, section 1244 of Public Law 110–181, section 602(b) of Division F, Title IV, of the Omnibus Appropriations Act, 2009, Public Law 111–8, authorizes SQ1 status for an Afghan national who has been employed by or on behalf of the United States Government in Afghanistan on or after October 7, 2001, for a period of not less than one year; has provided faithful and valuable service to the United States Government, which is documented in a positive recommendation or evaluation from the alien's senior supervisor; has been determined by the Chief of Mission (COM) or the COM's designee to have experienced, or be experiencing an ongoing serious threat as a consequence of the employment by or on behalf of the U.S. Government. Further, the alien must clear a background check and appropriate screening as determined by the Department of Homeland Security, be otherwise eligible to receive an immigrant visa, and be otherwise admissible to the United States for permanent residence, except that, in the determination of such admissibility, the
The new nonimmigrant classification symbols are for: Temporary Commonwealth of the Northern Mariana Islands (CNMI)-only transitional workers (CW1, CW2); and Long-Term Investors in the Commonwealth of the Northern Mariana Islands (E2C).
The Department of Homeland Security (DHS) created a new, temporary, CNMI-only transitional worker classification (CW) in accordance with title VII of the Consolidated Natural Resources Act of 2008 (CNRA), Public Law 110–229, that will be implemented beginning November 28, 2009. The transitional worker program is intended to provide for an orderly transition from the CNMI permit system to the U.S. federal immigration system under the INA. A CW transitional worker is an alien worker who is ineligible for another classification under the INA and who performs services or labor for an employer in the CNMI. The CNRA imposes a five-year transition period before the INA requirements become fully applicable in the CNMI. The new CW classification (CW1 for principal transitional workers and CW2 for dependents) will be in effect for the duration of the transition period, unless extended by the Secretary of Labor.
The Department of Homeland Security is amending its regulations governing E2 nonimmigrant treaty investors to establish procedures for classifying long-term investors in the CNMI as E2C nonimmigrants. The DHS rule implements the CNMI nonimmigrant investor visa provisions of the CNRA extending the immigration laws of the United States to the CNMI. Among the CNMI-specific provisions applicable during the five-year transition period is a provision authorizing the Secretary of Homeland Security to classify an alien foreign investor in the CNMI as a CNMI-only E2C nonimmigrant investor under section 101(a)(15)(E)(ii) of the INA. This status is provided upon application of the alien and notwithstanding the treaty requirements otherwise applicable. Eligible investors are those who: were admitted to the CNMI in long-term investor status under CNMI immigration law before the transition program effective date; have continuously maintained residence in the CNMI under long-term investor status; are otherwise admissible to the United States under the INA; and maintain the investment(s) that formed the basis for the CNMI long-term investor status.
Section 201 of the William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008, Public Law 110–457, amended section 101(a)(15)(T)(ii) of the INA to provide for T4 and T5 derivative status for any accompanying or following to join parent or unmarried sibling under the age of 18 of an alien who has been accorded T1 status as a victim of trafficking if the Secretary of Homeland Security determines that the parent or sibling faces a present danger of retaliation as a result of the victim's escape from the severe form of trafficking or cooperation with law enforcement. This provision applies without regard to the age of the T1 principal, and is in addition to existing authority in INA 101(a)(15)(T)(ii)(I) for T4 and T5 status for accompanying or following to join parents and unmarried siblings under age 18 of a principal alien who was under the age of 21 as of the date of the principal's application for T1 status. If the principal alien was under the age of 21 at the time of his or her application for T1 status, the parents and any unmarried sibling under 18 who are accompanying or following to join the principal would be entitled to T4 and T5 classification without a DHS determination that they face a present danger of retaliation.
The Nonimmigrant Visa class “Irish Peace Process Program Participant;” Q2, and the Spouse or Child of the Q2, Q3.
Section 1(d) of Public Law 108–449 repealed the “Irish Peace Process Cultural and Training Program Act of 1998, Public Law 105–319, effective October 1, 2008.
This regulation involves a foreign affairs function of the United States and, therefore, in accordance with 5 U.S.C. 553(a)(1), is not subject to the rule making procedures set forth at 5 U.S.C. 553.
Because this final rule is exempt from notice and comment rulemaking under 5 U.S.C. 553, it is exempt from the regulatory flexibility analysis requirements set forth at sections 603 and 604 of the Regulatory Flexibility Act (5 U.S.C. 603 and 604). Nonetheless, consistent with section 605(b) of the Regulatory Flexibility Act (5 U.S.C. 605(b)), the Department certifies that this rule will not have a significant economic impact on a substantial number of small entities. This regulates individual aliens who seek consideration for immigrant and nonimmigrant visas and does not affect any small entities, as defined in 5 U.S.C. 601(6).
Section 202 of the Unfunded Mandates Reform Act of 1995, Public Law 104–4, 109 Stat. 48, 2 U.S.C. 1532, generally requires agencies to prepare a statement before proposing any rule that may result in an annual expenditure of $100 million or more by State, local, or tribal governments, or by the private sector. This rule will not result in any such expenditure, nor will it significantly or uniquely affect small governments.
This rule is not a major rule as defined by 5 U.S.C. 804, for purposes of congressional review of agency rulemaking under the Small Business Regulatory Enforcement Fairness Act of 1996, Public Law 104–121. This rule will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices; or adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and import markets.
The Department of State has reviewed this rule to ensure its consistency with the regulatory philosophy and principles set forth in Executive Order 12866 and has determined that the benefits of the regulation justify its costs. The Department does not consider the rule to be an economically significant action within the scope of section 3(f)(1) of the Executive Order
This regulation will not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government. Nor will the rule have federalism implications warranting the application of Executive Orders No. 12372 and No. 13132.
The Department has reviewed the regulations in light of sections 3(a) and 3(b)(2) of Executive Order No. 12988 to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden.
This rule does not impose information collection requirements under the provisions of the Paperwork Reduction Act, 44 U.S.C. Chapter 35.
Aliens, Foreign Officials, Immigration, Nonimmigrants, Passports and Visas.
Immigration, Passports, Visas.
8 U.S.C. 1104; Pub. L. 105–277, 112 Stat. 2681–795 through 2681–801.
A visa issued to a nonimmigrant alien within one of the classes described in this section shall bear an appropriate visa symbol to show the classification of the alien. The symbol shall be inserted in the space provided on the visa. The following visa symbols shall be used:
8 U.S.C. 1104; Pub. L. 107–56, sec. 421.
A visa issued to an immigrant alien within one of the classes described below shall bear an appropriate visa symbol to show the classification of the alien.
Internal Revenue Service (IRS), Treasury.
Correcting amendment.
This document contains corrections to final regulations (TD 9468) that were published in the
This correction is effective on November 25, 2009 and is applicable in taxable years ending on or after October 20, 2009.
Karlene M. Lesho, (202) 622–3090 (not a toll-free number).
The final regulations that are the subject of this document are under sections 2051 and 2053 of the Internal Revenue Code.
As published, the final regulations (TD 9468) contain errors that may prove to be misleading and are in need of clarification.
Estate taxes, Reporting and recordkeeping requirements.
26 U.S.C. 7805 * * *
(d) * * *
(7) * * *
* * * Instead, pursuant to the protective claim for refund filed by E, the marital deduction will be reduced by the claim once a final judgment is entered in the case. * * *
(d) * * *
(3) * * * See further § 20.2053–1(d)(3).
Internal Revenue Service (IRS), Treasury.
Final regulations.
This document contains final regulations relating to the payment of tax liabilities in installments. The regulations reflect changes to the law made by the Taxpayer Bill of Rights II, the Internal Revenue Service Restructuring and Reform Act of 1998, and the American Jobs Creation Act of 2004. The regulations will affect taxpayers submitting installment agreements to the IRS.
Walter Ryan, (202) 622–3620 (not a toll-free number).
This document contains amendments to the Procedure and Administration Regulations (26 CFR part 301) under section 6159 of the Internal Revenue Code (Code). Section 6159 allows the IRS to enter into agreements for the payment of any unpaid tax in installments. Taxpayers may request administrative review of IRS decisions to terminate installment agreements pursuant to section 6159(e), added to the Code by section 202 of the Taxpayer Bill of Rights II, Public Law 104–168 (110 Stat. 1452, 1457 (1996)). Taxpayers may appeal rejections of proposed installment agreements under section 7122(e), added to the Code by section 3462 of Internal Revenue Service Restructuring and Reform Act of 1998 (RRA 98), Public Law 105–206 (112 Stat. 685, 764 (1998)). Section 6159(c), added to the Code by section 3467 of RRA 1998, requires the IRS to accept a proposed installment agreement for income taxes under certain circumstances. Section 3506 of RRA 1998 requires the IRS to send each taxpayer with an installment agreement an annual statement showing the balance due at the beginning of the year, the payments made during the year, and the remaining balance due at the end of the year.
Section 843 of the American Jobs Creation Act of 2004 (AJCA), Public Law 108–357 (118 Stat. 1418, 1600 (2004)), amended section 6159(a) to allow the IRS to enter into installment agreements that provide for partial (as well as full) payment of a tax liability, but excludes partial payment installment agreements from the scope of installment agreements that must be accepted by the IRS. Section 843 of the AJCA also added new section 6159(d), requiring the IRS to review partial payment installment agreements every two years. The primary purpose of the review is to determine whether the financial condition of the taxpayer has significantly changed so as to warrant an increase in the value of the payments being made.
On March 5, 2007, a notice of proposed rulemaking (REG–100841–97; 72 FR 9712) was published in the
The final regulations adopt certain recommendations contained in the comments by clarifying two provisions of the proposed regulations. As explained in this preamble, § 301.6159–1(e)(3) was amended to clarify that the taxpayer may submit a request to modify or terminate the installment agreement. Section 301.6159–1(e)(3) further clarifies that such a request will not suspend the statute of limitations on collection and the taxpayer must comply with the existing installment agreement while the request is being considered. As also explained in this preamble, § 301.6159–1(e)(1)(i) clarifies that the IRS may terminate an installment agreement if the taxpayer provides materially incomplete or inaccurate information in response to an IRS request for a financial update.
The following is a section-by-section analysis of the comments.
Section 301.6159–1(b) of the proposed regulations provided that an installment agreement request must be submitted according to procedures prescribed by the IRS. It did not require the IRS to accept or reject the request within a specific time frame. The commenter proposed to limit the IRS's time to consider an installment agreement to 90 days; if the IRS fails to act in that time, the agreement would be granted automatically. The commenter reasoned that the limited time frame would benefit the IRS because more installments agreements would be automatically allowed, thereby increasing revenues, and would benefit the taxpayer by allowing payments to begin quickly and efficiently. The recommendation was not adopted for two reasons. First, the IRS already grants installment agreements quickly and automatically in the vast majority of
Proposed § 301.6159–1(b)(2) provided that an installment agreement request becomes pending when it is accepted for processing. The commenter recommended that the IRS send an automatically-generated response acknowledging the date of acceptance for processing to the taxpayer and the taxpayer's representative. This recommendation was not adopted. The vast majority of installment agreements are streamlined agreements, which the IRS accepts very quickly. The IRS will, however, consider adopting an administrative procedure for the minority of cases where it anticipates a time lag between acceptance for processing and the acceptance or rejection of the installment agreement.
Proposed § 301.6159–1(b)(2) also provided that if an installment agreement request does not contain sufficient information to permit the IRS to evaluate whether the request should be accepted, the IRS will request the needed information. The commenter recommended that all requests for additional information should be reasonably necessary. The proposed regulations already address this recommendation by directing that requests be for “needed” information.
Proposed § 301.6159–1(b)(3) allowed a taxpayer to submit a good faith revision of a rejected installment agreement request within 30 days of rejection. The commenter recommended that the time for taxpayers to submit a good faith revision should be extended to 60 days because taxpayers often have difficulty obtaining the necessary documents within 30 days. This recommendation was not adopted. The recommendation would apply to a small number of installment agreement requests that are not accepted under the IRS's streamlined procedures. In these cases, the IRS requests the information necessary for a financial analysis before rejecting the installment agreement request.
Section 301.6159–1(c)(1) of the proposed regulations provided that an installment agreement request has not been accepted until the IRS notifies the taxpayer or the taxpayer's representative of the acceptance. Section 6159(a) requires that an installment agreement be in writing, and proposed § 301.6159–1(c)(2) provided that the writing may take the form of a document signed by the taxpayer and the IRS or the written confirmation of an agreement entered into by the taxpayer and the IRS that is mailed or personally delivered to the taxpayer. The commenter recommended that the IRS's notification of the acceptance or rejection of a proposed installment agreement also be directed to the taxpayer's representative and include the terms of the agreement and payment submission information. These recommendations were not adopted in the regulations because they are more appropriately addressed in the IRS's procedures. The IRS currently does, however, provide written notification to the taxpayer and the taxpayer's representative of the acceptance or rejection of an installment agreement and the suggested information.
The commenter was concerned that the IRS intended to change its streamlined procedures and recommended that the procedures be retained. The commenter was also concerned that proposed § 301.6159–1(c)(3)(iii)(A) may represent a departure from the IRS's current policy that limits the acceptance of extensions of the collection statute of limitations in connection with installment agreements to the narrow subset of partial payment installment agreements in which the liability will not be paid in full under the agreement before the collection statute expires. As stated in the preamble to the notice of proposed rulemaking, the regulations were intended to reflect existing practices. The regulations will have no effect on the IRS's streamlined procedures or its policy with regard to waivers of the collection statute.
The commenter stated that the proposed regulations did not explain the inclusion of § 301.6159–1(c)(3)(ii), which provided that an installment agreement may, by its terms, end upon the expiration of the period of limitations on collection, or at some prior date. As explained in the preamble to the proposed regulations, this provision clarifies that the IRS may enter into partial payment installment agreements that end upon the running of the collection statute, or that end prior to that time so that the IRS may collect the balance of the tax liability against any property belonging to the taxpayer before the collection period expires. The IRS does not currently enter into partial payment installment agreements that expire before the end of the collection statute and has no plans to do so routinely in the future.
Proposed § 301.6159–1(c)(3)(v) provided that while an installment agreement is in effect, the IRS may request a financial condition update from the taxpayer at any time. The commenter recommended that the IRS be permitted to request only one financial condition update per year. This recommendation was not adopted. The IRS very rarely requests updates more than once a year. In certain rare circumstances, more frequent updates may be appropriate, such as when the IRS has reason to believe that the taxpayer's financial condition has improved.
Section 301.6159–1(d)(2) of the proposed regulations provided that the IRS may not notify a taxpayer or the taxpayer's representative of the rejection of an installment agreement until an independent review of proposed rejection is completed. The commenter was concerned that the proposed regulations did not provide any guidance as to how the independent administrative review will be assured. The commenter recommended that the review be undertaken by an IRS office located in a different territory. The recommendation was not adopted. Managers in the IRS offices in San Jose, California, and Jacksonville, Florida, supervise employees throughout the United States who review rejected installment agreements. An independent review is assured by assigning these cases to an employee who has no prior involvement in the case and who reports to a supervisor in either of these two offices.
The commenter recommended that the determination that the taxpayer did not submit a good faith revision be
Proposed § 301.6159–1(d)(3) provided that a taxpayer may appeal the rejection of an installment agreement request within 30 days of the rejection. The commenter recommended that the 30-day period be tolled while a revised proposal of a rejected request is being evaluated so that the taxpayer would not have to file an appeal while the revision is under consideration. This recommendation was not adopted. The IRS's procedures are designed to allow a quick resolution of the taxpayer's request; tolling the appeal period would add an unneeded layer of complexity to the process and delay case resolution. The commenter also recommended that the IRS provide more definitive guidance as to what qualifies as a good faith revision. This recommendation was not adopted because this guidance is more appropriately left to the IRS procedures.
Proposed § 301.6159–1(e)(2)(i) provided that the IRS may modify or terminate an installment agreement if the IRS determines that the financial condition of the taxpayer has significantly changed. Proposed § 301.6159–1(c)(3)(vi) provided that the IRS and the taxpayer may agree to modify or terminate an installment agreement or may agree to a new installment agreement that supersedes the existing agreement. The commenter recommended that the regulations explicitly allow taxpayers to request a modification or termination of an existing installment agreement, as was stated in existing § 301.6159–1(c)(3). This clarification was adopted in § 301.6159–1(e)(3).
The commenter recommended that the regulations require the taxpayer to comply with the terms of an installment agreement while a request for modification is being considered and that a proposed modification will not result in a suspension of the statute of limitations on collection. These clarifications were also adopted in § 301.6159–1(e)(3).
The commenter recommended that a taxpayer's request to modify an existing installment agreement should be exempt from user fees under regulations §§ 300.1 and 300.2. This recommendation was not adopted because user fees are outside the scope of this regulation project.
Proposed § 301.6159–1(e)(2)(ii)(C) provided that the IRS may modify or terminate an installment agreement if the taxpayer fails to provide a financial condition update requested by the IRS. The commenter recommended that the regulations provide explicitly whether the IRS may terminate an installment agreement if the taxpayer provided materially inaccurate or incomplete information. This recommendation was adopted. Section 301.6159–1(e)(1)(i) was revised to clarify that the IRS may terminate an installment agreement if the taxpayer provided materially inaccurate or incomplete information in connection with a requested financial update.
Proposed § 301.6159–1(e)(3) provided that the IRS will generally notify the taxpayer in writing at least 30 days prior to terminating an installment agreement and describe the reason for the termination, after which the taxpayer may provide information showing that the IRS's reason is incorrect. Proposed § 301.6159–1(e)(4) provided for the administrative appeal of the modification or termination of an installment agreement to the Office of Appeals if the request is properly made within 30 days after the termination or modification is to take effect. The commenter recommended that the regulations clarify that an appeal should be made to the Office of Appeals within 30 days after the modification or termination will take effect, regardless of whether the taxpayer submits additional information under § 301.6159–1(e)(3), has filled out Form 9423, “Collection Appeal Request,” or has requested a meeting with a Collection Manager. This recommendation was not adopted in the regulations because it is more appropriately addressed in IRS forms and procedures.
Proposed § 301.6159–1(e)(4) provided, in part, that the taxpayer may administratively appeal the modification or termination of an installment agreement to the Office of Appeals. The commenter recommended that the taxpayer be allowed to appeal the IRS's determination not to modify an installment agreement. This recommendation was not adopted. The IRS routinely grants taxpayer modification requests that result in agreements within the streamlined criteria.
Section 301.6159–1(f)(1) of the proposed regulations stated that the IRS may not levy during the time an installment agreement is pending. Proposed § 301.6159–1(f)(2) stated that levy is not prohibited if an installment agreement request was made solely to delay collection. The commenter recommended that the solely to delay collection standard in the proposed regulations be replaced with language that references the “frivolous submission” standard in section 6702(b) of the Code. This recommendation was not adopted. Under existing IRS procedures, an installment agreement is returned as made solely to delay collection when there is no economic reality to the request, the request fails to address changes previously requested by the IRS in response to a prior request, the request ignores direction provided by revenue officers, the request is made by a taxpayer that has defaulted prior installment agreements, or the request is made at a time that causes it to be classified as a request made to delay enforcement action.
In the alternative, the commenter recommended that the regulations state that a taxpayer may appeal the IRS's levy action when the IRS determines that an installment agreement request was made solely to delay collection, and that damages may be appropriate under section 7433 of the Code. These recommendations were not adopted. Taxpayers' rights to appeal proposed
Section 301.6159–1(g) of the proposed regulations provided that the statute of limitations on collection under section 6502 of the Code is suspended for the period that a proposed installment agreement is pending, plus 30 days following a rejection, and during any appeal. The commenter recommended that the regulations clearly define when an installment agreement is pending. This recommendation is already addressed by proposed § 301.6159–1(b)(2), which provides a detailed explanation of when an installment agreement is pending.
Section 301.6159–1(h) of the proposed regulations requires the IRS to provide taxpayers with an annual statement setting forth the balance owed at the beginning of the year, the payments made during the year, and the remaining balance at the end of the year. The commenter recommends that the annual statement be as clear as possible and that the IRS provide the taxpayer with a single annual statement describing all tax liabilities covered by the agreement. Currently, the IRS sends an annual statement for each separate liability covered by an installment agreement. No change was made to the final regulations because this recommendation is more appropriately addressed when the IRS updates the forms used for the annual statements.
Section 301.6159–1(i) of the proposed regulations required the IRS to perform a review of the taxpayer's financial condition at least once every two years in cases of partial payment installment agreements. The proposed regulations also stated that the purpose of the review was to determine whether an increase in payments is warranted. The commenter recommended that § 301.6159–1(i) be rephrased to provide that the biennial review of a taxpayer's financial condition may result in a decrease, as well as an increase, in the amount of payments being made. This recommendation was not adopted. While taxpayers may request a decrease in the amount of payments due under an installment agreement, the IRS does not have the information to unilaterally make that determination. The automatic biennial review done by the IRS does not, in every case, result in a request for updated financial information. As explained above, taxpayers may request that their payments be lowered if their financial condition has worsened.
Section 301.6159–1(k) of the proposed regulations provided that the effective date of the final regulations would be the date the final regulations are published in the
It has been determined that this Treasury decision is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required. It also has been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations, and because the regulations do not impose a collection of information on small entities, the Regulatory Flexibility Act (5 U.S.C. chapter 6) does not apply. Pursuant to section 7805(f) of the Code, the proposed regulations preceding these regulations were submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business.
The principal author of these regulations is Walter Ryan, Office of Associate Chief Counsel (Procedure and Administration).
Employment taxes, Estate taxes, Excise taxes, Gift taxes, Income taxes, Penalties, Reporting and recordkeeping requirements.
26 U.S.C. 7805 * * *
This section lists the major captions that appear in the regulations under § 301.6159–1.
(a) Authority.
(b) Procedures for submission and consideration of proposed installment agreements.
(c) Acceptance, form, and terms of installment agreements.
(d) Rejection of a proposed installment agreement.
(e) Modification or termination of installment agreements by the Internal Revenue Service.
(f) Effect of installment agreement or pending installment agreement on collection activity.
(g) Suspension of the statute of limitations on collection.
(h) Annual statement.
(i) Biennial review of partial payment installment agreements.
(j) Cross reference.
(k) Effective/applicability date.
(a)
(b)
(2)
(3)
(c)
(ii)
(iii)
(A) The aggregate amount of the liability (not including interest, penalties, additions to tax, and additional amounts) does not exceed $10,000;
(B) The taxpayer (and, if the liability relates to a joint return, the taxpayer's spouse) has not, during any of the preceding five taxable years—
(
(
(
(C) The Commissioner determines that the taxpayer is financially unable to pay the liability in full when due (and the taxpayer submits any information the Commissioner requires to make that determination);
(D) The installment agreement requires full payment of the liability within three years; and
(E) The taxpayer agrees to comply with the provisions of the Internal Revenue Code for the period the agreement is in effect.
(2)
(3)
(ii) By its terms, an installment agreement may end upon the expiration of the period of limitations on collection in section 6502 and § 301.6502–1, or at some prior date.
(iii) As a condition to entering into an installment agreement with a taxpayer, the Commissioner may require that—
(A) The taxpayer agree to a reasonable extension of the period of limitations on collection; and
(B) The agreement contain terms that protect the interests of the Government.
(iv) Except as otherwise provided in an installment agreement, all payments made under the installment agreement will be applied in the best interests of the Government.
(v) While an installment agreement is in effect, the Commissioner may request, and the taxpayer must provide, a financial condition update at any time.
(vi) At any time after entering into an installment agreement, the Commissioner and the taxpayer may agree to modify or terminate an installment agreement or may agree to a new installment agreement that supersedes the existing agreement.
(d)
(2)
(3)
(e)
(i) Information which was provided to the IRS by the taxpayer or the taxpayer's representative in connection with either the granting of the installment agreement or a request for a financial update was inaccurate or incomplete in any material respect; or
(ii) Collection of any liability to which the installment agreement applies is in jeopardy.
(2)
(i) The Commissioner determines that the financial condition of a taxpayer that is party to the agreement has significantly changed; or
(ii) A taxpayer that is party to the installment agreement fails to—
(A) Timely pay an installment in accordance with the terms of the installment agreement;
(B) Pay any other Federal tax liability when the liability becomes due; or
(C) Provide a financial condition update requested by the Commissioner.
(3)
(4)
(5)
(f)
(2)
(3)
(A) Crediting an overpayment against the liability pursuant to section 6402;
(B) Filing or refiling notices of Federal tax lien; and
(C) Taking action to collect from any person who is not named in the installment agreement or proposed installment agreement but who is liable for the tax to which the installment agreement relates.
(ii)
(g)
(h)
(i)
(j)
(k)
(d)
(e)
Mine Safety and Health Administration (MSHA), Labor.
Final rule; correction.
This rule informs the mining community that MSHA rescinds the Agency's intent stated in the preamble to the final rule on Refuge Alternatives for Underground Coal Mines, concerning preemption of private tort litigation with respect to the Agency's approval of specifications for a refuge alternative.
Patricia W. Silvey, Director, Office of Standards, Regulations, and Variances, MSHA, 1100 Wilson Boulevard, Room 2350, Arlington, Virginia 22209–3939. Ms. Silvey can be reached at 202–693–9440 (voice), 202–693–9441 (facsimile), or
On December 31, 2008, MSHA published a final rule on Refuge Alternatives for Underground Coal Mines. (73 FR 80656). The preamble includes a discussion on preemption, and states that “it is MSHA's intent that its approval of specifications for a refuge alternative preempts private tort litigation questioning the propriety of those specifications.” (73 FR 80658).
On May 20, 2009, the President issued a Memorandum for the Heads of Executive Departments and Agencies on Preemption. The purpose of the Memorandum is to state the general policy of the Administration that preemption of State law by executive departments and agencies should be undertaken only with full consideration of the legitimate prerogatives of the States and with a sufficient legal basis for preemption. The Memorandum directs executive departments and agencies to “review regulations issued within the past 10 years that contain statements in regulatory preambles or codified provisions intended by the department or agency to preempt State law, in order to decide whether such statements or provisions are justified under applicable legal principles governing preemption.” In addition, the memorandum states that “where the head of a department or agency determines that a regulatory statement of preemption or codified regulatory provision cannot be so justified, the head of that department or agency should initiate appropriate action, which may include amendment of the relevant regulation.”
Section 506(b) of the Federal Mine Safety and Health Act of 1977 (Mine Act), concerning “Effect on State Laws,” specifically addresses preemption of state law as follows:
The provisions of any State law or regulation in effect upon the operative date of this Act, or which may become effective thereafter, which provide for more stringent health and safety standards applicable to coal or other mines than do the provisions of this Act or any order issued or any mandatory health or safety standard shall not thereby be construed or held to be in conflict with this Act. 30 U.S.C. 955.
In addition, the House Report to the Mine Act, states that “Federal law would supersede any State law in conflict with it,” but that “State laws providing more stringent standards than exist under the Federal law, however, would not be held in conflict with the [Mine] act.” H. Rep. No. 95–312, 95th Cong., 1st Sess., at 55 (1977).
In accordance with the Presidential Memorandum on Preemption, MSHA has reviewed the Agency's standards and regulations issued within the past 10 years. MSHA's review found that a statement in the preamble to the Refuge Alternatives final rule is the only rule issued in the past 10 years to contain a preemption statement.
MSHA has determined that the Mine Act does not show any basis, or Congressional intent, for inferring any attempt to preempt state tort law regarding MSHA's approval specifications for refuge alternatives. As stated earlier, the Mine Act provides, for example, that State laws or regulations that provide more stringent requirements than those imposed under the Mine Act, are not construed or held to be in conflict with the Mine Act. MSHA's determination to rescind the preemption statement in the preamble to the Refuge Alternatives rule is consistent with the intent of the Mine Act and is consistent with the Presidential Memorandum. The preemption statement in the preamble was, at best, interpretive guidance purporting to interpret statutory language in the Mine Act, which was included in the preamble of the final rule without seeking prior public comment. It did not create any new law or substantive rule, but simply stated what the agency thought the statute meant. Further, this interpretation was published only recently, making it unlikely that any member of MSHA's regulated community has relied to their detriment on the interpretation. Under these circumstances, notice and comment also are not required in withdrawing this interpretation.
Accordingly, MSHA rescinds the last paragraph of the section-by-section discussion of “Section 7.501 Purpose and Scope,” starting on line 51 of the center column and ending on line 24 of the third column, 73 FR 80658, for the reason that this statement is not justified under the Mine Act principles governing preemption, and there was no intent by Congress, under the Mine Act, to supersede state action in this regard.
Postal Regulatory Commission.
Final rule.
The Commission is adding the Priority Mail Contract 20 to the Competitive Product List. This action is consistent with changes in a recent law governing postal operations. Republication of the lists of market dominant and competitive products is also consistent with new requirements in the law.
Effective November 25, 2009 and is applicable beginning October 28, 2009.
Stephen L. Sharfman, General Counsel,
The Postal Service seeks to add a new product identified as Priority Mail Contract 20 to the Competitive Product List. For the reasons discussed below, the Commission approves the Request.
On October 14, 2009, the Postal Service filed a formal request pursuant to 39 U.S.C. 3642 and 39 CFR 3020.30
The Postal Service contemporaneously filed a contract related to the proposed new product pursuant to 39 U.S.C. 3632(b)(3) and 39 CFR 3015.5. The contract has been assigned Docket No. CP2010–2.
In support of its Request, the Postal Service filed the following materials: (1) A redacted version of the Governors' Decision, originally filed in Docket No. MC2009–25, authorizing the Priority Mail Contract Group;
In the Statement of Supporting Justification, Mary Prince Anderson, Acting Manager, Sales and Communications, Expedited Shipping, asserts that the service to be provided under the contract will cover its attributable costs, make a positive contribution to coverage of institutional costs, and will increase contribution toward the requisite 5.5 percent of the Postal Service's total institutional costs. Request, Attachment D, at 1. W. Ashley Lyons, Manager, Regulatory Reporting and Cost Analysis, Finance Department, certifies that the contract complies with 39 U.S.C. 3633(a).
The Postal Service filed much of the supporting materials, including the supporting data and the unredacted contract, under seal. The Postal Service maintains that the contract and related financial information, including the customer's name and the accompanying analyses that provide prices, certain terms and conditions, and financial projections, should remain confidential.
In Order No. 315, the Commission gave notice of the two dockets, appointed a public representative, and provided the public with an opportunity to comment.
Comments were filed by the Public Representative.
The Commission has reviewed the Request, the contract, the financial analysis provided under seal that accompanies it, and the comments filed by the Public Representative.
The Commission is further required to consider the availability and nature of enterprises in the private sector engaged in the delivery of the product, the views of those who use the product, and the likely impact on small business concerns. 39 U.S.C. 3642(b)(3).
The Postal Service asserts that its bargaining position is constrained by the existence of other shippers who can provide similar services, thus precluding it from taking unilateral action to increase prices without the risk of losing volume to private companies. Request, Attachment D, para. (d). The Postal Service also contends that it may not decrease quality or output without risking the loss of business to competitors that offer similar expedited delivery services.
No commenter opposes the proposed classification of Priority Mail Contract 20 as competitive. Having considered the statutory requirements and the support offered by the Postal Service, the Commission finds that Priority Mail Contract 20 is appropriately classified as a competitive product and should be added to the Competitive Product List.
Based on the data submitted, the Commission finds that Priority Mail Contract 20 should cover its attributable costs (39 U.S.C. 3633(a)(2)), should not lead to the subsidization of competitive products by market dominant products (39 U.S.C. 3633(a)(1)), and should have a positive effect on competitive products' contribution to institutional costs (39 U.S.C. 3633(a)(3)). Thus, an initial review of proposed Priority Mail Contract 20 indicates that it comports with the provisions applicable to rates for competitive products.
In conclusion, the Commission approves Priority Mail Contract 20 as a new product. The revision to the Competitive Product List is shown below the signature of this order and is effective upon issuance of this order.
1. Priority Mail Contract 20 (MC2010–2 and CP2010–2) is added to the Competitive Product List as a new product under Negotiated Service Agreements, Domestic.
2. The Postal Service shall notify the Commission if termination occurs prior to the scheduled termination date.
3. The Secretary shall arrange for the publication of this order in the
Administrative practice and procedure; Postal Service.
By the Commission.
39 U.S.C. 503; 3622; 3631; 3642; 3682.
Environmental Protection Agency (EPA).
Final rule.
EPA is taking final action to approve revisions to the Tennessee State Implementation Plan (SIP) submitted by the State of Tennessee through the Tennessee Department of Environment and Conservation (TDEC) on July 13, 2009. This revision incorporates provisions related to the implementation of EPA's Clean Air Interstate Rule (CAIR), promulgated on May 12, 2005, subsequently revised on April 28, 2006, and December 13, 2006, and the CAIR Federal Implementation Plan (FIP) concerning sulfur dioxides (SO
EPA has established a docket for this action under Docket Identification No. EPA–R04–OAR–2009–0765. All documents in the docket are listed on the
Twunjala Bradley, Regulatory Development Section, Air Planning Branch, Air, Pesticides and Toxics Management Division, Region 4, U.S. Environmental Protection Agency, 61 Forsyth Street, SW., Atlanta, Georgia 30303–8960. Ms. Bradley can be reached by telephone at (404) 562–9352 and by electronic mail at
EPA is taking final action to approve a revision to Tennessee's SIP, submitted by Tennessee on July 13, 2009, as clarified herein, that is modifying the application of certain provisions of the CAIR FIP concerning NO
On February 11, 2009, Tennessee adopted a revision to its CAIR NO
The CAIR FIPs established budgets for Tennessee as 50,973 (2009–2014) and 42,478 (2015–thereafter) tons for NO
EPA published a notice of proposed rulemaking to approve Tennessee's revisions to the CAIR SIP on October 14, 2009, (74 FR 52717). EPA did not receive any comments during the public comment period for the proposed rulemaking.
EPA notes that, in
EPA is taking final action to approve Tennessee's SIP revision that includes an abbreviated CAIR SIP submitted on July 13, 2009, as clarified herein. Tennessee is covered by the CAIR FIPs which require participation in the EPA administered CAIR FIP cap and trade programs for SO
As provided for in the CAIR FIP, the provisions in the abbreviated SIP revision will replace or supplement the corresponding provisions of the CAIR FIPs in Tennessee. The abbreviated SIP revision meets the applicable requirements in 40 CFR 51.123(ee), with regard to NO
This action also approves the termination of the State's NO
An expedited effective date for this action is authorized under both 5 U.S.C. 553(d)(1), which provides that rule actions may become effective less than 30 days after publication if the rule “grants or recognizes an exemption or relieves a restriction” and section 5 U.S.C. 553(d)(3), which allows an effective date less than 30 days after publication “as otherwise provided by the agency for good cause found and published with the rule.” EPA finds that there is good cause for this approval to become effective upon publication.
CAIR SIP approvals relieve States and CAIR sources within States from being subject to provisions in the CAIR FIPs that otherwise would apply to them, allowing States to implement CAIR based on their SIP-approved State rule. The relief from these obligations is sufficient reason to allow an expedited effective date of the rule under 5 U.S.C. 553(d)(1). In addition, Tennessee's relief from these obligations provides good cause to make this rule effective immediately upon publication, pursuant to 5 U.S.C. 553(d)(3). The purpose of the 30-day waiting period prescribed in 5 U.S.C. 553(d) is to give affected parties a reasonable time to adjust their behavior and prepare before the final rule takes effect. Where, as here, the final rule relieves obligations rather than imposes obligations, affected parties, such as the State of Tennessee and CAIR sources within the State, do not need time to adjust and prepare before the rule takes effect.
Under the Clean Air Act (CAA), the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve State choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves State law as meeting Federal requirements and does not impose additional requirements beyond those imposed by State law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4);
• Does not have Federalism implications as specified in Executive Order 1312 (64 FR 43255, August 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because applications of those requirements would be inconsistent with the CAA; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, this rule does not have Tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the State, and EPA notes that it will not impose substantial direct costs on Tribal governments or preempt Tribal law.
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by January 25, 2010. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (
Environmental protection, Air pollution control, Electric utilities, Intergovernmental relations, Incorporation by reference, Carbon monoxide, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur dioxide.
Environmental protection, Air pollution control, Electric utilities, Intergovernmental relations, Incorporation by reference, Nitrogen oxides, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur dioxide.
42 U.S.C. 7401
(c) * * *
42 U.S.C. 7401, 7403, 7410, 7426, 7601, and 7651,
Environmental Protection Agency (EPA).
Direct final rule.
EPA is taking direct final action amending and correcting portions of the Environmental Protection Agency's existing fuel economy and emission regulations. This action makes some minor corrections and amendments to EPA's December 27th 2006 final rule for fuel economy labeling requirements for cars and light trucks, including a slight revision to the minivan definition. This action also makes changes to EPA regulations to administer the Department of Transportation's (DOT's) 2008–2011 model year passenger automobile and light truck corporate average fuel economy (CAFE) standards. Changes include adding reporting requirements for manufacturers to report to EPA their applicable reformed CAFE fuel economy standards (also called “required fuel economy levels”) and reporting the basis for determining such “required fuel economy levels.”
This direct final rule also adds provisions to clarify that special test procedures, calculation methods and label formats may be used for advanced technology vehicles for fuel economy labeling and CAFE purposes. Advanced technology vehicles include, but are not limited to electric vehicles, fuel cell vehicles, plug-in hybrid vehicles and vehicles equipped with hydrogen-fueled internal combustion engines. In addition, today's action makes some minor changes to clarify the meaning of, and correct errata in EPA regulations. The above amendments and corrections will allow for the more effective administration of existing regulations.
This rule is effective on January 25, 2010 without further notice, unless EPA receives adverse comment by December 28, 2009. If EPA receives
Submit your comments, identified by Docket ID No. EPA–HQ–OAR–2005–0169, by one of the following methods:
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Christine Mikolajczyk, Environmental Protection Agency, Office of Transportation and Air Quality, Compliance and Innovative Strategies Division, 2000 Traverwood Drive, Ann Arbor, MI 48105, telephone number: (734) 214–4403; fax number: (734) 214–4503; e-mail address:
EPA is publishing this rule without a prior proposed rule because we view this as a non-controversial action and anticipate no adverse comment. However, in the “Proposed Rules” section of today's
If EPA receives adverse comment on a distinct provision of this rulemaking, we will publish a timely withdrawal in the
This action applies to manufacturers of new passenger cars and light trucks, including medium-duty passenger vehicles.
This list is not intended to be exhaustive, but rather provides a guide regarding entities likely to be regulated by this action. To determine whether particular activities may be regulated by this action, you should carefully examine the regulations. You may direct questions regarding the applicability of this action to the person listed in
Today's direct final rule makes minor, non-controversial changes to EPA's fuel economy and emission regulations. Three separate actions have precipitated most of these changes. First, on December 27, 2006 (71 FR 77872), EPA finalized regulations specifying new methods to determine the fuel economy label estimates posted on the window stickers of new cars and trucks. Second, on April 6, 2006 (71 FR 17566), the Department of Transportation's National Highway Traffic Safety Administration (NHTSA), finalized new average fuel economy (CAFE) standards for 2008–2011 trucks. Third, on March 30, 2009 (74 FR 14196), NHTSA revised CAFE requirements for 2011 trucks and finalized new average fuel economy (CAFE) standards for 2011 passenger automobiles. The EPA regulations being amended for these three actions are contained in 40 CFR Parts 86 and 600.
Today's direct final rule clarifies that special test procedures, calculation methods and label formats may be used for fuel economy labels and CAFE calculations of advanced technology vehicles. Advanced technology vehicles include, but are not limited to electric vehicles, fuel cell vehicles, plug-in hybrid vehicles and vehicles equipped with hydrogen-fueled internal combustion engines. This rule also includes technical amendments to the fuel economy label regulations, including changes to the minivan definition, van definition, interior volume measurements of passenger vehicles, and special purpose class of vehicles. Today's action also corrects some typographical errors and makes other minor modifications to ensure accurate interpretation of the regulations. The changes to the EPA CAFE regulations are being made to conform to the NHTSA regulations, and include adding new reporting provisions that will enable EPA to provide NHTSA with the data it needs to determine compliance with the 2008–2011 CAFE standards for passenger automobiles and light trucks.
In addition, two changes are being made to align the EPA CAFE regulations with a 2007 Energy Independence and Security Act (EISA) amendment extending the alternative fuel vehicle CAFE credits to 2019, and to align the EPA CAFE regulations with a previous NHTSA rulemaking which eliminated the requirement to report separate CAFE values for domestic and imported trucks.
According to 49 U.S.C. 32908, fuel economy labels are required for cars, light-duty trucks and other vehicles that meet the definition of automobile. For example, the provisions of 49 U.S.C. 32908 (b) read in part:
“(b) Labeling Requirements and Contents.—(1) Under regulations of the Administrator of the Environmental Protection Agency, a manufacturer of automobiles shall attach a label to a prominent place on each automobile manufactured in a model year. The dealer shall maintain the label on the automobile. The label shall contain the following information: * * *”
On December 27, 2006, EPA finalized a new fuel economy labeling rule.
Under the regulations in 40 CFR Part 600, advanced technology vehicles are required to meet the labeling requirements for conventional vehicles. Advanced technology vehicles include battery electric vehicles, fuel cell vehicles, plug-in hybrid electric vehicles and vehicles equipped with hydrogen internal combustion engines. While the labeling regulations as written apply the same requirements and options to advanced technology vehicles as are applied to conventional technology vehicles, this was an inadvertent error. EPA adopted the labeling regulations based on it's evaluation of what would be appropriate for conventional technology vehicles, and did not evaluate what changes might or might not be appropriate for advanced technology vehicles. EPA did not intend that these types of vehicles would be required to meet all of the requirements for conventional vehicles. For example, the specific labeling requirements of this subpart were not intended to apply to plug-in hybrids. In EPA's Response to Comments-Fuel Economy Labeling of Motor Vehicles, pages 53–54, EPA states:
“Bluewater Network commented that they believe plug-in hybrids will be commercially available in the future and EPA should consider how this emerging technology should be addressed with respect to fuel economy labeling and testing.”
EPA's response:
“Commercial hybrids available today ultimately obtain all propulsion energy from liquid fuel stored in the fuel tank, while a plug-in hybrid uses a combination of liquid fuel and supplemental energy from the electric grid stored in the battery (
In this context, EPA is revising several regulatory provisions in 40 CFR Part 600 related to fuel economy testing, labeling and CAFE, to make appropriate modifications for use with advanced technology vehicles. EPA reviewed the various applicable regulations to determine where appropriate modifications were needed to address advanced technology vehicles. In large part this called for changes to regulations that address test procedures for test vehicles and calculation procedures to determine fuel economy for the test vehicle, as well as regulations that address what fuel economy value and other information the label is to include. The Agency's detailed analysis of the need for regulation changes to 40 CFR Part 600 regulations is outlined below.
Subpart A contains general applicability, definitions, abbreviations, recordkeeping requirements, data and information requirements for fuel economy vehicles, vehicle acceptability requirements, review of fuel economy data, minimum data requirements and other largely administrative requirements. EPA's review of the requirements contained in this subpart indicated that regulation changes are not needed to this Subpart for purposes of advanced technology vehicles.
Subpart B contains general applicability, definitions, abbreviations, recordkeeping requirements, equipment requirements, fuel specifications, analytical gas requirements, EPA driving cycles, equipment calibration, test procedures, exhaust sample analysis and fuel economy calculation requirements. EPA's review of the requirements contained in this subpart indicated that regulation changes are needed to 40 CFR 600.111–08 of Subpart B regarding fuel economy test procedures used for advanced technology vehicles. EPA reviewed 40 CFR 600.111–08, which provides that manufacturers shall use the emissions test procedures from 40 CFR Part 86 for conducting FTP, HFET, the US06, SC03 and Cold temperature FTP tests for fuel economy. Part 86 allows for the use of special test procedures for emissions testing under 40 CFR 86.1840 when the Administrator determines that a vehicle in Part 86 “is not susceptible to satisfactory testing by the procedures set forth in this part.” A similar provision is not explicitly included in Subpart B for fuel economy testing, nor is 40 CFR 86.1840 referred to as an option. Therefore, under this rulemaking, EPA is modifying 40 CFR 600.111–08 to allow special test procedures for advanced technology vehicles not susceptible to satisfactory testing or testing results under the current test provisions. This can be allowed upon written application by the manufacturer and approval by the Administrator, or at the Administrator's own initiative.
For example, the test procedures used for battery electric vehicles for the FTP (city), highway, US06, SC03, and cold temperature FTP tests contain many differences from those test procedures used for conventional vehicles outlined in 40 CFR 600.111–08. To illustrate this point, consider the FTP (city) test. While electric vehicles are driven over the same preconditioning cycle and test cycle as conventional vehicles, electric vehicles are not refueled (their battery is recharged) and electric vehicles are not required to undergo evaporative canister preconditioning prior to the test (they have no canisters). The test procedure for electric vehicles consists of operating the vehicle over many successive FTP (city) cycles until the battery becomes depleted to the point where the vehicle can no longer follow the driving cycle. The test procedure for conventional vehicles outlined in 40 CFR 600.111–08 consists of operating the vehicle over one FTP (city) cycle. While the test procedures for battery electric and conventional vehicles are similar in general (and comparable to 1975 test procedures), the detailed step-by-step test procedures have many differences due to the inherent differences in the vehicles.
Similarly for plug-in hybrid electric vehicles, EPA did not intend that plug-in hybrid electric vehicles would be required to meet all the specific fuel economy requirements contained in 40 CFR 600.111–08 for conventional vehicles. EPA is currently working on guidance for test procedures and fuel economy labeling requirements for plug-in hybrids. Plug-in hybrid vehicles typically have two operating modes: (1) Operation after the battery has been fully charged (called charge depleting mode) and (2) operation after the battery has been discharged and the vehicle is operating similar to conventional hybrid vehicles (called charge sustaining mode). The Agency anticipates that the fuel economy test procedures for plug-in hybrids will be similar to those for battery electric vehicles during the charge depleting mode and similar to conventional vehicles during the charge sustaining mode. While the test procedures for plug-in hybrid electric vehicles and conventional vehicles are expected to be similar in general (and comparable to 1975 test procedures), the detailed step-by-step test procedures for plug-in hybrid vehicles are expected to contain many differences from the step-by-step requirements described in 40 CFR 600.111–08 due to the inherent differences in the vehicles.
The data derived from Part 86 emissions tests and Part 600 fuel economy tests (using test procedures outlined in Part 600 Subpart B) are used to calculate the fuel economy values for each vehicle model. The methods to calculate the test vehicle's fuel economy for the specific test are provided in 40 CFR 600.113–08. For example, this section specifies how to calculate the fuel economy for the test vehicle for FTP, HFET, US06, SC03 and cold temperature FTP tests. These calculation procedures are specified for vehicles fueled with gasoline, diesel, alcohol-based or natural gas fuel. There are specific calculations for automobiles fueled with natural gas, methanol-fueled automobiles and automobiles designed to operate on mixtures of gasoline and methanol.
Currently, tests of conventional hybrids use the calculation methodology for the gasoline, diesel, or other fuel that they use, as EPA considers that the electric energy used by the hybrid originates in the combustion of the gasoline, diesel, or other fuel. Advanced technology vehicles however may need different calculation procedures. For example, plug-in hybrids may not be treated the same as conventional hybrids, as the plug-in hybrid operates in part on fuel such as gasoline and diesel, and in part on electric power that originates from the electricity grid and not from the combustion of the gasoline or diesel fuel. In that case, EPA would use the current provision at 40 CFR 600.113–08(l) to approve appropriate calculation procedures for use with plug-in hybrids. This same provision could be used for other advanced technology vehicles as well. Electric vehicles could also be covered by this provision, at least for purposes of calculating fuel economy of the test vehicle for later use in labeling. For purposes of CAFE, fuel economy calculation procedures are provided by the Department of Energy to determine the electric vehicles urban and highway fuel economy value.
The use of special test procedures and appropriate fuel economy calculation methods for that test procedure, when determining the fuel economy of an advanced technology test vehicle, will affect both the fuel economy labeling and CAFE programs, as the fuel economy values from the test vehicles over the relevant test procedures are then used in both programs, under other provisions in Part 600.
Once EPA or the manufacturer tests the vehicle, using appropriate test procedures, and calculates the fuel economy for the test vehicle over the tests, then 40 CFR 600.114–08 specifies how to calculate the 5-cycle city and highway fuel economy values for that
Subpart C contains general applicability, definitions, abbreviations, recordkeeping requirements, calculation of FTP-based and HFET-based fuel economy values, calculation of vehicle-specific 5-cycle based fuel economy values, calculation of fuel economy values for labeling requirements. EPA's review of the requirements contained in this subpart indicated that regulation changes are needed to 40 CFR 600.210–08 of Subpart C for purposes of determining the fuel economy label values for advanced technology vehicles.
Fuel economy values for vehicle configurations are calculated under the provisions of 40 CFR 600.206–08, for FTP-based and HFET-based fuel economy, and under 40 CFR 600.207–08, for vehicle-specific 5-cycle based fuel economy values for vehicle configurations. Fuel economy calculations to determine highway and city fuel economy for a model type are provided under 40 CFR 600.208–08, FTP-based and HFET-based fuel economy values for a model type, and section 40 CFR 600.209–08, vehicle-specific 5-cycle fuel economy values for a model type. These provisions apply to all 2008 and later model year light-duty automobiles.
Section 600.210–08, however, specifies that manufacturers are to use either the 5 cycle value determined under 40 CFR 600.209–08, or the mpg derived value determined under 40 CFR 600.210–08, for fuel economy labeling for models. EPA is revising this section for advanced technology vehicles, so that the Administrator may prescribe an alternative method for determining the city and highway fuel economy values for general and specific labels for advanced technology vehicles. As discussed above, the 5-cycle and mpg-derived options were developed based on what was considered appropriate for conventional technology vehicles, and this will allow the Administrator to make changes, where appropriate, for use with advanced technology vehicles.
Subpart D contains general applicability, definitions, abbreviations, recordkeeping requirements, fuel economy label format, labeling of high altitude vehicles, range of fuel economy for comparable automobiles, label reporting and recordkeeping, timetable for data submittal, updating label values, classes of comparable automobiles and multistage manufacturer requirements. EPA's review of the requirements contained in this subpart indicated that regulation changes are needed to 40 CFR 600.307–08 of Subpart D for fuel economy label format requirements for advanced technology vehicles.
Subpart D specifies the fuel economy value and other information to include on the label and the format of the label. The fuel economy values are those determined pursuant to Subpart C. As stated earlier, Subpart D includes advanced technology vehicles in its requirements. The format requirements of 40 CFR 600.307–08 may not be appropriate for some advanced technology vehicles. EPA is revising 40 CFR 600.307–08 so that alternative label formats may be approved for advanced technology vehicles.
Subpart E contains general applicability, definitions, abbreviations, dealer requirements and requirements to display booklets (Fuel Economy Guides) by dealers. EPA's review of the requirements contained in this subpart indicated that regulation changes are not needed to this Subpart for advanced technology vehicles.
Subpart F contains general applicability, definitions, abbreviations, recordkeeping requirements, running change data requirements, voluntary submission of additional data, calculation of average fuel economy (CAFE), determination of domestic production, model year report and gas guzzler tax requirements. EPA's review of the requirements contained in this subpart indicated that regulation changes are needed to 40 CFR 600.501–08 of this Subpart to clarify that this section is applicable to advanced technology vehicles.
Subpart F, Procedures for Determining Manufacturer's Average Fuel Economy, is currently applicable to gasoline-fueled, diesel-fueled, alcohol-fueled, natural gas-fueled, alcohol dual fuel and natural gas dual fuel automobiles. Manufacturers that produce only electric vehicles and electric vehicles produced by small volume manufacturers are exempt from the requirements of this subpart, but may optionally comply with the requirements of this Subpart. In today's action, EPA is revising 40 CFR 600.501–93 so that advanced technology vehicles are included in Subpart F.
Section 600.510–08 describes the requirements for calculating manufacturer's corporate average fuel economy (commonly called CAFE). Results of calculations from 40 CFR 600.208–08 and 40 CFR 600.206–08 are used to determine CAFE using test procedures outlined in Subpart B. Since EPA is modifying Subpart B (40 CFR 600.111–08) to allow special test procedures for advanced technology vehicles, further modifications to Subpart F for advanced technology vehicles are not necessary.
As discussed above, EPA's authority to approve special test procedures will be used, for example, to approve test procedure modifications used for testing battery electric vehicles, fuel cell vehicles, plug-in hybrid vehicles and hydrogen-fueled vehicles equipped with internal combustion engines. As in 1998 to 2003 model years, when battery electric vehicles were included in manufacturer's CAFE calculations, the Agency will take steps to assure that the test procedures for advanced technology vehicles will be comparable to 1975 test procedures. While the Agency believes additional CAFE adjustments will not be necessary, EPA will follow the procedures specified in 40 CFR 600.510–08(f) if any additional average fuel economy adjustments is appropriate for purposes of CAFE calculation based on a special test procedure change.
On December 27, 2006 (71 FR 77872) EPA finalized the following definition for “minivan”, which was previously not defined as a separate comparable class, for the purpose of labeling:
The interior volume specification of no more than 180 cubic feet was included as a way to distinguish minvans from full-sized vans. However, after the labeling rule was finalized, we were informed by some manufacturers that their 2008 model year minivans exceeded the 180 cubic feet interior volume limit, and thus would not be considered a minivan for purposes of showing comparison fuel economy on the label. Our intention in creating the minivan class was to provide consumers with better comparison information, based on actual classes of vehicles that they may be shopping for. It was not our intention to exclude vehicles that have for years been marketed and advertised as “minivans.” Therefore, we are making two modifications to our regulations that will allow these vehicles to be considered as “minivans” for the purpose of presenting comparable fuel economy information on the label.
First, we are eliminating the total interior volume specification from the definition of “minivan” and updating the definition slightly to help avoid confusion with EPA's definition of full-sized vans. Absent the interior volume specification, the updated definition should be sufficient to distinguish the minivan class from full-size passenger and cargo vans, SUVs and other similar truck classes, in most cases. Second, in cases where the distinction between the different truck classes may be less clear, we are adding a provision to the truck classification regulations that parallels an existing provision for car classification which allows EPA to reclassify light trucks into a more appropriate classification, as appropriate. This added flexibility will allow EPA to better accommodate today's rapidly changing vehicle designs, not only for minivans, but for other designs that are gaining in popularity, such as the so-called “crossover” vehicles, which share attributes of minivans, SUVs and even station wagons.
The current EPA “Van” definition has been used for fuel economy labeling purposes since before 1980, as follows:
“
This definition was appropriate for vans which were marketed in the late 1970s and 1980s. However, over the past 20 years, the body styles of full sized vans have evolved to shapes with longer nose sections, where the nose of the van extends forward more than 30 inches from the leading edge of the windshield. This direct final rule makes a minor change in the “Van” definition to make it compatible with today's vehicles. The new definition will include vehicles that are considered to be full-sized vans, but have body sections which protrude more than 30 inches forward of the leading edge of the windshield.
We did not propose any changes to the existing EPA regulations for determining the interior volumes of vehicles. The interior volume measurements have been used to determine the various passenger car classes since the early 1980's. We received no comments about the interior volume measurement methods during the new fuel economy label rulemaking. However, after the rule became final, some manufacturers pointed out that the basis for the measurements, an SAE procedure J1100, dated 1975, was outdated, and that the newly revised SAE J1100 contained updated dimension codes which are referenced in our regulations. Rather than incorporating by reference the new version of the SAE procedure, we have simply updated some of the calculation procedures to be consistent with the new SAE methods, thus maintaining alignment with standard industry practices. In particular, the cargo volume index for station wagons is now calculated based on the average width of the cargo area (calculated by averaging the width at shoulder height and the width at the wheel wells), whereas it used to be based simply on the shoulder width measurement.
We are also revising the regulations for the “special purpose vehicle” class of comparable vehicles to clarify that EPA has the discretion to classify advanced technology vehicles in separate comparable classes. For example, the Administrator may determine that advanced technology vehicles (such as battery electric vehicles, fuel cell vehicles, plug-in hybrid electric vehicles and vehicles equipped with hydrogen internal combustion engines) or other types of vehicles are best classified as a type of “special purpose vehicle,” separate from other classes of vehicles. EPA will work with manufacturers in determining the need for separate classes. EPA used a similar approach from the 1999 to 2007 model year to classify minivans and SUVs listed in the Fuel Economy Guide, however the label (window sticker) for these “special purpose vehicles” included both minivans and SUVs until the regulations were revised for 2008 model year vehicles. Today's action provides EPA with the additional flexibility to determine appropriate names for such classes of vehicles, different from the name “special purpose vehicle.”
The provisions of 49 U.S.C. 32908(b) require fuel economy labels to contain “the range of fuel economy of comparable automobiles of all manufacturers.” Based on this authority, EPA regulations have traditionally required fuel economy labels to contain the highest and lowest fuel economy values for all vehicles in each comparable class. Separate city and highway ranges were required prior to model year 2008. Beginning with 2008 model year, fuel economy labels are required to contain the highest and lowest combined (city/highway) fuel economy values for all vehicles within each comparable class of vehicles. Vehicle classes currently include two seaters, minicompact cars, subcompact cars, compact cars, midsize cars, large cars, small station wagons, midsize station wagons, large station wagons, small pickup trucks, standard pickup trucks, vans, minivans, sport utility vehicles (SUVs) and a “catch-all” class of “special purpose vehicles.”
EPA is concerned that advanced technology vehicles (which are beginning to be introduced into commerce is relative small numbers)
In summary, today's action will provide EPA with the regulatory discretion to classify these advanced technology vehicles appropriately. For example, it may be appropriate to establish classes for electric-powered cars and electric-powered trucks. Again, we should emphasize that EPA will work with the affected manufacturers when determining the need for separate classes.
Today's action also includes the following minor changes and corrections:
In April, 2006, the National Highway Traffic Safety Administration (NHTSA) promulgated final rules which established CAFE standards for 2008–2011 trucks.
First, NHTSA is for the first time requiring trucks known as “medium duty passenger vehicles” (MDPVs) to be including in the manufacturers' fleet CAFE. NHTSA adopted the same criteria to define MDPVs as contained in EPA's Tier 2 emission regulations.
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(1) Is an “incomplete truck” as defined in this subpart; or
(2) Has a seating capacity of more than 12 persons; or
(3) Is designed for more than 9 persons in seating rearward of the
driver's seat; or
(4) Is equipped with an open cargo area (for example, a pick-up truck box or bed) of 72.0 inches in interior length or more. A covered box not readily accessible from the passenger compartment will be considered an open cargo area for purposes of this definition.” [49 CFR 523.2]
In EPA's recent fuel economy labeling rule, we also adopted this same definition and added labeling requirements for new MDPVs beginning in 2011, at the same time as the new “reformed” CAFE requirements take effect. However, we made no changes to our CAFE regulations at that time, saying that we would instead do so via today's separate regulatory action. We finalized the NHTSA definition of MDPV's in our regulations at 40 CFR 600.002–08 in the 2006 fuel economy labeling rule.
The second change needed to EPA CAFE regulations is to add manufacturer reporting requirements to the CAFE “model year report” submitted to EPA every year.
The Energy Independence and Security Act of 2007 extended the provision allowing CAFE incentives for alternate fuel vehicles to 2019, codified at 42 U.S.C. 32905. In today's direct final rule, we have amended our fuel economy regulations to be consistent with the Energy Independence and Security Act of 2007.
(1) 1.2 miles a gallon for each of model years 1993 through 2014;
(2) 1.0 miles per gallon for model year 2015;
(3) 0.8 miles per gallon for model year 2016;
(4) 0.6 miles per gallon for model year 2017;
(5) 0.4 miles per gallon for model year 2018;
(6) 0.2 miles per gallon for model year 2019; and
(7) 0 miles per gallon for model years after 2019.
In addition, the Energy Independence and Security Act of 2007 modified 49 U.S.C. 32906(b), removing the “offsets” to the maximum increase in average fuel economy in the event that NHTSA were to reduce the CAFE standard for passenger automobiles below 27.5 mpg.
On April 4, 1994, NHTSA finalized regulations combining all domestic and imported trucks into a single truck class for CAFE purposes beginning with the 1996 model year.
Today's action also includes the following minor changes and corrections:
This Direct Final Rule includes a technical amendment to the Durability regulations applicable to Light-Duty Vehicles, Light-Duty Trucks and complete Heavy-Duty Vehicles. Specifically, the equation used to calculate the equivalency factors under the Durability Program was incorrect in the final rulemaking despite the fact that the notice of proposed rulemaking (NPRM) had the correct equation format. The equivalency factors are used to equate aging on the manufacturer's durability cycles to aging on the EPA standard cycles if a manufacturer uses their own proprietary aging cycle as allowed under the Durability regulations. Therefore, this action revises the Durability Program regulatory language using the correct equivalency factor equation format stated in the NPRM. The correction essentially involves reversing the numerator and denominator of the equivalency factor definition as stated at 40 CFR 86.1823–08(e)(1)(iii)(B)(1), such that the equivalency factor is stated correctly as follows: “The equivalency factor is the ratio described by dividing the aging time on the alternative cycle by the aging time on the SRC.”
Today's action also includes a minor revision to the preconditioning cycle used by EPA for the US06 test. Previously, the provisions of 40 CFR 86.132–00(n) require EPA to use a UDDS preconditioning cycle if the soak period since the last exhaust test is greater than two hours. Manufacturers may use a UDDS, a 505, 866, highway, US06 or an SC03 preconditioning cycle (if the soak period since the last exhaust test is greater than two hours) and it is common industry practice to use the US06 cycle. Today's action revises the provisions of 40 CFR 86.132–00(n) so that EPA preconditioning for the US06 is consistent with manufacturers. We believe that this revision will reduce EPA burden (because a UDDS cycle takes approximately 23 minutes to run while a US06 cycle takes 10 minutes to run).
Under Executive Order (EO) 12866 (58 FR 51735, October 4, 1993), this action is a “significant regulatory action” because it has the potential to raise novel legal or policy issues. Accordingly, EPA submitted this action to the Office of Management and Budget (OMB) for review under EO 12866 and any changes made in response to OMB recommendations have been documented in the docket for this action.
This action does not impose any substantive new information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501
The revision to the minivan definition in today's action has a de minimis impact; however, if anything, the revision is expected to reduce manufacturers' information collection burden. For example, manufacturers were previously required to calculate and report to EPA the total interior volume of each style of minivan and full-sized van to determine whether the van was at or below 180 cubic feet in interior volume. Today's action eliminates the 180 cubic feet interior volume specification from the minivan definition, thus slightly reducing manufacturers reporting and recordkeeping burden.
Regarding the MDPV requirements for 2011 and later CAFEs, the following
“Also beginning with model year 2011, medium-duty passenger vehicles (MDPVs) will be included in the labeling program. MDPVs essentially include SUVs and passenger vans that are between 8,500 and 10,000 lbs. “GVWR” (gross vehicle weight ratings). This change is congruent with the National Highway Traffic Safety Administration's (NHTSA's) expansion of the Corporate Average Fuel Economy (CAFE) program to include MDPVs beginning the same model year (71 FR 17565; April 6, 2006). Because more vehicle testing is required under CAFE than under labeling, the impacts of increased testing for MDPVs will be in the ICR for the rule to implement EPA's role in the CAFE program, which will be finalized in a separate action, in time for model year 2011,
Thus, in the 2008 FE Label rulemaking EPA indicated we would either include the MDPV information collection requirements in an ICR for today's rulemaking or include it in the EPA's emission and fuel economy ICR renewal request to OMB (which occurs every three years). EPA elected the latter approach, and has included the additional MDPV testing, reporting and recordkeeping burden for fuel economy labeling and CAFE purposes in ICR 0783.54 (OMB 2060–0320), the renewal of the Motor Vehicle Emissions and Fuel Economy Compliance ICR which was submitted to OMB for review on October 23, 2008. Since EPA MDPV ICR requirements have been previously submitted to OMB and because they were also included in NHTSA's ICR (OMB 2127–00019), they are not included in today's action.
Regarding footprint information, the reporting requirements for footprint information and related data were not specifically addressed in the ICR for EPA's Fuel Economy Labeling Rule (ICR 0783.51, OMB 2060–0104) because any change in burden was considered to be negligible and within the margin of error for the information technology estimate in that ICR; and because the information collection burden was partially included in the NHTSA ICR (OMB 2127–00019). The information collection burden for footprint information is currently included in EPA's ICR 0783.54 (OMB 2060–0320), the renewal of the Motor Vehicle Emissions and Fuel Economy Compliance ICR, which was submitted to OMB for review on October 23, 2008.
Additionally, the footprint information reported to EPA for final CAFE reports (wheelbase, track width and sales information) is essentially the same information which will have been previously reported to NHTSA when manufacturers submitted their preliminary CAFE (PCAFE) and mid-model year CAFE reports to NHTSA. Reporting footprint information to EPA with final sales data is expected to be a minimal burden because manufacturers will have already established company business practices to track footprint and sales information for NHTSA and because manufacturers have been reporting CAFE final sales information to EPA since 1978.
The Regulatory Flexibility Act (RFA) generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions.
For purposes of assessing the impacts of this direct final rule on small entities, a small entity is defined as: (1) A small business as defined by the Small Business Administration (SBA) regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.
After considering the economic impacts of this final rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. Based on Small Business Administration size standards, small businesses in the automobile manufacturing industry are defined as those having less than 1000 employees per firm. Additionally, they are identified using the North America Industrial Classification System (NAICS) by NAICS code 336111. Out of a total of approximately 80 automotive manufacturers subject to this direct final rule, EPA estimates that approximately 10 of these could be classified as small entities based on SBA size standards. No new burden for fuel economy labeling is being imposed by this direct final rule. The new reporting requirement for the reform CAFE footprint data has already been established by NHTSA in its final rule for new truck CAFE standards,
This rule does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and Tribal governments, in the aggregate, or the private sector in any one year. This action simply makes minor amendments, clarifications, and corrections that will allow for the more effective administration of existing regulations. Thus, this rule is not subject to the requirements of sections 202 or 205 of the Unfunded Mandates Reform Act. This rule is also not subject to the requirements of section 203 of the Unfunded Mandates Reform Act because it contains no regulatory requirements that might significantly or uniquely affect small governments. This action imposes no enforceable duty on any State, local or Tribal governments.
Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects 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.”
This direct final rule does not have federalism implications. It will not have substantial direct effects 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, as specified in Executive Order 13132. Thus, Executive Order 13132 does not apply to this rule.
This action does not have Tribal implications, as specified in Executive Order 13175 (65 FR 67249, November 9, 2000). The impacts of this direct final rule are limited to the regulated entities: the automotive manufacturing industry. Thus, Executive Order 13175 does not apply to this action.
Executive Order 13045: “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997) applies to any rule that: (1) Is determined to be “economically significant” as defined under Executive Order 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency.
EPA interprets EO 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under section 5–501 of the EO has the potential to influence the regulation. This action is not subject to EO 13045 because it does not establish an environmental standard intended to mitigate health or safety risks.
This rule is not a “significant energy action” as defined in Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Further, we have concluded that this rule is not likely to have any adverse energy effects.
Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA”), Public Law 104–113, 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (
This action does not involved technical standards. Therefore, EPA did not consider the use of any voluntary consensus standards.
Executive Order (EO) 12898 (59 FR 7629, Feb. 16, 1994) establishes Federal executive policy on environmental justice. Its main provision directs Federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States.
EPA has determined that this direct final rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment. This action simply makes minor amendments, clarifications, and corrections that will allow for the more effective administration of existing regulations without impacting the current fuel economy and emission control measures.
The Congressional Review Act, 5 U.S.C. 801
Statutory authority for the fuel economy labeling program and for corporate average fuel economy can be found at 42 U.S.C. 7401–7671q, 49 U.S.C. 32901–32919, and Public Law 109–58. Statutory authority for vehicle emission control program is found in the Clean Air Act, as amended, 42 U.S.C. 7401
Administrative practice and procedure, Confidential business information, Incorporation by reference, Labeling, Motor vehicle pollution, Reporting and recordkeeping requirements.
Administrative practice and procedure, Electric power, Fuel economy, Incorporation by reference, Labeling, Reporting and recordkeeping requirements.
42 U.S.C. 7401–7671q.
(n) * * *
(1) * * *
(i) Preconditioning may consist of a 505, 866, highway, US06 or SC03 test cycles.
(ii) [Reserved]
(b) During dynamometer operation, a fixed speed cooling fan shall be positioned so as to direct cooling air to the vehicle in an appropriate manner with the engine compartment cover open. In the case of vehicles with front engine compartments, the fan shall be squarely positioned within 12 inches (30.5 centimeters) of the vehicle. In the case of vehicles with rear engine compartments (or if special designs
(b) * * *
(9) During dynamometer operation, a fixed speed cooling fan with a maximum discharge velocity of 15,000 cfm will be positioned so as to direct cooling air to the vehicle in an appropriate manner with the engine compartment cover open. In the case of vehicles with front engine compartments, the fan shall be positioned within 24 inches (61 centimeters) of the vehicle. In the case of vehicles with rear engine compartments (or if special designs make the above impractical), the cooling fan(s) shall be placed in a position to provide sufficient air to maintain vehicle cooling. The Administrator may approve modified cooling configurations, additional cooling, variable speed fan(s), and/or a closed engine compartment cover if necessary to satisfactorily perform the test. In approving requests for additional or modified cooling, the Administrator will consider such items as actual road cooling data and whether such additional cooling is needed to provide a representative test. For example, the hood may be closed to provide adequate air flow to an intercooler through a factory installed hood scoop. Additionally, the Administrator may conduct certification, fuel economy and in-use testing using the additional cooling set-up approved for a specific vehicle.
(c) * * *
(1) * * *
(i) * * *
(D) * * *
(
YUS06 = Calculated mass emissions per mile, using the summed mass emissions of the “US06 City” phase and the “US06 Highway” phase, based on the measured driving distance of the US06 test schedule. The “US06 City” phase shall be sampled during seconds 0–130 and from 495 seconds until five seconds after the engine stops running (
(2) * * *
(i) * * *
(C) * * *
(
YUS06 = Calculated mass emissions per mile, using the summed mass emissions of the “US06 City” phase and the “US06 Highway” phase, based on the measured driving distance of the US06 test schedule. The “US06 City” phase shall be sampled during seconds 0–130 and from 495 seconds until five seconds after the engine stops running (
(a)
(e) * * *
(3) The manufacturer may use, for certification and fuel economy testing, alternative engine compartment cooling fans or systems, including those which provide a variable air flow, if the manufacturer has determined that comparable results are obtained. Manufacturers may perform the test with the engine compartment closed,
(e) * * *
(3) The manufacturer may use, for certification and fuel economy testing, alternative engine compartment cooling fans or systems, including those which provide a variable air flow, if the manufacturer has determined that comparable results are obtained. For 2009 and later model year vehicles, manufacturers may perform the test with the engine compartment closed,
(e) * * *
(1) * * *
(iii) * * *
(B) * * *
(
49 U.S.C. 32901–23919q, Public Law 109–58.
(5) Liquid Petroleum Gas (LPG), commonly referred to as “propane,” for LPG-powered automobiles; or
(6) Hydrogen for hydrogen fuel cell automobiles and for automobiles equipped with hydrogen internal combustion engines.
(2) For the purpose of calculating average fuel economy pursuant to the provisions of Part 600, Subpart F, fuel economy for electrically powered automobiles means the equivalent petroleum-based fuel economy as determined by the Secretary of Energy in accordance with the provisions of 10 CFR 474.
(d) Minimum data requirements for the manufacturer's average fuel economy. For the purpose of calculating the manufacturer's average fuel economy under § 600.510, the manufacturer shall submit FTP (city) and HFET (highway) test data representing at least 90 percent of the manufacturer's actual model year production, by configuration, for each category identified for calculation under § 600.510–08(a).
(a)
(b) * * *
(3)
(c) Test fuels which do not have fuel specifications provided in the provisions of § 86.113 of this chapter may be used if approved in advance by the Administrator.
This section provides test procedures for the FTP, highway, US06, SC03, and the cold temperature FTP tests. Testing shall be performed according to test procedures and other requirements contained in Part 86 and Part 600 of this
(b) * * *
(9) * * *
(ii) Open the vehicle engine compartment cover and position the cooling fan(s) required. Manufacturers may request the use of additional cooling fans or variable speed fan(s) for additional engine compartment or under-vehicle cooling and for controlling high tire or brake temperatures during dynamometer operation. With prior EPA approval, manufacturers may perform the test with the engine compartment closed,
(f)
(h)(1) For gasoline-fueled automobiles tested on test fuel specified in § 86.113–04(a), the fuel economy in miles per gallon is to be calculated using the following equation:
(k) For automobiles fueled with natural gas, the fuel economy in miles per gallon of natural gas is to be calculated using the following equation:
(b) * * *
(2) * * *
(ii) * * *
(c) * * *
(1) * * *
(i) * * *
This section provides the criteria to determine if the derived 5-cycle method for determining fuel economy label values, as specified in § 600.210–08 (a)(2) or (b)(2), as applicable, may be used to determine label values for 2011 and later model year vehicles. Separate criteria apply to city and highway fuel economy for each test group. The provisions of this section are optional. If this option is not chosen, or if the criteria provided in this section are not met, fuel economy label values for 2011 and later model year vehicles must be determined according to the vehicle-specific 5-cycle method specified in § 600.210–08(a)(1) or (b)(1), as applicable. However, dedicated alternative-fuel vehicles, dual fuel vehicles when operating on alternative fuel, and MDPVs may use the derived 5-cycle method for determining fuel economy labels for 2011 and later model years whether or not the criteria provided in this section are met.
(a) * * *
(1) * * *
(i) The vehicle-specific 5-cycle city fuel economy from the official FTP, HFET, US06, SC03 and Cold FTP tests for the test group is determined according to the provisions of § 600.114–08(a) or (c) and rounded to the nearest one tenth of a mile per gallon.
(ii) Using the same FTP data as used in paragraph (a)(1)(i) of this section, the corresponding derived 5-cycle city fuel economy is calculated according to the following equation:
(a)
(2) * * *
(i) For each model type, determine the derived five-cycle city fuel economy using the following equation and coefficients determined by the Administrator:
(ii) For each model type, determine the derived five-cycle highway fuel economy using the equation below and coefficients determined by the Administrator:
(3) * * *
(i) City and Highway label values for dual fuel alcohol-based and natural gas vehicles when using the alternate fuel are separately determined by the following calculation:
The result, rounded to the nearest whole number, is the alternate fuel label value for dual fuel vehicles.
(e)
(2) For advanced technology vehicles, the Administrator may prescribe special methods for calculating and/or determining information other than fuel economy that is required to be displayed on fuel economy labels as specified in section 600.307–08(k) of this part. For example, the Administrator may prescribe methods to determine the city and highway electrical energy consumption values and the all electric driving range for battery electric vehicles and plug-in hybrid electric vehicles.
(k)
(a) * * *
(2) The Administrator will classify light trucks (nonpassenger automobiles) into the following classes: Small pickup trucks, standard pickup trucks, vans, minivans, and SUVs. Pickup trucks will be separated by car line on the basis of gross vehicle weight rating (GVWR). For pickup truck car lines with more than one GVWR, the GVWR of the pickup truck car line is the arithmetic average of all distinct GVWRs less than or equal to 8,500 pounds available for that car line. The Administrator may determine that specific light trucks should be most appropriately placed in a different class or in the special purpose vehicle class as provided in paragraph (a)(3)(i) and (a)(3)(ii) of this section, based on the features and characteristics of the specific vehicle, consumer information provided by the manufacturer, and other information available to consumers.
(3)(i)
(b)
(2) For all body styles except station wagons and hatchbacks with more than one seat (
(3) For all station wagons and hatchbacks with more than one seat (
(c) All interior and cargo dimensions are measured in inches to the nearest 0.1 inch. All dimensions and volumes shall be determined from the base vehicles of each body style in each car line, and do not include optional equipment. The dimensions H61, W3, W5, L34, H63, W4, W6, L51, H201, L205, L210, L211, H198, W201, and volume V1 are to be determined in accordance with the procedures outlined in Motor Vehicle Dimensions SAE J1100a (Report of Human Factors Engineering Committee, Society of Automotive Engineers, approved September 1973 and last revised September 1975), as incorporated by reference as specified in § 600.011–93, except as noted herein:
(1)
(e) The rear seat volume is calculated in cubic feet, for vehicles with a rear seat equipped with rear seat belts (as required by DOT), by dividing 1,728 into the product of three terms listed below and rounding the quotient to the nearest 0.001 cubic feet:
(2) * * *
(ii) W4—Shoulder room-second, if hip room is not more than 5 inches less than shoulder room. (In inches, W4 is obtained according to paragraph (c) of this section), and
(g) * * *
(1) For station wagons the cargo volume index V10 is calculated, in cubic feet, by dividing 1,728 into the product of three terms and rounding the quotient to the nearest 0.001 cubic feet:
(i) Average cargo width, which is the arithmetic average of:
(A) W4—Shoulder room-second (in inches obtained according to paragraph (c) of this section); and
(B) W201—Cargo width-wheelhouse (in inches obtained according to paragraph (c) of this section).
(2) For hatchbacks, the cargo volume index V11 is calculated, in cubic feet, by dividing 1,728 into the product of three terms and rounding the quotient to the nearest 0.001 cubic foot:
(iii) H198—Second seatback to load floor height. (In inches obtained according to paragraph (c) of this section.)
(h) * * *
(2) For all passenger automobiles except station wagons and hatchbacks with more than one seat (
(3) For station wagons with more than one seat (
(i) The dimensions H201, L205, and W201 determined in accordance with paragraph (c) of this section, and
(ii) The cargo volume index V10 determined in accordance with paragraph (g)(1) of this section.
(4) * * *
(ii) The cargo volume index V11 determined in accordance with paragraph (g)(2) of this section.
(a) The provisions of this subpart are applicable to 1993 and later model year passenger automobiles and light trucks, and to the manufacturers of passenger automobiles and light trucks as determined by the Secretary of Transportation in 49 CFR 531.3 and 49
(a) * * *
(4)
(a) * * *
(1) An average fuel economy calculation will be made for the category of passenger automobiles as determined by the Secretary of Transportation. For example, categories may include, but are not limited to domestically manufactured and/or non-domestically manufactured passenger automobiles as determined by the Secretary of Transportation.
(2) [Reserved]
(3) An average fuel economy calculation will be made for the category of trucks as determined by the Secretary of Transportation. For example, categories may include, but are not limited to domestically manufactured trucks, non-domestically manufactured trucks, light-duty trucks, medium-duty passenger vehicles, and/or heavy-duty trucks as determined by the Secretary of Transportation.
(4) [Reserved]
(b) * * *
(2) * * *
(i) Separate fuel economy values will be calculated for model types and base levels associated with car lines for each category of passenger automobiles and trucks as determined by the Secretary of Transportation pursuant to paragraphs (a)(1) and (a)(3) of this section.
(A) [Reserved]
(B) [Reserved]
(3) * * *
(i) Separate fuel economy values will be calculated for vehicle configurations associated with car lines for each category of passenger automobiles and trucks as determined by the Secretary of Transportation pursuant to paragraphs (a)(1) and (a)(3) of this section.
(A) [Reserved]
(B) [Reserved]
(c) * * *
(2) * * *
(v) For alcohol dual fuel model types, for model years 1993 through 2019, the harmonic average of the following two terms; the result rounded to the nearest 0.1 mpg:
(vi) For natural gas dual fuel model types, for model years 1993 through 2019, the harmonic average of the following two terms; the result rounded to the nearest 0.1 mpg:
(e) * * *
IW = (9.2917 × 10
(g) * * *
(3) Alcohol dual fuel passenger automobiles and natural gas dual fuel passenger automobiles manufactured during model years 1993 through 2019 must meet the minimum driving range requirements established by the Secretary of Transportation (49 CFR part 538) to obtain the CAFE credit determined in paragraphs (c)(2)(v) and (vi) of this section.
(h) For model years 1993 and later, and for each category of automobile identified in paragraph (a) of this section, the maximum increase in average fuel economy determined in paragraph (c) of this section attributable to alcohol dual fuel automobiles and natural gas dual fuel automobiles shall be as follows:
(i) [Reserved]
(a) Except with advance approval of the Administrator, an automobile shall be considered domestically produced in any model year if it is included within a domestically produced car line (car line includes station wagons for purposes of this paragraph), unless the assembly of such automobile is completed in Canada or Mexico and such automobile is not imported into the United States prior to the expiration of 30 days following the end of the model year. For purposes of this paragraph a car line will be considered domestically produced if the following ratio is less than 0.25:
(b) * * *
(5) All elections under paragraph (b)(4) of this section shall be made in accordance with the procedures established by the Secretary of Transportation pursuant to 49 U.S.C. 32904(b)(3)(C).
(c) * * *
(8) For 2008–2010 light truck model year reports, the average fuel economy standard or the “required fuel economy level” pursuant to 49 CFR Part 533, as applicable. Model year reports for light trucks meeting required fuel economy levels pursuant to 49 CFR 533.5(g) and (h) shall include information in sufficient detail to verify the accuracy of the calculated required fuel economy level. Such information is expected to include but is not limited to, production information for each unique footprint
(9) For 2011 and later model year reports, the “required fuel economy level” pursuant to 49 CFR Parts 531 or 533, as applicable. Model year reports shall include information in sufficient detail to verify the accuracy of the calculated required fuel economy level, including but is not limited to, production information for each unique footprint within each model type contained in the model year report and the formula used to calculate the required fuel economy level. Model year reports shall include a statement that the method of measuring vehicle track width, measuring vehicle wheelbase and calculating vehicle footprint is accurate and complies with applicable Department of Transportation requirements.
Federal Emergency Management Agency, DHS.
Final rule.
This rule identifies communities, where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP), that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the
If you want to determine whether a particular community was suspended on the suspension date or for further information, contact David Stearrett, Mitigation Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646–2953.
The NFIP enables property owners to purchase flood insurance which is generally not otherwise available. In return, communities agree to adopt and administer local floodplain management aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits flood insurance coverage as authorized under the NFIP, 42 U.S.C. 4001
In addition, FEMA has identified the Special Flood Hazard Areas (SFHAs) in these communities by publishing a Flood Insurance Rate Map (FIRM). The date of the FIRM, if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may legally be provided for construction or acquisition of buildings in identified SFHAs for communities not participating in the NFIP and identified for more than a year, on FEMA's initial flood insurance map of the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and public comment under 5 U.S.C. 553(b) are impracticable and unnecessary because communities listed in this final rule have been adequately notified.
Each community receives 6-month, 90-day, and 30-day notification letters addressed to the Chief Executive Officer stating that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications were made, this final rule may take effect within less than 30 days.
Flood insurance, Floodplains.
42 U.S.C. 4001
Federal Emergency Management Agency, DHS.
Final rule.
This rule identifies communities, where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP), that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the
If you want to determine whether a particular community was suspended on the suspension date or for further information, contact David Stearrett,
The NFIP enables property owners to purchase flood insurance which is generally not otherwise available. In return, communities agree to adopt and administer local floodplain management aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits flood insurance coverage as authorized under the NFIP, 42 U.S.C. 4001
In addition, FEMA has identified the Special Flood Hazard Areas (SFHAs) in these communities by publishing a Flood Insurance Rate Map (FIRM). The date of the FIRM, if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may legally be provided for construction or acquisition of buildings in identified SFHAs for communities not participating in the NFIP and identified for more than a year, on FEMA's initial flood insurance map of the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and public comment under 5 U.S.C. 553(b) are impracticable and unnecessary because communities listed in this final rule have been adequately notified.
Each community receives 6-month, 90-day, and 30-day notification letters addressed to the Chief Executive Officer stating that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications were made, this final rule may take effect within less than 30 days.
Flood insurance, Floodplains.
42 U.S.C. 4001
Federal Emergency Management Agency, DHS.
Final rule.
Modified Base (1% annual-chance) Flood Elevations (BFEs) are finalized for the communities listed below. These modified BFEs will be used to calculate flood insurance premium rates for new buildings and their contents.
The effective dates for these modified BFEs are indicated on the following table and revise the Flood Insurance Rate Maps (FIRMs) in effect for the listed communities prior to this date.
The modified BFEs for each community are available for inspection at the office of the Chief Executive Officer of each community. The respective addresses are listed in the table below.
Kevin C. Long, Acting Chief, Engineering Management Branch, Mitigation Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646–2820.
The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the modified BFEs for each community listed. These modified BFEs have been published in newspapers of local circulation and ninety (90) days have elapsed since that publication. The Assistant Administrator for Mitigation has resolved any appeals resulting from this notification.
The modified BFEs are not listed for each community in this notice. However, this final rule includes the address of the Chief Executive Officer of the community where the modified BFEs determinations are available for inspection.
The modified BFEs are made pursuant to section 206 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001
For rating purposes, the currently effective community number is shown and must be used for all new policies and renewals.
The modified BFEs are the basis for the floodplain management measures that the community is required to either adopt or to show evidence of being already in effect in order to qualify or to remain qualified for participation in the National Flood Insurance Program (NFIP).
These modified BFEs, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own, or pursuant to policies established by other Federal, State, or regional entities.
These modified BFEs are used to meet the floodplain management requirements of the NFIP and are also used to calculate the appropriate flood insurance premium rates for new buildings built after these elevations are made final, and for the contents in these buildings. The changes in BFEs are in accordance with 44 CFR 65.4.
Flood insurance, Floodplains, Reporting and recordkeeping requirements.
42 U.S.C. 4001
Federal Emergency Management Agency, DHS.
Final rule.
Base (1% annual-chance) Flood Elevations (BFEs) and modified BFEs are made final for the communities listed below. The BFEs and modified BFEs are the basis for the floodplain management measures that each community is required either to adopt or to show evidence of being already in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).
The date of issuance of the Flood Insurance Rate Map (FIRM) showing BFEs and modified BFEs for each
The final BFEs for each community are available for inspection at the office of the Chief Executive Officer of each community. The respective addresses are listed in the table below.
Kevin C. Long, Acting Chief, Engineering Management Branch, Mitigation Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646–2820.
The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the modified BFEs for each community listed. These modified elevations have been published in newspapers of local circulation and ninety (90) days have elapsed since that publication. The Assistant Administrator for Mitigation has resolved any appeals resulting from this notification.
This final rule is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.
Interested lessees and owners of real property are encouraged to review the proof Flood Insurance Study and FIRM available at the address cited below for each community. The BFEs and modified BFEs are made final in the communities listed below. Elevations at selected locations in each community are shown.
Administrative practice and procedure, Flood insurance, Reporting and recordkeeping requirements.
42 U.S.C. 4001
Federal Emergency Management Agency, DHS.
Final rule.
Base (1% annual-chance) Flood Elevations (BFEs) and modified BFEs are made final for the communities listed below. The BFEs and modified BFEs are the basis for the floodplain management measures that each community is required either to adopt or to show evidence of being already in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).
The date of issuance of the Flood Insurance Rate Map (FIRM) showing BFEs and modified BFEs for each community. This date may be obtained by contacting the office where the maps are available for inspection as indicated on the table below.
The final BFEs for each community are available for inspection at the office of the Chief Executive Officer of each community. The respective addresses are listed in the table below.
Kevin C. Long, Acting Chief, Engineering Management Branch, Mitigation Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646–2820.
The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the modified BFEs for each community listed. These modified elevations have been published in newspapers of local circulation and ninety (90) days have elapsed since that publication. The Assistant Administrator for Mitigation has resolved any appeals resulting from this notification.
This final rule is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.
Interested lessees and owners of real property are encouraged to review the proof Flood Insurance Study and FIRM available at the address cited below for each community. The BFEs and modified BFEs are made final in the communities listed below. Elevations at
Administrative practice and procedure, Flood insurance, Reporting and recordkeeping requirements.
42 U.S.C. 4001
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary orders; inseason orders; request for comments.
NMFS publishes Fraser River salmon inseason orders to regulate salmon fisheries in U.S. waters. The orders were issued by the Fraser River Panel (Panel) of the Pacific Salmon Commission (Commission) and subsequently approved and issued by NMFS during the 2009 salmon fisheries within the U.S. Fraser River Panel Area. These orders established fishing dates, times, and areas for the gear types of U.S. treaty Indian and all citizen fisheries during the period the Panel exercised jurisdiction over these fisheries.
The effective dates for the inseason orders are set out in this document under the heading Inseason Orders. Comments will be accepted through December 10, 2009.
You may submit comments, identified by 0648–XS30 by any one of the following methods:
Electronic Submissions: Submit all electronic public comments via the Federal eRulemaking Portal
Fax: 206–526–6736
Mail: NMFS NWR, 7600 Sand Point Way NE, Seattle, WA 98115.
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 PDF file formats only.
Peggy Busby, by phone at 206–526–4323,
The Treaty between the Government of the United States of America and the Government of Canada concerning Pacific Salmon was signed at Ottawa on January 28, 1985, and subsequently was given effect in the United States by the Pacific Salmon Treaty Act (Act) at 16 U.S.C. 3631–3644.
Under authority of the Act, Federal regulations at 50 CFR part 300, subpart F provide a framework for the implementation of certain regulations of the Commission and inseason orders of the Commission's Fraser River Panel for U.S. sockeye and pink salmon fisheries in the Fraser River Panel Area.
The regulations close the U.S. portion of the Fraser River Panel Area to U.S. sockeye and pink salmon fishing unless opened by Panel orders that are given effect by inseason regulations published by NMFS. During the fishing season, NMFS may issue regulations that establish fishing times and areas consistent with the Commission agreements and inseason orders of the Panel. Such orders must be consistent with domestic legal obligations and are issued by Regional Administrator, Northwest Region, NMFS. Official notification of these inseason actions is provided by two telephone hotline numbers described at 50 CFR 300.97(b)(1) and in 74 FR 20610 (May 5, 2009). The inseason orders are published in the
The following inseason orders were adopted by the Panel and issued for U.S. fisheries by NMFS during the 2009 fishing season. Each of the following inseason actions was effective upon announcement on telephone hotline numbers as specified at 50 CFR 300.97(b)(1)and in 74 FR 20610 (May 5, 2009); those dates and times are listed herein. The times listed are local times, and the areas designated are Puget Sound Management and Catch Reporting Areas as defined in the Washington State Administrative Code at Chapter 220–22.
Treaty Indian Fishery
The Fraser River Panel approved the following relinquishment of regulatory control in U.S. Puget Sound Panel waters:
The Fraser River Panel approved the following relinquishment of regulatory control in U.S. Puget Sound Panel waters:
The Assistant Administrator for Fisheries NOAA (AA), finds that good cause exists for the inseason orders to be issued without affording the public prior notice and opportunity for comment under 5 U.S.C. 553(b)(B) as such prior notice and opportunity for comments is impracticable and contrary to the public interest. Prior notice and opportunity for public comment is impracticable because NMFS has insufficient time to allow for prior notice and opportunity for public comment between the time the stock abundance information is available to determine how much fishing can be allowed and the time the fishery must open and close in order to harvest the appropriate amount of fish while they are available.
The AA also finds good cause to waive the 30–day delay in the effective date, required under 5 U.S.C. 553(d)(3), of the inseason orders. A delay in the effective date of the inseason orders would not allow fishers appropriately controlled access to the available fish at that time they are available.
This action is authorized by 50 CFR 300.97, and is exempt from review under Executive Order 12866.
16 U.S.C. 3636(b).
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS is prohibiting directed fishing for Pacific cod by vessels catching Pacific cod for processing by the inshore component in the Western Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the 2009 total allowable catch (TAC) of Pacific cod apportioned to vessels catching Pacific cod for processing by the inshore component of the Western Regulatory Area of the GOA.
Effective 1200 hrs, Alaska local time (A.l.t.), November 22, 2009, until 2400 hrs, A.l.t., December 31, 2009.
Josh Keaton, 907–586–7228.
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 2009 TAC of Pacific cod apportioned to vessels catching Pacific cod for processing by the inshore component of the Western Regulatory Area of the GOA is 14,558 metric tons (mt) as established by the final 2009 and 2010 harvest specifications for groundfish of the GOA (74 FR 7333, February 17, 2009).
In accordance with § 679.20(d)(1)(i), the Regional Administrator has determined that the 2009 TAC of Pacific cod apportioned to vessels catching Pacific cod for processing by the inshore component of the Western Regulatory Area of the GOA will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 14,508 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 Pacific cod by vessels catching Pacific cod for processing by the inshore component 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
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
Agricultural Marketing Service, USDA.
Withdrawal of proposed rule.
This document withdraws a proposed rule published in the
The proposed rule published on July 18, 2008 (73 FR 41302), is withdrawn effective November 25, 2009.
Rose M. Aguayo, Marketing Specialist, or Kurt J. Kimmel, Regional Manager, California Marketing Field Office, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA;
Small businesses may request information on complying with this regulation by contacting Jay Guerber, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, 1400 Independence Avenue, SW., STOP 0237, Washington, DC 20250–0237;
Marketing Agreement and Order No. 989, both as amended (7 CFR part 989), regulate the handling of raisins produced from grapes grown in California, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601–674), hereinafter referred to as the “Act.”
This action withdraws a proposed rule published in the
Historically, reserve raisins have been used by the Committee to support market development programs that have strengthened export sales and reduced surpluses, thus stabilizing the domestic market. In two previous years when raisin supplies were low, the Committee recommended an alternative method of calculating its volume control percentages, including the use of an estimated trade demand figure, to ensure that a reserve was maintained and the export programs could continue from year to year.
Subsequent to publication of the proposed rule, the Committee determined that the 2008–09 crop was larger than anticipated and that use of the alternative method for calculating volume control percentages would be unnecessary for that crop year. Therefore, the proposed action is no longer warranted.
Accordingly, the proposed rule regarding use of an estimated trade demand figure to compute volume regulation percentages for 2008–09 NS raisins published in the
Grapes, Marketing agreements, Raisins, Reporting and recordkeeping requirements.
7 U.S.C. 601–674.
Customs and Border Protection, Department of Homeland Security; Department of the Treasury.
Notice of proposed rulemaking; second extension of comment period.
This document provides a second 30-day extension period for interested parties to submit comments on the proposal to amend title 19 of the Code of Federal Regulations to preclude the filing of substitution drawback claims for internal revenue excise tax paid on imported merchandise in situations where no excise tax was paid upon the substituted merchandise or where the substituted merchandise is the subject of a different claim for refund or drawback of excise tax under any provision of the Internal Revenue Code. The proposed rule was published in the
Comments on the proposed rule must be received on or before January 12, 2010.
You may submit comments, identified by
•
•
William Rosoff, Entry Process and Duty Refunds, Regulations and Rulings, Office of International Trade, (202) 325–0047.
Interested persons are invited to participate in this rulemaking by submitting written data, views, or arguments on all aspects of the proposed rule. Customs and Border Protection (CBP) also invites comments that relate to the economic, environmental, or federalism effects that might result from this proposed rule. If appropriate to a specific comment, the commenter should reference the specific portion of the proposed rule, explain the reason for any recommended change, and include data, information, or authority that support such recommended change.
Customs and Border Protection (CBP) published a document in the
A related proposed rulemaking prepared by the Alcohol and Tobacco Tax and Trade Bureau (TTB) within the Department of the Treasury was published in the same edition of the
A subsequent notice extending the time within which the public may submit comments on CBP's proposed rulemaking to coincide with the December 14, 2009 TTB comment deadline was published in the
CBP received a written submission from the trade, dated November 2, 2009, requesting that the comment period be extended for an additional 30 days to provide adequate time to prepare comments on the proposed rule. Upon review, a decision has been made to grant the request. Accordingly, the comment period is extended to January 12, 2010 and comments must be received by CBP on or before that date.
Department of State.
Proposed rule.
The Department of State is proposing to amend Section 126.6 of the International Traffic in Arms Regulations (ITAR) pertaining to U.S. Government transfer programs and foreign-owned military aircraft and naval vessels. Section 126.6 is being amended to clarify the particular circumstances when a license is not required by the Directorate of Defense Trade Controls.
The Department of State will accept comments on this proposed rule until January 25, 2010.
Interested parties may submit comments within 60 days of the date of the publication by any of the following methods:
•
•
Persons with access to the Internet may also view this notice by going to the U.S. Government regulations.gov Web site at
Director Charles B. Shotwell, Office of Defense Trade Controls Policy, Department of State, Telephone (202) 663–2792 or Fax (202) 261–8199; E-mail
Section 126.6 of the ITAR specifies when a license from the Directorate of Defense Trade Controls is not required for certain specified U.S. Government transfer programs and exports involving foreign-owned military aircraft and naval vessels. The title of this particular section has been changed from “Foreign-owned military aircraft and naval vessels, and the Foreign Military Sales program” to “U.S. Government transfer programs and foreign-owned military aircraft and naval vessels” to more accurately describe its coverage. Section 126.6 is being amended to clarify the particular circumstances when a license is not required by the Directorate of Defense Trade Controls. Current regulatory language was implemented when the U.S. Government executed these programs with mostly U.S. Government personnel. Over the years the U.S. Government, especially the Department of Defense, has expanded operations and migrated to utilization of the Defense Transportation System as well as commercial carriers to, in some instances, fully replace government transportation systems and personnel. As a result, U.S. Customs and Border Protection was unclear as to which programs were U.S. Government programs and, therefore, which items were qualified to be exported from the United States without an associated export license. The proposed changes address this issue. Also, the proposed amendment addresses in more detail the export requirements involving the Foreign Military Sales program and extends the exemption to exports pursuant to section 1206 of the National Defense Authorization Act for Fiscal Year 2006, as amended and extended, or section 1206 of the National Defense Authorization Act for Fiscal Year 2008. It further delineates requirements, authorized periods for license exemptions, documentary requirements, and the applicable terms and conditions relating to the U.S. Government's transfer and/or loan of defense articles to foreign governments or international organizations.
Applicability of 5 U.S.C. 553 and Executive Order 12866 is under discussion with the Office of Management and Budget.
The applicability of the Regulatory Flexibility Act is contingent on the applicability of 5 U.S.C. 553, which will be determined at a later time.
This proposed amendment does not involve a mandate that will result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100 million or more in any year and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.
This proposed amendment has been found not to be a major rule within the meaning of the Small Business Regulatory Enforcement Fairness Act of 1996.
This proposed amendment will not have substantial effects 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. Therefore, in accordance with Executive Order 13132, it is determined that this amendment does not have sufficient federalism implications to require consultations or warrant the preparation of a federalism summary impact statement. The regulations implementing Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities do not apply to this proposed amendment.
This proposed rule would not impose any new reporting or recordkeeping requirements subject to the Paperwork Reduction Act, 44 U.S.C. Chapter 35.
Arms and munitions, Exports.
Accordingly, for the reasons set forth above, Title 22, Chapter I, Subchapter M, part 126 is proposed to be amended as follows:
1. The authority citation for part 126 continues to read as follows:
Secs. 2, 38, 40, 42 and 71, Public Law 90–629, 90 Stat. 744 (22 U.S.C. 2752, 2778, 2780, 2791 and 2797); E.O. 11958, 42 FR 4311; 3 CFR, 1977 Comp., p. 79; 22 U.S.C. 2651a; 22 U.S.C. 287c; E.O. 12918, 59 FR 28205; 3 CFR, 1994 Comp., p. 899; Sec. 1225, Public Law 108–375.
2. Section 126.6 is amended by revising paragraphs (a)(1), (a)(2), (a)(3), (b), (c), and (d) to read as follows:
(a) * * *
(1) The defense article to be exported was sold, granted, leased, or loaned by the Department of Defense to the government of a foreign country or to an international organization pursuant to the Arms Export Control Act, as amended, (AECA) or the Foreign Assistance Act of 1961, as amended;
(2) The defense article is exported to representatives of the government of the foreign country or international organization in the United States;
(3) The defense article is to be exported from the United States:
(i) On a military aircraft or naval vessel of the government of the foreign country or international organization. The shippers export declaration (SED) must be entered in the Automated Export System (AES) by such government or international organization prior to export;
(ii) By the Department of Defense via the Department of Defense Transportation System (DTS) in accordance with the vetting procedures and the requirements in DoD 5105.38–M, “Security Assistance Management Manual” (SAMM), and DoD Regulations 4500.9E and 4500.9R, “Defense Transportation Regulations” (DTR). The SED must be entered in the AES by the cognizant or responsible military service or implementing agency; or
(iii) By a Department of Defense contracted carrier via the DTS in accordance with the vetting procedures and the requirements in DoD 5105.38–M, “Security Assistance Management Manual” (SAMM), and DoD Regulations 4500.9E and 4500.9R, “Defense Transportation Regulations” (DTR). The SED must be entered in the AES by the cognizant or responsible military service or implementing agency; and
(4) In the event the defense article to be exported is classified, the export is made by a person having the appropriate USG security clearance, in compliance with the Department of Defense National Industrial Security Program Operating Manual (DoD NISPOM), and pursuant to an approved transportation plan.
(b)
(c)
(1) Exports of the defense article or defense service using this exemption may take place only during the period in which the FMS Program LOA and implementing USG FMS contracts and subcontracts are in effect and serve as authorization for the exports hereunder in lieu of a license. The Department of Defense shall ensure that defense articles and defense services exported are limited to those authorized under the valid LOA, maintain the dollar value balance shipped against the LOA, and shall promptly notify U.S. Customs and Border Protection (CBP) of any amendments or modifications to the LOA, including the remaining balance when the LOA is completed, closed, or is no longer valid as an authorization;
(2) The defense article or defense service to be exported is specifically identified in an executed LOA, in furtherance of the FMS program, signed by an authorized representative of the Department of Defense and an authorized representative of the foreign government;
(3) The total value of the defense articles and defense services exported must not exceed that value authorized by the relevant LOA and any relevant contract and subcontract;
(4) The export is not to a country proscribed in § 126.1 of this subchapter;
(5) The U.S. person responsible for the transfer or the Department of Defense (in the case of DTS shipments) maintains records of all exports in accordance with Part 122 of this subchapter;
(6) For exports of defense articles:
(i) The shipment is made by the relevant foreign diplomatic mission of the purchasing country or its authorized freight forwarder, provided that the freight forwarder is so designated in writing by the foreign government to, and is registered with, the Directorate of Defense Trade Controls pursuant to Part 122 of this subchapter;
(ii) Prior to shipment, the Department of Defense shall lodge the LOA, and any amendments or modifications thereto, with the Port Director of U.S. Customs and Border Protection of the primary port;
(iii) The relevant foreign diplomatic mission of the purchasing country, or its authorized freight forwarder, prepares and provides to the Port Director of U.S. Customs and Border Protection a properly executed DSP–94 that has been countersigned by an authorized representative of the Department of Defense verifying that the export is in accordance with the LOA. The exporter must also provide any other documents required by the Port Director of U.S. Customs and Border Protection in carrying out its responsibilities. The AES SED or, if authorized, the outbound manifest must be annotated as follows: “This shipment is being exported under the authority of Department of State Form DSP–94 pursuant to a current and valid FMS Case [case identification], implemented [implementation date]. 22 CFR 126.6(c) applicable. The U.S. Government point of contact is___, telephone number ___,”; and
(iv) In the event the defense article to be exported is classified, the export must be made by a person having the appropriate USG security clearance and must be made in compliance with the Department of Defense National Industrial Security Program Operating Manual (DoD NISPOM) and pursuant to an approved transportation plan; and
(7) For exports of defense services:
(i) The U.S. exporter must have entered into a contract with the Department of Defense that:
(A) Specifically defines the scope of the defense service to be exported;
(B) Cites the FMS case identifier;
(C) Identifies the foreign recipients of the defense service;
(D) Identifies any other U.S. or foreign parties that may be involved and their roles/responsibilities to the extent known when the contract is executed; and
(E) Specifies the period during which the defense service may be performed;
(ii) The U.S. person that is a party to a contract with the Department of Defense for the provision of defense services pursuant to an FMS case must maintain a valid registration with the Directorate of Defense Trade Controls for the entire time that the defense service is being provided. In any instance when that U.S. person employs a U.S. subcontractor, that subcontractor may only provide defense services pursuant to this subsection when registered with Directorate of Defense Trade Controls, and when such subcontract meets the requirements of paragraphs (c)(7)(i)(A) thorugh (E) of this section;
(iii) In instances when the defense service involves the transfer of classified technical data, the U.S. person transferring the defense service must have the appropriate USG security clearance and a transportation plan, if appropriate, in compliance with the Department of Defense National Industrial Security Program Operating Manual (DoD NISPOM);
(iv) Where defense articles are exported along with defense services, the exporter must comply with paragraph (c)(6) of this section; and
(v) The U.S. exporter reports its initial export, citing this section of the International Traffic in Arms Regulations. The U.S. exporter must maintain records of the export to include the FMS case identifier, the contract and subcontract number, the foreign country, and the duration of the service being provided. These records must be kept in accordance with § 122.5 of this subchapter.
(d)
(1) Defense articles to be exported were sold, granted, leased or loaned by the Department of Defense to a foreign country or international organization pursuant to section 1206 of the National Defense Authorization Act for Fiscal Year 2006, as amended and extended, or section 1206 of the National Defense Authorization Act for Fiscal Year 2008;
(2) The defense article is to be exported from the United States:
(i) By the Department of Defense via the Department of Defense Transportation System (DTS) in accordance with the vetting procedures and the requirements in DoD 5105.38–M, “Security Assistance Management Manual” (SAMM), and DoD Regulations 4500.9E and 4500.9R, “Defense Transportation Regulations” (DTR). The SED must be entered in the AES by the cognizant or responsible military service or implementing agency; or
(ii) By a Department of Defense contracted carrier via the DTS in accordance with the vetting procedures and the requirements in DoD 5105.38–M, “Security Assistance Management Manual” (SAMM), and DoD Regulations 4500.9E and 4500.9R, “Defense Transportation Regulations” (DTR). The SED must be entered in the AES by the cognizant or responsible military service or implementing agency; and
(3) In the event the defense article to be exported is classified, the export is made by a person having the appropriate USG security clearance, in
Internal Revenue Service (IRS), Treasury.
Notice of proposed rulemaking and notice of public hearing.
This document contains proposed regulations relating to awards of administrative costs and attorneys fees under section 7430 to conform to the amendments made in the Taxpayer Relief Act of 1997 and the IRS Restructuring and Reform Act of 1998. The regulations affect taxpayers seeking attorneys fees and costs. This document also provides notice of a public hearing on these proposed regulations.
Written or electronic comments must be received by February 8, 2010. Outlines of topics to be discussed at the public hearing scheduled for 10 a.m. on March 10, 2010 must be received by February 10, 2010.
Send submissions to: CC:PA:LPD:PR (REG–111833–99), room 5203, Internal Revenue Service, P.O. Box 7604, Ben Franklin Station, Washington, DC 20044. Submissions may be hand-delivered Monday through Friday between the hours of 8 a.m. and 4 p.m. to: CC:PA:LPD:PR (REG–111833–99), Courier's Desk, Internal Revenue Service, 1111 Constitution Avenue, NW., Washington, DC. Alternatively, taxpayers may submit comments electronically via the Federal eRulemaking Portal at
Concerning the hearing, submission of written comments, and to be placed on the building access list to attend the hearing, contact Regina Johnson, (202) 622–7180; concerning the proposed regulations, contact Ronald J. Goldstein (202) 622–4910 (not toll-free numbers).
The proposed amendments to the Treasury Regulations incorporate the 1997 and 1998 amendments to section 7430 of the Internal Revenue Code relating to awards of attorneys fees. These amendments were enacted as part of the Taxpayer Relief Act of 1997, Public Law 105–34, 111 Stat. 788, and the IRS Restructuring and Reform Act of 1998, Public Law 105–206, 112 Stat. 685.
The Taxpayer Relief Act of 1997 (TRA) contained several amendments to section 7430 that are addressed in the proposed amendments to the regulations. First, the TRA provided that a taxpayer has ninety days after the date the IRS mails to the taxpayer a final decision determining tax, interest or penalty, to file an application with the IRS to recover administrative costs. Second, a taxpayer has ninety days after the date the IRS mails to the taxpayer, by certified or registered mail, a final adverse decision regarding an award of administrative costs, to file a petition with the Tax Court. Third, the TRA clarified the application of the net worth requirements by providing that individuals filing joint returns should be treated as separate taxpayers for purposes of determining net worth. The TRA added trusts to the list of taxpayers subject to the net worth requirements and also specified the date on which the net worth determination should be made.
The TRA also added section 7436 to the Code, which gives the Tax Court jurisdiction in certain employment tax cases. Under section 7436, if the IRS determines in connection with an audit that (1) one or more individuals performing services for the taxpayer are employees of the taxpayer or (2) the taxpayer is not entitled to relief from employment taxes under section 530 of the Revenue Act of 1978 with respect to the individual(s), and the IRS sends a Notice of Determination of Worker Classification (NDWC) to the taxpayer by certified or registered mail, the taxpayer may petition the Tax Court to determine (1) whether the IRS's determination, as set forth in the NDWC, is correct and (2) the proper amount of employment tax under the determination. Various restrictions on assessment and collection in section 6213 apply to a section 7436 proceeding in the same manner as if the NDWC were a notice of deficiency. Section 7436(d)(2) provides that section 7430 applies to proceedings brought under section 7436.
The proposed amendments reflect the changes outlined in this preamble. Additional clarifying changes address the calculation of net worth. First, the regulation specifies that net worth will be calculated using the fair market value of assets to provide a more accurate assessment of a taxpayer's actual and current net worth as of the administrative proceeding date. Second, the regulation specifies which net worth and size limitations apply when a taxpayer is an owner of an unincorporated business. Third, the regulation has been amended to clarify the net worth requirement in cases involving partnerships subject to the unified audit and litigation procedures of sections 6221 through 6234 of the Code (the TEFRA partnership procedures).
The IRS Restructuring and Reform Act of 1998 (RRA) also contained several amendments affecting section 7430. First, the RRA increased the hourly rate limitation from $110 per hour to $125 per hour. Second, two special factors were added that may be considered to increase an attorney's hourly rate: Difficulty of the issues presented and local availability of tax experts. Third, the RRA added a provision that requires a court to consider whether the IRS has lost cases with substantially similar issues in other circuit courts of appeal in deciding whether the IRS's position was substantially justified. Fourth, the RRA created an exception to the requirement that to recover attorneys fees, the taxpayer must have paid or incurred the fees. The exception provides that if an individual who is authorized to practice before the Tax Court or the IRS is representing the taxpayer on a
It has been determined that this notice of proposed rulemaking is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required. It also has been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations and, because these regulations do not impose on small entities a collection of information requirement, the Regulatory Flexibility Act (5 U.S.C. chapter 6) does not apply. Therefore, a Regulatory Flexibility Analysis is not required. Pursuant to section 7805(f) of the Internal Revenue Code, this regulation has been submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business.
Before these proposed regulations are adopted as final regulations, consideration will be given to any written comments (a signed original and eight (8) copies) or electronic comments that are submitted timely to the IRS. The IRS and Treasury Department specifically request comments on the clarity of the proposed rules and how it may be made easier to understand. All public comments will be made available for public inspection and copying.
A public hearing has been scheduled for 10 a.m. on March 10, 2010 in the Internal Revenue Building, Room 2615, 1111 Constitution Avenue, NW., Washington, DC. Due to building security procedures, visitors must enter at the Constitution Avenue entrance. In addition, all visitors must present photo identification to enter the building. Because of access restrictions, visitors will not be admitted beyond the immediate entrance area more than 30 minutes before the hearing starts. For information about having a visitor's name placed on the building access list to attend the hearing,
An outline of the topics to be discussed and the time to be devoted to each topic (a signed original and eight (8) copies) must be submitted by any person that wishes to present oral comments at the hearing. Outlines must be received by February 10, 2010.
The rules of 26 CFR 601.601(a)(3) apply to the hearing. A period of 10 minutes will be allotted to each person for making comments.
An agenda showing the scheduling of the speakers will be prepared after the deadline for receiving requests to speak has passed. Copies of the agenda will be available free of charge at the hearing.
The principal author of these regulations is Ronald J. Goldstein, Office of Associate Chief Counsel (Procedure and Administration).
Employment taxes, Estate taxes, Excise taxes, Gift taxes, Income taxes, Penalties, Reporting and recordkeeping requirements.
Accordingly, 26 CFR part 301 is proposed to be amended as follows:
26 U.S.C. 7805 * * *
1. Adding a new entry for § 301.7430–3(c)(4).
2. Adding new entries for § 301.7430–4(b)(3)(iii)(A) through (F) and (d).
3. Revising the entries for § 301.7430–5.
4. Revising the section heading for § 301.7430–6.
5. Adding new entries for §§ 301.7430–7 and 301.7430–8.
The additions and revisions read as follows:
(c) * * *
(4) First letter of proposed deficiency that allows the taxpayer an opportunity for administrative review in the Office of Appeals.
(b) * * *
(3) * * *
(iii) * * *
(A) In general.
(B) Special factor.
(C) Limited availability.
(D) Local availability of tax expertise.
(E) Difficulty of the issues.
(F) Example.
(c) * * *
(d)
(1) In general.
(2) Requirements.
(3) Nominal fee.
(4) Payment when services provided for a nominal fee.
(5) Requirements.
(6) Hourly rate.
(7) Examples.
(a) In general.
(b) Position of the Internal Revenue Service.
(c) Examples.
(d) Substantially justified.
(1) In general.
(2) Position in courts of appeal.
(3) Examples.
(4) Included costs.
(5) Examples.
(6) Exception.
(7) Presumption.
(e) Amount in controversy.
(f) Most significant issue or set of issues presented.
(1) In general.
(2) Example.
(g) Net worth and size limitations.
(1) Individuals.
(2) Estates and trusts.
(3) Others.
(4) Special rule for charitable organizations and certain cooperatives.
(5) Special rule for TEFRA partnerships.
(h) Determination of prevailing party.
(i) Examples.
(a) In general.
(b) Requirements for treatment as a prevailing party based upon having made a qualified offer.
(1) In general.
(2) Liability under the last qualified offer.
(3) Liability pursuant to the judgment.
(c) Qualified offer.
(1) In general.
(2) To the United States.
(3) Specifies the offered amount.
(4) Designated at the time it is made as a qualified offer.
(5) Remains open.
(6) Last qualified offer.
(7) Qualified offer period.
(8) Interest as a contested issue.
(d) [Reserved].
(e) Examples.
(f) Effective date.
(a) In general.
(b) Prevailing party.
(c) Administrative proceeding.
(d) Costs incurred after filing of bankruptcy petition.
(e) Time for filing claim for administrative costs.
(f) Effective date.
1. Revising paragraphs (b)(1)(ii)(A), (d)(1)(i), (d)(1)(ii) and (d)(2) introductory text.
2. Removing the language “district director” in paragraphs (f)(2)(i), (f)(3)(ii), (f)(3)(iii), (f)(4)(i) and (g)
3. Removing the language “such” in the second sentence of paragraph (g)
The revisions read as follows:
(b) * * *
(1) * * *
(ii) * * *
(A) Requests an Appeals office conference in accordance with §§ 601.105 and 601.106 of this chapter or any successor published guidance; and
(d) * * *
(1) * * *
(i) The party follows all applicable Internal Revenue Service procedures for contesting the matter (including filing a written protest or claim, requesting an administrative appeal, and participating in an administrative hearing or conference); or
(ii) If there are no applicable Internal Revenue Service procedures, the party submits to the area director of the area having jurisdiction over the dispute a written claim for relief reciting facts and circumstances sufficient to show the nature of the relief requested and that the party is entitled to the requested relief; and the area director has denied the claim for relief in writing or failed to act on the claim within a reasonable period after the claim is received by the area director.
(2) For purposes of paragraph (d)(1)(ii) of this section, a
1. Adding the language “from the Internal Revenue Service” at the end of the last sentence of paragraph (a).
2. Removing the language “such” in the fourth and fifth sentences of paragraph (b)(2) and adding the language “these” in its place in both locations.
3. Removing the “;” at the end of paragraph (c)(3)(i)(B) and adding a “.” in its place.
4. Adding a new sentence at the end of paragraphs (c)(3)(i)(B), (c)(3)(i)(E) and (c)(7).
5. Revising paragraphs (c)(3)(ii)(C), (c)(5) and (e).
6. Adding new paragraph (c)(3)(iii)(C).
7. Removing the language “which” in the first sentence of paragraph (c)(4) and adding the language “that” in its place.
8. Removing the language “such” in the second sentence of paragraph (c)(6) and adding the language “the” in its place.
The additions and revisions read as follows:
(c) * * *
(3) * * *
(i) * * *
(B) * * * For costs incurred after January 18, 1999, if the taxpayer alleges that the United States has lost in courts of appeal for other circuits on substantially similar issues, the taxpayer must provide the full name of the case, volume and pages of the reporter in which the opinion appears, the circuit in which the case was decided, and the year of the opinion;
(E) * * * This statement must identify whether the representation is on a
(ii) * * *
(C) For costs incurred after January 18, 1999, if more than $125 per hour as adjusted for increases in the cost of living pursuant to § 301.7430–4(b)(3) is claimed for the fees of a representative in connection with the administrative proceeding, an affidavit stating that a special factor described in § 301.7430–4(b)(3) is applicable, such as the difficulty of the issues presented in the case or the lack of local availability of tax expertise. If a special factor is claimed based on specialized skills and distinctive knowledge as described in § 301.7430–4(b)(2)(ii), the affidavit must state—
(1) Why the specialized skills and distinctive knowledge were necessary in the representation;
(2) That there is a limited availability of representatives possessing these specialized skills and distinctive knowledge; and
(3) How the education and experience qualifies the representative as someone with the necessary specialized skills and distinctive knowledge.
(iii) * * *
(C) In cases of
(5)
(7) * * * If the notice of decision denying (in whole or in part) an award for reasonable administrative costs was mailed by the Internal Revenue Service via certified mail or registered mail, a taxpayer may obtain judicial review of that decision by filing a petition for review with the Tax Court prior to the 91st day after the mailing of the notice of decision.
(e) * * *
Taxpayer A receives a notice of proposed deficiency (30-day letter). A requests and is granted Appeals office consideration. Appeals requests that A submit certain documents as substantiation for the tax matters at issue. Appeals determines that the information submitted is
Taxpayer B files a request for an abatement of interest pursuant to section 6404 and the regulations thereunder. The Area Director issues a notice of proposed disallowance of the abatement request (akin to a 30-day letter). B requests and is granted Appeals office consideration. No agreement is reached with Appeals and the Office of Appeals issues a notice of disallowance of the abatement request. B does not file suit in the Tax Court, but instead contacts the Appeals office within 180 days after the mailing date of the notice of disallowance of the abatement request to attempt to reverse the decision. B convinces the Appeals office that the notice of disallowance is in error. The Appeals office agrees to abate the interest and mails the taxpayer a notification of this decision. The mailing date of the notification from Appeals of the decision to abate interest commences the 90-day period from which the taxpayer may request administrative costs. Assuming that all of the other requirements of section 7430 are satisfied, B may recover reasonable administrative costs incurred after the date of the notice of proposed disallowance of the abatement request (the administrative proceeding date). To recover these costs, B must file a request for costs with the Appeals office personnel who settled B's tax matter, or if that person is unknown to B, with the Area Director of the area that considered the underlying matter within 90 days after the date of mailing of the Office of Appeals' final decision that B is entitled to abatement of interest.
Taxpayer C receives a notice of proposed adjustment and employment tax 30-day letter. C requests and is granted Appeals office consideration. Appeals requests that C submit certain documents to support C's position in the tax matters at issue. Appeals determines that the documents submitted are insufficient. Appeals then issues a notice of determination of worker classification. After receiving the notice of determination but before the 90-day period for filing a petition with the Tax Court has expired, C convinces Appeals that the documents submitted during the review by Appeals adequately support its position and, therefore, C owes no additional employment tax. Appeals then closes the case showing a zero tax adjustment and mails C a no-change letter. Assuming that all of the other requirements of section 7430 are satisfied, C may recover reasonable administrative costs incurred after the date of the notice of proposed adjustment and 30-day letter (the administrative proceeding date). To recover these costs, C must file a request for administrative costs with the Appeals office personnel who settled C's tax matter, or if that person is unknown to C, with the Area Director of the area that considered the underlying matter, within 90 days after the date of mailing of the Office of Appeals' final decision that C owes no additional tax.
1. Revising paragraphs (b), (c)(1), (c)(3) and (d).
2. Adding paragraph (c)(4).
The addition and revisions read as follows:
(b)
(c)
(i) The date of the receipt by the taxpayer of the notice of the decision of the Internal Revenue Service Office of Appeals;
(ii) The date of the notice of deficiency; or
(iii) The date on which the first letter of proposed deficiency that allows the taxpayer an opportunity for administrative review in the Internal Revenue Service Office of Appeals is sent.
(2) * * *
(3)
(i) A notice of final partnership administrative adjustment described in section 6223(a)(2).
(ii) A notice of determination of worker classification issued pursuant to section 7436.
(iii) A final notice of determination denying innocent spouse relief issued pursuant to section 6015.
(4)
(d)
Taxpayer A receives a notice of proposed deficiency (30-day letter). A files a request for and is granted an Appeals office conference. At the Appeals conference no agreement is reached on the tax matters at issue. The Office of Appeals then issues a notice of deficiency. Upon receiving the notice of deficiency, A does not file a petition with the Tax Court. Instead, A pays the deficiency and files a claim for refund. The claim for refund is considered by the Internal Revenue Service and the Area Director issues a notice of proposed claim disallowance. A requests and is granted Appeals office consideration. A convinces Appeals that A's claim is correct and Appeals allows A's claim. A may recover reasonable administrative costs incurred on or after the date of the notice of proposed deficiency (30-day letter), but only if the other requirements of section 7430 and the regulations thereunder are satisfied. A cannot recover costs incurred prior to the date of the 30-day letter because these costs were incurred before the administrative proceeding date.
Taxpayer B files an individual income tax return showing a balance due. No payment is made with the return and the Internal Revenue Service assesses the amount shown on the return. The Internal Revenue Service issues a notice of levy pursuant to section 6330. B requests and is granted a Collection Due Process (CDP) hearing. In connection with the CDP hearing, B enters into an installment agreement as a collection alternative. The costs that B incurred in connection with the CDP hearing were not incurred in an administrative proceeding, but rather in a collection action. Accordingly, B may not recover those costs as reasonable administrative costs under section 7430 and the regulations thereunder.
1. Removing the language “such” in the second and fifth sentences of paragraph (b)(2)(ii) and adding the language “that” in its place in both locations.
2. Revising paragraphs (b)(3)(i), (b)(3)(iii)(B), and (c)(4)
3. Removing the language “$110” from the first and second sentences in paragraph (b)(3)(ii) and adding the language “$125” in its place in both locations.
4. Revising the first sentence in paragraph (b)(3)(iii)(C).
5. Redesignating paragraph (b)(3)(iii)(D) as paragraph (b)(3)(iii)(F) and revising newly-designated paragraph (b)(3)(iii)(F).
6. Adding new paragraphs (b)(3)(iii)(D), (b)(3)(iii)(E) and (d).
7. Removing the language “Such” in the third sentence of paragraph (c)(2)(i) and adding the language “These” in its place.
8. Removing the language “$110” from the second and third sentences in paragraph (c)(2)(ii) and adding the language “$125” in its place in both locations.
9. Removing the language “which” in the fourth sentence of paragraph (c)(2)(i) and adding the language “that” in its place.
The additions and revisions read as follows:
(b) * * *
(3)
(iii) * * *
(B)
(C)
(D)
(E)
(
(
(
(
(F)
Taxpayer A is represented by B, a CPA and attorney with a LL.M. Degree in Taxation with Highest Honors and who regularly handles cases dealing with TEFRA partnership issues. B represents A in an administrative proceeding involving TEFRA partnership issues that is subject to the provisions of this section. Assuming the taxpayer qualifies for an award of reasonable administrative costs by meeting the requirements of section 7430, the amount of the award attributable to the fees of B may not exceed the $125 per hour limitation (as adjusted for the cost of living), absent a special factor. B is not a specially qualified representative because extraordinary knowledge of the tax laws does not constitute distinctive knowledge or a unique and specialized skill constituting a special factor. A special factor must be comprised of nontax expertise unless the taxpayer establishes the limited local availability of tax expertise.
(c) * * *
(4) * * *
After incurring fees for representation during the Internal Revenue Service's examination of taxpayer A's income tax return, A receives a notice of proposed deficiency (30-day letter). A files a request for and is granted an Appeals office conference. At the conference no agreement is reached on the tax matters at issue. The Internal Revenue Service then issues a notice of deficiency. Upon receiving the notice of deficiency, A discontinues A's administrative efforts and files a petition with the Tax Court. A's costs incurred before the date of the mailing of the 30-day letter are not reasonable administrative costs because they were incurred before the administrative proceeding date. Similarly, A's costs incurred in connection with the preparation and filing of a petition with the Tax Court are litigation costs and not reasonable administrative costs.
Assume the same facts as in
(d)
(2)
(i) Legal services were provided for no fee or for a fee that (taking into account all the facts and circumstances) constitutes a nominal fee;
(ii) The legal services were provided to or on behalf of either—
(A) Persons of limited financial means who meet the eligibility requirements for programs funded by the Legal Services Corporation as set forth in 45 CFR 1611; or
(B) Organizations operating primarily to address the needs of persons with limited means if payment of a standard legal fee would significantly deplete the person's financial resources; and
(iii) The service provider intended to perform services for no fee or for a nominal fee from the commencement of the representation. Intent to perform services for no fee or for a nominal fee may be demonstrated through documentation such as a retainer agreement. An individual will not be considered to have represented a client on a
(3)
(4)
(5)
(6)
(i) The rate prescribed under section 7430(c)(1)(B); or
(ii) The hourly rate customarily charged by the representative in cases that are not handled on a
(7)
Taxpayer A, an attorney, files a petition with the Tax Court and pays a $60 filing fee. A appears pro se in the court proceeding. If A prevails, he will not be entitled to an award of reasonable litigation costs for his services. A is rendering services on his own behalf, not providing
Taxpayer retains attorney B with regard to the audit of taxpayer's individual income tax return. B agrees to represent taxpayer on a
Assume the same facts in
Organization C, a low income taxpayer clinic within the meaning of section 7526, agrees to represent taxpayer on a
1. Removing the language “only if—” at the end of the introductory text in paragraph (a) and adding the language “(other than by reason of section 7430(c)(4)(E)) only if—” in its place.
2. Adding new paragraphs (a)(1), (c), (d)(2), (d)(3), (d)(4), (d)(5), (g)(2) and (g)(5).
3. Revising paragraph (b).
4. Revising the third sentence and removing the language “(c)(3)” from the fourth sentence in newly-designated paragraph (d)(7) and adding the language “(d)(7)” in its place.
5. Revising the paragraph heading for newly-designated paragraph (f)(1) and adding new paragraph (f)(2).
6. Revising newly-designated paragraphs (g)(1) and (g)(3).
7. Removing the language “Internal Revenue Code” in the first sentence of newly-designated paragraph (g)(4) in both places.
8. Removing the language “such” in the first sentence of newly-designated paragraph (h) and adding the language “an” in its place.
9. Removing paragraph (h).
The additions and revisions read as follows:
(a) * * *
(1) At least one issue (other than recovery of administrative costs) remains in dispute as of the date that the Internal Revenue Service takes a position in the administrative proceeding, as described in paragraph (b) of this section;
(b)
(1) The date of the receipt by the taxpayer of the notice of the decision of the Internal Revenue Service Office of Appeals; or
(2) The date of the notice of deficiency or any date thereafter.
(c)
Taxpayer A receives a notice of proposed deficiency (30-day letter). A pays the amount of the proposed deficiency and files a claim for refund. A's claim is considered and a notice of proposed claim disallowance is issued by the Area Director. A does not request an Appeals office conference and the Area Director issues a notice of claim disallowance. A then files suit in a United States District Court. A cannot recover reasonable administrative costs because the notice of claim disallowance is not a notice of the decision of the Internal Revenue Service Office of Appeals or a notice of deficiency. Accordingly, the Internal Revenue Service has not taken a position in the administrative proceeding pursuant to section 7430(c)(7)(B).
Taxpayer B receives a notice of proposed deficiency (30-day letter). B disputes the proposed adjustments and requests an Appeals office conference. The Appeals office determines that B has no additional tax liability. B requests administrative costs from the date of the 30-day letter. B is not the prevailing party and may not recover administrative costs because all of the proposed adjustments in the case were resolved as of the date that the Internal Revenue Service took a position in the administrative proceeding.
(d) * * *
(2)
(3)
The Internal Revenue Service, in the conduct of a correspondence examination of taxpayer A's individual income tax return, requests substantiation from A of claimed medical expenses. A does not respond to the request and the Service issues a notice of deficiency. After receiving the notice of deficiency, A presents sufficient information and arguments to convince a revenue agent that the notice of deficiency is incorrect and that A owes no tax. The revenue agent then closes the case showing no deficiency. Although A incurred costs after the issuance of the notice of deficiency, A is unable to recover these costs because, as of the date these costs were incurred, A had not presented relevant information under A's control and relevant legal arguments supporting A's position to the appropriate Internal Revenue Service personnel. Accordingly, the position of the Internal Revenue Service was substantially justified at the time the costs were incurred.
(4)
(A) The date of the receipt by the taxpayer of the notice of decision from Appeals;
(B) The date of the notice of deficiency; or
(C) The date on which the first letter of proposed deficiency that allows the taxpayer an opportunity for administrative review in the Office of Appeals is sent.
(ii) If the Internal Revenue Service takes a position in an administrative proceeding, as defined in paragraph (b) of this section, and the position is not substantially justified, the taxpayer may be permitted to recover costs incurred before the position was taken, but not before the dates set forth in this paragraph (d)(4).
(5)
Pursuant to section 6672, taxpayer D receives from the Area Director Collection Operations (Collection) a proposed assessment of trust fund taxes (Trust Fund Recovery Penalty). D requests and is granted Appeals office consideration. Appeals considers the issues and decides to uphold Collection's recommended assessment. Appeals notifies D of this decision in writing. Collection then assesses the tax and notice and demand is made. D timely pays the minimum amount required to commence a court proceeding, files a claim for refund, and furnishes the required bond. Collection disallows the claim, but Appeals, on reconsideration, reverses its original position, thus upholding D's position. If Appeals concedes its initial determination was not substantially justified, D may recover administrative costs incurred on or after the mailing of the proposed assessment of trust fund taxes, because the proposed assessment is the first determination letter that allows the taxpayer an opportunity for administrative review in the Internal Revenue Service Office of Appeals.
Taxpayer E receives a notice of proposed deficiency (30-day letter). E pays the amount of the proposed deficiency and files a claim for refund. E's claim is considered and a notice of proposed disallowance is issued by the Area Director. E requests and is granted Appeals office consideration. No agreement is reached with Appeals and the Office of Appeals issues a notice of claim disallowance. E does not file suit in a United States District Court but instead contacts the Appeals office to attempt to reverse the decision. E convinces the Appeals officer that the notice of claim disallowance is in error. The Appeals officer then abates the assessment. E may recover reasonable administrative costs if the position taken in the notice of claim disallowance issued by the Office of Appeals was not substantially justified and the other requirements of section 7430 and the regulations thereunder are satisfied. If so, E may recover administrative costs incurred from the mailing date of the 30-day letter because the requirements of paragraph (c)(2) of this section are met. E cannot recover the costs incurred prior to the mailing of the 30-day letter because they were incurred before the administrative proceeding date.
(7)
(f)
(2)
In the purchase of an ongoing business, Taxpayer F obtains from the previous owner of the business a covenant not to compete for a period of five years. On audit of F's individual income tax return for the year in which the business is acquired, the Internal Revenue Service challenges the basis assigned to the covenant not to compete and a deduction taken as a business expense for a seminar attended by F. Both parties agree that the covenant not to compete is amortizable over a period of five years; however, the Internal Revenue Service asserts that the proper basis of the covenant is $2X while F asserts the basis is $4X. The deduction for the seminar attended by F was reported on the return in question in the amount of $7X. The Internal Revenue Service determines that the deduction for the seminar should be disallowed entirely. In the notice of deficiency, the Internal Revenue Service adjusts the amortization deduction to reflect the change to the basis of the covenant not to compete, and disallows the seminar expense. Thus, of the two adjustments determined for the year under audit, the adjustment attributable to the disallowance of the seminar is larger than that attributable to the covenant not to compete. Due to the impact on the next succeeding four years, however, the covenant not to compete adjustment is objectively the most significant issue to both F and the Internal Revenue Service.
(g)
(2)
(3)
(A) The taxpayer's net worth does not exceed seven million dollars.; and
(B) The taxpayer does not have more than 500 employees.
(ii) A taxpayer who is a natural person and owns an unincorporated business is subject to the net worth and size limitations contained in paragraph (g)(3)(i) of this section if the tax at issue (or any interest, additional amount, addition to tax, or penalty, together with any costs in addition to the tax) relates directly to the business activities of the unincorporated business.
(4) * * *
(5)
(A) The partnership's net worth does not exceed seven million dollars; and
(B) The partnership does not have more than 500 employees.
(ii) In addition, each partner requesting fees pursuant to section 7430 must meet the appropriate net worth and size limitations set forth in paragraph (g)(1), (g)(2) or (g)(3) of this section. For example, if a partner is an individual, his or her net worth must not exceed two million dollars as of the administrative proceeding date. If the partner is a corporation, its net worth must not exceed seven million dollars and it must not have more than 500 employees.
* * *Sections 301.7430–2(c)(3)(i)(B), (c)(3)(i)(E), (c)(3)(ii)(C), (c)(3)(iii)(C), (c)(5), (c)(7), (e); 301.7430–3(c)(1), (c)(4), (d); 301.7430–4(b)(3)(i), (b)(3)(iii)(B), (b)(3)(iii)(D), (b)(3)(iii)(E), (c)(4), (d); and 301.7430–5(a), (b), (c), (d)(2), (d)(3), (d)(4), (d)(5), (f)(2), (g)(1), (g)(2) and (g)(5), as proposed, apply to costs incurred and services performed as of the date of publication of a Treasury decision adopting these rules as final regulations in the
(c) * * *
(8)
(e) * * *
National Park Service, Interior.
Advance notice of proposed rulemaking.
We are seeking comments to assist us in developing proposed a proposed rule to revise regulations governing nonfederal oil and gas development within the boundaries of units of the National Park System. The regulations have been in effect for over thirty years and have not been substantively updated during that period. The National Park Service (NPS) is seeking public input on how to bring exempted operations under the scope of the regulations, and on how to improve resource protection aspects of the regulations while accounting for advances in oil and gas technology and industry practices.
Comments must be received by January 25, 2010.
You may submit comments, identified by RIN 1024–AD78, by any of the following methods:
Carol McCoy, Chief, Planning, Evaluation & Permits Branch, Geologic Resources Division, National Park Service, (303) 969–2096; P.O. Box 25287, Denver, Colorado 80225–0287.
The NPS promulgated regulations at 36 CFR part 9, subpart B (“9B regulations”) governing nonfederal oil and gas development in units of the National Park System in December 1978, with a January 1979 effective date. The regulations control all activities associated with nonfederal oil and gas development inside park boundaries where access is on, across, or through federally owned or controlled lands or waters. As of the drafting of this Advance Notice of Proposed Rulemaking (ANPR), there are 693 nonfederal oil and gas operations that exist in a total of 13 units of the National Park System.
The legal authority for the NPS to promulgate the 9B regulations is derived from the Property Clause (art. IV, section 3, cl. 2) and the Commerce Clause (art. I, section 8, cl. 3) of the United States Constitution, and from various statutes enacted by Congress for the administration of the National Park System. Under sections 1 and 3 of the NPS Organic Act, Congress has given the NPS, through the Secretary of the Interior, the authority to promulgate regulations necessary for the administration and management of the National Park System, which includes the authority to regulate nonfederal oil and gas activities within park boundaries for the purpose of protecting park resources and values. In addition, the enabling statutes for several individual parks contain specific provisions authorizing the NPS to regulate such oil-and gas-related activities.
Not all parks with non-federal oil and gas development occurring within their boundaries have such specific direction within their enabling statutes. Whether or not specified in an individual park enabling act, the Organic Act authority alone is legally sufficient to authorize such regulations.
Non-Federal oil and gas rights are the result of a conveyance of an interest in real property from a grantor other than the United States and may be held by individuals, companies, nonprofit organizations, or state and local governments. Such rights are a form of real property and fall under the protection of the 5th Amendment of the U.S. Constitution (“No person shall be * * * deprived of * * * property, without due process of law; nor shall private property be taken for public use, without just compensation.”). The NPS nonetheless may regulate these rights pursuant to the authority stated above.
Under the existing 9B regulations, an entity seeking to undertake nonfederal oil and gas activities in a park generally must submit and obtain NPS approval of a proposed plan of operations before commencing operations inside a park. A plan is essentially a prospective operator's blueprint of all intended activities within the boundary of the park, including exploration, drilling, production, transportation, and reclamation. The regulations require the operator to provide documentation demonstrating that the operator is exercising a bona fide property right to non-federal oil and gas in the park unit. In a proposed plan, an operator must also identify those specific measures that will be undertaken to protect park resources and values. Finally, an operator must submit a performance bond for the principal purpose of ensuring that funds will be available to reclaim a site should an operator default on its obligations under a plan.
The plan of operations requirement is the primary tool for protecting park resources and values from potential adverse impacts associated with the exercise of nonfederal oil and gas rights inside park boundaries. In reviewing a proposed plan to determine whether the NPS can approve an operation, the NPS undertakes a variety of analyses required by federal statutes, such as the National Environmental Policy Act, the Endangered Species Act, and the National Historic Preservation Act, as well as the standards specified in the 9B regulations. In analyzing proposed plans, the NPS coordinates and consults with a variety of other regulatory agencies at the federal and state level. The NPS also works closely with the operator in order to have park protection concerns addressed through the incorporation of appropriate mitigation measures into plans.
Once the NPS has completed its review and environmental compliance responsibilities and determined that a given proposal meets applicable requirements and approval standards, the NPS will approve an operator's plan of operations. The approved plan authorizes the operator to conduct its operation in a unit of the National Park System.
During the life of an oil and gas operation in a park, park resource managers monitor activities at the operator's site to ensure compliance with the plan. The existing regulations also authorize the NPS to enforce the terms of the plan as may be necessary via such means as suspension of operations or revocation of the plan approval.
It is important to note that while nonfederal oil and gas operations in parks must also comply with state requirements, the 9B regulations differ from most state oil and gas regulations by focusing on the protection of the park's natural and cultural resources and visitors. State regulations may contain some surface use provisions but
The NPS is interested in ideas from the public on ways the NPS could improve the existing regulations. The NPS intends to use the input from the public to aid in developing a proposed rulemaking, which will then also be published in the
Please indicate which of the topics your comments address and which question you are responding to. If your comments cover issues outside of these topics, please identify them as “other.”
The existing regulations, as provided at § 9.30(a), apply where an operator's access is “on across, or through federally owned or controlled lands or waters.” As a result, 109 operations (17%) are currently exempt from the regulatory requirements even though the operations occur inside park boundaries. For example, oil and gas rights under privately owned lands just inside the boundary of a park unit, and for which access to those lands is solely maintained without crossing park owned or administered lands, are not subject to these regulations.
In addition, under § 9.33, operations covered by a valid state permit in existence at the time the regulations became effective are also exempt (i.e., 255 operations or 37%). Ultimately, as these operations change hands or state permits expire, the exemption no longer applies and operators must comply with the regulations. However, the rate of turnover and permit expiration has been much slower than anticipated by the original drafters of the 9B regulations, leaving a large number of this class of operations outside the scope of the Service's regulations.
Because of these two exemptions, 53% (364 wells) of the wells in parks today are not subject to the requirements of the regulations to protect park resources and values. These exemptions are not specified in any statute, but were an exercise of the NPS's discretion at the time the regulations were promulgated.
The NPS has identified the following factors to be considered in evaluating options for possibly revising the current approach to existing operations:
A. Existing exempt operations already have established site locations and associated access routes.
B. The operations may or may not have equipment on site that reflects current-day industry standards.
C. Most of the currently exempt operations exist in 3 out of the 13 parks with nonfederal oil and gas operations within their boundaries.
D. Limited park staff and fiscal resources exist in parks for carrying out a multitude of responsibilities, including the administration of the 9B regulatory program.
The NPS is considering requiring all previously exempt operations to comply with the 9B regulations. The following ideas for how such operations could be brought under the regulations have been discussed:
Option #1—Require presently exempt operators to submit plans of operations, comply with operating standards, and provide financial assurance by a set date.
Option #2—Same as Option #1, however, the submittal of a plan of operations, compliance with operating standards, and financial assurance would be under a phased timeframe.
Option #3—Instead of requiring the submittal of a plan of operations for approval, require operators with exempt operations to verify that their operations are being conducted in a manner that fulfills a defined set of operating standards which would be enforceable by park staff. Under this option, operators will also be required to provide documentation of the legal basis for their respective oil and gas activities within the park unit, and submit financial assurance.
1. Taking into account the factors identified above, do any of the option(s) above have greater merit for bringing previously exempt operations under the 9B regulations, and if so, why?
2. Do you have another option that you would like to suggest?
Under the existing regulations at § 9.32(e), if an operator locates surface facilities outside the park and proposes to directionally drill from those surface facilities to reach its non-Federal oil and gas rights inside the park, the operator can apply for an exemption to the 9B regulatory requirements. This provision provides an incentive to operators to locate their surface facilities outside the park and thereby greatly reduce impacts to park resources and values.
The scope of § 9.32(e) addresses only those activities that are occurring within the external boundaries of a park; that is, the downhole operations that pass through Federal subsurface estate within the boundary of a park. Surface activities associated with directional drilling operations outside the park are not within the scope of the jurisdiction provided to the NPS under § 9.32(e), or under the 9B regulations in general. If granted an exemption, operators do not need to submit a proposed plan of operation or a bond covering the activities occurring in the park (i.e., the downhole activities) to the NPS for approval. Essentially, under this provision of the regulations if an operator meets the requirements, the NPS must determine that the 9B regulations do not apply to the operator's activities.
The Service's goal relative to non-Federal oil and gas operations is to protect parks by eliminating direct impacts to park resources and values. When an operator takes advantage of the directional drilling provision of the regulations and locates its surface facilities outside park boundaries, the operator has significantly reduced direct impacts to park resources and values. By so doing, the operator has deployed a major park protection mitigation measure. While potential indirect impacts of sight, sound, artificial light, odor, and spills may exist from drilling operations outside a park, they are usually much reduced relative to surface operations in a park. Such impacts are diminished even further once the operation progresses from the drilling to production phase.
In evaluating options for revising this section of the existing regulation, the NPS has identified the following factors:
A. The NPS wants to ensure that it retain incentives for operators to locate their surface facilities outside park boundaries, and, if possible, even enhance those incentives. The NPS realizes that the primary incentive for operators to locate facilities outside park boundaries is the ability to save time and money.
B. The NPS wants to ensure the protection of park resources and values from indirect effects potentially resulting from operations that are located outside park boundaries.
The NPS is evaluating how to address directional drilling operations for the proposed rulemaking. The following ideas have been discussed:
Option #1: Retain the scope of the existing regulatory provision governing directional drilling operations.
Option #2: Expand the regulation to cover all activities associated with directional drilling operations which may affect park resources and values, both the downhole operations in the
Option #3: Exempt directional drilling operations entirely from the scope of the 9B regulations.
3. Taking into account the factors identified above, what option(s) do you recommend for addressing directional drilling operations under the 9B regulations?
4. Are there other options for addressing the potential indirect impacts from directional drilling operations that retain the incentive for operators to locate their well pad and surface access routes outside the boundary of a park?
The existing regulations contain requirements that operators must meet in conducting their operations, such as using technologically feasible least damaging methods in their operations; locating facilities away from water courses, structures, and visitor and administrative developed areas; and maintaining sites in a safe and workmanlike manner. These operating standards are found throughout various sections of the existing regulations.
The NPS realizes that the formulation of the existing standards is 30 years old. The NPS is aware that in the intervening years other agencies and industry groups have developed effective standards (e.g., API and AGA Standards and Practices, BLM Gold Book, State operating standards) that the NPS could incorporate into its regulations.
5. Do you know of examples of effective, enforceable operating standards that the NPS should consider when it develops its own comprehensive list?
The existing 9B regulations require that an operator file a performance bond, or other acceptable method of financial assurance, for all types of nonfederal oil and gas operations and all phases of the operation(s). The objective of requiring a bond is to ensure that in the event an operator becomes insolvent or defaults on his/her obligations under an approved plan of operations, adequate funds will be available for the NPS to have a third party carry out the plugging and reclamation requirements. The existing regulations place a bonding cap of up to $200,000 per operator, per NPS unit. Therefore, if one operator has multiple wells in a park unit, the NPS can only require up to $200,000 financial assurance from that one operator.
The NPS is considering eliminating the bonding cap, which was established in 1978, and replacing it with a variable amount of financial assurance equal to the reasonable estimated cost of reclamation and liability today.
6. Are there alternatives to the existing acceptable financial assurance instruments (e.g., performance bonds, irrevocable letters of credit, and cash) that will protect the taxpayer in the event an operator defaults on its responsibilities under its approved plan of operations?
7. If so, please describe the advantages or disadvantages of one type of instrument over another.
The current 9B regulations at § 9.50(a)(1) authorize the park to impose a registration fee for vehicles used in connection with oil and gas operations that are using existing roads administered by the NPS. While this fee provision applies to the use of existing roads administered by the NPS, it does not apply to an operator's construction of new roads across federally owned lands to reach their non-Federal oil and gas rights.
As a result, the NPS is considering eliminating the current registration fee and replacing it with an access fee. This fee would compensate the United States for an operator's access across federally owned surface estate in order to reach the operator's non-Federal oil and gas rights, be it on an existing road administered by the NPS, or across undisturbed federally owned lands. Because the operator generally has only a right to reasonably use the federally owned surface estate immediately above the non-federal oil and gas right, this fee would not apply to access within this area. It would also bring NPS practice with respect to access fees in line with what other agencies and private land owners are doing.
Both the BLM and USFS charge fees for access where the operator has no pre-existing right to cross Federal lands. Similarly, adjacent private land owners also require operators to pay a fee to cross their land to reach the operator's oil and gas rights. Such fees are generally recognized today by the oil and gas industry as a cost of doing business.
8. Should the NPS calculate fees for the privilege of access across federally owned lands, and how?
9. Should the NPS use an appraisal, available data from other Federal agencies that calculate and compile fair market land values (such as the National Agricultural Statistics Service), or other means to determine fair compensation for such use?
The Superintendent's current enforcement mechanisms for operations under an approved plan are limited to suspension or revocation of the plan. If an operator fails to comply with a suspension or revocation order, the NPS must request that the Department of Justice file a civil action in Federal court seeking an injunction or restraining order to halt operations. The Superintendent has no practical method for dealing with minor regulatory infractions that do not rise to the level of suspension, revocation, or judicial intervention. Examples of minor infractions include accumulation of oilfield debris onsite, slow response to small contained spills, and lack of maintenance on access roads.
The NPS is considering revising the regulations to allow the use of administrative assessments to address minor violations of the regulations or a term or condition of an approved permit. Whenever the NPS learns of a compliance issue associated with an operation in a park, the Service's first approach is always to work with operators to have them rectify the situation. If this approach is not successful, then the NPS issues a formal notice of non-compliance to the operator. The NPS is now considering authorizing park staff to issue administrative assessments upon the failure of an operator to comply with a notice of non-compliance. The assessment would be a monetary amount that an operator must pay to the park, based on an estimation of the cost of damages to park resources due to the operator's violation of a term or condition of an approved permit. An example of such an approach is found under BLM regulations at 43 CFR 3163.1, which gives BLM authority to assess a penalty of $500 per day for major violations, and $250 for minor violations.
10. Are there other more effective means beyond the imposition of an administrative assessment that the NPS can use to address minor infractions and to provide operators an incentive to comply with the regulations?
NPS seeks responses to the above noted questions from the public. Additionally, the NPS seeks any relevant comments to other issues regarding these regulations. Where options are presented, the NPS especially seeks comments as to which ones may be considered the most
Additional information about the NPS Non-Federal Oil and Gas Program is available at
All submissions received must include the agency name and RIN 1024–AD78 for this notice. Before including your address, phone number, e-mail address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
At this time, the NPS is not soliciting comments on environmental impacts. The NPS will do so as part of its environmental compliance under the National Environmental Policy Act.
Environmental Protection Agency (EPA).
Proposed rule.
EPA is proposing to amend and correct portions of its existing fuel economy regulations. There are three reasons for this action. First, some minor corrections and amendments are needed to EPA's December 27, 2006 final rule for fuel economy labeling requirements for cars and light trucks. Second, the Department of Transportation finalized new average fuel economy standards for 2008–2011 light trucks on April 6, 2006. Third, on March 30, 2009, NHTSA revised CAFE requirements for 2011 trucks and finalized new average fuel economy (CAFE) standards for 2011 passenger automobiles. In order for DOT to administer these new standards, EPA must make some conforming changes to its regulations. In addition, some minor conforming changes to EPA's regulations are needed for two other separate statutory and regulatory actions. None of the above amendments and corrections would have any direct impact on human health and the environment, but they would allow for the more effective administration of existing regulations. In the “Rules and Regulations” section of this
Written comments must be received by December 28, 2009.
Submit your comments, identified by Docket ID No. EPA–HQ–OAR–2005–0169, by one of the following methods:
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Christine Mikolajczyk, Office of Transportation and Air Quality, Compliance and Innovative Strategies Division, Environmental Protection Agency, 2000 Traverwood Drive, Ann Arbor, MI 48105;
This document proposes to take action on minor amendments and corrections to EPA's existing emission and fuel economy regulations, located at 40 CFR Part 86 and Part 600. This proposal clarifies that special test procedures, calculation methods and label formats may be used for fuel economy labels and CAFE calculations of advanced technology vehicles. Advanced technology vehicles include, but are not limited to electric vehicles, fuel cell vehicles, plug-in hybrid vehicles and vehicles equipped with hydrogen-fueled internal combustion engines. This proposal also includes technical amendments to the fuel economy label regulations, including changes to the minivan definition, van definition, interior volume measurements of passenger vehicles, and special purpose class of vehicles. Today's action also proposes to correct some typographical errors and make other minor modifications to ensure accurate interpretation of the regulations. The changes to the EPA CAFE regulations are being proposed to conform to the NHTSA regulations, and include adding new reporting provisions that would enable EPA to provide NHTSA with the data it needs to determine compliance with the 2008–2011 CAFE standards for passenger automobiles and trucks.
In addition, two conforming changes are being proposed to align the EPA CAFE regulations with a 2007 Energy Independence and Security Act (EISA) amendment extending the alternative fuel vehicle CAFE credits to 2019, and to align the EPA CAFE regulations with a previous NHTSA rulemaking which eliminated the requirement to report separate CAFE values for domestic and imported trucks.
We have published a direct final rule which amends the Fuel Economy and Emission Regulation requirements in the “Rules and Regulations” section of this
If we receive no adverse comment, we will not take further action on this proposed rule. If we receive adverse comment, we will withdraw the direct final rule and it will not take effect. We would address all public comments in any subsequent final rule based on this proposed rule. If we receive adverse comment on a distinct provision of this rulemaking, we will publish a withdrawal in the
We do not intend to institute a second comment period on this action. Any parties interested in commenting must do so at this time. For further information, please see the information provided in the
This action applies to manufacturers of new passenger cars and light trucks, including medium-duty passenger vehicles.
Do not submit this information to EPA through
When submitting comments, remember to:
• Identify the rulemaking by docket number and other identifying information (subject heading,
• Follow directions—The agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
• Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
• Describe any assumptions and provide any technical information and/or data that you used.
• If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
• Provide specific examples to illustrate your concerns, and suggest alternatives.
• Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
• Make sure to submit your comments by the comment period deadline identified.
You may be charged a reasonable fee for photocopying docket materials, as provided in 40 CFR Part 2.
Under Executive Order (EO) 12866 (58 FR 51735, October 4, 1993), this action is a “significant regulatory action” because it has the potential to raise novel legal or policy issues. Accordingly, EPA submitted this action to the Office of Management and Budget (OMB) for review under EO 12866 and any changes made in response to OMB recommendations have been documented in the docket for this action.
This action does not impose any substantive new information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501
The revision to the minivan definition in today's action has a de minimis impact; however, if anything, the revision is expected to reduce manufacturers' information collection burden. For example, manufacturers were previously required to calculate and report to EPA the total interior volume of each style of minivan and full-sized van to determine whether the van was at or below 180 cubic feet in interior volume. Today's action eliminates the 180 cubic feet interior volume specification from the minivan definition, thus slightly reducing manufacturers' reporting and recordkeeping burden.
Regarding the MDPV requirements for 2011 and later CAFE, the following statement was made in EPA's Information Collection Request (ICR) for the 2008 Fuel Economy Labeling rule (71 FR 77872, December 27, 2006):
Also beginning with model year 2011, medium-duty passenger vehicles (MDPVs) will be included in the labeling program. MDPVs essentially include SUVs and passenger vans that are between 8,500 and 10,000 lbs. “GVWR” (gross vehicle weight ratings). This change is congruent with the National Highway Traffic Safety Administration's (NHTSA's) expansion of the Corporate Average Fuel Economy (CAFE) program to include MDPVs beginning the same model year (71 FR 17565; April 6, 2006). Because more vehicle testing is required under CAFE than under labeling, the impacts of increased testing for MDPVs will be in the ICR for the rule to implement EPA's role in the CAFE program, which will be finalized in a separate action, in time for model year 2011,
Thus, in the 2008 FE Label rulemaking EPA indicated we would either include the MDPV information collection requirements in an ICR for today's rulemaking or include it in the EPA's emission and fuel economy ICR renewal request to OMB (which occurs every three years). EPA elected the latter approach, and has included the additional MDPV testing, reporting and recordkeeping burden for fuel economy labeling and CAFE purposes in ICR 0783.54 (OMB 2060–0320), the renewal of the Motor Vehicle Emissions and Fuel Economy Compliance ICR which was submitted to OMB for review on October 23, 2008. Since EPA MDPV ICR requirements have been previously submitted to OMB and because they were also included in NHTSA's ICR (OMB 2127–00019), they are not included in today's action.
Regarding footprint information, the reporting requirements for footprint information and related data were not specifically addressed in the ICR for EPA's Fuel Economy Labeling Rule (ICR 0783.51, OMB 2060–0104) because any change in burden was considered to be negligible and within the margin of error for the information technology estimate in that ICR; and because the information collection burden was partially included in the NHTSA ICR (OMB 2127–00019). The information collection burden for footprint information is currently included in EPA's ICR 0783.54 (OMB 2060–0320), the renewal of the Motor Vehicle Emissions and Fuel Economy Compliance ICR, which was submitted to OMB for review on October 23, 2008.
Additionally, the footprint information reported to EPA for final CAFE reports (wheelbase, track width and sales information) is essentially the same information which will have been previously reported to NHTSA when manufacturers submitted their preliminary CAFE (PCAFE) and mid-model year CAFE reports to NHTSA. [Note that manufacturers are not required to submit PCAFE or mid-model year reports to EPA.] Reporting footprint information to EPA with final sales data is expected to be a minimal burden because manufacturers will have already established company business practices to track footprint and sales information for NHTSA and because manufacturers have been reporting CAFE final sales information to EPA since 1978.
The Regulatory Flexibility Act (RFA) generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions.
For purposes of assessing the impacts of this proposed rule on small entities, a small entity is defined as: (1) A small business as defined by the Small Business Administration (SBA) regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.
After considering the economic impacts of this action on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. Based on Small Business Administration size standards, small businesses in the automobile manufacturing industry are defined as those having less than 1000 employees per firm. Additionally, they are identified using the North America Industrial Classification System (NAICS) by NAICS code 336111. Out of a total of approximately 80 automotive manufacturers subject to this action,
This rule does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or the private sector in any one year. This action simply makes minor amendments, clarifications, and corrections that will allow for the more effective administration of existing regulations. Thus, this rule is not subject to the requirements of sections 202 or 205 of the Unfunded Mandates Reform Act. This rule is also not subject to the requirements of section 203 of the Unfunded Mandates Reform Act because it contains no regulatory requirements that might significantly or uniquely affect small governments. This action imposes no enforceable duty on any State, local or tribal governments.
Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects 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.”
This proposed rule does not have federalism implications. It will not have substantial direct effects 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, as specified in Executive Order 13132. Thus, Executive Order 13132 does not apply to this rule.
This action does not have tribal implications, as specified in Executive Order 13175 (65 FR 67249, November 9, 2000). The impacts of this proposed rule are limited to the regulated entities: the automotive manufacturing industry. Thus, Executive Order 13175 does not apply to this action. EPA specifically solicits additional comment on this proposed action from tribal officials.
EPA interprets EO 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under section 5–501 of the EO has the potential to influence the regulation. This action is not subject to EO 13045 because it does not establish an environmental standard intended to mitigate health or safety risks.
This rule is not a “significant energy action” as defined in Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Further, we have concluded that this rule is not likely to have any adverse energy effects.
Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA”), Public Law 104–113, 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.
This action does not involve technical standards. Therefore, EPA did not consider the use of any voluntary consensus standards.
Executive Order (EO) 12898 (59 FR 7629, Feb. 16, 1994) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States.
EPA has determined that this proposed rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not affect the level of protection provided to human health or the environment. This action simply makes minor amendments, clarifications, and corrections that will allow for the more effective administration of existing regulations without impacting the current fuel economy and emission control measures.
Statutory authority for the fuel economy labeling program and for corporate average fuel economy can be found in the Clean Air Act, 42 U.S.C. 7401–7671q, 49 U.S.C. 32901–32919, and Public Law 109–58. Statutory authority for vehicle emission control program is found in the Clean Air Act, as amended 42 U.S.C. 7401
Administrative practice and procedure, Confidential business
Administrative practice and procedure, Electric power, Fuel economy, Incorporation by reference, Labeling, Reporting and recordkeeping.
Federal Emergency Management Agency, DHS.
Proposed rule.
Comments are requested on the proposed Base (1% annual-chance) Flood Elevations (BFEs) and proposed BFE modifications for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the proposed regulatory flood elevations for the reach described by the downstream and upstream locations in the table below. The BFEs and modified BFEs are a part of the floodplain management measures that the community is required either to adopt or show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, these elevations, once finalized, will be used by insurance agents, and others to calculate appropriate flood insurance premium rates for new buildings and the contents in those buildings.
Comments are to be submitted on or before February 23, 2010.
The corresponding preliminary Flood Insurance Rate Map (FIRM) for the proposed BFEs for each community is available for inspection at the community's map repository. The respective addresses are listed in the table below.
You may submit comments, identified by Docket No. FEMA–B–1080, to Kevin C. Long, Acting Chief, Engineering Management Branch, Mitigation Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646–2820, or (e-mail)
Kevin C. Long, Acting Chief, Engineering Management Branch, Mitigation Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646–2820, or (e-mail)
The Federal Emergency Management Agency (FEMA) proposes to make determinations of BFEs and modified BFEs for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
These proposed BFEs and modified BFEs, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own, or pursuant to policies established by other Federal, State, or regional entities. These proposed elevations are used to meet the floodplain management requirements of the NFIP and are also used to calculate the appropriate flood insurance premium rates for new buildings built after these elevations are made final, and for the contents in these buildings.
Comments on any aspect of the Flood Insurance Study and FIRM, other than the proposed BFEs, will be considered. A letter acknowledging receipt of any comments will not be sent.
Administrative practice and procedure, Flood insurance, Reporting and recordkeeping requirements.
Accordingly, 44 CFR part 67 is proposed to be amended as follows:
1. The authority citation for part 67 continues to read as follows:
42 U.S.C. 4001
2. The tables published under the authority of § 67.4 are proposed to be amended as follows:
Federal Emergency Management Agency, DHS.
Proposed rule.
Comments are requested on the proposed Base (1% annual-chance) Flood Elevations (BFEs) and proposed BFE modifications for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the proposed regulatory flood elevations for the reach described by the downstream and upstream locations in the table below. The BFEs and modified BFEs are a part of the floodplain management measures that the community is required either to adopt or show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, these elevations, once finalized, will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents in those buildings.
Comments are to be submitted on or before February 23, 2010.
The corresponding preliminary Flood Insurance Rate Map (FIRM) for the proposed BFEs for each community is available for inspection at the community's map repository. The respective addresses are listed in the table below.
You may submit comments, identified by Docket No. FEMA–B–1076, to Kevin C. Long, Acting Chief, Engineering Management Branch, Mitigation Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646–2820, or (e-mail)
Kevin C. Long, Acting Chief, Engineering Management Branch, Mitigation Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646–2820, or (e-mail)
The Federal Emergency Management Agency (FEMA) proposes to make determinations of BFEs and modified BFEs for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
These proposed BFEs and modified BFEs, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own, or pursuant to policies established by other Federal, State, or regional entities. These proposed elevations are used to meet the floodplain management requirements of the NFIP and are also used to calculate the appropriate flood insurance premium rates for new buildings built after these elevations are made final, and for the contents in these buildings.
Comments on any aspect of the Flood Insurance Study and FIRM, other than the proposed BFEs, will be considered. A letter acknowledging receipt of any comments will not be sent.
Administrative practice and procedure, Flood insurance, Reporting and recordkeeping requirements.
Accordingly, 44 CFR part 67 is proposed to be amended as follows:
1. The authority citation for part 67 continues to read as follows:
42 U.S.C. 4001
2. The tables published under the authority of § 67.4 are proposed to be amended as follows:
Federal Emergency Management Agency, DHS.
Proposed rule.
Comments are requested on the proposed Base (1% annual-chance) Flood Elevations (BFEs) and proposed BFE modifications for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the proposed regulatory flood elevations for the reach described by the downstream and upstream locations in the table below. The BFEs and modified BFEs are a part of the floodplain management measures that the community is required either to adopt or show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, these elevations, once finalized, will be used by insurance agents, and others to calculate appropriate flood insurance premium rates for new buildings and the contents in those buildings.
Comments are to be submitted on or before February 23, 2010.
The corresponding preliminary Flood Insurance Rate Map (FIRM) for the proposed BFEs for each community is available for inspection at the community's map repository. The respective addresses are listed in the table below.
You may submit comments, identified by Docket No. FEMA–B–1078, to Kevin C. Long, Acting Chief, Engineering Management Branch, Mitigation Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646–2820, or (e-mail)
Kevin C. Long, Acting Chief, Engineering Management Branch, Mitigation Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646–2820, or (e-mail)
The Federal Emergency Management Agency (FEMA) proposes to make determinations of BFEs and modified BFEs for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
These proposed BFEs and modified BFEs, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own, or pursuant to policies established by other Federal, State, or regional entities. These proposed elevations are used to meet the floodplain management requirements of the NFIP and are also used to calculate the appropriate flood insurance premium rates for new buildings built after these elevations are made final, and for the contents in these buildings.
Comments on any aspect of the Flood Insurance Study and FIRM, other than the proposed BFEs, will be considered. A letter acknowledging receipt of any comments will not be sent.
Administrative practice and procedure, Flood insurance, Reporting and recordkeeping requirements.
Accordingly, 44 CFR part 67 is proposed to be amended as follows:
1. The authority citation for part 67 continues to read as follows:
42 U.S.C. 4001
2. The tables published under the authority of § 67.4 are proposed to be amended as follows:
Federal Railroad Administration (FRA), Department of Transportation (DOT).
Notice of proposed rulemaking (NPRM).
FRA proposes to amend its regulations on railroad workplace safety to reduce further the risk of serious injury or death to roadway workers. In particular, FRA proposes to require that railroads adopt specified on-track safety procedures to protect certain roadway work groups from the movement of trains or other on-track equipment on “adjacent controlled track.” FRA proposes to define “adjacent controlled track” to mean “a controlled track whose track center is spaced 19 feet or less from the track center of the occupied track.” These on-track safety procedures would be required for each adjacent controlled track when a roadway work group with at least one of the roadway workers on the ground is engaged in a common task with an on-track roadway maintenance machine or coupled equipment on an occupied track. FRA also proposes to require that railroads, contractors to railroads, and roadway workers comply with these procedures. The NPRM issued as “Notice No. 1” under this same docket number and published July 17, 2008 (73 FR 41214), was withdrawn by “Notice No. 2” published August 13, 2008 (73 FR 47124).
(1) Written comments must be received no later than January 25, 2010. Comments received after that date will be considered to the extent possible without incurring additional expense or delay.
(2) FRA anticipates being able to resolve this rulemaking without a public, oral hearing. However, if FRA receives a specific request for a public, oral hearing prior to December 28, 2009, one will be scheduled and FRA will publish a supplemental notice in the
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Kenneth Rusk, Staff Director, Track Division, Office of Safety Assurance and Compliance, FRA, 1200 New Jersey Avenue, SE., RRS–15, Mail Stop 25, Washington, DC 20590 (telephone 202–493–6236); or Anna Winkle, Trial Attorney, Office of Chief Counsel, FRA, 1200 New Jersey Avenue, SE., RCC–12, Mail Stop 10, Washington, DC 20590 (telephone 202–493–6166 or 202–493–6052).
As will be detailed in this NPRM, the recent increase in roadway worker fatalities that have occurred on an adjacent track (
The RWP Rule requires each railroad that operates rolling equipment on track that is part of the general railroad system of transportation to “adopt and implement a program that will afford on-track safety to all roadway workers whose duties are performed on that railroad.”
Several methods are authorized to be used to provide on-track safety for roadway workers, and many of those methods involve establishing “working limits,” which is defined in part as “a segment of track with definite boundaries established in accordance with [part 214] upon which trains and engines may move only as authorized by the roadway worker having control over that defined segment of track.”
Train approach warning is another common method of establishing on-
Section 214.335(c) of the RWP Rule currently requires that roadway work groups engaged in “large-scale maintenance or construction” be provided with on-track safety in the form of “train approach warning” for train or equipment movements on adjacent tracks if the adjacent tracks are not already included within the working limits. Under the current definition of “adjacent tracks,” on-track safety as discussed above is required for any tracks with track centers spaced less than 25 feet apart from the track center of the track to which a roadway work group is assigned to perform large-scale maintenance or construction.
Although the term “large-scale maintenance or construction” is not specifically defined in the regulation, FRA noted in the preamble to the 1996 final rule establishing the RWP Rule that the principle behind the reference to large-scale maintenance or construction “is the potential for distraction, or the possibility that a roadway worker or roadway maintenance machine might foul the adjacent track and be struck by an approaching or passing train,” and further stated that “conditions in which the risk of distraction is significant” require measures to provide on-track safety on adjacent tracks.”
After the occurrence of five roadway worker fatalities in one calendar year (2003), including one on an adjacent track, FRA responded on April 27, 2004, by issuing Notice of Safety Advisory 2004–01, which was later published in the
The safety advisory explained that the requirements of the RWP Rule, including the requirement to provide adjacent track on-track safety for large-scale maintenance or construction in § 214.335(c), are only minimum standards. The advisory emphasized that railroads and railroad contractors are free to prescribe additional or more-stringent standards consistent with the rule.
FRA recommended that railroads and contractors to railroads develop and implement basic risk assessment procedures for use by roadway workers to determine the likelihood that a roadway worker or equipment would foul an adjacent track prior to initiating work activities, regardless of whether those activities were “large-scale” or “small-scale.” The advisory provided examples of relevant factors to consider in making such an assessment. These factors included whether the work could be conducted by individuals positioned between the rails of a track on which on-track safety has been established, as opposed to being on the field side of such a track toward an adjacent track; whether there was a structure between the tracks to prevent intrusion (such as a fence between the tracks at a passenger train station and the tall beam of a through-plate girder bridge); the track-center distance, to ensure that the adjacent track would not be fouled if a worker were to inadvertently trip and fall; the nature of the work (inspection or repair); the sight distances; and the speed of trains on the adjacent track.
In addition to the above recommendation concerning basic risk assessment, FRA recommended that railroads and contractors to railroads consider taking the following actions:
• Use of working limits for activities where equipment could foul adjacent track (whether large-scale or small-scale activities);
• Use rotation stops to mitigate the dangers associated with on-track
• Review procedures for directing trains through adjacent track working limits, and enhance such procedures when necessary;
• Install adjacent track warning signs/devices in the operating cab of on-track machines to remind roadway maintenance machine operators to not inadvertently depart the equipment onto a track where there may be trains and other on-track equipment passing;
• Provide additional training and monitoring to employees, emphasizing the need to cross tracks in a safe manner (i.e., single file and after looking in both directions);
• Reinforce to individual roadway workers that it is critical not to foul a track except in the performance of duty and only when on-track safety has been established. This training could be accomplished through training sessions, as well as daily job briefings; and
• Institute peer-intervention measures by which workers are encouraged to intervene when observing another roadway worker engaging in potentially non-compliant and unsafe activity.
In the twelve years since the RWP Rule went into effect on January 15, 1997, there have been nine roadway worker fatalities on an adjacent track. Seven of those fatalities have occurred on a controlled track that was adjacent to the track on which a roadway work group, with at least one of the roadway workers on the ground, was engaged in a common task with an on-track roadway maintenance machine or coupled equipment. FRA notes that there has been only one adjacent-track fatality where a roadway work group had been engaged in a common task with a lone hi-rail vehicle, defined in § 214.7 as “a roadway maintenance machine that is manufactured to meet Federal Motor Vehicle Safety Standards and is equipped with retractable flanged wheels so that the vehicle may travel over the highway or on railroad tracks.”
Of the seven fatalities that occurred under the circumstances described above and which this rule proposes to address, three occurred during the period after the effective date of the rule and before the publication of the safety advisory on May 3, 2004, and four have occurred since that period. In the four-year period prior to May of 2004 (May 1, 2000—April 30, 2004), there has been one adjacent-track fatality known to have occurred under such circumstances, for a rate of .25 per year. In the four-year period since (May 1, 2004—April 30, 2008), there have been four adjacent-track fatalities, for a rate of one per year, which is four times the rate of the previous four-year period. While FRA recognizes that even one death can make rates change dramatically when the total number of deaths is small, the increase in the rate of these deaths despite the safety advisory leads FRA to conclude that regulatory action is needed to avert an escalating number of deaths. Moreover, given the extensive participation in developing these consensus regulatory provisions by representatives of all of the key interests involved in this issue, it is contrary to the public interest to wait for all of the other issues in the larger RWP rulemaking to be resolved or to engage in lengthy periods for notice and public comment before acting to prevent more deaths.
The following is a brief summary of the results of FRA's investigations of the four most recent incidents that resulted in these unfortunate fatalities:
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While the above discussion focuses on those fatalities that have occurred on an adjacent track where a roadway work group, with at least one of the roadway workers on the ground, was engaged in a common task with an on-track roadway maintenance machine or coupled equipment on an occupied track, it is important to discuss some of the common circumstances in all nine of the fatalities that have occurred on an
Second, all nine of the fatalities occurred on an adjacent track that was quite closely-spaced to the track that the roadway work group was occupying. Six of the adjacent tracks had track centers that were spaced approximately 14 feet or less from the respective track centers of the tracks that the roadway work groups were occupying, and all nine of the adjacent tracks were spaced 15 feet or less from the track centers of the respective occupied tracks. This common circumstance was also taken into consideration in FRA's proposed definition of “adjacent controlled track,” which would have a narrower applicability for purposes of proposed § 214.336 than the term “adjacent tracks,” because it would not include tracks with track centers that were spaced more than 19 feet (but less than 25 feet) away from the track center of the occupied track.
The third common circumstance of the nine fatalities on adjacent track is the time of year. Four of the fatalities occurred during the first quarter (January–March), none of the fatalities occurred in the second and third quarters of the year (April–June and July–September, respectively), and the other five fatalities occurred during the fourth quarter (October–December). As noted earlier in Section I., above, because incidents involving adjacent controlled tracks appear to present clear evidence of significant risk that is not effectively addressed by the current regulation, FRA has concluded that moving forward with this proposal in advance of the other proposals contained in the RSAC consensus is necessary and appropriate in order to reduce the risk of additional fatalities on adjacent track that are likely to occur late this year or early next year in the absence of further regulatory action.
On April 11, 2008, the Brotherhood of Maintenance of Way Employes Division (BMWED) and the Brotherhood of Railroad Signalmen (BRS) filed a joint petition requesting that FRA issue an emergency order under 49 U.S.C. 20104(a) requiring adjacent-track protection for roadway work groups. The petition noted that similar requests, which were filed on October 7, 2005, November 7, 2003, and December 21, 1999, were denied by FRA. The petitioners expressed their belief that, under the existing provisions of the rule, roadway workers will continue to suffer preventable serious injuries and death. The petitioners asserted that FRA should require railroads and their contractors to establish on-track safety on adjacent tracks (“adjacent-track on-track safety”) for a wider range of work activities. In FRA's January 5, 2006 denial of the October 2005 petition, FRA noted that the RSAC working group tasked to review and revise the RWP Rule (“RWP Working Group”) was “committed to presenting comprehensive draft language * * * that would more closely tailor the solution to the problem.” And while the RWP Working Group did in fact draft this language, and both the Working Group and the full RSAC were able to reach consensus on such language, BMWED and BRS were concerned that the language, which has not been published as an NPRM, would not become a final rule for a considerable period of time, leaving the possibility for further preventable fatalities. BMWED and BRS urged FRA to issue an emergency order that would adopt the adjacent-track consensus language of the RWP RSAC.
On April 18, 2008, the American Train Dispatchers Association (ATDA) filed a letter in support of the BMWED and BRS joint petition. In the letter, ATDA agreed that preventable injuries and deaths continue to occur because of a lack of positive regulation mandating adjacent-track on-track safety and urged FRA to issue an emergency order based upon the RSAC-approved and consensus-based replacement language for § 214.235(c), as indicated in the joint petition.
As an emergency order does not require prior notice to the affected party or an opportunity to be heard prior to issuance of the order, Congress declared that such an order may be invoked only where an unsafe condition or practice “causes an emergency situation involving a hazard of death or personal injury.” 49 U.S.C. 20104. By letter dated June 4, 2008, FRA denied the joint petition for emergency order, noting that the increased rate of adjacent-track-related fatalities cited in the joint petition makes a strong case for regulatory action, but does not constitute an emergency situation “that has developed suddenly and unexpectedly in which the danger is immediate.” To address this serious safety concern, FRA decided to issue a separate NPRM with an abbreviated comment period, as further discussed in Section VI.C., below.
In March 1996, FRA established RSAC, which provides a forum for developing consensus recommendations to FRA's Administrator on rulemakings and other safety program issues. The Committee includes representation from all of the agency's major stakeholder groups, including railroads, labor organizations, suppliers and manufacturers, and other interested parties. A list of member groups follows:
When appropriate, FRA assigns a task to RSAC, and after consideration and debate, RSAC may accept or reject the task. If the task is accepted, RSAC establishes a working group that possesses the appropriate expertise and representation of interests to develop recommendations to FRA for action on the task. These recommendations are developed by consensus. A working group may establish one or more task forces to develop facts and options on a particular aspect of a given task. The individual task force then provides that information to the working group for consideration. If a working group comes to unanimous consensus on recommendations for action, the package is presented to the full RSAC for a vote. If the proposal is accepted by a simple majority of RSAC, the proposal is formally recommended to FRA. FRA then determines what action to take on the recommendation. Because FRA staff play an active role at the working group level in discussing the issues and options and in drafting the language of the consensus proposal, FRA is often favorably inclined toward the RSAC recommendation. However, FRA is in no way bound to follow the recommendation, and the agency exercises its independent judgment on whether the recommended rule achieves the agency's regulatory goal, is soundly supported, and is in accordance with policy and legal requirements. Often, FRA varies in some respects from the RSAC recommendation in developing the actual regulatory proposal or final rule. Any such variations would be noted and explained in the rulemaking document issued by FRA. If the working group or RSAC is unable to reach consensus on a recommendation for action, FRA moves ahead to resolve the issue through traditional rulemaking proceedings.
On January 26, 2005, the RSAC formed the RWP Working Group (“Working Group”) to consider specific actions to advance the on-track safety of employees of covered railroads and their contractors engaged in maintenance-of-way activities throughout the general system of railroad transportation, including clarification of existing requirements. The assigned task was to review the existing rule, technical bulletins, and a safety advisory dealing with on-track safety. The Working Group was to consider implications and, as appropriate, consider enhancements to the existing rule. The Working Group would report to the RSAC any specific actions identified as appropriate, and would report planned activity to the full Committee at each scheduled Committee meeting, including milestones for completion of projects and progress toward completion.
The Working Group is comprised of members from the following organizations:
The Working Group held 12 multi-day meetings. The group worked diligently and was able to reach consensus on 32 separate items.
One of the items on which the Working Group was able to reach consensus dealt specifically with the adjacent-track on-track safety issue in § 214.335 On-track safety procedures for roadway work groups. The consensus language developed by the Working Group for this topic, which was approved by the full RSAC and formally recommended to FRA for paragraphs (c), (d), and (e), is as follows:
For paragraph (c)—“On-track safety is required for adjacent controlled track within 19 feet of the centerline of the occupied track when roadway work group(s) consisting of roadway workers on the ground and on-track self-propelled or coupled equipment are engaged in a common task on an occupied track.
• “Except as provided by paragraph (c)(3) of this section, when trains are cleared through working limits on an adjacent controlled track, or when watchman/lookout warning in accordance with § 214.329 is the form of adjacent on-track safety, roadway workers shall occupy a predetermined place of safety and all on-ground work and equipment movement activity within the fouling space of the occupied track shall cease upon notification of pending adjacent track movement (working limits) or upon receiving the watchman/lookout warning.
• “When single or multiple movements are cleared through adjacent controlled track working limits, on-ground work and equipment movement on the occupied track may resume only after all such movements on adjacent track have passed each component of the Roadway Work Group(s). If the train stops before passing all roadway workers, the employee in charge shall communicate with the engineer prior to allowing the work to resume.
• “When single or multiple movements are cleared through adjacent controlled track working limits at a speed no greater than 25 mph, work performed exclusively between the rails of the occupied track, or to the field side of the occupied track with no adjacent track, may continue upon notification of each roadway worker of movement on adjacent track. On-ground work shall not be performed within 25 feet to the front or 25 feet to the rear of roadway maintenance machine(s) on the
For paragraph (d), the Working Group recommended “Equipment may not foul an adjacent controlled track unless protected by working limits and there are no movements authorized through the working limits by the roadway worker in charge.”
And for paragraph (e), the Working Group recommended “The mandatory provisions for adjacent controlled track protection under this subpart are not applicable to work activities involving—
• “A hi-rail vehicle as defined in § 214.7, provided such hi-rail vehicle is not coupled to railroad cars. Where multiple hi-rail vehicles are engaged in a common task, the on-track safety briefing shall include discussion of the nature of the work to be performed to determine if adjacent controlled track protection is necessary. Nothing in this subpart prohibits the roadway worker in charge of the hi-rail vehicle from establishing adjacent controlled track protection, as he/she deems necessary.
• “On-ground roadway workers exclusively performing work on the field side of the occupied track.
• “Catenary maintenance tower cars with roadway workers positioned on the ground within the gage of the occupied track for the sole purpose of applying or removing grounds. Nothing in this subpart prohibits the roadway worker in charge of the catenary maintenance tower car from establishing adjacent track protection, as he/she deems necessary.”
Upon reviewing the joint petition of the BRS and BMWED for an emergency order, the consensus language of the Working Group quoted above, and the relevant accident data concerning roadway workers fouling adjacent tracks, FRA decided to issue a separate NPRM
In light of recent roadway worker fatality trends, FRA determined that the agency must propose a more prescriptive approach to prevent further fatalities. The need to mandate adjacent-track on-track safety was recognized by FRA, members of the Working Group, and members of the full RSAC. The consensus language developed by the Working Group and recommended by the full RSAC is expected to reduce the risk of roadway worker fatalities due to fouling an adjacent track while working in conjunction with on-track equipment on an occupied track. As part of the process in drafting the NPRM in the larger RWP rulemaking, FRA circulated the consensus rule text concerning adjacent track and other items for errata review. Both AAR and BMWED submitted comments on this provision. To address these issues, and other potential ambiguities discovered upon a closer review of the rule text, FRA reorganized and modified the consensus text in issuing an NPRM.
FRA published an NPRM addressing adjacent-track on-track safety on July 17, 2008 (73 FR 41214), but formally withdrew the notice on August 13, 2008 (73 FR 47124). The withdrawal stated, in part—“[i]n crafting the NPRM, FRA presented the RSAC consensus language in the preamble verbatim and transparently explained its rationale for all changes it made to the consensus language. As this was an NPRM, FRA sought comment on the entire proposal, including those portions that FRA sought to clarify.
“FRA recognizes that inadvertent errors do sometimes occur in formulating a proposal and expects that interested parties would provide comments to both FRA and all other interested parties through the established comment process detailed in the NPRM. Given the alleged discrepancies between the consensus language and the proposed rule, the need to clarify the essential issues and move toward resolution of the safety concern at hand, and the ex parte communications regarding this proposed rule, FRA has decided to withdraw this rulemaking and will take such further regulatory steps as safety requires.”
BMWED and BRS filed a joint request to extend the comment period to 60 days on July 28, 2008, as well as preliminary joint comments detailing their concerns with the substance of FRA's initial NPRM on August 10, 2008 (just after FRA issued the withdrawal notice, but prior to the publication of the notice in the
The first issue raised in the joint comments was the proposed removal of the definition of the term “Adjacent tracks” in § 214.7. BMWED and BRS stated that the removal of the definition in § 214.7 would remove tens of thousands of miles of non-controlled track from the scope of the regulation. FRA disagrees with this interpretation of the NPRM, since the proposed removal of the definition is not what would have removed non-controlled track from the scope of adjacent-track on-track safety; rather, it was the substantive provision itself that the RSAC recommended and that formed the basis for FRA's proposal that would have removed it. Since the term was no longer being used anywhere else in part 214, it would have caused confusion to have a definition that included non-
The joint comments also describe a concern with the withdrawn NPRM's proposed language in § 214.336(a)(1)(ii) that would have permitted a component of a roadway work group to resume all on-ground work and equipment movement after the “head-end” of a movement passed by the component's location when trains are cleared through working limits at speeds greater than 25 mph. The joint comments insist that the RSAC Working Group's intent was for work to stop for the entire movement, not just the head-end.
While drafting this section in the withdrawn NPRM, FRA made a good faith determination of the meaning of the consensus language and could not distinguish whether the Working Group meant “head-end” or entire “movement.” (This determination is reflected in the preamble, and comments were requested.) Based on AAR's errata review comments and FRA's review of the January 10–11, 2006 Working Group meeting minutes, it appeared possible that an error was made, with respect to the “head-end only” requirement, by the Working Group in creating the final draft of the consensus language that was eventually presented to the full RSAC for approval. The draft being discussed at the January meeting allowed work to commence at the head-end during movement at 30 mph, but required that the entire movement pass before allowing work to commence at speeds greater than 30 mph. The Working Group reached consensus on the “concepts of the proposal” for this item at its February 1–2, 2006 meeting.
Upon reviewing other documents from that meeting, FRA has determined that railroad management's proposal that included the 40-mph threshold also appears to have conceded that the entire movement must pass before permitting work to resume, regardless of speed. While it is possible that the concession of the entire movement passing was conditioned upon railroad labor accepting railroad management's proposal as a whole (including the 40-mph threshold), FRA did not receive any further comments from AAR or any of its members on this issue, despite the request for comments on this issue in the July 17, 2008 NPRM. Since the consensus language eventually approved by the full RSAC most closely resembled that which railroad labor proposed to the Working Group, FRA has decided to edit the language in this NPRM to require that all work not subject to an exception be permitted to resume only after the entire movement (
Regarding the limited work activities that would be permitted to continue under FRA's initial proposal when trains are passing on an adjacent controlled track at speeds of 25 mph or less, BMWED and BRS note that the language proposed by FRA in paragraph (a)(2) differed from the consensus language in paragraph (c)(3) (indicating that work conducted “exclusively between the rails of the occupied track, or to the field side of the occupied track with no adjacent track” would be permitted to continue, provided that the work was not conducted within 25 feet of the front or rear of any roadway maintenance machine). BMWED and BRS expressed their concern that it would be unsafe to permit work to the field side if working limits are not specifically required on any adjacent track on that side.
While paragraph (c)(3) of the consensus language permitted all work to continue to the field side of the occupied track only if there was no adjacent track present, the consensus language did not impose such a limitation in the broad exception for on-ground work on the field side of the occupied track in paragraph (e)(2) (now proposed paragraph (e)(1)). FRA's original proposal would have permitted certain work to continue to the field side, provided that on-track safety (including train approach warning) had been established in accordance with this subpart on any adjacent track on that side.
In consideration of the concern raised by BMWED and BRS in their joint comments, FRA has adjusted the language originally proposed so as to better ensure the safety of the workers on that side of the occupied track. In addition to permitting work to continue while exclusively positioned on the field side of an occupied track that has no adjacent track on that side, the new proposal would also permit work to continue while exclusively positioned on the field side of an occupied track that has an adjacent track on that side provided that working limits have been established on the closest adjacent track on that side and there are no movements authorized through the working limits by the roadway worker in charge on that adjacent track. The above proposed conditions for conducting work while positioned on the field side have been summarized in the definition of a new term, “clear side,” in § 214.336(a)(3), so as to avoid having to repeat these conditions in the rule text proposed in paragraphs (c) and (e)(1) of this section. In applying the exception in proposed paragraph (e)(1), FRA notes that the “clear side” portion of the proposal would have the effect of requiring that working limits be established on an adjacent track (on the field side where the on-ground roadway workers are exclusively positioned) that is non-controlled and whose centerline is 25 feet from the centerline of the occupied track, while no form of on-track safety (
Another issue that BMWED and BRS would like FRA to reconsider is the proposed requirement for railroads to provide training or issue a bulletin with the proposed new requirements for adjacent-track on-track safety. The proposed requirement that railroads issue a bulletin or other document to the roadway workers was intended as a stop-gap measure, together with extended on-track safety job briefings, since most railroads provide their employees with annual training at the beginning of the calendar year. This was not a new concept, as the proposal was based on a similar provision in Emergency Order No. 24, and because FRA believes that this, in conjunction with job briefings on the issue, is the approach most railroads take to train their employees when an operating rule change goes into effect mid-year. BMWED and BRS, however, noted in their joint comments that this was not adequate training, and expressed their fear that that this would shift the burden for effective training from the employer to unsuspecting employees. They also noted a concern that the proposed requirement for the employers to obtain a written receipt or acknowledgement may also affect their memberships' legal rights under the Federal Employers' Liability Act. Because of the timing of the withdrawal of the NPRM, FRA believes that it can coordinate this NPRM and final rule to correspond with the railroad's annual training cycle for roadway worker protection, thus making the requirement to issue a bulletin unnecessary as a stop-gap measure.
Finally, the joint comments note that FRA's initial proposal also differs from the RSAC consensus language because FRA proposed to move the section of the rule that pertains to adjacent-track on-track safety from § 214.335(c) to a new proposed § 214.336. FRA does not agree with these comments and denies that moving language from one section to another, for clarification purposes, changes the substance and intent of the provision. Currently, § 214.335 of the existing regulation for on-track safety for roadway work groups contains only one short provision that is applicable to adjacent track protection, that is, paragraph (c). The RSAC recognized that this provision is vague as to what circumstances mandate adjacent-track on-track safety, and this was the very reason for the RSAC's recommendation to amend it. Because of the complex revisions to the regulation with respect to adjacent-track on-track safety, and to avoid having too many levels of subparagraphs in the rule text, FRA believes it is necessary to create a new section. A new section would not change the substance or application of the regulation in any way, and additions to regulations often require the restructuring of subsections in order to promote clear, concise interpretation.
AAR submitted draft comments to FRA on September 16, 2008. Although the draft comments were received after the date that the NPRM was formally withdrawn, FRA has decided to post them to the docket and discuss them in this NPRM, in an effort to continue FRA's transparency in these proceedings as well as to encourage an open discussion and resolution of the related issues at this NPRM stage, rather than at the later, final rule stage.
The first issue concerns the applicability of proposed § 214.336(a) to “a roadway work group with at least
FRA had proposed to amend this portion of the consensus language for clarity, since the consensus language (“when roadway work group(s) consisting of roadway workers on the ground and on-track self-propelled or coupled equipment are engaged in a common task on an occupied track”) contained the words “roadway work group(s)” and “equipment,” both of which could be interpreted as plural and result in confusion concerning how many roadway workers needed to be on the ground before this section would apply. FRA specifically chose the clarifying words “one or more roadway workers on the ground” because FRA believed that this was the intent of the Working Group, since there was no safety rationale for excluding roadway work groups that consist of only two roadway workers. In choosing this language, FRA assumed that in a two-person roadway work group, one roadway worker was assigned to operate the equipment, and the other was assigned to perform duties on the ground in a common task with the machine and presumably its operator. The potential for distraction of the one roadway worker on the ground in a roadway work group consisting of only two roadway workers is the same as for each of the two roadway workers on the ground in a roadway work group consisting of three roadway workers. Moreover, FRA analysis of the agency's accident investigations of these types of incidents has revealed that four
AAR also requested that the exception for hi-rails in proposed § 214.336(b)(2) of the former NPRM be expanded to include rail-bound geometry and detection equipment, since the level of distraction posed by this equipment is similar to that of hi-rails. AAR suggests that the language in that section be amended by adding “or self-propelled track geometry or detector car.” FRA notes that while a rail-bound geometry car tends to be much larger than a hi-rail, it seems that the level of distraction is similar for a roadway worker on the ground who is field-verifying a measurement behind a geometry car and a roadway worker on the ground who is replacing a bolt behind a hi-rail; nonetheless, FRA seeks comment as to whether this type of equipment should be added to the exception.
The comments further request that an exception be added (
AAR also recommended that FRA permit the machine operator to perform work on the ground within 25 feet of the front or rear of the roadway maintenance machine that he or she is operating, during adjacent-controlled-track movements of 25 mph or less. It would be impractical not to allow the operator to step off of his machine and walk directly behind it. Accordingly, AAR suggests that the proposed paragraph 214.336(a)(2)(i) (now proposed as § 214.336(c)) be amended by adding after the word “movement” the phrase “unless the employee is operating the machine.” FRA believes that the phrase “unless the employee is the assigned operator of the machine” would better address AAR's concerns, since presumably the employee would place the machine in the idle position and set the brakes before alighting and, therefore, would not be operating or moving the machine from the ground. FRA seeks comment as to whether this amendment should be added.
Finally, AAR requested that FRA reconsider the proposed training and recordkeeping requirements in the initial NPRM. While recognizing that training is vital, AAR urges FRA to make the effective date for training on the new requirements consistent with the railroads' training schedules. Regarding the proposed recordkeeping requirements, AAR notes that the requirement for a written acknowledgment is “burdensome, unwarranted, and violates both Congressional and OMB mandates,” and requests that FRA permit railroads to use electronic signatures in lieu of handwritten signatures. While FRA is not opposed to permitting electronic signatures under the circumstances proposed in the initial NPRM, the proposed recordkeeping requirement has been deleted from this NPRM, making this a moot point.
FRA received a number of brief comments. The July 30, 2008 joint comments submitted by ATDA, BLET, and UTU, expressed support for the BMWED and BRS' joint request to extend the comment period on the initial NPRM to 60 days. Other brief comments raised different concerns, which have been summarized, below.
Three general comments were submitted to the docket. The first general comment was submitted by John Walsh. He indicates that while part 214 is intended to provide for the safety of railroad workers, it also preempts State laws concerning the railroads. As such, he believes that FRA's regulations should also require railroads to provide for the protection of emergency workers, including firefighters, emergency medical technicians (EMTs), and those working under their direction and control. He recommends that railroads annually notify every firefighting agency with tracks in their jurisdiction of whom to contact whenever the firefighters or EMTs are operating within the railroad's right of way, and that railroads have procedures in place to restrict train traffic in the area until the firefighters' or EMTs' incident commander grants the railroad permission to allow trains to pass through the incident area. As Mr. Walsh's comments are outside the scope of part 214, it appears that this request would be more appropriate if filed in the form of a petition for a new rulemaking under 49 CFR 211.11.
The second general comment was submitted by Michael McGinley, who indicates that he is a retiree from the Southern California Regional Rail Authority (Metrolink) engineering department. He states that the weakest link is the widespread failure of locomotive engineers to comply with sounding warning signals upon seeing roadway workers, and expressed his belief that this may be due to the part 214 requirements being taught to the engineering department employees and not to the transportation department employees. He recommends that the application of the present regulations be reinforced through the operating practices perspective and focus on the locomotive engineers. While FRA is not proposing to amend the section that relates to audible warning (§ 214.339) in this NPRM, FRA notes that this is one of the most common violations cited under part 214, and many railroads have taken steps to reinforce and raise awareness of these requirements through increased training and efficiency testing. Thus, FRA does not believe that this section should be amended at this time.
The third general comment was submitted by Frederic W. Yocum, who is a retired railroader who served on RSAC. He suggests that FRA amend the language to add the phrase “or desirable” to the language proposed in the initial NPRM so as to read “nothing in this section prohibits the roadway worker in charge from establishing adjacent-track on-track safety as he or she deems necessary
In addition to these comments, FRA also received comments from Todd Cotie, Health and Safety Coordinator for the United Steelworkers Local 2004, representing 3,200 track maintenance workers across Canada. He recommends that trains be ordered to reduce their speed to a maximum of 30 mph when passing in proximity to workers on adjacent mainline tracks, since a slower train would allow engineers and work crews more time to notice and react to various situations that occur from the passing train. This recommendation is based on various rules, including the speed restriction for trains passing in
Given the importance of an on-track safety job briefing in roadway workers' understanding of the nature of the work they will be conducting and the conditions under which they will conduct it, FRA thinks that the existing requirements in § 214.315 for a job briefing “when an employer assigns duties to a roadway worker that call for that employee to foul a track” should also be expanded to cover the new proposed procedures for adjacent-controlled-track on-track safety in § 214.336 if such procedures are required for that assignment or if adjacent-track on-track safety is deemed necessary by the roadway worker in charge. With a few minor changes, the text concerning the additional components of an on-track safety job briefing that is proposed in this NPRM was consensus language developed by the Working Group and recommended by the full RSAC. The consensus language relating to adjacent tracks was proposed as a new paragraph (a)(2) in § 214.315, to read: “Information about any tracks adjacent to the track to be occupied, on-track safety for such tracks, and identification of roadway maintenance machines that will foul any adjacent track. In such cases, the briefing shall include procedural instructions addressing the nature of the work to be performed and the characteristics of the work location to ensure compliance with this part.”
On December 18, 2007, FRA emailed the Working Group members and requested an errata review of a document in which FRA had compiled all of the consensus items. In its errata review comments, AAR requested that FRA clarify that the provision is not intended to require a discussion on the on-track safety of an adjacent track unless on-track safety is required on that track by part 214. FRA agrees that this is not the intent of the proposed requirement, and has added the language “if required by this subpart or deemed necessary by the roadway worker in charge” to the consensus rule text, which has been proposed as new paragraph (a)(3). The language concerning the roadway worker in charge's discretion was added to emphasize that the roadway worker in charge would still be permitted to establish on-track safety on an adjacent track, regardless of whether it is controlled or non-controlled, if it is reasonably necessary given the nature of the work that is to be performed. This proposed section would still require the on-track safety job briefing to include information concerning any “adjacent tracks” (as defined in § 214.7), so as to serve as a warning to each roadway worker of the potential danger in fouling such a track, even if no on-track safety is required for that particular track because it does not meet the definition of “adjacent controlled track” in proposed § 214.336(a)(3). While the second sentence of the consensus language began with the phrase “in such cases,” FRA has deleted that language, and proposes to move the rest of the language into a new paragraph (a)(4), since the on-track safety job briefing must always address the nature of the work to be performed and the characteristics of the work location to ensure compliance with this subpart, regardless of whether there is an adjacent track present.
FRA has further clarified in a proposed revision to introductory paragraph (a) that this section lists only the minimum items that must be discussed in an on-track safety briefing. The words “at a minimum” were added, and the rest of existing paragraph (a) has been moved to proposed paragraphs (a)(1) and (a)(2).
FRA proposes to amend this section by deleting paragraph (c) and creating new requirements in a separate section to address adjacent-controlled-track on-track safety procedures for certain roadway work groups, § 214.336, for the reasons discussed below. Existing paragraph (c) reads: “Roadway work groups engaged in large-scale maintenance or construction shall be provided with train approach warning in accordance with § 214.327 for movements on adjacent tracks that are not included within working limits.”
The proposal would also amend the heading of § 214.335 to reflect the general nature of the remaining requirements in that section.
As discussed in Section II.C., above, § 214.335(c) currently requires adjacent-track on-track safety for a roadway work group only if such a work group is engaged in “large-scale maintenance or construction.” Under this criterion and the limited guidance provided in the preamble to the final rule, many railroads have not been providing on-track safety on adjacent tracks for surfacing operations, small tie-renewal operations, or similar maintenance operations that, while smaller in scale, still include on-track, self-propelled equipment. This proposed new section seeks to eliminate this interpretive issue by establishing new, more objective criteria for determining whether adjacent-track on-track safety is required for a roadway work group. Fatalities have occurred in connection with such operations, which many believe the existing language should be interpreted to cover.
In developing language to address the increasing number of roadway worker fatalities on an adjacent track, the Working Group considered that most of the fatalities on an adjacent track occurred when a roadway work group with at least one of the roadway workers on the ground, was engaged in a common task with on-track, self-propelled equipment on an occupied track. In those circumstances, the potential for a roadway worker in the group to be distracted from the danger of an oncoming train was great due to the noise and dust generated by operation of the roadway maintenance machines, the need to avoid entanglement in the operation of those
The general rule would be set forth in paragraph (a), which would also direct the reader to the three exceptions described in proposed paragraph (e). The more specific procedures for adjacent-controlled-track on-track safety would be set forth in paragraphs (b) and (c), concerning movements on an adjacent controlled track at over 25 mph, and at 25 mph or less, respectively. Paragraph (a)(2) provides that if an occupied track has two adjacent controlled tracks, and one of these adjacent controlled tracks has one or more movements authorized at 25 mph or less, and the other adjacent controlled track has one or more concurrent movements authorized at over 25 mph, the more restrictive procedures in paragraph (b) would apply. This would require that all work (
Paragraph (a)(3) would add definitions of three new terms used exclusively in § 214.336 (“adjacent controlled track,” “clear side,” and “occupied track”), and one existing term (“adjacent tracks”) that is defined in § 214.7, but which would be repeated in this section to ensure that the reader is aware that two similar terms are being used in this section, with different meanings. For purposes of this section, “adjacent controlled track” would mean “a controlled track whose track center is spaced 19 feet or less from the track center of the occupied track.” In contrast, the definition of “adjacent tracks” (in § 214.7) includes any tracks, controlled or non-controlled, whose track centers are spaced less than 25 feet apart. FRA proposes to adopt this narrower definition of “adjacent controlled track” based on the roadway worker fatality data discussed above in “IV. Recent Roadway Worker Accidents (1997–2008),” which show that the adjacent tracks on which the roadway worker fatalities occurred were all controlled tracks and that the track centers of these controlled tracks were within 15 feet of the track centers of the occupied track. In light of these data, the Working Group agreed that 19 feet would be a reasonable and safe threshold to trigger the requirement to establish on-track safety on an adjacent track and that it would be reasonable to cover controlled tracks within that 19-foot zone but to exclude non-controlled tracks. FRA notes that the lack of fatalities on non-controlled adjacent tracks may be attributable to the reduced operating speeds on non-controlled tracks, where railroad operating rules generally require that movements must stop short of obstructions within half the range of vision. The Working Group discussed, and the full RSAC recommended for inclusion in § 214.335(c), that on-track safety be required for “adjacent controlled track within 19 feet of the centerline of the occupied track” for certain work activities. FRA agrees with this analysis and has reflected it in the proposed definition of “adjacent controlled track.” Note, however, that this section also uses the broader term “adjacent track” or “adjacent tracks” in paragraphs (c)(2)(i), (e)(1), and (f), as further discussed, below.
The third proposed definition in § 214.336(a) is for the term “clear side.” FRA proposes to define the term for purposes of § 214.336 to mean “the field side of the occupied track that either has no adjacent track on that side, or has an adjacent track or tracks on that side and working limits have been established in accordance with this subpart on the closest adjacent track on that side and there are no movements authorized through the working limits by the roadway worker in charge on that adjacent track.” This term was added so that the above language would not need to be included in the rule text in proposed paragraphs (c) and (e)(1) of this section. It should be noted that there are two field sides to each occupied track, beginning at each rail and continuing outward and away from the track center of the occupied track. One or both field sides may meet the definition of “clear” at some point during the work period (depending on the presence of an adjacent track on one or both sides and the method and circumstances of the on-track safety established on the adjacent track or tracks), but since the term is only used when making the determination as to whether work must cease due to one or more movements on an adjacent-controlled track, there could be only one “clear side” at the time of that determination.
FRA believes that the work permitted to continue under the circumstances described in proposed paragraphs (c) and (e)(1) should not be limited to only those situations where there is no adjacent track present. While paragraph (c)(3) of the consensus language (pertaining to single or multiple adjacent-track movements at a speed of 25 mph or less) permitted all work to continue to the field side of the occupied track only if there was no adjacent track present during such movements, the consensus language did not impose such a limitation in the broad exception for on-ground work on the field side of the occupied track in paragraph (e)(2) (now proposed paragraph (e)(1)). FRA's original proposal would have permitted certain work to continue, provided that on-track safety (including train approach warning) had been established in accordance with this subpart on any adjacent track on that side. In consideration of the joint comments submitted by BMWED and BRS, FRA has adjusted the language originally proposed so as to better ensure the safety of the workers on that side of the occupied track.
Specifically, under the proposed sections that use the term “clear side,” certain work would be permitted to continue on the field side furthest from the adjacent controlled track if working limits (including those established by making the track inaccessible per § 214.327 if the adjacent track is non-controlled) have been established on that track, and the roadway worker in charge has not authorized any movements through the working limits of that adjacent track. This proposal would allow the roadway worker in charge to better monitor and control the on-track safety of roadway workers performing work in triple-track territory, especially since the designated place of safety during an adjacent-controlled-track movement may very well be the field side towards another adjacent track on which no movement is occurring. Train approach warning would not be
The fourth proposed definition to be used for purposes of § 214.336 is “occupied track.” FRA proposes to define the term “occupied track” to mean the track on which a roadway maintenance machine or coupled equipment is located while engaged in a common task with a roadway work group. FRA replaced the consensus language of “on-track, self-propelled or coupled equipment” with “on-track roadway maintenance machine or coupled equipment” so as to use a term that is already defined in part 214. It should be noted that while the language that would trigger the requirement to establish adjacent-controlled-track on-track safety contains the term “on-track roadway maintenance machine” (which excludes hi-rails), the proposed definition of “occupied track” contains the broader term “roadway maintenance machine” (which includes hi-rails), since a roadway work group that is engaged in a common task with a hi-rail would still be “occupying” the track, regardless of whether adjacent-track on-track safety would be required during that task. The language in RSAC-recommended paragraph (a) was also modified in light of the proposed new definition of “adjacent controlled track,” namely by moving the reference to the 19-foot track center distance and placing it in the definition.
In an effort to make the section easier to understand, FRA has reorganized the section into proposed paragraph (b), which lists the procedures to follow for one or more adjacent-controlled-track movements over 25 mph (
Proposed paragraph (b)(1) would generally require that each roadway worker in the roadway work group stop any work on the ground and stop the movement of any roadway maintenance machine or coupled equipment in the fouling space of the occupied track and the adjacent controlled track, and occupy a predetermined place of safety. If on-track safety has been established on the adjacent controlled track through train approach warning in accordance with § 214.329 (either as the sole method of on-track safety or in addition to working limits), all work would have to cease upon receiving a watchman/lookout warning.
FRA notes that the language in proposed paragraph (b)(1) that would generally require roadway workers to cease all on-ground work within the fouling space of the occupied track could potentially be interpreted by some as conflicting with the language in proposed paragraph (e)(1), which would permit on-ground work on the clear (field) side, a portion of which would be within the fouling space of the occupied track. While proposed paragraphs (a) and (e) both contain language indicating, directly or indirectly, that paragraph (e) would apply notwithstanding any conflicting language in proposed paragraphs (a) through (c), to ensure that there is no confusion as to the interrelation of these sections, FRA has added the phrase “except as provided in paragraph (e) of this section” at the beginning of proposed paragraph (b)(1) and seeks comment regarding whether this was the intent of the consensus language. FRA does not believe that this same clarification would be necessary in proposed paragraph (c), since proposed paragraph (c) refers the reader to proposed paragraph (b).
In its errata review comments on the FRA document compiling all of the Working Group consensus language, AAR requested that FRA clarify whether work would be permitted to resume at a particular location after the head-end of the movement had passed or after the entire train had passed, under the RSAC-recommended § 214.335(c)(2). As discussed in section VI.C.1., above, upon an extensive review of all related meeting documents, FRA has determined that railroad management's proposal appears to have conceded that the entire movement must pass before permitting work to resume, regardless of speed. While it is possible that the concession of the entire movement passing was conditioned upon railroad labor accepting railroad management's proposal as a whole (including the proposal of a 40-mph threshold), FRA did not receive any further comments from AAR or any of its members on this issue, despite the request for comments on this issue in the July 17, 2008 NPRM. FRA did, however, receive joint comments from BMWED and BRS on this issue. The joint comments noted the hazards presented to roadway workers by abnormal consist conditions (
In modifying the language in consensus paragraphs (c)(2) (concerning when work would be permitted to resume) and (c)(3) (concerning which work would be permitted to continue during adjacent-controlled-track movements of 25 mph or less) for inclusion in its proposal, FRA realized that these same paragraphs did not address situations where train approach warning was the established method of adjacent-controlled-track on-track safety (either as the sole method, or in combination with working limits). Where train approach warning is the sole method of adjacent-controlled-track on-track safety, there are no working limits established on the adjacent controlled track, and trains are not being “cleared through adjacent-controlled-track working limits” by the roadway worker in charge. Regarding consensus paragraph (c)(3) (concerning which work would be permitted to continue during adjacent-controlled-track movements of 25 mph or less), this simply means that this type of work would always be permitted so long as train approach warning was in effect, since a train or other on-track equipment would not be authorized to exceed 25 mph. Regarding consensus paragraph (c)(2) (concerning when work would be permitted to resume), this means that the watchman/lookout may not know (depending on the span of the working limits and the available sight distance) how many movements at any given time are operating within the same segment of track on the adjacent-controlled-track as that of the working limits established on the occupied track. Thus, it would be reasonable for work to resume after the trailing-end of a train passes unless and until the watchman/lookout provides a warning for a subsequent train. To address these oversights, FRA made adjustments to the consensus language in paragraphs (c)(2) and (c)(3) in proposed §§ 214.336(b)(2)(i) and 214.336(c), respectively.
As the roadway workers are presented with similar safety risks and would still receive notification of the train or other on-track equipment movements, regardless of the method of adjacent-track on-track safety established, FRA has decided to adopt language in proposed § 214.336(b)(2)(i), that would clarify that a component of a roadway work group may resume on-ground work and movement of any roadway maintenance machine or coupled equipment on the occupied track only after the trailing-end of all trains or other on-track equipment moving on the adjacent controlled track (for which a notification or warning has been received in accordance with paragraph (b)(1) of this section) has passed and remains ahead of
On the other hand, if the train or other on-track equipment were to stop before its trailing-end passed all of the roadway workers in the roadway work group, then the work to be performed on or while fouling the occupied track ahead of the trailing-end of the train or other on-track equipment on the adjacent controlled track would be permitted to resume only if adjacent-controlled-track on-track safety has been established.
It should be noted that the train approach warning option provided in proposed § 214.336(b)(2)(ii)(A) would not be permitted alongside the train (or for a certain distance on the occupied track ahead of the location of the train on the adjacent controlled track), since the train, if it were traveling at the “maximum speed authorized on that track” would already be at the roadway worker's location (or, at certain distances, would be able to reach the roadway worker's location sooner than 15 seconds) and would not permit the roadway worker any (or sufficient) time to clear. Under such circumstances, work would not be permitted to resume until the conditions proposed in § 214.336(b)(2)(ii)(B) have been met, or until the train resumes its movement and its trailing-end passes the roadway worker's location, whichever comes first.
The proposed procedures to be followed for adjacent-track movements of 25 mph or less are the same as those procedures for adjacent-track movements over 25 mph, except that work would be permitted to continue in certain circumstances without regard to when the trailing-end passed the roadway work group's location, due to the low speed of the movements. In proposed paragraph (a)(2), FRA makes clear that if an occupied track has two adjacent controlled tracks, and one of the tracks has one or more adjacent-controlled-track movements authorized at 25 mph or less, and the other has one or more concurrent adjacent-controlled-track movements authorized at over 25 mph, the more restrictive procedures in paragraph (b) would apply.
The circumstances under which work may continue during low-speed movements on adjacent controlled tracks have been included in proposed paragraph (c). Unless the work falls under one of the exceptions in proposed paragraph (e), the work that would be permitted to continue after receiving a warning or notification of an adjacent-controlled-track movement would have to be performed more than 25 feet in front of or behind any roadway maintenance machine that is on or fouling the occupied track. While existing § 214.341(a)(5) requires each employer to include in its on-track safety program specific provisions addressing spacing “between machines and roadway workers to prevent personal injury,” the rule does not prescribe a specific distance, as certain work activities may require a roadway worker to work closer to a machine than others. Many railroads that subscribe to the General Code of Operating Rules (“GCOR”), for example, have adopted a 15-foot work zone in which roadway workers are not permitted to enter without first communicating with the
FRA believes that the intent of the consensus language regarding the 25-foot zone in paragraph (c) was to ensure that roadway workers were not performing on-ground work within 25 feet of the forward or rearward path of a moving machine; thus, workers would still be permitted to work alongside a machine on a clear side (to verify the quality of the work being performed by that machine, for example). A roadway worker that is performing duties alongside a roadway maintenance machine would, of course, need to be mindful of the machine's footprint (which would include any brooms or wings of a machine, if extended) in deciding where to position himself or herself in performing such duties. FRA believes that the procedures addressing spacing “between machines and roadway workers to prevent personal injury” that are required by existing § 214.341(a)(5) should adequately address the risk of working alongside a machine (under any circumstance, not just during movements on adjacent controlled track); however, FRA seeks comment regarding the adequacy of these procedures.
Proposed paragraph (c) would permit work to continue that is performed “exclusively while positioned on or between the rails of the occupied track or to the clear side” of the occupied track, provided it is performed outside of the 25-foot work zone discussed above. The rationale for permitting work to continue while positioned between the rails is that a roadway worker who is positioned between the rails of the occupied track is in little danger of fouling the adjacent controlled track. This proposed condition is similar to an existing provision in § 214.103(d) that permits bridge workers to perform minor repair work exclusively between the rails (so long as the weight-bearing portion of the roadway worker's body is between the rails) without any fall protection. As this condition has worked well in the bridge worker area, FRA proposes to adopt the RSAC-recommended condition in the roadway worker area.
The other set of circumstances in proposed paragraph (c) for permitting work to continue when a movement on the adjacent controlled track is authorized at 25 mph or less is when work is performed to the “clear side” of the occupied track, provided that it is performed outside of the 25-foot work zone. As discussed above in the analysis of proposed paragraph (a)(3) of this section, the “clear side” means “the field side of the occupied track that either has no adjacent track on that side, or has an adjacent track or tracks on that side and working limits have been established in accordance with this subpart on the closest adjacent track on that side and there are no movements authorized through the working limits by the roadway worker in charge on that adjacent track.” Both the Working Group and FRA recognize that if there is little danger of a roadway worker fouling an adjacent controlled track (
Given the potential danger posed by concurrent movements on two adjacent controlled tracks, it is important to note that while proposed § 214.336 would apply to each adjacent controlled track individually, the impact on the type of work that would be permitted to continue on the occupied track must be examined as a whole. Thus, where a roadway worker receives notification of adjacent-controlled-track movements authorized at 25 mph or less that are occurring concurrently on both adjacent tracks, FRA proposes that the roadway worker would not be permitted to work on either field side of the occupied track, as the movement on one adjacent controlled track would not permit any work on the field side closest to it, and the movement on the other adjacent (controlled or non-controlled) track would not permit any work on the field side closest to it.
It should also be noted that paragraph (c) only directly addresses the types of work that a component of a roadway work group may continue performing while waiting for the trailing-end of an adjacent-controlled-track movement to pass by that component's location. It does not directly address when all other work (
Regarding the prohibition in consensus paragraph (d) against “equipment” fouling an adjacent controlled track unless protected by working limits, FRA has changed the term to “roadway maintenance machine” to clarify that this prohibition is meant to be broad and would include hi-rails that are part of the roadway work group or otherwise working within the same working limits as the roadway
The Working Group also discussed, and the RSAC recommended, three exceptions when adjacent-controlled-track on-track safety would not have to be established at all.
The first proposed exception to the requirement for adjacent-controlled-track on-track safety would be for one or more on-ground roadway workers performing work while exclusively positioned on the clear (field) side of the occupied track, provided that there should essentially be no danger posed by any other adjacent track. In particular, there would be no danger posed by any other adjacent track either because there is no adjacent track on the field side of the occupied track or, even though there is an adjacent track on the field side of the occupied track, working limits have been established in accordance with this subpart on the closest adjacent track on that side and there are no movements authorized through the working limits on that adjacent track. Regarding the language “while exclusively positioned on the clear side,” FRA notes that this language refers to the positioning of the weight-bearing portion of the roadway worker's body. This interpretation is consistent with FRA's interpretation of a similar provision in the bridge worker area (
As noted above in the discussion of proposed paragraphs (b)(1) and (c), this exception would apply notwithstanding any conflicting language in proposed paragraphs (a) through (c). Thus, on-ground work within the fouling space of the occupied track on the clear (field) side would still be permitted to continue during adjacent-controlled-track movements occurring on the other field side of the occupied track, regardless of the speed of those movements. Moreover, this on-ground work would not be subject to the condition that the on-ground work permitted to continue must be conducted more than 25 feet in front of or behind any roadway maintenance machine on or fouling the occupied track. FRA seeks comment as to whether the 25-foot zone should apply to the work performed in paragraph (e)(1) as well.
The second exception to the requirement for adjacent-controlled-track on-track safety would be for a hi-rail vehicle on the occupied track, provided such hi-rail vehicle is not coupled to any equipment and not operating on the same occupied track and within working limits of a roadway work group as described in paragraph (a) of this section.
The consensus language for this second exception also included language indicating that where multiple hi-rails are engaged in a common task, the on-track safety briefing shall include discussion of the nature of the work to be performed to determine if “adjacent controlled track protection” is necessary. FRA has added a cross-reference to proposed § 214.315(a)(4) to this language in its proposal because the roadway worker in charge must always consider the nature of the work to be performed to determine the appropriate level of on-track safety. In fact, the consensus language emphasizes that nothing in this subpart prohibits the roadway worker in charge from establishing adjacent controlled track protection as he or she deems necessary. Consensus paragraph (e)(1) (now proposed paragraph (e)(2)) was also amended to remove the words “as defined in § 214.7,” since each time that a term defined in § 214.7 is used in part 214, FRA intends the term to be interpreted in the manner in which it is defined in § 214.7, unless otherwise noted. As discussed in section VI.C.2., above, FRA seeks comment as to whether this proposed exception should be expanded to include rail-bound geometry and detection equipment.
The third proposed exception to the requirement for adjacent-controlled-track on-track safety is for a catenary maintenance tower car with one or more roadway workers positioned on the ground exclusively within the gage of the occupied track for the sole purpose of applying or removing grounds. As discussed in Section IV. of this preamble, there have been no adjacent-track fatalities where a roadway work group had been engaged in a common task with a catenary maintenance tower car on the occupied track and the duties normally performed by an employee operating a catenary maintenance tower car tend to be less distracting to on-ground roadway workers and produce less dust and noise than a typical on-track roadway maintenance machine. FRA proposes to add this exception, with the same caveat added as for hi-rails, which is that once the catenary maintenance tower car is operating on the same occupied track and within the working limits of a roadway work group as described in paragraph (a) of this section, the exception would no longer apply.
As discussed in section VI.C.2., above, AAR is requesting that a fourth exception be added when there is a physical barrier between the occupied track and the adjacent controlled track. FRA seeks comment on whether a fourth exception should be added, and if so, whether it should be limited to “where there is a continuous permanent
In BMWED's errata review comments on the FRA document compiling all of the Working Group consensus language that was recommended to FRA by the RSAC, BMWED noted that from the manner in which the consensus exceptions (paragraphs (e)(1)-(e)(3)) were constructed, one could interpret that the roadway worker in charge of on-ground roadway workers exclusively performing work on the field side of the occupied track described in consensus paragraph (e)(2) would not be afforded the same right to establish a greater level of adjacent-track on-track safety as the roadway worker in charge of the hi-rail vehicle or catenary maintenance tower car described in paragraphs (e)(1) and (e)(3), respectively. FRA agrees that the provisions should be consistent. The section has been reorganized so that the language in paragraph (e)(3) stating that “[n]othing in this subpart prohibits the roadway worker in charge of the catenary maintenance tower car from establishing adjacent track protection, as he/she deems necessary” has been removed from paragraph (e)(3) (along with similar language in paragraph (e)(1)) and slightly reworded and moved into a new paragraph (f) so as to apply generally to proposed § 214.336, including all three exceptions in proposed paragraphs (e)(1)–(e)(3). Proposed paragraph (f) reads—“
This NPRM has been evaluated in accordance with existing policies and procedures, and determined to be significant under both Executive Order 12866 and DOT policies and procedures.
Certain of the requirements reflect current industry practice, or restate existing regulations, or both. As a result, in calculating the costs of this NPRM, FRA has neither included the costs of those actions that would be performed voluntarily in the absence of a regulation, nor has FRA included the costs of those actions that would be required by an existing regulation.
This evaluation includes quantitative measurements and qualitative discussions of implementation costs for this proposed rule. The costs would primarily be imposed by a small increase in job briefing time and additional resources spent to provide on-track safety for the safe conduct of other than large-scale maintenance and construction of track located adjacent to (and within a certain distance of) one or more controlled tracks on which train movements may be occurring. Training costs would also accrue. The benefits would primarily accrue from a reduction in roadway worker casualties (fatalities and injuries). Business benefits stemming from avoided train delays and property damages would also accrue.
FRA estimates that the present value (PV, 7%) of the total 20-year costs that the industry would be expected to incur to comply with the requirements in this NPRM would be $130.7 million. FRA also estimates that the PV (7%) of the total 20-year benefits accruing to society from the implementation of the requirements would be $131.9 million. The following table includes a summary of the regulatory impact analysis (RIA) costs and benefits, broken down by section of the rule and benefit category, respectively:
FRA believes that taking into account non-quantifiable benefits, including reduced train delays and property damages resulting from roadway worker incidents, the benefits associated with this proposed rule would justify the implementation costs. FRA requests comment on all of the assumptions used in the regulatory evaluation to calculate the costs and benefits.
The Regulatory Flexibility Act (5 U.S.C. 601
This Small Entity Impact Assessment and Evaluation concludes that this proposed rule would not have a significant economic impact on a substantial number of small entities. In order to determine the significance of the economic impact for the final rule's Regulatory Flexibility Act (RFA) requirements, FRA invites comments from all interested parties concerning data and information regarding the potential economic impact caused by this proposed rule, during the comment period.
The U.S. Small Business Administration (SBA) stipulates in its “Size Standards” that a “for profit” railroad business firm may not have more than “1,500 employees for “Line-Haul Operating” Railroads and 500 employees for “Switching and Terminal Establishments” to be considered as a “small entity.”
Pursuant to that authority, FRA has published a final policy that classifies “small entities” as, inter alia, being railroads that meet the line haulage revenue requirements of a Class III railroad.
There are approximately 665 small railroads.
In addition, FRA is not aware of any commuter railroads that qualify as small entities. This is likely because commuter railroad operations in the United States are part of larger governmental entities whose jurisdictions exceed 50,000 in population.
FRA is uncertain as to the number of contractors that would be affected by this proposed rule. FRA is aware that some railroads hire contractors to conduct some of the functions of roadway workers on their railroads. However, most of the costs associated with the burdens from this rulemaking would ultimately get passed on to the pertinent railroad. Most likely, the contracts would be written to reflect that, and the contractor would bear no additional burden for the proposed requirements. In addition, FRA is uncertain as to the number of contractors that would be considered to be small entities. FRA requests any information during the rulemaking comment period related to contractors and the burdens that might impact them as a result of this proposed rulemaking.
No other small businesses (non-railroads) are expected to be impacted by this proposed rulemaking.
The impacts from this regulation are primarily a result of the proposed requirements for roadway work groups to be provided on-track safety when working on a track within close proximity of an adjacent track that is controlled. Again, since small railroads either do not have any adjacent track or conduct track work on the occupied track with an adjacent track when the adjacent track is out of service, there is no impact for small railroads. Since FRA does not anticipate that this proposed rule would impose any burdens on small entities, there is no alternative treatment proposed for small entities.
Having made these determinations, FRA certifies that this NPRM is not expected to have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act or Executive Order 13272.
The information collection requirements in this proposed rule have been submitted for approval to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501
All estimates include the time for reviewing instructions; searching existing data sources; gathering or maintaining the needed data; and reviewing the information. Pursuant to 44 U.S.C. 3506(c)(2)(B), FRA solicits comments concerning whether these information collection requirements are necessary for the proper performance of the functions of FRA, including whether the information has practical utility; the accuracy of FRA's estimates of the burden of the information collection requirements; the quality, utility, and clarity of the information to be collected; and whether the burden of collection of information on those who are to respond, including through the use of automated collection techniques or other forms of information technology, may be minimized. For information or a copy of the paperwork package submitted to OMB, contact Mr. Robert Brogan, Information Clearance Officer, at 202–493–6292, or Ms. Nakia Jackson at 202–493–6073.
Organizations and individuals desiring to submit comments on the collection of information requirements should direct them to Mr. Robert Brogan or Ms. Nakia Jackson, Federal Railroad Administration, 1200 New Jersey Avenue, SE., 3rd Floor, Washington, DC 20590. Comments may also be submitted via e-mail to Mr. Brogan or Ms. Jackson at the following addresses:
OMB is required to make a decision concerning the collection of information requirements contained in this proposed rule between 30 and 60 days after publication of this document in the
FRA is not authorized to impose a penalty on persons for violating information collection requirements which do not display a current OMB control number, if required. FRA intends to obtain current OMB control numbers for any new information collection requirements resulting from this rulemaking action prior to the effective date of the final rule. The OMB control number, when assigned, will be announced by separate notice in the
FRA has analyzed this NPRM in accordance with the principles and criteria contained in Executive Order 13132, issued on August 4, 1999, which directs Federal agencies to exercise great care in establishing policies that have federalism implications.
One of the fundamental federalism principles, as stated in Section 2(a) of Executive Order 13132, is that “Federalism is rooted in the belief that issues that are not national in scope or significance are most appropriately addressed by the level of government closest to the people.” Congress expressed its intent that there be national uniformity of regulation concerning railroad safety matters when it enacted 49 U.S.C. 20106. As amended to date, that section provides that all regulations prescribed by the Secretary of Transportation with respect to railroad safety matters and the Secretary of Homeland Security with respect to railroad security matters preempt any State law, regulation, or order covering the same subject matter, except a provision necessary to eliminate or reduce an essentially local safety or security hazard that is not incompatible with a Federal law, regulation, or order and that does not unreasonably burden interstate commerce. Nothing in this NPRM proposes to alter the preemptive effect of the RWP Rule so these provisions, once adopted as a final rule, would have the same preemptive effect as the current RWP Rule in accordance with the statute.
FRA notes that the above factors have been considered throughout the development of this NPRM both internally and through discussions within the RSAC forum, as described in Sections VI and VII of this preamble. The full RSAC, which, prior to the publication of this NPRM, reached consensus on proposed rule text and recommended the proposal to FRA, has as permanent voting members two organizations representing State and local interests: AASHTO and ASRSM. As such, these State organizations concurred with the proposed requirements, which differ in only limited respects from the requirements contained in this NPRM. The RSAC regularly provides recommendations to the FRA Administrator for solutions to regulatory issues that reflect significant input from its State members. To date, FRA has received no indication of concerns about the Federalism implications of this rulemaking from these representatives or from any other representative.
For the foregoing reasons, FRA believes that this NPRM is in accordance with the principles and criteria contained in Executive Order 13132.
FRA has evaluated this NPRM in accordance with its “Procedures for Considering Environmental Impacts” (FRA's Procedures) (
Pursuant to Section 201 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4, 2 U.S.C. 1531), each Federal agency “shall, unless otherwise prohibited by law, assess the effects of Federal regulatory actions on State, local, and tribal governments, and the private sector (other than to the extent that such regulations incorporate
The written statement must detail the effect on State, local, and tribal governments and the private sector. This NPRM will not result in the expenditure, in the aggregate, of $141,300,000 in any one year, and thus preparation of such a statement is not required.
Executive Order 13211 requires Federal agencies to prepare a Statement of Energy Effects for any “significant energy action.”
The Trade Agreements Act of 1979 (Pub. L. 96–39, 19 U.S.C. 2501
FRA has assessed the potential effect of this NPRM on foreign commerce and believes that its requirements are consistent with the Trade Agreements Act. The requirements imposed are safety standards, which, as noted, are not considered unnecessary obstacles to trade.
Anyone is able to search the electronic form of all comments received into any of FRA's dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
Occupational safety and health, Penalties, Railroad safety.
In consideration of the foregoing, FRA proposes to amend part 214 of chapter II, subtitle B of title 49, Code of Federal Regulations, as follows:
1. The authority citation for part 214 is revised to read as follows:
49 U.S.C. 20102–20103, 20107, 21301–21302, 21304; 28 U.S.C. 2461, note; and 49 CFR 1.49.
2. Section 214.315 is amended by revising paragraph (a) to read as follows:
(a) When an employer assigns a duty to a roadway worker that calls for that employee to foul a track, the employer shall provide the employee with an on-track safety job briefing that, at a minimum, includes the following:
(1) Information on the means by which on-track safety is to be provided for each track identified to be fouled;
(2) Instruction on each on-track safety procedure to be followed;
(3) Information about any adjacent tracks, on-track safety for such tracks, if required by this subpart or deemed necessary by the roadway worker in charge, and identification of any roadway maintenance machines that will foul such tracks; and
(4) A discussion of the nature of the work to be performed and the characteristics of the work location to ensure compliance with this subpart.
3. Section 214.335 is amended by removing paragraph (c) and revising the section heading to read as follows:
4. New § 214.336 is added to read as follows:
(a)
(2) If an occupied track has two adjacent controlled tracks, and one of these adjacent controlled tracks has one or more adjacent-controlled-track movements authorized at 25 mph or less, and the other adjacent controlled track has one or more concurrent adjacent-controlled-track movements authorized at over 25 mph, the more restrictive procedures in paragraph (b) of this section apply.
(3) As used in this section—
“
“
“
“
(b)
(1)
(i) A notification in accordance with § 214.319(c) indicating that the roadway worker in charge intends to authorize one or more train or other on-track equipment movements through the working limits on the adjacent controlled track, if adjacent-controlled-track on-track safety has been established through working limits alone; or
(ii) A watchman/lookout warning, if on-track safety through train approach warning (§ 214.329) has been established on the adjacent controlled track either as the sole method of on-track safety or in addition to working limits.
(2)
(ii) If the train or other on-track equipment stops before its trailing-end has passed all of the roadway workers in the roadway work group, the work to be performed on or fouling the occupied track ahead of the trailing-end of the train or other on-track equipment on the adjacent controlled track may resume only—
(A) If on-track safety through train approach warning (§ 214.329) has been established on the adjacent controlled track; or
(B) After the roadway worker in charge has communicated with the train engineer or equipment operator and established that further movements of such train or other on-track equipment shall be made only as permitted by the roadway worker in charge.
(c)
(d)
(e)
(1) One or more on-ground roadway workers performing work while exclusively positioned on the clear side of the occupied track.
(2) A hi-rail vehicle on or fouling an occupied track while engaged in a common task with one or more roadway workers on the ground, provided that such hi-rail vehicle is not coupled to one or more railroad cars or operating on the same occupied track and within the working limits of a roadway work group as described in paragraph (a) of this section. In accordance with § 214.315(a)(3), where multiple hi-rail vehicles are engaged in a common task, the on-track safety briefing shall include discussion of the nature of the work to be performed to determine if adjacent-controlled-track on-track safety is necessary.
(3) A catenary maintenance tower car on or fouling an occupied track that is engaged in a common task with one or more roadway workers positioned on the ground within the gage of the occupied track for the sole purpose of applying or removing grounds, provided that such catenary maintenance tower car is not operating on the same occupied track and within the working limits of a roadway work group as described in paragraph (a) of this section.
(f)
Agricultural Marketing Service, USDA.
Notice.
The results of the Agricultural Marketing Service's (AMS) Request for Referendum indicate that too few soybean producers wanted a referendum on the Soybean Promotion and Research Order (Order) for one to be conducted. The Request for Referendum was conducted from May 4, 2009, through May 29, 2009, at the Department of Agriculture's (USDA) Farm Service Agency county offices. To trigger a referendum, 58,918 soybean producers needed to complete a Request for Referendum. The number of soybean producers requesting a referendum was 759.
Kenneth R. Payne, Chief, Marketing Programs Branch, Livestock and Seed Program, AMS, USDA, Room 2628–S, STOP 0251, 1400 Independence Avenue, SW., Washington, DC 20250–0251; Telephone 202/720–1115; Fax 202/720–1125; or e-mail to
Pursuant to the Soybean Promotion, Research, and Consumer Information Act (Act) (7 U.S.C. 6301
A notice of opportunity to Request a Soybean Referendum was published in the
A total of 759 valid Requests for Referendum were completed by eligible soybean producers. This number does not meet the requisite number of 58,918. Therefore, based on the Request for Referendum results, a referendum will not be conducted. In accordance with the provisions of the Act, soybean producers will be provided another opportunity to request a referendum in 5 years.
The following is the State-by-State results of the Request for Referendum:
7 U.S.C. 6301–6311.
United States Commission on Civil Rights.
Notice of meeting.
Friday, December 4, 2009; 9:30 a.m. EST.
624 9th St., NW., Room 540, Washington, DC 20425.
This meeting is open to the public.
Lenore Ostrowsky, Acting Chief, Public Affairs Unit (202) 376–8591. TDD: (202) 376–8116.
Persons with a disability requiring special services, such as an interpreter for the hearing impaired, should contact Pamela Dunston at least seven days prior to the meeting at 202–376–8105. TDD: (202) 376–8116.
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 7845, 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 David Rostker, OMB Desk Officer, FAX number (202) 395–7285, or
Import Administration, International Trade Administration, Department of Commerce.
November 25, 2009.
Paul Walker, AD/CVD Operations, Office 9, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW, Washington, DC 20230; telephone: (202) 482–0413.
On April 27, 2009, the Department of Commerce (“Department”) published in the
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. 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 this deadline to a maximum of 365 days.
The Department determines that completion of the preliminary results of this review within the statutory time period is not practicable, given the extraordinarily complicated nature of the proceeding. The Department requires more time to gather and analyze a significant amount of information pertaining to the respondent's corporate structure and ownership, sales practices, and manufacturing methods. The Department also requires additional time to analyze the questionnaire responses and conduct verification. Therefore, given the number and complexity of issues in this case, and in accordance with section 751(a)(3)(A) of the Act, we are extending the time period for issuing the preliminary results of review by 60 days until January 30, 2010. The final results continue to be due 120 days after the publication of the preliminary results.
This notice is published pursuant to sections 751(1)(3)(A) and 777(i)(1) of the Act and 19 CFR 351.213(h)(2).
Import Administration, International Trade Administration, Department of Commerce
November 25, 2009.
Jacqueline Arrowsmith, AD/CVD Operations, Office 6, Import Administration, International Trade Administration, Department of Commerce, Room 7866, 14th Street and Constitution Avenue, NW, Washington DC 20230; telephone: (202) 482–5255.
On April 27, 2009, the Department published the initiation of the administrative review of the antidumping duty order on circular welded carbon steel pipes and tubes (pipes and tubes) from Thailand for the period March 1, 2008 through February 28, 2009.
Section 751(a)(3)(A) of the Tariff Act of 1930, as amended (the Act), and section 351.213(h)(1) of the Department's regulations require the Department to issue the preliminary results of a review within 245 days after the last day of the anniversary month of the order or suspension agreement for which the administrative review was requested, and final results of the review within 120 days after the date on which the notice of the preliminary results is published in the
The Department requires additional time to evaluate Saha Thai's questionnaire responses in order to conduct a thorough analysis of all information on the record. Specifically, the Department needs more time to analyze respondent's cost information and to consider whether to use quarterly costs as Saha Thai has requested. The Department, therefore, finds that it is not practicable to complete the preliminary results of this review within the original time limit and is extending the deadline for completion of the preliminary results of this administrative review of the antidumping duty order on circular welded carbon steel pipes and tubes from Thailand by 120 days, from December 1, 2009 to March 31, 2010.
This notice is issued and published pursuant to sections 751(a)(3)(A) and 777(i)(1) of the Act.
An application has been submitted to the Foreign-Trade Zones (FTZ) Board (the Board) by the Puerto Rico Trade and Export Company, grantee of FTZ 61, requesting authority to expand its zone to include additional sites in the San Juan, Puerto Rico area, in and adjacent to the San Juan Customs and Border Protection port of entry. The application was submitted pursuant to the provisions of the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a–81u), and the regulations of the Board (15 CFR Part 400). It was formally filed on November 17, 2009.
FTZ 61 was approved on October 20, 1980 (Board Order No. 165, 45 FR 71408, 10/28/80) and expanded on September 28, 2007 (Board Order No. 1528, 72 FR 56723, 10/04/07). The zone project currently consists of the following sites:
The applicant is requesting authority to expand Sites 1, 5 and 10 to include additional acreage and to include 3 additional sites in the San Juan area:
The sites will provide public warehousing and distribution services to area businesses. No specific manufacturing authority is being requested at this time. Such requests would be made to the Board on a case-by-case basis.
In accordance with the Board's regulations, Kathleen Boyce of the FTZ Staff is designated examiner to evaluate and analyze the facts and information presented in the application and case record and to report findings and recommendations to the Board.
Public comment on the application is invited from interested parties. Submissions (original and 3 copies) shall be addressed to the Board's Executive Secretary at the address listed below. The closing period for their receipt is January 25, 2010. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period (to February 8, 2010).
A copy of the application will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 2111, U.S. Department of Commerce, 1401 Constitution Avenue, NW., Washington, DC 20230–0002, and in the “Reading Room” section of the Board's Web site, which is accessible via
For further information, contact Kathleen Boyce at
Import Administration, International Trade Administration, Department of Commerce.
The Department of Commerce (“the Department”) has received requests to conduct administrative reviews of various antidumping duty orders and findings with October anniversary dates. In accordance with the Department's regulations, we are initiating those administrative reviews.
November 25, 2009.
Sheila E. Forbes, Office of AD/CVD Operations, Customs Unit, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW, Washington, DC 20230, telephone: (202) 482–4697.
The Department has received timely requests, in accordance with 19 CFR 351.213(b), for administrative reviews of various antidumping duty orders and findings with October anniversary dates.
Under 19 CFR 351.213(d)(3), the Department may rescind a review where there are no exports, sales, or entries of subject merchandise during the respective period of review (“POR”) listed below. If a producer or exporter named in this notice of initiation had no exports, sales, or entries during the POR, it should notify the Department within 30 days of publication of this notice in the
In the event the Department limits the number of respondents for individual examination for administrative reviews, the Department intends to select respondents based on U.S. Customs and Border Protection (“CBP”) data for U.S. imports during the POR. We intend to release the CBP data under Administrative Protective Order (“APO”) to all parties having an APO within five days of publication of this initiation notice and to make our decision regarding respondent selection within 20 days of publication of this
In proceedings involving non–market economy (“NME”) countries, the Department begins with a rebuttable presumption that all companies within the country are subject to government control and, thus, should be assigned a single antidumping duty deposit rate. It is the Department's policy to assign all exporters of merchandise subject to an administrative review in an NME country this single rate unless an exporter can demonstrate that it is sufficiently independent so as to be entitled to a separate rate.
To establish whether a firm is sufficiently independent from government control of its export activities to be entitled to a separate rate, the Department analyzes each entity exporting the subject merchandise under a test arising from the
All firms listed below that wish to qualify for separate–rate status in the administrative reviews involving NME countries must complete, as appropriate, either a separate–rate application or certification, as described below. For these administrative reviews, in order to demonstrate separate–rate eligibility, the Department requires entities for whom a review was requested, that were assigned a separate rate in the most recent segment of this proceeding in which they participated, to certify that they continue to meet the criteria for obtaining a separate rate. The Separate Rate Certification form will be available on the Department's website at http://www.trade.gov/ia on the date of publication of this
For entities that have not previously been assigned a separate rate, to demonstrate eligibility for such, the Department requires a Separate Rate Status Application. The Separate Rate Status Application will be available on the Department's website at http://www.trade.gov/ia on the date of publication of this
For exporters and producers who submit a separate–rate status application or certification and subsequently are selected as mandatory respondents, these exporters and producers will no longer be eligible for separate–rate status
In accordance with 19 CFR 351.221(c)(1)(i), we are initiating administrative reviews of the following antidumping duty orders and findings. We intend to issue the final results of these reviews not later than October 31, 2010.
During any administrative review covering all or part of a period falling between the first and second or third and fourth anniversary of the publication of an antidumping duty order under 19 CFR 351.211 or a determination under 19 CFR 351.218(f)(4) to continue an order or suspended investigation (after sunset review), the Secretary, if requested by a domestic interested party within 30 days of the date of publication of the notice of initiation of the review, will determine, consistent with
For the first administrative review of any order, there will be no assessment of antidumping or countervailing duties on entries of subject merchandise entered, or withdrawn from warehouse, for consumption during the relevant provisional–measures “gap” period, of the order, if such a gap period is applicable for the POR.
Interested parties must submit applications for disclosure under APO in accordance with 19 CFR 351.305. On January 22, 2008, the Department published
These initiations and this notice are in accordance with section 751(a) of the Tariff Act of 1930, as amended (19 U.S.C. 1675(a)), and 19 CFR 351.221(c)(1)(i).
National Ocean Service, National Oceanic and Atmospheric Administration (NOAA), Department of Commerce.
Notice of public meeting (via conference call) on December 16, 2009.
The Hydrographic Services Review Panel (HSRP), a Federal Advisory Committee, will be holding a public meeting via teleconference on December 16, 2009. The purpose of the meeting is to discuss and vote on proposed revisions to an updated version of the Hydrographic Services Review Panel Federal Advisory Committee Special Report 2007, “HSRP Most Wanted Hydrographic Services Improvements.”
Rebecca Arenson, NOAA, Office of Coast Survey, National Ocean Service (NOS), NOAA (N/CS), 1315 East West Highway, Silver Spring, Maryland 20910; Telephone: 301–713–2780 x158, e-mail:
The Hydrographic Services Review Panel (HSRP) was established by the Secretary of Commerce to advise the Under Secretary of Commerce for Oceans and Atmosphere on matters related to the responsibilities and authorities set forth in section 303 of the Hydrographic Services Improvement Act of 1998, its amendments, and such other appropriate matters that the Under Secretary refers to the Panel for review and advice.
The HSRP conference call is open to the public; participation is available on a first-come, first-served basis, and may be limited.
Items on the meeting agenda include: (1) Proposed revisions to an updated version of the Hydrographic Services Review Panel Federal Advisory Committee Special Report 2007, “HSRP Most Wanted Hydrographic Services Improvements,” and (2) other topics. Agenda topics and times are subject to change. For the most current meeting agenda, refer to the HSRP Web site:
The Regulations and Procedures Technical Advisory Committee (RPTAC) will meet December 9, 2009, 9 a.m., Room 3884, in the Herbert C. Hoover Building, 14th Street between Constitution and Pennsylvania Avenues, NW., Washington, DC. The Committee advises the Office of the
1. Opening remarks by the Chairman.
2. Presentation of papers or comments by the Public.
3. Opening remarks by Bureau of Industry and Security.
4. Export Enforcement update.
5. Regulations update.
6. Working group reports.
7. Automated Export System (AES) update.
8. 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 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 the distribution of public presentation materials to the Committee members, the Committee suggests that presenters forward the public presentation materials prior to the meeting to Ms. Springer via e-mail.
The Assistant Secretary for Administration, with the concurrence of the delegate of the General Counsel, formally determined on March 23, 2009, pursuant to Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. app. 2 section (10)(d)), that the portion of the meeting dealing with matters the disclosure of which would be likely to frustrate significantly implementation of an agency action as described in 5 U.S.C. 552b(c)(9)(B) shall 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 remaining portions of the meeting will be open to the public.
For more information, call Yvette Springer at (202) 482–2813.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meeting.
This notice advises the public that the Western Pacific Fishery Management Council (Council) will convene a meeting of its Advisory Panel.
The Advisory Panel meeting will be held December 15–17, 2009. For the specific time and agenda for the meeting see
The meeting of the Advisory Panel will be held at the Council office at 1164 Bishop Street, Suite 1400, Honolulu, HI 96813.
Kitty M. Simonds, Executive Director; telephone: (808) 522–8220.
The date, time and agenda for each meeting are as follows:
1. Welcome and Introductions
2. Review and approval of agenda
3. Reports on fishery and community issues, American Samoa, Guam, CNMI and Hawaii
4. Status of Council programs
5. New directions
a. Council process
b. Administrative initiatives
c. Leveraging Council family resources and networks
d. Other initiatives
6. Guest presentation on effects of El Nino in the Western Pacific Region
7. Breakout session on how the Advisors can help implement Council programs
a. Improving communication
b. Public engagement strategies
8. Review and discussion on breakout outcomes
9. Hawaii Institute of Marine Biology site visit and guest presentations on (1) Using genetics and life history to track spread of introduced taape, roi and toau in Hawaii; (2) Recent advances in population resolution with examples from Hawaii; and (3) Complex population structure and management of migratory marine animals.
10. Council issues and actions
a. Catch shares
b. Annual Catch Limits
c. Collecting fishing information
i. Report on data workshop
ii. Non-commercial federal permit and reporting
iii. Voluntary data collection
d. Marine spatial planning
i. Offshore aquaculture options
ii. Hawaii bottomfish essential fish habitat and habitat of particular concern options
iii. Monuments
iv. Marine protected area policy
v. Buoys and Moorings
vi. Other
e. Community programs
i. Cooperative research
ii. Marine Education and Training
iii. Community networking
iv. Fish aggregation devices
v. Marine Conservation Plan community development project
vi. Traditional Ecological Knowledge Summit
f. Federal/agency presentations
i. Status of Western Pacific Region sea turtles
ii. Coral reef assessments
11. Breakout session to discuss fishery and program issues
a. Develop recommendations on action items as presented
b. Develop strategy and plan to further discuss issues with the public
12. Reconvene plenary
a. Review breakout outcomes
b. Summarize recommendations
c. Consider region-wide recommendations
13. Guest presentation - TBD
14. 2010 Calendar of meeting and events
a. Council meetings, workshops and events
b. Other meetings and events
15. Review and finalize outcomes
a. Recap recommendations and plans by island area
b. Consider additional actions
16. Other issues
The order in which agenda items are addressed may change. Public comment
Although non-emergency issues not contained in this agenda may come before this group for discussion, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), those issues may not be the subject of formal action during these meetings. Actions will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under Section 305(c) of the Magnuson-Stevens 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 Kitty M. Simonds, (808) 522–8220 (voice) or (808) 522–8226 (fax), at least 5 days prior to the meeting date.
16 U.S.C. 1801
Corporation for National and Community Service.
Notice.
The Corporation for National and Community Service (hereinafter the “Corporation”), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) (44 U.S.C. 3506(c)(2)(A)). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirement on respondents can be properly assessed.
Currently, the Corporation is soliciting comments on the Service-Learning Evaluation Study Feasibility Questionnaire. In this process, State Education Agencies will be asked about the type of service-learning within their state and the feasibility of the Service-Learning Evaluation Study. This information will be used to help determine the recruitment strategy for the Service-Learning Evaluation Study.
Copies of the information collection requests can be obtained by contacting the office listed in the
Written comments must be submitted to the individual and office listed in the
You may submit comments, identified by the title of the information collection activity, by any of the following methods:
(1)
(2) By hand delivery or by courier to the Corporation's mailroom at Room 8100 at the mail address given in paragraph (1) above, between 9 a.m. and 4 p.m. Monday through Friday, except Federal holidays.
(3)
(4)
Carla Fletcher, (202) 606–6720, or by e-mail at
The Corporation is particularly interested in comments that:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Corporation, 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 expected to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology (
The Corporation is developing a Service-Learning Evaluation in response to the Edward M. Kennedy Serve America Act (H.R. 1388) legislative mandate to assess the impact of the activities carried out under the Learn and Serve America Program. In developing the recruitment plan, the Corporation would like to work with the State Education Agencies to develop an effective strategy and begin to identify states that are able to participate in the study.
The Corporation seeks to collect new information on the feasibility of a Service-Learning Evaluation Study in order to identify an effective recruitment strategy and potential states that could participate in the Service-Learning Evaluation.
Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request; they will also become a matter of public record.
Notice is hereby given that the Delaware River Basin Commission will
The conference among the commissioners and staff will begin at 10:30 a.m. and will consist of a presentation by a spokesperson for New York City regarding temporary closure of the Delaware Aqueduct; a report by the chair of the Toxics Advisory Committee; a report by the chair of the Water Quality Advisory Committee; and a presentation on the Pocono Creek Watershed Sustainability Study.
The subjects of the public hearing to be held during the 1 p.m. business meeting include the dockets listed below:
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
In addition to the standard business meeting items, including adoption of the Minutes of the Commission's previous (October 22, 2009) business meeting; announcements of upcoming advisory committee meetings and events of interest; a report on hydrologic conditions; a report by the Executive Director; and a report by the Commission's General Counsel, the business meeting also will include public hearings and consideration by the Commission of resolutions: (a) Extending Docket No. D–69–210 CP Final (Revision 12) for the Limerick Generating Station Water Supply Modification Demonstration Project and Wadesville Mine Pool Withdrawal and Streamflow Augmentation Demonstration Project for a period of one year or until the Commission approves a revised docket, whichever occurs first; (b) authorizing the Executive Director to modify Docket D–71–86–2 for DuPont's Edge Moor Titanium Dioxide Facility Industrial Wastewater Discharge to provide additional time and to establish an approved schedule for installation of a diffuser by January 31, 2010; (c) approving the Commission's FY 2010–2015 Water Resources Program; (d) approving guidance consisting of a DRBC “penalty matrix” to assist regulated entities and DRBC staff in reaching negotiated settlements for suspected violations of DRBC regulations; (e) authorizing and directing the Executive Director to enter into a revised administrative agreement with the State of New Jersey for the submission and review of projects under Section 3.8 of the Compact; and (f) approving the DRBC fiscal year 2011 operating and capital budgets. An opportunity for public dialogue will be provided at the end of the meeting.
Draft dockets scheduled for public hearing on December 9, 2009 can be accessed through the Notice of Commission Meeting and Public Hearing on the Commission's Web site, drbc.net, ten days prior to the meeting date. Additional public records relating to the dockets may be examined at the Commission's offices. Please contact William Muszynski at 609–883–9500, extension 221, with any docket-related questions.
Note that conference items are subject to change and items scheduled for hearing are occasionally postponed to allow more time for the Commission to consider them. Please check the Commission's website, drbc.net, closer to the meeting for changes that may be made after the deadline for filing this notice.
Individuals in need of an accommodation as provided for in the Americans with Disabilities Act who wish to attend the informational meeting, conference session or hearings should contact the commission secretary directly at 609–883–9500 ext. 203 or through the Telecommunications Relay Services (TRS) at 711, to discuss how the Commission can accommodate your needs.
Department of Education.
The Acting 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.
Interested persons are invited to submit comments on or before December 28, 2009.
Written comments should be addressed to the Office of Information and Regulatory Affairs,
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. OMB may amend or waive the requirement for public consultation to the extent that public
Requests for copies of the information collection submission for OMB review may be accessed from
Comments regarding burden and/or the collection activity requirements should be electronically mailed to
Department of Education.
The Acting 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.
Interested persons are invited to submit comments on or before December 28, 2009.
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 send email 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. OMB may amend or waive the requirement for public consultation to the extent that public participation in the approval process would defeat the purpose of the information collection, violate State or Federal law, or substantially interfere with any agency's ability to perform its statutory obligations. The Acting Director, Regulatory Information Management Services, Office of Management, publishes that notice containing proposed information collection requests prior to submission of these requests to OMB. Each proposed information collection, grouped by office, contains the following: (1) Type of review requested, e.g. new, revision, extension, existing or reinstatement; (2) Title; (3) Summary of the collection; (4) Description of the need for, and proposed use of, the information; (5) Respondents and frequency of collection; and (6) Reporting and/or Recordkeeping burden. OMB invites public comment.
Requests for copies of the information collection submission for OMB review may be accessed from
Comments regarding burden and/or the collection activity requirements should be electronically mailed to
Department of Education.
The Acting 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.
Interested persons are invited to submit comments on or before December 28, 2009.
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 send email 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. OMB may amend or waive the requirement for public consultation to the extent that public participation in the approval process would defeat the purpose of the information collection, violate State or Federal law, or substantially interfere with any agency's ability to perform its statutory obligations. The Acting Director, Regulatory Information Management Services, Office of Management, publishes that notice containing proposed information collection requests prior to submission of these requests to OMB. Each proposed information collection, grouped by office, contains the following: (1) Type of review requested,
Requests for copies of the information collection submission for OMB review may be accessed from
Comments regarding burden and/or the collection activity requirements should be electronically mailed to
Take notice that the Commission received the following exempt wholesale generator filings:
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following electric securities filings:
Any person desiring to intervene or to protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214) on or before 5 p.m. Eastern time on the specified comment date. It is not necessary to separately intervene again in a subdocket related to a compliance filing if you have previously intervened in the same docket. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant. In reference to filings initiating a new proceeding, interventions or protests submitted on or before the comment deadline need not be served on persons other than the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 14 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First St., NE., Washington, DC 20426.
The filings in the above proceedings are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive e-mail notification when a document is added to a subscribed dockets(s). For assistance with any FERC Online service, please e-mail
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following electric securities filings:
Any person desiring to intervene or to protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214) on or before 5 p.m. Eastern time on the specified comment date. It is not necessary to separately intervene again in a subdocket related to a compliance filing if you have previously intervened in the same docket. Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant. In reference to filings initiating a new proceeding, interventions or protests submitted on or before the comment deadline need not be served on persons other than the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 14 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First St., NE., Washington, DC 20426.
The filings in the above proceedings are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive e-mail notification when a document is added to a subscribed dockets(s). For assistance with any FERC Online service, please e-mail
Environmental Protection Agency (EPA).
Notice of public comment period.
EPA is announcing a 30-day public comment period for the draft document titled, “A Framework for Categorizing the Relative Vulnerability of Threatened and Endangered Species to Climate Change” (EPA/600/R–09/011). The document was prepared by the National Center for Environmental Assessment within EPA's Office of Research and Development. This draft document describes an evaluative framework that may be used to categorize the relative vulnerability of species to climate change. To illustrate the use of this framework, it was applied to five U.S. threatened and endangered species: The golden-cheeked warbler, the salt marsh harvest mouse, the Mount Graham red squirrel, the Lahontan cutthroat trout, and the desert tortoise. A sixth species, the bald eagle which is no longer listed as threatened or endangered, except for the southwest population, was also evaluated.
An external peer review of this report has been completed. The public comment period and the external peer review are separate processes. The public comment period provides an opportunity for all interested parties to comment on the document. When finalizing the draft document, EPA will consider any public comments received in accordance with this notice.
EPA is releasing this draft document solely for the purpose of pre-dissemination review and comment under applicable information quality guidelines. This document has not been formally disseminated by EPA and does not represent and should not be construed to represent any Agency policy or determination. The first draft of this report was reviewed in 2002 by the U.S. Fish and Wildlife Service within the Department of the Interior. This final draft is being released to the public as well as to other federal agencies who may wish to comment.
The 30-day public comment period begins November 25, 2009, and ends December 28, 2009. Technical comments should be in writing and must be received by EPA by December 28, 2009.
The draft “A Framework for Categorizing the Relative Vulnerability of Threatened and Endangered Species to Climate Change” is available primarily via the Internet on the National Center for Environmental Assessment's home page under the Recent Additions and the Data and Publications menus at
Comments may be submitted electronically via
For information on the public comment period, contact the Office of Environmental Information Docket; telephone: 202–566–1752; facsimile: 202–566–1753; or e-mail:
For technical information, contact Susan Julius, NCEA; telephone: 703–347–8619; facsimile: 703–347–8694; or e-mail:
The document, “A Framework for Categorizing the Relative Vulnerability of Threatened and Endangered Species to Climate Change” describes an evaluative framework that may be used to categorize the relative vulnerability of species to climate change. It is intended that the results of applying the framework be regarded as indications of the comparative vulnerabilities of species, not estimates of a species' absolute vulnerability to climate change. Four modules compose this framework: Module 1 categorizes baseline vulnerability to extinction or major population reduction by scoring those elements of the species' life history, demographics, and conservation status that influence the likelihood of its survival or extinction (excluding climatic changes); Module 2 scores the likely vulnerability of a species to future climate change, including the species' potential physiological, behavioral, demographic, and ecological response to climate change; Module 3 combines the results of Modules 1 and 2 into a matrix to produce an overall score of the species' vulnerability to climate change, which maps to an adjectival category, such as “critically vulnerable,” “highly vulnerable,” “less vulnerable,” and “least vulnerable;” Module 4 is a qualitative determination of uncertainty of overall vulnerability (high, medium, and low) based on evaluations of uncertainty done in each of the first 3 modules.
To illustrate the use of this framework, it was applied to six U.S. species that were listed as threatened or endangered at the time the framework was developed. Based on the framework, four of those species were categorized as “critically vulnerable” to climate change: The golden-cheeked warbler (
This framework was developed by EPA's Global Change Research Program and is offered as one of a number of potential approaches for prioritizing those species most vulnerable to climate change. It is not intended to serve as a tool for determining whether a species is endangered or threatened under the Section 4 listing process of the Endangered Species Act.
EPA's Global Change Research is an assessment-oriented program committed to developing frameworks and tools to assist decision-makers in evaluating the impacts of climate change to air quality, water quality and ecosystems.
Submit your comments, identified by Docket ID No. EPA–HQ–ORD 2009–0816, by one of the following methods:
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•
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If you provide comments by mail or hand delivery, please submit three copies of the comments. For attachments, provide an index, number pages consecutively with the comments, and submit an unbound original and three copies.
Environmental Protection Agency (EPA).
Notice.
EPA has authorized contractor, Computer Sciences Corporation (CSC) of Chantilly, VA and its subcontractors, to access information which has been submitted to EPA under all sections of the Toxic Substances Control Act (TSCA). Some of the information may be claimed or determined to be Confidential Business Information (CBI).
Access to the confidential data will occur no sooner than December 2, 2009.
This action is directed to the public in general. This action may, however, be of interest to all who manufacture, process or distribute industrial chemicals. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under
EPA has established a docket for this action under docket identification (ID) number EPA–HQ–OPPT–2003–0004. All documents in the docket are listed in the docket index available at
Under Contract Number GS00T99ALD0203, Task Order Number EP10H000097, contractors CSC of 15000 Conference Center Drive, Chantilly, VA and its subcontractors Apex Systems, Inc. of 5430 Wade Park Blvd, Raleigh, NC; APPTIS Systems, Inc. of 4800 Westfields Blvd, Chantilly, VA; Berrett and Associates, Inc. of P.O. Box 2891, Sterling, VA; Digital Intelligence Systems Corp. of 4151 Lafayette Center Dr, Suite 600, Chantilly, VA; Excel Management Systems, Inc. of P.O. Box 8280, Columbus, OH; General Dynamics Advanced Information Systems of 10560 Arrowhead Dr., Fairfax, VA; KForce, Inc. of 12010 Sunset Hills Road, Suite 200, Reston, VA; and Paloma Systems, Inc. of 11250 Waples Mill Road, Suite 300, Fairfax, VA will assist the Office of Pollution Prevention and Toxics (OPPT) in the Local Technology Service (LTS) support task; provide Information Technology (IT) services in support of EPA’s program offices; provide the EPA community with voice, data, and video technologies that meet their needs and requirements. The contractors will also provide engineering, operational, consulting, and/or development support services as requested by the TSCA CBI office. Finally, the contractor team will manage each project from start to completion and provide follow-on support when applicable.
In accordance with 40 CFR 2.306(j), EPA has determined that under Contract Number GS00T99ALD0203, Task Order Number EP10H000097, CSC and its subcontractors will require access to CBI submitted to EPA under all sections of TSCA to perform successfully the duties specified under the contract. CSC and its subcontractors’ personnel will be given access to information submitted to EPA under all sections of TSCA.
EPA is issuing this notice to inform all submitters of information under all sections of TSCA that EPA may provide CSC and its subcontractors access to these CBI materials on a need-to-know basis only. All access to TSCA CBI under this contract will take place at EPA Headquarters and the Research Triangle Park, NC facilities in accordance with EPA’s TSCA CBI Protection Manual.
Access to TSCA data, including CBI, will continue until March 30, 2010. If the contract is extended, this access will also continue for the duration of the extended contract without further notice.
CSC and its subcontractors’ personnel will be required to sign nondisclosure agreements and will be briefed on appropriate security procedures before they are permitted access to TSCA CBI.
Environmental Protection, Confidential Business Information.
Environmental Protection Agency (EPA).
Notice.
EPA has authorized its contractor, Science Applications International Corporation (SAIC)], to access information which has been submitted to EPA under sections 4, 5, 8, 12, and 13 of the Toxic Substances Control Act (TSCA). Some of the information may be claimed or determined to be Confidential Business Information (CBI).
Access to the confidential data will occur no sooner than December 2, 2009.
This action is directed to the public in general. This action may, however, be of interest to all who manufacture, process, or distribute industrial chemicals. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under
Under Contract Number EP–W–09–032, contractor SAIC of 10260 Campus Point Drive, San Diego, CA, will assist the Office of Pollution Prevention and Toxics (OPPT) and the Office of Civil Enforcement (OCE) Core TSCA enforcement program by targeting facilities for inspections and investigations; inspecting and investigating facilities; case reviews and case development of activities relating to the manufacture, processing, distribution in commerce and disposal of toxic substances; developing and implementing data systems for internal enforcement tracking; and information collection from businesses that may request TSCA-CBI claims. SAIC may work in conjunction with the Information Management Division, Chemical Control Division, Economics, Exposure and Technology Division, and the Risk Assessment Division in OPPT. SAIC may work with data contained in the OPPT data systems, such as CICIS (TSCA Public Inventory), CCID (TSCA Confidential Inventory), CUS (Chemical Update System), CBITS (Confidential Business Information Tracking System), and MITS (Management Information Tracking System), to obtain information to support OCE’s enforcement activities. All CBI claims requested when conducting investigations and inspections, issuing warrants or delivering subpoenas from which information collected and reviewed determines compliance, will be handled in accordance to the CBI Procedures. SAIC will administer a CBI documents tracking system beginning when the initial control number is assigned until the document is transferred to the EPA DCO, other SAIC DCO, returned to the company by the DCO, or destroyed by the DCO as required.
In accordance with 40 CFR 2.306(j), EPA has determined that under Contract Number EP–W–09–032, SAIC will require access to CBI submitted to EPA under sections 4, 5, 8, 12, and 13 of TSCA to perform successfully the duties specified under the contract. SAIC personnel will be given access to information submitted to EPA under sections 4. 5, 8, 12, and 13 of TSCA.
EPA is issuing this notice to inform all submitters of information under sections 4, 5, 8, 12, and 13 of TSCA that EPA may provide SAIC access to these CBI materials on a need-to-know basis only. All access to TSCA CBI under this contract will take place at EPA Headquarters and SAIC’s sites located at the Energy, Environment and Infrastructure Business Unit, 12100 Sunset Hills Road, Reston, VA and 405 Urban Street, Suite 400, Lakewood, CO. However, no CBI storage or access will take place at the facilities until after an inspection has taken place and the Agency is satisfied that the sites meet the specifications for the use and storage of TSCA CBI materials.
Access to TSCA data, including CBI, will continue until September 30, 2014. If the contract is extended, this access will also continue for the duration of the extended contract without further notice.
SAIC personnel will be required to sign nondisclosure agreements and will be briefed on appropriate security procedures before they are permitted access to TSCA CBI.
Environmental Protection, Confidential Business Information.
Environmental Protection Agency (EPA).
Notice.
In compliance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Additional comments may be submitted on or before December 28, 2009.
Submit your comments, referencing Docket ID No. EPA–HQ–RCRA–2009–0319, to (1) EPA, either online using
Toshia King, Office of Resource Conservation and Recovery, mailcode 5303P, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 703–308–7033; fax number: 703–308–8617; 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 May 27, 2009 (74 FR 25236) 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–RCRA–2009–0319, which is available for online viewing at
Use EPA's electronic docket and comment system at
Environmental Protection Agency (EPA).
Notice.
In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
Additional comments may be submitted on or before December 28, 2009.
Submit your comments, referencing docket ID number EPA–HQ–OECA–2009–0417, to (1) EPA online using
Robert C. Marshall, Jr., Office of Compliance, Mail code: 2223A, Environmental Protection Agency, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone number: (202) 564–7021; fax number: (202) 564–0050; 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 July 8, 2009 (74 FR 32580), 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 number EPA–HQ–OECA–2009–0417, which is available for public viewing online at
Use EPA's electronic docket and comment system at
Environmental Protection Agency (EPA).
Notice.
In compliance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Additional comments may be submitted on or before December 28, 2009.
Submit your comments, referencing Docket ID No. EPA–HQ–OPP–2008–0917, to (1) EPA online using
Cameo Smoot, Field and External Affairs Division, Office of Pesticide Programs, 7506P, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 703–305–5454; fax number: 703–305–5884; 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 25, 2009 (74 FR 8537), 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–OPP–2008–0917, which is available for online viewing at
Environmental Protection Agency (EPA).
Notice of final order on petition to object to Clean Air Act (Act) operating permit.
This document announces that the Administrator of EPA has responded to a petition submitted by the Environmental Law and Policy Center, Hoosier Environmental Council, Natural Resources Defense Council, Save the Dunes, Sierra Club, Susan Eleuterio, and Tom Tsourlis (petitioners) asking EPA to object to an operating permit issued by the Indiana Department of Environmental Management to the BP Products North America, Inc., Whiting Business Unit (Whiting). The Administrator granted the petition in part and denied it in part.
Pursuant to section 505(b)(2) of the Act, a petitioner may seek in the United States Court of Appeals for the appropriate circuit judicial review of those portions of a petition which EPA denied. Any petition for review shall be filed within 60 days from the date this notice appears in the
You may review copies of the final order, the petition, and other supporting information at the EPA Region 5 Office, 77 West Jackson Boulevard, Chicago, Illinois 60604. If you wish to examine these documents, you should make an appointment at least 24 hours before visiting the EPA office. Additionally, the final order for the Whiting petition is available electronically at:
Pamela Blakley, Chief, Air Permits Section, Air Programs Branch, Air and Radiation Division, EPA, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, telephone (312) 886–4447.
The Act affords EPA a 45-day period to review, and object, as appropriate, to operating permits proposed by State permitting authorities. Section 505(b)(2) of the Act authorizes any person to petition the EPA Administrator within 60 days after the expiration of the EPA review period to object to a State operating permit if EPA has not done so. A petition must be based only on objections to the permit that were raised with reasonable specificity during the public comment period provided by the State, unless the petitioner demonstrates that it was impracticable to raise issues during the comment period, or the grounds for the issues arose after this period.
On August 19, 2008, EPA received a petition requesting that EPA object to the Title V operating permit for Whiting. The Petitioners allege that the permit is not in compliance with the requirements of the Act.
Specifically, the Petitioners allege that: (1) The permit application lacks emission information and calculations critical for determining applicable requirements and setting appropriate limits and conditions; (2) the minor source permit fails to comply with New Source Review requirements because the project is a major modification when all project emissions are properly included; (3) the permit does not include applicable Best Available Control Technology and Lowest Achievable Emission Rate limits for flares and other sources; (4) BP and IDEM failed to conduct the proper greenhouse gas Best Achievable Control Technology analysis; and (5) the permit omits compliance schedules that Title V requires to ensure compliance with all applicable requirements, as supported by the Notice of Violation issued by EPA to BP for its Whiting refinery.
On October 16, 2009, the Administrator issued an order granting the Whiting petition in part and denying it in part. The order explains the reasons behind EPA's conclusions.
Environmental Protection Agency (EPA).
Notice.
The EPA has authorized the following contractor to access trade secret information that has been, or will be, submitted to EPA under sections 303, 311 and 312 of the Emergency Planning and Community Right-to-Know Act (EPCRA): CGI Federal, Inc. and its subcontractor, Management Support Technology, Inc. (MSTI), (GSA Contract #GS–35F4797H TO#1518, expiring March 30, 2012). The EPA also announces a new address to which EPCRA trade secrets are to be sent.
This new address is effective on November 25, 2009.
EPCRA Trade Secrets submitted to EPA should be mailed to: CGI Federal, c/o CDX Reporting Center, P.O. 10162, Fairfax, VA 22038. Courier deliveries and express mail should be addressed to: CDX Reporting Center, c/o CGI Federal, 12601 Fair Lakes Circle, Fairfax, VA 22033.
Sicy Jacob at (202) 564–8019.
The EPA is issuing this notice to inform all submitters of trade secret claims submitted under sections 303, 311 and 312 of EPCRA that EPA may provide the above mentioned contractor and its subcontractor access to these materials on a need-to-know basis. This contractor will provide technical support to the Office of Emergency Management in the receipt, processing and storage of these trade secret claims submitted to EPA. In accordance with 40 CFR 350.23, EPA has determined that the contractor and its subcontractor require access to trade secret and confidential information submitted to EPA under 40 CFR part 350 in order to perform work satisfactorily under the above noted contract. The contractor's and subcontractor's personnel will be required to sign nondisclosure agreements prior to receiving access to trade secrets. All contractor access to trade secrets will take place at the contractor's facility. The contractor will have appropriate procedures and facilities in place to safeguard the trade secrets to which the contractor and its subcontractor have access. Clearance for access to trade secrets is scheduled to expire on March 30, 2012 or at contract termination.
EPCRA Trade Secrets submitted to EPA should be mailed to: CGI Federal, c/o CDX Reporting Center, P.O. 10162, Fairfax, VA 22038. Courier deliveries and express mail should be addressed to: CDX Reporting Center, c/o CGI Federal, 12601 Fair Lakes Circle, Fairfax, VA 22033.
Environmental Protection Agency (EPA).
Notice of Public Meetings.
EPA will conduct six public meetings to solicit input on methods being evaluated by the Office of Pesticide Programs (OPP) and the Office of Water (OW), with the support of the Office of Research and Development (ORD) to characterize effects from pesticides on fish, other aquatic organisms, and aquatic plants in aquatic ecosystems. These public meetings will be held in Chicago, IL (Region 5), Edison, NJ (Region 2), Kansas City, KS (Region 7), Atlanta, GA (Region 4), San Francisco, CA (Region 9), and Seattle, WA (Region 10), starting in January 2010. At the public meetings, EPA will provide presentations that detail its initial thinking on how to ensure that pesticide effects are characterized consistently by both OPP and OW.
The public meetings will be held on the following dates: January 11, 2010; January 12, 2010; January 14, 2010; January 19, 2010; January 21, 2010; and January 22, 2010.
The meetings will be held at the following locations and times:
To request accommodation of a disability, please contact the person listed under
Jane Hopkins, Field and External Affairs Division (7506P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, D.C. 20460; telephone number: (703) 305–7195; e-mail address:
This action is directed to the public in general, and may be of interest to a wide range of stakeholders, including environmental, water resources professionals, and agricultural advocates, the chemical industry, pesticide users, and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
EPA has established a docket for this action under docket ID number EPA–HQ–OPP–2009–0773. Publicly available docket materials are available either in the electronic docket at
Section 304(a)(1) of the Clean Water Act (CWA) requires EPA to develop, publish, and from time to time, revise criteria for water quality accurately reflecting the latest scientific knowledge. Water quality criteria are scientifically derived numeric values that measure the level beyond which pollutants in ambient water will have deleterious effects on aquatic life or human health. Water quality criteria developed under Section 304(a) are based solely on data and scientific judgments on the relationship between pollutant concentrations and environmental and human health effects. Section 304(a) criteria do not reflect consideration of economic impacts or the technological feasibility of meeting the chemical concentrations in ambient water.
Section 304(a) criteria provide guidance to states and authorized tribes in adopting water quality standards that ultimately provide the basis for controlling discharges or releases of pollutants. The criteria also provide guidance to EPA when promulgating Federal regulations under Section 303(c) when such action is necessary. Under the CWA and its implementing regulations, states and authorized tribes adopt water quality criteria to measure attainment of designated uses (e.g., public water supply, recreational use, industrial use). EPA’s recommended criteria do not impose legally binding requirements. States and authorized tribes have the discretion to adopt, where appropriate, other scientifically defensible water quality criteria that differ from EPA’s recommended criteria.
FIFRA requires that all pesticides used in the United States be registered by EPA for use and, thus, ensures Federal control of distribution, sale, and use of pesticides. Registration assures that pesticides will be properly labeled and that, if used in accordance with labeled specifications, will not cause unreasonable adverse effects on human health and the environment. FIFRA ecological risk assessments quantitatively evaluate reduced survival of aquatic animals from direct acute exposures and survival, growth, and reproductive impairment for aquatic animals from direct chronic exposures. Assessments for aquatic plants focus on growth rates and biomass (reproduction) measurements. Risk management decisions for pesticide registration under FIFRA take into consideration benefits in addition to risks of pesticides used; however, benefits are not considered in characterizing ecological effects under FIFRA or in deriving ambient water quality criteria (AWQC) values under CWA.
For FIFRA ecological effects assessments, EPA peer reviews toxicity data provided by the registrant as required by regulation, as well as data from public sources obtained from EPA’s ECOTOX database. Current testing requirements for aquatic organisms include toxicity studies containing information on survival, reproduction, and growth endpoints for freshwater and estuarine/marine animals and biomass and growth endpoints for aquatic plants. These test requirements are defined for each chemical class by use category in title 40 of the Code of Federal Regulations, part 158. Studies are performed on laboratory test organisms in the following broad taxonomic groupings: freshwater fish and invertebrates, estuarine/marine fish and invertebrates, and aquatic plants. For screening-level assessments, OPP’s effects assessments are based on the lowest acute and chronic toxicity values from the most sensitive species tested in acceptable studies. More refined assessments may use the full species sensitivity distribution for a given taxa or other toxicity endpoints, as for the variability and uncertainty of the data (probabilistic approaches). The “OPP Aquatic Benchmarks” is a web site developed by OPP that contains the aquatic toxicity endpoints used in EPA pesticide risk assessments. (
Although both OPP’s and OW’s approaches afford a high degree of protection for aquatic life, stakeholders have identified a need for consistent and timely Federal input that will allow EPA, states, tribes, and the public to gauge whether pesticides represent a concern for aquatic life, for example, based on water monitoring results. To address these concerns, the Agency has begun a process to explore how to build on the high quality science in both OW and OPP to develop additional tools and approaches to support a consistent and common set of effects characterization methods using best available information. A Scoping Document has been developed that describes this effort in more detail. A letter signed by the Office Directors of OPP and OW, and reinforced by the Scoping Document, has invited public participation in our collective efforts. Following through on this invitation, regional public meetings are being planned for January 2010 to solicit input on the Agency’s initial thinking regarding methods, tools, and approaches that are being developed and evaluated by OPP and OW, with the support of ORD, to assure that pesticide ecological effects are characterized consistently. The areas for consideration under this effort include:
• Development and evaluation of predictive tools for use in development of community level benchmarks
• Development of aquatic life community level benchmarks with datasets that do not conform to the “1985 Guidelines”
• Derivation of aquatic life screening values for aquatic plants
The tools and approaches developed by EPA will:
• Continue to be based upon sound science and utilize the available data,
• Be legally defensible under our statutory mandates,
• Be based upon methodologies that are as consistent and practical as possible,
• Be implementable at the Federal and State level.
• Be developed as quickly and efficiently as possible, and
• Reflect stakeholder input and comments.
During these meetings, EPA will also solicit input from Regional stakeholders regarding the following:
1. Additional sources of pesticide data and relevant reports.
2. The white paper topics.
3. The availability of data, tools, approaches, and data sets on aquatic toxicity that may be useful for this effort.
4. The types of values that are used by states and/or regions for protecting aquatic life in the absence of ambient water quality criteria.
5. Examples of situations in which differences between OW and OPP assessment approaches were an issue.
Following these meetings, the Agency plans to develop a set of white papers, describing potential new tools and analytical approaches that may be used by the Agency, state pesticide and water quality agencies, and other stakeholders.
For more information about water quality criteria and Water Quality Standards, refer to the following:
• Water Quality Standards Handbook (EPA 823–B94–005a);
• Advanced Notice of Proposed Rule Making (ANPRM), (63 FR 36742);
• Water Quality Criteria and Standards Plan – Priorities for the Future (EPA 822–R–98–003);
• Guidelines and Methodologies Used in the Preparation of Health Effects Assessment Chapters of the Consent Decree Water Criteria Documents (45 FR 79347);
• Methodology for Deriving Ambient Water Quality Criteria for the Protection of Human Health (2000), EPA–822–B–00–004);
• Guidelines for Deriving Numerical National Water Quality Criteria for the Protection of Aquatic Organisms and Their Uses (EPA 822/R–85–100);
• National Strategy for the Development of Regional Nutrient Criteria (EPA 822–R–98–002); and
• EPA Review and Approval of State and Tribal Water Quality Standards (65 FR 24641).
You can find these publications through EPA’s National Service Center for Environmental Publications (NSCEP, previously NCEPI) or on the Office of Science and Technology’s home page (
For more information about the OPP Ecological Exposure Assessment Process under FIFRA, refer to the following: “Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs,” which describes how pesticide data are used in ecological risk assessments (
This meeting is open to the public; registration is not required for attending or for participating in this meeting. Seats will be available on a first come, first served basis.
Environmental protection, Ambient water quality criteria, Aquatic benchmarks, Aquatic community, Aquatic life, Ecological risk assessment, Pesticides and pest.
Environmental Protection Agency (EPA).
Notice.
In accordance with section 6(f)(1) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended, EPA is issuing a notice of receipt of a request by the registrant to voluntarily cancel their registrations of products containing the pesticide difenzoquat. The request would terminate difenzoquat use on barley and wheat. The request would terminate the last difenzoquat products registered for use in the United States. EPA intends to grant this request at the close of the comment period for this announcement unless the Agency receives substantive comments within the comment period that would merit its further review of the request, or unless the registrant withdraws their request within this period. Upon acceptance of this request, any sale, distribution, or use of products listed in this notice will be permitted only if such sale, distribution, or use is consistent with the terms as described in the final order.
Comments must be received on or before December 28, 2009.
Submit your comments, identified by docket identification (ID) number EPA–HQ–OPP–2009–0787, by one of the following methods:
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•
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Eric Miederhoff, Pesticide Re-evaluation Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 347–8028; fax number: (703) 308–7070; e-mail address:
This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
1.
2.
i. Identify the document by docket ID number and other identifying information (subject heading,
ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information and/or data that you used.
v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
vi. Provide specific examples to illustrate your concerns and suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
viii. Make sure to submit your comments by the comment period deadline identified.
This notice announces receipt by EPA of a request from registrant AMVAC Chemical Corporation to cancel all 3 product registrations for the herbicide difenzoquat. Difenzoquat is registered for use on only two crops, wheat and barley. In a letter dated November 2, 2009, AMVAC Chemical Corporation requested EPA to cancel the affected product registrations identified in Table 1 of this notice. If the registrant's request is granted, the last difenzoquat products registered in the United States will be canceled effective December 31, 2009.
This notice announces receipt by EPA of a request from a registrant to cancel difenzoquat product registrations. The affected products and the registrants making the requests are identified in Table 1 of this unit.
Under section 6(f)(1)(A) of FIFRA, registrants may request, at any time, that their pesticide registrations be canceled or amended to terminate one or more pesticide uses. Section 6(f)(1)(B) of FIFRA requires that before acting on a request for voluntary cancellation, EPA must provide a 30–day public comment period on the request for voluntary cancellation or use termination. In addition, section 6(f)(1)(C) of FIFRA requires that EPA provide a 180–day comment period on a request for voluntary cancellation or termination of any minor agricultural use before granting the request, unless: The registrants request a waiver of the comment period, or; the Administrator determines that continued use of the pesticide would pose an unreasonable adverse effect on the environment.
The difenzoquat registrants have requested that EPA waive the 180–day comment period. EPA will provide a 30–day comment period on the proposed requests.
Unless a request is withdrawn by the registrant within 30 days of publication of this notice, or if the Agency determines that there are substantive comments that warrant further review of this request, an order will be issued canceling the affected registrations.
Table 2, of this unit includes the name and address of record for the
Section 6(f)(1) of FIFRA provides that a registrant of a pesticide product may at any time request that any of its pesticide registrations be canceled or amended to terminate one or more uses. FIFRA further provides that, before acting on the request, EPA must publish a notice of receipt of any such request in the
Registrants who choose to withdraw a request for cancellation must submit such withdrawal in writing to the person listed under
Existing stocks are those stocks of registered pesticide products which are currently in the United States and which were packaged, labeled, and released for shipment prior to the effective date of the cancellation action.
In any order issued in response to these requests for cancellation of difenzoquat product registrations, EPA proposes to include the following provisions for the treatment of any existing stocks of the products identified or referenced in Table 1 in Unit III.
If the request for voluntary cancellation is granted as discussed in this unit, the Agency proposes to issue a cancellation order that will allow AMVAC to sell and distribute existing stocks of the products identified in Unit III. until December 31, 2010. All sale or distribution of existing stocks by AMVAC is prohibited after December 30, 2010, unless that sale or distribution is solely for the purpose of facilitating disposal or export of the product.
The Agency will allow persons other than the registrant to continue to sell and/or use existing stocks of canceled products until such stocks are exhausted, provided that such use is consistent with the terms of the previously approved labeling on, or that accompanied, the canceled product. The order will specifically prohibit any use of existing stocks that is not consistent with such previously approved labeling. The Agency will publish the cancellation order in the
Environmental protection, Pesticides and pests.
Environmental Protection Agency (EPA).
Notice; correction and clarification.
EPA issued a rodenticides product Cancellation Order in the
The correction is effective date of publication in the
Rusty Wasem, Pesticide Re-evaluation Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: 703-305-6979; e-mail address:
The Agency included in the notice a list of those who may be potentially affected by this action. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under
EPA has established a docket for this action under docket identification (ID) number EPA–HQ–OPP–2006–0955. Publicly available docket materials are available either in the electronic docket at
In the
FR Doc.E9-23452 published in the
1. The
The products listed in Table 1 are cancelled on June 4, 2011.
2. On page 50195, table 1 is corrected to read as follows:
The registrations listed in Table 2 below were inadvertently included in Table 1 of the notice published on September 30, 2009, for which this notice corrects. The products listed in Table 2 below were canceled previously for non-payment of maintenance fees and do not have an effective cancellation date of June 4, 2011. Please note that regardless of the existing stocks provision for products listed in Table 2 below, registrants of these products are not permitted to release these products into the channels of trade after June 4, 2011.
Environmental protection, Pesticides and pests.
Environmental Protection Agency (EPA).
Notice.
The EPA is hereby granting a project waiver of the Buy American requirements of ARRA Section 1605 under the authority of Section 1605(b)(2) [manufactured goods are not produced in the United States in sufficient and reasonably available quantities and of a satisfactory quality] to the Gwinnett County, Georgia, Department of Water Resources (County) for the purchase of an Austrian manufactured Anaerobic digester gas fueled engine generator set specified as General Electric (GE) Jenbacher JMS 616, 2147 kilowatts for application in a combined heat and power system for use at the F. Wayne Hill Resources Center in the County. The product is manufactured by GE Jenbacher (Jenbach, Austria) and provided by General Electric Water & Process Technologies. The County stated that there was no apparent domestic manufactured biogas engine generator set with the specific fuel utilization/electric power output capacity and variable fuel blending capability required for the utility's combined heat and power needs. This is a project specific waiver and only applies to the use of the specified product for the ARRA funded project being proposed. Any other ARRA project that may wish to use the same product must apply for a separate waiver based on the specific project circumstances. The Acting Regional Administrator is making this determination based on the review and recommendation of the EPA Region 4, Water Protection Division, Grants and Infrastructure Branch. The County has provided sufficient documentation to support their request. The Assistant Administrator of the Office of Administration and Resources Management has concurred on this decision to make an exception to Section 1605 of ARRA. This action permits the purchase of an anaerobic digester gas fueled engine generator set manufactured by GE Jenbacher for the proposed project being implemented by Gwinnett County, Georgia.
Carl Biemiller, Project Officer, (404) 562–9341, Grants and Infrastructure Branch, Water Protection Division, Region 4, US EPA, Atlanta Federal Center, 61 Forsyth Street, SW., Atlanta, Georgia 30303–8960.
In accordance with ARRA Section 1605(c) and pursuant to Section 1605(b)(2) of Public Law 111–5, Buy American requirements, the EPA hereby provides notice that it is granting a project waiver to the County for the acquisition of the GE Jenbacher Austrian manufactured biogas engine generator set. The manufacturer is GE Water & Process Technologies Company.
Section 1605 of the ARRA requires that none of the appropriated funds may be used for the construction, alteration, maintenance, or repair of a public building or public work unless all of the iron, steel, and manufactured good use in the project are produced in the United States, unless a waiver is provided to the recipient by the EPA. A waiver may be provided if EPA determines that (1) Applying these requirements would be inconsistent with the public interest; (2) iron, steel, and the relevant manufactured goods are not produced in the United States in sufficient and reasonably available quantities and of a satisfactory quality; or (3) iron, steel and the relevant manufactured goods produced in the United States will increase the cost of the overall project by more than 25 percent.
The County's Department of Water Resources proposes to construct the F. Wayne Hill Water Resources Center (WRC) Digester Gas to Energy Project. This project would permit a renewable energy source for use by the project and the nearby wastewater treatment plant (WWTP). The project intends to convert previously flared anaerobic digester gas to electricity and heat for plant operations. The County proposes to use a General Electric (GE) Jenbacher JMS 616, 2147 kilowatts gas engine to convert digester gas to electrical and thermal energy with the recapture of the heat from the engine-generator in a combined heat and power (CHP) design. Electrical energy generated by the CHP system will reduce the utility needs of the WRC by an estimated thirty (30) percent, partially replacing grid purchased electricity. Thermal energy from the CHP system will be beneficially utilized to maintain the optimum temperature in the anaerobic digestion process now performed by natural gas boilers. The County's specifications require that the design rating of the biogas engine generator be sized to utilize as much of the WRC's available biogas as possible. The application states that based on this requirement, the engine generator set to be supplied must be rated for a power output in excess of 2000 kw. Also, to maximize the utilization of the Center's available biogas, the engine generator
The County's Department of Water Resources has requested a waiver from the Buy American provision for the purchase of a GE Jenbacher JMS 616, 2147 kilowatts gas engine set manufactured in Jenbach, Austria. The project specifications provided listed manufacturers for the project, and the prospective bidders consulted with multiple suppliers. All of the prospective bidders provided alternative pricing for a Caterpillar G3520C DM 5860, 1600kw/12.47V low BTU gas cogeneration system assembled in Mapelton, IL. Upon evaluation of the domestic manufacturer's product, the county determined that a single Caterpillar unit could not produce excess of 2000kw that could operate continuously over the specified range (as low as 400 SCFM and as high as 700 SCFM). The Caterpillar unit is rated at 1600kw and also has no blending capabilities.
The application also states that the Caterpillar unit is not able to run continuously due to its inability to “blend-on-the-fly” until the influent flow of a facility is in excess of approximately 50 million gallons per day (MGD). Above 50 MGD, the gas would have to be stored to burn at a later time. If the gas storage tanks are full, the gas would be burned through the flairs. Conversely, the GE Jenbacher gas engine generator can utilize the full range of gas production quantities by operating at reduced engine speeds with a variable speed drive or by operating at the full engine speed-supplementing the low BTU digester gas with natural gas provided by the gas utility to provide the greatest electrical output. This “blend-on-the-fly” technology beneficially utilizes the full amount of available gas, allowing for continuous operations through periods of variable digester gas production. Therefore, the GE Jenbacher gas engine can still be run during periods of low digester gas production to reduce utility fed electricity usage during peak consumption periods. Continuous operation of the engine-generator will also provide a contant heat source to meet the digester's process heating requirement, thereby eliminating the need for natural gas boilers. These boilers would still be required with the Caterpillar gas engine generator. Thus, the Caterpillar unit is neither as efficient nor is it otherwise of a satisfactory quality to meet the specifications of the project.
The functional requirement to maximize biogas use is clearly essential to the objective of substantially increasing the energy efficiency of the facility and turning the current environmental detriment of flaring methane, a particularly potent greenhouse gas, into an energy asset. By doing so, the project has also qualified for the ARRA Green Project Reserve, which is a high priority ARRA objective for SRF funded projects. Requiring a less efficient product would be inconsistent with the explicit and specific intent of Congress to achieve greater energy efficiency as stated in the SRF specific 20% Green Project Reserve requirements of Title VII of the ARRA. The County's submission clearly articulates entirely functional reasons for its technical specifications, and has provided sufficient documentation that the relevant manufactured goods are not produced in the United States in sufficient and reasonably available quantity and of a satisfactory quality to meet its technical requirements and specifications.
The April 28, 2009 EPA Headquarters Memorandum, “Implementation of Buy American provisions of Public Law 111–5, the American Recovery and Reinvestment Act of 2009,” defines “satisfactory quality” as “the quality of steel, iron or manufactured goods specified in the project plans and designs.”
EPA's national contractor prepared a technical assessment report dated August 14, 2009 based on the submitted waiver request. The report determined that the waiver request submittal was complete, that adequate technical information was provided, and that there were no weaknesses in the justification provided. The report confirmed the waiver applicant's claim that there are no comparable domestic products that can meet both the power output of the engine generator and the dual fuel capability needed for the project.
Furthermore, the purpose of the ARRA is to stimulate economic recovery in part by funding current infrastructure construction, not to delay projects that are ready to proceed. Approval of the waiver would permit construction to promptly proceed with positive economic benefits to the County in the form of jobs and related services and materials which would aid the economic recovery.
The Region 4 Grants and Infrastructure Branch has reviewed this waiver request and has determined that the supporting documentation provided by the County is sufficient to meet the criteria listed under ARRA Section 1605(b), OMB's regulation at 2 CFR 176.100 and the aforementioned EPA Headquarters Memorandum of April 28, 2009. ARRA Section 1605(b) (2) permits a waiver if “Iron, steel, and manufactured goods are not produced in the United States in sufficient and reasonably available quantities and of a satisfactory quality.” Based on the information provided to EPA from the County, and to the best of our knowledge at the time of the review, there does not appear to be any biogas engine generator set currently manufactured in the United States available to meet the County's specifications and requirements. Therefore, this waiver request meets the applicable criteria and is justified.
The Administrator's March 31, 2009, delegation of authority memorandum provided acting Regional Administrators with the authority to issue exceptions to Section 1605 of ARRA within the geographic boundaries of their respective regions and with respect to requests by individual grant recipients. Having established both a proper basis to specify the particular good required for this project, and that this manufactured good was not available from a producer in the United States, the Gwinnett County, Georgia, Department of Water Resources is granted a waiver from the Buy American requirements of Section 1605(a) of Public Law 111–5 for the purchase of a anaerobic digester gas-fueled engine generator set specified as GE Jenbacher JMS 616, 2147 kilowatts for application in a combined heat and power system as specified in the County's request of July 22, 2009, with supplemental information. This supplementary information constitutes the detailed written justification required by Section 1605(c) for waivers “based on a finding under subsection 9b.”
Public Law 111–5, section 1605.
Environmental Protection Agency (EPA).
Notice.
The Acting Regional Administrator of EPA Region 4 is hereby granting a waiver of the Buy America requirements of ARRA Section 1605 under the authority of Section 1605(b)(2) (manufactured goods are not produced in the United States in sufficient and reasonably available quantities and of a satisfactory quality) to the County for the purchase of resin beads (MIEX® DOC Resin) supplied by Orica Ltd, in Victoria, Australia and manufactured in Australia. The applicant indicates that MIEX® DOC Resin is necessary to the MIEX® process, a treatment process evaluated in pilot studies at the County and selected for implementation. The MIEX® DOC Resin is only manufactured in Australia. It is patented and no alternative exists which can be used with the MIEX® process. The Acting Regional Administrator is making this determination based on the review and recommendations of the Grants and SRF Section. The County has provided sufficient documentation to support their request.
Ed Springer, Chief, Grants and SRF Section, Water Protection Division (WPD), (404) 562–8410, U.S. EPA Region 4,61 Forsyth St. SW, Atlanta, GA 30303.
In accordance with ARRA Section 1605(c), the EPA hereby provides notice that it is granting a project waiver of the requirements of Section 1605(b)(2) of Public Law 111–5, Buy American requirements, to the County for the acquisition of resin beads (MIEX® DOC Resin) supplied by Orica Ltd, in Victoria, Australia and manufactured in Australia. The applicant indicates that MIEX® DOC Resin is necessary to the MIEX® process, a treatment process evaluated in pilot studies at the County and selected for use. The MIEX® DOC Resin is only manufactured in Australia. It is patented and no alternative exists which can be used with the MIEX® process. Section 1605 of the ARRA requires that none of the appropriated funds may be used for the construction, alteration, maintenance, or repair of a public building or public work unless all of the iron, steel, and manufactured goods used in the project is produced in the United States unless a waiver is provided to the recipient by EPA. A waiver may be provided if EPA determines that (1) applying these requirements would be inconsistent with public interest; (2) iron, steel, and the relevant manufactured goods are not produced in the United States in sufficient and reasonably available quantities and of a satisfactory quality; or (3) inclusion of iron, steel, and the relevant manufactured goods produced in the United States will increase the cost of the overall project by more than 25 percent.
In order to meet the new Long Term II Surface Water Treatment Rule and Stage 2 Disinfection By-Product Rule under the Safe Drinking Water Act, the County will be required to reduce the levels of dissolved organic carbon (DOC)—a disinfection byproduct precursor of regulatory concern—from its source water supply. In 2007, the County commissioned their engineer to conduct a treatability testing program to evaluate treatment technologies for removing DOC from the County's source water supply. The treatability testing program evaluated powdered activated carbon, granular activated carbon, and the MIEX® process/resin for DOC removal. The 2007 treatability study summarized a previous treatability testing program conducted for the County in 2000, which concluded that physical/chemical treatments (
Further, the County's waiver request states that “[t]he Public Water Supply Section, Division of Environmental Health, N.C. Department of Environment and Natural Resources has reviewed the report and subsequent design and approved the project.” Approval of a public water system's compliance technology by the primary regulatory enforcement agency of a State is a crucial prerequisite to initiation of a drinking water infrastructure project to comply with a National Primary Drinking Water Standard. Given this approval and in light of the outcome of the treatability testing program, the County did not have a basis to use a practicable alternative compliance technology within the ARRA time requirements for SRF projects to be under contract or construction by February 17, 2010.
The County's submission clearly articulates entirely reasonable reasons for choosing the type of technology that it chose for this project and has provided sufficient documentation that the relevant manufactured goods are not produced in the United States in sufficient and reasonably available quantity and of a satisfactory quality to meet its technical specifications.
The April 28, 2009 EPA HQ Memorandum, Implementation of Buy American provisions of Public Law 111–5, the “American Recovery and Reinvestment Act of 2009”, defines “reasonably available quantity” as the quantity of iron, steel, or relevant manufactured good is available or will be available at the time needed and place needed, and in the proper form or specification as specified in the project plans and design. The County has incorporated specific technical design features for the proposed project based on pilot studies which demonstrated MIEX® treatment is the best alternative.
The County has provided information to the EPA representing that there are currently no resin beads manufactured in the United States that have the exact same product specifications in place. The County has also provided certification from its supplier representing that there are no beads of comparable quality available from a domestic manufacturer to meet its exact specifications. Based on additional research by EPA's consulting contractor (Cadmus), and to the best of the Region's knowledge at this time, there do not appear to be other resin beads available to meet the County's specifications.
Furthermore, the purpose of the ARRA provisions was to stimulate economic recovery by funding current infrastructure construction, not to delay projects that are already shovel ready by requiring entities, like the County, to revise their design and potentially choose a more costly and less efficient project. The imposition of ARRA Buy American requirements on such projects eligible for DWSRF assistance would result in unreasonable delay and thus displace the “shovel ready” status for this project. To further delay construction is in direct conflict with the most fundamental economic purposes of ARRA: to create or retain jobs.
The Grants and SRF Section has reviewed this waiver request and has determined that the supporting documentation provided by the County is sufficient to meet the following criteria listed under Section 1605(b) and in the April 28, 2009, Implementation of Buy American provisions of Public Law 111–5, the “American Recovery and Reinvestment Act of 2009” Memorandum: Iron, steel, and the manufactured goods are not produced in the United States in sufficient and reasonably available quantities and of a satisfactory quality. The basis for this project waiver is the authorization provided in Section 1605(b)(2), due to the lack of production of this product in the United States in sufficient and reasonably available quantities and of a satisfactory quality in order to meet the County's design specifications. The March 31, 2009 Delegation of Authority Memorandum provided Regional Administrators with the authority to issue exceptions to Section 1605 of ARRA within the geographic boundaries of their respective regions and with respect to requests by individual grant recipients.
Having established both a proper basis to specify the particular good required for this project, and that this manufactured good was not available from a producer in the United States, the County is hereby granted a waiver from the Buy American requirements of Section 1605(a) of Public Law 111–5 for the purchase of resin beads (MIEX® DOC Resin) supplied by Orica Ltd, in Victoria, Australia and manufactured in Australia as specified in the County's request of June 26, 2009. This supplementary information constitutes the detailed written justification required by Section 1605(c) for waivers based on a finding under subsection (b).
Public Law 111–5, section 1605.
The Commission hereby gives notice of the filing of the following agreement under the Shipping Act of 1984. Interested parties may submit comments on the agreement to the Secretary, Federal Maritime Commission, Washington, DC 20573, within ten days of the date this notice appears in the
By Order of the Federal Maritime Commission.
Notice is hereby given that the following applicants have filed with the Federal Maritime Commission an application for license as a Non-Vessel-Operating Common Carrier and Ocean Freight Forwarder—Ocean Transportation Intermediary pursuant to section 19 of the Shipping Act of 1984 as amended (46 U.S.C. Chapter 409 and 46 CFR part 515).
Persons knowing of any reason why the following applicants should not receive a license are requested to contact the Office of Transportation Intermediaries, Federal Maritime Commission, Washington, DC 20573.
The Federal Maritime Commission hereby gives notice that the following Ocean Transportation Intermediary licenses have been revoked pursuant to section 19 of the Shipping Act of 1984 (46 U.S.C. Chapter 409) and the regulations of the Commission pertaining to the licensing of Ocean Transportation Intermediaries, 46 CFR
Notice is hereby given that the following Ocean Transportation Intermediary license has been reissued by the Federal Maritime Commission pursuant to section 19 of the Shipping Act of 1984 (46 U.S.C. Chapter 409) and the regulations of the Commission pertaining to the licensing of Ocean Transportation Intermediaries, 46 CFR Part 515.
Department of Health and Human Services, Office of the Secretary, Office of Public Health and Science, Office of Disease Prevention and Health Promotion.
Notice of meeting.
The U.S. Department of Health and Human Services (HHS) announces the next federal advisory committee meeting regarding the national health promotion and disease prevention objectives for 2020. This meeting will be open to the public and will be held online via WebEx software. The Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020 will address efforts to develop the nation's health promotion and disease prevention objectives and strategies to improve the health status and reduce health risks for Americans by the year 2020. The Committee will provide to the Secretary of Health and Human Services advice and consultation for developing and implementing the next iteration of national health promotion and disease prevention goals and objectives and provide recommendations for initiatives to occur during the initial implementation phase of the goals and objectives. HHS will use the recommendations to inform the development of the national health promotion and disease prevention objectives for 2020 and the process for implementing the objectives. The intent is to develop and launch objectives designed to improve the health status and reduce health risks for Americans by the year 2020.
The Committee will meet on December 11, 2009 from 1:30 p.m. to 4:30 p.m. Eastern Standard Time (EST).
The meeting will be held online, via WebEx software. For detailed instructions about how to make sure that your windows computer and browser is set up for WebEx, please visit the “Secretary's Advisory Committee” Web page of the Healthy People Web site at:
Emmeline Ochiai, Designated Federal Officer, Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020, U.S. Department of Health and Human Services, Office of Public Health and Science, Office of Disease Prevention and Health Promotion, 1101 Wootton Parkway, Room LL–100, Rockville, MD 20852, (240) 453–8259 (telephone), (240) 453–8281 (fax). Additional information is available on the Internet at
To listen to the Committee meeting, individuals must pre-register to attend at the Healthy People Web site located at
Registration questions may be directed to Hilary Scherer at
Agency for Healthcare Research and Quality, HHS.
Notice.
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: “Spreading Techniques to Radically Reduce Antibiotic Resistant Bacteria (Methicillin Resistant Staphylococcus aureus, or MRSA).” In accordance with the Paperwork Reduction Act, 44 U.S.C. 350 1–3520, AHRQ invites the public to comment on this proposed information collection.
Comments on this notice must be received by January 25, 2010.
Written comments should be submitted to: Doris Lefkowitz, Reports Clearance Officer, AHRQ, by e-mail at
Copies of the proposed collection plans, data collection instruments, and specific details on the estimated burden can be obtained from the AHRQ Reports Clearance Officer.
Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427–1477, or by e-mail at
Healthcare Acquired Infections (HAIs) caused almost 100,000 deaths among the 2.1 million people who acquired infections while hospitalized in 2000, and HAI rates have risen relentlessly since then. Alarmingly, 70% of HATs are due to bacteria that are resistant to commonly used antibiotics, with Methicillin Resistant Staphylococcus aureus (MRSA) being the most rapidly growing, and among the most virulent, pathogens. Resistance is increasing rapidly in all types of hospitals (Huang 2007). Despite evidence that routinely applied, simple interventions do work, most hospitals have failed to make notable progress in reducing MRSA infections. Hospitals in some European countries and select U.S. hospitals, however, have succeeded with impressive results.
Sites that have already achieved dramatic decreases in their MRSA infection rates have done so by implementing precautions to prevent transmission, using system redesign approaches. Further, many hospitals have successfully instituted isolation procedures for patients suspected to be MRSA carriers. In doing so, these hospitals have followed the broadly disseminated guidelines for hand hygiene and contact isolation precautions. This study is a follow up to a recent study implemented in 6 hospital systems in the Indianapolis metropolitan area that used a “MRSA intervention bundle” composed of active surveillance screening, contact isolation precautions, and increased hand hygiene. Preliminary data from that initial study suggest a 60% decrease in MRSA rates in participating intensive care units (ICUs) (Doebbeling, B. Redesigning Hospital Care for Quality and Efficiency Applications of Positive Deviance and Lean in Reducing MRSA. Presentation at AHRQ Annual Meeting, Rockville, MD, Sept 2009).
This study is designed to further test this intervention bundle in non-ICU settings in hospitals currently using the intervention bundle in their ICUs, as well as in additional ICUs in newly recruited hospital systems. This project will utilize the same guidelines and precautions that were applied in the original study, and will add an innovative feature that will use electronic medical record systems to improve identifying, communicating and tracking MRSA infections among healthcare systems. More specifically, this study has five aims:
(1) Further test the “MRSA intervention bundle” from the original Indianapolis MRSA study, and test the intervention in additional units in the 4 original Indianapolis hospital systems and an additional 3 hospital systems beyond Indianapolis;
(2) Identify and monitor healthcare associated community onset (HACO) MRSA cases and controls who receive care in participating hospitals and affiliated settings, identify strategies to reduce HACO MRSA and demonstrate reduction of HACO MRSA;
(3) Assess the relative effectiveness of various antibiotics in abatement or eradication of MRSA carriage in hospital patients;
(4) Evaluate the effectiveness of the tested implementation strategies and innovations by applying information technology to enable consistent collection, sharing, analysis and reporting of data;
(5) Disseminate findings and promote outreach to target audiences and other stakeholders.
While many secondary data are available for this study, Aims 1 and 2 involve primary data collection. Use of the intervention bundle requires that opinion leaders and front line workers be equipped with techniques used in the reorganization of healthcare delivery to improve health outcomes (Singhal and Greiner, 2007; IHI, 2005). These techniques will assist in identifying goals, implementing the interventions to meet local needs and measuring and feeding back progress on key processes and outcomes to staff and others.
The study also incorporates an additional informatics surveillance system to allow participating hospitals to more efficiently communicate, share and track MRSA infections. This system will save infection control and clinicians' time—for example, by electronically identifying patients with a known history of drug-resistant infections when they first contact a new institution.
This study is being conducted by AHRQ through its contractor, Indiana University and the Regenstrief Institute, pursuant to AHRQ's statutory authority to conduct and support research on healthcare and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness and value of healthcare services and with respect to quality measurement and improvement. 42 U.S.C. 299a(a)(l) and (2).
There will be 3 types of data collection to support the study Aims:
• Electronic medical record data on MRSA infections and rates will be collected from an existing and unique healthcare information exchange (Indiana Network for Patient Care or INPC) in the Indianapolis area, and the CDC's National Healthcare Safety Network (Aims 1–5).
• Data on hand washing, swabbing, and isolation rates will be collected by observation (Aims 1, 2, and 4).
• Four surveys will be conducted: A brief Social Network Analysis (SNA), a Cultural Survey, a Patient Healthcare Use survey, and an Implementation Assessment of key informants (Aims 1, 4, and 5).
The social network analysis questionnaire (SNA) (Wasserman
The implementation assessment will be an interview obtained quarterly to key informants at each organization to assess the approaches to implementation of the program (
Additionally, to better understand the healthcare associated community acquired aspect of MRSA transmission, 200 patients will be surveyed to gather risk factors and healthcare use statistics that we have found in preliminary studies are not otherwise available in electronic databases or medical records.
Exhibit 1 shows the estimated annualized burden hours associated with the hospital's time to participate in this research. Electronic medical record data will be collected weekly from 7 participating hospitals, however only two of these hospitals will use their staff to perform this data collection. Over the course of the project electronic medical record data will be extracted 52 times and each data extraction will take about 10 hours. Observational data will be collected weekly from all participating hospitals, however only 3 hospitals will use their staff to perform the observations. The project will require 52 observations per hospital and are estimated to take about 3 hours to perform.
Both the social network analysis questionnaire and the culture questionnaire will be administered twice, pretest and posttest, to about 75 personnel at each of the 7 hospitals. The social network analysis questionnaire will take about 15 minutes to complete while the culture questionnaire will take 30 minutes. The implementation assessment questionnaire will be administered quarterly to 3 key informants at each hospital and will take about one hour.
The patient healthcare use questionnaire will be completed by 200 patients sampled from the 7 participating hospitals. Each patient will respond once which will require about 15 minutes. The total annualized burden hours for all the associated data collections are estimated to be 2,430. Exhibit 2 shows the estimated annualized cost burden associated with the respondents' time to participate in this research. The total annual cost burden is estimated to be $76,118.
Exhibit 3 shows the total and annualized cost of this project to the Federal Government over a two-year period. The total cost of this project is $1.8 million dollars which includes $785,000 for project development, $70,000 for data collection activities, $235,000 for data analysis, $125,000 for publication of the results, $170,000 for project management and $415,000 for overhead costs.
In accordance with the above-cited Paperwork Reduction Act legislation, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ healthcare research and healthcare information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled “Residual Solvents in Drug Products Marketed in the United States.” On July 1, 2008, the United States Pharmacopeia (USP) published a new test requirement for the control of residual solvents, General Chapter <467> “Residual Solvents,” which replaced USP General Chapter <467> “Organic Volatile Impurities.” The change affects all compendial drug products marketed in the United States. This guidance reflects FDA's recommendations on how to comply with those USP changes.
Submit written or electronic comments on agency guidances at any time.
Submit written requests for single copies of the guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your requests. Submit written comments on the guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to
Chris Watts, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 4142 Silver Spring, MD 20993–0002, 301–796–1625.
FDA is announcing the availability of a guidance for industry entitled “Residual Solvents in Drug Products Marketed in the United States.” On August 7, 2008 (73 FR 46020), FDA announced the availability of the draft version of this guidance. The public comment period closed on October 6, 2008. A number of comments were received, which the agency considered carefully as it finalized the guidance. In response to the comments, FDA made appropriate changes. The guidance provides information on how new drug application (NDA) and abbreviated new drug application (ANDA) applicants for noncompendial drug products should limit residual solvents as described in the International Conference on Harmonisation guidance for industry “Q3C Impurities: Residual Solvents;” how manufacturers of compendial drug products that are not marketed under an approved NDA or ANDA can comply with the new General Chapter <467> and the Federal Food, Drug, and Cosmetic Act; and how holders of NDAs or ANDAs for compendial drug products should report changes in chemistry, manufacturing, and controls specifications to FDA to comply with the USP General Chapter <467> “Residual Solvents” and § 314.70 (21 CFR 314.70).
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on USP General Chapter <467> “Residual Solvents.” It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.
This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). Information submitted in the chemistry, manufacturing, and controls section of an application under 21 CFR 314.50(d)(1), as well as in amendments to pending applications under 21 CFR 314.60, is approved by OMB under Control Number 0910–0001. Information submitted in an annual report under § 314.70(d)(2)(i) and (d)(3) is approved by OMB under Control Number 0910–0001. Recordkeeping required under 21 CFR 211.165(e) and 211.194(a)(2) is approved by OMB under Control Number 0910–0139.
Interested persons may submit to the Division of Dockets Management (see
Persons with access to the Internet may obtain the document at either
Notice is hereby given of a change in the meeting of the National Cancer Advisory Board, November 30, 2009, 6:30 p.m. to December 2, 2009, 12 p.m., National Institutes of Health, Building 31, 31 Center Drive, 10, Bethesda, MD, 20892 which was published in the
This
Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Institutes of Health Peer Review Advisory Committee.
The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
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.
Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of an Interagency Autism Coordinating Committee (IACC) meeting.
The purpose of the IACC meeting is to continue discussing recommendations for the annual update of the IACC Strategic Plan for Autism Spectrum Disorders Research. The IACC meeting will be conducted and available to the public via a telephone conference call and a webinar.
Any interested person may submit written comments to the IACC prior to the meeting by sending the statement to the Contact Person listed on this notice by 5 p.m. ET on December 8, 2009. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. All written statements received by the deadline will be provided to the IACC for their consideration.
The meeting will be open to the public through a conference call phone number and a webinar conducted using a web presentation tool on the Internet. Individuals who participate using this service and who need special assistance, such as captioning of the conference call or other reasonable accommodations, should submit a request to the contact person listed above at least seven days prior to the meeting. If you experience any technical problems with the Web presentation tool or conference call, please e-mail
Members of the public who participate using the conference call phone number will be able to listen to the meeting but will not be heard. This phone call may end prior to or later than 1 p.m., depending on the needs of the Committee.
To access the webinar on the Internet the following computer capabilities are required: (A) Internet Explorer 5.0 or later, Netscape Navigator 6.0 or later or Mozilla Firefox 1.0 or later; (B) Windows® 2000, XP Home, XP Pro, 2003 Server or Vista; (C) Stable 56k, cable modem, ISDN, DSL or better Internet connection; (D) Minimum of Pentium 400 with 256 MB of RAM (Recommended); (E) Java Virtual Machine enabled (Recommended)
This meeting is being published less than 15 days prior to the meeting due to the timing limitations for completing the updating of the Annual Strategic Plan for Autism Spectrum Disorder Research.
Information about the IACC is available on the Web site:
Meeting schedule subject to change.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
U.S. Customs and Border Protection, Department of Homeland Security.
30-Day notice and request for comments; Extension of an existing information collection: 1651–0061.
U.S. Customs and Border Protection (CBP) of the Department of Homeland Security has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act: Application to Establish a Centralized Examination Station (CES). This is a proposed extension and revision of an information collection that was previously approved. CBP is proposing that this information collection be extended with no change to the burden hours. This document is published to obtain comments from the public and affected agencies. This proposed information collection was previously published in the
Written comments should be received on or before December 28, 2009.
Interested persons are invited to submit written comments on this proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to the OMB Desk Officer for Customs and Border Protection, Department of Homeland Security, and sent via electronic mail to
U.S. Customs and Border Protection (CBP) encourages the general public and affected Federal agencies to submit written comments and suggestions on proposed and/or continuing information collection requests pursuant to the Paperwork Reduction Act (Pub. L. 104–13). Your comments should address one of the following four points:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency/component, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agencies/components estimate 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; and
(4) Minimize the burden of the collections of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological techniques or other forms of information.
If additional information is required contact: Tracey Denning, U.S. Customs and Border Protection, Office of Regulations and Rulings, 799 9th Street, NW., 7th Floor, Washington, DC 20229–1177, at 202–325–0265.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster for the State of North Dakota (FEMA–1829–DR), dated March 24, 2009, and related determinations.
Peggy Miller, Disaster Assistance Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646–3886.
Notice is hereby given that, in a letter dated November 6, 2009, the President amended the cost-sharing arrangements regarding Federal funds provided 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 North Dakota resulting from severe storms and flooding during the period of March 13 to August 10, 2009, is of sufficient severity and magnitude that special cost sharing arrangements are warranted regarding Federal funds provided under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
Therefore, I amend my declaration of March 24, 2009, to authorize Federal funds for all categories of Public Assistance at 90 percent of total eligible costs.
This adjustment to State and local cost sharing applies only to Public Assistance costs and direct Federal assistance eligible for such adjustments under the law. The Robert T. Stafford Disaster Relief and Emergency Assistance Act specifically prohibits a similar adjustment for funds provided for Other Needs Assistance (Section 408), and the Hazard Mitigation Grant Program (Section 404). These funds will continue to be reimbursed at 75 percent of total eligible costs.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of an emergency declaration for the Commonwealth of Puerto Rico (FEMA–3306–EM), dated October 24, 2009, and related determinations.
Peggy Miller, Disaster Assistance Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646–3886.
Notice is hereby given that the incident period for this emergency is closed effective October 26, 2009.
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 of public meeting.
The Federal Radiological Preparedness Coordinating Committee (FRPCC) is holding a public meeting on December 9, 2009 in Washington, DC.
The meeting will take place on December 9, 2009 from 9 a.m. to 11 a.m. Send written statements and requests to make oral statements to the contact person listed below by close of business November 30, 2009.
The meeting will be held in the large first floor conference room in the North building of the Technology World Building Conference Facility located at 800 K St. NW., Washington, DC 20024.
Timothy Greten, FRPCC Executive Secretary, DHS/FEMA, 1800 South Bell Street-CC847, Mail Stop 3025, Arlington, VA 20598–3025; telephone (202) 646–3907; fax (703) 305–0837; or e-mail
The role and functions of the Federal Radiological Preparedness Coordinating Committee (FRPCC) are described in 44 CFR 351.10(a) and 351.11(a). The FRPCC is holding a public meeting on December 9, 2009, from 9 a.m. to 11 a.m., in the large first floor conference room in the North building of the Technology World Building Conference Facility located at 800 K St. NW., Washington, DC 20024. Please note that the meeting may close early. This meeting is open to the public, subject to the availability of space. Public meeting participants must pre-register to be admitted to the meeting. To pre-register, please provide your name and telephone number by close of business on November 30, 2009, to the individual listed in the
The tentative agenda for the FRPCC meeting includes: (1) Introductions; (2) reports from FRPCC Subcommittees; (3) old business and new business; and (4) business from the floor. The FRPCC Chair shall conduct the meeting in a way that will facilitate the orderly conduct of business. Reasonable provisions will be made, if time permits, for oral statements from the public of not more than five minutes in length. Any member of the public who wishes to make an oral statement at the meeting should send a written request for time by close of business on November 30, 2009, to the individual listed in the
For information on facilities or services for individuals with disabilities or to request special assistance at the meeting, please write or call the individual listed in the
44 CFR 351.10(a) and 351.11(a).
U.S. Customs and Border Protection, Department of Homeland Security.
Notice.
This notice announces that U.S. Customs and Border Protection is adding two new ports of entry to the list of ports through which nonimmigrant aliens subject to special registration requirements may depart from the United States. The new ports-of-entry include Oakland International Airport, California and Saipan, the Commonwealth of the Northern Mariana Islands. Special registration is required of nonimmigrant aliens whose presence in the United States requires closer monitoring.
Kenneth Sava, U.S. Customs and Border Protection, Office of Field Operations, at (202) 344–2589.
Certain nonimmigrant aliens, who apply for admission to the United States, are subject to special registration requirements. Upon arrival in the United States, they shall provide information required by the Department of Homeland Security (DHS), such as information relating to their visa status, and they shall be fingerprinted and photographed. Other special registration requirements include appearing at in-person verification or re-registration interviews at the discretion of DHS; providing notice to DHS of any change of address, residence, employment, or educational institution; and reporting departure from the United States to close their registration.
Pursuant to 8 CFR 264.1(f)(2)(i), the Secretary of Homeland Security, in consultation with the Secretary of State, may designate, by publishing a notice in the
Upon departure from the United States, nonimmigrant aliens subject to the special registration requirements must report to an inspecting officer at and depart from an approved port-of-entry (POE) as set forth by publication in the
This notice expands the August 8, 2006 listing by adding two POEs.
Effective November 25, 2009, Oakland International Airport, California, is designated as a POE authorized to provide final registration and departure by nonimmigrant aliens subject to special registration.
Effective November 28, 2009, Saipan, the Commonwealth of the Northern Mariana Islands, is designated as a POE authorized to provide final registration and departure by nonimmigrant aliens subject to special registration.
Due to the limited availability of resources, specifically departure staff and facilities, CBP must limit the POEs authorized for departure registration to effectively capture departure data. Nonimmigrant aliens who are subject to special registration may not depart the United States from any POE, or from any other location, other than those listed below.
The below updated list of POEs includes all POEs designated for final registration and departure by nonimmigrant aliens subject to special registration, including the two POEs added by this notice. Nonimmigrant aliens subject to special registration may be examined by CBP and may depart from the following POEs:
The regulations governing the manner in which aliens are registered in the
This updated list will also be available on the following Web site:
National Park Service, Department of the Interior.
Notice of Availability of the Record of Decision for the Final White-tailed Deer Management Plan and Environmental Impact Statement for Valley Forge National Historical Park.
Pursuant to Section 102(2)(C) of the National Environmental Policy Act of 1969, as amended, the National Park Service (NPS) announces the availability of the Record of Decision for the Final White-tailed Deer Management Plan/Environmental Impact Statement (Final plan/EIS) for Valley Forge National Historical Park, Pennsylvania. The Regional Director, Northeast Region, has approved the Record of Decision for the Final plan/EIS, selecting Alternative D, Combined Lethal and Nonlethal Actions, which was described as the NPS preferred alternative in the Final plan/EIS, released to the public for the required 30-day no-action period beginning August 28, 2009 and ending September 28, 2009. The Record of Decision includes a statement of the decision made, synopses of other alternatives considered, the basis for the decision, a description of the environmentally preferred alternative, a finding on impairment of park resources and values, a description of consistency with Section 101(b) of the National Environmental Policy Act, a listing of measures to minimize environmental harm, and an overview of public involvement in the decision-making process. As soon as practicable, the National Park Service will begin to implement the selected alternative.
Copies of the Record of Decision may be downloaded from the NPS Planning, Environment and Public Comment (PEPC) Web site (
Kristina M. Heister, Natural Resource Manager, Valley Forge National Historical Park, 1400 North Outer Line Drive, King of Prussia, PA 19406, (610) 783–0252, or online at
Development of the Environmental Impact Statement for the White-tailed Deer Management Plan for Valley Forge National Historical Park was initiated in 2006, pursuant to the 2006 House Appropriations Report (HR 109–465): “The public has been patient as the NPS has worked through its process in regard to management of the over-abundance of white-tailed deer at the park. Within existing funds, NPS is directed to begin the environmental impact statement for deer management. The Committee expects that the plan will be funded fully so that it can be completed in fiscal year 2008. The Committee further expects that implementation of the selected action will begin immediately upon signing of the Record of Decision.”
The purpose of the plan/EIS is to develop a white-tailed deer management strategy that supports long-term protection, preservation, and restoration of native vegetation and other natural and cultural resources while maintaining a deer population at Valley Forge NHP. Forest regeneration has been selected as the primary measure of plan success. Although other factors may affect forest regeneration, such as the forest canopy, nonnative invasive species, pests/disease, fire, and forest fragmentation, this plan focuses on the role and impact of white-tailed deer in the ecological environment, which has been documented through research and long-term monitoring at Valley Forge NHP. The secondary purpose of the plan/EIS is to provide appropriate response to chronic wasting disease (CWD), a fatal, neurological disease identified in free-ranging and captive mule deer, white-tailed deer, elk, and moose. CWD is not currently known to be present in the park or the Commonwealth of Pennsylvania; however, changes in the proximity of CWD to the park boundary and other risk factors have resulted in an elevated risk of CWD occurrence within the park; therefore, integration of CWD response into white-tailed deer management represents an effort on the part of the NPS to be proactive and fully prepared given the high level of risk of the park for exposure to and amplification of CWD.
The following objectives related to deer management at Valley Forge NHP were developed for the plan.
• Protect arid promote restoration of the natural abundance, distribution, structure, and composition of native plant communities by reducing deer browsing.
• Reduce deer browsing pressure enough to promote tree and shrub regeneration that results in a diverse forest structure dominated by native species.
• Promote a mix of native herbaceous plant species and reduce the competitive advantage of invasive, nonnative plant species.
• Maintain a white-tailed deer population within the park that allows for protection and restoration of native plant communities.
• Protect and preserve other native wildlife species by promoting the restoration of native plant communities.
• Reduce the probability of occurrence, promote early detection, and reduce the probability of spread of chronic wasting disease.
• Protect and promote restoration of special status plant and animal species and their habitat.
• Protect the integrity of the cultural landscape, including the patterns of open versus wooded land, commemorative plantings, and vegetative screenings.
• Protect archeological resources by promoting the growth and maintenance of native vegetative cover and reducing trampling and soil erosion.
Forest regeneration has been selected as the primary measure of plan success; therefore, tree seedlings will be monitored to determine at what point the browsing impacts will warrant implementation of the management actions contained in the selected alternative. Because the goal is to manage for successful forest regeneration within the park and not for deer density, the selected alternative incorporates an adaptive management strategy to better manage based on the uncertainty concerning the impacts the change in deer population densities will have on vegetation recovery. The results of deer removal would be documented annually through monitoring of forest regeneration so that the number of deer to be removed could be adjusted based on the response of the vegetation to a lower deer density. If monitoring indicated that vegetation was not regenerating, management actions would be adjusted.
By using an adaptive management approach, park managers will be able to change the timing or intensity of management treatments to better meet the goals of the plan as new information is obtained.
The selected alternative includes measures to respond to detection of CWD. Should chronic wasting disease (CWD) be confirmed within five miles of the park boundary or the park falls within a State established CWD-containment zone then active lethal surveillance will be implemented (lethal removal of deer for the purposes of assessing disease presence, prevalence, and distribution). Portions of the plan related to CWD were prepared in cooperation with the Pennsylvania Game Commission.
In addition to the selected alternative, two other action alternatives and the no action alternative were presented and analyzed in the Draft and Final Environmental Impact Statements.
Alternative A (no action) would continue the existing deer management activities of monitoring deer population size and vegetation, small scale fencing of selected vegetation, removal of deer killed on roadways, public education, coordination with the Pennsylvania Game Commission, and continuation of limited CWD surveillance; no new deer management actions would be implemented.
Alternative B, Combined Nonlethal Actions, would combine several non-lethal actions, including large-scale rotational fencing of 10% to 15% of the park's forested area and reproductive control of does to gradually reduce deer population in the park. Chronic wasting disease surveillance would include live testing (via tonsillar biopsy) and removal of CWD-positive individuals.
Alternative C, Combined Lethal Actions, would use qualified Federal employees or contractors to directly reduce the deer population in the park through sharpshooting and through capture and euthanasia, where appropriate. CWD response would include rapid reduction of the deer population to the target deer density and the potential for a one-time reduction action to not less than 10 deer per square mile through sharpshooting and through capture and euthanasia. These actions would be taken for the purposes of assessing disease presence, prevalence, and distribution. These actions may also minimize the likelihood of CWD becoming established, minimize the likelihood of amplification and spread if the disease is introduced, and promote elimination of CWD, if possible.
To identify the selected alternative, the planning team ranked each alternative based on: (1) The ability to meet the individual plan objectives; and (2) the potential impacts on the environment. The rankings were added up to determine which alternative best met the objectives. Alternatives C and D were closely ranked in their ability to meet all of the objectives. The NPS also considered the safety of implementing each alternative in identifying the selected alternative. Under Alternative D, the time that shooting would occur in the park would be less than under Alternative C. Because Alternative D maintains the efficiency of Alternative C in meeting the plan objectives and further improves safety by reducing the time that sharpshooting activities would occur in the park, Alternative D was selected for implementation.
The foreseeable environmental consequences of the selected alternative were fully assessed and documented in the Final plan/EIS. All practicable means to avoid and minimize environmental harm that could result from implementation of the selected alternative have been identified and incorporated into the selected alternative. After review of the potential environmental effects, the alternative selected for implementation will not impair park resources or values and will not violate the NPS Organic Act.
This decision is the result of a public planning process that began in 2006. At different points in the development of the plan/EIS, the NPS provided information and updates via newsletters, news releases, public meetings, the park Web site, and briefings. A Notice of Intent to prepare an ETS was published in the
A Notice of Availability of the Draft White-tailed Deer Management Plan/EIS (Draft plan/EIS) for Valley Forge NHP was published in the
The official primarily responsible for implementing the updated General Management Plan is the Superintendent of Valley Forge National Historical Park.
Bureau of Indian Affairs, Interior.
Notice.
This notice publishes an amendment to the Kalispel Tribe of Indians' Tobacco and Liquor Code published in the
Betty Scissons, Tribal Government Services Officer, Northwest Regional Office, 911 NE. 11th Ave., 8th Floor, Portland, OR 97232, Telephone: (503) 231–6723, Fax (503) 231–2189; or Elizabeth Colliflower, Office of Indian Services, 1849 C Street NW., Mail Stop 4513–MIB, Washington, DC 20240, Telephone: (202) 513–7640.
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 amended Kalispell Tribe of Indian's Tobacco and Liquor Code reads as follows:
This chapter shall be known as the Kalispel Tobacco and Liquor Code.
This Code is enacted to:
1. Regulate the distribution and sale of tobacco products on the Kalispel Reservation in conformity with the compact between the Kalispel Tribe and the State of Washington.
2. Regulate the distribution and sale of liquor and beer products on the Kalispel Reservation in conformity with 18 U.S.C. 1161 and any Tribal-State liquor compact.
3. Regulate tobacco, liquor and beer products in order to protect and promote the general health, safety and welfare of members of the Kalispel Tribe.
4. Generate revenue to fund needed Tribal programs and services.
Unless otherwise required by the context, the following words and phrases shall have the designated meanings:
1. “Alcohol” is that substance known as ethyl alcohol, hydrated oxide of ethyl, or spirit of wine, which is produced by the fermentation or distillation of grain, starch, molasses, or sugar, or other substance including all dilutions and mixtures of this substance.
2. “Beer” means any malt beverage, flavored malt beverage, or malt liquor as these terms are defined in this chapter.
3. “Cigarette” shall mean any roll for smoking made wholly or in part of tobacco being flavored, adulterated, or mixed with any other ingredients, where such wrapper is wholly or in the greater part made of paper of any material except where such is wholly or in the greater part made of natural leaf tobacco in its natural state.
4. “Commercial Sale” shall mean the transfer, exchange or barter, in any or by any means whatsoever for a consideration, by any person, association, partnership, or corporation, of cigarettes, tobacco products and/or liquor and beer products.
5. “Council” shall mean the Kalispel Tribal Business Committee as constituted by Article III of the Constitution and By-laws of the Kalispel Indian Tribe, Washington.
6. “Distributor” shall mean a person who buys liquor in any variety from a brewery, distillery, vineyard, foreign source outside of the United States, and includes any representatives of such a source such as a brewer or brewer agent.
7. “Liquor” includes the four varieties of liquor herein defined (alcohol, spirits, wine and beer), and all fermented, spirituous, vinous, or malt liquor, or combinations thereof, and mixed liquor, a part of which is fermented, spirituous, vinous or malt liquor, or otherwise intoxicating; and every liquid or solid or semisolid or other substance, patented or not, containing alcohol, spirits, wine or beer, and all drinks or drinkable liquids and all preparations or mixtures capable of human consumption, and any liquid, semisolid, solid, or other substance, which contains more than one percent of alcohol by weight shall be conclusively deemed to be intoxicating. Liquor does not include confections or food products that contain one percent or less of alcohol by weight.
8. “Liquor Outlet” shall mean a Tribally licensed retail sales business selling liquor or beer on the Kalispel Indian Reservation.
9. “Malt Beverage” or “malt liquor” means any beverage such as beer, ale, lager, stout, porter, flavored malt beverages such as wine coolers, or Guinness obtained by the alcoholic fermentation of an infusion or decoction of pure hops, or the pure extract of hops and pure barley malt or other
10. “Member” shall mean any person whose name appears on the official roll of the Kalispel Indian Tribe.
11. “Operator” shall mean an enrolled member of the Kalispel Tribe, enrolled member of another Federally recognized Tribe, a Tribal leasee or Tribally-licensed business entity licensed by the Kalispel Tribe of Indians to operate a tobacco and/or liquor and beer outlet.
12. “Reservation” shall mean the Kalispel Indian Reservation as set apart by Executive Order of March 23,1914, and all other lands, wherever located, owned by the Kalispel Tribe of Indians, including lands held in fee, or any interest in lands held by the Tribe, whether or not such lands or interests are held in trust for the Tribe by the United States, and any lands, wherever located, held in trust by the United States for a member or members of the Kalispel Tribe of Indians unless located on another Federally recognized Indian Tribe's Reservation and having already been determined by the Federal Government to be in “reservation” status as to a Tribe other than the Kalispel Tribe of Indians. All waterways, roadways, rights of way, public lands, lakes and streams located on the above described lands held by the Tribe or its members are considered Reservation lands, subject to applicable Federal and Tribal laws and regulations.
13. “Spirits” shall mean any beverage which contains alcohol obtained by distillation and intended for consumption.
14. “Tobacco Outlet” shall mean a Tribally licensed retail sales business selling tobacco products on the Kalispel Indian Reservation.
15. “Tobacco Products” shall mean cigars, cheroots, stogies, granulated, plug cut, crim cut, ready rubbed, and other smoking tobacco, snuff, cavendish, snuff flour, plug and twist tobacco, fine cut and other chewing tobaccos shorts and other kinds and forms of tobacco, prepared in such a manner as to be suitable for chewing or smoking in a pipe or otherwise, or both for smoking and chewing. Tobacco products shall not include cigarettes.
16. “Tribe” shall mean the Kalispel Indian Community of the Kalispel Indian Reservation, Washington.
17. “Wholesale Price” shall mean the established price for which cigarettes, tobacco products and/or liquor and beer products are sold to the Kalispel Indian Tribe or any licensed operator by the manufacturer or distributor, exclusive of any discount or other reduction.
18. “Wine” shall mean any alcoholic beverage obtained by fermentation of fruits or other agricultural products containing sugar and containing not more than twenty-four percent alcohol by volume and not less than one-half of one percent of alcohol by volume. For purposes of this chapter, “wine coolers” shall not be defined as wine but rather as a “malt beverage”.
The Kalispel Business Committee shall be the Kalispel Tobacco, Liquor and Beer Control Commission. The Commission is empowered to:
1. Administer this Code by exercising general control, management, and supervision of all tobacco and/or liquor and beer sales, places of sale and sales outlets as well as exercising all powers necessary to accomplish the purposes of this Code;
2. Adopt and enforce rules and regulations in furtherance of the purposes of this Code and in the performance of its administrative functions.
All records of the Kalispel Tobacco, Liquor and Beer Commission showing purchase of liquor by any individual or group shall be confidential and shall not be inspected except by members or employees of the Kalispel Tobacco, Liquor and Beer Commission or its authorized representative.
Operators of tobacco and/or liquor and beer outlets shall comply with applicable Tribal/State compact requirements and State of Washington liquor standards to the extent required by 18 U.S.C. 1161. However, total jurisdiction over the sale of liquor and beer products is reserved to and exercised by the Kalispel Tobacco, Liquor and Beer Commission within the boundaries of the Kalispel Indian Reservation.
Any person who sells, gives or otherwise provides liquor, wine or beer to a person apparently under the influence of liquor shall be in violation of this Chapter.
Where there may be question of a person's right to purchase cigarettes, tobacco products or alcoholic beverages by reason of his or her age, such person shall be required to present any one of the following officially issued cards of identification which shows correct age and bears his or her signature and photograph:
1. Driver's license of any State or Identification Card issued by any State Department of Motor Vehicles;
2. United States Active Duty Military Identification;
3. Passport;
4. Tribal Identification Card approved by the Washington State Liquor Control Board;
5. Kalispel Tribal Identification or Enrollment card.
An officially issued identification card described in Section 10–4.02 must be current to be valid identification. An officially issued identification card that is expired is not valid identification for the purpose of purchasing cigarettes, tobacco products or alcoholic beverages.
It shall be unlawful to:
1. Provide, give, sell or otherwise supply liquor, beer or other alcoholic beverages to any person under twenty-one (21) years of age, either for his or her own use or for the use of his or her parents or for the use of any other person.
2. Provide, give, sell or otherwise supply cigarettes or tobacco products to any person under eighteen (18) years of age, either for his or her own use or for the use of his or her parents or for the use of any other person.
No person under the age of twenty-one (21) years shall be employed in any service in connection with the sale, handling or dispensing of liquor, either on a paid or voluntary basis, except as otherwise provided herein.
1. Northern Quest Casino employees must be twenty-one (21) years of age to be employed in a position involving the sale or dispensing of liquor. Northern Quest Casino employees under twenty-one (21) years of age shall not sell or dispense liquor. Individuals under twenty-one (21) years of age may be employed as:
(a) Servers not working on the gaming floor who handle beer, wine and liquor
(b) As cashiers, greeters, cooks or custodians, or as a gaming employee as defined in Kalispel Tribal Code § 11–11.02(B), where they are not selling or handling beer, wine or liquor.
2. Non-gaming facility employees eighteen (18) years or older may sell and handle beer or wine not to be consumed on the premises provided that they have successfully completed Mandatory Alcohol Server Training (MAST) and there is direct supervision by an adult twenty-one (21) years of age or older.
No Tribal operator shall permit any person to open or consume liquor on his or her premises or any premises adjacent thereto and in his or her control. This prohibition shall not apply to lawful sales and consumption of alcohol at the Kalispel Tribe's Northern Quest Casino located on the Reservation lands in Airway Heights, Washington or upon approval of the Commission of additional licensed liquor outlets on Reservation lands acquired in the future.
1. No Tribal operator shall be disorderly, boisterous or intoxicated on the licensed premises or on any public premises adjacent thereto which are under his or her control, nor shall he or she permit any disorderly boisterous or intoxicated person to be thereon.
2. No operator or employee shall consume liquor of any kind while working on the licensed premises.
3. No Tribal operator shall encourage, sanction or knowingly permit any activity that would be in violation of Chapter 9 of the Kalispel Tribe Law and Order Code.
The Kalispel Tribe will levy a tax on the retail sale of each pack of cigarettes, the amount of which is established by the cigarette tax compact between the Kalispel Tribe and the State of Washington.
Other tobacco products, excluding cigarettes, shall be taxed at a rate determined to be fair and equitable by the Commission, but the Commission may establish tax rates dependent solely on the given class of merchandise.
An operator may, upon approval of the Commission and in a non-discriminatory manner, exempt enrolled members of the Kalispel Tribe and enrolled members of another Federally recognized Indian Tribe, band, or Alaskan Native, or a member of the Canadian First Nations, from imposition of the Tribe's cigarette and tobacco product taxes, provided, however, the individual present a valid Tribal identification card upon purchase of the cigarettes or tobacco products.
All alcoholic beverages, including packaged liquor, wine and beer, and those products dispensed for consumption at a licensed liquor outlet, shall be taxed at a rate determined to be fair and equitable by the Commission, but the Commission may establish tax rates dependent solely on the given class of merchandise.
The excise taxes levied hereunder shall be added to the retail selling price of cigarettes, tobacco products, and alcoholic beverages sold to the ultimate consumer.
The excise taxes levied hereunder shall be placed in the General Fund of the Kalispel Tribe. The revenue may be allocated at the discretion of the Tribal Council to Tribal projects and expenses for essential government services.
Any enrolled member of the Kalispel Indian Tribe, an enrolled member of another Federally recognized Tribe, a Tribal leasee or a Tribally-licensed business entity may apply to the Commission for a tobacco outlet license and/or a liquor and beer outlet license.
The Tribal secretary-treasurer shall receive and process applications, and be the official representative of the Tribe and Commission in matters relating to tobacco and/or liquor and beer outlets excise tax collections and related matters. The Commission or its authorized representative shall obtain additional information as deemed appropriate. If the Commission or its authorized representative is satisfied that the applicant is a suitable and reputable person, the Commission or its authorized representative may issue a license for the sale of tobacco products and/or liquor and beer products.
Each application shall be accompanied by an application charge or fee of fifty dollars ($50.00). An application for both a tobacco outlet license and a liquor and beer outlet license shall be considered to be two applications with an application charge of fifty dollars ($50.00) each.
Upon approval of an application, the Commission shall issue the applicant a tobacco outlet license and/or a liquor and beer outlet license whichever the case may be, for one year which shall entitle the operator to establish and maintain one outlet for the type being permitted on the Kalispel Indian Reservation. This license shall be nontransferable. It shall be renewable annually at the discretion of the Commission by filing a new application form and payment of the application fee as provided in this Section.
Any entity issued a license shall frame under glass and display the license on the premises.
Failure of an operator to abide by the provisions of this chapter and any additional regulations or requirements imposed by the Commission will constitute grounds for revocation of the operator's license as well as enforcement of the penalties provided in Section 10.10.
This Section applies to tobacco and liquor outlets that are owned and operated by an individual who is an enrolled member of the Kalispel Indian Tribe, an enrolled member of another Federally recognized Tribe, a Tribal leasee or a Tribally-licensed business entity. This section shall not apply to gaming facilities or outlets operated by the Kalispel Tribe as business enterprises of the Tribe.
Each tobacco and/or liquor and beer outlet, licensed hereunder, shall be managed by an operator pursuant to a license granted by the Commission, hereunder, and shall conform to the regulations and prohibitions outlined by this Chapter.
The operator of any licensed outlet shall keep the Commission informed in writing of the identity of suppliers and wholesalers who supply or are expected to supply tobacco or liquor stocks to the outlet. The Commission may at its discretion and for any reasonable cause limit or prohibit the purchase of said stock from a supplier or wholesaler.
Operators shall in their purchase of stock and in their business relationships with suppliers cooperate with and assure a free flow of information and data to the Commission from suppliers relating to all sales to and business arrangements between the suppliers and operators. The Commission may, in its discretion, require the receipt from the suppliers of all invoices, bills of lading, billings or other documentary record of sales to the operator.
The premises of all Tribal Operators, including vehicles used in connection with liquor sales, shall be open at all times to inspection by the Kalispel Liquor Commission.
The originals or copies of all sales slips, invoices and other memoranda covering all purchases of liquor by operators shall be kept on file in the retail premises of the operator purchasing the same for at least five (5) years after each purchase, and shall be filed separately and kept apart from all other records, and as nearly as possible shall be filed in consecutive order and each month's records kept separate so to render the same readily available for inspection and checking. All canceled checks, bank statements and books of accounting covering or involving the purchase of liquor, and all memoranda, if any, showing payment of money for liquor other than by check, shall be likewise preserved for availability for inspection and checking.
An operator may conduct another business simultaneously with managing a tobacco or liquor and beer outlet for the Tribe. The other business may be conducted on the same premises, but the operator shall be required to maintain separate books of account for the other business.
All of the books and other business records of the outlet shall be available for inspection and audit by the Commission or its authorized representative for any reasonable time.
An operator is forbidden to represent or give the impression to any supplier or other person with whom he or she does business that he is an official representative of the Tribe or Commission authorized to pledge Tribal credit or financial responsibility for any of the expenses of his or her business operation. The operator shall hold the Kalispel Indian Tribe harmless from all claims and liability of whatever nature. The Commission shall revoke the operator's outlet license if the outlet is not operated in a businesslike manner or if it does not remain financially solvent or does not pay its operating expenses and bills before they become delinquent.
The excise tax together with reports on forms to be supplied by the Tribe shall be remitted to the Tribal office monthly unless otherwise specified in writing by the Commission. The operator shall furnish a satisfactory bond to the Tribe in an amount to be specified by the Commission guaranteeing his or her payment of excise tax.
The operator shall maintain at his or her expense adequate insurance covering liability, fire, theft, vandalism and other insurable risks. The Commission or the Business Committee may establish as a condition of any licenses, higher limits and any additional coverage it deems advisable. All insurance policies shall name the Tribe as an insured.
The Tribe shall have no legal responsibility for any unpaid bills owed by a non-Tribally owned tobacco or liquor and beer outlet to a wholesale supplier or to any other person. The operator shall make arrangements with his or her wholesalers to send copies of all of his or her purchase invoices to the Tribal office.
Operation of a Tribally-licensed tobacco or liquor outlet by a business entity creates a consensual relationship between the Tribe and the operator and the operator consents to Tribal court jurisdiction.
This Section applies to Kalispel Tribal business enterprises, including tobacco and liquor outlets and gaming facilities. This Section is not applicable to outlets described in Section 10–7.01.
Each tobacco and/or liquor and beer outlet, owned, managed and operated as a Kalispel Tribal Business Enterprise shall conform to the regulations and prohibitions outlined by this Chapter, to the extent that they are not in conflict with Chapter 17 of the Kalispel Tribe Law and Order Code. In case of conflict, the provisions of this Chapter shall be subrogated for the applicable provisions in Chapter 17.
A tobacco and/or liquor and beer outlet, owned, managed and operated as a Kalispel Tribal Business Enterprise may conduct another business simultaneously with the outlet. The other business may be conducted on the same premises, but separate books of account for the other business shall be maintained.
A tobacco and/or liquor and beer outlet, owned, managed and operated as a Kalispel Tribal Business Enterprise shall be covered by adequate insurance covering liability, fire, theft, vandalism and other insurable risks. The Commission or the Business Committee may establish higher limits and any additional coverage it deems advisable. All insurance policies shall name the Tribe as an insured.
The Tribe shall have legal responsibility for any unpaid bills owed by a tobacco or liquor and beer outlet owned, managed and operated as a Kalispel Tribal Business Enterprise to a wholesale supplier or to any other person. This liability is expressly limited by Section 17–8 of the Kalispel Tribe Law and Order Code.
The Kalispel Tribal Court shall have jurisdiction over all matters described in this Code. This jurisdiction shall extend over Indians and Non-Indians to the full extent allowed by Federal, State and Tribal Law.
Any tobacco or liquor outlet operator violating this chapter shall be guilty of an offense and subject to fine that the Tribal Court determines to be appropriate and/or the Tribal Court may also order that the license to sell tobacco or liquor be revoked or suspended.
With the exception of Section 10–4.07, which permits purchase and consumption of alcoholic beverages at Northern Quest casino and other Tribally licensed liquor outlets, nothing in this chapter shall be deemed to override the criminal offenses described in Chapter 9 of the Kalispel Tribe Law and Order Code. The criminal offenses described therein shall have full force and effect concurrently with any violation of this Chapter.
If an action or omission is deemed to violate both this Chapter and Chapter 9, the Tribal prosecutor shall prosecute the offense or violation under whichever provision provides for the harsher sentence, either under this Chapter or Chapter 13 of the Kalispel Tribe Law and Order Code.
Non-Indian individuals found to be in violation of this Chapter, Chapter 9 or an applicable statute under the Revised Code of Washington shall be subject to legal action that is in conformity with current Washington law.
This Chapter does not grant jurisdiction or authority to bring suit against the Kalispel Indian Tribe. Nothing in this Chapter shall be deemed a waiver of the sovereign immunity from suit of the Tribe or its agents, entities, instrumentalities, or officials, which immunity is hereby held to extend to the Tribe and its officers and employees acting for the Tribe within the scope of their Tribal authority.
If any provision of this chapter, its application to any person or circumstance is held invalid, the remainder of the chapter or the application of the provision to other persons or circumstances is not affected.
Nominations for the following properties being considered for listing or related actions in the National Register were received by the National Park Service before November 6, 2009. Pursuant to § 60.13 of 36 CFR Part 60 written comments concerning the significance of these properties under the National Register criteria for evaluation may be forwarded by United States Postal Service, to the National Register of Historic Places, National Park Service, 1849 C St., NW., 2280, Washington, DC 20240; by all other carriers, National Register of Historic Places, National Park Service, 1201 Eye St., NW., 8th floor, Washington, DC 20005; or by fax, 202–371–6447. Written or faxed comments should be submitted by December 10, 2009.
Pursuant to (36 CFR 60.13(b,c)) and (36 CFR 63.5), this notice, through publication of the information included herein, is to apprise the public as well as governmental agencies, associations and all other organizations and individuals interested in historic preservation, of the properties added to, or determined eligible for listing in, the National Register of Historic Places from September 14, to September18, 2009.
For further information, please contact Edson Beall via: United States Postal Service mail, at the National Register of Historic Places, 2280, National Park Service, 1849 C St., NW., Washington, DC 20240; in person (by appointment), 1201 Eye St., NW., 8th floor, Washington DC 20005; by fax, 202–371–2229; by phone, 202–354–2255; or by e-mail,
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade
Panyin A. Hughes, Esq., Office of the General Counsel, U.S. International Trade Commission, 500 E Street, SW., Washington, DC 20436, telephone (202) 205–3042. 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 at
The Commission instituted this investigation on September 8, 2009, based on a complaint filed by The Lincoln Electric Company of Cleveland, Ohio and Lincoln Global, Inc. of City of Industry, California (collectively, “Lincoln”). 74 FR 46223 (Sept. 8, 2009). The complaint alleged violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain bulk welding wire containers and components thereof and welding wire by reason of infringement of certain claims of United States Patent Nos. 6,260,781; 6,648,141; 6,708,864; 6,913,145; 7,309,038; 7,398,881; and 7,410,111.
On October 28, 2009, Lincoln filed an unopposed motion to amend the complaint and notice of investigation to remove ESAB AB from the investigation and add The ESAB Group, Inc. of Florence, South Carolina (“The ESAB Group”). Lincoln stated that ESAB AB has represented that it is not involved in the manufacture, importation into the United States, sale for importation, or sale with the United States after importation of bulk wire containers, components thereof and welding wire. Lincoln further stated that the entity responsible for the activities that form the basis of Lincoln's claim against ESAB AB is The ESAB Group, and that neither ESAB AB nor The ESAB Group oppose the motion.
On October 30, 2009, the ALJ issued Order No. 9 granting Lincoln's motion. None of the parties petitioned for review of Order No 9. The Commission has determined not to review the ID.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in section 210.42(h) of the Commission's Rules of Practice and Procedure (19 CFR 210.42(h)).
By order of the Commission.
Notice is hereby given that on November 13, 2009, a proposed Consent Decree in
In this action the United States, and the State of Ohio in a cross-claim, sought civil penalties and injunctive relief for violations of the Clean Water Act, 33 U.S.C. 1251
Under the proposed Decree, Akron will develop and implement a comprehensive plan to eliminate or reduce (i) combined sewer overflows in its sewer system and (ii) bypasses around secondary treatment at the WPCS. Within eight years, Akron will expand secondary treatment capacity at the WPCS to at least 130 million gallons of wastewater per day and will construct separate sewer lines for five combined sewer outfall points. Akron will also implement capacity, maintenance and emergency response programs to improve sewer system performance and to eliminate or reduce releases from the sewer collection system, including basement backups, releases into buildings, and onto property. The proposed Decree requires Akron to pay a total civil penalty of $500,000. Also, as a State Supplemental Environmental Project to improve water quality in the Cuyahoga River, Akron will pay $900,000 towards the removal of the Brecksville (or Route 82) Dam.
The Department of Justice will receive for a period of sixty (60) days from the date of this publication comments relating to the proposed Consent Decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and either e-mailed to
The proposed Consent Decree may be examined at the Office of the United States Attorney, Northern District of Ohio, 208 Federal Building, Two South Main Street, Akron, OH 44308–1855 (contact Assistant United States Attorney James Bickett (330/761–0523), and at U.S. Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, IL 60604–3590 (contact Associate Regional Counsel Susan Perdomo (312/886–0557)). During the public comment period the proposed Consent Decree may also be examined on the following Department of Justice Web site,
60-day emergency notice of information collection under review: New collection; Cargo Theft Incident Report.
The Department of Justice, Federal Bureau of Investigation, Criminal Justice Information Services Division will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with emergency review procedures of the Paperwork Reduction Act of 1995. OMB approval has been requested by February 27, 2010. The proposed information collection is published to obtain comments from the public and affected agencies. Comments are encouraged and will be accepted until January 25, 2010 This process is conducted in accordance with 5 CFR 1320.10.
All comments and suggestions, or questions regarding additional information, to include obtaining a copy of the proposed information collection instrument with instructions, should be directed to Gregory E. Scarbro, Unit Chief, Federal Bureau of Investigation, Criminal Justice Information Services Division (CJIS), Module E–3, 1000 Custer Hollow Road, Clarksburg, West Virginia 26306, or facsimile to (304) 625–3566.
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Comments should address one or more of the following four points:
(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, including the validity of the methodology and assumptions used;
(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, electronic, mechanical, or other technological collection techniques of other forms of information technology,
(1)
(2)
(3)
(4)
(5)
(6)
If additional information is required contact: Ms. Lynn Bryant, Department Clearance Officer, Policy and Planning Staff, Justice Management Division, United States Department of Justice, Patrick Henry Building, Suite 1600, 601 D Street, NW., Washington, DC 20530.
The Department of Labor (DOL) hereby announces the submission of the following public information collection requests (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104–13, 44 U.S.C. chapter 35). A copy of each ICR, with applicable supporting documentation; including, among other things, a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained from the RegInfo.gov Web site at
Interested parties are encouraged to send comments to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for the Department of Labor—Occupational Safety and Health Administration (OSHA), Office of Management and Budget, Room 10235, Washington, DC 20503, Telephone: 202–395–7316/Fax: 202–395–5806 (these are not toll-free numbers), E-mail:
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,
Occupational Safety and Health Administration (OSHA), Labor.
Announcement of a meeting of the Advisory Committee on Construction Safety and Health (ACCSH) and ACCSH Work Group meetings.
ACCSH will meet December 10 and 11, 2009, in Washington, DC. In conjunction with ACCSH's meeting, its Work Groups will meet December 8 and 9, 2009.
Comments, speaker presentations and requests to speak, including personal information, are placed in the public
To read or download documents in the public docket for this ACCSH meeting, go to Docket No. OSHA–2009–0030 at
ACCSH will meet Thursday, December 10, 2009 and Friday, December 11, 2009, in Washington, DC. The meeting is open to the public.
ACCSH is authorized to advise the Secretary of Labor and Assistant Secretary of Labor for Occupational Safety and Health in the formulation of standards affecting the construction industry and on policy matters arising in the administration of the safety and health provisions of the Contract Work Hours and Safety Standards Act (Construction Safety Act) (40 U.S.C. 3701, 3704) and the Occupational Safety and Health Act of 1970 (29 U.S.C. 651
The agenda topics for this meeting include:
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• Proposed Rule on the Standards Improvement Project III (SIP III);
• Revisions to OSHA's Occupational Injury and Illness Recording and Reporting (Recordkeeping) regulation; and
• Proposed Rule on Occupational Exposure to Crystalline Silica;
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ACCSH meetings are transcribed and detailed minutes of the meetings are prepared. The transcript and minutes are placed in the public docket for the meeting. The docket also includes ACCSH Work Group reports, speaker presentations, comments, and other materials and requests submitted to the Committee.
In conjunction with the ACCSH meeting, the following ACCSH Work Groups will meet on Tuesday,
• Regulatory Compliance (Focused Inspection) 8 to 9:40 a.m.—Room C;
• Silica 9:50 to 11:30 a.m.—Room A/B;
• Residential Fall Protection 12:30 to 2:10 p.m.—Room A/B;
• Trenching 2:20 to 4 p.m.—Room C; and
• Multilingual 4:10 to 5:50 p.m.—Room C.
The following additional ACCSH Work Groups will meet on Wednesday,
December 9, 2009 in Rooms N–3437 A/B or C:
• Powered Fastening Tools (Nail guns) 8:30 to 10:10 a.m.—Room A/B;
• ROPS (Roll Over Protective Structures) 10:20 to Noon—Room A/B;
• Diversity—Women in Construction 1:00 to 2:40 p.m.—Room C; and
• Education and Training (OTI) 2:50 to 4:30 p.m.—Room A/B.
For additional information on ACCSH Work Group meetings or participating in them, please contact Mr. Buchet at the address above or look on the ACCSH page on OSHA's Web page at
Alternately at the ACCSH meeting, individuals may also request to address ACCSH by signing the public comment request sheet and listing the interests they represent, if any, and the topic(s) to be addressed. In addition, they must provide 20 hard copies of any materials, written or electronic, that they plan to present to ACCSH.
Requests to address the Committee may be granted at the ACCSH Chair's discretion and as time and circumstances permit.
Comments, requests to address ACCSH, and speaker presentations are included without change in the meeting record and may be made available online at
The Legal Services Corporation Board of Directors and four of the Board's Committees will meet on November 30, 2009 in the order set forth in the following schedule. The first meeting will commence at 11 a.m., Eastern Time. Each meeting thereafter will commence promptly upon adjournment of the immediately preceding meeting, with the Audit Committee and the Finance Committee meeting jointly.
Legal Services Corporation, 3333 K Street, NW., Washington, DC 20007, 3rd Floor Conference Center.
For all meetings and portions thereof open to public observation, members of the public who are unable to attend but wish to listen to the proceedings may do so by following the telephone call-in directions given below. You are asked to keep your telephone muted to eliminate background noises. From time to time the presiding Chairman may solicit comments from the public.
• Call toll-free number: 1–866–451–4981;
• When prompted, enter the following numeric pass code: 3899506694;
• When connected to the call, please mute your telephone immediately.
Open, except as noted below:
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A
1. Approval of agenda.
2. Briefing by the auditing firm performing the annual independent audit of LSC on the status of the fiscal year 2009 audit and any preliminary findings.
3. Consider and act on recommendations to make to the Board related to how the Corporation should proceed with self-correction of an independent contractor issue and what related actions to take on proposed resolutions revising LSC's 403(b) Thrift Plan with regard to the minimum hours
4. Consider and act on recommendations to make to the Board related to what actions to take on proposed resolutions revising LSC's 403(b) Thrift Plan with regard to the minimum hours requirements for participation, related conforming amendments to the LSC Employee Handbook, and amendments to the LSC Employee Handbook regarding merger of LSC's TDA and 403(b) thrift plans.
5. Consider and act on recommendation to make to the Board regarding proposed use of the LSC President's discretionary fund.
6. Consider and act on other business.
7. Public comment.
8. Consider and act on motion to adjourn meeting.
1. Approval of agenda.
2. Consider and act on performance review of the Inspector General.
3. Consider and act on other business.
4. Public comment.
5. Consider and act on motion to adjourn meeting.
1. Approval of agenda.
2. Consider and act on a recommendation to make to Board as to an interim President for LSC.
3. Consider and act on other business.
4. Public Comment.
5. Consider and act on motion to adjourn meeting.
1. Approval of agenda.
2. Consider and act on whether to authorize an executive session of the
3. Consider and act on recommendations regarding selection of labor counsel to advise and represent the Corporation on union matters.
4. Consider and act on recommendation as to selection of an interim President for LSC.
5. Consider and act on recommendations related to how the Corporation may proceed with self-correction of an independent contractor issue and related proposed resolutions revising LSC's 403(b) Thrift Plan with regard to the minimum hours requirements for participation and related conforming amendments to the LSC Employee Handbook.
6. Consider and act on the annual performance evaluation of the Inspector General.
7. Consider and act on recommendations related to what actions to take on proposed resolutions revising LSC's 403(b) Thrift Plan with regard to the minimum hours requirements for participation, related conforming amendments to the LSC Employee Handbook, and amendments to the LSC Employee Handbook regarding merger of LSC's TDA and 403(b) thrift plans.
8. Public comment.
9. Consider and act on other business.
10. Consider and act on motion to adjourn meeting.
National Archives and Records Administration (NARA).
Notice of availability of proposed records schedules; request for comments.
The National Archives and Records Administration (NARA) publishes notice at least once monthly of certain Federal agency requests for records disposition authority (records schedules). Once approved by NARA, records schedules provide mandatory instructions on what happens to records when no longer needed for current Government business. They authorize the preservation of records of continuing value in the National Archives of the United States and the destruction, after a specified period, of records lacking administrative, legal, research, or other value. Notice is published for records schedules in which agencies propose to destroy records not previously authorized for disposal or reduce the retention period of records already authorized for disposal. NARA invites public comments on such records schedules, as required by 44 U.S.C. 3303a(a).
Requests for copies must be received in writing on or before December 28, 2009. Once the appraisal of the records is completed, NARA will send a copy of the schedule. NARA staff usually prepare appraisal memorandums that contain additional information concerning the records covered by a proposed schedule. These, too, may be requested and will be provided once the appraisal is completed. Requesters will be given 30 days to submit comments.
You may request a copy of any records schedule identified in this notice by contacting the Life Cycle Management Division (NWML) using one of the following means:
Requesters must cite the control number, which appears in parentheses after the name of the agency which submitted the schedule, and must provide a mailing address. Those who desire appraisal reports should so indicate in their request.
Laurence Brewer, Director, Life Cycle Management Division (NWML), National Archives and Records Administration, 8601 Adelphi Road, College Park, MD 20740–6001.
Each year Federal agencies create billions of records on paper, film, magnetic tape, and other media. To control this accumulation, agency records managers prepare schedules proposing retention periods for records and submit these
The schedules listed in this notice are media neutral unless specified otherwise. An item in a schedule is media neutral when the disposition instructions may be applied to records regardless of the medium in which the records are created and maintained. Items included in schedules submitted to NARA on or after December 17, 2007, are media neutral unless the item is limited to a specific medium. (
No Federal records are authorized for destruction without the approval of the Archivist of the United States. This approval is granted only after a thorough consideration of their administrative use by the agency of origin, the rights of the Government and of private persons directly affected by the Government's activities, and whether or not they have historical or other value.
Besides identifying the Federal agencies and any subdivisions requesting disposition authority, this public notice lists the organizational unit(s) accumulating the records or indicates agency-wide applicability in the case of schedules that cover records that may be accumulated throughout an agency. This notice provides the control number assigned to each schedule, the total number of schedule items, and the number of temporary items (the records proposed for destruction). It also includes a brief description of the temporary records. The records schedule itself contains a full description of the records at the file unit level as well as their disposition. If NARA staff has prepared an appraisal memorandum for the schedule, it too includes information about the records. Further information about the disposition process is available on request.
1. Department of Agriculture, Grain Inspection, Packers and Stockyards Administration (N1–545–10–1, 1 item, 1 temporary item). Master files for an electronic information system used to manage the national grain inspection and weighing program.
2. Department of Health and Human Services, Food and Drug Administration (N1–88–09–11, 3 items, 3 temporary items). Files and reports relating to fees charged for services to industry and annual fees relating to products currently on the market. Also included are master files used for tracking the receipt and payment of user fees.
3. Department of Homeland Security, Immigration and Customs Enforcement (N1–567–09–5, 1 item, 1 temporary item). Master files for an electronic information system that contains information concerning aliens who are allowed to live outside of a detention facility while undergoing the deportation process.
4. Department of Homeland Security, Immigration and Customs Enforcement (N1–567–09–6, 3 items, 3 temporary items). Master files and outputs for an electronic information system that maintains information concerning suspected immigration status violators.
5. Department of the Interior, Southwestern Pennsylvania Heritage Preservation Commission (N1–48–09–14, 13 items, 6 temporary items). Records relating to operational functions of the Commission, including such records as project files, grants management records, and general correspondence. Proposed for permanent retention are substantive files, such as policy records, publications, Executive Committee records, and photographs.
6. Department of Justice, Executive Office for U.S. Attorneys (N1–60–09–30, 4 items, 4 temporary items). Records relating to the accreditation of continuing legal education courses sponsored by the Office of Legal Education. Included are such records as certifications, credit instruction packets, and individual state accreditation files.
7. Department of Justice, National Drug Intelligence Center (N1–523–09–3, 1 item, 1 temporary item). Master files of an electronic information system that tracks intelligence projects. Included is such information as project number and title, name of analyst assigned to the project, and dates of initiation and completion.
8. Department of Justice, U.S. Trustee Program (N1–60–09–53, 3 items, 3 temporary items). Master files of an electronic information system used to track the application and approval process for agencies and vendors being considered as credit and debt counseling providers.
9. Department of State, Bureau of East Asian and Pacific Affairs (N1–59–09–10, 6 items, 2 temporary items). Records relating to trips, as well as country files consisting of extra copies of telegrams. Proposed for permanent retention are calendars and appointment books of the Assistant Secretary, subject files, policy files, and files relating to interagency meetings. The proposed disposition instructions are limited to paper records for permanent items.
10. Department of State, Bureau of Human Resources (N1–59–09–46, 1 item, 1 temporary item). Records relating to career development workshops, such as instructors' materials and handouts.
11. Department of State, Bureau of Public Affairs (N1–59–09–23, 1 item, 1 temporary item). Master files of an electronic information system that contains data concerning the media environment in specific countries.
12. Department of State, Foreign Service Institute (N1–59–09–47, 1 item, 1 temporary item). Records relating to students at the School of Applied Information Technology. Records relate to such matters as courses taken, attendance, class rosters, funding for travel, and evaluations.
13. Department of State, Office of the Chief of Protocol (N1–59–09–45, 1 item, 1 temporary item). Master files of an electronic information system containing information on guests and participants at events.
14. Department of the Treasury, Internal Revenue Service (N1–58–09–38, 3 items, 3 temporary items). Master files, outputs, and system documentation associated with an electronic information system used to collect and centralize data from other agency systems for more efficient analysis.
15. Department of the Treasury, Internal Revenue Service (N1–58–09–39, 2 items, 2 temporary items). Master files and system documentation associated with an electronic information system used to provide states with taxpayer information.
16. Department of the Treasury, Internal Revenue Service (N1–58–09–46, 2 items, 2 temporary items). Master files and system documentation associated with an electronic information system used to track employee workload regarding taxpayer information requests at customer services sites.
17. Department of the Treasury, Internal Revenue Service (N1–58–09–47, 3 items, 3 temporary items). Master files, outputs, and system documentation associated with an electronic information system which
18. Department of the Treasury, Internal Revenue Service (N1–58–09–58, 4 items, 4 temporary items). Master files, inputs, outputs, and system documentation associated with an electronic information system used in connection with notifying taxpayers of potential backup withholding due to unmet tax obligations.
19. Department of the Treasury, Internal Revenue Service (N1–58–09–111, 4 items, 4 temporary items). Master files, inputs, and system documentation associated with an electronic information system used to issue calling cards to employees who must place long distance telephone calls while traveling on business.
20. Department of the Treasury, Internal Revenue Service (N1–58–09–112, 2 items, 2 temporary items). Master files and system documentation associated with an electronic information system used to store information concerning solutions and remedies to technical problems and issues.
21. Agency for International Development, Management Bureau (N1–286–09–5, 1 item, 1 temporary item). Master files associated with an electronic information system used in connection with agency procurement activities.
22. Environmental Protection Agency, Agency-wide (N1–412–08–16, 1 item, 1 temporary item). Duplicative comments received from stakeholders that have been summarized. Summaries were previously approved for permanent retention.
23. Environmental Protection Agency, Agency-wide (N1–412–10–1, 2 items, 2 temporary items). Electronic and paper input documents associated with an electronic information system that contains information on toxic chemical releases and other waste management activities. Records were previously approved for disposal. The related electronic information system was previously scheduled as permanent.
24. Federal Energy Regulatory Commission, Agency-wide (N1–138–09–5, 1 item, 1 temporary item). Docketed case files relating to electric utilities. Paper copies of these files were previously approved for disposal.
25. Nuclear Regulatory Commission, Office of Nuclear Security and Incident Response (N1–431–08–11, 3 items, 2 temporary items). Master files and system operations records for an electronic information system used to capture data on conditions at nuclear power plants during an emergency event. Proposed for permanent retention are reports documenting events.
The
The time of the meeting is being changed from 2:30 p.m.–4:30 p.m., to 8:30 a.m.–12 p.m. In addition to the review of the Draft Final Revision 1 to Regulatory Guide 1.151 (DG–1178), the Subcommittee will also review the Draft Final Revision 1 to Regulatory Guide 1.141 (DG–1213), “Containment Isolation Provisions for Fluid Systems.”
The notice of this meeting was previously published in the
Further information regarding this meeting can be obtained by contacting Zena Abdullahi, Designated Federal Official (
The ACRS Subcommittee on Digital Instrumentation and Control Systems (DI&C) will hold a meeting on December 17, 2009, Room T2–B1, 11545 Rockville Pike, Rockville, Maryland.
The agenda for the subject meeting shall be as follows:
The Subcommittee will hear presentations by and hold discussions with representatives of the NRC staff and the industry regarding review of Draft Final Regulatory Guide 1.62, “Manual Initiation of Protective Actions.” The Subcommittee will gather information, analyze relevant issues and facts, and formulate proposed positions and actions, as appropriate, for deliberation by the full Committee.
Members of the public desiring to provide oral statements and/or written comments should notify the Designated Federal Official (DFO), Ms. Christina Antonescu (Telephone: 301–415–6792, E-mail:
Detailed meeting agendas and meeting transcripts are available on the NRC Web site at
The ACRS Subcommittee on Radiation Protection and Nuclear Materials will hold a meeting on December 16, 2009, Room T2–B3, 11545 Rockville Pike, Rockville, Maryland.
The meeting will be open to public attendance.
The agenda for the subject meeting shall be as follows:
The Subcommittee will review (1) The NRC staff efforts to revise and update the radiation protection standards in 10 CFR Parts 20 and 50; (2) the status of NRC rulemaking efforts for unique waste streams including depleted uranium; and (3) the proposed Revision 2 to Regulatory Guide 4.11, “Terrestrial Environmental Studies for Nuclear Power Plants.” The Subcommittee will hear presentations by and hold discussions with NRC staff and other interested persons regarding these matters. The Subcommittee will gather information, analyze relevant issues and facts, and formulate proposed positions and actions, as appropriate, for deliberation by the full Committee.
Members of the public desiring to provide oral statements and/or written comments should notify the Designated Federal Official (DFO), Mr. Neil Coleman, (Telephone: 301–415–7656, E-mail:
Detailed meeting agendas and meeting transcripts are available on the NRC Web site at:
Nuclear Regulatory Commission.
Notice of opportunity for public comment.
The U.S. Nuclear Regulatory Commission (NRC or Commission) is proposing to issue this draft regulatory issue summary (RIS) to remind licensees of the requirements for the inservice inspection (ISI) and testing of dynamic restraints (snubbers) under 10 CFR 50.55a(g) and 10 CFR 50.55a(b)(3)(v). This RIS requires no action or written response on the part of an addressee.
Comment period expires January 11, 2010. Comments submitted after this date will be considered if it is practical to do so, but assurance of consideration cannot be given except for comments received on or before this date.
You may submit comments by any one of the following methods. Please include Docket ID NRC–2009–0511 in the subject line of your comments. Comments submitted in writing or in electronic form will be posted on the NRC Web site and on the Federal rulemaking Web site Regulations.gov. Because your comments will not be edited to remove any identifying or contact information, the NRC cautions you against including any information in your submission that you do not want to be publicly disclosed.
The NRC requests that any party soliciting or aggregating comments received from other persons for submission to the NRC inform those persons that the NRC will not edit their comments to remove any identifying or contact information, and therefore, they should not include any information in their comments that they do not want publicly disclosed.
You can access publicly available documents related to this notice using the following methods:
Gurjendra S. Bedi, NRR/DCI/CPTB, at 301–415–1393 or by e-mail at
All holders of operating licenses for nuclear power reactors under the provisions of Title 10 of the Code of Federal Regulations (10 CFR) part 50, “Domestic Licensing of Production and Utilization Facilities,” except those who have permanently ceased operations and have certified that fuel has been permanently removed from the reactor vessel.
All holders of, and applicants for, nuclear power plant construction permits, early site permits, and limited work authorizations for nuclear power reactors under the provisions of 10 CFR part 50.
The U.S. Nuclear Regulatory Commission (NRC or Commission) is issuing this regulatory issue summary (RIS) to remind licensees of the requirements for the inservice inspection (ISI) and testing of dynamic restraints (snubbers) under 10 CFR 50.55a(g) and 10 CFR 50.55a(b)(3)(v). This RIS requires no action or written response on the part of an addressee.
The regulations at 10 CFR 50.55a(b) detail the Codes and standards that have been approved for inclusion in 10 CFR part 50, including the effective edition and addenda of the American Society of Mechanical Engineer (ASME) Boiler and Pressure Vessel (BPV) Code and the ASME Code for Operation and Maintenance of Nuclear Power Plants (OM Code).
The regulations at 10 CFR 50.55a(g) establish the ISI requirements that licensees must use when performing ISI of components (including supports). 10 CFR 50.55a(g)(4) states, “Throughout the service life of a boiling or pressurized water-cooled nuclear power facility, components (including supports) which are classified as ASME Code Class 1, Class 2, and Class 3 must meet the requirements, except design and access provisions and preservice examination requirements, set forth in Section XI of editions of the ASME BPV Code and addenda.” ASME Section XI provides the rules for ISI of nuclear power plant components.
The regulation at 10 CFR 50.55a(g)(4)(ii) requires the use of the latest edition and addenda of the Code that has been incorporated by reference 12 months prior to the beginning of each 120-month inspection interval. This Code is considered the “Code of Record” for the inspection interval.
The regulation at 10 CFR 50.55a(g)(4)(iv) states that ISI of components (including supports) may meet the requirements set forth in subsequent editions to the “Code of Record” and addenda that are incorporated by reference in 10 CFR 50.55a(b), subject to limitations and modifications listed in 10 CFR 50.55a(b) and subject to Commission approval.
The regulations at 10 CFR 50.55a(g) require ISI of components (including supports) without specifically mentioning “snubbers.” Consequently, confusion resulted and some licensees mistakenly believed that ISI and testing of snubbers is not a regulatory requirement. The NRC clarified, in the final rule dated September 22, 1999, [(Volume 64 of the
The regulations at 10 CFR 50.55a(g)(4) require that ASME Code Class 1, 2, and 3 components (including supports) meet the ISI requirements of ASME Code Section XI. Article IWF–5000, “Inservice Inspection Requirements for Snubbers,” of ASME Code Section XI provides requirements for the examination and testing of snubbers in nuclear power plants. Therefore, inservice examination and testing of snubbers are required by 10 CFR 50.55a because it incorporates by reference ASME Section XI requirements, including Article IWF–5000. Article IWF–5000 has required the ISI and testing of snubbers since the first issuance of Subsection IWF in the Winter 1978 Addenda of ASME Section XI, which was incorporated in 10 CFR 50.55a in January 1982. Before ASME Section XI incorporated snubber examination and testing requirements, licensees used snubber examination and testing requirements as defined in their plants' TS.
Improved Standard TS for various boiling and pressurized water-cooled nuclear power plants (NUREG–1430 thru 1434, Revision 3, published in June 2004) allow relocating inservice examination and testing requirements of snubbers from the TS to a plant's Technical Requirements Manual (TRM). However, relocating snubber ISI and testing requirements from the TS to TRM does not eliminate the need to comply with the 10 CFR 50.55a requirements.
For plants using their TS to govern ISI and testing of snubbers, 10 CFR 50.55a (g)(5)(ii) requires that if a revised ISI program for a facility conflicts with the TS, the licensee shall apply to the Commission for amendment of the TS to conform the TS to the revised program. Therefore, when performing 120-month ISI program updates in accordance with 10 CFR 50.55a (g)(4), licensees must submit any required amendments to ensure their TS remain consistent with the new code of record or NRC-approved alternative used in lieu of the Code requirements. The TS governing the snubber ISI and test program do not eliminate the 10 CFR50.55a requirements to update the program at 120-month intervals or to request and receive NRC authorization for alternatives to the Code requirements when appropriate.
The 2004 edition of ASME Section XI and the ASME OM Code are incorporated in 10 CFR 50.55a (Industry Codes and Standards; Amended Requirements, 73 FR 52730; September 10, 2008). Article IWF–5000 of the ASME BPV Code, Section XI, 2004 Edition, requires preservice and inservice examinations and testing of snubbers at nuclear power plants as part of the licensee's ISI program in accordance with ASME/American National Standards Institute Standard for Operation and Maintenance of Nuclear Power Plants, Part 4 (OM–4), 1987 Edition with OMa-1988 Addenda.
The regulation at 10 CFR 50.55a(b)(3)(v) allows the optional use of Subsection ISTD, “Preservice and Inservice Examination and Testing of Dynamic Restraint (Snubbers) in Light-Water Reactor Nuclear Power Plants,” of the ASME OM Code-1995 Edition through the latest edition and addenda incorporated by reference in 10 CFR 50.55a(b)(3) in lieu of ASME Section XI, Articles IWF–5200(a) and (b) and IWF–5300(a) and (b) by making appropriate changes to TS or licensee-controlled documents. The regulation at 10 CFR 50.55a(b)(3)(v) also states, “Preservice and inservice examination must be performed using the VT–3 visual examination method described in IWA–2213.”
Licensees shall perform the ISI and testing of snubbers in accordance with ASME Section XI or the OM Code and the applicable addenda as required by 10 CFR 50.55a(g) or 10 CFR 50.55a(b)(3)(v), except where the NRC has granted specific written relief, pursuant to 10 CFR 50.55a(g)(6)(i), or authorized alternatives pursuant to 10 CFR 50.55a(3). The regulation at 10 CFR 50.55a(a)(3) states that licensees may use alternatives to the requirements of 10 CFR 50.55a(g) when authorized by the NRC if (1) the proposed alternatives would provide an acceptable level of quality and safety, or (2) compliance
Licensees have the option to control the ASME Code-required examination and testing of snubbers through their plant's TS or other licensee-controlled documents (
The staff has identified several instances in which nuclear power plant licensees have used a TRM, or other licensee-controlled documents and procedures which do not meet requirements of the “Code of Record” for the ISI and testing of snubbers without requesting approval to use these alternatives from the Commission. The staff is issuing this RIS to remind licensees that they must submit a request and receive NRC approval to use an alternative to control the examination and testing of snubbers through their plants licensee-controlled documents (
The regulation at 10 CFR 50.55a requires ISI of components (including supports) in accordance with ASME Section XI or OM Code requirements. The use of a TRM, or any other licensee-controlled documents that represent a departure from the Code requirements for snubber ISI and testing requires NRC approval. The use of alternatives in lieu of the Code requirements is addressed in 10 CFR 50.55a(a)(3). When requesting authorization to use an alternative, licensees must demonstrate the proposed alternative would provide an acceptable level of quality and safety, or they must demonstrate why compliance with the Code requirement would result in hardship or unusual difficulty without a compensating increase in the level of quality and safety.
In addition, for licensees using plant TS to control snubber examination and testing, the requirement to perform 10-year program updates in accordance with 10 CFR 50.55a(g)(4) still exists. If the TS represent an alternative to the requirements of the code edition and addenda specified in 10 CFR 50.55a(b) that is to be used for the ISI interval, licensees are required to request authorization from the NRC to use the alternative in accordance with 10 CFR 50.55a(a)(3). The regulation at 10 CFR 50.55a(g)(5)(ii) also requires that a licensee apply for an amendment to conform the TS to the revised program in cases where there is a conflict between the revised program and the TS.
Some licensees mistakenly concluded that the ISI and testing of snubbers is not a 10 CFR 50.55a regulatory requirement, because 10 CFR 50.55a requires ISI of components (including supports) without specifically mentioning snubbers and since snubber examination and testing was historically covered by a plant's TS. The resulting confusion led some licensees to believe that they do not need to request NRC approval to use an alternative (i.e., TS, TRM, or other licensee-controlled documents) in lieu of the Code requirements. The Commission has clarified, however, that snubber inspection and testing is a regulatory requirement.
Typically, if licensees use TS, TRM, or any other licensee-controlled documents which represent a departure from the ASME Code requirements for the ISI and testing of snubbers, they would submit an alternative for NRC approval as required by 10 CFR 50.55a(a)(3). The authorized alternative becomes a regulatory requirement that may be used in lieu of ASME Section XI or OM Code requirements for performing the ISI and testing of snubbers. The NRC staff must review and approve changes to these requirements for authorization under 10 CFR 50.55a(a)(3) or as an exemption under 10 CFR 50.12, “Specific Exemptions.” Alternatives requested and authorized pursuant to 10 CFR 50.55a(a)(3) are only valid for that particular 10-year ISI interval, unless specifically authorized for a different period in the associated NRC safety evaluation. In a subsequent 10-year ISI interval, licensees must resubmit an alternative for NRC staff review and approval if they choose not to adopt the ASME Code edition and addenda specified in the regulations for snubber examination and testing. In addition, for program changes that create a conflict with the plant TS, the licensee shall apply for an amendment to conform the TS to the program in accordance with 10 CFR 50.55a(g)(5)(ii).
This RIS reminds stakeholders of existing regulatory requirements within 10 CFR 50.55a(b) and 10 CFR 50.55a(g) for the ISI and testing of dynamic restraints (snubbers). This RIS does not represent a new or different staff position about the implementation of 10 CFR 50.55a. This RIS reminds addressees of the need to request NRC approval for the use of TS, TRM, or other licensee-controlled documents in lieu of the ASME Code requirements as required by 10 CFR 50.55a(a)(3). It requires no action or written response beyond what is required in 10 CFR 50.55a. Any action that addressees take to implement procedural or inspection changes in accordance with the information in this RIS ensures compliance with current regulations; and therefore, is not a backfit under 10 CFR 50.109, “Backfitting” and specifically the exception provided for in 10 CFR 50.109(a)(4)(i). Consequently, the NRC staff did not perform a backfit analysis.
To be done after the public comments periods.
This RIS is not a rule as designated by the Congressional Review Act (5 U.S.C. 801–886) and; therefore, is not subject to the Act.
This RIS does not contain any information collections and; therefore, is not subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Please direct any questions about this matter to Gurjendra S. Bedi, NRR/DCI/CPTB, at 301–415–1393 or by e-mail at
Documents may be examined, and/or copied for a fee, at the NRC's Public Document Room at One White Flint North, 11555 Rockville Pike (first floor), Rockville, Maryland. Publicly available records will be accessible electronically from the Agencywide Documents Access and Management System (ADAMS) Public Electronic Reading Room on the Internet at the NRC Web site,
Dated at Rockville, Maryland, this 19th day of November 2009.
For The Nuclear Regulatory Commission.
Postal Regulatory Commission.
Notice.
This document informs the public that an appeal of the closing of the Cranberry, PA post office has been filed. It identifies preliminary steps and provides a procedural schedule. Publication of this document will allow the Postal Service, petitioner, and others to take appropriate action.
Submit comments electronically via the Commission's Filing Online system at
Stephen L. Sharfman, General Counsel, 202–789–6820 or
Notice is hereby given that pursuant to 39 U.S.C. 404(d), the Commission has received an appeal of the closing of the Cranberry Post Office, Cranberry, PA 16319. The appeal was received by the Commission on October 6, 2009. The appeal was not filed as a Participant Statement on PRC Form 61; however, the petitioners have the option of filing supplemental information or facts. The Commission hereby institutes a proceeding under 39 U.S.C. 404(d)(5) and designates the case as Docket No. A2010–1 to consider the petitioner's appeal.
After the Postal Service files the administrative record and the Commission reviews it, the Commission may find that there are additional legal issues. Or, the Commission may find that the Postal Service's determination disposes of one or more of those issues. The deadline for the Postal Service to file the administrative record with the Commission is December 1, 2009. 39 CFR 3001.113.
The appeal and all related documents are also available for public inspection in the Commission's docket section. Docket section hours are 8 a.m. to 4:30 p.m., Monday through Friday, except on Federal government holidays. Docket section personnel may be contacted via electronic mail at
1. The Postal Service shall file the administrative record in this appeal, or otherwise file a responsive pleading to the appeal, by December 1, 2009.
2. The procedural schedule listed below is hereby adopted.
3. Pursuant to 39 U.S.C. 505, Patricia Gallagher is designated officer of the Commission (Public Representative) to represent the interests of the general public.
4. The Secretary shall arrange for publication of this notice and order in the
By the Commission.
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 350
Rule 23c–3 (17 CFR 270.23c–3) under the Investment Company Act of 1940 (15 U.S.C. 80a–1
The requirement that the fund send a notification to shareholders of each offer is intended to ensure that a fund provides material information to shareholders about the terms of each offer, which may differ from previous offers on such matters as the maximum amount of shares to be repurchased (the maximum repurchase amount may range from 5% to 25% of outstanding shares). The requirement that copies be sent to the Commission is intended to enable the Commission to monitor the fund's compliance with the notification requirement. The requirement that the shareholder notification be attached to Form N–23c–3 is intended to ensure that the fund provides basic information necessary for the Commission to process the notification and to monitor the fund's use of repurchase offers. The requirement that the fund describe its current policy on repurchase offers and the results of recent offers in the annual shareholder report is intended to provide shareholders current information about the fund's repurchase policies and its recent experience. The requirement that the board approve and review written procedures designed to maintain portfolio liquidity is intended to ensure that the fund has enough cash or liquid securities to meet its repurchase obligations, and that written procedures are available for review by shareholders and examination by the Commission. The requirement that the fund file advertisements and sales literature as if it were an open-end investment company is intended to facilitate the review of these materials by the Commission or FINRA to prevent incomplete, inaccurate, or misleading disclosure about the special characteristics of a closed-end fund that makes periodic repurchase offers.
Compliance with the collection of information requirements of the rule and form is mandatory only for those funds that rely on the rule in order to repurchase shares of the fund. The information provided to the Commission on Form N–23c–3 will not be kept confidential. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid control number.
The Commission staff estimates that 31 funds make use of rule 23c–3 annually, including one fund that is relying upon rule 23c–3 for the first time. The Commission staff estimates that on average a fund spends 89 hours annually in complying with the requirements of the rule and Form N–23c–3, with funds relying upon rule 23c–3 for the first time incurring an additional one-time burden of 28 hours. The Commission therefore estimates the total annual burden of the rule's and form's paperwork requirements to be 2787 hours.
Written comments are invited on: (a) Whether the collections of information are necessary for the proper performance of the functions of the Commission, including whether the information has practical utility; (b) the accuracy of the Commission's estimate of the burdens of the collections of information; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burdens of the collections of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and
Please direct your written comments to Charles Boucher, Director/CIO, Securities and Exchange Commission, C/O Shirley Martinson, 6432 General Green Way, Alexandria, VA 22312; or send an e-mail to:
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The title for the collection of information is “Form N–3 (17 CFR 239.17a and 274.11b) under the Securities Act of 1933 (15 U.S.C. 77) and under the Investment Company Act of 1940 (15 U.S.C. 80a), Registration Statement of Separate Accounts Organized as Management Investment Companies.” Form N–3 is the form used by separate accounts offering variable annuity contracts which are organized as management investment companies to register under the Investment Company Act of 1940 (“Investment Company Act”) and/or to register their securities under the Securities Act of 1933 (“Securities Act”). Form N–3 is also the form used to file a registration statement under the Securities Act (and any amendments thereto) for variable annuity contracts funded by separate accounts which would be required to be registered under the Investment Company Act as management investment companies except for the exclusion provided by Section 3(c)(11) of the Investment Company Act (15 U.S.C. 80a–3(c)(11)). Section 5 of the Securities Act (15 U.S.C. 77e) requires the filing of a registration statement prior to the offer of securities to the public and that the statement be effective before any securities are sold, and Section 8 of the Investment Company Act (15 U.S.C. 80a–8) requires a separate account to register as an investment company.
Form N–3 also permits separate accounts offering variable annuity contracts which are organized as investment companies to provide investors with a prospectus and a statement of additional information covering essential information about the separate account when it makes an initial or additional offering of its securities. Section 5(b) of the Securities Act requires that investors be provided with a prospectus containing the information required in a registration statement prior to the sale or at the time of confirmation or delivery of the securities. The form also may be used by the Commission in its regulatory review, inspection, and policy-making roles.
The Commission estimates that there is one initial registration statement and 30 post-effective amendments to initial registration statements filed on Form N–3 annually and that the average number of portfolios referenced in each initial filing and post-effective amendment is 2. The Commission further estimates that the hour burden for preparing and filing a post-effective amendment on Form N–3 is 154.7 hours per portfolio. The total annual hour burden for preparing and filing post-effective amendments is 9,282 hours (30 post-effective amendments × 2 portfolios × 154.7 hours per portfolio). The estimated annual hour burden for preparing and filing initial registration statements is 1,845.4 hours (1 initial registration statement × 2 portfolios × 922.7 hours per portfolio). The total annual hour burden for Form N–3, therefore, is estimated to be 11,127.4 hours (9,282 hours + 1,845.4 hours).
The information collection requirements imposed by Form N–3 are mandatory. Responses to the collection of information will not be kept confidential. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid control number.
Written comments are invited on: (a) 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; (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 the information collected; and (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. Consideration will be given to comments and suggestions submitted in writing within 60 days of this publication.
Please direct your written comments to Charles Boucher, Director/CIO, Securities and Exchange Commission, C/O Shirley Martinson, 6432 General Green Way, Alexandria, VA 22312; or send an e-mail to:
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 350l–3520), the Securities and Exchange Commission (the “Commission”) is soliciting comments on the collection of information summarized below. The Commission plans to submit this existing collection of information to the Office of Management and Budget for extension and approval.
Conflicts of interest between investment company personnel (such as portfolio managers) and their funds can arise when these persons buy and sell securities for their own accounts (“personal investment activities”). These conflicts arise because fund personnel have the opportunity to profit from information about fund transactions, often to the detriment of fund investors. Beginning in the early 1960s, Congress and the Securities and Exchange Commission (“Commission”) sought to devise a regulatory scheme to effectively address these potential conflicts. These efforts culminated in the addition of section 17(j) to the Investment Company Act of 1940 (the
Section 17(j) makes it unlawful for persons affiliated with a registered investment company (“fund”) or with the fund's investment adviser or principal underwriter (each a “17j–1 organization”), in connection with the purchase or sale of securities held or to be acquired by the investment company, to engage in any fraudulent, deceptive, or manipulative act or practice in contravention of the Commission's rules and regulations. Section 17(j) also authorizes the Commission to promulgate rules requiring 17j–1 organizations to adopt codes of ethics.
In order to implement section 17(j), rule 17j–1 imposes certain requirements on 17j–1 organizations and “Access Persons”
The rule requires each Access Person of a fund (other than a money market fund or a fund that does not invest in Covered Securities) and of an investment adviser or principal underwriter of the fund, who is not subject to an exception,
The requirements that the management of a rule 17j–1 organization provide the fund's board with new and amended codes of ethics and an annual issues and certification report are intended to enhance board oversight of personal investment policies applicable to the fund and the personal investment activities of Access Persons. The requirements that Access Persons provide initial holdings reports, quarterly transaction reports, and annual holdings reports and request approval for purchases of securities through IPOs and private placements are intended to help fund compliance personnel and the Commission's examinations staff monitor potential conflicts of interest and detect potentially abusive activities. The requirement that each rule 17j–1 organization maintain certain records is intended to assist the organization and the Commission's examinations staff in determining if there have been violations of rule 17j–1.
We estimate that annually there are approximately 75,757 respondents under rule 17j–1, of which 5,757 are rule 17j–1 organizations and 70,000 are Access Persons. In the aggregate, these respondents make approximately 105,125 responses annually. We estimate that the total annual burden of complying with the information collection requirements in rule 17j–1 is approximately 292,740 hours. This hour burden represents time spent by Access Persons that must file initial and annual holdings reports and quarterly transaction reports, investment personnel that must obtain approval before acquiring beneficial ownership in any securities through an IPO or private
We estimate that there is an annual cost burden of approximately $5,000 per fund complex, for a total of $3,275,000, associated with complying with the information collection requirements in rule 17j–1. This represents the costs of purchasing and maintaining computers and software to assist funds in carrying out rule 17j–1 recordkeeping.
These burden hour and cost estimates are based upon the Commission staff's experience and discussions with the fund industry. The estimates of average burden hours and costs are made solely for the purposes of the Paperwork Reduction Act. These estimates are not derived from a comprehensive or even a representative survey or study of the costs of Commission rules.
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid control number.
Written comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have practical utility; (b) the accuracy of the Commission's estimate of the burden of the collections of information; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burdens of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted in writing within 60 days of this publication.
Please direct your written comments to Charles Boucher, Director/CIO, Securities and Exchange Commission, C/O Shirley Martinson, 6432 General Green Way, Alexandria, VA 22312; or send an e-mail to:
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Rule 17Ad–16 requires a registered transfer agent to provide written notice to the appropriate qualified registered securities depository when assuming or terminating transfer agent services on behalf of an issuer or when changing its name or address. In addition, transfer agents that provide such notice shall maintain such notice for a period of at least two years in an easily accessible place. This rule addresses the problem of certificate transfer delays caused by transfer requests that are directed to the wrong transfer agent or the wrong address.
We estimate that the transfer agent industry submits 3,000 Rule 17Ad–16 notices to appropriate qualified registered securities depositories. The staff estimates that the average amount of time necessary to create and submit each notice is approximately 15 minutes per notice. Accordingly, the estimated total industry burden is 750 hours per year (15 minutes multiplied by 3,000 notices filed annually).
Because the information needed by transfer agents to properly notify the appropriate registered securities depository is readily available to them and the report is simple and straightforward, the cost is relatively minimal. The average cost to prepare and send a notice is approximately $7.50 (15 minutes at $30 per hour). This yields an industry-wide cost estimate of $22,500 (3,000 notices multiplied by $7.50 per notice).
Written comments are invited on: (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 estimates of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (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. Consideration will be given to comments and suggestions submitted in writing within 60 days of this publication.
Comments should be directed to Charles Boucher, Director/Chief Information Officer, Securities and Exchange Commission, c/o Shirley Martinson, 6432 General Green Way, Alexandria, VA 22312 or send an e-mail to:
Pursuant to Section 107(b) of the Sarbanes-Oxley Act of 2002 (the “Act”), notice is hereby given that on July 2, 2009, the Public Company Accounting Oversight Board (the “Board” or “PCAOB”) filed with the Securities and Exchange Commission (the “SEC” or “Commission”) the proposed rule changes described in Items I, II, and III below, which items have been prepared by the Board. The Commission is publishing this notice to solicit comments on the proposed rule from interested persons.
On June 25, 2009, the Board adopted an amendment to its rule relating to the
* * * * *
In its filing with the Commission, the Board included statements concerning the purpose of, and basis for, the proposed rule. The text of these statements may be examined at the places specified in Item IV below. The Board has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Sarbanes-Oxley Act of 2002 directs the Board to conduct a continuing program of inspections to assess registered public accounting firms' compliance with certain requirements.
The Board began a regular cycle of inspections of U.S. firms in 2004 and has conducted 982 such inspections, including repeat inspections of several firms. Inspections of non-U.S. firms began in 2005, and the Board has inspected 140 non-U.S. firms. Those firms are located in 26 jurisdictions.
The PCAOB has recognized since the outset of its inspection program that inspections of non-U.S. firms pose special issues.
Indeed, the Board has a specific framework for working cooperatively with its non-U.S. counterparts to conduct joint inspections and, to the extent deemed appropriate by the Board in any particular case, relying on inspection work performed by that counterpart.
In some jurisdictions, the PCAOB's ability to conduct inspections, either by itself or jointly with a local regulator, is complicated by the concerns of local authorities about potential legal obstacles and sovereignty issues. The Board seeks to work with the home-country authorities to try to resolve these and any other concerns.
The effort involved in attempting to resolve potential conflicts of law, or to evaluate a non-U.S. system in response to a Rule 4011 request, can be
Additional effort is involved in coordinating the scheduling of specific inspections. Where possible, the Board seeks to conduct inspections jointly with local authorities both to take advantage of potential efficiencies and to avoid imposing unnecessary regulatory burdens on firms. Like the PCAOB, several of these other authorities proceed according to inspection frequency requirements. While some of the Board's counterparts are established and have inspection programs, many have only recently begun inspections or are still building up their inspections resources. As a result, synchronizing the inspections schedules of these authorities and the PCAOB's requirements is sometimes difficult.
Notwithstanding these challenges, the Board has so far conducted 140 non-U.S. inspections. Moreover, 61 of those inspections, in six jurisdictions, have been conducted jointly with other auditor oversight authorities, while inspections in 20 jurisdictions have been conducted solely by the PCAOB.
As noted above, under existing Rule 4003, there are 68 non-U.S. firms that, by virtue of when they first issued audit reports after registering with the PCAOB, the Board is required to inspect for the first time by the end of 2009. Those firms are located in 36 jurisdictions, including several jurisdictions in which the Board has already conducted first inspections of other firms. Of those firms, 49 are located in 24 jurisdictions where the Board has not conducted any inspections to date. Most of those 24 jurisdictions have or soon will have a local auditor oversight authority with which the Board would seek to work toward cooperative arrangements before conducting inspections. Because of the steps involved in concluding such arrangements and to evaluate the local system, the Board has concerns about proceeding as if that work can be completed for all of the jurisdictions in which the PCAOB has not previously conducted inspections in time to conduct the required inspections by the end of 2009.
Accordingly, the Board is adopting a new paragraph (g) to Rule 4003 to allow the Board to postpone, for up to three years, the first inspection of any non-U.S. firm that the Board is currently required to conduct by the end of 2009 and that is in a jurisdiction where the Board has not conducted an inspection before 2009.
In determining the schedule for completion of the inspections subject to new paragraph (g), the Board will implement its proposal to sequence these 49 inspections such that certain minimum thresholds will be satisfied in each of the years from 2009 to 2012. The minimum thresholds relate to U.S. market capitalization of firms' issuer audit clients. The Board will begin by ranking the 49 firms according to the total U.S. market capitalization of a firm's foreign private issuer audit clients.
• By the end of 2009, the Board will inspect firms whose combined issuer audit clients' U.S. market capitalization constitutes at least 35 percent of the aggregate U.S. market capitalization of the audit clients of all 49 firms;
• By the end of 2010, the Board will inspect firms whose combined issuer audit clients' U.S. market capitalization constitutes at least 90 percent of that aggregate;
• By the end of 2011, the Board will inspect firms whose combined issuer audit clients' U.S. market capitalization constitutes at least 99.9 percent of that aggregate; and
• The Board will inspect the remaining firms in 2012.
In addition to meeting those market capitalization thresholds, the Board also will satisfy certain criteria concerning the number of those 49 firms that will be inspected in each year. Specifically, the Board will conduct at least four of the 49 inspections in 2009, at least 11 more in 2010, and at least 14 more in 2011.
It is important to note that the distribution described above will not operate to prevent an inspection from occurring earlier than called for by the schedule. Any inspection may be moved to an earlier year for a variety of reasons, such as the presence of risk factors (including risk factors relating to referred work
Conversely, the Board does not intend to make changes that would move an inspection of one of these 49 firms to a later year than in the initial distribution except as the result of a development relating to the market capitalization of the firm's issuer clients. Specifically, if a firm's issuer audit client market capitalization drops significantly and the firm performs no significant amount of referred work on audits, its inspection might be delayed to a later year. In any event, the Board will not, for any reason, move one of these 49 inspections to a later year than in the initial distribution without publicly describing the change and the reason for it.
In the Board's view, this adjustment to the inspection frequency requirement is consistent with the purposes of the Act, the public interest, and the protection of investors. The Board believes that its approach to implementing Rules 4011 and 4012, developing cooperative arrangements, and conducting joint inspections with foreign regulators is enhancing the Board's efforts to carry out its inspection responsibilities. There is long-term value in accepting a limited delay in inspections to continue working toward
The Board recognizes that some non-U.S. firms may be reluctant to comply with PCAOB inspection demands because of a concern that doing so might violate local law or the sovereignty of their home country. The Board believes that the purposes of the Act, the public interest, and the protection of investors are better served, up to a point, by delaying some of the first inspections to work toward a cooperative resolution than by precipitating legal disputes involving conflicts between U.S. and non-U.S. law that could arise if the Board sought to enforce compliance with its preferred schedule without regard for the concerns of non-U.S. authorities.
The Board does not intend, however, to make any further adjustments to the inspection frequency requirements applicable to firms whose first inspection was due no later than 2009. While the Board will continue to work toward cooperation and coordination with authorities in the relevant jurisdictions, the Board will make inspection demands on the firms early enough in the year in which they are scheduled for inspection according to the above described sequencing to allow the Board to conduct the inspections during that year.
The statutory basis for the proposed rule is Title I of the Act.
The Board does not believe that the proposed rule will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposed rule imposes no burden beyond the burdens clearly imposed and contemplated by the Act.
The Board released the proposed rule amendment for public comment in Release No. 2008–007 (December 4, 2008). A copy of Release No. 2008–007 and the comment letters received in response to the PCAOB's request for comment are available on the PCAOB's Web site at
Several commenters suggested that the Board exercise its authority under Section 106 of the Act to exempt firms that cannot cooperate with PCAOB inspections due to legal conflicts or sovereignty-based opposition from their local governments. The Board believes that it is not in the interests of investors or the public to exempt non-U.S. firms from the Act's inspection requirement given that the Board has previously determined not to exempt non-U.S. firms from the Act's registration requirements and given that an inspection is the Board's primary tool of oversight.
The Board also received several comment letters addressing the length of the proposed extension for certain firms with 2009 deadlines. Some comment letters expressed concern about the inspection delay of up to three years but ultimately expressed qualified support for the Board's decision. These comments urged the Board to permit no further delays and to proceed as described above by sequencing the inspection of firms subject to the extension based on certain thresholds relating to the U.S. market capitalization of firms' issuer audit clients. Some comments also suggested that the Board should utilize the additional time provided by the proposed extension to enhance its international inspections program, particularly in the areas of risk assessment and pre-inspection planning.
Other comment letters supported the Board's decision to extend the inspection deadlines, but some qualified their support by noting that three years may not be enough time to overcome the legal conflicts and sovereignty concerns in all relevant jurisdictions. Several comments expressed support for the Board's plan to sequence the deferred inspections in time based on the U.S. market capitalization of the firms' clients, but some also noted that this plan did not adequately take into account the varying degree of legal conflicts present in the different jurisdictions and might have the effect of requiring early on during the three year period the inspection of firms in jurisdictions with legal obstacles that cannot be overcome quickly.
As explained above, the Board believes that an extension of up to three years for the relevant firms is the appropriate course. Distributing the affected firms across three years strikes the proper balance between avoiding unnecessary delays in the inspection of registered firms and allowing reasonable time for the Board to continue its efforts to reach cooperative arrangements with the relevant home-country regulators. The Board believes that any longer or further extension would not be in the interests of investors or the public.
Within 60 days of the date of publication of this notice in the
(A) By order approve such proposed rule change, or
(B) Institute proceedings to determine whether the proposed rule change should be disapproved.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule changes are consistent with the requirements of Title I of 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.
By the Commission.
Pursuant to Section 19(b)(1)
The Exchange proposes to amend Rule 7.25 to remove the requirement that for each security in which a Market Maker is registered as a Lead Market Maker, the Lead Market Maker also register as an Odd Lot Dealer in that security. The text of the proposed rule change is available at the Exchange, the Commission's Public Reference Room, and
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 Exchange proposes to amend Rule 7.25 to remove the requirement that for each security in which a Market Maker is registered as a Lead Market Maker (“LMM”), the LMM also register as an Odd Lot Dealer (“OLD”) in that security (the “LMM–OLD requirement”). Going forward, LMMs may choose to register as an OLD, but will not be required to do so.
The LMM–OLD requirement was originally established in order to ensure that a mechanism existed whereby the Exchange could facilitate odd lot executions for its primary listings that could not otherwise be routed away to another market center for execution.
In addition, until recently, the Exchange paid a $0.02 per share credit to market makers that executed against an odd lot order. This rebate represented a higher than standard rebate, and acted as an incentive for market makers to register as OLDs. However, the Exchange notes that as of August 3, 2009, the Exchange eliminated all distinct odd lot pricing and now makes no distinction with respect to the rates applied to odd lot and round lot executions.
The Exchange is not otherwise altering any other rights or obligations of LMMs.
The Exchange believes the proposed rule change is consistent with and furthers the objectives of Section 6(b)(5) of 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.
Because the proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative prior to 30 days from the date on which it was filed, 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) of the Act
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”)
FINRA is proposing to (1) Modify various time requirements regarding expedited proceedings, (2) add an expedited proceeding for failure to pay restitution, and (3) harmonize a remedy in an expedited procedure with a remedy in the FINRA By-Laws.
The text of the proposed rule change is available on FINRA's Web site at:
In its filing with the Commission, FINRA 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. FINRA has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
In March 2004, the SEC approved a rule change that created the NASD Rule 9550 Series to consolidate, clarify, and streamline most procedural rules that had an expedited proceeding component.
The Rule 9550 Series provides a procedural mechanism for FINRA to address certain types of misconduct more quickly than would be possible using the ordinary disciplinary process. At the same time, the Rule 9550 Series provides firms and associated persons with numerous procedural protections, including the ability to request a hearing that often results in a stay of the action. FINRA proposes shortening the time within which a hearing must be held from the current 60 days after a hearing request to 30 days after the request in relation to the following FINRA rules:
• Rule 9551 (Failure To Comply With Public Communication Standards);
• Rule 9552 (Failure To Provide Information or Keep Information Current);
• Rule 9553 (Failure To Pay FINRA Dues, Fees and Other Charges);
• Rule 9554 (Failure To Comply With an Arbitration Award or Related Settlement); and
• Rule 9555 (Failure to Meet the Eligibility or Qualification Standards or Prerequisites for Access to Services).
The proposed change
In addition to modifying the timing of hearings, FINRA proposes amending Rule 9552 to shorten the period before a suspension automatically turns into an expulsion or bar. Rule 9552 allows FINRA to suspend a member or associated person for failure to provide any information requested or required to be filed pursuant to the FINRA By-Laws or rules, such as FOCUS reports or annual audits. Under the rule, FINRA may provide written notice to such member or person specifying the nature of the failure and stating that failure to take corrective action within 21 days after service of the notice will result in suspension. The rule also provides that a member or person suspended under the rule who fails to request termination of the suspension within six months is automatically expelled or barred. FINRA proposes shortening that timeframe from six months to three months. Three months provides sufficient time for respondents to seek to lift the suspension while moving the process forward at a more efficient and reasonable pace.
FINRA proposes amending Rule 9554, which contains expedited procedures for failure to pay FINRA arbitration awards, to also permit FINRA to take expedited action for failure to comply with a FINRA order of restitution or a FINRA settlement providing for restitution. Restitution is an equitable remedy used to restore victims to their position before the wrongful conduct occurred and to compensate them for unjust losses or injury suffered as the result of another's wrongdoing.
Although FINRA can take expedited action against a member firm or associated person for failure to pay fines, dues, and fees to FINRA and for failure to pay an arbitration award to a third party, FINRA currently does not have explicit authority to take expedited action against firms or associated persons who fail to pay restitution to a third party (usually investors who have been harmed). FINRA's only recourse is to initiate an ordinary disciplinary action, which can take several months to conclude. FINRA believes that firms and associated persons should not be permitted to continue doing business for prolonged periods when they have failed to pay restitution to third parties. The proposal would close this loophole.
FINRA proposes harmonizing the remedy for an individual's failure to pay an arbitration award in Rule 9554 with the remedy for the same misconduct in the FINRA By-Laws. At present, Rule 9554 states that FINRA may suspend or cancel the membership of a firm and may suspend or bar an individual for failure to pay an arbitration award. Article VI, Section 3(b) of the FINRA By-Laws, however, limits the remedy regarding an individual's failure to pay an arbitration award to a suspension. To make the rule consistent with the By-Laws, the proposed change would limit the remedy against individuals in such
FINRA will announce the effective date of the proposed rule change in a
The proposed rule change is consistent with the provisions of Section 15A(b)(6) of the Act,
FINRA 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.
Within 35 days of the date of publication of this notice in the
(A) By order approve such proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be disapproved.
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.
A meeting of the Advisory Committee on International Law will take place on Friday, December 11, 2009, from 9:15 a.m. to approximately 5:30 p.m., at the George Washington University Law School (Michael K. Young Faculty Conference Center, 5th Floor), 2000 H St., NW., Washington, DC. The meeting will be chaired by the Legal Adviser of the Department of State, Harold H. Koh, and will be open to the public up to the capacity of the meeting room. It is anticipated that the agenda of the meeting will cover a range of current international legal topics, including treaty scope and enforcement issues, the relationship between human rights treaties and humanitarian law; issues relating to the International Criminal Court; options for compliance with the International Court of Justice's decision in the
Members of the public who wish to attend the session should, by Monday, December 7, 2009, notify the Office of the Legal Adviser (telephone: 202–776–8323) of their name, professional affiliation, address, and telephone number. A valid photo ID is required for admittance. A member of the public who needs reasonable accommodation should make his or her request by December 4, 2009; requests made after that time will be considered but might not be possible to accommodate.
Notice is hereby given that the Department of State has forwarded the attached Notifications of Proposed Export Licenses to the Congress on the dates indicated on the attachments pursuant to sections 36(c) and 36(d) and in compliance with section 36(f) of the Arms Export Control Act (22 U.S.C. 2776).
Mr. Robert S. Kovac, Managing Director, Directorate of Defense Trade Controls, Bureau of Political-Military Affairs, Department of State (202) 663–2861.
Section 36(f) of the Arms Export Control Act mandates that notifications to the Congress pursuant to sections 36(c) and 36(d) must be published in the
Dear Madam Speaker: Pursuant to Section 36(c) of the Arms Export Control Act, I am transmitting, herewith, certification of a proposed technical assistance agreement to include the export of technical data, defense services, and defense articles in the amount of $50,000,000 or more.
The transaction contained in the attached certification involves the transfer of technical data, defense services, and hardware to support the Proton launch of the SkyTerra 2 Commercial Communication Satellite from the Baikonur Cosmodrome in Kazakhstan.
The United States Government is prepared to license the export of these items having taken into account political, military, economic, human rights, and arms control considerations.
More detailed information is contained in the formal certification which, though unclassified, contains business information submitted to the Department of State by the applicant, publication of which could cause competitive harm to the United States firm concerned.
Sincerely,
Dear Madam Speaker: Pursuant to Section 36(c) of the Arms Export Control Act, I am transmitting, herewith, certification of a proposed technical assistance agreement to include the export of defense articles, technical data and defense services in the amount of $50,000,000 or more.
The transaction contained in the attached certification involves the transfer of defense articles, to include technical data, and defense services to support the Proton launch of the Telstar 14R Commercial Communication Satellite from the Baikonur Cosmodrome in Kazakhstan.
The United States Government is prepared to license the export of these items having taken into account political, military, economic, human rights, and arms control considerations.
More detailed information is contained in the formal certification which, though unclassified, contains business information submitted to the Department of State by the applicant, publication of which could cause competitive harm to the United States firm concerned.
Sincerely,
Dear Madam Speaker: Pursuant to Section 36(d) of the Arms Export Control Act, I am transmitting, herewith, certification of a proposed manufacturing license agreement for the manufacture of significant military equipment abroad.
The transaction contained in the attached certification involves the export of defense articles, including technical data, and defense services for the manufacture of Modified 20mm x 102mm PELE Ammunition for end use by the U.S. Air Force in the F–15 and F–16 Aircraft.
The United States Government is prepared to license the export of these items having taken into account political, military, economic, human rights, and arms control considerations.
More detailed information is contained in the formal certification which, though unclassified, contains business information submitted to the Department of State by the applicant, publication of which could cause competitive harm to the United States firm concerned.
Sincerely,
Dear Madam Speaker: Pursuant to Section 36(c) of the Arms Export Control Act, I am transmitting, herewith, certification of a proposed amendment to a manufacturing license agreement for the export of defense articles, including technical data, and defense services in the amount of $100,000,000 or more.
The transaction contained in the attached certification involves the export of defense articles, including technical data, and defense services to support the manufacture of X200–Series transmissions in the Republic of Korea for an authorized sales territory.
The United States Government is prepared to license the export of these items having taken into account political, military, economic, human rights, and arms control considerations.
More detailed information is contained in the formal certification which, though unclassified, contains business information submitted to the Department of State by the applicant, publication of which could cause competitive harm to the United States firm concerned.
Sincerely,
Dear Madam Speaker: Pursuant to Section 36(c) and Section 36(d) of the Arms Export Control Act, I am transmitting, herewith, certification of a proposed manufacturing license agreement for the manufacture of significant military equipment abroad in the amount of $100,000,000 or more.
The transaction contained in the attached certification involves the export of defense articles, including technical data, and defense services for the manufacture of the 737 Airborne Early Warning & Control (AEW&C) System, Peace Eagle, for end-use by the Turkish Air Force.
The United States Government is prepared to license the export of these items having taken into account political, military, economic, human rights and arms control considerations.
More detailed information is contained in the formal certification which, though unclassified, contains business information submitted to the Department of State by the applicant, publication of which could cause competitive harm to the United States firm concerned.
Sincerely,
Dear Madam Speaker: Pursuant to Section 36(c) of the Arms Export Control Act, I am transmitting, herewith, certification of a proposed amendment to a technical assistance agreement for the export of defense articles, including technical data, and defense services in the amount of $50,000,000 or more.
The transaction contained in the attached certification involves the export of defense articles, including technical data and defense services for the integration of surfaced launched AMRAAM electronics kits for the National Advanced Surface to Air Missile System FIN Program in Finland.
The United States Government is prepared to license the export of these items having taken into account political, military, economic, human rights, and arms control considerations.
More detailed information is contained in the formal certification which, though unclassified, contains business information submitted to the Department of State by the applicant, publication of which could cause competitive harm to the United States firm concerned.
Sincerely,
Dear Madam Speaker: Pursuant to Section 36(c) of the Arms Export Control Act, I am transmitting, herewith, certification of a proposed technical assistance agreement to include the export of technical data, defense services, and defense articles in the amount of $50,000,000 or more.
The transaction contained in the attached certification involves the transfer of technical data, defense services, and hardware to support the Proton launch of the QuetzSat-1 Commercial Communication Satellite from the Baikonur Cosmodrome in Kazakhstan.
The United States Government is prepared to license the export of these items having taken into account political, military, economic, human rights, and arms control considerations.
More detailed information is contained in the formal certification which, though unclassified, contains business information submitted to the Department of State by the applicant, publication of which could cause competitive harm to the United States firm concerned.
Sincerely,
Dear Madam Speaker: Pursuant to Section 36(c) of the Arms Export Control Act, I am transmitting, herewith, certification of a proposed amendment to a manufacturing license agreement for the export of defense articles, to include technical data, and defense services in the amount of $50,000,000 or more.
The transaction contained in the attached certification involves the transfer of defense articles, to include technical data, and defense services to support the manufacture of the AN/ASA–70 Tactical Data Display Group for the Japanese Government's P–3C Anti-Submarine Warfare program.
The United States Government is prepared to license the export of these items having taken into account political, military, economic, human rights, and arms control considerations.
More detailed information is contained in the formal certification which, though unclassified, contains business information submitted to the Department of State by the applicant, publication of which could cause competitive harm to the United States firm concerned.
Sincerely,
Dear Madam Speaker: Pursuant to Section 36(c) of the Arms Export Control Act, I am transmitting, herewith, certification of a proposed permanent export license for the export of defense articles, to include technical data, related to firearms in the amount of $1,000,000 or more.
The transaction contained in the attached certification involves the export of defense articles, to include technical data, related to sale of Lewis Machine & Tool Co. (LMT) .308 caliber (7.62mm) Semi Automatic Rifles for use by the United Kingdom Ministry of Defence.
The United States Government is prepared to license the export of these items having taken into account political, military, economic, human rights and arms control considerations.
More detailed information is contained in the formal certification which, though unclassified, contains business information submitted to the Department of State by the applicant, publication of which could cause competitive harm to the United States firm concerned.
Sincerely,
Dear Madam Speaker: Pursuant to Section 36(c) of the Arms Export Control Act, I am transmitting, herewith, certification of a proposed amendment to a manufacturing license agreement for the export of defense articles, to include technical data, and defense services.
The transaction contained in the attached certification involves the export of defense articles, to include technical data, and defense services for the Laser Target Designator/Range Finders and Gated Laser illuminators for Night Television for the AC–130U Gunship for end-use by the U.S. Air Force.
The United States Government is prepared to license the export of these items having taken into account political, military, economic, human rights and arms control considerations.
More detailed information is contained in the formal certification which, though unclassified, contains business information submitted to the Department of State by the applicant, publication of which could cause competitive harm to the United States firm concerned.
Sincerely,
Dear Madam Speaker: Pursuant to Section 36(d) of the Arms Export Control Act, I am transmitting, herewith, certification of a proposed manufacturing license agreement for the manufacture of significant military equipment abroad.
The transaction contained in the attached certification involves the export of defense articles, including technical data, and defense services for the manufacture in Japan of the GAU–19 Gun.
The United States Government is prepared to license the export of these items having taken into account political, military, economic, human rights, and arms control considerations.
More detailed information is contained in the formal certification which, though unclassified, contains business information submitted to the Department of State by the applicant, publication of which could cause competitive harm to the United States firm concerned.
Sincerely,
Dear Madam Speaker: Pursuant to Section 36(c) of the Arms Export Control Act, I am transmitting, herewith, certification of a proposed amendment to a manufacturing assistance agreement for the export of defense articles, including technical data, and defense services in the amount of $100,000,000 or more.
The transaction contained in the attached certification involves the export of defense articles, to include technical data, and defense services to Japan for the overhaul and manufacture of SIIS–3XT4/T4 ejection seats for the XT4/T4 trainer aircraft for use in Japan.
The United States Government is prepared to license the export of these items having taken into account political, military, economic, human rights and arms control considerations.
More detailed information is contained in the formal certification which, though unclassified, contains business information submitted to the Department of State by the applicant, publication of which could cause competitive harm to the United States firm concerned.
Sincerely,
Dear Madam Speaker: Pursuant to Section 36(c) and Section 36(d) of the Arms Export Control Act, I am transmitting, herewith, certification of a proposed manufacturing license agreement for the manufacture of significant military equipment abroad in the amount of $50,000,000 or more.
The transaction contained in the attached certification involves the export of defense articles, including technical data, and defense services for the modification of CH–47SD Chinook Helicopters to the CH–47F configuration for the Singapore Ministry of Defence.
The United States Government is prepared to license the export of these items having taken into account political, military, economic, human rights and arms control considerations.
More detailed information is contained in the formal certification which, though unclassified, contains business information submitted to the Department of State by the applicant, publication of which could cause competitive harm to the United States firm concerned.
Sincerely,
October 22, 2009 (Transmittal 129–09)
Dear Madam Speaker: Pursuant to Section 36(c) of the Arms Export Control Act, I am transmitting, herewith, certification of a proposed amendment to a manufacturing license agreement for the export of defense articles, to include technical data, and defense services in the amount of $100,000,000 or more.
The transaction contained in the attached certification involves the export of defense articles, to include technical data, and defense services for the manufacture of control section units and associated electronics modules in the United Kingdom for the AIM–120 Medium Range Air-to-Air Missile for end-use by the United States of America.
The United States Government is prepared to license the export of these items having taken into account political, military, economic, human rights and arms control considerations.
More detailed information is contained in the formal certification which, though unclassified, contains business information submitted to the Department of State by the applicant, publication of which could cause competitive harm to the United States firm concerned.
Sincerely,
Dear Madam Speaker: Pursuant to Section 36(c) of the Arms Export Control Act, I am transmitting, herewith, certification of a proposed amendment to a manufacturing license agreement for the export of defense articles, including technical data, and defense services in the amount of $100,000,000 or more.
The transaction contained in the attached certification involves the export of defense articles, to include technical data, and defense services to Australia for the manufacture and service of F/A–18 Trailing Edge Flaps, Trailing Edge Flap Shrouds, Ailerons, and Aileron Shrouds and their associated minor components and parts.
The United States Government is prepared to license the export of these items having taken into account political, military, economic, human rights and arms control considerations.
More detailed information is contained in the formal certification which, though unclassified, contains business information submitted to the Department of State by the applicant, publication of which could cause competitive harm to the United States firm concerned.
Sincerely,
The following Applications for Certificates of Public Convenience and Necessity and Foreign Air Carrier Permits were filed under Subpart B (formerly Subpart Q) of the Department of Transportation's Procedural Regulations (
The following Agreements were filed with the Department of Transportation under the Sections 412 and 414 of the Federal Aviation Act, as amended (49 U.S.C. 1382 and 1384) and procedures governing proceedings to enforce these provisions. Answers may be filed within 21 days after the filing of the application.
Maritime Administration, DOT.
Notice of Availability of Record of Decision.
The Maritime Administration announces the availability of the Record of Decision for the Port Dolphin Energy LLC (Port Dolphin Energy) Deepwater Port License Application. On October 26, 2009, the Acting Maritime Administrator, David T. Matsuda, issued the Record of Decision “approving with conditions” Port Dolphin Energy's application to own, construct, and operate a liquefied natural gas (LNG) deepwater port 28 miles southwest of Tampa Bay, Florida. Issuance of this Record of Decision completes the application review and license approval process, mandated by the Deepwater Port Act of 1974, as amended (the Act).
Copies of the Record of Decision for the Port Dolphin Energy LNG Deepwater Port License Application are available on request from the Docket Management Facility, M–30, U.S. Department of Transportation, West Building, Ground Floor, Rm. W12–140, 1200 New Jersey Avenue, SE., Washington, DC 20590, or via the Internet at
Yvette Fields, Director, Office of Deepwater Ports and Offshore Activities, Maritime Administration, telephone: 202–366–0926, e-mail:
On March 29, 2007, Port Dolphin Energy LLC, a limited liability company organized and existing under the laws of the State of Delaware and an ultimate subsidiary of Leif Hoegh & Company Limited, submitted to the Maritime Administration and the U.S. Coast Guard (USCG), an application for approval of a license to own, construct, operate, and ultimately decommission a deepwater port, known as Port Dolphin, approximately 28 miles southwest of Tampa Bay, Florida, for the purpose of importing Liquefied Natural Gas (LNG) into the United States. On June 15, 2007, Port Dolphin Energy's application was deemed complete by the Maritime Administration and the USCG. On June 25, 2007, the Maritime Administration and USCG published a notice in the
Pursuant to the statutory requirements of the Act, the Maritime Administration and the USCG conducted an environmental review of the Port Dolphin project and prepared an environmental impact statement in accordance with procedures stipulated under the National Environmental Policy Act (NEPA). The Federal environmental review process was conducted in close coordination with cooperating Federal and Florida State agencies, integrating the environmental values and concerns expressed by local communities. Additional information
Provisions of the Act require the Maritime Administrator to render his decision on a deepwater port license application within 90 days from the date of the final public hearing. The final public hearing for the Port Dolphin project was held on July 28, 2009. In rendering a decision, the Maritime Administrator must either: (1) Approve the application as it is proposed, (2) approve the application “subject to certain conditions”, or (3) deny the application. This Record of Decision, approves the Port Dolphin Energy Deepwater Port License Application, “subject to certain conditions,” which have been designed to ensure that Port Dolphin Energy utilizes the best available technology in the operation of its port, exercises care to preserve and enhance the environment, and protect Florida's coastal communities and natural resources. Further, the Record of Decision describes the framework by which the Maritime Administrator must base his decision as defined by the nine approval criteria prescribed by the Act. These nine approval criteria ensure: (1) Financial responsibility; (2) compliance with all applicable laws, regulations and license conditions; (3) national interest; (4) international navigation, safety, and use of the high seas; (5) protection and enhancement of the environment; (6) advice of the Administrator of the Environmental Protection Agency; (7) consultation with the Secretaries of State, Defense, and Army, (8) approval of the Governor of the adjacent coastal State, in this case the Governor of Florida, and (9) consistency with the Coastal Zone Management Act.
The Port Dolphin Record of Decision provides an overview of the Federal environmental review process and describes the comprehensive consultation and technical review of the application conducted by the Maritime Administration and USCG, in consultation with the National Oceanic Atmospheric Administration (NOAA), the Environmental Protection Agency, the State of Florida, and other cooperating Federal and State agencies. During the decision-making process, the Acting Maritime Administrator gave careful consideration to the specific concerns expressed by members of the local Florida coastal communities, such as Longboat Key and Manatee County, regarding the potential impacts on local sand resources. Reasonable efforts were made by the Federal Government, the State of Florida, local communities, and Port Dolphin Energy to bring this matter to a satisfactory resolution. Conditions recommended by cooperating Federal and State agencies, including the specific conditions of approval required by the Governor of Florida, as outlined in his decision letter of September 11, 2009 and in a subsequent Memorandum of Agreement established between the State of Florida and Port Dolphin Energy, have been incorporated into this Record of Decision as conditions of approval. These conditions, which allow for removal of sand prior to the pipeline installation and sharing of costs, will become enforceable and binding under the official deepwater port License upon issuance. The Maritime Administration projects that the official Port Dolphin Energy Deepwater Port License will be issued in early 2010. The full text of the Record of Decision can be viewed at
By order of the Maritime Administrator.
Federal Aviation Administration (FAA), DOT.
Notice.
Under the provisions of Title 49, U.S.C. 47153(d), notice is being given that the FAA is considering a request from the North Carolina Global TransPark Authority to waive the requirement that a 9.683 acre parcel of surplus property, located at the Kinston Regional Jetport, be used for aeronautical purposes.
Comments must be received on or before December 28, 2009.
Comments on this notice may be mailed or delivered in triplicate to the FAA at the following address: Atlanta Airports District Office, 1701 Columbia Ave., Campus Building, Suite 2–260, College Park, GA 30337.
In addition, one copy of any comments submitted to the FAA must be mailed or delivered to Ms. Darlene A. Waddell, Executive Director at the following address: 2780 Jetport Road, Suite A, Kinston, NC 28504.
Rusty Nealis, Program Manager, Atlanta Airports District Office, 1701 Columbia Ave., Campus Bldg., Suite 2–260, College Park, GA 30337, (404) 305–7142. The application may be reviewed in person at this same location.
The FAA is reviewing a request by the North Carolina Global TransPark Authority to release 9.683 acres of surplus property at the Kinston Regional Jetport. The surplus property will be developed for industrial and commercial use.
Any person may inspect the request in person at the FAA office listed above under
In addition, any person may, upon request, inspect the request, notice and other documents germane to the request in person at 2780 Jetport Road, Suite A, Kinston, NC 28504.
Federal Aviation Administration (FAA), DOT.
Notice.
Under the provisions of Title 49, U.S.C. Section 47153(d), notice is being given that the FAA is considering a request from the North Carolina Global TransPark Authority to waive the requirement that a 35.19 acre parcel of surplus property, located at the Kinston Regional Jetport, be used for aeronautical purposes.
Comments must be received on or before December 28, 2009.
Comments on this notice may be mailed or delivered in triplicate to the FAA at the following address: Atlanta Airports District Office, 1701 Columbia Ave., Campus Building, Suite 2–260, College Park, GA 30337.
In addition, one copy of any comments submitted to the FAA must be mailed or delivered to Ms. Darlene A.
Rusty Nealis, Program Manager, Atlanta Airports District Office, 1701 Columbia Ave., Campus Bldg., Suite 2–260, College Park, GA 30337, (404) 305–7142. The application may be reviewed in person at this same location.
The FAA is reviewing a request by the North Carolina Global TransPark Authority to release 35.19 acres of surplus property at the Kinston Regional Jetport. The surplus property will be used to construct a facility for Spirit AeroSystems.
Any person may inspect the request in person at the FAA office listed above under
In addition, any person may, upon request, inspect the request, notice and other documents germane to the request in person at 2780 Jetport Road, Suite A, Kinston, NC 28504.
Financial Management Service, Fiscal Service, Treasury.
Notice of rate for use in Federal debt collection and discount and rebate evaluation.
Pursuant to Section 11 of the Debt Collection Act of 1982, as amended (31 U.S.C. 3717), the Secretary of the Treasury is responsible for computing and publishing the percentage rate to be used in assessing interest charges for outstanding debts owed to the Government. Treasury's Cash Management Requirements (TFM Volume I, Part 6, Chapter 8000) prescribe use of this rate by agencies as a comparison point in evaluating the cost effectiveness of a cash discount. In addition, 5 CFR 1315.8 of the Prompt Payment rule on “Rebates” requires that this rate be used in determining when agencies should pay purchase card invoices when the card issuer offers a rebate. Notice is hereby given that the applicable rate is 1.00 percent for calendar year 2010.
The rate will be in effect for the period beginning on January 1, 2010, and ending on December 31, 2010.
Inquiries should be directed to the Agency Enterprise Solutions Division, Financial Management Service, Department of the Treasury, 401 14th Street, SW., Washington, DC 20227 (Telephone: 202–874–6720).
The rate reflects the current value of funds to the Treasury for use in connection with Federal Cash Management systems and is based on investment rates set for purposes of Public Law 95–147, 91 Stat. 1227. Computed each year by averaging Treasury Tax and Loan (TT&L) investment rates for the 12-month period ending every September 30, rounded to the nearest whole percentage, for applicability effective each January 1, the rate is subject to quarterly revisions if the annual average, on a moving basis, changes by 2 percentage points. The rate in effect for the calendar year 2010 reflects the average investment rates for the 12-month period that ended September 30, 2009.
Centers for Medicare & Medicaid Services (CMS), HHS.
Final rule with comment period.
This final rule with comment period implements 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 implements or discusses certain provisions of the Medicare Improvements for Patients and Providers Act of 2008. (See the Table of Contents for a listing of the specific issues addressed in this rule.)
This final rule with comment period also finalizes the calendar year (CY) 2009 interim relative value units (RVUs) and issues interim RVUs for new and revised codes for CY 2010. In addition, in accordance with the statute, it announces that the update to the physician fee schedule conversion factor is −21.2 percent for CY 2010, the preliminary estimate for the sustainable growth rate for CY 2010 is −8.8 percent, and the conversion factor (CF) for CY 2010 is $28.4061.
In commenting, please refer to file code CMS–1413–FC. 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.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
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.
Rick Ensor, (410) 786–5617, for issues related to practice expense methodology.
Craig Dobyski, (410) 786–4584, for issues related to geographic practice cost indices and malpractice RVUs.
Ken Marsalek, (410) 786–4502, for issues related to the physician practice information survey and the multiple procedure payment reduction.
Regina Walker-Wren, (410) 786–9160, for issues related to the phasing out of the outpatient mental health treatment limitation.
Diane Stern, (410) 786–1133, for issues related to the physician quality reporting initiative and incentives for e-prescribing.
Lisa Grabert, (410) 786–6827, for issues related to the Physician Resource Use Feedback Program.
Colleen Bruce, (410) 786–5529, for issues related to value-based purchasing.
Sandra Bastinelli, (410) 786–3630, for issues related to the implementation of accreditation standards.
Jim Menas, (410) 786–4507, for issues related to teaching anesthesia services.
Sarah McClain, (410) 786–2994, for issues related to the coverage of cardiac rehabilitation services.
Dorothy Shannon, (410) 786–3396, for issues related to payment for cardiac and pulmonary rehabilitation services.
Roya Lotfi, (410) 786–4072, for issues related to the coverage of pulmonary rehabilitation.
Jamie Hermansen, (410) 786–2064, for issues related to kidney disease patient education programs.
Terri Harris, (410) 786–6830, for issues related to payment for kidney disease patient education.
Brijet Burton, (410) 786–7364, for issues related to the compendia for determination of medically-accepted indications for off-label uses of drugs and biologicals in an anti-cancer chemotherapeutic regimen.
Henry Richter, (410) 786–4562, or Lisa Hubbard, (410) 786–5472, for issues related to renal dialysis provisions and payments for end-stage renal disease facilities.
Cheryl Gilbreath, (410) 786–5919, for issues related to payment for covered outpatient drugs and biologicals.
Edmund Kasaitis, (410) 786–0477, or Bonny Dahm, (410) 786–4006, for issues related to the Competitive Acquisition Program (CAP) for Part B drugs.
Pauline Lapin, (410) 786–6883, for issues related to the chiropractic services demonstration BN issue.
Monique Howard, (410) 786–3869, for issues related to CORF conditions of coverage.
Roechel Kujawa, (410) 786–9111, for issues related to ambulance services.
Anne Tayloe Hauswald, (410) 786–4546, for clinical laboratory issues.
Troy Barsky, (410) 786–8873, or Roy Albert, (410) 786–1872, for issues related to physician self-referral.
Christopher Molling, (410) 786–6399, or Anita Greenberg, (410) 786–4601, for issues related to the repeal of transfer of title for oxygen equipment.
Michelle Peterman, (410) 786–2591, or Iffat Fatima, (410) 786–6709 for issues related to the grandfathering provisions of the durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) Competitive Acquisition Program.
Ralph Goldberg, (410) 786–4870, or Heidi Edmunds, (410) 786–1781, for issues related to the damages process caused by the termination of contracts awarded in 2008 under the DMEPOS Competitive Bidding program.
Diane Milstead, (410) 786–3355, or Gaysha Brooks, (410) 786–9649, for all other issues.
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 final rule with comment period, 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'
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 conversion factor (CF), in a manner to assure that fee schedule amounts for anesthesia services are consistent with those for other services of comparable value. We established a separate CF for anesthesia services, and we continue to utilize time units as a factor in determining payment for these services. As a result, there is a separate payment methodology for anesthesia services.
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 PE RVUs beginning in CY 2007 and provided for a 4-year transition for the new PE RVUs under this new methodology.
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
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).
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 with CY 2009 rather than the work RVUs.
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 2009 PFS final rule with comment period (73 FR 69726) implemented changes to the PFS and other Medicare Part B payment policies. It also finalized the CY 2008 interim RVUs and implemented interim RVUs for new and revised codes for CY 2009 to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. The CY 2009 PFS final rule with comment period also addressed other policies, as well as certain provisions of the MIPPA.
As required by the statute, and based on section 131 of the MIPPA, the CY 2009 PFS final rule with comment period also announced the following for CY 2009: the PFS update of 1.1 percent, the initial estimate for the sustainable growth rate of 7.4 percent, and the conversion factor (CF) of $36.0666.
In response to the CY 2010 PFS proposed rule (74 FR 33520) we received approximately 16,500 timely public comments. These included comments from concerned citizens, individual physicians, health care workers, professional associations and societies, manufacturers and Congressmen. The majority of the comments addressed proposals related to the MIPPA provisions concerning teaching anesthesiology and cardiac and pulmonary rehabilitation, the physician practice information survey (PPIS), and the impact of the proposed rule on specific specialties. To the extent that comments were outside the scope of the proposed rule, they are not addressed in this final rule with comment period.
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. Until that time, PE RVUs were based on historical allowed charges. This legislation stated that the revised PE methodology must consider the staff, equipment, and supplies used in the provision of a variety of medical and surgical services in various settings beginning in 1998. The Secretary has interpreted this to mean that Medicare payments for each service would be based on the relative PE resources typically involved with furnishing the service.
The initial implementation of resource-based PE RVUs was delayed from January 1, 1998, until January 1, 1999, by section 4505(a) of the BBA. In addition, section 4505(b) of the BBA required that the new payment methodology be phased in over 4 years, effective for services furnished in CY 1999, and fully effective in CY 2002. The first step toward implementation of the statute was to adjust the PE values for certain services for CY 1998. Section 4505(d) of the BBA required that, in developing the resource-based PE RVUs, the Secretary must—
• Use, to the maximum extent possible, generally-accepted cost accounting principles that recognize all staff, equipment, supplies, and expenses, not solely those that can be linked to specific procedures and actual data on equipment utilization.
• Develop a refinement method to be used during the transition.
• Consider, in the course of notice and comment rulemaking, impact projections that compare new proposed payment amounts to data on actual physician PE.
In CY 1999, we began the 4-year transition to resource-based PE RVUs utilizing a “top-down” methodology whereby we allocated aggregate specialty-specific practice costs to individual procedures. The specialty-specific PEs were derived from the American Medical Association's (AMA's) Socioeconomic Monitoring Survey (SMS). In addition, under section 212 of the BBRA, we established a process extending through March 2005 to supplement the SMS data with data submitted by a specialty. The aggregate PEs for a given specialty were then allocated to the services furnished by that specialty on the basis of the direct input data (that is, the staff time, equipment, and supplies) and work RVUs assigned to each CPT code.
For CY 2007, we implemented a new methodology for calculating PE RVUs. Under this new methodology, we use the same data sources for calculating PE, but instead of using the “top-down” approach to calculate the direct PE RVUs, under which the aggregate direct and indirect costs for each specialty are allocated to each individual service, we now utilize a “bottom-up” approach to calculate the direct costs. Under the “bottom up” approach, we 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 AMA's Relative Value Update Committee (RUC). For a more detailed
In section II.A.1 of this final rule with comment period rule, we discuss the current methodology used for calculating PE. In section II.A.2. of this final rule with comment period, which contains PE proposals for CY 2010, we summarize and respond to comments on our proposal to use data from the AMA Physician Practice Information Survey (PPIS) in place of the AMA's SMS survey data and supplemental survey data that is currently used in the PE methodology, as well as our proposal concerning equipment utilization assumptions.
The AMA's SMS survey data and supplemental survey data from the specialties of cardiothoracic surgery, vascular surgery, physical and occupational therapy, independent laboratories, allergy/immunology, cardiology, dermatology, gastroenterology, radiology, independent diagnostic testing facilities (IDTFs), radiation oncology, and urology are currently used to develop the PE per hour (PE/HR) for each specialty. For those specialties for which we do not have PE/HR, the appropriate PE/HR is obtained from a crosswalk to a similar specialty.
The AMA developed the SMS survey in 1981 and discontinued it in 1999. Beginning in 2002, we incorporated the 1999 SMS survey data into our calculation of the PE RVUs, using a 5-year average of SMS survey data. (See the CY 2002 PFS final rule with comment period (66 FR 55246).) The SMS PE survey data are adjusted to a common year, 2005. The SMS data provide the following six categories of PE costs:
• Clinical payroll expenses, which are payroll expenses (including fringe benefits) for nonphysician clinical personnel.
• Administrative payroll expenses, which are payroll expenses (including fringe benefits) for nonphysician personnel involved in administrative, secretarial, or clerical activities.
• Office expenses, which include expenses for rent, mortgage interest, depreciation on medical buildings, utilities, and telephones.
• Medical material and supply expenses, which include expenses for drugs, x-ray films, and disposable medical products.
• Medical equipment expenses, which include depreciation, leases, and rent of medical equipment used in the diagnosis or treatment of patients.
• All other expenses, which include expenses for legal services, accounting, office management, professional association memberships, and any professional expenses not previously mentioned in this section.
In accordance with section 212 of the BBRA, we established a process to supplement the SMS data for a specialty with data collected by entities and organizations other than the AMA (that is, those entities and organizations representing the specialty itself). (See the Criteria for Submitting Supplemental Practice Expense Survey Data interim final rule with comment period (65 FR 25664).) Originally, the deadline to submit supplementary survey data was through August 1, 2001. In the CY 2002 PFS final rule (66 FR 55246), the deadline was extended through August 1, 2003. To ensure maximum opportunity for specialties to submit supplementary survey data, we extended the deadline to submit surveys until March 1, 2005 in the Revisions to Payment Policies Under the Physician Fee Schedule for CY 2004 final rule with comment period (68 FR 63196) (hereinafter referred to as CY 2004 PFS final rule with comment period).
The direct cost data for individual services were originally developed by the Clinical Practice Expert Panels (CPEP). The CPEP data include the supplies, equipment, and staff times specific to each procedure. The CPEPs consisted of panels of physicians, practice administrators, and nonphysicians (for example, RNs) who were nominated by physician specialty societies and other groups. There were 15 CPEPs consisting of 180 members from more than 61 specialties and subspecialties. Approximately 50 percent of the panelists were physicians.
The CPEPs identified specific inputs involved in each physician's service provided in an office or facility setting. The inputs identified were the quantity and type of nonphysician labor, medical supplies, and medical equipment. The CPEP data has been regularly updated by various RUC committees on PE.
Currently, the aggregate level specialty-specific PEs are derived from the AMA's SMS survey and supplementary survey data. For CY 2010, we discuss in section II.A.2. of this final rule with comment period how a new data source, PPIS, will be used. To establish PE RVUs for specific services, it is necessary to establish the direct and indirect PE associated with each service.
(i)
(ii)
• We apply a specialty-specific indirect percentage factor to the direct expenses to recognize the varying proportion that indirect costs represent of total costs by specialty. For a given service, the specific indirect percentage factor to apply to the direct costs for the purpose of the indirect allocation is calculated as the weighted average of the ratio of the indirect to direct costs (based on the survey data) for the specialties that furnish the service. For example, if a service is furnished by a single specialty with indirect PEs that were 75 percent of total PEs, the indirect percentage factor to apply to the direct costs for the purposes of the indirect allocation would be (0.75/0.25) = 3.0. The indirect percentage factor is then applied to the service level adjusted indirect PE allocators.
• We currently use the specialty-specific PE/HR from the SMS survey data, as well as the supplemental surveys for cardiothoracic surgery, vascular surgery, physical and occupational therapy, independent laboratories, allergy/immunology, cardiology, dermatology, radiology, gastroenterology, IDTFs, radiation oncology, and urology. (
• When the clinical labor portion of the direct PE RVU is greater than the physician work RVU for a particular service, the indirect costs are allocated based upon the direct costs and the clinical labor costs. For example, if a service has no physician work and 1.10 direct PE RVUs, and the clinical labor portion of the direct PE RVUs is 0.65 RVUs, we would use the 1.10 direct PE RVUs and the 0.65 clinical labor portions of the direct PE RVUs to allocate the indirect PE for that service.
Procedures that can be furnished in a physician's office, as well as in a hospital or facility setting have two PE RVUs: facility and non-facility. The non-facility setting includes physicians' offices, patients' homes, freestanding imaging centers, and independent pathology labs. Facility settings include hospitals, ambulatory surgical centers (ASCs), and skilled nursing facilities (SNFs). The methodology for calculating PE RVUs is the same for both facility and non-facility RVUs, but is applied independently to yield two separate PE RVUs. Because the PEs for services provided in a facility setting are generally included in the payment to the facility (rather than the payment to the physician under the PFS), the PE RVUs are generally lower for services provided in the facility setting.
Diagnostic services are generally comprised of two components: a professional component (PC) and a technical component (TC), both of which may be performed independently or by different providers. When services have TCs, PCs, and global 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.)
As discussed in the CY 2007 PFS final rule with comment period (71 FR 69674), the change to the PE methodology was implemented over a 4-year period. In CY 2010, the transition period for the change to the PE methodology is complete and PE RVUs will be calculated based entirely on the current methodology.
The following is a description of the PE RVU methodology. While there are some changes to the data sources, the methodology remains the same.
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/non-facility place of service level, and the specialty-specific survey PE per physician hour data.
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
• If the clinical labor PE RVU exceeds the work RVU (and the service is not a global service), then the indirect allocator is:
For global services, the indirect allocator is based on both the work RVU and the clinical labor PE RVU. We do this to recognize that, for the professional service, indirect PEs will be allocated using the work RVUs, and for the TC service, indirect PEs will be allocated using the direct PE RVU and the clinical labor PE RVU. This also allows the global component RVUs to equal the sum of the PC and TC RVUs.
For presentation purposes in the examples in the Table 1, the formulas were divided into two parts for each service. The first part does not vary by service and is
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•
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•
•
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The equipment cost per minute is calculated as:
To illustrate the PE calculation, in Table 1 we have used the conversion factor (CF) of $28.3769 which is the CF effective January 1, 2010 as published in this final rule with comment period.
Currently, we use PE/HR obtained from the SMS surveys from 1995 through 1999. For several specialties that collected additional PE/HR data through a more recent supplemental survey, we accepted and incorporated these data in developing current PE/HR values.
While the SMS survey 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 multi-specialty 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 BBRA, we also established a process by which specialty groups could submit supplemental PE data. In the May 3, 2000 interim final rule entitled, Medicare Program; Criteria for Submitting Supplemental Practice Expense Survey Data, (65 FR 25664), we established criteria for acceptance of supplemental data. The criteria were modified in the CY 2001 and CY 2003 PFS final rules with comment period (65 FR 65380 and 67 FR 79971, respectively). We currently use supplemental survey data for the following specialties: cardiology; dermatology; gastroenterology; radiology; cardiothoracic surgery; vascular surgery; physical and occupational therapy; independent laboratories; allergy/immunology; independent diagnostic testing facilities (IDTFs); radiation oncology; medical oncology; and urology.
Because the SMS data and the supplemental survey data are from different time periods, we have historically inflated them by the MEI to help put them on as comparable a time basis as we can when calculating the PE RVUs. This MEI proxy has been necessary in the past due to the lack of contemporaneous, consistently collected, and comprehensive multispecialty survey data.
The AMA has conducted a new survey, the PPIS, which was expanded (relative to the SMS) to include nonphysician practitioners (NPPs) paid under the PFS. The PPIS, administered in CY 2007 and CY 2008, was designed to update the specialty-specific PE/HR data used to develop PE RVUs.
The AMA and our 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 has gathered information from 3,656 respondents across 51 physician specialty and health care professional groups. We believe the PPIS is the most comprehensive source of PE survey information available to date.
As noted, the BBRA required us to establish criteria for accepting supplemental survey data. Since the supplemental surveys were specific to individual specialties and not part of a comprehensive multispecialty survey, we had required that certain precision levels be met in order to ensure that the supplemental data was sufficiently valid, and acceptable for use in the development of the PE RVUs. Because the PPIS is a contemporaneous, consistently collected, and comprehensive multispecialty survey, we do not believe similar precision requirements are necessary and we did not propose to establish them for the use of the PPIS data.
For physician specialties, the PPIS responses were adjusted for non-response bias. Non-response bias is the bias that results when the characteristics of survey respondents differ in meaningful ways, such as in the mix of practice sizes, from the general population. The non-response adjustment was developed based on a comparison of practice size and other characteristic information between the PPIS survey respondents and data from the AMA Masterfile (for physician specialties) or information from specialty societies (for non-physician specialties). For six specialties (chiropractors, clinical social workers, nuclear medicine, osteopathic manipulative therapy, physical therapy, and registered dietitians) such an adjustment was not possible due to a lack of available characteristic data. The AMA and Lewin have indicated that the non-response weighting has only a small impact on PE/HR values.
Under our current policy, various specialties without SMS or supplemental survey data have been crosswalked to other similar specialties to obtain a proxy PE/HR. For specialties that were part of the PPIS for which we currently use a crosswalked PE/HR, we proposed instead to use the PPIS-based PE/HR. We also proposed to continue current crosswalks for specialties that did not participate in PPIS.
Supplemental survey data on independent labs, from the College of American Pathologists, was implemented for payments in CY 2005. Supplemental survey data from the National Coalition of Quality Diagnostic Imaging Services (NCQDIS), representing IDTFs, was 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 proposed to continue using the current PE/HR that was developed using their supplemental survey data.
We did not propose to 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 this data with Medicare recognized specialty data. We sought comment on this issue.
We did not propose changes to the manner in which the PE/HR data are used in the current PE RVU methodology. We proposed to update the PE/HR data itself based on the new survey. We proposed to utilize the PE/HR developed using PPIS data for all Medicare recognized specialties that participated in the survey for payments effective January 1, 2010. The impact of using the new PPIS-based PE/HR is discussed in the Regulatory Impact Analysis in section XIII. of this final rule with comment period.
The following is a summary of the public comments received on the PPIS survey and our responses.
Ensuring the accuracy of PE payments is important given that close to half of all payments under the physician fee schedule are associated with practice expense. The Commission has repeatedly raised concerns that the specialty-specific cost data that CMS uses to derive PE RVUs are not current for most specialties, which might lead to payments becoming inaccurate over time.
With respect to additional information on the PPIS survey, the AMA has continued to respond to requests from the individual specialty societies for additional data analysis as they have done since the PPIS results were first released. We have also performed further analyses in response to comments received on the proposed rule. The results of these analyses are available on our Web site (described later in this section) and have not changed our conclusion that the PPIS is the most comprehensive, multi-specialty, contemporaneous, consistently collected PE data source available.
We also agree with MedPAC that it is appropriate to consider the future of the PE RVUs moving forward. We did not propose any changes to the methodology in conjunction with the use of the PPIS data. However, we seek comments from other stakeholders on the issues raised by MedPAC for the future. In particular, we seek comments regarding MedPAC's suggestion that we consider alternatives for collecting specialty-specific cost data or options to decrease the reliance on such data. For example, MedPAC stated 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 specialty-specific cost pools from the method used to derive indirect PE RVUs. We would address any changes through future rulemaking.
Those in favor of using the PPIS data made one or more of the following points:
• PPIS was a nationally representative survey providing the most up-to-date and comprehensive data available from 51 specialties. It was a highly scientific and controlled undertaking, using a survey instrument that the AMA took great care to design, test, and implement.
• Seventy organizations contributed to the costs of the survey and agreed to take responsibility for communicating and publicizing the effort in order to enhance response rates. All groups had ample time to review and provide input and received monthly updates on response rates for their group.
• PPIS followed the exacting criteria that CMS has established for gathering this type of data and for producing results that are acceptable for submission. The AMA worked with CMS's contractor to ensure that all data met these criteria and were analyzed consistently across the various physicians and practitioner specialties. Any data that did not meet the criteria such as response outliers were excluded.
• The vast majority of the data currently used are completely outdated. MedPAC and GAO have been calling on CMS to update PE payments. The annual update of such data is inadequate to capture the true changes in practice costs that physicians have experienced over the years.
• Supplemental survey data from a limited number of specialties have caused significant distortions and misallocations of PE payments, and provided an unfair advantage to some specialties. Many organizations were unable to submit supplemental survey data due to the high cost of gathering the data.
• Concurrently and uniformly collected data will correct payment imbalances caused by the supplemental surveys. Due to BN, this leads to a shift in payment to some specialties at the expense of others. The new data will reduce the payment gap between primary care and other specialties.
• Blending PPIS data with existing data would preserve distortions and continue utilization of data that are more than 10 years old for some groups.
• Some commenters stated that data were not collected in a contemporaneous, consistent, and comprehensive way;
• Some commenters stated that the PPIS should be subject to the same level of analysis as the supplemental surveys to assess accuracy and precision. The commenters also indicated that the survey did not meet the target goal for useable responses. The commenters stated that the low response rates, for some specialties, means that the data are not representative of the specialties' PEs. The commenters also stated that specialty societies should be given the names of the survey respondents, especially those that failed to fully complete the survey, so they could be contacted;
• Some commenters stated that there was not adequate transparency in the PPIS survey process and that there was insufficient information provided about the survey methodology and process;
• Some commenters stated that CMS should withdraw the proposal and take the time necessary to adequately examine the data submitted by AMA, consider changes to the PE methodology, and solicit public input on the validity of the data and the most appropriate way to integrate this data into the PFS; and
• Some commenters stated that if PPIS data is used, it should be blended with supplemental survey data and/or phased in over a number of years.
The survey was conducted by external contractors. In 2007 the PPIS project was contracted to the Gallup Organization. In late 2007 the AMA transitioned the survey effort to dmrkynetec, formally Doane Marketing Research, to complete the project. Dmrkynetec conducted the majority of the specialty level surveys that were previously implemented by CMS. Dmrkynetec used the same survey instruments as did the Gallup Organization in order that survey data collected by Gallup could be appropriately merged in the dmrkynetec data collection.
The survey methodology was highly consistent with the prior SMS methodology because only small deviations were allowed to accommodate practice style differences across the various groups surveyed. The PPIS was conducted in accordance with known conventions governing PE collection activities. One hundred completed surveys for each specialty was set as a goal for the PPIS, but was not a minimum requirement. More than 7,000 surveys were collected for 51 physicians, non MD/DO specialties, and health professions. For the majority of specialties, at least 100 surveys were collected.
The AMA provided specialty groups with information on the survey throughout the survey process. Monthly progress reports were issued on response rates. Due to confidentiality agreements with the AMA and participating specialty groups, raw survey data was not distributed to CMS or the specialty groups. However, this does not mean that analysis was not performed on the PPIS data.
In conjunction with publication of the proposed rule, we posted information on our Web site on physician response rates, precision and PE/HR. In addition, we posted Lewin's report entitled, “Physician Practice Information Survey (PPIS) Data Submitted for 2010: Non-MD/DO and Health Professionals Practice Information” (June 19, 2009). This report includes information on the PPIS survey process as well as the methodology for determining the PE/HR.
As noted earlier in our response to the MedPAC comment, the AMA has continued to respond to requests from the individual specialty societies for additional data analysis, as they have done since the PPIS results were first released. In response to comments received on the proposed rule, we have also performed additional analyses of summary data supplied by the AMA, the supplemental survey, and cardiology, urology, and radiology groups. This additional analysis indicates that while the PE/HR for these specialties differs between the data sources reviewed for certain practice sizes, these differences do not validate the commenters' conclusion that the PPIS data is invalid. We continue to believe that the PPIS is the most appropriate data source available for the development of resource-based PE RVUs. To view this analysis, please see our Web site at
We disagree with some commenters that the same precision requirements that applied to the individual specialty supplemental surveys should apply to the broad multispecialty contemporaneous PPIS. Each individual specialty supplemental survey was being used alongside the multispecialty contemporaneous SMS survey data for all the other specialties. This is not the case for the PPIS data. We proposed to use the PPIS data in its entirety for all Medicare recognized specialties, with the exception of two supplier specialties that did not participate in the PPIS. Precision requirements were appropriate, and required by the BBRA, in the context of the selective acceptance of individual supplemental surveys, but are not necessary in the context of the much broader adoption of the PPIS data.
We also disagree that we should blend the supplemental survey data with the PPIS data. One of the advantages of the PPIS data is precisely that it is contemporaneous and collected in a consistent, broad multi-specialty manner. Blending this data with the supplemental survey data weakens the advantage of using the PPIS data, as was pointed out by commenters who favored its use.
However, we do recognize that some specialties experience significant payment reductions with the use of the PPIS data. Given the magnitude of these payment reductions for some specialties, we agree with commenters who suggested a transition to the new PE RVUs developed using the PPIS data. Historically, we have provided for 4-year transitions when we have significantly altered the PE methodology. While we did not propose any changes to the methodology in the proposed rule, we are persuaded by commenters that the use of the new PPIS data has a sufficiently significant impact to warrant the use of such a transition. In light of the comments received and our past practice, we are finalizing a 4-year transition (75/25, 50/50, 25/75, 0/100) from the current PE RVUs to the PE RVUs developed using the new PPIS data.
The PPIS data indicated a significant decrease in the percentage of PEs that are attributable to direct PEs and a corresponding increase in the percentage that are attributable to indirect PEs. The incorporation of the PPIS data, therefore, results in a decrease in the scaling factor applied in the development of the direct cost portion of the PE methodology from its current value of 0.63 to its new value of 0.51 and a corresponding increase in the scaling factor applied in development of the indirect cost portion. As stated earlier, the PPIS is the most comprehensive, multi-specialty, contemporaneous, consistently
Some commenters encouraged us to make these Medicare-recognized specialties because they perform work that is separate and apart from their parent specialty, require additional training, and have separate liability issues. Other commenters opposed the recognition of separate specialties for these groups, indicating that they are not markedly different from their parent specialties.
We did consider the comments on blending in the PPIS data for the above physician groups as suggested by some commenters. However, we are more persuaded by the commenters who indicated that determining the correct blend would be difficult. We are reluctant to assign utilization weights to the mix of specialties that perform these services in the absence of actual claims data. We suggest that the commenters who wish us to use the PPIS data for these groups apply for a specialty code using our normal process. If approved, the claims data associated with the new specialty code could be used to incorporate the PPIS survey data for that specialty.
In summary, based on the decisions described above, Table 2 shows the indirect PE/HR for the specialties that have PPIS survey data that we are adopting to calculate the PE RVUs. Also shown for these specialties is the previous indirect PE/HR used to calculate the PE RVUs. Note that for oncology, clinical laboratories, and IDTFs we are continuing to use the supplemental survey data as described above. Consistent with our past practice, the previous indirect PE/HRs for these specialties have been updated to CY 2006 using the MEI to put them on a comparable basis with the PPIS survey data.
As part of the PE methodology associated with the allocation of equipment costs for calculating PE RVUs, we currently perform these calculations with an equipment usage assumption of 50 percent. In the CY 2008 PFS proposed rule (72 FR 38132), we noted that if the assumed equipment usage percentage is set too high, the result would be an insufficient allowance at the service level for the practice costs associated with equipment. If the assumed equipment usage percentage is set too low, the result would be an excessive allowance for the practice costs of equipment at the service level. We acknowledged that the current 50 percent usage assumption does not capture the actual usage rates for all equipment, but stated that we did not believe that we had strong empirical evidence to justify any alternative approaches.
In the CY 2008 PFS final rule with comment period, we summarized comments received on this issue. Commenters' recommendations about making adjustments to the 50 percent utilization rate assumption varied. Some commenters recommended that we do nothing until stronger empirical evidence is available. Other commenters recommended a decrease in the utilization assumption while others recommended an increase in the utilization assumption. We agreed with the commenters that the equipment utilization rate should continue to be examined for accuracy. We indicated that we would continue to monitor the appropriateness of the equipment utilization assumption, and evaluate whether changes should be proposed in light of the data available.
In the CY 2010 PFS proposed rule (74 FR 33532), we acknowledged that since the publication of the CY 2008 PFS final rule with comment period, MedPAC addressed this issue in its March 2009 Report to Congress (see
In 2006, the Commission sponsored a survey by NORC of imaging providers in six markets, which found that MRI and CT machines are used much more than the 25 hours per week that CMS assumes (Table 2B–6). According to data from this survey, MRI scanners are used 52 hours per week, on average (median of 46 hours), and CT machines are operated 42 hours per week, on average (median of 40 hours) (NORC 2006). Although the survey results are not nationally representative, they are representative of imaging providers in the six markets included in the survey. We also analyzed data from a 2007 survey of CT providers by IMV, a market research firm (IMV Medical Information Division 2008). IMV data are widely used in the industry and have also appeared in published studies (Baker et al. 2008, Baker and Atlas 2004). Using IMV's data on 803 nonhospital CT providers (imaging centers, clinics, and physician offices), we calculated that the average provider uses its CT scanner 50 hours per week, which is twice the number CMS assumes. The IMV survey also found that nonhospital providers increased the average number of procedures per CT machine by 31 percent from 2003 to 2007, which indicates that providers either used their machines more hours per day or performed more scans per hour (IMV Medical Information Division 2008) (p. 108).
In the proposed rule, we stated that the studies cited by MedPAC indicated that the current equipment usage rate assumption is significantly understated, especially with respect to the types of high cost equipment that were the subject of the studies. The current 50 percent utilization rate translates into about 25 hours per week out of a 50-hour work week. The median value of 46 hours for Magnetic Resonance Imaging equipment from the first study cited by MedPAC is equivalent to a utilization rate of 92 percent on a 50-hour week. For Computed Tomography scanners, averaging the value from the first study of 40 hours per week and the value from the second study of 50 hours per week yields 45 hours and is equivalent to a 90 percent utilization rate on a 50-hour work week. Therefore, in the CY 2010 PFS proposed rule, we proposed to increase the equipment usage rate to 90 percent for all services containing equipment that cost in excess of $1 million dollars. We stated that the studies cited by MedPAC suggested that physicians and suppliers would not typically make huge capital investments in equipment that would only be utilized 50 percent of the time. We stated that we would continue to explore data sources regarding the utilization rates of equipment priced at less than $1 million dollars, but we did not propose a change in the usage rate for this less expensive equipment.
The following is a summary of the public comments received and our responses.
“The Commission supports CMS's proposal as it applies to diagnostic imaging machines that cost more than $1 million, and we encourage CMS to explore increasing the equipment use factor for diagnostic imaging machines that cost less than $1 million. MedPAC did not contemplate applying the policy to radiation therapy machines.”
Commenters supporting our proposal cited the MedPAC studies and the rationale we provided in the proposed rule.
Commenters opposing our proposal stated that the Balanced Budget Act of 1997 (BBA) directed CMS to “utilize, to the maximum extent practicable, generally accepted cost accounting principles which: (1) Recognize all staff, equipment, supplies and expense, not just those which can be tied to specific procedures; and (2) use actual data on equipment utilization and other key assumptions.” The commenters stated that the equipment usage proposal violates this provision of the BBA since we lacked sufficient empirical justification for the change. The commenters indicated that the National Opinion Research Center survey data, which was one data source used by MedPAC, was not nationally representative, and was never intended to determine equipment usage rates.
Some commenters referenced information submitted by the Radiology Benefit Management Association (RBMA) based on a survey of its members. The commenters stated that the information supported maintaining a 50 percent utilization usage rate assumption for diagnostic imaging equipment. The commenters also stated that the information indicated differences in utilization rates between rural and urban areas and that our proposal would create access issues, especially in rural areas.
In MedPAC's comment letter, it agreed with CMS that “decreasing PE RVUs for expensive diagnostic imaging services should not affect access to care in rural areas.”
The AMA submitted summary equipment utilization data from the PPIS survey on MRI, CT, angiography, IMRT, and gamma camera. It stated that although there was a relatively small sample size, the survey responses suggest that equipment utilization varies depending on the type of equipment involved. The AMA requested that we allow specialty societies to provide data supporting lower utilization rates, if appropriate. It stated that this would allow for varying equipment utilization rate assumptions depending on the type of equipment being used, rather than a single utilization assumption.
Some commenters indicated that even if the available data did indicate a higher utilization rate for certain types of diagnostic equipment, we should not apply the change to all types of expensive diagnostic equipment. For example, we should not apply the usage rate to new imaging technology.
Some commenters requested that we not change the equipment usage rate assumption to 90 percent for any equipment until additional data sources can be identified. The commenters suggested that the equipment usage rate policy should not be limited to increasing usage rate assumptions but should also include potentially decreasing equipment usage rate assumptions when appropriate.
If we were to implement a higher utilization rate, some commenters suggested that the change be phased in over a number of years.
As described earlier, the MedPAC analysis was performed on two data sources for different types of equipment. The first data source was the survey done by NORC for MRIs and CTs. The second data source was the IMV data for
As we have described in section II.A.2.b. of this final rule with comment, the PPIS is the best available data source currently available on PEs. Given the corroboration of the MedPAC analysis by the PPIS data, we are confident that we are using the best data currently available on the utilization of MRIs and CTs (90 percent), consistent with the BBA requirement that we use actual data on equipment utilization.
We are open to receiving more comprehensive data than the responses of 16 RBMA members on this issue from the RBMA or other members of the public. We will evaluate any data submitted for consideration in future rulemaking.
We continue to agree with the MedPAC analysis and comment indicating that decreasing the PE payments for expensive diagnostic imaging services should not affect access to care in rural areas.
We also agree with commenters that it would be appropriate to transition the new PE RVUs developed using the higher 90 percent utilization rate for MRIs and CTs. As discussed elsewhere in this final rule, we are providing for a 4-year transition (25/75, 50/50, 75/25, 100/0) to the new PE RVUs.
As indicated above, we are not finalizing our proposal to increase the utilization rate assumption for expensive equipment other than MRIs and CTs, including therapeutic equipment. We are finalizing our proposal to increase the utilization rate to 90 percent for expensive diagnostic equipment priced at more than $1 million.
As we have discussed in the past rulemaking (see the CY 2007 and CY 2008 PFS final rules with comment period (71 FR 69647 and 72 FR 66236, respectively), we continue to have concerns about the issue of PE RVUs for services which are utilized 24 hours a day/7 days a week, such as certain monitoring systems. For example, the PE equipment methodology was not developed with this type of 24/7 equipment in mind. As stated in the CY 2010 PFS proposed rule (74 FR 33532), we are continuing to analyze the issue of PEs for services, which are utilized 24 hours a day/7 days a week to identify any modifications to our methodology that would address the specific “constant use” issues associated with these services. Services that are currently contractor priced in CY 2009 would remain contractor priced in CY 2010. We also indicated that any proposed changes will be communicated through future rulemaking.
As discussed in the proposed rule, (74 FR 33532) we received comments regarding the PE direct cost inputs (for example, supply costs and the useful life of the renewable sources) related to the high dose radiation therapy (HDRT) and placement CPT codes (CPT codes 77785,
Several commenters supported the AMA RUC's recommended changes to the practice expense inputs for these codes. The commenters agreed that certain direct PE inputs were previously omitted.
The AMA RUC provided recommendations for PE inputs for the codes listed in Table 3 (74 FR 33532).
In the proposed rule, we stated that we were in agreement with the AMA RUC recommendations for the direct PE inputs for the codes listed in Table 3 and proposed to adopt these for CY 2010.
The AMA RUC reviewed the immunization administration services (CPT codes 90465 through 90474) in February 2008. It recommended similar PE inputs for the intramuscular and intranasal immunization administration codes. In the CY 2009 PFS final rule with comment period (73 FR 38512), we stated that we accepted all of the AMA RUC recommendations, except for inclusion of the clinical staff time related to quality activities for the codes. In the CY 2009 PFS final rule with comment period (73 FR 69736), we stated that we had reexamined the issue and that there was evidence to support the inclusion of QA time in this case. We revised the PE database to reflect QA time for these codes.
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.
Section 1848(e)(1)(C) of the Act requires us to review and, if necessary, adjust the GPCIs at least every 3 years. This section also specifies that if more than 1 year has elapsed since the last GPCI revision, we must phase in the adjustment over 2 years, applying only one-half of any adjustment in each year. As discussed in the CY 2009 PFS final rule with comment period (73 FR 69740), the CY 2009 adjustment to the GPCIs reflected the fully implemented fifth comprehensive GPCI update. We noted that a 1.0 work GPCI floor was enacted and implemented for CY 2006, and was set to expire on June 30, 2008. We also noted that section 134 of the MIPPA extended the 1.0 work GPCI floor from July 1, 2008, through December 31, 2009. Additionally, 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. Therefore, as required by the MIPPA, beginning on January 1, 2010, the 1.0 work GPCI floor will be removed. However, the 1.5 work GPCI floor for Alaska will remain in place. See Addenda D and E of this final rule for the GPCIs and summarized geographic adjustment factors (GAFs), respectively.
As stated above in this section, section 1848(e)(1)(A) of the Act requires us to develop separate GPCIs to measure resource cost differences among localities compared to the national average for each of the three fee schedule components (this is, work, PE, and malpractice). Payments under the PFS are based on the relative resources involved in furnishing physicians' services, and are adjusted for differences in relative resource costs among payment localities using the GPCIs. As a result, PFS payments vary between localities.
The current PFS locality structure was developed and implemented in 1997. There are currently 89 localities including 37 higher-cost areas; 16 Rest of State areas (comprising the remaining counties not located in a higher-cost area within a State); 34 Statewide areas; and Puerto Rico and the Virgin Islands which are designated as “territory-wide” 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 (61 FR 59494).
As we have frequently noted, 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 examination of existing payment localities.
For the past several years, we have been involved in discussions with California physicians and their representatives about recent shifts in relative demographics and economic conditions among a number of counties within the current California payment locality structure. In the CY 2008 PFS proposed and final rules with comment period, we described three potential options for changing the payment localities in California (72 FR 38139 and 72 FR 66245, respectively).
After reviewing the comments on these options, we decided not to proceed with implementing any of them at that time. We explained that there was no consensus among the California medical community as to which, if any, of the options would be most acceptable. We also received suggestions from the Medicare Payment Advisory Commission (MedPAC) for developing changes in payment localities for the entire country and other States expressed interest in having their payment localities reconfigured as well. In addition, other commenters wanted us to consider a national reconfiguration of localities rather than just making changes one State at a time. Because of the divergent views
As a follow-up to the CY 2008 PFS final rule with comment period, we contracted with Acumen, LLC (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,” is still 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:
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 inpatient hospital prospective payment system (IPPS) pre-reclassification CBSA assignments and with the geographic payment adjustments used in other Medicare payment systems. This option would increase the number of 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 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 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 localities from 89 to 140 using a 5 percent GAF differential to group similar counties into Statewide tiers.
Additionally, as discussed in the interim locality study report, our contractor, Acumen, applied a “smoothing” adjustment to the current PFS locality structure, as well as to each of the alternative locality configurations (except option 4: Statewide Tiers). The “smoothing” adjustment was applied to mitigate large payment differences (or payment “cliffs”) between adjacent counties. Since large payment differences between adjacent counties could influence a physician's decision on a practice location (and possibly impact access to care), the “smoothing” adjustment was applied to ensure that GAF differences between adjacent counties do not exceed 10 percent. (For more information on the “smoothing” adjustment see the interim locality study report on the PFS Web page via the link provided above).
In the CY 2009 PFS proposed rule (73 FR 38514), we encouraged interested parties to submit comments on the options presented both in the proposed rule and in the interim report posted on our Web site. We also requested comments and suggestions on other potential alternative locality configurations (in addition to the options described in the report). Additionally, we requested comments on the administrative and operational issues associated with the various options under consideration. We also emphasized that we would not be proposing any changes to the current PFS locality structure for CY 2009 and that we would provide extensive opportunities for public comment before proposing any change.
In the CY 2010 PFS proposed rule (74 FR 33533), we noted that approximately 200 industry comments were submitted on the alternative locality options discussed in the CY 2009 PFS proposed rule and on the interim locality study report. Comments were submitted from various specialty groups, medical societies, state medical associations, individual practitioners, and beneficiaries. Commenters generally commended us for acknowledging the need to reconfigure PFS payment localities and expressed support for our study of alternative locality configurations. Some urged us to expedite any changes while other commenters requested that we take a cautious approach.
Several commenters who supported the adoption of an MSA-based PFS locality structure suggested that option 3 could be used as a transition to the CMS CBSA locality configuration (option 1). Many commenters from the State of California supported option 3 (Separate High Cost MSAs) because the commenters believe it would improve payment accuracy (over the current locality configuration) and mitigate possible payment reductions to rural areas as compared to option 1 (CMS CBSA) and option 4 (Statewide Tiers. Because of the payment reductions to rural areas, most commenters did not support option 4 (Statewide Tiers).
Many commenters also acknowledged the significant redistribution of payments that would occur under each option and requested that we minimize the payment discrepancy between urban and rural areas to ensure continued access to services. One medical association stated that “budget neutral redistributions would only exacerbate an already flawed and under-funded Medicare PFS” and suggested that States with a Statewide locality be given the option of remaining a Statewide locality. The commenter also requested that we continue our policy of allowing any State the option of converting to a Statewide locality.
For a more detailed discussion of the comments submitted on the interim locality study, see the CY 2010 PFS proposed rule (74 FR 33534).
We did not make a specific proposal for changing the PFS locality structure in the CY 2010 PFS proposed rule. As noted by the commenters and reflected in the report, significant payment redistribution would occur if a nationwide change in the PFS locality configuration were undertaken. All four of the potential alternative payment locality configurations reviewed in the report would increase the number of localities and separate higher cost,
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. 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 (69 FR 66263). Minor modifications to the methodology were addressed in the CY 2006 PFS final rule (70 FR 70153). In the CY 2010 PFS proposed rule, we proposed to implement the second review and update of malpractice RVUs.
The proposed malpractice RVUs were developed by Acumen, LLC (Acumen) under contract to us (74 FR 33537).
The methodology used in calculating the proposed second review and update of resource-based malpractice RVUs largely parallels the process used in the CY 2005 update. The calculation requires information on malpractice premiums, linked to the physician work conducted by different specialties that furnish Medicare services. Because malpractice costs vary by State and specialty, the malpractice premium information must be weighted geographically and across specialties. Accordingly, the malpractice expense RVUs that we proposed are based upon three data sources:
• Actual CY 2006 and CY 2007 malpractice premium data.
• CY 2008 Medicare payment data on allowed services and charges.
• CY 2008 Geographic adjustment data for malpractice premiums.
Similar to the previous update of the resource-based malpractice expense RVUs, we proposed to revise the RVUs using specialty-specific malpractice premium data because they represent the actual malpractice expense to the physician. In addition, malpractice premium data are widely available through State Departments of Insurance. We proposed to use actual CY 2006 and CY 2007 malpractice premium data because they are the most current data available (CY 2008 malpractice premium data were not consistently available during the data collection process). Accounting for market share, three fourths of all included rate filings were implemented in CY 2006 and CY 2007. The remaining rate filings were implemented in CY 2003 through CY 2005 but still effective in CY 2006 and CY 2007. Carriers submit rate filings to their State Departments of Insurance listing the premiums and other features of their coverage. The rate filings include an effective date, which is the date the premiums go into effect. Some States require premium changes to be approved before their effective date; others just require the rate filings to be submitted. We attempted to capture at least 2 companies and at least 50 percent of the market share, starting with the largest carriers in a State.
The primary determinants of malpractice liability costs continue to be physician specialty, level of surgical involvement, and the physician's malpractice history. We collected malpractice premium data from 49 States and the District of Columbia for all physician specialties represented by major insurance providers. Rate filings were not available through Departments of Insurance in Mississippi or Puerto Rico. Premiums were for $1 million/$3 million, mature, claims-made policies (policies covering claims made, rather than services furnished during the policy term). A $1 million/$3 million liability limit policy means that the most that would be paid on any claim is $1 million and that the most that the policy would pay for several claims over the timeframe of the policy is $3 million. We collected data from commercial and physician-owned insurers and from joint underwriting associations (JUAs). A JUA is a State government-administered risk pooling insurance arrangement in areas where commercial insurers have left the market. Adjustments were made to reflect mandatory surcharges for patient compensation funds (PCFs) (funds to pay for any claim beyond the statutory amount, thereby limiting an individual physician's liability in cases of a large suit) in States where PCF participation is mandatory. We sought to collect premium data representing at least 50
Rather than select the top 20 physician specialties as we did when the malpractice RVU were originally established and updated, we included premium information for all physician and surgeon specialties, and risk classifications available in the collected rate filings. Most insurance companies provided crosswalks from insurance service office (ISO) codes to named specialties; we matched these crosswalks to CMS specialty codes. We also preserved information obtained regarding surgery classes, which are categorizations that affect premium rates. For example, many insurance companies grouped general practice physicians into nonsurgical, minor-surgical and major-surgical classes, each with different malpractice premiums. Some companies provided additional surgical subclasses; for example, distinguishing general practice physicians that conducted obstetric procedures, which further impacted malpractice rates. We standardized this information to CMS specialty codes.
We proposed a resource based methodology for developing malpractice RVUs for technical component (TC) services (for example diagnostic tests). Currently, the MP RVUs for TC services and the TC portion of global services are based on historical allowed charges and have not been made resource based due to a lack of available malpractice premium data for nonphysician suppliers. Over the last few years, we have requested malpractice premium data for nonphysician suppliers, but had not received any data prior to last year. In response to our request in last year's rulemaking cycle, one commenter did provide information on one of the largest insurance companies that provides liability insurance for medical physicists employed by imaging facilities. After our contractor, Acumen, verified the medical physicist premium information submitted in response to last year's proposed rule, we proposed to use the medical physicist premium data as a proxy for the malpractice premiums paid by all entities providing TC services; primarily independent diagnostic testing facilities (IDTFs).
Other than the change in methodology for developing malpractice RVUs for TC services, our proposed methodology for updating malpractice RVUs conceptually followed the same approach, with some minor refinements, used to originally develop the resource based malpractice RVUs in CY 2000 and used in the CY 2005 update. These refinements included an expansion in the malpractice premium data collection to include additional specialties, a distinction between major and minor surgical risk factors, and a proposal to use the malpractice risk factor of the specialty that performs a given service the most (dominant specialty) for services with less than 100 occurrences. We solicited comments on our proposed methodology for updating the malpractice RVUs and posted the Acumen report, “Interim Report on Malpractice RVUs for the CY 2010 Medicare Physician Fee Schedule Proposed Rule” on the CMS Web site. The interim report on Malpractice RVUs for the CY 2010 PFS proposed rule and Malpractice premium amounts and risk factors by specialty, which was produced by Acumen, LLC under contract to CMS, is accessible from the CMS PFS Web page under the heading “Interim Report on Malpractice RVUs for the CY 2010 Medicare PFS Proposed rule.” The report and malpractice premiums may also be accessed directly on the CMS Web site at
A more detailed explanation of our proposed malpractice RVU update can be found in the CY 2010 PFS proposed rule (74 FR 33537).
We received over 250 industry comments on the CY 2010 proposed malpractice RVU update.
After consideration of the comments, we will not finalize our proposal but will continue to use our current approach for assigning risk factors to individual services while we study this issue further. We will consider the request to assign the surgical risk factor to injection procedures as part of our further study and would propose any changes through future rulemaking.
As is done under the current methodology, we will continue to assign each service to either a nonsurgical or surgical risk factor based on CPT code ranges: Surgery (CPT code range 10000 through 69999; 92980 through 92998; 93501 through 93536; 92973 through 92974; 93501 through 93533; 93580 through 93581; 93600 through 93613; 93650 through 93652; 92975; 92980 through 92998; 93617 through 93641); and nonsurgery (all other CPT codes). Consistent with current practice, the surgery risk factor would not distinguish between major and minor.
By using the dominant specialty from our claims data to assign the specialty for these low volume services, we attempted to strike a balance between our preference for the empirical, objective use of all of our claims data in the development of the malpractice RVUs and the desire of commenters to override our claims data for these low volume services using less objective criteria. After careful consideration of the comments, we continue to believe that a more balanced approach between the complete reliance on all of the specialties in our claims data and the subjective review of each low volume service is the most appropriate way of approaching the development of malpractice RVUs for these low volume services. We disagree with the commenters that we should override the dominant specialty from the claims data
Section 1834(m)(4)(F) of the Act defines telehealth services as professional consultations, office visits, and office psychiatry services, and any additional service specified by the Secretary. In addition, the statute requires us to establish a process for adding services to or deleting services from the list of telehealth services on an annual basis.
In the December 31, 2002
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Since establishing the process, we have added the following to the list of Medicare telehealth services: psychiatric diagnostic interview examination; ESRD services with two to three visits per month and four or more visits per month (although we require at least one visit a month to be furnished in-person “hands on”, by a physician, clinical nurse specialist (CNS), nurse practitioner (NP), or physician assistant (PA) to examine the vascular access site); individual medical nutrition therapy; neurobehavioral status exam; and follow-up inpatient telehealth consultations.
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 2009 are considered for the CY 2011 proposed rule. Each request for adding a service to the list of Medicare telehealth services must include any supporting documentation you wish 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 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, visit our Web site at
We received requests in CY 2008 to add the following services as Medicare telehealth services effective for CY 2010: (1) Health and behavior assessment and intervention (HBAI) procedures; and (2) nursing facility services. In addition, we received a number of requests to add services that we did not approve as Medicare telehealth services in previous PFS rules. These requested services include critical care services; initial and subsequent hospital care; group medical nutrition therapy; diabetes self-management training; speech and language pathology services; and physical and occupational therapy services.
In the CY 2010 PFS proposed rule (74 FR 33543), we responded to these requests. We proposed to add individual HBAI services to the list of Medicare telehealth services, and we proposed to revise our regulations at § 410.78 and § 414.65 accordingly. We proposed to revise § 410.78 to restrict physicians and practitioners from using telehealth to furnish the physician visits required under § 483.40(c). We proposed to revise § 410.78 to specify that the G-codes for follow-up inpatient telehealth consultations (as described by HPCPCS codes G0406 through G0408) include follow-up telehealth consultations furnished to beneficiaries in hospitals and SNFs. We did not propose to add group HBAI, family-with-patient HBAI, nursing facility services, critical care services, or any of the other requested services to the list of Medicare telehealth services. The following is a summary of the discussion from the proposed rule, a summary of comments we received, and our responses.
The American Psychological Association (APA) submitted a request to add HBAI services (as described by HCPCS codes 96150 through 96154) to the list of approved telehealth services. The APA asked us to evaluate and approve HBAI services as a Category #1 service because they are comparable to the psychotherapy services currently approved for telehealth.
As discussed in the CY 2010 PFS proposed rule (74 FR 33543), clinical psychologists furnish HBAI services to beneficiaries to help them manage or improve their behavior in response to physical problems. Elements of HBAI services typically include interviewing, observing, and counseling beneficiaries to help them modify their behavior. These elements are also common to the office psychiatry services currently approved for telehealth. In the proposed rule, we stated that we believe the interaction between a practitioner and a beneficiary receiving individual HBAI services (as described by HCPCS codes 96150 through 96152) is similar to the assessment and counseling elements of the individual office psychiatry services currently approved for telehealth. Therefore, we proposed to revise § 410.78 and § 414.65 to include individual HBAI services as Medicare telehealth services.
With regard to group HBAI (as described by HCPCS code 96153) or family-with-patient HBAI (as described by HCPCS code 96154), we noted that group services are not currently approved as Medicare telehealth services. Group counseling services have a different interactive dynamic between the physician or practitioner and his or her patients as compared to individual services. Since the interactive dynamic for group HBAI services is not similar to that for individual HBAI services or any other approved telehealth services, we stated that we do not believe that group HBAI or family-with-patient HBAI services should be considered as Category #1 requests. To be considered as a Category #1 request, a service must be similar to the current list of Medicare telehealth services. (See 70 FR 45787 and 70157, and 73 FR 38516 and 69743). Instead,
Section 149 of the MIPPA added SNFs as telehealth originating sites effective for services furnished on or after January 1, 2009. We received a request from the American Telemedicine Association (ATA) to add subsequent nursing facility care; nursing facility discharge services; and other nursing facility services to the list of approved telehealth services. The Center for Telehealth and e-Health Law submitted a request to add the same nursing facility services and indicated its support of ATA's request. We also received a request from the Marshfield Clinic to add the same services requested by the ATA, plus the initial nursing facility care services.
The procedure codes included in these requests are used to report evaluation and management (E/M) services furnished onsite to patients in SNFs. The requestors drew analogies to the E/M services currently approved for Medicare telehealth, and they provided evidence in support of their belief that the use of telehealth could be a reasonable surrogate for the face-to-face delivery of this type of care.
As discussed in the CY 2010 PFS proposed rule (74 FR 33543), the long-term care regulations at § 483.40 require that residents of SNFs receive initial and periodic personal visits. These regulations insure that at least a minimal degree of personal contact between a physician or a qualified NPP and a resident is maintained, both at the point of admission to the facility and periodically during the course of the resident's stay. We believe that these Federally-mandated visits should be conducted in-person, and not as Medicare telehealth services. We proposed to revise § 410.78 to restrict physicians and practitioners from using telehealth to furnish the physician visits required under § 483.40(c).
We reviewed the use of telehealth for each of the subcategories of nursing facility services included in these requests. We identified the E/M services that fulfill Federal requirements for personal visits under § 483.40 and we did not propose to add any procedure codes that are used exclusively to describe these Federally-mandated visits.
The initial nursing facility care procedure codes (as described by HCPCS codes 99304 through 99306) are used to report the initial E/M visit in a SNF or NF that fulfills Federally-mandated requirements under § 483.40(c). We did not propose to add the initial nursing facility care services (as described by HCPCS codes 99304 through 99306) to the list of approved Medicare telehealth services because these procedure codes are used exclusively to describe E/M services that fulfill Federal requirements for personal visits under § 483.40.
The subsequent nursing facility care procedure codes (as described by HCPCS codes 99307 through 99310) are used to report either a Federally-mandated periodic visit under § 483.40(c), or any E/M visit, prior to and after the initial physician visit, that is reasonable and medically necessary to meet the medical needs of the individual resident. In the past, we have not added hospital E/M visits to the list of approved Medicare telehealth services because of our concern regarding the use of telehealth for the ongoing E/M of a high-acuity hospital inpatient. (See 69 FR 47511, 69 FR 66276, 72 FR 38144, 72 FR 66250, 73 FR 38517, and 73 FR 69745.) Many residents of SNFs also require medically complex care, and we have similar concerns about allowing physicians or NPPs to furnish E/M visits via telehealth to residents of SNFs.
The complexity of care required by many residents of SNFs may be significantly greater than the complexity of care generally associated with patients receiving the office visits approved for telehealth. Accordingly, we do not consider E/M visits furnished to residents of SNFs similar to the office visits on the current list of Medicare telehealth services. Therefore, we believe the use of subsequent nursing facility care for medically necessary E/M visits that are in addition to Federally-mandated periodic personal visits must be evaluated as a Category #2 service.
We evaluated whether these are services for which telehealth can be an adequate substitute for a face-to-face encounter. The requestors submitted supporting documentation to demonstrate that the use of telehealth could be a reasonable surrogate for the face-to-face delivery of this type of care. However, we did not receive sufficient comparative analysis or other compelling evidence to demonstrate that furnishing E/M visits via telehealth to residents of SNFs is an adequate substitute for the face-to-face encounter between the practitioner and the resident, especially in cases where the resident requires medically complex care. We were also concerned that one study demonstrated that services provided via telehealth do not elicit adequate participation in informed medical decision-making from residents with low to moderate illness when compared to face-to-face encounters. We determined that telehealth is not an adequate substitute for the face-to-face delivery of E/M visits to residents of SNFs. Therefore, we did not propose to
The nursing facility discharge day management codes (as described by HCPCS codes 99315 and 99316) are used to report an E/M visit that prepares a resident for discharge from a nursing facility. We note that there is no Medicare Part B requirement to furnish and bill an E/M visit in preparation for a resident's discharge from a SNF. However, if a physician or qualified NPP bills a Nursing Facility Discharge Services code, we believe that a face-to-face encounter will better insure that the resident is prepared for discharge. We do not have evidence that nursing facility discharge services furnished via telehealth are equivalent to face-to-face provision of this service. We did not propose to add the nursing facility discharge day management services to the list of approved Medicare telehealth services.
In 2006, CPT added a procedure code for Other Nursing Facility Service (CPT code 99318) to describe an annual nursing facility assessment. An annual assessment is not one of the required visits under the long-term care regulations at § 483.40. For Medicare purposes, this code can be used in lieu of a Subsequent Nursing Facility Care code to report a Federally-mandated periodic personal visit furnished under § 483.40(c). An annual assessment visit billed using CPT code 99318 does not represent a distinct benefit service for Medicare Part B physician services, and it cannot be billed in addition to the required number of Federally-mandated periodic personal visits. Under Medicare Part B, we cover this procedure code if the visit fully meets the CPT code 99318 requirements for an annual nursing facility assessment. In order to cover and pay for this service, we also require that this annual assessment falls on the 60-day mandated visit cycle. We did not propose to add the other nursing facility care services described by this code to the list of approved Medicare telehealth services because this code is payable by Medicare only if the visit is substituted for a Federally-mandated visit under § 483.40(c). We believe all of the Federally-mandated periodic visits must be conducted in person.
Prior to 2006, follow-up inpatient consultations (as described by CPT codes 99261 through 99263) were approved telehealth services. In 2006, the CPT Editorial Panel of the American Medical Association (AMA) deleted the codes for follow-up inpatient consultations. In the hospital setting, the AMA advised practitioners to bill for services that would previously have been billed as follow-up inpatient consultations using the procedure codes for subsequent hospital care (as described by CPT codes 99231 through 99233). In the nursing facility setting, the AMA advised practitioners to bill for these services using the procedure codes for subsequent nursing facility care (as described by CPT codes 99307 through 99310).
In the CY 2009 PFS final rule with comment period (73 FR 69745), we created follow-up inpatient telehealth consultation codes (as described by HCPCS codes G0406 through G0408) to furnish care to hospital inpatients, and we added these G-codes to the list of Medicare telehealth services. These HCPCS codes are limited to the range of services included in the scope of the previous CPT codes for follow-up inpatient consultations, and the descriptions limit the use of such services for telehealth.
In the CY 2010 PFS proposed rule (74 FR 33547), we stated that if the former codes for follow-up consultations (as described by CPT codes 99261 through 99263) still existed, these procedure codes would also be available to practitioners providing follow-up consultations via telehealth to SNF patients. Although we did not receive a public request to add follow-up inpatient consultations for SNF patients to the list of approved Medicare telehealth services, we stated that we also recognized a need to establish a method for practitioners to provide these services. For CY 2010, we proposed to revise § 410.78 to specify that the G-codes for follow-up inpatient telehealth consultations (as described by HCPCS codes G0406 through G0408) include follow-up inpatient telehealth consultations furnished to beneficiaries in SNFs, as well as in hospitals. The HCPCS codes clearly designate these services as follow-up consultations provided via telehealth, and not as subsequent care used for E/M visits. Utilization of these codes for patients in SNFs will facilitate payment for these services, as well as enable us to monitor whether the codes are used appropriately. (See the CMS Internet-Only Medicare Claims Processing Manual, Pub. 100–04, Chapter 12, Section 190, for the definition of follow-up inpatient telehealth consultations.)
The following is a summary of the comments we received regarding our proposed decisions on Nursing Facility Services.
Some commenters disagreed with our proposal not to add Nursing Facility Services to the list of approved Medicare telehealth services. Commenters acknowledged Congressional intent expressed in section 413 of the MMA that the use of telehealth should not be a substitute for the Federally-mandated periodic personal visits required under § 483.40(c). All commenters agreed with our proposal not to add any procedure codes that are used exclusively to describe these Federally-mandated visits. Commenters stated that they believed that the Congress intended to allow the use of telehealth to furnish E/M medically necessary visits onsite to residents of SNFs that are in addition to Federally-mandated periodic personal visits. Some commenters also noted that due to health professional shortages in rural areas, many SNFs lack essential onsite services. Some commenters believe adding nursing facility visits to the list of approved telehealth services will improve the quality of care furnished to residents of SNFs. Commenters also noted that not adding nursing facility visits to the list of approved Medicare telehealth services will not prevent the use of telehealth to furnish services to residents of SNFs, including those residents requiring medically complex care. These same residents could be transported to physicians' offices or hospitals where they could receive similar E/M visits via telehealth.
We agree with the commenters who noted that expanding the definition of Follow-Up Inpatient Telehealth Consultations (G0406–G0408) to allow their use for residents of SNFs will increase access to care for Medicare beneficiaries in rural areas. We believe the availability of inpatient consultations to furnish care via telehealth to residents of SNFs is consistent with the addition of SNFs as approved telehealth originating sites. Physicians and NPPs who furnish inpatient consultations via telehealth complement the care provided by the SNF and furnished onsite by the attending physician or physician of record.
In the CY 2009 PFS final rule with comment period (73 FR 69744), we did not add critical care services to the list of approved Medicare telehealth services. In 2009, Philips Healthcare submitted an expanded request to add critical care services to the list of approved Medicare telehealth services. It stated that critical care services can be approved as a Category #1 service based on their similarity to the inpatient consultation services currently approved for Medicare telehealth. The requestor also stated that many of the components of critical care are similar to a high-level inpatient consultation service, which is currently approved for Medicare telehealth. Common components include obtaining a patient history, conducting an examination, and engaging in complex medical decision-making for patients who may be severely ill. Because we classified critical care as a Category #2 service last year, the requestor also submitted evidence to support its belief that the use of telehealth could be a reasonable surrogate for the face-to-face delivery of this type of care.
In the CY 2010 PFS proposed rule (74 FR 33548), we stated that remote critical care services are different than the telehealth delivery of critical care (as described by HCPCS codes 99291 and 99292). We did not propose adding critical care services (as described by HCPCS codes 99291 and 99292) to the list of approved Medicare telehealth services. We reiterated that our decision not to add critical care services to the list of approved telehealth services does not preclude physicians from furnishing telehealth consultations to critically ill patients.
Another commenter who submitted the CY 2009 request submitted descriptions of telestroke technology to support the assertion that the elements of a stroke-related neurological assessment performed by a neurologist are effectively the same whether furnished in-person or via telehealth. The commenter acknowledges that some telestroke services satisfy the criteria for billing consultations via telehealth, but noted that the payment is less than the same neurological assessment furnished in-person and billed as a critical care service. The commenter requested that we consider adding critical care services to the list of approved Medicare telehealth services when the underlying diagnosis is stroke-related.
We did not find the studies submitted during the comment period persuasive that telehealth can be an adequate substitute for the face-to-face delivery of critical care services (as described by HCPCS codes 99291 and 99292). As described in these studies, the role of the physician furnishing remote critical care services includes monitoring patients and directing on-site staff to intervene, as necessary. Within the current standards of practice, we believe that critical care services (as described by HCPCS codes 99291 and 99292) require the physical presence of a physician who is available to furnish any hands-on intervention. We continue to believe that remote critical care services are different services than the telehealth delivery of critical care (as described by HCPCS codes 99291 and 99292). As noted above, we believe that the data collected for the remote critical care tracking codes will help provide useful information on how to best categorize and value remote critical care services in the future.
We received a number of requests to add services that we reviewed and did not accept in previous PFS Rules. The following are brief summaries of our discussions from the proposed rule, summaries of comments received, and our responses.
We received a request to add initial hospital care (as described by HCPCS codes 99221 through 99223) and subsequent hospital care (as described by HCPCS codes 99231 through 99233) to the list of approved Medicare telehealth services. In response to previous requests, we did not add initial or subsequent hospital care to the list of approved telehealth services because of our concern regarding the use of telehealth for the ongoing E/M of a high-acuity hospital inpatient. (See 69 FR 47510 and 66276, 72 FR 38144 and 66250, and 73 FR 38517 and 69745.) We did not receive any new information with this request that would alter our previous decision. Therefore, we did not propose adding initial hospital care or subsequent hospital care to the list of approved Medicare telehealth services. We did not receive any comments on this proposal.
We received a request to add group medical nutrition therapy (MNT) services (as described by HCPCS codes G0271 and 97804) to the list of approved Medicare telehealth services. In response to a previous request, we did not add group MNT to the list of approved telehealth services because we believe that group services are not appropriately delivered through telehealth. (See 70 FR 45787 and 70157.) We did not receive any new information with this request that would alter our previous decision. Therefore, we did not propose adding group MNT to the list of approved Medicare telehealth services. We did
We received a request to add diabetes self-management training (DSMT) (as described by HCPCS codes G0108 and G0109) to the list of approved telehealth services. In response to previous requests, we did not add DSMT to the list of approved telehealth services because of the statutory requirement that DSMT include teaching beneficiaries to self-administer injectable drugs. Furthermore, DSMT is often performed in group settings and we believe that group services are not appropriately delivered through telehealth. (See 70 FR 45787 and 70157, and 73 FR 38516 and 69743.) We did not receive any new information with this request that would alter our previous decision. Therefore, we did not propose to add DSMT to the list of approved Medicare telehealth services.
We received a request to add various speech and language pathology services to the list of approved telehealth services. Speech-language pathologists are not permitted under current law to furnish and receive payment for Medicare telehealth services. Therefore, we did not propose to add any speech and language pathology services to the list of approved Medicare telehealth services. (For further discussion, see 69 FR 47512 and 66276, and 71 FR 48995 and 69657.)
We received a request to add various physical and occupational therapy services to the list of approved Medicare telehealth services. The statute does not authorize Medicare payment to physical and occupational therapists for Medicare telehealth services. Therefore, we did not propose to add any physical and occupational therapy services to the list of approved Medicare telehealth services. (For further discussion, see 71 FR 48995 and 69657.)
We will finalize our proposal to add the individual HBAI services (as described by HCPCS codes 96150 through 96152) and not to add group HBAI (as described by HCPCS code 96153) or family-with-patient HBAI (as described by HCPCS code 96154) to the list of approved Medicare telehealth services. We will also finalize our proposal to add individual HBAI services to the list of approved Medicare telehealth services at § 410.78 and § 414.65.
We will finalize our proposal to revise § 410.78 to restrict physicians and practitioners from using telehealth to furnish the physician visits required under § 483.40(c). We will finalize our proposal not to add Nursing Facility Services (as described by HCPCS codes 99304 through 99318) to the list of approved Medicare telehealth services. We will also finalize our proposal to revise § 410.78 to specify that the G-codes for follow-up inpatient telehealth consultations (as described by HPCPCS codes G0406 through G0408) include follow-up telehealth consultations furnished to beneficiaries in hospitals and SNFs.
We will finalize our proposals not to add critical care services (as described by HCPCS codes 99291 and 99292) or any of the other requested services to the list of approved Medicare telehealth services.
We received other comments on matters related to Medicare telehealth services that were not the subject of proposals in the CY 2010 PFS proposed rule. We thank the commenters for sharing their views and suggestions. Because we did not make any proposals regarding these matters, we do not generally summarize or respond to such comments in this final rule. However, we have chosen to summarize and respond to the following comments in order to furnish more information.
In 2008, the CPT Editorial Panel created a new code for canalith repositioning (CRP). This procedure is a treatment for vertigo which involves therapeutic maneuvering of the patient's body and head in order to use the force of gravity to redeposit the calcium crystal debris in the semicircular canal system.
In the CY 2009 PFS final rule with comment period (73 FR 69896), new CPT code 95992,
After publication of the CY 2009 PFS final rule with comment period, we received comments on this issue from an organization representing physical therapists, as well as others expressing opposition to our decision to bundle the new code. Commenters stated that they believe that our decision to bundle CPT code 95992 was flawed since physical therapists are unable to bill E/M services. One commenter also stated that therapists would be precluded from using another code for billing for this service because CPT correct coding instructions require that the provider/supplier select the procedure that most accurately defines the service provided.
Based upon the commenters' feedback, we realized that we had failed to address how therapists would bill for the service since they cannot bill E/M services. In order to address this situation so that access to this service would not be impacted we released a MedLearn article informing PTs to continue using one of the more generally defined “always therapy” CPT codes (97112) as a temporary measure. See
In response to the concerns raised and upon additional review of this issue in the CY 2010 PFS proposed rule, we proposed to change the status indicator for this code from B (Bundled) to I (Not valid for Medicare purposes). We proposed that physicians would continue to be paid for CRP as a part of an E/M service. Physical therapists would continue to use one of the more generally defined “always therapy” CPT codes (97112). We stated that we believe that this will enable beneficiaries to continue to receive this service while at the same time it will address our concerns about the potential for duplicate billing for this service to the extent that this service is paid as a part of an E/M service. As a result of this proposal, CPT code 95992 would be removed as a “sometimes” therapy code from the therapy code list.
The following is a summary of the comments we received regarding the canalith repositioning proposal.
We will finalize our proposal to designate CPT code 95992 as “I”, not valid for Medicare purposes. We will also remove it from the “sometimes” therapy code list in order to allow therapists to bill appropriately for the service, using one of the more generally defined “always therapy” codes.
In the CY 2010 PFS proposed rule, we proposed to increase the payment for an initial preventive physical examination (IPPE) furnished face-to-face with the patient and billed with HCPCS code G0402,
Section 101(b) of the MIPPA changed the IPPE benefit by adding to the IPPE visit the measurement of an individual's body mass index and, upon an individual's consent, end-of-life planning. Section 101(b) of the MIPPA also removed the screening electrocardiogram (EKG) as a mandatory service of the IPPE.
In order to implement this MIPPA provision, in the CY 2009 PFS final rule with comment period (73 FR 69870), we created HCPCS code G0402 as a new HCPCS code and retained, on an interim basis, the work RVUs of 1.34 assigned to HCPCS code G0344, the code that was previously used to bill for the IPPE. While we did not believe the revisions to the IPPE required by MIPPA impacted the work RVUs associated with this service, we solicited public comments on this issue, as well as suggested valuations of this service to reflect resources involved in furnishing the service. (For a summary of the comments received on the CY 2009 PFS final rule with comment period, see the CY 2010 PFS proposed rule (74 FR 33549)).
Based on a review of the comments received on the CY 2009 PFS final rule with comment period and upon further evaluation of the component services of the IPPE, we stated in the CY 2010 PFS proposed rule that we believe the services, in the context of work and intensity, contained in HCPCS code G0402 are most equivalent to those services contained in CPT code 99204,
The following is a summary of the comments we received regarding the proposed increase to the payment for the IPPE billed with HCPCS code G0402.
In the CY 2009 PFS final rule with comment period (73 FR 69890), we noted that the AMA RUC reviewed and recommended work RVUs for 6 audiology codes with which we agreed (that is, CPT codes 92620, 92621, 92625, 92626, 92627, and 92640). We also noted that in the Medicare program, audiology services are covered under the diagnostic test benefit and that some of the work descriptors for these services include “counseling,” “potential for remediation,” and “establishment of interventional goals.”
Since audiology services fall under the diagnostic test benefit, aspects of services that are therapeutic or management activities are not payable to audiologists. This distinction is of particular importance since CPT codes 92620, 92621, 92626, 92627, and 92640 are “timed” codes. These codes are billed based on the actual time spent furnishing the service.
We noted that we do not believe these aspects fit within the diagnostic test benefit. We solicited comments on this issue. For a summary of the comments received and our responses to those comments, see the CY 2010 PFS proposed rule (74 FR 33550).
The following is summary of the comments we received regarding the policy clarification of existing CPT codes for audiology services.
The current physician visit and consultation codes were developed by the American Medical Association (AMA) Current Procedural Terminology (CPT) Editorial Panel in November 1990. A consultation service is an evaluation and management (E/M) service furnished to evaluate and possibly treat a patient's problem(s). It can involve an opinion, advice, recommendation, suggestion, direction, or counsel from a physician or qualified NPP at the request of another physician or appropriate source. (See the Internet-Only Medicare Claims Processing Manual, Pub. 100–04, chapter 12, § 30.6.10 A for more information.) A consultation service must be documented and a written report given to the requesting professional. Currently, consultation services are predominantly billed by specialty physicians. Primary care physicians infrequently furnish these services.
The required documentation supports the accuracy and medical necessity of a consultation service that is requested and provided. Medicare pays for a consultation service when the request and report are documented as a consultation service, regardless of whether treatment is initiated during the consultation evaluation service. (See the Internet-Only Medicare Claims Processing Manual, Pub. 100–04, chapter 12, § 30.6.10 B.) A consultation request between professionals may be done orally by telephone, face-to-face, or by written prescription brought from one professional to another by the patient. The request must be documented in the medical record.
In the Physician Fee Schedule Final Rule issued June 5, 1991, (56 FR 25828) we stated that the agency's goal for the development of the new visit and consultation codes was that they meet two criteria: (1) They should be used reliably and consistently by all physicians and carriers; that is, the same service should be coded the same way by different physicians; and (2) they should be defined in a way that enables us to properly crosswalk the new codes to the relative values for the Harvard vignettes so valid RVUs for work are assigned to the new codes.
Based on requests from the physician community to clarify our consultation payment policy and to provide consultation examples, we convened an internal workgroup of medical officers within CMS (then called the Health Care Financing Administration, or HCFA) and revised the payment policy instructions in August 1999 in the Medicare Claims Processing Manual (at § 30.6.10 as cited above). We provided examples of consultation services and examples of clinical scenarios that did not satisfy Medicare criteria for consultation services. Without explicit instructions for every possible clinical scenario outlined in national policy
Additional manual revisions in both January and September 2001 (at § 30.6.10 as cited above) clarified that NPPs can both request and furnish consultation services within their scope of practice and licensure requirements. We continued to explain our documentation requirements to the physician community through our Medicare contractors and in our discussions with the AMA CPT staff. Under our current policy and in the AMA CPT definition, a consultation service must have a request from another physician or other professional and be followed by a report to the requesting professional. The AMA CPT definition does not state that the request must be written in the requesting physician's medical record. However, we require the request to be documented in the requesting physician's plan of care in the medical record as a condition for Medicare payment. The E/M documentation guidelines which apply to all E/M visits or consultations (
In March 2006, the Office of the Inspector General (OIG) published a report entitled, “Consultations in Medicare: Coding and Reimbursement” (OEI–09–02–00030). The stated purpose of the report was to assess whether Medicare's payments for consultation services were appropriate. While the OIG study was being conducted, we continued our ongoing discussions with the AMA CPT staff for potential changes to the consultation definition and guidance in CPT. The findings in the OIG report (based on claims paid by Medicare in 2001) indicated that Medicare allowed approximately $1.1 billion more in 2001 than it should have for services that were billed as consultations. Approximately 75 percent of services paid as consultations did not meet all applicable program requirements (per the Medicare instructions) resulting in improper payments. The majority of these errors (47 percent of the claims reviewed) were billed as the wrong type or level of consultation. The second most frequent error was for services that did not meet the definition of a consultation (19 percent of the claims reviewed). The third category of improperly paid claims was a lack of appropriate documentation (9 percent of the claims reviewed). The OIG recommended that CMS, through our Medicare contractors, should educate physicians and other health care practitioners about Medicare criteria and proper billing for all types and levels of consultations with emphasis on the highest levels and follow-up inpatient consultation services.
We agreed with the OIG findings that additional education would help physicians understand the differences in the requirements for a consultation service from those for other E/M services. With each additional revision from 1999 until the OIG study began, we continually educated physicians through the guidance provided by our Medicare contractors. However, there remained discrepancies with unclear and ambiguous terms and instructions in the AMA CPT definition of a consultation, transfer of care and documentation, and the feedback from the physician community that indicated they disagreed with Medicare guidance.
Prior to the official publication of the OIG report, we issued a Medlearn Matters article, effective January 2006, to educate the physician community about requirements and proper billing for all types and levels of consultation services as requested by the OIG in their report. The Medlearn Matters article reflected the manual changes we made in 2006 and the AMA CPT coding changes as noted below. (This article and related documents can be accessed at
Our consultation policy revisions continued as a work-in-progress over several years as disagreements were raised by the physician community. We continued to work with AMA CPT coding staff in an attempt to have improved guidance for consultation services in the CPT coding definition. In looking at physician claims data (for example, the low usage of confirmatory consultation services) and in response to concerns from the physician community regarding how to correctly use the follow-up consultation codes, the AMA CPT Editorial Panel chose to delete some of the consultation codes for 2006. The Follow-Up Inpatient Consultation codes (CPT codes 99261 through 99263) and the Confirmatory Consultation codes (CPT codes 99271 through 99275) were deleted. During our ongoing discussions, the AMA CPT staff maintained that physicians did not fully understand the use of these codes and historically submitted them inappropriately for payment as was reflected in the OIG study.
We issued a manual revision in the Medicare Claims Processing Manual (at § 30.6.10 as cited above) simultaneously with the publication of AMA CPT 2006
We continue to hear from the AMA and from specific national physician specialty representatives that physicians are dissatisfied with Medicare documentation requirements and guidance that distinguish a consultation service from other E/M services such as transfer of care. CPT has not clarified transfer of care. Many physician groups disagree with our requirements for documentation of transfer of care. Interpretation differs from one physician to another as to whether transfer of care should be reported as an initial E/M service or as a consultation service.
Despite our efforts, the physician community disagrees with Medicare interpretation and guidance for documentation of transfer of care and consultation. The existing consultation coding definition in the AMA CPT definition has been ambiguous and confusing for certain clinical scenarios and without a clear definition of transfer of care. The CPT consultation codes are used by physicians and qualified NPPs to identify their services for Medicare payment. There has been an absence of any guidance in the AMA CPT consultation coding definition that distinguishes a transfer of care service (when a new patient visit is billed) from a consultation service (when a consultation service is billed). Although Medicare has provided guidance, there has continued to be disagreement with our policy from AMA CPT staff and some members of the physician community. Because of the disparity between AMA coding guidance and Medicare policy, some physicians have stated that they have difficulty in choosing the appropriate code to bill. The payment for both inpatient consultation and office/outpatient consultation services is higher than for initial hospital care and new patient office/outpatient visits. However, the associated physician work is clinically similar. Many physicians contend that there is more work involved with a new patient visit than a consultation service because of the post work involvement with a new patient. The payment for a consultation service has been set higher than for initial visits because a written report must be made to the requesting professional. However, all medically necessary Medicare services require documentation in some form in a patient's medical record. Over the past several years, some physicians have asked CMS to recognize the provision of the consultation report via a different form of communication in lieu of a written letter report to the requesting physician so as to lessen any paperwork burden on physicians. We have eased the consultation reporting requirements by lessening the required level of formality and permitting the report to be made in any written form of communication, (including submission of a copy of the evaluation examination taken directly from the medical record and submitted without a letter format) as long as the identity of the physician who furnished the consultation is evident. Although preparation and submission of the consultant's report is no longer the major defining aspect of consultation services, the higher payment has remained. (See the Internet-Only Medicare Claims Processing Manual, Pub. 100–04, chapter 12, § 30.6.10 F.)
Both AMA CPT coding rules and Medicare Part B payment policy have always required that there is only one admitting physician of record for a particular patient in the hospital or nursing facility setting. (AMA CPT 2009, Hospital Inpatient Services, Initial Hospital Care, p.12) This physician has been the only one permitted to bill the initial hospital care codes or initial nursing facility codes. All other physicians must bill either the subsequent hospital care codes, subsequent nursing facility care codes or consultation codes. (See the Internet-Only Medicare Claims Processing Manual, Pub. 100–04, chapter 12, § 30.6.9.1 G.)
Beginning January 1, 2008, we ceased to recognize office/outpatient consultation CPT codes for payment of hospital outpatient visits (72 FR 66790 through 66795). Instead, we instructed hospitals to bill a new or established patient visit CPT code, as appropriate to the particular patient, for all hospital outpatient visits. Regardless of all of our efforts to educate physicians on Medicare guidance for documentation, transfer of care, and consultation policy, disagreement in the physician community prevails.
In the CY 2010 PFS proposed rule (74 FR 33551), we proposed, beginning January 1, 2010, to budget neutrally eliminate the use of all consultation codes (inpatient and office/outpatient codes for various places of service except for telehealth consultation G-codes) by increasing the work RVUs for new and established office visits, increasing the work RVUs for initial hospital and initial nursing facility visits, and incorporating the increased use of these visits into our PE and malpractice RVU calculations.
We noted that section 1834(m) of the Act includes “professional consultations” (including the initial inpatient consultation codes “as subsequently modified by the Secretary”) in the definition of telehealth services. We recognize that consultations furnished via telehealth can facilitate the provision of certain services and/or medical expertise that might not otherwise be available to a patient located at an originating site. Therefore, for CY 2010, we proposed to create HCPCS codes specific to the telehealth delivery of initial inpatient consultations. The purpose of these codes would be solely to preserve the ability for practitioners to provide and bill for initial inpatient consultations delivered via telehealth. These codes are intended for use by practitioners when furnishing services that meet Medicare requirements relating to coverage and payment for telehealth services. Practitioners would use these codes to submit claims to their Medicare contractors for payment of initial inpatient consultations provided via
We also stated that, if we create HCPCS G-codes specific to the telehealth delivery of initial inpatient consultations, then we would crosswalk the RVUs for these services from the RVUs for initial hospital care (as described by CPT codes 99221 through 99223). We believed this is appropriate because a physician or practitioner furnishing a telehealth service is paid an amount equal to the amount that would have been paid if the service had been furnished without the use of a telecommunication system. Since physicians and practitioners furnishing initial inpatient consultations in a face-to-face encounter to hospital inpatients must continue to utilize initial hospital care codes (as described by CPT codes 99221 through 99223), we believe it is appropriate to set the RVUs for the proposed inpatient telehealth consultation G-codes at the same level as for the initial hospital care codes.
We considered creating separate G-codes to enable practitioners to bill initial inpatient telehealth consultations when furnished to residents of SNFs and crosswalking the RVUs to initial nursing facility care (as described by CPT codes 99304 through 99306). For the sake of administrative simplicity, if we create HCPCS G-codes specific to the telehealth delivery of initial inpatient consultations, they will be defined in § 410.78 and in our manuals as appropriate for use to deliver care to beneficiaries in hospitals or skilled nursing facilities.
We stated in the CY 2010 PFS proposed rule that if we adopt this proposal, we would then make corresponding changes to our regulations at § 410.78 and § 414.65. In addition, we would add the definition of these codes to the CMS Internet-Only Medicare Benefit Policy Manual, Pub. 100–02, Chapter 15, Medicare Claims Processing Manual, Pub. 100–04, Chapter 12, Section 190.
Outside the context of telehealth services, physicians will bill an initial hospital care or initial nursing facility care code for their first visit during a patient's admission to the hospital or nursing facility in lieu of the consultation codes these physicians may have previously reported. The initial visit in a skilled nursing facility and nursing facility must be furnished by a physician except as otherwise permitted as specified in § 483.40(c)(4). In the nursing facility setting, an NPP who is enrolled in the Medicare program, and who is not employed by the facility, may perform the initial visit when the State law permits this. (See this exception in the Internet-Only Medicare Claims Processing Manual, Pub. 100–04, chapter 12, § 30.6.13 A). An NPP, who is enrolled in the Medicare program, is permitted to report the initial hospital care visit or new patient office visit, as appropriate, under current Medicare policy.
Because of an existing CPT coding rule and current Medicare payment policy regarding the admitting physician, we will create a modifier to identify the admitting physician of record for hospital inpatient and nursing facility admissions. For operational purposes, this modifier will distinguish the admitting physician of record who oversees the patient's care from other physicians who may be furnishing specialty care. The admitting physician of record will be required to append the specific modifier to the initial hospital care or initial nursing facility care code which will identify him or her as the admitting physician of record who is overseeing the patient's care. Subsequent care visits by all physicians and qualified NPPs will be reported as subsequent hospital care codes and subsequent nursing facility care codes.
We believe that the rationale for a differential payment for a consultation service is no longer supported because documentation requirements are now similar across all E/M services. To be consistent with OPPS policy, as noted above, we will pay only new and established office or other clinic visits under the PFS.
We proposed that this change would be implemented in a budget neutral manner, meaning it would not increase or decrease PFS expenditures. We proposed to make this change budget neutral for the work RVUs by increasing the work RVUs for new and established office visits by approximately 6 percent to reflect the elimination of the office consultation codes and the work RVUs for initial hospital and facility visits by approximately 2 percent to reflect the elimination of the facility consultation codes. We crosswalked the utilization for the office consultation codes into the office visits and the utilization of the hospital and facility consultation codes into the initial hospital and facility visits. We proposed that this change would be made budget neutral in the PE and malpractice RVU methodologies through the use of the new work RVUs and the crosswalked utilization.
We solicited comments on the proposal to eliminate payment for all consultation services codes under the PFS and to allow all physicians to bill, in lieu of a consultation service code, an initial hospital care visit or initial nursing facility care visit for their first visit during a patient's admission to the hospital or nursing facility. Additionally, we solicited comments on the proposal to create HCPCS G-codes to identify the telehealth delivery of initial inpatient consultations.
We received many comments on our proposal. MedPAC also commented on our proposal. The following is a summary of the comments we received regarding the discussion of the proposed changes to consultation services and our responses.
As we stated when we implemented the PFS in 1992, one of our goals for the development of new visit and consultation codes was that they should be used reliably and consistently by all physicians and carriers, that is, that the same service should be coded the same way by different physicians. In addition, as we discussed in the CY 2010 PFS proposed rule, we believe that the confusion and disagreement about the use of the consultation codes have produced a situation in which that goal is far from being met.
As we also discussed in the proposed rule, we believe that a good deal of this confusion and disagreement arises from the use of terms such as referral, transfer, and consultation which are used sometimes interchangeably and sometimes inconsistently, by physicians in clinical settings.
The divergent interpretations and uses of these terms have served to confuse the meaning of a consultation service, as some label a transfer as a referral while others label a consultation as a referral. Even with the new definition of “transfer of care,” we foresee many clinical situations in which two physicians may not agree as to whether the referral was for consultation or transfer of care, and it may be difficult to resolve the issue based upon the conflicting interpretations reflected in the two physicians' medical records.
For more information on the impact of the changes in this rule, see section XIII. of this final rule with comment period.
As we have noted above, we did not develop that crosswalk for purposes of providing any guidelines or principles for using the visit codes in place of the consultation codes that physicians have employed prior to the implementation of this proposal. Rather, the crosswalk was developed solely for purposes of making the requisite BN calculations. For purposes of coding specific cases, adoption of this proposal will essentially require physicians to cease submitting the consultation codes on their Medicare claims, and to employ the appropriate visit codes in their place. The determination of the appropriate visit code should be made solely on the basis of the existing rules and guidelines for the use of the relevant visit codes (for example, office visit or inpatient visit), without any reference to the guidelines that have been employed for the use of the consultation codes. The guidelines for use of the visit codes are well established and well understood. Therefore, we do not believe that it is necessary to provide any coding
In crosswalking the codes for purposes of making the requisite BN calculations, we employed the same estimating techniques that we normally employ in such calculations. In the absence of concrete data on certain factors in the calculation, we also employed standard assumptions that are appropriate in a system based on averages. For example, office consultation CPT code 99245 was employed to report consultations provided to new
With each additional revision from 1999 until the OIG study began, we made repeated efforts to educate physicians through the guidance provided by, and through, our Medicare contractors. However, there were continued discrepancies with unclear and ambiguous terms and instructions in the AMA CPT consultation coding definition, transfer of care and documentation, and the feedback from the physician community indicated they disagreed with Medicare guidance. Despite our best, these disagreements and misunderstandings among the physician community with Medicare interpretations and guidance relating to documentation of transfer of care and consultation have continued.
Coding.—The Secretary shall establish a uniform coding system for the coding of all physician services. The Secretary shall provide for an appropriate coding structure for visits and consultations. The Secretary may incorporate the use of time in the coding for visits and consultations. The Secretary, in establishing such coding system, shall consult with the Physician Payment Review Commission and other organizations representing physicians.
* * * reduced consultation documentation may not sufficiently meet the needs of the requesting physician, and thus not help achieve the goals and benefits of well-coordinated care. While CMS' proposed payment policy for consultation may be appropriate in the light of current practice, in the future, the agency may wish to consider whether to increase the requirements for consultations in order to better coordinate care and increase consultation payments commensurately.
Other commenters expressed similar concerns that the elimination of the consultation codes might financially discourage coordination of care and communication among physicians.
Specifically, beginning January 1, 2010, we will eliminate the use of all consultation codes (inpatient and office/outpatient codes for various places of service except for telehealth consultation G-codes) on a budget neutral basis by increasing the work RVUs for new and established office visits, increasing the work RVUs for initial hospital and initial nursing facility visits, and incorporating the increased use of these visits into our PE and malpractice RVU calculations.
Since section 1834(m) of the Act includes “professional consultations” (including the initial inpatient consultation codes “as subsequently modified by the Secretary”) in the definition of telehealth services, we will not eliminate the use of these codes in the telehealth context. Therefore, for CY 2010, we will create HCPCS codes specific to the telehealth delivery of initial inpatient consultations. Specifically, we are establishing the following HCPCS codes to describe initial inpatient consultations approved for telehealth:
• G0425,
• G0426,
• G0427,
The purpose of these codes is solely to preserve the ability for practitioners to provide and bill for initial inpatient consultations delivered via telehealth. These codes are intended for use by practitioners when furnishing services that meet Medicare requirements relating to coverage and payment for telehealth services. Practitioners will use these codes to submit claims to their Medicare contractors for payment of initial inpatient consultations provided via telehealth. The new HCPCS codes will be limited to the range of services included in the scope of the CPT codes for initial inpatient consultations, and the descriptions will limit the use of such services for telehealth. Utilization of these codes will allow us to provide payment for these services, as well as enable us to monitor whether the codes are used appropriately.
As we also stated in the CY 2010 PFS proposed rule, we will crosswalk the RVUs for these services from the RVUs for initial hospital care (as described by CPT codes 99221 through 99223). We believed this is appropriate because a physician or practitioner furnishing a telehealth service is paid an amount equal to the amount that would have been paid if the service had been furnished without the use of a telecommunication system. Since physicians and practitioners furnishing initial inpatient consultations in a face-to-face encounter to hospital inpatients must continue to utilize initial hospital care codes (as described by CPT codes 99221 through 99223), we believe it is appropriate to set the RVUs for the proposed inpatient telehealth consultation G-codes at the same level as for the initial hospital care codes. As we stated in the CY 2010 PFS proposed rule, we also will make corresponding changes to our regulations at § 410.78 and § 414.65. In addition, we will add the definition of these codes to the CMS Internet-Medicare Claims Processing Manual, Pub. 100–04, Chapter 12, Section 190.
Outside the context of telehealth services, physicians will bill an initial hospital care or initial nursing facility care code for their first visit during a patient's admission to the hospital or nursing facility in lieu of the consultation codes these physicians may have previously reported. The initial visit in a skilled nursing facility and nursing facility must be furnished by a physician except as otherwise permitted as specified in § 483.40(c)(4). In the nursing facility setting, an NPP who is enrolled in the Medicare program, and who is not employed by the facility, may perform the initial visit when the State law permits this. (See this exception in the Internet-Only Medicare Claims Processing Manual, Pub. 100–04, chapter 12, § 30.6.13 A). An NPP, who is enrolled in the Medicare program is permitted to report the initial hospital care visit or new patient office visit, as appropriate, under current Medicare policy. Because of an existing CPT coding rule and current Medicare payment policy regarding the admitting physician, we will create a modifier to identify the admitting physician of record for hospital inpatient and nursing facility admissions. For operational purposes, this modifier will distinguish the admitting physician of record who oversees the patient's care from other physicians who may be furnishing specialty care. The admitting physician of record will be required to append the specific modifier to the initial hospital care or initial nursing facility care code which will identify him or her as the admitting physician of record who is overseeing the patient's care. Subsequent care visits by all physicians and qualified NPPs will be reported as subsequent hospital care codes and subsequent nursing facility care codes.
As proposed, this change will be implemented in a budget neutral manner, meaning that it will not increase or decrease aggregate PFS expenditures. We will make this change budget neutral for the work RVUs by increasing the work RVUs for new and established office visits by approximately 6 percent to reflect the elimination of the office consultation codes and the work RVUs for initial hospital and facility visits by approximately 0.3 percent to reflect the elimination of the facility consultation codes. As discussed above, in this final rule we are also increasing the incremental work RVUs for the E/M codes that are built into the 10-day and 90-day global surgical codes. As we did for the CY 2010 PFS proposed rule, we have crosswalked the utilization for the office consultation codes into the office visits and the utilization of the hospital and facility consultation codes into the initial hospital and facility visits. And, as we proposed, this change will be made budget neutral in the PE and malpractice RVU methodologies through the use of the new work RVUs and the crosswalked utilization.
As explained in the CY 2010 PFS proposed rule (74 FR 33554), the American Medical Association's (AMA) Relative Value System Update Committee (RUC) provides recommendations to CMS for the valuation of new and revised codes, as well as codes identified as misvalued. On an ongoing basis, the AMA RUC's Practice Expense (PE) Subcommittee reviews direct PE (clinical staff, medical supplies, medical equipment) for individual services and examines the many broad and methodological issues relating to the development of PE relative value units (RVUs).
To address concerns expressed by stakeholders with regard to the process we use to price services paid under the PFS, the AMA RUC created the Five-Year Review Identification Workgroup. As we stated in the CY 2009 PFS proposed rule (73 FR 38582), the workgroup identified some potentially misvalued codes through several vehicles. It focused on codes for which there have been shifts in the site of service (site of service anomalies), codes with a high intra-service work per unit of time (IWPUT), high volume codes, new technology designation, and shifts from practice expense to work. We also identified other methods that the AMA RUC could undertake to assist in identifying potentially misvalued services including reviewing the fastest growing procedures, Harvard-valued codes, and practice expense RVUs. There were 204 potentially misvalued services identified in 2008.
We believe that there are additional steps we can take to address the issue of potentially misvalued services. In the CY 2009 PFS proposed rule, we identified approaches to address this issue including reviewing services often billed together and the possibility of expanding the multiple procedure payment reduction (MPPR) to additional nonsurgical procedures and the update of high cost supplies.
We also share some the concerns expressed by the commenter with regards to IWPUT, which is a
In the CY 2010 PFS proposed rule (74 33554), we referenced our CY 2009 PFS proposal concerning updating prices for high cost supplies (73 FR 38582) and (73 FR 69882), and stated that we are continuing to examine alternatives on the best way to obtain accurate pricing information and will propose a revised process in future rulemaking.
The following is a summary of the comments received to date regarding high cost supplies and our response.
Commenters were in agreement that we must ensure accurate pricing of supplies, as the cost of supplies plays an important role in the payment calculation for services under the PFS.
Commenters also offered the following suggestions for pricing high cost supplies including:
• Identify high cost disposable supplies (that is, over $200) with separate HCPCS codes;
• Use the supply pricing methodology used by the Veterans Administration;
• Work with specialty societies to obtain invoices for high priced items from a designated group of physicians that are geographically representative; and
• Work with the industry or physicians directly to get current pricing information.
MedPAC stated it is important for us to update the prices of higher priced supplies on a regular basis as inaccurate prices can distort PE RVUs over time. MedPAC believes that prices drop over time as items diffuse through the market and as other companies begin to produce them, and encouraged us to regularly update information.
A few commenters also recommended that any pricing proposal should be available for public comment through future rulemaking, possibly on an annual basis. This would enable stakeholders to evaluate and provide feedback to the agency on pricing accuracy as well as practical availability of the item itself.
In the CY 2009 PFS final rule with comment period (73 FR 69882), we stated that we planned to perform a data analysis of nonsurgical CPT codes that are often billed together. We stated that we would identify whether there are inequities in PFS payments that are a result of variations between services in the comprehensiveness of the codes used to report the services or in the payment policies applied to each (for example, global surgery and MPPRs). The rationale for the MPPR is that certain clinical labor activities, supplies, and equipment are not performed or furnished twice when multiple procedures are performed. The MPPR currently applies to certain diagnostic and surgical procedures (73 FR 38586). We stated that we would consider developing a proposal either to bundle more services or expand application of the MPPR to additional procedures. Additionally, the Medicare Payment Advisory Committee (MedPAC) requested that we consider duplicative physician work and PE in any expansion of the MPPR.
In the CY 2010 PFS proposed rule (74 FR 33554), we stated that we planned to analyze codes furnished together more than 75 percent of the time, excluding E/M codes. We also stated that we planned to analyze both physician work and PE inputs. If duplications are found, we said that we would consider whether to propose to implement an MPPR or to bundle the services involved. We stated that we would propose any changes through future rulemaking.
A few commenters generally supported the analysis of codes furnished together more than 75 percent of the time. One commenter stated that almost all imaging procedures and equipment have become more efficient in recent years allowing more procedures in a given time.
Most commenters were in agreement that this policy should not be expanded until CMS has additional data and there is an opportunity for public comment through future rulemaking.
In the CY 2009 PFS final rule with comment period (73 FR 69883), we said that although we would accept the AMA RUC valuation for these site of service anomaly codes for 2009, we indicated that we had concerns about the methodology used by the AMA RUC to review these services because they may have resulted in removal of hospital days and deletion or reallocation of office visits without extraction of the associated RVUs from the valuation of the code. We also stated that we would continue to examine these codes and would consider whether it would be appropriate to propose additional changes in future rulemaking.
In the CY 2010 PFS proposed rule (74 FR 33554), we proposed work RVU changes to several of the codes where the valuation had been adjusted to
In addition to the proposed revisions to the AMA RUC-recommended RVUs, we encouraged the AMA RUC to utilize the building block methodology as described in the CY 2007 PFS proposed rule (71 FR 37172) in the future when revaluing codes with site of service anomalies. We recognized that the AMA RUC looks at families of codes and may assign RVUs based on a particular code ranking within the family. However, we stated that we believed that the relative value scale requires each service to be valued based on the resources used in furnishing the service.
We also sought public comment on alternative methodologies that could be used to establish work RVUs for codes that would have a negative valuation under the methodology we utilized to develop proposed revisions to the AMA RUC-recommended values described above.
The following is summary of the comments we received regarding the proposed revisions to the codes with site of service anomalies.
Services that are performed in the hospital outpatient setting and require a stay of less than 24 hours are considered outpatient services. We received recommendations from the AMA RUC for inclusion of inpatient services for services that are typically performed in an outpatient setting.
In the 2010 PFS proposed rule (74 FR 33556), we stated that we believed the use of E/M codes for services rendered in the post-service period for procedures requiring less than a 24-hour hospital stay would result in overpayment for pre- and post-service work that would not be provided. Therefore, we stated that we would not allow an additional 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.
The following is summary of the comments we received regarding the proposed revisions to the “23-Hour” stay.
We are addressing the AMA RUC's recommendations from the February and April 2009 meetings for potentially misvalued codes in this final rule with comment period in a manner consistent with the way we address other AMA RUC recommendations. Specifically, we completed our own review of the AMA RUC recommendations and we describe the AMA RUC's recommendations, indicate whether or not we accept them, and provide a rationale for our decision in this final rule with comment period. The values for these services are interim values for the next calendar year.
The AMA RUC continued its review of potentially misvalued codes using various screens, including codes with site of anomalies, high IWPUT, high volume, fastest growing procedures, and other CMS requests. For CY 2010, the AMA RUC submitted recommendations for 113 codes. Of those codes 1 was recommended for a reduction in valuation; 7 were recommended for an increase in valuation; 11 were recommended to maintain the same valuation; 45 were referred to CPT for further code clarification, 33 were recommended for PE changes and 16 were recommended for clinical labor revisions.
We have agreed to accept the valuation for these codes for CY 2010 as interim, including the conforming changes to the PE inputs for these codes, as applicable with the exception of CPT 92597,
We continue to have concerns about the methodology used by the AMA RUC to review services with site of service anomalies. We request that the AMA RUC utilize the building block methodology to revalue these services.
The AMA RUC also recommended that we review claims data for CPT codes 76970,
Previously, the AMA RUC recommended that an arthoscopic procedure (CPT code 29870,
In MedPAC's March 2006 Report to Congress, MedPAC made a number of recommendations to improve the review of the relative values for PFS services. Since that time, we have taken significant actions to improve the accuracy of the RVUs. As MedPAC noted in its recent March 2009 Report to Congress, “CMS and the AMA RUC have taken several steps to improve the review process” in the intervening years since those initial recommendations. Many of our efforts to improve the accuracy of RVUs have also resulted in substantial increases in the payments for primary care services.
The original March 2006 recommendation was summarized in the March 2008 Report to Congress:
We also recommended that CMS establish a group of experts, separate from the AMA RUC, to help the agency conduct these and other activities. This recommendation was intended not to supplant the AMA RUC but to augment it. To that end, the panel should include members who do not directly benefit from changes to Medicare's payment rates, such as experts in medical economics and technology diffusion and physicians who are employed by managed care organizations and academic medical centers.
The idea of a group of experts separate from the AMA RUC, to help the agency improve the review of relative values, raises a number of issues. In the proposed rule, we solicited input on specific points concerning the creation of such a group, including:
• How could input from a group of experts best be incorporated into existing processes of rulemaking and agency receipt of AMA RUC recommendations?
• What specifically would be the roles of a group of experts (for example, identify potentially misvalued services, provide recommendations on valuation of specified services, review AMA RUC recommendations selected by the Secretary, etc.)?
• What should be the composition of a group of experts? How could such a group provide expertise on services that clinician group members do not furnish?
• How would such a group relate to the AMA RUC and existing Secretarial advisory panels such as the Practicing Physician Advisory Committee?
We also requested comments on the resources required to establish and maintain such a group. We stated that we would consider these comments as we consider the establishment of a group of experts to assist us in our ongoing reviews of the PFS RVUs.
Some commenters expressed support of such a panel. The commenters offered suggestions concerning its establishment and operations. The commenters stated that adequate resources and funding would be needed. The commenters viewed the panel as a vehicle to independently assess the AMA RUC recommendations. Several commenters stressed the importance of including consumers or purchasing representatives on such a panel and that the current process is too narrowly focused on resource costs. Commenters stated there is a need to restructure the payment system so that it appropriately values coordinated care delivery, encourages appropriate use of services, and rewards value and not volume.
Other commenters opposed creation of such a panel. The commenters stated that the current process has been successful, is transparent, and the rulemaking process provides additional oversight of the AMA RUC's recommendations. The commenters also stated that the AMA RUC has the technical knowledge and objective judgment to assist CMS in maintenance of the RVUs and that a superimposed panel would lack its insight. Commenters also stated that the addition of a separate group would increase demands on CMS; create coordination problems; and would be fiscally unsound and imprudent. Commenters noted that CMS and the AMA RUC have made strides in the misvalued codes initiative. Some of the commenters suggested that we consider enhancing the existing refinement panel process used to address the comments received on interim work RVUs (see section III for additional information on this process). Some commenters expressed concern that the refinement panels have not been adequately developed and that there is a lack of transparency.
MedPAC stated there are valid reasons that a panel should be established. It stated that CMS needs a regular source of expertise available to assist in valuing services and that such expertise is not solely the domain of the AMA RUC.
We also appreciate the comments raised concerning the existing refinement panel process. Any revisions to this process would be discussed in future rulemaking.
This section addresses certain provisions of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110–275). We proposed to revise our policies and regulations as described below in order to conform them to the statutory amendments.
Prior to the enactment of the MIPPA, section 1833(c) of the Act provided that for expenses incurred in any calendar year in connection with the treatment of mental, psychoneurotic, and personality disorders of an individual who is not an inpatient of a hospital, only 62½ percent of such expenses are considered to be incurred under Medicare Part B when determining the amount of payment and application of the Part B deductible in any calendar year. This provision is known as the outpatient mental health treatment limitation (the limitation), and has resulted in Medicare paying only 50 percent of the approved amount for outpatient mental health treatment, rather than the 80 percent that is paid for most other outpatient services.
Section 102 of the MIPPA amends the statute to phase out the limitation on recognition of expenses incurred for outpatient mental health treatment, which will result in an increase in the Medicare Part B payment for outpatient mental health services to 80 percent by CY 2014. When this section is fully implemented in 2014, Medicare will pay for outpatient mental health services at the same level as other Part B services. For CY 2010, section 102 of the MIPPA provides that Medicare will recognize 68¾ percent of expenses incurred for outpatient mental health treatment, which translates to a payment of 55 percent of the Medicare-approved amount. Section 102 of the MIPPA specifies that the phase out of the limitation will be implemented as shown in Table 6 provided that the patient has satisfied his or her deductible.
At present, § 410.155(c) of the regulations includes examples to illustrate application of the current limitation. We proposed to remove these examples from the regulations and, instead, provided examples in the CY 2010 PFS proposed rule (74 FR 33521), in our manual, and under provider education materials as needed. (See the CY 2010 PFS proposed rule (74 FR 33557) for the examples illustrating the application of the limitation in various circumstances as it is gradually reduced under section 102 of the MIPPA.) Section 102 of the MIPPA did not make any other changes to the outpatient mental health treatment limitation. Therefore, other aspects of the limitation will remain unchanged during the transition period between CYs 2010 and 2014. The limitation will continue to be applied as it has been in accordance with our regulation at § 410.155(b) which specifies that the limitation applies to outpatient treatment of a mental, psychoneurotic, or personality disorder, identified under the International Classification of Diseases (ICD) diagnosis code range 290–319. We use this ICD diagnosis code range, place of service code, and the procedure code to identify services to which the limitation applies.
Additionally, we proposed to make technical corrections to § 410.155(b)(2) in order to update and clarify the services already under these regulations to which the limitation does not apply. We proposed the following technical changes:
• Under § 410.155(b)(2)(ii), revise the regulation to specify the HCPCS code, M0064 (or any successor code), that represents the statutory exception to the limitation for brief office visits for the sole purpose of monitoring or changing drug prescriptions used in mental health treatment.
• At § 410.155(b)(2)(iv), we proposed to revise the regulation to add neuropsychological tests and diagnostic psychological tests to the examples of diagnostic services that are not subject to the limitation when performed to establish a diagnosis.
• Under § 410.155(b)(2)(v), we proposed to revise the regulation to specify the CPT code 90862 (or any successor code) that represents pharmacologic management services to which the limitation does not apply when furnished to treat a patient who is diagnosed with Alzheimer's disease or a related disorder.
Finally, we proposed to add a new paragraph (c) to § 410.155 that provides a basic formula for computing the limitation during the phase-out period from CY 2010 through CY 2013, as well as after the limitation is fully removed from CY 2014 onward.
The following is a summary of the comments we received regarding the proposed implementation of section 102 of the MIPPA.
On this particular technical correction, another commenter suggested that we should consider including a definition of “diagnostic services” to provide further guidance to the field on this issue.
The other technical correction that the commenter opposed is the provision under § 410.155(b)(2)(v) that lists medical management services billed under CPT code 90862 (or its successor code), as opposed to psychotherapy, as not being subject to the limitation when furnished to treat a patient who is diagnosed with Alzheimer's disease or a related disorder. The commenter believes that medical management services are not limited to those billed under CPT code 90862, but also
One commenter who supports our implementation of the MIPPA provision commented that it is appropriate to update the list of services to which the limitation does not apply by specifying HCPCS code M0064, neuropsychological tests and diagnostic psychological tests, as well as CPT code 90862 when reporting services provided to a patient with Alzheimer's disease or a related disorder.
However, we believe that if we revise the wording under § 410.155(b)(2)(iv) to specify that
We agree with the commenter that our technical correction to § 410.155(b)(2)(v) might have been read to restrict application of the exception to CPT code 90862. We will refrain from addressing specifically in the regulation outpatient E/M codes or nursing facility E/M codes. Rather, we will continue to leave in the hands of our contractors decisions as to whether the exception applies for these codes under particular circumstances. We have provided policy guidance to our contractors that medical management services furnished under CPT code 90862 to treat a patient diagnosed with Alzheimer's disease or a related disorder are not subject to the limitation. Therefore, we believe it is consistent with current national policy to amend the regulatory exception under § 410.155(b)(2)(v) to read, “medical management such as that furnished under CPT code 90862 (or its successor code), as opposed to psychotherapy, furnished to a patient diagnosed with Alzheimer's disease or a related disorder.”
We received comments on issues that are outside the scope of our proposals for section 102 of MIPPA. These comments are not addressed in this final rule with comment.
The Physician Quality Reporting Initiative (PQRI) is a voluntary reporting program that provides an incentive payment to eligible professionals who satisfactorily report data on quality measures for covered professional services during a specified reporting period. Under section 1848(k)(3)(B) of the Act, the term “eligible professional” means any of the following a: (1) physician; (2) practitioner described in section 1842(b)(18)(C); (3) physical or occupational therapist or a qualified speech-language pathologist; or (4) 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, and 2009, are discussed in detail in the CY 2008 PFS proposed rule (72 FR 38196 through 38204), CY 2008 PFS final rule with comment period (72 FR 66336 through 66353), CY 2009 PFS proposed rule (73 FR 38558 through 38575), and CY 2009 PFS final rule with comment period (73 FR 69817 through 69847). In addition, detailed information about the PQRI is available on the CMS Web site at
We received several comments from the public on the CY 2010 PFS proposed rule related to the PQRI. General comments about the PQRI are addressed immediately below.
With respect to the commenters' suggestion to provide PQRI incentive payments to eligible professionals who participate in an ABMS MOC program and complete a qualified MOC practice assessment, section 1848(m)(3)(A) of the Act dictates the criteria that eligible professionals must meet in order to be treated as satisfactorily submitting data on quality measures. These criteria include the reporting, by eligible professionals, of quality data on a standardized set of national consensus-based measures. For years after 2009, section 1848(m)(3)(D) of the Act gives us the discretion to revise the criteria for satisfactorily submitting data on quality measures. The proposed criteria for 2010, which did not explicitly include the option suggested by the commenters, were discussed in the CY 2010 PFS proposed rule (74 FR 33565 through 33569). We believe that basing criteria for satisfactory reporting solely on participation in an ABMS MOC and completion of a qualified MOC practice assessment without the submission of PQRI measures results would defeat the ability of CMS to analyze and compare eligible professional performance based on a standardized set of measures. PQRI is not based upon such qualifications, but rather on the submission of data on quality measures to measure eligible professional performance.
However, to the extent that ABMS member certification boards collect information on PQRI quality measures from eligible professionals, the ABMS member boards may qualify as registries under the PQRI and report such information to CMS on behalf of eligible professionals. Currently, one of the ABMS member boards has qualified as a CMS PQRI registry and successfully submitted data on PQRI measures on behalf of eligible professionals. This would allow eligible professionals to concurrently participate in an ABMS MOC and PQRI.
• Publish a list of professions that have participated in PQRI.
• Communicate potential incentive amounts that could be earned by an individual participant.
• Work with the AMA and other national stakeholder organizations to increase education and outreach for professionals about the requirements for satisfactorily reporting under various options.
• Use provider-neutral language, such as “clinician” or “provider” in describing the array of eligible professionals.
We also plan to continue to host monthly national provider calls in which we expect to provide guidance on specific topics, including having our PQRI subject matter experts available to answer questions on the PQRI. Information about upcoming calls can be obtained from the CMS Sponsored Calls page of the PQRI section of the CMS Web site at
Finally, we anticipate conducting and publishing an evaluation of the 2008 PQRI similar to the “PQRI 2007 Reporting Experience” posted on the PQRI section of the CMS Web site at
As discussed below, to assist eligible professionals who may need additional time to make updates to their electronic systems or practice workflows, we also are finalizing a 6-month reporting period beginning July 1, 2010, for claims-based reporting of individual measures. Thus, the 6-month reporting period will be available for both those who wish to report individual measures, as well as measures groups through claims or a qualified registry.
We have assessed the feasibility of providing some type of interim feedback report to participants. We have determined, however, detailed, accurate, participant-level interim feedback reports cannot be provided in an appropriately secure access environment. However, given that the most prevalent underlying reasons for failure to meet incentive eligibility are due to (1) failure by the professional to identify and report on at least 80 percent of denominator-eligible cases for the measures selected, and (2) quality data code errors due to incorrect or insufficient coding, we have determined that an aggregate-level quality data submission error report could be published on a quarterly basis on the PQRI section of the CMS Web site, to provide information on the types of submission errors found for each measure. Following the posting of the “PQRI 2007 Reporting Experience” report, we have continued to post updated error reports on a quarterly basis on the PQRI section of the CMS Web site at
In addition, many registries provide interim feedback to their clients. Therefore, eligible professionals who participate in PQRI through a qualified registry may be able to receive interim feedback from the registry and have the opportunity to correct those errors prior to the program year data submission deadline.
For registry reporting, however, we note that many registries offer additional services beyond what is required to participate in PQRI. In the example provided by commenters, it is not clear whether those costs that are not related to reporting PQRI quality measure results and numerator and denominator data on PQRI measures have been taken into consideration and excluded. Our impact analysis is limited to the incremental cost of participating in PQRI.
For 2010, section 1848(m)(1)(B) of the Act authorizes the Secretary to provide an incentive payment equal to 2.0 percent of the estimated total 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 reporting period for 2010. Although PQRI incentive payments are only authorized through 2010 under section 1848(m)(1)(A) of the Act, section 1848(k)(2)(C) of the Act provides for the use of consensus-based quality measures for the PQRI for 2010 and subsequent years.
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 eligible professional, other Part B services and items that may be billed by eligible professionals but are not paid under or based upon the Medicare Part B PFS are not included in the calculation of the incentive payment amount.
Under section 1848(m)(6)(C) of the Act, the “reporting period” for the 2008 through 2011 PQRI 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.”
We are also required by section 1848(m)(5)(F) of the Act to establish alternative criteria for satisfactorily reporting and alternative reporting periods for registry-based reporting and for reporting measures groups. Therefore, eligible professionals who meet the alternative criteria for satisfactorily reporting for registry-based reporting and for reporting measures groups for the 2010 alternative reporting periods for registry-based reporting and for reporting measures groups will also be eligible to earn an incentive payment equal to 2.0 percent of the estimated total Medicare Part B PFS allowed charges for all covered professional services furnished by the eligible professional during the alternative reporting periods for 2010 PQRI registry-based reporting or for reporting measures groups.
Prior to 2010, the PQRI was an incentive program in which determination of whether an eligible professional satisfactorily reported quality data was made only at the individual professional level, based on the NPI. Although the incentive payments were made to the practice(s) represented by the Tax Identification Number (TIN) to which payments are made for the individual professional's services, there were no incentive payments made to the group practice based on a determination that the group practice, as a whole, satisfactorily reported PQRI quality measures data. To the extent individuals (based on the individuals' NPIs) satisfactorily reported data on PQRI quality measures that were associated with more than one practice or TIN, the determination of whether an eligible professional satisfactorily reported PQRI quality measures data was made for each unique TIN/NPI combination. Therefore, the incentive payment amount was calculated for each unique TIN/NPI combination and payment was made to the holder of the applicable TIN.
However, section 1848(m)(3)(C)(i) of the Act requires that by January 1, 2010, the Secretary establish and have in place a process under which eligible professionals in a group practice (as defined by the Secretary) shall be treated as satisfactorily submitting data on quality measures for the PQRI for covered professional services for a reporting period, if, in lieu of reporting measures under subsection (k)(2)(C), the group practice reports measures determined appropriate by the Secretary, such as measures that target high-cost chronic conditions and preventive care, in a form and manner, and at a time, specified by the Secretary. Therefore, beginning with the 2010 PQRI, group practices that satisfactorily submit data on quality measures also would be eligible to earn an incentive payment equal to 2.0 percent of the estimated total Medicare Part B PFS allowed charges for all covered professional services furnished by the group practice during the applicable reporting period. As required by section 1848(m)(3)(C)(iii) of the Act, payments to a group practice by reason of the process described above would be in lieu of the PQRI incentive payments that would otherwise be made to eligible professionals in the group practice for satisfactorily submitting data on quality measures. Therefore, an individual eligible professional who is participating in the group practice reporting option as a member of a group practice would not be able to separately earn a PQRI incentive payment as an individual eligible professional under that same TIN (that is, for the same TIN/NPI combination).
The following is summary of the comments we received regarding the 2010 PQRI incentive payment amount.
The relevant radiopharmaceutical codes are paid on the basis of invoices submitted by physicians. Such invoices are considered similar to contractor priced items or services. In addition, radiopharmaceuticals are classified as A codes (A9500–A9699) which inadvertently have not previously been included in Addendum B. Commencing with CY 2010, radiopharmaceuticals will be included in Addendum B as MPFSDB covered charges.
Furthermore, FAQ 8545, which can be accessed via the PQRI section of the CMS Web site, states that for “PQRI participants who report satisfactorily, radiopharmaceuticals furnished as part of a covered professional service will be included in the basis of total Medicare Part B PFS allowed charges on which the incentive is calculated.”
No changes in radiopharmaceutical payment will be necessary. Payment will continue to be contractor-priced on the basis of invoices under the physician fee schedule.
As we indicated above, section 1848(m)(6)(C) of the Act defines “reporting period” for 2010 to be the entire year. Section 1848(m)(6)(C)(ii) of the Act, however, authorizes the Secretary 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. In addition, section 1848(m)(5)(F) of the Act requires, for 2008 and subsequent years, the Secretary to establish alternative reporting periods for reporting groups of measures and for registry-based reporting.
In the CY 2010 PFS proposed rule (74 FR 33560), we proposed that the 2010 PQRI reporting period for the reporting of individual PQRI quality measures through claims or a qualified EHR would be the entire year (that is, January 1, 2010 through December 31, 2010). We also proposed to retain the 2 alternative reporting periods from the 2008 and 2009 PQRI for reporting measures groups and for registry-based reporting: (1) the entire year; and (2) a 6-month reporting period beginning July 1.
We solicited comments on these proposals and the decision not to propose a 6-month reporting period for claims-based reporting of individual PQRI quality measures. The following is a summary of the comments received regarding the proposed reporting periods.
Some commenters also requested that we have a 6-month reporting period for claims-based reporting of individual measures for situations in which an eligible professional who was planning to report through an alternative reporting mechanism may have to revert to claims-based reporting during the year, such as when an eligible professional's EHR system requires re-installation or significant maintenance or upgrades or when it takes longer for a practice to acquire a new EHR system than anticipated.
However, as a result of the compelling arguments presented by commenters, we will exercise our authority under section 1848(m)(6)(C)(ii) of the Act to revise the reporting period for the 2010 PQRI. Thus, in addition to the 12-month reporting period beginning January 1, 2010, we are finalizing a 6-month reporting period beginning July 1, 2010, available for claims-based reporting of individual measures for the 2010 PQRI.
For the reasons discussed above and based on the comments, for 2010, we will retain a 12-month reporting period beginning January 1, 2010, which will be available for all reporting mechanisms and regardless of whether an individual eligible professional chooses to report on 2010 PQRI individual measures or measures groups. In addition, we are adopting a 6-month reporting beginning July 1, 2010, for claims-based and registry-based reporting of 2010 PQRI individual measures or measures groups. This 6-month reporting period will not be available for EHR-based reporting in 2010. Once we have additional experience with EHR reporting in PQRI we may consider including a 6-month reporting period for EHR reporting in future years.
In addition, an eligible professional who satisfactorily reports 2010 PQRI measures or measures groups through claims or a qualified registry for the 6-month reporting period will qualify to earn a PQRI incentive payment equal to 2.0 percent of his or her total estimated Medicare Part B PFS allowed charges for covered professional services furnished between July 1, 2010 and December 31, 2010 only. As required by section 1848(m)(1)(A) of the Act, the incentive payment will be calculated based on the eligible professional's charges for covered professional services furnished during the applicable reporting period only.
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, the only way that eligible professionals could submit data on PQRI quality measures was by reporting the appropriate quality data codes on their Medicare Part B claims (claims-based reporting). For the 2008 PQRI, we added a second reporting mechanism as required by section 1848(k)(4) of the Act, so that eligible professionals could 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 on their behalf (registry-based reporting). 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.
To promote the adoption of EHRs, we also conducted limited testing of a third reporting mechanism for the 2008 and 2009 PQRI, which was the submission of clinical quality data extracted from an EHR, or the EHR-based reporting mechanism. No incentive payment was available to those eligible professionals who participated in testing the EHR-based reporting mechanism.
For the 2010 PQRI, we proposed to retain the claims-based reporting mechanism and the registry-based reporting mechanism. In addition, we proposed to accept PQRI quality measure data extracted from a qualified EHR product (that is, an EHR successfully completing the 2009 EHR Testing Program) for a limited subset of the proposed 2010 PQRI quality measures, as identified in Table 20 of the CY 2010 PFS proposed rule, 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 is practical and feasible. We solicited comments on the proposed reporting mechanisms for the 2010 PQRI, including the proposal to add an EHR-based reporting mechanism to the 2010 PQRI, contingent upon the successful completion of our 2009 EHR data submission testing process and a determination that accepting data from EHRs on quality measures for the 2010 PQRI is practical and feasible.
We also discussed in the CY 2010 PFS proposed rule how we may consider significantly limiting the claims-based mechanism of reporting clinical quality measures for the PQRI after 2010. We solicited comments on our intent to lessen our reliance on the claims-based reporting mechanism for the PQRI beyond 2010.
The following is a summary of the comments received with regard to the proposed 2010 PQRI reporting mechanisms and our intent to lessen reliance on the claims-based reporting mechanism for the PQRI beyond 2010.
For the reasons discussed above and based on the comments received, as well as our experience with the EHR testing process to date, we are finalizing the option for an eligible professional to be able to choose to report data on 2010 PQRI quality measures through claims, through a qualified registry, or through a qualified EHR product (contingent on there being a qualified 2010 EHR product). Depending on which PQRI individual quality measures or measures groups an eligible professional selects, however, one or more of the 2010 reporting mechanisms may not be available for reporting a particular 2010 PQRI individual quality measure or measures group. The 2010 reporting mechanism(s) through which each 2010 PQRI individual quality measure and measures group can be reported is identified in Tables 11 through 27 of this final rule with comment period.
Regardless of the reporting mechanism chosen by an eligible professional, there is no requirement for the eligible professional 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 criteria for satisfactory reporting of individual measures and measures groups described in sections II.G.2.e. and II.G.2.f. of this final rule with comment period, eligible professionals must ensure that they meet all requirements for their chosen reporting mechanism as described in sections II.G.2.d.1. through II.G.2.d.3. of this final rule.
For eligible professionals who choose to participate in the 2010 PQRI by submitting data on individual quality measures or measures groups through the claims-based reporting mechanism, we proposed that the eligible professional would be required to submit the appropriate PQRI quality data codes on the professionals' Medicare Part B claims. As in previous years, an eligible professional would be permitted to start submitting the quality data codes for the eligible professional's selected individual PQRI quality measures or measures group at any time during 2010. Please note, however, that as required by section 1848(m)(1)(A) of the Act, all claims for services furnished between January 1, 2010 and December 31, 2010, would need to be processed by no later than February 28, 2011, to be included in the 2010 PQRI analysis.
We did not receive any comments specific to the requirements for individual eligible professionals who choose claims-based reporting. Therefore, we are finalizing the requirements as proposed. Eligible professionals should refer to the “2010 PQRI Implementation Guide” to facilitate satisfactory reporting of quality data codes for 2010 PQRI individual measures on claims and to the “Getting Started with 2010 PQRI Reporting of Measures Groups” to facilitate satisfactory reporting of quality data codes for 2010 PQRI measures groups on claims. By no later than December 31, 2009, both of these documents will be posted on the PQRI section of the CMS Web site at
In order to report quality measures results and numerator and denominator data on the 2010 PQRI individual quality measures or measures group through a qualified clinical registry, we
To maintain compliance with applicable statutes and regulations, our program and its data system must maintain compliance with the HIPAA requirements for requesting, processing, storing, and transmitting data. Eligible professionals that conduct HIPAA covered transactions also would need to maintain compliance with the HIPAA requirements.
We proposed that eligible professionals choosing to participate in PQRI by submitting quality measures results and numerator and denominator data on PQRI individual quality measures or measures groups through the registry-based reporting mechanism for 2010 would be required 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 (74 FR 33562).
In addition to meeting the above proposed requirements specific to registry-based reporting, we proposed that eligible professionals 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 eligible professionals must meet in order to qualify to earn a 2010 PQRI incentive payment (74 FR 33563).
The following is a summary of the comments we received regarding the proposed requirements for individual eligible professionals who choose the registry-based reporting mechanism for the 2010 PQRI.
As a result of the comments, we are finalizing the requirements for individual eligible professionals who choose the registry-based reporting mechanism as proposed (74 FR 33562 through 33563) and discussed above.
We will post on the PQRI section of the CMS Web site at
In the first phase, we will post, by December 31, 2009, a list of those registries qualified for the 2010 PQRI based on: (1) Being a qualified registry for the 2008 and 2009 PQRI that successfully submitted 2008 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 2010; and (3) the registry's compliance with the 2010 PQRI registry requirements. By posting this first list of qualified registries for the 2010 PQRI, we seek to make available the names of registries that can be qualified at the start of the 2010 reporting period.
In the second phase, we will complete posting of the list of qualified 2010 registries as soon as we have completed vetting the additional registries interested in participating in the 2010 PQRI and identified the qualified registries for the 2010 PQRI, which we anticipate will be completed by no later than Summer 2010. An eligible professional's ability to report PQRI quality measures results 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 2010 PQRI being made available after the start of the reporting period. First, registries will not begin submitting eligible professionals' PQRI quality measures results and numerator and denominator data on the quality measures or measures groups to CMS until 2011. Second, if an eligible professional decides that he or she is no longer interested in submitting quality measures results 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 does not preclude the eligible professional from attempting to meet the criteria for satisfactory reporting through another 2010 PQRI reporting mechanism.
The process and requirements that will be used to determine whether a registry is qualified to submit quality measures results and numerator data on PQRI quality measures or measures groups on an eligible professional's behalf in 2010 are described in section II.G.2.d.4. of this final rule with comment period.
For eligible professionals who choose to participate in the 2010 PQRI by submitting data on individual quality measures through the EHR-based reporting mechanism, the requirements we proposed associated with EHR-based reporting other than meeting the criteria for satisfactory reporting of individual measures were to: (1) select a qualified EHR product and (2) submit clinical quality data extracted from the EHR to a CMS clinical data warehouse (74 FR 33563). Provided that our 2009 EHR data submission testing process is successful, we proposed to begin accepting submission of clinical quality data extracted from “qualified” EHRs on January 1, 2010, or as soon thereafter as is technically feasible. We proposed that eligible professionals will have until March 31, 2011, to complete data submission through qualified EHRs for services furnished during the 2010 PQRI reporting period.
We did not propose any option to report measures groups through EHR-based reporting on services furnished during 2010. Because EHR-based reporting to CMS of data on quality measures would be new to PQRI for 2010, we proposed, for EHR-based reporting, to make available only the criteria applicable to reporting of individual PQRI measures. The criteria applicable to reporting of measures groups were not proposed to be available for EHR-based reporting for 2010.
The following is a summary of the comments we received regarding the proposed requirements for individual eligible professionals who choose the EHR-based reporting mechanism.
As is the case for other eligible professionals participating in PQRI, eligible professionals submitting their quality data through an EHR will receive a feedback report from us that will be accessible in the same manner as other feedback reports we provide for other reporting mechanisms.
As a result of the comments and our experience thus far with the ongoing 2009 EHR Testing Program, eligible professionals who choose the EHR-based reporting mechanism for the 2010 PQRI will be required to (in addition to meeting the criteria for satisfactory reporting of individual measures):
• Have a qualified EHR product;
• Have an active IACS user account that will be used to submit clinical quality data extracted from the EHR to a CMS clinical data warehouse;
• Submit a test file containing real or dummy clinical quality data extracted from the EHR to a CMS clinical data warehouse via IACS between July 1, 2010 and September 30, 2010 (if technically feasible); and
• Submit a file containing the eligible professional's 2010 PQRI clinical quality data extracted from the EHR for the entire reporting period (that is January 1, 2010 through December 31, 2010) via IACS between January 1, 2011 through February 28, 2011.
As stated above, however, the 2009 EHR Testing Program is still ongoing. Since only EHR vendors that self-nominated to participate in the 2009 EHR Testing Program and successfully complete the 2009 EHR Testing Program will be considered qualified EHR vendors for the 2010 PQRI, there is no guarantee that there will be any qualified EHR vendors available for the 2010 PQRI. In addition, as we complete the 2009 EHR Testing Program and are better able to determine what is technically feasible, the actual dates on which eligible professionals are required to submit their test files and/or to begin submitting the actual 2010 PQRI data are subject to change.
As stated above, we also cannot assume responsibility for the successful submission of data from eligible professionals' EHRs. Any eligible professional 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
The specifications for the electronic transmission of the 2010 PQRI measures identified in Table 14 of this final rule as being available for EHR-based reporting in 2010 are posted on Alternative Reporting Mechanisms page of the PQRI section of the CMS Web site.
For the 2010 PQRI, we proposed to require a self-nomination process for registries wishing to submit 2010 PQRI quality measures or measures groups on behalf of eligible professionals for services furnished during the applicable reporting periods in 2010 (74 FR 33563). The proposed registry self-nomination process for the 2010 PQRI would be based on a registry meeting specific technical and other requirements.
To be considered a qualified registry for purposes of submitting individual quality measures and measures groups on behalf of eligible professionals who choose to report using this reporting mechanism under the 2010 PQRI, we proposed that a registry would need to:
• Be in existence as of January 1, 2009;
• Be able to collect all needed data elements and calculate results for at least 3 measures in the 2010 PQRI program (according to the posted 2010 PQRI Measure Specifications);
• Be able to calculate and submit measure-level 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;
• 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 (eligible professional 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 and 2009 PQRI. This layout will be provided to registries in 2010;
• Comply with a CMS-specified secure method for data submission, such as submitting its data in an XML file through an IACS user account;
• Submit an acceptable “validation strategy” to CMS by March 31, 2010. A validation strategy ascertains whether eligible professionals 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 participants' 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;
• 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 eligible professionals, as well as the registry's disclosure of quality measure results and numerator and denominator data on behalf of eligible professionals 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 results and numerator and denominator data to CMS for the purpose of PQRI participation. This documentation must be obtained at the time the eligible professional 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) to review the Medicare beneficiary data on which 2010 PQRI registry-based submissions are founded;
• Provide the reporting option (reporting period and reporting criteria) that the eligible professional has satisfied or chosen; and
• Provide CMS a signed, written attestation statement via mail or e-mail which states that the quality measure results and numerator and denominator data provided to CMS are accurate and complete (74 FR 33563 through 33564).
With respect to the submission of 2010 measure results and numerator and denominator data on measures groups, we proposed to retain in 2010 the following registry requirements from the 2009 PQRI:
• Indicate the reporting period chosen for each eligible professional 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 2010 or the 6-month reporting period of July 2010 through December 2010;
• Agree that the registry's data may be inspected by CMS under our oversight authority if non-Medicare patients are included in the patient sample;
• Be able to report data on all of the measures in a given measures group and on either 30 patients from January 1 through December 31, 2010 (note this patient sample must include some Medicare Part B FFS beneficiaries) or on 80 percent of applicable Medicare Part B FFS patients for each eligible professional (with a minimum of 15 patients during the January 1, 2010 through December 31, 2010 reporting period or a minimum of 8 patients during the July 1, 2010 through December 31, 2010 reporting period); and
• Be able to report the number of Medicare FFS patients and the number of Medicare Advantage patients that are included in the patient sample for a given measures group (74 FR 33564).
In addition to the above requirements, we proposed the following new requirements for registries for the 2010 PQRI:
• Registries must have at least 25 participants;
• Registries must provide at least 1 feedback report per year to participating eligible professionals;
• Registries must 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);
• Registries must participate in ongoing 2010 PQRI mandatory support conference calls hosted by CMS
• Registries must provide a flow and XML of a measure's calculation process for each measure type that the registry intends to calculate; and
• Registries must use PQRI measure specifications to calculate reporting or performance unless otherwise stated (74 FR 33654).
The following is summary of the comments we received regarding the proposed qualification requirements and self-nomination process for registries for the 2010 PQRI.
As a result of the comments, we are finalizing the 2010 qualification requirements for registries as proposed (74 FR 33563 through 33565).
We will post the 2010 PQRI registry requirements, including the exact date by which registries that wish to qualify for 2010 must submit a self-nomination letter and instructions for submitting the self-nomination letter, on the PQRI section of the CMS Web site at
We are finalizing our proposal (74 FR 33563 through 33565) that registries that were “qualified” for 2009 and wish to continue to participate in 2010 will not need to be “re-qualified” for 2010 unless they are unsuccessful at submitting 2009 PQRI data (that is, fail to submit 2009 PQRI data per the 2009 PQRI registry requirements). Registries that are “qualified” for 2009 and wish to continue to participate in 2010 were required to indicate 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 no later than October 31, 2009. Instructions regarding the procedures for submitting this letter were provided to qualified 2009 PQRI registries on the 2009 PQRI registry support conference calls.
If a qualified 2009 PQRI registry fails to submit 2009 PQRI data per the 2009 PQRI registry requirements, the registry will be considered unsuccessful at submitting 2009 PQRI data and will need to go through the full self-nomination process again to participate in the 2010 PQRI. By March 31, 2010, registries that are unsuccessful submitting quality measures results and numerator and denominator data for 2009 will need to be able to meet the 2010 PQRI registry requirements and go through the full vetting process again.
As stated in the proposed rule, the above registry requirements will apply not only for the purpose of a registry qualifying to report 2010 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 2010 E-Prescribing Incentive Program (see section II.G.5. of this final rule with comment period.
As stated in the proposed rule (74 FR 33565), we proposed that EHR products listed on the PQRI section of the CMS Web site at
Vendors' EHR products that are listed as “qualified” products 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
As stated in the proposed rule (74 FR 33565), we proposed that the EHR vendor requirements described above would apply not only for the purpose of a vendor's EHR product being qualified for the purpose of the product's users being able to submit data extracted from the EHR for the 2010 PQRI, but also for the purpose of a vendor's EHR product being qualified for the purpose of the product's users being able to electronically submit data extracted from the EHR for the electronic prescribing measure for the 2010 E-Prescribing Incentive Program.
The following is a summary of the comments received regarding the proposed 2010 EHR vendor qualification requirements and/or process.
During 2010, we expect to use a similar self-nomination process described in the “Requirements for Electronic Heath Record (EHR) Vendors to Participate in the 2009 PQRI EHR Testing Program” posted on the PQRI section of the CMS Web site at
As previously stated above, only EHR vendors that self-nominated to participate in the 2009 EHR Testing Program and successfully complete the 2009 EHR Testing Program will be considered qualified EHR vendors for the 2010 PQRI. There is no guarantee that there will be any qualified EHR vendors available for the 2010 PQRI since the 2009 EHR Testing Program is still ongoing.
During 2010, we expect to use the self-nomination process described in the “Requirements for Electronic Health Record (EHR) Vendors to Participate in the 2009 PQRI EHR Testing Program” posted on the PQRI section of the CMS Web site at
As discussed in the proposed rule (74 33565 through 33568), for years after 2009, section 1848(m)(3)(D) of the Act authorizes 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 received from stakeholders via the invitation to submit suggestions for the 2010 PQRI reporting options posted on the PQRI section of the CMS Web site at
• Report on at least 3 2010 PQRI measures; and
• Report each measure for at least 80 percent of the eligible professional's Medicare Part B FFS patients for whom services were furnished during the reporting period to which the measure applies.
These criteria would apply to all 2010 PQRI reporting mechanisms available for reporting individual PQRI quality measures.
If an eligible professional has fewer than 3 PQRI measures that apply to the professional's services, then the professional would be able to meet the criteria for satisfactorily reporting data on individual quality measures by meeting the following 2 criteria:
• Reporting on all measures that apply to the services furnished by the professional (that is 1 to 2 measures); and
• Reporting each measure for at least 80 percent of the eligible professional's Medicare Part B FFS patients for whom services were furnished during the reporting period to which the measure applies.
We proposed that, as in previous years, these criteria for satisfactorily reporting data on fewer than 3 individual quality measures would be available for the claims-based reporting mechanism only. An eligible professional who has fewer than 3 PQRI measures that apply to the professional's services would not be able to meet the criteria for satisfactory reporting by reporting on all applicable measures (that is, 1 or 2 measures) through the registry-based or EHR-based reporting mechanisms.
We also proposed that an eligible professional who reports on fewer than 3 measures through the claims-based reporting mechanism in 2010 may be subject to the Measure Applicability Validation (MAV) process, which allows us to determine whether an eligible professional should have reported quality data codes for additional measures. When an eligible professional reports on fewer than 3 measures, we proposed 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 professional). If an eligible professional who reports on fewer than 3 measures in 2010 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 professional would not qualify to receive a 2010 PQRI incentive payment. Additional information on the MAV process can be found on the Analysis and Payment page of the PQRI section of the CMS Web site at
In addition to the above criteria related to the number of measures on which an eligible professional would be required to report and the frequency of reporting, we proposed a third criterion for satisfactory reporting of individual measures. Based on our authority to revise the criteria for satisfactory reporting under section 1848(m)(3)(D) of the Act, we proposed (74 FR 33566) that an eligible professional also be required to report data on at least one individual measure on a minimum number of Medicare Part B FFS patients seen during the reporting period, as detailed below.
Regardless of the reporting mechanism chosen by the eligible professional, we proposed (74 FR 33567) that the minimum patient sample size for reporting individual quality measures be 15 Medicare Part B FFS patients for the 12-month reporting period. An eligible professional would need to meet this minimum patient sample size requirement for at least one measure on which the eligible professional chooses to report. Similarly, for the 6-month reporting period (which was proposed to be available for registry-based reporting only), we proposed that the minimum patient sample size for reporting on individual quality measures be 8 Medicare Part B FFS patients seen during the 6-month reporting period. An eligible professional would need to meet this minimum patient sample size requirement for at least one measure on which the eligible professional chooses to report.
We solicited comments on the proposal to add a minimum patient sample size criterion to the criteria for satisfactory reporting of data on individual quality measures. In addition, we solicited comments on the specific thresholds proposed for the 12-month reporting period (which was proposed to be available for claims-based, registry-based, and EHR-based reporting) and for the 6-month reporting period (which was proposed to be available for registry-based reporting only) for reporting individual quality measures.
The following is summary of the comments we received regarding the criteria for satisfactory reporting of individual quality measures for individual eligible professionals.
In addition, we believe that such significant changes should occur gradually. The criteria for satisfactory reporting are specifically defined under section 1848(m)(3)(A) of the Act. With
Based on the new 2010 PQRI measures, the only new clusters being contemplated are a second preventive cluster, 2 new anesthesia care clusters, an ear care cluster, and an Ischemic Vascular (IVD) cluster. The second preventive cluster would consist of the following 2 measures: (1) Measure #114 Preventive Care and Screening: Inquiry Regarding Tobacco Use and (2) Measure #115 Preventive Care and Screening: Advising Smokers and Tobacco Users to Quit. The first anesthesia care cluster would consist of 2 measures: (1) Measure #30 Perioperative Care: Timely Administration of Prophylactic Parenteral Antibiotics and (2) Measure #76 Prevention of Catheter-Related Bloodstream Infections (CRBI): Central Venous Catheter (CVC) Insertion Protocol. The second anesthesia care cluster would consist of Measure #76 and the new Perioperative Temperature Management measure. For both of the anesthesia care clusters, however, the MAV would not apply if an eligible professional reports only Measure #76. Measure # 76 is a broadly applicable measure that encompasses services often provided by eligible professionals for whom Measure #30 and the Perioperative Temperature Management measure do not apply such as intensivists, hospitalists, internists, and emergency physicians. The ear care cluster would consist of the 3 new referral for otologic evaluation measures listed in Table 13 of this final rule. The IVD cluster would consist of the following 4 new PQRI measures:
• Ischemic Vascular Disease (IVD): Blood Pressure Management Control;
• Ischemic Vascular Disease (IVD): Complete Lipid Profile;
• Ischemic Vascular Disease (IVD): Low Density Lipoprotein (LDL–C) Control; and
• Ischemic Vascular Disease (IVD): Use of Aspirin or Another Anti-Thrombotic.
By no later than December 31, 2009, we will post the final MAV process for 2010 and the final 2010 MAV clusters on the Analysis and Payment page of the PQRI section of the CMS Web site at
After considering the comments and the new 6-month reporting period for claims-based reporting of individual PQRI quality measures that we are adding to the 2010 PQRI at the request of commenters, the final 2010 criteria for satisfactory reporting of data on individual PQRI quality measures are summarized in Table 7 and are arranged by reporting mechanism and reporting period. The criteria for satisfactory reporting for claims-based reporting of individual PQRI quality measures for the 6-month reporting period are consistent with the criteria for satisfactory reporting of individual PQRI quality measures.
For the 2010 PQRI, there are a total of 5 reporting options, or ways, in which an eligible professional may meet the criteria for satisfactory reporting on individual quality measures. Each reporting option consists of the criteria for satisfactory reporting such data and results on individual quality measures relevant to a given reporting mechanism and reporting period. While eligible professionals may potentially qualify as satisfactorily reporting individual quality measures under more than one of the reporting criteria, reporting mechanisms, and/or for more than one reporting period, only one incentive payment will be made to an eligible professional based on the longest reporting period for which the eligible professional satisfactorily reports.
For the 2010 PQRI, we proposed 2 basic sets of criteria for satisfactory reporting on a measures group (74 FR 33568). Both sets of criteria would apply to the claims-based and registry-based reporting mechanism. We did not propose to make the EHR-based reporting mechanism available for reporting on measures groups in 2010.
The first set of proposed criteria, which we proposed to make available for either the 12-month or 6-month reporting period in 2010, would be consistent with the 2009 criteria for satisfactory reporting of measures groups through registry-based reporting, which require the reporting of at least 1 measures group for at least 80 percent of patients to whom the measures group applies during the applicable reporting period (with reporting required on a minimum number of Medicare Part B FFS patients commensurate with the reporting period duration). In the 2009 PQRI, there was a requirement under these criteria to report each measures group on at least 30 Medicare Part B FFS patients for the 12-month reporting period and at least 15 Medicare Part B FFS patients for the 6-month reporting period for registry-based reporting of measures groups. For the 2010 PQRI, we proposed to revise the requirement by making these criteria applicable to both registry-based and claims-based reporting and to change the number of Medicare Part B FFS patients on which an eligible professional would be required to report a measures group. We proposed to require an eligible professional who chooses to report on measures groups based on reporting on 80 percent of applicable patients to report on a minimum of 15 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, regardless of whether the eligible professional chooses to report the measures group through claims-based reporting or registry-based reporting.
The second set of proposed criteria, which we proposed to make available for the 12-month reporting period only, would be based on reporting on a measures group on a specified minimum number of patients (74 FR 33568). The second set of criteria would require reporting on at least 1 measures group for at least 30 patients seen between January 1, 2010 and December 31, 2010 to whom the measures group applies. Unlike the 2009 PQRI, which required that eligible professionals report on consecutive patients (that is, patients seen in order, by date of service), the 30 patients on which an eligible professional would need to report a measures group for 2010 would not need to be consecutive patients. The eligible professional would be able to report on
We solicited comments on our proposal to make the criteria for satisfactory reporting of measures groups more consistent with those proposed for reporting individual measures, including our proposal to revise the minimum sample size requirement related to satisfactory reporting on measures group through the registry-based reporting mechanism so that the criteria for satisfactory reporting of measures groups, regardless of reporting mechanism, would be identical to those proposed for reporting individual measures. We also solicited comments on our proposal to allow eligible professionals to report on measures groups on any 30 patients rather than a consecutive patient sample.
The following is summary of the comments we received regarding the criteria for satisfactory reporting measures groups for individual eligible professionals.
With respect to commenters' concerns that removing the requirement that eligible professionals report on 30 patients, we reiterate that we believe that it would be difficult for eligible professionals to selectively choose which patients to report on since they must report on multiple measures for a given clinical condition or focus. We will, however, continue to monitor the PQRI data to determine whether this needs to be reassessed in future years.
As suggested by another commenter, however, we will continue to monitor the PQRI data on an ongoing basis to determine whether the criteria for satisfactory reporting of measures groups, including the minimum patient sample size requirements, need to be re-evaluated for future years.
After considering the comments and for the reasons discussed previously, the final 2010 criteria for satisfactory reporting of data on measures groups are summarized in Table 8 and are arranged by reporting mechanism and reporting period. Accordingly, there are a total of 6 reporting options, or ways in which an eligible professional may meet the criteria for satisfactory reporting of measures groups for the 2010 PQRI. Each reporting option consists of the criteria for satisfactory reporting relevant to a given reporting mechanism and reporting period. As stated previously, while eligible professionals may potentially qualify as satisfactorily reporting on measures groups under more than one of the reporting criteria, reporting mechanisms, and/or for more than one reporting period, only one incentive payment will be made to an eligible professional based on the longest reporting period for which the eligible professional satisfactorily reports. Similarly, an eligible professional 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 eligible professional based on the longest reporting period for which the professional satisfactorily reports.
As discussed above, for 2010, incentive payments will be available to group practices based on the determination that the group practice, as a whole (that is, for the TIN), satisfactorily reports on PQRI quality measures for 2010. If, however, an individual eligible professional is affiliated with a group practice participating in the group practice reporting option and the group practice satisfactorily reports under the group practice reporting option, the eligible professional will not be eligible to earn a separate PQRI incentive payment for 2010 on the basis of his or her satisfactorily reporting PQRI quality measures data at the individual level under that same TIN (that is, for the same TIN/NPI combination).
As stated in the proposed rule (74 FR 33570), 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 proposed that a “group practice” would consist of a physician group practice, as defined by a single TIN, with at least 200 or more individual eligible professionals (as identified by Individual NPIs) who have reassigned their billing rights to the TIN. We solicited comments on the proposed definition of “group practice” and our proposal to limit initial implementation of the PQRI group practice reporting option in 2010 to practices with 200 or more individual eligible professionals.
We also proposed to require group practices to complete a self-nomination process and to meet certain technical and other requirements in order to participate in the 2010 PQRI through the group practice reporting option (74 FR 33570). Group practices interested in participating in the 2010 PQRI through the group practice reporting option would be required to submit a self-nomination letter to CMS requesting to participate in the 2010 PQRI group practice reporting option. The following is a summary of the comments received regarding the proposed definition of “group practice” and the proposed self-nomination requirements.
• The reporting process for group practices needs to be further tested to ensure that there are no problems when we implement this process into PQRI, that validity and accuracy of the measures as a reflection of performance, and that there are no unintended consequences;
• CMS does not have specific authority from the Congress to post performance results;
• Doing so would be premature and discourage groups from participating in this option;
• Many issues identified in the CMS Issue Paper: Development of a Plan to Transition to a Medicare Value-Based Purchasing Program for Physician and Other Professional Services should be addressed prior to public reporting of performance results. Once addressed, public reporting of performance results should be conducted for all PQRI participants, not just group practices;
For similar reasons, other commenters requested that we delay public reporting of the group practices' performance results for at least 1 year or wait until we are fully satisfied with the reliability and validity of the performance data collected from group practices.
Furthermore, we believe that public reporting of performance information at the group level does not present some of the same issues that public reporting of performance information at the individual eligible professional would. For example, as we stated in the CY 2010 PFS proposed rule, no performance results would be calculated based on small denominator sizes due to the reporting criteria for the group practice reporting option, which require that group practices report each disease module or preventive care measure under the group practice reporting option for 411 patients. Nevertheless, we take note of the importance of working through the concerns raised by commenters about publicly posting groups' performance results, especially commenters' concerns about doing so in the first year of implementation of the group practice reporting option and the importance of giving participating group practices an opportunity to review their results from the first year of the group practice reporting option before any information is publicly reported. Therefore, we are not finalizing our proposal to require group practices that wish to utilize the group practice reporting option in 2010 to agree to have their PQRI performance results publicly reported. In addition, we will not report any 2010 group practice performance results publicly except as otherwise required by law and will limit public reporting of information on the PQRI group practice reporting for 2010 to the information required by section 1848(m)(5)(G)(i) of the Act (that is, the names of group practices that satisfactorily submitted data on 2010 PQRI quality measures). Instead, we will consider implementing public reporting of group practices' performance results in the 2011 PQRI program year.
For the reasons discussed above and based on these comments, a group practice, for purposes of finalizing the 2010 PQRI group practice reporting option, a group practice will consist of a single TIN with at least 200 or more individual eligible professionals (as identified by Individual NPIs) who have reassigned their billing rights to the TIN. Additionally, the TIN and all Individual NPIs must be established Medicare providers.
To participate in the 2010 PQRI group practice reporting option, a group practice will be required to submit a self-nomination letter indicating the group practice's interest in participating in the 2010 PQRI group practice reporting option. Also, the letter 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 and the Individual NPI numbers, name of the group practice, and names of all eligible professionals who will be participating as part of the group practice (that is, all Individual NPI numbers, which are established Medicare providers and associated with the group practice's TIN), a single point of contact for handling administrative issues as well as a single point of contact for technical support purposes. In addition, 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 training sessions; and
• Have billed Medicare Part A and Part B on or after January 1, 2009 and prior to October 29, 2009.
The final participation requirements listed above for group practices, including instructions for submitting the self-nomination letter and other requested information, will be posted on the PQRI section of the CMS Web site at
As discussed further in section II.G.5. of this final rule, participation in the E-Prescribing Incentive Program is voluntary for group practices selected to participate in the PQRI group practice reporting option. However, we are requiring group practices to participate in the PQRI group practice reporting option in order to be eligible to
For physician groups selected to participate in the PQRI group practice reporting option for 2010, we proposed (74 FR 33570) the reporting period would be the 12-month reporting period beginning January 1, 2010. We proposed that group practices would be required to submit information on these measures using a data collection tool based on the data collection tool used in CMS' MCMP demonstration and the quality measurement and reporting methods used in CMS' PGP demonstration. We proposed that physician groups selected to participate in the 2010 PQRI through the group practice reporting option would be required to report on a common set of 26 NQF-endorsed quality measures that are based on measures currently used in the MCMP and/or PGP demonstration and that target high-cost chronic conditions and preventive care.
As part of the data submission process, we proposed that, beginning in 2011, each group practice would be required to report quality measures with respect to services furnished during the 2010 reporting period (that is, January 1, 2010 through December 31, 2010) on an assigned sample of Medicare beneficiaries. We proposed to analyze the January 1, 2010 through October 29, 2010 (that is, the last business day of October 2010) National Claims History (NCH) file to assign Medicare beneficiaries to each physician group practice using the same patient assignment methodology used in the PGP demonstration.
We solicited comments on our proposal to adopt the PGP demonstration's quality measurement and reporting methods for the PQRI group practice reporting option. We specifically requested comments on the proposed patient assignment methodology and our proposal to use a data collection tool based on the one used in the MCMP demonstration as the reporting mechanism for physician groups selected to participate in the PQRI group practice reporting option.
We also proposed 2 criteria for satisfactory reporting of quality measures by a physician group (74 FR 33571). First, the physician group would be required to report completely on all of the proposed modules and measures listed in Table 34 of the proposed rule (74 FR 33588). Second, the physician group would be required to report completely on the first 411 consecutively assigned and ranked Medicare beneficiaries per disease module or preventive care measure.
The following is a summary of the comments we received regarding the proposed reporting option for satisfactory reporting on quality measures by group practices under PQRI.
The eligible professional can receive separate incentive payments by participating and qualifying under one or more unique TIN/NPI combinations. For example, if an eligible professional with TIN/NPI 003/001 participates in the group practice reporting option for one practice and also participates as an
For the reasons discussed above and after taking into consideration the comments, we are finalizing the process group practices will be required to use to report data on quality measures for the 2010 PQRI as a group practice and the associated criteria for satisfactory reporting of data on quality measures by group practices, which are summarized in Table 9. Group practices participating in PQRI as a group practice will be required to report on all of the measures listed in Table 28 of this final rule with comment period. These quality measures are grouped into preventive care measures and four disease modules: diabetes; heart failure; coronary artery disease; and hypertension.
Although the process for physician groups to participate in PQRI as a group practice incorporates some characteristics and methods from the PGP demonstration and the MCMP demonstration, the PQRI group practice reporting option is a separate program with its own specifications and methodology from the PGP and MCMP demonstration programs. The reporting process for the group practice reporting option, including the use of a data collection tool as the reporting mechanism, will not be available to individual eligible professionals participating in the 2010 PQRI.
As stated in the proposed rule (74 FR 33570 through 33571), we will analyze the January 1, 2010 through October 29, 2010, NCH file to assign Medicare beneficiaries to each physician group practice using the same patient assignment methodology used in the PGP demonstration. Assigned beneficiaries will be limited to those Medicare FFS beneficiaries with Medicare Parts A and B for whom Medicare is the primary payer. Assigned beneficiaries will not include Medicare Advantage enrollees. A beneficiary will be assigned to the physician group that provides the plurality of a beneficiary's office or other outpatient E/M allowed charges (based on Medicare Part B claims submitted for the beneficiary for dates of services between January 1, 2010 and October 29, 2010). Beneficiaries with only 1 visit to the group practice between January 1, 2010 and October 29, 2010, will be eliminated from the group practice's assigned patient sample. For inclusion in the sample, beneficiaries will be required to have at least 2 visits to the group practice between January 1, 2010 and October 29, 2010.
Once the beneficiary assignment has been made for each physician group
As discussed in the proposed rule (74 FR 33571 through 33572), the statutory requirements with respect to the use of quality measures for the 2010 PQRI are different from the statutory requirements for previous program years. For purposes of reporting data on quality measures for covered professional services furnished during 2010 and subsequent years for the PQRI, subject to the exception noted below, section 1848(k)(2)(C)(i) of the Act, as added by MIPPA, requires that the 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). 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, however, 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.
Finally, section 1848(k)(2)(D) of the Act requires that for each 2010 PQRI quality measure, “the Secretary shall ensure that eligible professionals have the opportunity to provide input during the development, endorsement, or selection of measures applicable to services they furnish.”
Based on the statutory requirements described above, we stated in the CY 2010 PFS proposed rule (74 FR 33572 through 33573) that we proposed to apply the following considerations with respect to the selection of 2009 PQRI quality measures for inclusion in the 2010 PQRI quality measure set:
• Where some 2009 PQRI quality measures have been endorsed by the NQF and others have not, those 2009 PQRI quality measures that have been specifically considered by NQF for possible endorsement, but NQF has declined to endorse it, will not be included in the 2010 PQRI quality measure set (that is, we will retire the measure for 2010).
• In circumstances where no NQF-endorsed measure is available, we will exercise the exception under section 1848 (k)(2)(C)(ii) of the Act. Under these circumstances, a 2009 PQRI quality measure that previously (that is, prior to January 31, 2009) has been adopted by the AQA will meet the requirements under the Act and it would be appropriate for eligible professionals to use the measure to submit quality measures data and/or quality measures results and numerator and denominator data on quality measures, as appropriate.
• Although we are not including any 2009 PQRI measures that have not been endorsed by the NQF or adopted by the AQA in the final 2010 PQRI quality measure set, we acknowledge that section 1848(k)(C)(ii) of the Act provides an exception to the requirement that the Secretary select measures that have been endorsed by the entity with a contract under section 1890(a) of the Act (that is, the NQF) as long as an area or medical topic for which a feasible and practical NQF-endorsed measure is not available has been identified and due consideration has been given to measures that have been endorsed by the NQF and/or, prior to January 31, 2009, adopted by the AQA.
• 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
• 2009 PQRI measures that were part of the 2007 and/or 2008 PQRI in which the 2007 and 2008 PQRI analytics indicate a lack of significant reporting and usage were not considered for inclusion in the 2010 PQRI.
In addition to reviewing the 2009 PQRI measures and previously retired measures, for purposes of developing the proposed 2010 PQRI measures, we reviewed and considered measure suggestions including comments received in response to the CY 2009 PFS proposed rule and final rule with comment period. Additionally, suggestions and input received through other venues, such as an invitation for measures suggestions posted on the PQRI section of the CMS Web site in February 2009 were also reviewed and considered for purposes of our development of the list of proposed 2010 PQRI quality measures. All measures and measures groups reviewed for potential inclusion in the 2010 PQRI measure set are listed in the “Table of 2010 Measure Suggestions” posted on the Statute/Regulations/Program Instructions 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 2009 or any prior year), we stated in the CY 2010 PFS proposed rule (74 FR 33572 through 33573) that we would apply the following considerations, which include many of the same considerations applied to the selection of 2009 PQRI quality measures for inclusion in the 2010 PQRI quality measure set described above:
• High Impact on Healthcare.
+ Measures that are high impact and support CMS and HHS priorities for improved quality and efficiency of care for Medicare beneficiaries. These current and long term priority topics include: prevention; chronic conditions; high cost and high volume conditions; elimination of health disparities; healthcare-associated infections and other conditions; improved care coordination; improved efficiency; improved patient and family experience of care; improved end-of-life/palliative care; effective management of acute and chronic episodes of care; reduced unwarranted geographic variation in quality and efficiency; and adoption and use of interoperable HIT.
+ Measures that are included in, or facilitate alignment with, other Medicare, Medicaid, and CHIP programs in furtherance of overarching healthcare goals.
• NQF Endorsement.
+ Measures must be NQF-endorsed by July 1, 2009, in order to be considered for inclusion in the 2010 PQRI quality measure set.
+ Although we did not propose to include any new measures that were not endorsed by the NQF by July 1, 2009 in the final 2010 PQRI quality measure set, we acknowledge that section(k)(2)(C)(ii) of the Act provides an exception to the requirement that the Secretary select measures that have been endorsed by the entity with a contract under section 1890(a) of the Act (that is, the NQF). As long as an area or medical topic for which a feasible and practical NQF-endorsed measure is not available has been identified and due consideration has been given to measures that have been adopted by the AQA or other consensus organization identified by the Secretary.
+ 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 eligible professionals 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. The requirements under section 1848(k)(2)(C) of the Act pertain only to the selection of measures and not to the development of measures.
• Address Gaps in PQRI Measure Set.
+ Measures that increase the scope of applicability of the PQRI measures to services furnished to Medicare beneficiaries and expand opportunities for eligible professionals to participate in PQRI. We seek to achieve broad ability to assess the quality of care furnished to Medicare beneficiaries, and ultimately to compare performance among professionals. We seek to increase the circumstances where eligible professionals have at least three measures applicable to their practice and measures that help expand the number of measures groups with at least four measures in a group.
+ 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 proposed to apply to the selection of measures for 2010, regardless of whether the measure is a 2009 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 2009 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 new measures, preference is given to those that can be most efficiently implemented for data collection and submission. Therefore, any measures that have 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, have not been included in the 2010 PQRI. For example, in some cases, we are replacing existing 2009 PQRI measures with updated and improved measures that are less technically challenging to report.
• 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)
We also reviewed 33 measures that have been retired from the PQRI in previous years using the considerations for selecting measures for the 2010 PQRI discussed above (74 FR 33573). None were found to be eligible for inclusion in the 2010 PQRI quality measure set because they did not meet the criteria described above.
We solicited comments on the implication of including or excluding any given measure or measures in the final 2010 PQRI quality measure set and to our approach in selecting measures. As we stated in the proposed rule, we recognize that some commenters may also wish to recommend additional measures for inclusion in the 2010 PQRI measures that we did not propose (74 FR 33573). While we 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 2010 measure set.
The following is a summary of the comments we received regarding the statutory requirements and other considerations for the selection of 2010 PQRI measures.
We proposed to exercise this authority for 2010 in the CY 2010 PFS proposed rule (74 FR 33576 through 33579) by proposing to include in the 2010 PQRI several 2009 PQRI measures that had not yet achieved NQF endorsement but that were AQA adopted. As we stated in the proposed rule, we would include such measures in the 2010 PQRI as long as a measure had not been reviewed by the NQF prior to July 1, 2009 and specifically declined for endorsement.
We are also exercising this authority with respect to our decision to finalize 3 proposed new measures (that is, Referral for Otologic Evaluation for Patients with Congenital or Traumatic Deformity of the Ear; Referral for Otologic Evaluation for Patients with History of Active Drainage from the Ear within the Previous 90 days; and Referral for Otologic Evaluation for Patients with History of Sudden or Rapidly Progressive Hearing Loss) that were neither NQF endorsed prior to July 1, 2009 nor AQA adopted prior to January 31, 2009. We decided to finalize these 3 measures despite the lack of consensus endorsement or adoption due to the lack of measures available for audiologists to report on. Audiologists are a new a category of eligible professionals that were added to the list of professionals eligible to participate in the PQRI beginning with the 2009 PQRI.
We stress, however, 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. Therefore, we do believe that this exception authority should be exercised in very limited circumstances, such as when few or no measures are available for a particular specialty or category of eligible professionals to report.
• Measures with high impact on healthcare.
• Measures that support CMS and HHS priorities for improved quality and efficiency of care for Medicare beneficiaries (such as, prevention; chronic conditions; high cost and high volume conditions; elimination of health disparities; healthcare-associated infections and other conditions; improved care coordination; improved efficiency; improved patient and family experience of care; improved end-of-life/palliative care; effective management of acute and chronic episodes of care; reduced unwarranted geographic variation in quality and efficiency; and adoption and use of interoperable HIT).
• Measures that are included in, or facilitate alignment with, other Medicare, Medicaid, and CHIP programs in furtherance of overarching healthcare goals.
• Measures that address gaps in the PQRI measure set in order to increase the scope of applicability of the PQRI measures to services furnished to Medicare beneficiaries and expand opportunities for eligible professionals to participate in PQRI.
For 2010, we proposed that final PQRI quality measures would be selected from 153 of the 2009 PQRI measures and the measures listed in the “Table of 2010 Measure Suggestions” posted on the Statute/Regulations/Program Instructions page of the PQRI section of the CMS Web site at
The following is a summary of the comments received on the 2010 PQRI measures in general and comments on the measures from the 2009 PQRI not proposed for inclusion in the 2010 PQRI, which are addressed below. Comments specific to measures proposed for inclusion in the 2010 PQRI are addressed in sections II.G.2.i.1. through II.G.2.i.5. below.
As stated previously, however, we largely depend on the development of measures by professional organizations and other measure developers for the PQRI. Many major measures developers follow a similar process for the measures that they develop, in that they publish measures and specifications during development and seek public comment. Both the NQF and AQA also publish measures and specifications during their consensus processes and seek public comment.
Having detailed information on measures available in advance of the reporting period also enhances the ability of vendors (such as practice management software, billing services, and electronic health records vendors) to support professionals' successful implementation of revised data-capture processes for the measures. Our intent is to provide the final list of 2010 PQRI measures and the detailed measures specifications on the PQRI section of the CMS Web site by November 15, 2009, but no later than December 31, 2009. These detailed specifications will include instructions for reporting and identifying the circumstances in which each measure is applicable. The detailed technical specifications for measures in the final listing for the 2010 PQRI remain potentially subject to corrections until the start of the 2010 reporting period, as we stated in the proposed rule.
We are unclear, however, with respect to the commenter's remark that continued revision of the PQRI quality measure set will reduce undue burden on participants. Although there are several measures available in the PQRI quality measure set, participants are not required, nor are they expected to, report on all measures included in the PQRI quality measure set. As discussed further in sections II.G.2.e. and II.G.2.f. above, an individual eligible professional generally needs to report on only 3 individual 2010 PQRI quality measures or 1 2010 PQRI measures group in order to meet the criteria for satisfactory reporting for 2010.
Based on the criteria discussed above and our review of these comments, we are retiring the 4 measures listed in Table 10 and are including the 175 individual measures listed in Tables 11 through 13 in the final 2010 PQRI individual quality measure set. We are also including 13 measures groups in the final 2010 PQRI quality measure set, which are listed in Tables 15 through 27. The individual measures selected for the 2010 PQRI can be categorized as follows:
(1) 2010 Individual Quality Measures Selected From the 2009 PQRI Quality Measures Set Available for Claims-based Reporting and Registry-Based Reporting;
(2) 2010 Individual Quality Measures Selected From the 2009 PQRI Quality Measures Set Available for Registry-based Reporting Only;
(3) New Individual Quality Measures Selected for 2010; and
(4) 2010 Measures Available for EHR-based Reporting.
We proposed to include in the 2010 PQRI quality measure set 116 of the 2009 PQRI measures, which would be available for either claims-based reporting or registry-based reporting as individual quality measures (74 FR 33574 through 33579). We also noted that one of the proposed measures, Measure #46 Medication Reconciliation: Reconciliation After Discharge from an Inpatient Facility, is reportable through the registry-based reporting mechanism only in the 2009 PQRI. However, for the 2010 PQRI, we proposed to make this measure available for either claims-based reporting or registry-based reporting.
These 116 proposed measures did not include any measures that were proposed to be included as part of the 2010 Back Pain measures group. Similar to the 2009 PQRI, we proposed that any 2010 PQRI measure that is included in the Back Pain measures group would not be reportable as individual measures through claims-based reporting or registry-based reporting.
The following is a summary of the comments received on the 116 proposed measures selected from the 2009 PQRI quality measure set.
• Measure #1 Diabetes Mellitus: Hemoglobin A1c Poor Control in Diabetes Mellitus;
• Measure #2 Diabetes Mellitus: Low Density Lipoprotein (LDL–C) Control in Diabetes Mellitus;
• Measure #3 Diabetes Mellitus: High Blood Pressure Control in Diabetes Mellitus;
• Measure #9 Major Depressive Disorder (MDD): Antidepressant Medication During Acute Phase for Patients with MDD;
• Measure #18 Diabetic Retinopathy: Documentation of Presence or Absence of Macular Edema and Level of Severity of Retinopathy;
• Measure #19 Diabetic Retinopathy: Communication with the Physician Managing On-going Diabetes Care;
• Measure #67 Myelodysplastic Syndrome (MDS) and Acute Leukemias: Baseline Cytogenetic Testing Performed on Bone Marrow;
• Measure #68 Myelodysplastic Syndrome (MDS): Documentation of Iron Stores in Patients Receiving Erythopoietin Therapy;
• Measure #102 Prostate Cancer: Avoidance of Overuse of Bone Scan for Staging Low-Risk Prostate Cancer Patients;
• Measure #104 Prostate Cancer: Adjuvant Hormonal Therapy for High-Risk Prostate Cancer Patients;
• Measure #105 Prostate Cancer: Three-Dimensional (3D) Radiotherapy;
• Measure #106 Major Depressive Disorder (MDD): Diagnostic Evaluation;
• Measure #107 Major Depressive Disorder (MDD): Suicide Risk Assessment;
• Measure #110 Preventive Care and Screening: Influenza Immunization for Patients ≥50 Years Old;
• Measure #111 Preventive Care and Screening: Pneumonia Vaccination for Patients 65 Years and Older;
• Measure #112 Preventive Care and Screening: Screening Mammography;
• Measure #113 Preventive Care and Screening: Colorectal Cancer Screening;
• Measure #114 Preventive Care and Screening: Inquiry Regarding Tobacco Use;
• Measure #115 Preventive Care and Screening: Advising Smokers and Tobacco Users to Quit;
• Measure #117 Diabetes Mellitus: Dilated Eye Exam in Diabetic Patient;
• Measure #119 Diabetes Mellitus: Urine Screening for Microalbumin or Medical Attention for Nephropathy in Diabetic Patients;
• Measure #124 Health Information Technology (HIT): Adoption/Use of Electronic Health Records (EHR);
• Measure #126 Diabetes Mellitus: Diabetic Foot and Ankle Care, Peripheral Neuropathy-Neurological Evaluation;
• Measure #127 Diabetes Mellitus: Diabetic Foot and Ankle Care, Ulcer Prevention—Evaluation of Footwear;
• Measure #134 Screening for Clinical Depression and Follow-Up Plan;
• Measure #136 Melanoma: Follow-Up Aspects of Care;
• Measure #137 Melanoma: Continuity of Care—Recall System;
• Measure #138 Melanoma: Coordination of Care;
• Measure #156 Oncology: Radiation Dose Limits to Normal Tissues; and
• Measure #163 Diabetes Mellitus: Foot exam.
Specifically, one commenter suggested that in order to maximize the impact of Measure #1 Diabetes Mellitus: Hemoglobin A1c Poor Control in Diabetes Mellitus, the PQRI specification should continue to require a performance period of 12 months and reporting that identifies whether A1c control is good (that is, A1c ≤ 7.0 percent), moderate (that is, A1c ≤ 9.0 percent, but > 7.0 percent), or poor (that is, A1c > 9.0 percent).
Another commenter suggested that audiologists should be included in Measure #154 Falls: Risk Assessment. The commenter noted that audiologists are consulted to provide vestibular rehabilitation that results in improved quality of care for these patients and reduces unnecessary and excessive cost.
Another commenter requested that Measure #52 Chronic Obstructive Pulmonary Disease (COPD): Spirometry Evaluation needs to be re-evaluated and CMS should consider modifying this measure or creating a new one that addresses the appropriate use of LABA.
We received one comment regarding Measure #158 Carotid Endarterectomy: Use of Patch During Conventional Carotid Endarterectomy, expressing concern that there is no reliable data, controlled or otherwise, that shows that use of patch graft results in better outcomes.
Finally, one commenter suggested that the following proposed 2010 measures selected from the 2009 PQRI quality measure set available for either claims-based reporting or registry-based reporting may not promote quality care because they do not adequately address concerns of patient groups that rely on plasma derived treatments such as those with primary immune deficiency or alpha-1 antitrypsin deficiency:
• Measure #51 Chronic Obstructive Pulmonary Disease (COPD): Spirometry Evaluation;
• Measure #64 Asthma: Asthma Assessment;
• Measure #65 Treatment for Children with Upper Respiratory Infection (URI): Avoidance of Inappropriate Use;
• Measure #110 Preventive Care and Screening: Influenza Immunization for Patients ≥ 50 Years Old; and
• Measure #126 Diabetes Mellitus: Diabetic Foot and Ankle Care, Peripheral Neuropathy—Neurological Evaluation.
The commenter suggested that we focus on aligning these measures with accepted clinical practices for patients that rely on plasma-derived treatments.
Quality measures that have completed the consensus processes of NQF or AQA have a designated party (generally 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 substantive changes to a measure, including any updates to the measure to reflect the current clinical evidence such as the changes suggested by the commenters above. The measure maintainer and/or the developer/owner of a measure included in the final set of quality measures selected for the 2010 PQRI is identified as the “Measure Developer” in Tables 11 through 28. In addition, NQF has, for its endorsed measures, an established maintenance process which may be accessed. The Secretary is required to provide opportunities for public comment on selected measures and do so through notice and comment rulemaking. We do not, however, use notice and comment rulemaking as a means to update or modify measure specifications. We retain the ability to update or modify specifications to the measures until December 31, 2009.
After that date, there will be no changes to the measure for the 2010 reporting period(s).
For the reasons discussed above and based on the comments received, we are finalizing in the 2010 PQRI quality measure set the 116 2009 PQRI measures that were proposed to be available in the 2010 PQRI for claims and registry reporting identified in Table 11. In addition, Table 11 includes 1 2009 PQRI measure that was proposed for retirement in 2010 and 2 2009 PQRI measures that were proposed to be available for registry reporting only (see sections II.G.2.i. and II.G.2.i.2., respectively, of this final rule for further details). The 119 individual 2009 PQRI measures selected for inclusion in the 2010 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 11, along with the name of the measure's developer/owner. 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 11 can be found in the “2009 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 that detailed measure specifications, including the measure's title, for 2009 individual PQRI quality measures may have been updated or modified during the NQF endorsement process or for other reasons prior to 2010. The 2010 PQRI quality measure specifications for any given individual quality measure may, therefore, be different from specifications for the same quality measure used for 2009. Specifications for all 2010 individual PQRI quality measures, whether or not included in the 2009 PQRI program, must be obtained from the specifications document for 2010 individual PQRI quality measures, which will be available on the PQRI section of the CMS Web site on or before December 31, 2009.
We proposed to select 26 registry-only individual measures from the 2009 PQRI for the 2010 PQRI (74 FR 33579 through 33580). Nine of the 26 proposed measures were previously available for either claims-based reporting or registry-based reporting. We solicited comments on our proposal to increase the number of registry-only measures for the 2010 PQRI.
The following is a summary of the comments received on the 26 proposed registry-only measures.
• Measure #136 Melanoma: Follow-Up Aspects of Care;
• Measure #137 Melanoma: Continuity of Care—Recall System; and
• Measure #138 Melanoma: Coordination of Care.
• Measure #83 Hepatitis C: Testing for Chronic Hepatitis C—Confirmation of Hepatitis C Viremia;
• Measure #136 Melanoma: Follow-Up Aspects of Care;
• Measure #137 Melanoma: Continuity of Care—Recall System;
• Measure #138 Melanoma: Coordination of Care;
• Measure #139 Cataracts: Comprehensive Preoperative Assessment for Cataract Surgery with Intraocular Lens (IOL) Placement; and
• Measure #141 Primary Open-Angle Glaucoma (POAG): Reduction of Intraocular Pressure (IOP) by 15 percent OR Documentation of a Plan of Care.
The primary reason cited by commenters for opposing limiting certain measures to registry reporting is the lack of an available registry.
We do, however, agree with commenters' concerns about limiting Measures #139 and #141 to registry reporting. These measures were first introduced in the PQRI quality measure set for the 2009 PQRI and are currently available for claims and registry reporting for 2009. Keeping these measures as measures available for claims and registry reporting for 2010 will allow us to collect more data to analyze the measures' feasibility via claims reporting. Therefore, the measures are listed in Table 11 of this final rule with comment period as 2009 PQRI measures selected for the 2010 PQRI that are available for registry and claims reporting.
However, in response to the commenters' concern that there are only 2 2010 PQRI measures that apply to pediatric nephrologists and only 1 of them (that is, Measure #175) is available for claims-based reporting, eligible professionals who have fewer than 3 applicable measures can still participate in the 2010 PQRI via claims. Such eligible professionals would need to report on all applicable measures that are available for claims-based reporting via claims and meet the appropriate criteria for satisfactory reporting of individual measures in order to qualify for a 2010 PQRI incentive payment.
For the reasons discussed above and based on the comments received, we are finalizing in the 2010 PQRI quality measure set 24 of the 26 proposed 2009 PQRI measures identified in Table 18 of the proposed rule for registry reporting only. As stated above, 2 of the 26 2009 PQRI measures that were proposed to be available for registry reporting only for the 2010 PQRI (that is, Measure #139 and Measure #141), will be available for both registry and claims reporting in the 2010 PQRI and are listed in Table 11 of this final rule with comment period. In addition, we are also retaining 2 2009 PQRI measures that were proposed for retirement for 2010, but we are limiting reporting of these measures to registry reporting for the 2010 PQRI. The 26 2009 PQRI measures selected for the 2010 PQRI that are available for registry reporting only are listed in Table 12 of this final rule with comment period. The 26 individual 2009 PQRI measures selected for inclusion in the 2010 PQRI quality measure set as individual quality measures for registry-based reporting only are listed by their Measure Number and Title in Table 12, along with the name of the measure's developer/owner. A description of the measures listed in Table 12 can be found in the “2009 PQRI Quality Measures List,” which is available on the Measures and Codes page of the PQRI section of the CMS Web site at
Although we are designating certain measures as registry-only measures, we cannot guarantee that there will be a registry qualified to submit each registry-only measure for 2010. 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 2010, then an eligible professional would not be able to report that particular measure type.
We note also that detailed measure specifications, including a measure's title, for 2009 PQRI quality measures may have been updated or modified during the NQF endorsement process or for other reasons prior to 2010. Therefore, the 2010 PQRI quality measure specifications for any given quality measure may be different from specifications for the same quality measure used for 2009. Specifications for all 2010 individual PQRI quality measures, whether or not included in the 2009 PQRI program, must be obtained from the specifications document for 2010 individual PQRI quality measures, which will be available on the PQRI section of the CMS Web site on or before December 31, 2009.
We proposed to include in the 2010 PQRI quality measure set 30 measures that were not included in the 2009 PQRI quality measures provided that each measure obtains NQF endorsement by July 1, 2009 and its detailed specifications are completed and ready for implementation in PQRI by August 15, 2009. Besides having NQF endorsement, we proposed that the development of a measure is considered complete for the purposes of the 2010 PQRI if by August 15, 2009—(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, 2010.
Due to the complexity of their measure specifications, we proposed that 24 of these 30 measures would be available as registry-only measures for the 2010 PQRI. The remaining 6 measures were proposed to be available for reporting through either claims-based reporting or registry-based reporting.
The following is a summary of the comments received on the 30 new individual quality measures proposed for 2010.
• Functional Communication—Spoken Language Comprehension;
• Functional Communication—Attention;
• Functional Communication—Memory;
• Functional Communication—Motor Speech;
• Functional Communication—Reading;
• Functional Communication—Spoken Language Expression;
• Functional Communication—Writing;
• Functional Communication—Swallowing;
• Perioperative Temperature Management;
• Oncology: Cancer Stage Documented;
• Cataracts: 20/40 or Better Visual Acuity within 90 days following Cataract Surgery;
• Cataracts: Complications within 30 days following Cataract Surgery requiring Additional Surgical;
• Ischemic Vascular Disease (IVD): Blood Pressure Management Control;
• Stenosis Management in Cardiac Imaging Studies;
• Referral for Otologic Evaluation for Patients with Congenital or Traumatic Deformity of the Ear;
• Referral for Otologic Evaluation for Patients with History of Active Drainage from the Ear within the Previous 90 days;
• Referral for Otologic Evaluation for Patients with a History of Sudden or Rapidly Progressive Hearing Loss;
• Coronary Artery Disease (CAD): Symptom and Activity Assessment;
• Coronary Artery Disease (CAD): Drug Therapy for Lowering LDL–Cholesterol;
• Heart Failure: Left Ventricular Function (LVF) Assessment;
• Heart Failure: Patient Education; and
• Heart Failure: Warfarin Therapy for Patients with Atrial Fibrillation.
• Ischemic Vascular Disease (IVD): Blood Pressure Management Control.
• Ischemic Vascular Disease (IVD): Complete Lipid Profile.
• Ischemic Vascular Disease (IVD): Low Density Lipoprotein (LDL–C) Control.
• Ischemic Vascular Disease (IVD): Use of Aspirin or Another Anti-Thrombotic.
The measure specifications developed by the measure developer for the remaining 15 measures are too complex for claims-based reporting.
Based on the reasons discussed above and comments received, we are finalizing in the 2010 PQRI quality measure set all of 30 proposed 2010 PQRI measures identified in Table 19 of the proposed rule. Please note that 4 measures that were proposed to be available for registry only will be made available for either registry or claims reporting in the 2010 PQRI. These measures are:
• Ischemic Vascular Disease (IVD): Blood Pressure Management Control;
• Ischemic Vascular Disease (IVD): Complete Lipid Profile;
• Ischemic Vascular Disease (IVD): Low Density Lipoprotein (LDL–C) Control; and
• Ischemic Vascular Disease (IVD): Use of Aspirin or Another Anti-Thrombotic.
The titles of the 30 additional, or new, PQRI measures for 2010 are listed in Table 13 along with the name of the measure developer and the reporting mechanism(s) available (that is, whether the measure will be reportable using claims, registries, or both).
We note also that we are finalizing the following new measures for the 2010 PQRI even though they are still pending NQF endorsement and were not AQA adopted as of January 31, 2009:
• Referral for Otologic Evaluation for Patients with Congenital or Traumatic Deformity of the Ear;
• Referral for Otologic Evaluation for Patients with History of Active Drainage from the Ear within the Previous 90 days; and
• Referral for Otologic Evaluation for Patients with a History of Sudden or Rapidly Progressive Hearing Loss. As stated above, we are exercising our exception authority under section 1848(k)(2)(C)(ii) of the Act due to the lack of available measures for audiologists. Measures for audiologists represent a specific area for which there are a dearth of measures that have been endorsed by the NQF and/or adopted by the AQA.
We proposed to accept PQRI data from EHRs for a limited subset (10) of the proposed 2010 PQRI quality measures, contingent upon the successful completion of our 2009 EHR data submission testing process and a determination that accepting data from EHRs on quality measures for the 2010 PQRI is practical and feasible (74 FR 33582).
The following is a summary of the comments received on the proposed electronic submission of these 10 measures.
We should note that only eligible professionals using EHR systems that have been “qualified” by CMS by virtue of passing our self-nomination and testing process will be able to report their quality data to CMS via their EHR.
With respect to practices that have not implemented technology that would allow for electronic prescribing, we reiterate that the E-Prescribing Incentive Program is a separate and distinct incentive program for eligible professionals. Participation in the E-Prescribing Incentive Program is voluntary and is not required for participation in the 2010 PQRI. Details of the 2010 E-Prescribing Incentive Program can be found in section II.G.5. of this final rule with comment period.
Based on the reasons discussed above and the comments received, we are finalizing the option of accepting clinical quality data extracted from qualified EHRs on all 10 of the proposed 2010 PQRI quality measures identified in Table 20 of the proposed rule. The final 2010 measures available for EHR-based reporting are identified in Table 14 of this final rule with comment period.
We proposed to retain the 7 2009 PQRI measures groups for the 2010 PQRI: (1) Diabetes Mellitus; (2) CKD; (3) Preventive Care; (4) CABG; (5) Rheumatoid Arthritis; (6) Perioperative Care; and (7) Back Pain (74 FR 33582 through 33587). As in 2009, we proposed the CABG measures group would be reportable through the registry-based reporting mechanism only for 2010 while the remaining 6 2009 PQRI measures groups would be reportable through either claims-based reporting or registry-based reporting for the 2010 PQRI.
In addition to the 7 measures groups that we proposed to retain from the 2009 PQRI, we proposed 6 new measures groups for the 2010 PQRI, for a total of 13 CY 2010 measures groups. The 6 new measures groups proposed for the 2010 PQRI were: (1) Coronary Artery Disease (CAD); (2) Heart Failure; (3) Ischemic Vascular Disease (IVD); (4) Hepatitis C; (5) Human Immunodeficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS); and (6) Community Acquired Pneumonia (CAP). Since many of the 6 new measures groups proposed for 2010 contained proposed new registry-only measures, only 8 proposed 2010 measures groups would be reportable through either claims-based reporting or registry-based reporting: Diabetes Mellitus; CKD; Preventive Care; Perioperative Care; Rheumatoid Arthritis; Back Pain; Hepatitis C; and Community Acquired Pneumonia. We solicited comments on our proposal to limit claims-based reporting of measures groups in 2010.
Finally, we also proposed that except for the measures included in the Back Pain measures group, the measures included in any proposed 2010 measures group would be reportable either as individual measures or as part of a measures group. Similar to the 2009 PQRI, we proposed that the measures proposed for inclusion in the Back Pain measures group would be reportable only as part of a measures group and not as individual measures in 2010.
The measures proposed for inclusion in each of the proposed 2010 measures groups were identified in Tables 21 through 33 of the CY 2010 PFS proposed rule (74 FR 33582 through 33587).
The following is a summary of the comments received on the proposed 2010 measures groups.
Although we proposed that the IVD measures group would also be registry-only for 2010, we determined, based on comments that it is feasible to make the proposed registry-only measures proposed for inclusion in the IVD measures group available for either claims or registry reporting for 2010. Therefore, the IVD measures group will be available for either claims or registry reporting.
Based on the reasons discussed above and comments received, we are finalizing the following proposed 2010 measures groups: (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. The following 4 measures groups are reportable through the registry-based reporting mechanism only: (1) CABG; (2) CAD; (3) Heart Failure; and (4) HIV/AIDS. The IVD measures group is no longer limited to registry only reporting since 4 measures included in the group that were proposed to be registry-only measures are now available for either claims or registry reporting for 2010 (see section II.G.2.i.2. above).
The measures selected for inclusion in each of the 2010 measures groups are identified in Tables 15 through 27 of this final rule with comment period. Some measures selected for inclusion in these 6 measures group are current 2009 individual PQRI measures. The title of each such measure is preceded with its PQRI Measure Number in Tables 15 through 27. 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
In addition, some measures selected for inclusion in some of these measures groups for 2010 were not included in the measures groups in 2009. The 2009 measures selected for inclusion in a 2010 measures group that were not included in the measures group for 2009 are identified with an asterisk (*).
We also note that the proposed 2010 Heart Failure measures group included the measure Heart Failure: Warfarin Therapy for Patients with Atrial Fibrillation, which is not included in the final 2010 Heart Failure measures group. The measure does not meet the common denominator criteria for the Heart Failure measures group because it requires an additional denominator code for atrial fibrillation. This additional code is not in the other 7 measures included in the Heart Failure measures group. As stated previously, measures groups must have a particular condition or focus in common, as identified by the denominator definition and coding of the measures group.
As with measures group reporting in the 2008 and 2009 PQRI, each eligible professional electing to report a group of measures for 2010 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. The measures selected for the Back Pain measures group continue to be reportable only as part of a measures group and not as individual measures for the 2010 PQRI. Measures selected for inclusion in all other 2010 PQRI measures groups are reportable either as individual measures or as part of a measures group.
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 be provided separately from the specifications and instructions for the individual 2010 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 2010 measures groups that were also included as 2009 PQRI measures groups may be updated or modified prior to 2010. Therefore, the 2010 PQRI measure specifications for any given measures group could be different from specifications and submission instructions for the same measures group used for 2009. These measure specification changes do not materially impact the intended meaning of the measures or the strength of the measures.
In the CY 2010 PFS proposed rule (74 FR 33587), we invited commenters to submit suggestions for individual quality measures and measures groups (that is, suggestions for new measures groups and/or suggestions for the composition of measures groups) for consideration for possible inclusion in the proposed set of quality measures for use in the 2011 PQRI. We asked individuals or organizations submitting suggestions to provide us with the following information:
• Requestor contact information, such as name and title, organization/practice name, phone number and e-mail address;
• Measure title;
• Measure description;
• Measure owner/developer;
• NQF endorsement status, including the date of endorsement or anticipated endorsement (if not NQF-endorsed) and type of endorsement (for example, time-limited endorsement);
• AQA adoption status, including date of AQA adoption or anticipated AQA adoption;
• Preferred PQRI reporting option for the suggested measure(s) (that is, claims, registry, registry-only, measures group, measures group only, EHRs); and
• The measure specifications.
The following is summary of the comments we received regarding suggestions for individual quality measures and measures groups (that is, suggestions for new measures groups and/or suggestions) for the 2011 PQRI.
We proposed that physician groups selected to participate in the 2010 PQRI group practice reporting option would be required to report on 26 measures (74 FR 33587). These measures are NQF-endorsed measures currently collected
The following is summary of the comments we received regarding the proposed 2010 PQRI Quality Measures for physician groups selected to participate in the PQRI group practice reporting option.
• Measure #1 Diabetes Mellitus: Hemoglobin A1c Poor Control;
• Measure #5 Heart Failure: Angiotensin-Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) Therapy for Left Ventricular Systolic Dysfunction (LVSD);
• Measure #6 Coronary Artery Disease (CAD): Oral Antiplatelet Therapy Prescribed for Patients with CAD;
• Measure #7 Coronary Artery Disease (CAD): Beta-Blocker Therapy for CAD Patients with Prior Myocardial Infarction (MI);
• Measure #8 Heart Failure: Beta-Blocker Therapy for Left Ventricular Systolic Dysfunction (LVSD); Measure #118 Coronary Artery Disease (CAD): Angiotensin-Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) Therapy for Patients with CAD and Diabetes and/or Left Ventricular Systolic Dysfunction (LVSD);
• Heart Failure: Left Ventricular Function (LVF) Testing;
• Heart Failure: Left Ventricular Function (LVF) Assessment;
• Heart Failure: Weight Measurement;
• Heart Failure: Patient Education;
• Heart Failure: Warfarin Therapy for Patients with Atrial Fibrillation; and
• Coronary Artery Disease (CAD): Drug Therapy for Lowering LDL-Cholesterol.
Based on the reasons discussed above and after considering the comments, for the 2010 PQRI, group practices selected to participate in the PQRI group practice reporting option will be required to report on all measures listed in Table 28. To the extent that a measure is an existing PQRI measure available for reporting by individual eligible professionals, 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 2010 PQRI for purposes of the group practice reporting option.
A separate measures specifications manual and other supporting documents will be available for group practices participating in the 2010 PQRI group practice reporting option. We anticipate that the group practice measures specifications manual will be available by November 15, 2009 on the PQRI section of the CMS Web site at
Section 1848(m)(5)(G) of the Act, as added by the MIPPA, requires the Secretary to post on the CMS Web site, in an easily understandable format, a list of the names of eligible professionals (or group practices) who satisfactorily submitted data on quality measures for the PQRI and the names of the eligible professionals (or group practices) who are successful electronic prescribers. In accordance with section 1848(m)(5)(G) of the Act, we stated in the CY 2010 PFS proposed rule (74 FR 33588 through 33589) our intent to make public the names of eligible professionals and group practices that satisfactorily submit quality data for the 2010 PQRI on the Physician and Other Health Care Professionals Directory. In addition to posting the information required by section 1848(m)(5)(G) of the Act, for those group practices that are selected to participate in PQRI under the group practice reporting option, we also proposed to make the group practices' PQRI performance rates publicly available, for each of the measures. We solicited comments regarding our proposal to publicly report group practices' PQRI performance results.
The following is summary of the comments we received regarding the public reporting of PQRI data required under section 1848(m)(5)(G)(i) of the Act and our proposal to publicly report group practices' PQRI performance results.
• The errors identified with the 2007 PQRI have compromised the program's validity within the participant community;
• The program's plans to transition away from claims-based reporting may force eligible professionals who satisfactorily reported in the past to stop doing so;
• The potential for consumers to misunderstand the significance of the information being publicly reported since there are still many valid reasons why an eligible professional may not have participated or may have participated but was not considered a satisfactory reporter.
One commenter suggested that we consider alternative data sets for public reporting such as Board certification, CAHPS data, and/or a physician or other health care professional's participation in a registry. Other commenters requested that a formal evaluation of the 2007 and 2008 PQRI be conducted before releasing any participation, reporting, or performance rates.
• Establishing a process that allows for prior review and comment before data are made public and that allows for any comments received to be included with the publicly reported data;
• Establishing an appeals process with regard to any data that is to be publicly reported;
• Providing information outlining the data's potential uses and limitations;
• Providing information that clearly and specifically states that information about whether an eligible professional is a satisfactory reporter does not necessarily indicate that higher quality care was or will be provided by those eligible professionals (or group practices) who qualified to earn PQRI incentive payments;
• Providing better access to and more timely feedback;
• Avoiding characterization of the names of satisfactory reporters as comparative quality information; and
• Giving eligible professionals an opportunity to explain why they are not participating.
• Providing group practices the opportunity to suppress their data;
• Precisely defining what performance data CMS plans to post; and
• Conducting and publishing an evaluation of PQRI on its impact on quality of care before selecting measures for public reporting.
As stated in section II.G.2.g.1. above, however, we have taken the commenters' concerns about publicly reporting the group practices' performance results in the first year of implementation of the PQRI group practice reporting option into consideration. We are not finalizing our proposal to require group practices that wish to utilize the group practice reporting option in 2010 to agree to have their PQRI performance results publicly reported. In addition, we will not report any 2010 group practice performance results publicly at all except as otherwise required by law and will limit public reporting of information on the PQRI group practice reporting to the information required by section 1848(m)(5)(G)(i) of the Act (that is, the names of group practices that satisfactorily submitted data on PQRI quality measures). Instead, we will consider implementing public reporting of group practices' performance results in the 2011 PQRI program year.
• CMS only has the specific authority to publicly report the information
• There continue to be substantial gaps in the PQRI quality measure set that may create a barrier to participation in PQRI;
• The value of PQRI data is questionable since there has been no formal evaluation of the PQRI to determine its impact on the quality of care, whether it allows for fair and meaningful comparisons of performance on eligible professionals, and whether it is valid; and
• PQRI is not available to all specialties.
After considering the comments above, we intend to post the names of eligible professionals who: (1) Submit data on the 2010 PQRI quality measures through one of the reporting mechanisms available for the 2010 PQRI; (2) meet one of the proposed satisfactory reporting criteria of individual measures or measures groups for the 2010 PQRI; and (3) qualify to earn a PQRI incentive payment for covered professional services furnished during the applicable 2010 PQRI reporting period for purposes of satisfying the requirements under section 1848(m)(5)(G)(i) of the Act, on the Physician and Other Health Care Professionals Directory.
Similarly, for purposes of satisfying the requirements under section 1848(m)(5)(G)(i) of the Act with respect to group practices, on the Physician and Other Health Care Professionals Directory, we intend to post the names of group practices that: (1) Submit data on the 2010 PQRI quality measures through the proposed group practice reporting option; (2) meet the proposed criteria for satisfactory reporting under the group practice reporting option; and (3) qualify to earn a PQRI incentive payment for covered professional services furnished during the applicable 2010 PQRI reporting period for group practices.
We do not intend to make performance rates for group practices participating in the 2010 PQRI group practice reporting option publicly available but anticipate publicly reporting group practices' performance results for the 2011 PQRI program year.
We anticipate that information with respect to quality data submitted for the 2010 PQRI (that is, the names of individual eligible professionals and group practices that satisfactorily report in 2010) will not be available until after the 2010 incentive payments are paid in 2011.
As required under section 1848(n) of the Act, as added by section 131(c) of the MIPPA, we established and implemented by January 1, 2009, the Physician Resource Use Measurement & Reporting Program for purposes of providing confidential reports to physicians that measure the resources involved in furnishing care 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.
As stated in the CY 2009 PFS final rule with comment period (73 FR 69866), the Program would consist of multiple phases. We included a summary of the activities of phase I of the Program in the CY 2009 PFS final rule with comment period (73 FR 69866 through 69869). In addition to discussing phase I of the Program, we also highlighted the activities of several other initiatives, including Medicare Value-Based Purchasing (VBP) programs and demonstrations and related activities undertaken by the MedPAC and the Government Accountability Office (GAO). We refer readers to the CY 2009 PFS final rule with comment period (73 FR 69866 through 69869) for a detailed discussion of these activities.
In the CY 2009 PFS final rule with comment period (73 FR 69866 through 69869), we finalized, on an interim basis, the following parameters for phase I of the Program: (1) Use of both per capita and episode of care methodologies for resource use measurement; (2) cost of service category analysis (for example, imaging services or inpatient admissions); (3) use of 4 calendar years of claims data; (4) focus on high cost and/or high volume conditions; (5) reporting to physician specialties relevant to the selected focal conditions; (6) focus on physicians practicing in certain geographic areas, and (7) low, median, and high cost benchmarks.
In the CY 2010 PFS proposed rule (74 FR 33589 through 33591), we summarized the comments received from the CY 2009 PFS final rule with comment period and our responses. Further, we made the following proposals in the CY 2010 PFS proposed rule (74 FR 33591): (1) Reporting on quality measures in addition to resource use measures, and (2) reporting to groups of physicians in addition to individual physicians.
As indicated above, the Program consists of multiple phases. Under this approach, each phase of the Program will inform future phases of the Program. We refer readers to the CY 2009 PFS final rule with comment period (73 FR 69866 through 69869) for a description of phase I Program activities. Using the parameters that were finalized on an interim basis, we have disseminated approximately 310 resource use reports (a sample report is available at
Commenters supported the Program parameters that were finalized on an interim basis in the CY 2009 PFS final rule (73 FR 69866 through 69869). Our summary of those comments and our responses are contained in the CY 2010 PFS proposed rule (74 FR 33589 through 33591). Accordingly, we are finalizing the interim final Program parameters.
In addition to the eight conditions finalized on an interim basis in the CY 2009 PFS final rule(74 FR 33590), we solicited public comment on adding diabetes as an episode of care.
In the CY 2010 PFS proposed rule (74 FR 33591), we referred readers to the following Web site to review a de-identified sample of the resource use reports disseminated to physicians:
In the CY 2010 PFS proposed rule, we referred readers to two publicly available Web sites for commercial episode grouper vendors regarding transparency of their methodologies (74 FR 33591). We solicited public comment on the use of proprietary products to measure episodes of care in the Program.
For phase II, we proposed to expand the Program in ways that that targets specific performance areas for physicians. We proposed to add reporting to groups of physicians, recognizing that many physicians practice in arrangements other than solo practices. We noted that group level reporting will be more likely to resolve the sample size issues that arise when individual physicians have too few Medicare beneficiaries with specific conditions to generate statistically significant information. We solicited public comment on potential types of groups including the following: (1) Formally-established single or multi-specialty group practices; (2) physicians practicing in defined geographic regions; and (3) physicians practicing
This definition applies to the following 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. With respect to ACOs, the term is not defined at this time in either the law or regulations but to the extent that the ACO includes more than one physician, the physicians in the ACO would constitute a group for resource use reporting. We are therefore, finalizing the definition for group practices and these three types of groups of physicians.
Phase I of the Program focused on providing confidential feedback on resource use measures. Section 1848(n)(1)(A) of the Act states that the Secretary may also include information on the quality of care furnished to Medicare beneficiaries by physicians (or groups of physicians) in the feedback reports. Providing physicians with feedback on both quality and cost of care better captures the value of the care provided. Including quality measures in the Program is consistent with the direction for other CMS VBP initiatives. We solicited public comments on the use of PQRI, GEM, and other aggregate quality measures to be used in the Physician Resource Use Measurement and Reporting Program.
In addition to the areas where we specifically solicited comments, we also received several general comments.
Value-based purchasing uses payment incentives and transparency to increase the value of care by rewarding providers for higher quality and more efficient services and for publicly reporting performance information. Section 131(d) of the MIPPA requires the Secretary to develop a plan to transition to a value-based purchasing (VBP) program for Medicare payment for covered professional services made under, or based on, the PFS. Section 131(d) of the MIPPA also states that by May 1, 2010, the Secretary shall submit a report to the Congress, containing the plan, together with recommendations for such legislation and administrative action as the Secretary determines appropriate. The Secretary, through the Physician and Other Health Professional VBP (PVBP) Workgroup, submitted a progress letter to Congress on January 8, 2009 detailing the progress made on the PVBP plan for physicians and other professionals.
Currently, Medicare health professional payments are based on quantity of services and procedures provided, without recognition of quality or efficiency. Under various authorities, we have pursued the implementation of building blocks to support the establishment of a VBP program for health professionals. These include initiatives in the following major topic areas: quality and efficiency measurement and reporting, approaches for aligning incentives with providing higher quality care instead of higher volume of care, care coordination, prevention, and health information technology (HIT). The following are examples of the initiatives specifically relevant to physicians and other health professionals:
• Pay for reporting of quality measurement data instituted under the Physician Quality Reporting Initiative (PQRI);
• Resource use reports comparing overall costs, as well as costs for treatment across episodes of care, as required by the Physician Resource Use Measurement and Reporting Program; and
• Demonstration projects including the Physician Group Practice demonstration of a shared savings model, gainsharing demonstrations, medical home and other care coordination and disease management demonstrations, and the Acute Care Episodes demonstration of a bundled payment model.
We are fully committed to implementing VBP incentives to drive quality improvement and greater efficiency for services furnished to Medicare beneficiaries.
We have created an internal cross-component team, the PVBP Steering Committee (formerly referred to as PVBP Workgroup), to lead development of the PVBP plan. Four Subgroups were established to address the major sections of the Plan: measures; incentives; data strategy and infrastructure; and public reporting. The PVBP Steering Committee was tasked with reviewing the state-of-the-art in performance-based payment for physicians, including relevant Medicare programs and demonstrations and private sector initiatives; preparing an Issues Paper to present program objectives and design principles; engaging stakeholders and obtaining input on program design; and developing the PVBP Plan and Report to Congress. A similar approach was used in the development of the CMS Hospital VBP Plan.
To guide the planning process, the PVBP Steering Committee adopted the following goal to improve Medicare beneficiary health outcomes and experience of care by using payment incentives and transparency to encourage higher quality, more efficient professional services. In pursuit of this goal, the Workgroup has defined the following objectives:
• Promote evidence-based medicine through measurement, payment incentives, and transparency.
• Reduce fragmentation and duplication through accountability across settings, alignment of measures and incentives across settings, better care coordination for smoother transitions, and attention to episodes of care.
• Encourage effective management of chronic disease by improving early detection and prevention, focusing on preventable hospital readmissions, and emphasizing the importance of advanced care planning and appropriate end-of-life care.
• Accelerate the adoption of effective, interoperable HIT, including clinical registries, e-prescribing, and electronic health records.
• Empower beneficiaries to make value-based health care choices, and encourage health professionals to improve the value of care they provide by disseminating information designed to help them change their practice patterns to improve performance.
The goal and objectives were captured in an Issues Paper that was posted on the CMS Web site on November 24, 2008, in preparation for the December 9, 2008 Listening Session which was held at CMS headquarters. The Issues Paper included questions seeking public input on key design considerations. The Issues Paper is available on the CMS Web site at
Building on input from the Listening Session on the Issues Paper topics, the PVBP Steering Committee has begun to develop potential recommendations for inclusion in the Report to Congress. The first step is to design various approaches for performance-based payment that will address the planning goal and objectives for different practice arrangements. This design process will include identifying appropriate measures and incentive structures, considering the necessary data infrastructure, and addressing public reporting options. Consideration will be given to approaches that:
(1) Overlay the current PFS, such as differential fee schedule payments based on measured performance;
(2) Address multiple levels of accountability, including individual health professionals, as well as larger care teams or organizations made up of a variety of health professionals and facilities; and
(3) Promote more integrated care through shared savings models and bundled payment arrangements.
In the proposed rule, we solicited public comment on the development of the PVBP plan and Report to Congress. We specifically requested for comments on two topics: (1) the appropriate level at which to hold practitioners accountable (for example, individuals or groups); and (2) appropriate data submission mechanisms. We received comments on these topics, as well as comments on other issues we should consider when developing the PVBP Report to Congress. The following is summary of the comments we received regarding section 131(d) of the MIPPA.
We received other comments that were outside the scope of the proposed rule, and are therefore not discussed in this final rule with comment period.
As described in the CY 2010 PFS proposed rule (74 FR 33593 through 33600), section 1848(m)(2) of the Act, as amended by section 132 of the MIPPA, promotes the use of electronic prescribing by authorizing incentive payments to eligible professionals or group practices who are “successful electronic prescribers.” This E-Prescribing Incentive Program is expected to encourage significant expansion of the use of electronic prescribing by authorizing a combination of financial incentives and payment adjustment and is separate from, and in addition to, any incentive payment that eligible professionals may earn through the PQRI program. Individual eligible professionals do not have to participate in PQRI in order to participate in the E-Prescribing Incentive Program (and vice versa).
For 2010, which is the second year of the E-Prescribing 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 2.0 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 2010 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 eligible professional. The applicable electronic prescribing percent (2.0 percent) authorized for the 2010 E-Prescribing Incentive Program is the same as that authorized for the 2009 E-Prescribing Incentive Program.
We received several comments from the public on the CY 2010 PFS proposed rule related to the E-Prescribing Incentive Program. General comments about the E-Prescribing Incentive Program are addressed immediately below.
With respect to the suggestion to make information about potential incentive payment amounts available, we are concerned that doing so may be misleading since incentive payments will differ for each eligible professional based on his or her Medicare Part B PFS allowed charges for covered
As we stated in the CY 2009 PFS proposed rule (74 FR 33549), we will discuss the application of the payment adjustment in future notice and comment rulemaking. We will address the circumstances under which the hardship exemption applies at that time.
Section 1848(m)(6)(C)(i)(II) of the Act defines “reporting period” for the 2010 E-Prescribing 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 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. In the CY 2010 PFS proposed rule (74 FR 33594 through 33595), we proposed that the 2010 E-Prescribing Incentive Program reporting period would be the entire calendar year (January 1, 2010–December 31, 2010).
After considering these comments, we are finalizing the entire calendar year as
Under section 1848(m)(3)(B) of the Act, in order to qualify for the incentive payment, an eligible professional 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 eligible professional'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 eligible professional 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(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 eligible professional 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 eligible professionals. 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 2010, we proposed to continue to require eligible professionals to report on the electronic prescribing measure used in the 2009 E-Prescribing Incentive Program to determine whether an eligible professional is a successful electronic prescriber, but we proposed to modify the measure's specifications and to use modified reporting criteria based on the authority provided under section 1848(m)(3)(D) of Act, as discussed below.
For 2010, we proposed to make 3 reporting mechanisms available to individual eligible professionals to report the electronic prescribing measure. First, we proposed to retain the claims-based reporting mechanism that is used in the 2009 E-Prescribing Incentive Program. In addition, similar to the PQRI, for the E-Prescribing Incentive Program, we proposed to implement a registry-based reporting mechanism and, depending on whether we finalize the proposed EHR-based reporting mechanism for PQRI, we also proposed that an EHR-based reporting mechanism be available for the electronic prescribing measure.
We proposed that only registries qualified to submit quality measure results and numerator and denominator data on quality measures on behalf of eligible professionals for the 2010 PQRI would be qualified to submit measure results and numerator and denominator data on the electronic prescribing measure on behalf of eligible professionals for the 2010 E-Prescribing Incentive Program. Similarly, we proposed that only EHR products “qualified” to potentially be able to submit clinical quality data extracted from the EHR to CMS for the 2010 PQRI would be considered “qualified” for the purpose of an eligible professional potentially being able to submit data on the electronic prescribing measure for the 2010 E-Prescribing Incentive Program.
We solicited comments on our proposal to provide alternatives to the claims-based reporting mechanism for reporting the electronic prescribing measure, as well as on our proposal to limit the registries and EHR products qualified to submit the electronic prescribing measure for the 2010 E-Prescribing Incentive Program to those that are qualified registries and EHR products, respectively, for the 2010 PQRI.
All commenters supported having alternatives to the claims-based reporting mechanism for reporting the electronic prescribing measure. All commenters were also in agreement that only registries qualified to submit quality measure results and numerator and denominator data on quality measures on behalf of eligible professionals for the 2010 PQRI and EHR products “qualified” to submit clinical quality data extracted from the EHR to CMS for the 2010 PQRI be considered “qualified” for the purpose of an eligible professional being able to submit data on the electronic prescribing measure for the 2010 E-Prescribing Incentive Program. Based on these comments, we are finalizing our proposal that for the 2010 E-Prescribing Incentive Program, eligible professionals will be able to choose whether to submit data on the electronic prescribing measure through claims, a qualified registry, or a qualified EHR product.
Only registries qualified to submit quality measure results and numerator and denominator data on quality measures on behalf of eligible professionals for the 2010 PQRI will be qualified to submit measure results and numerator and denominator data on the electronic prescribing measure on behalf of eligible professionals for the 2010 E-Prescribing Incentive Program. We will post a list of qualified registries for the 2010 E-Prescribing Incentive Program on the E-Prescribing Incentive Program section of the CMS Web site at
Similarly, only EHR products “qualified” to submit clinical quality data extracted from the EHR to CMS for the 2010 PQRI will be considered “qualified” for the purpose of an eligible professional being able to submit data on the electronic prescribing measure for the 2010 E-Prescribing Incentive Program. As stated in section II.G.2.d.3. of this final rule with comment period, 2009 EHR Testing Program is underway. Therefore, we cannot guarantee that any of the EHR vendors that self-nominated to have one or more of their EHR products “qualified” for the PQRI will successfully complete the testing process and therefore, be eligible for participation as a qualified EHR vendor the E-Prescribing Incentive Program. An EHR vendor will need to indicate its intention to have one or more of their EHR products qualified for the purpose of an eligible professional potentially being able to submit data on the electronic prescribing measure for the 2010 E-Prescribing Incentive Program at the time that they are being vetted for the 2010 PQRI. We will post a list of qualified EHR vendors and products for the 2010 E-Prescribing Incentive Program on the E-Prescribing 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 eligible professional 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 proposed to expand 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 proposed to add the following CPT codes to the denominator of the electronic prescribing measure for 2010: 90862, 99304; 99305; 99306; 99307; 99308; 99309; 99310; 99315; 99316; 99341; 99342; 99343; 99344; 99345; 99347; 99348; 99349; and 99350. We solicited comments on the proposed changes to codes identified for the electronic prescribing measure denominator.
The following is a summary of the comments we received regarding the proposed denominator codes for the 2010 electronic prescribing measure.
Accordingly, we are finalizing the following denominator codes for the 2010 electronic prescribing measure: 90862; 99304; 99305; 99306; 99307; 99308; 99309; 99310; 99315; 99316; 99324; 99325; 99326; 99327; 99328; 99334; 99335; 99336; 99337; 99341; 99342; 99343; 99344; 99345; 99346; 99347; 99348; 99349; and 99350. 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). Eligible professionals are not required to report this measure in all cases in which the measure is reportable. Eligible professionals 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.
By December 31, 2009, we will post the final specifications of the measure on the “E-Prescribing Measure” page of the E-Prescribing Incentive Program section of the CMS Web site at
To report the electronic prescribing measure in 2010, we proposed that the eligible professional must report one of the measure's numerator “G” codes (74 FR 33597). However, when reporting any of the G-codes for purposes of qualifying for the incentive payment for electronic prescribing in 2010, we proposed that the professional must have and regularly use a “qualified” electronic prescribing system, as defined in the electronic prescribing measure specifications.
(a) Generate a complete active medication list incorporating electronic data received from applicable pharmacies and PBMs, if available.
(b) Allow eligible professionals 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.
(c) 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 suffice for this requirement for 2010 and until this function is more widely available in the marketplace.
(d) 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 eligible professionals 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:
(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;
(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.
There are, however, 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 E-Prescribing 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 2010 Electronic Prescribing Program and incentive payments, we did not propose 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 proposed that a “qualified” system must use the adopted Part D electronic prescribing standards for electronic messaging.
The following is a summary of the comments we received regarding the proposed required functionalities and Part D electronic prescribing standards for a qualified electronic prescribing system for 2010.
• Use computerized physician order entry (CPOE) for all orders;
• Implement drug/drug, drug/allergy, drug/formulary checks;
• Generate and transmit permissible prescriptions electronically;
• Maintain active medication lists; and
• Maintain active medication allergy lists.
After considering the comments, we are finalizing as the required functionalities for a qualified electronic prescribing system for 2010 those outlined in the section above entitled “Required Functionalities for a `Qualified' Electronic Prescribing System.” In addition, for each required functionality of a qualified system, the system must use the adopted Part D electronic prescribing standards for electronic messaging listed above in the section entitled “Part D Electronic Prescribing Standards.”
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 E-Prescribing 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 eligible professionals who are interested in earning the incentive payment, 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. If the professional does not have general access to an electronic prescribing system in the practice setting, there is nothing to report and the eligible professional would not be able to participate in the E-Prescribing Incentive Program.
Currently, to report for an applicable case where 1 of the denominator codes is billed for Part B covered professional services, an eligible professional must report 1 of 3 G-codes specified in the electronic prescribing measure.
For 2010, we proposed to modify the first G-code (G8443) to indicate that at least 1 prescription in connection with the visit billed was electronically prescribed (74 FR 33597). In addition, we proposed to eliminate the 2 remaining G-codes from the measure's numerator: G8445: Qualified E-prescribing System Available, but no Prescription(s) were Generated During the Encounter; and G8446: E-prescribing System Available, but not Used for One or More Prescriptions Due to Patient/System Reasons. We solicited comments on the proposed modifications to the electronic prescribing measure numerator.
The following is a summary of the comments we received regarding the proposed reporting numerator for the electronic prescribing measure for 2010.
The criteria for successful reporting we are finalizing for 2010 are designed to reward those eligible professionals 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 as to 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 2010 electronic prescribing measure, we are finalizing the following numerator G-code: Gxxxx: At least 1 prescription created during the encounter was generated and transmitted electronically using a qualified electronic prescribing system.
A new G-code will be assigned by CMS to the above code for 2010 and will be included in the measure's specifications, which we will post on the “E-Prescribing Measure” page of the E-Prescribing Incentive Program section of the CMS Web site at
Because the electronic prescribing quality measure will apply only when an eligible professional 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 eligible professional 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 eligible professional 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 eligible professional furnishes services indicated by one of the G-codes included in the measure's numerator. That is, only when at least 1 prescription created during the encounter was generated and transmitted electronically using a qualified electronic prescribing system.
As discussed above, section 1848(m)(3)(B)(ii) of the Act specifies that an eligible professional shall be treated as a successful electronic prescriber for a reporting period based on the eligible professional's reporting of the electronic prescribing measure in at least 50 percent of applicable cases. For 2010, however, we proposed to exercise our authority under section 1848(m)(3)(D) of the Act to revise the criteria for submitting data on the electronic prescribing measure (74 FR 33598). For 2010, rather than requiring that the electronic prescribing measure be reported for a certain proportion of reportable cases, we proposed to make the determination of whether an eligible professional is a successful electronic prescriber based on a count of the number of times (minimum threshold of 25) an eligible professional reports that at least one prescription created during the encounter was generated using a qualified electronic prescribing system. We solicited comments on the proposed criteria for determination of successful electronic prescriber.
The following is a summary of the comments we received regarding the proposed criteria for determination of successful electronic prescriber for the 2010 E-Prescribing Incentive Program.
Some commenters suggested that in lieu of a fixed threshold, we establish a percent threshold based upon the percent of eligible cases in 2009. Another commenter suggested that if an eligible professional has an electronic prescribing system, he or she should be using the system for all prescriptions. Other commenters suggested a threshold of 250–500 electronic prescribing events during the reporting period.
We agree with commenters that some eligible professionals may be able to meet the criteria for successful reporting in a matter of a few days or weeks. However, in establishing the threshold of 25 electronic prescribing events, we also took into account the many valid circumstances that would prevent eligible professionals who have adopted a qualified electronic prescribing system from having 25 electronic prescribing events during the calendar year and variations in practice characteristics. In addition to the patient-related, system-related, or legal reasons that were formerly addressed by reporting the G8446 code for the measure, some eligible professionals may have few opportunities to report the electronic prescribing measure since they generate a low volume of prescriptions, have few Medicare patients, infrequently provide the services included in the measure's denominator, or a combination of these factors.
After considering the comments, for 2010, an eligible professional will be required to report the electronic prescribing measure at least 25 times during the reporting period for purposes of meeting the criteria for successful electronic prescriber and qualifying to earn the electronic prescribing incentive (subject to the limitation required under section 1848(m)(2)(B) of the Act). In other words, an eligible professional will be required to report that he or she
As stated previously, by December 31, 2009, we will post the final specifications of the measure on the “E-Prescribing Measure” page of the E-Prescribing 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 eligible professional during the reporting period. The second criterion, under section 1848(m)(2)(B)(ii) of the Act, is based on whether the eligible professional submits (both electronically and nonelectronically) 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 future application of the payment adjustment.
Based on our proposal to make the determination of whether an eligible professional is a “successful electronic prescriber” based on submission of the electronic prescribing measure, we proposed to apply the criterion under section 1848(m)(2)(B)(i) of the Act for the limitation for the 2010 E-Prescribing Incentive Program.
The following is a summary of the comments we received regarding the proposed criterion for the limitation.
Since, as discussed above, we are finalizing for 2010 our proposal to make the determination of whether an eligible professional is a “successful electronic prescriber” based on submission of the electronic prescribing measure, we also are finalizing our proposal to analyze the claims submitted by the eligible professional 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 2010 by an eligible professional. This calculation is expected to take place in the first quarter of 2011 and will be performed by dividing the eligible professional's total 2010 Medicare Part B PFS allowed charges for all such covered professional services submitted for the measure's denominator codes by the eligible professional'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 eligible professional 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 2010 reporting period. Although an individual eligible professional 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 eligible professional may report the electronic prescribing measure without regard to the statutory limitation for the incentive payment.
In the CY 2010 PFS proposed rule (74 FR 33599 through 33600), we discussed making incentive payments to group practices based on the determination that the group practice, as a whole (that is, the TIN), is a successful electronic prescriber for 2010, as required under section 1848(m)(3)(C)(i) of the Act. In addition, we noted that 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 eligible professionals in the group practice for being a successful electronic prescriber.
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, we proposed that a “group practice” would consist of a physician group practice, as defined by a TIN, with at least 200 or more individual eligible professionals (or, NPIs) who have reassigned their billing rights to the TIN (74 FR 33599). In addition, we proposed to limit the group practices eligible to participate in the 2010 E-Prescribing Incentive
The following is a summary of the comments received regarding our proposed definition of “group practice”.
In order for a group practice to participate in the electronic prescribing group practice reporting option for 2010, the group practice must be one that is selected to participate in the PQRI group practice reporting option, which requires that group practices have 200 or more eligible professionals. Group practices cannot solely participate in the electronic prescribing group practice reporting option. A group practice can choose to participate in: (1) both the PQRI group practice reporting option and the electronic prescribing group practice reporting option; (2) the PQRI group practice reporting option but participate in the E-Prescribing Incentive Program as individual eligible professionals; or (3) the PQRI group practice reporting option but not participate in the E-Prescribing Incentive Program at all.
We will use this initial implementation year to explore and refine the group practice reporting option and anticipate expanding this option to group practices with less than 200 individual eligible professionals in future program years.
For those group practices who choose to participate in both the PQRI and electronic prescribing group practice reporting option, it is important to note that the electronic prescribing measure is not reportable using the PQRI group practice reporting option data collection tool. The electronic prescribing measure is reportable via the same reporting mechanisms that are available to individual eligible professionals participating in the 2010 E-Prescribing Incentive Program (that is claims, a qualified registry, or a qualified EHR).
In an attempt to ensure the group practices have sufficient time to become acclimated to the PQRI group practice reporting option, for the 2010 PQRI, the group practice will be notified of the selection decision to participate in the PQRI group practice reporting option no later than the second quarter of 2010. Training on the data collection tool is projected to be provided in the third quarter of 2010. The group practice will not be expected to complete and return the data collection tool until the end of the first quarter of 2011.
For the 2010 E-Prescribing Incentive Program, we proposed requiring that reporting of the electronic prescribing measure by group practices would occur under the same data submission timeline as reporting of the electronic prescribing measure by individual eligible professionals. The proposed reporting mechanisms for the electronic prescribing measure would be the same regardless of whether an eligible professional is participating individually or as a group practice. Furthermore, the electronic prescribing measure was not proposed to be reportable via the PQRI group practice reporting option data collection tool.
To summarize, based on these comments, for purposes of the 2010 E-Prescribing Incentive Program, we are finalizing a group practice reporting option that will consist of “group practice” being defined as a TIN with at least 200 or more individual eligible professionals (as identified by NPIs) who have reassigned their billing rights to the TIN and who are participating in the 2010 PQRI group practice reporting option. Therefore, unlike individual eligible professionals who are not required to participate in the PQRI, to be eligible to earn an electronic prescribing incentive in 2010, 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. Participation in the E-Prescribing Incentive Program, including participation in the electronic prescribing group practice reporting option is, however, optional for group
Group practices interested in participating in the 2010 PQRI through the group practice reporting option are required to submit a self-nomination letter to CMS, requesting to participate in the 2010 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, 2009. A group practice that wishes to participate in the E-Prescribing Incentive Program group practice reporting option will be notified of the selection decision to participate in the E-Prescribing 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 eligibility requirements discussed in section II.G.5.e.1. of this final rule with comment period, a group practice that wishes to participate in the 2010 E-Prescribing 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 2010 E-Prescribing Incentive Program group practice reporting option.
For group practices selected to participate in the electronic prescribing group practice reporting option for 2010, we proposed the reporting period would be January 1, 2010 to December 31, 2010 (74 FR 33599 through 33600).
We proposed that physician groups selected to participate in the 2010 E-Prescribing Incentive Program through the group practice reporting option would be able to choose to report the electronic prescribing measure through the claims-based, the registry-based, or, contingent upon us finalizing this reporting mechanism for the 2010 PQRI, the EHR-based reporting mechanism.
In order for a group practice to be considered a successful electronic prescriber, we proposed that the group practice would have to report that at least 1 prescription during an encounter was generated using a qualified electronic prescribing system in at least 2,500 instances during the reporting period. We solicited comments on the proposed criteria for determining whether a group practice is a successful electronic prescriber. We also invited feedback on our underlying assumptions.
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 eligible professionals. Therefore, in determining whether a group practice will receive an electronic prescribing incentive payment for 2010 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.
The following is a summary of the comments we received regarding the proposed process for group practices to participate as group practices and criteria for successful reporting of the electronic prescribing measure by group practices.
For the reasons mentioned above and after considering the comments, we are finalizing for the 2010 E-Prescribing Incentive Program the group practice reporting option discussed above. Specifically, group practices will be required to report the 2010 electronic prescribing measure at least 2,500 times during the reporting period in order for the group practice to be considered a successful electronic prescriber.
Group practices will be able to choose to report the electronic prescribing
In addition, in determining whether a group practice will receive an electronic prescribing incentive payment for 2010 by meeting the reporting criteria described above, we will determine whether the 10 percent threshold is met based on our analysis of the claims submitted by the group practice during the reporting period. This calculation is expected to take place in the first quarter of 2011 and will be determined by dividing the group practice's total 2010 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 will not apply and a group practice that is determined to be 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 group practice will not qualify to earn the electronic prescribing incentive payment.
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 eligible professionals (or group practices) who satisfactorily submit data on quality measures for the PQRI and the names of the eligible professionals (or group practices) who are successful electronic prescribers. As required by section 1848(m)(5)(G) of the Act, we proposed to make public the names of eligible professionals and group practices who are successful electronic prescribers for the 2010 E-Prescribing Incentive Program on the Physician and Other Health Care Professionals Directory.
The following is summary of the comments we received regarding requirements under section 1848(m)(5)(G) of the Act with respect to the E-Prescribing Incentive Program.
• The E-Prescribing Incentive Program is voluntary and excludes many eligible professionals;
• A formal independent evaluation of the E-Prescribing Incentive Program's processes and an analysis and validation of the data gathered needs to be conducted prior to any information being publicly released;
• CMS needs to provide eligible professionals with better access and feedback to the quality data they report (especially feedback on why they failed to report successfully) before the release of any information;
• There is little to be gained from this effort since eligible professionals and patients do not fully understand the details of the program and are still learning about this program;
• Patients may not understand the purpose for posting this information since the program is still new; and
• The criteria for becoming a successful electronic prescriber are changing from 2009 to 2010.
Eligible professionals who have concerns about their results or any other information included on their feedback reports are encouraged to contact the QualityNet Help Desk at (866) 288–8912 or
After considering the comments, we will publicly report the names of eligible professionals and group practices who are successful electronic prescribers for the 2010 E-Prescribing Incentive Program on the Physician and Other Health Care Professionals Directory. We anticipate that the names of individual eligible professionals and group practices who are successful electronic prescribers for the 2010 E-Prescribing Incentive Program will be available in 2011 after the 2010 incentive payments are paid.
Although we stated in the CY 2009 PFS proposed rule (74 FR 33600) and the CY 2008 PFS final rule with comment period (73 FR 69852) that we intended to post the names of individual eligible professionals who meet the criteria for successful electronic prescriber and for whom the limitation does not apply (in other words, eligible professionals who qualify to earn an incentive payment), we would like to clarify that for purposes of publicly reporting the names of individual eligible professionals on the Physician and Other Health Care Professionals Directory, section 1848(m)(5)(G) of the Act requires only that the Secretary post the names of eligible professionals (or group practices) who are successful electronic prescribers. Therefore, with respect to the 2010 E-Prescribing Incentive Program we intend to post the names of individual eligible professionals who report the electronic prescribing measure at least 25 times during the 2010 reporting period for patient encounters included in the measure's denominator, without regard to whether the limitation applied to the eligible professional and without regard to whether the eligible professional actually qualified to earn an incentive payment. In addition, since the PQRI and the E-Prescribing Incentive Program are two separate incentive programs and individual eligible professionals are not required to participate in both programs to earn an incentive under either program, we point out that it is possible for an eligible professional who participates in both incentive programs to be listed both as an individual eligible professional who satisfactorily submits data on quality measures for the PQRI and is a successful electronic prescriber under the E-Prescribing Incentive Program. Likewise, an individual eligible professional may be listed as an individual eligible professional who satisfactorily submits data on quality measures for the PQRI but not as a successful electronic prescriber under the E-Prescribing 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 and Other Health Care Professionals Directory, we intend to post the names of group practices who report the electronic prescribing measure at least 2,500 times during the 2010 reporting period for patient encounters included in the measure's denominator without regard to whether the limitation applied to the group practice or whether the group practice actually qualified to earn an incentive payment. Although any group practice participating in the E-Prescribing Incentive Program under the group practice reporting option would have had to also participate in the 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 E-Prescribing Incentive Program, or vice versa.
Section 1834(e) of the Act, as added by section 135(a) of the MIPPA, requires that beginning January 1, 2012, Medicare payment may only be made for the technical component (TC) of advanced diagnostic imaging services for which payment is made under the fee schedule established in section 1848(b) of the Act to a supplier who is accredited by an accreditation organization (AO) designated by the Secretary.
In the proposed rule, we proposed criteria for designating organizations to accredit suppliers furnishing the TC of advanced diagnostic imaging services as specified in section 1834(e) of the Act. In addition, we proposed the required procedures to ensure that the criteria used by an AO meets minimum standards for each imaging modality in § 414.68.
We did not propose any substantive standards that suppliers furnishing the TC of advanced imaging would have to meet. We have chosen to utilize clinical guidelines that are already accepted by the experienced accreditation organizations already performing accreditation. We believe that the suppliers should be able to assimilate these new accreditation requirements very easily into their medical practice.
We will be designating organizations based on, at minimum, their ability to meet the requirements set forth in the statute. In addition, in this rule we have
As proposed, the CMS-designated AO would apply standards that set qualifications for medical personnel who are not physicians but who furnish the TC. The standards would describe the qualifications and responsibilities of medical directors and supervising physicians. including the following: recognizing whether a particular medical director or supervising physician received training in advanced imaging services in a residency program; and has attained, through experience, the necessary expertise to be a medical director or supervising physician; has completed any continuing medical education courses related to advanced imaging services; or has met such other standards as the Secretary determines appropriate.
In addition, the standards would require suppliers to: (1) Establish and maintain a quality control program to ensure the technical quality of diagnostic images produced by the supplier; (2) ensure the equipment used meets performance specifications; and (3) ensure safety of personnel. While the statute authorizes the Secretary to establish as criteria for accreditation any other standards or procedures the Secretary determines appropriate, we did not propose to establish other standards or procedures.
In the proposed rule, we also stated that we expect to publish a notice to solicit applications from entities for the purposes of becoming a designated AO the same day that this final rule with comment period is issued. We still expect to meet the January 1, 2010 statutory deadline in order to designate organizations to accredit suppliers furnishing the TC of advanced diagnostic imaging services by waiving the 60-day delay in the imaging accreditation provisions in the final rule.
We believe that we have furnished enough detail in the proposed rule, in addition to receiving extensive comments from prospective AOs, so that AOs will find that 30 days is sufficient time to respond to the solicitation.
Section 1834(e) of the Act requires the Secretary to designate and approve AOs to accredit suppliers of the TC of advanced diagnostic imaging services. To promote consistency in accrediting providers and suppliers throughout the Medicare program, we proposed to review existing procedures for the application, selection, and oversight of AOs detailed at 42 CFR part 488, subparts A and D, and apply them (with appropriate revisions) to organizations accrediting suppliers of the TC of advanced diagnostic imaging services. We proposed modifications to the existing part 488 requirements to meet the specialized needs of the advanced imaging industry. These modifications would require an independent AO applying for approval as a designated AO to include in their application:
• A detailed description of how the organization's accreditation criteria satisfy the statutory standards at section 1834(e)(3) of the Act, specifically:
+ Qualifications of medical personnel who are not physicians and who furnish the TC of advanced diagnostic imaging services;
+ Qualifications and responsibilities of medical directors and supervising physicians, such as training in advanced diagnostic imaging services in a residency program, expertise obtained through experience, or continuing medical education courses;
+ Procedures to ensure the safety of persons who furnish the TC of advanced diagnostic imaging services and individuals to whom such services are furnished;
+ Procedures to ensure the reliability, clarity, and accuracy of the technical quality of diagnostic images produced by the supplier.
• An agreement to conform accreditation requirements to any changes in Medicare statutory requirements in section 1834(e) of the Act.
• Information to demonstrate the AO's knowledge and experience in the advanced diagnostic imaging arena.
• The organization's proposed fees for accreditation for each modality in which the organization intends to offer accreditation and any plans for reducing the burden and cost of accreditation to small and rural suppliers.
• Any specific documentation requirements and attestations requested by CMS as a condition of designation under this part.
If, after review of an AO's submission of information, we determined that additional information was necessary to make a determination for approval or denial of the AO's application to be designated as an AO for suppliers of the TC of advanced diagnostic imaging services, the organization would be notified and afforded an opportunity to provide the additional information. We could visit the organization's offices to verify representations made by the organization in its application, including, but not limited to, review of documents and interviews with the organization's staff. The AO would receive a formal notice from CMS stating whether the request for designation was approved or denied. If approval was denied, the notice would include the basis for denial and outline the reconsideration procedures. We would make every effort to issue a final decision no more than 30 calendar days from the time the completed reapplication was received by CMS. An AO could withdraw its application for designation under section 1834(e) of the Act at any time before the formal notice of approval is received. An AO that was notified that its request for designation was denied could request reconsideration in accordance with § 488.201 through § 488.211 in Subpart D. Any AO whose request for designation was denied could resubmit its application if the organization (1) Revised its accreditation program to address the rationale for denial of its previous request; (2) provided reasonable assurance that its accredited companies meet applicable Medicare requirements; and (3) resubmitted the application in its entirety. If an AO requested a reconsideration of a denial, it could not submit a new application for the type of modality that is at issue in the reconsideration until the reconsideration was final.
A panel would evaluate all proposals from AOs seeking designation under section 1834(e) of the Act using existing CMS survey and certification processes, similar to those established at § 488.4.
We would implement at § 414.68 the statutory requirement of section 1834(e) of the Act that all suppliers of the TC of advanced diagnostic imaging services be accredited by a CMS-designated AO by January 1, 2012 for payments made under the fee schedule established under section 1848(b). In § 414.68(a), we proposed to define the following:
• “Accredited supplier” would mean a supplier that has been accredited by a CMS-approved AO.
• “Advanced Diagnostic Imaging Services” would mean diagnostic magnetic resonance imaging, computed tomography, nuclear medicine, and positron emission tomography. We did not propose to include other diagnostic imaging services in this definition under section 1834(e)(1)(B)(ii) of the Act.
• “CMS-approved accreditation organization” would mean an independent AO designated by CMS to perform the accreditation function established in section 1834(e) of the Act.
We proposed to require a CMS-approved AO to perform several activities on an ongoing basis. The organization would provide to CMS in written form and on an ongoing basis all of the following:
• Copies of all accreditation surveys of specific suppliers along with any survey-related information that we may require (including corrective action plans and summaries of CMS requirements that were not met).
• Notice of all accreditation decisions.
• Notice of all complaints related to suppliers of the TC of advanced diagnostic imaging service.
• Information about any suppliers of the TC of advanced diagnostic imaging service for which the accrediting organization has denied the supplier's accreditation status.
• Notice of any proposed changes in its accreditation standards or requirements or survey process. If the organization implemented the changes before or without CMS approval, we could withdraw approval of the AO.
• Written notice of any deficiencies and adverse actions implemented by the CMS-approved AO against an accredited supplier of the TC of advanced diagnostic imaging within 2 days of identifying such deficiencies, if the deficiencies pose immediate jeopardy to a beneficiary or to the general public.
• Written notice of the withdrawal to all accredited suppliers within 10 days of CMS' notice to withdraw approval of the AO.
• Summary data specified by CMS related to the past year's accreditation activities and trends, on an annual basis.
In addition, the AO would permit its surveyors to serve as witnesses if CMS takes an adverse action based on accreditation findings.
We proposed to add § 414.68 to establish specific criteria and procedures for continuing oversight and for withdrawing approval of an approved AO.
We proposed to audit the accredited organizations in order to validate the survey accreditation process of approved AOs in the TC of advanced imaging. The audits would be conducted on a representative sample of suppliers who have been accredited by a particular accrediting organization or in response to allegations of supplier noncompliance with the standards. When conducted on a representative sample basis, we proposed that the audit would be comprehensive and address all of the standards or would focus on a specific standard in issue. When conducted in response to an allegation, we proposed to specify that the CMS team or our contractor would audit for any standard that we determined was related to the allegations. We also proposed to require a supplier selected for a validation audit to authorize the validation audit to occur and authorize the CMS team or our contractor to monitor the correction of any deficiencies found through the validation audit. If a supplier selected for a validation audit failed to comply with the requirements at § 414.68, the supplier would no longer meet the Medicare requirements and, under this proposal, the supplier's accreditation for the TC of the advanced medical imaging would be revoked.
We proposed that a CMS team or our contractor would conduct an audit of an accredited organization, examine the results of the AO's own survey procedure onsite, or observe the AO's survey, in order to validate the organization's accreditation process. At the conclusion of the review, we would identify any accreditation programs for which validation audit results indicated the following:
• A 10 percent or greater rate of disparity between findings by the AO and findings by CMS or our contractor on standards that did not constitute immediate jeopardy to patient health and safety if not met;
• Any disparity between findings by the AO and findings by CMS or our contractor on standards that constituted immediate jeopardy to patient health and safety if not met; or
• There were widespread or systemic problems in the organization's accreditation process such that the accreditation no longer provided assurance that suppliers met or exceeded the Medicare requirements, irrespective of the rate of disparity.
As proposed, if a validation audit, onsite observation, or our concerns with the ethical conduct (that impacted the health and safety of the beneficiary) of an AO suggest that the AO was not meeting the requirements of § 414.68, we would provide the organization written notice of our intent to withdraw approval of the AO's designating authority.
We proposed to withdraw approval of an AO at any time if we determined that:
• Accreditation by the organization no longer provided sufficient assurance that the suppliers of the TC of advanced imaging meet the requirements of section 1834(e) of the Act and the failure to meet those requirements could pose an immediate jeopardy to the health and safety of Medicare beneficiaries;
• Conditions at an imaging supplier accredited by an AO constituted a significant hazard to the public health; or
• The AO failed to meet its obligations for application and reapplication procedures.
We proposed to implement requirements similar to those set out under 42 CFR part 488 without substantive changes, as the requirements have been utilized for the health care providers covered under 42 CFR part 488 since 1992. We proposed that an AO dissatisfied with a determination that its accreditation requirements did not provide or do not continue to provide reasonable assurance that the suppliers accredited by the AO met the applicable standards would be entitled to a reconsideration. We also proposed to reconsider any determination to deny, remove, or not renew the approval of the designating authority to AOs if the AO filed a written request for reconsideration through its authorized officials or through its legal representative.
We proposed to require the AO to file the request for reconsideration within 30 calendar days after the issuance of CMS notice of an adverse determination or non-renewal. We proposed to require the request for reconsideration to specify the findings or issues with which the AO disagreed and the reasons for the disagreement. A requestor could withdraw its request for reconsideration at any time before the issuance of a reconsideration determination. In response to a request for reconsideration, we would provide the accrediting organization the opportunity for an informal hearing that would be conducted by a hearing officer appointed by the CMS Administrator and provide the accrediting organization the opportunity to present, in writing and in person, evidence or documentation to refute the determination to deny approval, or to withdraw or not renew its designating authority.
As proposed, we would provide written notice of the time and place of the informal hearing at least 10 business days before the scheduled date. The informal reconsideration hearing would be open to CMS and the organization requesting the reconsideration, including authorized representatives, technical advisors (individuals with knowledge of the facts of the case or presenting interpretation of the facts), and legal counsel. The hearing would be conducted by the hearing officer, who would receive testimony and documents related to the proposed action. Testimony and other evidence could be accepted by the hearing officer. However, the normal evidentiary exclusions applicable in Federal courts would not apply to these hearings. The hearing officer would not have the authority to compel by subpoena the production of witnesses, papers, or other evidence. Within 45 calendar days of the close of the hearing, the hearing officer would present the findings and recommendations to the accrediting organization that requested the reconsideration. The written report of the hearing officer would include separate numbered findings of fact and the legal conclusions of the hearing officer. The hearing officer's decision would be final.
The following is a summary of the comments we received regarding our proposals for implementation of section 135 of MIPPA.
In the proposed rule, we solicited information on the role of radiology assistants (RA) and radiology practitioner assistants (RPA), including the level of physician supervision that would be appropriate when RAs and RPAs are involved in the performance of the TC of advanced medical imaging, whether the role varies by State, and related information.
After reviewing the public comments, we are finalizing the accreditation provisions of the CY 2010 PFS proposed rule as follows:
• Clarifying that the—
++ Medical directors and supervising physicians are equivalent positions;
++ Equipment used by the supplier must performance specifications;
++ AOs may maintain or adopt standards that are more stringent than those of Medicare;
++ The AOs are required to notify Medicare of the accreditation decision of those suppliers billing Medicare
++ Accreditation requirement does not apply to hospitals; and
++ AO only needs to notify CMS for significant changes from what was approved on the AO's initial approved application.
• Including a requirement that a supplier must assist the beneficiary in obtaining his/her medical records if he/she requests.
• Including a requirement that the supplier must notify the AO of any subsequent changes to the modalities being offered since the accreditation decision was made.
• Clarifying that AOs must respond to complaints from any source with respect to an accredited supplier.
• Changing the regulations text to require that an AO notify CMS of any supplier deficiency putting Medicare beneficiaries in immediate jeopardy within 2 business days (previously 2 calendar days).
• Confirming that when a designated accrediting organization has its deeming authority withdrawn, CMS and the remaining AOs will work together in a collaborative effort to distribute suppliers affected by such withdrawal amongst other accreditations organizations within a reasonable time period.
Section 139 of the MIPPA establishes a special payment rule for teaching anesthesiologists and provides a directive to the Secretary regarding payments for the services of teaching certified registered nurse anesthetists (teaching CRNAs). It also specifies the periods when the teaching anesthesiologist must be present during the procedure in order to receive payment for the case at 100 percent of the fee schedule amount (the regular fee schedule rate). These provisions are effective for services furnished on or after January 1, 2010.
The criteria for the payment of teaching anesthesiology services and the special rule for the teaching anesthesiologist are similar to the current criteria for payment of teaching surgeon services and the payment rule for the teaching surgeon involved in overlapping resident cases. Thus, there is a similarity in the payment rules for these physician specialties who work closely together.
Currently, if the physician, usually an anesthesiologist, is involved in furnishing anesthesia services to a patient, the services can be furnished under one of three different scenarios. The anesthesiologist may—
• Personally perform the anesthesia services alone;
• Be involved in the case as a teaching anesthesiologist with an anesthesia resident; or
• Provide medical direction of the performance of anesthesia services for two, three or four concurrent cases involving a qualified individual (who may be a CRNA, an anesthesiologist
Under the statute and CMS policy, if the anesthesiologist personally performs the anesthesia service alone or is involved in the case as a teaching anesthesiologist with an anesthesia resident, payment for the anesthesiologist's service is made at the regular fee schedule rate.
If the anesthesiologist furnishes medical direction for two, three, or four concurrent anesthesia procedures, then payment for the anesthesiologist's service is made, in accordance with section 1848(a)(4)(B) of the Act, at 50 percent of the otherwise applicable fee schedule amount.
Payment for anesthesia services furnished by a physician is made under the PFS under section 1848(b)(2)(B) of the Act. The methodology for the calculation of the allowable amount is unique to anesthesia services only. Payment is made on the basis of anesthesia base units and time units, calculated from the actual anesthesia time of the case, instead of on the basis of work, PE, and malpractice RVUs. The base unit reflects all activities other than anesthesia time and includes usual preoperative and postoperative visits, the administration of fluids, and blood incident to anesthesia care and monitoring services. Payment for anesthesia services is also based on the anesthesia CF instead of the general PFS CF.
Section 139(a) of the MIPPA adds a new paragraph at section 1848(a)(6) of the Act to establish a “special payment rule for teaching anesthesiologists”. This provision allows payment to be made at the regular fee schedule rate for the teaching anesthesiologist's involvement in the training of residents in either a single anesthesia case or in two concurrent anesthesia cases furnished on or after January 1, 2010.
The Accreditation Council on Graduate Medical Education (ACGME) is a branch of the AMA, and it accredits allopathic residency programs. In order for a hospital to receive Medicare graduate medical education payments for its training programs, the residents must be in an “approved medical residency program” Under § 413.75(b), an approved medical residency program is one approved by one of the national organizations listed in § 415.152. One of the national organizations is the ACGME.
ACGME's policies and procedures require that each accredited residency program comply with the institutional requirements and the specialty program requirements. For approved anesthesia residency programs, ACGME requirements for faculty supervision and training of anesthesia residents specify that a faculty member not direct anesthesia at more than two anesthetizing locations in the clinical setting. (See the ACGME Web site at
Consistent with this requirement, the American Society of Anesthesiologists (ASA) has advised us that, when providing services in two concurrent cases, a teaching anesthesiologist might be engaged in two concurrent anesthesia resident cases, or in two mixed concurrent cases, one a resident case and the other a CRNA or AA case.
The statute applies the special payment rule for teaching anesthesiologists to the single resident case or two concurrent cases involving anesthesia residents as long as the teaching anesthesiologist meets the requirements in sections 1848(6)((A) and 1848(6)(B) of the Act. However, the statute does not directly address a single resident case that is concurrent to another case involving a CRNA, AA, or other qualified individual who can be medically directed. The issue is whether the medical direction payment rules apply to each of these cases or whether an alternative payment policy may apply.
As an alternative to applying the medical direction payment rules to the concurrent mixed cases, we proposed to apply the payment rule for teaching anesthesiologists to the resident case that is concurrent to another case which is paid under the medical direction payment rules. While this represents a broader interpretation, it still limits the applicability of the special payment rule for teaching anesthesiologists to resident cases consistent with the terms of section 139 of the MIPPA. (See 74 FR 33603 for a more detailed discussion of this option.)
Accordingly, we proposed to delete the current regulatory language at § 414.46(e) (which is no longer relevant) and add new language to specify that the special payment rule for teaching anesthesiologists applies to resident cases under the following scenarios:
• The teaching anesthesiologist is involved in one resident case (which is not concurrent to any other anesthesia case);
• The teaching anesthesiologist is involved in each of two concurrent resident cases (which are not concurrent to any other anesthesia case); or
• The teaching anesthesiologist is involved in one resident case that is concurrent to another case paid under medical direction payment rules.
Other than the application of the special payment rule for teaching anesthesiologists in the mixed concurrent case described above, we did not propose any other revisions to our medical direction payment policies.
As part of the special payment rule established for teaching anesthesiologists, the statute requires that the teaching anesthesiologist is present during all key or critical
In the proposed rule, we discussed two options for implement this provision. One option would allow different teaching anesthesiologists in the same anesthesia group practice to be considered the “teaching physician” for purposes of being present at the key or critical portions of the anesthesia procedure. This option would permit a teaching anesthesiologist to handoff a key or critical portion of the anesthesia procedure to another teaching anesthesiologist as long as the other anesthesiologist is a member of the same group. Another option presented was to require that only one teaching anesthesiologist must be present during all of the key or critical portions of the procedure, which would effectively permit no handoffs. We proposed to more narrowly interpret the law and require that only one individual teaching anesthesiologist be present during all of the key or critical portions of the anesthesia procedure.
Anesthesiologists, including the ASA, have advised us that it may be common for different members of a teaching anesthesia group to provide the anesthesia service instead of a single teaching anesthesiologist. In the proposed rule, we solicited comments on how continuity of care and the quality of anesthesia care are preserved during handoffs, whether there is an accepted maximum number of handoffs, any industry studies that have examined this issue, what factors contribute to handoffs, and whether there are anesthesia practices that do not use handoffs. A handoff refers to any transfer of care for any period or a terminal transfer between two anesthesia providers during a single anesthesia case.
Several medical organizations objected to our proposal and recommended that we implement the alternative proposal in the proposed rule to permit different anesthesiologists in the same anesthesia group practice to be considered the teaching anesthesiologist for purposes of being present at the key or critical periods of the anesthesia case.
Some commenters discussed handoffs in general and did not specifically tie their comments regarding handoffs to a key or critical period of the teaching anesthesia service.
Some commenters cited a 1982 study in the
The study noted that “there is a strong implication that relief is beneficial more often than not even aside from the presumed beneficial effect on the vigilance of the primary anesthetists.” The study further noted that from the descriptions of the causes and discoveries of errors in these relief-related incidents, guidance can be drawn for the safe and effective conduct of the intraoperative exchange of anesthesia personnel. This article referred to substitutions for short breaks during long surgical procedures. It did not specify whether any of these substitutions took place during key or critical periods of the teaching case.
Based on its study of relief-associated events, the authors suggested the adoption of specific handoff protocols and communication processes to reduce errors. This protocol would address such factors as familiarity with the status of the patient, progress of the surgical procedure, trends in the anesthetic course, significant medical history, anesthesia plan, and arrangement of equipment, apparatus, drugs, and fluids. This is the only study on handoffs that commenters presented.
In its comments, the ASA described the “SBAR” protocol, or a variation of it, as the handoff procedure most widely taught and used in anesthesia practices, both academic and private. The SBAR protocol gives physicians a format to follow when initiating handoffs. SBAR is an acronym used to describe four basic requirements for transfer of patient care:
According to the ASA, some anesthesia departments have defined written protocols that they follow for handoffs, but many do not because the fundamentals of the handoff process are part of the skill set that is believed to be taught and practiced by all teaching anesthesiologists.
The ASA simply expressed the opinion that the appropriate timing of a handoff is a decision best left to the physicians responsible for the care of the patient. The ASA also stated that to raise the issue of quality in anesthesia handoffs where no issue or evidence exists exceeds CMS's authority in implementing section 139 of the MIPPA. The ASA is supportive of an approach where its members use their judgment to decide when to use handoffs and the necessary information exchanged. The ASA recommended that we implement the payment provision only and leave any issues involving handoffs unexamined.
We identified two abstracts to be presented to the ASA later this year that present limited information on handoffs. One study, “Transfer of Anesthesia Care: Are We Hiding Bad Outcomes?” by Vilma A. Joseph, M.D., M.P.H., Charles E. Kamen, B.A., Rhonda D. Levine, M.D., Alla Krayman, M.S., and Robert S. Lagasse, M.D. This study showed that of 1740 anesthesia cases without a transfer of care, there were 12 recorded adverse outcomes, while there were zero adverse outcomes in the 132 cases where there was a transfer of care. The other study is: “Evaluating Safety of Handoffs between Anesthesia Care Providers” by Rhonda Leopold, M.D., Stuart Hart, M.D., Heather Scuderi
There appears to be a limited amount of research on handoffs, and a lack of a detailed, industry-defined process on their use. Commenters did not report widespread use of written protocols by academic facilities.
As noted previously, we think the teaching anesthesiologist payment policy in section 139 of the MIPPA and the handoff issues are separate, but related issues. The handoff issue is a quality of care issue not directly addressed in section 139 of the MIPPA. Therefore, we are implementing the payment provision of section 139 but not finalizing a formal policy on handoffs in this final rule. For future rulemaking, we may consider working with the industry to develop guidelines on handoffs. These guidelines may, among other things, address the content and type of information exchanged during handoffs and whether there should be any limitations on the number of handoffs permitted.
In response to comments, we believe it is appropriate to implement this payment provision consistent with current teaching anesthesia practices and handoff arrangements. Thus, different anesthesiologists in the same anesthesia group practice can be considered the teaching physician for purposes of the statutory requirement that the teaching anesthesiologist be present at the key or critical portions of the anesthesia service. Of course, the criteria for the presence of the teaching physician would also be met if only one teaching anesthesiologist was present during the key or critical periods of the anesthesia service.
We are revising § 415.178 to incorporate our policy that allows either a single teaching anesthesiologist or different teaching anesthesiologists in the same anesthesia group practice to be considered the teaching physician for purposes of being present at the key or critical portions of the anesthesia service.
Currently, a CRNA who provides anesthesia services while under the medical direction of an anesthesiologist is paid at 50 percent of the regular fee schedule rate as specified in section 1833(l)(4)(B)(iii) of the Act. A CRNA who provides anesthesia services without the medical direction of a physician is paid the regular fee schedule rate as specified in section 1833(l)(4)(A) of the Act.
The legislation that initially directed CMS to establish the CRNA fee schedule (that is, section 9320 of the Omnibus Budget Reconciliation Act of 1986 (Pub. L. 99–509)) did not address payment for services furnished by teaching CRNAs involved in the training of student nurse anesthetists.
In the preamble to the CRNA fee schedule final rule published in the July 31, 1992
In August 2002, based on the recommendations of the American Association of Nurse Anesthetists (AANA), we modified our policy to allow the teaching CRNA not medically directed by a physician to be paid a portion of the regular fee schedule rate for each of two concurrent cases involving student nurse anesthetists. If the teaching CRNA is present with the student nurse anesthetist during the pre- and post-anesthesia care for each of the cases involving student nurse anesthetists, the teaching CRNA can bill the full base units (comprised of pre- and post-anesthesia services not included in the anesthesia time units) for each case and the actual amount of anesthesia time per case. The resulting payment for each of these anesthesia cases is greater than 50 percent, but less than 100 percent, of the regular fee schedule amount because the full base units plus the actual anesthesia time units spent by the teaching CRNA in each of the two cases yields a payment that is greater than 50 percent of the regular fee schedule amount.
For several years, the ASA requested that we revise our payment regulations to allow the teaching anesthesiologist to be paid the regular fee schedule amount for each of two concurrent resident cases. In the CY 2004 PFS final rule with comment period (68 FR 63224), we finalized a policy to permit the teaching anesthesiologist to be paid similarly to a teaching CRNA for each of two concurrent resident cases. This policy took effect for services furnished on or after January 1, 2005.
Thus, the payment policy is the same for a teaching CRNA for each of two concurrent student nurse anesthetist cases, and for a teaching anesthesiologist for each of two concurrent resident cases. The policy is that the anesthesia provider is paid the full base units plus time units, based on the actual anesthesia time, relating to each of two concurrent cases.
Currently, there are circumstances where an anesthesiologist may be involved in the training of student nurse anesthetists in two concurrent anesthesia cases. These anesthesia cases are not paid under the teaching anesthesiologist payment policy, but are paid under the usual medical direction payment policy. Payment can be made for the physician's medical direction (that is, 50 percent of the regular fee schedule amount) for each of two concurrent cases.
If an anesthesiologist is medically directing two concurrent cases involving student nurse anesthetists and a CRNA is also jointly involved with the two student nurse anesthetist cases, then the physician service, in each case, can be paid under the medical direction rules at 50 percent of the regular fee schedule. Payment for the CRNA services would also be made at the medically directed rate (that is, 50 percent of the regular fee schedule) for CRNA services, but the time units used to compute the anesthesia fee would be based on the actual time the CRNA is involved in each case.
Section 139(b) of the MIPPA instructs the Secretary to make appropriate adjustments to Medicare teaching CRNA payment policy so that it—
• Is consistent with the adjustments made by the special payment rule for teaching anesthesiologists under section 139(a) of the MIPPA; and
• Maintains the existing payment differences between teaching anesthesiologists and teaching CRNAs.
We proposed to implement the first directive (under section 139(b)(1) of the MIPPA) by establishing a new payment policy for teaching CRNAs that is similar to the special payment rule for teaching anesthesiologists, and to limit applicability of the rule to teaching CRNAs who are not medically directed. We proposed to add a new regulation at § 414.61 to explain the conditions under which the special payment rule will apply and the method for calculating the amount of payment for anesthesia services furnished on or after January 1, 2010, by teaching CRNAs involved in the training of student nurse anesthetists. As proposed, we would pay the teaching CRNA at the regular fee schedule rate for each of two concurrent student nurse anesthetist cases. Our medical direction payment policy would continue to apply if both an anesthesiologist and a CRNA are involved in a student nurse anesthetist case that is concurrent to another medically directed anesthesia case.
We believe the second directive in section 139(b)(2) of the MIPPA will be satisfied as a result of these proposals. Section 139(b)(1) of the MIPPA instructs CMS to make appropriate adjustments to implement a payment policy for teaching CRNAs that is consistent with the special payment rule for teaching anesthesiologists. Section 139(b)(2) of the MIPPA instructs CMS to maintain the existing payment differences between teaching anesthesiologists and teaching CRNAs. There currently are no substantive differences in payment between teaching anesthesiologists and teaching CRNAs, and there would continue to be no such differences under our proposed policies.
Under current policy, when a CRNA is involved in a single student nurse anesthetist case, the teaching CRNA can be paid at the regular fee schedule rate if the teaching CRNA is present with the student for the pre- and post anesthesia services included in the base units and is continuously present during the anesthesia time of the case. We did not propose any change to this policy.
When the teaching CRNA is involved in two concurrent student nurse anesthetist cases, payment is based on the amount of anesthesia time the teaching CRNA spends with the student in each case. For example, as noted in the proposed rule, if the teaching CRNA spends 40 percent of his or her time in concurrent case #1 and 60 percent of his or her time in concurrent case #2, and the total anesthesia time in both cases is 3 hours (or 180 minutes), then we would currently pay as follows:
•
•
(The base units are explained earlier in section on general anesthesiology payment methodology.)
The current payment policy has been predicated on paying the teaching CRNA for his or her actual time spent in the student nurse anesthetist case. In the CY 2010 PFS proposed rule, we proposed to pay the teaching CRNA at the regular fee schedule rate for his or her involvement in two concurrent cases. To bill the base units for each concurrent case, the teaching CRNA must be present with the student nurse anesthetist during the pre and post anesthesia services included in the anesthesia base units.
If our goal is to minimize the effect of this change on teaching CRNAs' practice arrangements and time devoted to cases, then, as proposed, the teaching CRNA would continue to devote his or her time to the two concurrent anesthesia cases and not be involved in other services. The teaching CRNA would decide how to allocate his or her time to optimize patient care in the two cases based on the complexity of the anesthesia case, the experience and skills of the student nurse anesthetist, the patient's health status, and other factors.
We note that the Congress did not amend the statutory provisions relating to medical direction at section 1848(a)(4) of the Act. We do not believe the directives at section 139(b) of the MIPPA extend to other arrangements in which an anesthesiologist alone or both an anesthesiologist and CRNA together jointly supervise student nurse anesthetists during concurrent anesthesia cases. Therefore, we did not propose any changes to our current payment policies for anesthesia services furnished under other circumstances. We proposed that when an anesthesia provider (physician or CRNA) furnishes anesthesia services in concurrent cases under other circumstances, the current policies regarding medical direction will continue to apply.
The following is summary of the comments we received regarding section 139 of the MIPPA and teaching CRNAs.
Subsequent to issuing the proposed rule and receiving comments, we learned more about the supervision requirements for student nurse anesthetists. According to the AANA, the standards of the Council on Accreditation of Nurse Anesthesia Programs address supervision of student nurse anesthetists in anesthesia cases. These standards require that in any case involving a student nurse anesthetist, including concurrent cases, a qualified anesthesia provider (CRNA or anesthesiologist) must be present and immediately available in the anesthetizing locations.
Furthermore, according to these standards, the qualified individual must be physically present in the area and immediately available for the student to summon for clinical assistance should it be required. As a result, if one teaching CRNA were temporarily occupied, another qualified anesthetist would respond.
Based on information received and in response to comments, we are requiring that the teaching CRNA be present during the case with the student nurse anesthetist. For periods of concurrency for two student nurse anesthetist cases, we are requiring that another anesthesia provider is available and can fulfill the requirements of the AANA standards.
Additionally, if we were to consider paying each student nurse anesthetist case at the regular fee schedule amount, it would be unclear what payment criteria would apply for the physician service. The teaching anesthesiologist criteria in section 139(a) of the MIPPA apply only to physician resident cases and not to student nurse anesthetist cases. It also does not seem appropriate to pay the regular fee schedule rate if the services fall within the terms of the statutory provision addressing medical direction under which the anesthesiologist is paid at 50 percent of the regular fee schedule rate. Therefore, we believe the most appropriate course is to maintain our current policy.
Section 144(a) of the MIPPA amended Title XVIII of the Act, in pertinent part, to establish the benefit of cardiac rehabilitation (CR) and intensive cardiac rehabilitation (ICR) under Medicare Part B. The statute specifies certain conditions for these programs, with an effective date of January 1, 2010. The addition of the new CR and ICR programs is designed to improve the health care of Medicare beneficiaries with cardiovascular disease. This final rule with comment period implements these MIPPA provisions in order to ensure CR and ICR programs enhance the patient's clinical outcomes.
Intensive cardiac rehabilitation (ICR) is a relatively new practice that is also commonly referred to as a “lifestyle modification” program. These programs typically involve the same elements as CR programs, but are furnished in highly structured environments in which sessions of the various components may be combined for longer periods of CR and may be more rigorous.
One mechanism we use to establish coverage for certain items and services is the national coverage determination (NCD) process. An NCD is a determination by the Secretary with respect to whether or not a particular item or service is covered nationally under Title XVIII.
Since 1982, Medicare has covered, under an NCD, cardiac rehabilitation for patients who experience stable angina, have had coronary artery bypass grafts, or have had an acute myocardial infarction within the past 12 months. The NCD is located in the Medicare NCD Manual (Pub. 100–03), section 20.10. Effective March 22, 2006, we modified the NCD language to cover comprehensive cardiac rehabilitation programs for patients who experience one of the following:
• A documented diagnosis of acute myocardial infarction within the preceding 12 months.
• A coronary bypass surgery.
• Stable angina pectoris.
• A heart valve repair/replacement.
• A percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting.
• A heart or heart-lung transplant.
Comprehensive programs must include a medical evaluation, a program to modify cardiac risk factors, prescribed exercise, education, and counseling and may last for up to 36 sessions over 18 weeks or no more than 72 sessions over 36 weeks if determined appropriate by the local Medicare contractors. Facilities furnishing cardiac rehabilitation must have immediately available necessary cardio-pulmonary, emergency, diagnostic, and therapeutic life-saving equipment and be staffed with personnel necessary to conduct the program safely and effectively who are trained in advanced life support techniques and exercise therapy for coronary disease. The program must also be under the direct supervision of a physician. Until section 144(a) of the MIPPA is effective on January 1, 2010. ICR programs are covered under this NCD and are subject to the same coverage requirements.
Section 144(a) of the MIPPA amended the Medicare Part B program by adding new sections 1861(s)(2)(CC) and 1861(s)(2)(DD) of the Act to include items and services furnished under a new benefit referred to as a “cardiac rehabilitation program” and an “intensive cardiac rehabilitation program,” respectively. A cardiac rehabilitation program is defined in new section 1861(eee)(1) of the Act and an intensive cardiac rehabilitation program is defined in new section 1861(eee)(4)(A) of the Act.
A cardiac rehabilitation program is a physician-supervised program that furnishes the following: physician-prescribed exercise; cardiac risk factor modification, including education, counseling, and behavioral intervention; psychosocial assessment; outcomes assessment; and other items or services as determined by the Secretary under certain conditions. These items and services must be furnished in a physician's office, in a hospital on an outpatient basis, or in other settings as determined appropriate by the Secretary. A physician must be immediately available and accessible for medical consultation and emergencies at all times items and services are being furnished in a CR program except when provided in a hospital setting where such availability is presumed. The items and services furnished by a CR program are individualized and set forth in written treatment plans that describe the patient's individual diagnosis; the type, amount, frequency, and duration of items and services furnished under the plan; and the goals set for the individual under the plan. These written plans must be established, reviewed, and signed by a physician every 30 days.
An ICR program provides the same items and services under the same conditions as CR programs but must demonstrate, as shown in peer-reviewed published research, that they have accomplished one or more of the following: positively affected the progression of coronary heart disease, or reduced the need for coronary bypass surgery, or reduced the need for percutaneous coronary interventions (PCIs). The peer-reviewed published research must also show that the ICR program has resulted in a statistically significant reduction in 5 or more measures from their levels before ICR services to their levels after receipt of such services. These measures include low density lipoprotein; triglycerides; body mass index; systolic blood pressure; diastolic blood pressure; or the need for cholesterol, blood pressure, and diabetes medications. Beneficiaries eligible for ICR must have experienced the following: an acute myocardial infarction within the preceding 12 months; a coronary bypass surgery; current stable angina pectoris; a heart valve repair or replacement; a percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting; or a heart or heart-lung transplant. Section 1861(eee)(4)(C) of the Act, as added by section 144(a)(1)(B) of the MIPPA, states that an ICR program may be provided in a series of 72, 1-hour sessions (as defined in section 1848(b)(5) of the Act), up to 6 sessions per day, over a period of up to 18 weeks.
The statute authorizes the Secretary to establish standards for the physician supervising the ICR and/or CR programs to ensure that the physician has expertise in the management of individuals with cardiac pathophysiology and is licensed by the State in which the CR program (or ICR program) is offered. These standards ensure that the physician is responsible for the program and, in consultation with appropriate staff, is involved substantially in directing the progress of individuals in the program.
We proposed to add § 410.49, “Cardiac Rehabilitation Program and Intensive Cardiac Rehabilitation Program: Conditions of Coverage” to our regulations.
Below is a summary of what we proposed for the new ICR and CR benefit in the proposed rule. (To read the proposed rule in its entirety, see the CY 2010 PFS proposed rule (74 FR 33606 through 33610, and 33675 through 33676.)
We proposed definitions with respect to the programs and services related to CR and ICR programs.
We listed the cardiac-related conditions for which CR and ICR items and services are eligible for coverage under this new benefit. We received several comments to add other conditions unrelated to cardiac conditions and will address those comments in section II.G.8.e. below.
We proposed that CR and ICR programs may only be provided in a physician's office or a hospital on an outpatient basis. Any additional settings will be added through future rulemaking.
We proposed that only a physician as defined in section 1861(r)(1) of the Act may establish the written individualized treatment plan, review the plan and update that plan. We received a few comments on this provision, specifically requesting that staff other than the physician should be able to update the plan. We address those comments in the section II.G.8.e. of this rule.
We proposed components of the CR and ICR program. All of the items and service related to the ICR and CR programs must be individualized to the beneficiary and delivered as part of the CR and ICR program. Any additional mandatory items and services will be added through future rulemaking.
We defined outcomes assessment as an evaluation of the patient's progress in the program using assessments from the commencement and conclusion of CR and ICR programs that are based upon patient centered outcomes. We also outlined the timing of when the patient centered outcomes must be measured—at the beginning of the CR and ICR program, prior to each 30-day review of
Based on the outcomes assessment, the beneficiaries' plan of care should be updated as needed to ensure that the beneficiary continues to receive appropriate items and services based on his or her clinical needs.
We proposed the number of sessions that may be provided to a beneficiary participating in a CR program. The number of sessions that may be provided as part of an ICR program were specifically set forth in the statute and were included in the proposed rule as well.
We requested comments for specific physician standards that should be required to ensure that the physician is qualified to supervise the CR and ICR program. In addition to requesting comments for physician standards, we discussed two physician roles in the CR and ICR programs.
• Medical director: The physician who oversees or supervises the CR and ICR program at each site and who has expertise in the management of patients with cardiac pathophysiology. This person must be involved substantially in directing the progress of individuals in the program.
• Supervising physician: A physician that is immediately available and accessible for medical consultations and medical emergencies at all times items and services are being furnished under the CR and ICR program. This physician must also have expertise in the management of individuals with cardiac pathophysiolgy.
We have added definitions for the medical director and supervising physician to the regulations text and discuss these additions in section II.G.8.f. of this final rule with comment period.
We noted in the proposed rule that physician supervision of the program is limited to a physician who is the program medical director or a program staff physician serving as the supervising physician. This person must be a physician as defined in section 1861(r)(1) of the Act and not another CR or ICR staff member.
We proposed that the statutorily-required ongoing physician availability for medical consultations and medical emergencies would be met through existing definitions for direct physician supervision in physicians' offices and hospital outpatient departments at § 410.26(a)(2) (defined through cross references to § 410.32(b)(3)(ii)) and § 410.27(f), respectively. We stated that direct supervision, as defined in the regulations, is consistent with the language of the MIPPA because the physician must be present and immediately available where the services are being furnished. The physician must also be able to furnish assistance and direction throughout the performance of the services, which would include medical consultations and medical emergencies.
For CR and ICR services provided in physicians' offices and other Part B settings paid under the PFS, we proposed that the physician must be present in the office suite and immediately available to furnish assistance and direction throughout the performance of the service or procedure in accordance with the § 410.26(b)(5) as described in § 410.26(a)(2) of this subpart (defined through cross references to § 410.32(b)(3)(ii) of this subpart). This does not mean that the physician must be in the room when the service or procedure is performed.
For CR and ICR services provided to hospital outpatients, direct physician supervision is the standard set forth in the April 7, 2000 OPPS final rule with comment period (68 FR 18524 through 18526) for supervision of hospital outpatient therapeutic services covered and paid by Medicare in hospitals and provider-based departments of hospitals. We stated that we currently define and specify the requirement for direct supervision for services furnished in provider-based departments of hospitals at § 410.27(f). For this purpose, the physician must be on the premises of the location (meaning the provider-based department) and immediately available to furnish assistance and direction throughout the performance of the procedure. This does not mean that the physician must be present in the room when the procedure is furnished. We also noted that if we were to propose future changes to the physician office or hospital outpatient policies for direct physician supervision, we would provide our assessment of the implications of those proposals for the supervision of cardiac rehabilitation services at that time. We note that in the CY 2010 OPPS/ASC proposed rule (74 FR 35362 through 35370), we proposed changes to the policy for direct physician supervision of hospital outpatient therapeutic services. We have addressed the application of the proposed and final hospital outpatient physician supervision policies in section II.G.8.e. below.
The MIPPA provisions state that in the case of items and services furnished under such a program in a hospital, physician availability shall be presumed. As we have stated in the CY 2009 OPPS/ASC final rule with comment period (73 FR 68702 through 68704), the longstanding presumption relating to direct physician supervision for hospital outpatient services means that direct physician supervision is the standard for supervision of hospital outpatient therapeutic services covered and paid by Medicare in hospitals and provider-based departments of hospitals, and we expect that hospitals are providing services in accordance with this standard.
We received the majority of the comments on the above supervising physician provision and have addressed those in section II.G.8.e. of this final rule.
In our proposal, we noted that the program medical director may fulfill both roles of medical director and supervising physician (of individual CR and ICR services furnished to patients) provided that the requirements for direct physician supervision as required in § 410.26 and § 410.27 are met when CR or ICR items and services are furnished, as discussed above.
In addition to the CR requirements, section 1861(eee)(4) of the Act requires ICR programs to meet several additional standards. To become qualified, an ICR program must demonstrate through peer-reviewed, published research that it has accomplished one or more of the following: (1) Positively affected the progression of coronary heart disease; (2) reduced the need for coronary bypass surgery; or (3) reduced the need for percutaneous coronary interventions (PCIs). A qualified ICR program must also demonstrate through peer-reviewed published research that the ICR program accomplished a statistically significant reduction for patients in 5 or more specific measures from the individual's levels before ICR services to their levels after receipt of such services. These measures include: (1) Low density lipoproteins; (2) triglycerides; (3) body mass index; (4) systolic blood pressure; (5) diastolic blood pressure; and (6) the need for cholesterol, blood pressure, and diabetes medications. To ensure that ICR programs meet these standards, we proposed that ICR programs apply to CMS to receive approval as a qualified ICR programs. Only approved programs would be eligible for Medicare coverage and would be required to undergo regular re-evaluation to maintain such status. We did not propose any specific approval process(es), but requested comments on what process should be adopted by CMS. No comments were received advocating for any specific process(es), but we did receive comments requesting that any process adopted must allow public input and be open and transparent. We have
We received over 100 public comments. Many were supportive of our proposals to establish CR and ICR rules. Most comments also addressed several of the proposed provisions in the rule. The following is a summary of the issues and our responses.
We disagree with the suggestion that we remove contractor discretion under section 1862(a)(1)(A) of the Act to approve additional sessions of CR. As noted in the background, the statute required that CR programs be highly individualized and structured to meet an individual's needs. The programs are directed by physicians with expertise in cardiac pathophysiology. Our experience has been that not all patients require, and not all supervising physicians support, additional sessions for all beneficiaries. While some patients may continue to benefit from additional sessions, we believe that beneficiaries and the Medicare program will be best served if the 36 additional CR sessions are approved by local Medicare contractors based on each individual patient's specific circumstances. Therefore, we have changed the final rule to allow coverage of up to 36 CR sessions for up to 36 weeks and with the option for Medicare contractors to approve an additional 36 sessions over an extended period of time. The amount of additional time is determined by the Medicare contractor.
In this final rule with comment period, we are requiring that all ICR programs be approved through the NCD process. The NCD process will review each ICR program based on peer-reviewed published research, to ensure the program (or programs) under evaluation demonstrates that it satisfies the specific standards set forth in section 1861(eee)(4) of the Act. This process will involve at least one 30-day public comment period at which time the public may comment on the proposed decision. We believe this process allows for significant stakeholder involvement and is open and transparent, consistent with the commenters' request. Once we have approved an ICR program or programs through the NCD process, individual sites wishing to furnish ICR items and services via an approved ICR program may enroll with their local Medicare contractor to become an ICR program supplier as outlined in § 424.510.
We note that this enrollment process will ensure that specific sites meet the remaining statutory and regulatory requirements needed to furnish ICR services and provide a mechanism to appeal an adverse determination. With regards to billing and payment of CR and ICR services, physician office suppliers and hospital providers will continue to use their CMS Certification Number (supplier or provider number) and appeals related to the payment of claims will follow those separate processes.
Once ICR programs are approved through the NCD process, individual sites wishing to furnish ICR services must enroll with their local Medicare contractors. The ICR sites will be required to demonstrate that they meet the remaining regulatory and statutory requirements relating to state licensure, expertise in the management of individuals with cardiac pathophysiology, cardiopulmonary training, and certification in basic life support and advanced cardiac life support. By requiring enrollment via a local Medicare contractor as a supplier, a prospective ICR site would be entitled to appeal rights as outlined in 42 CFR part 498 if a site is not approved as meeting those standards. As noted above, this enrollment does not affect reporting and payment of CR and ICR services furnished by the hospital provider in the hospital outpatient setting. A hospital's enrollment as an ICR site ensures a separate appeal right related to the ICR site approval.
This final rule maintains and refines coverage for CR for beneficiaries with the six conditions as originally established in Pub. 100–03, section 20.10 as this coverage was determined to be reasonable and necessary under section 1862(a)(1)(A) of the Act due to a high level of supporting clinical evidence. We may use the NCD process in the future if necessary to identify additional medical indications for cardiac patients who could obtain CR under Medicare Part B.
In § 410.49(a), we provide definitions of key terms used in this section. Most of the key terms received no comments
We have added the following terms and definitions to § 410.49(a):
• Intensive cardiac rehabilitation program site which means a hospital outpatient setting or physician's office that is providing intensive cardiac rehabilitation utilizing an approved ICR program.
• Medical director which means a physician that oversees or supervises the cardiac rehabilitation or intensive cardiac rehabilitation program at a particular site.
• Supervising physician which means a physician that is immediately available and accessible for medical consultations and medical emergencies at all times items and services are being furnished to individuals under cardiac rehabilitation and intensive cardiac rehabilitation programs.
In § 410.49(b), we set forth the general rules for covered beneficiary rehabilitation services and describe the required components of the program. The covered patient populations remain unchanged and include beneficiaries who have experienced one or more of the following:
• An acute myocardial infarction within the preceding 12 months.
• A coronary artery bypass surgery.
• Current stable angina pectoris.
• Heart valve repair or replacement.
• Percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting.
• A heart or heart-lung transplant.
We are changing the final indication to include “cardiac” when discussing other conditions that may be considered for coverage. The final indication states, for cardiac rehabilitation only, other cardiac conditions as specified through a national coverage determination.
The required components of cardiac rehabilitation programs remain unchanged, but we have clarified that the individualized treatment plan must be established, reviewed, and signed by a physician every 30 days.
In § 410.49(c), we establish the specific standards that ICR programs must meet. We have clarified how an ICR program will be evaluated through the NCD process, and how specific ICR sites will be evaluated to ensure those entities meet the regulatory requirements.
In order to utilize a clear and transparent process for approving ICR programs, the programs will be evaluated through the NCD process to determine if each program demonstrates through peer-reviewed published research that it has accomplished one or more of the following for its patients:
• Positively affected the progression of coronary heart disease.
• Reduced the need for coronary bypass surgery.
• Reduced the need for percutaneous coronary interventions.
ICR programs must also demonstrate through peer-reviewed published research a statistically significant reduction in 5 or more of the following measures for patients from their levels before CR services to after CR services:
• Low density lipoprotein.
• Triglycerides.
• Body mass index.
• Systolic blood pressure.
• Diastolic blood pressure.
• The need for cholesterol, blood pressure, and diabetes medications.
Individual sites wishing to furnish ICR items and services through an approved ICR program must enroll with their local Medicare contractor as an ICR program site. An ICR site will be considered a supplier or putative supplier for purposes of the appeals process in 42 CFR part 498 related to the approval of the ICR site.
In § 410.49(d), we list the specific standards that physicians must meet to be a medical director or supervising physician. All medical directors and supervising physicians must possess all of the following:
• Expertise in the management of individuals with cardiac pathophysiology.
• Cardiopulmonary training in basic life support or advanced cardiac life support.
• Be licensed to practice medicine in the State in which the cardiac rehabilitation program is offered.
In § 410.49(f), we list the specific limitations for the number of and time period over which CR and ICR sessions may be provided. The limitations for ICR coverage remain unchanged and allow for coverage of up to 72, 1-hour sessions, up to 6 sessions per day, over a period of up to 18 weeks. We have changed the limitations for CR coverage to allow a maximum of 2, 1-hour sessions per day for up to 36 sessions over up to 36 weeks with the option for an additional 36 sessions over an extended period of time if approved by the Medicare contractor under 1862(a)(1)(A) of the Act.
In addition to the provisions above, we have made the following revisions in the final rule:
• To clarify that the proposed and final policies for the direct supervision of hospital outpatient therapeutic services, as discussed in the CY 2010 OPPS/ASC final rule with comment period, do apply to CR and ICR services furnished to hospital outpatients. Due to specific language in the MIPPA pertaining to a physician being immediately available and accessible for medical consultation and medical emergencies at all times items and services are being furnished under the program, a physician as defined in section 1861(r)(1) of the Act must supervise CR and ICR sessions, whether furnished in physicians' offices, hospital outpatient settings, or other Part B settings.
• To remove the term “general cardiac rehabilitation” and replace with “cardiac rehabilitation.”
• To clarify CR and ICR medical director and supervising physician standards.
• To clarify that CR and ICR patients must exercise aerobically each day CR and/or ICR services are furnished and are not required to exercise aerobically during every CR or ICR session. If more than one session is furnished during 1 day, then patients are required to exercise aerobically during only one of the sessions.
• To allow flexibility in the 30-day patient centered outcomes measurements in order to allow outcomes that may not exhibit changes during a 30-day period of time to be measured less frequently, but no fewer times than at the beginning and end of patients' participation in a CR or ICR program.
Currently, the following CPT codes are used for CR services described in section 144(a) of the MIPPA: CPT code 93797,
The statute requires that the hospital Outpatient Prospective Payment System
• GXX28,
• GXX29,
These HCPCS codes will be recognized under the PFS and the OPPS. Under the OPPS, the existing CR HCPCS codes, CPT codes 93797 and 93798, are assigned to APC 0095 (Cardiac Rehabilitation) for CY 2009. Because the payment under the PFS for the two proposed ICR G-codes is required to be the same as the payment for CR services under OPPS, we proposed to pay the same amount as will be established through rulemaking for CY 2010 OPPS. We proposed that this amount will be adjusted for the appropriate locality by applying the GPCI under the PFS. The CY 2010 proposed APC assignments and payment rates for these two ICR G-codes were published in the CY 2010 OPPS/ASC proposed rule (74 FR 35361).
We note that when a CR/ICR service is furnished in a hospital outpatient department, a physician cannot bill the Medicare contractor for CR/ICR unless the physician personally performs the CR/ICR service. To personally perform the CR/ICR service, the physician would provide direct care to a single patient for the entire session of CR/ICR that is being reported. In this case, the hospital would report the CR/ICR service and be paid the OPPS payment amount for the facility services associated with the CR/ICR session and the physician would report and be paid the PFS amount for the CR/ICR service. A physician cannot bill under the PFS for CR/ICR services furnished in a hospital for which the physician furnishes only supervision or for services furnished in part by others. If the physician furnishes no direct CR/ICR services for a given session on a given day or provides direct CR/ICR services for less than the full session, then only the hospital would report the CR/ICR services and these services would be paid only under the OPPS.
The following is a summary of the comments we received regarding the payment of CR services under section 144(a) of the MIPPA.
We received comments concerning the role of physical therapists, and occupational therapists in providing CR, ICR, and pulmonary rehabilitation (PR). Those comments are addressed in the PR section which follows this section.
After consideration of the public comments we received, we are finalizing our CY 2010 proposal, without modification, to pay for CR using CPT codes 93797 and 93798.
We also are also finalizing our CY 2010 proposal to adopt the new 2010 PFS HCPCS G-codes for ICR with the following descriptors:
• G0422,
• G0423,
As required by statute, payment under PFS for these services will be based on the OPPS payment amount for CR services. For more information on how the OPPS payment amount for ICR was established, see section XII.B.3 of the CY 2010 OPPS/ASC final rule. We have added the phrase “per hour” to the descriptors of these codes because we believe that CR services generally last one hour as documented by existing claims data for CR services. Section 1861(eee)(4)(C) of the Act provides for up to 72, 1-hour sessions of ICR and hence, adding “per hour” to the two new HCPCS code descriptors for ICR services implements the statutory definition of an ICR session as being 1 hour of service.
Moreover, we have established the payment for ICR services on the presumption that one session represents 1 hour of care. Therefore, we believe that it is appropriate to specify in the descriptors of the HCPCS codes for ICR services that one unit of the code represents 1 hour of care. As discussed previously, CR is covered for up to 36 1-hour sessions, with a minimum of 1 session per week and a maximum of 2 sessions per day, and Medicare contractors have authority to approve additional sessions, up to 72 sessions, over an additional period of time. Section 144(a)(1) of the MIPPA authorizes coverage of ICR programs in a series of 72, 1-hour sessions, up to 6 sessions per day, over a period of 18 weeks.
Section 144 of the MIPPA amended Title XVIII of the Act to provide for coverage of pulmonary rehabilitation (PR) under Part B, under certain conditions, for services furnished on or after January 1, 2010. This final rule with comment period implements the new Medicare standards for a pulmonary rehabilitation program and establishes the requirements for furnishing such items and services to Medicare beneficiaries with chronic obstructive pulmonary disease (COPD).
COPD is one of the more common and severely debilitating chronic respiratory diseases, exemplified by chronic bronchitis and emphysema. Other conditions in this category include
A PR program is typically a multidisciplinary program, individually tailored and designed to optimize physical and social performance and autonomy of care for patients with chronic respiratory impairment. The main goal is to empower and facilitate the individuals' ability to exercise independently. Exercise is combined with other training and support mechanisms to encourage long-term adherence to the treatment plan. The appropriate PR program will train and motivate the patient to attain his or her maximum potential in self-care and overall quality of life.
Prior to the MIPPA, some components of a pulmonary rehabilitation program were covered in office settings as individual services or as services incident to physician services.
In pertinent part, section 144 of the MIPPA amended section 1861(s)(2) of the Act to add a new subparagraph (CC) establishing coverage and payment of items and services furnished under a “pulmonary rehabilitation program.” A pulmonary rehabilitation program is defined in new subsection (fff)(1) to mean a “physician supervised program” that furnishes several specific items and services. Pulmonary rehabilitation consists of certain mandatory components including all of the following:
• Physician-prescribed exercise.
• Education or training (to the extent that the education and training is closely and clearly related to the individual's care and treatment and is tailored to such individual's needs).
• Psychosocial assessment.
• Outcomes assessment.
• Other items and services determined by the Secretary to be appropriate under certain conditions. These mandatory components are to be provided in physicians' offices, hospital outpatient settings, and other settings determined appropriate by the Secretary.
A physician must at all times be immediately available and accessible for medical consultation and medical emergencies when PR items and services are being furnished under the program. The individual's treatment is furnished under a written treatment plan for each beneficiary participating in a PR program. The plan is developed by a physician in conjunction with the interdisciplinary team. A physician, who is involved in the patient's care and has knowledge of his or her condition, must establish and review the plan and it must be signed by a physician every 30 days. This plan must include the individual's diagnosis, the scope of services to be provided in terms of type, amount, frequency and duration, and the goals set for the individual. To be covered and receive payment from Medicare, the PR program must provide all of the specified mandatory items and services.
The statute authorizes the Secretary to establish standards for the physician supervising the PR program to ensure the physician has expertise in the management of individuals with respiratory pathophysiology and is licensed by the State in which the PR program is offered. These standards ensure that the physician is responsible for the program and, in consultation with appropriate staff, is involved substantially in directing the progress of individuals in the program.
We proposed to add § 410.47, “Pulmonary Rehabilitation Program: Conditions of Coverage” to our regulations. The following is a summary of our proposals from the CY 2010 PFS proposed rule. For the full text, please see the CY 2010 PFS proposed rule (74 FR 33610 through 33614, and 33673 through 33674).
We proposed several definitions with respect to the services related to PR. These were for:
• Pulmonary rehabilitation.
• Individualized treatment plan.
• Outcomes Assessment.
• Physician.
• Physician-prescribed exercise.
• Psychosocial assessment.
We also proposed that Medicare would cover PR for beneficiaries with moderate (Stage II) to severe COPD (Stage III) when referred by the physician treating chronic respiratory diseases. Moderate and severe COPD was defined using the GOLD classification II and III.
We proposed that any additional covered clinical indications for the PR program would be added using the National Coverage Determination process.
We proposed that all PR programs must have the following components:
• Physician-prescribed exercise;
• Education or training;
• Psychosocial assessment;
• Outcomes assessment; and
• An individualized treatment plan.
The MIPPA provisions also authorized the Secretary to include other mandatory items and services within the scope of the PR program under certain conditions. We did not propose any other items or services. However, we stated that if we determine that the addition of any other items or services is appropriate, additions will made and implemented through future rulemaking.
We proposed that PR may be provided in a physician's office or in a hospital outpatient setting. If we determine that additional settings are appropriate, those settings will be added through future rulemaking. All settings should have all equipment and staff necessary to provide statutorily-mandated items and services.
We proposed that physicians furnishing PR items and services must have expertise in the management of individuals with respiratory pathophysiology and be licensed in the State in which the PR program is offered.
In the CY 2010 PFS proposed rule with comment period (74 FR 33613), we discussed that section 144 of the MIPPA includes requirements for immediate and ongoing physician availability and accessibility at all times for both medical consultations and medical emergencies when items and services are being furnished under the program. We proposed to define such availability in accordance with existing definitions for direct physician supervision services furnished in physician offices and hospital outpatient departments at § 410.26(a)(2) (defined through cross reference to § 410.32(b)(3)(ii)) and § 410.27(f), respectively. We stated that direct supervision, as defined in the regulations, is consistent with the language of the MIPPA because a physician must be present and immediately available where and when the items and services are being furnished. A physician must also be able to furnish assistance and direction throughout the performance of the services, which would include medical consultations and medical emergencies.
For PR services furnished in physicians' offices and other Part B settings paid under the PFS, we stated that this means that the physician must be present in the office suite and immediately available to furnish
For PR services furnished in hospital outpatient settings, we stated that direct physician supervision is the standard set forth in the April 7, 2000 OPPS final rule with comment period (68 FR 18524 through 18526) for supervision of hospital outpatient therapeutic services covered and paid by Medicare in hospitals and provider-based departments of hospitals. We currently define and specify the requirement for direct supervision for services provided in provider-based departments of hospitals at § 410.27(f). For this purpose, the physician must be on the premises of the location (meaning the provider-based department) and immediately available to furnish assistance and direction throughout the performance of the procedure. This does not mean that the physician must be present in the room when the procedure is performed.
The MIPAA provisions state that in the case of items and services furnished under such a program in a hospital, physician availability shall be presumed. As we have stated in the CY 2009 OPPS/ASC final rule with comment period (73 FR 68702 through 68704), the longstanding presumption of direct physician supervision for hospital outpatient services means that direct physician supervision is the standard and we expect that hospitals are providing services in accordance with this standard.
We proposed that up to 36 sessions in the facility setting are appropriate, no more than one session per day. Patients should generally receive 2 to 3 1-hour sessions per week. We solicited comments regarding the proposed number of sessions. We addressed these comments in the response to public comment section of this final rule with comment.
We received many public comments on various provisions of our proposed rule. Comments were generally supportive of the new PR program but requested some changes related to the sessions and covered conditions. Commenters were in support of our definitions of pulmonary rehabilitation, individual treatment plan, psychosocial assessment, physician, and physician-prescribed exercise. The commenters also were supportive of the physician standards but asked for clarification of the direct supervision rules. The commenters suggested that we add language acknowledging the role and use of the PR staff/interdisciplinary team.
We also received comments related to NCDs but they were largely focused on the effect of the rule on current local coverage determinations (LCDs). Commenters did not request the addition of new items and services. We received a few comments regarding the addition of settings for PR, such as the CORF.
We received numerous comments noting that in the CY 2010 OPPS/ASC proposed rule with comment period (74 FR 35362 through 35370), we proposed that certain NPPs may supervise hospital outpatient therapeutic services that are within their State scope of practice and hospital granted privileges, provided that they also continue to meet all other requirements. Commenters requested that we allow the use of NPPs for PR services because NPPs may provide and supervise other therapeutic services in the HOPD. We received several significant comments and are providing our responses below.
In this final rule with comment period, we announce that we will consider other conditions for which a PR program can be used through the NCD process. The number of various respiratory diseases is expansive and variance within the stages of each disease is broad. The need for, and benefit of, a PR program may relate to the specific respiratory function rather than a broad category of diseases. The NCD process will enable us to evaluate
Even within the population of patients with moderate to very severe COPD, an individual's ability to participate in additional sessions would require a specific review of evidence to determine whether an additional 36 sessions are warranted under section 1862(a)(1)(A) of the Act. This case-by-case expansion allows greatest flexibility for individual needs. It also takes into account the short term nature of the program based on lifestyle modification goals towards self management of the disease. Since the programs are highly individualized, we do not specify a duration by which sessions must be completed; this allows the possibility of sessions, if necessary, up to the maximum allowable of 72, over a longer period of time.
“(B) provides at least the following comprehensive outpatient following rehabilitative (i) physicians' services (rendered by physicians, as defined in section 1861 (r) (1) who are available at the facility on a full or
The MIPPA provisions require that PR services be provided under written individualized treatment plans “established, reviewed, and signed by a physician every 30 days.” The individualized plan includes the individual's diagnosis, the types of services appropriate, the frequency and duration, and the treatment goals. This plan may initially be developed by the referring physician or the PR physician. If the plan is developed by the referring physician who is not the PR physician, the PR physician must also review and sign the plan prior to initiation of PR. The PR staff may make recommendations for modifications to the program, but the physician will still modify the plan as needed, and review and sign the plan every 30 days.
In the final rule we are adopting the provisions as set forth in the July 2009 proposed rule with the following revisions:
• Based on public comments and the GOLD guidelines we are expanding coverage to include individuals with very severe COPD (Stage IV) as a covered condition. We are modifying the final rule § 410.47 (b)(1) “Beneficiaries who may be covered”, to state the addition. The GOLD standard evidence defines GOLD classification IV (Very Severe COPD) as FEV1/FVC 70 percent and FEV1 <30 percent of predicted or FEV1 <50 percent predicted plus chronic respiratory failure.
• We expanded section § 410.47(f) to include additional sessions by changing the total number of allowable sessions to 72 sessions; we did so by allowing an additional 36 at contractor discretion when medically necessary. We also expanded the daily number of the allowable sessions from one session to two sessions.
• We added definitions in § 410.47(a) for the “Medical director” and the “Supervising physician”.
In addition, we are making the following clarifying and technical changes:
• We clarified in § 410.47(c)(5) that the physician establishing the treatment plan needs to be one who is involved in the patient's care and has knowledge of his or her condition.
• We added language in § 410.47(e)(1) to clarify the physician interaction with PR staff.
• We added the word “medicine” in § 410.47(e)(4) to conform the rule to the MIPPA statutory language.
• We added language in § 410.47(e)(3) for training requirements related to the use of emergency equipment; this correlates to the established requirements in the proposed rule for availability of this equipment.
• We added in § 410.47(f) the words “up to” to clarify the contractor is permitted to prescribe any additional amount lower than, and up to, 36 sessions based on medical necessity. We also added a reference to the pertinent statute.
We proposed to create one HCPCS code to describe and to bill for the services of a PR program as specified in section 144(a) of the MIPPA, GXX30 (now assigned code number G0424,
To establish the PE RVU payment for the proposed new PR G-code, we reviewed the PE inputs of similar services, particularly those of the respiratory therapy HCPCS codes, G0237 and G0238, as well as the cardiac rehabilitation codes, CPT codes 93797 and 93798 for non-facility settings. Given that various individuals, acting under the supervision of a physician, can make up the PR multidisciplinary team, we proposed that the clinical labor for the PR G-code could be best represented by the following labor types taken from the PE database: the nurse “blend” (RN/LPN/MTA), the respiratory therapist (RT), the social worker/psychologist and the medical/technical assistant—which we selected to represent various specialists involved in furnishing this service; these are valued at $0.37, $0.42, $0.45, and $0.26 per minute, respectively. Using an average of these values, $0.375 per minute, we proposed to use the nurse blend labor type found in the cardiac rehabilitation CPT codes, at $0.37 per minute, as the typical value for the PR clinical labor and assigning 28 minutes of clinical labor time for the new PR G-code based on the various components of the proposed PR program.
For the equipment PE inputs, we reviewed the direct PE inputs for similar existing codes and proposed a pulse oximeter (with printer), a 1-channel ECG, and a treadmill. Since no typical supplies were listed for similar existing codes in the PE database, we did not propose any specific supplies for this proposed new G-code.
The following is a summary of the comments we received regarding payment for pulmonary rehabilitation services under section 144(a) of the MIPPA.
With regard to PR, some commenters stated that we have a longstanding history of recognizing the services of a therapist as an integral part of a PR program and requiring that these services be reported and paid as PT services. Specifically, the commenters indicated that in the CY 2002 PFS final rule (66 FR 55246) and in the current Medicare Claims Processing Manual (Pub. 100–04, Chapter 5, section 20.A), we specify that when physical therapists treat respiratory conditions, they should report CPT codes for PT in the 97000 series and should not report HCPCS codes G0237,
In addition, with regard to CR/ICR, the commenters requested that CMS confirm that skilled PT services that are rendered in the CR setting by a qualified physical therapist should be conducted, reported, and paid as PT services, and that physician supervision is not necessary in the CR setting when the physical therapist is delivering treatment that clearly meets the criteria for a PT service. The commenters explained that we have recognized and codified that PT is a separate benefit and that physical therapists are qualified to perform certain services independent of direct physician supervision. Similar comments were received concerning occupational therapy services.
In the outpatient physicians office setting, we expect that most patients participating in PR, CR, or ICR programs authorized by section 144(a)(1) of the MIPPA and covered by Medicare will be debilitated based on their underlying medical condition, age, or other factors. In order to develop a PR, CR, or ICR treatment plan, some debilitated patients may require evaluations by therapists on the multidisciplinary team, in addition to assessments by other team members. In order to participate successfully in the prescribed exercise component of the PR, CR, or ICR program, we also expect that these patients may receive individualized treatments by therapists on the multidisciplinary team and others to promote the increased functionality that is a principle goal of PR, CR, and ICR programs. As we stated in the CY 2010 PFS proposed rule, the items and services furnished by a CR or PR program are individualized and set forth in written treatment plans for each beneficiary (74 FR 33607 and 33611). We believe these evaluations and individualized treatments are a part of the PR, CR, or ICR program for those beneficiaries who need them. As such, we believe they should be conducted by one or more members of the multidisciplinary team of the PR, CR, or ICR program with the appropriate expertise.
While we have not defined PR, CR, or ICR services as always including therapists' services as part of the comprehensive benefit (74 FR 33608 and 33614), we have acknowledged in the CY 2010 PFS proposed rule that written treatment plans are highly individualized and that there should be flexibility in the type, amount, frequency, and duration of services provided in each session (74 FR 33607).
We expect that physical therapists could conduct assessments and individualized treatments as part of the PR, CR, or ICR program because physical therapists have the knowledge and skills to assist in addressing common problems that lead to physicians ordering PR, CR, or ICR services for their patients, including poor aerobic capacity, poor endurance, and shortness of breath, in the context of chronic pulmonary or cardiovascular disease. In the context of PR, while we also stated that individuals requiring PR services have a chronic respiratory
Patients in PR, CR, or ICR programs must receive the full complement of care as defined under these benefits as specified in section 144(a)(1) of the MIPPA, in accordance with their individualized treatment plan, including assessments and prescribed exercise. Additionally, the standard HCPCS coding guidance instructs practitioners and providers to report the code for the procedure or service that most accurately describes the service performed. As stated in Section 20.12.1.b. of Chapter 5 of the Medicare Contractor Beneficiary and Provider Communications Manual, in instances where several component services, which have different CPT/HCPCS codes, may be described in one more comprehensive code, only the single code most accurately describing the procedure performed or service rendered should be reported. Therefore, we would expect that when physical therapists provide evaluations and individualized treatment services under a PR, CR, or ICR treatment plan, these services would be billed as PR, CR, or ICR services under the PR, CR, or ICR CPT or Level II HCPCS G-codes that apply. When these programs are provided in a physician office setting and the physical therapist serves as a member of a multidisciplinary team, the services may not be separately billed as therapy services or as services incident to physician services and they need not follow the requirements of those policies. Services must be provided according to the policies for PR, CR, or ICR. For example, for therapy services in physician offices, qualifications of therapists, 90-day certification of plan of care, supervision by NPPs, treatment notes, and progress reports do not apply unless required by PR, CR, and ICR policies. As discussed in detail in sections II.G.8.e. and II.G.9.d. above in this final rule with comment period, for purposes of PR, CR, and ICR services, the required direct supervision must be provided by a doctor of medicine or osteopathy as defined in section 1861(r)(1) of the Act for all services furnished under the plan. For services provided in physician's offices, direct supervision is defined in accordance with existing requirements and the existing definition of direct physician supervision for all therapeutic services furnished in physician offices at § 410.26.
We continue to believe that direct supervision, as defined in the regulations, is consistent with the language of the MIPAA because a physician must be present and immediately available where services are being furnished. A physician must also be able to furnish assistance and direction throughout the performance of the services, which would include medical consultations and medical emergencies.
We expect that most patients who meet the diagnosis requirements for coverage of PR, CR, or ICR would receive component services covered under the PR, CR, or ICR benefit as part of a comprehensive PR, CR, or ICR program, subject to the coverage and payment policies that we are finalizing in this final rule with comment period and the CY 2010 OPPS/ASC final rule with comment period. We understand that some component services of PR, CR, or ICR have previously been furnished to beneficiaries and paid by Medicare under other benefits, such as the outpatient PT benefit.
As stated above, since section 144(a)(1) of the MIPPA authorized a new comprehensive PR program and legislated the CR benefit to also recognize ICR services, we believe that outpatient Part B providers and suppliers should furnish the components of PR, CR, or ICR as comprehensive programs to those patients who qualify for coverage. We would not expect the component services of PR, CR, and ICR programs to be unbundled and billed separately by different providers or practitioners under other benefit categories, such as the PT benefit. Therefore, we expect that it would be uncommon for a patient receiving care under a PR, CR, or ICR treatment plan to also be receiving PT services under a separate PT plan of care.
There may be patients with therapy needs that are outside the treatment plan appropriate for PR, CR, or ICR and such patients should receive medically necessary PT services specific to those other needs under a PT plan of care and according to the policies for PT services. However, we would not expect it to be the norm that PT services and PR, CR, or ICR services are furnished to the same beneficiaries in the same day. Clearly, a single period of care can only be billed as one type of treatment service, so providers and suppliers could never bill both PT and PR, CR, or ICR services for the same time period for the same patient (for example, during an hour session from 10 to 11 a.m. on a single date of service).
We plan to monitor claims data for PR, CR, and ICR services as well as any additional claims for therapy services. If we detect patterns of care that are inconsistent with our stated expectations for PR, CR, or ICR services and therapy services, we may encourage Medicare contractors to review cases in which a provider or supplier reports both types of services for the same patient during the same span of time (for example, over a several month period) or we may propose changes to our payment methodologies for these services.
After considering the public comments received, we are clarifying that we would expect component services that are furnished under a PR, CR, or ICR treatment plan to beneficiaries who qualify for PR, CR, or ICR services to be furnished as PR, CR, or ICR services, regardless of whether they are furnished by a physical therapist or other healthcare practitioner, and that all of the coverage and payment requirements, including, but not limited to, the physician supervision requirements for services incident to a physician in the physician office setting, apply to those PR, CR, or ICR services. We expect that providers and suppliers of Part B services will furnish the comprehensive set of services that is described in the criteria for PR, CR, or ICR programs to beneficiaries who qualify for the benefit.
Similar comments were expressed concerning the inclusion of occupational therapy services in PR programs. The policies for occupational therapy services are the same as for physical therapy services.
The existing HCPCS G-codes do not represent the full scope of services in a comprehensive PR program now authorized by the new PR benefit. We want to ensure that when a physician office bills and is paid for PR services that it attests to meeting all of the requirements of the comprehensive PR program by the reporting of a HCPCS G-code specific to a PR session. We would expect beneficiaries who could qualify for a PR program, where a program is available, to receive services related to those conditions in such a program rather than having services unbundled and provided separately outside a PR program. Therefore, specific codes have been developed to identify and make payment for services furnished as part of pulmonary rehabilitation programs. However, a beneficiary who was receiving treatment in a CORF and in need of respiratory therapy services could receive those services and the CORF could bill using the existing G-codes, as they would have prior to the MIPPA.
In addition, we are modifying our final policy to cover up to 2 sessions of PR per day.
After reviewing the public comments, we will finalize our proposals with modifications. In summary, we will:
• Change the HCPCS code descriptor as follows: G0424,
• As discussed above, we will also allow up to two sessions of PR per day.
• Modify PE inputs, as recommended by commenters, resulting in increased PE RVUs. However, we continue to believe the physician work for PR is comparable to CR and will make no changes to the work RVUs.
The general Medicare payment rules for durable medical equipment (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
Specific rules regarding payment for oxygen and oxygen equipment are set forth in sections 1834(a)(5), (a)(9), (a)(14) and (a)(21) of the Act and § 414.226 of our regulations. Suppliers are paid a monthly payment amount for furnishing medically necessary stationary oxygen equipment under the class described in § 414.226(c)(1)(i) and oxygen contents (for both stationary and portable). 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.
We also pay a monthly add-on payment 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 includes portable liquid oxygen systems and portable gaseous oxygen systems and oxygen generating portable equipment (OGPE) that includes 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 portable) require on-going delivery of oxygen contents.
Section 5101(b) of the DRA amended section 1834(a)(5) of the Act by limiting monthly rental payments to suppliers for oxygen equipment to 36 months of continuous use. At the end of this 36-month rental period, suppliers were required to transfer title of the oxygen equipment to the beneficiary. This requirement started for existing beneficiaries using oxygen on January 1, 2006 and new beneficiaries using oxygen on or after January 1, 2006. The provision also required payments for oxygen contents continue after title to the equipment has been transferred. In the November 9, 2006
Section 5101(b) of the DRA also authorized payments for maintenance and servicing of beneficiary-owned oxygen equipment if the Secretary determined such payments to be reasonable and necessary. We determined that paying for necessary repairs and periodic maintenance and servicing of beneficiary-owned oxygen equipment was reasonable and necessary to ensure that oxygen equipment owned by beneficiaries continued to function properly. Without these payments, we were concerned that there was little incentive for suppliers to maintain this equipment, because the equipment was no longer owned by the supplier.
In the November 9, 2006 final rule, we established other safeguards for beneficiaries receiving oxygen and oxygen equipment, which are set forth at § 414.210(e)(5) and § 414.226(g). Section 414.210(e)(5) requires suppliers—after transferring title of the oxygen equipment to the beneficiary—to furnish replacement equipment at no cost to the beneficiary or the Medicare program if the item furnished by the supplier does not last (that is, it breaks down and is irreparable) for the entire reasonable useful lifetime established for the equipment in accordance with § 414.210(f)(1). Per § 414.210(f), a beneficiary is allowed to elect to receive new oxygen equipment if the original equipment has been in continuous use by the beneficiary for the equipment's reasonable useful lifetime. Section 414.210(f)(1) states the reasonable useful lifetime for equipment is determined through program instructions. In the absence of 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 in accordance with § 414.226(a). Section 414.226(g)(2) prohibits suppliers from replacing oxygen equipment prior to the expiration of the 36-month rental period unless a specific exception applies. This was intended to protect the beneficiary from the supplier changing the beneficiary's equipment in order to maximize Medicare payments. For example, the supplier may want to move a beneficiary from a portable oxygen concentrator to portable gaseous equipment for which Medicare makes additional payments after the 36-month rental period ends.
Section 414.226(g)(4) provides that, by no later than 2 months before the date on which the supplier must transfer title to oxygen equipment to the beneficiary, the supplier must disclose to the beneficiary: (1) whether, in the case of oxygen transfilling equipment and stationary or portable oxygen concentrators, it can maintain and service the equipment after the beneficiary acquires title to it; and (2) whether, in the case of stationary or portable gaseous or liquid oxygen systems, it can continue to deliver oxygen contents to the beneficiary after the beneficiary acquires title to the equipment.
In the CY 2009 PFS final rule with comment period, we outlined the provisions of section 144(b) of the MIPPA (73 FR 69875 through 69876). Section 144(b) of the MIPPA repeals the requirement that the supplier transfer title to oxygen equipment to the beneficiary after the 36-month rental period. In its place, section 144(b) establishes a 36-month rental cap and amends section 1834(a)(5)(F) of the Act by adding three new payment rules and supplier requirements for furnishing oxygen and oxygen equipment after the 36-month rental period. Each of these provisions is discussed below.
Under this new provision, the supplier that furnishes oxygen equipment during the 36-month rental period must continue to furnish the oxygen equipment after the 36-month rental period. The supplier is required to continue to furnish the equipment during any period of medical need for the remainder of the reasonable useful
We revised § 414.226(f) to conform our regulations to this new 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.
In addition, we revised § 414.230 to specify that under no circumstance will a new period of continuous use begin following the 36-month rental period and before the end of the equipment's reasonable useful lifetime since the supplier is responsible for furnishing the equipment after the 36-month rental period for any period of medical need for the remainder of the reasonable useful lifetime of the equipment. Regardless of the length of any break in medical need that occurs following the 36-month rental period, once the break ends and medical need for the oxygen equipment resumes, the supplier is obligated to continue furnishing the item for no additional rental payments until the end of the equipment's reasonable useful lifetime. If the equipment's reasonable useful lifetime ends during the break in medical need, the supplier is under no obligation to continue furnishing the equipment. However, in accordance with § 414.210(f), the beneficiary may elect to obtain new equipment in these situations. If the beneficiary elects to obtain new equipment, a new 36-month rental period begins. It is important to note that, in accordance with section 5101(b)(2)(B) of the DRA, in the case of beneficiaries receiving oxygen equipment on December 31, 2005, the 36-month rental period begins on January 1, 2006. However, in accordance with § 414.210(f)(1), the reasonable useful lifetime of durable medical equipment, including oxygen equipment, begins on the date that the equipment is first delivered to the beneficiary. The reasonable useful lifetime of oxygen equipment furnished to beneficiaries on December 31, 2005, is not adjusted to begin anew on January 1, 2006, to correspond with the start of the 36-month rental period. Therefore, in these situations, the equipment's reasonable useful lifetime may end at any point during or after the 36-month rental period depending on the first day the equipment was delivered to the beneficiary. In these situations, a new period of continuous use and a new 36-month rental period would begin if the beneficiary elects to obtain new equipment.
We also revised § 414.210(e)(2), (e)(4) and (e)(5) to delete regulatory text which relates to beneficiary ownership of oxygen equipment. In addition, we deleted § 414.210(e)(3) because beneficiaries will no longer own oxygen tanks and cylinders. Because § 414.210(e)(3) was deleted, we redesignated § 414.210(e)(4) and § 414.210(e)(5) as § 414.210(e)(3) and § 414.210(e)(4), respectively.
We also revised § 414.226 to state that the protection against supplier replacement of oxygen equipment, unless an exception applies, continues to be in effect after the 36-month rental period ends. Specifically, we revised § 414.226(g)(2) to indicate that this prohibition applies until the expiration of the reasonable useful lifetime established for the equipment. As discussed in the November 9, 2006 final rule (71 FR 65894), we believe this is a necessary safeguard for the beneficiary against changes in equipment made by the supplier in order to maximize payments resulting from moving from one modality to another. Finally, we deleted § 414.226(g)(4) because the transfer of ownership of oxygen equipment provision has been repealed, rendering this provision inapplicable.
The following is a summary of the comments we received and our responses.
As we discussed above, if a supplier is found to not meet a mandatory supplier standard, we may invoke administrative remedies. For example, in accordance with § 424.57(d), failure to meet a mandatory supplier standard may be addressed by revoking a supplier's billing privileges.
However, as discussed in our response above, we have worked with our contractors who issued subregulatory guidance on billing for situations when a beneficiary travels or permanently relocates because these situations necessitate attention to the date of service and location of the supplier. When a beneficiary travels or relocates during the 36-month rental period, the existing supplier can aid the beneficiary in locating a supplier in the new service area. In addition, ombudsman staff at 1–800–Medicare has been trained to assist beneficiaries in these situations to find a new supplier. We will continue to monitor this issue closely and will take appropriate actions to address these situations.
After consideration of the public comments, we are finalizing these provisions without modification.
Section 144(b)(1) of the MIPPA amends section 1834(a)(5)(F)(ii)(II) of the Act and requires us to continue to make payments to suppliers for furnishing oxygen contents after the 36-month rental cap for oxygen equipment ends. Under this provision, an oxygen supplier that furnished liquid or gaseous oxygen equipment during the 36-month rental period, and is required by section 1834(a)(5)(F)(ii)(I) of the Act to continue furnishing the equipment after the 36-month rental period ends, will receive payment for furnishing oxygen contents necessary for use with liquid or gaseous oxygen equipment after the 36-month rental period. Section 1834(a)(5)(F)(ii)(II) of the Act establishes the payment amount for the
We revised § 414.226(d) and (f) to specify that payment shall be made for oxygen contents for use with supplier-owned liquid or gaseous oxygen equipment furnished after the 36-month rental period. An oxygen supplier that furnishes liquid or gaseous oxygen equipment during the 36-month rental month must continue to furnish the oxygen contents for any period of medical need for the remainder of the reasonable useful lifetime of the liquid or gaseous oxygen equipment established in accordance with § 414.210(f)(1). This requirement is necessary because liquid and gaseous oxygen systems (stationary and portable) require on-going delivery of oxygen contents in tanks or cylinders to furnish oxygen to the patient. We believe that the MIPPA provisions when read together provide that the supplier that continues to furnish liquid or gaseous oxygen equipment in accordance with section 1834(a)(5)(F)(ii)(I) of the Act is also required to furnish the oxygen contents housed in those tanks. This is based on the nature of the benfit and the requirement in the statute that the supplier “must continue to furnish” the equipment during any period of medical need. Empty tanks furnished in accordance with section 1834(a)(5)(F)(ii)(I) of the Act would provide no benefit to the patient, since the patient would not be receiving oxygen through the equipment.
We revised § 414.226(f) to specify that the supplier must make arrangements for the beneficiary to continue receiving the equipment if the beneficiary relocates at some time after the 36-month rental period but before the end of the reasonable useful lifetime of the equipment. Likewise, we revised § 414.226(f) to specify that, in the case of liquid or gaseous equipment (stationary and portable) the supplier must make arrangements for the beneficiary to continue receiving oxygen contents if the beneficiary relocates at some time after the 36-month rental period but before the end of the reasonable useful lifetime of the liquid or gaseous equipment (stationary and portable). The supplier must make arrangements for the beneficiary to continue receiving the oxygen contents and equipment at his or her new residence.
After consideration of the comments received, we are adopting these provisions as final without modifications.
Section 1834(a)(5)(F)(ii)(III), as amended by section 144(b)(1) of the MIPPA, authorizes payment for maintenance and servicing of supplier-owned oxygen equipment furnished after the 36-month rental period if we determine such payments are reasonable and necessary.
In the CY 2009 PFS final rule with comment period, we determined that it is not reasonable and necessary to pay for servicing (repair) and non-routine maintenance of supplier-owned oxygen equipment. Given that the supplier owns the equipment, we believe the supplier should be responsible for maintaining its equipment in working order as it did during the 36-month rental period. In addition, warranties covering 5 years are generally available for the top selling brands of oxygen equipment and as discussed in the November 9, 2006 final rule (71 FR 65917) and the CY 2009 PFS final rule with comment period (73 FR 69878), we understand from manufacturers that such products are generally dependable. In a September 2006 report entitled “Medicare Home Oxygen Equipment: Cost and Servicing,” (OEI–09–04–00420), the Office of Inspector General (OIG) of the Department of Health and Human Services found that only 22 percent of beneficiaries who began renting oxygen equipment in 2001 rented the equipment for 36 months or longer. Recent claims data analysis indicates that more than 75 percent of Medicare beneficiaries do not rent oxygen equipment for longer than the 36 months (see Table 52 in section XIII. of this final rule with comment period.) Therefore, oxygen equipment is returned to suppliers before the end of the 36-month rental period in more than 75 percent of cases, and suppliers are then able to furnish the equipment to other beneficiaries, starting new 36-month periods of rental payments for the same equipment. Given that equipment that is less than 5 years old requires minimal maintenance and servicing, and in more than 75 percent of oxygen equipment rental episodes, suppliers receive more than 36 rental payments for the same piece of equipment, we concluded that suppliers should be responsible for maintaining their equipment in working order after the 36-month rental period as they did during the 36-month rental period.
Although we determined as part of the CY 2009 PFS final rule with comment period provisions that it is not reasonable and necessary to make payments for repair or non-routine maintenance of the supplier-owned oxygen equipment, we made an initial determination applicable to CY 2009 only that it is reasonable and necessary for the safety of the beneficiary to make
Separate payment is not made for parts replaced during the general maintenance and servicing visit, as the primary purpose of the periodic visit is to check the supplier-owned equipment to ensure that it is functioning properly. If parts need to be replaced in order to make the equipment serviceable, we concluded that the supplier should be responsible for replacing the parts on equipment from their inventory that they are furnishing to the beneficiary in order to meet the beneficiary's medical need for oxygen.
We solicited comments from interested parties on whether these payments should continue past CY 2009. The following is a summary of the comments we received and our responses.
A number of commenters suggested that the maintenance and servicing rules and payments for oxygen equipment should be similar to those described at § 414.229(e) for capped rental items furnished prior to January 1, 2006. Under these rules, the maintenance and servicing payment amounts are made every 6 months, beginning 6 months after the end of the rental cap period and cover all maintenance, servicing, and repair of the equipment that is needed after the rental cap. The payment amounts are limited to one month's rental payment for the item.
Nevertheless, we agree with commenters that it is reasonable and necessary to increase the maintenance and servicing payment established for 2009 to further ensure the equipment is maintained and serviced by the supplier, thereby protecting beneficiaries who rely on oxygen equipment to deliver a sufficient concentration and quantity of oxygen on an uninterrupted basis. We also agree with commenters who believe that it is reasonable and necessary to establish rules for maintenance and servicing of certain oxygen equipment that are similar to the rules described at § 414.229(e) for capped rental items furnished to beneficiaries beginning on or before December 31, 2005.
These rules allow payment every 6 months, beginning 6 months after the end of the rental cap period, for all necessary maintenance and servicing. In accordance with § 414.229(e), a reasonable fee is established for maintenance and servicing not to exceed 10 percent of the purchase price of the item. Our experience and an OIG report from June 2002 entitled “Medicare Maintenance Payments for Capped Rental Equipment” (OEI–03–00–00410) indicates that such rules more than adequately reimbursed suppliers for maintenance and servicing of capped rental items. In addition, we believe it is necessary to continue requiring that suppliers make visits every 6 months to the beneficiary's home to inspect the oxygen equipment to ensure that all of the equipment maintenance and servicing needs are being addressed.
Regarding the fee for maintenance and servicing, in order to model the payment for maintenance and servicing of certain oxygen equipment after the capped rental maintenance and servicing provision at § 414.229(e), it is necessary to develop maintenance and servicing payments for oxygen equipment in a way that ensures that the amount does not exceed 10 percent of the purchase price of the equipment. The monthly payment amount for oxygen and oxygen equipment includes payment for oxygen contents in addition to equipment rental and is not established based on a percentage of the purchase price of the equipment, as is the case for capped rental items. In the September 2006 report on oxygen equipment, the OIG found that the average cost of an oxygen concentrator was $587. Increasing this amount to a 2010 price based on the percentage change in the Consumer Price Index for all Urban Consumers (CPI–U) from 2006 to 2010 yields a purchase price of $660. We note that the percentage change in the CPI–U from June 2008 to June 2009, the factor used to inflate prices from 2009 to 2010, is a negative 1.41 percent. Therefore, we use a factor of zero percent as the indicator for inflation for this year. Establishing the maintenance
After careful consideration of comments on this issue, we are adding § 414.210(e)(5) to make ongoing maintenance and servicing payments for oxygen concentrators and transfilling equipment (or equipment other than stationary or portable gaseous or liquid oxygen equipment) furnished on or after July 1, 2010 based on a reasonable fee not to exceed 10 percent of the purchase price for a stationary oxygen concentrator. We are making these changes effective for items furnished on or after July 1, 2010, to allow time for necessary systems changes. We are revising § 414.210(e)(2) to continue the maintenance and servicing policy established for certain oxygen equipment for 2009, for items furnished from January 1, 2010 through June 30, 2010. For items furnished on or after July 1, 2010, the maintenance and servicing payments would be made following each subsequent 6-month period until either medical necessity ends or the beneficiary elects to obtain new equipment. Only one maintenance and servicing payment will be made during each 6-month period for any combination of concentrator and oxygen transfilling equipment used by the beneficiary in their home. The maintenance and servicing payment includes payment for all necessary maintenance and servicing of the beneficiary's oxygen concentrator (stationary or portable) and transfilling equipment and a minimum of one required visit to the beneficiary's home to inspect the equipment. Consistent with our existing policy, no payment is made for maintenance and servicing of gaseous or liquid oxygen equipment. Finally, in response to comments, we are revising § 414.210(e)(2), and adding (e)(2)(iii) and (e)(5)(iv) to clarify that the visit to the beneficiary's home must occur during the first month of the 6-month period. This will ensure that the visits occur in 6-month intervals so that maintenance and servicing necessary to keep the equipment in good working order for the next 6 months is performed for each subsequent 6-month period and avoids overlap of 6-month maintenance and servicing episodes.
After consideration of the comments received, we are adopting as final § 414.210 by revising § 414.210(e)(2) and adding § 414.210(e)(5).
Section 152(b) of the MIPPA provides for coverage of kidney disease education (KDE) services for patients. The following is an outline of our final rule to implement the statutory amendments.
Section 152(b) of the MIPPA amended section 1861(s)(2) of the Act by adding a new subparagraph (EE) “kidney disease education services” as a Medicare-covered benefit under Part B. This new benefit is available for Medicare beneficiaries diagnosed with Stage IV CKD, who in accordance with accepted clinical guidelines identified by the Secretary, will require dialysis or a kidney transplant. KDE services will be designed to provide comprehensive information regarding:
• The management of comorbidities, including delaying the need for dialysis;
• Prevention of uremic complications;
• Options for renal replacement therapy (including hemodialysis and peritoneal dialysis, at home and in-center, as well as vascular access options and transplantation);
• Ensuring that the beneficiary has the opportunity to actively participate in his or her choice of therapy; and
• Tailored to meet the needs of the beneficiary involved.
Section 1861(ggg)(3), as added by section 152(b) of the MIPPA, requires that the Secretary set standards for the content of the KDE services after consulting with various stakeholders, who to the extent possible, had not received industry funding from a drug or biological manufacturer or dialysis facility. On November 6, 2008, and December 16, 2008, we held two feedback sessions to solicit stakeholder comments regarding the implementation of section 152(b) of the MIPPA. Both feedback sessions were open to the public. In addition to the feedback sessions, we conducted an internal review of the available medical evidence, literature, and currently available CKD patient education programs. Transcripts from both events are available on the CMS Web site at
We proposed, consistent with section 1861(ggg) of the Act, to amend 42 CFR part 410 to add new § 410.48 for KDE services as a Medicare Part B benefit. The following is a summary of the provisions of the proposed rule, and the comments we received on the proposed rule, and the changes we are making in this final rule regarding coverage of KDE under section 152(b) of the MIPPA. We received broad support from commenters regarding the addition of KDE services as a Medicare Part B covered benefit. Most were generally pleased with the proposed rule and commended us for our expeditious implementation of the MIPPA provisions. Commenters appreciated that CMS collected and incorporated broad stakeholder feedback in the development of the proposed rule.
As related to the implementation of section 1861(ggg) of the Act, we proposed the following definitions in § 410.48:
• Kidney Disease Patient Education Services: Consistent with section 1861(ggg)(1) of the Act, we defined Kidney Disease Patient Education Services as face-to-face educational services provided to patients with stage IV CKD. We specified that KDE services are provided in a face-to-face manner based on stakeholder feedback received during the consultation meetings and our general rulemaking authority. Face-to-face education is consistent with sections 1861(ggg)(C)(ii) and (iii) of the Act, which provide that the services should be designed to ensure that the beneficiary has the opportunity to actively participate in the choice of therapy and be tailored to meet the needs of the beneficiary involved.
At this time, we believe that it would be more appropriate to consider the addition of KDE services for telehealth through full notice and comment procedures in the CY 2011 PFS proposed rule, based on the experience we gain observing the KDE programs over 1 year. We will accept requests for consideration to add KDE services to the list of approved telehealth services in the CY 2011 PFS proposed rule if received prior to December 31, 2009. For more information on submitting a request for an addition to the list of Medicare telehealth services, including where to mail these requests, visit our Web site at
We are retaining the definition of Kidney Disease Patient Education Services as proposed in this final rule.
• Physician: For purposes of KDE services, we proposed to define physician using the definition in section 1861(r)(1) of the Act; it defines “physician” as “a doctor of medicine or osteopathy legally authorized to practice medicine and surgery by the State in which he or she performs such function or action (including a physician within the meaning of section 1101(a)(7) [of the Act].” We received no comments regarding our proposed definition of physician and are adopting this definition in this final rule.
• Qualified Person: Consistent with section 1861(ggg)(2)(A) of the Act, for purposes of KDE services, we proposed to define a “qualified person” as a
In order for a provider of services to be a “qualified person,” the entity must be located in a rural area. We include in the definition of a “qualified person”, only those hospitals, critical access hospitals (CAHs), skilled nursing facilities (SNFs), comprehensive outpatient rehabilitation facilities (CORFs), home health agencies (HHAs), and hospice programs that are located in a rural area under section 1886(d)(2)(D) of the Act (as defined in our regulations at § 412.64(b)(ii)(C)) and include hospitals and CAHs that are reclassified from urban to rural status pursuant to section 1886(d)(8)(E) of the Act, as defined in § 412.103. Specifically, § 412.64(b)(ii)(C) defines “rural” to mean any area outside an urban area, which § 412.64(b)(ii)(A) defines as a metropolitan statistical area (MSA) as defined by the President's Office of Management and Budget (OMB). Therefore, we believe that a hospital, CAH, SNF, CORF, HHA, or hospice program that is not physically located in an MSA should be considered “rural” for this benefit.
Section 1886(d)(8)(E) of the Act, implemented in § 412.103, requires us to treat hospitals that meet specified criteria as geographically rural under section 1886(d)(2)(D) of the Act even though they are physically located in an MSA. Because the statute identifies these hospitals as rural, we believe that it is appropriate to consider these hospitals as qualified persons for purposes of the KDE benefit.
In addition, section 1861(u) of the Act defines a provider of services to be a hospital, critical access hospital, skilled nursing facility, comprehensive outpatient rehabilitation facility, home health agency, or hospice. The provisions of MIPAA require that the provider of services must be located in a rural area in order to furnish KDE services. In implementing the KDE benefit, to exclude these providers of services located within a rural area would be contrary to the statutory definition of the term “provider of services.”
Therefore, in this final rule with comment period and as specified in the statutory definition of a “qualified person,” we consider a qualified person to be either a physician (as defined in section 1861 (r)(1) of the Act) or a PA, NP, or CNS; or a provider of services located in a rural area, which includes a hospital, critical access hospital, skilled nursing facility, comprehensive outpatient rehabilitation facility, home health agency or hospice. A qualified person under this benefit does not include a renal dialysis facility, whether freestanding or hospital-based, regardless of whether the renal dialysis facility is located in a rural area or not. While the hospital-based renal dialysis facility located in a rural area is not a “qualified person” for purposes of payment for KDE services, we note that the hospital of which the hospital-based renal dialysis facility is a part would meet the definition of a “qualified person” because it is in a rural area.
• Renal Dialysis Facility: The Congress has provided in section 1861(ggg)(2)(B) of the Act that a “renal dialysis facility” may not be a “qualified person.” We proposed to define this term, consistent with § 405.2102 of this title, as “a unit which is approved to furnish dialysis services(s) directly to ESRD patients.” We received no comments on the definition and are adopting the proposed definition in this final rule.
• Stage IV Chronic Kidney Disease: Section 1861(ggg)(1)(A) of the Act states that KDE services shall be furnished to beneficiaries diagnosed with Stage IV CKD, who according to accepted clinical guidelines identified by the Secretary, will require dialysis or a kidney transplant. Based on stakeholder feedback, we proposed to define Stage IV CKD as kidney damage with a severe decrease in GFR quantitatively defined by a GFR value of 15–29 ml/min/1.73 m
Consistent with section 1861(ggg)(1)(A) of the Act, we proposed that Medicare beneficiaries are eligible to receive KDE services if the beneficiaries are diagnosed with Stage IV CKD (as defined in new § 410.48(a)), and have been referred for such services by the physician managing the beneficiary's kidney condition.
Therefore, in this final rule, we are retaining our proposed provisions for covered beneficiaries.
We proposed requiring that a qualified person be able to properly receive Medicare payment under 42 CFR part 424 (Conditions for Medicare Payment). Consistent with section 1861(ggg)(2)(B) of the Act, we proposed to specifically exclude a hospital, CAH, SNF, CORF, HHA, or hospice that is physically located outside of a rural area under § 412.64(b)(ii)(C), except for a hospital or CAH that is treated as being located in a rural area under § 412.103. In addition, consistent with section 1861(ggg)(2)(B) of the Act, a renal dialysis facility is not a qualified person.
While we did not propose specific education, experience, training, and/or certification requirements in the proposed rule, we solicited public comments on the appropriate level of education, experience, training, and/or certification appropriate for a qualified person to effectively provide KDE services. Factors to consider included specific education and expertise regarding the topic and the ability to explain these areas for the purpose of patient education.
In this final rule with comment period, we are retaining the proposed standards for the “Qualified Persons and Exclusions” provisions.
We believe that patient education needs vary by severity of the disease, the age of the patient, the patient's comorbid conditions and disabilities, the patient's primary language and culture, and desire to learn more about the disease and treatment options. Education services are more effective if the services are tailored to meet an individual beneficiary's needs. We proposed that KDE services include the content as specified in proposed new § 410.48(d).
Commenters were overwhelmingly supportive of the proposed standards for content and provided suggestions for improvement.
• Nature and treatment for co-morbidities that accompany CKD such as anemia, mineral and bone disorders, diabetes, and high blood pressure;
• Separate vascular access into its own topic heading and specify the benefits and risks of each option, the need to preserve vasculature for creation of fistulas, and care of vascular access to avoid infection and stenosis;
• Transplantation including preparation for transplantation, pre-emptive transplantation and differences between living donor and deceased donor transplantation, immunosuppression, allocation policies, and lifestyle post-transplant;
• Smoking cessation;
• Use of non-steroidal anti-inflammatory agents;
• Impact of blood transfusions on transplant candidacy;
• Nutrition, risk of malnutrition, impact of dietary interventions on the progression to kidney failure, and pre-dialysis and dialysis patient dietary prescriptions;
• Conservative management without renal replacement therapy and palliative care as a therapeutic option; and
• Advanced directives education.
(a) Limitations on the number of sessions: Consistent with section 1861(ggg)(4) of the Act, we limit the number of KDE sessions to six (6). We did not receive any comments on the session limitations. Therefore, we are adopting the limits, as proposed, in this final rule.
(b) Session Length: In the proposed rule we defined the session length as 60 minutes.
(c) Individual and Group Session Format: Consistent with section 1861(ggg)(C)(iii) of the Act, we specify that the qualified person tailor the design of the education services to meet the needs of the beneficiary based on whether the beneficiary needs more individualized education, would benefit more from a group environment, or a combination; and consider any communication accessibility needs based on disability, language and health literacy.
Generally speaking, medical services are provided to beneficiaries on an individual basis. Beneficiaries can also benefit from the interaction in a group setting. We believe that the beneficiary, in consultation with the referring physician, will be able to best determine the education services modality that most effectively meets his or her needs.
The intent of the education services is for the beneficiary to take the information he or she has learned during the educational sessions in order to facilitate active participation by the beneficiary in the healthcare decision-making process with the physician managing his or her kidney condition. We believe that it is important that beneficiaries be assessed at the conclusion of the education sessions and that program assessments be used by the educators and CMS to assess the effectiveness of the education services, to help improve the programs for future participants, and better facilitate patient understanding of the material.
Based on stakeholder feedback and our general rulemaking authority, we proposed that qualified persons develop outcomes assessments and that each beneficiary be assessed during one of the education sessions. Section 410.48(d)(5) specifies that the outcomes assessment measures beneficiary knowledge about CKD and its treatment for the purpose of, and as a contributor to, the beneficiary's ability to make informed decisions regarding their healthcare and treatment options.
After completing the KDE services, the beneficiary should be able to take the information learned and use it to make informed choices about their healthcare during future consultations with the physician managing the beneficiary's kidney condition. It is important that the assessments be tailored to the beneficiary's reading level and language if the assessment is not administered by the qualified person that provided the education services, and be made available to CMS in a summarized format upon request. In the proposed rule, we specifically
As a result of the comments received, we are making the following changes in this final rule with comment period:
• In the Standards for Content section, we are changing “all vascular access options” to “all dialysis access options for hemodialysis and peritoneal dialysis.”
• In the standards for content section, we are clarifying that qualified persons discuss, but not be limited to, the topics listed under the `therapeutic options' content standard heading.
• In the Limitations for Coverage of Kidney Disease Education Services section, we are changing the description of session length from “60 minutes” to “one (1) hour.”
Section 152(b) of the MIPPA creates a new benefit category for KDE services. The MIPPA amends section 1848(j)(3) of the Act, which allows for payment of KDE services under the PFS. As we stated in the CY 2010 PFS proposed rule (74 FR 33619), KDE services are covered when they are furnished by a qualified person as defined in § 410.48(a) that meets the requirements of § 410.48(c) which means a physician, PA, NP, CNS, or a provider of services located in a rural area including a CAH, SNF, HHA, CORF, and hospice. We note that there is a possibility that a beneficiary may receive services from more than one “qualified person”; however, payment should be made to only one qualified person on the same day for the same beneficiary.
In the proposed rule, we noted that the “incident to” requirements for physician services at section 1861(s)(2)(A) of the Act do not apply to KDE services. The MIPPA requirements are explicit, that the education services must be provided by a qualified person. We noted that rural health clinics (RHCs) do not meet the statutory definition of a provider of services (as defined in 1861(u) of the Act) and cannot be separately paid for furnishing KDE services.
In the proposed rule, we noted that the “incident to” provision does not apply to the implementation of a new service with a distinct benefit category under the PFS. We stated that the “incident to” requirements would not apply to KDE services.
It is our policy that only services without a benefit category may be provided “incident to” the services of physicians or NPPs.
In summary we are finalizing our determination that the “incident to” benefit does not apply to KDE.
Section 1861(ggg)(4) of the Act limits the number of KDE services that a beneficiary may receive to up to six sessions in the NPRM. We proposed to create two HCPCS codes GXX26 now assigned as G0420 (individual) and GXX27 now assigned as G0421 (group), to describe and to bill for KDE services. The two G-codes consist of 1-hour face-to-face KDE sessions for an individual or group. We proposed to pay both G0420 and G0421 at the nonfacility rate. We also proposed that G0420 educational services related to the care of chronic kidney disease; individual per session will be crossed-walked to CPT code 97802; and that G0421, educational services related to the care of chronic kidney disease; group, per session will be crosswalked to CPT code 97804. We stated that the rationale for the proposed pricing of the G-codes is based on the similarity of this service to MNT in the individual (97802) and group (97804) setting.
In the CY 2010 OPPS/ASC proposed rule (74 FR 35358), we discussed our proposed payment for KDE to qualified persons located in rural areas who are hospitals, CAHs, SNFs, CORFs, HHAs, or hospices (74 FR 35358).
The following is a summary of the comments we received regarding our proposals related to the MPFS payment for kidney disease education under section 152(b) of the MIPPA.
In summary, we are finalizing the proposed HCPCS codes G0420,
Section 153 of the MIPPA requires changes to ESRD facilities for ESRD services effective January 1, 2010. The following is a summary of these changes.
Section 153(a)(1) of the MIPPA increases the current ESRD composite rate by 1.0 percent for services furnished on or after January 1, 2010. This also requires us to update the adjusted drug add-on. Since we compute the drug add-on adjustment as a percentage of the composite rate, the drug add-on percentage is decreased to account for the higher CY 2010 composite payment rate and results in a 15.0 percent drug add-on adjustment for CY 2010. As a result, the drug add-on amount of $20.33 per treatment remains the same for CY 2010, which results in a 15.0 percent increase to the base composite payment rate of $135.15 (see section II.I of this final rule with comment).
The composite rate paid to hospital-based facilities will be the same as the composite rate paid to independent renal dialysis facilities for services furnished on or after January 1, 2010, as required by section 153(a)(2) of the MIPPA. In addition, section 153(a)(2) of the MIPPA requires that in applying the geographic index to hospital-based facilities, the labor share shall be based on the labor share otherwise applied for renal dialysis facilities.
These MIPPA provisions are self-implementing and require no substantive exercise of discretion on the part of the Secretary. A detailed discussion of the MIPPA provisions can be found in section III. of the CY 2009 PFS final rule with comment period (73 FR 69881).
The following is summary of the comments we received regarding section 153 of the MIPPA.
Generally, compendia are “pharmacopeia providing information on drugs, their effectiveness, safety, toxicity, and dosing and are frequently used to determine whether a medication has a role in the treatment of a particular disease; these roles include both therapeutic uses approved by the U.S. Food and Drug Administration (FDA) and off-label indications” (Agency of Healthcare Research and Quality (AHRQ),
Compendia publishers, including internal editorial staff and external experts, review requests received for the inclusion of recommendations regarding off-label uses of drugs or biologicals in anticancer regimens. These requests may be internally generated by the publisher or may be received as requests from external parties. The publisher reviews evidence related to the request and reaches a disposition of the request.
Section 1861(t)(2)(B)(ii)(I) of the Act lists the following compendia as authoritative sources for use in the determination of a “medically-accepted indication” of drugs and biologicals used off-label in an anti-cancer chemotherapeutic regimen: American Medical Association Drug Evaluations (AMA–DE); United States Pharmacopoeia-Drug Information (USP–DI) or its successor publication; American Hospital Formulary Service-Drug Information (AHFS–DI); and other authoritative compendia as identified by the Secretary. Due to changes in the pharmaceutical reference industry, AHFS–DI was the only statutorily
Section 1861(t)(2)(B) of the Act provides the Secretary the authority to revise the list of compendia in section 1861(t)(2)(B)(ii)(I) for determining medically-accepted indications for off-label use of drugs and biologicals in an anti-cancer chemotherapeutic regimen. Consequently, in § 414.930, we established an annual process to revise the list and a definition of “compendium” in the CY 2008 PFS final rule with comment period (72 FR 66222, 66303 through 66306, and 66404).
Currently, four compendia are recognized for purposes of section 1861(t)(2) of the Act: National Comprehensive Cancer Network Compendium, Gold Standard Clinical Pharmacology, Thompson Micromedex DrugDex, and AHFS–DI.
In addition to these compendia, the statute provides an alternative method for identifying medically-accepted off-label uses of drugs and biologicals in an anti-cancer chemotherapeutic regimen. Section 1861(t)(2)(B)(ii)(II) of the Act provides that local contractors may use “supportive clinical evidence in peerreviewed medical literature” to make such determinations. Thus these medically-accepted uses could be identified even if there were no compendia recognized for this purpose. We discussed this in our response to comments in the CY 2008 PFS final rule with comment period (72 FR 66305).
Section 182(b) of the MIPPA amended section 1861(t)(2)(B) of the Act (42 U.S.C. 1395x(t)(2)(B)) by adding the sentence, “On and after January 1, 2010, no compendia may be included on the list of compendia under this subparagraph unless the compendia has a publicly transparent process for evaluating therapies and for identifying potential conflicts of interests.”
As discussed in the proposed rule, we proposed revisions to the compendia standards to implement the MIPPA amendments. We note that the publishers of the four compendia that are currently recognized for purposes of section 1861(t)(2) of the Act have already adopted conflict of interest disclosure policies that are similar to our proposal. Though there are individual differences among the publishers, we note that these policies commonly include publication on the compendia publisher's Web site of the name of the individuals that participate in the compendia recommendation and the entity with which there is a significant relationship, the nature of the relationship (for example, salary, ownership, grant support), and the value of the relationship.
Additional information with respect to the conflict of interest policies of those compendia can be found on their Web sites.
In addition, there is a growing body of literature, including that from the Institute of Medicine (IOM),
As discussed in the proposed rule, we believe that the implementation of this statutory provision that compendia have a “publicly transparent process for evaluating therapies and for identifying potential conflicts of interests” is best accomplished by amending the current definition of a compendium at § 414.930(a) to include the MIPPA requirements and by defining the key components of publicly transparent processes for evaluating therapies and for identifying potential conflicts of interests.
In order to implement the MIPPA requirements concerning a publicly transparent process for evaluating therapies, we proposed that a compendium could meet this standard by publishing materials used in its evaluation process on its Web site. This mode of publication provides broad contemporaneous public access to relevant materials. We believe that public access to such materials will increase transparency of the process used by compendia publishers for evaluating therapies and facilitate independent review of recommendations by interested parties. In addition, as discussed in the CY 2008 PFS final rule with comment period (72 FR 66305 through 66306), such disclosure may assist beneficiaries and their physicians in choosing among treatment options.
In the CY 2010 PFS proposed rule (74 FR 33620 through 33623), we proposed the following amendments to § 414.930(a):
• To revise the definition of “compendium” by adding an additional requirement that a compendium have a publicly transparent process for evaluating therapies and for identifying potential conflicts of interests.
• To add a definition of a “publicly transparent process” for evaluating therapies whereby a compendium publisher would publish on its Web site the complete application for inclusion of a therapy including criteria used to evaluate the request; disclosure of the evidence considered; the names of the individuals who have substantively participated in the development of the compendia recommendations; and transcripts of meetings and records of votes for disposition of the request. We requested comments on the requirement for publication of the transcript and the suitability of other alternatives such as minutes or other documents.
• To add a definition of a “publicly transparent process for identifying potential conflicts of interests” whereby a compendium publisher would disclose by publication on its Web site information regarding potential conflicts of interests associated with individuals who are responsible for the compendium's recommendations, as well as their immediate family members. We requested comments on the suitability of this process or whether the compendia should prescribe their own process. The specific details of the proposed process were outlined in the proposed rule (74 FR 33621 through 33623). We received the following comments on our proposed revisions.
We have also amended the publicly transparent process for identifying potential conflicts to include a provision that requires compendia to have a process for collecting and maintaining conflict of interest information and disclosure, if requested by the public in lieu of publishing this information on their Web sites. We believe this strikes a reasonable balance between the individual's personal privacy and the public interest in transparency.
This final regulation amends § 414.930(a) to revise the definition of
•
(i) The internal or external request for listing of a therapy recommendation including criteria used to evaluate the request.
(ii) A listing of all the evidentiary materials reviewed or considered by the compendium pursuant to the request.
(iii) A listing of all individuals who have substantively participated in the review or disposition of the request.
(iv) Minutes and voting records of meetings for the review and disposition of the request.
•
(i) Direct or indirect financial relationships that exist between individuals or the spouse or minor child of individuals who have substantively participated in the development or disposition of compendia recommendations and the manufacturer or seller of the drug or biological being reviewed by the compendium. This publicly transparent process may include disclosure of, for example, compensation arrangements such as salary, grant, contract, or collaboration agreements between individuals or the spouse or minor child of individuals who have substantively participated in the review and disposition of the request and the manufacturer or seller of the drug or biological being reviewed by the compendium.
(ii) Ownership or investment interests between individuals or the spouse or minor child of individuals who have substantively participated in the development or disposition of compendia recommendations and the manufacturer or seller of the drug or biological being reviewed by the compendium.
Before enactment of section 9335(c) of the Omnibus Budget Reconciliation Act of 1986 (Pub. L. 99–509) (OBRA '86), there was no specific Medicare benefit that provided for Medicare Part B coverage of prescription drugs used in immunosuppressive therapy. OBRA '86 added subparagraph (J) to section 1861(s)(2) of the Act to provide Medicare coverage for immunosuppressive drugs, furnished to an individual who receives an organ transplant for which Medicare payment is made, for a period not to exceed 1 year after the transplant procedure. Coverage of these drugs under Medicare Part B began January 1, 1987.
Section 13565 of the Omnibus Budget Reconciliation Act of 1993 (Pub. L. 103–66) amended section 1861(s)(2)(J) of the Act to allow eligible beneficiaries to receive additional Part B coverage within 18 months after the discharge date for immunosuppressive drugs furnished in 1995; within 24 months for immunosuppressive drugs furnished in 1996; within 30 months for immunosuppressive drugs furnished in 1997; and within 36 months for immunosuppressive drugs furnished after 1997. Beginning January 1, 2000, section 227 of the Medicare, Medicaid and SCHIP Balanced Budget Refinement Act of 1999 (Pub. L. 106–113) (BBRA) extended coverage to eligible beneficiaries whose coverage for drugs used in immunosuppressive therapy expires during the calendar year, an additional 8 months beyond the 36-month period.
Section 113 of the Medicare, Medicaid and SCHIP Benefits Improvement and Protection Act of 2000 (Pub. L. 106–554) (BIPA 2000) revised section 1861(s)(2)(J) of the Act to eliminate the time limits for coverage of prescription drugs used in immunosuppressive therapy under the Medicare program. Effective with immunosuppressive drugs furnished on or after December 21, 2000, there is no longer any time limit for Medicare benefits. This policy applies to all Medicare entitled beneficiaries who meet all of the other program requirements for coverage under this benefit. Therefore, for example, entitled beneficiaries who had been receiving benefits for immunosuppressive drugs under section 1861(s)(2)(J) of the Act, but whose immunosuppressive drug benefit was terminated solely because of the time limit described above, resumed receiving that benefit for immunosuppressive drugs furnished on or after December 21, 2000.
According to section 226A(b)(2) of the Act, “ESRD only” beneficiaries continue to lose their general Medicare coverage and, by extension, Part B coverage for immunosuppressive drug therapy 36 months after discharge from a hospital following a covered transplant. Beneficiaries will have Part B coverage for immunosuppressive drug therapy for as long as they remain eligible for Medicare.
Our proposal to codify the immunosuppressive drug coverage does not cause a substantive programmatic change since the provisions in section 113 of the BIPA 2000 eliminating the time limit from section 1861(s)(2)(J) of the Act are self implementing for services on or after December 21, 2000. We included this topic in the proposed rule in order to make conforming changes to the regulatory text at § 410.30. We proposed to amend paragraph (b) to codify the changes to the immunosuppressive drug coverage time limit as required by section 113 of the BIPA 2000.
The following is a summary of the comments we received and our responses:
After reviewing the public comments, we are finalizing our proposed revisions to § 410.30.
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 threshold percentage (as defined in subparagraph (B)).” The applicable threshold is specified as 5 percent for CY 2005. For CY 2006 and subsequent years, section 1847A(d)(3)(B) of the Act establishes that the applicable threshold 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 CY 2006 through CY 2009, we specified an applicable threshold percentage of 5 percent for both the WAMP and AMP. We based this decision on the limited data available to support a change in the current threshold percentage.
For CY 2010, we proposed to specify an applicable threshold percentage of 5 percent for the WAMP and the AMP. At present, the OIG is continuing its comparisons of both the WAMP and the AMP. In April 2008, we implemented a change in the weighting methodology for calculating ASP. Information on how recent changes to the calculation of the ASP may affect the comparison of ASP to WAMP or AMP is limited at this time. In addition, due to the ongoing legal issues surrounding the availability of AMP, we believe it is prudent not to change the threshold at this time. Since we do not have sufficient data that suggest another level is more appropriate, we believe that continuing the 5 percent applicable threshold percentage for both the WAMP and AMP is appropriate for CY 2010.
As we noted in the CY 2009 PFS final rule with comment period (73 FR 69752), we understand that there are complicated operational issues associated with potential payment substitutions. We will continue to proceed cautiously in this area and provide 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 or the AMP for the ASP.
The following is a summary of the comments we received and our responses:
After reviewing the public comments, we are finalizing our proposal to continue the 5 percent WAMP/AMP threshold for CY 2010.
Section 303(d) of the MMA requires the implementation of a competitive acquisition program (CAP) for certain Medicare Part B drugs not paid on a cost or PPS basis. The provisions for acquiring and billing drugs under the CAP were described in the Competitive Acquisition of Outpatient Drugs and Biologicals Under Part B proposed rule (March 4, 2005, 70 FR 10746) and the interim final rule (July 6, 2005, 70 FR 39022), and certain provisions were finalized in the CY 2006 PFS final rule with comment period (70 FR 70236). The CY 2007 PFS final rule with comment period (72 FR 66260) then finalized portions of the July 6, 2005 IFC that had not already been finalized.
The CAP is an alternative to the ASP (buy and bill) methodology of obtaining certain Part B drugs used incident to physicians' services. Physicians who choose to participate in the CAP obtain drugs from vendors selected through a competitive bidding process and approved by CMS. Under the CAP, participating physicians agree to obtain all of the drugs on the CAP drug list from an approved CAP vendor. The approved CAP vendor retains title to the drug until it is administered, bills Medicare for the drug, and bills the beneficiary for cost sharing amounts once the drug has been administered. The participating CAP physician bills Medicare only for administering the drug to the beneficiary. The initial implementation of the CAP operated with a single CAP drug category from July 1, 2006 to December 31, 2008.
After the CAP was implemented, section 108 of the MIEA–TRHCA made changes to the CAP payment methodology. Section 108(a)(2) of the MIEA–TRHCA requires the Secretary to establish (by program instruction or otherwise) a post payment review process (which may include the use of statistical sampling) to assure that payment is made for a drug or biological only if the drug or biological has been administered to a beneficiary. The Secretary is required to recoup, offset, or collect any overpayments. This statutory change took effect on April 1, 2007. Conforming changes were proposed in the CY 2008 PFS proposed rule (72 FR 38153) and finalized in the CY 2008 PFS final rule with comment period (72 FR 66260).
In the CY 2009 PFS proposed rule, we proposed several refinements to the CAP regarding the annual CAP payment amount update mechanism, the definition of a CAP physician, the restriction on physician transportation of CAP drugs, and the dispute resolution process (73 FR 38522). However, after the publication of the CY 2009 proposed rule, we announced the postponement of the CAP for 2009 due to contractual issues with the successful bidders. As a result, CAP physician election for participation in the CAP in 2009 was put on hold, and CAP drugs have not been available from an approved CAP vendor for dates of service after December 31, 2008. Physicians who participated in the CAP have transitioned back into the Average Sales Price (ASP) method of acquiring part B drugs for dates of service after December 31, 2008.
After the postponement was announced, we solicited public feedback on the CAP from participating physicians, potential vendors, and other interested parties. We solicited public comments on several issues, including, but not limited to the following: the categories of drugs provided under the CAP; the distribution of areas that are served by the CAP; and procedural changes that may increase the program's flexibility and appeal to potential vendors and participating physicians.
In the CY 2009 PFS final rule with comment period, we stated that we would review the public comments and consider implementing changes to the CAP before proceeding with another bid solicitation for approved CAP vendor contracts. Based on this information, we addressed items that were not finalized in the CY 2009 PFS final rule with comment period, and made additional proposals for the CAP. Our approach seeks to better define certain aspects of the program based on our experience. We also seek to continue to increase participation by minimizing the administrative burden for physicians and vendors who choose to participate. We appreciate the additional comments that we have received during the comment period.
As described in the July 6, 2005 IFC (70 FR 39070 through 39071) and § 414.906(c), payment amounts for drugs furnished under the CAP are set through a competitive bidding process, and as described in § 414.908(b), bids that exceed a composite bid threshold of 106 percent of the weighted ASP for the drugs in the CAP category are not accepted. The CAP payment amounts that are calculated from successful bids are updated from the time of the bidding period to the payment year. During the 2006 through 2008 CAP contract period, the initial update calculation used the change in the Producer Price Index (PPI) for prescription preparations to account for the time period between the bidding and the period in which the payment amounts were to be in effect, which was the middle of the first year of the three year CAP contract period (70 FR 39074). Finally, as specified in § 414.906(c), CAP payment amounts were updated again during the second and third year of the contract period based on the approved CAP vendor's reported reasonable net acquisition costs (RNAC). The annual updates are limited by payment amounts described in section 1847A of the Act and codified in § 414.906(c).
Section 1847B(c)(7) of the Act gives the Secretary the discretion to establish an appropriate schedule for the approved CAP vendor's disclosure of RNAC information to us, provided that disclosure is not required more frequently than quarterly. In the July 6, 2005 IFC (70 FR 39075 through 39076), we specified that each approved CAP vendor will disclose its RNAC for the drugs covered under the contract annually during the period of its contract and that we would calculate an annual payment adjustment based on this information. We specified an annual disclosure of RNAC because it imposes the minimal burden on approved CAP vendors. In 2005, some commenters suggested that more frequent updates would be desirable. Additional feedback about the CAP that was obtained after the program's postponement in 2008, as well as comments on previous rules, indicated that potential vendors would like the frequency of price adjustments to increase. In the past, various commenters have suggested a quarterly price adjustment in order to parallel the ASP process, to better match payment amounts with increases or decreases in drug costs, and to attract vendor interest. We believe that quarterly adjustments also would lower approved CAP vendors' financial risks because CAP payment amounts will be better able to keep up with unanticipated drug cost increases and would benefit the Medicare program by reacting to significant cost decreases more promptly.
Quarterly price updates also will eliminate the PPI-based increase that currently occurs between the time bids are submitted and the first day of CAP claims processing. The application of the PPI-based payment adjustment described in the July 6, 2005 IFC (70 FR 39074) has resulted in situations where the ASP+6 percent payment amount was exceeded during the first year of the 3-year approved CAP vendor contract. We do not believe that CAP payment amounts should exceed ASP+6 percent. In our discussion of bid ceilings in the July 6, 2005 IFC, we stated that the bid ceiling “ensures that the CAP will be no more costly to the Medicare program than the alternative method of paying for drugs at 106 percent of ASP. This ceiling is thus consistent with the possibility of realizing savings to the Medicare program. It would also serve to maintain a level of parity between the two systems, preventing a situation in which significant payment differentials might skew incentives and choices (70 FR 39070).” For this reason, and to remain consistent with current regulation text at § 414.906, we believe that all payment amounts calculated under the update process should be limited by the weighted payment amount established under section 1847A of the Act. We also believe that this approach will continue to provide for an “appropriate price adjustment” as required under section 1847B(c)(7) of the Act by improving responsiveness to unexpected price changes, and continuing a prudent limitation on the magnitude of payment amount adjustments.
Our approach for implementing quarterly updates is consistent with the ASP+6 percent limit on payment amounts and is based on composite bid price calculations, as described in the July 6, 2005 IFC (70 FR 39072 through 39073). Briefly stated, the ASP+6 percent limit would be applied by comparing the (weighted) composite update payment amount, calculated from participating approved CAP vendors' reasonable net acquisition cost data, to the most recent available weighted ASP prices for the same drugs. If the composite drug update payment amount exceeds the weighted ASP+6 percent payment limit, the composite payment amount for that group of drugs would be reduced to equal the ASP+6 percent limit by applying an equal percent reduction to each drug in the group. By way of example only, if a quarter's composite update payment was calculated as +2.3 percent, based on the median of all participating approved CAP vendors' data, but the calculated weighted ASP+6 percent limit for that group of drugs was +2.1 percent, the payment amounts for all HCPCS codes in the composite group would be increased by 2.1 percent in order to account for reported increases to the vendor's acquisition cost, but not to exceed the ASP+6 percent limit. This means that a 2.1 percent increase would be applied to CAP payment amounts for all HCPCS codes that are in the composite drug list and are being supplied under the CAP by one or more approved CAP vendors. For HCPCS codes that are priced separately, each code available through the CAP will be compared to the most recent ASP+6 percent limit for that code. CAP payment amounts for codes that exceed the ASP+6 percent limit will be reduced to ASP+6 percent. Each “Not Otherwise Classified” (NOC) drug described in § 414.906(f)(2)(iv), would also be updated on an individual (rather than composite) basis.
We proposed to discontinue annual CAP payment amount updates and to implement quarterly CAP payment amount updates at § 414.906(c). We also proposed to discontinue the special quarterly adjustments described at § 414.906(c)(2) (for the introduction of new drugs, expiration of drug patents or availability of generic drugs, material shortages, or withdrawal of a drug from the market) and instead to add details about the payment amount update
The following is summary of the comments we received regarding the proposed revisions to the frequency of drug payment amount updates under the CAP.
We also believe that the elimination of many low cost items from the drug list, as discussed in the next section, will decrease financial risk and administrative burden for approved CAP vendors, and therefore, we do not believe that transaction fees are necessary or are consistent with the policy to maintain an ASP+6 percent ceiling. Finally, we remind readers that although payment amount updates for the core group of CAP drugs will be done as a group, payment amount updates for drugs added by approved CAP vendor request will continue to be calculated by individual HCPCS code, thereby further minimizing the financial risk associated with the addition of new drugs to the approved CAP vendor's CAP drug list.
Therefore, we are finalizing all of our proposals for this section without change. This includes the discontinuation of the annual payment amount adjustments, the discontinuation of PPI-based increases and the discontinuation of special quarterly payment amount increases described in § 414.906(c). We are also finalizing the implementation of quarterly payment amount increases that begin in the first quarter of the CAP claims contract period, the ASP+6 percent limit on payment amount increases, and all corresponding regulation text changes.
In the July 6, 2005 IFC, we responded to comments on our proposed approach for determining the CAP drug categories and how we select the specific drugs in the CAP drug list (70 FR 39026 through 39034). As stated in the CY 2006 PFS final rule with comment period (70 FR 70237), the CAP is intended to provide beneficiaries with access to Medicare Part B drugs and maintain physician flexibility when prescribing medications. Our approach incorporated drugs commonly administered by the range of physician specialties that bill for Part B drugs (70 FR 39030) and resulted in a list of about 180 drugs that were available through the CAP during the CY 2006 through CY 2008 contract period. We also developed a number of methods by which an approved CAP vendor's CAP drug list could be changed (see Table 26 at 70 FR 70242).
We believe that our general approach, to provide a wide variety of drugs to a variety of physicians over a large portion of the United States, is on target. Although we believe that the CAP is a means for physicians to minimize their drug inventory costs, we acknowledge that participation in the CAP cannot completely eliminate the need for participating CAP physicians to maintain at least a minimal drug inventory at the office. Many physicians who participate in Medicare also provide services to non-Medicare patients, and even physicians with a predominantly Medicare patient population may find it useful to keep a small stock of drugs on hand for unforeseen situations, such as emergencies and breakage.
During the CAP postponement, we became aware that both participating CAP physicians and potential vendors supported narrowing the CAP drug list. Both agreed that low cost drugs should be removed from the CAP. Although these items were initially included in the CAP so that an approved CAP vendor would be in a position to supply many of the Part B drugs that an office might administer, CAP physicians and the vendor community have stated that the inclusion of these items in the CAP creates an accounting, tracking, and claims submission burden for some participants. Based on these comments, we believe that low-cost, frequently utilized items, such as corticosteroid injections, could be removed from the list without significant impact on the CAP's utility to participating CAP physicians. Furthermore, it appears that physicians would be more interested in obtaining expensive products, such as biologicals, through the CAP. However, we are also mindful that narrowing the CAP drug list significantly also would decrease an approved CAP vendor's overall purchase volume, and we believe that this could limit the approved CAP vendor's ability to obtain volume-based discounts from the manufacturers or distributors from which it obtains drugs for use in the CAP. Creating a more tailored CAP drug category also could limit physician participation to one or several specialties, and may create a situation
We proposed to create a new CAP drug category for the next round of CAP contracting. Our approach is intended to address comments about the administrative burden of tracking and billing low cost/high volume items while maintaining access to a variety of high cost items. We proposed to identify the new CAP drug category using the existing CAP drug category as a starting point. The 2008 CAP drug list was compiled based on Part B drug claims data, the identification of specialties that frequently administer drugs under Part B, and public comment during rulemaking in 2005 (70 FR 39026 through 39033). We believe that using the 2008 CAP drug list as a starting point would maintain prescribing flexibility for a wide range of specialties and would also maintain access to a wide spectrum of drugs that have been utilized under the program previously. Furthermore, we do not believe it is necessary to develop a new approach because the 2008 CAP drug list was based on heavily utilized drugs in Medicare Part B physician practices; we believe that this approach is on target.
We proposed to amend our list based on CAP physician participation, claims data, and comments indicating that the list should be narrowed to higher cost items. First, we “filtered” the original CAP drug category (drugs furnished in 2006 through 2009) by the specialties that most frequently prescribe drugs under the CAP, and the highest dollar volume CAP drugs (top 20 percent of allowed charges) compiled from 2008 claims data. This filtered list is the starting point for the updated CAP drug category. However, we acknowledged that a filtering process based on frequency of claims from a subset of physicians who might participate in the CAP cannot fully capture all drugs that may be used by certain specialties. In other words, the filtering steps described above narrow the CAP drug list based on physician specialties and dollar volume and do not necessarily preserve groups of drugs that certain prescribers may utilize, especially the less frequently utilized items in such groups. Therefore, we also proposed to “fill in” groups of drugs with related items that do not appear on our list. We stated that we will consider “filling in” any drug or biological product that is physician-administered, has a reasonably high utilization in the Medicare population, is related to drugs already in the CAP (for example, because of similar clinical uses), and is otherwise appropriate for inclusion in the program. The concept of “filling in” drug groups is supported by feedback from former participating CAP physicians who suggested that certain categories of drugs, such as antibiotics, be more fully represented.
We solicited comments on specific drugs that should be added to the 29 item draft list presented in the proposed rule (Table 35 in the CY 2010 PFS proposed rule (74 FR 33627)), and we also sought comments on the method to assess whether a particular drug should be “filled in” so that it is included in the new, narrowed CAP drug category, especially drugs that did not pass the “filtering” step described above. We proposed an approach using the 180 item 2009 through 2011 CAP vendor bidding list (See the Downloads section at
In order to provide additional flexibility for participating CAP physicians and approved CAP vendors, and to allow for participants to further tailor the program to meet their needs, we also proposed to add § 414.906(f)(2)(v) to allow approved CAP vendors to submit a request to CMS to add drugs (or biologicals) to the list of drugs furnished by the requesting vendor if there is sufficient demand and if the drug has therapeutic uses that are similar to other drugs already available through the CAP. The request and approval process would follow the existing regulations at § 414.906(f), and HCPCS code additions that are requested under this process would still be subject to CMS approval. This process adds to the process for adding newly issued HCPCS codes under § 414.906(f)(2)(iii) and newly approved drugs without HCPCS codes (NOC drugs) under § 414.906(f)(2)(iv). It is intended to facilitate more complete access to groups of drugs that may be used by certain specialties, and drugs used to treat certain disease states without having to rely on rigid definitions of classes of drugs that may not apply well to actual clinical practice across a large and diverse geographic area. We believe that this addition to the methods for changing an approved CAP vendor's drug list (see Table 26 in the CY 2007 PFS final rule with comment period (70 FR 70242)) will add to the flexibility of the program.
The following is summary of the comments we received regarding the proposed revisions the CAP drug list.
Although we did not receive any comments that presented a specific and detailed method to further expand or fill in the drug list, the use of volume based filtering and the concept of filling in the drug list was supported by commenters. Thus, as noted above, we are including the potential additions specified in the proposed rule. Further, we are finalizing the proposed approach for approved CAP vendor-requested additions of drugs that have similar uses to drugs on the bid list.
We believe that selecting the larger base drug list and providing a process for approved CAP vendors to request to add drugs that can further “fill in” this list strikes a balance between specifying a minimum scope of drugs and biologicals that will be available under the CAP and providing flexibility for the approved CAP vendor to manage the risk associated with providing a broader array of drugs and biologicals. For this reason, we are not adding any other drugs or biologicals to the bid list or creating an addendum to the bid list at this time. We believe that vendors will be interested in expanding groups of drugs and biologicals available under the CAP in order to maximize physician participation and order volume, and that this will tend to increase the number of therapeutically similar items within the drug list.
We disagree with the commenter who requested that parties other than the approved CAP vendor, for example manufacturers, be permitted to request that CMS add drugs to the CAP category. First, we believe this rulemaking has provided an opportunity for the public to provide input on the CAP drug category, so an additional process is unnecessary. Second, we believe it would be imprudent to permit such a process during the CAP contracting period, because we believe it would be inappropriate to force an approved CAP vendor, mid-contract, to supply drugs that it did not initially consider in its bid and that may be financially risky, may require highly specialized handling, or may necessitate participation in specialized purchasing arrangements.
We believe that requiring approved CAP vendors to add products that they did not choose to bid on or subsequently provide may also limit bidders' interest and could limit the number of approved CAP vendors for physicians to choose from, thereby restricting all access to CAP drugs. We will continue with our policy that allows only approved CAP vendors to request changes to the CAP drug list; however, external stakeholders may approach approved CAP vendors to discuss the potential addition of products to an approved CAP vendor's drug list. As noted above, we believe approved CAP vendors would have an incentive to be responsive to such requests. The new mechanism for deleting drugs from the CAP drug list is discussed in the following section.
With respect to the specific drug and biological products mentioned in the comments, we believe that the addition of specific items mentioned in the comments appears to be best suited for addition to the CAP drug list through vendor requests. We have discussed issues pertaining to orphan drugs, leuprolide and drugs similar to leuprolide and in a previous rule (70 FR 70241 and 70 FR 70243, respectively). While we appreciate these suggestions, we are not compelled to add these drugs to the CAP drug list as required items based on these comments. For the reasons stated in our previous rules, we continue to believe it is prudent to continue to omit these drugs from the CAP. Further, because we are not certain of the potential market volume for these drugs in the CAP, we will not add them to the drug list at this time. We are aware that leuprolide and other gonadotropin releasing hormone agonists are commonly used to treat prostate cancer and are highly utilized items in Medicare; however CAP participation by providers that prescribe these drugs has been low. However, we note that triptorelin (J3315), a gonadotropin releasing hormone agonist used in the treatment of prostate cancer is on the CAP drug list, and therefore, the addition of other gonadotropin releasing hormone analogues though the approved CAP vendor process for adding drugs described above and in new regulation text at § 414.908 would be feasible.
Similarly, new drugs such as Vetibix® and some antibiotics, which were on the CAP drug list during the last contract period, but were filtered out during the development of the new drug list, appear to be good candidates for approved CAP vendor-requested additions because agents with similar therapeutic uses are on the drug list. We will not add these drugs to the drug list at this time because we are not certain that these drugs will have sufficient market volume in the CAP. We also note that one item, Nplate®, an orphan drug only available through a single specialty vendor, and with limited use potential in the Medicare population, also appears to be a candidate for addition upon approved CAP vendor request. As discussed above, we are seeking to balance physician access and approved CAP vendor risk related to the drug list. In light of the lack of widespread demand for such drugs to be included in the CAP drug list (and thus available from all approved CAP vendors), we believe that permitting approved CAP vendors to request to supply those drugs, but not requiring them to do so, strikes the appropriate balance.
Although there are several methods under the CAP to add drugs to an approved CAP vendor's drug list, the current regulations do not specify a process for removing drugs from an approved CAP vendor's list. Our experience has shown that interruptions in availability can affect an approved CAP vendor's ability to supply CAP drugs during the course of a 3-year contract. For example, during the first contract period, we became aware of long-term and permanent drug unavailability, sometimes at the HCPCS level, due to removal of drugs from the market, or interruption of supply to an approved CAP vendor for reasons beyond the approved CAP vendor's control, such as changes to drug distribution methods, changes in agreements between manufacturers and distributors and/or pharmacies regarding who may purchase certain drugs, and direct distribution arrangements.
In order to better respond to sudden, long-term changes in drug supply that are beyond the control of the approved CAP vendor, we proposed to allow an approved CAP vendor to request the permanent removal from its CAP drug list of a HCPCS code for which no NDCs are available. Our proposal is intended to better manage situations where all NDCs from an entire HCPCS code unexpectedly become unavailable to an approved CAP vendor, and we would require the approved CAP vendor: (1) to document the situation in writing, including the unavailability of all NDC codes in a HCPCS code that is supplied under the CAP; (2) to describe the reason for the unavailability and its anticipated duration; and (3) to attest that the unavailability is beyond the approved CAP vendor's control. Approval of the deletion would apply only to the approved CAP vendor or vendors that requested the deletion. Our proposal was not intended to be used frequently, or to permit an approved CAP vendor to remove a HCPCS code from its CAP drug list simply because it has become unprofitable to provide it—we believe the payment amount adjustment proposals discussed in sections II.J.2.a. and f. of this final rule addresses that concern. Furthermore, our proposal was also not intended to be used for managing short-term unavailability, or unavailability of a finite duration—we believe the existing drug substitution policy described in § 414.906(f) already addresses those concerns. We proposed to add this process as § 414.906(g) because those regulations currently provide for additions and substitutions to the CAP drug list, and would therefore require a
Participating CAP physicians who are affected by the deletion of a HCPCS code from an approved CAP vendor's drug list would have the option of remaining with their selected approved CAP vendor and using the ASP (buy and bill) methodology for obtaining the drug that has been deleted, or selecting another approved CAP vendor under the exigent circumstances provision at § 414.908(a)(2). We believe that the deletion of an expensive and highly utilized CAP drug by one approved CAP vendor in the middle of a physician election period could cause hardship for a practice if it had to revert to the ASP methodology of acquiring and billing for that drug. Such a situation would constitute an exigent circumstance. Given CAP's goal of improving access to drugs, allowing the participating CAP physician to switch approved CAP vendors outside of a regular election period in this instance would be prudent.
The following is summary of the comments we received regarding the proposed method to remove items from an approved CAP vendor's drug list.
We believe that the preamble text provides sufficiently detailed guidance about the process. Specifically, we require the approved CAP vendor: (1) to document the situation in writing, including the unavailability of all NDC codes in a HCPCS code that is supplied under the CAP; (2) to describe the reason for the unavailability and its anticipated duration; and (3) to attest that the unavailability is beyond the approved CAP vendor's control. By way of example only, situations that create unavailability beyond the vendor's control could include: FDA action to remove a drug from the market, long-term unavailability of specialized raw materials or long-term manufacturing delays, and changes in distribution arrangements that prevent the approved CAP vendor from buying or supplying the drug within CAP requirements. CMS will assess the information provided by the vendor and approve such requests as described in regulation text at § 414.908(f)(3) and (4).
This process is intended to provide the approved CAP vendor with flexibility to respond to long-term drug supply issues, however, this process is not intended to be used frequently, or to permit an approved CAP vendor to remove a HCPCS code from its CAP drug list simply because it has become unprofitable to provide it, and this process is not intended to be used for managing short-term unavailability, or unavailability of a finite duration.
In the July 6, 2005 IFC (70 FR 39034 through 39036), we established a single, national competitive acquisition area for the initial stage of the CAP. This national distribution area included the 50 States, the District of Columbia, Puerto Rico, and U.S. territories. We recognized that designating a single national area might limit participation to those vendors that could compete to bid and supply drugs nationally, but we indicated this approach was a part of the phase-in plan for the CAP. We also discussed potential phase-in options for the future, stating that smaller areas might become a solution as the program expanded.
According to the vendor community, certain areas of the United States (especially Alaska, Hawaii, and the Territories) currently present logistical challenges and are associated with high drug shipping costs. Moreover, physician participation in these areas has been low; in 2008, physicians from Alaska, Hawaii, and the Territories represented less than 2 percent of total participating CAP physicians. Temporarily limiting the geographic areas served by the CAP could help limit costs and risks for approved CAP vendors associated with shipping drugs to distant parts of the country. However, we believe that the CAP is intended to provide services to all Medicare physicians (including those in distant parts of the country), and therefore, we do not believe that a limitation on the geographic area in which the CAP is available should be permanent.
Section 1847B(a)(1)(B) of the Act specifically requires the Secretary to phase-in the CAP with respect to the categories of drugs and biologicals in the program, in such a manner as the Secretary determines to be appropriate. We believe that this provision, particularly in conjunction with the statutory definition of a competitive acquisition area as “an appropriate geographic region established by the Secretary” provides broad authority for the Secretary to phase in the CAP with respect to the geographical areas in which the program would be implemented. As stated in the July 6, 2005 IFC, we considered several factors when defining geographic areas for the CAP, including aspects of vendors and their distribution systems, such as current geographic service areas, the density of distribution centers, the distances drugs and biologicals are typically shipped, and costs associated with shipping and handling (70 FR 39035). Taking these factors into consideration again, and considering entities who have bid on, or expressed interest in bidding on approved CAP vendor contracts, we believe that it is appropriate to use the authority granted under the Statute to temporarily narrow the area served by the CAP during the program's re-implementation. We appreciate the logistical issues associated with shipping drugs to remote areas and the uncertainties associated with transportation costs that have been described by the potential vendor community; however, we are reluctant to significantly reduce the area served by the CAP because at some point, the approved CAP vendor's volume would be affected and the likelihood of obtaining volume based discounts would decrease.
In the current proposed rule, we proposed to designate the CAP competitive acquisition area as the 48 contiguous States and the District of Columbia for the next round of CAP contracting. This change in the geographic area that is served by the CAP is meant as an interim measure under our phase-in authority and the statutory definition of a competitive acquisition area. We believe that omitting Alaska, Hawaii, and the Territories from the CAP competitive acquisition area at this time will balance the need to revise the CAP to attract more vendors with the need to offer the maximum number of physicians a meaningful opportunity to participate. We believe that the proposal will encourage potential vendors to participate in the CAP because it would temporarily omit areas associated with low physician participation, long shipping times, and high shipping costs. Furthermore, this measure is unlikely to
The following is summary of the comments we received regarding the proposed to revisions the geographic area serviced by the CAP.
As suggested in comments and discussed in the proposed rule, we will continue to assess the CAP and update plans for phase in activity in future rulemaking efforts, including determining the circumstances under which CAP participation will be offered to physicians in Alaska, Hawaii, and the Territories. We will also continue to consider modifying the definition of competitive acquisition area on the basis of regions, States, or some smaller geographic area, which might expand the number of vendors that could bid to participate in the program.
Our discussion about the CAP emergency restocking option in the July 6, 2005 IFC indicated that a participating CAP physician could not maintain a stock of an approved CAP vendor's drug in his or her inventory. This was done because we had reservations about potential program integrity and drug diversion issues (70 FR 39047).
Since that time, we have gained operational experience with the CAP and a better understanding of the ordering and drug delivery process. We have also received additional public feedback about the different ways that the program could be refined, and we have not received any negative feedback from the vendor community indicating a concern about storing CAP drugs in physicians' offices. Therefore, we believe at this time it is appropriate to consider allowing additional flexibility to encourage CAP participation.
Our experience with the CAP, and our increased understanding about the options approved CAP vendors might have for furnishing drugs to a participating CAP physician's office also support considering additional flexibility in this area. For example, we are aware of electronic inventory control and charge capture devices that could be utilized in ways that conform to CAP regulations and are compliant with applicable State and Federal laws. Such devices utilize an electronic transaction based on a physician's order to track the administration of drugs from inventory to a specific patient and to document appropriate charges for the drug. We believe that such systems could fit into the current CAP framework when transactions in such systems are based on a physician's order, because such systems can track inventory, and can be used to capture patient charge data.
For these reasons, we proposed to allow approved CAP vendors to utilize electronic transactions to furnish CAP drugs from nominal quantities of approved CAP vendor-owned stock located at the physician's office in response to specific prescription orders and to capture charges related to such transactions. The proposal was also intended to clarify that entities with alternative approaches to supplying drugs that utilize an electronic transaction are welcome to participate in the CAP bidding process. We believe that this will allow for additional flexibility and efficiency in the ordering and delivery of drugs within the program because it allows for more efficient shipping of approved CAP vendor-owned stock and provides the option of CAP participation for physicians who use or may choose to use such drug inventory management platforms. The proposal did not change our position that a participating CAP physician shall not take title to or pay for CAP drugs, nor does it alter the requirements for information that must be submitted with a prescription order under § 414.908(a) or the application of HIPAA to such data.
Furthermore, the proposal does not affect the applicability of State licensing requirements for an approved CAP vendor. As stated in the July 6, 2005 IFC (70 FR 39066), either the approved CAP vendor, its subcontractor under the CAP, or both, must be licensed appropriately by each State to conduct its operations under the CAP. Therefore, if a State requires it, an approved CAP vendor would be required to be licensed as a pharmacy, as well as a distributor. We did not propose to revise the requirements at § 414.908(c) and § 414.914(f)(9), and we noted that sections 1847B(b)(6) and 1847B(b)(2)(B) of the Act continue to apply. In order to participate in the CAP successful bidders must continue to submit proof of pharmacy licensure, consistent with applicable State requirements.
Also, we stated that the proposal would not modify our definition of “emergency delivery” or its corresponding requirements at § 414.902. As we stated in our July 6, 2005 IFC, the intent of the 1-business-day timeframe for emergency deliveries is to address the participating CAP physician's need for more rapid delivery of drugs in certain clinical situations with the approved CAP vendor's ability to ship the drug and have it delivered promptly in a nationwide delivery area (70 FR 39045). The emergency delivery timeframe still applies in situations when CAP drugs are not available in the office for electronic delivery.
Moreover, the proposal did not seek to change the CAP inventory requirements. CAP drugs belong to the approved CAP vendor, and as indicated in the July 6, 2005 IFC (70 FR 39048), participating CAP physicians are required to maintain a separate electronic or paper inventory for each CAP drug obtained. CAP drugs must be tracked separately in some way (for example, an electronic spreadsheet). CAP drugs do not have to be stored separately from a physician's own stock; that is, co-mingling of CAP drug with drug from a participating CAP physician's own private stock is acceptable as long as a record of approved CAP vendor-owned drug is kept in a manner that is consistent with § 414.908(a)(3)(x) and the approved CAP vendor-owned drug can be accounted for, as needed.
Also, the proposal did not affect the CAP emergency restocking requirements. Section 1847B(b)(5) of the Act and § 414.906(e) provide criteria for the replacement of drugs taken from a participating CAP physician's inventory in the event of an emergency situation. When the emergency resupply criteria are met, a participating CAP physician can replace the drugs that were used from his or her own inventory by submitting a prescription order to the approved CAP vendor.
The proposal sought to clarify the potential approaches that a bidder may use (separately or in combination) to supply drugs under the CAP and did not seek to specify a particular approach that bidders must use in future responses to CAP bid solicitations or to strictly define the types of entities that
The following is a summary of the comments we received regarding CAP drug stock at the participating CAP physician's office.
Instead, we are providing a framework under which certain quantities of vendor-owned CAP drug stock may be located in a participating CAP physician's office and delivered in conjunction with electronic transactions and charge capture. An electronic transaction may be used to communicate the fact that participating CAP physician is submitting a prescription order for a CAP drug and, on the basis of that prescription order, the drug is being delivered to the participating CAP physician from the nominal amount of vendor-owned stock at the office for administration to a beneficiary. Once the approved CAP vendor receives the prescription order it may bill for the drug in accordance with existing rules. Corresponding documentation of drug administration in the medical record is still required for meeting post-payment review requirements to establish that the drug has been administered to a beneficiary and is thus eligible for payment under section 1847B(a)(3)(D) of the Act.
This process is intended to work with CAP inventory requirements in § 414.906(e) and § 414.908(a), and can also work with office stock models that utilize periodic shipment of stock to maintain predetermined levels. In such systems, periodic shipments of regularly used amounts of items are made, for example, weekly. The shipped amounts are based on average amounts used over the time period between shipments, but may be modified as necessary to accommodate for actual use.
We agree with commenters that we should provide further information about what we would consider to be a “nominal” level of vendor-owned stock. Therefore, we are clarifying that that “nominal quantities of stock” means quantities that do not exceed what is typically used by the participating CAP physician's office between the approved CAP vendor shipment periods. We are not specifying what the shipment periods must be, however, we would like to point out that we do not intend this process to mean that large quantities of CAP drug would be kept at a physician's office.
We also remind readers that CAP drug stock remains the property of the approved CAP vendor, and that participating CAP physicians do not take title to CAP drug stock or make any payment for drugs that furnished and administered under the CAP. CAP drugs must be stored in a manner that is consistent with applicable law and regulations, as well as product integrity and handling requirements.
However, we do not believe that the physician's office stock, that is, drugs bought by the physician's office, should be used as a primary source of drugs for the CAP because such a structure is inconsistent with the CAP program as set forth in section 1847B of the Act, which clearly contemplates that the approved CAP vendor supply CAP drugs to the participating CAP physician rather than merely just bill for drugs that the participating CAP physician already owns. Furthermore, the CAP is an alternative to the ASP or buy and bill process of obtaining drugs administered incident to a physicians' services, and under the CAP as we have implemented it, participating CAP physicians do not take title to or make any payment for drugs furnished under the CAP.
In situations where an approved CAP vendor maintains a certain nominal amount of drugs in a participating CAP physician's office, as discussed above, we anticipate that at certain times a prescription order for an unusual drug or an unexpectedly great demand may result in a situation where the approved CAP vendor's stock is not immediately available in the participating CAP physician's office. In such situations, the approved CAP vendor must ship the drug under the timeframe definitions at § 414.902.
In cases where the drug cannot be delivered in time to meet a clinical need, a participating CAP physician is permitted to use the practice's own inventory and obtain replacement inventory from the approved CAP vendor under § 414.906(e) if all of the following requirements are met: (1) The drugs are required immediately; (2) The participating CAP physician could not have anticipated the need for the drugs; and (3) The approved CAP vendor could not have delivered the drugs in a timely manner, as defined in § 414.902.
This provision is intended for clinical emergencies if a CAP drug is not available from the approved CAP vendor in time. Additional information about the emergency restocking provision appears in the July 6, 2005 interim final rule with comment (70 FR 39047). The physician will be expected to maintain documentation in the patient's medical record to verify that he or she complied with the criteria governing the resupply provision.
We believe that details associated with inventory reconciliation, such as the frequency that the process is carried out, whether a vendor's representative would visit the location, etc., could be arranged under such an agreement. However, parties to such arrangements must ensure that the arrangements do not violate the physician self-referral (“Stark”) prohibition (section 1877 of the Act), the Federal anti-kickback statute (section 1128B(b) of the Act), or any other Federal or State law or regulation governing billing or claims submission.
In response to the March 4, 2005 proposed rule, many commenters requested clarification about whether the prices determined under the CAP will be taken into account in computing the ASP under section 1847A of the Act. In the July 6, 2005 IFC, we responded that prices offered under the CAP must be included in ASP calculations (70 FR 39077). This was done because we initially believed that we did not have the statutory authority to exclude prices determined under the CAP from the computation of ASP under section 1847A of the Act. Section 1847A(c)(2) of the Act contains a specific list of sales that are exempt from the ASP calculation, and sales to approved CAP vendors operating under CAP are not included on that list (70 FR 39077). Comments received in response to the July 6, 2005 IFC opposed this policy (70 FR 70479).
Ultimately, as stated in the November 21, 2005 IFC, we recognized commenters' concerns about the effect of including CAP prices in the calculation of ASP and agreed that the best outcome for both the ASP methodology and the CAP programs would be one in which prices under CAP did not affect payment amounts under the ASP methodology. In particular, we found compelling arguments from commenters about the separation of the ASP and CAP programs and that the two programs are intended to be alternatives to each other. Therefore, we excluded units of CAP drugs that are administered to beneficiaries by participating CAP physicians from the ASP calculation for the initial 3-year approved CAP vendor contract period (70 FR 70479). Accordingly, the definition of “Unit” at § 414.802 was also revised to reflect this exclusion.
In our August 18, 2006 interim final rule, we further addressed concerns pertaining to our definition of Unit. We published a PRA notice regarding a proposed modification of the OMB-approved ASP information collection requirements (CMS Form 10110 (OMB #0938–0921)) about the collection of the number of CAP units excluded from the ASP calculation. In response, a commenter expressed concern over manufacturers' reliance on approved CAP vendors for information about the number of units of CAP drugs that are administered to beneficiaries by participating CAP physicians (71 FR 48132). Since approved CAP vendors are the only entities with direct information on CAP units administered, the commenter believed that the requirement to exclude units of CAP drugs administered to beneficiaries by participating CAP physicians placed the manufacturer in the untenable position of reporting ASP and certifying reports of ASP based on second-hand information from approved CAP vendors. Further, the commenter noted that manufacturers may not have timely access to this information and that they could not independently confirm its accuracy (71 FR 48132). Additional feedback received as part of our ongoing work with manufacturers also indicated that they were concerned that they would have difficulty obtaining information from approved CAP vendors that would be necessary to accurately exclude administered CAP units from the ASP calculation (71 FR 48132).
Therefore, we further revised the definition of unit to clarify that for the initial 3-year contract period under the CAP units of CAP drugs sold to an approved CAP vendor for use under the CAP would be excluded from the calculation of ASP (70 FR 48132).
In the July 6, 2005 and August 18, 2006 IFCs, we stated that we would examine the effect of this exclusion and, if necessary, revisit our decision at the end of the initial 3-year period of the CAP (70 FR 70480 and 71 FR 48132, respectively).
Since then, operational experience has not indicated a reason for changing our policy of excluding CAP units sold to approved CAP vendors for use under the CAP from ASP calculations. Therefore, in the current proposed rule, we proposed to permanently exclude drugs supplied under the CAP from ASP calculations and make conforming
The following is a summary of the comments we received regarding the proposed revisions to the exclusion of CAP sales from ASP calculations.
In the July 6, 2005 IFC (70 FR 39076), we described a two-step process to calculate RNAC-based price adjustment if there is a change in the RNAC reported by a particular approved CAP vendor. We stated that “we would adjust the bid price that the vendor originally submitted by the percentage change indicated in the cost information that the vendor disclosed. Next, we would recompute the single price for the drug as the median of all of these adjusted bid prices.” The two-step process contemplated that there would be more than one approved CAP vendor at the time prices were to be adjusted and that all successful bidders would participate in the CAP.
However, during the first round of CAP contracting, after offering more than one contract, we entered into a contract with only one successful bidder. Thus, during the 2008 price update calculation process, we developed an approach to account for the lack of RNAC data for bidders who chose not to participate in the CAP. In the CY 2009 PFS proposed rule, we stated that the approach we used to adjust prices for the 2008 contract year is consistent with § 414.906(c) and with the July 6, 2005 IFC because it retains a two-step calculation based on the approved CAP vendor's RNAC, as well as the calculation of a median of adjusted bid prices.
We also posted our approach on the Approved CAP Vendor page of the CMS CAP Web site at
Then, in the CY 2009 PFS proposed rule (73 FR 38522 through 38523), we proposed to continue using this approach for future CAP payment amount updates where the number of approved CAP vendors is less than the number of successful bidders. We proposed that the average of the approved CAP vendor-supplied RNAC data would be used as a proxy for data from vendors who bid successfully but are not participating in the CAP. For example, if the payment amounts for the first year of a CAP contract are based on five successful bidders, but only four have signed contracts to supply drugs under the CAP (that is, there are four approved CAP vendors), only RNAC data collected from the four approved CAP vendors would be used to calculate the percent change in the RNAC. The average of the four approved CAP vendors' adjusted payment amounts would be used as a proxy for the RNAC of the successful bidder that is not participating in the CAP. The updated CAP payment amount would then be calculated as the median of the five data points (one data point for each approved CAP vendor's updated payment amount, and one data point calculated using the average of the approved CAP vendors' RNAC). Similarly, if there were five successful bidders but only three chose to become approved CAP vendors, the average of the three approved CAP vendors' RNAC would be the proxy for the RNAC of the two bidders who did not participate. The median of those five data points would become the updated CAP payment amount.
Our approach in the CY 2009 PFS proposed rule was intended to provide us with a flexible method for updating CAP prices, to be consistent with our original policy as stated in the July 6, 2005 IFC, and to account for bidders or approved CAP vendors who are not participating in the program at the time the price updates are calculated. However, our approach was limited in scope because it was made during a contract period and during bidding for an upcoming contract and we did not want to make any significant changes to the CAP program which could affect contractual obligations. Furthermore, we received a comment in response to the CY 2009 PFS proposed rule that suggested the elimination of the proxy procedure so that payments would be based on actual data from participating vendors and would better reflect experience within the program.
After additional consideration, we believe that it would be prudent to simplify and update our 2009 proposal in order to account for successful bidders who choose not to participate in the CAP, possible changes in the number of approved CAP vendors over the life of a 3-year CAP contract, and to allow for flexibility in setting the frequency of payment amount adjustments as described in section II.J.2.a. above. We believe that our updated proposal is easier for the vendor community to understand and for us to implement. Furthermore, our revised proposal is not constrained by concerns about the impact of changes on an active contract.
We proposed to clarify that the RNAC-based adjustment calculations are intended to apply only to approved CAP vendors (not all bidders), and that the most recent previous CAP payment amount (for example, the previous year's or the previous quarter's payment amount) will be the starting point for making the subsequent period's adjustment. Simply put, we proposed to eliminate the use of proxy data for bidders that are no longer participating in the program. Instead, we proposed to use RNAC data only from approved CAP vendors that are participating in the CAP at the time that an RNAC-based price update is being calculated. We also proposed to clarify that the starting point for the payment amount adjustment is the most recent payment amount. The percent change calculated from each participating approved CAP vendor's RNAC data will be applied to the most recent payment amount by recomputing the single price using the median of all participating vendors' adjusted prices.
For example, if quarterly adjustments beginning at the start of claims processing approved CAP vendor's contract as described in section a. above are implemented, and the post bid period's CAP payment amounts are calculated based on five successful bids, but only four approved CAP vendors are participating when CAP claims processing begins, the RNAC-based payment amount adjustment for the first quarter of CAP claims would be based on RNAC data provided by the four approved CAP vendors that will be furnishing drugs under the CAP. The four approved CAP vendors would be required to submit a quarter of RNAC data within thirty days of the close of the quarter to which the data applied, prior to the beginning of CAP claims processing for the new contract. We would apply the percentage change in RNAC reported by each of the four approved CAP vendors to the CAP payment amounts calculated from successful bids, and the adjusted payment amount would be the median of those four adjusted amounts. Assuming that these four vendors are
This process would apply to the composite bid drug list as amended by rulemaking, meaning that a single weighted percent change in RNAC is calculated for all drugs in the composite bid list (also referred to as the single drug category) and that single percent change is applied to all drugs in the list. For drugs that are bid as separate line items, such as drugs that were included in addendum B of the 2006 bidding period (see 70 FR 39072 and updated as addendum G in 70 FR 70238), or for drugs that are added during a contract period, each HCPCS code will be adjusted as a separate line item. Such codes will not be included in the composite, weighted drug list. Our process will continue to assign a single payment amount to all approved CAP vendors that supply a given HCPCS code; we do not intend to have more than one payment amount for any HCPCS code under the CAP or for individual “NOC” drugs described in § 414.906(f)(2)(iv).
This updated approach is flexible, and we believe it can accommodate a variety of scenarios, including a changing number of approved CAP vendors and changes to the frequency with which payment amount updates are made. It provides a straightforward and accurate clarification of the price adjustment mechanism described in regulation text. We believe that this proposal remains consistent with our original preamble language and with our CY 2009 PFS proposal, because it retains the two-step calculation using the percent change in RNAC. Finally, we believe that our approach will eliminate any perception that nonparticipating vendors can significantly affect CAP payment amount adjustments.
The following is summary of the comments we received regarding the proposed to revisions to the annual CAP payment amount update mechanism.
We appreciate the comment that suggested that price updates be done at the product or NDC level. However, bidding and payment for drugs furnished under the CAP is made at the HCPCS level. We believe that the smaller single drug category list finalized in section II.J.2.b will decrease the risk associated with applying a single percentage update over a group of drugs, and we also note that drugs added during the CAP contract period through a CMS approved vendor request and drugs that are separately bid will continue to be updated at the individual HCPCS level.
In the July 6, 2005 IFC, we stated that section 1847B of the Act most closely describes a system for the provision of and the payment for drugs provided incident to a physician's service (70 FR 39026). In the November 21, 2005 IFC (70 FR 70258), we stated that for the purposes of the CAP, a physician includes all practitioners that meet the definition of a “physician” in section 1861(r) of the Act. This definition includes doctors of medicine, osteopathy, dental surgery, dental medicine, podiatry, and optometry, as well as chiropractors. However, this definition does not include other health care professionals, such as nurse practitioners (NPs), clinical nurse specialists (CNSs), and other professions such as physician assistants (PAs) who may be able to legally prescribe medications and enroll in Medicare.
In the CY 2009 PFS proposed rule (73 FR 38523), we proposed to further clarify that, for the purposes of the CAP, the definition of a physician included all practitioners that meet the definition of a “physician” in section 1861(r) of the Act, as well as practitioners (such as NPs, CNSs and PAs) described in section 1861(s)(2)(K) of the Act and other practitioners who legally prescribe drugs associated with services under section 1861(s) of the Act if those services and the associated drugs are covered when furnished incident to a physician's service. While we believed that most practitioners described in section 1861(s)(2)(K) of the Act would bill under specific physician provider numbers, it was not our intent to exclude practitioners who are able to bill independently for drugs associated with services that are covered when provided by a physician and legally authorized to be performed.
In response to our CY 2009 proposed rule, only a few commenters were concerned about the inclusion of inadequately trained practitioners and risks to patient safety under this expanded definition. Another commenter stated that this definition goes beyond the scope of the provisions in the MMA and the strict definition of “physician” in the statute. However, the majority of comments supported this proposal.
We did not receive any feedback during the CAP postponement that would lead for us to reconsider this proposal. Therefore, we again proposed to further clarify that, for the purposes of the CAP, the definition of a physician included all practitioners that meet the definition of a “physician” in section 1861(r) of the Act, as well as practitioners (such as NPs, CNSs and PAs) described in section 1861(s)(2)(K) of the Act and other practitioners who legally prescribe drugs associated with services under section 1861(s) of the Act if those services and the associated drugs are covered when furnished incident to a physician's services.
Our proposal was specific to the Part B Drug CAP and was not intended to affect the definition of physician in section 1861(r) of the Act, or the definition of “Medical and Other Health Services” described in section 1861(s) of the Act. The proposal also did not seek to expand the scope of the CAP beyond what has been described in previous rules, other than to clarify that a small number of providers who are enrolled in Medicare, and who legally prescribe drugs associated with services under section 1861(s) of the Act and can be paid by Medicare may elect to participate in the CAP if billing independently. In short, the CAP remains a program that provides Part B drugs furnished incident to a physician's services.
The following is summary of the comments we received regarding the updated definition of a CAP physician.
Therefore, at this time, we will not be revising the definition of a CAP physician beyond what was previously stated in the November 21, 2005 IFC (70 FR 70258), that is for the purposes of the CAP, a physician includes all practitioners that meet the definition of a “physician” in section 1861(r) of the Act. Based on CAP physician election data, we believe that the impact of not updating our definition at this time will have minimal impact on access to CAP drugs.
Although section 1847B(b)(4)(E) of the Act provides for the shipment of CAP drugs to settings other than a participating CAP physician's office under certain conditions, in initially implementing the CAP, we did not propose to implement the CAP in alternative settings. We implemented the CAP with a restriction that CAP drugs be shipped directly to the participating CAP physician, as stated in § 414.906(a)(4), and that participating CAP physicians may not transport CAP drugs from one location to another, as stated in § 414.908(a)(3)(xii). However, we were aware that physicians may desire to administer drugs in alternative settings. Therefore, in the July 6, 2005 IFC, we sought comment on how this could be accommodated under the CAP in a way that addresses the potential vendors' concerns about product integrity and damage to the approved CAP vendors' property (70 FR 39048). We discussed comments submitted in response to the July 6, 2005 IFC in the CY 2008 PFS proposed rule (72 FR 38158). We also requested comments in the CY 2008 PFS proposed rule (72 FR 38157) on the potential feasibility of easing the restriction on transporting CAP drugs where this is permitted by State law and other applicable laws and regulations. We responded to submitted comments in the CY 2008 PFS final rule with comment period (72 FR 66268).
In the CY 2009 PFS proposed rule (70 FR 38523), we proposed to permit the transportation of CAP drug between a participating CAP physician's practice locations subject to voluntary agreements between the approved CAP vendor and the participating CAP physician. Because of the 2009 CAP postponement, we did not address this issue in the CY 2009 PFS final rule. However, we did receive the following comments in response to our proposed rule on easing transportation restrictions in the CAP:
• Many commenters indicated that this change would increase program flexibility and facilitate patient treatment.
• Some commenters were supportive, but also raised concerns about drug integrity and liability, and requested that appropriate safeguards be in place before transportation restrictions were eased.
• Generally, commenters wanted CMS to explicitly delineate standards about voluntary agreements that address concerns about product integrity, liability, transportation procedures, and documentation. One commenter indicated that such standards should be developed through a separate rulemaking period to allow for public comment.
• Several commenters cited State pedigree laws as possible impediments to physician transport of drugs.
We also requested and received feedback about the program during the 2009 postponement period. One member of the potential vendor community urged us to be mindful of increased legal liability for an approved CAP vendor if this policy were to be implemented, but also acknowledged that the proposal might substantially increase physician interest in the program.
We continue to be mindful of the concerns expressed by the commenters, and have evaluated both the advantages and disadvantages of easing the restriction on transportation of CAP drugs. Thus, we again proposed to permit transport of CAP drug between a participating CAP physician's practice locations subject to voluntary agreements between the approved CAP vendor and the participating CAP physician. As indicated in our CY 2009 PFS proposed rule, we continued to propose that such agreements must comply with all applicable State and Federal laws and regulations and product liability requirements, and be documented in writing.
We would again like to reiterate the voluntary nature of these proposed agreements. Approved CAP vendors would not be required to offer and participating CAP physicians would not be required to accept such agreements when selecting an approved CAP vendor. An approved CAP vendor may not refuse to do business with a participating CAP physician because the participating CAP physician has declined to enter into such an agreement with the approved CAP vendor. Furthermore, we are not seeking to define which CAP drugs may be subject to the proposed voluntary agreements. In other words, each approved CAP vendor could specify which CAP drug(s) could be transported.
However, our proposal continues to contain certain limitations. In previous rulemaking, we have described requirements for voluntary agreements between approved CAP vendors and participating CAP physicians. In the July 6, 2005 IFC (70 FR 39050) and the CY 2006 PFS final rule (70 FR 70251 through 70252), we stated that we will not dictate the breadth of use or the specific obligations contained in voluntary arrangements between approved CAP vendors and
We remain concerned about opportunities for disruption in the drug's chain of custody and appropriate storage and handling conditions that may ultimately affect patient care or increase the risk of drug theft or diversion. Therefore, in order to maintain safety and drug integrity in the CAP and to protect against the fraudulent diversion of CAP drugs, we reproposed that any voluntary agreements between an approved CAP vendor and a participating CAP physician regarding the transportation of CAP drug must include requirements that drugs are not subjected to conditions that will jeopardize their integrity, stability, and/or sterility while being transported. We solicited comments on these issues, including the identification of who may transport the drugs, how documentation of transportation activities could be accomplished, and how the oversight of such agreements will be carried out.
In conclusion, we believe that the proposal to ease the restriction on transporting CAP drugs between a participating CAP physician's practice locations—when agreed upon by the participating CAP physician and the approved CAP vendor—will make the CAP more flexible and ultimately more appealing to participating CAP physicians. Additionally, we believe that this proposal will facilitate the participation of CAP physicians who have office locations in rural areas and/or have satellite offices with limited hours. Moreover, we believe that this proposal will promote beneficiary care, particularly for beneficiaries who live in rural locations. Since participating CAP physicians would be able to transport CAP drugs to another office location in accordance with a voluntary agreement with their approved CAP vendor, beneficiaries would have more flexibility in scheduling the location of their appointments. We solicited comments about this proposal.
The following is summary of the comments we received regarding the proposal to ease transport restrictions between participating CAP physicians' offices.
A number of comments were supportive of our proposal and indicated that this change would increase program flexibility, make the program more desirable to physicians, and facilitate patient treatment. One commenter understood our proposal to mean that we would “ship” CAP drug directly to the site of service. Another commenter suggested that approved CAP vendors should be required to offer such agreements. Several commenters cited State pedigree laws as possible impediments to physician transport of drugs.
We are not seeking to define specific items in these agreements, such as which CAP drugs may be subject to the proposed voluntary agreements regarding drug transport because the parties involved in the agreement will have the greatest insight regarding such details and will better understand the variables and practical applications associated with these decisions. Drugs that may be furnished under the CAP are subject to a broad range of storage requirements—some drugs are especially temperature sensitive and some may be light sensitive.
Also, some CAP drugs are very expensive, and the loss of even a single dose could create significant financial impact for an approved CAP vendor. We believe that assessments and decisions about which drugs may be transported must be made by the approved CAP vendor at the drug level in order to allow the approved CAP vendor to better control the risk associated with transporting vendor-owned product and to apply its knowledge and expertise in product handling in order to either facilitate, or to choose not to allow the transportation of certain drugs that may require special handling, such as strict temperature control or limits to light exposure. So long as they are consistent with the standards we have set forth for these voluntary agreements, we also believe such agreements can address issues of financial liability for the drug, and we believe that the approved CAP vendor is in the best position to assess the financial risk associated with the transportation of specific drugs, and to make corresponding changes as new drugs are added to the CAP, or information about drugs already supplied under the CAP changes.
We are also concerned that additional CMS involvement regarding the details of these agreements could cause negative consequences by further delaying the implementation of this provision, or delays in responding to changes as new drugs become available under the CAP. Because the parties to the agreement have a better understanding of the specific information that must be used to assess each drug, CMS involvement could also result in the addition of requirements that may not be necessary, or the exclusion of requirements that may be beneficial. Providing a framework rather than specific requirements also provides an adaptable and scalable solution that can accommodate different drugs with different handling requirements, different participating CAP physician populations, and individual approved CAP vendors' financial risk assessments at the drug level.
We also note that shipment of drugs and biologicals often across significant distances is being done routinely by pharmacies, drug distributors, and home infusion providers. Therefore, we believe that significant practical experience associated with safely transporting drugs between various locations outside of standard shipping arrangements exists, and this experience could be applied to the transportation agreements. We encourage approved CAP vendors who enter into agreements with participating CAP physicians to permit transport of one or more CAP drugs between offices to assist with the dissemination of details and practical applications of specialized knowledge about drug handling and to either specify, or provide mechanisms to track, drugs that are being transported between offices.
We also agree with the comments that stated that participating CAP physicians and other CAP practitioners are able to follow the handling requirements associated with the drugs that they administer and we agree that they may be held responsible for adherence to those requirements. We believe that the participating CAP physicians will want to adhere to these requirements not only for the safety of the beneficiary who will receive the drug, but also for the financial well being of the approved CAP vendor—the entity that still owns the drug.
Based on the comments that we received, we are finalizing our proposal to ease the transportation restriction between a participating CAP physicians' offices as listed on the CAP physician election agreement using voluntary agreements between the approved CAP vendors and participating CAP physicians. The finalized proposal does not affect the current requirement that drugs be shipped from the approved CAP vendor only to a participating CAP physician.
We also remind readers that the change applies only to transportation of CAP drugs between the offices of a group to which the drug was shipped and does not include shipment to office locations not listed on the physician's election agreement, or transportation to sites other than the participating CAP physician's offices; these issues are outside the scope of what we had proposed.
We also remind readers that at a minimum, voluntary agreements that allow the transportation of CAP drugs between office locations must comply with all applicable State and Federal laws and regulations and product liability requirements, and be documented in writing and must include requirements that drugs are not subjected to conditions that will jeopardize their integrity, stability, and/or sterility while being transported. While we are not dictating the breadth of use or the specific obligations contained in voluntary arrangements between approved CAP vendors and participating CAP physicians, including the drugs covered by an agreement, the agreements must comply with applicable law and prohibit approved CAP vendors from coercing participating CAP physicians into entering any of these arrangements. Parties to such arrangements must also ensure that the arrangements do not violate the physician self-referral (“Stark”) prohibition (section 1877 of the Act), the Federal anti-kickback statute (section 1128B(b) of the Act), or any other Federal or State law or regulation governing billing or claims submission.
By way of example only, we believe that a voluntary agreement between the participating CAP physician and approved CAP vendor could also be used to address the following issues: assignment of financial liability associated with product loss or damage, tracking and stock reconciliation mechanisms, oversight and compliance mechanisms, who may transport the drug, and specific handling requirements for the each of the drugs that may be transported.
In the CY 2009 PFS proposed rule (73 FR 38524 through 38525), we discussed two changes to the CAP dispute resolution process. Section 1847B(b)(2)(A)(ii)(II) of the Act requires an approved CAP vendor to have a grievance and appeals process for the resolution of disputes. In the July 6, 2005 IFC (70 FR 39054 through 39058), we described the process for the resolution of participating CAP physicians' drug quality and service complaints and approved CAP vendors' complaints regarding noncompliant participating CAP physicians. We encouraged participating CAP physicians, beneficiaries, and vendors to use informal communication as a first step to resolve service-related administration issues. However, we recognized that certain disputes would require a more structured approach, and therefore, we established processes under § 414.916 and § 414.917.
Section 414.917 outlines the dispute resolution process for participating CAP physicians. As discussed in the July 6, 2005 IFC (70 FR 39057 through 39058), if a participating CAP physician finds an approved CAP vendor's service or the quality of a CAP drug supplied by the approved CAP vendor to be unsatisfactory, then the physician may address the issues first through the approved CAP vendor's grievance process, and second through an alternative dispute resolution process administered by the designated carrier and CMS. In turn, the designated carrier would gather information about the issue as outlined in § 414.917(b)(2) and make a recommendation to CMS on whether the approved CAP vendor has been meeting the service and quality obligations of its CAP contract. We would then review and act on that recommendation after gathering any necessary, additional information from the participating CAP physician and approved CAP vendor. If we suspend an approved CAP vendor's CAP contract for noncompliance or terminate the CAP contract in accordance with § 414.914(a), the approved CAP vendor may request a reconsideration in accordance with § 414.917(c).
In the July 6, 2005 IFC (70 FR 39058), we indicated that the approved CAP vendor's participation in the CAP would be suspended while the approved CAP vendor's appeal of our decision is pending. This suspended status is also implied in § 414.917(c)(9), which states that the “approved CAP vendor may resume participation in CAP” if the final reconsideration determination is favorable to the approved CAP vendor. In order to improve the clarity of our regulations, we proposed in the CY 2009 PFS proposed rule that the approved CAP vendor's contract will remain suspended during the reconsideration
Comments submitted in response to our CY 2009 PFS proposed rule supported this proposed clarification and we did not receive additional feedback about this issue after the CAP was postponed. Based on this and our continued need to improve the clarity of our regulations, we reproposed that the approved CAP vendor's contract will remain suspended during the reconsideration period in § 414.917. We solicited additional comments on our proposal.
Section 414.916 provides a mechanism for approved CAP vendors to address noncompliance problems with participating CAP physicians. As stated at § 414.916(a), “Cases of an approved CAP vendor's dissatisfaction with denied drug claims are resolved through a voluntary alternative dispute resolution process delivered by the designated carrier, and a reconsideration process provided by CMS.” Once the decision is made to suspend a participating CAP physician's CAP election agreement, the participating CAP physician will be suspended from the CAP as described in § 414.916(b)(3).
Physicians whose participation in the CAP has been suspended are not eligible to receive CAP drugs. This is implied in § 414.906(a)(4), which speaks of approved CAP vendors providing CAP drugs directly to “[a] participating CAP physician.” However, we believe that the clarity of our dispute resolution regulations would be improved if this drug delivery issue were stated explicitly. Therefore, in the CY 2009 PFS proposed rule, we proposed to revise § 414.916 to specify that approved CAP vendors shall not deliver CAP drugs to participating CAP physicians whose participation in the CAP has been suspended after an initial determination by CMS. The proposal also applied to physicians engaged in the reconsideration process outlined in § 414.916(c) and included a conforming change at § 414.914(f)(12). We believed that these changes were in accord with the underlying intent of § 414.916, namely to provide a mechanism for approved CAP vendors to address noncompliance problems with participating CAP physicians, and we believe that these changes will increase the clarity of our regulations. We also noted that the participating CAP physicians who are suspended from participation in the CAP will be able to obtain drugs and bill for them under the ASP payment system provided they have not been excluded from participation in Medicare and/or their billing privileges have not been revoked.
Comments submitted in response to the CY 2009 PFS proposed rule agreed with our proposal. Though we did not finalize this proposal due to the 2009 CAP postponement, we received no comments from the public in response to our request for feedback during the CAP 2009 postponement. Based on positive public feedback and our continued belief that the clarity of our dispute resolution regulations would be improved by being explicit about this issue, we reproposed to revise § 414.916 to specify that approved CAP vendors shall not deliver CAP drugs to participating CAP physicians whose participation in the CAP has been suspended after an initial determination by CMS. This suspension in drug shipment would also apply to physicians engaged in the reconsideration process outlined in § 414.916(c). We have also proposed a conforming change to § 414.914(f)(12). Physicians who are suspended from participation in the CAP will be able to obtain drugs and bill for them under the ASP payment system provided they have not been excluded from participation in Medicare and/or their billing privileges have not been revoked.
Furthermore, physicians who are suspended from participation in the CAP and to whom the approved CAP vendor has ceased shipments of CAP drugs are able to obtain drugs and bill for them under the ASP payment system. Thus, these physicians will have continuous access to Part B drugs. Finally, because a participating CAP physician's failure to comply with regulations at § 414.908(a)(2) can negatively affect the approved CAP vendor's ability to receive payment for CAP drugs that it shipped to the physician, we believe that suspending shipment of CAP drugs upon CMS's initial determination of suspension of the CAP physician election agreement appropriately balances the needs of the participating CAP physician and those of the approved CAP vendor. For the foregoing reasons, at this time, we are finalizing our proposal that approved CAP vendors shall not ship CAP drugs to physicians whose participation in the CAP has been suspended after an initial determination by CMS.
In the CY 2010 PFS proposed rule (74 FR 33634 through 33639), we outlined the proposed updates to the case-mix adjusted composite rate payment system established under section 1881(b)(12) of the Act, as added by section 623 of the Medicare Modernization Act (MMA), which included updates to the drug add-on component of the composite rate system, as well as the wage index values used to adjust the labor component of
• A zero growth update to the proposed 15.0 add-on adjustment to the composite rates for 2010 required by section 1881(b)(12)(F) of the Act (resulting in a $20.33 per treatment drug add-on amount).
• An update to the wage index adjustment to reflect the latest available wage data, including a revised BN adjustment factor of 1.057888.
• A reduction to the ESRD wage index floor from 0.7000 to 0.6500.
We received few public comments on our proposals. The ESRD payment related comments are discussed in detail below in this section. In addition, as discussed in section II.G.12. of this rule, section 1881(b)(12)(G)(iv) of the Act, as added by section 153(a)(1) of the MIPPA, increases the composite rate by 1.0 percent for ESRD services furnished on or after January 1, 2010. Therefore, the 1.0 percent increases the current composite rate of $133.81 to $135.15 for services furnished on or after January 1, 2010.
Section 1881(b)(12)(B)(ii) of the Act, as added by section 623(d) of the MMA, requires an add-on to the composite rate to account for changes in the drug payment methodology. Section 1881(b)(12)(C) of the Act provides that the drug add-on must reflect the difference in aggregate payments between the revised drug payment methodology for separately billable ESRD drugs and the Average Wholesale Price (AWP) payment methodology. In 2005, we generally paid for ESRD drugs based on average acquisition costs. Thus the difference from AWP pricing was calculated using acquisition costs. However, in 2006 when we moved to Average Sales Price (ASP) pricing for ESRD drugs, we recalculated the difference from AWP pricing using ASP prices.
In addition, section 1881(b)(12)(F) of the Act requires that, beginning in CY 2006, we establish an annual increase to the drug add-on to reflect estimated growth in expenditures for separately billable drugs and biologicals furnished by ESRD facilities. This growth update applies only to the drug add-on portion of the case-mix adjusted payment system. The CY 2009 drug add-on adjustment to the composite rate was 15.2 percent. The drug add-on adjustment for CY 2009 reflected a zero increase. This computation is explained in detail below and in the CY 2009 PFS final rule with comment period (73 FR 69755 through 69757).
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.
In the CY 2007 PFS final rule with comment period (71 FR 69682), we established an interim methodology for annually estimating the growth in ESRD drugs and biological expenditures that used the Producer Price Index (PPI) for pharmaceuticals as a proxy for pricing growth in conjunction with 2 years of ESRD drug data to estimate per patient utilization growth. We indicated that this interim methodology would be used to update the drug add-on to the composite rate until such time that we had sufficient ASP drug expenditure data to project the growth in ESRD drug expenditures.
However, for CY 2008, due to declining ASP prices, we no longer believed that using the PPI as a proxy for pricing growth was appropriate. Accordingly, for CY 2009, we revised the interim methodology for estimating the growth in ESRD drug expenditures by using ASP pricing to estimate the price component of the update calculation. Due to the declining trend in ASP pricing and utilization, we calculated a decrease in the drug add-on adjustment, and applied a zero update to the drug add-on adjustment (73 FR 69755 through 69757).
Since we now have 3 years of drug expenditure data based on ASP pricing, we have reevaluated our methodology for estimating growth in drug expenditures. We believe that 3 years of drug expenditure data based on ASP pricing is sufficient to project drug expenditure growth based on trend analysis. Therefore, for CY 2010, we proposed to use trend analysis from ASP drug expenditure data to update the per treatment drug add-on adjustment (74 FR 33636).
In addition, we proposed to estimate per patient growth in drug expenditures by removing growth in ESRD enrollment from growth in total drug expenditures. To estimate drug expenditure growth using trend analysis, we looked at the average annual growth in total drug expenditures between 2006 and 2008. First we had to estimate the total drug expenditures for all ESRD facilities in CY 2008. For the CY 2010 PFS proposed rule, we used the final CY 2006, the final CY 2007 ESRD claims data, and the latest available CY 2008 ESRD facility claims, updated through December 31, 2008 (that is, claims with dates of service from January 1 through December 31, 2008, that were received, processed, paid, and passed to the National Claims History File as of December 31, 2008). For the CY 2010 PFS proposed rule, we adjusted the December 2008 file to reflect our estimate of what total drug expenditures would be using the final June 30, 2009 bill file for CY 2008 (74 FR 33636). The net adjustment we applied to the CY 2008 claims data was an increase of 11.1 percent to the December 2008 claims file. In this final rule with comment period, we are using additional updated CY 2008 claims with dates of service for the same timeframe. This updated CY 2008 data file will include claims received, processed, paid, and passed to the National Claims History File as of June 30, 2009.
Using the full-year 2008 drug expenditure figure, we calculated the average annual change in drug expenditures from 2006 through 2008. This average annual change showed a decrease of 1.7 percent for this timeframe. We are using this 1.7 percent decrease to project drug expenditures for both 2009 and 2010.
Once we determined the projected growth in drug expenditures from 2009 to 2010, we then removed growth in enrollment for the same time period from the expenditure growth, so that the residual reflects per patient expenditure growth (which includes price and utilization combined). We believe that this approach is consistent with section 1881(b)(12)(F) of the Act, which requires us to annually update the drug add-on adjustment. To calculate the per patient growth in drug expenditures between CYs 2009 and 2010, we removed the enrollment component which represents the estimated growth in enrollment between CY 2009 and CY 2010. This was approximately 1.9 percent. To determine the growth in per patient expenditures, we divided the total drug expenditure decrease between 2009 and 2010 of 1.7 percent (1.000−0.017 = 0.983) by enrollment growth of 1.9 percent (1.019) for the same timeframe. The result is a per patient expenditure growth factor equal to 0.965 (0.983/1.019 = 0.965). Thus, we
In the CY 2006 PFS final rule (71 FR 69683), 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.
In the CY 2008 PFS final rule with comment period (72 FR 66282), we revised our update methodology by applying the growth update to the per treatment drug add-on amount. That is, for CY 2008, we applied the growth update factor of 3.5 percent to the $19.64 per treatment drug add-on amount for an updated amount of $20.33 per treatment.
In the CY 2009 PFS final rule with comment period (73 FR 69755 through 69757), we applied a zero update to the per treatment drug add-on amount which left it at $20.33. As discussed in detail below, for CY 2010, we again will apply a zero 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 1.7 percent decrease in total drug expenditures between CY 2009 and CY 2010. Growth in per patient drug expenditures is computed by dividing growth in total drug expenditures by growth in enrollment for the same time period. Therefore, to calculate growth in per patient drug expenditures, we remove the enrollment component, which is an estimated increase of 1.9 percent (1.019) from growth in total drug expenditures, which is an estimated decrease of 1.7 percent (1.000−1.017 = 0.983). As described above, the removal of the enrollment component from total drug expenditures is computed as follows: 0.983/1.019 = 0.965. Therefore, we are projecting a 3.5 percent decrease in per patient growth of drug expenditures between CY 2009 and CY 2010. However, similar to last year and as indicated above, we are finalizing 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 basic case-mix adjusted payment amounts by an amount determined by applying the estimated growth in expenditures for separately billed ESRD drugs for the drug add-on amount. Our understanding of the statute contemplates “annually increase” to mean a positive or zero update to the drug add-on. Therefore, we will apply a zero update to maintain the $20.33 per treatment drug add-on amount for CY 2010. The current $20.33 per treatment drug add-on reflected a 15.2 percent drug add-on adjustment to the composite rate in effect for CY 2009. However, given that the MIPPA mandates a 1 percent increase to the composite rate (effective January 1, 2010), this 1 percent increase results in a decrease in the CY 2009 drug add-on adjustment from 15.2 percent to 15.0 percent to keep the drug add-on amount at $20.33 per treatment.
Section 1881(b)(12)(D) of the Act, as amended by section 623(d) of the MMA, gives the Secretary the authority to revise the wage indexes previously applied to the ESRD composite rate. 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 the CY 2006 PFS final rule with comment period (70 FR 70167), we announced our adoption of the OMB CBSA-based geographic area designations to develop revised urban/rural definitions and corresponding wage index values for purposes of calculating ESRD composite rates. In addition, we generally have followed wage index policies related to these definitions 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 CBSA-based geographic area
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 final wage index values for CY 2010 were developed from FY 2006 wage and employment data obtained from the Medicare hospital cost reports. As we indicated above, 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 proposed to use the same methodology for CY 2010, using FY 2006 hospital data to develop the CY 2010 ESRD wage index values. For a detailed description of the development of the CY 2010 wage index values based on FY 2006 hospital data, see the FY 2010 IPPS final rule with comment period (74 FR 43834). Section III.G. of the preamble to the FY 2010 IPPS final rule with comment period, “Method for Computing the Proposed FY 2010 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 2009 final rule with comment period (73 FR 69758 and 69759), we indicated that CY 2009 was the final year of the transition period and each ESRD facility's composite payment rate would be based entirely on its applicable CBSA-based wage index value.
In the CY 2009 PFS final rule with comment period, we stated our intention to continue to reassess the need for a wage index floor (73 FR 63758). 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. For CY 2010, we proposed to reduce the wage index floor from 0.70 to 0.65. We also anticipate that we may reduce the floor gradually until full implementation of the ESRD PPS required by section 1881(b)(14) of the Act.
There are 2 facilities located in Wheeling, WV–OH CBSA, which have an actual wage index value of 0.6869 and is above the proposed 0.65 floor, but not significantly below the CY 2009 0.70 floor. We note that the CY 2010 wage index value of 0.6869 for the Wheeling, WV–OH CBSA is prior to application of the wage index BN factor. After application of the wage index BN factor of 1.057735, the wage index value for Wheeling, WV–OH CBSA is 0.7266.
We also note that section 106(b)(2) of the Medicare Improvements and Extension Act (MIEA) of 2006 (which is Division B of the Tax Relief and Health Care Act (TRCHA) of 2006, Pub. L. 109–432, collectively referred to as “MIEA–TRHCA”) required the Secretary of Health and Human Services, taking into account MedPAC's recommendations on the Medicare wage index classification system, to include in the FY 2009 IPPS proposed rule one or more proposals to revise the wage index adjustment applied under section 1886(d)(3)(E) of the Act for purposes of the IPPS. To assist CMS in meeting the requirements of section 106(b)(2) of MIEA–TRHCA, in February 2008, we awarded a Task Order under its Expedited Research and Demonstration Contract, to Acumen, LLC. Acumen, LLC conducted a study of both the current methodology used to construct the Medicare wage index and the recommendations reported to the Congress by MedPAC. Part One of Acumen's final report, which analyzes the strengths and weaknesses of the data sources used to construct the CMS and MedPAC indexes, is available online at
Moreover, in light of all of the pending research and review of wage index issues in general, we believe that it would be premature at this time to adopt the IPPS rural floor policy to the ESRD wage index.
In CY 2006, while adopting the CBSA designations, we identified a 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. The affected areas were rural Puerto Rico, and the urban area of Hinesville, GA (CBSA 25980), and rural Massachusetts. For CY 2006, CY 2007, CY 2008, and CY 2009, we calculated the ESRD wage index values for those areas as follows:
• For the urban area of Hinesville, GA, we calculated the CY 2006 through CY 2009 wage index value based on the average wage index value for all urban areas within the State of Georgia.
• For rural Massachusetts, because we had not determined a reasonable wage proxy, we used the FY 2005 wage index value in CY 2006 and CY 2007. As discussed below, we adopted an alternative methodology for CYs 2008 and 2009.
• For rural Puerto Rico, because all geographic areas in Puerto Rico were subject to the wage index floor in CYs 2006 through 2009, we applied the ESRD wage index floor to rural Puerto Rico as well. We note that there are currently no ESRD facilities located in rural Puerto Rico.
For CY 2008, we adopted an alternative methodology for establishing a wage index value for rural Massachusetts and continued to apply this methodology in CY 2009. Because we used the same wage index value for 2 years with no update, we believed it was appropriate to establish a methodology which employed reasonable proxy data for rural areas (including rural Massachusetts) and also permitted annual updates to the wage index based on that proxy data. For rural areas without hospital wage data, we used the average wage index values from all contiguous CBSAs as a reasonable proxy for that rural area.
In determining the imputed rural wage index, we interpreted the term “contiguous” to mean sharing a border. 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 proposed to use the same methodology for CY 2010. Under this methodology, the CY 2010 final wage index values for CBSA 12700 (Barnstable Town, MA—1.2618) and CBSA 39300 (Providence-New Bedford-Fall River, RI–MA—1.0782) averages results in an imputed wage index value of 1.1700 for rural Massachusetts in CY 2010.
For rural Puerto Rico, for CY 2010, all areas in Puerto Rico that have a wage index are eligible for the proposed ESRD wage index floor of 0.65. Therefore, we proposed to apply the proposed ESRD wage index floor of 0.65 to facilities that are located in rural Puerto Rico.
For Hinesville-Fort Stewart, GA (CBSA 25980), which is an urban area without specific hospital wage data, we proposed to apply the same methodology used to impute a wage index value that we used in CY 2009. Specifically, we proposed to utilize the average wage index value for all urban areas within the State of Georgia. That would result in a CY 2010 final wage index value of 0.9028 for the Hinesville-Fort Stewart GA CBSA.
We received no comments on our proposals for wage areas with no hospital data. Therefore, we are finalizing our policies for wage areas with no hospital data as proposed.
In the CY 2009 PFS final rule with comment period (73 FR 69759 through 69760), 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 2010 and subsequent years. To date, no data from other sources, superior to that currently used in connection with the IPPS wage index has emerged. Therefore, for ESRD purposes, we continue to believe this is an appropriate policy.
Section 1881(b)(12)(E)(i) of the Act, as added by section 623(d) of the MMA, required that any revisions to the ESRD composite rate payment system as a result of the MMA provision (including 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 2010 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 did not propose any changes to the case-mix measures for CY 2010, the current case-mix BN adjustment of 0.9116 would remain in effect for CY 2010. As in CY 2009, for CY 2010, we proposed to apply the proposed wage-index BN adjustment factor of 1.057888 directly to the ESRD wage index values. 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 2010 wage index BN adjustment factor (1.057888), we used the FY 2006 pre-floor, pre-reclassified, non-occupational mix-adjusted hospital data to compute the wage index values, 2008 outpatient claims (paid and processed as of December 31, 2008), 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 2008 claims and facility-specific CY 2009 composite rates, we computed the estimated total dollar amount each ESRD provider would have received in CY 2009. The total of these payments became the target amount of expenditures for all ESRD facilities for CY 2010. Next, we computed the estimated dollar amount that would have been paid for the same ESRD facilities using the ESRD wage index for CY 2010. The total of these payments became the new CY 2010 amount of wage-adjusted composite rate expenditures for all ESRD facilities. Section 153(a) of the MIPPA revised section 1881(b)(12)(G) of the Act to provide for an update of 1 percent to the composite rate component of the payment system effective January 1, 2010. We note that when computing the new CY 2010 amount, we did not include this 1 percent increase because the BN adjustment would negate the increase.
After comparing these two dollar amounts (target amount divided by the new CY 2010 amount), we calculated an
To ensure BN, we also must apply the wage index BN adjustment factor to the wage index floor of 0.6500 which results in an adjusted wage index floor of 0.6875 (0.6500 x 1.057735) for CY 2010.
The CY 2010 ESRD wage index tables are located in Addenda F and G of this final rule with comment period.
Section 651 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108–173) 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 the 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 BN and the method for adjusting chiropractor fees in the event the demonstration results 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. If the demonstration was not budget neutral, we anticipated making reductions in the CY 2010 and CY 2011 physician fee schedules. We indicated that if we determined that the adjustment for BN was greater than 2 percent of spending for the chiropractor fee schedule codes, we would implement the adjustment over a 2-year period. However, if the adjustment was less than 2 percent of spending under the chiropractor fee schedule codes, we would implement the adjustment over a 1-year period.
Brandeis University, the demonstration evaluator, used two approaches in examining BN. The “All Neuromusculoskeletal Analysis (NMS)” reflects an intent-to-treat approach whereby the utilization of all beneficiaries who received any Medicare covered services for neuromusculoskeletal conditions in the demonstration areas was examined. This method is potentially subject to large external forces because of its inclusion of all beneficiaries including those who did not use chiropractic services and who would not become users of chiropractic services, even with expanded coverage for them. Therefore, a second analysis, termed the “Chiropractic User Analysis” was conducted to examine only the subset of beneficiaries who used chiropractic services for the treatment of their neuromusculoskeletal conditions. Both approaches use hierarchical linear modeling of costs over 3 years—1 year prior to the demonstration and the 2 years of the demonstration. We posted a report describing these analyses on CMS Web site at
The results of both analyses indicate that the demonstration was not budget neutral. In the “All NMS Analysis,” which compared the Medicare costs associated with NMS conditions for
Both approaches to assessing BN have strengths and limitations. The “All NMS Analysis” provides the broadest view of the Medicare population that would have been eligible for the demonstration's expanded coverage of chiropractic services. Its inclusion of all beneficiaries with neuromusculoskeletal conditions guards against validity threats of selection. However, this approach creates a large heterogeneous group which may only include a small proportion of chiropractic service users. Basing estimates of BN on such a large heterogeneous group increases the potential for changes in the use of services seldom affected by chiropractors to be falsely attributed to the demonstration, which could result in the costs of the demonstration to appear larger than actual.
Consistent with the CY 2010 PFS proposed rule (74 FR 33520, 33639 through 33640), for this final rule with comment period, we continue to believe
The CMS Office of the Actuary (OACT) estimates chiropractic expenditures in CY 2010 to be approximately $487 million based on actual Medicare spending for chiropractic services for the most recent available year. 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 are finalizing our proposal (74 FR 33639 through 33640) to recoup the $50 million in expenditures from this demonstration over a 5-year period rather than over a 2-year period. As proposed, we are recouping $10 million each year through adjustments to the PFS for chiropractic codes in calendar years 2010 through 2014. This approach reflects a change from our BN discussion in the CY 2006, 2007, and 2008 PFS rules, which was described previously in this section. In those rules, we had proposed that if the adjustment for BN was greater than 2 percent of spending for the chiropractor fee schedule codes, the adjustment would be implemented over a 2-year period. Under this final rule, we are recouping costs by reducing payment under the PFS for chiropractic fee codes by $10 million each year starting CY 2010 through CY 2014. We note that in the proposed rule, we proposed a 2 percent reduction in the chiropractic fee codes in order to achieve the $10 million yearly recoupment. We note that 2 percent was an approximation. Because of rounding, the $10 million recoupment in each of CYs 2010 through 2014 will amount to approximately a 2 percent reduction since the reduction in the chiropractic fee codes may be slightly higher or lower than 2 percent, depending on OACT's estimate of chiropractic expenditures for that calendar year. In order to reflect this fact, we are refining the language in this final rule to indicate that the chiropractic fee codes will be reduced by approximately 2 percent for CYs 2010 through 2014. Additionally, we believe that spreading this adjustment over a longer period of time will minimize its potential negative impact on chiropractic practices.
To implement the required BN adjustment, as was proposed (74 FR 33640), we are reducing the payment amount under the PFS for the chiropractic CPT codes (that is, CPT codes 98940, 98941, and 98942). As explained previously, we are finalizing our plans to recoup $10 million each year through adjustments to chiropractic CPT codes for calendar years 2010 through 2014. In order to achieve the $10 million recoupment during such years, payment under the PFS for these codes will be reduced by approximately 2 percent. As stated in prior PFS rules, application of the BN adjustment would be specific to these three codes which represent the “chiropractic fee schedule” because they are the only chiropractic codes recognized under the PFS. This methodology also appropriately impacts the chiropractic profession that is directly affected by the demonstration. Consistent with the proposed rule, for this final rule with comment period, 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. The RVUs published in Addendum B and posted on our Web site will not show this reduction but will be annotated to state that the reduction resulting from the chiropractic demonstration is not reflected in the RVUs.
We received the following comments regarding the methodology used to evaluate BN in the chiropractic services demonstration.
With respect to the comment questioning how the increase in costs for all NMS conditions could be causally related to the demonstration, we are unsure of what the commenter is asking. If the commenter is asking if Medicare costs associated with all neuromusculoskeletal conditions were used in the evaluation, the response is no, only costs for specific NMS diagnoses that can be treated by chiropractors were included in the evaluation. If the commenter is asking for the rationale for the “All NMS” analysis, the response is that this analysis provides a broader view of all of the beneficiaries who would have been eligible for the expanded coverage under the demonstration. This analysis includes beneficiaries with the appropriate neuromusculoskeletal conditions who could have been treated by either a chiropractic physician or other medical physician. The intent-to-treat approach of the “All NMS” analysis guards against selection threats to validity. As mentioned previously in this section, we did not base the BN estimate on the “All NMS” analysis because it included Medicare beneficiaries who did not use chiropractic services and who would not have become users of chiropractic services even with expanded coverage for them.
A Comprehensive Outpatient Rehabilitation Facility (CORF) is a Medicare provider that furnishes respiratory therapy services among other services. In § 485.70, we set forth the personnel qualifications that must be satisfied by a CORF as a condition of participation under § 485.58 and as a condition of coverage of CORF services, including personnel qualifications for respiratory therapists providing CORF respiratory therapy services.
In the CY 2009 PFS proposed rule (73 FR 38502) and subsequent final rule with comment period (73 FR 69942), we revised the definition of a respiratory therapist under § 485.70(j). The change in the definition of respiratory therapist was intended to ensure accuracy in reference to persons who are qualified to perform respiratory therapy and to ensure that language regarding these professionals is consistent with current industry requirements for education, training, and practice.
Prior to its modification by the CY 2009 PFS final rule with comment period, § 485.70(j) reflected the qualifications for Certified Respiratory Therapists (CRTs)” and “Registered Respiratory Therapists (RRTs)” as terms commonly used by the professional industry to identify persons furnishing respiratory therapy services.
Since publication of the CY 2009 PFS final rule with comment, we have been informed by the industry that the changes made in the definition of respiratory therapist exclude a category of professional that has completed the requirements of a CRT, has completed a nationally accredited educational program that confers eligibility for the National Board for Respiratory Care (NBRC) registry exam for respiratory therapists (RTs), and is eligible to sit for the national registry examination administered by the NBRC, but has not yet passed the examination. These persons are referred to in the industry as CRTs.
Because it is our policy that Medicare payment is available for respiratory services provided to Medicare beneficiaries in a CORF only if provided by a respiratory therapist meeting the qualifications set forth in § 485.70(j), payment is not available for respiratory services provided by CRTs in the CORF setting. We note that personnel qualifications for respiratory therapists previously set forth at § 485.70(j) prior to its modification by the CY 2009 PFS final rule with comment period did not exclude this category of personnel from the definition of respiratory therapist. We have also heard from CRTs and from CORFs that this change has limited the availability of respiratory therapy services to Medicare beneficiaries in certified CORFs, as many of these services are provided by CRTs. Thus, in modifying the definition of respiratory therapist in the CY 2009 PFS final rule with comment period, we may have inadvertently impacted access to respiratory therapy services for some Medicare beneficiaries.
Thus, we proposed to modify the definition of respiratory therapist and to clarify the terms that are used to identify those persons who furnish respiratory services in CORFs in § 485.70(j) to include CRTs, that is those individuals who have completed a nationally accredited educational program for respiratory therapists and are eligible to sit for the national registry examination administered by the National Board for Respiratory Care (NBRC), but who have not yet passed the examination. The change in the definition we proposed would permit CRTs to furnish respiratory therapy services to Medicare beneficiaries in the CORF setting.
As proposed, our intent was to assure that persons who were qualified to furnish respiratory therapy services to patients in CORFs prior to the finalization of CY 2009 PFS final rule with comment period (73 FR 69942), will continue to qualify to furnish RT services to CORF patients under this proposed rule.
We solicited public comment on the proposed change to § 485.70(j). We also solicited comments from the industry regarding the difference in services furnished by the different levels of professionals who provide RT services in CORFs.
The following is summary of the comments we received regarding the discussion of the proposed changes to § 485.70(j).
Section 1834(l)(9) of the Act provides that for “ground ambulance services furnished on or after July 1, 2001, and before January 1, 2004, for which transportation originates in a rural area * * * or in a rural census tract of a metropolitan statistical area * * * the fee schedule established under this subsection shall provide that, with respect to the payment rate for mileage for a trip above 17 miles, and up to 50 miles, the rate otherwise established shall be increased by not less than
In this final rule with comment period, we are finalizing our proposal to reinstate the language that was originally finalized in “Medicare Program; Coverage and Payment of Ambulance Services; Inflation Update for CY 2004” final rule with comment period (68 FR 67963), but then inadvertently omitted again when § 414.610(c)(5) was later republished, so that § 414.610(c)(5)(i) correctly sets forth the statutory time period during which this rural mileage bonus was applicable. This revision to the regulation is a technical correction to conform the regulation to the statute. For further information, see program instruction, Transmittal AB–03–110; Date August 1, 2003; Change Request 2767 which was issued to inform contractors to discontinue paying such bonuses effective January 1, 2004 in accordance with the statute.
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 for physician pathology services.” Based on further review, we have determined that there are no clinical diagnostic laboratory tests paid under the PFS. After Transmittal 94 was published, we received numerous inquiries from laboratory, diagnostic testing, and hospital representatives who had questions about whether the provision applied to all diagnostic services, including x-rays, MRIs, and other nonclinical laboratory fee schedule diagnostic services.
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 Clinical Laboratory Fee Schedule (CLFS); however, it must be evident, in accordance with our regulations at § 410.32(d)(2) and (3), that the physician ordered the services. The policy that
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 lab 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). An order may be delivered via 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; or
• 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 labs 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.
The following is summary of the comments we received regarding the discussion of the physician signature on requisitions issue.
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 will continue to carefully consider the issues of physician signatures on requisitions and orders. We plan to revisit these issues in the future paying particular attention to the definition of order and requisition.
Section 1877 of the Act, also known as the physician self-referral law, prohibits the following: (1) 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 direct or indirect financial relationship (an ownership/investment interest or a compensation arrangement), unless an exception applies; and (2) the entity from presenting or causing a claim to be presented to Medicare (or billing another individual, entity, or third party payor) for those referred services. The statute establishes a number of exceptions and grants the Secretary the authority to create regulatory exceptions for financial relationships that pose no risk of program or patient abuse.
In the proposed rule, we proposed to clarify § 411.354(c)(3)(i) regarding the application of certain exceptions to arrangements in which a physician stands in the shoes of his or her physician organization. In section II.N.2. of this final rule with comment period, we respond to public comments on this proposal and finalize it without change.
In the FY 2009 IPPS final rule (73 FR 48721), we revised the definition of “entity” to include any person or entity that has “performed services that are billed as DHS.” In section II.N.3 of this final rule with comment period, we solicit comments regarding whether we should issue further guidance on what constitutes performing services billed as DHS and if so, the nature or content of such guidance.
Determining whether an entity furnishing DHS and a physician have a direct or indirect compensation arrangement is a key step in applying the statute because it affects which compensation exceptions may apply to the arrangement. Section 411.354(c) governs when a physician “stands in the shoes” of his or her physician organization and may therefore, depending on the circumstances, have a direct, rather than an indirect, compensation arrangement with an entity furnishing DHS.
Our proposal (74 FR 33643) sought to clarify one aspect of the physician stand in the shoes provisions at § 411.354(c). Specifically, we proposed to clarify the second sentence of § 411.354(c)(3)(i) to provide that, “[w]hen applying the exceptions in § 411.355 and § 411.357 of this part to arrangements in which a physician stands in the shoes of his or her physician organization, the relevant referrals and other business generated `between the parties' are referrals and other business generated between the entity furnishing DHS and the physician organization (including all members, employees, and independent contractor physicians).”
Section 411.354(c)(3)(i) addresses the application of the general exceptions to the referral prohibition related to both ownership/investment and compensation (§ 411.355) and the exceptions to the referral prohibition related to compensation arrangements (§ 411.357), to arrangements in which a physician stands in the shoes of his or her physician organization. Many of these exceptions require the arrangement to be in writing and signed by the parties and prohibit the compensation from taking into account the volume or value of referrals or other business generated by the referring physician.
Under § 411.354(c)(3)(i), a physician who stands in the shoes of his or her physician organization is deemed to have the same compensation arrangements with the same parties and on the same terms as the physician organization. The second sentence of § 411.354(c)(3)(i) provides that “[f]or purposes of applying the exceptions in § 411.355 and § 411.357 to arrangements in which a physician stands in the shoes of his or her physician organization, the `parties' to the arrangements are considered to be the entity furnishing DHS and the physician organization (including all members, employees, or independent contractor physicians).”
After the publication of Phase III, some members of the industry questioned whether the second sentence of § 411.354(c)(3)(i) defined the term “parties” everywhere it appears in the physician self-referral regulations, including the requirement in many exceptions that a compensation arrangement be in writing and “signed by the parties.” Consequently, these members believed it was necessary for everyone within a physician organization (that is, all members, employees, and independent contractor physicians) to sign a myriad of different arrangements with an entity furnishing DHS. This was not our intent. In January 2008, we posted a frequently asked question (FAQ) on our Web site to explain that “we consider a physician who is standing in the shoes of his or her physician organization to have signed the written agreement when the authorized signatory of the physician organization has signed the agreement.” After the FY 2009 IPPS final rule, under which only physician owners are deemed to stand in the shoes of their physician organizations, some industry representatives questioned whether physicians who did
We proposed to clarify the second sentence of § 411.354(c)(3)(i) to provide that, “[w]hen applying the exceptions in § 411.355 and § 411.357 of this part to arrangements in which a physician stands in the shoes of his or her physician organization, the relevant referrals and other business generated `between the parties' are referrals and other business generated between the entity furnishing DHS and the physician organization (including all members, employees, and independent contractor physicians).”
Our proposed change clarifies that we are not defining the term “parties” and should eliminate any possible public misconception that all physicians in a physician organization (whether or not they stand in the shoes of the physician organization) must sign the writing(s) memorializing a compensation arrangement between their physician organization and an entity furnishing DHS. Furthermore, we note that some members of the industry have erroneously applied the second sentence of § 411.354(c)(3)(i) by analyzing whether the compensation takes into account the referrals between the entity furnishing DHS and the physician who stands in the shoes of the physician organization
We solicited public comments regarding our proposal and alternative approaches to address this issue. We received five public comments that related to our proposal which supported our proposal. After consideration of the public comments received, we are adopting our proposal unchanged. We are revising the second sentence of § 411.354(c)(3)(i) to provide that, “[w]hen applying the exceptions in § 411.355 and § 411.357 of this part to arrangements in which a physician
Under section 1877(a)(1)(A) of the Act, if a physician (or an immediate family member) has a financial relationship with an “entity,” it may not make a referral to the entity for the “furnishing” of DHS, unless the financial relationship meets an exception. In the Phase I final rule, we defined the term “entity” at § 411.351 and specified that “a person or entity is considered to be furnishing DHS if it is the person or entity to which [Medicare] makes payment.” Thus, under the Phase I rule, only the person or entity that billed Medicare for the DHS was considered the DHS “entity,” and not the person or entity that actually performed the DHS (where that person or entity was not the person or entity billing for it) (66 FR 953). In the CY 2008 PFS proposed rule (72 FR 38186 through 38187, 38219, and 38224), we expressed concern that the Phase I definition of “entity” might permit certain abusive agreements for services provided under arrangements with hospitals and other providers. Based upon our concerns about overutilization, corruption of medical judgment and other abuse, we proposed to revise the definition of “entity” at § 411.351 to include “the person or entity that has performed the DHS”.
In the FY 2009 IPPS final rule (73 FR 48434 and 48729), we stated our belief that, in some instances, hospitals would prefer to furnish services directly but have been concerned about losing referral streams if they compete with physician service providers. Very few comments submitted by hospitals objected to our proposed revision to the definition of entity, and, instead, two major hospital associations were generally supportive of it. Some physician commenters asserted that hospitals are risk averse to bringing services to communities. We questioned whether physicians are less risk averse because they can control the referral stream. We stated that hospitals may be more concerned about risk because they fear that referrals will go to their competitors if they do not enter into contractual arrangements with physician groups. Finally, we stated that “our proposal as finalized will create a more level playing field between hospitals and physicians and also among hospital competitors.”
In that rule, we finalized the proposal by amending the definition of entity at § 411.351 to specify that an entity furnishing DHS includes the person or entity that has presented a claim to Medicare for the DHS as well as any person or entity that has “performed services that are billed as DHS,” notwithstanding that another person or entity actually billed the services as DHS.
Commenters to the proposed rule expressed concern regarding the potential ambiguity of the meaning of “performs.” We declined to provide a specific definition of “performed services that are billed as DHS,” but stated the following in response to one of the commenters:
By way of example only, we consider a service to have been “performed” by a physician or physician organization if the physician or physician organization does the medical work for the service and could bill for the service, but the physician or physician organization has contracted with the hospital and the hospital bills for the service instead * * *. We do not consider an entity that leases or sells space or equipment used for the performance of the service,
We delayed the effective date of the amendment to the definition of “entity” until October 1, 2009, in order to afford parties an adequate time to restructure arrangements (73 FR 48723).
We assume that health care providers have restructured their arrangements to come into compliance with the new rule by the October 1, 2009 effective date. We have received numerous inquiries regarding whether we plan to issue additional guidance on the revised definition of entity, including the meaning of “performed services that are billed as DHS.” We continue to believe that the changes set forth in the FY 2009 IPPS final rule effectuated our intent to minimize overutilization and anti-competitive behavior and, as such, we decline to issue a specific proposal concerning the definition of entity at this time. In order to keep abreast of the views of industry stakeholders, we are soliciting comments to determine if further guidance is necessary and, if so, what clarification(s) may be beneficial to the industry in interpreting and applying the changes finalized in the FY 2009 IPPS final rule. Therefore, we are interested in receiving comments on the following:
• Whether we should define or clarify “performed services that are billed as DHS,” and, if so, how.
• Whether “performed services that are billed as DHS” should be analyzed in the same manner for inpatient and outpatient services provided under arrangements.
• Whether performance of a service billed as DHS should be determined based on how many of the following elements are provided: (1) Lease of space used for performance of the service; (2) lease of equipment used for the performance of the service; (3) supplies that are not separately billable but used in the performance of the service; (4) management services; (5) billing services, and (6) nonphysician services that are not separately billable.
• Whether an interpretation of “medical work” was relied upon in restructuring arrangements and, if so, how.
• The degree to which the amount and nature of services provided by physician and nonphysician personnel (for example, technicians) should influence the determination of whether a person or organization has performed services billed as DHS.
• The degree to which the ability to bill separately for the service should influence the determination regarding whether a person or organization has “performed services that are billed as DHS.”
• Whether there are other comments or alternative approaches or criteria that would address our policy concerns about overutilization and other abuse while minimizing the impact on legitimate non-abusive arrangements.
We welcome any information concerning how the industry interpreted and applied the definition of entity and how under arrangement agreements may have been restructured in order to comply with the new definition of entity at § 411.351.
Section 1847 of the Act, as amended by section 302(b)(1) of the MMA, requires the Secretary to establish and implement a Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Competitive Bidding Program (DMEPOS CBP). 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 competitive bidding program, including adding a new subsection (a)(1)(D) to section 1847 of the Act. Section 1847(a)(1)(D) terminates retroactively the competitive bidding contracts that were awarded to suppliers in 2008 for the Round 1 of competitive bidding and prohibits payment based on such contracts. Section 154 of the MIPPA effectively reinstated payment for competitively bid items and services to the Medicare fee schedule amounts, as set forth in section 1834 of the Act and 42 CFR part 414, subpart D of our regulations.
Section 1847(a)(1)(D)(i)(I) of the Act, as amended by the MIPPA, stipulates that to the extent any damages may be applicable as a result of the termination of contracts, payment is to be made from the Federal Supplementary Medical Insurance Trust Fund under section 1841 of the Act. Section 1847(a)(1)(D) of the Act also states that nothing in section 1847(a)(1)(D)(i)(I) of the Act, which includes the reference to damages, shall be construed to provide an independent cause of action or right to administrative or judicial review with the regard to the termination of the Round 1 contracts.
For further discussion of the Competitive Bidding Program and the bid evaluation process, see the Medicare Program; Competitive Acquisition for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) and Other Issues final rule published in the April 10, 2007
We proposed to add new § 414.425 to establish a process to evaluate any claims for damages caused by the termination of contracts awarded in early 2008 under the DMEPOS CBP that were terminated as a result of section 154(a)(1)(A)(iv) of the MIPPA.
We offered contracts in March 2008 to selected suppliers for the first round of the DMEPOS CBP. The contracts that were accepted were terminated by the MIPPA retroactive to June 30, 2008. We considered the terms of the contracts and other processes of the DMEPOS CBP as we developed this proposed process to determine, on a case-by-case basis, whether to award damages and, where applicable, the amount of damages to be awarded for the termination of these contracts.
When considering whether to submit a claim for damages, suppliers may consider the following factors:
• Each contract stipulated that the contract is subject to any changes to the statute or regulations that affect the Medicare program.
• Each contract indicated CMS does not guarantee any amount of business or profits.
• Each contract stipulated that CMS shall not pay for any expenses incurred by the supplier for the work performed under the contract other than for payment of Medicare claims authorized under the contract.
• Upon termination of the contracts by the MIPPA, payments reverted to the CY 2008 fee schedule amount, which was on average 26 percent higher than payment amounts under the DMEPOS CBP.
• We will review a supplier's estimated and historic capacity and any expansion plans that were submitted as part of a supplier's bid.
• We will review a supplier's action to meet its obligation to mitigate its damages.
• We listed the winning suppliers on the Medicare.gov Web site in the supplier locator tool; a supplier is allowed to keep any new customers they may have obtained because of being listed on the supplier locator tool.
• This list is not intended to suggest that there are not legitimate claims for damages. However, these are factors that a supplier may consider when deciding whether to submit a claim for damages.
The proposed provisions outline the information that suppliers would need to provide when submitting claims for damages and the process that we would follow to review these claims. The information we proposed to collect from suppliers is necessary for us to make a reasonable decision on whether damages are warranted and how much in damages should be awarded. We believe that the process is not overly burdensome to those suppliers choosing to participate in this review process and would ensure a thorough review of a supplier's claim for damages.
We proposed the following process to file a claim for damage claims:
Any aggrieved supplier that was awarded a contract in March 2008 for the Round 1 DMEPOS CBP and believes it has suffered damages is eligible to submit a claim. The supplier must be able to demonstrate how its company was damaged. These damages must be substantiated and be as a direct result of the termination by MIPPA of their Round 1 DMEPOS CBP contract. Only a contract supplier, and not a subcontractor of a contract supplier, is eligible to submit a claim for damages.
After consideration of the public comments we received, we are not making any changes to the proposed process for awarding damages for contracts terminated under the MIPPA.
A completed claim, including all documentation described below in section II.O.1.c., must be filed within 90 days of January 1, 2010, which is the effective date of these damages provisions, unless the 90th day is a weekend or Federal holiday. In that case, the last date to file a claim will be the day following the weekend or Federal holiday. The date of filing is the actual date of receipt by the Competitive Bidding Implementation Contractor (CBIC) of a completed claim from the supplier that includes all of the information required by this rule. We strongly urge claimants to use a tracking method such as with the United States Postal Service or a carrier that requires a return receipt that indicates the date on which the claim was delivered.
We did not receive any comments on this section of the proposed process for awarding damages for contracts terminated under the MIPPA. Therefore, we are finalizing these provisions as proposed with a minor change by adding the effective date of these damages provisions.
At a minimum, a claim should include all of the following:
• Supplier's name and bidding number.
• Supplier's current contact information (Name of authorized official, U.S. Post Office mailing address, phone number and e-mail address).
• A copy of the DMEPOS CBP Round 1 contract(s) the supplier signed with CMS.
• A detailed explanation of the damages incurred by the supplier. The explanation must document the supplier's damages through receipts and records that establish the claimant's damages directly related to meeting the terms of the DMEPOS CBP Round 1 contract.
• The supplier must also explain how it would be damaged if not reimbursed.
• A detailed explanation of the steps of all attempts to use for other purposes, return, or dispose of equipment or other assets purchased or rented for use in the Round 1 DMEPOS CBP contract performance.
Damages claimed must be specifically related to carrying out the terms of the contract, and may include, but are not limited to, the following:
• Items or equipment purchased or rented and dates of such rental or purchases.
• Additional employee costs.
• Additional inventory costs.
• Additional facility costs.
The supplier must include a separate justification for any of these items for which it is claiming damages and explain how they were necessary to meet the deadline of July 14, 2008 of the Round 1 DMEPOS CBP contract. This does not include expenses that would have occurred if the supplier had not been awarded a contract but only those expenses that were incurred for the Round 1 DMEPOS CBP contract performance. The claim must also detail steps taken by the supplier to mitigate damages that they may have incurred due to the contract termination.
In addition, we are not considering claims for expenses incurred prior to March 20, 2008, including the purchase or rental of items or equipment before that date, because a supplier would not have known that it was going to be offered a contract. We are not considering claims for most expenses incurred after July 14, 2008, including the purchase or rental of items or equipment, because this is the date on which MIPPA terminated all of the Round 1 contracts. The only exception to this requirement would be for expenses incurred to mitigate damages associated with the termination of the Round 1 contracts.
After consideration of the public comments we received, we are not making any changes to this section of the proposed process for awarding damages for contracts terminated under the MIPPA.
Suppliers should submit claims, with all supporting documentation, with the CMS CBIC at the following address: CBIC; Bldg 200, Suite 400; 2743 Perimeter Parkway; Augusta, Georgia 30909. The authorized official for the supplier must certify the accuracy of the information on the claim and all supporting documentation. The authorized official is appointed by the supplier and has the legal authority granted by the supplier to submit the claim for damages. This person may be the supplier's general partner, chairman of the board, chief financial officer, chief executive officer, president, direct owner of the supplier organization, or must hold a position of similar status and authority within the supplier's organization. The CBIC will not accept electronic submissions of claims for damages.
After consideration of the public comments, we are not making any changes to this section of the proposed process for awarding damages for contracts terminated under the MIPPA.
The CBIC will conduct the first level of review and make recommendations to CMS, hereafter referred to as the Determining Authority regarding:
• Whether the claim is complete and was filed in a timely manner. The CBIC may seek further information from the claimant when making its recommendation. The CBIC may set a deadline for receipt of additional information.
• When the claim is incomplete or was not filed in a timely manner, the CBIC will make a recommendation to the Determining Authority not to process the claim further.
• Whether the government owes damages because of the MIPPA. The CBIC will include an explanation supporting its recommendation. The CBIC will recommend a reasonable amount of damages, if any, based on the claim submitted, including all accompanying documentation. The CBIC will consider the language of the contract, as well as both costs incurred and the contract supplier's attempts and actions to limit the damages.
CMS is the Determining Authority because we are responsible for the final review and final determination regarding claims for damages.
• The Determining Authority shall review the recommendation of the CBIC.
• The Determining Authority may seek further information from the claimant or the CBIC in making a concurrence or non-concurrence determination.
• The Determining Authority may set a deadline for receipt of additional information. A claimant's failure to respond timely may result in a denial of the claim.
• If the Determining Authority concurs with the CBIC recommendation, the Determining Authority shall submit a final signed decision to the CBIC and direct the CBIC to notify the claimant of the determination and the reasons for the final determination.
• If the Determining Authority nonconcurs with the CBIC recommendation, the Determining Authority may:
+ Write a determination granting (in whole or in part) a claim for damages or denying a claim in its entirety; or direct the CBIC to write said determination for the Determining Authority's signature.
+ Return the claim to the CBIC with further instructions.
• The Determining Authority's determination is final and binding; it is not subject to administrative or judicial review under section 1847(a)(1)(D) of the Act, as amended by section 154(a)(1) of the MIPPA.
After consideration of the public comments, we are not making any changes to this section of the proposed process for awarding damages for contracts terminated under the MIPPA.
Every effort will be made to make a final determination within 120 days of initial receipt of the claim for damages by the CBIC or the receipt of additional information that was requested by the CBIC, whichever is later. In the case of more complex cases, or in the event of a large workload, a decision will be issued as soon as practicable.
We did not receive any comments on this section of the proposed process for awarding damages for contracts terminated under the MIPPA. Therefore, we are finalizing the provisions as proposed.
The CBIC shall mail the final determination to the claimant by
We did not receive any comments on this section of the proposed process for awarding damages for contracts terminated under the MIPPA. Therefore, we are finalizing these provisions as proposed.
We are finalizing the provisions concerning damages as proposed in the CY 2010 PFS proposed rule (74 FR 33644).
Section 1847(a)(4) of the Act requires that in the case of covered durable medical equipment (DME) items for which payment is made on a rental basis under section 1834(a) of the Act, and in the case of oxygen for which payment is made under section 1834(a)(5) of the Act, the Secretary shall establish a “grandfathering” process under which rented DME items that were furnished prior to the start of the Competitive Bidding Program (CBP) may be continued to be rented to the beneficiary by a noncontract supplier. Agreements for those covered items and supplies that were rented by the supplier to the beneficiary before the start of a CBP may be continued, regardless of whether the existing supplier participates in the CBP.
In the April 10, 2007 final rule (72 FR 17992), in § 414.408(j), we established the grandfathering process described below for rented DME and oxygen and oxygen equipment when these items are included under the Medicare DMEPOS CBP. A supplier that is furnishing DME or is furnishing oxygen or oxygen equipment on a rental basis to a beneficiary prior to the implementation of a CBP in the competitive bidding area (CBA) where the beneficiary maintains a permanent residence may elect to continue furnishing the item as a grandfathered supplier. This process only applies to suppliers that began furnishing the competitive bid items described above before the start of the CBP to beneficiaries who maintain a permanent residence in a CBA.
In the case of the rented DME and oxygen and oxygen equipment identified in this section, we established in § 414.408(j)(4) that Medicare beneficiaries have the choice of deciding whether they would like to continue receiving the rented item from a grandfathered supplier or if they would like to receive the item from a contract supplier.
Suppliers that agree to be a grandfathered supplier for an item must agree to be a grandfathered supplier for all current beneficiaries who request to continue to rent that item from them. The beneficiary's decision to use a grandfathered supplier depends on the decision of the noncontract supplier that is currently renting the competitive bidding item to continue renting the item as a grandfathered supplier after the start of the CBP in accordance with the terms we have specified. The payment rules for grandfathered suppliers are specified in existing § 414.408(j)(2).
In addition, the beneficiary may elect, at any time, to transition from a noncontract supplier to a contract supplier. The contract supplier would be required to accept the beneficiary as a customer regardless of how many rental months had already been paid for the beneficiary to receive this item. If the grandfathered supplier is not willing to continue furnishing the item, a beneficiary must select a contract supplier to furnish the item in order to receive Medicare payment for that item. The grandfathered supplier is paid based on the payment rules outlined in the final rule on Competitive Bidding at § 414.408(j).
As a result of what we learned from Round 1 of the CBP, we proposed changes to the “grandfathering” rules by establishing notification requirements for noncontract suppliers that are furnishing rented DME competitive bid items at the time of implementation of the CBP in the CBA in which the beneficiary resides. We also proposed a new definition for a grandfathered item to include all rented item(s) in a competitive bidding product category that a supplier currently provides to its beneficiaries. Under the current regulation, suppliers may choose the items within a product category for which they want to become a grandfathered supplier.
As proposed, a noncontract supplier would have to choose to be either a grandfathered supplier for all or for none of the rented DME items within a product category that the supplier currently provides.
For further discussion of the CBP and the bid evaluation process, see the April 10, 2007 final rule and the January 16, 2009 interim final rule with comment period.
We proposed to revise the definition of “grandfathered item” in § 414.402 so that the term would refer to all rented items within a competitive bid product category that the supplier currently rents to beneficiaries. In addition, we proposed to redesignate the current § 414.408(j)(5) as § 414.408(j)(7) and add new § 414.408(j)(5) and (j)(6). The new § 414.408(j)(5) and (j)(6) will specify the notification requirements that apply to noncontract suppliers that are renting DME competitive bid items in a CBA at the time of implementation of the CBP.
We proposed to revise the definition of a “grandfathered item” in § 414.402 to avoid confusion, on the part of beneficiaries, regarding rented DME items for which a noncontract supplier is willing or not willing to be a grandfathered supplier. Under the current regulations, a supplier may make separate choices regarding grandfathering for each individual HCPCS code. For example, a supplier may choose to be a grandfathered supplier for a particular type of walker within the product category instead of all of the walkers included in that product category that are furnished on rental basis.
Under the revised definition, a noncontract supplier would have to choose to be either a grandfathered supplier for all or for none of the DME rented items within a product category that the supplier currently provides. We believe that it would be easier for beneficiaries to recognize which items a supplier is grandfathering or not grandfathering if the supplier's election concerning grandfathering was made by product category rather than making separate choices for each individual HCPCS code. In addition, this proposed revision would prevent suppliers from choosing to be a grandfathered supplier for only the more profitable items, which could disadvantage certain beneficiaries.
After consideration of the public comments we received, we are not making any changes to this section of the proposed rule.
We proposed to add a new § 414.408(j)(5)to require suppliers furnishing items to be included in a CBP that are eligible for grandfathering to notify beneficiaries in the CBA and CMS regarding their decision whether to become grandfathered suppliers.
The notification requirements we proposed will prohibit certain inappropriate practices of noncontract suppliers. These inappropriate practices include: (1) suppliers attempting to receive additional monthly rental payments from Medicare by circumventing the grandfathering requirements; and (2) suppliers not formally notifying beneficiaries before picking up the rented item from the beneficiary's home. We also proposed to require a notification process to protect beneficiaries and to ensure less confusion during the transition period prior to implementation of the CBP. The proposed requirements will help ensure that beneficiaries are contacted and informed about the grandfathering process and what choices they have concerning their choice of supplier. Moreover, the notice will help to ensure that beneficiaries do not have medically necessary DME equipment taken from them unexpectedly by a noncontract supplier.
We proposed to add § 414.408(j)(5)(i) which requires a noncontract supplier that elects to become a grandfathered supplier in a CBA to provide a written notification to each Medicare beneficiary in that CBA who is currently renting a grandfathered item from that supplier. The notification must state that the supplier is willing to continue to rent the grandfathered item(s) to the beneficiary as a grandfathered supplier. The notice must identify the DME grandfathered rented items for which the supplier will be a grandfathered supplier.
To ensure that beneficiaries are sufficiently informed and prepared for competitive bidding changes that affect rented DME, we proposed in § 414.408(j)(5) to require that the notification of the beneficiary must meet the following requirements. The notification must:
• Be sent by the supplier to the beneficiary at least 30 business days before the start date of the implementation of the CBP in the CBA in which the beneficiary resides. The 30-day notice is necessary to give the beneficiary sufficient time before the start of the CBP to consider whether to continue to use their current supplier. Suppliers will be given sufficient time to meet the 30-day notification requirement.
• Identify the grandfathered items that the supplier is willing to continue to rent to the beneficiary.
• Be in writing (for example, by letter or postcard) and the supplier must maintain proof of delivery.
• State that the supplier is offering to continue to furnish certain rented DME, oxygen and oxygen equipment, and supplies that the supplier is currently furnishing to the beneficiary (that is, before the start of the CBP) and is willing to continue to provide these items to the beneficiary for the remaining rental months.
• State that the beneficiary has the choice to continue to receive a grandfathered item(s) from the grandfathered supplier or may elect to receive the item(s) from a contract supplier after the end of the last month for which a rental payment is made to the noncontract supplier.
• Provide the supplier's telephone number and instruct the beneficiaries to call the supplier with questions regarding grandfathering and to notify the supplier of his or her election.
• State that the beneficiary can obtain information about the CBP by calling 1–800–MEDICARE or accessing
In § 414.408(j)(i)(B), we proposed that the supplier should obtain an election from the beneficiary and maintain a record of its attempts to communicate with the beneficiary to obtain the beneficiary's election regarding grandfathering. We also proposed that the supplier maintain a record of the beneficiary's choice, the date on which the choice was made, and how the beneficiary communicated his or her choice to the supplier. The 30-day notice to the beneficiary must be in writing to ensure that there is a record that the notification was made.
After consideration of the public comments, we are finalizing this section of the proposed rule as proposed.
We proposed to add paragraphs § 414.408(j)(5)(i)(C)(
Ten business days prior to picking up the item, the supplier should have direct contact (for example, a phone call) with the beneficiary or the beneficiary's caregiver and receive acknowledgement that the beneficiary understands their equipment will be picked up and that this should occur on the first anniversary date after the start of the CBP or another date agreed to by the beneficiary. The noncontract supplier must bill and will be paid for the furnishing of the equipment up to the first anniversary date after the start of the CBP and the new supplier cannot bill for furnishing the equipment prior to this anniversary date. This requirement still applies if a date other than the anniversary date is chosen.
The beneficiary's anniversary date occurs every month on the date of the month on which the item was first delivered to the beneficiary by the current supplier. The anniversary date marks the date of every month on which a new monthly rental period begins. For example, using July 1 as the beginning date of the Medicare DMEPOS CBP:
• If a beneficiary's last anniversary date before the beginning of the CBP is June 29, the noncontract supplier must submit a claim for the rental month beginning June 29 and ending July 28. The noncontract supplier should not pick up the equipment prior to July 29. In this case, the noncontract supplier has been paid up to July 29 and therefore should pick up its equipment on July 29, and the contract supplier would deliver its equipment on July 29 and begin billing for the next month's rental as of that date.
• If a beneficiary's anniversary date is July 1, also the beginning date for the CBP, the noncontract supplier should not pick up the equipment before July 1 and should not submit a claim for the July rental period. The contract supplier should deliver the equipment to the beneficiary on July 1 and submit a claim for this month.
When a DME supplier submits a monthly bill for capped rental DME items, the date of delivery (“from” date) on the first claim must be the “from” or anniversary date on all subsequent claims for the item. For example, if the first claim for a wheelchair is dated September 15, all subsequent bills must be dated for the 15th of the following months (October 15, November 15, etc.). In cases where the anniversary date falls at the end of the month (for example, January 31) and a subsequent month does not have a day with the same date (for example, February), the final date in the calendar month (for example, February 28) will be used.
After consideration of the public comments we received, we are finalizing this section of the proposed rule as proposed.
Two business days prior to picking up the item, the supplier must contact the beneficiary by phone to remind the beneficiary of the date the supplier will pick up the item. This supplier should not pick up the item before the beneficiary's first anniversary date that occurs after the start of the CBP.
There may be unusual circumstances that make it difficult to contact certain beneficiaries. However, we do not expect this to occur often because these suppliers have been submitting monthly rental claims for providing services to these beneficiaries. Therefore, the supplier should have an ongoing relationship with the beneficiary and be aware of how to contact them and any changes in their circumstances. However, under no circumstance should a supplier pick up a rented item prior to the supplier's receiving acknowledgement from the beneficiary that they are aware of the date on which the supplier is picking up the item and that arrangements have been made to have the item replaced on that date by a contract supplier. The pickup of the
After consideration of the public comments we received, we are not making any changes to this section of the proposed rule and finalizing it as proposed.
We proposed to add § 414.408(j)(5)(ii) to state that suppliers that have chosen to become grandfathered suppliers must also notify CMS of their decision at least 30 business days before the start of the CBP. We believe that 30 business days is a reasonable period to allow CMS to compile a list of grandfathered suppliers and to answer questions about the availability of these suppliers. Unless the supplier notifies CMS consistent with this subsection, the supplier will not be considered a grandfathered supplier. Having a list of grandfathered suppliers is important to assist CMS in administering the grandfathering process. The list will be used to answer questions from beneficiaries concerning which suppliers have chosen the grandfathering option. The notification requirement will also help us to ensure that suppliers are not offering the grandfathering option to only a select number of beneficiaries. Also, having a list of suppliers that have chosen to be grandfathered suppliers will assist us in reviewing whether only noncontract suppliers that have elected to be grandfathered suppliers have received Medicare payment for rented competitive bid items in a CBA.
The notice that a noncontract supplier must provide to CMS if it elects to become a grandfathered supplier must meet the following requirements:
• State that the supplier agrees to continue to furnish certain rented DME, oxygen and oxygen equipment that it is currently furnishing to beneficiaries (that is, before the start of the CBP) in a CBA and will continue to provide these grandfathered items to these beneficiaries for the remaining months of the rental period.
• Include all of the following: Name and address of the supplier; 6-digit NSC number of the supplier; and product category(s) by CBA for which the supplier is willing to be a grandfathered supplier.
• Suppliers with multiple locations must submit one notification for the company rather than for each individual location.
• State that the supplier agrees to meet all the terms and conditions applicable to grandfathered suppliers.
• Be provided by the supplier to CMS in writing at least 30 business days before the start date of the implementation of a CBP.
We propose to clarify under § 414.408(j)(6) that a noncontract supplier that elects not to become a grandfathered supplier is required to pick up the item it is currently renting to the beneficiary from the beneficiary's home after proper notice to the beneficiary. A noncontract supplier that decides not to become a grandfathered supplier does not have the option of leaving its equipment in the beneficiary's home. The noncontract supplier is responsible for picking up the item from the beneficiary.
Proper notification by a supplier who chooses not to become a grandfathered supplier must include a 30-day, a 10-day, and a 2-day notice of its decision not to be a grandfathered supplier. These notifications must meet all of the requirements listed above for the 30-day, 10-day and 2-day notices that must be sent by suppliers who decide to be grandfathered suppliers, except for the following differences for the 30-day notice.
• The 30-day notice must indicate the items for which the supplier has decided not to become a grandfathered supplier and indicate the date upon which the equipment will be picked up.
• It must state that the supplier will only continue to rent these competitively bid item(s) up to the beneficiary's first anniversary date, as defined in § 414.408(j)(5), that occurs after the start of the Medicare DMEPOS CBP.
• It must also state that the beneficiary must select a contract supplier for Medicare to continue to pay for these items.
It must state that the beneficiary can obtain information about the CBP by calling 1–800–MEDICARE or accessing
• It must also refer him or her to the supplier locator tool on
The supplier must also provide the beneficiary with the 10-day and the 2-day notices prior to picking up their equipment.
When a beneficiary chooses to switch to a new contract supplier, the current noncontract supplier and the new contract supplier must make arrangements that are suitable to the beneficiary. This provides some latitude, but the new equipment may not be billed by the contract supplier until the first anniversary date following the start of the CBP. Also, the old equipment may not be taken from the beneficiary before proper arrangements are made and the date of service cannot occur before the anniversary date.
As discussed above, under no circumstance should a supplier pick up the rented item prior to the supplier making an arrangement with the new contract supplier for the delivery of the new equipment at a time suitable to meet the beneficiary's medical needs. The noncontract supplier has been furnishing services to the beneficiary and receiving payments from the program. To ensure that the beneficiary has continued access to medically necessary equipment, the noncontract
We are finalizing the provisions concerning grandfathering as proposed in the CY 2010 PFS proposed rule (74 FR 33644).
Section 1848(c)(2)(C)(i) of the statute states that the Secretary shall determine a number of work RVUs for the service based on the relative resources incorporating physician time and intensity required in furnishing the service. Section 1848(c)(2)(B)(i) of the Act requires that we review all RVUs no less than every 5 years.
We initiated the first Five-Year Review of work RVUs in 1994 and refinements went into effect beginning in 1997 (59 FR 63410 and 61 FR 59490). The scope of the Five-Year Review was limited to work values, since at that time, the statute required that PE and malpractice RVUs be calculated based on 1991 allowed charges and PE and malpractice expense shares for the specialties performing the services.
The second Five-Year Review of physician work RVUs began in 1999 and refinements went into effect beginning in CY 2002 (64 FR 59380 and 66 FR 55246). The third Five-Year Review of the physician work RVUs began in CY 2004 with the resulting changes being effective beginning in 2007 (69 FR 66236 and 71 FR 69624).
While the statute requires the Secretary to review the relative values for services no less than every 5 years, the work RVUs for many services, have never been specifically reviewed since the inception of the PFS. Since we approach our review with the underlying assumption that services are appropriately valued, the focus of the Five-Year Reviews has been on potentially misvalued services that are identified by us or commenters.
Although it was our practice for many years to wait for the next Five-Year Review to review and revise any potentially misvalued services, we remained concerned that it was inappropriate to wait 5 years (or until the next Five-Year Review of work RVUs) when we had some evidence that certain services were not valued correctly. MedPAC, the Congress, and other stakeholders have expressed similar concerns.
Subsequent to the completion of the third Five-Year Review, in collaboration with the AMA RUC, based on the additional concern that some services had not been reviewed since the inception of the PFS we have undertaken to review certain potentially misvalued codes. This effort is discussed elsewhere in this final rule with comment period (see section II.F.). The fourth Five–year Review will be conducted independently of the review of codes under the potentially misvalued code initiative.
We are initiating the fourth Five-Year Review of work RVUs with the resulting changes being effective beginning in 2012. As with the previous Five-Year Reviews, we are soliciting comments only on services for which the currently assigned work RVUs may be inappropriate. To the extent that there are changes in physician time or in the number or level of post procedure visits as a result of the Five-Year Review of work, the PE inputs, and we could be impacted and we would them accordingly.
Under the Five-Year Review process, we solicit comments from the public on codes that are potentially misvalued. We then review the public comments and forward codes identified in those comments, as well as codes that we have identified as potentially misvalued, to the AMA RUC. The AMA RUC then follows a process, similar to that used for new CPT codes (see description below). The AMA RUC:
• Surveys its members to assess their level of interest in reviewing relative values for certain services (and to identify services for which the code descriptors may no longer be appropriate);
• Develops survey instruments for the specialty societies to use to assess the work or level of effort involved with the service;
• Asks specialty committees to conduct the surveys, review the results and prepare their recommendations for the AMA RUC; and
• Reviews the specialty committee recommendations and may either adopt them, refer them back to the specialty society or modify them prior to submitting its recommendations to CMS.
We then review the AMA RUC recommendations, decide whether we agree or disagree, and propose to accept or reject/revise the AMA RUC recommendations. Our responses to the AMA RUC recommendations are presented, and any changes in valuations are established through notice and comment rulemaking.
Consistent with the format for the previous Five-Year Reviews, in addition to the codes submitted by the commenters, we will also identify codes and submit them to the AMA RUC. Our focus will be on codes (especially high-volume codes across specialties) that:
• Are valued as being performed in the inpatient setting, but that are now predominantly performed on an outpatient basis, and
• Were not previously reviewed by the AMA RUC, (for example, Harvard-based codes).
In prior years, we solicited comments on codes for which there is a rank order anomaly within the family of codes, and accepted the possible existence of a rank order anomaly as a primary reason for specialty societies to submit codes for review. An anomalous relationship may exist between the code being valued and other codes. For example, code A describes a service that requires more work than codes B, C, and D, but code A is valued lower. For the fourth Five-Year Review of work RVUs, we will no longer consider the existence of a possible rank order anomaly to be the primary basis for undertaking the review of a code. However, rank order anomalies will continue to be used as a way to screen for potential problem areas.
In addition, when we submit codes to the RUC for review, we note that in order to maintain relativity, we may decide to submit the entire family of codes (including the base code) for review. The base code is the most important code to review because it is the basis for the valuation of other codes within the family and allows for all related codes to be reviewed at the same time. We believe that reviewing the entire family of codes can assist in ensuring relativity between services and consistent valuation of services.
We also note that codes that have been reviewed/revised under the potentially misvalued code initiative may also be considered for review under
The AMA RUC has developed detailed “Compelling Evidence Standards” which are used by the RUC as part of its process to determine if a recommendation to change the work RVU is warranted for a given code. We are including these standards in section II.P.4. of this final rule with comment period solely for informational purposes so that commenters are aware of the kind of information that has been used in the past to make a successful argument to the RUC for changing work RVUs.
We typically publish a proposed notice for the Five-Year Review separate from the annual notice of proposed rulemaking that is published for the PFS. Publishing the Five-Year Review notice separate from the annual PFS rule allows time for the potential establishment of refinement panels to address comments received on proposed work RVU changes resulting from the Five-Year Review.
The fourth Five-Year Review of Work RVUs will be addressed in a proposed notice that we intend to publish in the spring of 2011. In that proposed notice, we will discuss: the codes considered for review under this fourth Five-Year Review; the AMA RUC recommended work RVUs; and our proposed valuation of the services, including the rationale for the work valuation. We will solicit comments on our proposed valuation of the codes. We will then review and analyze the comments received in response to the proposed notice and publish our decisions as part of the CY 2012 PFS final rule with comment period. (As previously mentioned, in past years we have addressed comments on the proposed notice through the use of refinement panels, similar to those used to address comments received on interim values for new or revised codes.) The changes would be effective January 1, 2012.
In the last Five-Year Review of work RVUs, some specialty societies used methods other than the AMA RUC-developed survey instrument to arrive at recommended work RVUs. These methods included reliance on other data sources (for example, Department of Veteran Affairs (VA) National Surgical Quality Improvement Program (NSQIP) and the Society for Thoracic Surgeons (STS) databases).
• The NSQIP was initiated by the VA for quality improvement purposes in 1991 with 128 VA medical centers. It currently includes a large volume of surgical procedures from non-VA medical centers as well. The total number of cases for VA and non-VA medical centers is greater than one million. The NSQIP database contains pre-, intra-, and post-operative data, including intra-service times and length of stay data.
• The STS National database is a voluntary reporting system for the collection of outcomes data related to cardiothoracic surgical services. This database currently contains over two million patient records collected from more than 450 practices (from 1995 through 2004). Over 70 percent of the hospitals currently performing heart surgeries in the U.S. reportedly participate in this database.
As discussed earlier in this section, specialty societies usually rely on the AMA RUC survey process to arrive at work values for their services, often referencing the median work value (50th percentile) resulting from the survey as a recommendation for a proposed work RVU. However, for the last Five-Year Review, a few specialty societies used other data sources, such as those mentioned above, to establish recommended work values. We are concerned that reliance solely on these other data sources could result in an inconsistent assignment of work RVUs, eroding the relativity of the PFS.
We would like to emphasize that the most common approach used by the AMA RUC for valuation of the work of a service is the building block approach. In constructing the building blocks, a service is divided into pre-, intra-, and post-service components. For a surgical procedure, the pre-service component consists of all services furnished before the physician makes the skin incision (for example, pre-operative evaluation and scrubbing); the intra-service component consists of the “skin-to-skin” time (that is the operative time between surgical opening and closing); and the post-service component includes immediate post-surgery services and subsequent hospital and office visits. Each component (or building block) is then assigned work RVUs. Pre-service and intra-service work RVUs are based on time and the intensity of the activities. Post-service work is based on the specified E/M service for each post-operative visit. These three component work values are then summed to compute “building-block” work RVUs.
For purposes of the fourth Five-Year Review of work RVUs and in order to gain a better understanding of the distribution of data from surveys and other data sources submitted in support of work RVU refinements, we will require that the minimum/maximum values, the 5th, 25th, 50th (median), 75th, and 95th percentiles be reported. In addition, we will require reporting of the geometric mean. This is similar to information currently reported for the specialty surveys, with some additional percentiles and the geometric mean being included. However if the AMA RUC recommendation does not include the information discussed above we may reject the recommendation.
To the extent the PQRI databases may include information similar to that previously described in the physician surveys, these databases might serve as an additional source for establishing or validating work RVUs.
The AMA RUC operates with the initial presumption that the current values assigned to the codes under review are correct. This presumption can be challenged by a society or other organization presenting a compelling argument that the existing values are no longer rational or appropriate for the codes in question. The justification for a change must be substantial and meet the RUC's compelling evidence standards.
The argument in support of a change in work RVUs must be provided in a comment letter to us, and then later to the AMA RUC in writing on the Summary of Recommendation form. The following guidelines may be used to develop a “compelling argument” that the published relative value units assigned for a service are inappropriate:
• Documentation in the peer reviewed medical literature or other reliable data that there have been changes in physician work due to one or more of the following:
++ Technique.
++ Knowledge and technology.
++ Patient population.
++ Site-of-service.
++ Length of hospital stay.
++ Physician time.
• An anomalous relationship between the code being proposed for review and other codes. For example, if code A describes a service that requires more work than codes B, C, and D, but is nevertheless valued lower. The specialty would need to assemble evidence on service time, technical skill, patient severity, complexity, length of stay and other factors for the code being consideredand the codes to which it is compared. These reference services may be both inter- and intra-specialty. (
• Evidence that technology has changed physician work, that is, diffusion of technology.
• Analysis of other data on time and effort measures, such as operating room logs or national and other representative databases.
• Evidence that incorrect assumptions were made in the previous valuation of the service, as documented, such as:
++ A misleading vignette, survey, or flawed crosswalk assumptions in a previous evaluation;
++ A flawed mechanism or methodology used in the previous valuation, for example, evidence that no pediatricians were consulted in assigning pediatric values; and
++ A previous survey was conducted by one specialty to obtain a value, but in actuality that service is currently provided primarily by physicians from a different specialty according to utilization data.
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. 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 (69 FR 66263). Minor modifications to the methodology were addressed in the CY 2006 PFS final rule (70 FR 70153). In this rule, we are implementing the second review and update of malpractice RVUs (see section II.C. of this final rule with comment period).
The resource-based PE RVUs were effective January 1, 1999. To assist in the refinement of the direct PE inputs (developed by the specialty-specific Clinical Practice Expense Panels conducted in the late 1990s), the AMA RUC created the Practice Expense Advisory Committee (PEAC) in CY 1999. The PEAC refined the PE inputs for nearly all of the CPT codes in the PFS by the time it sunsetted 5 years later in March 2004. (The remainder of the codes, approximately 200, were refined at the September 2004 and February 2005 AMA RUC meetings.) These PEAC (and subsequent AMA RUC) refinements of the PE inputs were provided as recommendations to CMS.
A comprehensive review of PE was undertaken prior to the 4-year transition period for the PE methodology from the top-down to the bottom-up methodology which will be complete in 2010. In this final rule with comment period we are incorporating new Physician Practice Information Survey (PPIS) data. (These data are used to update the specialty-specific PE/HR data used to develop PE RVUs.)
The next Five-Year Review of PE RVUs will be addressed in CY 2014 and we are soliciting comments on approaches to take for this next Five-Year Review of PE RVUs. However, to the extent that there are changes in physician time or in the number or level of post procedure visits as a result of the fourth Five-Year Review of work, there will be a potential impact on the practice expense inputs, and we will revise the inputs accordingly.
In the interim, we will continue with our efforts as part of the misvalued code initiative to develop a process to ensure that prices for certain high cost supplies that are used to determine PE RVUs are accurate and reflect current information.
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. Also beginning January 1, 2006, the Deficit Reduction Act (Pub. L. 109–171) (DRA) provided for an exception process to the therapy cap until December 31, 2006. Subsequent legislation (MIEA–TRHCA and the MMSEA) extended the exception process for therapy caps until December 31, 2007 and June 30, 2008, respectively. Section 141 of the MIPPA extended the exception process through December 31, 2009. Several therapy associations have requested that we announce the amount of the therapy cap for CY 2010 in the PFS final rule.
The annual, per beneficiary therapy cap for CY 2010 is computed by multiplying the cap amount for CY 2009, which is $1840, by the Medicare Economic Index, which is 1.2 percent, and rounding to the nearest $10. Therefore, each cap for CY 2010 will be $1860. The agency's authority to provide for exceptions to therapy caps will expire on December 31, 2009, unless the Congress acts to extend it. If the current exception process expires, the only exceptions to therapy caps will be for services billed by the outpatient hospitals.
Sections III.B. and III.C. of this final rule with comment describe the methodology used to review the comments received on the RVUs for physician work and the process used to establish RVUs for new and revised CPT codes. Changes to the RVUs and billing status codes reflected in Addendum B are effective for services furnished beginning January 1, 2010.
The CY 2009 PFS final rule with comment period (73 FR 69726) contained the work RVUs for Medicare payment for existing procedure codes under the PFS and interim RVUs for new and revised codes beginning January 1, 2009. We considered the RVUs for the interim codes to be subject to public comment under the annual refinement process. In this section, we address comments on the interim work RVUs published in the CY 2009 PFS final rule with comment period, and our establishment of the work RVUs for new and revised codes for the CY 2010 PFS.
Although the RVUs in the CY 2009 PFS final rule with comment period were used to calculate 2009 payment amounts, we considered the RVUs for the new or revised codes to be interim.
To evaluate these comments we used a process similar to the process used since 1997. (See the October 31, 1997 final rule (62 FR 59084) for the discussion of refinement of CPT codes with interim work RVUs.) We convened a multispecialty panel of physicians to assist us in the review of the comments. We invited representatives from the organizations from which we received substantive comments to attend a panel for discussion of the code on which they had commented. The panel was moderated by our medical staff, and consisted of the following voting members:
• One or two clinicians representing the commenting organization.
• Two primary care clinicians nominated by the American Academy of Family Physicians and the American College of Physicians.
• Four carrier medical directors.
• Clinicians with practices in related specialties who were expected to have knowledge of the services under review.
The panel discussed the work involved in the procedure under review in comparison to the work associated with other services under the PFS. We assembled a set of 300 reference services and asked the panel members to compare the clinical aspects of the work of the service a commenter believed was incorrectly valued to one or more of the reference services. In compiling the set, we attempted to include: (1) Services that are commonly performed whose work RVUs are not controversial; (2) services that span the entire spectrum from the easiest to the most difficult; and (3) at least three services performed by each of the major specialties so that each specialty would be represented. The intent of the panel process was to capture each participant's independent judgment based on the discussion and his or her clinical experience. Following the discussion, each participant rated the work for the procedure. Ratings were individual and confidential, and there was no attempt to achieve consensus among the panel members.
We then analyzed the ratings based on a presumption that the interim RVUs were correct. To overcome this presumption, the inaccuracy of the interim RVUs had to be apparent to the broad range of physicians participating in each panel.
Ratings of work were analyzed for consistency among the groups represented on each panel. In addition, we used statistical tests to determine whether there was enough agreement among the groups of the panel and whether the agreed-upon RVUs were significantly different from the interim RVUs published in Addendum C of the final rule. We did not modify the RVUs unless there was a clear indication for a change. If there was agreement across groups for change, but the groups did not agree on what the new RVUs should be, we eliminated the outlier group and looked for agreement among the remaining groups as the basis for new RVUs. We used the same methodology in analyzing the ratings that we first used in the refinement process for the 1993 PFS. The statistical tests were described in detail in the November 25, 1992 final rule (57 FR 55938).
Our decision to convene multispecialty panels of physicians and to apply the statistical tests described above was based on our need to balance the interests of those who commented on the work RVUs against the redistributive effects that would occur in other specialties.
The following table lists those interim codes reviewed under the refinement panel process described in this section. This table includes the following information:
• CPT Code. This is the CPT code for a service.
• Description. This is an abbreviated version of the narrative description of the code.
• 2009 Work RVU. The work RVUs that appeared in the November 2008 rule are shown for each reviewed code.
• Requested Work RVU. This column identifies the work RVUs requested by commenters.
• 2010 Work RVU. This column contains the final RVUs for physician work.
CPT codes 17106,
For CPT code 46930,
For CPT codes 61796,
For CPT codes 92382,
For CPT codes 97802,
In the CY 2009 PFS final rule with comment period we also responded to the RUC recommendations on the PE inputs for new and revised CPT codes for CY 2009. In addition to the PE comments discussed in section II.B.2. of this final rule with comment period we received the following comments concerning PE inputs.
• CPT Codes 46606, 46608, 46610, 46612, and 46930: CPT code 46930,
• CPT Codes 93306, 93307, 93320, 93325, and 93351: In the CY 2009 PFS final rule (73 FR 69898), we discussed the AMA RUC PE recommendations for CPT codes 93306,
For CPT code 93306, we stated that the AMA RUC did not recommend any changes to the PE direct inputs for the related echocardiography codes 93307,
For CPT code 93351, we stated that the AMA RUC-recommended PE inputs included three new equipment items. These items included an ultrasound machine, an echocardiography exam table, and a dual image viewing and reporting system. We did not accept the recommended ultrasound machine valued at $325,000 but used a model in a similar procedure priced at $248,000 in the PE database. We also did not accept the echocardiography exam table ($11,095) because we did not believe it was a typical equipment item found in the physician's office. Instead, we assigned the PE input typical for a similar service—a $1,915 stretcher. We
We asked commenters to provide us with documentation as to the type and cost of equipment that is used in furnishing the procedure in the physician office along with a rationale for suggested changes from the existing inputs. We also asked commenters to provide us with the typical scenario as to whether one, two, or three ultrasound units will be connected to the third equipment item, the “dual” echocardiography image viewing, and reporting system. We asked for information as to the amount of time that the dual image management system is in use for this procedure.
• CPT Codes 93293 and 93296: In the CY 2009 final rule (73 FR 69897), we discussed CPT codes 93293,
• CPT Codes 97802 and 97803: 97802,
The above codes were revalued in the CY 2009 PFS final rule with comment period as a result of the AMA RUC Recommendations for Potentially Misvalued Codes (73 FR 69890).
One aspect of establishing RVUs for 2009 was to assign interim work RVUs for all new and revised CPT codes. As described in our November 25, 1992 notice on the 1993 PFS (57 FR 55951) and in section III.B. of the CY 1997 PFS final rule (61 FR 59505), we established a process, based on recommendations received from the AMA RUC, for establishing interim work RVUs for new and revised codes.
We received work RVU recommendations for 161 new and revised CPT codes from the AMA RUC for 2010. We reviewed the AMA RUC recommendations by comparing them to our reference set or to other comparable services for which work RVUs had previously been established. We also considered the relationships among the new and revised codes for which we received AMA RUC recommendations and agreed with the majority of the relative relationships reflected in the AMA RUC values. Table 30: AMA RUC Recommendations and CMS' Decisions for New and Revised 2010 CPT Codes lists the new or revised CPT codes, and their associated work RVUs, that will be interim in CY 2010. Table 30 includes the following information:
• A “#” identifies a new code for CY 2010.
• CPT code. This is the CPT code for a service.
• Modifier. A “26” in this column indicates that the work RVUs are for the PC of the code.
• Description. This is an abbreviated version of the narrative description of the code.
• AMA RUC recommendations. This column identifies the work RVUs recommended by the AMA RUC.
• CMS decision. This column indicates whether we agreed or we disagreed with the AMA RUC recommendation. Codes for which we did not accept the AMA RUC recommendation are discussed in greater detail following this table.
• 2010 Work RVUs. This column establishes the interim 2010 work RVUs for physician work.
The following is an explanation of our rationale for not accepting particular AMA RUC-recommended work RVUs. It is arranged by type of service in CPT order and refers only to work RVUs.
In February 2009, the CPT Editorial Panel approved the coding proposal submitted by the Soft Tissue Tumor and Bone Workgroup, which revised and expanded the soft tissue tumor and bone tumor section codes to more accurately describe the services being provided and to address the concerns raised by the AMA RUC during the Third Five-Year Review. For CY 2010, the CPT Editorial Panel split 31 codes into 62 codes differentiated by the size of the excised lesion, 18 codes were revised, and 12 additional codes were created. These codes were created to fill in anatomic gaps in the coding convention for excision of soft tissue tumors.
The survey results for these codes reflected that the majority of these services, while previously performed as outpatient services (based on 2007 Medicare claims data), had now been valued as inpatient services by the AMA RUC. We believe the Medicare claims data are accurate and do not agree with the inclusion of inpatient services in these codes, particularly, the smaller sized tumors. We have concerns about the additional minutes added to the pre-service time for positioning of the patient. We believe the additional minutes are excessive and request that the AMA RUC re-examine the minutes allocated for positioning of the patient. We also have concerns about the projected utilization for these codes. We understand that the specialty society had difficulty in estimating the frequency split for current codes and frequency estimates for new codes and for the majority of the codes, estimated that the smaller sized tumors would be reported 90 percent of the time, while the larger tumors would be reported only 10 percent of the time. The AMA RUC recommended that these services should be re-reviewed to determine the accuracy of these utilization assumptions once 2 years of frequency data from Medicare have been obtained. We agree with the AMA RUC and plan to monitor the frequency data for these codes and may propose further changes to the work RVUs in the future based upon this data.
Although we have serious concerns with the valuation of these codes for 2010, and due to the comments received on the site of service anomaly codes, we have agreed to accept the AMA RUC-recommended values for these codes on an interim basis. However, we will work with the AMA RUC to address our concerns about the valuation of these codes and will consider whether it would be appropriate to propose further changes in future rulemaking.
We note that the CPT 2010 instructions regarding the use of the excision and resection of soft tissue and bone tumor codes advise that a complex repair may be separately reported. Longstanding Medicare policy generally includes payment for all simple, intermediate, and complex repairs of procedural incisions. Therefore, Medicare will not separately pay for complex repairs for these codes.
For CY 2010, the AMA RUC-recommended 6.30 work RVUs for CPT code 46707,
For CY 2010 the AMA RUC recommended 2.40 work RVUs for CPT code 74261,
CPT code 74263 was previously reported using Category III code 0066T,
Although we have accepted the AMA RUC recommendation for this service, we have assigned a status indicator of “N” (Non-covered) to CPT code 74263 since the code descriptor describe services that include screening services.
For CY 2010 the AMA RUC recommended 1.40 work RVUs for CPT code 78451,
For CPT code 78451, it was unclear what methodology the AMA RUC used to calculate the recommended RVU and, therefore, we disagree with the AMA RUC-recommended value. We believe the work RVU for the 25th percentile is more appropriate and have assigned 1.38 work RVUs to CPT code 78451.
For CPT code 78452, we disagree with the reference code used, CPT code 70496,
We received comments on new CPT codes for CY 2010. Since these are new codes for CY 2010, they are subject to comment as part of this final rule. To the extent that commenters have additional concerns, we would encourage them to submit comments in response to this rule.
The CPT Editorial Panel created CPT code 90470,
Effective January 1, 2007, section 5102(b)(1) of the Deficit Reduction Act of 2005 (Pub. L. 109–171) (DRA) capped the TC of most imaging services paid under the PFS at the amount paid under the Outpatient Prospective Payment System (OPPS) (71 FR 69659).
The list of codes subject to the OPPS cap has been revised to reflect new and deleted CPT codes for 2010. The complete list of codes subject to the OPPS cap is in Addendum H.
We have developed a process for establishing interim PE RVUs for new and revised codes that is similar to that used for work RVUs. Under this process, the AMA RUC recommends the PE direct inputs (the staff time, supplies and equipment) associated with each new code. CMS reviews the recommendations in a manner similar to our evaluation of the RUC-recommended work RVUs. The AMA RUC recommendations on the PE inputs for the new and revised CY 2010 codes were submitted to CMS as interim recommendations.
We have accepted, in the interim, the PE recommendations submitted by the RUC for the codes listed in Table 30: AMA RUC Recommendations and CMS' Decisions for New and Revised 2010 CPT Codes.
Section 1877 of the Act prohibits a physician from referring a Medicare beneficiary for certain designated health services (DHS) to a health care entity with which the physician (or a member of the physician's immediate family) has a financial relationship, unless an exception applies. Section 1877 of the Act also prohibits the DHS entity from submitting claims to Medicare or billing the beneficiary or any other entity for Medicare DHS that are furnished as a result of a prohibited referral.
Section 1877(h)(6) of the Act and § 411.351 of our regulations specify that the following services are DHS:
• Clinical laboratory services.
• Physical therapy services.
• Occupational therapy services.
• Outpatient speech-language pathology services.
• Radiology services.
• Radiation therapy services and supplies.
• Durable medical equipment and supplies.
• Parenteral and enteral nutrients, equipment, and supplies.
• Prosthetics, orthotics, and prosthetic devices and supplies.
• Home health services.
• Outpatient prescription drugs.
• Inpatient and outpatient hospital services.
In § 411.351, we specify that the entire scope of four DHS categories is defined in a list of CPT/HCPCS codes (the Code List), which is updated annually to account for changes in the most recent CPT and HCPCS publications. The DHS categories defined and updated in this manner are:
• Clinical laboratory services.
• Physical therapy, occupational therapy, and outpatient speech-language pathology services.
• Radiology and certain other imaging services.
• Radiation therapy services and supplies.
The Code List also identifies those items and services that may qualify for either of the following two exceptions to the physician self-referral prohibition:
• EPO and other dialysis-related drugs furnished in or by an ESRD facility (§ 411.355(g)).
• Preventive screening tests, immunizations, or vaccines (§ 411.355(h)).
The Code List was last updated in the CY 2009 PFS final rule with comment period (73 FR 69726) and in a subsequent correction notice (73 FR 80302).
We received one public comment relating to the Code List that became effective January 1, 2009. The comment involved CPT code 0019T,
The updated, comprehensive Code List effective January 1, 2010 appears as Addendum I in this final rule with comment period and is available on our Web site at
Tables 31 and 32 identify the additions and deletions, respectively, to the comprehensive Code List that was published in Addendum J of the CY 2009 PFS final rule (73 FR 70214 through 70237) and revised in a subsequent correction notice (73 FR 80302). Tables 31 and 32 also identify the additions and deletions to the lists of codes used to identify the items and services that may qualify for the exceptions in § 411.355(g) (regarding EPO and other dialysis-related outpatient prescription drugs furnished in or by an ESRD facility) and in § 411.355(h) (regarding preventive screening tests, immunizations, and vaccines).
In Table 31, we specify additions that generally reflect new CPT and HCPCS codes that become effective January 1, 2010, or that became effective since our last update. We also are adding HCPCS codes G0416 through G0419 that represent pathology codes for prostate needle saturation biopsy sampling to the “Clinical Laboratory Services” category of the Code List. These codes became effective January 1, 2009, and were discussed in the preamble of the CY 2009 PFS final rule (73 FR 69751). We inadvertently failed to add them to the Code List update that was published in that rule.
Table 32 reflects the deletions necessary to conform the Code List to the most recent publications of the CPT and HCPCS. In addition, we are making other deletions based on changes in Medicare coverage and payment status. We are deleting CPT code 0085T, representing a breath test for heart transplant rejection, since this code is no longer payable by Medicare. We also are deleting CPT code 95992, a code for canalith repositioning procedures, as it will be designated as “invalid” for Medicare purposes as discussed in section II.E.1 of this preamble.
We will consider comments regarding the codes listed in Tables 31 and 32. Comments will be considered if we receive them by the date specified in the “DATES” section of this final rule with comment period. We will not consider any comment that advocates a substantive change to any of the DHS defined in § 411.351.
The PFS update is determined using a formula specified in section 1848(d)(4) of the Act. Section 101 of the MIEA–TRHCA provided a 1-year increase in the CY 2007 conversion factor (CF) and specified that the CF for CY 2008 must be computed as if the 1-year increase had never applied. Section 101 of the MMSEA provided a 6-month increase in the CY 2008 CF, from January 1, 2008, through June 30, 2008, and specified that the CF for the remaining portion of 2008 and the CFs for CY 2009 and subsequent years must be computed as if the 6-month increase had never applied. Section 131 of the MIPPA extended the 6-month increase that was applicable to the CF for the first half of CY 2008 to the entire year, provided for a 1.1 percent increase to the CY 2009 CF, and specified that the CFs for CY 2010 and subsequent years must be computed as if the increases for CYs 2007, 2008, and 2009 had never applied.
If section 101 of the MIEA–TRHCA had not been enacted, the CY 2007 CF update would have been −5.0 percent (0.94953), as published in the CY 2007 PFS final rule with comment period (71 FR 69760). If section 101 of the MMSEA had not been enacted, the CY 2008 CF update would have been −10.1 percent (0.89896), as published in the CY 2008 PFS final rule with comment period (72 FR 66383).
If section 131 of the MIPPA had not been enacted, the CY 2009 CF update would have been −15.1 percent (0.84941), as discussed in the CY 2009 PFS final rule with comment period (73 FR 69900).
For CY 2010, the Medicare Economic Index (MEI) is equal to 1.2 percent (1.012). The update adjustment factor (UAF) is −7.0 percent. Our calculations of these figures are explained below in this section.
In order to determine the 2010 PFS CF update, the CFs for 2007, 2008, and 2009 must be calculated as if the various legislative changes to the CFs for those years had not occurred. Consistent with the formula specified by the statute, the CY 2010 CF update is −21.2 percent (0.78760). Our calculations are explained below in this section.
The Medicare Economic Index (MEI) is authorized 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 the higher level is justified by year-to-year economic changes.
The MEI measures the weighted-average annual price change for various inputs needed to produce physicians' services. The MEI is a fixed-weight input price index, with an adjustment for the change in economy-wide multifactor productivity. This index, which has CY 2000 base year weights, is comprised of two broad categories: (1) physician's own time; and (2) physician's practice expense (PE).
The physician's own time component represents the net income portion of business receipts and primarily reflects the input of the physician's own time into the production of physicians' services in physicians' offices. This category consists of two subcomponents: (1) wages and salaries; and (2) fringe benefits.
The physician's PE category represents nonphysician inputs used in the production of services in physicians' offices. This category consists of wages and salaries and fringe benefits for nonphysician staff and other nonlabor inputs. The physician's PE component also includes the following categories of nonlabor inputs: office expense; medical materials and supplies; professional liability insurance; medical equipment; prescription drugs; and other expenses. The components are adjusted to reflect productivity growth in physicians' offices by the 10-year moving average of productivity in the private nonfarm business sector.
Table 33 presents a listing of the MEI cost categories with associated weights and percent changes for price proxies for the 2010 update. For CY 2010, the increase in the MEI is 1.2 percent, which includes a 1.3 percent productivity offset based on the 10-year moving average of multifactor productivity. This is the result of a 3.2 percent increase in physician's own time and a 1.8 percent increase in physician's PE. Within the physician's PE, the largest increase occurred in prescription drugs, which increased 7.1 percent.
Section 1848(d) of the Act provides that the PFS update is equal to the product of the MEI and the UAF. The UAF is applied to make actual and target expenditures (referred to in the statute as “allowed expenditures”) equal. Allowed expenditures are equal to actual expenditures in a base period updated each year by the sustainable growth rate (SGR). The SGR sets the annual rate of growth in allowed expenditures and is determined by a formula specified in section 1848(f) of the Act.
Under section 1848(d)(4)(B) of the Act, the UAF for a year beginning with CY 2001 is equal to the sum of the following—
•
+ Computing the difference (which may be positive or negative) between the amount of the allowed expenditures for physicians' services for the prior year (the year prior to the year for which the update is being determined) and the amount of the actual expenditures for those services for that year;
+ Dividing that difference by the amount of the actual expenditures for those services for that year; and
+ Multiplying that quotient by 0.75.
•
+ Computing the difference (which may be positive or negative) between the amount of the allowed expenditures for physicians' services from April 1, 1996, through the end of the prior year and the amount of the actual expenditures for those services during that period;
+ Dividing that difference by actual expenditures for those services for the prior year as increased by the SGR for the year for which the UAF is to be determined; and
+ Multiplying that quotient by 0.33.
Section 1848(d)(4)(E) of the Act requires the Secretary to recalculate allowed expenditures consistent with section 1848(f)(3) of the Act. Section 1848(f)(3) specifies that the SGR (and, in turn, allowed expenditures) for the upcoming CY (CY 2010 in this case), the current CY (that is, CY 2009) and the preceding CY (that is, CY 2008) are to be determined on the basis of the best data available as of September 1 of the current year. Allowed expenditures for a year generally are estimated initially and subsequently revised twice. The second revision occurs after the CY has ended (that is, we are making the second revision to 2008 allowed expenditures in this final rule with comment).
In the CY 2010 PFS proposed rule (74 FR 33650), we noted that section 1848(f)(4)(A) of the Act provides the Secretary with clear discretion to determine what items and services should be included in the definition of “physicians' services” for purposes of determining allowed expenditures and the SGR. As the statute affords the Secretary clear discretion to revise the definition of “physicians' services”, we proposed to remove physician-administered drugs from the definition of “physicians' services” in section 1848(f)(4)(A) of the Act for purposes of computing the SGR and levels of allowed expenditures and actual expenditures in all future years. Furthermore, given the past effect of spending growth for physician-administered drugs on future PFS updates, in order to effectuate fully the Secretary's policy decision to remove drugs from the definition of “physicians' services”, we also indicated that we believed it was reasonable to remove drugs from the calculation of allowed and actual expenditures for all prior years.
In the proposed rule (74 FR 33651), we noted that the term “actual expenditures” is not defined in the statute, nor are there any statutory limitations on the Secretary's ability to recompute actual expenditures to reflect changes in the amount of actual expenditures. On several occasions, we have made revisions to the amount of actual expenditures to reflect new information regarding spending on physicians' services. In order to eliminate the disproportionate impact that the large past increases in the costs attributable to physician-administered drugs would otherwise have upon future PFS updates, we proposed to remove drugs from the calculation of allowed and actual expenditures under sections 1848(d)(3)(C) and 1848(d)(4) of the Act retrospectively to the 1996/1997 base year. Further, we proposed to remove drugs from the calculation of the SGR beginning with 2010.
Accordingly, we are removing physician-administered drugs from the calculation of allowed and actual expenditures under sections 1848(d)(3)(C) and 1848(d)(4) of the Act for CY 2010 and retrospectively to the 1996/1997 base year in this final rule. We are also finalizing our proposal to remove drugs from the calculation of the SGR beginning with 2010.
With respect to the many suggestions we received in the public comments asking the Secretary and the Congress to do more to avert the reduction in PFS payments for 2010 and future years, all other options suggested in the comments would require a change to the statute. We also received a comment requesting that we include estimates of the updates from 2010 through 2014 in this final rule. We are providing the 2010 update in the final rule, but are not providing estimates of the updates for later years as future updates will vary depending on the baseline used and will also change as additional information becomes available.
Our decision to remove drugs from the allowed and actual expenditures and the SGR will have no effect on the 2010 PFS update of −21.3 percent because removing drugs from allowed and actual expenditures retroactively to the base year changes the UAF for CY 2010 from −30.9 percent to −8.8 percent. As the statute limits the UAF for a year to −7.0 percentage points, the UAF would be −7.0 percent irrespective of whether drugs are included or excluded from allowed and actual expenditures retroactive to the base year. Although the magnitude of future updates remains uncertain, as the following analysis demonstrates, it is clear that our proposal to remove drugs from allowed expenditures, actual expenditures, and the SGR will make a positive PFS update far more likely. Removing drugs from allowed and actual expenditures for all years and from future SGRs reduces the difference between cumulative allowed and actual expenditures from $71.8 billion to $19.4 billion or by over $50 billion. Future PFS updates will only have to be reduced by $19.4 billion rather than $71.8 billion to equate actual and allowed expenditures. The UAF for 2010 changes from −30.9 percent to −8.8 percent, but is limited to −7.0 percent under either scenario. If physician-administered drugs were to remain included in allowed and actual expenditures, the UAF would be expected to be at the maximum reduction of −7.0 percent for several years beyond 2010. By excluding these drugs, far fewer negative UAFs are expected in future years.
Table 34 shows annual and cumulative allowed and actual expenditures for physicians' services from April 1, 1996, through the end of the current CY, including the short periods in 1999 when we transitioned to a CY system. As discussed in the CY 2010 PFS proposed rule (74 FR 33651), once the Secretary has revised the level of allowed expenditures during the base year (as is authorized under the statute), it is reasonable to carry this revision through into all subsequent years. Thus, Table 34 also reflects recomputed allowed and actual expenditures from the base year and subsequent years to remove the costs associated with physician-administered drugs.
Table 34 also shows the SGR corresponding with each period. The calculation of the SGR is discussed in detail below in this section.
Consistent with section 1848(d)(4)(E) of the Act, Table 34 includes our second revision of allowed expenditures for CY 2008, a recalculation of allowed expenditures for CY 2009, and our initial estimate of allowed expenditures for CY 2010. To determine the UAF for CY 2010, the statute requires that we use allowed and actual expenditures from April 1, 1996 through December 31, 2009 and the CY 2010 SGR. Consistent with section 1848(d)(4)(E) of the Act, we will be making revisions to the CY 2009 and CY 2010 SGRs and CY 2009 and CY 2010 allowed expenditures. Because we have incomplete actual expenditure data for CY 2009, we are using an estimate for this period. Any difference between current estimates and final figures will be taken into account in determining the UAF for future years. In addition, as discussed above, in order to effectuate fully the Secretary's policy decision to remove drugs from the definition of “physicians' services,” we are removing drugs from the calculation of allowed expenditures for CY 2010, CY 2009, CY 2008, and all prior years.
We are using figures from Table 34 in the following statutory formula:
If we had not removed the costs associated with physician-administered drugs from the calculation of allowed and actual expenditures retrospectively to the 1996/1997 base year and from the calculation of the SGR beginning with 2010 SGR, the UAF determined using the statutory formula would have been −30.9 percent.
The increase in the UAF reflects the reduced discrepancy between actual and target expenditures resulting from removing the costs of physician-administered drugs from our calculations.
Section 1848(d)(4)(D) of the Act indicates that the UAF determined under section 1848(d)(4)(B) of the Act for a year may not be less than −0.07 or greater than 0.03. Since −0.088 is less than −0.07, the UAF for CY 2010 will be −0.07. Moreover, because −0.088 and −0.309 are both less than −0.07, removing the costs of physician-administered drugs from our calculations did not change the effective UAF for CY 2010.
Section 1848(d)(4)(A)(ii) of the Act indicates that 1.0 should be added to the UAF determined under section 1848(d)(4)(B) of the Act. Thus, adding 1.0 to −0.07 makes the UAF equal to 0.93.
Section 1848(d) of the Act provides that the PFS update is equal to the product of the MEI and the UAF. Because the effective UAF for CY 2010 is −0.07 whether or not the costs of physician-administered drugs are included in the levels of allowed and actual expenditures, removing these costs from our calculation did not change the physician payment update for services furnished on or after January 1, 2010.
The SGR is an annual growth rate that applies to physicians' services paid by Medicare. The use of the SGR is intended to control growth in aggregate Medicare expenditures for physicians' services. Payments for services are not withheld if the percentage increase in actual expenditures exceeds the SGR. Rather, the PFS update, as specified in section 1848(d)(4) of the Act, is adjusted based on a comparison of allowed expenditures (determined using the SGR) and actual expenditures. If actual expenditures exceed allowed expenditures, the update is reduced. If actual expenditures are less than allowed expenditures, the update is increased.
Section 1848(f)(2) of the Act specifies that the SGR for a year (beginning with CY 2001) is equal to the product of the following four factors:
(1) The estimated change in fees for physicians' services;
(2) The estimated change in the average number of Medicare fee-for-service beneficiaries;
(3) The estimated projected growth in real GDP per capita; and
(4) The estimated change in expenditures due to changes in statute or regulations.
In general, section 1848(f)(3) of the Act requires us to publish SGRs for 3 different time periods, no later than November 1 of each year, using the best data available as of September 1 of each year. Under section 1848(f)(3)(C)(i) of the Act, the SGR is estimated and subsequently revised twice (beginning with the FY and CY 2000 SGRs) based on later data. (The Act also provides for adjustments to be made to the SGRs for FY 1998 and FY 1999. See the February 28, 2003
Section 1848(f)(4)(A) of the Act defines the scope of physicians' services covered by the SGR. The statute indicates that “the term physicians' services includes other items and services (such as clinical diagnostic laboratory tests and radiology services), specified by the Secretary, that are commonly performed or furnished by a physician or in a physician's office, but does not include services furnished to a Medicare+Choice plan enrollee.”
We published a definition of physicians' services for use in the SGR in the November 1, 2001
Thus, for purposes of determining allowed expenditures, actual expenditures for all years, and SGRs for CY 2010 and subsequent years, we are specifying that physicians' services include the following medical and other health services if bills for the items and services are processed and paid by Medicare carriers (and those paid through intermediaries where specified) or the equivalent services processed by the Medicare Administrative Contractors:
• Physicians' services.
• Services and supplies furnished incident to physicians' services, except for the expenditures for drugs and biologicals which are not usually self-administered by the patient.
• Outpatient physical therapy services and outpatient occupational therapy services.
• Services of PAs, certified registered nurse anesthetists, certified nurse midwives, clinical psychologists, clinical social workers, NPs, and certified nurse specialists.
• Screening tests for prostate cancer, colorectal cancer, and glaucoma.
• Screening mammography, screening pap smears, and screening pelvic exams.
• Diabetes outpatient self-management training (DSMT) services.
• MNT services.
• Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests (including outpatient diagnostic laboratory tests paid through intermediaries).
• X-ray, radium, and radioactive isotope therapy.
• Surgical dressings, splints, casts, and other devices used for the reduction of fractures and dislocations.
• Bone mass measurements.
• An initial preventive physical exam.
• Cardiovascular screening blood tests.
• Diabetes screening tests.
• Telehealth services.
• Physician work and resources to establish and document the need for a power mobility device.
Our preliminary estimate of the CY 2010 SGR is −8.8 percent. We first estimated the CY 2010 SGR in March 2009, and we made the estimate available to the MedPAC and on our Web site. Table 35 shows the March 2009 estimate and our current estimates of the factors included in the CY 2010 SGR.
Our current estimate of the CY 2009 SGR is 6.1 percent. Table 36 shows our preliminary estimate of the CY 2009 SGR that was published in the CY 2009 PFS final rule with comment period (73 FR 69904) and our current estimate.
The SGR for 2008 is 4.5 percent. Table 37 shows our preliminary estimate of the 2008 SGR from the CY 2008 PFS final rule with comment period (72 FR 66379), our revised estimate from the CY 2009 PFS final rule with comment period (73 FR 69904) and the final figures determined using the best available data as of September 1, 2009.
A more detailed explanation of each figure is provided in section VIII.F.3. of this final rule.
All of the figures used to determine the CY 2010 SGR are estimates that will be revised based on subsequent data. Any differences between these estimates and the actual measurement of these figures will be included in future revisions of the SGR and allowed expenditures and incorporated into subsequent PFS updates.
•
This factor is calculated as a weighted-average of the CY 2010 changes in fees for the different types of services included in the definition of physicians' services for the SGR. Medical and other health services paid using the PFS are estimated to account for approximately 90.8 percent of total allowed charges included in the SGR in CY 2010 and are updated using the MEI. The MEI for CY 2010 is 1.2 percent. Diagnostic laboratory tests are estimated to represent approximately 9.2 percent of Medicare allowed charges included in the SGR for CY 2010. Medicare payments for these tests are updated by the Consumer Price Index for Urban Areas (CPI–U), which is −1.4 percent for CY 2010. However, section 145 of the MIPPA reduces the update applied to clinical laboratory tests by 0.5 percent for CY 2009 through CY 2013. Therefore, for CY 2010, diagnostic laboratory tests will receive an update of −1.9 percent. As noted in Section VII.C. of this final rule with comment period, we are finalizing our proposal to remove physician-administered drugs from the allowed charges included in the SGR in CY 2010 and in all future years. Therefore, drugs represent 0.0 percent of Medicare allowed charges included in the SGR in CY 2010.
Table 38 shows the weighted-average of the MEI and laboratory price changes for CY 2010.
We estimate that the weighted-average increase in fees for physicians' services in CY 2010 under the SGR (before applying any legislative adjustments) will be 0.9 percent.
•
This factor is our estimate of the percent change in the average number of fee-for-service enrollees from CY 2009 to CY 2010. Services provided to Medicare Advantage (MA) plan enrollees are outside the scope of the SGR and are excluded from this estimate. We estimate that the average number of Medicare Part B fee-for-service enrollees will increase by 1.2 percent from CY 2009 to CY 2010. Table 39 illustrates how this figure was determined.
An important factor affecting fee-for-service enrollment is beneficiary enrollment in MA plans. Because it is difficult to estimate the size of the MA enrollee population before the start of a CY, at this time we do not know how actual enrollment in MA plans will compare to current estimates. For this reason, the estimate may change substantially as actual Medicare fee-for-service enrollment for CY 2010 becomes known.
•
We estimate that the growth in real GDP per capita from CY 2009 to CY 2010 will be 0.7 percent (based on the 10-year average GDP over the 10 years of 2001 through 2010). Our past experience indicates that there have also been changes in estimates of real per capita GDP growth made before the year begins and the actual change in GDP computed after the year is complete. Thus, it is possible that this figure will change as actual information on economic performance becomes available to us in 2010.
•
The statutory and regulatory provisions that will affect expenditures in CY 2010 relative to CY 2009 are estimated to have an impact on expenditures of −11.3 percent. These include the MIPPA provisions regarding the physician update, e-prescribing bonuses, the expiration of the work GPCI floor, and the expiration of payment provisions related to certain pathology services.
A more detailed discussion of our revised estimates of the four elements of the 2009 SGR follows.
•
This factor was calculated as a weighted-average of the 2009 changes in fees that apply for the different types of services included in the definition of physicians' services for the SGR in 2009.
We estimate that services paid using the PFS account for approximately 82.4 percent of total allowed charges included in the SGR in CY 2009. These services were updated using the CY 2009 MEI of 1.6 percent. We estimate that diagnostic laboratory tests represent approximately 8.0 percent of total allowed charges included in the SGR in CY 2009. Medicare payments for these tests are updated by the CPI–U, which is 5.0 percent for CY 2009. However, section 145 of the MIPPA reduces the update applied to clinical laboratory tests by 0.5 percent for CY 2009 through CY 2013. Therefore, for CY 2009, diagnostic laboratory tests will receive an update of 4.5 percent. We estimate that drugs represent 9.7 percent of Medicare-allowed charges included in the SGR in CY 2009. We estimate a weighted-average change in fees for drugs included in the SGR (using the ASP+6 percent pricing method) of 1.6 percent for CY 2009.
Table 40 shows the weighted-average of the MEI, laboratory, and drug price changes for CY 2009.
After considering the elements described in Table 40, we estimate that the weighted-average increase in fees for physicians' services in 2009 under the SGR (before applying any legislative adjustments) will be 1.8 percent. Our estimate of this factor in the CY 2009 PFS final rule with comment period was 2.1 percent (73 FR 69905). The decrease in the estimate is due to the availability of some actual data.
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We estimate that the average number of Medicare Part B fee-for-service enrollees (excluding beneficiaries enrolled in Medicare Advantage plans) decreased by 0.8 percent in CY 2009. Table 41 illustrates how we determined this figure.
Our estimate of the − 0.8 percent change in the number of fee-for-service enrollees, net of Medicare Advantage enrollment for CY 2009 compared to CY 2008, is a larger change than our original estimate of − 0.2 percent in the CY 2009 PFS final rule with comment period (73 FR 69905). While our current projection based on data from 8 months of 2009 differs from our original estimate of − 0.2 percent when we had no actual data, it is still possible that our final estimate of this figure will be different once we have complete information on CY 2009 fee-for-service enrollment.
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We estimate that the growth in real GDP per capita will be 0.9 percent for
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The statutory and regulatory provisions that will affect expenditures in CY 2009 relative to CY 2008 are estimated to have an impact on expenditures of 4.1 percent. These include the DRA provision reducing payments for imaging services, the MMSEA provision regarding the PQRI bonuses payable in 2009, and the MIPPA provisions regarding the change in cost sharing for mental health services, the physician update, and the change in application of BN to the CF.
A more detailed discussion of our final revised estimates of the four elements of the CY 2008 SGR follows.
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This factor was calculated as a weighted-average of the CY 2008 changes in fees that apply for the different types of services included in the definition of physicians' services for the SGR in 2008.
Services paid using the PFS accounted for approximately 82.7 percent of total Medicare-allowed charges included in the SGR for CY 2008 and are updated using the MEI. The MEI for CY 2008 was 1.8 percent. Diagnostic laboratory tests represented approximately 7.7 percent of total CY 2008 Medicare allowed charges included in the SGR and are updated by the CPI–U. However, section 628 of the MMA specifies that diagnostic laboratory tests will receive an update of 0.0 percent from CY 2004 through CY 2008. Drugs represented approximately 9.7 percent of total Medicare-allowed charges included in the SGR for CY 2008. We estimate a weighted-average change in fees for drugs included in the SGR of − 0.7 percent for 2007. Table 42 shows the weighted-average of the MEI, laboratory, and drug price changes for CY 2008.
After considering the elements described in Table 42, we estimate that the weighted-average increase in fees for physicians' services in CY 2008 under the SGR (before applying any legislative adjustments) was 1.4 percent. This figure is a final one based on complete data for CY 2008.
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We estimate the decrease in the number of fee-for-service enrollees (excluding beneficiaries enrolled in MA plans) from CY 2007 to CY 2008 was − 2.0 percent. Our calculation of this factor is based on complete data from CY 2008. Table 43 illustrates the calculation of this factor.
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We estimate that the growth in real per capita GDP was 1.6 percent in 2008 (based on the 10-year average GDP over the 10 years of CY 1999 through CY 2008). This figure is a final one based on complete data for CY 2008.
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Our final estimate for the net impact on expenditures from the statutory and regulatory provisions that affect expenditures in CY 2008 relative to CY 2007 is 3.5 percent. These include the DRA provision reducing payments for imaging services, the MIEA TRHCA provisions regarding the 2007 PQRI reporting bonuses payable in 2008, and the MIPPA provisions regarding the physician update and bonus payments for mental health services.
The CY 2010 PFS CF is $28.4061. The CY 2010 national average anesthesia CF is $16.6191.
The PFS CF for a year is calculated in accordance with section 1848(d)(1)(A) of the Act by multiplying the previous year's CF by the PFS update. The formula for calculating the PFS update is set forth in section 1848(d)(4)(A) of the Act. In general, the PFS update is determined by multiplying the CF for the previous year by the percentage increase in the MEI times the UAF, which is calculated as specified under section 1848(d)(4)(B) of the Act. However, Section 101 of the MIEA–TRHCA provided a 1-year increase in the CY 2007 CF and specified that the CF for CY 2008 must be computed as if the 1-year increase had never applied. Section 101 of the MMSEA provided a 6-month increase in the CY 2008 CF, from January 1, 2008, through June 30, 2008, and specified that the CF for the remaining portion of 2008 and the CFs for CY 2009 and subsequent years must be computed as if the 6-month increase had never applied. Section 131 of the MIPPA extended the increase in the CY 2008 CF that applied during the first half of the year to the entire year, provided for a 1.1 percent increase to the CY 2009 CF, and specified that the CFs for CY 2010 and subsequent years must be computed as if the increases for
In order to determine the 2010 PFS CF update, the CFs for 2007, 2008, and 2009 must be calculated as if the various legislative changes to the CFs for those years had not occurred.
Section 1848(c)(2)(B)(ii)(II) of the Act requires that increases or decreases in RVUs may not cause the amount of expenditures for the year to differ more than $20 million from what would have been in the absence of these changes. If this threshold is exceeded, we must make adjustments to preserve BN. We estimate that CY 2010 RVU changes would result in a decrease in Medicare physician expenditures of more than $20 million. Therefore, we are increasing the CF by 1.00103 to offset this estimated decrease in Medicare physician expenditures due to the CY 2010 RVU changes.
We illustrate the calculation of the CY 2010 PFS CF in Table 44.
Payment for services under the PFS will be calculated as follows:
We calculate the anesthesia CF as indicated in Table 45. Anesthesia services do not have RVUs like other PFS services. Therefore, we account for any necessay RVU adjustments through an adjustment tothe anesthesia CF to simulate changes to RVUs. More specifically, if there is an adjustment to thework, PE, or malpractice RVUs, these adjustments are applied to the respective shares of the anesthesia CF as these shares are proxies for the work, PE, and malpractice RVUs for anesthesia services.
As explained above, section 101 of the MIEA–TRHCA provided a 1-year increase in the CY 2007 CF and specified that the CF for CY 2008 must be computed as if the 1-year increase had never applied. Section 101 of the MMSEA provided a 6-month increase in the CY 2008 CF, from January 1, 2008, through June 30, 2008, and specified that the CF for the remaining portion of 2008 and the CFs for CY 2009 and subsequent years must be computed as if the 6-month increase had never applied. Section 131 of the MIPPA extended the increase in the CY 2008 CF from the first half of the year to the entire year, provided for a 1.1 percent increase to the CY 2009 CF, and specified that the CFs for CY 2010 and subsequent years must be computed as if the increases for CYs 2007, 2008, and 2009 had never applied.
In order to determine the 2010 PFS CF update, the CFs for 2007, 2008, and 2009 must be calculated as if the various legislative changes to the CFs for those years had not occurred. Also, section 133(b) of the MIPPA provided for the application of the 2007–2008 5-Year work review BN adjuster to the CF for years beginning with 2009. To make this change for the anesthesia CF, we recalculated the adjustments to the anesthesia CF for CY 2007 and CY 2008 by removing the BN adjuster for work which had been applied to calculate the CF for each of these years. (See the CY 2009 PFS final rule with comment period (73 FR 69909) for more information on this calculation.) Table 45 also includes the CY 2010 adjustment to the anesthesia CF due to changes in CY 2010 payment polices for PE and malpractice RVUs.
Section 1834(m) of the Act establishes the payment amount for the Medicare telehealth originating site facility fee for telehealth services provided from October 1, 2001, through December 31 2002, at $20. For telehealth services provided on or after January 1 of each subsequent calendar year, the telehealth originating site facility fee is increased by the percentage increase in the MEI as defined in section 1842(i)(3) of the Act. The MEI increase for 2010 is 1.2 percent.
Therefore, for CY 2010, the payment amount for HCPCS code Q3014, Telehealth originating site facility fee, is 80 percent of the lesser of the actual charge or $24.00. The Medicare telehealth originating site facility fee and MEI increase by the applicable time period is shown in Table 46.
The provisions of this final rule with comment period restate the provisions of the CY 2010 PFS proposed rule, except as noted elsewhere in the preamble.
We ordinarily publish a notice of proposed rulemaking in the
We utilize HCPCS codes for Medicare payment purposes. The HCPCS is a national drug coding system comprised of Level I (CPT) codes and Level II (HCPCS National Codes) that are intended to provide uniformity to coding procedures, services, and supplies across all types of medical providers and suppliers. Level I (CPT) codes are copyrighted by the AMA and consist of several categories, including Category I codes which are 5-digit numeric codes, and Category III codes which are temporary codes to track emerging technology, services, and procedures.
The AMA issues an annual update of the CPT code set each Fall, with January 1 as the effective date for implementing the updated CPT codes. The HCPCS, including both Level I and Level II codes, is similarly updated annually on a CY basis. Annual coding changes are not available to the public until the Fall immediately preceding the annual January update of the PFS. Because of the timing of the release of these new codes, it is impracticable for CMS to provide prior notice and solicit comment on these codes and the RVUs assigned to them in advance of publication of the final rule that implements the PFS. Yet, it is imperative that these coding changes be accounted for and recognized timely under the PFS for payment because services represented by these codes will be provided to Medicare beneficiaries by physicians during the CY in which they become effective. Moreover, regulations implementing HIPAA (42 CFR parts 160 and 162) require that the HCPCS be used to report health care services, including services paid under the PFS. We also assign interim RVUs to any new codes based on a review of the RUC recommendations for valuing these services. By reviewing these RUC recommendations for the new codes, we are able to assign RVUs to services based on input from the medical community and to establish payment for them, on an interim basis, that corresponds to the relative resources associated with furnishing the services. If we did not assign RVUs to new codes on an interim basis, the alternative would be to either not pay for these services during the initial CY or have each carrier establish a payment rate for these new codes. We believe both of these alternatives are contrary to the public interest, particularly since the RUC process allows for an assessment of the valuation of these services by the medical community prior to our establishing payment for these codes on an interim basis. Therefore, we believe it would be contrary to the public interest to delay establishment of fee schedule payment amounts for these codes.
For the reasons outlined above in this section, we find good cause to waive the notice of proposed rulemaking for the interim RVUs for selected procedure codes identified in Addendum C and to establish RVUs for these codes on an interim final basis. We are providing a 60-day public comment period.
Section II.F. of this final rule with comment period discusses the identification and review of potentially misvalued codes by a workgroup of the AMA RUC, as well as our review and decisions regarding the AMA RUC workgroup's recommendations. Similar to the AMA RUC recommendations for new and revised codes discussed above, due to the timing of the AMA RUC workgroup's recommendations for the potentially misvalued codes, it was impracticable for CMS to solicit public comment regarding specific proposals for revision prior to this final rule with comment period. We believe it is in the public interest to implement the revised RVUs for the codes that were identified as misvalued, and that have been reviewed and re-evaluated by the AMA RUC workgroup, on an interim final basis for CY 2010. The revisions of RVUs for these codes will establish a more appropriate payment that better corresponds to the relative resources associated with furnishing these services. A delay in implementing revised values for these misvalued codes would not only perpetuate the known misvaluation for these services, it would also perpetuate a distortion in the payment for other services under the PFS. Implementing the changes now allows for a more equitable distribution of payments across all PFS services. We believe a delay in implementation of these revisions would be contrary to the public interest, particularly since the AMA RUC process allows for an assessment of the valuation of these services by the medical community prior to the AMA RUC's recommendation to CMS. For the reasons described above, we find good cause to waive notice and comment procedures with respect to the misvalued codes identified in Table 5, and to revise RVUs for these codes on an interim final basis. We are providing a 60-day public comment period.
We ordinarily provide a 60-day delay in the effective date of the provisions of a rule in accordance with the Administrative Procedure Act (APA) (5 U.S.C. 553(d)), which requires a 30-day delayed effective date, and the Congressional Review Act (5 U.S.C. 801(a)(3)), which requires a 60-day delayed effective date for major rules. However, we can waive the delay in the effective date if the Secretary finds, for good cause, that the delay is impracticable, unnecessary, or contrary to the public interest, and incorporates a statement of the finding and the reasons in the rule issued (5 U.S.C. 553(d)(3); 5 U.S.C. 808(2)).
In section II. G. 6 of this final rule with comment period, we are finalizing our proposed criteria for designating organizations to accredit suppliers furnishing the TC of advanced diagnostic imaging services as specified in section 1834(e) of the Act. We also discuss our expectation to publish a notice the same day that this final rule is issued to solicit applications from entities for the purpose of becoming a designated accreditation organization. We note that section 1834(e) of the Act requires us to designate organizations to accredit suppliers furnishing the TC of advanced diagnostic imaging services by January 1, 2010. Given the statutory deadline to designate organizations and the timing of the publication of this final rule with comment period, we believe it is impracticable to delay the effective date of these criteria for designating organizations to accredit suppliers furnishing the TC of advanced diagnostic imaging services. Therefore, we believe that we have good cause for making the imaging accreditation provisions effective upon publication.
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):
Section 410.47(c) lists the components of a pulmonary rehabilitation program. Specifically, § 410.47(c)(3) through (c)(5) discuss psychosocial assessments, outcome assessments and individualized treatment plans, respectively, and the role of these tools in pulmonary rehabilitation programs. The burden associated with meeting the requirements for conducting psychosocial assessments, outcome assessments, and individualized treatment plans is the time and effort necessary for providers to document the necessary information in the patient record. While these requirements are subject the PRA, we believe the associated burden is exempt as stated under 5 CFR 1320.3(b)(2). Psychosocial assessments, outcome assessments and individualized treatment plans are routine tools used in pulmonary rehabilitation programs and the practice of using these tools is generally recognized as an industry standard as part of usual and customary business practices.
Section 410.48(f) states qualified persons will develop outcomes assessments designed to:
• Measure beneficiary knowledge about chronic kidney disease (CKD) and its treatment;
• Assess program effectiveness of preparing the beneficiary to make informed decisions about their healthcare options related to CKD; and
• Assess program effectiveness in meeting the communication needs of underserved populations, including persons with disabilities, persons with limited English proficiency, and persons with health literacy needs.
The assessment will be administered to the beneficiary during one of the kidney disease education (KDE) sessions prescribed by the referring physician. The assessments will be made available to CMS upon request.
The burden associated with these requirements is the time and effort necessary to conduct an outcomes assessment, maintain record of the assessment, and to make the documentation available to CMS upon request. At this time, we are not able to accurately quantify the burden because we cannot estimate the number of entities that must comply with these requirements. Additionally, we are trying to determine if the use and maintenance of outcome assessments in KDE services is a standard industry business practice. Our preliminary research gathered during a CMS Open Door Forum held on November 6, 2008 and a stakeholders meeting hosted by the Agency for Healthcare Research and Quality (AHRQ) on December 16, 2008 indicates that outcome assessments are used by most but not all of the entities bound by the requirements in § 410.48. We solicited comments pertaining to this issue in the proposed rule that published July 13, 2009 (74 FR 33520); however, we did not receive any information to assist us in accurately quantifying the number of entities that must comply with this requirement. We will continue to evaluate the issue. If we find that the number of affected entities approaches the threshold of 10 as specified in 5 CFR 1320.3(c)(4), we will submit an information collection request to OMB for review and approval.
Section 410.49(b)(2) lists the required components of a cardiac rehabilitation program. Four of the five required components, including cardiac risk factor modification, psychosocial assessments, outcomes assessments and individualized treatment plans, impose information collection burdens. The burden associated with these requirements is the time and effort necessary to providers to customize each patient's cardiac risk modification program. Additionally, there is burden associated with conducting psychosocial assessments and outcome assessments and drafting individualized treatment plans. Although section 144(a) of the MIPPA sets forth these information collection requirements, we believe the associated information collection burden is exempt as stated under 5 CFR 1320.3(b)(2). Performing cardiac risk modification, psychosocial assessments, outcome assessments, and individualized treatment plans are routine tools used in cardiac rehabilitation programs. As stated earlier in the preamble of this final rule with comment period, intensive cardiac rehabilitation programs typically involve the same elements as general cardiac rehabilitation programs, but are furnished in highly structured environments in which sessions of the various components may be combined for longer periods of cardiac rehabilitation and also may be more rigorous. The ICRs and associated burden are generally recognized as an industry standard as part of usual and customary business practices.
Section 410.49(c)(1) states that to be approved as an intensive cardiac rehabilitation program, a program in an approved setting must be approved through the national coverage determination (NCD) process which may be generated internally by CMS or requested by a non-CMS entity. To be approved as an intensive cardiac rehabilitation program, the program must demonstrate through peer-reviewed, published research that it accomplishes one or more of the requirements listed in § 410.49(c)(1)(i) through (iii), as well as statistically significant reductions in 5 or more of the measures listed in § 410.49(c)(2)(i) through (vi). As described in § 410.49(c)(4), all prospective intensive cardiac rehabilitation sites must apply to enroll as an intensive cardiac rehabilitation program site using the designated forms as specified at § 424.510.
The burden associated with the requirements in § 410.49(c) is the time and effort necessary for a program to demonstrate through peer-reviewed, published research that it accomplishes one or more of the requirements listed in § 410.49(c)(1)(i) through (iii), as well as statistically significant reductions in 5 or more of the measures listed in § 410.49(c)(2)(i) through (vi) and the time and effort necessary for intensive cardiac rehabilitation sites to apply to enroll using the designated forms as specified at 424.510. At this time, we are not able to accurately quantify the burden because we cannot estimate the number of entities that will seek approval as intensive cardiac rehabilitation programs. We solicited comments pertaining to this issue in the CY 2010 PFS proposed rule (74 FR 33520); however, we did not receive any information to assist us in accurately quantifying the number of entities that must comply with this requirement. We will continue to evaluate the issue. If we find that the number of affected entities
Section 414.68(b) contains the application and reapplication procedures for accreditation organizations. Specifically, an independent accreditation organization applying for approval or reapproval of authority to survey suppliers for purposes of accrediting suppliers furnishing the technical component (TC) of advanced diagnostic imaging services must furnish CMS with all of the information listed in § 414.68(b)(1) through (14). The requirements include but are not limited to reporting, notification, documentation, and survey requirements.
The burden associated with the collection requirements in § 414.68(b) is the time and effort necessary to develop, compile and submit the information listed in § 414.68(b)(1) through (14). We believe that 3 entities will choose to comply with these requirements. We estimate that it will take each of the 3 entities, 80 hours to submit a complete application for approval or reapproval authority to become an accrediting organization approved by CMS.
Section 414.68(c) contains the information collection requirements pertaining to CMS approved accrediting organizations. An accrediting organization approved by CMS must undertake all of the activities listed in § 414.68(c)(1) through (6). The burden associated with the collection requirements in § 414.68(c) is the time and effort necessary to develop, compile and submit the information listed in § 414.68(c)(1) through (6). We believe that 3 entities will choose to comply with these requirements. We estimate that it will take each of the 3 entities, 80 hours to submit the required information on an ongoing basis.
For the aforementioned requirements in § 414.68(b) and § 414.68(c), we are aware that the potential respondent universe is greater than 10 entities; however, at this time, there are only three entities committed to the program. If the number of respondents approaches the threshold of 10 or more persons as defined in 5 CFR 1320.3(c)(4), we will develop and submit an information collection request to OMB for review and approval.
Section 414.68(d)(1) states that CMS or our contractor may conduct an audit of an accredited supplier, examine the results of a CMS-approved accreditation organization's survey of a supplier, or observe a CMS-approved accreditation organization's onsite survey of a supplier, in order to validate the CMS-approved accreditation organizations accreditation process. The burden associated with this requirement is the time and effort necessary for an accrediting organization to comply with the components of the validation audit. While this requirement is subject to the PRA, we believe the associated burden is exempt as stated in 5 CFR 1320.3(h)(6). The burden associated with a request for facts addressed to a single person, as defined in 5 CFR 1320.3(j), is not subject to the PRA.
As stated in § 414.68(e)(1), an accreditation organization dissatisfied with a determination that its accreditation requirements do not provide or do not continue to provide reasonable assurance that the suppliers accredited by the organization meet the applicable quality standards is entitled to a reconsideration. CMS reconsiders any determination to deny, remove, or not to renew the approval of deeming authority to an accreditation organization if the accrediting organization files a written request for reconsideration by our authorized officials or through its legal representative. The written request must be filed within 30 calendar days of the receipt of CMS' notice of an adverse determination or nonrenewal. In addition, the request must also specify the findings or issues with which the accreditation organization disagrees and the reasons for the disagreement.
The burden associated with this requirement is the time and effort necessary for an accrediting organization to develop and file a written request for reconsideration. While this requirement is subject to the PRA, the associated burden is exempt under 5 CFR 1320.4. The information in question is being collected as a result of an administrative action; accrediting organizations are submitting requests for reconsideration after receiving a notice of an adverse determination or nonrenewal.
Section 414.408(j)(5) contains the notification requirements for suppliers electing to become grandfathered suppliers. Specifically, § 414.408(j)(5)(i) states that a noncontract supplier that elects to become a grandfathered supplier must provide a 30-day written notification to each Medicare beneficiary that resides in a competitive bidding area and is currently renting a competitively bid item from that supplier. The 30-day notification to the beneficiary must meet the requirements as listed in § 414.408(j)(5)(i)(A) through (G).
Subsequent to the initial 30-day notice to the beneficiary, as required by § 414.408(j)(5)(ii), suppliers must also obtain and maintain a record of the beneficiary's election choice, the date the choice was made, and the manner through which the beneficiary communicated his or her choice. Additionally, § 414.408(j)(5)(iii) states that if a beneficiary chooses not to continue to receive a grandfathered item(s) from his or her current supplier, the supplier must provide the beneficiary with two more notices prior to the supplier picking up its equipment. The supplier must provide a 10-day notification and a 2-day notification. These notification requirements must meet the criteria listed in § 414.408(j)(5)(iii)(A) though (C).
Section § 414.408(j)(5)(iv) requires suppliers that elect to become grandfathered suppliers to provide a written notification to CMS of its election decision. The notification must meet the requirements as specified in § 414.408(j)(5)(iv)(A) through (D).
The burden associated with the information collection requirements contained in § 414.408(j)(5) is the time and effort necessary for a noncontract supplier to make the aforementioned notifications to both beneficiaries and CMS. We estimate that 1,305 suppliers will elect to become grandfathered suppliers. Similarly, we estimate that each grandfathered supplier will need to make an average of 53 notifications based on an average of 52 beneficiaries per supplier and one notice to CMS. We estimate that it will take 2 hours to develop the notification to the beneficiary and 2 hours to develop the notification to CMS. Similarly, we estimate that each notification will take 15 minutes to send. The total estimated burden associated with each of the 1305 suppliers complying with the requirements in § 414.408(j)(5) is 17.25 hours per supplier for a total of 22,511 hours.
Section 414.408(j)(6) contains the information collection requirements pertaining to suppliers that choose not to become grandfathered suppliers. A noncontract supplier that elects not to become a grandfathered supplier is required to pick up the item it is currently renting to the beneficiary from the beneficiary's home after proper notification. Proper notification includes a 30-day, a 10-day, and a 2-day notice of the supplier's decision not to
The burden associated with the information collection requirements in § 414.408(j)(6) is the time and effort necessary for a supplier to make the required notifications to beneficiaries. We estimate that 145 suppliers will not elect to become grandfathered suppliers. Similarly, we estimate that each nongrandfathered supplier will need to make an average of 156 notifications based on an average of 52 beneficiaries per supplier. We estimate that it will take 2 hours to develop the 30-day notification to the beneficiary and 15 minutes to send out each notification. The 10-day notification will take approximately 15 minutes and the 2-day will take approximately 15 minutes. We estimate to send out all 3 notifications it will take a total of approximately 45 minutes. The total burden associated with the requirements in § 414.408(j)(6) is approximately 5,945 hours.
Section 414.425(a) states that any aggrieved supplier, including a member of a network that was awarded a contract for the Round 1 Durable Medical Prosthetics, Orthotics, and Supplies Competitive Bidding Program (DMEPOS CBP), may file a claim under this section for certain alleged damages arising out of MIPPA's termination of the Round 1 DMEPOS CBP contracts. Section 414.425(b) states that a completed claim, including all documentation, must be filed within 90 days of the effective date of the final rule on damages, unless that day is a holiday or Sunday in which case it will revert to the next business day. Section 414.425(c) lists the required documentation for submitting a claim.
The burden associated with this requirement is the time and effort necessary to gather required documentation as specified in § 414.425(c) and submit a claim for damages. This requirement is for a one-time process that will only impact those suppliers who were awarded a contract and were potentially damaged by the termination of their contracts by MIPPA. We awarded contracts to 329 suppliers. We expect that it will take approximately 3 hours for a supplier to gather the necessary documents and to file a claim. We anticipate that anywhere between 5 and 250 suppliers may submit a claim for damages.
While this requirement is subject to the PRA, we believe the associated burden is exempt under 5 CFR 1320.4. The information in question is being collected as a result of an administrative action; suppliers are submitting claims for damages caused by the termination of contracts awarded in 2008 under the DMEPOS CBP that were terminated as a result of section 154(a)(1)(A)(iv) of the MIPPA.
As stated in § 414.97, an approved CAP vendor may appeal that termination by requesting a reconsideration. A determination must be made as to whether the approved CAP vendor has been meeting the service and quality obligations of its CAP contract. The approved CAP vendor's contract will remain suspended during the reconsideration process.
The burden associated with this requirement is the time and effort necessary for a CAP vendor to request a reconsideration of the termination. While this requirement is subject to the PRA, we believe the associated burden is exempt under 5 CFR 1320.4. The burden associated with collecting information subsequent to an administrative action is not subject to the PRA.
As stated in the definition for a publicly transparent process for evaluating therapies in § 414.930(a), a compendium must make the following materials available to the public on its Web site, coincident with the compendium's publication of the related recommendation:
(i) The internal or external request for listing of a therapy recommendation including criteria used to evaluate the request.
(ii) A listing of all the evidentiary materials reviewed or considered by the compendium pursuant to the request.
(iii) A listing of all individuals who have substantively participated in the review or disposition of the request.
(iv) Minutes and voting records of meetings for the review and disposition of the request.
The definition for a publicly transparent process for identifying conflicts of interests in § 414.930(a), states that a compendium must make the following materials available to the public, coincident with the compendium's publication of the related recommendation:
(i) Direct or indirect financial relationships that exist between individuals or the spouse or minor child of individuals who have substantively participated in the development or disposition of compendia recommendations and the manufacturer or seller of the drug or biological being reviewed by the compendium. This may include, for example, compensation arrangements such as salary, grant, contract, or collaboration agreements between individuals or the spouse or minor child of individuals who have substantively participated in the review and disposition of the request and the manufacturer or seller of the drug or biological being reviewed by the compendium.
(ii) Ownership or investment interests between individuals or the spouse or minor child of individuals who have substantively participated in the development or disposition of compendia recommendations and the manufacturer or seller of the drug or biological being reviewed by the compendium.
Based on our estimate, the burden we derived for all our conflict of interest and transparency provisions above, the total burden would range from 1950 hours per compendium with 75 responses to 2600 hours per compendium with 100 responses. The variation in responses is due to the varying size of compendia publications and different processes used by compendia publishers to generate a recommendation. In our estimate we also found that the total burden from respondents would range from 30 hours per compendium with 10 respondents to 2535 hours per compendium with 845 respondents. The variation in respondents depends on a compendium's use of internal or external staff to generate compendia recommendations. Therefore, based on these burden totals, the total burden hours per compendium to comply with our conflict of interest and transparency
We are soliciting public comments on the aforementioned requirements and the associated burden estimates in an emergency PRA notice published elsewhere in this
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,
This final rule with comment period imposes collection of information requirements as outlined in the regulation text and specified above. However, this final rule with comment period 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 II.H.1 of this final rule with comment period 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 II.H.2. of this final rule with comment period discusses issues related to the competitive acquisition program for Part B drug payment. There are no new information collection requirements associated with the CAP; however, there are several previously approved information collection requests (ICR) associated with the CAP.
Section II.G.2. of this final rule with comment period discusses the background of the PQRI, provides information about the measures to be available to eligible professionals who choose to participate in the 2010 PQRI, and the criteria for satisfactory reporting in 2010. Beginning on January 1, 2010, the Secretary is also required by section 1848(m)(3)(C) of the Act, to establish and have in place a process under which eligible professionals in a group practice (as defined by the Secretary) shall be treated as satisfactorily submitting data on quality measures under the PQRI.
With respect to satisfactory submission of data on quality measures by eligible professionals, eligible professionals 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. Eligible professionals 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 2010, the eligible professional must meet one of the criteria for satisfactory reporting described in sections II.G.2.e. and II.G.2.f. of this final rule with comment period.
For individual eligible professionals, the burden associated with the requirements of this voluntary reporting
We believe the burden associated with participating in PQRI has declined for those familiar with the program and who have satisfactorily participated in the 2007 PQRI and/or the 2008 PQRI. However, because we anticipate even greater participation in the 2010 PQRI, including participation by eligible professionals who are participating in PQRI for the first time in 2010, we will assign 5 hours as the amount of time needed for eligible professionals to review the list of PQRI quality measures, identify the applicable measures for which they can report the necessary information, review the measure specifications for those measures applicable to the eligible professional, incorporate reporting of the measures selected by the eligible professional into the office work flows, and select a 2010 PQRI reporting option. Information from the Physician Voluntary Reporting Program (PVRP), which was a predecessor to the PQRI, indicated an average labor cost of $50 per hour per practice. To account for salary increases over time, we will use an average practice labor cost of $55 per hour in our estimates based on an assumption of an average annual increase of approximately 3 percent. Thus, we estimate the cost for an eligible professional to review the list of PQRI quality measures, identify the applicable measures for which they can report the necessary information, review the measure specifications for those measures applicable to the eligible professional, incorporate reporting of the selected measures into the office work flows, and select a 2010 PQRI reporting option to be approximately $275 per eligible professional ($55 per hour × 5 hours).
We continue to expect the ongoing costs associated with PQRI participation to decline based on an eligible professional'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.
In addition, for claims-based reporting, eligible professionals must gather the required information, select the appropriate quality data codes, and include the appropriate quality data codes on the claims they submit for payment. The PQRI will collect quality data codes as additional (optional) line items on the existing HIPAA transaction 837–P and/or CMS Form 1500. We do not anticipate any new forms or modifications to the existing transaction or form. We also do not anticipate changes to the 837–P or CMS Form 1500 for CY 2010.
Because this is a voluntary program, it is difficult to accurately estimate how many eligible professionals will opt to participate in the PQRI in CY 2010. Information from the “PQRI 2007 Reporting Experience Report,” which is available on the PQRI section of the CMS Web site at
Moreover, the time needed for an eligible professional 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, incorporate reporting of the selected measures into the office work flows, and select a 2010 PQRI reporting option is expected to vary along with the number of measures that are potentially applicable to a given professional's practice. Since eligible professionals are generally required to report on at least 3 measures to earn a PQRI incentive, we will assume that each eligible professional who attempts to submit PQRI quality measures data is attempting to earn a PQRI incentive payment and that each eligible professional reports on an average of 3 measures for this burden analysis.
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. With an average practice labor cost of $55 per hour, the cost associated with this burden ranges from $0.23 in labor time to about $11.00 in labor time for more complicated cases and/or measures, with the cost for the median practice being $1.44.
The total estimated annual burden for this requirement will also vary along with the volume of claims on which quality data is reported. Results from the 2007 PQRI indicate that eligible professionals reported on 1 to 3,331 eligible instances per measure. For all 2007 PQRI measures, the median number of eligible instances reported on per measure was less than 60. On average the median number of eligible instances reported on per measure was about 9. Therefore, for this burden analysis we estimate that for each measure, an eligible professional reports the quality data on 9 cases. The actual number of cases on which an eligible professional will be required to report quality measures data will vary, however, with the eligible professional's patient population and the types of measures on which the eligible professional chooses to report (each measure's specifications includes a required reporting frequency).
Based on the assumptions discussed above, we estimate the total annual burden per eligible professional associated with claims-based reporting to range from 306.75 minutes, or 5.1125 hours [(0.25 minutes per measure × 3 measures × 9 cases per measure) + 5 hours] to 624 minutes, or 10.4 hours [(12 minutes per measure × 3 measures × 9 cases per measure) + 5 hours]. We estimate the total annual cost per eligible professional associated with claims-based reporting to range from $281.21 [($0.23 per measure × 3 measures × 9 cases per measure) + $275] to $572 [($11.00 per measure × 3 measures × 9 cases per measure) + $275].
For registry-based reporting, we are estimating that it would cost an eligible professional approximately $1,000 to participate in a registry based on input we received from commenters (these comments are addressed in the section II.G.2.a. of the preamble). This takes into account the participation fee charged by registries and the fact that this fee often includes services above and beyond what is required for PQRI. However, registries vary in their participation fees as some registries do not charge a participation fee at all or charge only nominal fees. Eligible professionals also need to authorize or instruct the registry to submit quality measures results and
Registries interested in submitting quality measure results and numerator and denominator data on quality measures to CMS on their participants' behalf in 2010 will need to complete a self-nomination process in order to be considered “qualified” to submit on behalf of eligible professionals unless the registry was qualified to submit on behalf of eligible professionals for the 2009 PQRI and does so successfully. We estimate that the self-nomination process for qualifying additional registries to submit on behalf of eligible professionals for the 2010 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 for the development of a measure flow. However, the time it takes to complete the measure flow could vary depending on the registry's experience. 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 measure 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 measure results, and submit the measure results and numerator and denominator data on the quality measures on their participants' behalf is expected to vary along with the number of eligible professionals reporting data to the registry and the number of applicable measures. However, since it is customary for most registries to provide their participants with information that can be used for the participants' internal quality improvement efforts, 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 eligible professional must review the quality measures on which we will be accepting PQRI data extracted from EHRs, select the appropriate quality measures, 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 will be new to PQRI for 2010 and participation in this reporting initiative is voluntary, we believe it is difficult to estimate with any degree of accuracy how many eligible professionals will opt to participate in the PQRI through the EHR mechanism in CY 2010. The time needed for an eligible professional 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 is expected to be similar for EHR-based reporting and claims-based reporting. Once the EHR is programmed by the vendor to allow data submission to CMS, the burden to the eligible professional associated with submission of data on PQRI quality measures should be minimal.
An EHR vendor interested in having their product(s) be used by eligible professionals 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 2010. It is difficult for us 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 × 10 hours per EHR vendor).
The burden associated with the EHR-based reporting requirements of this voluntary reporting initiative is the time and effort associated with the EHR vendor programming its EHR product(s) to extract the clinical data that the eligible professional needs to submit to CMS for purposes of reporting 2010 PQRI quality measures. The time needed for an EHR vendor to review the quality measures and other information and program each qualified EHR product to enable eligible professionals to submit PQRI quality measures data to the CMS-designated clinical data warehouse 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 × 40 hours per vendor). However, given the variability in the capabilities of the vendors, we believe a more conservative estimate for those vendors with minimal experience would be approximately 200 hours at $50 per hour, for a total estimate of $10,000 per vendor ($50 per hour × 200 hours per EHR vendor).
With respect to the process for group practices to be treated as satisfactorily submitting quality measures data under the 2010 PQRI discussed in section II.G.2. of this final rule with comment period, group practices interested in participating in the 2010 PQRI through the group practice reporting option must complete a self-nomination process similar to the self-nomination process required of registries and EHR vendors. Therefore, we estimate that the self-nomination process for the group practices for the 2010 PQRI involves approximately 2 hours per group practice to review the 2010 PQRI reporting option and make the decision to participate as a group rather than individually and an additional 2 hours per group practice to draft the letter of intent for self-nomination, gather the requested TIN and NPI information, and provide this requested information. It is estimated that each self-nominated entity will also spend 2 hours undergoing the vetting process with CMS officials. We assume that the group practice staff involved in the group practice self-nomination process have an average practice labor cost of $55 per hour. Therefore, assuming the total burden hours per group practice associated with the group practice self-nomination process is 6 hours, we estimate the total cost to a group
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 group practices, this would be the time associated with the group practice completing the 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, for use in the Physician Group Practice, Medicare Care Management Performance (MCMP), and EHR demonstrations. Based on burden estimates for the PGP demonstration, which uses the same data submission methods as what we will be using for PQRI, we estimate the burden associated with a group practice completing the data collection tool will be approximately 79 hours per physician group. Therefore, we estimate the total annual burden hours per physician group would be approximately 85 hours (2 hours for decision-making + 4 hours for self-nomination + 79 hours for data submission). Based on an average labor cost of $55 per physician group, we estimate the cost per physician group associated with participating in the PQRI group practice reporting option would be $4,675 ($55 per hour × 85 hours per group practice).
We believe it is difficult to accurately estimate how many eligible professionals will opt to participate in the E-Prescribing Incentive Program in CY 2010. Information from the “PQRI 2007 Reporting Experience Report,” which is available on the PQRI section of the CMS Web site at
Section II.G.5. of the preamble discusses the background of the E-Prescribing Incentive Program. Section II.G.5.c. of the preamble provides information on how eligible professionals can qualify to be considered a successful electronic prescriber in 2010 in order to earn an incentive payment. Similar to the PQRI, the E-Prescribing Incentive Program is a voluntary initiative. Eligible professionals 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 II.G.5.c. of this final rule with comment period, they can qualify to receive an incentive payment for 2010.
For the 2010 E-Prescribing Incentive Program, as discussed in section II.G.5. of the preamble, each eligible professional will need to report the 2010 electronic prescribing measure, which indicates that at least 1 prescription created during an eligible encounter was generated and transmitted electronically using a qualified electronic prescribing system. Similar to PQRI, this measure will be reportable through claims, a qualified registry, or a qualified EHR.
Similar to claims-based reporting for the PQRI, we estimate that the burden associated with the requirements of this incentive program is the time and effort associated with eligible professionals determining whether the electronic prescribing quality measure applies to them, gathering the required information, selecting the appropriate quality data codes, and including the appropriate quality data codes on the claims they submit for payment. We expect the ongoing costs associated with participation in the E-Prescribing Incentive Program to decline based on an eligible professional's familiarity with and understanding of the E-Prescribing Incentive Program, experience with participating in the E-Prescribing Incentive Program, and increased efforts by CMS and stakeholders to disseminate useful educational resources and best practices. Since the E-Prescribing Incentive Program consists of only 1 quality measure, we will assign 1 hour as the amount of time needed for eligible professionals to review the electronic prescribing measure and incorporate reporting of the measure into their office work flows and an additional hour as the amount of time needed for eligible professionals to select an appropriate reporting mechanism for them. At an average cost of approximately $55 per hour (see section XIII.E.2. above for a discussion of how we arrived at this figure), we estimate the total cost to eligible professionals for reviewing the e-prescribing measure, incorporating the reporting of the measure into the office work flows, and selecting an appropriate reporting mechanism to be approximately $110 ($55 per hour × 2 hours).
For claims-based reporting, the quality data codes 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 or modifications to the existing transaction or form. We also do not anticipate changes to the 837–P or CMS Form 1500 for CY 2010.
Based on our experience with the PVRP described in section II.G.5., we estimate that the time needed to perform all the steps necessary to report the electronic prescribing measure via claims to be 1.75 minutes. We also estimate the cost to perform all the steps necessary to report the electronic prescribing measure to be $1.44 based on the experience with the PVRP described above.
Based on the 2010 criteria for determination of whether an eligible professional is a successful electronic prescriber, we estimate that each eligible professional will report the electronic prescribing measure in 25 instances during the reporting period.
Therefore, we estimate the total annual burden per eligible professional who chooses to participate in the 2010 E-Prescribing Incentive Program through claims-based reporting of the electronic prescribing measure to be 163.75 minutes, or 2.73 hours [(1.75 minutes per measure × 1 measure × 25 cases per measure) + 2 hours]. The total estimated cost per eligible professional to report the electronic prescribing measure is estimated to be $146 [($1.44 per measure × 1 measure × 25 cases per measure) + $110].
Because registry-based reporting of the electronic prescribing measure to CMS will be new for 2010 and participation in this reporting initiative is voluntary, it is impossible to estimate with any degree of accuracy how many eligible professionals will opt to participate in the E-Prescribing Incentive Program through the registry-based reporting mechanism in CY 2010. We do not anticipate, however, any additional burden for eligible professionals to report data to a registry as eligible professionals opting for registry-based reporting would more than likely already be reporting data to the registry for other purposes
Based on our policy to consider only registries qualified to submit 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 E-Prescribing Incentive Program, there will be no need for a registry to undergo a separate self-nomination process for the E-Prescribing Incentive Program other than to indicate to us its desire to become a qualified registry for the E-Prescribing Incentive Program at the time that it does so for PQRI. Therefore, we estimate that any additional associated with the registry self-nomination process would be minimal.
The burden associated with the registry-based reporting requirements of this voluntary reporting initiative is the time and effort 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 measure 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 eligible professionals reporting data to the registry. 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 eligible professional must review the electronic prescribing measure, 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 will be new for 2010 and participation in this reporting initiative is voluntary, it is difficult to accurately estimate how many eligible professionals will opt to participate in the E-Prescribing Incentive Program through the EHR-based reporting mechanism in CY 2010. The time needed for an eligible professional to review the electronic prescribing measure and other information to determine whether the measure is applicable to his or her patients and the services he or she furnishes to them and to review the available reporting mechanisms to select the EHR reporting mechanism is expected to be similar for EHR-based reporting and claims-based reporting. Once the EHR is programmed by the vendor to allow data submission to CMS, the burden to the eligible professional associated with submission of data on the electronic prescribing measure should be minimal.
Based on our policy to consider only EHR products qualified for the 2010 PQRI to be qualified for the 2010 E-Prescribing Incentive Program, there will be no need for EHR vendors to undergo a separate self-nomination process for the E-Prescribing Incentive Program and therefore, no additional burden associated with the self-nomination process.
The burden associated with the EHR-based reporting requirements of this voluntary reporting initiative is the time and effort associated with the EHR vendor programming its EHR product(s) to extract the clinical data that the eligible professional needs to submit to CMS for purposes of reporting the 2010 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 eligible professionals 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 2010 PQRI will be qualified for the 2010 E-Prescribing Incentive Program and the E-Prescribing Incentive Program consists of only one measure, we believe that any burden associated with the EHR vendor to program its product(s) to enable eligible professionals 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 2010 E-Prescribing Incentive Program discussed in section II.G.5., a group practice will be required to report the electronic prescribing measure in at least 2,500 instances. Group practices have the same options as individual eligible professionals in terms of the form and manner for reporting the electronic prescribing measure (that is, group practices have the option of reporting the measure through claims, a qualified registry, or a qualified EHR product). The only difference between an individual eligible professional and group practice reporting of the electronic prescribing measure is the number of times that a group practice is required to report the electronic prescribing measure. Reporting of the electronic prescribing measure can continue to occur at the individual eligible professional level under the electronic prescribing group practice reporting option. In our analysis of the information, however, we will aggregate all of the information reported by the eligible professionals within the group practice to determine whether the group practice reported the measure a sufficient number of times. For group practices that are selected to participate in the 2010 E-Prescribing Incentive Program group practice reporting option and choose to do so through claims-based reporting of the electronic prescribing measure, we estimate the total annual burden to be 74.92 hours [(1.75 minutes per measure × 1 measure × 2,500 cases per measure) + 2 hours]. The total estimated cost per group practice to report the electronic prescribing measure through claims-based reporting is estimated to be $3,710 [($1.44 per measure × 1 measure × 2,500 cases per measure) + $110].
For group practices that are selected to participate in the 2010 E-Prescribing Incentive Program group practice reporting option and choose to do so through registry-based reporting of the
For group practices that are selected to participate in the 2010 E-Prescribing Incentive Program group practice reporting option and choose to do so 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.
In addition to the burden associated with group practices reporting the electronic prescribing measure, group practices will also be required to self-nominate in order to participate in the 2010 E-Prescribing Incentive Program under the group practice reporting option. Since we are limiting participation in the electronic prescribing group practice reporting option to those group practices selected to participate in the PQRI group practice reporting option, there will not be a separate group practice self-nomination process for the E-Prescribing Incentive Program and, thus, no additional burden.
We invite comments on this burden analysis, including the underlying assumptions used in developing our burden estimates.
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 final rule with comment period 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 Small Business Administration (SBA) definition of a small business (having revenues of less than $7.0 million to $34.5 million in any 1 year) (for details see the SBA's Web site at
The RFA requires that we analyze regulatory options for small businesses and other entities. We prepare a regulatory flexibility analysis unless we certify that a rule would not have a significant economic impact on a substantial number of small entities. The analysis must include a justification concerning the reason action is being taken, the kinds and number of small entities the rule affects, and an explanation of any meaningful options that achieve the objectives with less significant adverse economic impact on the small entities.
For purposes of the RFA, physicians, NPPs, and suppliers including IDTFs are considered small businesses if they generate revenues of $7 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. We estimate that approximately 105,000 DMEPOS suppliers are enrolled in Medicare currently and bill Medicare for DMEPOS each year. Total annual estimated Medicare revenues for DMEPOS suppliers are approximately $11.7 billion in 2008 for which $8.7 billion was for fee-for-service (FFS) and $3.0 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 $7 million to $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,
Because we acknowledge that many of the affected entities are small entities, the analysis discussed throughout the preamble of this final rule with comment period 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 604 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 final rule with comment period has impact on significant operations of a substantial number of small rural hospitals because most dialysis facilities are freestanding. While there are 176 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 176 rural hospital-based dialysis facilities will experience an estimated 1.1 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 final rule with comment period 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 2009, that threshold is approximately $133 million. This final rule with comment period will not mandate any requirements for State, local, or tribal governments. 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 V. of this regulatory impact analysis. Rather, it focuses on certain categories of cost, mainly those “Federal mandate” costs resulting from (A) imposing enforceable duties on State, local, or tribal governments, or on the private sector, or (B) increasing the stringency of conditions in, or decreasing the funding of, State, local, or tribal governments under entitlement programs.
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 final rule with comment period in accordance with Executive Order 13132 and have determined that this regulation would not have any substantial direct effect on State or local governments, would not 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 final rule with comment period; 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 final rule with comment period. We are unaware of any relevant Federal rules that duplicate, overlap, or conflict with this final rule with comment period. The relevant sections of this rule contain a description of significant alternatives if applicable.
We did review the potential impact of our revised policies in the regulatory impact analysis. In light of the comments received on the proposed rule, we have revised many of the proposals made in the proposed rule such that we estimate that the impact on portable x-ray suppliers and providers of radiation therapy services in this final rule with comment period will be significantly different than in the proposed rule, as shown in Table 49. However, the PFS update, which is based in part on the SGR, is required by law, affects all PFS services, and we have no discretion to waive this provision for small businesses.
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
Our estimates of changes in Medicare revenues for PFS services compare payment rates for CY 2009 with payment rates for CY 2010 using CY 2008 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 49. 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 provides. 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 80 percent of their Medicare revenues from clinical laboratory services that are not paid under the PFS.
Table 49 shows only the payment impact on PFS services. The following is an explanation of the information represented in Table 49:
• Specialty: The physician specialty or type of practitioner/supplier.
• Allowed charges: Allowed charges are the PFS amounts for covered services and include coinsurance and deductibles (which are the financial responsibility of the beneficiary). These amounts have been summed across all services furnished by physicians, practitioners, or suppliers within a specialty to arrive at the total allowed charges for the specialty.
• Impact of Work RVU changes for the CY 2010 PFS.
• Impact of PE RVU changes (Full) if these changes were fully implemented in CY 2010 PFS. These are not the estimated CY 2010 impacts since we have implemented a 4-year transition to the new PE RVUs for existing codes.
• Impact of the CY 2010 PE RVU changes under the 4-year transition (Tran) adopted in this final rule with comment period. These are the estimated CY 2010 impacts. Note that the transition does not apply to new and significantly revised codes.
• Impact of MP RVU changes for the CY 2010 PFS.
• Combined impact of all RVU changes (Full) if these changes were fully implemented in CY 2010 PFS. These are not the estimated CY 2010 impacts since we have implemented a 4-year transition to the new PE RVUs for existing codes. These impacts are prior to the application of the CY 2010 negative PFS CF update under the current statute.
• Combined impact of all of the estimated CY 2010 RVU changes under the 4-year transition (Tran) adopted in this final rule with comment period for the PE changes. These are the estimated CY 2010 impacts, prior to the application of the CY 2010 negative PFS CF update under the current statute.
The average work RVU impacts are primarily attributable to the changes for consultation services. As described earlier in this final rule with comment period, we are proposing to no longer recognize the billing codes for consultation services so we are budget neutrally eliminating the use of all consultation codes (except for telehealth) and have allocated the work RVUs that were allotted to these services to the work RVUs for new and established office visit services, initial hospital visits, and initial nursing facility visits to reflect this change.
In addition, the impacts reflect the work done by the AMA RUC related to the Five-Year Review Identification Workgroup's Codes Reported Together screen. Based upon the AMA RUCs review of the myocardial perfusion imaging family of services, it was determined that some of the existing codes for these services are performed together more than 95 percent of the time and were thus referred to CPT for creation of new bundled services. In recognition of the efficiencies associated with the services being performed together, there are less aggregate RVUs under the new bundled 2010 CPT coding structure and pricing than there are under the current 2009 CPT coding structure and pricing. These fewer aggregate RVUs will be offset by an adjustment to the CF in order to maintain overall BN. For further information on the myocardial perfusion imaging family coding changes, see section III.F.4. of this final rule with comment period.
The PE RVU impacts are primarily attributable to the incorporation of PE data from the Physician Practice Information Survey (PPIS). For a discussion of the use of this updated survey data, see section II.A.2. of this final rule with comment period. The impacts are shown both as if they were fully implemented in CY 2010 and under our 4-year transition policy to the new PE RVUs for existing codes that have not been substantially revised.
For IDTFs, the impact of our change in the utilization rate for expensive diagnostic equipment is also significant. We estimate that for IDTFs, the utilization rate change will result in a fully implemented impact of approximately −2 percent after taking into account the OPPS payment cap. This −2 percent impact is included in the −29 percent fully implemented PE RVU impact shown in Table 49 for IDTFs. The change in the utilization rate for expensive diagnostic imaging equipment does not significantly impact overall payments for other specialties after taking into account the OPPS payment cap.
The impacts also reflect the reduced utilization for the myocardial perfusion imaging family of services stemming from the AMA RUC's review of these services as described above.
The payment impact for an individual physician may be different from the average, based on the mix of services the physician provides. Using the RVU information contained in Appendix B, an impact can be calculated for any particular mix of services either under the fully implemented RVUs or the 4-year transition RVUs.
The average MP RVU impacts are attributable to the changes adopted for the Five-Year Review of MP RVUs described earlier in this final rule with comment period. Of particular note are the impacts on the specialties of Audiology (−7 percent), and IDTFs (−4 percent). These impacts are primarily driven by the expansion of the MP premium data collection and the changes to the methodology for TC services.
Column E of Table 49 displays the combined average impact of all RVU changes by specialty. The impacts are shown both as if the new PE RVUs were fully implemented in CY 2010 and under our 4-year transition policy to the new PE RVUs for existing codes that have not been significantly revised.
The estimated CY 2010 transition impacts range from increases of +5 percent for ophthalmology to decreases of −18 percent for nuclear medicine. The effect of our policies on primary care specialties such as General Practice, Family Practice, Internal Medicine, and Geriatrics are positive with CY 2010 transition increases ranging from +2 percent to +4 percent. Again, these impacts are prior to the application of the negative CY 2010 CF update under the current statute.
Table 49 shows the estimated transition impact on total payments for selected high-volume procedures of all of the changes discussed previously, including the effect of the CY 2010 negative PFS CF update. We selected
As discussed in section II.B. of this final rule with comment period, the application of the 1.000 work GPCI floor, as extended by section 134(a) of the MIPPA, expires effective January 1, 2010. As a result, 54 (out of 89) PFS localities will receive a decrease in their work GPCI. Puerto Rico receives the largest decrease (−9.6 percent), followed by South Dakota (−5.8 percent), North Dakota (−5.3 percent), Rest of Missouri (−5.1 percent), and Montana (−5.0 percent).
In section II.D. of this final rule with comment period, we are adding individual health behavior and assessment services (as described by HCPCS codes 96150 through 96152) to the list of telehealth services. We are also revising § 410.78 to specify that the G-codes for follow-up inpatient telehealth consultations (as described by HCPCS codes G0406 through G0408) include follow-up telehealth consultations furnished to beneficiaries in hospitals and skilled nursing facilities.
The total annual Medicare payment amount for telehealth services (including the originating site facility fee) is approximately $2 million. Previous additions to the list of telehealth services have not resulted in a significant increase in Medicare program expenditures. While we believe that these proposals will provide more beneficiaries with access to these services, we do not anticipate that these changes will have a significant budgetary impact on the Medicare program.
This section of the MIPPA will have a positive impact on Medicare patients because coinsurance payment percentages for outpatient mental health services will be gradually reduced from January 1, 2010 through January 1, 2014. At the conclusion of this 5-year period, Medicare patients will pay the same coinsurance payment percentage for outpatient mental health services as they currently pay for most other health services under the Medicare Part B program.
Since the inception of the Medicare Part B program, Medicare patients have been required to pay for a greater percentage of the cost of outpatient mental health treatment services than for other health services because of the Medicare payment limitation (the outpatient mental health treatment limitation). While a dollar cap that previously applied to mental health services was eliminated January 1, 1991, the statute maintained the 62
During the transition, the Medicare Part B program will incur increased expenditures as Medicare patients pay less out-of-pocket for outpatient mental health services until, in 2014, patients will pay only the deductible (if applicable) and 20 percent coinsurance. Section 102 of the MIPPA will shift cost-sharing for mental health services from Medicare patients to the program. This provision will result in a cost impact to the Medicare program of approximately $100 million for CY 2010. As section 102 of the MIPPA is implemented, the impact of the changes to the coinsurance payment percentages (that is, recognized incurred expenses) for Medicare patients and the program is as shown in Table 51.
As discussed in section II.G.2. of this final rule with comment period, the 2010 PQRI measures satisfy the requirement of section 1848(k)(2)(D) of the Act that the Secretary shall ensure that eligible professionals have the opportunity to provide input during the development, endorsement, or selection of measures applicable to services they furnish. As discussed in section II.G.2.d. of this final rule with comment period, we are also offering options in 2010 for reporting the 2010 PQRI measures via submission of data to a qualified clinical registry, options for reporting some of the 2010 PQRI measures via submission of data extracted from a qualified EHR, options for reporting on measures groups rather than individual measures, and options for group practices to be treated as satisfactorily submitting quality data under the PQRI. We received some comments regarding the cost estimates for PQRI included in the CY 2010 PFS proposed rule (74 FR 33655 through 33657). These comments have been addressed in section II.G.2. of this final rule with comment period or by revisions to our cost estimates below, where appropriate.
Although there may be some cost incurred for maintaining the measures used 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 PQRI by eligible professionals is voluntary and eligible professionals and group practices may have different processes for integrating the PQRI into their practices' work flows. Therefore, it is difficult to accurately estimate the impact of the PQRI on providers. We note also that for eligible professionals who satisfactorily submit PQRI quality measures, some (if not all) of the costs incurred by the professional to participate in PQRI may be offset by the PQRI incentive payment amount earned.
With respect to satisfactory submission of data on quality measures by eligible professionals, one factor that influences the cost to eligible professionals is the time and effort associated with eligible professionals identifying applicable PQRI quality measures for which they can report the necessary information. We have no way to accurately quantify the burden because it would vary with each eligible professional by the number of measures applicable to the eligible professional, the eligible professional's familiarity, understanding of the PQRI, and experience with participating in the PQRI, and the reporting option selected by the eligible professional. In addition, eligible professionals may employ different methods for incorporating reporting of their selected measures into the office work flows. Therefore, based on an assumption that eligible professionals will select 3 measures on average and our own estimates that it takes at least 1 hour to read and understand each measure, we will assign 3 hours as the amount of time needed for eligible professionals to review the PQRI quality measures, identify the applicable measures for which they can report the necessary information, and incorporate reporting of the selected measures into the office work flows. After considering the comments received, that indicated that we need to include time for eligible professionals to review all of the reporting options, and our own estimates of the amount of time it takes to read and digest the reporting options, we will also assign an additional 2 hours as the amount of time needed for eligible professionals to review the 2010 PQRI reporting options and select the option most appropriate for their practice. Information from the Physician Voluntary Reporting Program (PVRP), which was a predecessor to the PQRI, indicated an average practice labor cost of approximately $50 per hour. To account for salary increases over time, we will use an average practice labor cost of $55 per hour for our estimates based on an assumption of an average annual increase of approximately 3 percent. Thus, we estimate the cost for an eligible professional to review the PQRI quality measures, identify the applicable measures for which they can report the necessary information, incorporate reporting of the selected measures into the office work flows, review, and select an appropriate reporting option to be approximately $275 per eligible professional ($55 per hour × 5 hours).
For claims-based PQRI reporting, one factor in the cost to eligible professionals is the time and effort associated with gathering the required information, selecting the appropriate quality data codes, and including the appropriate quality data codes on the Medicare Part B claims an eligible professional submits for payment. Information from the PVRP estimates that the time needed to perform all the steps necessary to report each measure 1 time (that is, reporting the relevant quality data code(s) for a measure on 1 case) 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. With an average practice labor cost of $55 per hour, the cost to eligible professionals to perform all the steps necessary to report 1 quality measure 1 time ranges from $0.23 in labor time to about $11.00 in labor time for more complicated cases and/or measures. For the median practice, the cost is about $1.44 in labor time per measure per reporting instance. Eligible professionals generally are required to report at least 3 measures to satisfactorily report PQRI quality measures data. Therefore, for purposes of this impact analysis we will assume that eligible professionals participating in the 2010 PQRI will report an average of 3 measures each.
The cost of implementing claims-based reporting of PQRI quality measures data will vary with the volume of claims on which quality data is reported. Results from the 2007 PQRI indicate that eligible professionals reported on 1 to 3,331 eligible instances per measure. For all 2007 PQRI measures, the median number of eligible instances reported on per measure was less than 60. On average the median number of eligible instances reported on per measure was about 9. Therefore, for this analysis we estimate that for each measure, an eligible professional reports the quality data on 9 cases. The actual number of cases on which an eligible professional will be required to report quality measures data will vary, however, with the eligible professional's patient population and the types of measures on which the eligible professional chooses to report (each measure's specifications include a required reporting frequency).
Based on the assumptions discussed above, we estimate the total annual cost per eligible professional associated with claims-based reporting to range from $281.21 [($0.23 per measure × 3 measures × 9 cases per measure) + $275] to $572.00 [($11.00 per measure × 3 measures × 9 cases per measure) + $275].
For registry-based reporting, eligible professionals 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 eligible professional to use the registry to costing eligible professionals several thousand dollars, with a majority of registries charging fees ranging from $500–$1,000. Registries also often
In addition, an eligible professional who chooses to submit PQRI quality measures results and numerator and denominator data on quality measures through a registry more than likely is already reporting data to the registry for other purposes. Little, if any, additional data needs to be reported to the registry for purposes of participation in the 2010 PQRI. Therefore, there should be little additional cost to the eligible professional associated with submitting data to the registry.
Registries interested in submitting quality measures results and numerator and denominator data on quality measures to CMS on their participants' behalf must complete a self-nomination process in order to be considered “qualified” to submit on behalf of eligible professionals. We estimate the registry self-nomination process to 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 a $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.
The cost to the registry 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 eligible professionals reporting data to the registry and the number of applicable measures. However, since it is customary for most registries to provide their participants with information that can be used for the participants' internal quality improvement efforts, we believe that registries already perform many of these activities for their participants.
For EHR-based reporting, an eligible professional generally would incur a cost associated with purchasing an EHR product. The cost of purchasing an EHR product can range anywhere from as low as $500 to well over $50,000. After considering the information above and the comments received, we estimate that, on average, it costs between $15,000 and $25,000 to purchase an EHR product. An EHR vendor interested in having their product(s) be used by eligible professionals 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 2010. Therefore, one factor in the cost to EHR vendors is the cost associated with completing the self-nomination process in order for the vendor's EHR product(s) to be considered “qualified.” Similar to the estimated cost to the registry associated with the registry self-nomination process, the estimated cost for an EHR vendor to complete the self-nomination process, including the vetting process with CMS officials, is conservatively 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 EHR 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.
Another factor in the cost to EHR vendors is the time and effort associated with the EHR vendor programming its EHR product(s) to extract the clinical data that the eligible professional needs to submit to CMS for purposes of reporting 2010 PQRI quality measures. The cost associated with the time and effort needed for an EHR vendor to review the quality measures and other information and program each qualified EHR product to enable eligible professionals 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 capabilities, as well as the vendor's programming capabilities. Some vendors already have these 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 a more conservative estimate for those vendors with minimal experience would be approximately $10,000 per vendor ($50 per hour × 200 hours per EHR vendor).
With respect to the process for group practices to be treated as satisfactorily submitting quality measures data under the 2010 PQRI discussed in section II.G.2.g. of this final rule with comment period, group practices interested in participating in the 2010 PQRI through the group practice reporting option must complete a self-nomination process similar to the self-nomination process required of registries and EHR vendors. We estimate that the group practice staff involved in the group practice self-nomination process have an average labor cost of $55 per hour. Therefore, assuming the total burden hours per group practice associated with the group practice self-nomination process is 4 hours, we estimate the total cost to a group practice associated with the group practice self-nomination process to be approximately $220 ($55 per hour × 4 hours per group practice). After considering the comments received, we will also assign an additional 2 hours as the time needed by group practices to review the 2010 PQRI reporting options and make the decision to participate as a group rather than individually. The total costs associated with the decision-making process is estimated to be $110 ($55 per hour × 2 hours per group practice)
The cost 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 physician group practices, 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 OMB control number 0938–0941, with an expiration date of December 31, 2011. Based on cost estimates for the Physician Group Practice (PGP) demonstration, we estimate the cost associated with a physician group completing the data collection tool will be approximately 79 hours per physician group. Therefore, we estimate the total annual burden hours per physician group to be approximately 85 hours (2 hours for decision-making process + 4 hours for self-nomination + 79 hours for data submission). Based on
As discussed in section II.G.3. of this final rule with comment period, section 131(c) of the MIPPA amends section 1848 of the Act by adding subsection (n), which requires the Secretary to establish and implement by January 1, 2009, a Physician Feedback Program using Medicare claims data and other data to provide confidential feedback reports to physicians (and as determined appropriate by the Secretary, to groups of physicians) that measure the resources involved in furnishing care to Medicare beneficiaries. If determined appropriate by the Secretary, the Secretary may also include information on quality of care furnished to Medicare beneficiaries by the physician (or group of physicians) in the reports. We anticipate the impact of this section to be negligible for the work completed in the Program to date.
Section II.G.5. of this final rule with comment period describes the 2010 E-Prescribing Incentive Program. To be considered a successful electronic prescriber in 2010, an eligible professional must meet the requirements in section II.G.5.c. of this final rule with comment period.
We anticipate that the cost impact of the E-Prescribing Incentive Program on the Medicare program will be the cost incurred for maintaining the electronic prescribing measure and its associated code set, and for expanding an existing clinical data warehouse to accommodate registry-based reporting and, potentially, EHR-based reporting for the electronic prescribing measure. We, however, do not anticipate a significant cost impact on the Medicare program since much of this infrastructure had already been established for the PQRI.
Participation in the E-Prescribing Incentive Program by eligible professionals is voluntary and eligible professionals may have different processes for integrating the E-Prescribing Incentive Program into their practices' work flows. Therefore, it is difficult to accurately estimate the impact of the E-Prescribing Incentive Program on eligible professionals. In addition, for eligible professionals who are successful electronic prescribers, some (if not all) of the cost of participating in the E-Prescribing Incentive Program may be offset by the incentive payment earned.
Similar to claims-based reporting for PQRI, one factor in the cost to eligible professionals, for those eligible professionals who choose to report the electronic prescribing measure through claims, is the time and effort associated with eligible professionals determining whether the quality measure is applicable to them, gathering the required information, selecting the appropriate quality data codes, and including the appropriate quality data codes on the claims they submit for payment. Since the E-Prescribing Incentive Program consists of only 1 quality measure, we will assign 1 hour as the amount of time needed for eligible professionals to review the electronic prescribing measure and incorporate reporting of the selected measures into their office work flows and an additional hour as the amount of time needed for eligible professionals to select an appropriate reporting mechanism for them. At an average cost of approximately $55 per hour (see section XIII.E.2. above for a discussion of how we arrived at this figure), we estimate the total cost to eligible professionals for reviewing the electronic prescribing measure, incorporating reporting of the selected measures into the office work flows, and selecting an appropriate reporting mechanism to be approximately $110 ($55 per hour × 2 hours).
Another factor in the cost to eligible professionals is the time and effort associated with gathering the required information, selecting the appropriate quality data codes, and including the appropriate quality data codes on the claims an eligible professional submits for payment. Information from the PVRP estimates that the time needed to perform all the steps necessary to report 1 measure 1 time (that is, reporting the relevant quality data code(s) for the measure for 1 case) 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. With an average practice labor cost of $55 per hour, the cost to eligible professionals to perform all of the steps necessary to report 1 quality measure 1 time on claims ranges from $0.23 in labor time to about $11.00 in labor time for more complicated cases and/or measures. For the median practice, the cost is about $1.44 in labor time per measure. Therefore, we estimate the costs to eligible professionals to perform all the steps necessary to report the electronic prescribing measure once on a claim to be approximately $1.44.
The cost for this requirement will also vary along with the volume of claims on which quality data is reported. Based on our proposal to require an eligible professional to report the electronic prescribing measure for at least 25 instances, we estimate the total annual estimated cost per eligible professional to report the electronic prescribing measure to be $146.00 [($1.44 per measure × 1 measure × 25 cases per measure) + $110].
Because registry-based reporting of the electronic prescribing measure to CMS will be new for 2010 and participation in this reporting initiative is voluntary, it is difficult to accurately estimate how many eligible professionals will opt to participate in the E-Prescribing Incentive Program through the registry-based reporting mechanism in CY 2010. We do not anticipate, however, any additional cost for eligible professionals to report data to a registry as we believe that most eligible professionals opting for registry-based reporting would more than likely already be reporting data to the registry for other purposes, such reporting data to the registry for the PQRI. Little, if any, additional data would need to be reported to the registry for purposes of participation in the 2010 E-Prescribing Incentive Program. Furthermore, the same information has to be reported for the E-Prescribing Incentive Program and for the same number of instances regardless of the reporting mechanism selected by the eligible professional. That is, the eligible professional must report that he or she generated and transmitted at least one prescription electronically for at least 25 eligible patient encounters during the reporting period.
One potential cost to some eligible professionals associated with either claims-based reporting or registry-based reporting would be the cost of purchasing and using an electronic prescribing system. There are currently many commercial packages available for electronic prescribing. The cost to an eligible professional of obtaining and utilizing an electronic prescribing system varies not only by the commercial software package selected but also by the level at which the professional currently employs information technology in his or her practice and the level of training needed. One study indicated that a mid-range complete electronic medical record with electronic prescribing functionality costs $2500 per license with an annual fee of $90 per license for
Based on our policy to consider only registries qualified to submit 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 E-Prescribing Incentive Program, we do not anticipate any cost to the registry associated with becoming a registry qualified to submit the electronic prescribing measure for 2010.
The cost associated with the registry-based reporting requirements of this voluntary reporting initiative for the registry will be the time and effort 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 eligible professionals reporting data to whom the measure applies. However, we believe that registries already perform many of these activities for their participants since the registries are already required to perform these activities for the PQRI. Since the E-Prescribing Incentive Program consists of only one measure, we believe that the cost 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 eligible professional must review the electronic prescribing measure, extract the necessary clinical data from his or her qualified EHR, and submit the necessary data to the CMS-designated clinical data warehouse. Because this manner of reporting quality data to CMS will be new for 2010 and participation in this reporting initiative is voluntary, it is difficult to accurately estimate how many eligible professionals will opt to participate in the E-Prescribing Incentive Program through the EHR-based reporting mechanism in CY 2010. The cost associated with an eligible professional reviewing the electronic prescribing measure and other information to determine whether the measure is applicable to his or her patients and the services he or she furnishes to them and to review the available reporting mechanisms to select the EHR reporting mechanism is expected to be similar for EHR-based reporting and claims-based reporting (that is, $110 at a rate of $55 per hour). Once the EHR is programmed by the vendor to allow data submission to CMS, the cost to the eligible professional associated with the time and effort to submit data on the electronic prescribing measure should be minimal.
Based on our policy to consider only EHR products qualified for the 2010 PQRI to be qualified to submit results and numerator and denominator data on the electronic prescribing measure for the 2010 E-Prescribing Incentive Program, there will be no need for EHR vendors to undergo a separate self-nomination process for the E-Prescribing Incentive Program and therefore, no additional cost associated with the self-nomination process.
The cost to the EHR vendor associated with the EHR-based reporting requirements of this voluntary reporting initiative is the time and effort associated with the EHR vendor programming its EHR product(s) to extract the clinical data that the eligible professional needs to submit to CMS for purposes of reporting the 2010 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 eligible professionals 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 2010 PQRI will be qualified for the 2010 E-Prescribing Incentive Program and the E-Prescribing Incentive Program consists of only one measure, we believe that any burden associated with the EHR vendor to program its product(s) to enable eligible professionals to submit data on the electronic prescribing measure to the CMS-designated clinical data warehouse would be minimal.
With respect to the process for group practices to be treated as successful electronic prescribers under the 2010 E-Prescribing Incentive Program discussed in section II.G.5.e. of this final rule with comment period, a group practice will be required to report the electronic prescribing measure in at least 2,500 instances. Group practices have the same options as individual eligible professionals in terms of the form and manner for reporting the electronic prescribing measure (that is, group practices have the option of reporting the measure through claims, a qualified registry, or a qualified EHR product). The only difference between an individual eligible professional and group practice reporting of the electronic prescribing measure is the number of times a group practice is required to report the electronic prescribing measure. Reporting of the electronic prescribing measure can continue to occur at the individual eligible professional level under the electronic prescribing group practice reporting option. In our analysis of the information, however, we will aggregate all of the information reported by the eligible professionals within the group practice to determine whether the group practice reported the measure a sufficient number of times. For group practices that are selected to participate in the 2010 E-Prescribing Incentive Program group practice reporting option and choose to do so through claims-based reporting of the electronic prescribing measure, we estimate the total annual estimated cost per group practice to be $3,710 [($1.44 per measure × 1 measure × 2,500 cases per measure) + $110].
For group practices that are selected to participate in the 2010 E-Prescribing Incentive Program group practice reporting option and choose to do so through registry-based reporting of the electronic prescribing measure, we do not anticipate any additional burden to report data to a registry as group practices opting for registry-based reporting would more than likely already be reporting data to the registry for other purposes, such as the PQRI. Little, if any, additional data would need to be reported to the registry for
For group practices that are selected to participate in the 2010 E-Prescribing Incentive Program group practice reporting option and choose to do so 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.
In addition to the burden associated with group practices reporting the electronic prescribing measure, group practices will also be required to self-nominate in order to participate in the 2010 E-Prescribing Incentive Program under the group practice reporting option. Since we are limiting participation in the E-Prescribing Incentive Program group practice reporting option to those group practices selected to participate in the PQRI group practice reporting option, there will be no additional burden associated with the group practice self-nomination process for the E-Prescribing Incentive Program.
As discussed in section II.G.6. of this final rule with comment period, suppliers that provide the TC of advanced diagnostic imaging services will have to be accredited by an approved accreditation organization in order to receive Medicare payment for advanced diagnostic imaging services described in section 1848(b)(4)(B) furnished to beneficiaries. This section of the rule will impact the suppliers that provide the TC of advanced diagnostic imaging services and the organizations that accredit suppliers of such services. Suppliers that provide the TC of advanced diagnostic imaging services will incur costs for becoming accredited. Accreditation organizations will incur costs to accredit suppliers. To estimate the impact on suppliers, we calculate the total cost of accreditation as the sum of accreditation fees and other accreditation costs, and we multiply this cost by the number of providers of care requiring accreditation.
According to our Services Tracking and Reporting System (STARS) database for 2008, there are a total of 1,131,115 physicians, IDTFs, and others billing Part B for the TC of advanced diagnostic imaging. This total includes both suppliers and providers that furnish items under Medicare Part B as suppliers.
Currently, there are suppliers accredited by one of three of the nationally recognized accreditation. We anticipate that the following accreditation organizations will seek approval from CMS to accredit suppliers that provide the TC of advanced diagnostic imaging services:
• American College of Radiology;
• Intersocietal Accreditation Commission; and
• The Joint Commission.
Fees vary between accreditation organizations and, in general, currently cover all of the following items: application fee, manuals, initial accreditation fee, onsite surveys or other auditing (generally once every 3 years), and travel, when necessary for survey personnel. Accreditation costs also vary by the size of the supplier seeking accreditation, its number of locations, and the number of services it provides. Because of these factors, it is sometimes difficult to compare fees across accreditation organizations. We obtained information on total accreditation fees from the three accreditation organizations that currently accredit suppliers who provide the TC of advanced diagnostic imaging services. Based on all information we obtained, we estimate accreditation fees for each review cycle and modality will be approximately $5,000 for an advanced diagnostic imaging supplier. Because accreditation is for a 3-year period, the estimated average cost per year would be approximately $1,666 per modality.
We recognize that becoming accredited may impose a burden on suppliers that provide the TC of advanced diagnostic imaging services, especially small suppliers. We have attempted to minimize that burden. We have implemented the following options to minimize the burden of accreditation on suppliers, including small businesses:
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It is difficult to precisely estimate the costs of preparing for accreditation. We do recognize there is cost to the supplier in order to come into compliance initially and thus prepare for the accreditation survey. This should result in minimal preparation and cost.
There are at least two important sources of uncertainty in estimating the impact of accreditation on suppliers that provide the TC of advanced diagnostic imaging services. First, our estimates assume that all current suppliers with positive Medicare payments will seek accreditation. We assume that suppliers who currently receive no Medicare allowed charges will choose not to seek
Second, it is unclear what accreditation fees will be in the future. However, we are requiring the accreditation organization to submit their fees that are based on the size of the supplier, or on the amount billed. Our experience with another accreditation program has lead us to believe that the accreditation rates will go up, although minimally, if travel costs continue to rise.
In summary, suppliers of the TC of advanced diagnostic imaging services for which payment is made under the fee schedule established under section 1848(b) of the Act must become accredited by an accreditation organization designated by the Secretary beginning January 1, 2012. In these options, we have attempted to minimize the burden of accreditation on suppliers, which include approving multiple accreditation organizations that consider the small suppliers. Also, the fact that the surveys will be either performed as a desk review or unannounced deletes the time and cost for the accreditation organization in travel, if required.
As discussed in section II.G.7., this final rule with comment period would provide for increased payments under the Medicare PFS for certain cases involving teaching anesthesiologists with anesthesia residents or for teaching CRNAs with student nurse anesthetists. This provision of the MIPPA is anticipated to have a minimal budgetary impact.
As described in section II.G.8. of this final rule with comment period, current levels of coverage for CR programs are expected to continue under this rule, and new ICR programs will likely develop and request approval by CMS to receive Medicare payments. Because the payment amount for ICR services under section 144(a) of the MIPPA is higher than for CR services, this expansion of coverage will result in greater costs to the Medicare program. The requirements for ICR programs, also specified in section 144(a) of the MIPPA, are extensive and will likely limit the number of individual ICR program sites that request approval. As a result, significantly fewer ICR programs and ICR program sites than CR programs will function throughout the country; however, we currently do not know how many ICR programs may request approval or how many individual sites may furnish ICR services under an approved program.
We believe that the expansion of coverage for ICR programs will enable beneficiaries to take advantage of more focused and rigorous programs that will more quickly lead to improved cardiovascular health. Having the choice of CR and ICR programs, beneficiaries eligible for coverage will be able to determine the best manner in which to achieve improved cardiovascular health, through traditional CR or more rigorous ICR program. We also expect this expansion of coverage to bring more attention to the importance of cardiac rehabilitation and the extensive benefits these programs provide to beneficiaries. As a result, the number of beneficiaries participating in CR programs may increase. We estimate that the provisions for establishing coverage of cardiac rehabilitation and intensive cardiac rehabilitation programs, as discussed in section II.G.8. of this final rule with comment period, will have a minimal budgetary impact on the Medicare program.
As discussed in section II.G.9. of this final rule with comment period, the implementation of the Medicare pulmonary rehabilitation program will allow Medicare, for the first time, to provide for payment for exercise and other services as part of a comprehensive treatment plan for beneficiaries with moderate to very severe COPD. We believe this program has the potential of not only improving the quality of life for beneficiaries who engage in it, but also reducing Medicare costs in the long range by decreasing the chances of exacerbations and further rehabilitation related to their chronic respiratory disease. We estimate this provision will have a minimal budgetary impact on the Medicare program.
The revisions pertaining to oxygen and oxygen equipment in section II.G.10. of this final rule reflect changes made by the MIPPA of 2008. Section 1834(a)(5)(F) of the Act limited monthly payments to suppliers furnishing oxygen equipment to 36 months of continuous use. Prior to the MIPPA, at the end of this 36-month period, suppliers were required to transfer title to oxygen equipment to the beneficiary. Section 144(b) of the MIPPA repealed the transfer of title requirement. In its place, section 144(b) amends section 1834(a)(5)(F) of the Act by adding additional payment rules and supplier responsibilities discussed previously in this preamble that apply after the 36 month rental cap.
Based on data from the Small Business Administration (SBA), we estimate that 85 percent of suppliers of the items and services affected by this rule would be defined as small entities with total revenues of $7 million or less in any 1 year. In the case of oxygen and oxygen equipment, it is difficult to estimate the impact of section 144(b) of the MIPPA on small entities and oxygen and oxygen equipment suppliers in general. Nevertheless, we do believe that the net impact on small entities and other suppliers of oxygen and oxygen equipment will be positive rather than negative. This is based on the fact that this change allows suppliers to retain ownership of oxygen equipment in all cases when it is no longer needed by the beneficiary. Prior to this change, suppliers were required to relinquish ownership of oxygen equipment after 36 continuous rental months. While suppliers will be required to continue furnishing the equipment after the 36 month rental period for up to 2 additional years in some cases until the 5 year reasonable useful lifetime of the equipment ends, they will retain ownership of equipment when it is no longer needed and can furnish the equipment to other patients. As explained in more detail below, we estimate that suppliers could potentially receive approximately $58 million per year in payments for furnishing oxygen equipment that is returned to them after the 36 month cap and before the end of the 5 year reasonable useful lifetime. Suppliers in these situations are able to forgo the expense of purchasing new equipment from manufacturers to replace equipment they would have transferred to beneficiaries had the transfer of title requirement not been repealed.
Our data indicates that most beneficiaries who receive stationary oxygen equipment are furnished with a stationary oxygen concentrator. As we have indicated previously, oxygen concentrators require very minimal maintenance and servicing if less than
Again, if a beneficiary discontinues use of oxygen after the 36-month rental cap but before the end of the reasonable useful lifetime of the equipment (currently 5 years), the supplier will be able to retrieve the equipment and rent it to another Medicare beneficiary or other customer and receive additional rental payments for the remainder of the equipment's reasonable useful lifetime. It is difficult to estimate the magnitude of this positive impact on suppliers. If the equipment is older than 5 years at the time the 36-month rental cap is reached, the supplier may have already received 24 monthly payments or more from Medicare or other payers for rental of the equipment prior to the start of the most recent 36 month rental payment period for the equipment. Combined with the 36 monthly payments made by Medicare in situations where the cap is reached (24 percent of cases based on current data), this would equal or exceed 60 monthly payments for the equipment. On the other hand, assuming the equipment is brand new at the time it is initially furnished in the 24 percent of cases where the cap is reached, the supplier will only have received 36 monthly payments for the new equipment before the rental cap is reached. However, since the equipment will only be 3 years old at this point, depending on when the beneficiary's medical need for or use of the equipment ends, the supplier will be able to furnish the equipment to other patients for any months remaining in the equipment's 5 year or 60 month reasonable useful lifetime. Table 52 illustrates earnings that the supplier could realize from furnishing oxygen equipment that they would have been required to transfer to the beneficiary prior to the enactment of MIPPA.
Again, we understand that oxygen equipment is very durable and should need few repairs in the first 5 years. Therefore, we have determined that any costs suppliers may incur in repairs and service visits would be more than offset by the gains they achieve by retaining ownership of the equipment they can then reuse and by payments received for maintenance and servicing after the cap that are established as a result of this final rule with comment period.
Finally, Medicare program expenditures will increase slightly as a result of the payments for maintenance and servicing after the 36 month rental cap for oxygen concentrators and transfilling equipment. Medicare will make maintenance and servicing payments at 6 month intervals following the 36th month payment rental cap. Through June 30, 2010, the payment for these visits is based on 30 minutes of labor. After June 30, 2010, the payment rate is a reasonable fee not to exceed 10 percent of the purchase price for a stationary oxygen concentrator. The total cost in terms of allowed charges per year is calculated to be about $8 million.
The implementation of Medicare coverage of kidney disease patient education services as discussed in section II.G.11. of this final rule with comment period will allow Medicare to provide for payment for kidney disease education services for beneficiaries with Stage IV chronic kidney disease. We believe this program can help patients achieve better understanding of their illness, dialysis modality options, and may help delay the need for dialysis. We believe this program has the potential of improving the quality of life for beneficiaries since they will be better equipped to make informed decisions. We estimate a cost to the Medicare program of approximately $10 million for CY 2010, because the statute limits the number of kidney disease education sessions to 6, as a lifetime maximum.
A discussion of the impact of section 153 of the MIPPA is addressed in section V.H. of this regulatory impact analysis in conjunction with the other ESRD provisions of this rule.
We anticipate that the proposals related to the compendia discussed in section II.G.13. of this final rule with comment period will have a negligible cost to the Medicare program and to the public. The information that is required to be collected and published on the compendia Web sites is information that is already collected in the normal course of business by the compendia publishers, which all have Web sites. The changes will enable CMS to efficiently implement the provisions of section 182(b) of the MIPPA that require transparent evaluative and conflict of interest policies and practices for current and future listed compendia on and after January 1, 2010.
The changes discussed in section II.H.1. of this final rule with comment period with respect to payment for covered outpatient drugs and biologicals, are estimated to have no impact on Medicare expenditures as we are not making any change to the AMP/WAMP threshold and the change concerning the immunosuppressive drug period of eligibility is a conforming change to reflect the statute.
As discussed in section II.H.2., this final rule with comment period finalizes several CAP proposals and updates to regulations, specifically the frequency of drug payment amount updates, changes to the CAP drug list, the geographic area served by the CAP, CAP drug stock at the physician's office, exclusion of CAP sales from ASP calculations, the annual CAP payment amount update mechanism, and updates to proposals made in the 2009 PFS rule. Our changes and refinements may improve compliance, promote program flexibility, improve the quality, and maintain the availability of services for participating CAP physicians. We anticipate that these changes associated with the CAP will not result in significant additional cost savings or increases relative to the ASP payment system for two reasons. First, in 2006 through 2008, the dollar volume of claims paid under the CAP was small compared to the volume of claims paid under section 1847A of the Act, and although we anticipate that the CAP will continue to grow, we do not anticipate a significant change in the proportion of claims paid under these payment systems. Second, because CAP payment amounts are limited to prices calculated under section 1847A of the Act, we expect payment rates for the two programs to remain very similar.
The ESRD-related provisions are discussed in sections II.G.11 and II.I. of this final rule with comment period. 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 2009 payments) to estimated payments under the revisions to the composite rate payment system (CY 2010 payments) as discussed in section II.I. of this final rule with comment period. To estimate the impact among various classes of ESRD facilities, it is imperative that the estimates of current payments and estimates of payments contain similar inputs. Therefore, we simulated payments only for those ESRD facilities that we are able to calculate both current 2009 payments and 2010 payments.
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 June 2009 update of CY 2008 National Claims History file as a basis for Medicare dialysis treatments and separately billable drugs and biologicals. Due to data limitations, we are unable to estimate current and payments for 42 of the 5186 ESRD facilities that bill for ESRD dialysis treatments.
Table 53 shows the impact of this year's changes to CY 2010 payments to hospital-based and independent ESRD facilities. The first column of Table 53 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 changes to the ESRD wage index for CY 2010 as it affects the composite rate payments to ESRD facilities. The fourth column compares aggregate ESRD wage adjusted composite rate payments in CY 2010 to aggregate ESRD wage adjusted
The fifth column shows the effect of changes to the ESRD wage index in CY 2010 and the effect of the MIPPA provisions on ESRD facilities. Section 153(a) of MIPPA amended section 1881(b)(12)(G) of the Act to revise payments to ESRD facilities. For services furnished on or after January 1, 2010, MIPPA provides a 1 percent increase to the composite rate component of the payment system. The fifth column also reflects the changes in payment based on changes to the wage index from CY 2009 to CY 2010.
The sixth column shows the overall effect of the changes in composite rate payments to ESRD providers including the drug add-on. The overall effect is measured as the percent change between the CY 2010 payments to ESRD facilities with all changes as finalized in this rule and CY 2009 payments to ESRD facilities under current payment policies. These payment amounts are computed by multiplying the wage adjusted composite rate including the drug add-on for each provider times the number of dialysis treatments from the CY 2008 claims. The CY 2010 payments are the wage adjusted composite rate for each provider (with the 15.0 percent drug add-on) times dialysis treatments from CY 2008 claims. The CY 2009 current payments are the wage adjusted composite rate for each provider (with the current 15.2 percent drug add-on) times dialysis treatments from CY 2008 claims.
The overall impact to ESRD providers in aggregate is 0.8 percent as shown in Table 53. Most ESRD facilities will see an increase in payments as a result of the MIPPA provision. While the MIPPA provision includes a 1 percent increase to the ESRD composite rate for services provided on or after January 1, 2009, this 1 percent increase does not apply to the drug add-on to the composite rate. For this reason, the impact of all changes in this final rule with comment period is a 0.8 percent increase for all ESRD providers. Overall, payments to independent ESRD facilities will increase by 0.8 percent and payments to hospital-based ESRD facilities will increase by 1.0 percent.
As discussed in section II.J. of this final rule with comment period, we are going to recoup the $50 million in expenditures from this demonstration over a 5-year period rather than over a 2-year period. We will recoup $10 million each year through adjustments to the PFS for all chiropractors in CYs 2010 through 2014.
To implement this required BN adjustment, we will reduce the payment amount under the PFS for the chiropractic CPT codes (that is, CPT codes 98940, 98941, and 98942) by approximately 2 percent.
The revisions to the conditions of participation (CoP) discussed in section II.K. of this final rule with comment period make technical corrections and update the regulations to reflect current industry standards for respiratory therapists. The revisions to the regulations will clarify the qualifications necessary for respiratory therapists' to continue to qualify to furnish respiratory therapy services to CORF patients. These changes are similar to prior rules and will have no impact on CORFs cost.
In section II N.1. of this final rule with comment period, we discuss our clarification of the physician stand in the shoes provisions at § 411.354(c)(3)(i). This revision will assist designated health services entities in structuring legitimate compensation arrangements by clarifying that the standard for determining compensation between the parties will be dictated by the language of the exceptions within § 411.355 and § 411.357. Furthermore, like other physician self-referral policies, we anticipate that this clarification will result in savings to the Medicare program by reducing overutilization and anti-competitive business arrangements. However, we cannot gauge with any degree of certainty the extent of these savings to the Medicare program.
In section II.O.1. of this final rule with comment period, we establish a one-time process that will only impact those suppliers who were awarded a contract and were potentially damaged by the termination of their supplier contracts by MIPPA. The DMEPOS Competitive Bidding Program that was implemented on July 1st, 2008, awarded contracts to 329 suppliers. The following factors may be considered by a contract supplier before deciding to submit a claim:
• The contract itself stipulated that the contract is subject to any changes to the statute or regulations that affect the Medicare program;
• The contract does not guarantee any amount of business or profits, therefore, an efficient business would not be expected to incur large expenses without any guaranteed increase in business and profits;
• The contract stipulates that CMS shall not pay for any expenses incurred by the supplier for the work performed under the contract other than for payment of Medicare claims authorized pursuant to the contract;
• Upon termination of the contracts by MIPPA, payments reverted back to the fee schedule amount, which was on average 26 percent higher than under the DMEPOS Competitive Bidding Program.
• There is a required responsibility under contract law for a company to take action to mitigate expenses to any stop work order.
• CMS listed the winning suppliers on the Medicare Web site at
By mentioning the list above, we are not suggesting that there would not be legitimate claims for damages. However, these are factors that a supplier may consider when deciding whether to submit a claim for damages.
Based on these reasons and because there have been so few inquiries or responses to the reference in the MIPPA to damages (fewer than 7 suppliers), we believe that as few as 1 percent of the 329 winning suppliers may make a claim for damages. However, as a high estimate, we would estimate that approximately 76 percent of the suppliers (250) may submit a claim. We anticipate that it will take approximately 3 hours at $34/hour (3 × $34 = $102) for an accountant and a company official to review and gather the necessary documents to file a claim for a total of $25,500 (250 × $102). The hourly accountant rate was based on the Bureau of Labor Statistics data collected for June 2006 which was then adjusted to account for inflation. We estimate that this regulation will not have a large budgetary impact. The total cost range of $408 to $25,500 for potential claims from contract suppliers will not result in expenditures of $133 million or more annually. An analysis of the damage payments that may result would be dependent upon an evaluation of the actual claims once they are received.
In section II.O.2. of this final rule with comment period, we are revising the definition of a
We also believe the revision of this definition will have a negligible impact on suppliers as product categories consist of related items routinely provided by suppliers. We are only requiring a supplier to provide those rented items within a product category that the supplier was currently furnishing at the start of the competitive bidding program.
While difficult to estimate, we believe that based on 2008 data, there were approximately 1,850 suppliers in the 9 CBAs, for which we will be doing the Round 1 rebid that rented competitively bid items, on average at different points in time during 2008. Therefore, we are using this number to indicate how many suppliers would be renting a DME competitively bid item at the start of the competitive bid program. We believe some suppliers may decide not to bid because of the cost of bidding and accreditation requirements while other suppliers may not qualify for a contract. Since not all suppliers will be awarded contracts and some may not choose to submit a bid, we estimate that in the worst case scenario there will be 1,450 suppliers that will not be awarded contracts, would be renting DME competitive bid items at the time the program is implemented.
Based on our experience from the competitive bidding demonstrations, of the 1,450 suppliers who are not
Based on 2008 data, we estimate that there will be 96,000 beneficiaries who reside in a CBA and are renting competitively bid items from suppliers at the start of the round 1 rebid. Based on the 2007 round 1 of the competitive bidding program, we estimate that there would be 74,880 (96,000 × 0.78 = 74,880) beneficiaries who would be renting items from a noncontract supplier.
For those suppliers that choose to grandfather (1,305), we estimate that it would take the supplier on average 2 hours to develop the 30-day notification that it is required to send to CMS. We estimate that the cost to the supplier to develop the 30-day notification to CMS would be $89.60 for skilled administrative staff (2 hours × $44.80 per hour). The $44.80 is based on 2009 data from the Bureau of Labor Statistics plus an increase for overhead of 40 percent. We estimate that the cost to the supplier to send the notification to CMS would be $5.51 for clerical staff (0.25 hour to send the notification × $22.02 per hour = $5.51). The $22.02 is based on 2009 data from the Bureau of Labor Statistics plus an increase for overhead of 40 percent. We estimate the cost of supplies necessary to send the notification would be $2.00. The total cost for sending the notification would be $7.51 which includes the cost of clerical staff ($5.51) and supplies ($2.00). The individual costs for all suppliers to notify CMS would be $97.11 ($89.60 for development of the letter + $7.51 for preparing and sending each notification = $97.11). The overall cost for suppliers to notify CMS would be approximately $126,728.55 ($97.11 per supplier × 1,305 suppliers = $126,728.55).
We estimate based on 2008 data, we expect that there will be 74,880 beneficiaries who will have been renting competitive bid items from a noncontract supplier at the start of the round 1 rebid of the CBP. Of the 74,880, we believe that approximately 100 percent of these beneficiaries will accept the offer to continue to rent competitively bid items from the noncontract supplier that offers to be a grandfathered supplier. We believe that the beneficiaries will choose to continue to rent from a grandfathered supplier if given the choice because it would be more convenient, assure continuity of care, and eliminate the need to have equipment taken from their home.
Based upon the number of suppliers and beneficiaries, we estimate that there will be an average of 52 beneficiaries per supplier that was not awarded a contract (74,880 beneficiaries/1,450 suppliers = 52). Therefore, we estimate that each noncontract supplier that chooses to grandfather would send the 30-day notification on average to 52 beneficiaries.
We expect that the cost of developing the 30-day notification to a beneficiary will be equivalent to the cost of developing the 30-day notification to CMS ($89.60 per notification). We also expect the cost of sending the 30-day notification per beneficiary to be equivalent to sending the 30-day notification to CMS ($7.51 per notification). The total costs for the 30-day notification to beneficiaries for suppliers that choose the grandfathering option would be $89.60 for development of the letter, and $7.51 for preparing and sending each notification. To calculate the total cost we multiplied $7.51 × 52 beneficiaries and added the development cost for the letter of $89.60 for a total of $480.12 per supplier. The overall cost for these suppliers to provide the 30-day notification to their beneficiaries will be approximately $626,556.60 ($480.12 per supplier × 1,305 suppliers = $626,556.60).
We expect that suppliers who choose not to grandfather will incur costs equivalent to the cost of developing and sending the 30-day notification to a beneficiary by those suppliers that choose to grandfather. The overall cost for all suppliers who choose not to grandfather to provide the 30-day notification to the beneficiary is approximately $69,617.40 ($480.12 total cost per supplier × 145 non-grandfathered suppliers = $69,617.40). The estimate of 145 suppliers not choosing to be grandfathered suppliers represents 10 percent of the total number of noncontract suppliers.
While the cost for the 30-day notification to beneficiaries will be exactly the same for all suppliers, those who choose not to become a grandfathered supplier will also incur the cost of the 10-day and 2-day notification.
For the 10-day notification to a beneficiary, we estimate the supplier will make at least 1 phone call that would take an average of 15 minutes to discuss that the beneficiary must switch to a contract supplier, the schedule for picking up the current equipment by the noncontract supplier, and the delivery of new equipment by the contract supplier. For the 2-day notification to the beneficiary, we estimate that the supplier will make at least 1 phone call that would take an average of 15 minutes to ensure that all of the arrangements are finalized and to answer any last minute questions. We anticipate that clerical staff will perform both of these tasks.
The estimated cost of the 10-day notification totals $5.51 (.25 of an hour × $22.02 per hour for clerical staff based on the 2009 Bureau of Labor Statistics including overhead = $5.51). The estimated cost of the 2-day notification totals $5.51 (.25 of an hour × $22.02 per hour for clerical staff based on the 2009 Bureau of Labor Statistics including overhead = $5.51). Therefore, the 10-day and 2-day notifications for each supplier will cost approximately $11.02. The total cost for each supplier would be approximately $573.04 ($11.02 × 52 beneficiaries = $573.04). The overall impact for all suppliers to make the 10-day and 2-day notifications will be approximately $83,090.80 (145 suppliers × $573.04 per supplier = $83,090.80).
We anticipate that this process will not place a greater burden on the overall small supplier community. This process is only going to affect those small suppliers that were renting items when the competitive bidding program begins and who did not win a contract. The burden on these suppliers will generally be less because small suppliers will have fewer beneficiaries to furnish notifications to.
As an alternative, we considered relying on suppliers to develop their own schedule for informing beneficiaries regarding grandfathering. This alternative would have left the beneficiaries vulnerable to having equipment removed from the home before new equipment was delivered. The process finalized in this regulation ensures the beneficiaries can make an informed decision about the transition policy that works best for them. The alternative we selected ensures the
In sections V. and VI. of this final rule with comment period, we described our decision to remove drugs from the calculation of allowed and actual expenditures since the 1996/1997 base year and the SGR rate of increase for future years. While removing physician-administered drugs from allowed and actual expenditures will not change the −21.3 percent physician payment rate update (the −21.2 percent change to the CF accounts for an additional 0.1 percent BN adjustment for changes to the RVUs) for services furnished on or after January 1, 2010, this change reduces the discrepancy between actual and target expenditures. Based on the President's budget, we estimate this proposal will cost $45.4 billion from 2010 to 2014 and $122 billion for 2010 to 2019.
This final rule with comment period contains a range of policies, including some provisions related to specific MIPPA provisions. The preceding preamble provides descriptions of the statutory provisions that are addressed, identifies those policies when discretion has been exercised, responds to comments on our proposals, presents rationale for our decisions and, where relevant, alternatives that were considered.
There are a number of changes in this final rule with comment period that would have an effect on beneficiaries. In general, we believe these changes, including the refinements of the PQRI with its focus on measuring, submitting, and analyzing quality data, the coding provisions related to the IPPE and consultation services, the changes with respect to telehealth services, the kidney disease patient education, pulmonary rehabilitation and intensive cardiac rehabilitation proposals will have a positive impact and improve the quality and value of care provided to Medicare beneficiaries. Additionally, the grandfathering process for DME suppliers will help ensure that beneficiaries are contacted and informed about this process and the choices they have concerning whether or not to use a grandfathered supplier. Moreover, the notice will help to ensure that beneficiaries do not have necessary DME equipment taken from them unexpectedly by a noncontact supplier.
As explained in more detail subsequently in this section, the regulatory provisions may affect beneficiary liability in some cases. Most changes aggregate in 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). Beneficiary liability would also be impacted by the effect of the aggregate cost (savings) of the provision on the standard calculation of the Medicare Part B premium rate (generally 25 percent of the provision's cost or savings). In 2010, total cost sharing (coinsurance and deductible) per Part B enrollee associated with PFS services is estimated to be $399. In addition, the portion of the 2010 standard monthly Part B premium attributable to PFS services is estimated to be $25.70.
To illustrate this point, as shown in Table 50, the 2009 national payment amount in the non-facility setting for CPT code 99203 (Office/outpatient visit, new), is $91.97 which means that in 2009 a beneficiary is responsible for 20 percent of this amount, or $18.39. Based on this rule, the 2010 national payment amount in the non-facility setting for CPT code 99203, as shown in Table 49, is $76.98 which means that, in 2010, the beneficiary coinsurance for this service would be $15.40.
Policies discussed in this rule, such as the coding changes with respect to the RVUs for IPPE and the changes to consultation services, would similarly impact beneficiaries' coinsurance.
As required by OMB Circular A–4, in Table 54, we have prepared an accounting statement showing the classification of the expenditures associated with this final rule with comment period. This estimate includes the incurred benefit impact associated with the estimated CY 2010 PFS update based on the 2009 Trustees Report baseline, as well as certain MIPPA provisions. All estimated impacts are classified as transfers.
In accordance with the provisions of Executive Order 12866, this final rule with comment period was reviewed by the Office of Management and Budget.
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.
Administrative practice and procedure, Health facilities, Health professions, Kidney diseases, Medicare, Reporting and recordkeeping.
Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements.
Grant programs-health, Health facilities, Medicaid, Medicare, Reporting and recordkeeping requirements.
Administrative practice and procedure, Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements.
Secs. 1102, 1834, 1871, and 1893 of the Social Security Act (42 U.S.C. 1302, 1395m, 1395hh, and 1395ddd).
(b)
(a)
(i) The individual's diagnosis.
(ii) The type, amount, frequency, and duration of the items and services under the plan.
(iii) The goals set for the individual under the plan.
(i) Beginning and end evaluations, based on patient-centered outcomes, which are conducted by the physician at the start and end of the program.
(ii) Objective clinical measures of effectiveness of the PR program for the individual patient, including exercise performance and self-reported measures of shortness of breath and behavior.
(b)
(2) Additional medical indications for coverage for pulmonary rehabilitation program services may be established through a national coverage determination (NCD).
(c)
(1)
(2)
(ii) Education includes information on respiratory problem management and, if appropriate, brief smoking cessation counseling.
(iii) Any education or training prescribed must assist in achievement of individual goals towards independence in activities of daily living, adaptation to limitations and improved quality of life.
(3)
(i) An assessment of those aspects of an individual's family and home situation that affects the individual's rehabilitation treatment.
(ii) A psychosocial evaluation of the individual's response to and rate of progress under the treatment plan.
(4)
(5)
(d)
(i) Physician's offices.
(ii) Hospital outpatient settings.
(2) All settings must have the following available for immediate use and accessible at all times:
(i) The necessary cardio-pulmonary, emergency, diagnostic, and therapeutic life-saving equipment accepted by the medical community as medically necessary (for example, oxygen, cardiopulmonary resuscitation equipment, and defibrillator) to treat chronic respiratory disease.
(ii) A physician must be immediately available and accessible for medical consultations and emergencies at all times when services are being provided under the program. This provision is satisfied if the physician meets the requirements for direct supervision for physician office services at § 410.26 of this subpart and for hospital outpatient services at § 410.27 of this subpart.
(e)
(1) Is responsible and accountable for the pulmonary rehabilitation program, including oversight of the PR staff.
(2) Is involved substantially, in consultation with staff, in directing the progress of the individual in the program including direct patient contact related to the periodic review of his or her treatment plan.
(3) Has expertise in the management of individuals with respiratory pathophysiology, and cardiopulmonary training and/or certification including basic life support.
(4) Is licensed to practice medicine in the State in which the pulmonary rehabilitation program is offered.
(f)
(g)
(a)
(i) One of the following healthcare professionals who furnishes services for which payment may be made under the physician fee schedule:
(A) Physician (as defined in section 1861(r)(1) of the Act).
(B) Physician assistant as defined in section 1861(aa)(5) of the Act and § 410.74 of this subpart).
(C) Nurse practitioner as defined in section 1861(aa)(5) of the Act and § 410.75 of this subpart).
(D) Clinical nurse specialist (as defined in section 1861(aa)(5) of the Act and § 410.76 of this subpart),
(ii)(A) A hospital, critical access hospital, skilled nursing facility, comprehensive outpatient rehabilitation facility, home health agency, or hospice that is located in a rural area as defined in § 412.64(b)(ii)(C) of this chapter; or
(B) A hospital or critical access hospital that is treated as being rural under § 412.103 of this chapter.
(b)
(1) Is diagnosed with Stage IV chronic kidney disease.
(2) Obtains a referral from the physician (as defined in section 1861(r)(1) of the Act) managing the beneficiary's kidney condition.
(c)
(2) A qualified person does not include either of the following:
(i) A hospital, critical access hospital, skilled nursing facility, comprehensive outpatient rehabilitation facility, home health agency or hospice if kidney disease patient education services are provided outside of a rural area as defined in § 412.64(b)(ii)(C) of this chapter unless the services are furnished in a hospital or critical access hospital that is treated as being in a rural area under § 412.103 of this chapter.
(ii) A renal dialysis facility, as defined in § 405.2102 of this chapter.
(d)
(1) The management of comorbidities including for the purpose of delaying the need for dialysis which includes, but not limited to, the following topics:
(i) Prevention and treatment of cardiovascular disease.
(ii) Prevention and treatment of diabetes.
(iii) Hypertension management.
(iv) Anemia management.
(v) Bone disease and disorders of calcium and phosphorus metabolism management.
(vi) Symptomatic neuropathy management.
(vii) Impairments in functioning and well-being.
(2) The prevention of uremic complications which includes, but not limited to, the following topics:
(i) Information on how the kidneys work and what happens when the kidneys fail.
(ii) Understanding if remaining kidney function can be protected, preventing disease progression, and realistic chances of survival.
(iii) Diet and fluid restrictions.
(iv) Medication review, including how each medication works, possible side effects and minimization of side effects, the importance of compliance, and informed decision-making if the patient decides not to take a specific drug.
(3) Therapeutic options, treatment modalities, and settings, including a discussion of the advantages and disadvantages of each treatment option and how the treatments replace the kidney, which includes, but not limited to, the following topics:
(i) Hemodialysis, both at home and in-facility.
(ii) Peritoneal dialysis (PD), including intermittent PD, continuous ambulatory PD, and continuous cycling PD, both at home and in-facility.
(iii) All dialysis access options for hemodialysis and peritoneal dialysis.
(iv) Transplantation.
(4) Opportunities for beneficiaries to actively participate in the choice of therapy and be tailored to meet the needs of the individual beneficiary involved which includes, but not limited to, the following topics:
(i) Physical symptoms.
(ii) Impact on family and social life.
(iii) Exercise.
(iv) The right to refuse treatment.
(v) Impact on work and finances.
(vi) The meaning of test results.
(vii) Psychological impact.
(5) Qualified persons must develop outcomes assessments designed to measure beneficiary knowledge about chronic kidney disease and its treatment.
(i) The outcomes assessments serve to assess program effectiveness of preparing the beneficiary to make informed decisions about their healthcare options related to chronic kidney disease.
(ii) The outcomes assessments serve to assess the program's effectiveness in meeting the communication needs of underserved populations, including persons with disabilities, persons with limited English proficiency, and persons with health literacy needs.
(iii) The assessment must be administered to the beneficiary during a kidney disease education session.
(iv) The outcomes assessments must be made available to CMS upon request.
(e)
(2) A session is 1 hour long and may be provided individually or in group settings of 2 to 20 individuals who need not all be Medicare beneficiaries.
(f)
(a)
(i) A description of the individual's diagnosis.
(ii) The type, amount, frequency, and duration of the items and services furnished under the plan.
(iii) The goals set for the individual under the plan.
(i) Minimally, assessments from the commencement and conclusion of cardiac rehabilitation and intensive cardiac rehabilitation, based on patient-centered outcomes which must be measured by the physician immediately at the beginning of the program and at the end of the program.
(ii) Objective clinical measures of exercise performance and self-reported measures of exertion and behavior.
(b)
(i) An acute myocardial infarction within the preceding 12 months;
(ii) A coronary artery bypass surgery;
(iii) Current stable angina pectoris;
(iv) Heart valve repair or replacement;
(v) Percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting;
(vi) A heart or heart-lung transplant.
(vii) For cardiac rehabilitation only, other cardiac conditions as specified through a national coverage determination.
(2)
(i) Physician-prescribed exercise each day cardiac rehabilitation items and services are furnished.
(ii) Cardiac risk factor modification, including education, counseling, and behavioral intervention, tailored to the patients' individual needs.
(iii) Psychosocial assessment.
(iv) Outcomes assessment.
(v) An individualized treatment plan detailing how components are utilized for each patient. The individualized treatment plan must be established, reviewed, and signed by a physician every 30 days.
(3)
(A) A physician's office.
(B) A hospital outpatient setting.
(ii) All settings must have a physician immediately available and accessible for medical consultations and emergencies at all times when items and services are being furnished under the program. This provision is satisfied if the physician meets the requirements for direct supervision for physician office services, at § 410.26 of this subpart; and for hospital outpatient services at § 410.27 of this subpart.
(c)
(i) Positively affected the progression of coronary heart disease.
(ii) Reduced the need for coronary bypass surgery.
(iii) Reduced the need for percutaneous coronary interventions;
(2) An intensive cardiac rehabilitation program must also demonstrate through peer-reviewed published research that it accomplished a statistically significant reduction in 5 or more of the following measures for patients from their levels before cardiac rehabilitation services to after cardiac rehabilitation services:
(i) Low density lipoprotein.
(ii) Triglycerides.
(iii) Body mass index.
(iv) Systolic blood pressure.
(v) Diastolic blood pressure.
(vi) The need for cholesterol, blood pressure, and diabetes medications.
(3) A list of approved intensive cardiac rehabilitation programs, identified through the national coverage determination process, will be posted to the CMS Web site and listed in the
(4) All prospective intensive cardiac rehabilitation sites must apply to enroll as an intensive cardiac rehabilitation program site using the designated forms as specified at § 424.510 of this chapter. For purposes of appealing an adverse determination concerning site approval, an intensive cardiac rehabilitation site is considered a supplier (or prospective supplier) as defined in § 498.2 of this chapter.
(d)
(1) Expertise in the management of individuals with cardiac pathophysiology.
(2) Cardiopulmonary training in basic life support or advanced cardiac life support.
(3) Be licensed to practice medicine in the State in which the cardiac rehabilitation program is offered.
(e)
(1) Expertise in the management of individuals with cardiac pathophysiology.
(2) Cardiopulmonary training in basic life support or advanced cardiac life support.
(3) Be licensed to practice medicine in the State in which the cardiac rehabilitation program is offered.
(f)
(2)
The revisions read as follows:
(b)
(e)
(2) The physician visits required under § 483.40(c) of this title may not be furnished as telehealth services.
The revisions and addition read as follows:
(a)
(1) For expenses incurred in years before 2010, 62
(2) For expenses incurred in 2010 and 2011, 68
(3) For expenses incurred in 2012, 75 percent.
(4) For expenses incurred in 2013, 81
(5) For expenses incurred in CY 2014 and subsequent years, 100 percent.
(b) * * *
(2) * * *
(i) Services furnished to a hospital inpatient.
(ii) Brief office visits for the sole purpose of monitoring or changing drug prescriptions used in the treatment of mental, psychoneurotic, or personality disorders
(iv) Psychiatric diagnostic services billed under CPT codes 90801 and 90802 (or successor codes) and diagnostic psychological and neuropsychological tests billed under CPT code range 96101 through 96125 (or successor codes) that are performed to establish a diagnosis.
(v) Medical management such as that furnished under CPT code 90862 (or its successor code), as opposed to psychotherapy, furnished to a patient diagnosed with Alzheimer's disease or a related disorder.
(3)
(c)
(1) Multiply the Medicare approved amount by the percentage of incurred expenses that is recognized as incurred expenses for Medicare payment purposes for the year involved;
(2) Subtract from this amount the amount of any remaining Part B deductible for the patient and year involved; and,
(3) Multiply this amount by 0.80 (80 percent) to obtain the Medicare payment amount.
(4) Subtract the Medicare payment amount from the Medicare-approved amount to obtain the patient liability amount.
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).
(c) * * *
(3)(i) For purposes of paragraphs (c)(1)(ii) and (c)(2)(iv) of this section, a physician who “stands in the shoes” of his or her physician organization is deemed to have the same compensation arrangements (with the same parties and on the same terms) as the physician organization. When applying the exceptions in § 411.355 and § 411.357 of this part to arrangements in which a physician stands in the shoes of his or her physician organization, the relevant referrals and other business generated “between the parties” are referrals and other business generated between the entity furnishing DHS and the physician organization (including all members, employees, and independent contractor physicians).
Secs. 1102, 1871, and 1881(b)(l) of the Social Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(l)).
(d) * * *
(2) The rules for medical direction differ for certain time periods depending on the nature of the qualified individual who is directed by the physician.
(i) If more than two procedures are directed on or after January 1, 1994, the qualified individuals could be AAs, CRNAs, interns, or residents. The medical direction rules apply to student nurse anesthetists only if the physician directs two concurrent cases, each of which involves a student nurse anesthetist or the physician directs one case involving a student nurse anesthetist and the other involving a CRNA, AA, intern, or resident.
(ii) For services furnished on or after January 1, 2010, the medical direction rules do not apply to a single anesthesia resident case that is concurrent to another case which is paid under the medical direction payment rules as specified in paragraph (e) of this section.
(e)
(a)
(1) The teaching CRNA, who is not under medical direction of a physician, is present with the student nurse anesthetist for the pre and post anesthesia services included in the anesthesia base units payment and is continuously present during anesthesia time in a single case with a student nurse anesthetist.
(2) The teaching CRNA, who is not under the medical direction of a physician, is involved with two concurrent anesthesia cases with student nurse anesthetists. The teaching CRNA must be present with the student nurse anesthetist for the pre and post anesthesia services included in the anesthesia base unit. For the anesthesia time of the two concurrent cases, the teaching CRNA can only be involved with those two concurrent cases and may not perform services for other patients.
(b)
(a) * * *
(1) The Medicare payment amount for office or other outpatient visits, consultation, individual psychotherapy, psychiatric diagnostic interview examination, pharmacologic management, end-stage renal disease related services included in the monthly capitation payment (except for one visit per month to examine the access site), individual medical nutrition therapy, and individual health and behavior assessment and intervention services furnished via an interactive telecommunications system is equal to the current fee schedule amount applicable for the service of the physician or practitioner.
(i)
(ii)
(a)
(b)
(i) Magnetic resonance imaging.
(ii) Computed tomography.
(iii) Nuclear medicine.
(iv) Positron emission tomography.
(c)
(1) A detailed description of how the organization's accreditation criteria satisfy the statutory standards authorized by section 1834(e)(3) of the Act, specifically—
(i) Qualifications of medical personnel who are not physicians and who furnish the TC of advanced diagnostic imaging services;
(ii) Qualifications and responsibilities of medical directors and supervising physicians (who may be the same person), such as their training in advanced diagnostic imaging services in a residency program, expertise obtained through experience, or continuing medical education courses;
(iii) Procedures to ensure the reliability, clarity, and accuracy of the technical quality of diagnostic images produced by the supplier, including a thorough evaluation of equipment performance and safety;
(iv) Procedures to ensure the safety of persons who furnish the TC of advanced diagnostic imaging services and individuals to whom such services are furnished;
(v) Procedures to assist the beneficiary in obtaining the beneficiary's imaging records on request; and
(vi) Procedures to notify the accreditation organization of any changes to the modalities subsequent to the organization's accreditation decision.
(2) An agreement to conform accreditation requirements to any changes in Medicare statutory requirements authorized by section 1834(e) of the Act. The accreditation organization must maintain or adopt standards that are equal to, or more stringent than, those of Medicare.
(3) Information that demonstrates the accreditation organization's knowledge and experience in the advanced diagnostic imaging arena.
(4) The organization's proposed fees for accreditation for each modality in which the organization intends to offer accreditation, including any plans for reducing the burden and cost of accreditation to small and rural suppliers.
(5) Any specific documentation requirements and attestations requested by CMS as a condition of designation under this part.
(6) A detailed description of the organization's survey process, including the following:
(i) Type and frequency of the surveys performed.
(ii) The ability of the organization to conduct timely reviews of accreditation applications, to include the organizations national capacity.
(iii) Description of the organization's audit procedures, including random site visits, site audits, or other strategies for ensuring suppliers maintain compliance for the duration of accreditation.
(iv) Procedures for performing unannounced site surveys.
(v) Copies of the organization's survey forms.
(vi) A description of the accreditation survey review process and the accreditation status decision-making process, including the process for addressing deficiencies identified with the accreditation requirements, and the procedures used to monitor the correction of deficiencies found during an accreditation survey.
(vii) Procedures for coordinating surveys with another accrediting organization if the organization does not accredit all products the supplier provides.
(viii) Detailed information about the individuals who perform evaluations for the accreditation organization, including all of the following information:
(A) The number of professional and technical staff that are available for surveys.
(B) The education, employment, and experience requirements surveyors must meet.
(C) The content and length of the orientation program.
(ix) The frequency and types of in-service training provided to survey personnel.
(x) The evaluation systems used to monitor the performance of individual surveyors and survey teams.
(xi) The policies and procedures regarding an individual's participation in the survey or accreditation decision process of any organization with which the individual is professionally or financially affiliated.
(xii) The policies and procedures used when an organization has a dispute regarding survey findings or an adverse decision.
(7) Detailed information about the size and composition of survey teams for each category of advanced medical imaging service supplier accredited.
(8) A description of the organization's data management and analysis system for its surveys and accreditation decisions, including the kinds of reports, tables, and other displays generated by that system.
(9) The organization's procedures for responding to and for the investigation of complaints against accredited facilities, including policies and procedures regarding coordination of these activities with appropriate licensing bodies and CMS.
(10) The organization's policies and procedures for the withholding or removal of accreditation status for facilities that fail to meet the accreditation organization's standards or requirements, and other actions taken by the organization in response to noncompliance with its standards and requirements. These policies and procedures must include notifying CMS of Medicare facilities that fail to meet the requirements of the accrediting organization.
(11) A list of all currently accredited suppliers, the type and category of accreditation currently held by each supplier, and the expiration date of each supplier's current accreditation.
(12) A written presentation that demonstrates the organization's ability to furnish CMS with electronic data in ASCII comparable code.
(13) A resource analysis that demonstrates that the organization's staffing, funding, and other resources are adequate to perform the required surveys and related activities.
(14) A statement acknowledging that, as a condition for approval of designation, the organization agrees to carry out the following activities:
(i) Prioritize surveys for those suppliers needing to be accredited by January 1, 2012.
(ii) Notify CMS, in writing, of any Medicare supplier that had its accreditation revoked, withdrawn, revised, or any other remedial or adverse action taken against it by the accreditation organization within 30 calendar days of any such action taken.
(iii) Notify all accredited suppliers within 10 calendar days of the organization's removal from the list of designated accreditation organizations.
(iv) Notify CMS, in writing, at least 30 calendar days in advance of the effective date of any significant proposed changes in its accreditation requirements.
(v) Permit its surveyors to serve as witnesses if CMS takes an adverse action based on accreditation findings.
(vi) Notify CMS, in writing (electronically or hard copy), within 2 business days of a deficiency identified in any accreditation supplier from any source where the deficiency poses an immediate jeopardy to the supplier's beneficiaries or a hazard to the general public.
(vii) Provide, on an annual basis, summary data specified by CMS that relates to the past year's accreditations and trends.
(viii) Attest that the organization will not perform any accreditation surveys of Medicare-participating suppliers with which it has a financial relationship in which it has an interest.
(ix) Conform accreditation requirements to changes in Medicare requirements.
(x) If CMS withdraws an accreditation organization's approved status, work collaboratively with CMS to direct suppliers to the remaining accreditation organizations within a reasonable period of time.
(d)
(e)
(f)
(g)
(1) Provide CMS with all of the following in written format (either electronic or hard copy):
(i) Copies of all accreditation surveys, together with any survey-related information that CMS may require (including corrective action plans and summaries of findings with respect to unmet CMS requirements).
(ii) Notice of all accreditation decisions.
(iii) Notice of all complaints related to suppliers.
(iv) Information about all accredited suppliers against which the accreditation organization has taken remedial or adverse action, including revocation, withdrawal, or revision of the supplier's accreditation.
(v) Notice of any proposed changes in its accreditation standards or requirements or survey process. If the organization implements the changes before or without CMS' approval, CMS may withdraw its approval of the accreditation organization.
(2) Within 30 calendar days after a change in CMS requirements, the accreditation organization must submit an acknowledgment of receipt of CMS' notification to CMS.
(3) The accreditation organization must permit its surveyors to serve as witnesses if CMS takes an adverse action based on accreditation findings.
(4) Within 2 business days of identifying a deficiency of an accredited supplier that poses immediate jeopardy to a beneficiary or to the general public, the accreditation organization must provide CMS with written notice of the deficiency and any adverse action implemented by the accreditation organization.
(5) Within 10 calendar days after CMS' notice to a CMS-approved accreditation organization that CMS intends to withdraw approval of the accreditation organization, the accreditation organization must provide written notice of the withdrawal to all of the organization's accredited suppliers.
(6) The organization must provide, on an annual basis, summary data specified by CMS that relate to the past year's accreditation activities and trends.
(h)
(1)
(ii) The audits must be conducted on a representative sample of suppliers who have been accredited by a particular accrediting organization or in response to allegations of supplier noncompliance with the standards.
(A) When conducted on a representative sample basis, the audit is comprehensive and addresses all of the standards, or may focus on a specific standard in issue.
(B) When conducted in response to an allegation, CMS audits any standards that CMS determines are related to the allegations.
(2)
(A) A 10 percent or greater rate of disparity between findings by the accreditation organization and findings by CMS on standards that do not constitute immediate jeopardy to patient health and safety if unmet; or
(B) Any disparity between findings by the accreditation organization and findings by CMS on standards that constitute immediate jeopardy to patient health and safety if unmet; or,
(C) Irrespective of the rate of disparity, widespread or systemic problems in an organization's accreditation process such that accreditation by that accreditation organization no longer provides CMS with adequate assurance that suppliers meet or exceed the Medicare requirements; then CMS will give the organization written notice of its intent to withdraw approval as specified in paragraph (h)(3) of this section.
(ii) CMS may also provide the organization written notice of its intent to withdraw approval if an equivalency review, onsite observation, or CMS' daily experience with the accreditation organization suggests that the accreditation organization is not meeting the requirements of this section.
(3)
(i) Accreditation by the organization no longer adequately assures that the suppliers furnishing the technical component of advanced diagnostic imaging service are meeting the established industry standards for each modality and that failure to meet those requirements could jeopardize the health or safety of Medicare beneficiaries and could constitute a
(ii) The accreditation organization has failed to meet its obligations with respect to application or reapplication procedures.
(i)
(1)
(ii) The request for reconsideration must specify the findings or issues with which the accreditation organization disagrees and the reasons for the disagreement.
(iii) A requestor may withdraw its request for reconsideration at any time before the issuance of a reconsideration determination.
(2)
(i) The opportunity for an informal hearing to be conducted by a hearing officer appointed by the Administrator of CMS and provide the accreditation organization the opportunity to present, in writing and in person, evidence or documentation to refute the determination to deny approval, or to withdraw or not renew designation; and
(ii) Written notice of the time and place of the informal hearing at least 10 business days before the scheduled date.
(3)
(A) CMS.
(B) The organization requesting the reconsideration including—
(
(
(
(ii) The hearing is conducted by the hearing officer who receives testimony and documents related to the proposed action.
(iii) Testimony and other evidence may be accepted by the hearing officer even though such evidence may be inadmissible under the Federal Rules of Civil Procedure.
(iv) The hearing officer does not have the authority to compel by subpoena the production of witnesses, papers, or other evidence.
(v) Within 45 calendar days of the close of the hearing, the hearing officer presents the findings and recommendations to the accreditation organization that requested the reconsideration.
(vi) The written report of the hearing officer includes separate numbered findings of fact and the legal conclusions of the hearing officer.
(vii) The hearing officer's decision is final.
The revision and addition read as follows:
(e) * * *
(2)
(i) For the first 6-month period following the date on which the 36-month rental period ends in accordance with § 414.226(a)(1) of this subpart, no payments are made.
(ii) For each succeeding 6-month period, payment may be made during the first month of that period for 30 minutes of labor for routine maintenance and servicing of the equipment in the beneficiary's home (including an institution used as the beneficiary's home).
(iii) The supplier must visit the beneficiary's home (including an institution used as the beneficiary's home) to inspect the equipment during the first month of the 6-month period.
(5)
(i) For the first 6-month period following the date on which the 36-month rental period ends in accordance with § 414.226(a)(1) of this subpart, no payments are made.
(ii) For each succeeding 6-month period, payment may be made during the first month of that period for routine maintenance and servicing of the equipment in the beneficiary's home (including an institution used as the beneficiary's home).
(iii) Payment for maintenance and servicing is made based on a reasonable fee not to exceed 10 percent of the purchase price for a stationary oxygen concentrator. This payment includes payment for maintenance and servicing of all oxygen equipment other than liquid or gaseous equipment (stationary or portable).
(iv) The supplier must visit the beneficiary's home (including an institution used as the beneficiary's home) to inspect the equipment during the first month of the 6-month period.
(1) An inexpensive or routinely purchased item described in § 414.220 of this part.
(2) An item requiring frequent and substantial servicing, as described in § 414.222 of this part.
(3) Oxygen and oxygen equipment described in § 414.226 of this part.
(4) Other DME described in § 414.229 of this part.
The additions and revision read as follows:
(j) * * *
(5)
(
(
(
(
(
(
(
(B)
(C)
(
(
(D)
(
(
(
(
(ii)
(A) State that the supplier agrees to continue to furnish certain rented DME, oxygen and oxygen equipment that it is currently furnishing to beneficiaries (that is, before the start of the competitive bidding program) in a CBA and will continue to provide these items to these beneficiaries for the remaining months of the rental period.
(B) Include the following information:
(
(
(
(C) State that the supplier agrees to meet all the terms and conditions pertaining to grandfathered suppliers.
(D) Be provided by the supplier to CMS in writing at least 30 business days before the start date of the implementation of the Medicare DMEPOS Competitive Bidding Program.
(6)
(ii)
(iii)
(A) State that, for those items for which the supplier has decided not to be a grandfathered supplier, the supplier will only continue to rent these competitively bid item(s) to its beneficiaries up to the first anniversary date that occurs after the start of the Medicare DMEPOS Competitive Bidding Program.
(B) State that the beneficiary must select a contract supplier for Medicare to continue to pay for these items.
(C) Refer the beneficiary to the contract supplier locator tool on and to 1–800–MEDICARE to obtain information about the availability of contract suppliers for the beneficiary's area.
(iv)
(B) Under no circumstance should a supplier pick up a rented item prior to the supplier's receiving acknowledgement from the beneficiary that the beneficiary is aware of the date on which the supplier is picking up the item and the beneficiary has made arrangements to have the item replaced on that date by a contract supplier.
(C) When a beneficiary chooses to switch to a new contract supplier, the current noncontract supplier and the new contract supplier must make arrangements that are agreeable to the beneficiary.
(D) The contract supplier cannot submit a claim with a date of delivery for the new equipment that is prior to the first anniversary date that occurs after the beginning of the CBP.
(k) * * *
(2) Additional payments are made in accordance with § 414.210(e)(2), (e)(3) and (e)(5) of this part for the maintenance and servicing of oxygen equipment if performed by a contract supplier or a noncontract supplier having a valid Medicare billing number.
(a)
(1) Any aggrieved supplier, including a member of a network that was awarded a contract for the Round 1 Durable Medical Prosthetics, Orthotics, and Supplies Competitive Bidding Program (DMEPOS CBP) that believes it has been damaged by the termination of its competitive bid contract, may file a claim under this section.
(2) A subcontractor of a contract supplier is not eligible to submit a claim under this section.
(b)
(2) The date of filing is the actual date of receipt by the CBIC of a completed claim that includes all the information required by this rule.
(c)
(2) A copy of the signed contract entered into with CMS for the Round 1 DMEPOS Competitive Bidding Program;
(3) A detailed explanation of the damages incurred by this supplier as a direct result of the termination of the Round 1 competitive bid contract by MIPPA. The explanation must include all of the following:
(i) Documentation of the supplier's damages through receipts.
(ii) Records that substantiate the supplier's damages and demonstrate that the damages are directly related to performance of the Round 1 contract and are consistent with information the supplier provided as part of their bid.
(4) The supplier must explain how it would be damaged if not reimbursed.
(5) The claim must document steps the supplier took to mitigate any damages they may have incurred due to the contract termination, including a detailed explanation of the steps of all attempts to use for other purposes, return or dispose of equipment or other assets purchased or rented for the use in the Round 1 DMEPOS CBP contract performance.
(d)
(1) The cost of submitting a bid.
(2) Any fees or costs incurred for consulting or marketing.
(3) Costs associated with accreditation or licensure.
(4) Costs incurred before March 20, 2008.
(5) Costs incurred for contract performance after July 14, 2008 except for costs incurred to mitigate damages.
(6) Any profits a supplier may have expected from the contract.
(7) Costs that would have occurred without a contract having been awarded.
(8) Costs for items such as inventory, delivery vehicles, office space and equipment, personnel, which the supplier did not purchase specifically to perform the contract.
(9) Costs that the supplier has recouped by any means, and may include use of personnel, material, suppliers, or equipment in the supplier's business operations.
(e)
(2) Claims must include a statement from a supplier's authorized official certifying the accuracy of the information provided on the claim and all supporting documentation.
(3) The CBIC does not accept electronic submissions of claims for damages.
(f)
(ii) For complete, timely claims, the CBIC will review the claim on its merits to determine if damages are warranted and may seek further information from the claimant when making its recommendation to the Determining Authority. The CBIC may set a deadline for receipt of additional information. A claimant's failure to respond timely may result in a denial of the claim.
(iii) The CBIC will make a recommendation to the Determining Authority for each claim filed and
(iv) The recommendation must be either to award damages for a particular amount (which may not be the same amount requested by the claimant) or that no damages should be awarded.
(A) If the CBIC recommends that damages are warranted, the CBIC will calculate a recommended reasonable amount of damages based on the claim submitted.
(B) The reasonable amount will consider both costs incurred and the contractor's attempts and action to limit the damages;
(v) The recommendation will be sent to the Determining Authority for a final determination.
(2)
(ii) The Determining Authority may seek further information from the claimant or the CBIC in making a concurrence or non-concurrence determination.
(iii) The Determining Authority may set a deadline for receipt of additional information. A claimant's failure to respond timely may result in a denial of the claim.
(iv) If the Determining Authority concurs with the CBIC recommendation, the Determining Authority shall submit a final signed decision to the CBIC and direct the CBIC to notify the claimant of the decision and the reasons for the final decision.
(v) If the Determining Authority non-concurs with the CBIC recommendation, the Determining Authority may return the claim for further processing or the Determining Authority may:
(A) Write a determination granting (in whole or in part) a claim for damages or denying a claim in its entirety;
(B) Direct the CBIC to write said determination for the Determining Authority's signature; or
(C) Return the claim to the CBIC with further instructions.
(vi) The Determining Authority's determination is final and not subject to administrative or judicial review.
(g)
(2) In the case of more complex cases, or in the event of a large workload, a decision will be issued as soon as practicable.
(h)
(c) * * *
(5) * * *
(i) For ground ambulance services where the point of pickup is in a rural area, the mileage rate is increased by 50 percent for each of the first 17 miles and, for services furnished before January 1, 2004, by 25 percent for miles 18 through 50. The standard mileage rate applies to every mile over 50 miles and, for services furnished after December 31, 2003, to every mile over 17 miles. For air ambulance services where the point of pickup is in a rural area, the total payment is increased by 50 percent; that is, the rural adjustment factor applies to the sum of the base rate and the mileage rate.
The revision and additions read as follows:
(c)
(1)
(ii) The single payment amount is then updated quarterly based on the approved CAP vendor's reasonable net acquisition costs for that category as determined by CMS, and limited by the weighted payment amount established under section 1847A of the Act across all drugs for which a composite bid is required in the category.
(iii) The payment amount for each other drug for which the approved CAP vendor submits a bid in accordance with § 414.910 of this subpart and each other drug that is approved by CMS for the approved CAP vendor to furnish under the CAP is also updated quarterly based on the approved CAP vendor's reasonable net acquisition costs for each HCPCS code and limited by the payment amount established under section 1847A of the Act.
(2)
(ii) For subsequent quarters, each approved CAP vendor must report to CMS or its designee RNAC data for a quarter of CAP drug purchases within 30 days of the close of that quarter.
(iii) For all quarters, only RNAC data from approved CAP vendors that are supplying CAP drugs under their CAP contract at the time updates are being calculated must be used to calculate updated CAP payment amounts.
(iv) CMS excludes such RNAC data submitted by an approved CAP vendor if, during the time calculations are being
(v) The payment amount weights must be calculated based on the more recent of the following:
(A) Contract bidding weights.
(B) CAP claims data.
(vi) The payment limit must be determined using the most recent payment limits available to CMS under section 1847A of the Act.
(vii) The following payment amount update calculation must be applied for the group of all drugs for which a composite bid is required.
(A) The most recent previous composite payment amount for the group is updated by—
(
(
(
(B) The median percent change, subject to the limit described in paragraph (c)(1) of this section, must be the update percentage for that quarter.
(C) The single update percentage must be applied to the payment amount for each drug in the group of drugs for which a composite bid is required in the category.
(viii) The following payment amount update calculation must be applied for each of the following items: Each HCPCS code not included in the composite bid list; Each HCPCS code added to the drug list during the contract period; and each drug that has not yet been assigned a HCPCS code, but for which a HCPCS code will be established.
(A) The most recent previous payment amount for each drug must be updated by calculating the percent change in reasonable net acquisition costs for each approved CAP vendor, then calculating the median of all participating approved CAP vendors' adjusted CAP payment amounts.
(B) The median percent change calculated for each drug, subject to the limit described in paragraph (c)(1) of this section, must be applied to the payment amount for each drug.
(3)
(f) * * *
(2) * * *
(v) On or after January 1, 2010, the proposed addition of drugs with similar therapeutic uses to drugs already supplied under the CAP by the approved CAP vendor(s).
(3) * * *
(iv) In the case of additions requested under paragraph (f)(2)(v) of this section, address and document the need for such an expansion based on demand for the product(s).
(g)
(a) * * *
(3) * * *
(xii) Agrees not to transport CAP drugs from one practice location or place of service to another location except in accordance with a written agreement between the participating CAP physician and the approved CAP vendor that requires that drugs are not subjected to conditions that will jeopardize their integrity, stability, and/or sterility while being transported.
(f) * * *
(12) Supply CAP drugs upon receipt of a prescription order to all participating CAP physicians who have selected the approved CAP vendor, except when the conditions of paragraph (h) of this section or § 414.916(b) of this subpart are met;
The addition reads as follows:
(b) * * *
(4) Upon notification from CMS of a participating CAP physician's suspension from the program, the approved CAP vendor must cease delivery of CAP drugs to the suspended participating CAP physician until the suspension has been lifted.
(b) * * *
(4) The approved CAP vendor may appeal that termination by requesting a reconsideration. A determination must be made as to whether the approved CAP vendor has been meeting the service and quality obligations of its CAP contract. The approved CAP vendor's contract will remain suspended during the reconsideration process.
The revision and addition read as follows:
(a)
(i) Includes a summary of the pharmacologic characteristics of each drug or biological and may include information on dosage, as well as recommended or endorsed uses in specific diseases.
(ii) Is indexed by drug or biological.
(iii) Has a publicly transparent process for evaluating therapies and for identifying potential conflicts of interests.
(i) The internal or external request for listing of a therapy recommendation including criteria used to evaluate the request.
(ii) A listing of all the evidentiary materials reviewed or considered by the compendium pursuant to the request.
(iii) A listing of all individuals who have substantively participated in the review or disposition of the request.
(iv) Minutes and voting records of meetings for the review and disposition of the request.
(i) Direct or indirect financial relationships that exist between individuals or the spouse or minor child of individuals who have substantively participated in the development or disposition of compendia recommendations and the manufacturer or seller of the drug or biological being reviewed by the compendium. This may include, for example, compensation arrangements such as salary, grant, contract, or collaboration agreements between individuals or the spouse or minor child of individuals who have substantively participated in the review and disposition of the request and the manufacturer or seller of the drug or biological being reviewed by the compendium.
(ii) Ownership or investment interests between individuals or the spouse or minor child of individuals who have substantively participated in the development or disposition of compendia recommendations and the manufacturer or seller of the drug or biological being reviewed by the compendium.
(b) * * *
(1) * * *
(v) Considers whether the publication that is the subject of the request meets the definition of a compendium in this section.
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
(a)
(2)
(b)
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395(hh)).
(j) A respiratory therapist must complete one the following criteria:
(1)
(i) Be licensed by the State in which practicing, if applicable.
(ii) Have successfully completed a nationally-accredited educational program for respiratory therapists.
(iii)(A) Be eligible to take the registry examination administered by the National Board for Respiratory Care for respiratory therapists; or
(B) Have passed the registry examination administered by the National Board for Respiratory Care for respiratory therapists.
(2)
(i) Be licensed by the State in which practicing, if applicable.
(ii) Have equivalent training and experience as determined by the National Board for Respiratory Care.
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
(13) A site approved by CMS to furnish intensive cardiac rehabilitation services.
Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program.
These addenda will not appear in the Code of Federal Regulations.
The addenda on the following pages provide various data pertaining to the Medicare fee schedule for physicians' services furnished in 2010. Addendum
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 alphanumeric 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 alphanumeric HCPCS code, except for: alphanumeric 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 “Non-facility PE RVUs” column of Addendum B means that CMS has not developed a PE RVU in the non-facility 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 non-facility PE RVU column, and the contractor determines that this service can be performed in the non-facility 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 using 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 outpatient hospital prospective payment system or bundled into the hospital inpatient prospective payment system payment.
1.
2.
Modifier-53 is shown for a discontinued procedure, for example a colonoscopy that is not completed. There will be RVUs for a code with this modifier.
3.
A = Active code. These codes are separately payable under the PFS if covered. There will be RVUs for codes with this status. The presence of an “A” indicator does not mean that Medicare has made a national coverage determination regarding the service. Carriers remain responsible for coverage decisions in the absence of a national Medicare policy.
B = Bundled code. Payments for covered services are always bundled into payment for other services not specified. If RVUs are shown, they are not used for Medicare payment. If these services are covered, payment for them is subsumed by the payment for the services to which they are incident (an example is a telephone call from a hospital nurse regarding care of a patient).
C = Carriers price the code. Carriers will establish RVUs and payment amounts for these services, generally on an individual case basis following review of documentation, such as an operative report.
D
E = Excluded from the PFS by regulation. These codes are for items and services that CMS chose to exclude from the fee schedule payment by regulation. No RVUs are shown, and no payment may be made under the PFS for these codes. Payment for them, when covered, continues under reasonable charge procedures.
F = Deleted/discontinued codes. (Code not subject to a 90-day grace period.) These codes are deleted effective with the beginning of the year and are never subject to a grace period. This indicator is no longer effective beginning with the 2005 fee schedule as of January 1, 2005.
G = Code not valid for Medicare purposes. Medicare uses another code for reporting of, and payment for, these services. (Codes subject to a 90-day grace period.) This indicator is no longer effective with the 2005 PFS as of January 1, 2005.
H
I = Not valid for Medicare purposes. Medicare uses another code for the reporting of, and the payment for these services. (Codes not subject to a 90-day grace period.)
L = Local codes. Carriers will apply this status to all local codes in effect on January 1, 1998 or subsequently approved by central office for use. Carriers will complete the RVUs and payment amounts for these codes.
M = Measurement codes, used for reporting purposes only. There are no RVUs and no payment amounts for these codes. Medicare uses them to aid with performance measurement. No separate payment is made. These codes should be billed with a zero (($0.00) charge and are denied) on the MPFSDB.
N = Non-covered service. These codes are noncovered services. Medicare payment may not be made for these codes. If RVUs are shown, they are not used for Medicare payment.
R = Restricted coverage. Special coverage instructions apply. If the service is covered and no RVUs are shown, it is carrier-priced.
T = There are RVUs for these services, but they are only paid if there are no other services payable under the PFS billed on the same date by the same provider. If any other services payable under the PFS are billed on the same date by the same provider, these services are bundled into the service(s) for which payment is made.
X = Statutory exclusion. These codes represent an item or service that is not within the statutory definition of “physicians' services” for PFS payment purposes. No RVUs are shown for these codes, and no payment may be made under the PFS. (Examples are ambulance services and clinical diagnostic laboratory services.)
4.
5.
6.
7.
8.
9.
10.
The BN reduction resulting from the chiropractic demonstration is
9.
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 1999 Physicians' Current Procedural Terminology for specific definitions.
XXX = The global concept does not apply.
YYY = The global period is to be set by the carrier (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 in the post service time.
Centers for Medicare & Medicaid Services (CMS), HHS.
Notice.
This notice announces to independent accreditation organizations an opportunity to submit applications to participate in the advanced diagnostic imaging supplier accreditation program as a designated accreditation organization. Advanced diagnostic imaging accreditation is required for suppliers furnishing the technical component (TC) of advanced diagnostic imaging services. This notice contains information on accreditation application guidelines for CMS approval of suppliers who furnish the TC of advanced diagnostic imaging services.
Applications will be considered for the January 1, 2010 designation deadline if received at the address, provided in the
Applications should be sent to the following: Attention: Sandra Bastinelli, Office of Financial Management, Mail stop C3–02–16, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244.
Sandra Bastinelli, (410) 786–3630.
Section 135(a) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) added section 1834(e) of the Social Security Act (the Act) that requires the Secretary to designate organizations in order to accredit suppliers furnishing the technical component (TC) of advanced diagnostic imaging service and establish procedures to ensure that the criteria used by an accreditation organization is specific to each imaging modality. Section 1834 (e)(1)(B) of the Act defines advanced diagnostic imaging services as—
(i) Diagnostic magnetic resonance imaging, computed tomography, and nuclear medicine—including positron emission tomography, and
(ii) Such other diagnostic imaging services, including services described in section 1848(b)(4)(B) (excluding x-ray, ultrasound, and fluoroscopy, as specified by the Secretary in consultation with physician specialty organizations and other stakeholders.
Section 1848(b)(4)(B) of the Act defines imaging services as “imaging and computer-assisted imaging services, including x-ray, ultrasound (including echocardiography), nuclear medicine (including positron emission tomography), magnetic resonance imaging, computed tomography, and fluoroscopy, but excluding diagnostic and screening mammography.” Suppliers of the TC of advanced diagnostic imaging services for which payment is made under the fee schedule established under section 1848(b) of the Act, must become accredited by an accreditation organization designated by the Secretary beginning January 1, 2012.
This notice solicits applications from accreditation organizations with the ability to accredit the TC of at least one of the categories of advanced diagnostic imaging services.
An accreditation organization that can show evidence of the ability to accredit at least one of the categories of advanced diagnostic imaging services as defined in sections 1834(e)(1)(B) and 1848 (b)(4)(B) of the Act is eligible to apply for approval as a designated accreditation organization.
To be considered for approval as a designated accreditation organization for Medicare requirements under 42 CFR 414.68, an accreditation organization must furnish to us all of the following information:
• A list of the categories of advanced diagnostic imaging services for which the organization is requesting approval.
• A description of the accrediting organization's duration of accreditation (annual, biannual, and triennial), to include a summary of activities that occur at each cycle.
• A detailed description of how the organization's accreditation criteria satisfy the statutory standards at section 1834(e)(3) of the Act, including the following:
++ Qualifications of medical personnel who are not physicians and who furnish the TC of advanced diagnostic imaging services.
++ Qualifications and responsibilities of medical directors and supervising physicians, such as training in advanced diagnostic imaging services in a residency program, expertise obtained through experience or continuing medical education courses.
++ Procedures to ensure the safety of persons who furnish the TC of advanced diagnostic imaging services and individuals to whom such services are furnished.
++ Procedures to ensure the reliability, clarity, and accuracy of the technical quality of diagnostic images produced by the supplier.
• A detailed description of the organization's survey process, to include the following:
++ Type and frequency of the surveys performed.
++ The ability of the organization to conduct timely reviews of accreditation applications, to include a projection of the organization's national capacity for processing new applications before the January 1, 2012 accreditation deadline.
++ Description of the organization's audit procedures, including—random site visits; site audits or other strategies for ensuring suppliers accredited by the organization maintain compliance throughout the period of accreditation.
++ Procedures for performing unannounced site surveys.
++ Copies of the organization's survey forms.
++ A description of the accreditation survey review process and the accreditation status decision-making process, including the process for addressing identified deficiencies with the accreditation requirements, and the procedures used to monitor the correction of deficiencies found during an accreditation survey.
++ Procedures for coordinating surveys with another accrediting organization (when the organization does not accredit all modalities) provided by an applicant for accreditation which the supplier provided.
++ Comprehensive information about the individuals who perform evaluations for the accreditation organization, including all of the following information:
++ Policies and procedures used when an organization has a dispute regarding survey findings or an adverse decision.
• A description of the organization's data management and analysis capabilities in support of its surveys and accreditation decisions, including the kinds of reports, tables, and other displays generated by that system.
• The organization's procedures for investigating and responding to complaints against accredited facilities, including policies and procedures regarding coordination of these activities with relevant licensing bodies and CMS.
• A description of the organization's policies and procedures for withholding or removal of accreditation status for facilities that fail to meet the organization's accreditation standards and other actions taken by the organization in response to noncompliance with its accreditation criteria. These policies and procedures must include notifying CMS of facilities that fail to meet the requirements of the accrediting organization as required by CMS.
• The information submitted for notification of these organizations includes—
++ A list of all accredited suppliers that the accrediting organization has accredited to include the type and category of accreditation currently held by each supplier, and the expiration date of each supplier's current accreditation;
++ A list of all accreditation surveys scheduled to be performed by the organization;
++ A plan for reducing the burden and cost of accreditation to small and rural suppliers;
++ Information to demonstrate the accreditation organization's knowledge and experience in the advanced medical imaging arena;
++ The organization's proposed fees for accreditation for each modality in which the organization intends to offer accreditation; and
++ Any specific documentation requirements and attestations requested by CMS as a condition of designation.
• The accreditation organization must also submit the following supporting documentation:
++ A written presentation that demonstrates the organization's ability to furnish us with electronic data in ASCII comparable code.
++ A resource analysis that demonstrates that the organization's staffing, funding, and other resources are adequate to perform the required surveys and related activities.
++ A statement acknowledging that, as a condition for approval the organization will agree to the following:
If, after review of an accreditation organization's submission of information we determine that additional information is necessary to make a determination for approval or denial of the accreditation organization's application, the organization will be notified and afforded an opportunity to provide additional information. We may visit the organization's office(s) to verify representations made in the organization's accreditation application. The site visit may include, but is not limited to, review of documents and interviews with the organization's staff. The accreditation organization will receive a formal notice from us stating whether the request for designation has been approved or denied, the rationale for any denial and reconsideration, and reapplication procedures.
We will make every effort to issue a final decision within 30 days from the time we receive the completed accreditation reapplication. An accreditation organization may withdraw its application for designation under section 1834(e) of the Act at any time prior to the formal notice of approval or denial is received. An accreditation organization notified of a denial of request for designation may request a reconsideration in accordance with 42 CFR 488.201 through 488.211. Any accreditation organization whose request for approval of designation has been denied may resubmit the application if the organization—
• Revises its accreditation program to address the rationale for denial of its previous request;
• Provides reasonable assurance that its accredited companies meet applicable Medicare requirements; and
• Resubmits the application in its entirety. If an accreditation organization is denied reconsideration determination (as designated under section 1834(e) of the Act), the organization may not submit a new application as a designated accreditation organization for the type of modality that is at issue in the reconsideration until the reconsideration is final.
The deadline for the submission of applications is the date specified in the
A panel will evaluate all applications from accreditation organizations seeking designation under section 1834(e) of the Act using the existing survey and certification process as established in 42 CFR part 488.
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):
We detailed the burden associated with the submission of advanced diagnostic imaging provider accreditation applications from independent accrediting bodies in the CY 2010 Physician Fee Schedule final rule that published elsewhere in this
Section 414.68(b) contains the application and reapplication procedures for accreditation organizations. Specifically, an independent accreditation organization applying for approval or reapproval of authority to survey suppliers for purposes of accrediting suppliers furnishing the technical component (TC) of advanced diagnostic imaging services must furnish CMS with all of the information listed in proposed § 414.68(b)(1) through (14). The requirements include but are not limited to reporting, notification, documentation, and survey requirements.
The burden associated with the collection requirements in § 414.68(b) is the time and effort necessary to develop, compile and submit the information listed in § 414.68(b)(1) through (14). We believe all 3 entities will choose to comply with these requirements. We estimate that it will take each of the 3 entities, 80 hours to submit a complete application for approval or reapproval authority to become an accrediting organization approved by CMS.
Section 414.68(c) contains the information collection requirements pertaining to CMS approved accrediting organizations. An accrediting organization approved by CMS must undertake all of the activities listed in § 414.68(c)(1) through (6). The burden associated with the collection requirements in § 414.68(c) is the time and effort necessary to develop, compile and submit the information listed in § 414.68(c)(1) through (6). We believe that 3 entities will choose to comply with these requirements. We estimate that it will take each of the 3 entities, 80 hours to submit the required information on an ongoing basis.
Section 414.68(d)(1) states that CMS or its contractor may conduct an audit of an accredited supplier, examine the results of a CMS approved accreditation organization's survey of a supplier, or observe a CMS approved accreditation organization's onsite survey of a supplier, in order to validate the CMS approved accreditation organizations accreditation process. The burden associated with this requirement is the time and effort necessary for an accrediting organization to comply with the components of the validation audit. While this requirement is subject to the PRA, we believe the associated burden is exempt as stated in 5 CFR 1320.3(h)(6). The burden associated with a request for facts addressed to a single person, as defined in 5 CFR 1320.3(j), is not subject to the PRA.
As stated in § 414.68(e)(1), an accreditation organization dissatisfied with a determination that its accreditation requirements do not provide or do not continue to provide reasonable assurance that the suppliers accredited by the organization meet the applicable quality standards is entitled to a reconsideration. CMS reconsiders any determination to deny, remove, or not to renew the approval of deeming authority to an accreditation organization if the accrediting organization files a written request for reconsideration by its authorized officials or through its legal representative. The written request must be filed within 30 calendar days of the receipt of CMS' notice of an adverse determination or nonrenewal. In addition, the request must also specify the findings or issues with which the accreditation organization disagrees and the reasons for the disagreement.
The burden associated with this requirement is the time and effort necessary for an accrediting organization to develop and file a written request for reconsideration. While this requirement is subject to the PRA, the associated burden is exempt under 5 CFR 1320.4. The information in question is being collected as a result of an administrative action; accrediting organizations are submitting requests for reconsideration after receiving a notice of an adverse decision.
Section 1834(e) of the Act.