Historic Preservation, Advisory Council
National Agricultural Statistics Service
National Institute of Food and Agriculture
Rural Utilities Service
Engineers Corps
National Foundation on the Arts and the Humanities
Committee for Purchase From People Who Are Blind or Severely Disabled
Minority Business Development Agency
National Oceanic and Atmospheric Administration
Defense Acquisition Regulations System
Engineers Corps
Navy Department
Energy Efficiency and Renewable Energy Office
Federal Energy Regulatory Commission
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Food and Drug Administration
Coast Guard
Federal Emergency Management Agency
U.S. Customs and Border Protection
Fish and Wildlife Service
Indian Affairs Bureau
Land Management Bureau
National Park Service
Employee Benefits Security Administration
Occupational Safety and Health Administration
Fiscal Service
National Agricultural Statistics Service
Federal Aviation Administration
Federal Railroad Administration
Surface Transportation Board
Fiscal Service
Foreign Assets Control Office
Internal Revenue Service
Consult the Reader Aids section at the end of this page for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions.
National Institute of Food and Agriculture, USDA.
Final rule.
This rule updates our regulations to show a list of institutions that are granted HSACU certification by the Secretary and are eligible for HSACU programs for the period starting October 1, 2012 and ending September 30, 2013.
This rule is effective November 16, 2012 and applicable October 1, 2012.
Matthew Lockhart; Senior Policy Specialist; National Institute of Food and Agriculture; U.S. Department of Agriculture; STOP 2299; 1400 Independence Avenue SW.; Washington, DC 20250-2299; Voice: 202-559-5088; Fax: 202-401-7752; Email:
This rule makes changes to the existing list of institutions in Appendix B of 7 CFR part 3434. The list of institutions is amended to reflect the institutions that are granted HSACU certification by the Secretary and are eligible for HSACU programs for the period starting October 1, 2012, and ending September 30, 2013.
As stated in 7 CFR part 3434, an institution must meet the following criteria to receive HSACU certification: (1) Be a Hispanic-Serving Institution (HSI), (2) offer agriculture-related degrees, and (3) award at least 15% of agriculture-related degrees to Hispanic students over the two most recent academic years.
NIFA obtained the latest report from the U.S. Department of Education's National Center for Education Statistics that lists all HSIs and the degrees conferred by these institutions (completions data) during the 2010-11 academic year. NIFA used this report to identify HSIs that conferred a degree in an instructional program that appears in Appendix A of 7 CFR part 3434 and to confirm that over the 2009-10 and 2010-11 academic years at least 15% of the degrees in agriculture-related fields were awarded to Hispanic students.
The updated list of HSACUs is based on (1) completions data from 2009-10 and 2010-11, and (2) enrollment data from Fall 2011. NIFA identified 80 institutions that will meet the eligibility criteria and receive HSACU certification for FY 2013 (October 1, 2012 to September 30, 2013).
NIFA will permit HSIs that are not granted HSACU certification to submit an appeal within 30 days of the publication of this notice. The appellant must submit a request for review to the NIFA official specified in this notice with details on the nature of the disagreement and include supporting documents.
This rule relates to internal agency management. Accordingly, pursuant to 5 U.S.C. 553, notice of proposed rulemaking and opportunity for comment are not required, and this rule may be made effective less than 30 days after publication in the
Administrative practice and procedure; Agricultural research, education, extension; Hispanic-Serving Institutions; Federal assistance.
Title 7, part 3434 of the Code of Federal Regulations is amended accordingly as set forth below:
7 U.S.C. 3103.
The institutions listed in this appendix are granted HSACU certification by the Secretary and are eligible for HSACU programs for the period starting October 1, 2012, and ending September 30, 2013. Institutions are listed alphabetically under the state of the school's location, with the campus indicated where applicable.
Board of Governors of the Federal Reserve System.
Final rule.
The Board of Governors of the Federal Reserve System (the Board) is amending its rules of practice and procedure to adjust the amount of each civil money penalty (CMP) provided by law within its jurisdiction to account for inflation. This action is required under the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Debt Collection Improvement Act of 1996.
This rule is effective November 16, 2012.
Katherine H. Wheatley, Associate General Counsel (202) 452-3779, or Mehrnoush Bigloo, Attorney (202) 475-6361, Legal Division, Board of Governors of the Federal Reserve System, 20th and C Streets NW., Washington, DC 20551. For users of Telecommunication Device for the Deaf (TDD) only, contact (202) 263-4869.
The Federal Civil Penalties Inflation Adjustment Act of 1990, 28 U.S.C. 2461
The FCPIA Act defines the inflation adjustment as a cost-of-living adjustment based on the percentage change in the Consumer Price Index between June of the calendar year in which the particular CMP was last set or adjusted and June of the calendar year preceding the current adjustment (in this case, June 2011). The Act specifies the use of the Consumer Price Index for All Urban Consumers (CPI-U) published by the Department of Labor. Accordingly, to obtain the percent inflation adjustment for each CMP within the Board's jurisdiction, we calculated the percent change in the CPI-U between June of the year in which the CMP was last adjusted and June 2011.
The following is an example of the methodology for adjusting CMPs, using the penalty for a first tier violation of 12 U.S.C. 1847(d). First, because that CMP was last adjusted in 2000, we calculated the percent increase between the CPI-U for June 2000 (172.4) and the CPI-U for June 2011 (225.72). We then took that percentage (30.9%) and multiplied it by the current CMP amount of $2,200 to obtain an inflation increase of $679.80. Because the current CMP amount is greater than $1,000 but less than $10,000, the Act requires us to round the inflation increase to the nearest multiple of $1,000. Rounding $679.80 to the nearest multiple of $1,000 yields $1,000. Accordingly, the increase to the $2,200 penalty for a first tier violation of 12 U.S.C. 1847(d) is $1,000, resulting in an adjusted CMP of $3,200.
This rule is not subject to the provisions of the Administrative Procedure Act (APA), 5 U.S.C. 553, requiring notice, public participation, and deferred effective date. The FCPIA Act provides Federal agencies with no discretion in the adjustment of CMPs to the rate of inflation, and it also requires that adjustments be made at least every four years. Moreover, this regulation is ministerial and technical. For these reasons, the Board finds good cause to determine that public notice and comment for this new regulation is unnecessary, impracticable, and contrary to the public interest, pursuant to the APA, 5 U.S.C. 553(b)(3)(B). These same reasons also provide the Board with good cause to adopt an effective date for this regulation that is less than 30 days after the date of publication in the
The Regulatory Flexibility Act, 5 U.S.C. 601
There is no collection of information required by this final rule that would be subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501
Administrative practice and procedure, Claims, Crime, Equal Access to Justice, Lawyers, Penalties.
For the reasons set forth in the preamble, the Board of Governors amends 12 CFR part 263 as follows:
5 U.S.C. 504, 554-557; 12 U.S.C. 248, 324, 504, 505, 1464, 1467, 1467a, 1468, 1817(j), 1818, 1820(k), 1828(c), 1829(e), 1831o, 1831p-1, 1847(b), 1847(d), 1884(b), 1972(2)(F), 3105, 3107, 3108, 3349, 3907, 3909, 4717; 15 U.S.C. 21, 78(1), 78o-4, 78o-5, 78u-2; 28 U.S.C. 2461
(a)
(b)
(1) 12 U.S.C. 324:
(i) Inadvertently late, false or misleading reports,
(ii) Other late, false or misleading reports,
(iii) Knowingly or recklessly false or misleading reports,
(2) 12 U.S.C. 504, 505, 1817(j)(16), 1818(i)(2) and 1972(2)(F):
(i) First tier—$7,500.
(ii) Second tier—$37,500.
(iii) Third tier—$1,425,000.
(3) 12 U.S.C. 1820(k)(6)(A)(ii)—$275,000.
(4) 12 U.S.C. 1832(c)—$1,100.
(5) 12 U.S.C. 1847(b), 3110(a)—$37,500.
(6) 12 U.S.C. 1847(d), 3110(c):
(i) First tier—$3,200.
(ii) Second tier—$32,000.
(iii) Third tier—$1,425,000.
(7) 12 U.S.C. 334, 374a, 1884—$110.
(8) 12 U.S.C. 3909(d)—$1,100.
(9) 15 U.S.C. 78u-2:
(i) 15 U.S.C. 78u-2(b)(1)—$7,500 for a natural person and $70,000 for any other person.
(ii) 15 U.S.C. 78u-2(b)(2)—$70,000 for a natural person and $350,000 for any other person.
(iii) 15 U.S.C. 78u-2(b)(3)—$140,000 for a natural person and $700,000 for any other person.
(10) 42 U.S.C. 4012a(f)(5)—$2,000.
(11) 12 U.S.C. 1467a(i):
(i) 12 U.S.C. 1467a(i)(2)—$32,500.
(ii) 12 U.S.C. 1467a(i)(3)—$32,500.
(12) 12 U.S.C. 1467a(r):
(i) 12 U.S.C. 1467a(r)(1)—$3,200.
(ii) 12 U.S.C. 1467a(r)(2)—$32,500.
(iii) 12 U.S.C. 1467a(r)(3)—$1,425,000.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action amends Class E airspace at Anthony, KS. Additional controlled airspace is necessary to accommodate new Area Navigation (RNAV) Standard Instrument Approach Procedures at Anthony Municipal Airport. The FAA is taking this action to enhance the safety and management of Instrument Flight Rule (IFR) operations at the airport.
Scott Enander, Central Service Center, Operations Support Group, Federal Aviation Administration, Southwest Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone 817-321-7716.
On August 2, 2012, the FAA published in the
This action amends Title 14 Code of Federal Regulations (14 CFR) Part 71 by amending Class E airspace extending upward from 700 feet above the surface to accommodate new standard instrument approach procedures at Anthony Municipal Airport, Anthony, KS. This action is necessary for the safety and management of IFR operations at the airport.
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. Therefore, this regulation: (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 U.S. Code. Subtitle 1, 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 Anthony Municipal Airport, Anthony, KS.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures,” paragraph 311a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (Air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
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 700 feet above the surface within a 6.4-mile radius of Anthony Municipal Airport, and within 2 miles each side of the 000° bearing from the airport extending from the 6.4-mile radius to 12 miles north of the airport.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action amends Class E airspace at Guthrie, IA. Decommissioning of the Guthrie Center non-directional radio beacon (NDB) at Guthrie County Regional Airport has made reconfiguration necessary for standard instrument approach procedures and for the safety and management of Instrument Flight Rule (IFR) operations at the airport. Geographic coordinates of the airport are also adjusted.
Scott Enander, Central Service Center, Operations Support Group, Federal Aviation Administration, Southwest Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone 817-321-7716.
On August 2, 2012, the FAA published in the
This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 by
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. Therefore, this regulation: (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 U.S. Code. Subtitle 1, 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 Guthrie County Regional Airport, Guthrie, IA.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures,” paragraph 311a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (Air)
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
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 700 feet above the surface within a 6.4-mile radius of Guthrie County Regional Airport.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action amends Class E airspace at Forest City, IA. Additional controlled airspace is necessary to accommodate new Area Navigation (RNAV) Standard Instrument Approach Procedures at Forest City Municipal Airport. The Forest City nondirectional beacon's (NDB) geographic coordinates are also adjusted. The FAA is taking this action to enhance the safety and management of Instrument Flight Rule (IFR) operations at the airport.
Effective date: 0901 UTC, January 10, 2013. The Director of the Federal Register approves this incorporation by reference action under 1 CFR part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.
Scott Enander, Central Service Center, Operations Support Group, Federal Aviation Administration, Southwest Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone 817-321-7716.
On August 16, 2012, the FAA published in the
This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 by amending Class E airspace extending upward from 700 feet above the surface to accommodate new standard instrument approach procedures at Forest City Municipal Airport, Forest City, IA. This action is necessary for the safety and management of IFR operations at the airport. Geographic coordinates of the Forest City NDB are updated to coincide with the FAA's aeronautical database.
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. Therefore, this regulation: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, 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 Forest City Municipal Airport, Forest City, IA.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures,” paragraph 311a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (Air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
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 700 feet above the surface within a 6.9-mile radius of Forest City Municipal Airport, and within 4 miles each side of the 347° bearing from the airport extending from the 6.9-mile radius to 10.6 miles north of the airport, and within 2.6 miles each side of the 162° bearing from the Forest City NDB extending from the 6.9-mile radius to 7.4 miles southeast of the airport.
Occupational Safety and Health Administration (OSHA), Labor.
Final rule; confirmation of effective date.
OSHA is confirming the effective date of its direct final rule that revises the Head Protection standards for general industry, shipyard employment, marine terminals, longshoring, and construction by updating the reference to a standard published by a standards-developing organization, the American National Standards Institute. In the June 22, 2012, direct final rule, OSHA stated that it would withdraw the companion proposed rule and confirm the effective date of the direct final rule if the Agency received no significant adverse comments. OSHA did not receive significant adverse comments on the direct final rule. Therefore, OSHA is confirming that the direct final rule became effective on September 20, 2012.
The direct final rule published on June 22, 2012 (77 FR 37587), was effective on September 20, 2012. For the purposes of judicial review, OSHA considers November 16, 2012, as the date of issuance.
In compliance with 28 U.S.C. 2112(a), OSHA designates the Associate Solicitor of Labor for Occupational Safety and Health as the recipient of petitions for review of the final standard. Contact Joseph M. Woodward, Associate Solicitor, at the Office of the Solicitor, Room S-4004, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210; telephone: (202) 693-5445.
In that
Head protection, Incorporation by reference, Occupational safety and health, Safety.
David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210, authorized the preparation of this final rule. OSHA is issuing this final rule pursuant to 29 U.S.C. 653, 655, and 657, 5 U.S.C. 553, Secretary of Labor's Order 1-2012 (77 FR 3912), and 29 CFR part 1911.
Pension Benefit Guaranty Corporation.
Final rule.
This final rule amends the Pension Benefit Guaranty Corporation's regulation on Benefits Payable in Terminated Single-Employer Plans to prescribe interest assumptions under the regulation for valuation dates in December 2012. The interest assumptions are used for paying benefits under terminating single-employer plans covered by the pension insurance system administered by PBGC.
Effective December 1, 2012.
Catherine B. Klion (
PBGC's regulation on Benefits Payable in Terminated Single-Employer Plans (29 CFR part 4022) prescribes actuarial assumptions—including interest assumptions—for paying plan benefits under terminating single-employer plans covered by title IV of the Employee Retirement Income Security Act of 1974. The interest assumptions in the regulation are also published on PBGC's Web site (
PBGC uses the interest assumptions in Appendix B to Part 4022 to determine whether a benefit is payable as a lump sum and to determine the amount to pay. Appendix C to Part 4022 contains interest assumptions for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using PBGC's historical methodology. Currently, the rates in Appendices B and C of the benefit payment regulation are the same.
The interest assumptions are intended to reflect current conditions in the financial and annuity markets. Assumptions under the benefit payments regulation are updated monthly. This final rule updates the benefit payments interest assumptions for December 2012.
The December 2012 interest assumptions under the benefit payments regulation will be 0.75 percent for the period during which a benefit is in pay status and 4.00 percent during any years preceding the benefit's placement in pay status. In comparison with the interest assumptions in effect for November 2012, these interest assumptions are unchanged.
PBGC has determined that notice and public comment on this amendment are impracticable and contrary to the public interest. This finding is based on the need to determine and issue new interest assumptions promptly so that the assumptions can reflect current market conditions as accurately as possible.
Because of the need to provide immediate guidance for the payment of benefits under plans with valuation dates during December 2012, PBGC finds that good cause exists for making the assumptions set forth in this amendment effective less than 30 days after publication.
PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866.
Because no general notice of proposed rulemaking is required for this amendment, the Regulatory Flexibility Act of 1980 does not apply. See 5 U.S.C. 601(2).
Employee benefit plans, Pension insurance, Pensions, Reporting and recordkeeping requirements.
In consideration of the foregoing, 29 CFR part 4022 is amended as follows:
29 U.S.C. 1302, 1322, 1322b, 1341(c)(3)(D), and 1344.
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes an exemption from the requirement of a tolerance for residues of xylenesulfonic acid, sodium salt (also known as sodium xylene sulfonate) (CAS Reg. No. 1300-72-7) when used as an inert ingredient in antimicrobial pesticide formulations applied to food-contact surfaces in public eating places, diary processing equipment, and food processing equipment and utensils at 500 parts per million (ppm) utensils. The firm Exponent on behalf of Ecolab Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of sodium xylene sulfonate.
This regulation is effective November 16, 2012. Objections and requests for hearings must be received on or before January 15, 2013, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2011-0951, is available at
Mark Dow, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 305-5533; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2011-0951 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before January 15, 2013. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2011-0951, by one of the following methods:
•
•
•
In the
Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue * * *.”
EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.
Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for sodium xylene sulfonate including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with sodium xylene sulfonate follows.
EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by sodium xylene sulfonate as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit.
Sodium xylene sulfonate has low acute toxicity by the oral, dermal and inhalation route of exposure. Sodium xylene sulfonate is a slight skin and mild eye irritant. Based upon information regarding sodium toluene sulfonate, sodium xylene sulfonate is negative for dermal sensitization. Several subchronic studies via the oral route of exposure are available in the database. In two 14-day toxicity studies in mice and rats, no significant treatment related toxicity was observed at doses up to 4% in the diet (approximately 4,000 milligrams/kilogram/day (mg/kg/day)) in mice. In rats, there were some mortalities which were not observed in a dose-related manner and losses of body weight that were probably due to palatability of the test article. In a repeat toxicity study in rats, mortality was not observed at doses up to 4% in the diet. A 90-day subchronic toxicity study was conducted in Wistar rats with doses of sodium xylene sulfonate up to 5% in
Sodium xylene sulfonate was tested for its mutagenic potential in various
There are no reproductive toxicity studies for sodium xylene sulfonate. However, the Organisation for Economic Co-operation and Development (OECD) Screening Information Dataset (SIDS) Assessment included reviews of a 91-day oral rat feeding study with sodium cumene sulfonate, a 90-day feeding study with sodium xylene sulfonate (mice and rats), and the 2-year dermal studies with sodium xylene sulfonate (mice and rats) which included examination of the reproductive organs of both sexes. There was no evidence from these studies to suggest that sodium xylene sulfonate would have an adverse effect on reproductive organs by either the oral or dermal route. No developmental toxicity studies in rats and rabbits are available in the sodium xylene sulfonate database. However, a developmental study with the rat is available for a surrogate chemical, calcium xylene sulfonate. In this study the NOAEL for maternal and fetal toxicity was the highest dose tested; 3,000 mg/kg/day which correspond to 936 mg/kg bw/day. Based on the calcium xylene sulfonate OECD Guideline study, there is no evidence to consider these materials as being developmental toxicants. There is no evidence in the sodium xylene sulfonate database that sodium xylene sulfonate is an immunotoxin.
Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see
No endpoint of concern following a single dose was identified in the available database. The Agency identified a NOAEL of 763 mg/kg bw/day for systemic toxicity, which was selected from an oral subchronic study. Effects observed in this study were a decrease in spleen weight in females along with some clinical chemistry and hematology changes at the LOAEL of 3,454 mg/kg bw/day. No adverse effects were reported in males. This study was used for chronic dietary exposure assessment. An uncertainty factor of 100X is applied (10X for interspecies extrapolation and 10X for intraspecies variability). Based on the physicochemical data and lack of systemic toxicity in the available dermal toxicity studies, EPA concluded that there is no need to conduct quantitative dermal risk exposure assessment. For several reasons, no additional uncertainty factor is necessary for the use of subchronic study data for chronic exposure assessment. First there was a wide dose spread between the toxic effects seen at the LOAEL of 3,454 mg/kg/day and the NOAEL of 763 mg/kg/day. Second, the changes observed in clinical chemistry and hematological parameters were small in magnitude and no effects on organs were observed in the study. Therefore, the changes observed were not considered toxicologically significant. Finally, the NOAEL in a separate 90-day study in rats was 2,467 mg/kg/day indicating the lower NOAEL value in the selected study is an artifact of dose selection. Therefore, EPA concluded that there is no need to add an additional uncertainty factor for use of short-term study for long-term exposure assessment.
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In the absence of actual dietary exposure data resulting from this proposed use the EPA has utilized a conservative, health-protective method of estimating dietary intake that is based upon conservative assumptions related to the amount of residues that can be transferred to foods as a result of the proposed use of sodium xylene sulfonates in food contact sanitizing pesticide products. This same methodology has been utilized by EPA in estimating dietary exposures to antimicrobial pesticides used in food-handling settings. The Agency believes the assumptions used to estimate chronic dietary exposures lead to an extremely conservative assessment of chronic dietary risk due to a series of compounded conservatisms as described in the unit. First, when a surface is treated with a disinfectant, a quantity of the disinfectant remains on the surface (Residual Solution). In the absence of any other data, EPA has used an estimated worst-case concentration of 1 mg of solution per square centimeter (cm
In conducting the acute and chronic dietary exposure assessments for sodium xylene sulfonate, EPA used food consumption information from the United States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, no residue data are available for sodium xylene sulfonate. In the absence of specific residue data, EPA has developed an approach which uses surrogate information to derive upper bound exposure estimates for the subject inert ingredient. Upper bound exposure tolerance for a given commodity from a list of high-use insecticides, herbicides, and fungicides. A complete description of the general approach taken to assess inert ingredient risks in the absence of residue data is contained in the memorandum entitled “Alkyl Amines Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessments for the Inerts.” (D361707, S. Piper, 2/25/09) and can be found at
In the dietary exposure assessment, the Agency assumed that the residue level of the inert ingredient would be no higher than the highest tolerance for a given commodity. Implicit in this assumption is that there would be similar rates of degradation (if any) between the active and inert ingredient and that the concentration of inert ingredient in the scenarios leading to these highest of tolerances would be no higher than the concentration of the active ingredient.
The Agency believes the assumptions used to estimate dietary exposures lead to an extremely conservative assessment of dietary risk due to a series of compounded conservatisms.
First, assuming that the level of residue for an inert ingredient is equal to the level of residue for the active ingredient will overstate exposure. The concentration of active ingredient in agricultural products is generally at least 50% of the product and often can be much higher. Further, pesticide products rarely have a single inert ingredient; rather there is generally a combination of different inert ingredients used which additionally reduces the concentration of any single inert ingredient in the pesticide product in relation to that of the active ingredient.
Second, the conservatism of this methodology is compounded by EPA's decision to assume that, for each commodity, the active ingredient which will serve as a guide to the potential level of inert ingredient residues is the active ingredient with the highest tolerance level. This assumption overstates residue values because it would be highly unlikely, given the high number of inert ingredients, that a single inert ingredient or class of ingredients would be present at the level of the active ingredient in the highest tolerance for every commodity.
Finally, a third compounding conservatism is EPA's assumption that all foods contain the inert ingredient at the highest tolerance level. In other words, EPA assumed 100% of all foods are treated with the inert ingredient at the rate and manner necessary to produce the highest residue legally possible for an active ingredient.
In summary, EPA chose a very conservative method for estimating what level of inert residue could be on food, then used this methodology to choose the highest possible residue that could be found on food and assumed that all food contained this residue. No consideration was given to potential degradation between harvest and consumption even though monitoring data shows that tolerance level residues are typically one to two orders of magnitude higher than actual residues of magnitude higher than actual residues in food when distributed in commerce. Accordingly, although sufficient information to quantify actual residue levels in food is not available, the compounding of these conservative assumptions will lead to a significant exaggeration of actual exposures.
2.
The proposed use of sodium xylene sulfonate will not result in its presence in surface water or ground water and therefore not contribute to dietary exposure.
3.
Sodium xylene sulfonate is not used as an inert ingredient in pesticide products that are registered for specific uses that may result in either indoor and outdoor residential exposures. However, sodium xylene sulfonate is used as a component of personal care products. The OECD SIDS Assessment estimated highest human exposures resulting from personal care product use. The exposure estimates ranged from 0.02-0.14 mg/kg/day for shampoos and hair conditioners to 0.11-0.17 mg/kg/day for liquid face and hand soaps. Exposure estimates for cleaning product use and residuals on clothing range from 0.01-0.08 mg/kg/day. All exposure evaluations included conservative (protective) input assumptions (e.g., all modeled human exposures are conservative due to the use of a default assumption of 100% absorption). However, the physicochemical data and available toxicological data suggest that dermal absorption is likely to be minimal. Based on the lack of concern for dermal toxicity and the low estimates of residential exposure, a quantitative residential risk assessment was not performed.
4.
EPA has not found sodium xylene sulfonate to share a common mechanism of toxicity with any other substances, and sodium xylene sulfonate does not appear to produce a toxic metabolite produced by other substances. However, there are other chemicals belonging to the xylene sulfonate class of chemicals that may have a similar toxicity profile but these chemicals will be used as an alternative to sodium xylene sulfonate. Therefore, a cumulative risk assessment was not performed. Furthermore, the cPAD for pesticidal uses occupies only 7% of the cPAD for the general population and any potential increase in exposure to this class of chemicals will still be below any levels of concern. For the purposes of this tolerance action, therefore, EPA has assumed that sodium xylene sulfonate does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at
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In a developmental toxicity study in rats with calcium xylene sulfonate, no maternal or developmental effects were observed at doses of 3,000 mg/kg/day (equal to 936 mg/kg/day corrected for purity of test material).
There is no evidence of prenatal or postnatal sensitivity as a result of exposure to sodium xylene sulfonate.
3.
i. Available studies included several 90-day toxicity studies via oral and dermal routes, chronic studies, mutagenicity battery, a developmental study in rats and metabolism studies. These studies provide an adequate characterization of sodium xylene sulfonate toxicity.
ii. There is no indication that sodium xylene sulfonate is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.
iii. No reproductive toxicity study or developmental toxicity study are available for sodium xylene sulfonate. However, the concern for increased susceptibility of infants and children exposure to sodium xylene sulfonate are low because no effects on reproductive parameters were observed in various oral toxicity studies and the developmental toxicity in rats for a surrogate chemical show lack of systemic toxicity at doses up to 936 mg/kg/day (mentioned under pre and post natal susceptibility).
iv. No evidence of immunotoxicity was observed in the database except slightly decreased in spleen weight was observed at the LOAEL of 3,454 mg/kg bw/day. There are no concerns for immunotoxicity and an immunotoxicity study is not required because the slight decreased in spleen weights were observed at high doses without any evidence of histopathological findings.
v. No additional uncertainty factor is needed for the use of subchronic study data for chronic exposure assessment. The rational for this decision is provided in Unit IV.B.
vi. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% CT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground water and surface water modeling used to assess exposure to sodium xylene sulfonate in drinking water. EPA used similarly conservative assumptions to assess post-application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by sodium xylene sulfonate.
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An analytical method is not required for enforcement purposes since the Agency is not establishing a numerical tolerance for residues of xylene sulfonic acid, sodium salt in or on any food commodities. EPA is establishing a limitation on the amount of xylene sulfonic acid, sodium salt that may be used in pesticide formulations. That limitation will be enforced through the pesticide registration process under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nation Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.
The Codex has not established a MRL for sodium xylene sulfonate.
Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.940(a) for xylenesulfonic acid, sodium salt (CAS Reg. No. 1300-72-7) when used as an inert ingredient in antimicrobial formulations in pesticide formulations applied to food contact surfaces in public eating places, dairy processing equipment, and food processing equipment and utensils at a maximum of 500 parts per million of final solution. Additionally the exemption from the requirement of a tolerance for xylenesulfonic acid under 40 CFR 180.940(c), can be removed as the establishment of a broader exemption from the requirement of a tolerance for xylenesulfonic acid under 180.940(a) obviates the need for 40 CFR 180.940(c) tolerance exemption.
This final rule establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4).
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).
The Congressional Review Act, 5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
(a) * * *
Environmental Protection Agency (EPA).
Final rule.
This regulation amends the existing exemption from the requirement of a tolerance for residues of the plant growth regulator, 1,4-dimethylnaphthalene (1,4-DMN) by expanding the current exemption to include all sprouting root and tuber vegetables (EPA Crop Group 01) and all bulb vegetables (EPA Crop Group 03). On behalf of D-I-1-4, Inc., a division of 1,4Group, Inc., Technology Sciences Group, Inc. (TSG) submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting that EPA amend the existing exemption from the requirement of a tolerance for 1,4-DMN. This regulation eliminates the need to establish a maximum permissible level for residues of 1,4-DMN under the FFDCA.
This regulation is effective November 16, 2012. Objections and requests for hearings must be received on or before January 15, 2013, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2011-1029, is available at
Colin G. Walsh, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 308-0298; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2011-1029 in the subject line on
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any CBI) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2011-1029, by one of the following methods:
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In the
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue * * *.” Additionally, FFDCA section 408(b)(2)(D) requires that the Agency consider “available information concerning the cumulative effects of [a particular pesticide's] * * * residues and other substances that have a common mechanism of toxicity.”
EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.
Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability, and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.
EPA established a tolerance exemption for 1,4-DMN in a Final Rule published in the
As discussed in the
As stated previously in this Unit, new toxicity data have been submitted in support of the request by the petitioner to expand the current tolerance exemption to cover all sprouting root, tuber, and bulb crops. These data include: (1) A prenatal developmental toxicity study and (2) additional data not required by EPA, but used to further support the developmental data and this expansion of the tolerance exemption. All new data, coupled with the data submitted to support the previous tolerance exemption (60 FR 7456), confirm the minimal human health hazard effects, as reported in the original assessment of the tolerance exemption, associated with dietary exposures of 1,4-DMN and fully demonstrate the lack of mammalian toxicity. Summaries of the new toxicological data submitted in support of the expansion of the tolerance exemption follow.
A new developmental study (Master Record Identification (MRID) Number 48590905) was performed for 1,4-DMN to support the expansion of the tolerance exemption. 1,4-DMN was administered by oral gavage to female rabbits at the dose levels of 0, 25, 80, or 250 milligrams/per/day (mg/kg/day) (23 rabbits per test group) over gestation days 6 through 28. No treatment-related clinical signs were noted during the study, and gross necropsy findings were limited to those rabbits that underwent abortion (Ref. 1). The gross necropsy findings consisted of changes in the gastrointestinal tract (dilatation of stomach and/or intestines) and were likely related to the lack of eating prior to and during the abortion. Mean food consumption was significantly reduced in the 250 mg/kg/day treated doses shortly after treatment initiation (over gestation days 6 to 9 and 9 to 12). This reduction in food consumption was likely treatment-related. Corollary reductions in mean body weight gain were observed in the 250 mg/kg/day treated group over gestation days 6 to 9. Alterations in uterus weight were not observed, nor were changes seen in maternal body weight or body weight gain when corrected for uterus weight. As such, the changes seen early on in gestational body weight gain were considered to be solely associated with maternal toxicity. Therefore, the lowest observed adverse effect level (LOAEL) for maternal toxicity of 1,4-DMN in rats is 250 mg/kg/day based on reduced food consumption and reduced body weight gain. The no observed adverse effect level (NOAEL) for maternal toxicity is 80 mg/kg/day based on no effects observed at this dose.
For developmental toxicity, no treatment-related differences in litter viability were detected at any dose level tested. The number of male, female, and total fetuses (sexes combined) were similar across the treatment and control groups and average fetal weights were unaffected. No structural alterations, including gross external, visceral, skeletal, and cephalic, were evident from the fetal examinations; as such, 1,4-DMN did not produce any frank malformations and was not teratogenic. Based on no effects observed for developmental toxicity at any doses tested, the NOAEL for developmental toxicity is greater than 250 mg/kg/day (highest dose tested). The LOAEL was not identified for developmental toxicity, suggesting that the test animals could have tolerated a higher dose.
Based on the developmental toxicity data submitted for this expansion to the tolerance exemption, which showed no adverse effects at the highest dose tested, 250 mg/kg/day, there are sufficient data and information to confirm that 1,4-DMN is not a developmental toxicant. Therefore, the consumption of food commodities that have been treated with 1,4-DMN when used as a pesticide is safe and will not result in any harm to human health, specifically women of child-bearing age, from dietary exposure.
Additional toxicity data for 1,4-DMN that were not required by EPA to support this expansion of the tolerance exemption were submitted by the petitioner. The additional data include the following: Unscheduled DNA synthesis (mutagenicity),
1. An
2. An
3. A dermal sensitization test (MRID 48590904) utilizing the Local Lymph Node Assay (LLNA) method showed that 1,4-DMN is not a dermal sensitizer (Ref. 1). The dermal sensitization test utilizing the Buehler method submitted to support the previous tolerance exemption (60 FR 7456) also showed that 1,4-DMN is not a dermal sensitizer.
4. A one-generation reproductive toxicity study (MRID 48590906) was conducted on rats to assess systemic, developmental, and reproductive toxicity. 1,4-DMN was administered in the diet at the dose concentrations of 0, 500, 2,000, and 7,500 ppm with each dose group consisting of 24 males and 24 female rats. The results of the study showed that the NOAEL for systemic toxicity was 2,000 ppm (equivalent to 121 to 207 mg/kg/day in parental male and female rats and 184 to 213 mg/kg/day in F
Based on the reproductive toxicity data submitted for this expansion to the tolerance exemption, which showed no adverse reproductive effects at the highest dose tested, 7,500 ppm (equivalent to 441 to 591 mg/kg/day in parental male and female rats and 776 to 839 mg/kg/day in F
5. A combined chronic toxicity and carcinogenicity study (MRID 48590907) was conducted on rats (65 rats/sex/group for carcinogenicity and 20 rats/sex/group for chronic toxicity) to assess the chronic toxicity and carcinogenicity potential for 1,4-DMN. 1,4-DMN was administered in the diet of rats 7 days/week for a minimum of 52 weeks (chronic toxicity phase) or 104 weeks (carcinogenicity phase), at the dose concentrations of 0, 150, 500, and 3,750 ppm, equivalent to the dose concentrations of 0, 10, 33, and 250 mg/kg/day. For the chronic study, decreased food consumption with concurrent decreases in body weight and body weight gain were noted in the 250 mg/kg/day dose group. Minimal to moderate histologic test material-related effects in the kidney (proteinosis, papillary necrosis and karyomegaly) were noted in male rats at 250 mg/kg/day, while minimal to mild karyomegaly was noted in the kidney of female rats administered 1,4-DMN at dosages of 33 or 250 mg/kg/day. Based on the results of the chronic toxicity study, the NOAEL for chronic toxicity was 33 mg/kg/day for males and 10 mg/kg/day for females. For the carcinogenicity study, no incidences of carcinogenicity were noted in rats in any of the dose concentrations after the 97 weeks and 104 weeks of treatment for female and male rats, respectively.
Based on the results of the carcinogenicity data submitted for this expansion to the tolerance exemption, which showed that there was no evidence of carcinogenicity at the highest dose tested, 3,750 ppm (equivalent to 250 mg/kg/day), there are sufficient data and information to confirm that 1,4-DMN is not a carcinogen, and that consumption of food commodities that have been treated with this substance when used as a pesticide is safe and will not result in any harm to human health from dietary exposure.
In examining aggregate exposure, FFDCA section 408 directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).
Dietary risks to humans are considered negligible based on the lack of significant dietary toxicological endpoints for 1,4-DMN, its non-toxic mode of action, and the fact that it is applied to postharvest root, tuber, and bulb crops at the relatively low application rate of 20 ppm up to four applications during the storage season. No significant acute, subchronic, mutagenic, developmental, chronic, or carcinogenicity dietary toxicity hazards were identified in the studies submitted to support this expansion of the tolerance exemption or the previous tolerance exemption (60 FR 7456). The submitted data and information for this expansion of the tolerance exemption show that any residues of 1,4-DMN found in or on the sprouting root, tuber, and bulb crops are far below any toxicological endpoints identified in this expansion of the tolerance exemption or in the previous tolerance exemption (60 FR 7456) and confirm 1,4-DMN's lack of dietary toxicity hazards for mammals (Ref. 2).
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Based on the submitted data and information for this expansion of the tolerance exemption, any residues of 1,4-DMN found in or on the sprouting root, tuber, and bulb crops are far below any toxicological endpoints identified in this expansion of the tolerance exemption or in the previous tolerance exemption (60 FR 7456). These toxicological endpoints identified in Unit III of this final rule include: Maternal toxicity NOAEL of 80 mg/kg/day, developmental toxicity NOAEL greater than 250 mg/kg/day, reproductive toxicity NOAEL of 7,500 ppm (equivalent to 441 to 591 mg/kg/day in parental male and female rats and 776 to 839 mg/kg/day in F
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No new non-occupational exposure is expected to result from the new food uses of 1,4-DMN. No health risks are expected from any non-occupational exposure to 1,4-DMN based on the data submitted for the previous tolerance exemption (60 FR 7456) and for this expansion of the tolerance exemption.
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Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information concerning the cumulative effects of [a particular pesticide's] * * * residues and other substances that have a common mechanism of toxicity.”
EPA has not found 1,4-DMN to share a common mechanism of toxicity with any other substances, and 1,4-DMN does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that 1,4-DMN does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at
FFDCA section 408(b)(2)(C) provides that EPA shall assess the available information about consumption patterns among infants and children, special susceptibility of infants and children to pesticide chemical residues, and the cumulative effects on infants and children of the residues and other substances with a common mechanism of toxicity. In addition, FFDCA section 408(b)(2)(C) provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database unless EPA determines that a different margin of safety will be safe for infants and children. Margins of exposure (safety), which are often referred to as uncertainty factors, are incorporated into EPA risk assessments either directly or through the use of a margin of exposure analysis, or by using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk.
Relevant data and information submitted for the previous tolerance exemption (60 FR 7456) and for this expansion of the tolerance exemption indicate that 1,4-DMN has negligible acute, subchronic, mutagenic, developmental, chronic, or carcinogenicity toxicity hazards. Moreover, 1,4-DMN has a nontoxic mode of action and naturally occurs in various crops as listed in Unit IV.A.1. Therefore, the Agency concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to the residues of 1,4-DMN. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. EPA has arrived at this conclusion because the data and information available on 1,4-DMN do not demonstrate significant toxic potential to mammals. Thus, there are no threshold effects of concern and, as a result, an additional margin of safety is not necessary.
An analytical method is not required for enforcement purposes for the reasons stated above, and because EPA is establishing an exemption from the requirement of a tolerance without any numerical limitation.
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.
The Codex has not established a MRL for 1,4-DMN.
EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of 1,4-DMN. Therefore, the existing exemption from the requirement of a tolerance for residues of the plant growth regulator, 1,4-DMN, when applied postharvest to potatoes is amended by establishing the exemption from the requirement of a tolerance for residues of the plant growth regulator, 1,4-DMN, when applied postharvest to sprouting root, tuber, and bulb crops in accordance with good agricultural practices.
The following references used in this document and the previous Final Rule published in the
1. U.S. EPA. 2012. Memorandum from Gina M. Burnett to Colin Walsh. Science Review of Tolerance Petition 1F7920,
2. U.S. EPA. 2012. Memorandum from Russell S. Jones, Ph.D., to Colin Walsh. Science Review of Registrant's Response to Deficiencies in Tolerance Petition 1F7920, Intended to Expand the Use of 1,4-Dimethylnaphthalene to Include Use on All Root and Tuber Vegetables (Crop Group 01) and Bulb Vegetables (Crop Group 03); Label Amendments for 67727-1, -3 and -4 Upon Tolerance Amendment Approval. U.S. Environmental Protection Agency, Office of Pesticide Programs. June 21, 2012.
This final rule establishes an exemption from the requirement of a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1501
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
An exemption from the requirement of a tolerance is established for the residues of the plant growth regulator, 1,4-dimethylnaphthalene (1,4-DMN), when applied postharvest to all sprouting root, tuber, and bulb crops in accordance with good agricultural practices.
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, Federal Insurance and Mitigation
The NFIP enables property owners to purchase Federal flood insurance that is not otherwise generally available from private insurers. In return, communities agree to adopt and administer local floodplain management measures 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 the sale of NFIP flood insurance unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with program regulations, 44 CFR part 59. Accordingly, the communities will be suspended on the effective date in the third column. As of that date, flood insurance will no longer be available in the community. We recognize that some of these communities may adopt and submit the required documentation of legally enforceable floodplain management measures after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue to be eligible for the sale of NFIP flood insurance. A notice withdrawing the suspension of such communities will be published in the
In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that identifies the Special Flood Hazard Areas (SFHAs) in these communities. 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 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 FIRM for 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 procedures 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.
Accordingly, 44 CFR part 64 is amended as follows:
42 U.S.C. 4001
Defense Acquisition Regulations System, Department of Defense (DoD).
Interim rule.
DoD is issuing an interim rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement the United States-Panama Trade Promotion Agreement. This Trade Promotion Agreement is a free trade agreement that provides for mutually non-discriminatory treatment of eligible products and services from Panama.
Submit comments identified by DFARS Case 2012-D044, using any of the following methods:
Comments received generally will be posted without change to
Ms. Amy Williams, Defense Acquisition Regulations System, OUSD(AT&L)DPAP/DARS, Room 3B855, 3060 Defense Pentagon, Washington, DC 20301-3060. Telephone 571-372-6106.
This interim rule amends DFARS part 252 to implement the United States-Panama Trade Promotion Agreement Implementation Act (Pub. L. 112-43) (19 U.S.C. 3805 note).
This Trade Promotion Agreement is designated in the FAR as the Panama Free Trade Agreement (FTA). The FTA provides for—
• Waiver of the applicability of the Buy American statute (41 U.S.C. chapter 83) for some foreign supplies and construction materials from Panama; and
• Applicability of specified procurement procedures designed to ensure fairness in the acquisition of supplies and services (see FAR 25.408).
This interim rule adds Panama to the definition of “Free Trade Agreement country” in multiple locations in the DFARS. The Panama FTA covers acquisitions of supplies and services equal to or exceeding $202,000. The Panama FTA threshold for supplies and services is higher than the threshold for supplies and services for most of the FTAs ($77,494), and equals the Bahrain, Morocco, and Peru FTA thresholds for supplies and services ($202,000). Therefore, for acquisition less than $202,000 (or $100,000 for Korea), all FTAs are applicable except for the Bahrain, Korea, Morocco, Panama, and Peru FTAs.
Because the Panama FTA's construction threshold of $7,777,000 is the same as the WTO GPA threshold, no new clause alternates are required for the Balance of Payments Program—
There are also conforming changes to the clause at DFARS 252.212-7001, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Applicable to Defense Acquisitions of Commercial Items.
Executive Orders (E.O.s) 12866 and 13563 direct 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). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.
DoD does not expect this rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601,
DoD will also consider comments from small entities concerning the existing regulations in subparts affected by the rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (DFARS Case 2012-D044), in correspondence.
This rule affects the certification and information collection requirements in the provisions at DFARS 252.225-7020 and 252.225-7035, currently approved under OMB Control Number 0704-229, titled Defense Federal Acquisition Regulation Supplement part 225, Foreign Acquisition, and related clauses, in accordance with the Paperwork Reduction Act (44 U.S.C. chapter 35). The impact, however, is negligible, because it is just a question of under which category offered goods from Panama would be listed. The rule also affects DFARS 252.225-7018, which is a variant of the Buy American-trade agreements certifications already approved, which was issued as an interim rule under DFARS Case 2011-D046 (76 FR 78858, December 20, 2011).
A determination has been made under the authority of the Secretary of Defense that urgent and compelling reasons exist to promulgate this interim rule without prior opportunity for public comment. This action is necessary because the Free Trade Agreement with Panama, for which the President signed the implementing legislation into law on October 21, 2012 (Pub. L. 112-043), took effect on October 31, 2012. This is a reciprocal agreement, approved by Congress and the President of the United States. It is important for the United States Government to honor its new trade obligations to Panama, as Panama in turn honors the new trade obligations to the United States. However, pursuant to 41 U.S.C. 1707 and FAR 1.501-3(b), DoD will consider public comments received in response to this interim rule in the formation of the final rule.
Government procurement.
Therefore, 48 CFR part 252 is amended as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
The additions and revisions read as follows:
(a) * * *
“Panamanian photovoltaic device” means an article that—
(i) Is wholly manufactured in Panama; or
(ii) In the case of an article that consists in whole or in part of materials from another country, has been substantially transformed in Panama into a new and different article of commerce with a name, character, or use distinct from that of the article or articles from which it was transformed.
(c) * * *
(3) $77,494 or more but less than $100,000, then the Contractor shall utilize under this contract only domestic photovoltaic devices, qualifying country photovoltaic devices, or Free Trade Agreement country photovoltaic devices (other than Bahrainian, Korean, Moroccan, Panamanian, or Peruvian photovoltaic devices), unless, in its offer, it specified utilization of other foreign photovoltaic devices in paragraph (c)(4)(ii) of the Photovoltaic Devices—Certificate provision of the solicitation. If the Contractor certified in its offer that it will utilize a qualifying country photovoltaic device or a Free Trade
(4) $100,000 or more but less than $202,000, then the Contractor shall utilize under this contract only domestic photovoltaic devices, qualifying country photovoltaic devices, or Free Trade Agreement country photovoltaic devices (other than Bahrainian, Moroccan, Panamanian or Peruvian photovoltaic devices), unless, in its offer, it specified utilization of other foreign photovoltaic devices in paragraph (c)(4)(ii) of the Photovoltaic Devices—Certificate provision of the solicitation. If the Contractor certified in its offer that it will utilize a qualifying country photovoltaic device or a Free Trade Agreement country photovoltaic device (other than a Bahrainian, Moroccan, Panamanian, or Peruvian photovoltaic device), the Contractor shall utilize a qualifying country photovoltaic device; a Free Trade Agreement country photovoltaic device (other than a Bahrainian, Moroccan, Panamanian, or Peruvian photovoltaic device), or, at the Contractor's option, a domestic photovoltaic device; or
(a)
(c) * * *
(4) If $77,494 or more but less than $100,000—
__(i) The offeror certifies that each photovoltaic device to be utilized in performance of the contract is a domestic photovoltaic device; a qualifying country (except Australian or Canadian) photovoltaic device; a Free Trade Agreement country photovoltaic device (other than a Bahrainian, Korean, Moroccan, Panamanian, or Peruvian photovoltaic device) [
__(ii) The offered foreign photovoltaic devices (other than those from countries listed in paragraph (c)(4)(i) of this provision) are the product of ______. [
(5) If $100,000 or more but less than $202,000—
__(i) The offeror certifies that each photovoltaic device to be utilized in performance of the contract is a domestic photovoltaic device; a qualifying country (except Australian or Canadian) photovoltaic device; a Free Trade Agreement country photovoltaic device (other than a Bahrainian, Moroccan, Panamanian, or Peruvian photovoltaic device) [
__(ii) The offered foreign photovoltaic devices (other than those from countries listed in paragraph (c)(4)(i) of this provision) are the product of ______. [
(a) * * *
“Designated country” means—
(ii) A Free Trade Agreement country (Australia, Bahrain, Canada, Chile, Colombia, Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, Korea (Republic of), Mexico, Morocco, Nicaragua, Panama, Peru, or Singapore);
The revisions read as follows:
(a)
(b)
(1) Will evaluate offers in accordance with the policies and procedures of Part 225 of the Defense Federal Acquisition Regulation Supplement; and
(2) For line items subject to Free Trade Agreements, will evaluate offers of qualifying country end products or Free Trade Agreement country end products other than Bahrainian end products, Moroccan end products, Panamanian end products, or Peruvian end products without regard to the restrictions of the Buy American or the Balance of Payments Program.
(c)
(i) Each end product, except the end products listed in paragraph (c)(2) of this provision, is a domestic end product; and
(ii) Components of unknown origin are considered to have been mined, produced, or manufactured outside the United States or a qualifying country.
(2) The offeror shall identify all end products that are not domestic end products.
(i) The offeror certifies that the following supplies are qualifying country (except Australian or Canadian) end products:
(ii) The offeror certifies that the following supplies are Free Trade Agreement country end products other than Bahrainian end products, Moroccan end products, Panamanian end products or Peruvian end products:
(iii) The following supplies are other foreign end products, including end products manufactured in the United States that do not qualify as domestic end products, i.e., an end product that is not a COTS item and does not meet the component test in paragraph (ii) of the definition of “domestic end product”:
As prescribed in 225.1101(10)(ii), substitute the phrase “Canadian end product” for the phrases “Bahrainian end product,” “Free Trade Agreement country,” “Free Trade Agreement country end product,” “Moroccan end product,” “Panamanian end product,” and “Peruvian end products” in paragraph (a) of the basic provision; substitute the phrase “Canadian end products” for the phrase “Free Trade Agreement country end products other than Bahrainian end products, Moroccan end products, or Peruvian end products” in paragraphs (b)(2) and (c)(2)(ii) of the basic provision; and delete the phrase “Australian or” from paragraph (c)(2)(i) of the basic provision.
As prescribed in 225.1101(10)(iii), add the terms “South Caucasus/Central and South Asian (SC/CASA) state” and “South Caucasus/Central and South Asian (SC/CASA) state end product” in paragraph (a) and substitute the following paragraphs (b)(2) and (c)(2)(i) for paragraphs (b)(2) and (c)(2)(i) of the basic clause.
(b)(2) For line items subject to Free Trade Agreements, will evaluate offers of qualifying country end products, SC/CASA state end products, or Free Trade Agreement country end products other than Bahrainian end products, Moroccan end products, Panamanian end products, or Peruvian end products without regard to the restrictions of the Buy American or the Balance of Payments Program.
(c)(2)(i) The offeror certifies that the following supplies are qualifying country (except Australian or Canadian) or SC/CASA state end products:
As prescribed in 225.1101(10)(v), add a definition of “Korean end product” in paragraph (a) of the basic provision; substitute the phrase “Free Trade Agreement country end products other than Bahrainian end products, Korean end products, Moroccan end products, Panamanian end products, or Peruvian end products” for the phrase “Free Trade Agreement country end products other than Bahrainian end products, Moroccan end products, Panamanian end products, or Peruvian end products” in paragraphs (b)(2) and (c)(2)(ii) of the basic provision.
As prescribed in 225.1101(10)(vi), substitute the following paragraphs (a), (b)(2), (c)(2)(i), and (c)(2)(ii) for paragraphs (a), (b)(2), (c)(2)(i), and (c)(2)(ii) of the basic clause:
(a)
(b)(2) For line items subject to Free Trade Agreements, will evaluate offers of qualifying country end products, SC/CASA state end products, or Free Trade Agreement end products other than Bahrainian end products, Korean end products, Moroccan end products, Panamanian end products, or Peruvian end products without regard to the restrictions of the Buy American Act or the Balance of Payments Program.
(c)(2)(i) The offeror certifies that the following supplies are qualifying country (except Australian or Canadian) or SC/CASA state end products:
(ii) The offeror certifies that the following supplies are Free Trade Agreement country end products other than Bahrainian end products, Korean end products, Moroccan end products, Panamanian end products, or Peruvian end products:
The additions and revisions read as follows:
(a) * * *
“Panamanian end product” means an article that—
(i) Is wholly the growth, product, or manufacture of Panama; or
(ii) In the case of an article that consists in whole or in part of materials from another country, has been substantially transformed in Panama into a new and different article of commerce with a name, character, or use distinct from that of the article or articles from which it was transformed. The term refers to a product offered for purchase under a supply contract, but for purposes of calculating the value of the end product includes services (except transportation services) incidental to its supply, provided that the value of those incidental services does not exceed the value of the product itself.
(c) The Contractor shall deliver under this contract only domestic end
As prescribed in 225.1101(11)(i)(A), add the following new definitions to paragraph (a) and substitute the following paragraph (c) for paragraph (c) of the basic clause:
(a) “South Caucasus/Central and South Asian (SC/CASA) state” means Armenia, Azerbaijan, Georgia, Kazakhstan, Kyrgyzstan, Pakistan, Tajikistan, Turkmenistan, or Uzbekistan.
“South Caucasus/Central and South Asian (SC/CASA) state end product” means an article that—
(i) Is wholly the growth, product, or manufacture of an SC/CASA state; or
(ii) In the case of an article that consists in whole or in part of materials from another country, has been substantially transformed in an SC/CASA state into a new and different article of commerce with a name, character, or use distinct from that of the article or articles from which it was transformed. The term refers to a product offered for purchase under a supply contract, but for purposes of calculating the value of the end product includes services (except transportation services) incidental to its supply, provided that the value of those incidental services does not exceed the value of the product itself.
(c) The Contractor shall deliver under this contract only domestic end products unless, in its offer, it specified delivery of qualifying country end products, SC/CASA state end products, Free Trade Agreement country end products other than Bahrainian end products, Moroccan end products, Panamanian end products, or Peruvian end products, or other foreign end products in the Buy American—Free Trade Agreements—Balance of Payments Program Certificate provision of the solicitation. If the Contractor certified in its offer that it will deliver a qualifying country end product, SC/CASA state end products, or a Free Trade Agreement country end product other than a Bahrainian end product, a Moroccan end product, a Panamanian end product, or a Peruvian end product, the Contractor shall deliver a qualifying country end product, an SC/CASA state end product, a Free Trade Agreement country end product other than a Bahrainian end product, a Moroccan end product, a Panamanian end product, or a Peruvian end product or, at the Contractor's option, a domestic end product.
As prescribed in 225.1101(11)(i)(C), add the following definition to paragraph (a) and substitute the following paragraph (c) for paragraph (c) of the basic clause:
(a) “Korean end product” means an article that—
(i) Is wholly the growth, product, or manufacture of Korea; or
(ii) In the case of an article that consists in whole or in part of materials from another country, has been substantially transformed in Korea (Republic of) into a new and different article of commerce with a name, character, or use distinct from that of the article or articles from which it was transformed. The term refers to a product offered for purchase under a supply contract, but for purposes of calculating the value of the end product includes services (except transportation services) incidental to its supply, provided that the value of those incidental services does not exceed the value of the product itself.
(c) The Contractor shall deliver under this contract only domestic end products unless, in its offer, it specified delivery of qualifying country end products, Free Trade Agreement country end products other than Bahrainian end products, Korean end products, Moroccan end products, Panamanian end products, or Peruvian end products, or other foreign end products in the Buy American—Free Trade Agreements—Balance of Payments Program Certificate provision of the solicitation. If the Contractor certified in its offer that it will deliver a qualifying country end product or a Free Trade Agreement country end product other than a Bahrainian end product, a Korean end product, a Moroccan end product, a Panamanian end product, or a Peruvian end product, the Contractor shall deliver a qualifying country end product, a Free Trade Agreement country end product other than a Bahrainian end product, a Korean end product, a Moroccan end product, a Panamanian end product, or a Peruvian end product, or, at the Contractor's option, a domestic end product.
As prescribed in 225.1101(11)(i)(C), add the following new definitions to paragraph (a) and substitute the following paragraph (c) for paragraph (c) of the basic clause:
(a) “Korean end product” means an article that—
(i) Is wholly the growth, product, or manufacture of Korea; or
(ii) In the case of an article that consists in whole or in part of materials from another country, has been substantially transformed in Korea (Republic of) into a new and different article of commerce with a name, character, or use distinct from that of the article or articles from which it was transformed. The term refers to a product offered for purchase under a supply contract, but for purposes of calculating the value of the end product includes services (except transportation services) incidental to its supply, provided that the value of those incidental services does not exceed the value of the product itself.
“South Caucasus/Central and South Asian (SC/CASA) state” means Armenia, Azerbaijan, Georgia, Kazakhstan, Kyrgyzstan, Pakistan, Tajikistan, Turkmenistan, or Uzbekistan.
“South Caucasus/Central and South Asian (SC/CASA) state end product” means an article that—
(i) Is wholly the growth, product, or manufacture of an SC/CASA state; or
(ii) In the case of an article that consists in whole or in part of materials from another country, has been substantially transformed in an SC/CASA state into a new and different article of commerce with a name, character, or use distinct from that of the article or articles from which it was transformed. The term refers to a product offered for purchase under a supply contract, but for purposes of calculating the value of the end product includes services (except transportation services) incidental to its supply, provided that the value of those incidental services does not exceed the value of the product itself.
(c) The Contractor shall deliver under this contract only domestic end products unless, in its offer, it specified delivery of qualifying country end products, SC/CASA state end products, Free Trade Agreement country end products other than Bahrainian end products, Korean end products, Moroccan end products, Panamanian end products, or Peruvian end products, or other foreign end products in the Buy American—Free Trade Agreements—Balance of Payments Program Certificate provision of the solicitation. If the Contractor certified in its offer that it will deliver a qualifying country end product, SC/CASA state end products, or a Free Trade Agreement country end product other than a Bahrainian end product, a Korean end product, a Moroccan end product, a Panamanian end product, or a Peruvian end product, the Contractor shall deliver a qualifying country end product, an SC/CASA state end product, a Free Trade Agreement country end product other than a Bahrainian end product, a Korean end product, a Moroccan end product, a Panamanian end product, or a Peruvian end product or, at the Contractor's option, a domestic end product.
(a)
“Designated country” means—
(2) A Free Trade Agreement country (Australia, Bahrain, Canada, Chile, Colombia, Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, Korea (Republic of), Mexico, Morocco, Nicaragua, Panama, Peru, or Singapore);
Rural Utilities Service, USDA.
Proposed rule.
The Rural Utilities Service (RUS), a Rural Development agency of the United States Department of Agriculture (USDA), hereinafter referred to as RUS or the Agency, amends its regulations for the Community-Oriented Connectivity Broadband Grant Program (Community Connect Grant Program). The purpose of this regulatory change is to provide the Agency the ability to target limited resources to geographical as well as technological areas of need.
This rule is not applicable to Community Connect grant applications filed for funding prior to the publication of a Notice of Funds Availability (NOFA) under this regulation.
Comments must be submitted on or before January 15, 2013.
Submit comments by either of the following methods:
•
•
Additional information about the Agency and its programs is available on the Internet at
Kenneth Kuchno, Director, Broadband Division, USDA Rural Utilities Service, STOP 1599, 1400 Independence Avenue SW., Washington, DC 20250-1599, Telephone (202) 690-4673, Facsimile (202) 690-4389. Email address:
This rule has been determined to be not significant for purposes of Executive Order 12866, and therefore has not been reviewed by the Office of Management and Budget (OMB).
The Catalog of Federal Domestic Assistance (CFDA) Program number assigned to the Community Connect Grant Program is 10.863. The Catalog is available on the Internet at
This program is not subject to the requirements of Executive Order 12372, “Intergovernmental Review of Federal Programs,” as implemented under USDA's regulations at 7 CFR part 3015.
This rule has been reviewed under Executive Order 12988, Civil Justice Reform. The Agency has determined that this rule meets the applicable standards provided in section 3 of the Executive Order. In addition, all state and local laws and regulations that are in conflict with this rule will be preempted. No retroactive effect will be given to this rule and, in accordance with section 212(e) of the Department of Agriculture Reorganization Act of 1994 (7 U.S.C. 6912(e)), administrative appeal procedures, must be exhausted before an action against the Department or its agencies may be initiated.
The policies contained in this rule do not have any substantial direct effect on 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. Nor does this rule impose substantial direct compliance costs on state and local governments. Therefore, consultation with states is not required.
Pursuant to 5 U.S.C. 553(a)(2), this rule related to grants is exempt from the rulemaking requirements of the Administrative Procedure Act (5 U.S.C. 551
This rule contains no Federal mandates (under the regulatory provision of Title II of the Unfunded Mandates Reform Act of 1995) for State, local, and tribal governments or the private sector. Therefore, this final rule is not subject to the requirements of sections 202 and 205 of the Unfunded Mandates Reform Act of 1995.
This rule has been examined under Agency environmental regulations at 7 CFR part 1794. The Administrator has determined that this action is not a major Federal action significantly affecting the environment. Therefore, in accordance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321
This rule contains no new reporting or recordkeeping burdens under OMB control number 0572-0127 that would require approval under the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35).
Executive Order 13175 imposes requirements on Rural Development in the development of regulatory policies that have tribal implications or preempt tribal laws. Rural Development has determined that this proposed rule does not have a substantial direct effect on one or more Indian tribe(s) or on either the relationship or the distribution of powers and responsibilities between the Federal Government and Indian tribes. Additionally, two of the changes contained in this rule (rural eligibility based on a place recognized by the census or the Rand McNally
Rural Development is committed to the E-Government Act, which requires Government agencies in general to provide the public the option of submitting information or transacting business electronically to the maximum extent possible.
The Rural Utilities Service, a Rural Development agency of the United States Department of Agriculture (the Agency) works to improve the quality of life in rural America by providing investment capital, in the form of loans and grants, for the deployment of rural telecommunications, broadband, electric, water and environmental infrastructure. Financial assistance is provided to rural utilities; municipalities; commercial corporations; limited liability companies; public utility districts; Indian tribes; and cooperative, nonprofit, limited-dividend, or mutual associations. In order to achieve the goal of increasing economic opportunity in rural America, the Agency finances infrastructure that enables access to seamless, nation-wide telecommunications and broadband networks. With access to the same advanced telecommunications networks of its urban counterparts, especially broadband networks designed to accommodate distance learning, telework, e-government and telemedicine, rural America will see improving educational opportunities, health care, economies, safety and security, and ultimately higher employment. Of particular concern to the Agency are communities where broadband service is not available and where population densities are such that the cost of deployment to them is so high that build-out of infrastructure is unlikely. The Agency is committed to helping rural communities gain access to affordable, reliable, advanced communications services, comparable to those available throughout the rest of the United States, to provide a healthy, safe and prosperous place to live and work.
The Community Connect Grant Program was started as a Pilot Program. After administering the program as a pilot program for two years, the Agency proposed rules for the program and on July 28, 2004, the program was formally implemented. The regulations were amended to clarify, among other things, which rural communities are eligible under the program. The main purpose of this grant program is the construction of broadband facilities in areas where no broadband exists today with a secondary benefit of providing for a community center that provides free broadband service to all critical community facilities in the proposed funded service area for a two year period.
The new rule addresses several areas to streamline and improve the program for applicants and the Agency, with the goal of bringing broadband to unserved communities. The new rules provide flexibility to address the dynamic broadband needs of rural Americans and enhance the Agency's ability to target funds to areas where they are needed the most. The new rules also seek to make the application process easier for applicants and evaluators. For example, a single concise project summary and map can be used to inform USDA Rural Development State Directors of pending applications within their states as well as the general public. Major changes include:
1.
2.
3.
Broadband; Grant programs—Communications; Rural areas; Telecommunications; and Telephone.
For reasons set forth in the preamble, the Rural Utilities Service proposes to
1. Revise Part 1739 to read as follows:
Title III, Pub. L. 108-199, 118 Stat. 3.
(a) The provision of broadband service is vital to the economic development, education, health, and safety of rural Americans. The purpose of the Community Connect Grant Program is to provide financial assistance in the form of grants to eligible applicants that will provide, on a “community-oriented connectivity” basis, broadband service that fosters economic growth and delivers enhanced educational, health care, and public safety benefits. The Agency will give priority to rural areas that have the greatest need for broadband services, based on the criteria contained herein and in the Notice of Funds Availability (hereinafter referred to as NOFA) published in the
(b) Grant authority will be used for the deployment of service to all premises in eligible rural areas at the Broadband Grant Speed on a “community-oriented connectivity” basis. In addition to providing service to all premises the “community-oriented connectivity” concept will stimulate practical, everyday uses and applications of broadband by cultivating the deployment of new broadband services that improve economic development and provide enhanced educational and health care opportunities in rural areas. Such an approach will also give rural communities the opportunity to benefit from the advanced technologies that are necessary to achieve these goals.
(a) The Agency will periodically publish, (usually on an annual basis) in the
(b) Notwithstanding paragraph (a) of this section, the Agency may, in response to a surplus of qualified eligible applications which could not be funded from the previous fiscal year, decline to publish a NOFA for the following fiscal year and fund said applications without further public notice.
As used in this subpart:
(i) A city, town, or incorporated area that has a population of greater than 20,000 inhabitants; or
(ii) An urbanized area contiguous and adjacent to a city or town that has a population of greater than 50,000 inhabitants. For purposes of the definition of rural area, an urbanized area means a densely populated territory as defined in the latest decennial census of the U.S. Census Bureau.
Applicants shall complete a notification form which will be a public document that the RUS provides to USDA Rural Development State Directors and others in the state(s) of the proposed funded service area. The notification shall include a brief project description and the location of the proposed funded service area.
To be eligible for a Community Connect competitive grant, the applicant must:
(a) Be legally organized as an incorporated organization, an Indian tribe or tribal organization, as defined in 25 U.S.C. 450b(b) and (c), a state or local unit of government, or other legal entity, including cooperatives or private corporations or limited liability companies organized on a for-profit or not-for-profit basis.
(b) Have the legal capacity and authority to own and operate the broadband facilities as proposed in its application, to enter into contracts and to otherwise comply with applicable federal statutes and regulations.
(c) As required by the Office of Management and Budget (OMB), all applicants for grants must supply a Dun and Bradstreet Data Universal Numbering System (DUNS) number when applying. The Standard Form 424 (SF-424) contains a field for you to use when supplying your DUNS number. Obtaining a DUNS number costs nothing and requires a short telephone call to Dun and Bradstreet. Please see
(d) Register in the System for Award Management (SAM) (formerly Central Contractor Registry (CCR).
(1) In accordance with 2 CFR part 25, applicants, whether applying electronically or by paper, must be registered in the SAM prior to submitting an application. Applicants may register for the SAM at
(2) The SAM registration must remain active, with current information, at all times during which an entity has an application under consideration by an agency or has an active Federal Award. To remain registered in the SAM database after the initial registration, the applicant is required to review and update, on an annual basis from the date of initial registration or subsequent updates, its information in the SAM database to ensure it is current, accurate and complete.
To be eligible for a Community Connect competitive grant, the Project must:
(a) Serve a PFSA in which Broadband Service does not currently exist.;
(b) Offer service at the Broadband Grant Speed to all residential and business customers within the PFSA;
(c) Offer free service at the Broadband Grant Speed to all Critical Community Facilities located within the PFSA for at least 2 years starting from the time service becomes available to each Critical Community Facility; and
(d) Provide a Community Center with at least two (2) Computer Access Points and wireless access at the Broadband Grant Speed, free of all charges to all users for at least 2 years.
Grant funds may be used to finance the following:
(a) The construction, acquisition, or leasing of facilities, including spectrum, land or buildings, used to deploy service at the Broadband Grant Speed to all residential and business customers located within the Proposed Funded Service Area and all participating Critical Community Facilities, including funding for up to ten Computer Access Points to be used in the Community Center. Leasing costs will only be covered through the advance of funds period included in the award documents;
(b) The improvement, expansion, construction, or acquisition of a Community Center and provision of Computer Access Points. Grant funds for the Community Center will be limited to ten percent of the requested grant amount;
(c) The cost of providing the necessary bandwidth for service free of charge to the Critical Community Facilities for 2 years.
Operating expenses not specifically permitted in § 1739.12.
(a) At the time of closing of the award, the awardee must contribute or demonstrate available cash reserves in an account(s) of the awardee equal to at least 15% of the grant. Matching contributions must be used solely for the Project and shall not include any financial assistance from federal sources unless there is a federal statutory exception specifically authorizing the federal financial assistance to be considered as such. An applicant must provide evidence of its ability to comply with this requirement in its application.
(b) At the end of every calendar quarter, the award must submit a schedule to RUS that identifies how the match contribution was used to support the project until the total contribution is expended.
Applications should be prepared in conformance with the provisions of this part and all applicable USDA regulations, including 7 CFR parts 3015, 3016, and 3019. Applicants must also conform to the requirements of the individual NOFA to be published when funds are available for the program, and are advised to use the Agency's Application Guide for this program, found at the Agency's Web site. The application guide contains instructions and forms, as well as other important information needed to prepare an application and may be updated periodically. Paper copies of the application guide can be requested by contacting the, Director, Broadband Division at the following address: Stop 1599, South Agriculture Building, Room 2868, Washington, DC 20250. Completed applications must include the following documentation, studies, reports and information, in form and substance satisfactory to the Agency:
(a)
(b)
(1) A description of why the Project is needed;
(2) A description of the applicant;
(3) An explanation of the total Project costs;
(4) A general overview of the broadband telecommunications system to be developed, including the types of equipment, technologies, and facilities to be used;
(5) Documentation describing the procedures used to determine the unavailability of existing Broadband Service; and
(6) A list of the Critical Community Facilities that will take service from the Applicant at the Broadband Grant Speed, and evidence that any remaining Critical Community Facility located in the PFSA has rejected the offer;
(c)
(d)
(e)
(1) A map, submitted electronically through RUS' web-based Mapping Tool,
(2) The total population, number of households, and number of businesses located within the PFSA;
(f)
(1) The specific activities and services to be performed under the Project;
(2) Who will carry out the activities and services;
(3) A construction build-out schedule and project milestones, showing the time-frames for accomplishing the Project objectives and activities on a quarterly basis; and
(4) A budget for all capital and administrative expenditures reflecting the line item costs for Eligible Grant Purposes and other sources of funds necessary to complete the Project;
(g)
(1) A listing of all participating Critical Community Facilities to be connected. The applicant must also provide documentation that it has consulted with the appropriate agent of every Critical Community Facility in the PFSA, and must provide statements from each one as to its willingness to participate, or not to participate, in the proposed Project;
(2) A description of the services the applicant will make available to local residents and businesses; and
(3) A list of any other telecommunications provider (including interexchange carriers, cable television operators, enhanced service providers, wireless service providers and providers of satellite services) that is participating in the delivery of services and a description of the consultations and the anticipated role of such provider in the Project;
(h)
(1) If the applicant is an existing company, it must provide complete copies of audited financial statements, if available, for the two fiscal years preceding the application submission. If audited statements are unavailable, the applicant must submit unaudited financial statements for those fiscal years. Applications from start-up entities must, at minimum, provide an opening balance sheet dated within 30 days of the application submission date; and
(2) Annual financial projections in the form of balance sheets, income statements, and cash flow statements for a forecast period of five years, which prove the sustainability of the Project for that period and beyond. These projections must be inclusive of the applicant's existing operations and the Project, and must be supported by a detailed narrative that fully explains the methodology and assumptions used to develop the projections, including details on the number of subscribers projected to take the applicant's services. Applicants submitting multiple applications for funding must demonstrate that each Project is feasible and sustainable on its own, funds are available to cover each of the matching requirements and that all Projects for which funding is being requested are financially feasible as a whole;
(i)
(j)
(k)
(l)
(1) 7 CFR part 15, subpart A—Nondiscrimination in Federally Assisted Programs of the Department of Agriculture—Effectuation of Title VI of the Civil Rights Act of 1964;
(2) 7 CFR part 3015—Uniform Federal Assistance Regulations;
(3) 2 CFR part 417—Nonprocurement Debarment and Suspension;
(4) 7 CFR part 3018—New Restrictions on Lobbying;
(5) 2 CFR part 421—Requirements for Drug-Free Workplace (Financial Assistance);
(6) Certification regarding Architectural Barriers;
(7) Certification regarding Flood Hazard Precautions;
(8) An environmental report/questionare, in accordance with 7 CFR part 1794;
(9) A certification that grant funds will not be used to duplicate lines, facilities, or systems providing Broadband Service;
(10) Federal Obligation Certification on Delinquent Debt; and
(11) Assurance Regarding Felony Conviction or Tax Delinquent Status for Corporate Applicants.
(a) All applications for grants must be delivered to the Agency at the address and by the date specified in the NOFA (
(b) Incomplete applications as of the deadline for submission will not be considered. If an application is determined to be incomplete, the applicant will be notified in writing and the application will be returned with no further action.
(c) If the Agency determines that the Project is technically or financially infeasible or unsustainable, the Agency will notify the applicant, in writing, and the application will be returned with no further action.
(d) Applications conforming with this part will be evaluated competitively by the Agency and will be ranked in accordance with § 1739.17 below. Applications will then be awarded generally in rank order until all grant funds are expended, subject to subparagraphs (e) and (f) below.
(e) In addition to scoring, the Agency may take geographic distribution into consideration when making final award determinations.
(f) An award may be made out of rank order if a higher ranked application would require an award that exceeded available funding or would consume a disproportionate amount of funds available relative to its ranking.
(g) The Agency reserves the right to offer an applicant a lower amount than proposed in the application.
The ranking of the “community-oriented connectivity” benefits of the
(a) An analysis of the challenges of the following criteria, laid out on a community-wide basis, and how the Project proposes to address these issues (up to 50 point):
(1) The economic characteristics;
(2) Educational challenges;
(3) Health care needs; and
(4) Public safety issues;
(b) The extent of the Project's planning, development, and support by local residents, institutions, and Critical Community Facilities. Documentation must include evidence of community-wide involvement, as exemplified by community meetings, public forums, and surveys. In addition, applicants should provide evidence of local residents' participation in the Project planning and development (up to 40 points).
(c) The level of experience and past success of operating broadband systems for the management team. (up to 10 points)
(d) In making a final selection among and between applications with comparable rankings and geographic distribution, the Administrator may take into consideration the characteristics of the PFSA. Only information provided in the application will be considered. Applicants should therefore specifically address each of the following criteria to differentiate their applications:
(i) Persistent poverty counties that will be served within the PFSA;
(ii) Out-migration Communities that will be served within the PFSA;
(iii) The rurality of the PFSA;
(iv) The speed of service provided by the project;
(v) Substantially underserved trust areas that will be served within the PFSA;
(vi) Community members with disabilities that will be served within the PFSA; and
(vi) Any other additional factors that may be outlined in the NOFA.
The terms and conditions of grants shall be set forth in grant documents prepared by the Agency. The documents shall require the applicant to own all equipment and facilities financed by the grant. Among other matters, the Agency may prescribe conditions to the advance of funds that address concerns regarding the Project feasibility and sustainability. The Agency may also prescribe terms and conditions applicable to the construction and operation of the Project and the delivery of service at the Broadband Grant Speed to eligible Rural Areas, as well as other terms and conditions applicable to the individual Project. Dividend distributions will not be allowed until all grant funds and matching contributions have been expended.
(a) A project performance activity report will be required of all recipients on an annual basis until the Project is complete and the funds are expended by the applicant. The reporting period will start with the calendar year the award is made and continue for every calendar year through the term of the award. The report must be submitted by January 31 of the following year if the reporting period. Recipients are to submit an original and one copy of all project performance reports, including, but not limited to, the following:
(1) A comparison of actual accomplishments to the objectives established for that period;
(2) A description of any problems, delays, or adverse conditions which have occurred, or are anticipated, and which may affect the attainment of overall Project objectives, prevent the meeting of time schedules or objectives, or preclude the attainment of particular Project work elements during established time periods. This disclosure shall be accompanied by a statement of the action taken or planned to resolve the situation; and
(3) Objectives and timetable established for the next reporting period.
(b) A final project performance report must be provided by the recipient. It must provide an evaluation of the success of the Project in meeting the objectives of the program. The final report may serve as the last annual report.
(c) The Agency will monitor recipients, as it determines necessary, to assure that Projects are completed in accordance with the approved scope of work and that the grant is expended for Eligible Grant Purposes.
(d) Recipients shall diligently monitor performance to ensure that time schedules are being met, projected work within designated time periods is being accomplished, and other performance objectives are being achieved.
(e) The applicant must have the necessary processes and systems in place to comply with the reporting requirements for first-tier sub-awards and executive compensation under the Federal Funding Accountability and Transparency Act of 2006 in the event the applicant receives funding unless such applicant is exempt from such reporting requirements pursuant to 2 CFR part 170, § 170.110(b). The reporting requirements under the Transparency Act pursuant to 2 CFR part 170 are as follows:
(1) First Tier Sub-Awards of $25,000 or more in non-Recovery Act funds (unless they are exempt under 2 CFR part 170) must be reported by the Recipient to
(2) The Total Compensation of the Recipient's Executives (5 most highly compensated executives) must be reported by the Recipient (if the Recipient meets the criteria under 2 CFR part 170) to
(3) The Total Compensation of the Subrecipient's Executives (5 most highly compensated executives) must be reported by the Subrecipient (if the Subrecipient meets the criteria under 2 CFR part 170) to the Recipient by the end of the month following the month in which the subaward was made.
A grant recipient shall provide the Agency with an audit for each year in which a portion of the financial assistance is expended, in accordance with the following:
(a) If the recipient is a for-profit entity, an existing Telecommunications or Electric Borrower with the Agency, or any other entity not covered by the following paragraph, the recipient shall provide an independent audit report in accordance with 7 CFR part 1773, “Policy on Audits of the Agency's Borrowers.”
(b) If the recipient is a State or local government, or non-profit organization, the recipient shall provide an audit in accordance with 7 CFR part 3052, “Audits of States, Local Governments, and Non-Profit Organizations.”
The information collection requirements in this part are approved by the Office of Management and Budget (OMB) and assigned OMB control number 0572-0127.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to supersede an existing airworthiness directive (AD) that applies to all Airbus Model A330-200 and -300 series airplanes; and Model A340-200, -300, -500, and -600 series airplanes. The existing AD currently requires a one-time detailed inspection of both main landing gear (MLG) bogie beams in the region of the bogie stop pad for detection of deformation and damage, and corrective actions if necessary. Since we issued that AD, we have received reports of corroded bogie stop pads, including some with cracking. This proposed AD would add Model A330-200 Freighter series airplanes to the applicability. For certain airplanes, this proposed AD would also add repetitive inspections for damage and corrosion of the sliding piston sub-assembly, with new related investigative and corrective actions. We are proposing this AD to detect and correct deformation or damage under the bogie stop pad of both MLG bogie beams, which could result in a damaged bogie beam and consequent detachment of the beam from the airplane or collapse of the MLG and departure of the airplane from the runway.
We must receive comments on this proposed AD by December 31, 2012.
You may send comments by any of the following methods:
•
•
•
•
For service information identified in this proposed AD, contact Airbus SAS—Airworthiness Office—EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45 80; email
You may examine the AD docket on the Internet at
Vladimir Ulyanov, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone (425) 227-1138; fax (425) 227-1149.
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
On January 14, 2010, we issued AD 2010-02-10, Amendment 39-16181 (75 FR 4477, January 28, 2010). That AD required actions intended to address an unsafe condition on Airbus Model A330-200 and -300 series airplanes; and Model A340-200, -300, -500, and -600 series airplanes.
Since we issued AD 2010-02-10, Amendment 39-16181 (75 FR 4477, January 28, 2010), the European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA Airworthiness Directive 2011-0211, dated October 31, 2011 (referred to after this as “the MCAI”), to supersede EASA AD 2008-0223, dated December 15, 2008 (referred to in the existing AD), and correct an unsafe condition for the specified products. The MCAI states:
During a scheduled maintenance inspection on the MLG [main landing gear], the bogie stop pad was found deformed and cracked. Upon removal of the bogie stop pad for replacement, the bogie beam was also found cracked.
Laboratory investigation indicates that an overload event has occurred and no fatigue propagation of the crack was evident.
A second bogie beam crack has subsequently been found on another aeroplane, located under a bogie stop pad which only had superficial paint damage.
This condition, if not detected and corrected, could result in the aeroplane departing the runway or to the bogie detaching from the areoplane or gear collapses, which would all constitute unsafe conditions at speeds above 30 knots.
As a precautionary measure, EASA AD 2008-0223 [which corresponds to FAA AD 2010-02-10, Amendment 39-16181 (75 FR 4477, January 28, 2010] required one-time detailed inspections under the bogie stop pad of both MLG bogie beams and, in case deformation or damage is detected, to apply the associated repair.
Numerous bogie stop pad were found corroded and a few cracked as a result of the one-time inspection required by EASA AD 2008-0223 on A330, A340-200, and A340-300 aeroplanes.
For the reasons describe above, this [EASA] AD, which supersedes EASA AD 2008-0223:
The required actions include repetitive detailed inspections for
You may obtain further information by examining the MCAI in the AD docket.
Airbus has issued the following service bulletins:
• Airbus Mandatory Service Bulletin A330-32-3220, Revision 01, dated October 5, 2011 (for Model A330-200 and -300 series airplanes).
• Airbus Mandatory Service Bulletin A330-32-3248, including Appendix 1, dated October 5, 2011 (for Model A330-200, -200 Freighter, and -300 series airplanes).
• Airbus Mandatory Service Bulletin A340-32-4286, including Appendix 1, dated October 5, 2011 (for Model A340-200 and -300 series airplanes).
The actions described in this service information are intended to correct the unsafe condition identified in the MCAI.
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.
Although the service information specifies to contact the manufacturer for instructions to repair certain conditions, this proposed AD would require repairing those conditions using a method approved by the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the EASA (or its delegated agent).
Based on the service information, we estimate that this proposed AD would affect about 67 products of U.S. registry.
The actions that are required by AD 2010-02-10, Amendment 39-16181 (75 FR 4477, January 28, 2010), and retained in this proposed AD take about 2 work-hours per product, at an average labor rate of $85 per work hour. Based on these figures, the estimated cost of the currently required actions is $170 per product.
We estimate that it would take about 16 work-hours per product to comply with the new basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of the proposed AD on U.S. operators to be $91,120, or $1,360 per product.
We have received no definitive data that would enable us to provide cost estimates for the on-condition actions specified in this proposed AD.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
1. The authority citation for part 39 continues to read as follows:
49 U.S.C. 106(g), 40113, 44701.
2. The FAA amends § 39.13 by removing airworthiness directive (AD) 2010-02-10, Amendment 39-16181 (75 FR 4477, January 28, 2010), and adding the following new AD:
We must receive comments by December 31, 2012.
This AD supersedes AD 2010-02-10, Amendment 39-16181 (75 FR 4477, January 28, 2010).
This AD applies to all Airbus Model A330-201, -202, -203, -223, -223F, -243, -243F, -301, -302, -303, -321, -322, -323, -341, -342, and -343 series airplanes; and Model A340-211, -212, -213, -311, -312, -313 series airplanes; and A340-541 and -642 airplanes; certificated in any category; all serial numbers.
Air Transport Association (ATA) of America Code 32: Landing gear.
This AD was prompted by reports of corroded bogie stop pads, some with cracking. We are issuing this AD to detect and correct deformation or damage under the bogie stop pad of both main landing gear (MLG) bogie beams, which could result in a damaged bogie beam and consequent detachment of the beam from the airplane or collapse of the MLG and departure of the airplane from the runway.
You are responsible for having the actions required by this AD performed within the
This paragraph restates the requirements of paragraph (f)(1) of AD 2010-02-10, Amendment 39-16181 (75 FR 4477, January 28, 2010), with revised service information. For Model A330-200 and -300 series airplanes, and Model A340-200, -300, -500, and -600 series airplanes, except as required by paragraph (i) of this AD: At the applicable compliance time specified in paragraph (g)(1), (g)(2), (g)(3), (g)(4), (g)(5), or (g)(6) of this AD, perform one-time detailed inspections of both MLG bogie beams in the region of the bogie stop pad for detection of deformation and damage, and apply the applicable corrective actions, in accordance with the Accomplishment Instructions of the applicable service bulletin specified in paragraph (g)(7) of this AD. Do all applicable corrective actions before further flight.
(1) Airplanes with 22 months or less and 2,500 flight cycles or less from the first flight with the original bogie beam as of March 4, 2010 (the effective date of AD 2010-02-10, Amendment 39-16181 (75 FR 4477, January 28, 2010)): Not earlier than 2,500 flight cycles or 22 months on the original bogie beam, whichever occurs first, but not later than 40 months from first flight.
(2) Airplanes with 22 months or less and 2,500 flight cycles or less from the installation date of a new bogie beam in service as of March 4, 2010 (the effective date of AD 2010-02-10, Amendment 39-16181 (75 FR 4477, January 28, 2010)): Not earlier than 2,500 flight cycles or 22 months from the installation date of the new bogie beam, whichever occurs first, but not later than 40 months from the installation date of a new bogie beam in service.
(3) Airplanes with 22 months or less and 2,500 flight cycles or less from the installation date of an overhauled bogie beam in service as of March 4, 2010 (the effective date of AD 2010-02-10, Amendment 39-16181 (75 FR 4477, January 28, 2010)): Not earlier than 2,500 flight cycles or 22 months from the installation date of the overhauled bogie beam in service, whichever occurs first, but not later than 40 months from the installation date of the overhauled bogie beam in service.
(4) Airplanes with more than 22 months or more than 2,500 flight cycles from the first flight with the original bogie beam, as of March 4, 2010 (the effective date of AD 2010-02-10, Amendment 39-16181 (75 FR 4477, January 28, 2010)): Within 18 months after March 4, 2010 (the effective date of AD 2010-02-10).
(5) Airplanes with more than 22 months or more than 2,500 flight cycles from the installation date of a new bogie beam in service, as of March 4, 2010 (the effective date of AD 2010-02-10, Amendment 39-16181 (75 FR 4477, January 28, 2010)): Within 18 months after March 4, 2010 (the effective date of AD 2010-02-10).
(6) Airplanes with more than 22 months or more than 2,500 flight cycles from the installation date of an overhauled bogie beam in service, as of March 4, 2010 (the effective date of AD 2010-02-10, Amendment 39-16181 (75 FR 4477, January 28, 2010)): Within 18 months after March 4, 2010 (the effective date of AD 2010-02-10).
(7) Use the applicable service information to accomplish the actions required by paragraph (g) of this AD.
(i) For Model A330-200 and -300 series airplanes: Airbus Mandatory Service Bulletin A330-32-3220, dated October 10, 2008; or Airbus Mandatory Service Bulletin A330-32-3220, Revision 01, dated October 5, 2011.
(ii) For Model A340-200 and -300 series airplanes: Airbus Mandatory Service Bulletin A340-32-4264, dated October 10, 2008.
(iii) For Model A340-500 and -600 series airplanes: Airbus Mandatory Service Bulletin A340-32-5087, dated October 10, 2008.
This paragraph restates the requirements of paragraph (f)(2) of AD 2010-02-10, Amendment 39-16181 (75 FR 4477, January 28, 2010). Report the results of the inspection required by paragraph (g) of this AD, including no findings, to Airbus, Customer Services Directorate, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex France; Attn: SEDCC1 Technical Data and Documentation Services; fax (+33) 5 61 93 28 06; email
(1) If the inspection is done on or after March 4, 2010 (the effective date of AD 2010-02-10, Amendment 39-16181 (75 FR 4477, January 28, 2010)): Submit the report within 30 days after doing the inspection.
(2) If the inspection was done prior to March 4, 2010 (the effective date of AD 2010-02-10, Amendment 39-16181 (75 FR 4477, January 28, 2010)): Submit the report within 30 days after March 4, 2010 (the effective date of AD 2010-02-10).
For bogie beams on which the inspection required by paragraph (g) of this AD has not been accomplished as of the effective date of this AD: At the later of the times specified in paragraphs (i)(1) and (i)(2) of this AD, perform one-time detailed inspections of both main landing gear bogie beams in the region of the bogie stop pad for detection of deformation and damage, and apply the applicable corrective actions, in accordance with the Accomplishment Instructions of the applicable service information specified in paragraph (i)(3) of this AD. Do all applicable corrective actions before further flight.
(1) At the applicable time in paragraph (i)(1)(i) or (i)(1)(ii) of this AD.
(i) For bogie beams that have not been overhauled: Not earlier than 2,500 flight cycles or 22 months, whichever occurs first, on a bogie beam since its first flight on an airplane since new, but not later than 40 months since its first flight on an airplane since new.
(ii) For bogie beams that have been overhauled: Not earlier than 2,500 flight cycles or 22 months, whichever occurs first, on a bogie beam since its first flight on an airplane after its most recent overhaul, but not later than 40 months since its first flight on an airplane after its most recent overhaul.
(2) Within 90 days after the effective date of this AD.
(3) Use the applicable service information specified in paragraph (i)(3)(i), (i)(3)(ii), or (i)(3)(iii) of this AD, to accomplish the actions required by paragraph (i) of this AD.
(i) For Model A330-200 and -300 series airplanes: Airbus Mandatory Service Bulletin A330-32-3220, Revision 01, dated October 5, 2011.
(ii) For Model A340-200 and -300 series airplanes: Airbus Mandatory Service Bulletin A340-32-4264, dated October 10, 2008.
(iii) For Model A340-500 and -600 series airplanes: Airbus Mandatory Service Bulletin A340-32-5087, dated October 10, 2008.
Except for bogie beams that have been inspected as specified in Airbus Mandatory Service Bulletin A340-32-5087: At the later of the times specified in paragraphs (j)(1) and (j)(2) of this AD, do the detailed inspection of both MLG bogie beams in the bogie stop pad area for damage and corrosion, and all applicable related investigative and corrective actions, in accordance with the Accomplishment Instructions of Airbus Mandatory Service Bulletin A330-32-3248, dated October 5, 2011 (for Model A330-200, -200 Freighter, and -300 series airplanes); or Airbus Mandatory Service Bulletin A340-32-4286, dated October 5, 2011 (for Model A340-200 and -300 series airplanes); except as required by paragraph (k) of this AD. Do all applicable related investigative and corrective actions before further flight. Repeat the inspection thereafter at intervals not to exceed 2,500 flight cycles or 24 months, whichever is first.
(1) Within 2,500 flight cycles or 24 months, whichever occurs first, accumulated by a MLG bogie beam since its first flight after the most recent accomplishment of Airbus Mandatory Service Bulletin A330-32-3220 or A340-32-4264, as applicable.
(2) Within 3 months after the effective date of this AD.
If any cracking of the bogie beam is detected during any inspection or repair required by paragraph (j) of this AD, or any repair required by paragraph (j) of this AD is beyond the maximum repair allowance specified in the service information required by paragraph (j) of this AD: Before further flight, repair using a method approved by either the Manager, International Branch, ANM-116, Transport Airplane Directorate, FAA; or the European Aviation Safety Agency (EASA) (or its delegated agent).
Report the results of the initial inspection required by paragraph (j) of this AD, including both positive and negative findings, to Airbus, Customer Services Directorate, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex France; Attn: SEDCC1 Technical Data and Documentation Services; fax (+33) 5 61 93 28 06; email
(1) If the inspection is done on or after the effective date of this AD: Submit the report within 30 days after doing the inspection.
(2) If the inspection was done prior to the effective date of this AD: Submit the report within 30 days after the effective date of this AD.
The following provisions also apply to this AD:
(1)
(2)
(3)
Special flight permits, as described in Section 21.197 and Section 21.199 of the Federal Aviation Regulations (14 CFR 21.197 and 21.199), are not allowed if any crack is found during any inspection required by this AD.
(1) Refer to MCAI EASA Airworthiness Directive 2011-0211, dated October 1, 2011, and the service information specified in paragraphs (o)(1)(i) through (o)(1)(vi) of this AD, for related information.
(i) Airbus Mandatory Service Bulletin A330-32-3220, dated October 10, 2008.
(ii) Airbus Mandatory Service Bulletin A330-32-3220, Revision 01, dated October 5, 2011.
(iii) Airbus Mandatory Service Bulletin A330-32-3248, dated October 5, 2011.
(iv) Airbus Mandatory Service Bulletin A340-32-4264, dated October 10, 2008.
(v) Airbus Mandatory Service Bulletin A340-32-4286, dated October 5, 2011.
(vi) Airbus Mandatory Service Bulletin A340-32-5087, dated October 10, 2008.
(2) For service information identified in this AD, contact Airbus SAS—Airworthiness Office—EAL, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 45 80; email
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for all Rolls-Royce Deutschland Ltd & Co KG (RRD) BR700-710A1-10 and BR700-710A2-20 turbofan engines, and certain BR700-710C4-11 model engines. This proposed AD was prompted by RRD performing an evaluation that determined that certain high-pressure turbine (HPT) stage 1 and stage 2 discs from a specific supplier may contain steel inclusions that may cause the discs to fail before they reach their current life limits. This proposed AD would require reducing the life limits for certain HPT stage 1 and stage 2 discs. We are proposing this AD to prevent failure of the HPT stage 1 and stage 2 discs, which could result in uncontained failure of the engine and damage to the airplane.
We must receive comments on this proposed AD by January 15, 2013.
You may send comments by any of the following methods:
•
•
•
•
For service information identified in this proposed AD, contact Rolls-Royce Deutschland Ltd & Co KG, Eschenweg 11, Dahlewitz, 15827 Blankenfelde-Mahlow, Germany; phone: 49 0 33-7086-1883; fax: 49 0 33-7086-3276. You may view this service information at the FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7125.
You may examine the AD docket on the Internet at
Robert Morlath, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803; phone: 781-238-7154; fax: 781-238-7199; email:
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA AD 2012-0166, dated August 30, 2012 (referred to hereinafter as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:
The results of a recent quality review of high pressure turbine (HPT) stage 1 and stage 2 discs identified potential for steel inclusions in some production scale parts. Further investigation concluded that all affected parts were manufactured by Udimet 720I and melted by a certain supplier. Subsequent evaluation concluded that the affected parts life limitation values declared in the engine Time Limits Manual cannot be supported for discs with potential steel inclusion.
This condition, if not corrected, could lead to an uncontained HPT disc failure, potentially resulting in damage to, and/or reduced control of the aeroplane.
This product has been approved by the aviation authority of Germany, and is approved for operation in the United States. Pursuant to our bilateral agreement with Germany, they have notified us of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all information provided by EASA and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design. This proposed AD would require reducing the life limits for certain HPT stage 1 and HPT stage 2 discs that have a serial number listed in this proposed AD.
We estimate that this proposed AD would affect about 10 engines installed on airplanes of U.S. registry. Prorated parts life will cost about $210,000. Based on these figures, we estimate the cost of the proposed AD on U.S. operators to be $2,100,000. Our cost estimate is exclusive of possible warranty coverage.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and
3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
1. The authority citation for part 39 continues to read as follows:
49 U.S.C. 106(g), 40113, 44701.
2. The FAA amends § 39.13 by adding the following new AD:
We must receive comments by January 15, 2013.
None.
This AD applies to the following Rolls-Royce Deutschland Ltd & Co KG (RRD) turbofan engines that have any of the high-pressure turbine (HPT) stage 1 or stage 2 discs with a serial number (S/N) listed in Table 1 to paragraph (c) of this AD, installed:
(1) RRD BR700-710A1-10 and BR700-710A2-20 turbofan engines; and
(2) BR700-710C4-11 model engines that have hardware configuration standard 710C4-11 or 710C4-11/10 engraved on the engine data plate.
This AD was prompted by RRD performing an evaluation that determined that certain HPT stage 1 and stage 2 discs from a specific supplier may contain steel inclusions that may cause the discs to fail before they reach their current life limits. We are issuing this AD to prevent failure of the HPT stage 1 and stage 2 discs, which could result in uncontained failure of the engine and damage to the airplane.
Unless already done, remove from service the HPT stage 1 and stage 2 discs listed by S/N in Table 1 to paragraph (c) of this AD, at the following:
(1) For BR700-710A1-10, BR700-710A2-20, and BR700-710C4-11 engine models (without RRD Mod 72-101466), remove the HPT stage 1 and stage 2 discs from service before accumulating 3,000 cycles-since-new (CSN).
(2) For the BR700-710C4-11 engine model (with RRD Mod 72-101466), remove the HPT stage 1 and stage 2 discs from service before accumulating 2,300 CSN.
After the effective date of this AD, do not install an HPT stage 1 and an HPT stage 2 disc, identified by S/N in Table 1 to paragraph (c) of this AD, in the same engine.
The Manager, Engine Certification Office, may approve AMOCs for this AD. Use the procedures found in 14 CFR 39.19 to make your request.
(1) For more information about this AD, contact Robert Morlath, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803; phone: 781-238-7154; fax: 781-238-7199; email:
(2) Refer to European Aviation Safety Agency Airworthiness Directive 2012-0166, dated August 30, 2012, and Rolls-Royce Deutschland Ltd & Co KG Alert Service Bulletin SB-BR700-72-A900508, dated July 26, 2012, for related information. Contact Rolls-Royce Deutschland Ltd & Co KG, Eschenweg 11, Dahlewitz, 15827 Blankenfelde-Mahlow, Germany; phone: 49 0 33-7086-1883; fax: 49 0 33-7086-3276, for a copy of this service information.
(3) You may view this service information at the FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7125.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to amend Class E airspace at Hot Springs, SD. Additional controlled airspace is necessary to accommodate new Standard Instrument Approach Procedures (SIAPs) at Hot Springs Municipal Airport. The FAA is taking this action to enhance the safety and management of Instrument Flight Rules (IFR) operations for SIAPs at the airport. Geographic coordinates of the airport would also be updated.
0901 UTC. Comments must be received on or before December 31, 2012.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE., West Building Ground Floor, Room W12-140, Washington, DC 20590-0001. You must identify the docket number FAA-2012-0655/Airspace Docket No. 12-AGL-6, at the beginning of your comments. You may also submit comments through the Internet at
Scott Enander, Central Service Center, Operations Support Group, Federal Aviation Administration, Southwest Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone: (817) 321-7716.
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2012-0655/Airspace Docket No. 12-AGL-6.” The postcard will be date/time stamped and returned to the commenter.
An electronic copy of this document may be downloaded through the Internet at
You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Office (see
Persons interested in being placed on a mailing list for future NPRMs should contact the FAA's Office of Rulemaking (202) 267-9677, to request a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.
This action proposes to amend Title 14, Code of Federal Regulations (14 CFR), Part 71 by amending Class E airspace extending upward from 700 feet above the surface to accommodate new standard instrument approach procedures at Hot Springs Municipal Airport, Hot Springs, SD. Controlled airspace is needed for the safety and management of IFR operations at the airport. The airport's geographic coordinates also would be updated to coincide with the FAA's aeronautical database.
Class E airspace areas are published in Paragraph 6005 of FAA Order 7400.9W, dated August 8, 2012 and effective September 15, 2012, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document would be published subsequently in the Order.
The FAA has determined that this proposed 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. 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 U.S. Code. Subtitle 1, 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 would amend controlled airspace at Hot Springs Municipal Airport, Hot Springs, SD.
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (Air).
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
1. The authority citation for part 71 continues to read as follows:
49 U.S.C. 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9W, Airspace Designations and Reporting Points, dated August 8, 2012, and effective September 15, 2012, is amended as follows:
That airspace extending upward from 700 feet above the surface within a 7.4-mile radius of Hot Springs Municipal Airport, and within 2 miles each side of the 021° bearing from the airport extending from the 7.4-mile radius to 12.1 miles north of the airport.
Occupational Safety and Health Administration (OSHA), Labor.
Proposed rule; withdrawal.
With this notice, OSHA is withdrawing the proposed rule that accompanied its direct-final rule revising its Head Protection standards for general industry, shipyard employment, marine terminals, longshoring, and construction.
Effective November 16, 2012, the proposed rule published June 22, 2012 (77 FR 37617), is withdrawn.
OSHA is publishing a notice announcing this determination and confirming the effective date of the direct-final rule as September 20, 2012. Accordingly, OSHA is not proceeding with the proposed rule, and is withdrawing it from the rulemaking process.
Head protection, Occupational safety and health, Safety.
David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210, authorized the preparation of this document. OSHA is issuing this document pursuant to 29 U.S.C. 653, 655, and 657, 5 U.S.C. 553, Secretary of Labor's Order 1-2012 (77 FR 3912), and 29 CFR part 1911.
Coast Guard, DHS.
Notice of proposed rulemaking.
The Coast Guard proposes to establish a temporary safety zone encompassing certain waters of the Upper Potomac River. This action is necessary to provide for the safety of life on navigable waters during a fireworks display launched from a barge located within the Alexandria Channel at Washington, DC. This safety zone is intended to protect the maritime public in a portion of the Upper Potomac River.
Comments and related material must be received by the Coast Guard on or before December 17, 2012. If finalized, this rule would be effective from 10:30 p.m. on December 31, 2012 through 9 p.m. on January 1, 2013.
You may submit comments identified by docket number using any one of the following methods:
•
•
•
See the “Public Participation and Request for Comments” portion of the
If you have questions on this rule, call or email Mr. Ronald L. Houck, Sector Baltimore, Waterways Management Division, U.S. Coast Guard; telephone (410) 576-2674, email
We encourage you to participate in this rulemaking by submitting comments and related materials. All comments received will be posted without change to
If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online at
To submit your comment online, go to
If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8
To view comments, as well as documents mentioned in this preamble as being available in the docket, go to
Anyone can search the electronic form of comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review a Privacy Act notice regarding our public dockets in the January 17, 2008, issue of the
We do not now plan to hold a public meeting. But you may submit a request for one, using one of the methods specified under
This rule involves a New Years Eve fireworks display, an event that takes place in Alexandria, Virginia each year on December 31st and attracts thousands of spectators. This year, the launch site for the annual fireworks display is being moved from land to a discharge barge located on the Upper Potomac River. The permanent safety zone listed as Number 21 in the Table to 33 CFR 165.506 does not apply to this event.
First Night Alexandria, of Alexandria, Virginia, will conduct a fireworks display launched from a barge located on the Upper Potomac River, near Alexandria, Virginia, scheduled on December 31, 2012 at approximately 12 a.m. Midnight. If necessary, due to inclement weather, the fireworks display may be re-scheduled to take place on January 1, 2013 at approximately 8 p.m.
Fireworks displays are frequently held from locations on or near the navigable waters of the United States. The potential hazards associated with fireworks displays are a safety concern during such events. The purpose of this rule is to promote public and maritime safety during a fireworks display, and to protect mariners transiting the area from the potential hazards associated with a fireworks display, such as the accidental discharge of fireworks, dangerous projectiles, and falling hot embers or other debris. This rule is needed to ensure safety on the waterway before, during and after the scheduled event.
Through this regulation, the Coast Guard proposes to establish a temporary safety zone. The proposed zone would encompass all waters of the Upper Potomac River, Alexandria Channel, within a 200 yards radius of a fireworks discharge barge in approximate position latitude 38°48′40″ N, longitude 077°02′07″ W, located near the waterfront of Alexandria, Virginia. The temporary safety zone would be enforced from 10:30 p.m. on December 31, 2012 through 1 a.m. on January 1, 2013 and, if necessary due to inclement weather, from 6:30 p.m. through 9 p.m. on January 1, 2013.
The effect of this temporary safety zone would be to restrict navigation in the regulated area during, as well as the set up and take down of, the fireworks display. Vessels would be allowed to transit the waters of the Upper Potomac River outside the safety zone.
This rule would require that entry into or remaining in this safety zone is prohibited unless authorized by the Coast Guard Captain of the Port Baltimore. Vessels already at berth, mooring, or anchor in the safety zone at the time the safety zone is implemented would not have to depart the zone. All vessels underway within this safety zone at the time it is implemented would have to depart the zone. To seek permission to transit the area of the safety zone, the Captain of the Port Baltimore can be contacted at telephone number 410-576-2693 or on Marine Band Radio VHF-FM channel 16 (156.8 MHz). Coast Guard vessels enforcing the safety zone can be contacted on Marine Band Radio VHF-FM channel 16 (156.8 MHz). Federal, state, and local agencies may assist the Coast Guard in the enforcement of the safety zone. The Coast Guard will issue notices to the maritime community to further publicize the safety zone and notify the public of changes in the status of the zone. Such notices will continue until the event is complete.
We developed this proposed rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes or executive orders.
This proposed rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders. There is no vessel traffic associated with recreational boating and commercial fishing expected during the effective period.
Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered the impact of this proposed rule on small entities. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule will not have a significant economic impact on a substantial number of small entities. This proposed rule would affect the following entities, some of which might be small entities: the owners or operators of vessels intending to operate or transit through or within the safety zone during the enforcement period. Before the effective period, maritime advisories will be widely available to the maritime community.
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
This proposed rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on 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. We have analyzed this proposed rule under that Order and determined that this rule does not have implications for federalism.
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the “For Further Information Contact” section to coordinate protest activities so that your
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
This proposed rule would not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This proposed rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this proposed rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and would not create an environmental risk to health or risk to safety that might disproportionately affect children.
This proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
This proposed rule is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.
This proposed rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.
We have analyzed this proposed rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule involves establishing a temporary safety zone. This rule is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. A preliminary environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 165 as follows:
1. The authority citation for part 165 continues to read as follows:
33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1.
2. Add § 165.T05-0969 to read as follows:
(a)
(b)
(1) All persons are required to comply with the general regulations governing safety zones found in 33 CFR 165.23.
(2) Entry into or remaining in this zone is prohibited unless authorized by the Coast Guard Captain of the Port Baltimore. Vessels already at berth, mooring, or anchor at the time the safety zone is implemented do not have to depart the safety zone. All vessels underway within this safety zone at the time it is implemented are to depart the zone.
(3) Persons desiring to transit the area of the safety zone must first obtain authorization from the Captain of the Port Baltimore or his designated representative. To seek permission to transit the area, the Captain of the Port Baltimore and his designated representatives can be contacted at telephone number 410-576-2693 or on Marine Band Radio VHF-FM channel 16 (156.8 MHz). The Coast Guard vessels enforcing this section can be contacted on Marine Band Radio VHF-FM channel 16 (156.8 MHz). Upon being hailed by a U.S. Coast Guard vessel, or other Federal, State, or local agency vessel, by siren, radio, flashing light, or other means, the operator of a vessel shall proceed as directed. If permission is granted, all persons and vessels must comply with the instructions of the Captain of the Port Baltimore or his designated representative and proceed at the minimum speed necessary to maintain a safe course while within the zone.
(4)
(c)
(d)
Environmental Protection Agency (EPA).
Proposed rule; reopening of the comment period.
EPA is reopening the comment period for a notice of proposed rulemaking (NPR) published on September 7, 2012. In the NPR, EPA proposed approval of a revision to the Maryland State Implementation Plan (SIP) that would incorporate EPA's “Biomass Deferral” into the Maryland SIP. At the request of Community Research, (College Park, Maryland), EPA is reopening the comment period. Comments submitted between the close of the original comment period and the re-opening of this comment period will be accepted and considered.
The comment period for the proposed rule published on September 7, 2012 (77 FR 55171) is reopened through December 17, 2012. All comments received on or before December 17, 2012 will be entered into the public record and considered by EPA before taking final action on the proposed rule.
Submit your comments, identified by Docket ID Number EPA-R03-OAR-2012-0305 by one of the following methods:
A.
B.
C.
D.
Mr. David Talley, (215) 814-2117, or by email at
Federal Communications Commission.
Petition for reconsideration.
In this document, Petitions for Reconsideration (Petitions) have been filed in the Commission's rulemaking proceeding filed by Dale Woodin, Executive Director of American Society for Healthcare Engineering of American Hospital Association, on behalf of American Society for Healthcare Engineering of the American Hospital Association, and David R. Sidall, Esq., for DS Law PLLC, on behalf of Phillips Healthcare, Ari Q. Fitzgerald, Esq., for Hogan Lovells US LLP, on behalf of GE Healthcare, and William K. Keane, Esq., for Duane Morris LLP, on behalf of AFTRCC.
Oppositions to the Petitions must be filed on or before December 3, 2012. Replies to an opposition must be filed on or before December 11, 2012.
Federal Communications Commission, 445 12th Street SW., Washington, DC 20554.
Brian Butler, Policy and Rules Division, Office of Engineering and Technology, (202) 418-2702, email
This is a summary of Commission's document, Report No. 2966, released October 31, 2012. The full text of Report No. 2966 is available for viewing and copying in Room CY-B402, 445 12th Street SW., Washington, DC or may be purchased from the Commission's copy contractor, Best Copy and Printing, Inc. (BCPI) (1-800-378-3160). The Commission will not send a copy of this
Number of Petitions Filed: 2.
Federal Communications Commission.
Petition for reconsideration.
In this document, Petitions for Reconsideration (Petitions) have been filed in the Commission's rulemaking proceeding by Dennis Farrell, International Sales Manager of Navtech Radar Ltd., on behalf of Navtech Radar Ltd. and Bruce A. Olcott, for Squire Sanders LLP, on behalf of Honeywell International, Inc.
Oppositions to these Petitions must be filed on or before December 3, 2012. Replies to an opposition must be filed on or before December 11, 2012.
Federal Communications Commission, 445 12th Street SW., Washington, DC 20554.
Aamer Zain, Policy and Rules Division, Office of Engineering and Technology, (202) 418-2473, email
This is a summary of Commission's document, Report No. 2965, released October 31, 2012. The full text of Report No. 2965 is available for viewing and copying in Room CY-B402, 445 12th Street SW., Washington, DC or may be purchased from the Commission's copy contractor, Best Copy and Printing, Inc. (BCPI) (1-800-378-3160). The Commission will not send a copy of this
Federal Railroad Administration (FRA), Department of Transportation (DOT).
Announcement of technical symposium and extension of comment period.
On October 18, 2012, FRA published a Notice of Proposed Rulemaking (NPRM) on National Highway-Rail Crossing Inventory Reporting Requirements. In the NPRM, FRA announced that it would schedule a technical symposium to give interested parties the opportunity to discuss issues associated with the electronic submission of data to the U.S. DOT National Highway-Rail Crossing Inventory (Crossing Inventory). This notice announces the scheduling of the technical symposium. This notice also extends the NPRM comment period to allow time for interested parties to submit comments after the technical symposium.
The technical symposium will be held on December 13, 2012 in Washington, DC and will commence at 10 a.m. The comment period in this proceeding is extended to January 31, 2013.
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For information on facilities or services for persons with disabilities or to request special assistance at the meeting, please contact Larry Woolverton in FRA's Office of Railroad Safety, by telephone (202-493-6212) or email (
The purpose of the technical symposium is to facilitate discussion on technical issues associated with the electronic submission of data to the Crossing Inventory. The meeting is not intended as a forum for discussion or comment on any other aspects of the proposed rule. The proposed topics for discussion include the draft Instructions for Submitting U.S. DOT Crossing Inventory Data by Electronic Methods (Electronic Submission Instructions) referenced in the NPRM (and available in the docket at FRA-2011-0007-0005), proposed options for the submission of electronic crossing data to the Crossing Inventory, data formats that would be accepted for the submission of electronic crossing data to the Crossing Inventory, and the proposed timeframe and related concerns associated with meeting the proposed new requirements for the electronic submission of crossing data to the Crossing Inventory. In order to facilitate discussion at the technical symposium, FRA intends to supplement the docket with revised draft Electronic Submission Instructions prior to the symposium. The revised draft Electronic Submission Instructions will contain information on the proposed file formats and data specifications that would need to be followed when preparing electronic crossing data for submission to the Crossing Inventory. Therefore, interested parties are advised to review, prior to attending the technical symposium, the draft revised Electronic Submission Instructions that will be placed in the docket. Parties are reminded that the docket (No. FRA-2011-0007) can be accessed via the Internet at
A transcript of the technical symposium will be taken and placed in the public docket of this proceeding.
Any person wishing to participate in the technical symposium should notify FRA by telephone, email, or mail as provided in the Attendance section of this notice at least five business days prior to the date of the technical symposium. The notification should identify the docket number of this proceeding (Docket No. FRA-2011-0007), as well as the organization the person represents (if any) and the particular issues associated with electronic data submission that the person plans to address. The notification should also provide a phone number, mailing address, and email address (if applicable) at which the registrant can be reached.
To afford interested parties the opportunity to submit comments in response to views or information provided at the technical symposium, FRA is extending the comment period in this proceeding to January 31, 2013.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Proposed specifications; request for comments.
NMFS proposes specifications for the 2013 summer flounder, scup, and black sea bass fisheries, and the 2014 summer flounder and scup fisheries, and provides notice of two projects that may be requesting exempted fishing permits as part of the Mid-Atlantic Fishery Management Council's Research Set-Aside Program. The implementing regulations for the Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan require NMFS to publish specifications for the upcoming fishing year for each of these species and to provide an opportunity for public comment. Furthermore, regulations under the Magnuson-Stevens Fishery Conservation and Management Act require that NMFS allow the public an opportunity to comment on applications for exempted fishing permits. Accordingly, in addition to proposing catch specifications, NMFS announces exempted fishing permit requests, in accordance with the fishery management plan and Magnuson-Stevens Fishery Conservation and Management Act.
Comments must be received on or before December 3, 2012.
An environmental assessment (EA) was prepared for the specifications and describes the proposed action and other considered alternatives, and provides an analysis of the impacts of the proposed measures and alternatives. Copies of the Specifications Document, including the EA and the Initial Regulatory Flexibility Analysis (IRFA), are available on request from Dr. Christopher M. Moore, Executive Director, Mid-Atlantic Fishery Management Council, Suite 201, 800 North State Street, Dover, DE 19901. These documents are also accessible via the Internet at
You may submit comments, identified by NOAA-NMFS-2012-0201, by any one of the following methods:
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Moira Kelly, Fishery Policy Analyst, (978) 281-9218.
The Mid-Atlantic Fishery Management Council (Council) and the Atlantic States Marine Fisheries Commission (Commission) cooperatively manage the summer flounder, scup, and black sea bass fisheries. Fishery specifications in these fisheries include various catch and landing subdivisions, such as the commercial and recreational sector annual catch limits (ACLs), annual catch targets (ACTs), sector-specific landing limits (i.e., the commercial fishery quota and recreational harvest limit (RHL)), and research set-aside (RSA) established for the upcoming fishing year. An explanation of each subdivision appears later in this rule.
Rulemaking for measures used to manage the recreational fisheries for these three species occurs separately and typically takes place in the first quarter of the fishing year. The Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan (FMP) and its implementing regulations establish the Council's process for establishing specifications. All requirements of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), including the 10 national standards, also apply to specifications.
The management units specified in the FMP include summer flounder (
The Council's Scientific and Statistical Committee (SSC) met on July 25 and 26, 2012, to recommend acceptable biological catches (ABC) for the 2013-2015 summer flounder, scup, and black sea bass fisheries. The FMP's implementing regulations require the involvement of a monitoring committee in the specification process for each species. Since the Magnuson-Stevens Act requirements for the SSC to recommend ABC became effective, the monitoring committees' role has largely been to recommend any reduction in catch limits from the SSC-recommended ABCs to offset management uncertainty, and to recommend other management measures (e.g., mesh requirements, minimum commercial fish sizes, gear restrictions, possession restrictions, and area restrictions) needed for the efficient management of these three species' fisheries. The Summer Flounder, Scup, and Black Sea Bass Monitoring Committees met on July 27, 2012, to discuss specification-related recommendations for the three fisheries.
Following the SSC and Monitoring Committee meetings, the Council and the Commission's Summer Flounder, Scup, and Black Sea Bass Management Board (Board) considered the recommendations of the SSC, the three monitoring committees, and public comments, and made their specification recommendations at a meeting held on August 15, 2012. While the Board action was finalized at the August meeting, the Council's recommendations must be reviewed by NMFS to ensure that they comply with the FMP and applicable law. NMFS also must conduct notice-and-comment rulemaking to propose and implement the final specifications.
The FMP also contains formulas to divide the specification catch limits into commercial and recreational fishery allocations, state-by-state quotas, and quota periods, depending on the species in question. The FMP allocation provisions cannot be modified through the specification process. Rather, the Council would be required to develop and recommend allocation changes by amending the FMP. This proposed rule outlines the application of the existing allocation provisions for each species and provides the resulting allocations, by state and sector, as appropriate, for each species.
In 2001, NMFS implemented regulations under Framework Adjustment 1 to the FMP to allow up to 3 percent of the total allowable landings (TAL) for each species to be set aside each year to support scientific research. NMFS intends to conditionally approve two research projects to harvest a portion of the set-aside quota that has been recommended by the Council and the Commission. In anticipation of receiving applications for exempted fishing permits (EFP) to conduct this research and harvest set-aside quota, the Assistant Regional Administrator for Sustainable Fisheries, Northeast Region, NMFS (Assistant Regional Administrator), has made a preliminary determination that the activities authorized under the EFPs would be consistent with the goals and objectives of the FMP. However, further review and consultation may be necessary before a final determination is made to issue any EFP.
For informational purposes, these proposed specifications include a statement indicating the amount of quota that has been preliminarily set aside for research purposes (a percentage of the TAL for each fishery, not to exceed 3 percent, as recommended by the Council and Board), and a brief description of the likely 2013 Mid-Atlantic RSA projects, including exemptions that will likely be required to conduct the proposed research. The RSA amounts may be adjusted, following consultation with RSA applicants, in the final rule establishing the 2013 specifications for the summer flounder, scup, black sea bass, longfin squid, butterfish, and Atlantic bluefish fisheries. If the total amount of available RSA is not awarded, NMFS will publish a document in the
For 2013, the conditionally approved projects may collectively be awarded up to the following amounts of RSA: 589,880 lb (267.6 mt) of summer flounder; 961,200 lb (436 mt) of scup; 111,900 lb (51 mt) of black sea bass; 1,1453,711 lb of longfin squid; 332,898 lb of butterfish; and 715,830 lb of bluefish. For 2014, projects may collectively be awarded up to 587,100 lb (266 mt) of summer flounder and 896,100 lb (404 mt) of scup. The harvest of RSA quota would occur January 1-December 31, 2013, and January 1-December 31, 2014, by vessels conducting compensation fishing.
Project number two is a fishery-independent black sea bass survey of four separate hard bottom sites in Southern New England and Mid‐Atlantic waters. Unvented black sea bass pots would be fished on each site for 5 months from June through October in Southern New England, and April through August in the Mid‐Atlantic. The project is designed to collect black sea bass from areas un‐sampled by current state and Federal finfish bottom trawl surveys. The length frequency distribution of the catch will be compared statistically to each of the other collection sites, and to finfish trawl data collected by NMFS and state agencies. Black sea bass would be collected from four general zones along the coast utilizing black sea bass pots made with coated wire mesh, single mesh entry head, and single mesh inverted parlor nozzle. The four general zones will include one in Massachusetts, one south of Rhode Island, one south of New Jersey, and one south of Virginia. This particular configuration is being proposed as it generally corresponds to the northern and southern core range of the species, and each is an area in which a major black sea bass fishery takes place. In each of these general zones, four individual sampling sites would be selected, each of which would be 1 square mile (2.6 km
Research vessels for project number two would require an EFP for exemption from minimum scup and black sea bass pot vent size requirements to ensure that black sea bass length frequency data are representative and not biased. If a participating vessel holds a Federal lobster permit, it would need exemption from lobster pot vent size requirements. Exemption from scup and black sea bass closures and time restrictions would also be needed to ensure the survey is not disrupted by such regulations. Exemption from scup and black sea bass minimum fish sizes and possession limits would also be needed for data collection purposes only. All undersized fish would be discarded as soon as practicable to minimize mortality, and fish in excess of possession limits would either be discarded as soon as practicable or landed as RSA quota.
The summer flounder stock was declared rebuilt in 2011. The stock assessment update utilized to derive specification recommendations indicates that summer flounder were not overfished and that overfishing did not occur in 2011, the most recent year of available data. This stock assessment update did, however, indicate that biomass is currently lower than in recent years. This results in catch limits that are lower than 2012 (Table 1).
The overfishing limit (OFL) for 2012 was estimated to be 29.81 million lb (13,523 mt). Based on this information, the SSC recommended to the Council that the 2013 ABC for summer flounder be set no higher than 22.34 million lb (10,133 mt), and, using a strategy of a constant fishing rate, that the 2014 ABC for summer flounder be set no higher than 22.24 million lb (10,088 mt). The SSC did not provide an ABC recommendation for 2015 because it is expected that a benchmark assessment for summer flounder will be conducted in 2013 and it would be more appropriate to wait for that assessment before making a 2015 recommendation.
Consistent with the summer flounder regulations, the sum of the recreational and commercial sector ACLs is equal to ABC. ACL is an expression of total catch (i.e., landings and dead discarded fish). To derive the ACLs, the sum of the sector-specific estimated discards is removed from the ABC to derive the landing allowance. The resulting landing allowance is apportioned to the commercial and recreational sectors by applying the FMP allocation criteria: 60 percent to the commercial fishery and 40 percent to the recreational fishery. Using this method ensures that each sector is accountable for its respective discards, rather than simply apportioning the ABC by the allocation percentages to derive the sector ACLs. Although the derived ACLs are not split exactly at 60/40, the landing portions of the ACLs preserve the 60/40 allocation split, consistent with the FMP. This process results in a commercial ACL of 12.11 million lb (5,491 mt) for 2013 and 12.05 million lb (5,467 mt) for 2014. The recreational ACLs would be 10.23 million lb (4,642 mt) for 2013 and 10.19 million lb (4,621 mt) for 2014.
The Summer Flounder Monitoring Committee met to discuss the SSC's recommendations and to determine if additional reductions in the catch limits were necessary to account for management uncertainty. Because the recreational fishery in recent years has not reached the RHL, discards in the commercial fishery have been relatively low, and the landings monitoring and fishery closure system is timely, the Summer Flounder Monitoring Committee determined that no additional reductions to account for management uncertainty were necessary. Therefore, it was recommended that the ACTs (both commercial and recreational) should be set equal to their respective ACL for both 2013 and 2014. Removing the estimated discards and, as recommended, 3 percent of the TAL for RSA, the commercial summer flounder quotas would be 11.44 million lb (5,189 mt) for 2013 and 11.39 million lb (5,166 mt) for 2014. The RHLs would be 7.63 million lb (3,459 mt) for 2013 and 7.59 million lb (3,444 mt) for 2014.
The Council and Board considered the SSC and Summer Flounder Monitoring Committee recommendations before concurring with the catch recommendations specified in Table 2. Fishing under these catch limits for 2013 and 2014 is not expected to compromise the summer flounder stock, nor will fishing at this level present a high likelihood of overfishing the stock. The Council recommended all other management measures by remain status quo.
Tables 3 and 4 present the proposed allocations for 2013 and 2014, respectively, by state, with and without the commercial portion of the RSA deduction. These state quota allocations are preliminary and are subject to reductions if there are overages of states' quotas carried over from a previous fishing year. Any commercial quota adjustments to account for overages will be included in the final rule implementing these specifications.
The OFL for scup is 47.80 million lb (21,680 mt). Using the appropriate control rule and applying the Council's risk policy, the SSC recommended an ABC for scup of 38.71 million lb (17,557 mt) for 2013. The SSC also recommended a constant fishing mortality strategy for scup, using a rate of 0.142, which results in a 2014 ABC of 35.99 million lb (16,325 mt). Similar to summer flounder, the stock assessment update upon which the specifications are based indicates that scup biomass is currently lower than in recent years. Therefore, the proposed catch limits are lower than 2012, but are still relatively high compared to recent landings.
The scup management measures specify that the ABC is equal to the sum of the commercial and recreational sector ACLs. The Scup Monitoring Committee met to discuss the SSC's recommendations and to determine if additional reductions in the catch limits were necessary to account for management uncertainty. Because both the recreational and commercial fisheries have not reached their respective landings limits because of the very high quotas, and the landings monitoring and fishery closure system is timely, the Monitoring Committee determined that no additional reductions to account for management uncertainty were necessary. Therefore, it was recommended that the ACTs (both commercial and recreational) should be set equal to the respective ACL for 2013-2014. Therefore, commercial sector ACL/ACT would be 30.19 million lb (13,694 mt) for 2013 and 28.07 million lb (12,734 mt) for 2014. The recreational sector ACLs/ACTs would be 8.52 million lb (3,863 mt), and 7.92 million lb (3,592 mt) for 2013 and 2014, respectively.
The Council recommended up to 3 percent of the landings for RSA. After RSA is removed, the commercial quotas would be 23.53 million lb (10,671 mt) for 2013 and 21.95 million lb (9,955 mt) for 2014. The recreational harvest limits would be 7.55 million lb (3,425 mt) for 2013 and 7.03 million lb (3,188 mt) for 2014.
The scup commercial quota is divided into three commercial fishery quota periods. There are no previous commercial overages applicable to the 2013 scup commercial quota. The period quotas, after deducting for RSA, are detailed in tables 6 and 7. Unused Winter I quota may be carried over for use in the Winter II period. The Council recommended all other management measures remain status quo.
The updated stock assessment indicates that black sea bass were not overfished and overfishing did not occur in 2011. Black sea bass remains a data-poor stock, with relatively high uncertainty for the purposes of calculating ABC. The SSC rejected the OFL estimate provided from the stock assessment, stating that it was highly uncertain and not sufficiently reliable to use as the basis of management advice. The ABC recommendation is the status quo ABC of 4.50 million lb (2,041 mt). The SSC recommended a 3-year specification period, with a constant harvest strategy that would implement the same ABC for 2013-2015. However, the Council only endorsed the ABC for 2013, and recommended the ACL, ACT, and quotas for 2013 only. The Council was concerned with the SSC's determination that black sea bass was a “Level 4” fishery under the Council's ABC control rule, despite some data improvements that may have led to a “Level 3” determination that could result in higher catch limits. The SSC debated the categorization of black sea bass extensively at its July meeting, but in the end determined that continuing the Level 4 designation was appropriate. The Council decided to recommend specifications for just 2013 in the hope that additional information will be available for the SSC in the coming year.
The Black Sea Bass Monitoring Committee met to discuss the SSC's recommendations and to determine if additional reductions in the catch limits were necessary to account for management uncertainty. The Monitoring Committee determined that no additional reductions to account for management uncertainty were necessary because the constant catch strategy adequately addresses uncertainty. Therefore, it was recommended that the ACTs (both commercial and recreational) should be set equal to their respective ACL for 2013.
The Council and Board considered the SSC and Black Sea Bass Monitoring Committee recommendations at their August meeting. The Council recommends a commercial ACL and ACT of 2.13 million lb (966 mt), a recreational ACL and ACT of 2.37 million lb (1,075 mt), a commercial quota of 1.78 million lb (805 mt), and an RHL of 1.85 million lb (838 mt). The quotas include a reduction of 3 percent, as recommended by the Council, for RSA. While the ABC is the same as last year, the ACL/ACTs and quotas are different from 2012 because the updated discard estimate is higher than the previous year.
Recent data indicate that the 2012 recreational black sea bass ACL has been exceeded, and may be further exceeded, by a significant amount. The regulations require that we deduct the amount of landings that exceeded the RHL from a single subsequent year's ACT. Therefore, the proposed ACT and RHL may be adjusted in the final rule to account for this overage.
Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this proposed rule is consistent with the Summer Flounder, Scup, and Black Sea Bass FMP, other provisions of the Magnuson-Stevens Act, and other applicable law, subject to further consideration after public comment.
These proposed specifications are exempt from review under Executive Order 12866.
An IRFA was prepared by the Council, as required by section 603 of the Regulatory Flexibility Act (RFA), to examine the impacts of these proposed specifications on small business entities, if adopted. A description of the specifications, why they are being considered, and the legal basis for proposing and implementing specifications for the summer flounder, scup, and black sea bass fisheries are contained in the preamble to this proposed rule. A copy of the detailed RFA analysis is available from NMFS or the Council (see ADDRESSES). The Council's analysis made use of quantitative approaches when possible. Where quantitative data on revenues or other business-related metrics that would provide insight to potential impacts were not available to inform the
Small businesses operating in commercial and recreational (i.e., party and charter vessel operations) fisheries have been defined by the Small Business Administration as firms with gross revenues of up to $4.0 and $6.5 million, respectively.
The Council estimates that the proposed 2013-2014 specifications could affect 2,039 vessels that held a Federal summer flounder, scup, and/or black sea bass permit in 2011 (the most recent year of complete permit data). However, the more immediate impact of this rule will likely be realized by the approximately 870 vessels that actively participated in these fisheries (i.e., landed these species) in 2011. Estimates of costs associated with this rule are discussed further below.
There are no new reporting or recordkeeping requirements contained in any of the alternatives considered for this action. In addition, NMFS is not aware of any relevant Federal rules that may duplicate, overlap, or conflict with this proposed rule.
If the Council took no action regarding the 2013 specifications, several indefinite measures would remain in effect until otherwise changed; however, many components of the 2012 specifications expire on December 31, 2012. These include catch limits for all three species. There are no roll-over provisions for the quotas if the 2013 specifications are not made effective, and so, without specified quotas, NMFS would have no mechanism to close fisheries if management limits were exceeded. This would give rise to a situation in which the goals and objectives of the FMP, its implementing regulations, and the Magnuson-Stevens Act would all be violated. Therefore, the no action alternative is not considered to be a reasonable alternative to the preferred action of developing and implementing 2013 specifications, and it was excluded from detailed analysis in the Council's EA/RFA analyses.
The Council analyzed three sets of combined catch limit alternatives for the 2013-2014 summer flounder, scup, and black sea bass fisheries. Of these, one alternative, labeled Alternative 3 for each species, contained the most restrictive options (i.e., lowest total landing levels). While the Alternative 3 measures would achieve the objectives of the proposed action for each of three species, they have the highest potential adverse economic impacts on small entities in the form of potential foregone fishing opportunities. Alternative 3 was not preferred by the Council because the other alternatives considered are expected have lower adverse impacts on small entities while achieving the stated objectives of sustaining the summer flounder, scup, and black sea bass stocks, consistent with the FMP and Magnuson-Stevens Act.
Alternative 1 (Council's preferred) would implement the following ABCs in 2013: Summer flounder, 22.34 million lb (10,133 mt); scup, 38.71 million lb (17,577 mt); and black sea bass, 4.5 million lb (2,041 mt). Alternative 1 would also implement the following ABCs for 2014: Summer flounder, 22.40 million lb (10,088 mt), and scup, 35.99 million lb (16,325 mt). Alternative 2 (status quo) would implement the following ABCs in 2013 and 2014: Summer flounder, 25.58 million lb (11,603 mt); scup, 40.88 million lb (18,543 mt); and black sea bass (2013 only), 4.5 million lb (2,041 mt).
As a result of the proposed decrease in commercial and recreational landings from 2012 levels, it is expected that small negative economic impacts on the summer flounder fisheries in 2013 and 2014 may occur. Each state's summer flounder allocation commercial limits will decrease under these adjusted commercial quotas. The proposed scup commercial quota and recreational harvest limits under the proposed alternative are lower than the quotas implemented in 2012; however, they are substantially higher than the 2011 commercial and recreational landings. In 2011, the commercial quota and recreational harvest limit each increased by 91 percent when compared to the limits implemented in 2010. The high 2011 commercial quota and recreational harvest limit values did not constrain the fishery in 2011 as had occurred in previous years when the commercial quota and recreational harvest limits were considerably lower. In fact, the scup fishery did not harvest its full 2011 allocation. Unless market conditions change substantially in 2013, it would be expected that commercial and recreational landings will likely be close to the 2011 landings. There is no indication that the market environment for commercially and recreationally caught scup will change considerably in years 2013 or 2014. Therefore, there are no expected negative impacts from the proposed scup quotas, even though they are lower than the previous year. As a result of the potential increase in landings under the black sea bass commercial quota and recreational harvest limits under preferred alternative 1, it is expected that a small positive economic impacts are likely to occur when compared to 2012.
While the specifications proposed would establish a 2013 and 2014 recreational harvest limit for summer flounder, scup, and black sea bass, the management measure details for recreational fisheries will be developed by the Council in December 2012, followed by NMFS rulemaking in the first quarter of 2013. A comprehensive analysis of the impacts associated with the recommended recreational management measures will be provided to NMFS from the Council to support these activities. If recreational landings for these three species are the same in 2012 as in 2011 (5.96 million lb for summer flounder, 3.66 million lb for scup, and 1.27 million for black sea bass), the recreational harvest limits proposed for 2013 (7.62 million lb for summer flounder, 7.56 million for scup, and 1.84 million for black sea bass) and 2014 (6.12 million lb for summer flounder and 3.01 million for scup) are not expected to constrain recreational landings in 2013, but may constrain summer flounder recreational landings in 2014. As such, it is unlikely that more restrictive limits (i.e., lower possession limits, higher minimum size limits, and/or shorter open seasons) will be required in 2013 when compared to 2012, but more restrictive recreational harvest measures may be necessary in 2014 for summer flounder. Specific recreational management measures (for all three species) will be determined in December when more complete data regarding 2012 recreational landings are available.
The Council selected Alternative 1 (preferred) over Alternative 2 (status quo) and Alternative 3 (most restrictive) stating that, while each alternative would provide adequate stock protection, the Alternative 1 measures were expected to result in the least amount of long-term negative economic impact to the summer flounder, scup,
16 U.S.C. 1801
National Agricultural Statistics Service, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the intention the National Agricultural Statistics Service (NASS) to request revision and extension of a currently approved information collection, the Cold Storage Survey. Revision to burden hours will be needed due to changes in the size of the target population, expected increases in response rates, and modes of data collection. The questionnaires have had some minor modifications to accommodate changes in the products stored by the industry, and to make the questionnaires easier to complete. The target population for cold storage operators (both mandatory and voluntary samples) will be contacted for this data on a monthly basis. Fruit storage operations are contacted on a monthly basis. The capacity survey is conduced once every other year of all operations with refrigerated storage capacity. Most of these surveys are voluntary; the one exception is for operations that store certain manufactured dairy products that are required by Public Law No. 106-532 and 107-171 to respond.
Comments on this notice must be received by January 15, 2013 to be assured of consideration.
You may submit comments, identified by docket number 0535-0001, by any of the following methods:
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Joseph T. Reilly, Associate Administrator, National Agricultural Statistics Service, U.S. Department of Agriculture, (202) 720-4333.
The monthly Cold Storage Survey provides information on national supplies of food commodities in refrigerated storage facilities. A biennial survey of refrigerated warehouse capacity is also conducted to provide a benchmark of the capacity available for refrigerated storage of the nation's food supply. Information on stocks of food commodities that are in refrigerated facilitates have a major impact on the price, marketing, processing, and distribution of agricultural products.
NASS also complies with OMB Implementation Guidance, “Implementation Guidance for Title V of the E-Government Act, Confidential Information Protection and Statistical Efficiency Act of 2002 (CIPSEA),”
Most of these surveys are voluntary; the one exception is for operations that store certain manufactured dairy products that are required by Public Law 106-532 and 107-171 to respond.
Copies of this information collection and related instructions can be obtained without charge from David Hancock, NASS Clearance Officer, at (202) 690-2388.
All responses to this notice will become a matter of public record and be summarized in the request for OMB approval.
National Agricultural Statistics Service, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the intention of the National Agricultural Statistics Service (NASS) to request revision and extension of a currently approved information collection, the Vegetable Surveys Program. Revision to burden hours will be needed due to changes in the size of the target population, sampling design, and/or questionnaire length. Some of the vegetable production surveys will incorporate sampling of the total population of producers, while the processing surveys will involve a total enumeration of the entire population. Changes are being made to some of the questionnaires to accommodate changes in the industry and to make the questionnaires easier for the respondent to complete. This should help to reduce respondent burden and improve the overall response rates.
Comments on this notice must be received by January 15, 2013 to be assured of consideration.
You may submit comments, identified by docket number 0535-0037, by any of the following methods:
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Joseph T. Reilly, Associate Administrator, National Agricultural Statistics Service, U.S. Department of Agriculture, (202) 720-4333.
NASS also complies with OMB Implementation Guidance, “Implementation Guidance for Title V of the E-Government Act, Confidential Information Protection and Statistical Efficiency Act of 2002 (CIPSEA),”
All responses to this notice will become a matter of public record and be summarized in the request for OMB approval.
National Agricultural Statistics Service, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the intention the National Agricultural Statistics Service (NASS) to request revision and extension of a currently approved information collection, the Agricultural Prices Surveys. Revision to burden hours will be needed due to changes in the size of the target population, sampling design, and/or questionnaire length.
Comments on this notice must be received by January 15, 2013 to be assured of consideration.
You may submit comments, identified by docket number 0535-0003, by any of the following methods:
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Joseph T. Reilly, Associate Administrator, National Agricultural Statistics Service, U.S. Department of Agriculture, (202) 720-4333.
The Agricultural Prices surveys provide data on the prices received by farmers and prices paid by them for production goods and services. NASS estimates based on these surveys are used by agencies of the U.S. Department of Agriculture to prepare the economic accounts of the United States. These price estimates are also used to compute Parity Prices in accordance with requirements of the Agricultural Adjustment Act of 1938 as amended (Title III, Subtitle A, Section 301(a)). In addition, price data are used by the Federal Crop Insurance Corporation to help determine payment rates, program option levels, and disaster programs.
These data will be collected under authority of 7 U.S.C. 2204(a). Individually identifiable data collected under this authority are governed by Section 1770 of the Food Security Act of 1985 as amended, 7 U.S.C. 2276, which requires USDA to afford strict confidentiality to non-aggregated data provided by respondents. This Notice is submitted in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-113) and Office of Management and Budget regulations at 5 CFR part 1320.
NASS also complies with OMB Implementation Guidance, “Implementation Guidance for Title V of the E-Government Act, Confidential Information Protection and Statistical Efficiency Act of 2002 (CIPSEA),”
Copies of this information collection and related instructions can be obtained without charge from David Hancock, NASS Clearance Officer, at (202) 690-2388.
All responses to this notice will become a matter of public record and will be summarized in the request for OMB approval.
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).
National Marine Fisheries Service (NMFS) has issued regulations under authority of the Western and Central Pacific Fisheries Convention Implementation Act (WCPFCIA; 16 U.S.C. 6901
The application for WCPFC Area Endorsements calls for specified information about the vessel and its operator that is not already collected via the application for high seas fishing permits issued under 50 CFR 300.13. The Foreign EEZ Form calls for specified information about the vessel, its owners and operators and any fishing authorizations issued by other nations.
This information collected under the two requirements is used by NOAA, the U.S. Coast Guard, and the Commission to monitor the size and composition of the HMS fleets in the Convention Area for compliance-related and scientific purposes.
Copies of the above information collection proposal can be obtained by calling or writing Jennifer Jessup, Departmental Paperwork Clearance Officer, (202) 482-0336, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
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 Jennifer Jessup, Departmental Paperwork Clearance Officer, (202) 482-0336, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Minority Business Development Agency, U.S. Department of Commerce.
Notice of open meeting.
The National Advisory Council for Minority Business Enterprise (NACMBE) will hold its seventh meeting to discuss final recommendations in support of accelerating the growth of minority-owned businesses. The members of the Council will come to a consensus regarding the final recommendations to fulfill NACMBE's charter mandate in preparation for submission to the Secretary of the U.S. Department of Commerce. The agenda may change to accommodate Council business.
The meeting will be held on Thursday, December 6, 2012, from 9 a.m. to 5 p.m. Eastern Time (ET).
This meeting will be held at the Marriott Wardman Park Hotel, 2660 Woodley Road Northwest, Washington, DC 20008.
Demetria Gallagher, National Director's Office, Minority Business Development Agency (MBDA), U.S. Department of Commerce at (202) 482-1624
A limited amount of time, in the afternoon, will be available for pertinent brief oral comments from members of the public attending the meeting. Any member of the public may submit pertinent written comments concerning affairs of the NACMBE at
This meeting is physically accessible to people with disabilities. Requests for
Copies of the NACMBE open meeting minutes will be available to the public upon request.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; public meeting.
The New England Fishery Management Council (Council) is scheduling a public meeting of its Habitat Oversight Committee to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.
This meeting will be held on Tuesday, December 4, 2012 at 9 a.m.
The meeting will be held at the Fairfield Inn & Suites, 185 MacArthur Drive, New Bedford, MA 02740; telephone: (774) 634-2000; fax: (774) 634-2001.
Paul J. Howard, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.
The Committee will continue to develop options and alternatives for Omnibus Essential Fish Habitat Amendment 2 (OA2). Specifically, the Committee will review Habitat Advisory Panel and Plan Development Team recommendations about Dedicated Habitat Research Areas and gear modification measures, and select options for inclusion in the OA2 document. In addition, the PDT will provide advice on combining management options into alternatives to meet overall adverse effects minimization requirements. Other area-management options and combined alternatives may also be discussed.
As a reminder, the Habitat Committee's work will feed into a joint process between the Habitat and Groundfish Committees. This joint process will draft combined alternatives that merge habitat options with yet-to-be-developed groundfish productivity-related options. This range of alternatives will be presented to the Council early next year for their approval for analysis in the OA2 Environmental Impact Statement/Magnuson-Stevens Act document.
Bureau of Ocean Energy Management staff will provide a brief status update on the Massachusetts and Rhode Island Wind Energy Areas (WEA) where leasing is under consideration, and will solicit feedback on a recently completed Environmental Assessment for the MA WEA.
Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Paul J. Howard, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; public meeting.
The New England Fishery Management Council (Council) is scheduling a public meeting of its Monkfish Oversight Committee and Advisory Panel in December, 2012 to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.
This meeting will be held on Thursday, December 6, 2012 at 10 a.m.
This meeting will be held at the Providence Biltmore, 11 Dorrance Street, Providence, RI 02903; telephone: (401) 421-0700; fax: (401) 455-3050.
Paul J. Howard, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.
The Committee and Advisory Panel will continue development of Amendment 6 to the Monkfish Fishery Management Plan, including modifications to the current system, incorporation of monkfish into groundfish sectors, and/or individually transferable quotas (ITQs). This meeting is a continuation of the discussions at the August 8th joint meeting. The Committee will provide further direction to the Plan Development Team in the development of a range of alternatives to be incorporated into a draft amendment document for consideration by the Councils.
Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Paul J. Howard, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meetings of the South Atlantic Fishery Management Council.
In addition to a Council Member Visioning Workshop, the South Atlantic Fishery Management Council (Council) will hold a joint meeting of its Habitat and Environmental Protection Committee and Ecosystem-Based Management Committee; meetings of its Dolphin Wahoo Committee; Southeast Data, Assessment and Review (SEDAR) Committee; Snapper Grouper Committee; Ad Hoc Data Collection Committee; Personnel Committee (CLOSED SESSION); Executive Finance Committee; and a meeting of the Full Council. The Council will take action as necessary. The Council will also hold an informal public question and answer session regarding agenda items, and a formal public comment session. See
The Council meeting will be held December 3-7, 2012. See
The meeting will be held at the Hilton Wilmington Riverside Hotel, 301 North Water Street, Wilmington, NC 28401; telephone: (1-888) 324-8170 or (910) 763-5900; fax: (910) 763-0038.
Kim Iverson, Public Information Officer; telephone: (843) 571-4366 or toll free at (866) SAFMC-10; fax: (843) 769-4520; email:
1. Council Member Visioning Workshop: December 3, 2012, 9 a.m. until 12 noon.
Council members will receive a presentation on the visioning process used by the Mid-Atlantic Fishery Management Council, discuss the visioning process and provide direction to staff.
2. Joint Meeting of the Habitat and Environmental Protection Committee and Ecosystem-Based Management Committee: December 3, 2012, 1:30 p.m. until 3 p.m.
The Habitat and Environmental Protection Committee and the Ecosystem-Based Management Committee will meet jointly and will receive a report from the joint meeting of the respective advisory panels as well as a report from the Habitat and Environmental Protection Advisory Panel (AP). The joint committee will receive: an overview on Coral Amendment 7, pertaining to Coral Habitat Areas of Particular Concern (HAPCs) and transit through the Oculina Bank HAPC; and an update on ecosystem activities. The joint committee will modify Coral Amendment 7 as appropriate and will either recommend an adjustment to the timing of the amendment or recommend the amendment for public hearing.
3. Dolphin Wahoo Committee Meeting: December 3, 2012, 3 p.m. until 4 p.m.
The Dolphin Wahoo Committee will review Dolphin Wahoo Amendment 5, pertaining to bag limit sales of fish and changes to the Allowable Biological Catch (ABC) and the Annual Catch Limit (ACL). The Committee is scheduled to recommend approval of the amendment for the scoping process.
4. SEDAR Committee Meeting: December 3, 2012, 4 p.m. until 5:30 p.m. (
The SEDAR Committee will receive an activities update as well as a report from the Steering Committee. The Committee will discuss SEDAR schedules, terms of reference (TORs) and SEDAR appointments (closed session).
5. Snapper Grouper Committee Meeting: December 4, 2012, 8:30 a.m. until 5 p.m. and December 5, 2012, 8:30 a.m. until 12 noon.
The Snapper Grouper Committee will receive: an update on the status of catches versus quotas for commercial and recreational species under ACLs; an update on the status of amendments under formal review; a report from the Snapper Grouper AP meeting; and a report from the Scientific and Statistical Committee (SSC). The Committee will consider an Emergency Action to increase the commercial ACL for vermilion snapper and will receive overviews of the following amendments: Regulatory Amendment 13, regarding adjustments of snapper grouper ACLs based on Marine Recreational Fishing Statistical Survey (MRFSS)/Marine Recreational Information Program (MRIP) calibration; Regulatory Amendment 15, pertaining to management measures for yellowtail snapper and modifying the Accountability Measure (AM) for gag that currently prohibits the harvest of shallow water grouper species when the gag ACL is met; and Snapper Grouper Amendment 28, addressing framework actions to reopen the red snapper fishery. The Committee will modify these amendments as necessary and is scheduled to recommend approval of these amendments for formal review. The Committee will also receive an overview of Snapper Grouper Amendment 27, which addresses management measures for blue runner and would transfer management responsibility of yellowtail snapper, mutton snapper and Nassau grouper from the Gulf of Mexico Fishery Management Council to the South Atlantic Council. The Committee will modify the amendment as necessary and is scheduled to recommend approval of Amendment 27 for public hearing. The Committee will: discuss the use of Marine Protected Areas (MPAs) and HAPCs for speckled hind and warsaw grouper; receive a presentation on the reorientation of existing MPAs based on occurrence and habitat; and develop guidance on alternatives to be included in Snapper Grouper Regulatory Amendment 17, which involves the use of MPAs for speckled hind and warsaw grouper.
6. Ad Hoc Data Collection Committee Meeting: December 5, 2012, 1:30 p.m. until 5 p.m.
The Ad Hoc Data Collection Committee will receive presentations on: post-stratification methodology used to arrive at recreational landings estimates; and the results of the demonstration of the quota monitoring system. The Committee will receive a status update on the Joint Gulf and South Atlantic Council Generic Dealer Permit and an overview of Comprehensive Ecosystem-Based Amendment 3 (CE-BA 3). The Committee will receive guidance on actions and alternatives in CE-BA 3 and is scheduled to recommend approval of the amendment for formal review.
There will be an informal public question and answer session with the NMFS Regional Administrator and the Council Chairman on December 5, 2012, beginning at 5:30 p.m.
7. Personnel Committee Meeting: December 6, 2012, 8:30 a.m. until 9:30 a.m. (closed session)
The Personnel Committee will discuss the Executive Director's performance review.
8. Executive Finance Committee Meeting: December 6, 2012, 9:30 a.m. until 11 a.m.
The Executive Finance Committee will discuss: the status of calendar year (CY) 2012 budget expenditures; the draft 2013 activities schedules; and the draft 2013 budget. The Committee will also: Discuss joint South Florida management issues and schedule 2013 meetings; develop a position on SSC review responsibilities; address Council follow-up and priorities; and discuss other issues as appropriate.
From 11 a.m. until 11:15 a.m., the Council will call the meeting to order, adopt the agenda, and approve the September 2012 meeting minutes.
A formal public comment session will be held on December 6, 2012, beginning at 11:15 a.m., on: Snapper Grouper Regulatory Amendment 13; Snapper Grouper Regulatory Amendment 15; Snapper Grouper Amendment 28; an Emergency Action to increase the commercial ACL for vermilion snapper; and Comprehensive Ecosystem-Based Amendment 3 (CE-BA 3); followed by comment on any other item on the agenda.
From 2:30 p.m. until 4:30 p.m., the Council will receive a report from the Snapper Grouper Committee and approve the following amendments for formal Secretarial review: Snapper Grouper Regulatory Amendment 13; Snapper Grouper Regulatory Amendment 15; and Snapper Grouper Amendment 28. The Council will approve Snapper Grouper Amendment 27 for public hearing and approve an Emergency Action to increase the commercial ACL for vermilion snapper. The Council will consider other Committee recommendations and take action as appropriate.
From 4:30 p.m. until 4:45 p.m., the Council will receive a report from the Ad Hoc Data Collection Committee, approve CE-BA 3 for formal Secretarial review, consider recommendations and take action as appropriate.
From 4:45 p.m. until 5 p.m., the Council will receive a report from the Joint Habitat and Environmental Protection and Ecosystem-Based Management Committees, approve Coral Amendment 7 for public hearing, consider other recommendations and take action as appropriate.
From 5 p.m. until 5:30 p.m., the Council will receive a briefing on Amendment 5 to the Highly Migratory Species (HMS) Fishery Management Plan from HMS staff. The Council will take action as appropriate.
From 8:30 a.m. until 8:45 a.m., the Council will receive a legal briefing on litigation. (closed session)
From 8:45 a.m. until 9 a.m., the Council will receive a report from the SEDAR Committee, consider other recommendations and take action as appropriate.
From 9 a.m. until 9:15 a.m., the Council will receive a report from the Dolphin Wahoo Committee, approve Dolphin Wahoo Amendment 5 items for scoping, consider other recommendations and take action as appropriate.
From 9:15 a.m. until 9:30 a.m., the Council will receive a report from the Executive Finance Committee, consider other recommendations and take action as appropriate.
From 9:30 a.m. until 12 noon, the Council will receive presentations and status reports from the NOAA Southeast Regional Office (SERO) and the NMFS Southeast Fisheries Science Center (SEFSC), receive an outreach update on the Marine Resource Education Program, review agency and liaison reports, and discuss other business, including upcoming meetings.
Documents regarding these issues are available from the Council office (see
Although non-emergency issues not contained in this agenda may come before this Council for discussion, those issues may not be the subjects of formal final Council action during these meetings. Council action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
Except for advertised (scheduled) public hearings and public comment, the times and sequence specified on this agenda is subject to change.
These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to the Council office (see
Committee for Purchase From People Who Are Blind or Severely Disabled.
Proposed Deletions from the Procurement List.
The Committee is proposing to delete services from the Procurement List that were provided by nonprofit agencies employing persons who are blind or have other severe disabilities.
Committee for Purchase From People Who Are Blind or Severely Disabled, Jefferson Plaza 2, Suite 10800, 1421 Jefferson Davis Highway, Arlington, Virginia 22202-3259.
Barry S. Lineback, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email
This notice is published pursuant to 41 USC 8503 (a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.
The following services are proposed for deletion from the Procurement List:
Committee for Purchase From People Who Are Blind or Severely Disabled.
Additions to the Procurement List.
This action adds products and services to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.
Committee for Purchase From People Who Are Blind or Severely Disabled, Jefferson Plaza 2, Suite 10800, 1421 Jefferson Davis Highway, Arlington, Virginia 22202-3259.
Barry S. Lineback, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email
On 9/14/2012 (77 FR 56813-56814) and 9/21/2012 (77 FR 58528-58529), the Committee for Purchase From People Who Are Blind or Severely Disabled published notices of proposed additions to the Procurement List.
After consideration of the material presented to it concerning capability of qualified nonprofit agencies to provide the products and services and impact of the additions on the current or most recent contractors, the Committee has determined that the products and services listed below are suitable for procurement by the Federal Government under 41 USC 8501-8506 and 41 CFR 51-2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will furnish the products and services to the Government.
2. The action will result in authorizing small entities to furnish the products and services to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 USC 8501-8506) in connection with the products and services proposed for addition to the Procurement List.
Accordingly, the following products and services are added to the Procurement List:
San Angelo, TX.
Department of Defense, Defense Security Cooperation Agency.
Notice.
The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.
Ms. B. English, DSCA/DBO/CFM, (703) 601-3740. The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 12-40 with attached transmittal, and policy justification.
(i)
(ii)
(iii)
(iv)
(v)
(vi)
(vii)
(viii)
* as defined in Section 47(6) of the Arms Export Control Act.
The Government of the United Arab Emirates (UAE) has requested a possible sale of 48 Terminal High Altitude Area Defense (THAAD) missiles, 9 THAAD launchers; test components, repair and return, support equipment, spare and repair parts, personnel training and training equipment, publications and technical data, U.S. Government and contractor technical assistance, and other related logistics support. The estimated cost is $1.135 billion.
This proposed sale will contribute to the foreign policy and national security of the United States by helping to improve the security of a friendly country that has been, and continues to be, an important force for political stability and economic progress in the Middle East.
This proposed sale will help strengthen the UAE's capability to counter current and future threats in the region and reduce dependence on U.S. forces.
The proposed sale of these missiles and equipment will not alter the basic military balance in the region.
The principal contractors will be Lockheed Martin Space Systems Corporation in Sunnyvale, CA and Raytheon Corporation in Andover, MA. There are no known offset agreements proposed in connection with this potential sale.
Implementation of this proposed sale will not require the assignment of any additional U.S. Government or contractor representatives to the UAE.
There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.
(vii)
1. The Terminal High Altitude Area Defense System (THAAD) is the first weapons system with both endo and exo atmospheric capability developed specifically to defend against ballistic missiles. The higher altitude and theater wide protection offered by THAAD provides more protection of larger areas than lower-tier systems alone. THAAD is designed to defend against short, medium, and intermediate range ballistic missiles. The THAAD system consists of four major components: Fire Control/Communications, Radar, Launchers and Interceptors.
2. THAAD contains classified Confidential/Secret components and critical/sensitive technology. This critical/sensitive technology is primarily in the area of design and production know-how and primarily inherent in the design, development and/or manufacturing data related to certain critical components. Information on operational effectiveness with respect to countermeasures, low observable technologies, select software documentation and test data are classified up to and including Secret.
3. If a technologically advanced adversary were to obtain knowledge of specific hardware, the information could be used to develop countermeasures which might reduce weapons system effectiveness or be used in the development of a system with similar or advanced capabilities.
Defense Security Cooperation Agency, Department of Defense.
Notice.
The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.
Ms. B. English, DSCA/DBO/CFM, (703) 601-3740.
The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 12-49 with attached transmittal, and policy justification.
(i)
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(iii)
* as defined in Section 47(6) of the Arms Export Control Act.
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(viii)
The Government of Qatar has requested a possible sale of 2 Terminal High Altitude Area Defense (THAAD) Fire Units, 12 THAAD Launchers, 150 THAAD Interceptors, 2 THAAD Fire Control and Communications, 2 AN/TPY-2 THAAD Radars, and 1 Early Warning Radar (EWR). Also included are fire unit maintenance equipment, prime movers (trucks), generators, electrical power units, trailers, communications equipment, tools, test and maintenance equipment, repair and return, system integration and checkout, spare/repair parts, publications and technical documentation, personnel training and training equipment, U.S. Government and contractor technical and logistics personnel support services, and other related support elements. The estimated cost is $6.5 billion.
This proposed sale will contribute to the foreign policy and national security of the United States by helping to improve the security of a friendly country that has been and continues to be an important force for political stability and economic progress in the Middle East.
This proposed sale will help strengthen U.S. efforts to promote regional stability by enhancing regional defense capabilities of a key U.S. partner. The proposed sale will help strengthen Qatar's capability to counter current and future threats in the region and reduce dependence on U.S. forces. Qatar will have no difficulty absorbing this weapon system into its armed forces.
The proposed sale of this equipment and support will not alter the basic military balance in the region.
The principal contractors are Lockheed Martin Space Systems Corporation in Sunnyvale, California, and the sub-contractor is Raytheon Corporation in Andover, Massachusetts.
There are no known offset agreements proposed in connection with this potential sale at this time.
Implementation of this proposed sale will require periodic travel of up to 13 U.S. Government and contractor representatives to Qatar for an undetermined period for delivery, system checkout, and training as determined by the schedule. There is no known adverse impact on U.S. defense readiness as a result of this proposed sale.
(vii)
1. The Terminal High Altitude Area Defense System (THAAD) Ballistic Missile Defense System contains classified Confidential/Secret components and critical/sensitive technology. The THAAD Fire Unit is a ground-based, forward deployable terminal missile defense system that represents significant technological advances. The THAAD System continues to hold a technology lead over other terminal ballistic missile systems. THAAD is the first weapon system with both endo- and exo-atmospheric capability developed specifically to defend against ballistic missiles. The higher altitude and theater-wide protection offered by THAAD provides more protection of larger areas than lower-tier systems alone. THAAD is designed to defend against short, medium, and intermediate range ballistic missiles. The THAAD system consists of four major components: Fire Control/Communications, Radar, Launchers, and Interceptors.
2. The THAAD Ballistic Missile Defense System contains sensitive/critical Technology, primarily in the area of design and production know-how and primarily inherent in the design, development and/or manufacturing data related to certain critical components. Information on operational effectiveness with respect to countermeasures and counter-counter measures, low observable technologies, select software documentation and test data are classified up to and including Secret.
3. If a technologically advanced adversary were to obtain knowledge of specific hardware, the information could be used to develop countermeasures which might reduce weapons system effectiveness or be used in the development of a system with similar or advanced capabilities.
Defense Security Cooperation Agency, Department of Defense.
Notice.
The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.
Ms. B. English, DSCA/DBO/CFM, (703) 601-3740.
The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 12-58 with attached transmittal, policy justification and sensitivity of technology.
(i)
(ii)
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* as defined in Section 47(6) of the Arms Export Control Act.
(iv) Military Department: Army (UAP)
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The Government of Qatar has requested a possible sale of 11 PATRIOT Configuration-3 Modernized Fire Units, 11 AN/MPQ-65 Radar Sets, 11 AN/MSQ-132 Engagement Control Systems, 30 Antenna Mast Groups, 44 M902 Launching Stations, 246 PATRIOT MIM-104E Guidance Enhanced Missile-TBM (GEM-T) with canisters, 2 PATRIOT MIM-104E GEM-T Test Missiles, 768 PATRIOT Advanced Capability 3 (PAC-3) Missiles with canisters, 10 PAC-3 Test Missiles with canisters, 11 Electrical Power Plants (EPPII), 8 Multifunctional Information Distribution Systems/Low Volume Terminals (MIDS/LVTs), communications equipment, tools and test equipment, support equipment, publications and technical documentation, personnel training and training equipment, spare and repair parts, facility design, U.S. Government and contractor technical, engineering, and logistics support services, and other related elements of logistics and program support. The estimated cost is $9.9 billion.
This proposed sale will contribute to the foreign policy and national security of the United States by improving the security of an important ally which has been, and continues to be, a force for political stability and economic progress in the Middle East. This sale is consistent with U.S. initiatives to provide key allies in the region with modern systems that will enhance interoperability with U.S. forces and increase security.
Qatar will use the Patriot Missile System to improve its missile defense capability, strengthen its homeland defense, and deter regional threats. The proposed sale will enhance Qatar's interoperability with the U.S. and its allies, making it a more valuable partner in an increasingly important area of the world. Qatar should have no difficulty absorbing this system into its armed forces.
The proposed sale of these missiles and equipment will not alter the basic military balance in the region.
The prime contractors will be Raytheon Corporation in Andover, Maryland, and Lockheed-Martin in Dallas, Texas. There are no known offset agreements proposed in connection with this potential sale.
Implementation of this proposed sale will require approximately 30 U.S. Government and 40 contractor representatives to travel to Qatar for an extended period for equipment de-processing/fielding, system checkout, training and technical and logistics support.
There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.
(vi)
1. The PATRIOT Advanced Capability-3/Configuration-3 Ground Support Equipment (PAC-3/C-3) Air Defense System contains classified Confidential hardware components, Secret tactical software, and critical/sensitive technology. The PAC-3 Missile Four-Pack and Guidance Enhanced Missile (GEM-T) hardware is classified Confidential and the associated launcher hardware is Unclassified. The items requested represent significant technological advances for Qatar. The PAC-3/C-3Air Defense System continues to hold a significant technology lead over other surface-to-air missile systems in the world.
2. The PAC-3/C-3 sensitive/critical technology is primarily in the area of design and production know-how and primarily inherent in the design, development and/or manufacturing data related to the following components:
3. Information on vulnerability to electronic countermeasures and counter-counter measures, system performance capabilities and effectiveness, survivability and vulnerability data, PAC-3 Missile seeker capabilities, non-cooperative target recognition, low observable technologies, select software/software documentation and test data are classified up to and including Secret.
4. If a technologically advanced adversary were to obtain knowledge of the specific hardware and software elements, the information could be used to develop countermeasures which might reduce weapons systems effectiveness or be used in the development of a system with similar or advanced capabilities.
Office of the Assistant Secretary of Defense, Department of Defense.
Notice of meeting.
Under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150, the Department of Defense announces that the following Federal Advisory Committee meeting of the Department of Defense Task Force on the Care, Management, and Transition of Recovering Wounded, Ill, and Injured Members of the Armed Forces (subsequently referred to as the Task Force) will take place.
Tuesday, December 4, 2012-Wednesday, December 5, 2012 from 8:30 a.m. to 5:00 p.m. EDT each day.
DoubleTree by Hilton Hotel Washington DC-Crystal City, 300 Army Navy Drive, Arlington, VA 22202 (in the Commonwealth Room).
Mail Delivery service through Recovering Warrior Task Force, Hoffman Building II, 200 Stovall St, Alexandria, VA 22332-0021 “Mark as Time Sensitive for December Meeting”. Emails can be sent to
Pursuant to 41 CFR 102-3.105(j) and 102-3.140, and section 10(a)(3) of the Federal Advisory Committee Act of 1972, the public or interested organizations may submit written statements to the Department of Defense Task Force on the Care, Management, and Transition of Recovering Wounded, Ill, and Injured Members of the Armed Forces about its mission and functions. If individuals are interested in making an oral statement during the Public Forum time period, a written statement for a presentation of two minutes must be submitted as below and must identify it is being submitted for an oral presentation by the person making the submission. Identification information must be provided and at a minimum must include a name and a phone number. Individuals may visit the Task Force Web site at
Written statements in which the author does not wish to present orally may be submitted at any time or in response to the stated agenda of a planned meeting of the Department of Defense Task Force on the Care, Management, and Transition of Recovering Wounded, Ill, and Injured Members of the Armed Forces.
All written statements shall be submitted to the Designated Federal Officer for the Task Force through the contact information in
Statements, either oral or written, being submitted in response to the agenda mentioned in this notice must be received by the Designated Federal Officer at the address listed in
The Designated Federal Officer will review all timely submissions with the Task Force Co-Chairs and ensure they are provided to all members of the Task Force before the meeting that is the subject of this notice.
Reasonable accommodations will be made for those individuals with disabilities who request them. Requests for additional services should be directed to Heather Jane Moore, (703) 325-6640, by 5:00 p.m. EDT, Tuesday, November 27, 2012.
National Defense University, DoD.
Notice of open meeting.
The National Defense University (NDU), Designated Federal Officer, has scheduled a meeting of the Board of Visitors. The National Defense University Board of Visitors is a Federal Advisory Board. The Board meets twice each year in proceedings that are open to the public.
The meeting will be held on December 10-11, 2012, from 9:00 a.m. to 5:30 p.m. on December 10 and continuing on December 11 from 9:00 a.m. to 12:30 p.m.
The Board of Visitors meeting will be held at Lincoln Hall, Building 64, Room 1105, the National Defense University, 300 5th Avenue SW., Fort McNair, Washington, DC 20319-5066.
The point of contact for this notice of open meeting is Ms. Joycelyn Stevens at (202) 685-0079, Fax (202) 685-3920 or
The future agenda will include discussion on
Under Secretary of Defense for Personnel and Readiness, DoD.
Notice of meeting.
Under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150, the Department of Defense announces that the following Federal advisory committee meeting of the Defense Advisory Committee on Military Personnel Testing will take place.
Thursday, December 6, 2012, from 8:30 a.m. to 4:00 p.m. and Friday, December 7, 2012, from 8:30 a.m. to 12 p.m.
The meeting will be held at the Omni Hotel, 100 South 12th Street, Richmond, Virginia 23219.
Dr. Jane Arabian, (703) 697-9271.
Committee's Designated Federal Officer or Point of Contact: Dr. Jane M. Arabian, Assistant Director, Accession Policy, Office of the Under Secretary of Defense (Personnel and Readiness), Room 3D1066, The Pentagon, Washington, DC 20301-4000, telephone (703) 697-9271. Persons desiring to make oral presentations or submit written statements for consideration at the Committee meeting must contact Dr. Jane M. Arabian at the address or telephone number above no later than November 28, 2012.
Defense Information Systems Agency, DoD.
Notice to add a new system of records.
The Defense Information Systems Agency proposes to add a new system of records in its inventory of record systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended.
This proposed action will be effective on December 17, 2012 unless comments are received which result in a contrary determination. Comments will be accepted on or before December 17, 2012.
You may submit comments, identified by docket number and title, by any of the following methods:
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Jeanette Weathers-Jenkins, 6916 Cooper Avenue, Fort Meade, MD 20755-7901, or (301) 225-8158.
The Defense Information Systems Agency notices for systems of records subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, have been published in the
DoD Enterprise Portal Service (DEPS).
Defense Enterprise Computing Centers (DECC), 5450 Carlisle Pike Mechanicsburg, PA 17055-0975.
Defense Enterprise Computing Centers (DECC), 8705 Industrial Blvd., Bldg 3900, Tinker AFB, Oklahoma 73145-3009.
Department of Defense civilian employees, military personnel, and contractors.
Full name, DoD ID Number, birth date, email address, organizational address, telephone, and fax number, military rank/grade, military branch, and current DoD identification badge for registration and access management.
5 U.S.C. 301, Departmental Regulations; Pub. L. 106-229, Electronic Signatures in Global and National Commerce; OASD (C3I) Policy Memorandum, subject: Department of Defense (DoD) Public Key Infrastructure (PKI); and OASD (C3I) Memorandum, subject: Common Access Card (CAC).
DEPS will utilize Microsoft Office SharePoint Server as an integrated suite of server capabilities that will improve organizational effectiveness by providing comprehensive content management and enterprise search, accelerating shared business processes, and facilitating information-sharing across boundaries for better business insight. Additionally, this collaboration and content management server provides information technology (IT) professionals and developers with the platform and tools they need for server administration, application extensibility, and interoperability.
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act of 1974 as amended, these records contained therein may specifically be disclosed outside the DoD as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
The DoD Blanket Routine Uses set forth at the beginning of the DISA's compilation of systems of records notices may apply to this system.
Electronic storage media.
Retrieved by full name.
Records are maintained in a controlled facility. Physical entry is restricted by the use of locks, guards, password protection, and encryption and is accessible only to authorized personnel. Access to records is limited to person(s) responsible for servicing the record in performance of their official duties and who are properly screened and cleared for need-to-know. Access to computerized data is restricted by Common Access Card (CAC) and/or password which are changed periodically. Additionally, users receive training and awareness notices on the proper marking of sensitive information. Host Based Security System (HBSS) is operational and provides mechanisms to protect, detect, track, and report malicious computer-related activities in near real-time.
Disposition pending (until the National Archives and Records Administration approves retention and disposal schedule, records will be treated as permanent).
DEPS Program Manager, Enterprise Services Division, Defense Information Systems Agency, Acquisition Building, 6914 Cooper Ave, Ft. Meade, MD 20755-7088.
Individuals seeking to determine whether information about themselves is contained in this system of records should address written inquiries to the Defense Information Systems Agency (DISA), Defense Enterprise Service Directorate (ESD), 6914 Cooper Ave, Fort Meade, MD 20755-7088.
Written requests should contain the full name of the requesting individual, current DoD identification badge or a copy of driver's license as proof of identity. The requester may also visit the system manager listed above.
Individuals seeking access to information about themselves contained in this system of records should address written inquiries to the Defense Information Systems Agency, Defense Enterprise Service Directorate (ESD), 6914 Cooper Ave, Fort Meade, MD 20755-7088.
Written requests should contain the full name of the requesting individual, current DoD identification badge or a copy of driver's license as proof of identity. The requester may also visit the system manager listed above.
DISA's rules for accessing records, for contesting content and appealing initial agency determinations are published in DISA Instruction 210-225-2; 32 CFR part 316; or may be obtained from the systems manager at the Defense Information Systems Agency (DISA), Defense Enterprise Service Directorate (ESD), 6914 Cooper Ave, Fort Meade, MD 20755-7088.
Data obtained and manually entered by system administrators.
None.
DoD.
Notice to reestablish Federal Advisory Committee.
Under the provisions of 5 CFR 532, Federal Wage System (Pub. L. 92-392), the Federal Advisory Committee Act of 1972 (5 U.S.C. Appendix), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b), and 41 CFR 102-3.50(c), the Department of Defense (DoD) gives notice that it is reestablishing the charter for the Department of Defense Wage Committee (hereafter referred to as “the Committee”).
The Committee is a discretionary federal advisory committee that shall provide the Secretary and the Deputy Secretary of Defense, through the Under Secretary of Defense for Personnel and Readiness (USD(P&R)), independent advice and recommendations on all matters relating to the conduct of wage surveys and the establishment of wage schedules for all appropriated fund and non-appropriated fund wage areas of blue-collar employees within the DoD.
The Committee shall report to the Secretary and Deputy Secretary of Defense, through the USD(P&R). The USD(P&R) may act upon the Committee's advice and recommendations.
The Committee, consistent with 5 CFR 532.227, shall be comprised of seven members—a chairperson and six additional members. Committee members shall be appointed by the Secretary of Defense and their appointments will be renewed on an annual basis. Those members, who are not full-time or permanent part-time Federal officers or employees, shall be appointed to serve as experts and consultants under the authority of 5 U.S.C. § 3109 and serve as special government employees. Each Committee member is appointed to provide advice on behalf of the government on the basis of his or her best judgment without representing any particular point of view and in a manner that is free from conflict of interest. With the exception of travel and per diem for official Committee related travel, Committee members shall serve without compensation, unless authorized by the Secretary of Defense.
The Secretary of Defense may approve the appointment of Committee members for one-to-two year terms of service,
The Department, when necessary, and consistent with the Committee's mission and DoD policies/procedures, may establish subcommittees to support the Committee. Establishment of subcommittees will be based upon a written determination, to include terms of reference, by the Secretary of Defense, or the Committee's sponsor.
These Subcommittees shall not work independently of the chartered Committee, and shall report all their recommendations and advice to the Committee for full deliberation and discussion. Subcommittees have no authority to make decisions on behalf of the chartered Committee; nor can any subcommittee or its members update or report directly to the DoD or any Federal officers or employees.
All subcommittee members shall be appointed in the same manner as the Committee members; that is, the Secretary of Defense shall appoint subcommittee members even if the member in question is already a Committee member. Subcommittee members, with the approval of the Secretary of Defense, may serve a term of service on the Subcommittee of one to four years; however, no member shall serve more than two consecutive terms of service on the Subcommittee, unless authorized by the Secretary of Defense.
Subcommittee members, if not full-time or part-time government employees, shall be appointed to serve as experts and consultants under the authority of 5 U.S.C. § 3109, and shall serve as special government employees, whose appointments must be renewed by the Secretary of Defense on an annual basis. With the exception of travel and per diem for official Committee-related travel, Subcommittee members shall serve without compensation.
All subcommittees operate under the provisions of FACA, the Government in the Sunshine Act, governing Federal statutes and regulations, and governing DoD policies/procedures.
Jim Freeman, Advisory Committee Management Officer for the Department of Defense, 703-692-5952.
The Committee shall meet at the call of the Committee's Designated Federal Officer, in consultation with Committee's Chairperson. The estimated number of Committee meetings is twenty-six per year.
In addition, the Designated Federal Officer is required to be in attendance at all Committee and subcommittee meetings for the entire duration of each and every meeting; however, in the absence of the Designated Federal Officer, a properly approved Alternate Designated Federal Officer shall attend the entire duration of the Committee or subcommittee meeting.
The Designated Federal Officer, or the Alternate Designated Federal Officer, shall call all of the Committee's and Subcommittee's meetings; prepare and approve all meeting agendas; adjourn any meeting when the Designated Federal Officer, or the Alternate Designated Federal Officer, determines adjournment to be in the public interest or required by governing regulations or DoD policies/procedures; and chair meetings when directed to do so by the official to whom the Committee reports.
Pursuant to 41 CFR §§ 102-3.105(j) and 102-3.140, the public or interested organizations may submit written statements to Department of Defense Wage Committee membership about the Committee's mission and functions. Written statements may be submitted at any time or in response to the stated agenda of planned meeting of Department of Defense Wage Committee.
All written statements shall be submitted to the Designated Federal Officer for the Department of Defense Wage Committee, and this individual will ensure that the written statements are provided to the membership for their consideration. Contact information for the Department of Defense Wage Committee's Designated Federal Officer can be obtained from the GSA's FACA Database—
The Designated Federal Officer, pursuant to 41 CFR § 102-3.150, will announce planned meetings of the Department of Defense Wage Committee. The Designated Federal Officer, at that time, may provide additional guidance on the submission of written statements that are in response to the stated agenda for the planned meeting in question.
Department of the Army, U.S. Army Corps of Engineers, DoD.
Notice of Intent.
The Jacksonville District, U.S. Army Corps of Engineers (Corps) intends to prepare a Draft Environmental Impact Statement (DEIS) and Feasibility Report (FR) for the ecosystem restoration of the Can
U.S. Army Corps of Engineers, Jacksonville District, Planning Division, Environmental Branch, P.O. Box 4970, Jacksonville, FL 32232-0019.
Wilberto Cubero by email at
These DEIS and FR will be prepared under the provisions of the Memorandum for Commander, South Atlantic Division (CESAD-PM) Implementation Guidance for Section 5127 of the Water Resources Development Act of 2007 (WRDA 2007)—Can
All the alternatives may restore open water resources and improve the wetland and benthic habitat functional value. The Corps will consider other project measures such as in-bay sediment disposal and the relocation of infrastructure.
Department of the Army, U.S. Army Corps of Engineers, DoD.
Notice of Intent.
The Los Angeles District of the U.S. Army Corps of Engineers (Corps) and Orange County Water District (OCWD), the non-Federal sponsor for the project, intend to jointly prepare an Environmental Impact Statement/Environmental Impact Report (EIS/EIR) to study, plan, and implement a multifaceted project to restore
Christopher T. Jones, U.S. Army Corps of Engineers, Los Angeles District, Ecosystem Planning Section, CESPL-PD-RN, P.O. Box 532711, Los Angeles, CA 90053-2325.
Christopher T. Jones, Biologist,
The Prado Basin, California study was authorized by a study resolution dated May 8, 1964, the Committee on Public Works, U.S. House of Representatives (House Document No. 135, 81st Congress, 1st Session). It was additionally authorized by Section 401(a) of the Water Resources Development Act of 1986.
The U.S. Army Corps of Engineers (USACE) previously conducted a Reconnaissance Phase Study of the Santa Ana River Basin and Orange County Streams, California. Ecosystem restoration and water conservation problems were identified as having a Federal interest. The study did not identify sediment management as a Federal interest to address at that time. However, sediment management has been determined to contribute to ecosystem restoration goals and is a planning objective of the study.
1. Project Description. The proposed feasibility study will investigate alternatives to restore environmental resources, conserve water and resolve issues related to alterations to the natural sediment transport regime in the Santa Ana River.
Preliminary objectives for this study were based on identification and consideration of problems, needs and opportunities in the areas associated with ecosystem restoration and watershed development. The establishment of these objectives focused primarily on the authorized study purpose of determining the Federal interest in ecosystem restoration in Prado Basin. However, related problems and needs in the study area were also given consideration.
The first objective is to restore environmental resources in the study area, which would contribute to the National Ecosystem Restoration (NER) Federal objective. The efficiency of the restoration would be measured in the increases in the net quantity and/or quality of desired ecosystem resources.
A second objective is to provide a more efficient means of meeting the study area's water demands. The efficiency of meeting these water demands is measured in the cost of providing the needed water supplies. A reduced cost in providing water supply as compared to the without project condition would result in savings to the nation's economic development (NED).
A third objective is to improve sediment management and sediment transport in the study area. Improvements to sediment management and transport could result in habitat, water supply and flood risk reduction benefits.
2. Alternatives. Several potential measures have been discussed that may meet the objectives of this study. Measures will be grouped into discrete alternatives and analyzed in the EIS/EIR. These potential measures include, but are not limited to, wetland and riparian habitat creation, restoration of stream banks through bio-engineering, creation of perennial stream habitat for the Santa Ana sucker, removal of non-native vegetation, eradication of non-native fish species, enhancement of habitats and structures to facilitate wildlife movement, dredging sediment, sluicing sediment past Prado Dam, fish passage structures, passage of sediment through the dam's spillway via various means, re-operate dam for water conservation year-round at 505 feet in elevation, and to re-operate the dam for water conservation at a level higher than 498 feet elevation, but lower than 505 feet in elevation. This initial list of potential measures may be enhanced by input received at public meetings.
3. Scoping. a. The Corps intends to hold a public scoping meeting(s) for the EIS/EIR to aid in the determination of significant environmental issues associated with the proposed project. Affected federal, state and local resource agencies, Native American groups and concerned interest groups/individuals are encouraged to participate in the scoping process. Public participation is critical in defining the scope of analysis in the Draft EIS/EIR, identifying significant environmental issues in the Draft EIS/EIR, providing useful information such as published and unpublished data, and knowledge of relevant issues and recommending mitigation measures to offset potential impacts from proposed actions. The time and location of the public scoping meeting will be advertised in letters, public announcements and news releases.
b. Potential impacts associated with the proposed project will be fully evaluated. Resource categories that will be analyzed include: physical environment, geology, biological resources, air quality, water quality, recreational usage, aesthetics, cultural resources, transportation, noise, hazardous waste, socioeconomics and safety.
c. Individuals and agencies may offer information or data relevant to the environmental or socioeconomic impacts of the proposed project by submitting comments, suggestions, and requests to be placed on the mailing list for announcements by sending correspondence to the address listed above, or to the following email address:
d. The project will require certification under Section 401 of the Clean Water Act from the Regional Water Quality Control Board. Depending upon the recommended alternative, the project may also require additional real property rights for construction and operation of a facility, compliance with Federal and State Endangered Species Acts, and relevant Department of California Fish and Game Code.
4. Public Scoping Meeting: A public scoping meeting will be held at the Inland Empire Utilities Agency (IEUA) Events Center on Wednesday, November 28, 2012, from 2:00 p.m. to 8:00 p.m. The project will be presented twice during this open house style meeting. The address for the IEUA Events Center is: Inland Empire Utilities Agency, 6075 Kimball Avenue, Chino, CA 91708, Phone: (909) 993-1600.
5. The Draft EIS/EIR is scheduled to be published and circulated for public review in May 2014.
Department of the Navy, DoD.
Notice to amend a System of Records.
The Department of the Navy is amending a system of records notice in its existing inventory of record systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended.
This proposed action will be effective on December 17, 2012 unless comments are received which result in a contrary determination. Comments will be accepted on or before December 17, 2012.
You may submit comments, identified by docket number and title, by any of the following methods:
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Ms. Robin Patterson, at (202) 685-6545.
The Department of the Navy systems of records notices subject to the Privacy Act of 1974, (5 U.S.C. 552a), as amended, have been published in the
Department of the Navy (DON) Military Awards System (May 5, 2010, 75 FR 24667).
Delete entry and replace with “Individuals seeking to determine whether information about themselves is contained in this system of records should contact their local Personnel Support Activity or Personnel Support Detachment for a search of their Navy military personnel record or go to the Navy awards Web site at
Marine Corps personnel seeking to determine whether information about themselves is contained in this system of records should contact their unit administrative officer (G-1/S-1) for a search of their Service Record Book/Officer Qualification Record or write to Headquarters U.S. Marine Corps, Manpower and Reserve Affairs Department, Personnel Management Division, Military Awards Branch (MMMA), 3280 Russell Road, MCB Quantico, Virginia 22134-5103.
All other individuals seeking to determine whether information about themselves is contained in this system of records should contact either the Chief of Naval Operations, Navy Awards Branch (DNS-35), 2000 Navy Pentagon, Washington, DC 20350-2000 (for U.S. Navy awards) or Headquarters U.S. Marine Corps, Manpower and Reserve Affairs Department, Personnel Management Division, Military Awards Branch (MMMA), MCB Quantico, Virginia 22134-5103 (for U.S. Marine Corps awards).
Written requests should include full name, SSN, time period of award, and must be signed. The system manager may require an original signature or a notarized signature as a means of proving the identity of the individual requesting access to the records.”
Delete entry and replace with “Navy Department Awards Web Service; OPNAV Form 1650/3, Personal Award Recommendation Form, OPNAV 1650/14, Unit Award Recommendation Form, general orders; military personnel file, medical file, deck logs, command histories, award letter 1650.
Marine Corps Awards histories, Marine Corps Awards Processing System, Personal Award Recommendation (OPNAV 1650/3), Marine Corps orders, official military records, command histories, historical paper copies of personal award citations, and microfilm copies of Navy and Marine Corps 3 x 5 award cards.”
Institute of Education Sciences, Department of Education.
Notice; correction.
On October 12, 2012, the Institute of Education Sciences in the U.S. Department of Education (Department) published in the
Effective November 16, 2012.
On page 62230 of the RTT-SIG SORN, in the second column, under the heading the ROUTINE USES OF RECORDS MAINTAINTED IN THE SYSTEM, INCLUDING CATEGORIES OF USERS AND THE PURPOSE OF SUCH USES, in the last sentence of the introductory paragraph, we correct the phrase “individually identifying information” to read “personally identifiable information”.
Dr. Audrey Pendleton, Associate Commissioner, Evaluation Division, National Center for Education Evaluation and Regional Assistance, Institute of Education Sciences, U.S. Department of Education, 555 New Jersey Avenue NW., Room 502D, Washington, DC 20208-0001. Telephone: (202) 208-7078.
If you use a telecommunications device for the deaf (TDD) or text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.
You may also access documents of the Department published in the
National Energy Technology Laboratory, Department of Energy.
Notice of Intent To Grant Exclusive License.
This notice is issued in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i). The National Energy Technology Laboratory (NETL) hereby gives notice of its intent to grant an exclusive license to practice the inventions described and claimed in U.S. Patent No 7,553,517, issued June 30, 2009, entitled “Method of applying a cerium diffusion coating to a metallic alloy,” to Corrosion Solutions having its principal place of business in Eugene, Oregon. The inventions are owned by the United States of America as represented by the Department of Energy (DOE). The prospective exclusive license will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7.
Written comments or nonexclusive license applications are to be received at the address listed below no later than December 3, 2012. Objections submitted in response to this notice will not be made available to the public for inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.
Objections relating to the prospective exclusive license may be submitted to the Office of Chief Counsel, National Energy Technology Laboratory, P.O. Box 10940, Pittsburgh, PA 15236, or via facsimile at (412) 386-5949.
Jessica Sosenko, Technology Transfer Program Manager, U.S. Department of Energy, National Energy Technology Laboratory, P.O. Box 10940, Pittsburgh, PA 15236; Telephone (412) 386-7417; Email:
Section 209(c) gives DOE with authority to grant exclusive or partially exclusive licenses in department-owned inventions, where a determination can be made, among other things, that the desired practical application of the invention has not been achieved, or is not likely expeditiously to be achieved, under a nonexclusive license. The statute and implementing regulations (37 CFR 404) require that the necessary determinations be made after public notice and opportunity for filing written objections.
Corrosion Solutions, a new small business, has applied for an exclusive license to practice the inventions and has a plan for commercialization of the invention. DOE intends to grant the license, upon a final determination in accordance with 35 U.S.C. 209(c), unless, within 15 days of publication of this notice, NETL's Office of Chief Counsel (contact information listed above) receives in writing any of the following, together with the supporting documents:
(i) A statement from any person setting forth reasons why it would not be in the best interest of the United States to grant the proposed license; or
(ii) An application for a nonexclusive license to the invention, in which the applicant states that it already has brought the invention to practical application or is likely to bring the invention to practical application expeditiously.
The proposed license would be exclusive, subject to a license and other rights retained by the U.S. Government, and subject to a negotiated royalty. DOE will review all timely written responses to this notice and will grant the license if, after expiration of the 15-day notice period and after consideration of any written responses to this notice, a determination is made in accordance with Section 209(c) that the license is in the public interest.
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Decision and Order.
The U.S. Department of Energy (DOE) gives notice of the decision and order (Case No. CAC-039) that grants Fujitsu General Limited (Fujitsu) a waiver from the DOE commercial package air-source central air conditioners and heat pumps test procedures for determining the energy consumption set forth in its petition for waiver. Under today's decision and order, Fujitsu shall be required to test and rate its AIRSTAGE V-II multi-split heat pump with a capacity of 264,000 Btu/h, and specified compatible indoor units using American National Standards Institute (ANSI)/Air-conditioning, Heating and Refrigeration Institute (AHRI) Standard 1230, as adopted in DOE's final rule dated May 16, 2012.
This Decision and Order is effective November 16, 2012 through May 12, 2013.
Mr. Bryan Berringer, U.S. Department of Energy, Building Technologies Program, Mailstop EE-2J, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-0371. Email:
Ms. Elizabeth Kohl, U.S. Department of Energy, Office of the General Counsel, Mail Stop GC-71, Forrestal Building, 1000 Independence Avenue SW., Washington, DC 20585-0103. Telephone: (202) 586-7796. Email:
DOE issues notice of this Decision and Order in accordance with Title 10 of the Code of Federal Regulations (10 CFR) 431.401(f)(4). In this Decision and Order, DOE grants Fujitsu a waiver for the Airstage V-II multi-split equipment specified in its waiver submitted on December 16, 2011. Fujitsu must test and rate this equipment using ANSI/AHRI 1230, as adopted in DOE's final rule dated May 16, 2012 (77 FR 28928), as the alternative test procedure. DOE's
Today's decision requires Fujitsu to make representations concerning the energy efficiency of this equipment consistent with the provisions and restrictions of the alternate test procedure in the Decision and Order below, and the representations must fairly disclose the test results. (42 U.S.C. 6314(d)) The same standard applies to distributors, retailers, and private labelers when making representations of the energy efficiency of this equipment.
Title III, Part C of the Energy Policy and Conservation Act of 1975 (EPCA), Pub. L. 94-163 (42 U.S.C. 6311-6317), established the Energy Conservation Program for certain industrial equipment, which includes commercial air conditioning equipment, the focus of this decision and order.
For commercial package air-conditioning and heating equipment, EPCA provides that “the test procedures shall be those generally accepted industry testing procedures or rating procedures developed or recognized by the Air-Conditioning and Refrigeration Institute [ARI] or by the American Society of Heating, Refrigerating and Air-Conditioning Engineers [ASHRAE], as referenced in ASHRAE/IES Standard 90.1 and in effect on June 30, 1992.” (42 U.S.C. 6314(a)(4)(A)) If the industry test procedure for commercial package air-conditioning and heating equipment is amended, EPCA directs the Secretary to amend the corresponding DOE test procedure unless the Secretary determines, by rule and based on clear and convincing evidence, that such a modified test procedure does not meet the statutory criteria set forth in 42 U.S.C. 6314(a)(2) and (3). (42 U.S.C. 6314(a)(4)(B))
On December 8, 2006, DOE published a final rule adopting test procedures for commercial package air-conditioning and heating equipment, effective January 8, 2007. 71 FR 71340. Table 1 to Title 10 of the Code of Federal Regulations (10 CFR) 431.96 directs manufacturers of commercial package air conditioning and heating equipment to use the appropriate procedure when measuring energy efficiency of this equipment. For commercial package air-source equipment with capacities between 65,000 and 760,000 Btu/h, ARI Standard 340/360-2004 is the applicable test procedure.
DOE's regulations for covered products and equipment permit a person to seek a waiver from the test procedure requirements for covered commercial equipment if at least one of the following conditions is met: (1) The petitioner's basic model contains one or more design characteristics that prevent testing according to the prescribed test procedures; or (2) the prescribed test procedures may evaluate the basic model in a manner so unrepresentative of its true energy consumption as to provide materially inaccurate comparative data. 10 CFR 431.401(a)(1). Petitioners must include in their petition any alternate test procedures known to the petitioner to evaluate the basic model in a manner representative of its energy consumption. 10 CFR 431.401(b)(1)(iii). The Assistant Secretary for Energy Efficiency and Renewable Energy (Assistant Secretary) may grant a waiver subject to conditions, including adherence to alternate test procedures. 10 CFR 431.401(f)(4). Waivers remain in effect according to the provisions of 10 CFR 431.401(g).
On December 16, 2011, Fujitsu submitted a petition for waiver from the DOE test procedure applicable to commercial package air-source and water-source central air conditioners and heat pumps set forth in 10 CFR 431.96. Fujitsu requested the waiver for specified basic model of Fujitsu AIRSTAGE V-II multi-split heat pump with a capacity of 264,000 Btu/h, and specified compatible indoor units. The applicable test procedure for these heat pumps is ARI 340/360-2004. Manufacturers are directed to use these test procedures pursuant to Table 1 of 10 CFR 431.96. Fujitsu seeks a waiver from the applicable test procedures under 10 CFR 431.96 on the grounds that its AIRSTAGE V-II multi-split heat pumps contain design characteristics that prevent testing according to the current DOE test procedures. Fujitsu requested that DOE allow it to test and rate its Airstage V-II multi-split heat pump with a capacity of 264,000 Btu/h, and specified compatible indoor units according to the American National Standards Institute (ANSI)/Air-conditioning, Heating and Refrigeration Institute (AHRI) Standard 1230-2010: Performance Rating of Variable Refrigerant Flow (VRF) Multi-Split Air-Conditioning and Heat Pump Equipment (AHRI 1230).
On May 16, 2012, DOE published a final rule (77 FR 28928) adopting American Society of Heating, Refrigerating, and Air-Conditioning Engineers (ASHRAE) Standard 90.1-2010 (ASHRAE final rule). The ASHRAE final rule incorporated by reference ANSI/AHRI 1230-2010 but omits sections 5.1.2 and 6.6 for the products addressed in this waiver request. The rule was effective on July 16, 2012 and requires use of the test procedure on or after May 13, 2013. This decision and order (D&O) requires Fujitsu to use ANSI/AHRI 1230-2010 as addressed in the DOE's May 16, 2012 final rule (77 FR 28928) to test and rate specified models in order to be consistent with future test procedure requirements.
In its December 16, 2011 petition, Fujitsu seeks a waiver from the applicable test procedures under 10 CFR 431.96 on the grounds that its AIRSTAGE V-II multi-split heat pumps contain design characteristics that prevent testing according to the current DOE test procedures. Specifically, Fujitsu asserts that the two primary factors that prevent testing of its AIRSTAGE V-II multi-split variable speed products are the same factors stated in the waivers that DOE granted to Mitsubishi Electric & Electronics America USA, Inc. (Mitsubishi) and other manufacturers for similar lines of commercial multi-split air-conditioning systems:
• Testing laboratories cannot test products with so many indoor units; and
• There are too many possible combinations of indoor and outdoor units to test. See, e.g., 72 FR 17528 (April 9, 2007) (Mitsubishi); 76 FR 19069 (April 6, 2011) (Daikin); 76 FR 19078 (April 6, 2011) (Mitsubishi); 76 FR 31951 (June 2, 2011) (Carrier); 76 FR
The AIRSTAGE V-II systems have operational characteristics similar to the commercial multi-split products manufactured by other manufacturers. As indicated above, DOE has already granted waivers for these products. The AIRSTAGE V-II system consists of multiple indoor units connected to an air-cooled outdoor unit. These multi-splits are used in zoned systems where an outdoor or water-source unit can be connected with up to 45 separate indoor units, which need not be the same models. According to Fujitsu, the various indoor and outdoor models can be connected in a multitude of configurations, with many thousands of possible combinations. Consequently, Fujitsu requested that DOE grant a waiver from the applicable test procedures for its AIRSTAGE V-II product designs until a suitable test method is prescribed.
For the reasons discussed above, and because DOE prescribed ANSI/AHRI 1230 as the alternate test procedure in waivers granted to other manufacturers (including the grant of Fujitsu's interim waiver request (77 FR 13107, Mar. 5, 2012)), DOE determined that the equipment specified in Fujitsu's December 16, 2011 petition contains design characteristics that prevent testing according to the DOE test procedure, and that allowing Fujitsu to use as an alternate test procedure ANSI/AHRI 1230, as adopted in DOE's final rule dated May 16, 2012 (77 FR 28928), addresses these testing difficulties.
DOE consulted with the Federal Trade Commission (FTC) staff concerning the Fujitsu petition for waiver. The FTC staff did not have any objections to granting a waiver to Fujitsu.
After careful consideration of all the material that was submitted by Fujitsu and consultation with the FTC staff, it is ordered that:
(1) The petition for waiver submitted by Fujitsu (Case No. CAC-039) is hereby granted as set forth in the following paragraphs.
(2) Fujitsu shall be required to test and rate the following basic model groups according to the alternate test procedure set forth in paragraph (3) of this section.
With nominal cooling capacity of 264,000 Btu/h.
Compatible indoor units for the above listed outdoor units:
(3) Fujitsu shall not be required to test the products listed in paragraph (2) of this section according to the test procedure for commercial package air conditioners and heat pumps prescribed by DOE at 10 CFR 431.96 (ARI Standard 340/360-2004 (incorporated by reference in 10 CFR 431.95(b)(2)-(3)), but instead shall use as the alternate test procedure ANSI/AHRI 1230-2010 as adopted in DOE's final rule dated May 16, 2012 (77 FR 28928).
(4)
(i) For multi-split combinations tested in accordance with this alternate test procedure, Fujitsu may make representations based on those test results.
(ii) For multi-split combinations that are not tested, Fujitsu may make representations based on the testing results for the tested combination and that are consistent with one of the following methods:
(a) Rating of non-tested combinations according to an alternative rating method approved by DOE; or
(b) Rating of non-tested combinations having the same outdoor unit and all non-ducted indoor units shall be set equal to the rating of the tested system having all non-ducted indoor units.
(c) Rating of non-tested combinations having the same outdoor unit and all ducted indoor units shall be set equal to the rating of the tested system having all ducted indoor units. To be considered a ducted unit, the indoor unit must be intended to be connected with ductwork and have a rated external static pressure capability greater than zero (0).
(d) Rating of non-tested combinations having the same outdoor unit and a mix of non-ducted and ducted indoor units shall be set equal to the average of the ratings for the two required tested combinations.
(5) This waiver amendment shall remain in effect from the date this Decision and Order is issued, consistent with the provisions of 10 CFR 431.401(g). Compliance with the ASHRAE final rule, (77 FR 28928, May 16, 2012), is required as of May 13, 2013. Therefore, this Decision and Order is valid through May 12, 2013. Beginning on May 13, 2013, all manufacturers must use the ASHRAE procedures to determine the energy use of this type of equipment.
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Decision and Order.
The U.S. Department of Energy (DOE) gives notice of the decision and order (Case No. CAC-038) that grants Samsung Electronics America, Inc. (Samsung) a waiver from the DOE commercial package air-source central air conditioners and heat pumps test procedures for determining the energy consumption set forth in its petition for waiver. Under today's decision and order, Samsung shall be required to test and rate its variable capacity Digital Variable Multi (DVM) (commercial) multi-split heat pumps with cooling capacities ranging from 72,000 Btu/h to 120,000 Btu/h, as specified in its petition using American National Standards Institute (ANSI)/Air-conditioning, Heating and Refrigeration Institute (AHRI) Standard 1230, as adopted in DOE's final rule dated May 16, 2012.
This Decision and Order is effective November 16, 2012 through May 12, 2013.
Mr. Bryan Berringer, U.S. Department of Energy, Building Technologies Program, Mailstop EE-2J, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-0371. Email:
Ms. Jennifer Tiedeman, U.S. Department of Energy, Office of the General Counsel, Mail Stop GC-71, Forrestal Building, 1000 Independence Avenue SW., Washington, DC 20585-0103. Telephone: (202) 287-6111. Email:
DOE issues notice of this Decision and Order in accordance with Title 10 of the Code of Federal Regulations (10 CFR) 431.401(f)(4). In this Decision and Order, DOE grants Samsung a waiver for the variable capacity DVM (commercial) multi-split heat pump equipment specified in its waiver submitted on October 17, 2011. Samsung must test and rate this equipment using ANSI/AHRI 1230, as adopted in DOE's final rule dated May 16, 2012 (77 FR 28928), as the alternative test procedure. DOE's final rule specifies use of ANSI/AHRI 1230, but omits sections 5.1.2 and 6.6.
Today's decision requires Samsung to make representations concerning the energy efficiency of this equipment consistent with the provisions and restrictions of the alternate test procedure in the Decision and Order below, and the representations must fairly disclose the test results. (42 U.S.C. 6314(d)) The same standard applies to distributors, retailers, and private labelers when making representations of the energy efficiency of this equipment.
Title III, Part C of the Energy Policy and Conservation Act of 1975 (EPCA), Public Law 94-163 (42 U.S.C. 6311-6317), established the Energy Conservation Program for certain industrial equipment, which includes commercial air conditioning equipment, the focus of this decision and order.
For commercial package air-conditioning and heating equipment, EPCA provides that “the test procedures shall be those generally accepted industry testing procedures or rating procedures developed or recognized by the Air-Conditioning and Refrigeration Institute [ARI] or by the American Society of Heating, Refrigerating and Air-Conditioning Engineers [ASHRAE], as referenced in ASHRAE/IES Standard 90.1 and in effect on June 30, 1992.” (42 U.S.C. 6314(a)(4)(A)) If the industry test procedure for commercial package air-conditioning and heating equipment is amended, EPCA directs the Secretary to amend the corresponding DOE test procedure unless the Secretary determines, by rule and based on clear and convincing evidence, that such a modified test procedure does not meet the statutory criteria set forth in 42 U.S.C. 6314(a)(2) and (3). (42 U.S.C. 6314(a)(4)(B))
On December 8, 2006, DOE published a final rule adopting test procedures for commercial package air-conditioning and heating equipment, effective January 8, 2007. 71 FR 71340. Table 1 to Title 10 of the Code of Federal Regulations (10 CFR) 431.96 directs manufacturers of commercial package air conditioning and heating equipment to use the appropriate procedure when measuring energy efficiency of this equipment. For commercial package air-source equipment with capacities between 65,000 and 760,000 Btu/h, ARI Standard 340/360-2004 is the applicable test procedure.
DOE's regulations for covered products and equipment permit a person to seek a waiver from the test procedure requirements for covered commercial equipment if at least one of the following conditions is met: (1) The petitioner's basic model contains one or more design characteristics that prevent testing according to the prescribed test procedures; or (2) the prescribed test procedures may evaluate the basic model in a manner so unrepresentative of its true energy consumption as to provide materially inaccurate comparative data. 10 CFR 431.401(a)(1). Petitioners must include in their petition any alternate test procedures known to the petitioner to evaluate the basic model in a manner representative of its energy consumption. 10 CFR 431.401(b)(1)(iii). The Assistant Secretary for Energy Efficiency and Renewable Energy (Assistant Secretary) may grant a waiver subject to conditions, including adherence to alternate test procedures. 10 CFR 431.401(f)(4). Waivers remain in effect according to the provisions of 10 CFR 431.401(g).
On October 17, 2011, Samsung submitted a petition for waiver from the DOE test procedure applicable to commercial package air-source and water-source central air conditioners and heat pumps set forth in 10 CFR 431.96. Samsung requested the waiver for the specified basic model of Samsung's variable capacity Digital Variable Multi (DVM) (commercial) multi-split heat pumps with cooling capacities ranging from 72,000 Btu/h to
On May 16, 2012, DOE published a final rule (77 FR 28928) adopting certain revised efficiency standards and test procedures provided in American Society of Heating, Refrigerating, and Air-Conditioning Engineers (ASHRAE) Standard 90.1-2010 (ASHRAE final rule). The ASHRAE final rule incorporated by reference ANSI/AHRI 1230-2010 but it omits sections 5.1.2 and 6.6 for the products addressed in this waiver request. The rule was effective on July 16, 2012 and requires use of the test procedure on or after May 13, 2013. This decision and order (D&O) requires Samsung to use ANSI/AHRI 1230-2010 as addressed in the DOE's May 16, 2012 final rule (77 FR 28928) to test and rate specified models in order to be consistent with future test procedure requirements.
In its October 17, 2011 petition, Samsung seeks a waiver from the applicable test procedures under 10 CFR 431.96 on the grounds that its DVM multi-split heat pumps contain design characteristics that prevent testing according to the current DOE test procedures. Specifically, Samsung asserts that the two primary factors that prevent testing of its DVM multi-split variable speed products are the same factors stated in the waivers that DOE granted to Mitsubishi Electric & Electronics America USA, Inc. (Mitsubishi) and other manufacturers for similar lines of commercial multi-split air-conditioning systems:
• Testing laboratories cannot test products with so many indoor units; and
• There are too many possible combinations of indoor and outdoor units to test.
See, e.g., 72 FR 17528 (April 9, 2007) (Mitsubishi); 76 FR 19069 (April 6, 2011) (Daikin); 76 FR 19078 (April 6, 2011) (Mitsubishi); 76 FR 31951 (June 2, 2011) (Carrier); 76 FR 50204 (August 12, 2011) (Fujitsu General Limited); 76 FR 65710 (October 24, 2011) (Mitsubishi).
The DVM systems have operational characteristics similar to the commercial multi-split products manufactured by other manufacturers. As indicated above, DOE has already granted waivers for these products. The DVM system consists of multiple indoor units connected to an air-cooled outdoor unit. These multi-splits are used in zoned systems where an outdoor or water-source unit can be connected with up to 10 separate indoor units, which need not be the same models. According to Samsung, the various indoor and outdoor models can be connected in a multitude of configurations, with many thousands of possible combinations. Consequently, Samsung requested that DOE grant a waiver from the applicable test procedures for its DVM product designs until a suitable test method can be prescribed.
For the reasons discussed above, and because DOE prescribed ANSI/AHRI 1230 as the alternate test procedure in waivers granted to other manufacturers (including the grant of Samsung's interim waiver request (76 FR 80916, Dec. 27, 2011), DOE determined that the equipment specified in Samsung's October 17, 2011 petition contains design characteristics that prevent testing according to the DOE test procedure, and that allowing Samsung to use as an alternate test procedure ANSI/AHRI 1230, as adopted in DOE's final rule dated May 16, 2012 (77 FR 28928), addresses these testing difficulties.
DOE consulted with the Federal Trade Commission (FTC) staff concerning the Samsung petition for waiver. The FTC staff did not have any objections to granting a waiver to Samsung.
After careful consideration of all the material that was submitted by Samsung and consultation with the FTC staff, it is ordered that:
(1) The petition for waiver submitted by the Samsung (Case No. CAC-038) is hereby granted as set forth in the paragraphs below.
(2) Samsung shall be required to test and rate the following basic model groups according to the alternate test procedure set forth in paragraph (3) of this section.
(3) Samsung shall not be required to test the products listed in paragraph (2) of this section according to the test procedure for commercial package air conditioners and heat pumps prescribed by DOE at 10 CFR 431.96 (ARI Standard 340/360-2004 (incorporated by reference in 10 CFR 431.95(b)(2)-(3)), but instead shall use as the alternate test procedure ANSI/AHRI 1230-2010 as adopted in DOE's final rule dated May 16, 2012 (77 FR 28928).
(4)
(i) For multi-split combinations tested in accordance with this alternate test procedure, Samsung may make representations based on those test results.
(ii) For multi-split combinations that are not tested, Samsung may make representations based on the testing results for the tested combination and that are consistent with one of the following methods:
(a) Rating of non-tested combinations according to an alternative rating method approved by DOE; or
(b) Rating of non-tested combinations having the same outdoor unit and all non-ducted indoor units shall be set equal to the rating of the tested system having all non-ducted indoor units.
(c) Rating of non-tested combinations having the same outdoor unit and all ducted indoor units shall be set equal to the rating of the tested system having all ducted indoor units. To be considered a ducted unit, the indoor unit must be intended to be connected with ductwork and have a rated external static pressure capability greater than zero (0).
(d) Rating of non-tested combinations having the same outdoor unit and a mix of non-ducted and ducted indoor units shall be set equal to the average of the ratings for the two required tested combinations.
(5) This waiver amendment shall remain in effect from the date this Decision and Order is issued, consistent with the provisions of 10 CFR 431.401(g). Compliance with the ASHRAE final rule, (77 FR 28928, May 16, 2012), is required beginning on May 13, 2013. Therefore, this D&O is valid through May 12, 2013. Beginning on May 13, 2013, all manufacturers must use the amended DOE test procedures to determine the energy use of this type of equipment.
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Daniel Lissner, General Counsel, Free Flow Power Corporation, 239 Causeway Street, Suite 300, Boston, MA 02114; or at (978) 283-2822.
Alan Topalian, Regulatory Attorney, Free Flow Power Corporation, 239 Causeway Street, Suite 300, Boston, MA 02114; or at (978) 283-2822.
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k. Pursuant to section 4.32(b)(7) of 18 CFR of the Commission's regulations, if any resource agency, Indian tribe, or person believes that an additional scientific study should be conducted in order to form an adequate factual basis for a complete analysis of the application on its merit, the resource agency, Indian tribe, or person must file a request for a study with the Commission not later than 60 days from the date of filing of the application, and serve a copy of the request on the applicant.
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All documents may be filed electronically via the Internet. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site
m. The applications are not ready for environmental analysis at this time.
n. The proposed Beverly Lock and Dam Water Power Project would be located on the Muskingum River at river mile (RM) 24.6, and consist of the following new facilities: (1) A 37-foot-long, 52-foot-high, 75-foot-wide intake structure with 2-inch clear bar spacing trash racks; (2) a 160-foot by 75-foot powerhouse located downstream of the dam on the left bank of the Muskingum River; (3) two turbine-generator units providing a combined installed capacity of 3.0 megawatts (MW); (4) a 65-foot-long, 75-foot-wide draft tube section; (5) a 40-foot by 40-foot substation; (6) a 970-foot-long, three-phase, overhead 69-kilovolt (kV) transmission line to connect the project substation to the local utility distribution lines; and (7) appurtenant facilities. The average annual generation would be about 17,853 megawatt-hours (MWh).
The proposed Devola Lock and Dam Water Power Project would be located at RM 5.8, and consist of the following new facilities: (1) A 160-foot-long, 66-foot-high, 80-foot-wide intake structure with 2-inch clear bar spacing trash racks; (2) a 160-foot by 80-foot powerhouse located on the bank of the Muskingum River opposite the existing lock; (3) two turbine-generator units providing a combined installed capacity of 4.0 MW; (4) a 65-foot-long, 80-foot-wide draft tube section; (5) a 40-foot by 40-foot substation; (6) a 3,600-foot-long, three-phase, overhead 69-kV transmission line to connect the project substation to the local utility distribution lines; and (7) appurtenant facilities. The average annual generation would be about 20,760 MWh.
The proposed Malta Lock and Dam Water Power Project would be located at RM 49.4, and consist of the following new facilities: (1) A 37-foot-long, 52-foot-high, 80-foot-wide intake structure with 2-inch clear bar spacing trash racks; (2) a 160-foot by 80-foot powerhouse located adjacent to the right bank of the dam; (3) two turbine-generator units providing a combined installed capacity of 4.0 MW; (4) a 65-foot-long, 80-foot-wide draft tube section; (5) a 40-foot by 40-foot substation; (6) a 1,500-foot-long, three-phase, overhead 69-kV transmission line to connect the project substation to the local utility distribution lines; and (7) appurtenant facilities. The average annual generation would be about 21,895 MWh.
The proposed Lowell Lock and Dam Water Power Project would be located at RM 13.6, and consist of the following new facilities: (1) A 37-foot-long, 52-foot-high, 80-foot-wide intake structure with 2-inch clear bar spacing trash racks; (2) a 160-foot by 75-foot powerhouse located adjacent to the left bank of the dam; (3) two turbine-generator units providing a combined installed capacity of 5 MW; (4) a 65-foot-long, 75-foot-wide draft tube section; (5) a 40-foot by 40-foot substation; (6) a 1,200-foot-long, three-phase, overhead 69-kV transmission line to connect the project substation to the local utility distribution lines; and (7) appurtenant facilities. The average annual generation would be about 30,996 MWh.
The proposed Philo Lock and Dam Water Power Project would be located at RM 68.6, and consist of the following new facilities: (1) A 40-foot-long, 20-foot-high flap gate bay; (2) a 37-foot-long, 52-foot-high, 80-foot-wide intake structure with 2-inch clear bar spacing trash racks; (3) a 160-foot by 75-foot
The proposed Rokeby Lock and Dam Water Power Project would be located at RM 57.4, and consist of the following new facilities: (1) A 37-foot-long, 52-foot-high, 80-foot-wide intake structure with 2-inch clear bar spacing trash racks; (2) a 160-foot by 75-foot powerhouse located on the bank of the Muskingum River opposite the existing lock; (3) two turbine-generator units providing a combined installed capacity of 4 MW; (4) a 65-foot-long, 75-foot-wide draft tube section; (5) a 40-foot by 40-foot substation; (6) a 490-foot-long, three-phase, overhead 69-kV transmission line to connect the project substation to the local utility distribution lines; and (7) appurtenant facilities. The average annual generation would be about 17,182 MWh.
The proposed Zanesville Lock and Dam Water Power Project would be located at RM 77.4, and consist of the following new facilities: (1) A 135-foot-long, 16-foot-high, 30-foot-wide intake structure with 2-inch clear bar spacing trash racks; (2) two 10-foot diameter, 62-foot-long buried steel penstocks; (3) a 45-foot by 37-foot powerhouse located approximately 2,750 feet downstream of the dam; (4) two turbine-generator units providing a combined installed capacity of 2 MW; (5) a 31-foot-long, 37-foot-wide draft tube; (6) a 40-foot by 40-foot substation; (7) a 400-foot-long, three-phase, overhead 69-kV transmission line to connect the project substation to the local utility distribution lines; and (8) appurtenant facilities. The average annual generation would be about 12,295 MWh.
The applicant proposes to operate all seven projects in a run-of-river mode, such that the water surface elevations within each project impoundment would be maintained at the crest of each respective dam spillway.
o. A copy of the applications are available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
You may also register online at
p. Procedural schedule: The applications will be processed according to the following preliminary Hydro Licensing Schedule. Revisions to the schedule will be made as appropriate.
Final amendments to the applications must be filed with the Commission no later than 30 days from the issuance date of the notice of ready for environmental analysis.
Take notice that the Commission received the following electric rate filings:
Description: Notice of Change in Status of Canandaigua Power Partners, LLC,
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR § 385.211 and § 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR § 385.211 and § 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
Any person desiring to protest in any the above proceedings must file in accordance with Rule 211 of the Commission's Regulations (18 CFR § 385.211) on or before 5:00 p.m. Eastern time on the specified comment date.
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, and service can be found at:
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
Any person desiring to protest in any the above proceedings must file in accordance with Rule 211 of the Commission's Regulations (18 CFR § 385.211) on or before 5:00 p.m. Eastern time on the specified comment date.
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, and service can be found at:
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR § 385.211 and § 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission received the following exempt wholesale generator filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
The staff of the Federal Energy Regulatory Commission (FERC or Commission) will prepare an environmental assessment (EA) that will discuss the environmental impacts of the Rose Lake Expansion Project involving the modification of compression facilities by Tennessee Gas Pipeline Company, L.L.C. (TGP) in Bradford and Tioga Counties, Pennsylvania. The Commission will use this EA in its decision-making process to determine whether the project is in the public convenience and necessity.
This notice announces the opening of the scoping process the Commission will use to gather input from the public and interested agencies on the project. Your input will help the Commission staff determine what issues they need to evaluate in the EA. Please note that the scoping period will close on December 10, 2012.
This notice is being sent to the Commission's current environmental mailing list for this project. State and local government representatives should notify their constituents of this proposed project and encourage them to comment on their areas of concern.
TGP provided landowners with a fact sheet prepared by the FERC entitled “An Interstate Natural Gas Facility On My Land? What Do I Need To Know?”. This fact sheet addresses a number of typically-asked questions, including the use of eminent domain and how to participate in the Commission's proceedings. It is also available for viewing on the FERC Web site (
TGP proposes to construct, abandon, and replace certain compression facilities at three existing compressor stations on its 300 Line in northeastern Pennsylvania. The proposed Rose Lake Expansion Project includes the following:
• Installation of a new 12,630 horsepower (hp) compressor unit, ancillary equipment, and station piping modifications at Station 315 in Tioga County, Pennsylvania;
• Abandonment in place of two 4,500 hp compressor units and replacing these with the installation of a new 12,661 hp compressor unit, ancillary equipment, and station piping modifications at Station 319 in Bradford County, Pennsylvania; and
• Abandonment by removal of an existing gear box and compressor unit and replacement with a new gear box and compressor unit, ancillary equipment, and station piping modifications at Station 317 in Bradford County, Pennsylvania.
Construction of the project would disturb about 70 acres of land, of which approximately 5.4 acres would be permanently impacted. All land disturbance would occur on land owned by TGP adjacent to its existing facilities. The general location of the project facilities is shown in appendix 1.
The National Environmental Policy Act (NEPA) requires the Commission to take into account the environmental impacts that could result from an action whenever it considers the issuance of a Certificate of Public Convenience and Necessity. NEPA also requires us
In the EA we will discuss impacts that could occur as a result of the construction and operation of the proposed project under these general headings:
• Geology and soils;
• Land use;
• Water resources, fisheries, and wetlands;
• Cultural resources;
• Vegetation and wildlife;
• Air quality and noise;
• Endangered and threatened species; and
• Public safety.
We will also evaluate reasonable alternatives to the proposed project or portions of the project, and make recommendations on how to lessen or avoid impacts on the various resource areas.
The EA will present our independent analysis of the issues. The EA will be available in the public record through eLibrary. Depending on the comments received during the scoping process, we may also publish and distribute the EA to the public for an allotted comment period. We will consider all comments on the EA before making our recommendations to the Commission. To ensure we have the opportunity to consider and address your comments, please carefully follow the instructions in the Public Participation section beginning on page 4.
With this notice, we are asking agencies with jurisdiction by law and/or special expertise with respect to the environmental issues of this project to formally cooperate with us in the preparation of the EA.
In accordance with the Advisory Council on Historic Preservation's implementing regulations for section 106 of the National Historic Preservation Act, we are using this notice to initiate consultation with the Pennsylvania State Historic Preservation Office (SHPO), and to solicit their views and those of other government agencies, interested Indian tribes, and the public on the project's potential effects on historic properties.
You can make a difference by providing us with your specific comments or concerns about the project. Your comments should focus on the potential environmental effects, reasonable alternatives, and measures to avoid or lessen environmental impacts. The more specific your comments, the more useful they will be. To ensure that your comments are timely and properly recorded, please send your comments so that the Commission receives them in Washington, DC on or before December 10, 2012.
For your convenience, there are three methods which you can use to submit your comments to the Commission. In all instances please reference the project docket number (CP13-3-000) with your submission. The Commission encourages electronic filing of comments and has expert staff available to assist you at (202) 502-8258 or
(1) You can file your comments electronically using the eComment feature on the Commission's Web site (
(2) You can file your comments electronically using the eFiling feature on the Commission's Web site (
(3) You can file a paper copy of your comments by mailing them to the following address: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Room 1A, Washington, DC 20426.
The environmental mailing list includes federal, state, and local government representatives and agencies; elected officials; Native American Tribes; other interested parties; and local libraries and newspapers. This list also includes all affected landowners (as defined in the Commission's regulations) who are current right-of-way grantors, whose property may be used temporarily for project purposes, or who own homes within certain distances of aboveground facilities, and anyone who submits comments on the project. We will update the environmental mailing list as the analysis proceeds to ensure that we send the information related to this environmental review to all individuals, organizations, and government entities interested in and/or potentially affected by the proposed project.
If we publish and distribute the EA, copies will be sent to the environmental mailing list for public review and comment. If you would prefer to receive a paper copy of the document instead of the CD version or would like to remove your name from the mailing list, please return the attached Information Request (appendix 2).
In addition to involvement in the EA scoping process, you may want to become an “intervenor” which is an official party to the Commission's proceeding. Intervenors play a more formal role in the process and are able to file briefs, appear at hearings, and be heard by the courts if they choose to appeal the Commission's final ruling. An intervenor formally participates in the proceeding by filing a request to intervene. Instructions for becoming an intervenor are in the User's Guide under the “e-filing” link on the Commission's Web site.
Additional information about the project is available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC Web site at
In addition, the Commission now offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to
Finally, public meetings or site visits will be posted on the Commission's calendar located at
Take notice that the following hydroelectric applications have been filed with Commission and are available for public inspection:
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All documents may be filed electronically via the Internet. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site
The Commission's Rules of Practice and Procedure require all interveners filing documents with the Commission to serve a copy of that document on each person on the official service list for the project. Further, if an intervener files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.
k. This application is not ready for environmental analysis at this time.
l. The proposed project would be a closed-loop pumped storage system, with an initial fill from the existing Otter Creek reservoir. Parker Knoll would include the following new facilities: (1) An approximately 175-feet-high upper main dam with a crest length of approximately 1,650 feet and one saddle dam; (2) an upper reservoir with a storage capacity of approximately 6,780 acre-feet and a surface area of approximately 110 acres; (3) an approximately 100-feet-high lower dam with a crest length of approximately 1,750 feet and two saddle dams; (4) a lower reservoir with storage capacity of approximately 6,760 acre-feet and a surface area of approximately 130 acres; (5) a 2,390-feet-long and 27-feet-diameter headrace tunnel; (6) a 2,200-feet-long and 27-feet-diameter vertical shaft; (7) a 1,000-feet-long and 27-feet-diameter steel-lined penstock tunnel; (8) a 7,126-feet-long and 35-feet-diameter tailrace tunnel; (9) a powerhouse containing four variable speed, reversible pump-turbine units with a minimum rating of 250 megawatt (MW); (10) an approximately 585-feet by 340-feet substation; (11) a 16-inch diameter and 68,000-feet-long fill pipeline and system; (12) approximately one mile of 345-kV transmission line; and (13) appurtenant facilities. The project would occupy 458.7 acres of federal land and would have an estimated annual generation of 2,630 gigawatt hours.
m. A copy of the application is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
You may also register online at
n.
FERC staff will conduct one agency scoping meeting and one public meeting. The agency scoping meeting will focus on resource agency and non-governmental organization (NGO) concerns, while the public scoping meeting is primarily for public input. All interested individuals, organizations, and agencies are invited to attend one or both of the meetings, and to assist the staff in identifying the scope of the environmental issues that should be analyzed in the EIS. The times and locations of these meetings are as follows:
Copies of the Scoping Document (SD1) outlining the subject areas to be addressed in the EIS were distributed to the parties on the Commission's mailing list. Copies of the SD1 will be available at the scoping meeting or may be viewed on the web at
At the scoping meetings, the staff will: (1) Summarize the environmental issues tentatively identified for analysis in the EIS; (2) solicit from the meeting participants all available information, especially quantifiable data, on the resources at issue; (3) encourage statements from experts and the public on issues that should be analyzed in the EIS, including viewpoints in opposition to, or in support of, the staff's preliminary views; (4) determine the resource issues to be addressed in the EIS; and (5) identify those issues that require a detailed analysis, as well as those issues that do not require a detailed analysis.
The meetings are recorded by a court reporter and become part of the formal record of the Commission proceeding on the project.
Individuals, organizations, and agencies with environmental expertise and concerns are encouraged to attend the meeting and to assist the staff in defining and clarifying the issues to be addressed in the EIS.
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.
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All documents may be filed electronically via the Internet. See 18
The Commission's Rules of Practice require all intervenors filing documents with the Commission to serve a copy of that document on each person on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.
k. This application is not ready for environmental analysis at this time.
l. The proposed project would utilize the existing U.S. Army Corps of Engineers' Braddock Locks and Dam and the Braddock Pool, and would consist of the following new facilities: (1) A new powerhouse with five turbine-generators having a total installed capacity of 3,750 kilowatts; (2) a new approximately 3,450-foot-long, 23-kilovolt electric distribution line; (3) a switchyard and control room; and (4) appurtenant facilities. The average annual generation is estimated to be 25,020 megawatt-hours.
The proposed project would deploy hydropower turbines within a patented “Large Frame Module” (LFM) that would be deployed on the south (river left) side of the dam, opposite the location of the existing navigational locks and at the upstream face of the existing left closure weir. The proposed modular, low environmental impact powerhouse would be approximately 60.4 feet long, 16.6 feet wide, and 40 feet high, and constructed of structural-grade steel. The powerhouse will bear on a concrete foundation on rock that is anchored to the existing left closure weir. A trash rack with 6-inch openings would be placed at the powerhouse intake to increase safety and protect the turbines from large debris.
m. A copy of the application is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
You may also register online at
The Commission intends to prepare an Environmental Assessment (EA) on the project in accordance with the National Environmental Policy Act. The EA will consider both site-specific and cumulative environmental impacts and reasonable alternatives to the proposed action.
FERC staff will conduct one daytime scoping meeting and one evening meeting. The daytime scoping meeting will focus on resource agency and non-governmental organization (NGO) concerns, while the evening scoping meeting is primarily for public input. All interested individuals, organizations, and agencies are invited to attend one or both of the meetings, and to assist the staff in identifying the scope of the environmental issues that should be analyzed in the EA. The times and locations of these meetings are as follows:
Copies of the Scoping Document (SD1) outlining the subject areas to be addressed in the EA are being distributed to the parties on the Commission's mailing list and the applicant's distribution list. Copies of the SD1 will be available at the scoping meeting or may be viewed on the web at
The Applicant and FERC staff will conduct a project Environmental Site Review beginning at 10:00 a.m. on Wednesday December 5, 2012. All interested individuals, organizations, and agencies are invited to attend. All participants should meet in the parking lot at the Great Allegheny Passage Trailhead, Pump House, 880 East Waterfront Drive, Munhall, Pennsylvania at 10:00 a.m. All participants are responsible for their own transportation to the site.
At the scoping meetings, the staff will: (1) Summarize the environmental issues tentatively identified for analysis in the EA; (2) solicit from the meeting participants all available information, especially quantifiable data, on the resources at issue; (3) encourage statements from experts and the public on issues that should be analyzed in the EA, including viewpoints in opposition to, or in support of, the staff's preliminary views; (4) determine the resource issues to be addressed in the EA; and (5) identify those issues that require a detailed analysis, as well as those issues that do not require a detailed analysis.
The meetings are recorded by a stenographer and become part of the formal record of the Commission proceeding on the project.
Individuals, organizations, and agencies with environmental expertise and concerns are encouraged to attend the meetings and to assist the staff in defining and clarifying the issues to be addressed in the EA.
This is a supplemental notice in the above-referenced proceeding, of CPV Shore, LLC's application for market-
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability is November 29, 2012.
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 Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding(s) 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 email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
This is a supplemental notice in the above-referenced proceeding, of Shiloh IV Lessee, LLC's application for market-based rate authority, with an accompanying rate schedule, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability is November 29, 2012.
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 Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding(s) 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 email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
This is a supplemental notice in the above-referenced proceeding, of Chisholm View Wind Project, LLC's application for market-based rate authority, with an accompanying rate schedule, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability is November 19, 2012.
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 Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding(s) 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 email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
This is a supplemental notice in the above-referenced proceeding, of CPV Maryland, LLC's application for market-based rate authority, with an accompanying rate schedule, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability is November 29, 2012.
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 Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding(s) 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 email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
The Federal Energy Regulatory Commission staff will hold a one-day conference on Order No. 768.
There will be a morning session and an afternoon session. The public may attend. The conference will principally address satisfying the Electric Quarterly Reports (EQRs) reporting requirements. The conference will not address the merits of issues raised on rehearing of Order No. 768. Advance registration is not required but is encouraged. Please register at
The morning session will begin at 9:00 a.m. (EST) and is intended for new EQR filers who are not currently filing EQR reports. However, anyone may attend. FERC staff will provide introductory and background information about the EQR, including data fields that existed prior to Order No. 768. These data fields include information on seller names, customer names, contract data, transaction data, product type, quantity, and rate, among others.
The afternoon session will begin at 1:00 p.m. (EST). This session is intended for all EQR filers, including new filers, and will focus on refinements to the existing filing requirements as set forth in Order No. 768, including the new data fields. The requirements for these data fields will include (1) reporting the trade date and type of rate; (2) identifying the exchange used for a sales transaction, if applicable; (3) reporting whether a broker was used to consummate a transaction; (4) reporting electronic tag ID data; and (5) reporting standardized prices and quantities for energy, capacity, and booked out power transactions, among others.
A free webcast of the conference will be available through
Commission staff encourages participants to email questions in advance to
The conference will be transcribed and the transcript placed in the record in Docket No. RM 10-12.
FERC conferences and meetings are accessible under section 508 of the Rehabilitation Act of 1973. For accessibility accommodations, please send an email to
For more information on this conference, please contact Sarah McKinley at
Environmental Protection Agency (EPA).
Notice.
EPA has authorized its contractor, Abt Associates, Inc. (Abt) of Cambridge, MA, to access information which has been submitted to EPA under section 8 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 occurred on or about October 11, 2012.
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 EPA Contract Number EP-W-12-001, contractor Abt of 55 Wheeler Street, Cambridge, MA is assisting the EPA in developing public information products for the 2012 Chemical Data Reporting (CDR) data. These products shall include individual fact sheets; a natural report with various descriptions of the data resulting from data queries and associated program analyses; trend analysis and other items.
In accordance with 40 CFR 2.306(j), EPA has determined that under EPA Contract Number EP-W-12-001, Abt requires access to CBI submitted to EPA under section 8 of TSCA to perform successfully the duties specified under the contract. Abt's personnel were given access to information submitted to EPA under section 8 of TSCA. Some of the information may be claimed or determined to be CBI.
EPA is issuing this notice to inform all submitters of information under section 8 of TSCA that EPA is providing Abt 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 Abt's Bethesda, MD and Cambridge, MA sites, in accordance with EPA's
Access to TSCA data, including CBI, will continue until November 30, 2016. If the contract is extended, this access will also continue for the duration of the extended contract without further notice.
Abt's personnel were required to sign nondisclosure agreements and were briefed on appropriate security procedures before they were permitted access to TSCA CBI.
Environmental protection, Confidential business information.
Environmental Protection Agency (EPA).
Notice.
EPA has authorized its contractor, Eastern Research Group (ERG) of Chantilly, VA, 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 occurred on or about September 26, 2012.
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 EPA Contract Number EP-C-12-021, contractor ERG of 14555 Avion Parkway, Suite 200, Chantilly, VA, will assist the EPA in data analysis of data and reports provided by industry on hydraulic fracturing. The work includes preparation of technical analysis and technical information; and report preparation.
In accordance with 40 CFR 2.306(j), EPA has determined that under EPA Contract Number EP-C-12-021, ERG will require access to CBI submitted to EPA under all sections of TSCA to perform successfully the duties specified under the contract. ERG's personnel will be given access to information submitted to EPA under all sections of TSCA. Some of the information may be claimed or determined to be CBI.
EPA is issuing this notice to inform all submitters of information under all sections of TSCA that EPA may provide ERG 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 ERG's Chantilly, VA site, in accordance with EPA's
Access to TSCA data, including CBI, will continue until September 26, 2017. If the contract is extended, this access will also continue for the duration of the extended contract without further notice.
ERG's 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.
This notice announces EPA's approval of the State of Vermont's request to revise/modify certain of its EPA-authorized programs to allow electronic reporting.
EPA's approval is effective December 17, 2012 for the State of Vermont's National Primary Drinking Water Regulations Implementation program if no timely request for a public hearing is received and accepted by the Agency; and on November 16, 2012 for the State of Vermont's other authorized programs.
Evi Huffer, U.S. Environmental Protection Agency, Office of Environmental Information, Mail Stop 2823T, 1200 Pennsylvania Avenue NW., Washington, DC 20460, (202) 566-1697,
On October 13, 2005, the final Cross-Media Electronic Reporting Rule (CROMERR) was published in the
On December 5, 2011, the Vermont Department of Environmental Conservation (VT DEC) submitted an application titled “Online Report Submittal System Electronic Document Receiving System” for revisions/modifications of its EPA-authorized programs under title 40 CFR. EPA reviewed VT DEC's request to revise/modify its EPA-authorized programs and, based on this review, EPA determined that the application met the standards for approval of authorized program revisions/modifications set out in 40 CFR part 3, subpart D. In accordance with 40 CFR 3.1000(d), this notice of EPA's decision to approve Vermont's request to revise/modify its following EPA-authorized programs to allow electronic reporting under 40 CFR parts 51, 60-63, 70, 141, 144-148, 262-265, 266, 268, 270-271, and 403 is being published in the
Part 52—Approval and Promulgation of Implementation Plans;
Part 61—National Emission Standards for Hazardous Air Pollutants;
Part 62—Approval and Promulgation of State Plans for Designated Facilities and Pollutants;
Part 63—National Emission Standards for Hazardous Air Pollutants for Source Categories;
Part 70—State Operating Permit Programs;
Part 142—National Primary Drinking Water Regulations Implementation;
Part 147—State Underground Injection Control Programs;
Part 272—Approved State Hazardous Waste Management Programs; and
Part 403—General Pretreatment Regulations for Existing and New Sources of Pollution.
VT DEC was notified of EPA's determination to approve its application with respect to the authorized program listed above.
Also, in today's notice, EPA is informing interested persons that they may request a public hearing on EPA's action to approve the State of Vermont's request to revise its authorized public water system program under 40 CFR part 142, in accordance with 40 CFR 3.1000(f). Requests for a hearing must be submitted to EPA within 30 days of publication of today's
(1) The name, address and telephone number of the individual, organization or other entity requesting a hearing;
(2) A brief statement of the requesting person's interest in EPA's determination, a brief explanation as to why EPA should hold a hearing, and any other information that the requesting person wants EPA to consider when determining whether to grant the request; and
(3) The signature of the individual making the request, or, if the request is made on behalf of an organization or other entity, the signature of a responsible official of the organization or other entity.
In the event a hearing is requested and granted, EPA will provide notice of the hearing in the
Section 309(a) of the Clean Air Act requires that EPA make public its comments on EISs issued by other Federal agencies. EPA's comment letters on EISs are available at:
As of October 1, 2012, EPA will not accept paper copies or CDs of EISs for filing purposes; all submissions on or after October 1, 2012 must be made through e-NEPA.
While this system eliminates the need to submit paper or CD copies to EPA to meet filing requirements, electronic submission does not change requirements for distribution of EISs for public review and comment. To begin using e-NEPA, you must first register with EPA's electronic reporting site—
Environmental Protection Agency (EPA).
Notice.
Pursuant to the Federal Advisory Committee Act, the Environmental Protection Agency's (EPA's) Office of Pesticide Programs is
The PPDC meeting will be held on Thursday, November 29, 2012, from 9 a.m. to 5 p.m., and Friday, November 30, 2012, from 9 a.m. to noon. On Wednesday, November 28, 2012, PPDC work group meetings are scheduled as follows: Integrated Pest Management from 1 p.m. to 4 p.m.; Comparative Safety Statements from 1 p.m. to 4 p.m.; and Pollinator Protection from 1 p.m. to 4 p.m.; and on Thursday, November 29, 2012, the PPDC Work Group on 21st Century Toxicology/Integrated Testing Strategies will meet from noon to 1:15 p.m. in N-4850-70 Potomac Yards North. Information regarding PPDC Work Groups is available on EPA's Web site at
To request accommodation of a disability, please contact the person listed under
The PPDC and Work Group meetings will be held at EPA's location at 1 Potomac Yard South, 2777 S. Crystal Drive, Arlington, VA. The PPDC meeting will be held in the lobby-level Conference Center. The PPDC Work Group on Pollinator Protection will meet on November 28, 2012, in the lobby-level Conference Center. The PPDC Work Group on Integrated Pest Management will meet on November 28, 2012, in room S-4850-70 Potomac Yards South. The PPDC Work Group on Comparative Safety Statements will meet on November 28, 2012, in S-4370-80 Potomac Yards South. On November 29, 2012, the PPDC Work Group on 21st Century Toxicology/Integrated Testing Strategies will meet in N-4850-70 Potomac Yards North. EPA's Potomac Yard South building is approximately one mile from the Crystal City Metro Station.
Margie Fehrenbach, Office of Pesticide Programs (7501P), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 308-4775; fax number: (703) 308-4776; email address:
This action is directed to the public in general, and may be of particular interest to persons who work in agricultural settings or persons who are concerned about implementation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA); the Federal Food, Drug, and Cosmetic Act (FFDCA); and the amendments to both of these major pesticide laws by the Food Quality Protection Act (FQPA) of 1996; and the Pesticide Registration Improvement Act. Potentially affected entities may include, but are not limited to: Agricultural workers and farmers; pesticide industry and trade associations; environmental, consumer, and farm worker groups; pesticide users and growers; animal rights groups; pest consultants; State, local, and tribal governments; academia; public health organizations; and the public. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2012-0873, is available at
The Office of Pesticide Programs (OPP) is entrusted with the responsibility to help ensure the safety of the American food supply, the education and protection from unreasonable risk of those who apply or are exposed to pesticides occupationally or through use of products, and general protection of the environment and special ecosystems from potential risks posed by pesticides.
The Charter for EPA's PPDC was established under the Federal Advisory Committee Act (FACA), Public Law 92-463, in September 1995, and has been renewed every 2 years since that time. PPDC's Charter was renewed October 28, 2011, for another 2-year period. The purpose of PPDC is to provide advice and recommendations to the EPA Administrator on issues associated with pesticide regulatory development and reform initiatives, evolving public policy and program implementation issues, and science issues associated with evaluating and reducing risks from use of pesticides. It is determined that PPDC is in the public interest in connection with the performance of duties imposed on the Agency by law. The following sectors are represented on the current PPDC: Environmental/public interest and animal rights groups; farm worker organizations; pesticide industry and trade associations; pesticide user, grower, and commodity groups; Federal and State/local/tribal governments; the general public; academia; and public health organizations.
Copies of the PPDC Charter are filed with appropriate committees of Congress and the Library of Congress and are available upon request.
PPDC meetings are open to the public and seating is available on a first-come basis. Persons interested in attending do not need to register in advance of the meeting. Comments may be made during the public comment session of each meeting or in writing to the address listed under
Environmental protection, Agricultural workers, Agriculture, Chemicals, Endangered species, Foods, Integrated pest management, Pesticide labels, Pesticides and pests, Public health, Spray drift, 21st Century toxicology.
Environmental Protection Agency (EPA).
Notice.
There will be a 4-day meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to consider and review scientific issues associated with Prioritizing the Universe of Endocrine Disruptor Screening Program (EDSP) Chemicals Using Computational Toxicology Tools.
The meeting will be held on January 29-February 1, 2013, from approximately 9 a.m. to 5:30 p.m.
The meeting will be held at the Environmental Protection Agency, Conference Center, Lobby Level, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA 22202.
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If your comments contain any information that you consider to be CBI or otherwise protected, please contact the DFO listed under
Sharlene Matten, DFO, Office of Science Coordination and Policy (7201M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (202) 564-0130; fax number: (202) 564-8382; email address:
This action is directed to the public in general. This action may, however, be of interest to persons who are or may be required to conduct testing of chemical substances under the Federal Food, Drug, and Cosmetic Act (FFDCA) and FIFRA. 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.
When submitting comments, remember to:
1. Identify the document by docket ID number and other identifying information (subject heading,
2. 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.
3. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
4. Describe any assumptions and provide any technical information and/or data that you used.
5. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
6. Provide specific examples to illustrate your concerns and suggest alternatives.
7. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
8. Make sure to submit your comments by the comment period deadline identified.
You may participate in this meeting by following the instructions in this unit. To ensure proper receipt by EPA, it is imperative that you identify docket ID number EPA-HQ-OPP-2012-0818 in the subject line on the first page of your request.
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• Organic and analytical chemistry (expertise focused on developing criteria for physical chemical properties that cannot be easily tested in
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• Quantitative structural-activity relationship (QSAR) models and estrogen receptor (ER) expert systems development.
• High-throughput data generation and analysis (expertise focused on how this methodology can be applied to assess toxicity potential of environmental compounds with a range of potency).
• Application of QSAR models and expert systems in prioritization processes for regulatory toxicity testing programs.
The selection of scientists to serve on FIFRA SAP is based on the function of the panel and the expertise needed to address the Agency's charge to the panel. No interested scientists shall be ineligible to serve by reason of their membership on any other advisory committee to a Federal department or agency or their employment by a Federal department or agency except the EPA. Other factors considered during the selection process include availability of the potential panel member to fully participate in the panel's reviews, absence of any conflicts of interest or appearance of lack of impartiality, independence with respect to the matters under review, and lack of bias. Although financial conflicts of interest, the appearance of lack of impartiality, lack of independence, and bias may result in disqualification, the absence of such concerns does not assure that a candidate will be selected to serve on FIFRA SAP. Numerous qualified candidates are identified for each panel. Therefore, selection decisions involve carefully weighing a number of factors including the candidates' areas of expertise and professional qualifications and achieving an overall balance of different scientific perspectives on the panel. In order to have the collective breadth of experience needed to address the Agency's charge for this meeting, the Agency anticipates selecting approximately 12-15 ad hoc scientists.
FIFRA SAP members are subject to the provisions of 5 CFR part 2634, Executive Branch Financial Disclosure, as supplemented by the EPA in 5 CFR part 6401. In anticipation of this requirement, prospective candidates for service on the FIFRA SAP will be asked to submit confidential financial information which shall fully disclose, among other financial interests, the candidate's employment, stocks and bonds, and where applicable, sources of research support. The EPA will evaluate the candidates financial disclosure form to assess whether there are financial conflicts of interest, appearance of a lack of impartiality or any prior involvement with the development of the documents under consideration (including previous scientific peer review) before the candidate is considered further for service on FIFRA SAP. Those who are selected from the pool of prospective candidates will be asked to attend the public meetings and to participate in the discussion of key issues and assumptions at these meetings. In addition, they will be asked to review and to help finalize the meeting minutes. The list of FIFRA SAP members participating at this meeting will be posted on the FIFRA SAP Web site at
FIFRA SAP serves as the primary scientific peer review mechanism of EPA's Office of Chemical Safety and Pollution Prevention (OCSPP) and is structured to provide scientific advice, information and recommendations to the EPA Administrator on pesticides and pesticide-related issues as to the impact of regulatory actions on health and the environment. FIFRA SAP is a Federal advisory committee established in 1975 under FIFRA that operates in accordance with requirements of the Federal Advisory Committee Act. FIFRA SAP is composed of a permanent panel consisting of seven members who are appointed by the EPA Administrator from nominees provided by the National Institutes of Health and the National Science Foundation. FIFRA established a Science Review Board consisting of at least 60 scientists who are available to the SAP on an ad hoc basis to assist in reviews conducted by the SAP. As a peer review mechanism, FIFRA SAP provides comments, evaluations and recommendations to improve the effectiveness and quality of analyses made by Agency scientists. Members of FIFRA SAP are scientists who have sufficient professional qualifications, including training and experience, to provide expert advice and recommendation to the Agency.
Under the 1996 FFDCA, section 408(p), and Safe Drinking Water Act, section 1457, EPA is required to screen all pesticide chemicals (active and inert ingredients) and only those drinking water contaminants to which a “substantial population” is exposed for the
In 2009, EPA developed the Estrogen Receptor (ER) Expert System (ERES) to help prioritize candidate chemicals specific to an estrogen receptor (ER) mediated pathway for testing in the Tier 1 Endocrine Disruptor Screening Program. The ERES was initially developed for pesticide, food use inert ingredients and antimicrobial pesticides and predicts ER binding affinity based on data derived from two types of
EPA incorporated the 2009 SAP's recommendations and is expanding the ERES training set through the use of chemical read across techniques (i.e., using data from a tested chemical for a particular property or effect to a similar untested chemical) and
While this SAP is focused on the estrogenic toxicity pathway, the recommendations may be more broadly applied for additional toxicity pathways (e.g., androgen and thyroid). In addition, this SAP review will establish a solid foundation upon which the agency seeks to build upon as we advance the use of these computational toxicology tools beyond EDSP chemical prioritization and into Tier 1 data replacement.
EPA's background paper, related supporting materials, charge/questions to FIFRA SAP, FIFRA SAP composition (i.e., members and ad hoc members for this meeting), and the meeting agenda will be available at least 15 days prior to the meeting. In addition, the Agency may provide additional background documents as the materials become available. You may obtain electronic copies of these documents, and certain other related documents that might be available electronically, at
FIFRA SAP will prepare meeting minutes summarizing its recommendations to the Agency approximately 90 days after the meeting. The meeting minutes will be posted on the FIFRA SAP Web site or may be obtained from the OPP Docket or at
Environmental protection, Pesticides and pests.
Environmental Protection Agency (EPA).
Notice; request for public comment.
In accordance with Section 122 (i) of the Comprehensive Environmental Response, Compensation, and Liability Act, as amended (“CERCLA”), notice is hereby given of a proposed administrative settlement concerning the Agrifos Phosphoric Acid Release Superfund Site in Pasadena, Harris County, Texas.
The settlement requires the settling party to pay a total of $385,000 as payment of response costs to the Hazardous Substances Superfund. The settlement includes a covenant not to sue pursuant to Section 107 of CERCLA.
For thirty (30) days following the date of publication of this notice, the Agency will receive written comments relating to this notice and will receive written comments relating to the settlement. The Agency will consider all comments received and may modify or withdraw its consent to the settlement if comments received disclose facts or considerations which indicate that the settlement is inappropriate, improper, or inadequate. The Agency's response to any comments received will be available for public inspection at 1445 Ross Avenue, Dallas, Texas 75202-2733.
Comments must be submitted on or before December 17, 2012.
The proposed settlement and additional background information relating to the settlement are available for public inspection at 1445 Ross Avenue, Dallas, Texas 75202-2733. A copy of the proposed settlement may be obtained from Robert Werner at 1445 Ross Avenue, Dallas, Texas 75202-2733 or by calling (214) 665-6724. Comments should reference the Agrifos Phosphoric Acid Release Site, Pasadena, Harris County, Texas and EPA Docket Number 06-01-13, and should be addressed to Robert Werner at the address listed above.
Elizabeth Pletan, Assistant Regional Counsel, 1445 Ross Avenue, Dallas, Texas 75202-2733 or call (214) 665-8525.
Export-Import Bank of the United States.
Notice of 25 day comment period regarding an application for final commitment for a long-term loan or financial guarantee in excess of $100 million.
To support the export of U.S. services and equipment for the construction of a liquefied natural gas (LNG) plant in Australia.
Brief non-proprietary description of the anticipated use of the items being exported:
Production of LNG.
To the extent that Ex-Im Bank is reasonably aware, the item(s) being exported are not likely to produce exports or provide services in competition with the exportation of goods or provision of services by a United States industry.
Comments must be received on or before December 11, 2012 to be assured of consideration before final consideration of the transaction by the Board of Directors of Ex-Im Bank.
Comments may be submitted through
This notice is to inform the public that the Export-Import Bank of the United States has received an application for a $135 million direct loan to support the export of approximately $103 million in U.S. aluminum manufacturing equipment and services to a smelter in the United Arab Emirates. The U.S. exports will enable the foreign buyer to increase its production capacity of aluminum by about 574,000 metric tons of aluminum per year. Available information indicates that the majority of this new foreign production will be sold in the following markets: Netherlands, Japan, United Arab Emirates, United States, South Korea, and Thailand. The balance of the foreign production will be sold to China, Cyprus, Egypt, France, Germany, Greece, Hungary, Indonesia, Italy, Kenya, Malaysia, Philippines, Poland, Romania, Slovakia, South Africa, Spain, Sri Lanka, Taiwan, Turkey, and United Kingdom. Interested parties may submit comments on this transaction by email to
Federal Communications Commission.
Notice; request for comments.
As part of its continuing effort to reduce paperwork burden and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3502-3520), the Federal Communications Commission invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s). Comments are requested concerning: 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; the accuracy of the Commission's burden estimates; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a valid OMB control number.
Written Paperwork Reduction Act (PRA) comments should be submitted on or before December 17, 2012. If you anticipate that you will be submitting PRA comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the FCC contact listed below as soon as possible.
Submit your PRA comments to Nicholas A. Fraser, Office of Management and Budget (OMB), via fax at 202-395-5167 or via Internet at
Judith B. Herman, Office of Managing Director, FCC, at 202-418-0214.
Under the Commission's E911 rules, a wireless carrier must provide E911 service to a particular Public Safety Answering Point (PSAP) within six months only if that PSAP makes a request for the service and is capable of receiving and utilizing the information provided. In the City of Richardson, TX Order, the Commission's actions were intended to facilitate the E911 implementation process by encouraging parties to communicate with each other earl in the implementation process, and to maintain a constructive, on-going dialog throughout the implementation process. See the 60 day notice for more details on the specific information collection requirements in this information collection which was published in the
Federal Communications Commission.
Notice; request for comments.
As part of its continuing effort to reduce paperwork burden and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s). Comments are requested concerning: 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; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information burden for small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a valid OMB control number.
Written Paperwork Reduction Act (PRA) comments should be submitted on or before January 15, 2013. If you anticipate that you will be submitting PRA comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the FCC contact listed below as soon as possible.
Submit your PRA comments to Judith B. Herman, Federal Communications Commission, via the Internet at
Judith B. Herman, Office of Managing Director, (202) 418-0214.
Information on private land mobile licensees is maintained in the Commission's system of records. The licensee records will be publicly available and routinely used in accordance with subsection b of the Privacy Act.
Federal Communications Commission.
Notice; request for comments.
As part of its continuing effort to reduce paperwork burden and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s). Comments are requested concerning: 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; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information burden for small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a valid OMB control number.
Written Paperwork Reduction Act (PRA) comments should be submitted on or before January 15, 2013. If you anticipate that you will be submitting PRA comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the FCC contact listed below as soon as possible.
Submit your PRA comments to Nicholas A. Fraser, Office of Management and Budget, via fax at 202-395-5167 or via Internet at
Judith B. Herman, Office of Managing Director, (202) 418-0214.
This collection will promote Congress' goal of regulatory parity for all Commercial Mobile Radio Services (CMRS) and encourage the participation of a wide variety of applicants, including small businesses, in the SMR industry. In addition, this collection will establish rules for the SMR services in order to streamline the licensing process and provide a flexible operating environment for licensees, foster competition, and promote the delivery of service to all areas of the country, including rural areas.
Federal Communications Commission.
Notice; request for comments.
As part of its continuing effort to reduce paperwork burden and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s). Comments are requested concerning: 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; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and further ways to reduce the information burden for small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it
Written Paperwork Reduction Act (PRA) comments should be submitted on or before January 15, 2013. If you anticipate that you will be submitting PRA comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the FCC contact listed below as soon as possible.
Submit your PRA comments to Leslie F. Smith, Federal Communications Commission (FCC), via the Internet at
Leslie F. Smith, Office of Managing Director, (202) 418-0217. For additional information, contact Leslie F. Smith at (202) 418-0217, or via the Internet at
On April 7, 2011, the FCC released a
Section 1.1424 states that the procedures for handling pole attachment complaints filed by incumbent local exchange carriers are the same as the procedures for handling other pole attachment complaints. Section 1.1424 further requires incumbent local exchange carriers that claim they are similarly-situated to other attachers to bear the burden of demonstrating their similarity.
The Commission has also revised Section 1.1403(b) which requires that requests for access to a utility's poles, ducts, conduits or rights-of-way by a telecommunications carrier or cable operator be in writing. If access is not granted within 45 days of the request for access, the utility must explain the denial or grant of access conditioned on the performance of make-ready by the 45th day.
The other applicable rule sections remain unchanged:
Section 1.1403(c) requires a utility to provide a cable television system operator or telecommunications carrier no less than 60 days written notice prior to removal of facilities, termination of any services to those facilities, increase in pole attachment rates, or modification of facilities.
Section 1.1403(d) allows a cable television system operator or telecommunications carrier to file a “Petition for Temporary Stay” of the action contained in a notice received pursuant to Section 1.1403(c) within 15 days of receipt of such notice. The “Petition for Temporary Stay” must contain, in concise terms, the relief sought, the reasons for such relief, including a showing of irreparable harm and likely cessation of cable television service or telecommunications service, a copy of the notice, and a certificate of service. The named respondent may file an answer within 7 days of the date the Petition was filed.
Section 1.1403(e) requires cable operators to notify pole owners upon offering telecommunications services.
Section 1.1404 specifies the information that must be included in a pole attachment complaint.
Section 1.1406(b) requires a complainant to file additional information supporting its complaint, if requested by the Commission.
Section 1.1407 requires the respondent to file a response within 30 days from the date the complaint was filed. The complainant then has 20 days from the date the response was filed to file a reply. The response and reply shall be served on all parties listed in the certificate of service.
Section 1.1414 requires states that regulate the rates, terms and conditions for pole attachments to file a certification with the FCC.
Section 1.1417 requires a utility to apportion the cost of providing unusable space on a pole so that such apportionment equals two-thirds of the costs of providing unusable space that would be allocated to such entity under an equal apportionment of such costs among all attaching entities. Section 1.1417 sets forth the procedures to be followed in establishing a maximum just and reasonable pole attachment rate.
The Commission 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. 40101) effective on the date shown.
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the President's Advisory Council on Faith-based and Neighborhood Partnerships announces the following meeting:
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-7570 and send comments to Ron Otten, at CDC 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an email to
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 shall have practical utility; (b) the accuracy of the agency's estimate 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. Written comments should be received within 60 days of this notice.
Spectrum of Flavoring Chemical-Related Lung Disease—New—National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC).
The mission of the National Institute for Occupational Safety and Health (NIOSH) is to promote safety and health at work for all people through research
Preliminary evidence suggests that flavorings exposures may be associated with restrictive lung disease in exposed workers. In two previous NIOSH health hazard evaluations, we found excesses of restrictive spirometry among workers in a flavoring manufacturing plant and a flavoring-exposed food production plant. There was virtually no obstructive lung disease in either of these health hazard evaluations. Over the course of eight cross-sectional studies at a microwave popcorn plant, we also found strong relationships between decreases in FEV1 and cumulative exposure estimates, without differentiating between obstructive and restrictive abnormalities.
NIOSH requests OMB approval to collect additional information on a subset of participants from previous NIOSH studies to determine if restrictive lung disease is occurring among flavoring and popcorn workers. Diagnostic methods for restrictive lung disease will be applied in field settings. This will include spirometry, lung volume testing such as total lung capacity (TLC) and diffusing capacity of the lung to carbon monoxide (DLCO), as well as high resolution computed tomography (HRCT), which can detect lung abnormalities consistent with interstitial lung disease. These medical tests are critical to establishing lung disease of a fibrotic or inflammatory nature in persons with spirometric restriction.
Recent literature has demonstrated that bronchiolitis obliterans and obstructive lung disease are related to flavoring exposures in an exposure-dependent way. However, secondary prevention of further impairment among flavoring workers with spirometric restriction and excessive declines in lung function of a restrictive nature is not occurring. Flavoring workers with restrictive abnormalities are not identified as having possible occupational lung disease, are not removed from further flavorings exposure, are not counseled about respiratory protection and work practices, and are unlikely to be successful in claims for work-related lung disease and medical expenses. These cases of restrictive spirometric abnormality do not motivate employers to implement controls to prevent lung injury to co-workers or to enhance medical surveillance programs.
Results from this study will benefit many stakeholders, including physicians who can appropriately manage workers with restrictive lung disease with consideration of enhanced respiratory protection or reassignment; workers who can make decisions regarding continued exposures and apply for compensation if warranted; companies who can set data driven priorities for preventive interventions; and policy makers who can recommend measures to prevent flavoring-related lung diseases.
For this study, we will recruit participants from two study populations: approximately 100 workers from a flavorings plant for whom we have spirometry data and 130 workers that had abnormal spirometry on any test from a previous NIOSH health hazard evaluation at a microwave popcorn plant. Thirty additional workers from the microwave popcorn plant who had normal spirometry on their last test also will be chosen at random.
NIOSH anticipates that information collection will begin during the summer of 2013 for the microwave popcorn workers and for the flavorings workers in the summer of 2014. Both study populations will be offered a questionnaire, spirometry, TLC test, DLCO, and HRCT of the chest. Those with abnormal spirometry will also be offered a bronchodilator test. Testing is expected to take between 3 to 3.25 hours per respondent. All testing will be conducted by trained NIOSH personnel, except for the HRCT chest scan, which will be done at a local hospital or radiology clinic. Participants will receive a letter which will explain their testing results. All study results will be stored at NIOSH.
The total estimated burden for the one-time collection of data is 822 hours. This is an overestimate of the actual burden to account for any possible waiting at the radiology clinic. Participation in this study is voluntary, and there are no costs to respondents other than their time.
The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these requests, call (404) 639-7570 or send an email to
Nationally Notifiable Sexually Transmitted Disease (STD) Morbidity Surveillance (OMB No. 0920-0819, Expiration 08/31/2012)—Reinstatement with Change—National Center for HIV, Viral Hepatitis, STD and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).
Because the STD epidemiology in the United States is changing rapidly, CDC must continue to monitor disease indicators that are included in the STD surveillance currently being implemented. CDC is proposing to continue electronic information collection which includes information elements that are integrated into the existing nationally notifiable STDs. These information elements are beyond the scope of the OMB-approved collection called Weekly and Annual Morbidity and Mortality Reports (MMWR, OMB #0920-0007). This ongoing collection will have a title change from “Sexually Transmitted Disease (STD) Morbidity Surveillance” to “Nationally Notifiable Sexually Transmitted Disease (STD) Morbidity Surveillance and provides evidence to better define STD distribution and epidemiology in the United States. The surveillance system modifies several data elements currently included in the MMWR collection and add others to produce a set of sensitive indicators. This surveillance will continue to provide the evidence to enhance our understanding of STDs, develop intervention strategies, and evaluate the impact of ongoing control efforts. CDC works closely with state and local STD control programs to monitor and respond to STD outbreaks and trends in STD-associated risk behavior. Users of data include, but are not limited to, congressional offices, state and local health agencies, health care providers, and other health-related groups.
CDC disseminates all STD surveillance information through the MMWR series of publications, including the MMWR, the CDC Surveillance Summaries, the Recommendations and Reports, and the annual Summary of Notifiable Diseases, United States. Additionally, DSTDP publishes an annual STD-specific surveillance summary and supplements in hard copy and on the Internet
There is no cost to respondents other than their time. The total estimated annualized burden hours are 989.
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC), announces the following meeting of the aforementioned committee:
Teleconference login information is as follows:
TOLL-FREE PHONE #: 800-857-4875.
Participant passcode: 9377.
Net Conference URL:
Conference number: PW6978681.
Audience passcode: 9377, or
Public can join the event directly:
There is also a toll number for anyone outside of the USA:
TOLL # 1-212-287-1661.
Participant passcode: 9377.
Please go to the ACBCYW meeting Web page to register for this meeting:
Agenda items are subject to change as priorities dictate.
The Director, Management Analysis and Services Office, has been delegated the authority to sign
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice.
This is a notice in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i) that the Technology Transfer Office, Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS), is thinking about giving a co-exclusive license in Africa, in the field of use of veterinary vaccines, to practice the inventions listed in the patent applications referred to below to Deltamune Ltd., having a place of business in Centurion, South Africa. The patent rights in these inventions have been assigned to the government of the United States of America. The patent applications(s) to be licensed are:
US Provisional Application 61/016,065, filed 12/21/2007, entitled “Development of Rift Valley Fever Virus Utilizing Reverse Genetics,” US Provisional Application 61/042,987, filed 4/7/2008, entitled “Recombinant Rift Valley Fever (RVF) Viruses and Method of Use,” PCT Application PCT/US2008/087023, filed 12/16/2008, entitled “Recombinant Rift Valley Fever (RVF) Viruses and Method of Use,” US National Stage Application 12/809,561, filed 6/18/2010, entitled “Recombinant Rift Valley Fever (RVF) Viruses and Methods of Use,” and all related continuing and foreign patents/patent applications for the technology family. CDC Technology ID No. I-008-08.
The planned co-exclusive license will be royalty-bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7.
Only written comments and/or applications for a license which are received by CDC on or before December 17, 2012 will be considered.
Requests for a copy of these patent applications, inquiries, comments, and other materials relating to the planned license should be directed to Donald Prather, J.D., Ph.D., Technology Licensing and Marketing Specialist, Technology Transfer Office, Centers for Disease Control and Prevention (CDC), 4770 Buford Highway, Mailstop K-79, Atlanta, GA 30341, Telephone: (770) 488-8612; Facsimile: (770) 488-8615; Email:
Applications for a license filed in response to this notice will be treated as objections to giving the planned license.
Comments and objections submitted in response to this notice will not be made available for public inspection, and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice.
This is a notice in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i) that the Technology Transfer Office, Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS), is thinking of giving a co-exclusive license in Africa, and an exclusive license in all territories other than Africa, in the field of use of veterinary vaccines, to practice the inventions listed in the patent applications referred to below to Merial Limited, having a place of business in Duluth, Georgia. The patent rights in these inventions have been assigned to the government of the United States of America. The patent application(s) to be licensed are:
US Provisional Application 61/016,065, filed 12/21/2007, entitled “Development of Rift Valley Fever Virus Utilizing Reverse Genetics,” US Provisional Application 61/
The planned co-exclusive license and exclusive license will be royalty-bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7.
Only written comments and/or applications for a license which are received by CDC on or before December 17, 2012 will be considered.
Requests for a copy of these patent applications, inquiries, comments, and other materials relating to the planned license should be directed to Donald Prather, J.D., Ph.D., Technology Licensing and Marketing Specialist, Technology Transfer Office, Centers for Disease Control and Prevention (CDC), 4770 Buford Highway, Mailstop K-79, Atlanta, GA 30341, Telephone: (770) 488-8612; Facsimile: (770) 488-8615; Email:
Applications for a license filed in response to this notice will be treated as objections to giving the planned license.
Comments and objections submitted in response to this notice will not be made available for public inspection, and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice.
This is a notice in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i) that the Technology Transfer Office, Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS), is thinking about giving a worldwide, exclusive license to practice the inventions listed in the patent referred to below to Flow Applications, Inc., having a place of business in Okawville, Illinois. The patent rights in these inventions have been assigned to the government of the United States of America. The patent to be licensed is:
US Patent 7,642,068, entitled, “Multiple-Valent Opsonophagocytic Assay Selection Panel Arrays and Uses Therefor”, issued 1/5/2010. CDC Technology ID No. I-035-04.
The planned exclusive license will be royalty-bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7.
Only written comments and/or applications for a license which are received by CDC on or before December 3, 2012 will be considered.
Requests for a copy of this patent, inquiries, comments, and other materials relating to the contemplated license should be directed to Donald Prather, J.D., Ph.D., Technology Licensing and Marketing Specialist, Technology Transfer Office, Centers for Disease Control and Prevention (CDC), 4770 Buford Highway, Mailstop K-79, Atlanta, GA 30341, Telephone: (770) 488-8612; Facsimile: (770) 488-8615: Email:
Applications for a license filed in response to this notice will be treated as objections to giving the planned license.
Comments and objections submitted in response to this notice will not be made available for public inspection, and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Respirators with Composite Protection for Wildland Fire-Fighting Operations; Notice of Testing and Evaluation.
The Centers for Disease Control and Prevention's (CDC) National
Wildland firefighting presents many hazards to firefighters, including inhalation exposure to smoke and other combustion (fire) byproducts. Studies indicate that most wildland firefighters work in smoke levels that are not expected to cause health problems or exceed legal and recommended limits.
NIOSH is now accepting applications for respiratory protective devices designed for the inhalation hazards of this occupational setting.
On July 10, 2012 NIOSH issued a letter to manufacturers
Under NFPA 1984, the wildland firefighter respirator must be approved by NIOSH as an APR or a PAPR. NIOSH has developed test procedures for a composite particulate and multi-gas protection for APR and PAPR approvals in accordance with 42 CFR 84.60(b); 84.63(a), (b), (c), and (d); 84.110(c); and 84.190(b). The standard test procedures are available upon request and will be available on the NIOSH NPPTL Web site at:
Tim Rehak, NIOSH National Personal Protective Technology Laboratory (NPPTL), P.O. Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236; (412) 386-5200 (this is not a toll-free number).
Centers for Medicare & Medicaid Services, HHS.
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services, is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the Agency's function; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
1.
2.
3.
The overall burden of hours and expected number of respondents increase is based on projected future service growth and projected future increases in staffing to accommodate the increased demand to utilize the SHIP network to raise awareness about new CMS policies, outreach initiatives, or both. However, the instruments themselves have not changed.
4.
The data will also include the variables on the eight item Kansas City Cardiomyopathy Questionnaire (KCCQ-10) to assess heath status, functioning and quality of life. In the KCCQ, an overall summary score can be derived from the physical function, symptoms (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
The conduct of the STS/ACC TVT Registry and the KCCQ-10 is in accordance with Section 1142 of the Social Security Act (the Act) that describes the authority of the Agency for Healthcare Research and Quality (AHRQ). Under section 1142, research may be conducted and supported on the outcomes, effectiveness, and appropriateness of health care services and procedures to identify the manner in which disease, disorders, and other health conditions can be prevented, diagnosed, treated, and managed clinically. Section 1862(a)(1)(E) of the Act allows Medicare to cover under coverage with evidence development (CED) certain items or services for which the evidence is not adequate to support coverage under section 1862(a)(1)(A) and where additional data gathered in the context of a clinical setting would further clarify the impact of these items and services on the health of beneficiaries.
The data collected and analyzed in the TVT Registry will be used by CMS to determine if the TAVR is reasonable and necessary (e.g., improves health outcomes) for Medicare beneficiaries under Section 1862(a)(1)(A) of the Act. Furthermore, data from the Registry will assist the medical device industry and the Food and Drug Administration (FDA) in surveillance of the quality, safety and efficacy of new medical devices to treat aortic stenosis. For purposes of the TAVR NCD, The TVT Registry has contracted with the Data Analytic Centers to conduct the analyses. In addition, data will be made available for research purposes under the terms of a data use agreement that only provides de-identified datasets.
To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS Web site
To be assured consideration, comments and recommendations for the proposed information collections must be received by the OMB desk officer at the address below, no later than 5 p.m. on December 17, 2012. OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395-6974, Email:
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).
Fax written comments on the collection of information by December 17, 2012.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to
Ila S. Mizrachi, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-7726,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
This draft guidance provides information on the implementation of section 901 of the Food and Drug Administration Amendments Act of 2007, which authorizes FDA to require certain drug and biological product application holders to make safety related labeling changes based upon new safety information that becomes available after the drug or biological product is approved under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) or the Public Health Service Act. FDA plans to request safety labeling changes by sending a notification letter to the application holder. Under section 505(o)(4)(B) of the FD&C Act (21 U.S.C. 355(o)(4)(B)), the application holder must respond to FDA's notification by submitting a labeling supplement or notifying FDA that the applicant does not believe the labeling change is warranted and submitting a statement detailing the reasons why the application holder does not believe a change is warranted (a rebuttal statement).
The submission of rebuttal statements may result in the collection of information that is not already approved by OMB. Based on FDA's experience thus far with safety labeling changes requirements under section 505(o)(4) of the FD&C Act, FDA estimates that approximately six application holders will elect to submit approximately one rebuttal statement each year and that each rebuttal statement will take approximately 6 hours to prepare.
In addition, in the draft guidance, the Agency states that new labeling prepared in response to a safety labeling change notification should be available on the application holder's Web site within 10 calendar days of approval, which may result in the collection of information that is not already approved by OMB. FDA estimates that approximately 197 application holders will post new labeling one time each year in response to a safety labeling change notification and that the posting of the labeling will take approximately 4 hours to prepare.
In the
FDA estimates the burden of the collections of information that have not already been approved by OMB is as follows:
This draft guidance also refers to previously approved collections of information. Specifically, the draft guidance describes: Labeling supplements for new drug applications, abbreviated new drug applications, and biologics license applications submitted under 21 CFR 314.70, 314.71, 314.97, and 601.12, and the content and format of prescription drug labeling submitted under 21 CFR 201.56 and 201.57. These collections of information are subject to review by OMB under the PRA and are approved under OMB control numbers 0910-0001, 0910-0338, and 0910-0572. Section V of the draft guidance refers to the guidance entitled “Formal Dispute Resolution: Appeals Above the Division Level,” which describes collections of information approved under OMB control number 0910-0430.
Food and Drug Administration, HHS.
Notice.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. This meeting is being rescheduled due to the postponement of the November 1, 2012, meeting due to unanticipated weather conditions caused by hurricane Sandy.
The CoAxia NeuroFlo Catheter is a 7F multilumen device with two balloons mounted near the distal tip. The proximal end has a multiport manifold that provides access for the guidewire, monitoring of blood pressure, and independent inflation of the individual balloons. The device is placed in the descending aorta. On March 30, 2005, a humanitarian device exemption application for the CoAxia NeuroFlo Catheter was approved for the following indication for use: The CoAxia NeuroFlo Catheter is intended for the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurismal subarachnoid hemorrhage, secured by either surgical or endovascular intervention for patients who have failed maximal medical management.
Of note, the CoAxia NeuroFlo Catheter is identical in design to the CoAxia FloControl, which is currently cleared for the following general indications for use:
1. The CoAxia FloControl Catheter is intended for use in selectively stopping or controlling flow in the peripheral vasculature (K023914).
2. The CoAxia FloControl Catheter is intended for use in selectively stopping or controlling flow in the peripheral vasculature, which includes the descending aorta (K090970).
CoAxia has submitted a de novo application for the NeuroFlo for the following indication: The CoAxia NeuroFlo Catheter is intended for use in diversion of cardiac output via partial occlusion of the descending aorta, including patients with acute ischemic stroke within 14 hours of symptom onset. The CoAxia NeuroFlo Catheter is also intended for use in selectively stopping or controlling blood flow in the peripheral vasculature, which includes the descending aorta.
FDA is convening this committee to seek expert scientific and clinical opinion on the risks and benefits of this device based on the available premarket and postmarket data. In particular, the committee will be asked to discuss the safety and effectiveness data from the “Safety and Efficacy of NeuroFlo Technology in Ischemic Stroke” (SENTIS) clinical trial as they relate to the proposed indications for use.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at
Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact AnnMarie Williams, Committee Management Staff, 301-796-5966, at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Food and Drug Administration, HHS.
Notice of public hearing; request for comments.
The Food and Drug Administration (FDA) is announcing a public hearing to obtain input on establishing a list of qualifying pathogens (i.e., those that have the potential to pose a serious threat to public health), as required under the Food and Drug Administration Safety and Innovation Act (FDASIA). This public hearing is being held to obtain comments from the public to determine the methodology that should be used in developing the list of qualifying pathogens, and to elicit suggestions for adding specific pathogens to the list.
If you need special accommodations due to a disability, please contact Lee Lemley (see
FDA will notify registered presenters of their scheduled times, and will make available an agenda at
A live Webcast of this public hearing will be viewable at the following Web site:
To permit time for all interested persons to submit data, information, or views on this subject, the administrative record of the hearing will remain open until January 25, 2013.
Title VIII of FDASIA (Pub. L. 112-144), entitled “Generating Antibiotic Incentives Now (GAIN),” amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to add new section 505E (21 U.S.C. 355E), among other things. This new section of the FD&C Act is designed to encourage development of treatments for serious or life-threatening infections caused by bacteria or fungi. For an application for a drug that is designated a “qualified infectious disease product” under section 505E(d) of the FD&C Act, section 505E(a) provides an extension of 5 years of market exclusivity to the exclusivity periods provided by sections 505(c)(3)(E)(ii) through (c)(3)(E)(iv) (21 U.S.C. 355(c)(3)(E)(ii) through (c)(3)(E)(iv)), 505(j)(5)(F)(ii) through (j)(5)(F)(iv) (21 U.S.C. 355(j)(5)(F)(ii) through (j)(5)(F)(iv)), 505A (21 U.S.C. 355a), and 527 (21 U.S.C. 360cc) of the FD&C Act. However, as section 505E(c) of the FD&C Act states, not all applications for a “qualified infectious disease product” are eligible for the additional market exclusivity. In addition, an application for a drug designated as a “qualified infectious disease product” is eligible for priority review and fast track status (sections 524A and 506(a)(1) of the FD&C Act (21 U.S.C. 356(a)(1))), respectively.
The term “qualifying infectious disease product” refers to an antibacterial or antifungal human drug that is intended to treat serious or life-threatening infections (section 505E(g) of the FD&C Act). It includes treatments for diseases caused by antibiotic- or antifungal-resistant pathogens (including new or emerging pathogens), or “qualifying pathogens” listed by the Secretary of the Department of Health and Human Services (and, by delegation, FDA) under section 505E(f) (section 505E(g) of the FD&C Act).
According to the statute, “the term `qualifying pathogen' means a pathogen identified and listed by the Secretary * * * that has the potential to pose a serious threat to public health, such as[:] (A) resistant [G]ram positive pathogens, including methicillin-resistant
• The impact on the public health due to drug-resistant organisms in humans;
• The rate of growth of drug-resistant organisms in humans;
• The increase in resistance rates in humans; and
• The morbidity and mortality in humans.
We are holding this hearing to fulfill the statutory consultation requirement and to obtain public comment on the following issues related to establishing the list of qualifying pathogens described in section 505E(f) of the FD&C Act:
1. FDASIA requires FDA to “consider” the following factors in establishing and maintaining the list of qualifying pathogens:
• The impact on the public health due to drug-resistant organisms in humans;
• The rate of growth of drug-resistant organisms in humans;
• The increase in resistance rates in humans; and
• The morbidity and mortality in humans.
2. Aside from the considerations noted in question 1 (i.e., those required by section 505(E)(f)(2)(B)(i) of the FD&C Act), are there any other factors FDA should consider when establishing and maintaining the list of qualifying pathogens? If so, how should these factors be applied to a pathogen to determine whether it should be included in the list?
3. Which specific pathogens do you believe should be listed as qualifying pathogens? Provide justification for your recommendations, including how you applied the considerations described in section 505E(f)(2)(B)(i) of the FD&C Act, and any other factors that you considered, in recommending the pathogen for inclusion on the list of qualifying pathogens.
The Commissioner of Food and Drugs (the Commissioner) is announcing that the public hearing will be held in accordance with part 15 (21 CFR part 15). The hearing will be conducted by a presiding officer, who will be accompanied by FDA senior management from the Office of the Commissioner and the Center for Drug Evaluation and Research.
Under § 15.30(f), the hearing is informal and the rules of evidence do not apply. No participant may interrupt the presentation of another participant. Only the presiding officer and panel members may question any person during or at the conclusion of each presentation.
Public hearings under part 15 are subject to FDA's policy and procedures for electronic media coverage of FDA's public administrative proceedings (see 21 CFR part 10, subpart C). Under § 10.205, representatives of the electronic media may be permitted, subject to certain limitations, to videotape, film, or otherwise record FDA's public administrative proceedings, including presentations by participants.
To the extent that the conditions for the hearing, as described in this notice, conflict with any provisions set out in part 15, this notice acts as a waiver of those provisions as specified in § 15.30(h).
Advisory Council on Historic Preservation.
Program Comment issued for streamlining Section 106 review for undertakings affecting post-1945 concrete and steel bridges.
The Advisory Council on Historic Preservation (ACHP) issued a
The Program Comment was issued by the ACHP on November 2, 2012.
Address all questions concerning the Program Comment to Carol Legard, Office of Federal Agency Programs, Advisory Council on Historic Preservation, 1100 Pennsylvania Avenue NW., Suite 803, Washington, DC 20004. Fax (202) 606-8522. You may submit electronic questions to:
Carol Legard, (202) 606-8522,
Section 106 of the National Historic Preservation Act (Section 106) requires federal agencies to consider the effects of their undertakings on historic properties and to provide the Advisory Council on Historic Preservation (ACHP) a reasonable opportunity to comment with regard to such undertakings. The ACHP has issued the regulations that set forth the process through which Federal agencies comply with these duties. Those regulations are codified under 36 CFR part 800 (Section 106 regulations).
Under Section 800.14(e) of those regulations, agencies can request the ACHP to issue a “Program Comment” on a particular category of undertakings in lieu of conducting reviews of each individual undertaking under such category, as set forth in 36 CFR 800.3 through 800.7. An agency can meet its Section 106 responsibilities with regard to the effects of particular aspects of those undertakings by taking into account an applicable Program Comment that has been issued by the ACHP and following the steps set forth in that comment.
The ACHP has issued a Program Comment to relieve all federal agencies from the Section 106 requirement to consider the effects of undertakings on common bridges and culverts constructed of concrete or steel after 1945. The ACHP membership voted in favor of issuing the Program Comment via an unassembled vote that concluded on November 2, 2012.
According to the requirements for obtaining a Program Comment, the Federal Highway Administration (FHWA) formally requested the ACHP to comment on the effects of a category of undertakings in lieu of conducting individual reviews for effects to certain types of bridges commonly constructed in the United States since 1945. Bridges of the types covered in the Program Comment were constructed in vast numbers from plans that quickly became standardized around the middle of the 20th century. These bridges are generally undistinguished from an engineering or architectural perspective, are considered to have little value for preservation in place, and are rarely viable candidates for relocation. However, because they may meet or approach the age criteria for evaluation as historic properties, considerable time and resources are currently expended to address effects to them on a case-by-case basis under the Section 106 process. The Program Comment applies to effects of undertakings on certain common concrete and steel bridges lacking distinction, not previously listed in or determined eligible for listing in the National Register of Historic Places, and not located within or adjacent to historic districts. The Program Comment proposed by FHWA was received by the ACHP on August 6, 2012.
To develop the Program Comment, FHWA met with individuals from the ACHP staff, the National Conference of State Historic Preservation Officers, the American Association of State Highway and Transportation Officials, and the National Trust for Historic Preservation. With the assistance of these individuals, FHWA prepared an initial draft of the proposed Program Comment which was then shared with key stakeholders and additional organizations and individuals with expertise in historic bridges and in the Section 106 review process. This outreach effort resulted in a number of revisions intended to address concerns raised about the applicability of the Program Comment, the ability of states to identify examples of common bridges that should be excluded from the Program Comment, and the types and range of bridges that would be exempted from Section 106 review. FHWA worked with the ACHP in developing the new draft, which was discussed at the ACHP Federal Agency Program Committee meeting on August 8, 2012.
Upon submitting its formal request to the ACHP, FHWA took additional steps to inform the public and stakeholders about the proposed Program Comment, including an email distribution, posting on the agency web site, and a notice published in the
In accordance with our regulations at 36 CFR 800.14(e), the ACHP is responsible for obtaining the views of State Historic Preservation Officers (SHPOs) and Tribal Historic Preservation Officers before reaching a decision on issuing a Program Comment. Although the Program Comment was drafted so that it does not apply to tribal lands, the ACHP transmitted the proposed Program Comment to Indian tribes and Tribal Historic Preservation Officers to ensure that their views were considered in its decision on whether to issue the program comment. The ACHP requested comments on the Program Comment, as submitted by FHWA, on September 7, 2012.
As a result of both FHWA's
The proposed Program Comment received strong support from the American Public Works Association (APWA), National Association of County Engineers (NACE), American Road and Transportation Builders Association (ARTBA), the Commissioner of Highways for the Commonwealth of Virginia, the New York State County Highway Superintendents Association (NYSCHSA), and the County of Los Angeles Department of Public Works. Comments from these organizations stressed that the Program Comment is a logical, common sense approach that will save taxpayers money and allow needed infrastructure improvements to be completed more efficiently. The President of the NYSCHSA stated that by excluding these common bridges from Section 106 review, taxpayers could save up to $78 million over a 10-year period.
Four respondents to the
Two commenters expressed confusion about how the identification of exceptional bridges can be completed by December 31, 2012, particularly where the main source of data is the National Bridge Inventory (NBI). Distrust for the accuracy of information in the NBI and the fact that a number of states lack recent historic bridge inventories were the reasons these parties were concerned about the ability of the FHWA Division in each state to identify especially important examples of the common bridge types within the tight timeframe provided in the review draft.
In response to these concerns, the Program Comment was revised to extend the timeframe for completing the list of exceptional bridges to March 31, 2013. It also encourages, but does not require, FHWA Divisions to complete the list by that date. If additional time is needed to complete the list, it will be granted. Also, FHWA Divisions may add to the list of exceptional bridges, as more information becomes available regarding the historic bridges in a state. The Program Comment also now clarifies that to complete the list of exceptional bridges, a statewide survey or context does not need to be developed where none exists. The list need not be exhaustive; the intent behind the list is to be able to exclude readily recognizable exceptional bridges from the Program Comment. Although the commenters are correct that this may not be sufficient in some states to identify all exceptionally significant bridges, we believe that the Program Comment establishes a good balance between protecting the most significant historic bridges of these common types and eliminating repetitive and redundant documentation and reviews that can be costly to the government and have limited value to the broader public.
One Federally Recognized Indian tribe and one Native Hawaiian Organization commented on the Program Comment. Both expressed concern that the Program Comment may be seen as a broad waiver of Section 106 review for projects affecting historic bridges, leading to the destruction of other types of sites as a result of construction. To address this concern, the Introduction (Section I) and Section III (Applicability) were revised to explicitly and clearly state that while the Program Comment relieves Federal agencies from the Section 106 requirement to consider the effects of undertakings on the bridge types identified in Section V, it is not a waiver from Section 106 requirements for the consideration of other historic properties that may be affected by a bridge rehabilitation or replacement project. It further clarifies that the Program Comment is not a waiver from applicable Federal requirements to consult with Indian tribes or Native Hawaiian organizations (NHOs) regarding undertakings that may affect historic properties to which a tribe or NHO ascribe traditional cultural and religious significance.
Three commenters proposed changes to the common bridge types covered by the Program Comment (Section V). One proposed that pre-stressed concrete should be included as a discrete bridge type and that all pre-stressed concrete bridges built prior to 1966 be excluded from the Program Comment. The ACHP declined to make this change as it would be inconsistent with the other bridge types in Section V, which are based on structure type (design) and material, and not just the material with which it is constructed. Other recommendations were incorporated into the final Program Comment including: Removing reinforced concrete rigid frames, metal rigid frames, and curved metal girders from the list of common types (they are, in fact, not as common as the other types); and adding culverts and reinforced concrete boxes among the common bridge types covered by the Program Comment.
Two commenters offered recommendations for improving the programmatic mitigation in Section VI. One recommended including specifics regarding the manner in which the FHWA will encourage the update of inventories. The other offered additional suggestions for mitigation. One additional mitigation measure was incorporated into the Program Comment based on these recommendations. Section VI now requires FHWA to complete and make available to the public a brief illustrated history of post-1945 highway bridge engineering and design to document for the general public the innovations and contributions of the bridges to transportation in the post-World War II era. FHWA is required to complete this illustrated history and documentation using Historic American Engineering Record (HAER) standards of at least one example of each common bridge type before December 31, 2013. A third programmatic mitigation measure was left unchanged: A commitment for FHWA to encourage State transportation agencies that have not recently done so to update inventories of historic bridges in their states. The ACHP agrees with commenters that updating and maintaining statewide historic bridge inventories and management plans for historic bridges is the best way to plan for the protection and preservation of the State's most significant bridges. However, requiring State transportation agencies to complete these inventories would place an unfair burden on states without the resources to do these studies, and we do not agree that such inventories are necessary to identify exceptional examples in a state, provided the state DOT and Federal Highway Administration consults with the SHPO and others in developing the list of exceptional bridges, as required.
The ACHP received comments on the FHWA proposed Program Comment from six SHPOs: Delaware, Hawaii, Nevada, New Hampshire, Puerto Rico, and Wisconsin. Wisconsin and Nevada SHPOs support the Program Comment and offered minor suggestions for improving Section IV (Considerations) which were incorporated into the final document.
Four SHPO representatives expressed objections or strong reservations to the approach because of concerns that important post-1945 concrete and steel bridges would remain unidentified and unprotected in the absence of a comprehensive statewide historic bridge survey. As with some of the commenters on the
The National Conference of State Historic Preservation Officers (NCSHPO) worked closely with FHWA to develop the Program Comment, and has expressed strong support for it.
Finally, Federal agencies may only use the Program Comment in states where the relevant FHWA Division has completed and filed a list of exceptional common bridges with the FHWA Federal Preservation Officer (FPO) in accordance with Section IV. While the ACHP does not intend to limit the usefulness of the Program Comment to federal agencies wishing to use it, we note that the effectiveness of the Program Comment hinges on the FHWA Divisions in each state taking the step to identify bridges that should be exempted from the Program Comment. We encourage Federal agencies other than FHWA wishing to use the Program Comment to contact the relevant FHWA Division office or the State Historic Preservation Office to find out the status of its efforts to complete the list required in Section IV. The FHWA FPO has agreed to post on FHWA's Web site (
The following is the text of the proposed Program Comment:
Every year, the Federal Highway Administration (FHWA) funds the rehabilitation and replacement of hundreds of bridges under the Federal-aid program administered across the U.S. by State departments of transportation (DOT) and the Federal Lands Highway program. Other Federal agencies are also involved with projects affecting bridges through Federal assistance, approvals, or permits. Many of the bridges affected by these programs are of common types constructed by State transportation agencies after 1945, using reinforced concrete or steel beams and designs that quickly became standardized. These common bridge types are generally undistinguished, and although some of them may be eligible for inclusion in the National Register of Historic Places, when repair or replacement is needed, they are rarely viable candidates for either preservation in place or relocation. Yet, every federally funded or permitted undertaking affecting such a bridge requires review and consultation pursuant to Section 106 of the National Historic Preservation Act (Section 106), 16 U.S.C. 470f to assess whether the bridge is eligible for inclusion in the National Register and, if so, to resolve adverse effects to it. The regulations implementing Section 106, codified at 36 CFR part 800, describe the procedures Federal agencies must follow to meet this obligation.
Alternate compliance methods, provided by the Section 106 regulations, allow agencies to meet these Section 106 obligations but tailor the process to their mission and needs. Section 800.14(e) of the regulations provides that any agency may request a “Program Comment” from the ACHP in lieu of case-by-case review. The benefit of a Program Comment is that it allows a federal agency to comply with Section 106 in a single action for a class of undertakings rather than addressing each undertaking as a separate action. At FHWA's request, the ACHP has issued the following Program Comment in accordance with 36 CFR § 800.14(e) in order to waive, with limited exceptions, case-by-case Section 106 consideration of effects on common post-1945 bridges. This Program Comment is available for use by all federal agencies and State officials delegated the responsibility to comply with Section 106 for the particular undertakings by statute or a program alternative under 36 CFR § 800.14 (federal agencies). It relieves federal agencies from the need, under Section 106, to individually consider the effects of undertakings on the bridges described in Section V of this Program Comment, with the exceptions noted in Section IV.
It is important to note that this Program Comment is not a waiver from Section 106 review for undertakings that may affect common bridges or other historic properties as described in Section V. Neither is it a waiver from applicable federal requirements to consult with Indian tribes or Native Hawaiian organizations (NHO) regarding undertakings that may affect historic properties to which a tribe or NHO ascribes traditional cultural and religious significance. Federal agency officials must still complete Section 106 review and consider effects of the undertaking on historic properties other than the common bridge itself. Such effects to other historic properties may be direct or indirect, and must be considered by the federal agency official whether or not the Program Comment is applicable to the subject bridge.
In October 2005, the National Cooperative Highway Research Program published “A Context for Common Historic Bridge Types.” That context revealed that a great many of the bridge structures built after 1935, and especially since 1946, are strictly utilitarian and lacking in distinctive engineering or architectural qualities. Increasing standardization associated with highway design as a result of growing federal funding and the evolving standards of the American Association of State Highway and Transportation Officials (AASHTO) both contributed to the uniformity of design in bridges of certain types.
Information about America's bridges, including their age and condition, is readily available in FHWA's National Bridge Inventory (NBI). The NBI is a collection of information (database) covering just under 600,000 of the nation's bridges located on public roads, including Interstate Highways, U.S. highways, State and county roads, as well as publicly accessible bridges on federal lands. It presents a State by State summary analysis of the number, location, and general condition of highway bridges within each State. This database contains technical and engineering information about hundreds of thousands of bridges in the United States, including year built, bridge type, condition and many other fields. Some 45,000 bridges in the NBI are rated as structurally deficient, meaning that portions of the bridge may be in poor condition. Approximately 61,680 are identified as functionally obsolete, meaning that the design of the bridge does not meet current guidelines for its use, such as lack of safety shoulders or the inability to handle certain traffic volume, speed, size, or weight. Bridges in these categories are frequent candidates for replacement. This Program Comment is intended to eliminate the administrative burden of considering the effects of replacement on these bridges on a case-by-case basis and make delivery of these critical projects more efficient in recognition of the very limited preservation value of the vast majority of common post-1945 bridges.
This Program Comment relieves federal agencies from the Section 106 requirement to consider the effects of undertakings on the bridge types identified in Section V of this Program Comment, except for those subject to the considerations noted in Section IV of this Program Comment.
Undertakings include those that involve applications from State transportation agencies or local governments for federal permits, approvals, or assistance that will result in alteration, replacement, or
The Program Comment applies to common bridges regardless of ownership, except for those located on tribal lands.
A federal agency is not required to use this Program Comment. Federal agencies that choose not to use this Program Comment must comply with Section 106 through the process in the Section 106 regulations at 36 CFR §§ 800.3 through 800.7, or 36 CFR § 800.8(c), or another existing program alternative under 36 CFR § 800.14. Any federal agency that chooses to use this Program Comment for an undertaking should notify consulting parties that it will use it with regard to the effects of the undertaking on the bridge types identified in Section V of this Program Comment.
Prior to utilizing this Program Comment for an undertaking that may affect a common bridge, a federal agency, based on the work of a qualified cultural resource specialist, must complete a review to determine if any of the considerations listed below apply to the bridge at issue. If the federal agency determines that the common bridge in question meets any of these considerations, the agency may not utilize this Program Comment with regard to that common bridge.
(A) The bridge is listed in or has previously been determined eligible for the National Register of Historic Places or is located adjacent to or within a National Register listed or eligible historic district, including linear historic districts such as a parkway, historic road, or canal;
(B) The bridge in question is or includes spans of the following types: Arch bridges, truss bridges, bridges with movable spans, suspension bridges, cable-stayed bridges, or covered bridges; or
(C) The bridge was identified in a list created through the process detailed below as having exceptional significance for association with an event or individual, or being a very early or particularly important example of its type in a State or the nation, having distinctive engineering or architectural features that depart from standard designs, such as an aesthetic railing or balustrade, includes spans of exceptional length or complexity, or displaying other elements that were engineered to respond to a unique environmental context.
Before the Program Comment may be used for undertakings in a State, the relevant FHWA Division must first develop a list of bridges in that State that are of the types considered common bridges, but that also meet the considerations in IV.C above, and therefore fall outside the scope of this Program Comment. Each FHWA Division wishing to apply the provisions of this Program Comment must organize a meeting of the relevant SHPO, DOT, and other interested parties in order to develop the list of bridges that meet the criteria considerations in IV.C. The list should be finalized and submitted to the Federal Preservation Officer of FHWA by March 31, 2013. FHWA Divisions are not required to develop a statewide survey or context studies to support the development of such lists where none exist. The list is not intended to be exhaustive, but will be informed by input received at the meeting. The intent behind the list is to be able to exclude readily recognizable exceptional bridges from the Program Comment. Where States already have a current (within the last 5 years) Programmatic Agreement, inventory, or management plan for historic bridges that identifies common bridges meeting any of the listed considerations, the data included in those Programmatic Agreements, inventories, or management plans may suffice to create the list. States lacking up to date historic bridge inventories may subsequently identify additional bridges to include on the list of exceptional bridges excluded from the Program Comment based on information obtained in a field verification required in Section III of this Program Comment.
Based on the historic bridge context, the NBI, information developed in statewide bridge inventories across the United States, and consultation with the National Conference of SHPOs and other stakeholders, the following common bridge types are considered well-documented standardized designs that lack individual distinction.
The programmatic mitigation measures in this section resolve adverse effects that could result from the potential replacement of common bridges and provide appropriate documentation of those common bridges covered by this program comment. By completing the requirements of Section IV, federal agencies will ensure that this Program Comment is appropriately applied to individual undertakings affecting common bridges. The measures included in this Section, when completed by FHWA, will provide a long-term record of these common bridge types and information about the historic and technological significance of this period of innovation in transportation.
(A) If a suitable example from at least one State is not already included in the Historic American Engineering Record (HAER) collection, one set of HAER documentation, including at least narrative history and photographs, for each bridge type in Section V shall be prepared and submitted by FHWA for acceptance by HAER before December 31, 2013. The FHWA will coordinate with HAER to determine which, if any, of these types are not yet represented in the HAER collection and will work with the FHWA Division offices and State DOTs to identify a candidate for each type not already represented.
(B) FHWA will complete a brief illustrated history of post-1945 highway bridge engineering and design to document for the general public the innovations and
(C) The FHWA will encourage State transportation agencies that have not done so within the last 5 years to update inventories of historic bridges in their States to better ensure that bridges meeting the considerations in Section IV above are identified and considered early in the Section 106 review process.
If not specifically addressed below, terms used within this Program Comment shall be defined consistent with the definitions provided in 36 CFR Part 800.
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36 CFR 800.14(e).
National Protection and Programs Directorate, DHS.
60-day notice and request for comments; New Information Collection Request: 1670—NEW.
The Department of Homeland Security (DHS), National Protection and Programs Directorate (NPPD), Office of Infrastructure Protection (IP), Infrastructure Information Collection Division (IICD), Protected Critical Infrastructure Information (PCII) Program will submit the following Information Collection Request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chapter 35).
Comments are encouraged and will be accepted until January 15, 2013. This process is conducted in accordance with 5 CFR 1320.10.
Written comments and questions about this Information Collection Request should be forwarded to DHS/NPPD/IP/IICD, 245 Murray Lane, SW., Mail Stop 0602, Arlington,VA 20598-0602. Emailed requests should go to Joseph Maltby,
• Federal eRulemaking Portal:
• Email: Include the docket number in the subject line of the message.
Congress created the PCII Program under the Critical Infrastructure Information Act of 2002 for DHS to encourage voluntary information sharing by owners and operators of critical infrastructure and protected systems. IICD administers the PCII Program. The PCII Program is implemented by 6 CFR part 29, Procedures for Handling Critical Infrastructure Information; Final Rule (the Regulation), issued in 2006. PCII refers to critical infrastructure information not customarily in the public domain and related to the security of critical infrastructure or protected systems, which is voluntarily submitted to DHS for homeland security purposes and validated under the authority of the PCII Program Manager. The PCII Program provides a statutory exemption from release of information under the Freedom of Information Act and state and local sunshine laws, and prohibits the use of the information in civil litigation.
The PCII Program is responsible for ensuring compliance with the regulation's uniform procedures for the handling, use, dissemination, and safeguarding of PCII. In this capacity, the PCII Program oversees a community of stakeholders, including submitters of critical infrastructure information, authorized users of PCII and accredited Federal, state and local entities with homeland security duties. The PCII Program is required by its authorizing regulation to assist the PCII Officers in overseeing their own accredited PCII programs at the state and local level.
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 or other forms of information technology, e.g., permitting electronic submissions of responses.
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of an emergency for the Commonwealth of Massachusetts (FEMA-3350-EM), dated October 28, 2012, and related determinations.
Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-3886.
Notice is hereby given that, in a letter dated October 28, 2012, the President issued an emergency declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as follows:
I have determined that the emergency conditions in the Commonwealth of Massachusetts resulting from Hurricane Sandy beginning on October 27, 2012, and continuing, are of sufficient severity and magnitude to warrant an emergency declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
You are authorized to provide appropriate assistance for required emergency measures, authorized under Title V of the Stafford Act, to save lives and to protect property and public health and safety, and to lessen or avert the threat of a catastrophe in the designated areas. Specifically, you are authorized to provide assistance for emergency protective measures (Category B), limited to direct Federal assistance, under the Public Assistance program.
Consistent with the requirement that Federal assistance is supplemental, any Federal funds provided under the Stafford Act for Public Assistance will be limited to 75 percent of the total eligible costs. In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal emergency assistance and administrative expenses.
Further, you are authorized to make changes to this declaration for the approved assistance to the extent allowable under the Stafford Act.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, Department of Homeland Security, under Executive Order 12148, as amended, Justo Hernández, of FEMA is appointed to act as the Federal Coordinating Officer for this declared emergency.
The following areas of the Commonwealth of Massachusetts have been designated as adversely affected by this declared emergency:
All counties in the Commonwealth of Massachusetts for emergency protective measures (Category B), limited to direct federal assistance, under the Public Assistance program.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of an emergency for the State of New Hampshire (FEMA-3360-EM), dated October 30, 2012, and related determinations.
Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-3886.
Notice is hereby given that, in a letter dated October 30, 2012, the President issued an emergency declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as follows:
I have determined that the emergency conditions in the State of New Hampshire resulting from Hurricane Sandy beginning on October 26, 2012, and continuing, are of sufficient severity and magnitude to warrant an emergency declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
You are authorized to provide appropriate assistance for required emergency measures, authorized under Title V of the Stafford Act, to save lives and to protect property and public health and safety, and to lessen or avert the threat of a catastrophe in the designated areas. Specifically, you are authorized to provide assistance for emergency protective measures (Category B), limited to direct Federal assistance, under the Public Assistance program.
Consistent with the requirement that Federal assistance is supplemental, any Federal funds provided under the Stafford Act for Public Assistance will be limited to 75 percent of the total eligible costs. In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal emergency assistance and administrative expenses.
Further, you are authorized to make changes to this declaration for the approved assistance to the extent allowable under the Stafford Act.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, Department of Homeland Security, under Executive Order 12148, as amended, Kevin L. Hannes, of FEMA is appointed to act as the Federal Coordinating Officer for this declared emergency.
The following areas of the State of New Hampshire have been designated as adversely affected by this declared emergency:
All counties in the State of New Hampshire for emergency protective measures (Category B), limited to direct federal assistance, under the Public Assistance program.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of an emergency for the State of Rhode Island (FEMA-3355-EM), dated October 29, 2012, and related determinations.
Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-3886.
Notice is hereby given that, in a letter dated October 29, 2012, the President issued an emergency declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as follows:
I have determined that the emergency conditions in certain areas of the State of Rhode Island resulting from Hurricane Sandy beginning on October 26, 2012, and continuing, are of sufficient severity and magnitude to warrant an emergency declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
You are authorized to provide appropriate assistance for required emergency measures, authorized under Title V of the Stafford Act, to save lives and to protect property and public health and safety, and to lessen or avert the threat of a catastrophe in the designated areas. Specifically, you are authorized to provide assistance for emergency protective measures (Category B), limited to direct Federal assistance, under the Public Assistance program.
Consistent with the requirement that Federal assistance is supplemental, any Federal funds provided under the Stafford Act for Public Assistance will be limited to 75 percent of the total eligible costs. In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal emergency assistance and administrative expenses.
Further, you are authorized to make changes to this declaration for the approved assistance to the extent allowable under the Stafford Act.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, Department of Homeland Security, under Executive Order 12148, as amended, James N. Russo, of FEMA is appointed to act as the Federal Coordinating Officer for this declared emergency.
The following areas of the State of Rhode Island have been designated as adversely affected by this declared emergency:
All counties in the State of Rhode Island for emergency protective measures (Category B), limited to direct federal assistance, under the Public Assistance program.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of an emergency for the State of New York (FEMA-3351-EM), dated October 28, 2012, and related determinations.
Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-3886.
Notice is hereby given that, in a letter dated October 28, 2012, the President issued an emergency declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as follows:
I have determined that the emergency conditions in the State of New York resulting from Hurricane Sandy beginning on October 27, 2012, and continuing, are of sufficient severity and magnitude to warrant an emergency declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (“the Stafford Act”). Therefore, I declare that such an emergency exists in the State of New York.
You are authorized to provide appropriate assistance for required emergency measures, authorized under Title V of the Stafford Act, to save lives and to protect property and public health and safety, and to lessen or avert the threat of a catastrophe in the designated areas. Specifically, you are authorized to provide assistance for emergency protective measures (Category B), limited to direct Federal assistance, under the Public Assistance program.
Consistent with the requirement that Federal assistance is supplemental, any Federal funds provided under the Stafford Act for Public Assistance will be limited to 75 percent of the total eligible costs. In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal emergency assistance and administrative expenses.
Further, you are authorized to make changes to this declaration for the approved assistance to the extent allowable under the Stafford Act.
The Federal Emergency Management Agency (FEMA) hereby gives notice that
The following areas of the State of New York have been designated as adversely affected by this declared emergency:
All counties in the State of New York for emergency protective measures (Category B), limited to direct federal assistance, under the Public Assistance program.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of an emergency for the State of Connecticut (FEMA-3353-EM), dated October 28, 2012, and related determinations.
Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-3886.
Notice is hereby given that, in a letter dated October 28, 2012, the President issued an emergency declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as follows:
I have determined that the emergency conditions in the State of Connecticut resulting from Hurricane Sandy beginning on October 27, 2012, and continuing, are of sufficient severity and magnitude to warrant an emergency declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
You are authorized to provide appropriate assistance for required emergency measures, authorized under Title V of the Stafford Act, to save lives and to protect property and public health and safety, and to lessen or avert the threat of a catastrophe in the designated areas. Specifically, you are authorized to provide assistance for emergency protective measures (Category B), limited to direct Federal assistance, under the Public Assistance program.
Consistent with the requirement that Federal assistance is supplemental, any Federal funds provided under the Stafford Act for Public Assistance will be limited to 75 percent of the total eligible costs. In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal emergency assistance and administrative expenses.
Further, you are authorized to make changes to this declaration for the approved assistance to the extent allowable under the Stafford Act.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, Department of Homeland Security, under Executive Order 12148, as amended, Albert Lewis, of FEMA is appointed to act as the Federal Coordinating Officer for this declared emergency.
The following areas of the State of Connecticut have been designated as adversely affected by this declared emergency:
All counties in the State of Connecticut for emergency protective measures (Category B), limited to direct federal assistance, under the Public Assistance program.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of an emergency for the State of New Jersey (FEMA-3354-EM), dated October 28, 2012, and related determinations.
Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-3886.
Notice is hereby given that, in a letter dated October 28, 2012, the President issued an emergency declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as follows:
I have determined that the emergency conditions in certain areas of the State of New Jersey resulting from Hurricane Sandy beginning on October 26, 2012, and continuing, are of sufficient severity and magnitude to warrant an emergency declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (“the Stafford Act”). Therefore, I declare that such an emergency exists in the State of New Jersey.
You are authorized to provide appropriate assistance for required emergency measures, authorized under Title V of the Stafford Act, to save lives and to protect property and public health and safety, and to lessen or avert the threat of a catastrophe in the designated areas. Specifically, you are authorized to provide assistance for emergency protective measures (Category B), limited to direct Federal assistance, under the Public Assistance program.
Consistent with the requirement that Federal assistance is supplemental, any
Further, you are authorized to make changes to this declaration for the approved assistance to the extent allowable under the Stafford Act.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, Department of Homeland Security, under Executive Order 12148, as amended, Elizabeth Turner, of FEMA is appointed to act as the Federal Coordinating Officer for this declared emergency.
The following areas of the State of New Jersey have been designated as adversely affected by this declared emergency:
All counties in the State of New Jersey for emergency protective measures (Category B), limited to direct federal assistance, under the Public Assistance program.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of an emergency declaration for State of New Jersey (FEMA-3354-EM), dated October 28, 2012, and related determinations.
Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-3886.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Michael J. Hall of FEMA is appointed to act as the Federal Coordinating Officer for this emergency.
This action terminates the appointment of Elizabeth Turner as Federal Coordinating Officer for this emergency.
(The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households in Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.)
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of an emergency declaration for the District of Columbia (FEMA-3352-EM), dated October 28, 2012, and related determinations.
Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-3886.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Jack Schuback, of FEMA is appointed to act as the Federal Coordinating Officer for this emergency.
This action terminates the appointment of Steven S. Ward as Federal Coordinating Officer for this emergency.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of an emergency disaster declaration for State of New York (FEMA-3351-EM), dated October 28, 2012, and related determinations.
Peggy Miller, Office of Response and
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Michael F. Byrne, of FEMA is appointed to act as the Federal Coordinating Officer for this emergency.
This action terminates the appointment of Philip E. Parr as Federal Coordinating Officer for this emergency.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households in Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of an emergency declaration for the State of Delaware (FEMA-3357-EM), dated October 29, 2012, and related determinations.
Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-3886.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Jack Schuback, of FEMA is appointed to act as the Federal Coordinating Officer for this emergency.
This action terminates the appointment of Regis Leo Phelan as Federal Coordinating Officer for this emergency.
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of a major disaster for the State of Connecticut (FEMA-4087-DR), dated October 30, 2012, and related determinations.
Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-3886.
Notice is hereby given that, in a letter dated October 30, 2012, the President issued a major disaster declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
I have determined that the damage in certain areas of the State of Connecticut resulting from Hurricane Sandy beginning on October 27, 2012, and continuing, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses.
You are authorized to provide Individual Assistance, assistance for debris removal and emergency protective measures (Categories A and B), including direct federal assistance, under the Public Assistance program in the designated areas, Hazard Mitigation throughout the State, and any other forms of assistance under the Stafford Act that you deem appropriate subject to completion of Preliminary Damage Assessments (PDAs).
Consistent with the requirement that Federal assistance is supplemental, any Federal funds provided under the Stafford Act for Public Assistance, Hazard Mitigation, and Other Needs Assistance will be limited to 75 percent of the total eligible costs.
Further, you are authorized to make changes to this declaration for the approved assistance to the extent allowable under the Stafford Act.
The time period prescribed for the implementation of section 310(a), Priority to Certain Applications for Public Facility and Public Housing Assistance, 42 U.S.C. 5153, shall be for a period not to exceed six months after the date of this declaration.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Albert Lewis, of FEMA is appointed to act as the Federal Coordinating Officer for this major disaster.
The following areas of the State of Connecticut have been designated as adversely affected by this major disaster:
Fairfield, Middlesex, New Haven, and New London Counties and the Mashantucket Pequot Tribal Nation and Mohegan Tribal Nation located within New London County for Individual Assistance.
Fairfield, Middlesex, New Haven, and New London Counties and the Mashantucket Pequot Tribal Nation and Mohegan Tribal Nation located within New London County for debris removal and emergency protective measures (Categories A and B), including direct federal assistance, under the Public Assistance program.
All counties and Indian Tribes in the State of Connecticut are eligible to apply for assistance under the Hazard Mitigation Grant Program.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used
Federal Emergency Management Agency, DHS.
Notice.
This is a notice of the Presidential declaration of a major disaster for the State of Utah (FEMA-4088-DR), dated November 3, 2012, and related determinations.
Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-3886.
Notice is hereby given that, in a letter dated November 3, 2012, the President issued a major disaster declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
I have determined that the damage in certain areas of the State of Utah resulting from a severe storm and flooding on September 11, 2012, is of sufficient severity and magnitude to warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121
In order to provide Federal assistance, you are hereby authorized to allocate from funds available for these purposes such amounts as you find necessary for Federal disaster assistance and administrative expenses.
You are authorized to provide Public Assistance in the designated areas and Hazard Mitigation throughout the State. Consistent with the requirement that Federal assistance is supplemental, any Federal funds provided under the Stafford Act for Public Assistance and Hazard Mitigation will be limited to 75 percent of the total eligible costs.
Further, you are authorized to make changes to this declaration for the approved assistance to the extent allowable under the Stafford Act.
The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Gary R. Stanley, of FEMA is appointed to act as the Federal Coordinating Officer for this major disaster.
The following areas of the State of Utah have been designated as adversely affected by this major disaster:
Washington County for Public Assistance.
All counties within the State of Utah are eligible to apply for assistance under the Hazard Mitigation Grant Program.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households in Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of New Jersey (FEMA-4086-DR), dated October 30, 2012, and related determinations.
Peggy Miller, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-3886.
The notice of a major disaster declaration for the State of New Jersey is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of October 30, 2012.
Burlington, Camden, Cumberland, Gloucester, Hunterdon, Mercer, Morris, Passaic, Salem, Sussex, and Warren Counties for Individual Assistance (already designated for Public Assistance).
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050 Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
U.S. Customs and Border Protection, Department of Homeland Security.
Notice of accreditation of Dixie Services, Inc., as a commercial laboratory.
Notice is hereby given that, pursuant to 19 CFR 151.12, Dixie Services, Inc., 1706 First Street, Galena Park, TX 77547, has been accredited to
The accreditation of Dixie Services, Inc., as commercial laboratory became effective on July 12, 2012. The next triennial inspection date will be scheduled for July 2015.
Christopher Mocella, Laboratories and Scientific Services, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue NW., Suite 1500N, Washington, DC 20229, 202-344-1060.
U.S. Customs and Border Protection, Department of Homeland Security (DHS).
Committee Management; Notice of Federal Advisory Committee Meeting.
The Advisory Committee on Commercial Operations of Customs and Border Protection (COAC) will meet on December 4, 2012, in Washington, DC. The meeting will be open to the public.
COAC will meet on Tuesday, December 4, 2012, from 1:00 p.m. to 6:00 p.m. EST. Please note that the meeting may close early if the committee has completed its business.
If you have completed an online on-site registration and wish to cancel your registration, you may do so at
The meeting will be held at Ronald Reagan Building in the Horizon Ballroom, 1300 Pennsylvania Avenue NW., Washington, DC 20229. All visitors to the Ronald Reagan Building must show a state-issued ID or Passport to proceed through the security checkpoint to be admitted to the building.
For information on facilities or services for individuals with disabilities or to request special assistance at the meeting, contact Ms. Wanda Tate, Office of Trade Relations, U.S. Customs and Border Protection at 202-344-1661 as soon as possible.
To facilitate public participation, we are inviting public comment on the issues to be considered by the committee as listed in the “Agenda” section below.
Comments must be submitted in writing no later than November 26, 2012, and must be identified by USCBP-2012-0041 and may be submitted by
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There will be three public comment periods held during the meeting on December 4, 2012. Speakers are requested to limit their comments to two (2) minutes or less to facilitate greater participation. Contact the individual listed below to register as a speaker. Please note that the public comment period for speakers may end before the time indicated on the schedule that is posted on the CBP web page at the time of the meeting.
Ms. Wanda Tate, Office of Trade Relations, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue NW., Room 3.5A, Washington, DC 20229; telephone 202-344-1440; facsimile 202-325-4290.
Notice of this meeting is given under the
The COAC will hear from the following subcommittees on the topics listed below and then will review, deliberate, provide observations and formulate recommendations on how to proceed on those topics:
• The work of the Trade Facilitation Subcommittee: Recommendations and resolutions on CBP's Trade Transformation initiatives, recommendations on the role of the customs brokers in regard to the Centers of Excellence and Expertise (CEEs), and recommendations based on the results from the COAC Industry Survey regarding the expected benefits of the CEEs.
• The work of the Role of the Broker Subcommittee: Recommendations and resolutions on various aspects of CBP's effort to revise the role of the customs broker in the CBP regulations (19 CFR Part 111) which includes whether the initiative in the area of continuing education should be pursued, requirements for brokers to obtain
• The work of Automated Commercial Environment (ACE) Strategic Communications Working Group: Presentation of a white paper and recommendation how CBP should
• The work of the One U.S. Government at the Border Subcommittee: Recommendation for addressing a One U.S. Government Approach to Trusted Trader Programs and provide the subcommittee term end report.
• The Intellectual Property Rights Enforcement Subcommittee's work on providing CBP with guidance on new tools to be used in the port of entry to help identify counterfeit products, the distribution chain management and serialization pilot project, and modification to the CBP recordation database of federally registered trademarks, trade names and copyrights.
• The Anti-Dumping/Countervailing Duties Subcommittee's term end report and a discussion on the impact of trade enforcement and trade intelligence initiatives.
• The Bond Subcommittee's work on proposed modifications to the CBP Form 5106 (Importer Identification Input Record), liquidated damages/mitigation guidelines, and the use of single transaction bonds (STBs) when additional security is merited. The Subcommittee will respond to the CBP Deputy Commissioner's request to look into the possibility of issuing bonds prior to the foreign departure of goods that are intended for importation into the United States.
• An update from CBP's Agriculture Programs and Trade Liaison on the July 2012 USDA/Animal Plant Health Inspection Service (APHIS) and CBP Joint Stakeholder Conference.
Prior to the COAC taking action on any of these topics of the eight above-mentioned subcommittees, working groups, and Agriculture Programs and Trade Liaison, members of the public will have an opportunity to provide comments orally or, for comments submitted electronically during the meeting, by reading the comments into the record.
The COAC will also receive term-end reports, updates and discuss the following Initiatives and Subcommittee topics that were discussed throughout the 12th Term meetings as set forth below:
• The National Strategy for Global Supply Chain Security as it relates to an effort to solicit, consolidate, and provide to DHS sector and stakeholder input on implementation of the National Strategy.
• The work of the Land Border Security Subcommittee: updates and observations on the Customs—the 21st Century Border Management Initiative and Beyond the Border initiatives.
• The Air Cargo Security Subcommittee's work on the Air Cargo Advance Screening (ACAS) pilot, and a discussion of the operational involvement of freight forwarders as well as the next steps in drafting a notice of proposed rulemaking.
• The Export Subcommittee's work on where it stands in identifying incentives for U.S. exporters to participate in Customs-Trade Partnership Against Terrorism (C-TPAT)/Authorized Economic Operator (AEO) programs and a review of the subcommittee's scope and goals for the 13th Term COAC.
Office of the Assistant Secretary for Community Planning and Development, HUD.
Notice of Intent to Prepare an EIS and to Conduct Public Scoping Meeting.
The Department of Housing and Urban Development (HUD) gives notice to the public, agencies, and Indian tribes that the City and County of San Francisco's Mayor's Office of Housing (MOH) as the Responsible Entity in accordance with 24 CFR 58.2, intends to prepare a Draft Environmental Impact Report/Environmental Impact Statement (EIR/EIS) for the HOPE SF Development at the Sunnydale and Velasco Public Housing Developments (Sunnydale HOPE SF Master Plan Project). The EIR/EIS will be a joint National Environmental Policy Act (NEPA) and California Environmental Quality Act (CEQA) document.
The EIR will satisfy requirements of CEQA (Public Resources Code 21000 et seq.) and the State CEQA Guidelines (14 California Code of Regulations 15000 et seq.), which require that state and local government agencies consider the environmental consequences of projects over which they have discretionary authority before acting on those projects. The Proposed Action is subject to NEPA, because funding for the project may include HUD funds from programs subject to regulation by 24 CFR part 58; these include, but are not limited to, Community Development Block Grant (CDBG) funds under Title I of the Housing and Community Development Act of 1974; Home Investment Partnership Program (HOME) grants under Title II of the Cranston-Gonzales National Affordable Housing Act of 1990, as amended; Project Based Section 8 Vouchers under Section 8(o)(13) of the United States Housing Act of 1937; and/or Public Housing operating subsidies for mixed income developments authorized under the U.S. Housing Act of 1937, Section 35. In accordance with specific statutory authority and HUD's regulations at 24 CFR part 58 (Environmental Review Procedures for Entities Assuming HUD Environmental Responsibilities), HUD has provided for assumption of its NEPA authority and NEPA lead agency responsibility by the City and County of San Francisco. This notice is issued in accordance with the Council on Environmental Quality (CEQ) regulations at 40 CFR parts 1500-1508.
A Draft EIR/EIS will be prepared for the Proposed Action described herein. Comments relating to the Draft EIR/EIS are requested and will be accepted by the contact person listed below. When the Draft EIR/EIS is completed, a notice will be sent to individuals and groups known to have an interest in the Draft EIR/EIS and particularly in the environmental impact issues identified therein. Any person or agency interested in receiving a notice and making comment on the Draft EIR/EIS should contact the person listed below within 30 days of publication of this notice.
This EIS will be a NEPA document intended to satisfy requirements of Federal environmental statutes. In accordance with specific statutory authority and HUD's regulations at 24 CFR part 58 (Environmental Review Procedures for Entities Assuming HUD Environmental Responsibilities), HUD has provided for assumption of its NEPA authority and NEPA lead agency responsibility by the City and County of San Francisco. The EIR will be a CEQA document intended to satisfy State environmental statutes (Public Resources Code 21000 et seq. and 14 California Code of Regulations 15000 et seq.).
All interested agencies, tribes, groups, and persons are invited to submit written comments on the scope of the Draft EIS to the contact person shown below. Comments received will be considered in the preparation and distribution of the Draft EIS. Particularly solicited is information on reports or other environmental studies planned or completed in the project area, major issues that the EIS should consider, recommended mitigation measures, and alternatives to the Proposed Action. Federal agencies having jurisdiction by law, special expertise or other special interest should report their interest and indicate their readiness to aid in the EIS effort as a “Cooperating Agency.”
Eugene Flannery, Environmental Compliance Manager, City and County of San Francisco Mayor's Office of Housing, 1 South Van Ness Avenue, 5th Floor, San Francisco, CA 94103; Phone: (415) 701-5598; Fax (415) 701-5501; email:
The MOH, acting under authority of section 104(g) of the Housing and Community Development Act of 1974 (42 U.S.C. 5304(g)), section 288 of the HOME Investment Partnerships Act (42 U.S.C. 12838), section 26 of the United States Housing Act of 1937 (42 U.S.C. 1437x) and HUD's regulations at 24 CFR part 58, in cooperation with other interested agencies, will prepare an EIS to analyze potential impacts of the Sunnydale HOPE SF Master Plan Project.
Constructed in 1941 and 1963 respectively, the Sunnydale and Velasco Public Housing Developments together form the City's largest public housing community. Located in the Visitacion Valley area of San Francisco, the project site is bounded by Hahn Street to the east, Velasco Avenue to the south, Brookdale Avenue to the west, and McLaren Park to the north and northwest. It includes Assessor's Blocks 6310-Lot 1, Block 6311-Lot 1, Block 6312-Lot 1, Block 6313-Lot 1, Block 6314-Lot 1, and Block 6315-Lot 1. The 2,127,187-square-foot (approximately 50-acre) project site slopes down from west (Brookdale Avenue) to east (Hahn Street), at slopes ranging from 15.5 percent at its highest and steepest point to a 2-percent slope at the lower elevations. The average grade change is 9 percent. Elevations range from 250 feet above sea level (asl) at the western edge of the site to 75 feet asl at the southeastern corner.
The project site is a quarter of a mile north of Geneva Avenue, which is roughly the border between the City of San Francisco and Daly City and also leads to the I-280 freeway to the west. The project site is approximately three-quarters of a mile west of Bayshore Boulevard, which is a main street that connects the neighborhood to U.S. Highway 101 to the east. Single-family residential and small-multifamily residential uses are immediately adjacent to the site to the south and east, and these uses characterize most of the Visitacion Valley neighborhood. The north and west is McLaren Park, which is the City's second largest park at 312 acres. The park's Gleneagles Golf Course and Herz Playground are directly north of the project site. A sloped natural area of McLaren Park with a walking path to the Crocker Amazon Playground abuts the project site to the west. Also to the west is the partially occupied McLaren campus of the San Francisco Unified School District, which currently houses a pre-kindergarten school.
The Sunnydale and Velasco Public Housing Developments consist of 785 residential units and the Willie Brown Community Center (including the Housing Authority's Leasing Center) located in 94 buildings that are one and two stories (20-35 feet) in height. The buildings are laid out according to the site topography, as are the streets; neither follow the grid pattern of the surrounding neighborhood. In between the buildings is open space of grass and unmaintained landscaping with three play areas. A bungalow on Velasco Street is occupied by Wu Yee Children's Services, which operates a child care program for the neighborhood. Several asphalt surface parking lots are located throughout the site and provide 430 off street parking spaces. The streets internal to the project site provide parking for another 452 automobiles. Three bus stops are located within the project site.
The Sunnydale HOPE SF Master Plan (Proposed Action) would replace all 785 units, the current utility and open space infrastructure, re-align the streets and add new community facilities and park spaces. The Proposed Action would consist of the development of up to 1,700 new residential units that are a mix of public housing replacement units, new affordable units and new market rate units in buildings that range from 40-65 feet in height. The Proposed Action would also include up to 6 acres of new park spaces within the project site, up to 72,500 square feet of community facilities including a new community center, neighborhood-serving retail space, and a child care program.
There are three alternatives to the Proposed Action to be analyzed in the EIS. Alternative 1 is a variation of the project density. Alternative sites for the project were explored early in the process, and it was determined that no other more viable site was available.
Number of Units: 1,372.
Maximum Height: 65 feet.
Acreage: 48.8 acres (no change).
Percent Reduction in Units Compared to Proposed Action: 19 percent.
Number of Units: 785 units.
Acreage: 48.8 acres.
No new Community Center, no retail, no additional open space.
Percent Reduction in Units Compared to Proposed Action: 53 percent.
The No Project Alternative would analyze the “no action” alternative, which would be the continuation of uses on the site; therefore, existing buildings and tenants would remain at the project site and no new buildings or uses would be constructed.
The proposed project may constitute an action significantly affecting the quality of the human environment and an EIS will be prepared on this project by the City and County of San Francisco's MOH in accordance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321
A public joint EIR/EIS scoping meeting will be held on a date within the comment period and after at least 15 days of publishing this Notice of Intent. Notices of the scoping meeting will be mailed when the date has been determined. The joint EIR/EIS scoping meeting will provide an opportunity for the public to learn more about the project and provide input to the
The following subject areas will be analyzed in the combined EIR/EIS for probable environmental effects: Land Use and Planning (land use patterns, relationship to plans/policies and regulations; Visual Quality/Aesthetics (views/light and glare); Socioeconomics and Community (demographic character changes, displacement); Environmental Justice (disproportionately high and adverse effects on minority and low income populations); Cultural/Historic Resources; Transportation and Circulation; Noise (construction and operational); Air Quality (construction and operational); Greenhouse Gas Emissions; Wind and Shadow; Recreation; Utilities and Service Systems (water supply, stormwater, sewer, solid waste); Public Services (fire, police, schools, parks); Biological Resources; Geology/Soils; Hydrology/Water Quality (erosion control and drainage); Toxic and Hazardous Materials; Mineral and Energy Resources; and Agriculture and Forest Resources.
Questions may be directed to the individual named in this notice under the heading
Office of the Assistant Secretary for Community Planning and Development, HUD.
Notice.
This Notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for use to assist the homeless.
Juanita Perry, Department of Housing and Urban Development, 451 Seventh Street SW., Room 7266, Washington, DC 20410; telephone (202) 402-3970; TTY number for the hearing- and speech-impaired (202) 708-2565 (these telephone numbers are not toll-free), or call the toll-free Title V information line at 800-927-7588.
In accordance with 24 CFR part 581 and section 501 of the Stewart B. McKinney Homeless Assistance Act (42 U.S.C. 11411), as amended, HUD is publishing this Notice to identify Federal buildings and other real property that HUD has reviewed for suitability for use to assist the homeless. The properties were reviewed using information provided to HUD by Federal landholding agencies regarding unutilized and underutilized buildings and real property controlled by such agencies or by GSA regarding its inventory of excess or surplus Federal property. This Notice is also published in order to comply with the December 12, 1988 Court Order in
Properties reviewed are listed in this Notice according to the following categories: Suitable/available, suitable/unavailable, suitable/to be excess, and unsuitable. The properties listed in the three suitable categories have been reviewed by the landholding agencies, and each agency has transmitted to HUD: (1) Its intention to make the property available for use to assist the homeless, (2) its intention to declare the property excess to the agency's needs, or (3) a statement of the reasons that the property cannot be declared excess or made available for use as facilities to assist the homeless.
Properties listed as suitable/available will be available exclusively for homeless use for a period of 60 days from the date of this Notice. Where property is described as for “off-site use only” recipients of the property will be required to relocate the building to their own site at their own expense. Homeless assistance providers interested in any such property should send a written expression of interest to HHS, addressed to Theresa Ritta, Division of Property Management, Program Support Center, HHS, room 5B-17, 5600 Fishers Lane, Rockville, MD 20857; (301) 443-2265. (This is not a toll-free number.) HHS will mail to the interested provider an application packet, which will include instructions for completing the application. In order to maximize the opportunity to utilize a suitable property, providers should submit their written expressions of interest as soon as possible. For complete details concerning the processing of applications, the reader is encouraged to refer to the interim rule governing this program, 24 CFR part 581.
For properties listed as suitable/to be excess, that property may, if subsequently accepted as excess by GSA, be made available for use by the homeless in accordance with applicable law, subject to screening for other Federal use. At the appropriate time, HUD will publish the property in a Notice showing it as either suitable/available or suitable/unavailable.
For properties listed as suitable/unavailable, the landholding agency has decided that the property cannot be declared excess or made available for use to assist the homeless, and the property will not be available.
Properties listed as unsuitable will not be made available for any other purpose for 20 days from the date of this Notice. Homeless assistance providers interested in a review by HUD of the determination of unsuitability should call the toll free information line at 1-800-927-7588 for detailed instructions or write a letter to Ann Marie Oliva at the address listed at the beginning of this Notice. Included in the request for review should be the property address (including zip code), the date of publication in the
For more information regarding particular properties identified in this Notice (i.e., acreage, floor plan, existing sanitary facilities, exact street address), providers should contact the appropriate landholding agencies at the following addresses: AIR FORCE: Mr. Robert Moore, Air Force Real Property Agency, 143 Billy Mitchell Blvd., San Antonio, TX 78226, (210) 925-3047; GSA: Mr. Flavio Peres, General Services Administration, Office of Real Property
Office of the Assistant Secretary for Community Planning and Development, HUD.
Notice of Intent to Prepare an EIS.
This provides notice to the public, agencies, and Indian tribes that the City of New York—Department of Housing Preservation & Development (HPD), as the Responsible Entity in accordance with 24 CFR 58.2(a)(7), and the New York City Department of City Planning (DCP) serving as lead agency on behalf of the City Planning Commission (CPC) in accordance with City Environmental Quality Review (CEQR), Executive Order No. 91, and the New York State Environmental Quality Review Act (SEQRA), 6 NYCRR 617, intend to prepare a Draft Environmental Impact Statement (EIS) for the Halletts Point Rezoning Project. The EIS will be a joint National Environmental Policy Act (NEPA) and CEQR document. The EIS will satisfy requirements of SEQR (6 NYCRR 617.8) and CEQR (Sections 6-08 and 6-12 of Executive Order No. 91 of 1977 as amended), which require that state and local government agencies consider the environmental consequences of projects over which they have discretionary authority before acting on those projects. The proposed action is subject to NEPA because the proposed disposition of NYCHA property at Astoria Houses will require a federal approval from HUD under Section 18 of the U.S. Housing Act of 1937. This notice is in accordance with the Council on Environmental Quality (CEQ) regulations at 40 CFR parts 1500-1508.
A Draft EIS will be prepared for the proposed action described herein. Comments relating to the Draft EIS are requested and will be accepted by the contact person listed below. When the Draft EIS is completed, a notice will be sent to individuals and groups known to have an interest in the Draft EIS and particularly in the environmental impact issues identified therein. Any person or agency interested in receiving a notice and making comment on the Draft EIS should contact the person listed below up to 30 days following publication of this notice.
The EIS will be a NEPA document intended to satisfy requirements of federal environmental statutes. In accordance with specific statutory authority at Section 26 of the U.S. Housing Act (42 U.S.C. 1437x) and HUD's regulations at 24 CFR part 58 (Environmental Review Procedures for Entities Assuming HUD Environmental Responsibilities), HUD has provided for assumption of its NEPA authority and NEPA lead agency responsibility by HPD. The EIS will be a CEQR document intended to satisfy State and City environmental statutes as described above.
All interested agencies, tribes, groups, and persons are invited to submit written comments on the project named in this notice and on the Draft EIS to the contact person shown in this notice. The office of the contact person should receive comments and all comments so received will be considered prior to the preparation and distribution of the Draft EIS. Particularly solicited is information on reports or other environmental studies planned or completed in the project area, major issues that the EIS should consider, recommended mitigation measures, and alternatives associated with the proposed action. Federal agencies having jurisdiction by law, special expertise, or other special interest should report their interest and indicate their readiness to aid in the EIS effort as a “Cooperating Agency.”
Patrick Blanchfield, Director of Environmental Planning, City of New York—Department of Housing Preservation & Development, 100 Gold Street, Room 9I-7, New York, NY 10038; Fax: (212) 863-5052; email:
HPD, acting under authority of Section 26 of the United States Housing Act of 1937 and HUD's regulations at 24 CFR part 58, in cooperation with other interested agencies, will prepare an EIS to analyze potential impacts of the Halletts Point Rezoning Project.
The proposed new development would occur on approximately 9.65 acres in the Astoria neighborhood of Queens, New York, adjacent to the East River on the Halletts Point peninsula. The project site affected by the proposed actions comprises all or portions of eight tax lots: Block 913, Lot 1; Block 915, Lot 6; Block 916, Lots 1 and 10; Block 490, Lots 1, 11, 100, and 101. In total, there would be development of twelve buildings. Building 1 (Block 915, Lot 6) would be located on the block bounded by 27th Avenue to the south, 1st Street to the west, 26th Avenue to the north, and 2nd Street to the east. Buildings 2 through 5 (Block 490, Lots 1 and 11 and Block 916, Lots 1 and 10), including the mapped streetbeds of 26th and 27th Avenues between 1st Street and the East River, would be bounded by Hallet's Cove Playground (Block 490, Lot 100) to the south, the East River to the west, Whitey Ford Field (Block 913, Lot 1) to the north, and 1st Street to the east. The land on which Buildings 1 through 5would be constructed is privately owned. The privately owned portions of the project site consist of light industrial uses, vacant buildings, and open land used for temporary storage of vehicles and equipment.
Buildings 6 through 8 would be located within the existing New York City Housing Authority (NYCHA) Astoria Houses campus (Block 490, Lot 101) bounded by 27th Avenue, 1st Street, and 8th Street. The Astoria
In order to facilitate the proposed mixed-use development project, discretionary approvals from the City Planning Commission (CPC) would be required, including a number of zoning map changes; zoning text amendments; Large-Scale General Development (LSGD) special permits related to bulk; waterfront special permits, authorizations, and certifications; and mapping actions. These discretionary approvals are subject to review under the City's Uniform Land Use Review Procedure (ULURP), which requires a determination pursuant to CEQR. In addition to the proposed actions subject to CPC approval, the proposed project will require approval from other City, State, and Federal agencies, including disposition of public housing property (i.e., NYCHA property), use of development rights associated with lands underwater, jurisdictional transfer of parkland, and potential financing approval for affordable housing.
The proposed actions would facilitate the development of a total of approximately 2.67 million gross square feet (gsf) consisting of a total of approximately 2.15 million gsf of residential space (2,573 housing units including 2,161 market-rate and 412 affordable housing units); approximately 68,000 gsf of retail space; and approximately 1,253 garage parking spaces and 85 on-site surface parking spaces. The proposed project would also include approximately 96,000 sf (2.2 acres) of publicly accessible open space, including a waterfront esplanade along the East River and upland connections to 1st Street. In addition, it is expected that a number of street improvements and improvements to stormwater and sanitary sewer infrastructure would be provided to support the new development.
The new development on Buildings 1 through 5 would consist of seven new buildings with high-rise towers rising from low- to mid-rise bases. On Buildings 1 through 5, the proposed project would include residential, retail, and parking uses in low- to mid-rise bases and residential uses in high-rise towers. The low- to mid-rise bases would include one level of below-grade parking and up to four floors of additional parking above-grade. The above-grade parking would be located in the building cores, wrapped by residential and retail uses. The residential uses wrapping the parking garages would consist of townhouses below apartment units. Ground floor retail would line portions of 1st Street and the demapped portion of 27th Avenue, leading to the waterfront. An approximately 30,000 gsf retail space (designed for a supermarket use) would be located on the ground floor of Building 1. The parking garages in the building cores may be topped by a rooftop terrace for use by the buildings' tenants. The structures on Buildings 1 through 5 would range from 16 to 30 stories in height (160 to 300 feet). The low- to mid-rise bases would be a minimum of four stories and would range from approximately 40 to 80 feet in height. Buildings 6 and 7 would contain four new mid-rise buildings rising to a maximum height of 100 feet and 110 feet, respectively (10 and 11 stories). These structures would contain residential and retail uses and surface parking. Local retail uses would be located along 27th Avenue and surface parking lots would be provided at the rear of the buildings. In addition to the Applicant's proposed development program for Buildings 1 through 7, the proposed actions would facilitate a proposal by NYCHA to dispose of the site for Building 8 along Astoria Boulevard for development pursuant to a future RFP. Building 8 would contain one new high-rise building rising to a maximum height of 240 feet (24 stories). This structure would contain market-rate residential units and retail uses and garage parking. Local retail uses would be located on Astoria Boulevard at the intersection of 1st Street.
Alternatives to the proposed action will be analyzed in the EIS. Typically the alternatives section in an EIS is examines development options that would tend to reduce project-related impacts. The full range of alternatives will be defined when the full extent of the proposed project's impacts is identified, but at this time, it is anticipated that they will include the following:
The No Action Alternative would analyze the continuation of uses on the site; therefore, existing buildings and tenants would remain at the project site and no new buildings or uses would be constructed.
If significant adverse impacts are identified in the EIS, the No Adverse Impacts Alternative will describe the modifications to the project that would be needed to avoid any such impacts.
Other possible alternatives may be developed in consultation with DCP, NYCHA, and HPD during the EIS preparation process and may be suggested by the public during the scoping of the EIS.
The proposed project may constitute an action significantly affecting the quality of the human environment and an EIS will be prepared on this project in accordance with CEQR and NEPA. Responses to this notice will be used to: (1) Determine significant environmental issues, (2) identify data that the EIS should address, and (3) identify agencies and other parties that will participate in the EIS process and the basis for their involvement.
A public EIS scoping meeting will be held on a date within the comment period and after at least 15 days of publishing this Notice of Intent. Notices of the scoping meeting will be published in the New York City Record and a newspaper of general circulation when the date has been determined. The EIS scoping meeting, which will also satisfy the scoping meeting requirement for CEQR, will provide an opportunity for the public to learn more about the project and provide input to the environmental process. At the meeting, an overview of the project will be presented and members of the public will be invited to comment on the proposed project and the scope of work for the environmental analyses in the EIS. Written comments and testimony concerning the scope of the EIS will be accepted at this meeting. In accordance with 40 CFR 1501.7, affected Federal, State, and local agencies, any affected Indian tribe, and other interested parties will be sent a scoping notice. In accordance with 24 CFR 58.59, the scoping hearing will be preceded by a
The following subject areas will be analyzed in the combined EIS for probable environmental effects: Land Use, Zoning, and Public Policy; Socioeconomic Conditions; Community Facilities and Services; Open Space; Shadows; Historic Resources; Urban Design/Visual Resources; Natural Resources (including a floodplain analysis); Hazardous Materials; Water and Sewer Infrastructure; Solid Waste and Sanitation Services; Energy; Transportation (including traffic, parking, pedestrian conditions, and transit); Air Quality; Greenhouse Gases; Noise; Neighborhood Character; Construction Impacts; Public Health; and Environmental Justice.
Questions may be directed to the individual named in this notice under the heading
Fish and Wildlife Service, Interior.
Notice of receipt of applications for permit.
We, the U.S. Fish and Wildlife Service, invite the public to comment on the following applications to conduct certain activities with endangered species. With some exceptions, the Endangered Species Act (ESA) prohibits activities with listed species unless Federal authorization is acquired that allows such activities.
We must receive comments or requests for documents on or before December 17, 2012.
Brenda Tapia, Division of Management Authority, U.S. Fish and Wildlife Service, 4401 North Fairfax Drive, Room 212, Arlington, VA 22203; fax (703) 358-2280; or email
Brenda Tapia, (703) 358-2104 (telephone); (703) 358-2280 (fax);
Send your request for copies of applications or comments and materials concerning any of the applications to the contact listed under
Please make your requests or comments as specific as possible. Please confine your comments to issues for which we seek comments in this notice, and explain the basis for your comments. Include sufficient information with your comments to allow us to authenticate any scientific or commercial data you include.
The comments and recommendations that will be most useful and likely to influence agency decisions are: (1) Those supported by quantitative information or studies; and (2) Those that include citations to, and analyses of, the applicable laws and regulations. We will not consider or include in our administrative record comments we receive after the close of the comment period (see
Comments, including names and street addresses of respondents, will be available for public review at the street address listed under
To help us carry out our conservation responsibilities for affected species, and in consideration of section 10(a)(1)(A) of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
The applicant requests reissuance of their permit to introduce from the high seas samples and/or whole carcasses of green sea turtle (
The applicant requests a permit to re-import two captive bred Western gorillas (
The applicant requests renewal of their captive-bred wildlife registration under 50 CFR 17.21(g) for radiated tortoise (
The applicant requests renewal of their captive-bred wildlife registration
The applicant requests renewal of their captive-bred wildlife registration under 50 CFR 17.21(g) for the following families, to enhance their propagation or survival. This notification covers activities to be conducted by the applicant over a 5-year period.
The applicant requests renewal of their captive-bred wildlife registration under 50 CFR 17.21(g) for the leopard (
The applicant requests renewal of their captive-bred wildlife registration under 50 CFR 17.21(g) for the following families, to enhance their propagation or survival. This notification covers activities to be conducted by the applicant over a 5-year period.
The applicant requests renewal of their captive-bred wildlife registration under 50 CFR 17.21(g) for the following families and species, to enhance their propagation or survival. This notification covers activities to be conducted by the applicant over a 5-year period.
The applicant requests a permit to import one captive-bred male and one captive-bred female cheetah (
The applicant requests a permit to export the following whole mount trophies; three dama gazelle (
The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for the scimitar-horned oryx (
The applicant requests a permit authorizing interstate and foreign commerce, export, and cull of excess scimitar-horned oryx (
The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for the golden parakeet (
The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for the scimitar-horned oryx (
The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for the scimitar-horned oryx (
The applicant requests a permit authorizing interstate and foreign commerce, export, and cull of excess scimitar-horned oryx (
The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for the scimitar-horned oryx (
The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for the barasingha (
The applicant requests a permit authorizing interstate and foreign commerce, export, and cull of excess scimitar-horned oryx (
The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for the scimitar-horned oryx (
The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for the barasingha (
The applicant requests a permit authorizing interstate and foreign commerce, export, and cull of excess scimitar-horned oryx (
The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for the barasingha (
The applicant requests a permit authorizing interstate and foreign commerce, export, and cull of excess barasingha (
The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for the barasingha (
The applicant requests a permit authorizing interstate and foreign commerce, export, and cull of excess scimitar-horned oryx (
The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for the barasingha (
The applicant requests a permit authorizing interstate and foreign commerce, export, and cull of excess barasingha (
The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for the golden parakeet (
The applicant requests a permit to import one captive-bred female cheetah (
The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for the following species, to enhance their propagation or survival. This notification covers activities to be conducted by the applicant over a 5-year period.
The applicant requests a captive-bred wildlife registration under 50 CFR 17.21(g) for the radiated tortoise (
The applicant request a permit to export the sport-hunted trophy of one addax
The following applicants each request a permit to import the sport-hunted trophy of one male bontebok (
Bureau of Indian Affairs, Interior.
Notice of submission to OMB.
In compliance with the Paperwork Reduction Act of 1995, the Assistant Secretary—Indian Affairs is submitting to the Office of Management and Budget (OMB) a request for renewal for the collection of information for Class III Gaming Procedures authorized by OMB Control Number 1076-0149, Tribal Revenue Allocation Plans authorized by OMB Control Number 1076-0152, and Gaming on Trust Lands Acquired After October 17, 1988 authorized by OMB Control Number 1076-0158. These information collections expire November 30, 2012.
Interested persons are invited to submit comments on or before December 17, 2012.
You may submit comments on the information collections to the Desk Officer for the Department of the Interior at the Office of Management and Budget, by facsimile to (202) 395-5806 or you may send an email to:
Nancy Pierskalla, (202) 219-4066. You may review the information collection requests online at
The Assistant Secretary—Indian Affairs is seeking comments on the Class III Gaming Procedures, Tribal Revenue Allocation Plans, and Gaming on Trust Lands Acquired after October 17, 1988, as we prepare to renew these collections as required by the Paperwork Reduction Act of 1995. This information is necessary for the BIA, Office of Indian Gaming, to ensure that the applicable requirements for IGRA, 25 U.S.C. 2701 et seq., are met with regard to Class III gaming procedures, tribal revenue allocation plans, and applications for gaming on trust lands acquired after October 17, 1988.
The BIA requests your comments on this collection concerning: (a) The necessity of this information collection 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 (hours and cost) of the collection of information, including the validity of the methodology and assumptions used; (c) Ways we could enhance the quality, utility, and clarity of the information to be collected; and (d) Ways we could minimize the burden of the collection of the information on the respondents.
Please note that an agency may not conduct or sponsor, and an individual need not respond to, a collection of information unless it displays a valid OMB Control Number.
It is our policy to make all comments available to the public for review at the location listed in the
Bureau of Land Management, Interior.
Notice.
The Bureau of Land Management (BLM) has closed approximately 210 acres of public land described as the Airport Mesa/Carrizo Creek shooting area located in eastern San Diego County, California. The closure order prohibits recreational shooting and target practice. The use of firearms will continue to be allowed for hunting consistent with California Department of Fish and Game regulations and seasons. This closure order is necessary in order to protect U.S. Border Patrol agents as they perform their duties along the top of Airport Mesa.
The closure order is effective as of June 19, 2012, until June 19, 2014.
Daniel Steward, BLM El Centro Field Office, 1661 S. 4th St., El Centro, CA 92243, telephone 760-337-4400.
The BLM recognizes that recreational target shooting is a valid use of public lands, and seeks to balance this with the need to provide for public safety. The BLM El Centro Field Office prepared an environmental assessment (EA) for this temporary closure (DOI-BLM-CA-D070-2012-0058-EA). This 2-year temporary closure will allow the BLM to proceed through a land use plan amendment process and utilize public input to consider a permanent closure of the area and options for alternative shooting areas.
The purpose of this closure order is to protect persons, property, and public land and resources, and the protection of U.S. Border Patrol agents as they perform their duties along the top of Airport Mesa.
The closure order is in accordance with provisions of the Federal Land Policy and Management Act of 1976 (Pub. L. 94-579, 90 stat. 2743, 43 U.S.C. 1701
The order closes the following public lands in eastern San Diego County to recreational shooting and target practice:
The areas described aggregate 230.20 acres, according to the official plats of the surveys of the said lands, on file in the Bureau of Land Management.
The following persons are exempt from the identified restrictions:
(1) Federal, State, or local law enforcement officers, while engaged in the execution of their official duties;
(2) BLM personnel or their representatives while engaged in the execution of their official duties;
(3) Any member of an organized rescue, firefighting force, or emergency medical services organization while in the performance of their official duties;
(4) Any person in receipt of a written authorization of exemption obtained from the authorized officer; and
(5) Any person with a legal California hunting license in their possession and in the legal act of hunting.
This Notice and maps of the restricted area will be clearly posted at main entry points to the Airport Mesa shooting area and will also be available at the BLM El Centro Field Office.
43 CFR 8364.1; 43 CFR 8360.0-7.
Bureau of Land Management, Interior.
Notice of availability.
In accordance with the National Environmental Policy Act of 1969, as amended (NEPA); the Federal Land Policy and Management Act of 1976, as amended; and the California Environmental Quality Act of 1970 (CEQA); the Bureau of Land Management (BLM) Bishop Field Office, Bishop, California; the United States Forest Service (USFS) Inyo National Forest; and the Great Basin Unified Air Pollution Control District (GBUAPCD) (a California state agency) have prepared a Draft Environmental Impact Statement (EIS)/Environmental Impact Report (EIR) for the proposed Casa Diablo IV Geothermal Development Project near the Town of Mammoth Lakes in Mono County, California. This notice announces the opening of the public comment period.
To ensure comments will be considered, comments on the Draft EIS/EIR must be received within 60 days following the date the Environmental Protection Agency publishes this Notice of Availability in the
Written comments on the Draft EIS/EIR for the Casa Diablo IV Geothermal Development Project may be submitted by any of the following methods:
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Oral comments may be submitted to Margie DeRose via telephone at 760-873-2424 or in person at the Inyo National Forest, Supervisor's Office, 351 Pacu Lane, Suite 200, Bishop, CA 93514. Oral comments may also be submitted at any public meeting that is designed to elicit public comments.
Copies of the Draft EIS/EIR for the Casa Diablo IV Geothermal Development Project are available at the Bishop Field Office at the above address and at the Mono County Library at 400 Sierra Park Road, Mammoth Lakes, California.
Collin Reinhardt, Project Manager, telephone 760-872-5024; address 351 Pacu Lane, Suite 100, Bishop, CA 93514; email
The Draft EIS/EIR analyzes the potential impacts of authorizing the proposed Casa Diablo IV Geothermal Development Project near the Town of Mammoth Lakes in Mono County, California. In accordance with the Geothermal Steam Act of 1970, as amended (30 U.S.C. 1001
The purpose and need for action is to respond to an application to construct and operate the proposed Casa Diablo IV Geothermal Development Project on Federal geothermal leases administered by the BLM Bishop Field Office. The proposed project would be located on Inyo National Forest lands and adjacent private lands within portions of Federal geothermal leases CACA-11667, CACA-14407, CACA-14408, and CACA-11672. The leases proposed for development are part of an existing geothermal unit, which is currently providing energy sufficient to power three operating geothermal plants.
The applicant's proposed action includes the construction of a new 33-MW binary geothermal power plant, which would be the fourth geothermal plant in the vicinity; up to 16 wells for production and reinjection, drilled to an approximate 1,600- to 2,500-ft depth; and associated pipelines. A 650-ft long transmission line is proposed to interconnect the new power plant to the existing Southern California Edison (SCE) substation at Substation Road. The proposed Casa Diablo IV plant, access roads, well pads, pipelines and transmission line would occupy approximately 80 acres. Of the 16 proposed production/injection well locations, 14 were previously analyzed and approved by the BLM as exploration wells in EA-170-02-15 (2001) and EA-170-05-04 (2005). Three of these exploration wells have already been drilled as of the time of the publication of this notice. The proposed well field contains two existing production wells and associated pipelines that currently serve the three existing power plants in the area. The BLM published a Notice of Intent (NOI) to prepare a joint EIS/EIR on March 25, 2011, in the
Alternatives identified and evaluated in the Draft EIS/EIR include: Alternative 1, the applicant's proposed action which is outlined above; Alternative 2, which considers an alternative location for the proposed power plant; Alternative 3, which considers alternative pipeline alignments in Basalt Canyon and slightly alters the location of one proposed well; and Alternative 4, the no action alternative which would limit geothermal development activities on the affected leases to those previously authorized by the BLM. In accordance with NEPA (40 CFR 1502.14(e)), the BLM and USFS have identified Alternative 3 as the preferred alternative. The GBUAPCD has also identified Alternative 3 as the “environmentally superior alternative” pursuant to the CEQA (14 C.C.R. 15126.6(e)(2)).
Public comments and information submitted, including names, street addresses, and email addresses of persons who submit comments, will be available for public review at the above address during regular business hours (8 a.m. to 4 p.m.), Monday through Friday, except holidays.
Before including your address, phone number, email 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.
40 CFR 1506.6, 40 CFR 1506.10.
Bureau of Land Management, Interior.
Notice.
In accordance with the National Environmental Policy Act of 1969, as amended (NEPA), the Bureau of Land Management (BLM) has prepared a Draft Environmental Impact Statement (EIS) for the Gas Hills In Situ Recovery (ISR) Uranium Project and by this notice
To ensure that comments will be considered, the BLM must receive written comments on the Gas Hills ISR Uranium Project draft EIS within 45 days following the date the Environmental Protection Agency publishes its Notice of Availability in the
Comments on the Gas Hills ISR Uranium Project may be submitted by any of the following methods:
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Documents pertinent to this proposal may be examined at the following BLM offices:
• Lander Field Office, 1335 Main Street, Lander, Wyoming 82520;
• High Plains District Office, 2987 Prospector Drive, Casper, Wyoming 82604;
• Wind River/Bighorn Basin District Office, 101 South 23rd, Worland, Wyoming 82401; and
• Wyoming State Office, 5353 Yellowstone Road, Cheyenne, Wyoming 82009; Interested persons may also view the documents online at:
Kristin Yannone, Project Manager, telephone: 307-332-8400; address: mail: 1335 Main Street, Lander, WY 82520; email:
The applicant, Power Resources, Inc. (PRI), a wholly owned subsidiary of Cameco US Holdings, Inc., doing business as Cameco Resources, has filed a plan of operations pursuant to 43 CFR subpart 3809 regulations to construct uranium recovery facilities including: Waste water disposal facilities; access roads; pipelines and utility lines; delineation, injection and production wells; and improvement of one existing and construction of one new equipment-housing satellite facility used in the ISR process. The project would be located in eastern Fremont and western Natrona counties, approximately 45 road miles east of Riverton, Wyoming, and approximately 65 road miles west of Casper, Wyoming.
The boundary of the Gas Hills Project Area (GHPA) encompasses approximately 8,500 acres, of which approximately 1,300 acres would incur surface disturbance from the proposed project. Approximately 15 percent of the surface within the GHPA has been disturbed by past mining and exploration activities. This disturbance includes an existing warehouse structure (the Carol Shop) and access road (the AML Road).
If the proposed mining operation is not approved, existing reclamation responsibilities under the No-Action Alternative would require Cameco to remove and reclaim the existing disturbance once ongoing exploratory activities are concluded. This reclamation would include a minimum of 26.7 acres for the removal of the Carol Shop. If no other use for the existing 1.8 miles of road were identified, it would need to be removed and reclaimed, an additional 10.9 acres. Additional notice-level activities resulting from exploration would need to be reclaimed as well for a total of 40.2 acres. The use of the road and Carol Shop have been allowed during active exploration in the area and currently maintained mill-site claims.
The Plan of Operations identifies five production areas, or mine units, with subsurface ore bodies within the Wind River Formation for ISR extraction. Construction, operation, groundwater restoration, and surface reclamation of five mine units would occur during an estimated period of approximately 25 years. At the end of the project, all surface structures would be removed, and all disturbances would be re-contoured and reclaimed. In accordance with Nuclear Regulatory Commission (NRC) regulations, any radiological contaminated wastes, including any processing pipe and equipment as well as solid residue or liners from evaporation ponds, would be removed from the Project Area and disposed of in accordance with regulations.
The Draft EIS addresses the direct, indirect, and cumulative impacts of the Proposed Action and two alternatives including the No Action Alternative and the Resource Protection Alternative.
The Proposed Action Alternative is the project proposed by Cameco as identified by the Plan of Operations, the NRC license application, and the Wyoming Department of Environmental Quality Land Quality Division's Mine Permit Application #687.
Under the Resource Protection Alternative, the project would utilize the same ISR process occurring over the same time period as the Proposed Action, but modifications to the project would reduce surface disturbance and heavy truck transportation. Modifications would include on-site resin processing to produce slurry, submittal of an annual development plan, construction timing constraints, a disturbance offset for an additional satellite facility, reduced number of evaporation ponds, enhanced reclamation, and power line burial.
The Notice of Intent to prepare an EIS was published in the
The public is encouraged to comment on any of the draft alternatives. The BLM asks that those submitting comments make them as specific as possible with reference to chapters, page numbers, and paragraphs in the draft EIS document. Comments that contain only opinions or preferences will not receive a formal response; however, they will be considered and included as part of the BLM decision-making process. The most useful comments will include new technical or scientific information, identification of data gaps in the impact analysis, or technical or scientific rationale for opinions or preference.
Before including your address, phone number, email 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 may ask us in your comment to withhold your personal identifying information from public review, we
Bureau of Land Management, Interior.
Notice.
In accordance with the National Environmental Policy Act of 1969, as amended (NEPA), and the Federal Land Policy and Management Act of 1976, as amended (FLPMA), the Bureau of Land Management (BLM) has prepared a Draft Environmental Impact Statement (EIS) for the Proposed Sun Valley to Morgan 500/230-kilovolt (kV) Transmission Line Project (Project) and Draft Bradshaw-Harquahala Resource Management Plan (RMP) amendment for the BLM Hassayampa Field Office, and by this notice is announcing the opening of the comment period.
To ensure that comments will be considered, the BLM must receive written comments on the Draft EIS and Draft RMP amendment within 90 days following the date the Environmental Protection Agency publishes its Notice of Availability in the
You may submit comments by any of the following methods:
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Copies of the Draft EIS and Draft RMP amendment are available in the BLM Hassayampa Field Office at the above address.
Joe Incardine, BLM National Project Manager, telephone 801-539-4118; address BLM Phoenix District Office, Hassayampa Field Office, 21605 North 7th Avenue, Phoenix, Arizona 85027-2929; email
The Arizona Public Service Company (APS) submitted a right-of-way (ROW) application to construct, operate, and maintain a 500/230kV overhead transmission line from the Sun Valley Substation to the Morgan Substation in Maricopa County. The Project would be located on a combination of BLM-managed lands, Arizona State Trust lands, and private lands in northern Maricopa County, northwest of Phoenix, Arizona. The Project is an overhead transmission line, approximately 38 miles long, on monopole structures. The BLM-managed lands within the Project area are managed under the existing Bradshaw-Harquahala Resource Management Plan (RMP).
Environmental and social concerns and issues were identified through internal and public scoping. The issues addressed in the EIS that shaped the Project's scope and alternatives include:
• Need and reliability;
• RMP amendment;
• Project design features, mitigation measures, and alternatives;
• Air and climate;
• Biological resources;
• Cultural resources;
• Health and safety;
• Recreation;
• Socioeconomic;
• Scenic/Visual; and
• Transportation and traffic.
In addition to the Proposed Action and No Action Alternative, three Action Alternative routes and one sub-alternative route (as proposed by the Arizona State Land Department) were analyzed in detail in the Draft EIS. As proposed, the Project would require an RMP amendment because the current RMP requires high-voltage transmission lines crossing BLM-managed lands to be within designated utility corridors, and a utility corridor for the proposed ROW on public lands was not established in the current RMP, the proposed action is within a designated transportation corridor. In addition, the Visual Resource Management (VRM) class designation would need to be amended from Class III to Class IV for those BLM-managed lands where views would be dominated by the transmission line, and thus would not meet the objectives of the current VRM designation. The VRM class would also be changed for those BLM-managed public lands north and south of State Route (SR) 74 surrounding the proposed transmission line ROW (i.e., the existing transportation corridor north of SR 74 and the key-shaped piece south of SR 74) in order to avoid creating narrow linear strips with different VRM classes.
An interdisciplinary approach was used to develop the Draft EIS in order to consider the variety of resource issues and concerns identified. An amendment to the Bradshaw Harquahala RMP would be based upon the following planning criteria:
• The amendment will be completed in compliance with FLPMA, NEPA, and all other relevant Federal laws, Executive Orders, and management policies of the BLM;
• Where existing planning decisions are still valid, those decisions will remain unchanged and be incorporated into the new amendment; and
• The amendment will recognize valid existing rights.
The BLM has identified a modified Proposed Action route crossing BLM-managed lands as the Agency Preferred Alternative route for the proposed transmission line, including best management practices and mitigative measures. Mitigative measures could consist of minor route deviations for micro-siting of structures or segments of the line at the time of route engineering to reduce impacts to visual and other sensitive resources. However, mitigative measures would still allow for the transmission line route to remain within the Arizona Corporation Commission-certificated route.
Under the Agency Preferred Alternative, the BLM would amend the RMP to:
• Designate a 200-foot-wide single-use utility corridor on public lands managed by the BLM north of SR 74;
• Designate a multi-use utility corridor on 1,021 acres of public lands managed by the BLM south of SR 74 to address potential future BLM management considerations; and
• Change the existing VRM class designations of 2,362 acres north of SR 74 and 1,013 acres south of SR 74 from Class III to Class IV to allow for the newly established utility corridors.
Once the RMP were amended, the BLM would approve a 200-foot-wide ROW within the newly designated utility corridor on public lands managed by the BLM north of SR 74 and within the existing designated utility corridor northeast of the Sun Valley Substation.
The BLM will utilize and coordinate the NEPA comment period to satisfy the public involvement process for Section 106 of the National Historic Preservation Act (16 U.S.C. 470) as provided for in 36 CFR 800.2(d)(3). Native American tribal consultations will be conducted in accordance with policy, and tribal concerns, including impacts on Indian trust assets, will be given due consideration. Federal, State, and local agencies, along with other stakeholders that may be interested or affected by the BLM's decisions on this project, are invited to participate in the public comment process. The BLM has determined that public hearings to solicit comments on the Draft EIS are necessary. Accordingly, the BLM invites all interested persons to participate in one of the following public hearings:
All public hearings begin with an open house at 5:30 p.m., followed by a presentation at 6 p.m.
Interested parties are invited to present oral statements at the hearings. For information on facilities or services for persons with disabilities or to request special assistance at the hearing, contact Ellen Carr at 480-629-4705 or email
The hearings will be conducted in accordance with 455 DM 1 and the BLM NEPA Handbook by a representative designated by the BLM.
Before including your address, phone number, email 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.
40 CFR 1506.6, 40 CFR 1506.10, 43 CFR 1610.2.
Bureau of Land Management, Interior.
Notice.
The plats of survey of the following described lands are scheduled to be officially filed in the Bureau of Land Management, Oregon State Office, Portland, Oregon, 30 days from the date of this publication.
A copy of the plats may be obtained from the Public Room at the Bureau of Land Management, Oregon State Office, 333 SW. 1st Avenue, Portland, Oregon 97204, upon required payment.
Kyle Hensley, (503) 808-6132, Branch of Geographic Sciences, Bureau of Land Management, 333 SW. 1st Avenue, Portland, Oregon 97204. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 to contact the above individual during normal business hours. The FIRS is available 24 hours a day, 7 days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours.
A person or party who wishes to protest against this survey must file a written notice with the Oregon State Director, Bureau of Land Management, stating that they wish to protest. A statement of reasons for a protest may be filed with the notice of protest and must be filed with the Oregon State Director within thirty days after the protest is filed. If a protest against the survey is received prior to the date of official filing, the filing will be stayed pending consideration of the protest. A plat will not be officially filed until the day after all protests have been dismissed or otherwise resolved. Before including your address, phone number, email 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.
National Park Service, Interior.
Notice; request for comments.
We (National Park Service, NPS) will ask the Office of Management and Budget (OMB) to approve the information collection (IC) described below. As required by the Paperwork Reduction Act of 1995 and as part of our continuing efforts to reduce paperwork and respondent burden, we invite the general public and other Federal agencies to take this opportunity to comment on this IC. This IC is scheduled to expire on May 31, 2013. We may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a valid OMB control number.
To ensure we are able to consider your comments, we must receive them on or before January 15, 2013.
Please send your comments on the IC to Madonna L. Baucum, Information Collection Clearance Officer, National Park Service, 1201 I Street NW., MS 1242, Washington, DC 20005 (mail); or
Diane Miller, National Manager, National Underground Railroad Network to Freedom Program, National Park Service, Midwest Regional Office, 601 Riverfront Dr., Omaha, Nebraska 68102; via fax at (402) 661-1982; or via email at
Public Law 105-23, National Underground Railroad Network to Freedom Act of 1998, requires the establishment of a network justifiably associated with the Underground Railroad. The Network is designed to be a collection of sites, facilities, and programs, both governmental and non-governmental, around the United States with a verifiable association with the historic Underground Railroad movement. The National Park Service National Underground Railroad Network to Freedom application form is completed by Federal agencies, State Historic Preservation Offices, other State agencies, local governments, organizations, and individuals. We use the information collected to determine eligibility to become part of the Network. We are requesting a 3-year term of approval for this information collection activity.
Respondents must verify associations and characteristics through descriptive texts that are the result of historical research. Evaluations are based on subjective analysis of the information provided, which often includes copies of rare documents and photographs. Much of the information is submitted in electronic format, but, at the present time, there is no automated way to gather all of the required information.
We invite comments concerning this information collection on:
• Whether or not the collection of information is necessary, including whether or not the information will have practical utility;
• The accuracy of the burden for this collection of information;
• Ways to enhance the quality, utility, and clarity of the information to be collected; and
• Ways to minimize the burden to respondents, including use of automated information techniques or other forms of information technology.
Please note that the comments submitted in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this IC. Before including your address, phone number, email 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 it will be done.
National Park Service, Interior.
Notice.
The U.S. Department of Energy Oak Ridge Office has completed an inventory of human remains and associated funerary object, in consultation with the appropriate Indian tribes, and has determined that there is a cultural affiliation between the human remains and the associated funerary object and a present-day Indian tribe. Representatives of any Indian tribe that believes itself to be culturally affiliated with the human remains and associated funerary object may contact the U.S. Department of Energy Oak Ridge Office. Repatriation of the human remains and associated funerary object to the Indian tribe stated below may occur if no additional claimants come forward.
Representatives of any Indian tribe that believes it has a cultural affiliation with the human remains and associated funerary object should contact the U.S. Department of Energy Oak Ridge Office at the address below by December 17, 2012.
Katatra Vasquez, U.S. Department of Energy Oak Ridge Office, P.O. Box 2001, SE-32, Oak Ridge, TN 37831, telephone (865) 576-0835.
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains and associated funerary object in the possession of the U.S. Department of Energy Oak Ridge Office. The human remains and associated funerary object were removed from Roane County, TN.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains and associated funerary object. The National Park Service is not responsible for the determinations in this notice.
A detailed assessment of the human remains was made by the U.S.
In July 1981, human remains representing, at minimum, one individual were removed from site 40RE86 in Roane County, TN, as a result of an archeological investigation. The site dates to the Mississippian period (specifically, the eastern Tennessee Dallas Phase, A.D. 1300 to 1600). Based on the associated pottery found at the site, the human remains date to about A.D. 1400. No known individuals were identified. The one associated funerary object is a small shell tempered vessel.
The Dallas Phase people of the Upper Tennessee Valley are not clearly identifiable as being culturally affiliated with a modern-day tribe. However, based on consultation and the totality of circumstances surrounding acquisition of the human remains and associated funerary object, the U.S. Department of Energy Oak Ridge Office has determined by a reasonable belief that the human remains and associated funerary object are culturally affiliated with the Eastern Band of Cherokee Indians.
Officials of the U.S. Department of Energy Oak Ridge Office have determined that:
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of one individual of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(3)(A), the one object described above is reasonably believed to have been placed with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the Native American human remains and the Eastern Band of Cherokee Indians.
Representatives of any Indian tribe that believes itself to be culturally affiliated with the human remains and associated funerary object should contact Katatra Vasquez, U.S. Department of Energy Oak Ridge Office, P.O. Box 2001, SE-32, Oak Ridge, TN 37831, telephone (865) 576-0835 before December 17, 2012. Repatriation of the human remains and associated funerary object to the Eastern Band of Cherokee Indians may proceed after that date if no additional claimants come forward.
The U.S. Department of Energy Oak Ridge Office is responsible for notifying the Cherokee Nation; Chickasaw Nation; Choctaw Nation of Oklahoma; Eastern Band of Cherokee; Eastern Shawnee Tribe of Oklahoma; Poarch Band of Creeks (previously listed as the Poarch Band of Creek Indians of Alabama); Quapaw Tribe of Indians; The Muscogee (Creek) Nation; The Seminole Nation of Oklahoma; and the United Keetoowah Band of Cherokee Indians in Oklahoma, that this notice has been published.
National Park Service, Interior.
Notice.
The U.S. Department of Agriculture (USDA), Forest Service, Ozark-St. Francis National Forests has completed an inventory of human remains and associated funerary objects, in consultation with the appropriate Indian tribes, and has determined that there is a cultural affiliation between the human remains and associated funerary objects and present-day Indian tribes. Representatives of any Indian tribe that believes itself to be culturally affiliated with the human remains and associated funerary objects may contact the Ozark-St. Francis National Forests. Repatriation of the human remains and associated funerary objects to the Indian tribes stated below may occur if no additional claimants come forward.
Representatives of any Indian tribe that believes it has a cultural affiliation with the human remains and associated funerary objects should contact the Ozark-St. Francis National Forests at the address below by December 17, 2012.
Judith L. Henry, Forest Supervisor, USDA Forest Service, Ozark-St. Francis National Forests, Russellville, AR 72801, telephone (479) 964-7202.
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains and associated funerary objects in the possession of the Ozark-St. Francis National Forests. The human remains and associated funerary objects were removed from private land and donated to the Ozark-St. Francis National Forests by private collectors.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains and associated funerary objects. The National Park Service is not responsible for the determinations in this notice.
A detailed assessment of the human remains was made by the Ozark-St. Francis National Forests professional staff in consultation with representatives of the Absentee-Shawnee Tribe of Indians of Oklahoma; Alabama-Quassarte Tribal Town; Caddo Nation of Oklahoma; Cherokee Nation; Chickasaw Nation; Choctaw Nation of Oklahoma; Delaware Nation, Oklahoma; Eastern Shawnee Tribe of Oklahoma; Jena Band of Choctaw Indians; Kialegee Tribal Town; Miami Tribe of Oklahoma; Mississippi Band of Choctaw Indians; Peoria Tribe of Indians of Oklahoma; Quapaw Tribe of Indians; Shawnee Tribe; The Muscogee (Creek) Nation; The Osage Nation (previously listed as the Osage Tribe); The Seminole Nation of Oklahoma; Thlopthlocco Tribal Town; Tunica-Biloxi Indian Tribe; United Keetoowah Band of Cherokee Indians in Oklahoma; and the Wichita and Affiliated Tribes (Wichita, Keechi, Waco & Tawakonie), Oklahoma.
In 1970 and 1971, human remains representing, at minimum, 16 individuals were removed from site 3NW101, on private property, in Newton County, AR, by Thelma and Louis Gregoire of the AAS. In 1988, they donated their collection to the USDA-Forest Service. No known individuals were identified. The 74 associated funerary objects from identified burials include 25 ceramic vessels, 15 dart points, 19 knives, 2 blanks, 6 scrapers,
Officials of the USDA Forest Service, Ozark-St. Francis National Forests have determined that:
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of 16 individuals of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(3)(A), the 74 objects described above are reasonably believed to have been placed with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the Native American human remains and associated funerary objects and the Caddo Nation of Oklahoma.
Representatives of any Indian tribe that believes itself to be culturally affiliated with the human remains and associated funerary objects should contact Judith L. Henry, Forest Supervisor, USDA Forest Service Ozark-St. Francis National Forests, Russellville, AR 72801, telephone (479) 964-7202, before December 17, 2012. Repatriation of the human remains and associated funerary objects to the Caddo Nation of Oklahoma may proceed after that date if no additional claimants come forward.
The USDA Forest Service, Ozark-St. Francis National Forests, is responsible for notifying the Absentee-Shawnee Tribe of Indians of Oklahoma; Alabama-Quassarte Tribal Town; Caddo Nation of Oklahoma; Cherokee Nation; Chickasaw Nation; Choctaw Nation of Oklahoma; Delaware Nation, Oklahoma; Eastern Shawnee Tribe of Oklahoma; Jena Band of Choctaw Indians; Kialegee Tribal Town; Miami Tribe of Oklahoma; Mississippi Band of Choctaw Indians; Peoria Tribe of Indians of Oklahoma; Quapaw Tribe of Indians; Shawnee Tribe; The Muscogee (Creek) Nation; The Osage Nation (previously listed as the Osage Tribe); The Seminole Nation of Oklahoma; Thlopthlocco Tribal Town; Tunica-Biloxi Indian Tribe; United Keetoowah Band of Cherokee Indians in Oklahoma; and the Wichita and Affiliated Tribes (Wichita, Keechi, Waco & Tawakonie), Oklahoma, that this notice has been published.
Office of Foreign Assets Control, Treasury.
Notice.
The Treasury Department's Office of Foreign Assets Control (“OFAC”) is publishing the name of four (4) individuals and five (5) entities designated on November 8, 2012, as persons whose property and interests in property are blocked pursuant to Executive Order 13628 of October 9, 2012, “Authorizing the Implementation of Certain Sanctions Set Forth in the Iran Threat Reduction and Syria Human Rights Act of 2012 and Additional Sanctions With Respect to Iran.”
The designation by the Director of OFAC of the four (4) individuals and five (5) entities identified in this notice, pursuant to Executive Order 13628 of October 9, 2012, is effective November 8, 2012.
Assistant Director, Sanctions Compliance and Evaluation, Office of Foreign Assets Control, Department of the Treasury, Washington, DC 20220, tel.: 202/622-2490.
This document and additional information concerning OFAC are available from OFAC's Web site (
On October 9, 2012, the President issued Executive Order 13628, “Authorizing the Implementation of Certain Sanctions Set Forth in the Iran Threat Reduction and Syria Human Rights Act of 2012 and Additional Sanctions With Respect to Iran” (the “Order”), pursuant to the International Emergency Economic Powers Act (50 U.S. C. 1701
Section 3 of the Order blocks, with certain exceptions, all property and interests in property that are in the United States, that come within the United States, or that are or come within the possession or control of any United States person, of persons determined by the Secretary of the Treasury, in consultation with, or at the recommendation of, the Secretary of State, to satisfy certain criteria set forth in the Order.
On November 8, 2012, the Director of OFAC, in consultation with or at the recommendation of, the Secretary of State, designated, pursuant to Section 3 of the Order, four (4) individuals and five (5) entities whose names have been added to the list of Specially Designated Nationals and Blocked Persons and whose property and interests in property are blocked. The listing for these individuals and entities is below.
5. PRESS SUPERVISORY BOARD (a.k.a. IRANIAN PRESS SUPERVISORY BOARD), Tehran, Iran [IRAN-TRA]
National Park Service, Interior.
Notice.
The U.S. Department of Agriculture (USDA), Forest Service, Ozark-St. Francis National Forests has completed an inventory of human remains and associated funerary objects, in consultation with the appropriate Indian tribes, and has determined that there is a cultural affiliation between the human remains and associated funerary objects and present-day Indian tribes. Representatives of any Indian tribe that believes itself to be culturally affiliated with the human remains and associated funerary objects may contact the Ozark-St. Francis National Forests. Repatriation of the human remains and associated funerary objects to the Indian tribes stated below may occur if no additional claimants come forward.
Representatives of any Indian tribe that believes it has a cultural affiliation with the human remains and associated funerary objects should contact the Ozark-St. Francis National Forests at the address below by December 17, 2012.
Judith L. Henry, Forest Supervisor, USDA Forest Service, Ozark-St. Francis National Forests, Russellville, AR 72801, telephone (479) 964-7202.
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains and associated funerary objects in the possession of the Ozark-St. Francis National Forests. The human remains and associated funerary objects were removed from lands on the Ozark-St. Francis National Forests or were removed from private land and donated to the Ozark-St. Francis National Forests by private collectors.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains and associated funerary objects. The National Park Service is not responsible for the determinations in this notice.
A detailed assessment of the human remains was made by the Ozark-St. Francis National Forests professional staff in consultation with representatives of the Absentee-Shawnee Tribe of Indians of Oklahoma; Alabama-Quassarte Tribal Town; Caddo Nation of Oklahoma; Cherokee Nation; Chickasaw Nation; Choctaw Nation of Oklahoma; Delaware Nation, Oklahoma; Eastern Shawnee Tribe of Oklahoma; Jena Band of Choctaw Indians; Kialegee Tribal Town; Miami Tribe of Oklahoma; Mississippi Band of Choctaw Indians; Peoria Tribe of Indians of Oklahoma; Quapaw Tribe of Indians; Shawnee Tribe; The Muscogee (Creek) Nation; The Osage Nation (previously listed as the Osage Tribe); The Seminole Nation of Oklahoma; Thlopthlocco Tribal Town; Tunica-Biloxi Indian Tribe; United Keetoowah Band of Cherokee Indians in Oklahoma; and the Wichita and Affiliated Tribes (Wichita, Keechi, Waco & Tawakonie), Oklahoma.
In 1955, human remains representing, at minimum, one individual were removed from site 3ST27, on the Ozark-St. Francis National Forests, by caver Roger Bottoms, in Stone County, AR. No known individuals were identified. No associated funerary objects are present.
In 1973, additional human remains representing, at minimum, two individuals were removed from sites 3ST12 and 3ST26, on private property, by Don Williams, USDA-Forest Service Geologist, also in Stone County, AR, and added to the human remains from site 3ST27. No known individuals were identified. No associated funerary objects are present.
The sites date from A.D. 165 to 1600. Sites 3ST27, 3ST12, and 3ST26 are located within the historical range of The Osage Nation and the Quapaw Tribe of Indians.
Officials of the USDA Forest Service, Ozark-St. Francis National Forests have determined that:
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of 3 individuals of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the Native American human
Representatives of any Indian tribe that believes itself to be culturally affiliated with the human remains and associated funerary objects should contact Judith L. Henry, Forest Supervisor, USDA Forest Service Ozark-St. Francis National Forests, Russellville, AR 72801, telephone (479) 964-7202, before December 17, 2012. Repatriation of the human remains and associated funerary objects to The Osage Nation and the Quapaw Tribe of Indians may proceed after that date if no additional claimants come forward.
The USDA Forest Service, Ozark-St. Francis National Forests, is responsible for notifying the Absentee-Shawnee Tribe of Indians of Oklahoma; Alabama-Quassarte Tribal Town; Caddo Nation of Oklahoma; Cherokee Nation; Chickasaw Nation; Choctaw Nation of Oklahoma; Delaware Nation, Oklahoma; Eastern Shawnee Tribe of Oklahoma; Jena Band of Choctaw Indians; Kialegee Tribal Town; Miami Tribe of Oklahoma; Mississippi Band of Choctaw Indians; Peoria Tribe of Indians of Oklahoma; Quapaw Tribe of Indians; Shawnee Tribe; The Muscogee (Creek) Nation; The Osage Nation (previously listed as the Osage Tribe); The Seminole Nation of Oklahoma; Thlopthlocco Tribal Town; Tunica-Biloxi Indian Tribe; United Keetoowah Band of Cherokee Indians in Oklahoma; and the Wichita and Affiliated Tribes (Wichita, Keechi, Waco & Tawakonie), Oklahoma, that this notice has been published.
National Park Service, Interior.
Notice.
The U.S. Department of Agriculture (USDA), Forest Service, Ozark-St. Francis National Forests has completed an inventory of human remains and associated funerary objects, in consultation with the appropriate Indian tribes, and has determined that there is a cultural affiliation between the human remains and associated funerary objects and present-day Indian tribes. Representatives of any Indian tribe that believes itself to be culturally affiliated with the human remains and associated funerary objects may contact the Ozark-St. Francis National Forests. Repatriation of the human remains and associated funerary objects to the Indian tribes stated below may occur if no additional claimants come forward.
Representatives of any Indian tribe that believes it has a cultural affiliation with the human remains and associated funerary objects should contact the Ozark-St. Francis National Forests at the address below by December 17, 2012.
Judith L. Henry, Forest Supervisor, USDA Forest Service, Ozark-St. Francis National Forests, Russellville, AR 72801, telephone (479) 964-7202.
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains and associated funerary objects in the possession of the Ozark-St. Francis National Forests. The human remains and associated funerary objects either were removed from lands on the Ozark-St. Francis National Forests or, as noted, were removed from private land and donated to the Ozark-St. Francis National Forests by private collectors.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains and associated funerary objects. The National Park Service is not responsible for the determinations in this notice.
A detailed assessment of the human remains was made by the Ozark-St. Francis National Forests professional staff in consultation with representatives of the Absentee-Shawnee Tribe of Indians of Oklahoma; Alabama-Quassarte Tribal Town; Caddo Nation of Oklahoma; Cherokee Nation; Chickasaw Nation; Choctaw Nation of Oklahoma; Delaware Nation, Oklahoma; Eastern Shawnee Tribe of Oklahoma; Jena Band of Choctaw Indians; Kialegee Tribal Town; Miami Tribe of Oklahoma; Mississippi Band of Choctaw Indians; Peoria Tribe of Indians of Oklahoma; Quapaw Tribe of Indians; Shawnee Tribe; The Muscogee (Creek) Nation; The Osage Nation (previously listed as the Osage Tribe); The Seminole Nation of Oklahoma; Thlopthlocco Tribal Town; Tunica-Biloxi Indian Tribe; United Keetoowah Band of Cherokee Indians in Oklahoma; and the Wichita and Affiliated Tribes (Wichita, Keechi, Waco & Tawakonie), Oklahoma.
In 1978, human remains representing, at minimum, one individual were removed from site 3BE276 in Benton County, AR. The site was recorded in 1978 by Monroe Hutton and Gayle J. Fritz of the Arkansas Archeological Survey (AAS). Based on a close examination of the landlines in 2007, this site is located outside the Ozark-St. Francis National Forests, on private property adjacent to an Arkansas Highway Department right-of-way. The AAS transferred the remains to the Ozark-St. Francis National Forests Supervisor's Office in 1992. The human remains consist of a single human tibia. No known individuals were identified. No associated funerary objects are present. The site dates from 2000 B.C. to A.D. 1200. The location of this site is within the historical range of the Caddo Nation of Oklahoma and The Osage Nation.
In 1969, human remains representing, at minimum, four individuals were removed from site 3NW79 in Newton County, AR, by Thelma and Louis Gregoire of the AAS. In 1988, they donated the remains to the USDA Forest Service. The Gregoires identified human remains from one burial at the site, and the USDA Forest Service identified additional human remains in faunal collections from the site. No known individuals were identified. The two associated funerary objects from the identified burial are a lanceolate dart point and a soil sample. The site dates from 8000 B.C. to A.D. 1600. The location of this site is within the historical range of the Caddo Nation of Oklahoma and The Osage Nation.
In 1972, human remains representing, at minimum, two individuals were removed from site 3NW428 in Newton County, AR, by Thelma and Louis Gregoire of the AAS. In 1988, they donated the remains to the USDA Forest Service. The Gregoires identified human remains of a young adult female from one burial at the site, and determined that those remains had previously been excavated and reburied by unknown looters. The USDA Forest Service identified additional human remains in faunal collections from the site. No
In 1986, human remains representing, at minimum, three individuals were removed from site 3NW623 in Newton County, AR, by John Slay, Forest Archeologist, Ozark-St. Francis National Forests. No known individuals were identified. No associated funerary objects are present. The site dates from the Early Archaic through Mississippi periods (7000 B.C.-A.D. 1600). The location of this site is within the historical range of the Caddo Nation of Oklahoma and The Osage Nation.
In 1971, human remains representing, at minimum, one individual were removed from site 3NW405 in Newton County, AR, by Steve Erwin of the AAS. The site is located on USDA-Forest Service land. No known individuals were identified. No associated funerary objects are present. The site dates from 2000 B.C. to A.D. 1600. The location of this site is within the historical range of the Caddo Nation of Oklahoma and The Osage Nation.
In 1971, human remains representing, at minimum, two individuals were removed from site 3NW408 in Newton County, AR, by Steve Erwin of the AAS. The site is located on USDA-Forest Service land. No known individuals were identified. No associated funerary objects are present. The site dates from 2000 B.C. to A.D. 1600. The location of this site is within the historical range of the Caddo Nation of Oklahoma and The Osage Nation.
In 1967, human remains representing, at minimum, one individual were removed from site 3NW67 in Newton County, AR, by Thelma and Louis Gregoire of the AAS. In 1988, they donated their collection to the USDA-Forest Service. The USDA-Forest Service identified these human remains in faunal collections from the site. No known individuals were identified. No associated funerary objects are present. The site dates from 500 B.C. to A.D. 1600. The location of this site is within the historical range of the Caddo Nation of Oklahoma and The Osage Nation.
In 1970, human remains representing, at minimum, one individual were removed from site 3NW77, on private property, in Newton County, AR, by Thelma and Louis Gregoire of the AAS. In 1988, they donated their collection to the USDA-Forest Service. The USDA-Forest Service identified these human remains in faunal collections from the site. No known individuals were identified. No associated funerary objects are present. The site dates from 500 B.C. to A.D. 1600. The location of this site is within the historical range of the Caddo Nation of Oklahoma and The Osage Nation.
In 1967 and 1969, human remains representing, at minimum, one individual were removed from site 3NW122 in Newton County, AR, by Thelma and Louis Gregoire of the AAS. In 1988, they donated their collection to the USDA-Forest Service. The USDA-Forest Service identified these human remains in faunal collections from the site. No known individuals were identified. No associated funerary objects are present. The site dates from 500 B.C. to A.D. 1600. The location of this site is within the historical range of the Caddo Nation of Oklahoma and The Osage Nation.
In 1967 and 1968, human remains representing, at minimum, one individual were removed from site 3NW129 in Newton County, AR, by Thelma and Louis Gregoire of the AAS. In 1988, they donated their collection to the USDA-Forest Service. The USDA-Forest Service identified these human remains in faunal collections from the site. No known individuals were identified. No associated funerary objects are present. The site dates from 500 B.C. to A.D. 1600. The location of this site is within the historical range of the Caddo Nation of Oklahoma and The Osage Nation.
In 1971, human remains representing, at minimum, two individuals were removed from site 3NW136 in Newton County, AR, by Thelma and Louis Gregoire of the AAS. In 1988, they donated their collection to the USDA-Forest Service. The USDA-Forest Service identified these human remains in faunal collections from the site. No known individuals were identified. No associated funerary objects are present. The site dates from 5000 B.C. to A.D. 1600. The location of this site is within the historical range of the Caddo Nation of Oklahoma and The Osage Nation.
In 1971, human remains representing, at minimum, one individual were removed from site 3NW161, on private property, in Newton County, AR, by Thelma and Louis Gregoire of the AAS. In 1988, they donated their collection to the USDA-Forest Service. The USDA-Forest Service identified these human remains in faunal collections from the site. No known individuals were identified. No associated funerary objects are present. The site dates from A.D. 500 to 900. The location of this site is within the historical range of the Caddo Nation of Oklahoma and The Osage Nation.
In 1971, human remains representing, at minimum, one individual were removed from site 3NW234, on private property, in Newton County, AR, by Thelma and Louis Gregoire of the AAS. In 1988, they donated their collection to the USDA-Forest Service. The USDA-Forest Service identified these human remains in faunal collections from the site. No known individuals were identified. No associated funerary objects are present. The site dates from 500 B.C. to A.D. 900. The location of this site is within the historical range of the Caddo Nation of Oklahoma and The Osage Nation.
In 1969, human remains representing, at minimum, one individual were removed from site 3NW247, on private property, in Newton County, AR, by Thelma and Louis Gregoire of the AAS. In 1988, they donated their collection to the USDA-Forest Service. The USDA-Forest Service identified these human remains in faunal collections from the site. No known individuals were identified. No associated funerary objects are present. The site dates from 2000 B.C. to A.D. 900. The location of this site is within the historical range of the Caddo Nation of Oklahoma and The Osage Nation.
In 1970, human remains representing, at minimum, one individual were removed from site 3NW267, on private property, in Newton County, AR, by Thelma and Louis Gregoire of the AAS. In 1988, they donated their collection to the USDA-Forest Service. The USDA-Forest Service identified these human remains in faunal collections from the site. No known individuals were identified. The six associated funerary objects are three shell beads, a bone pendant, a Langtry dart point, and a portion of a small mammal skeleton. The site dates from 2000 B.C. to A.D. 1000. The location of this site is within the historical range of the Caddo Nation of Oklahoma and The Osage Nation.
In 1970, human remains representing, at minimum, one individual were removed from site 3NW269, on private property, in Newton County, AR, by Thelma and Louis Gregoire of the AAS. In 1988, they donated their collection to the USDA-Forest Service. The USDA-Forest Service identified these human remains in faunal collections from the site. No known individuals were identified. No associated funerary objects are present. The site dates from 500 B.C. to A.D. 900. The location of this site is within the historical range of the Caddo Nation of Oklahoma and The Osage Nation.
In 1970, human remains representing, at minimum, one individual were removed from site 3NW372 in Newton County, AR, by Thelma and Louis Gregoire of the AAS. In 1988, they donated their collection to the USDA-Forest Service. The USDA-Forest Service identified these human remains in faunal collections from the site. No known individuals were identified. No associated funerary objects are present. The site dates from 2000 B.C. to A.D. 900. The location of this site is within the historical range of the Caddo Nation of Oklahoma and The Osage Nation.
In 1977, human remains representing, at minimum, three individuals were removed from site 3NW457, on private property, in Newton County, AR, by Thelma and Louis Gregoire of the AAS. In 1988, they donated their collection to the USDA-Forest Service. The Gregoires identified human remains from one burial from the site, and the USDA-Forest Service identified additional human remains in faunal collections from the site. No known individuals were identified. No associated funerary objects are present. The site dates from 5000 B.C. to A.D. 1600. The location of this site is within the historical range of the Caddo Nation of Oklahoma and The Osage Nation.
Officials of the USDA Forest Service, Ozark-St. Francis National Forests have determined that:
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of 28 individuals of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(3)(A), the 10 objects described above are reasonably believed to have been placed with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the Native American human remains and associated funerary objects and the Caddo Nation of Oklahoma and The Osage Nation.
Representatives of any Indian tribe that believes itself to be culturally affiliated with the human remains and associated funerary objects should contact Judith L. Henry, Forest Supervisor, USDA Forest Service Ozark-St. Francis National Forests, Russellville, AR 72801, telephone (479) 964-7202, before December 17, 2012. Repatriation of the human remains and associated funerary objects to the Caddo Nation of Oklahoma and The Osage Nation may proceed after that date if no additional claimants come forward.
The USDA Forest Service, Ozark-St. Francis National Forests, is responsible for notifying the Absentee-Shawnee Tribe of Indians of Oklahoma; Alabama-Quassarte Tribal Town; Caddo Nation of Oklahoma; Cherokee Nation; Chickasaw Nation; Choctaw Nation of Oklahoma; Delaware Nation, Oklahoma; Eastern Shawnee Tribe of Oklahoma; Jena Band of Choctaw Indians; Kialegee Tribal Town; Miami Tribe of Oklahoma; Mississippi Band of Choctaw Indians; Peoria Tribe of Indians of Oklahoma; Quapaw Tribe of Indians; Shawnee Tribe; The Muscogee (Creek) Nation; The Osage Nation (previously listed as the Osage Tribe); The Seminole Nation of Oklahoma; Thlopthlocco Tribal Town; Tunica-Biloxi Indian Tribe; United Keetoowah Band of Cherokee Indians in Oklahoma; and the Wichita and Affiliated Tribes (Wichita, Keechi, Waco & Tawakonie), Oklahoma, that this notice has been published.
National Park Service, Interior.
Notice.
The U.S. Department of Agriculture (USDA), Forest Service, Tongass National Forest, and the University of Alaska, Museum of the North, have completed an inventory of human remains in consultation with the appropriate Indian tribe, and have determined that there is a cultural affiliation between the human remains and a present-day Indian tribe. Representatives of any Indian tribe that believes itself to be culturally affiliated with the human remains may contact the Tongass National Forest. Repatriation of the human remains to the Indian tribe stated below may occur if no additional claimants come forward.
Representatives of any Indian tribe that believes it has a cultural affiliation with the human remains should contact the Tongass National Forest at the address below by December 17, 2012.
Forrest Cole, Forest Supervisor, Tongass National Forest, 648 Mission St, Ketchikan, AK 99901, telephone (907) 228-6281.
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains under the control of the USDA Tongass National Forest and in the possession of the University of Alaska, Museum of the North, Fairbanks, AK. The human remains were removed from the Tongass National Forest, near Juneau, AK.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains. The National Park Service is not responsible for the determinations in this notice.
A detailed assessment of the human remains was made by the Museum of the North professional staff in consultation with representatives of Douglas Indian Association.
Sometime in 1964 or earlier, human remains representing, at minimum, two individuals were removed from the Taku Village Site, near Juneau, AK. The Taku Village site is located approximately 12 miles from Juneau, AK, on lands of the Tongass National Forest. The human remains consist of two skulls found in a grave at the extreme east end of the village, about 50 feet from the high water line of the beach. The grave was marked by a marble headstone and bore the inscription: “Johnny Age 25 years, Died February 1895 Erected by his brother William.” The second individual buried in the grave is likely a woman. The gravesite may be described as a buried house, including a wooden floor, log sides, and three layers of hand-sawed planks for a roof. About six inches of soil covered the top layer of planks. A fence surrounded the grave and the marble headstone. One individual was identified by the grave marker; the other
The human remains are determined to be Native American due to the nature of the burial and the location within the graveyard of the Taku Village. The Taku Village site was one of the primary villages inhabited by the Taku Tlingit until about 1926, with graves at the cemetery dating from 1895 to 1926. The Taku Village site and cemetery is located within the traditional territory of the Taku Tlingit, represented today by the Douglas Indian Association. Oral traditions confirm the affiliation of the Taku Tlingit with the Taku Village site and cemetery, and support the culturally affiliation with present day Douglas Indian Association.
Officials of the USDA Tongass National Forest and the Museum of the North have determined that:
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of two individuals of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the Native American human remains and the Douglas Indian Association.
Representatives of any Indian tribe that believes itself to be culturally affiliated with the human remains should contact Forrest Cole, Forest Supervisor, Tongass National Forest, 648 Mission St, Ketchikan, AK 99901, telephone (907) 228-6281, before December 17, 2012. Repatriation of the human remains to the Douglas Indian Association may proceed after that date if no additional claimants come forward.
The Tongass National Forest is responsible for notifying the Douglas Indian Association that this notice has been published.
National Park Service, Interior.
Notice; correction.
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains and associated funerary objects in the possession of the U.S. Department of the Interior, National Park Service, Casa Grande Ruins National Monument, Coolidge, AZ. The human remains and cultural items were removed from Pinal County, AZ.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003 (d)(3). The determinations in this notice are the sole responsibility of the Superintendent, Casa Grande Ruins National Monument.
This notice corrects the minimum number of individuals and associated funerary objects for a Notice of Inventory Completion previously published in the
In the
The Monument's collection of human remains represents a minimum of 54 Native American individuals and 55 associated funerary objects recovered from Hohokam sites within the Monument.
Human remains recovered from Hohokam sites dating between 975-1400 A.D. within the Monument boundaries comprise a minimum of 31 individuals. No known individuals were identified. The 36 associated funerary objects are 21 jars, 5 bowls, 2 pitchers, 7 sherds, and 1 jar cover.
In addition, cremations, burials, and incomplete lots of human bone representing a minimum of 23 individuals whose archeological context are unknown have also been classified as Hohokam, primarily dating to the Classic Period (1150-1400 A.D.). No known individuals were identified. The 19 associated funerary objects are 15 jars, 2 bowls, 1 sherd, and 1 bag of beads.
In the
Based on the above mentioned information, and the consultation with the above mentioned tribes, officials of the National Park Service have determined that, pursuant to 43 CFR 10.2 (d)(1), the human remains listed above represent the physical remains of 54 individuals of Native American ancestry. National Park Service officials have determined that, pursuant to 25 U.S.C. 3001 (3)(A), the 55 objects listed above are reasonably believed to have been placed with or near individual human remains at the time of death or later as part of the death rite or ceremony.
Repatriation of the human remains and associated funerary objects occurred after the 30-day waiting period expired for the original March 12, 1996, Notice of Inventory Completion. For questions related to this notice, contact Karl Cordova, Superintendent, Casa Grande Ruins National Monument, 1100 W. Ruins Drive, Coolidge, AZ 85128, telephone (520) 723-3172.
Casa Grande Ruins National Monument is responsible for notifying the Ak Chin Indian Community of the Maricopa (Ak Chin) Indian Reservation, Arizona; Gila River Indian Community of the Gila River Indian Reservation, Arizona; Hopi Tribe of Arizona; Salt River Pima-Maricopa Indian Community of the Salt River Reservation, Arizona; Tohono O'odham Nation of Arizona; and Zuni Tribe of the Zuni Reservation, New Mexico, that this notice has been published.
National Park Service, Interior.
Notice.
The U.S. Department of the Interior, Bureau of Indian Affairs, and U.S. Department of the Interior, National Park Service, Western Archeological and Conservation Center, have completed an inventory of human remains and associated funerary objects in consultation with the appropriate Indian tribes, and have determined that there is a cultural affiliation between the human remains and associated funerary objects and present-day Indian tribes. Representatives of any Indian tribe that believes itself to be culturally affiliated with the human remains and associated funerary objects may contact the U.S. Department of the Interior, Bureau of Indian Affairs. Repatriation of the human remains and associated funerary objects to the Indian tribes stated below may occur if no additional claimants come forward.
Representatives of any Indian tribe that believes it has a cultural affiliation with the human remains and associated funerary objects should contact the U.S. Department of the Interior, Bureau of Indian Affairs at the address below by December 17, 2012.
Anna Pardo, Museum Program Manager/NAGPRA Coordinator, U.S. Department of the Interior, Indian Affairs, 12220 Sunrise Valley Drive, Room 6084, Reston, VA 20191, telephone (703) 390-6343.
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains and associated funerary objects under the control of the U.S. Department of the Interior, Bureau of Indian Affairs, Washington, DC, and in the physical custody of the U.S. Department of the Interior, National Park Service, Western Archeological and Conservation Center, Tucson, AZ. The human remains and associated funerary objects were removed from sites on the Gila River Indian Reservation in Pinal County, AZ.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains and associated funerary objects.
A detailed assessment of the human remains was made by National Park Service professional staff in consultation with representatives of the Ak Chin Indian Community of the Maricopa (Ak Chin) Indian Reservation, Arizona; Gila River Indian Community of the Gila River Indian Reservation, Arizona; Hopi Tribe of Arizona; Salt River Pima-Maricopa Indian Community of the Salt River Reservation, Arizona; Tohono O'odham Nation of Arizona; and the Zuni Tribe of the Zuni Reservation, New Mexico (hereafter referred to as “The Tribes”').
In 1916, human remains representing, at minimum, one individual were removed from an unnamed site on the Gila River Indian Reservation in Pinal County, AZ, during the excavation of the Indian Hospital foundation. The human remains and associated funerary object were given to the National Park Service in 1916. Ownership was transferred to the Bureau of Indian Affairs in 2012. No known individuals were identified. The one associated funerary object is a cremation jar.
Between 1931 and 1934, human remains representing, at minimum, 12 individuals were removed from unnamed sites on the Gila River Indian Reservation in Pinal County, AZ. The human remains and associated funerary objects were given to the National Park Service in 1934. Ownership was transferred to the Bureau of Indian Affairs in 2012. No known individuals were identified. The 22 associated funerary objects are 8 jars, 2 bowls, 1 plate, 1 shell bracelet, 8 unworked shell pieces, and 2 awls.
The sites date to A.D. 975-1400. Oral tradition, historical records, ethnography, history, archeological evidence, and a cultural affiliation study indicate that The Tribes all have cultural ties to the sites from which the human remains and associated funerary objects were removed.
Officials of the Bureau of Indian Affairs and the National Park Service have determined that:
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of 13 individuals of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(3)(A), the 23 objects described above are reasonably believed to have been placed with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the Native American human remains and associated funerary objects and The Tribes.
Representatives of any Indian tribe that believes itself to be culturally affiliated with the human remains and associated funerary objects should contact Anna Pardo, Museum Program Manager/NAGPRA Coordinator, U.S. Department of the Interior, Indian Affairs, 12220 Sunrise Valley Drive, Room 6084, Reston, VA 20191, telephone (703) 390-6343, before December 17, 2012. Repatriation of the human remains and associated funerary objects to The Tribes may proceed after that date if no additional claimants come forward.
The Bureau of Indian Affairs is responsible for notifying The Tribes that this notice has been published.
National Park Service, Interior.
Notice of Meeting.
Notice is hereby given in accordance with the Federal Advisory Committee Act (FACA) (5 U.S.C. Appendix (1988)), that the Preservation
The PTT Board was established by Congress to provide leadership, policy advice, and professional oversight to the National Center for Preservation Technology and Training (NCPTT) in compliance with Section 404 of the National Historic Preservation Act of 1966, as amended, (16 U.S.C. 470x-2(e)).
The PTT Board will meet at the Presidio, Long Avenue, Building #989, San Francisco, CA 94129—telephone (318) 356-7444. The meeting will run from 9:00 a.m. to 5:00 p.m. on November 28, 2012, and from 9:00 a.m. to noon on November 29, 2012 (PACIFIC).
The PTT Board's meeting agenda will include: Review and comment on NCPTT FY2012 accomplishments and operational priorities for FY2013; FY2012 and FY2013 National Center budget and initiatives; recent research; and training programs.
The PTT Board meeting is open to the public. Facilities and space for accommodating members of the public are limited; however, visitors will be accommodated on a first-come, first-served basis. Any member of the public may file a written statement concerning any of the matters to be discussed by the PTT Board.
The Meeting Dates are: November 28, 2012, 9:00 a.m. to 5:00 p.m. and November 29, 2012, 9:00 a.m. to noon, San Francisco, CA 94129 (PACIFIC).
The meeting location is: The Presidio, Long Avenue, Building #989, San Francisco, CA 94129.
Persons wishing more information concerning this meeting, or who wish to submit written statements, may contact: Mr. Kirk A. Cordell, Executive Director, National Center for Preservation Technology and Training, National Park Service, U.S. Department of the Interior, 645 University Parkway, Natchitoches, LA 71457; telephone (318) 356-7444. In addition to U.S. Mail or commercial delivery, written comments may be sent by fax to Mr. Cordell at (318) 356-9119. Before including your address, phone number, email 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. Minutes of the meeting will be available for public inspection no later than 90 days after the meeting at the office of the Executive Director, National Center for Preservation Technology and Training, National Park Service, U.S. Department of the Interior, 645 University Parkway, Natchitoches, LA 71457; telephone (318) 356-7444.
National Park Service, Interior.
Notice.
The Museum of Indian Arts and Culture, Museum of New Mexico, in consultation with the appropriate Indian tribe, has determined that the cultural items meet the definition of unassociated funerary objects and repatriation to the Indian tribe stated below may occur if no additional claimants come forward. Representatives of any Indian tribe that believes itself to be culturally affiliated with the cultural items may contact the Museum of Indian Arts and Culture.
Representatives of any Indian tribe that believes it has a cultural affiliation with the cultural items should contact the Museum of Indian Arts and Culture at the address below by December 17, 2012.
Elena Sweeney, Acting Director, Museum of Indian Arts and Culture, P.O. Box 2087, Santa Fe, NM 87504, telephone (505) 690-1415.
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3005, of the intent to repatriate cultural items in the possession of the Museum of Indian Arts and Culture that meet the definition of unassociated funerary objects under 25 U.S.C. 3001.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American cultural items. The National Park Service is not responsible for the determinations in this notice.
Between 1928 and 1932, joint excavations by the University of New Mexico and the School of American Research removed human remains and funerary objects from the Unshagi site (LA 123), in Sandoval County, NM. Human remains from these burials are under the control of the Maxwell Museum of Anthropology at the University of New Mexico and the Peabody Museum of Harvard University. The Museum of Indian Arts and Culture has control over seven unassociated funerary objects from the site, including one worked glycimeris shell, three Jemez Black-on-white bowls, one Kuaua Glaze Polychrome bowl, one Glaze F bowl, and one necklace made of fish-vertebrae. The seven objects were removed from numbered burials, but it is not possible to link these funerary objects with specific human remains in the Maxwell Museum
Between 1910 and 1913, excavations by the American Bureau of Ethnology and the School of American Research removed human remains and funerary objects from the Amoxiumqua site (LA 481), in Sandoval County, NM. Human remains from these burials are under the control of the Smithsonian Institution in Washington DC. The Museum of Indian Arts and Culture has control over three unassociated funerary objects from the site, including two Jemez Black-on-white bowls and one strand of Venetian glass beads. The objects were removed from numbered burials, but it is not possible to link these funerary objects with specific human remains in the Smithsonian collection.
In 1921, the School of American Research and the Laboratory of Anthropology removed human remains and funerary objects from the Guisewa site (LA 679), in Sandoval County, NM. Human remains from these burials are under the control of the Maxwell Museum of Anthropology at the University of New Mexico. The Museum of Indian Arts and Culture has control over five unassociated funerary objects from the site, including four Jemez Black-on-white bowls and one charred textile fragment. The objects were
In 1937, the University of New Mexico archaeological field school removed human remains and funerary objects from the Guisewa site (LA 679), in Sandoval County, NM. Human remains from these burials are under the control of the Maxwell Museum of Anthropology at the University of New Mexico. The Museum of Indian Arts and Culture has control over three unassociated funerary objects from the site, including one small culinary bowl, one Jemez Black-on-white bowl, and one restorable Black-on-white bowl. The objects were removed from numbered burials, but it is not possible to link these funerary objects with specific human remains in the Maxwell Museum collection.
In 1965, the Museum of New Mexico removed human remains and funerary objects from the Guisewa site (LA 679), in Sandoval County, NM, prior to the installation of a new water line. Human remains from these burials are under the control of the Maxwell Museum of Anthropology at the University of New Mexico. The Museum of Indian Arts and Culture has control over three unassociated funerary objects from the site, including one corn, one lot of animal bones, and one small restorable utility ware bowl. The objects were removed from numbered burials, but it is not possible to link these funerary objects with specific human remains in the Maxwell Museum collection.
At an unknown date, an unknown individual removed human remains and funerary objects from an excavated burial at the Giusewa site (LA 679), in Sandoval County, NM. The location of human remains from this site is unknown, but they are presumed to be in the collections of the Maxwell Museum of Anthropology. The Museum of Indian Arts and Culture has control over one unassociated funerary object from the site. It is not possible to link this funerary object with specific human remains in the Maxwell Museum collection.
Based on material culture and associated architecture, the unassociated funerary objects listed in this notice have been identified as Native American. The burials from which these objects were removed can be identified as ancestral Jemez because they came from known Puebloan sites of the upper Jemez River drainage. Populations that inhabited these sites are linked by Native oral tradition, Euro-American records, and archeological evidence to members of the present-day Pueblo of Jemez, New Mexico.
Officials of the Museum of Indian Arts and Culture have determined that:
• Pursuant to 25 U.S.C. 3001(3)(B), the 22 cultural items described above are reasonably believed to have been placed with or near individual human remains at the time of death or later as part of the death rite or ceremony and are believed, by a preponderance of the evidence, to have been removed from a specific burial site of a Native American individual.
• Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the unassociated funerary objects and the Pueblo of Jemez, New Mexico.
Representatives of any other Indian tribe that believes itself to be culturally affiliated with the unassociated funerary objects should contact Elena Sweeney, Acting Director, Museum of Indian Arts and Culture, P.O. Box 2087, Santa Fe, NM 87504, telephone (505) 690-1415, before December 17, 2012. Repatriation of the unassociated funerary objects to the Pueblo of Jemez, New Mexico, may proceed after that date if no additional claimants come forward.
The Museum of Indian Arts & Culture, Museum of New Mexico, is responsible for notifying the Pueblo of Jemez, New Mexico, that this notice has been published.
U.S. International Trade Commission.
Notice.
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on September 26, 2012, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of Speculative Product Design, LLC of Mountain View, California. The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain cases for portable electronic devices by reason of infringement of certain claims of U.S. Patent No. 8,204,561 (“the '561 patent”). The complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337.
The complainant requests that the Commission institute an investigation and, after the investigation, issue an exclusion order and cease and desist orders.
The complaint, except for any confidential information contained therein, is available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Room 112, Washington, DC 20436, telephone (202) 205-2000. Hearing impaired individuals are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on (202) 205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at (202) 205-2000. General information concerning the Commission may also be obtained by accessing its Internet server at
The Office of Unfair Import Investigations, U.S. International Trade Commission, telephone (202) 205-2560.
The authority for institution of this investigation is contained in section 337 of the Tariff Act of 1930, as amended, and in section 210.10 of the Commission's Rules of Practice and Procedure, 19 CFR 210.10 (2012).
(1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain cases for portable electronic devices that infringe one or
(2) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served:
(a) The complainant is:
(b) The respondents are the following entities alleged to be in violation of section 337, and are the parties upon which the complaint is to be served:
(c) The Office of Unfair Import Investigations, U.S. International Trade Commission, 500 E Street SW., Suite 401, Washington, DC 20436; and
(3) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge.
Responses to the complaint and the notice of investigation must be submitted by the named respondents in accordance with section 210.13 of the Commission's Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(d)-(e) and 210.13(a), such responses will be considered by the Commission if received not later than 20 days after the date of service by the Commission of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown.
Failure of a respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing such findings, and may result in the issuance of an exclusion order or a cease and desist order or both directed against the respondent.
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the presiding administrative law judge has issued a Final Initial Determination and Recommended Determination on Remedy and Bonding in the above-captioned investigation. The Commission is soliciting comments on public interest issues raised by the recommended relief, specifically a limited exclusion order against certain electronic digital media devices and components thereof imported by respondents Samsung Electronics Co, Ltd. of Korea; Samsung Electronics America, Inc. of Ridgefield Park, New Jersey; and Samsung Telecommunications America, LLC of Richardson, Texas (collectively “Samsung”), and cease and desist orders against Samsung.
Cathy Chen, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2392. The public version of the complaint can be accessed on the Commission's electronic docket (EDIS) at
General information concerning the Commission may also be obtained by accessing its Internet server (
Section 337 of the Tariff Act of 1930 provides that if the Commission finds a violation it shall exclude the articles concerned from the United States:
The Commission is interested in further development of the record on the public interest in these investigations. Accordingly, members of the public are invited to file submissions of no more than five (5) pages, inclusive of attachments, concerning the public interest in light of the administrative law judge's Recommended Determination on Remedy and Bonding issued in this investigation on November 7, 2012. Comments should address whether issuance of an exclusion order and/or cease and desist orders in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) Explain how the articles potentially subject to the recommended orders are used in the United States;
(ii) Identify any public health, safety, or welfare concerns in the United States relating to the recommended orders;
(iii) Identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;
(iv) Indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the recommended exclusion order and/or a cease and desist order within a commercially reasonable time; and
(v) Explain how the exclusion order and/or cease and desist orders would impact consumers in the United States.
Written submissions must be filed no later than by close of business on December 3, 2012.
Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to section 210.4(f) of the Commission's Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the investigation number (“Inv. No. 337-TA-796”) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. § 1337), and of sections 201.10 and 210.50 of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.50).
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined not to review the presiding administrative law judge's (“ALJ”) initial determination (“ID”) (Order No. 24) terminating the above-captioned in its entirety based on withdrawal of the complaint.
Megan M. Valentine, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 708-2301. 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 November 25, 2011, based on a complaint filed on October 21, 2011, as supplemented on November 2, 2011, by Compound Photonics Ltd. of London, United Kingdom and Compound Photonics U.S. Corporation of Phoenix, Arizona (collectively “Compound Photonics”). 76
On October 17, 2012, Compound Photonics filed a motion to terminate the investigation in its entirety based on withdrawal of the complaint. The motion stated that the respondents do not oppose the motion. On October 19, 2012, the Commission investigative attorney filed a response in support of the motion.
On October 19, 2012, the ALJ issued the subject ID, granting Compound Photonics' motion pursuant to section 210.21(a)(1) of the Commission's Rules of Practice and Procedure (19 CFR 210.21(a)(1)). No petitions for review of this ID were filed.
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 of the Commission's Rules of Practice and Procedure (19 CFR 210.42).
By order of the Commission.
Department of Justice.
Notice.
On November 9, 2012, the Attorney General issued Attorney General Order No. 3350-2012, which delegates all of the power and authority of the Assistant Attorney General for the Civil Division to the Principal Deputy Assistant Attorney General for the Civil Division, unless any such power or authority is required by law to be exercised by the Assistant Attorney General for the Civil Division personally. With this delegation, the Assistant Attorney General for the Civil Division and the Principal Deputy Assistant Attorney General for the Civil
Attorney General Order No. 3350-2012 became effective November 9, 2012.
Rosemary Hart, Special Counsel, Office of Legal Counsel, Department of Justice, Washington, DC 20530; (202) 514-2027.
Pursuant to 28 U.S.C. 509, “[a]ll functions of other officers of the Department of Justice and all functions of agencies and employees of the Department of Justice are vested in the Attorney General” but for exceptions not applicable here. Pursuant to 28 U.S.C. § 510, the Attorney General has broad authority to “authorize[e] the performance by any other officer, employee, or agency of the Department of Justice of any function of the Attorney General.” Various powers and authorities have been delegated to the Assistant Attorney General for the Civil Division.
The delegation order is a matter of internal Department management. Accordingly, the requirements under the Administrative Procedure Act for notice and comment and a delay in effective date are not applicable. See 5 U.S.C. 553. Although publication is not required, the Department has chosen to publish this notice to advise the public of this recent delegation.
The order is not a “significant regulatory action” under section 3(f) of Executive Order 12866 and accordingly it has not been reviewed by the Office of Management and Budget. In addition, the order will not have a significant economic impact on a substantial number of small entities. See 5 U.S.C. 605(b). Nor will it 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. Therefore, this order does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment pursuant to Executive Order 13132.
Attorney General Order 3350-2012 reads as follows:
“By virtue of the authority vested in me by law, including 28 U.S.C. §§ 509 and 510, I hereby delegate to the Principal Deputy Assistant Attorney General for the Civil Division all the power and authority of the Assistant Attorney General for the Civil Division, unless any such power or authority is required by law to be exercised by the Assistant Attorney General for the Civil Division personally.”
On November 9, 2012, the Department of Justice lodged a proposed consent decree (“proposed Decree”) with the United States District Court for the Western District of Pennsylvania in the lawsuit entitled
The United States filed this lawsuit under the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA). The United States' complaint names Cast Parts, Inc., Energy Control Systems, Inc., Gutierrez Machine Corporation, Kirschbaum-Krupp Metal Corporation, K&K Metal Recycling, LLC., Lavigne Manufacturing Co., M.J. Metal, Inc., Marshalltown Company, Metal Mart International, Inc., Middletown Aerospace Corporation, Mid-State Investment Company, Mid-State Machine Company, LLC, National Machine Company, Premco, Inc., Rolls-Royce Corporation, Black & Decker (U.S.) Inc., Johns Hopkins University, Johns Hopkins University Applied Physics Laboratory, LLC, and Winter's Performance Products as defendants. The complaint requests recovery of costs that the United States incurred responding to releases of hazardous substances at the Remacor Superfund Site in West Pittsburg, Lawrence County, Pennsylvania. All defendants signed the consent decree, and collectively agree to pay $1,110,865.40 of the United States' response costs. In return, the United States agrees not to sue the defendants under sections 106 and 107 of CERCLA, 42 U.S.C. 9606 and 9607(a).
The publication of this notice opens a period for public comment on the proposed Decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and should refer to
During the public comment period, the consent decree may be examined and downloaded at this Justice Department Web site:
Please enclose a check or money order for $10.25 (25 cents per page reproduction cost) payable to the United States Treasury.
Employee Benefits Security Administration, Labor.
Grant of Individual Exemptions.
This document contains exemptions issued by the Department of Labor (the Department) from certain of the prohibited transaction restrictions of the Employee Retirement Income Security Act of 1974 (ERISA or the Act) and/or the Internal Revenue Code of 1986 (the Code). This notice includes the following: D-11710, El Paso Corporation Retirement Savings Plan
The Department published notices in the
The notices of proposed exemptions were issued and the exemptions are being granted solely by the Department because, effective December 31, 1978, section 102 of Reorganization Plan No. 4 of 1978, 5 U.S.C. App. 1 (1996), transferred the authority of the Secretary of the Treasury to issue exemptions of the type proposed to the Secretary of Labor.
In accordance with section 408(a) of the Act and/or section 4975(c)(2) of the Code and the procedures set forth in 29 CFR part 2570, subpart B (76 FR 66637, 66644, October 27, 2011)
(a) The exemptions are administratively feasible;
(b) The exemptions are in the interests of the plans and their participants and beneficiaries; and
(c) The exemptions are protective of the rights of the participants and beneficiaries of the plans.
The restrictions of sections 406(a)(1)(A), 406(a)(1)(E), 406(a)(2), 406(b)(1), 406(b)(2), and 407(a)(1)(A) of the Act and the sanctions resulting from the application of section 4975 of the Code, by reason of section 4975(c)(1)(A) and 4975(c)(1)(E) of the Code,
(a) To the acquisition by the individually directed accounts of the participants of the Plan (the Invested Participants) of certain publicly traded warrants (the Warrants) issued by KMI, which became a party in interest with respect to the Plan after the merger (the Merger); and
(b) To the holding of the Warrants by the accounts in the Plan of the Invested Participants; provided that the conditions, as set forth in Section II of this exemption, were satisfied at the time of the acquisition of the Warrants by the accounts in the Plan of such Invested Participants and throughout the duration of the holding of the Warrants in the accounts of such Invested Participants.
The relief provided in this exemption is conditioned upon adherence to the material facts and representations described, herein, and as set forth in the application file and upon compliance with the conditions, as set forth in this exemption.
(a) The Warrants were acquired by the individually-directed accounts of the Invested Participants, all or a portion of whose accounts in the Plan hold the common stock of El Paso (the EP Stock);
(b) The exchange by the shareholders, including the Invested Participants, of the EP Stock for Warrants resulted from an independent act of El Paso and KMI, as corporate entities in connection with the Merger, and occurred automatically without any action or control on the part of such shareholders, including the Invested Participants;
(c) The acquisition of the Warrants by the Invested Participants occurred in connection with the Merger, and such Warrants were made available on the same terms to all shareholders of the EP Stock, including the Invested Participants;
(d) The decisions with regard to the holding and disposition of the Warrants were made by each of the Invested Participants in accordance with the provisions under the Plan for individually-directed accounts;
(e) The Warrants allocated to the accounts of the Invested Participants in the Plan may be exercised or sold at any time by such Invested Participants giving investment directions in accordance with the provisions of the Plan;
(f) The Invested Participants did not pay any fees or commissions in connection with the acquisition and holding of the Warrants, nor did the Invested Participants pay any fees on the exercise of the Warrants; and
(g) Prior to entering into the Merger, El Paso obtained all necessary approvals from any relevant state agencies and federal agencies, including, but not limited to the U.S. Department of Justice Antitrust Division, the Federal Energy Regulatory Commission, the Securities and Exchange Commission, and the Federal Trade Commission.
In the Notice, the Department invited all interested persons to submit written comments and requests for a hearing within sixty (60) days of the date of the publication of the Notice in the
In his letter, Mr. Street informed the Department that the Merger was effective on May 25, 2012. Accordingly, Mr. Street represents that the subject transactions were entered into on the effective date of the Merger for business expediency reasons before a final exemption could be obtained from the Department. As the subject transactions have already been consummated, Mr. Street, on behalf of KMI, requests that the Department grant a retroactive exemption, effective as of May 25, 2012, the date when the Merger closed.
The Department concurs, and accordingly, the final exemption has been amended to change the tense of the verbs to reflect that the subject transactions have been entered into, and to insert the following paragraph:
In response to an inquiry by the Department, Mr. Street, on behalf of KMI, in a letter dated September 25, 2012, confirmed that, to the best of his knowledge and belief, the material facts presented and the representations made by El Paso in the original prohibited transaction exemption application (the Application) submitted to the Department on November 23, 2011, and in the supplemental submissions relating to the Application remain true and correct and that the conditions set forth in Section II of the Notice, as published in the
For a more complete statement of the facts and representations supporting the Department's decision to grant this exemption refer to the Notice of Proposed Exemption which was published on June 1, 2012, at 77 FR 32692.
Ms. Angelena C. Le Blanc of the Department, telephone (202) 693-8540. (This is not a toll-free number.)
A. The restrictions of sections 406(a)(1)(A), 406(a)(1)(D), 406(b)(1), and 406(b)(2) of the Act shall not apply, effective August 1, 2006 through and until November 15, 2012, to the purchase of health insurance by the Sharp HealthCare Health and Dental Plan (the Plan) from the Sharp Health Plan (the HMO), provided that the conditions of Section II have been met.
B. The restrictions of sections 406(a)(1)(A), 406(a)(1)(D), 406(b)(1), and 406(b)(2) of the Act shall not apply, effective as of November 16, 2012, to the purchase of health insurance by the Plan from the HMO, provided that the conditions of Section II and Section III are met.
(a) Sharp is the sole member of the HMO, and more than 50% of the appointment power for the HMO's Board of Directors is held by Sharp.
(b) Sharp is licensed to sell HMO coverage in the State of California.
(c) The HMO is certified by the California Department of Managed Health Care as being in compliance with the requirements for a licensed HMO within the last 18 months.
(d) The HMO has undergone a financial examination by the California Department of Managed Health Care within the past 5 years and will continue to undergo such financial examinations at least once every five years.
(e) The HMO has been, and will continue to be, examined by an independent certified public accountant annually.
(f) The amount the Plan pays to Sharp for HMO coverage is reasonable and does not exceed the amount the Plan would have paid for similar services in an arm's length transaction between unrelated parties.
(g) All HMO-offered health care providers meet all applicable licensure requirements and certifications.
(h) The HMO offers a sufficient number of non-Sharp affiliated health care providers to effectively allow Plan participants the opportunity to receive health care services from either Sharp or non-Sharp affiliated health care providers.
(i) No commissions are paid by the Plan with respect to the sale of HMO coverage.
(j)(i) With respect to the relief provided in section I. A., for each taxable year of the HMO, the gross premiums received in that taxable year by the HMO from the Plan did not exceed 50% of the gross premiums received by the HMO for all HMO coverage issued in that taxable year; or
(ii) with respect to the relief provided in section I. B., for each taxable year of the HMO, the gross premiums received in that taxable year by the HMO from the Plan will not exceed 50% of the gross premiums received by the HMO for all HMO coverage issued in that taxable year.
(k) Sharp maintains or causes to be maintained for a period of six years from the date of any covered transaction hereunder such records as are necessary to enable the persons described in paragraph (l)(i) below to determine whether the conditions of this exemption have been met, provided that (i) a separate prohibited transaction will not be considered to have occurred if, due to circumstances beyond the control of Sharp, the records are lost or destroyed prior to the end of the six-year period, and (ii) no party in interest other than Sharp shall be subject to a civil penalty that may be assessed under section 502(i) of the Act, if such records are not maintained, or are not available for examination as required by paragraph (l)(i) below.
(l)(i) Except as provided below in paragraph (l)(ii), and notwithstanding any provisions of subsections (a)(2) and (b) of section 504 of the Act, the records referred to above in paragraph (k) are unconditionally available at their customary location for examination during normal business hours by:
(A) Any duly authorized employee or representative of the Department,
(B) Any duly authorized representative of the California Department of Managed Health Care or any State or Federal governmental body responsible for regulatory oversight of Sharp or the HMO, and
(C) Any fiduciary of the Plan or the Plan's authorized representative; and
(ii) None of the persons described above in paragraph (l)(i)(C) shall be authorized to examine trade secrets of Sharp, or commercial or financial information which is privileged or confidential, and should Sharp refuse to disclose information on the basis that such information is exempt from disclosure, Sharp shall, by the close of the thirtieth (30th) day following the request, provide a written notice advising that person of the reasons for the refusal and that the Department may request such information.
(a) Sharp retains annually the services of an independent third-party consultant to determine whether the amount employees and/or their dependents pay for coverage is reasonable and does not exceed the amount that would be paid for similar services in an arm's length transaction between unrelated parties, which amount includes the cost of co-payments and other out-of-pocket expenses for such coverage borne by participants and/or their dependents, and written copies of such determination are distributed to Plan participants along with summaries of health care costs for similar, competing health care providers.
(b) The Board of Directors of Sharp appoints a committee (the Plan Committee) consisting of the Senior Vice President and General Counsel, the Senior Vice President and Chief Financial Officer, and the Vice President, Compensation and Benefits, and such other representatives as the Board of Directors may deem appropriate. The Plan Committee will annually ascertain and certify in writing
Section I.A. of this exemption is effective as of August 1, 2006, through and until November 15, 2012, and Section I.B. of this exemption is effective as of November 16, 2012.
The Department invited all interested persons to submit written comments with respect to the proposed exemption on or before September 30, 2012. During the comment period, the Department received one email inquiry which generally concerned the individual's difficulty in understanding the notice of proposed exemption. However, the Department received no comments or requests for a hearing from interested persons.
Therefore, after giving full consideration to the entire record, the Department has decided to grant the exemption. For further information regarding the individual exemption, interested persons are encouraged to obtain copies of the exemption application file (Application No. L-11688) that the Department maintains with respect to the individual exemption. The complete application file, as well as supplemental submissions received by the Department, is made available for public inspection in the Public Documents room of the Employee Benefits Security Administration, Room N-1513, U.S. Department of Labor, 200 Constitution Ave. NW., Washington, DC 20210.
For a complete statement of the facts and representations supporting the Department's decision to grant this exemption refer to the proposed exemption published in the
Mr. Warren Blinder, Office of Exemption Determinations, Employee Benefits Security Administration, U.S. Department of Labor, telephone (202) 693-8553. (This is not a toll-free number.)
The attention of interested persons is directed to the following:
(1) The fact that a transaction is the subject of an exemption under section 408(a) of the Act and/or section 4975(c)(2) of the Code does not relieve a fiduciary or other party in interest or disqualified person from certain other provisions to which the exemption does not apply and the general fiduciary responsibility provisions of section 404 of the Act, which among other things require a fiduciary to discharge his duties respecting the plan solely in the interest of the participants and beneficiaries of the plan and in a prudent fashion in accordance with section 404(a)(1)(B) of the Act; nor does it affect the requirement of section 401(a) of the Code that the plan must operate for the exclusive benefit of the employees of the employer maintaining the plan and their beneficiaries;
(2) Each exemption is supplemental to and not in derogation of, any other provisions of the Act and/or the Code, including statutory or administrative exemptions and transactional rules. Furthermore, the fact that a transaction is subject to an administrative or statutory exemption is not dispositive of whether the transaction is in fact a prohibited transaction; and
(3) The availability of an exemption is subject to the express condition that the material facts and representations contained in the application accurately describes all material terms of the transaction which is the subject of the exemption.
Employee Benefits Security Administration, Labor.
Notice of Proposed Exemptions.
This document contains notices of pendency before the Department of Labor (the Department) of proposed exemptions from certain of the prohibited transaction restrictions of the Employee Retirement Income Security Act of 1974 (ERISA or the Act) and/or the Internal Revenue Code of 1986 (the Code). This notice includes the following proposed exemptions: D-11610, UBS Financial Services, Inc. D-11666, Central Pacific Bank 401(k) Retirement and Savings Plan (the Plan); D-11672, Studley, Inc. Section 401(k) Plan Profit Sharing Plan (the Plan); and D-11724, EquiLend Holdings LLC (EquiLend).
All interested persons are invited to submit written comments or requests for a hearing on the pending exemptions, unless otherwise stated in the Notice of Proposed Exemption, within 45 days from the date of publication of this
Comments and requests for a hearing should state: (1) The name, address, and telephone number of the person making the comment or request, and (2) the nature of the person's interest in the exemption and the manner in which the person would be adversely affected by the exemption. A request for a hearing must also state the issues to be addressed and include a general description of the evidence to be presented at the hearing. All written comments and requests for a hearing (at least three copies) should be sent to the Employee Benefits Security Administration (EBSA), Office of Exemption Determinations, Room N-5700, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210. Attention: Application No.___, stated in each Notice of Proposed Exemption. Interested persons are also invited to submit comments and/or hearing requests to EBSA via email or FAX. Any such comments or requests should be sent either by email to:
Notice of the proposed exemptions will be provided to all interested persons in the manner agreed upon by the applicant and the Department within 15 days of the date of publication in the
The proposed exemptions were requested in applications filed pursuant to section 408(a) of the Act and/or section 4975(c)(2) of the Code, and in accordance with procedures set forth in 29 CFR Part 2570, Subpart B (76 FR 66637, 66644, October 27, 2011).
The applications contain representations with regard to the proposed exemptions which are summarized below. Interested persons are referred to the applications on file with the Department for a complete statement of the facts and representations.
Based on the facts and representations set forth in the application, the Department is considering granting the following exemption under the authority of Code section 4975(c)(2), and in accordance with the procedures set forth in 29 CFR Part 2570, subpart B (76 FR 66637, October 27, 2011), as follows:
If the proposed exemption is granted, the sanctions resulting from the application of Code section 4975, by reason of Code section 4975(c)(1)(A) and (D)-(E), shall not apply, effective January 4, 2002, until December 9, 2005, to (1) principal trades by UBS Financial Services Inc. (the Applicant) with certain plans, subject to Code section 4975, but not subject to Title I of ERISA (the IRAs), which resulted in the IRAs purchasing or selling securities from the Applicant (collectively, the Transactions); and (2) compensation paid by the IRAs to the Applicant in connection with the Transactions (the Transaction Compensation).
This proposed exemption is subject to the conditions set forth below in Sections II and III.
(a) The Transactions and the Transaction Compensation were corrected (1) pursuant to the requirements set forth in the Department's Voluntary Fiduciary Correction Program (the VFC Program)
(b) The Applicant received a “no-action letter” from the Department in connection with the Qualified Plan Transactions described in the VFC Program Application.
(c) An independent fiduciary confirmed that the methods utilized to correct the Transactions and Transaction Compensation were sufficient to return each affected IRA to at least the position that it would have been in had the Transactions and Transaction Compensation not occurred, and that the correction methods were properly applied to the Transactions and Transaction Compensation based on a review of a representative sample of the corrections, selected at random by the independent fiduciary.
For purposes of this exemption, a fiduciary is “independent” if it is independent of and unrelated to Applicant and its affiliates. In this regard, a fiduciary will not be deemed independent of Applicant and its affiliates if: (1) Such fiduciary directly or indirectly controls, is controlled by, or is under common control with Applicant or its affiliates, (2) such fiduciary directly or indirectly receives any compensation or other consideration in connection with any transaction described in this exemption, except that it may receive compensation for acting as an independent fiduciary from Applicant in connection with the transactions described herein, if the amount or payment of such compensation is not contingent upon, or in any way affected by such fiduciary's decision; or (3) the annual gross revenue received by the fiduciary, in any fiscal year, from Applicant or its affiliates exceeds one percent (1%) of the fiduciary's annual gross revenue from all sources (for federal income tax purposes) for its prior tax year.
(d) The terms of the Transactions and the Transaction Compensation were at least as favorable to the IRAs as the terms generally available in arm's-length transactions between unrelated parties.
(e) The Transactions and Transaction Compensation were not part of an agreement, arrangement or understanding designed to benefit a disqualified person, as defined in Code section 4975(e)(2).
(f) The Applicant did not take advantage of the relief provided by the VFC Program and Prohibited Transaction Exemption 2002-51
(a) The Applicant maintains, or causes to be maintained, for a period of six (6) years from the date of any Transaction such records as are necessary to enable the persons described in Section III(b)(1) to determine whether the conditions of this exemption have been met, except that:
(1) A separate prohibited transaction shall not be considered to have occurred if, due to circumstances beyond the control of Applicant, the records are lost or destroyed prior to the end of the six-year period; and
(2) No disqualified person with respect to an IRA, other than Applicant, shall be subject to excise taxes imposed by Code section 4975, if such records are not maintained, or are not available for examination, as required by Section III(b)(1).
(b)(1) Except as provided in Section III(b)(2), the records referred to in Section III(a) are unconditionally available at their customary location for examination during normal business hours by:
(A) Any duly authorized employee or representative of the Department, the Internal Revenue Service, or the Securities and Exchange Commission;
(B) Any fiduciary of any IRA that engaged in a Transaction, or any duly authorized employee or representative of such fiduciary; or
(C) Any owner or beneficiary of an IRA that engaged in a Transaction or a representative of such owner or beneficiary.
(2) None of the persons described in Sections III(b)(1)(B) and (C) shall be authorized to examine trade secrets of Applicant, or commercial or financial information which is privileged or confidential.
(3) Should Applicant refuse to disclose information on the basis that such information is exempt from disclosure, Applicant shall, by the close of the thirtieth (30th) day following the request, provide a written notice advising that person of the reasons for the refusal and that the Department may request such information.
1. The Applicant is UBS Financial Services Inc., a wholly owned subsidiary of UBS AG. The Applicant is a large financial institution headquartered in Basel and Zurich, Switzerland. As of December 31, 2011, UBS AG had invested assets of 2,167 billion CHF.
2. From January 4, 2002, to December 9, 2005, contrary to the Applicant's policies, certain of Applicant's financial advisors (the FAs) caused Applicant to engage in a number of principal transactions involving IRAs for which the Applicant or the FA acted as an ERISA fiduciary. These principal transactions included: (a) 711 principal purchases of bonds from the Applicant, with an aggregate purchase price of $18,359,746 in 88 IRAs (the Bond Purchase Transactions) (b) 110 principal sales of bonds to the Applicant, with an aggregate sales price of $4,257,643 in 45 IRAs (the Bond Sale Transactions); (c) 128 principal purchases of stock from the Applicant, for an aggregate purchase price of $1,882,230 in 37 IRAs (the Stock Purchase Transactions); and (d) 1 principal sale of stock to the Applicant, for a sales price of less than $1 (the Stock Sale Transaction) (collectively, the Bond Purchase Transactions, the Bond Sale Transactions, the Stock Purchase Transactions and Stock Sale Transaction are referred to as the Transactions). A total of 105 IRAs were involved in the Transactions. (Some of the IRAs were involved in more than one type of transaction.)
3. The Transactions caused the payment of compensation to the Applicant (Transaction Compensation). With respect to Bond Purchase Transactions and Bond Sale Transactions, the Applicant was compensated through a “mark-up” of the bond price; the aggregate amount of such mark-ups was $115,363. With respect to the Stock Purchase Transactions and the Stock Sale Transaction, the Applicant was compensated through commissions totaling $44,964.
4. Upon discovering that certain of the FAs caused the Applicant to engage in the Transactions, the Applicant implemented changes to its policies and procedures to prohibit the opening of any brokerage accounts that would permit FAs to exercise discretion. The Applicant represents that the FAs can now only open accounts that would permit the exercise of discretion under a discretionary advisory program where principal trades are blocked.
5. The Applicant seeks relief with respect to the Transactions and with respect to the payment of the Transaction Compensation. Specifically, the Applicant believes that: (a) The purchase and sale of securities, both bonds and stocks, between the IRAs and the Applicant was prohibited by Code section 4975(c)(1)(A); (b) both the Transactions and the payment of Transaction Compensation were prohibited by Code section 4975(c)(1)(D); and (c) the Transactions and the receipt of Transaction Compensation were prohibited by Code section 4975(c)(1)(E). The Applicant believes that, if the proposed exemption is not granted, the IRAs would be subject to hardship resulting from the uncertainty of not having the prohibited transactions outlined herein resolved. Further, if the proposed exemption is not granted, the IRAs would be subject to additional hardship as a result of the resultant uncertainty regarding the correction methodology applied by the Applicant.
6. The Applicant represents that as soon as the Transactions and the Qualified Plan Transactions were discovered it began an investigation that led to the correction process. The Applicant corrected the Qualified Plan Transactions pursuant to the requirements set forth in the VFC Program. The Applicant filed a VFC Program Application, dated March 5, 2010, with respect to the Qualified Plan Transactions, and it received a no-action letter from the Department, dated February 4, 2011, with respect to the Qualified Plan Transactions.
7. While the Qualified Plan Transactions were properly corrected under the VFC Program, the Applicant was not able to similarly correct the Transactions and the Transaction Compensation. Despite being substantially similar to the Qualified Plan Transactions, the Transactions and the Transaction Compensation are ineligible for relief under the VFC Program and PTE 2002-51 because they involved IRAs which are not covered under Title I of ERISA. The Applicant, however, believes that granting relief pursuant to the proposed exemption is consistent with the Department's statement that “[the VFC Program] does not foreclose its future consideration of individual exemption requests for transactions involving IRAs that are outside the scope of relief provided by both the VFC Program and the class exemption under circumstance when, for example, a financial institution received a no action letter applicable only to plans subject to [the VFC Program] for a transaction(s) that involved both plans and * * * IRAs.” 71 FR 20135, 20137 (April 19, 2006).
8. The Applicant represents that the Transactions were corrected pursuant to the requirements set forth in the VFC Program and in a manner consistent with the Applicant's VFC Program Application, with such representation made in the Applicant's exemption application, dated March 5, 2010, under penalty of perjury. In this regard, the Applicant corrected the Transactions in the manner described below:
(a) With respect to the Bond Purchase Transactions, since bonds are debt instruments, the Applicant corrected the Bond Purchase Transactions, based on economic similarity to a loan transaction correction, under the procedures for loans made at a fair market interest rate in Section 7.2(a) of the VFC Program. The correction method for a loan, which is set forth in Section 7.2(a)(2) of the VFC program, is for the party in interest to pay back the loan in full, including any prepayment penalties. The Applicant represents that the Bond Purchase Transactions were conducted at fair market values (FMVs) because, among other things, the transactions were conducted using trading systems and procedures designed to result in trades being conducted at prices that are as favorable as possible to the IRAs under prevailing market conditions and were in fact conducted at prices not less favorable to the IRAs than the prices the FAs could have obtained for the IRAs by conducting the trades in arm's-length transactions with third-party market participants.
(b) With respect to the Bond Sale Transactions and the Stock Sale Transaction, the Applicant corrected these Transactions under the procedures for sale of an asset by a plan to a party in interest under Section 7.4(b) of the VFC Program. Section 7.4(b)(2)(i) of the VFC Program generally requires that the asset be repurchased from the party in interest at the lower of the price for which it originally sold the property or the FMV of the property at the time of correction. As an alternative, Section 7.4(b)(2)(ii) of the VFC Program provides that a plan may receive a cash
It was impractical or impossible for the IRAs to repurchase most of the bonds in the Bond Sale Transactions because most of the bonds had been called, matured, were thinly traded or not in the inventory of the Applicant or its affiliates. For the remaining bonds in the Bond Sale Transactions, none of the IRAs elected to repurchase the bond from the Applicant despite the Applicant's offer to sell the bond back to the IRA at the lower of the price for which the IRA originally sold the bond or the FMV of the bond at the time of correction. Therefore, the Applicant corrected all of the Bond Sale Transactions by paying the IRAs the Transaction Compensation, if any, plus Lost Earnings on the Transaction Compensation from the time of the Transaction.
For the Stock Sale Transaction, it was impossible to repurchase the stock because the company had dissolved. Further, because no commissions were charged by the Applicant for the Stock Sale Transaction, no payment to the IRA with respect to compensation was necessary to correct the Stock Sale Transaction. Finally, since the Principal Amount with respect to the Stock Sale Transaction was zero, there were no Lost Earnings on the Principal Amount to pay to the IRA.
(c) With respect to the Stock Purchase Transactions, the Applicant corrected the Stock Purchase Transactions under the procedures for the purchase by a plan of an asset from a party in interest pursuant to Section 7.4(a) of the VFC Program. Section 7.4(a) generally requires that the asset be sold back to the party in interest who originally sold the asset to the plan or to a person who is not a party in interest for a price equal to the greater of (1) the FMV of the asset at the time of resale, without reduction for the costs of sale, plus restoration to the plan of the party in interest's investment return from the proceeds of the sale, to the extent they exceed the plan's net profits from owning the property, or (2) the plan's original purchase price, plus the greater of Lost Earnings on the plan's original purchase price or the Restoration of Profits, if any. As an alternative, the plan may retain the asset and receive (1) the greater of the Lost Earnings or the Restoration of Profits, if any, on the original purchase price, but only to the extent that such Lost Earnings or Restoration of Profits exceeds the difference between the FMV of the asset as of correction and the original purchase price and (2) the amount by which the original purchase price exceeded the FMV of the asset (at the time of the original purchase), plus the greater of Lost Earnings or Restoration of Profits, if any, on such excess; provided, an independent fiduciary determined that the plan will realize a greater benefit from this correction than it would from the resale described in section 7.4(a)(2)(i) of the VFC Program. The Applicant corrected the Stock Purchase Transactions under the alternative correction methodology, taking into account any prior disposition of the stock by an IRA subsequent to the original purchase.
9. With respect to the Applicant's correction of the Transactions, (a) the Applicant took into account all transaction costs (e.g., Transaction Compensation), if any, paid by the IRAs in calculating the corrective payments; and (b) the Applicant engaged an independent fiduciary, Evercore Trust Company. Evercore Trust Company stated that (x) the methods utilized to correct the Transactions were sufficient to return each affected IRA to at least the position that it would have been in had the Transactions not occurred, (y) the alternative correction method utilized for the Stock Purchase Transactions did not result in the affected IRAs being returned to more unfavorable financial positions than if the general correction method described in 7.4(a) of the VFC Program been used instead, and (z) the correction methods were properly applied to the Transactions based on a review of a representative sample of the corrections.
10. Evercore Trust Company confirmed to the Applicant that (a) during the period beginning with the date on which the earliest Transaction occurred and ending with the date Evercore Trust Company completed its engagement as an independent fiduciary with respect to the Transactions and the Transaction Compensation, it was not an entity that was directly or indirectly controlling, controlled by, or under common control with, the Applicant or its affiliates, (b) the compensation received by Evercore Trust Company from the Applicant for its services as an independent fiduciary with respect to the Transactions and the Transaction Compensation was not contingent upon, or in any way affected by, Evercore Trust Company's determination, and Evercore Trust Company did not, and will not, directly or indirectly receive any other compensation or consideration from the Applicant in connection with the Transactions or Transaction Compensation, and (c) for any fiscal year of Evercore Trust Company, during which, or during part of which, it acted as an independent fiduciary with respect to the Transactions or Transaction Compensation, or received any compensation from the Applicant for its services as an independent fiduciary with respect to the Transactions or Transaction Compensation (Subject Fiscal Year), the annual gross revenue received by Evercore Trust Company and its affiliates from the Applicant or its affiliates for the Subject Fiscal Year did not exceed one percent (1%) of the annual gross revenue received by Evercore Trust Company and its affiliates from all sources (for federal income tax purposes) for their most recent fiscal years that ended prior to the Subject Fiscal Year.
11. The Applicant represents that it credited, or issued a check to, each IRA to which a corrective payment was due.
12. The Applicant believes that the Transactions were inadvertent and resulted in the IRAs paying no more than the market price with respect to the Bond Purchase Transactions and the Stock Purchase Transactions, and receiving at least the market price with respect to the Bond Sale Transactions and the Stock Sale Transaction, because the Transactions were conducted using trading systems and procedures designed to result in trades being conducted at prices that are as favorable as possible to the IRAs under prevailing market conditions and were in fact conducted at prices not less favorable to the IRAs than the prices the FAs could have obtained for the IRAs by conducting the trades in arm's-length transactions with third-party market participants.
13. The Applicant represents that it has not taken advantage of the relief provided by the VFC Program and PTE 2002-51 for the three (3) years prior to
14. The Applicant represents that the proposed exemption is: (a) Administratively feasible because the Applicant has corrected the Transactions pursuant to the requirements set forth in the VFC Program; has obtained relief under the VFC Program for the Qualified Plan Transactions; has put procedures in place to ensure that no similar Transactions occur in the future; and has obtained an opinion from an independent fiduciary, Evercore Trust Company, confirming that the methods utilized to correct the Transactions and Transaction Compensation were sufficient to return each affected IRA to at least the position that it would have been in had the Transactions and Transaction Compensation not occurred, and that the correction methods were properly applied to the Transactions and Transaction Compensation based on a review of a representative sample of the corrections, selected at random by the independent fiduciary; (b) in the interests of the affected IRAs and their owners and beneficiaries because the Transactions have been corrected pursuant to the procedures set forth in the VFC Program, which are designed to ensure that the corrections are made in a manner that is in the interests of the IRAs and their owners and beneficiaries; and (c) protective of the rights of the owners and beneficiaries of the IRAs because the requested relief is only with respect to past transactions, which the Applicant believes were conducted at prices no less favorable to the IRAs than prices the IRAs could have paid or received in arm's-length transactions with third party market participants, that have already been effectively unwound pursuant to the requirements set forth in the VFC Program.
15. In summary, the Applicant represents that the Transactions and the Transaction Compensation satisfy the statutory criteria for an administrative exemption contained in Code section 4975(c)(2) because, among other things: (a) The Transactions and Transaction Compensation were substantially similar to the Qualified Plan Transactions; (b) the Transactions and Transaction Compensation were corrected pursuant to the requirements set forth in the VFC Program and in a manner similar to those described in the Applicant's VFC Program Application; (c) the Applicant received a “no-action letter” from the Department in connection with Applicant's VFC Program Application; (d) the Applicant obtained an opinion from an independent fiduciary, Evercore Trust Company, confirming that the methods utilized to correct the Transactions and Transaction Compensation were sufficient to return each affected IRA to at least the position that it would have been in had the Transactions and Transaction Compensation not occurred, and that the correction methods were properly applied to the Transactions and Transaction Compensation based on a review of a representative sample of the corrections, selected at random by the independent fiduciary; (e) the terms of the Transactions and the Transaction Compensation were at least as favorable to the IRAs as the terms generally available in arm's-length transactions between unrelated parties; (f) the Transactions and Transaction Compensation were not part of an agreement, arrangement or understanding designed to benefit a disqualified person; and (g) the Applicant did not take advantage of the relief provided by the VFC Program and PTE 2002-51 for three (3) years prior to the date of the Applicant's submission of the VFC Program Application.
Mr. Brian Shiker of the Department, telephone (202) 693-8552. (This is not a toll-free number.)
The Department is considering granting an exemption under the authority of section 408(a) of the Act and section 4975(c)(2) of the Code and in accordance with the procedures set forth in 29 CFR part 2570, subpart B (55 FR 32836, 32847, August 10, 1990).
If the proposed exemption is granted, effective for the period beginning April 11, 2011 and ending May 6, 2011, the restrictions of sections 406(a)(1)(A), 406(a)(1)(E), 406(a)(2), 406(b)(1), 406(b)(2), and 407(a)(1)(A) of the Act and the sanctions resulting from the application of section 4975 of the Code, by reason of section 4975(c)(1)(A) and 4975(c)(1)(E) of the Code,
(a) To the acquisition of certain subscription right(s) (the Right or Rights) by the individually-directed account(s) (the Account or Accounts) of certain participant(s) in the Plan in connection with an offering (the Offering) of shares of common stock (the Stock) of Central Pacific Financial Corporation (CPFC) by CPFC, a party in interest with respect to the Plan; and
(b) To the holding of the Rights received by the Accounts during the subscription period of the Offering; provided that the conditions, as set forth in Section II of this proposed exemption were satisfied for the duration of the acquisition and holding.
The relief provided in this proposed exemption is conditioned upon adherence to the material facts and representations described, herein, and as set forth in the application file, and upon compliance with the conditions, as set forth in this proposed exemption.
(a) The receipt of the Rights by the Accounts occurred in connection with the Offering, and the Rights were made available by CPFC to all shareholders of the Stock of CPFC, including the Accounts;
(b) The acquisition of the Rights by the Accounts resulted from an independent corporate act of CPFC;
(c) Each shareholder of the Stock, including each of the Accounts, received the same proportionate number of Rights, and this proportionate number of Rights was based on the number of shares of Stock held by each such shareholder;
(d) The Rights were acquired pursuant to, and in accordance with, provisions under the Plan for individually-directed investment of the Accounts by the individual participants in the Plan, all or a portion of whose Accounts in the Plan held the Stock (the Invested Participant(s));
(e) The decision with regard to the holding and disposition of the Rights by an Account was made by the Invested Participant whose Account received the Rights;
(f) If any of the Invested Participants failed to give instructions as to the exercise of the Rights received in the Offering, such Rights were sold in blind transactions on the New York Stock Exchange (NYSE) and the proceeds from such sales were distributed
(g) No brokerage fees, no commissions, and no fees or expenses
(h) Based on the difference ($1.13) between the average proceeds per Right ($6.05) received by other holders who sold Rights during the Offering and the average proceeds per Right ($4.92) received by Invested Participants whose Accounts sold Rights, between April 26, 2011 and May 3, 2011, CPFC will make a corrective payment to the Plan in the amount of $30,618.48 ($1.13 x 27,096 Rights sold), plus a lost earnings component on such amount, calculated at a 2.83% annual rate of interest for the period from May 6, 2011 to the date of the grant of this proposed exemption, and will distribute such corrective payment, and the lost earnings component,
1. The Plan is a defined contribution 401(k) retirement saving plan which provides for a cash and deferred arrangement. The Plan was adopted, effective as of November 1, 1985.
As of April 11, 2011, there were 1,115 participants in the Plan. The Plan is a participant directed account plan designed and operated to comply with the requirements of section 404(c) of the Act.
The Plan is funded by elective employee contributions, as well as employer matching contributions, and discretionary employer profit sharing contributions in cash to the ESOP. It is represented that no discretionary contributions were made in 2008, 2009, and 2010. The fair market value of the total assets of the Plan, as of April 11, 2011, was $85,827,254. As of August 30, 2012, the fair market value of the Plan's assets was $90,594,733. 2. CPFC is the sponsor of the Plan. CPFC is a bank holding company, incorporated in the State of Hawaii on February 1, 1982, as “CPB Inc.” CPFC's principal place of business is Honolulu, Hawaii.
CPFC, a parent company, through its subsidiaries, offers full-service commercial banking throughout the State of Hawaii and offers limited commercial banking services in certain areas of California. CPFC does not employ any persons other than the officers of the Central Pacific Bank (the Bank) and from time to time the support staff of the Bank. It is represented that substantially all of the activities of CPFC are conducted through the Bank.
According to the Form 10-Q, as of March 3, 2012, on a consolidated basis, CPFC and its subsidiaries had total assets of $4,158,288,000, total liabilities of $3,680,848,000, and total stockholders' equity of $477,440,000.
3. The Bank is a wholly-owned subsidiary of CPFC. The Bank is a full-service commercial bank incorporated in the State of Hawaii on March 16, 1982, with 34 branches and 120 ATMs located throughout the State of Hawaii. The Bank also has an office in California. The Bank offers a broad range of products and services, including accepting time and demand deposits, and originating commercial, construction, and consumer loans, and commercial and residential mortgages. All employees of the Bank, its subsidiaries, and certain other affiliated companies are covered by the Plan.
4. Vanguard Fiduciary Trust Company (Vanguard) is the third party administrator, the trustee, and the custodian of the Plan. Vanguard, as trustee, has the responsibility of investing, holding, collecting, distributing, and accounting for the assets of the Plan in the trust.
5. The Plan is administered by a committee (the Committee), which is composed of certain appointed employees of the Bank. The Committee has the responsibility of selecting the investment options of the trust into which the participants of the Plan can direct their contributions.
6. Participants in the Plan are permitted to self-direct the investments in their Accounts based on certain options held under the Plan. Among the investment options offered to participants are various types of securities, including shares of the Stock held in the CPFC stock fund (the Stock Fund). Investment in the Stock Fund by the Accounts of participants in the Plan is entirely voluntary. It is represented that neither CPFC nor its subsidiaries contribute any capital Stock to the Plan. Instead all employer contributions are made in cash, and the Stock is acquired by the Accounts in the Plan only as a result of participant-directed investment decisions.
The Plan provides that participants are entitled to direct the voting of the Stock held in their Accounts in the Plan. Vanguard, as trustee, has the responsibility of carrying out such directions. As of December 31, 2009, and December 31, 2010, respectively, the Plan investments included 938,180 shares and 893,122 shares of the Stock held in the Stock Fund.
7. The Stock of CPFC is publicly-traded on the NYSE under the symbol “CPF.” The Stock has no par value. It is represented that the Stock is the same class of shares available to other investors. The Stock is a “qualifying employer security,” as defined under section 407(d)(5) of the Act and 4975(e) of the Code.
8. On February 2, 2011, CPFC effected a one-for-twenty reverse stock split (the Reverse Stock Split) of the outstanding shares of Stock. As a result of the Reverse Stock Split, the outstanding shares of Stock decreased from 30,539,999 shares to 1,528,935 shares.
As part of its recapitalization plan to raise $325 million from accredited investors in a private placement (the Private Placement), CPFC, on February 18, 2011, entered into subscription agreements with affiliates of the Carlyle Group and the Anchorage Capital Group, LLC and with various other investors. In this regard, CPFC sold 32,500,000 shares of Stock at a price of $10 per share.
On the same day, February 18, 2011, CPFC entered into an exchange agreement (the Exchange Agreement) with the United States Department of the Treasury (Treasury), pursuant to which the Treasury agreed, subject to the terms and conditions in the Exchange Agreement, to exchange 135,000 shares of CPFC's preferred stock designated as Fixed Rate Cumulative Preferred Stock, having a liquidation amount of $1,000 per share, held by the Treasury and accrued and unpaid dividends thereon for 5,620,117 shares of CPFC's Stock, and amended a warrant held by the Treasury to reduce the
Following the closing of the Private Placement and the TARP Exchange, CPFC had 39,649,052 shares of Stock outstanding, as of April 11, 2011. CPFC commenced the Offering whereby shareholders of record, as of 5 p.m. EST on the February 17, 2011 (the Record Date), would receive the Rights. CPFC represents that it conducted the Offering, because it wanted to provide existing shareholders and other investors, including the Accounts of Invested Participants in the Plan, who could not participate in the Private Placement, with the opportunity to purchase the Stock at the same price per share paid by the investors in the Private Placement.
9. The Offering commenced on April 11, 2011, and closed on May 6, 2011. It is represented that 2,000,000 shares of Stock were subscribed for by all shareholders. In this regard, the Offering was fully subscribed. There were valid exercises to purchase an aggregate of 1,325,230 shares, pursuant to directions from holders of the basic Rights. The remaining 674,770 shares available to be issued in the Offering were allocated
10. At the close of business on April 11, 2011, the date of the Offering, the Stock was trading on the NYSE at $19.43 per share. The closing price of the Stock on the ending date of the Offering on May 6, 2011, was $13.70.
11. Under the terms of the Offering, all shareholders of the Stock, including the Accounts of Invested Participants in the Plan, automatically received the Rights, at no charge. Each of the Rights entitled the shareholders of the Stock, including the Accounts of Invested Participants in the Plan, to purchase, through the exercise of such Rights, the Stock issued by CPFC in connection with the Offering. With respect to the Rights, under the terms of the Offering, one (1) Right was issued for each whole share of the Stock held by each shareholder, including the Accounts of Invested Participants in the Plan, on the Record Date.
12. The Rights entitled the holders thereof to a basic right to subscribe for their
However, the over-subscription privilege was conditioned on each shareholder first exercising their basic Rights in full. Because the Accounts of Invested Participants in the Plan did not exercise all of their basic Rights in full and, because, as a practical matter it was unlikely that all of the Accounts of Invested Participants in the Plan would do so, given the number of Invested Participants in the Plan whose Accounts held the Stock, the over-subscription privilege was not available to Rights attributable to the Accounts of Invested Participants in the Plan.
13. All shareholders of the Stock, including the Accounts of Invested Participants in the Plan, held the Rights until such Rights were exercised, or such Rights were sold. With regard to the exercise of the Rights, it is represented that the Rights could only be exercised in whole numbers. Upon exercise, each of the Rights permitted a shareholder of the Stock, including each of the Accounts of Invested Participants in the Plan, to purchase 1.3081 shares of Stock at a subscription price of $10.00 per share (such amount is represented to take into account the Reverse Stock Split that occurred on February 2, 2011). Fractional shares of Stock resulting from the exercise of basic Rights on an aggregate basis as to any holder of such Rights, including the Accounts of Invested Participants in the Plan, were rounded down to the nearest whole number.
A shareholder, including each of the Accounts of Invested Participants in the Plan, had the right to choose to exercise some, all, or none of its Rights. The election to exercise, some, all or none of its Rights had to be received by 5 p.m. EST on April 29, 2011, by the tabulation agent, Wells Fargo Bank, NA Shareowner Services (WFSS), in order to allow sufficient processing time. The election to exercise any of the Rights was irrevocable.
14. With regard to the sale of the Rights, it is represented that the Rights were transferable. Further, it is represented that the Rights were traded on the NYSE. Any Rights that were not exercised either as a result of a partial exercise or as a result of insufficient assets in an Account to cover an exercise (excluding the assets in the Stock Fund), or as a result of a failure to timely return the election form were automatically sold on the NYSE to unrelated third parties by Vanguard, as trustee, acting on behalf of each such Account. The proceeds from such sale were credited
15. The Invested Participants were notified of the issuance of the Rights in a news release, in a posting on the CPFC's Web site, and in various letters and email communications from CPFC during the month of April 2011. In addition, each of the Invested Participants was also provided detailed information regarding the Rights Offering, including a copy of the prospectus which described the Offering, a document providing frequently asked questions and answers regarding the Offering, an election form, a return envelope addressed to WFSS, the tabulating agent, and a statement indicating the number of shares of Stock each such Invested Participant held in his/her Account in the Plan, as of the Record Date.
16. In order to exercise some or all of the Rights, an Invested Participant
The Department is offering no view, as to whether the requirements of the statutory exemption provided in section 408(e) of the Act have been satisfied. Further, the Department, herein, is not providing any relief with respect to the exercise of the Rights.
Each Invested Participant who submitted an election form was required to indicate on such election form a sufficient amount of current investments in the Account of such Invested Participant in the Plan (other than the assets in the Stock Fund) to be liquidated on a pro-rated basis to cover the purchase of Stock in connection with the exercise of the Rights. The pro-rated funds were segregated from the other investments within the Invested Participant's Account into a separate holding fund (the Rights Fund) at Vanguard which was established in anticipation of the Offering. Vanguard placed the order to purchase the Stock with the subscription agent, Wells Fargo Bank, N.A. (Wells Fargo Bank), a registered broker-dealer that is unrelated
17. As of the Record Date, February 17, 2011, 287 Accounts of Invested Participants in the Plan held the Stock. As of the Record Date, the approximate percentage of the fair market value of the total assets of the Plan invested in the Stock was two percent (2%). Also, as of the Record Date, the shares of Stock held in the Accounts of Invested Participants in the Plan constituted approximately three percent (3%) of the shares of Stock outstanding.
18. It is represented that based on the ratio of one (1) Right for each share of Stock held by the Accounts of Invested Participants, the Plan acquired 46,327 Rights as a result of the Offering. Of the Rights received by the Plan on behalf of Accounts of the Invested Participants, all such Rights were either exercised or sold. None of the Rights expired.
Of the 46,327 Rights received by the Accounts of Invested Participants as a result of the Offering, it is represented that 19,231 Rights held by 102 Accounts of Invested Participants in the Plan were exercised for Stock. It is represented that on May 19, 2011, the Accounts of the Invested Participants in the Plan received the Stock purchased as a result of the exercise of the Rights. It is further represented that the Stock purchased in connection with the Offering was eligible for trading on NYSE by the Accounts of the Invested Participants in the Plan on May 19, 2011.
Unlike the other holders of the Rights, the Invested Participants whose Accounts in the Plan received the Rights were not permitted to sell the Rights throughout the period April 11-25, 2012, due to Plan administrative constraints. However, of the 46,327 Rights received by the Accounts of Invested Participants as a result of the Offering, it is represented that over the period from April 26, 2011 to May 3, 2011, the Invested Participants of 186 Accounts sold 27,096 Rights on the NYSE. On May 9, 2011, the Accounts of those Invested Participants received the proceeds from the sales of such Rights totaling $133,339.44.
Based on the difference ($1.13) between the average proceeds per Right ($6.05) received by other holders who sold Rights during the Offering and the average proceeds per Right ($4.92) received by Invested Participants whose Accounts sold Rights, between April 26, 2011 and May 3, 2011, CPFC will make a corrective payment to the Plan in the amount of $30,618.48 ($1.13 × 27,096 Rights sold). Further, CPFC proposes to include a lost earnings component on the amount of the corrective payment calculated at a 2.83% annual rate of interest for the period from May 6, 2011, to the date of the grant of this proposed exemption. It is represented that the interest rate on the lost earnings component was calculated taking the greater of the weighted average return for all investment funds available under the Plan and the average return for the Retirement Savings Trust (the stable value fund under the Plan in which the proceeds from the sale of the Rights were distributed). CPFC will distribute such corrective contribution, plus the lost earnings component,
19. No brokerage fees, no commissions, no subscription fees, and no other charges were paid by the Plan or by any of the Accounts of Invested Participants in the Plan with respect to the acquisition and holding of the Stock and no brokerage fees, no commissions, and no fees or expenses were paid by the Plan or by any of the Accounts of Invested Participants in the Plan to any related broker in connection with the sale of the Rights or in connection with the exercise of the Rights.
20. The application was filed on behalf of CPFC. In this regard, CPFC has requested an exemption: (a) For the acquisition of the Rights by the Accounts of the Invested Participants in the Plan in connection with the Offering of Rights by CPFC; and (b) for the holding of the Rights by the Accounts of the Invested Participants in the Plan during the subscription period of the Offering.
It is represented that the Rights acquired by the Accounts of Invested Participants in the Plan satisfy the definition of “employer securities,” pursuant to section 407(d)(1) of the Act. However, as the Rights were not stock or a marketable obligation, such Rights do not meet the definition of “qualifying employer securities,” as set forth in section 407(d)(5) of the Act. Accordingly, the subject transactions constitute an acquisition and holding on behalf of the Accounts of Invested Participants in the Plan, of employer securities which are not qualifying employer securities, in violation of section 407(a) of the Act, for which CPFC has requested relief from sections 406(a)(1)(A), 406(a)(1)(E), 406(a)(2), and 407(a)(1)(A) of the Act. CPFC has also requested relief from the prohibitions of section 406(b)(1) and 406(b)(2) of the Act.
21. It is represented that the subject transactions have already been consummated. In this regard, the Accounts of Invested Participants in the Plan acquired the Rights pursuant to the Offering on April 11, 2011, and held such Rights pending the closing of the Offering on May 6, 2011, when such Rights either were exercised or sold. As there was insufficient time between the dates when the Accounts of Invested Participants in the Plan acquired the Rights and when such Rights were exercised or sold, to apply for and be granted an exemption, CPFC is seeking a retroactive exemption to be granted, effective from April 11, 2011, the date that the Accounts of Invested Participants in the Plan acquired the Rights, to May 6, 2011, the closing date of the Offering.
22. CPFC represents that the proposed exemption is administratively feasible. In this regard, the acquisition and holding of the Rights by the Accounts of Invested Participants in the Plan were one-time transactions that involved an automatic distribution of the Rights to all shareholders. It is represented that it is customary for corporations to make a rights offering available to all shareholders.
23. CPFC represents that the transactions which are the subject of this proposed exemption are in the interest of the Accounts of Invested Participants in the Plan, because the subject transactions represented a valuable opportunity to such Accounts to buy the Stock at a discount or to sell the Rights. It is represented that this discount could be realized by the Accounts of Invested Participants in the Plan by selling the Stock immediately after the exercise of the Rights and investing the proceeds from such sale of the Stock in other investment options under the Plan.
24. CPFC represents that the proposed exemption provides sufficient safeguards for the protection of the Accounts of Invested Participants in the Plan and the beneficiaries of such Accounts. In this regard, participation in the Offering protected the Accounts of the Invested Participants in the Plan from having their interests in CPFC diluted as a result of the Offering.
It is further represented that the interests of the Accounts of Invested Participants in the Plan were adequately protected in that such Accounts acquired and held the Rights automatically as a result of the Offering. In addition, CPFC made the Rights
The Accounts of Invested Participants in the Plan were protected against economic loss by exercising the Rights or by selling the Rights. It is represented that the closing price of the Stock on May 6, 2011, was $13.70 per share which was in excess of the strike price of $10.00 per share.
25. In summary, CPFC represents that the subject transactions satisfy the statutory criteria of section 408(a) of the Act and section 4975(c)(2) of the Code because:
(a) The receipt of the Rights by the Accounts occurred in connection with the Offering, and the Rights were made available by CPFC to all shareholders of the Stock of CPFC, including the Accounts;
(b) The acquisition of the Rights by the Accounts resulted from an independent corporate act of CPFC;
(c) Each shareholder of the Stock, including each of the Accounts, received the same proportionate number of Rights, and this proportionate number of Rights was based on the number of shares of Stock held by such shareholder;
(d) The Rights were acquired pursuant to, and in accordance with, provisions under the Plan for individually-directed investment of the Accounts by the Invested Participants, all or a portion of whose Accounts in the Plan held the Stock;
(e) The decision with regard to the holding and disposition of the Rights by an Account was made by the Invested Participant whose Account received the Rights;
(f) If any of the Invested Participants failed to give instructions as to the exercise of the Rights received in the Offering, such Rights were sold in blind transactions on the NYSE and the proceeds from such sales were distributed
(g) No brokerage fees, no commissions, and no fees or expenses were paid by the Plan or by the Accounts to any related broker in connection with the sale of any of the Rights or in connection with the exercise of any of the Rights, and no brokerage fees, no commissions, no subscription fees, and no other charges were paid by the Plan or by the Accounts with respect to the acquisition and holding of the Stock; and
(h) Based on the difference ($1.13) between the average proceeds per Right ($6.05) received by other holders who sold Rights during the Offering and the average proceeds per Right ($4.92) received by Invested Participants whose Accounts sold Rights, between April 26, 2011 and May 3, 2011, CPFC will make a corrective payment to the Plan in the amount of $30,618.48 ($1.13 × 27,096 Rights sold), plus a lost earnings component on such amount calculated at a 2.83% annual rate of interest for the period from May 6, 2011 to the date of the grant of this proposed exemption, and will distribute such corrective payment, and the lost earnings component,
The persons who may be interested in the publication in the
It is represented that all such interested persons will be notified of the publication of the Notice by first class mail, to each such interested person's last known address within fifteen (15) days of publication of the Notice in the
All comments will be made available to the public. Warning: Do not include any personally identifiable information (such as name, address, or other contact information) or confidential business information that you do not want publicly disclosed. All comments may be posted on the Internet and can be retrieved by most Internet search engines.
Ms. Angelena C. Le Blanc of the Department, telephone (202) 693-8551. (This is not a toll-free number.)
The Department is considering granting an exemption under the authority of section 408(a) of the Act and section 4975(c)(2) of the Code, and in accordance with the procedures set forth in 29 CFR Part 2570 Subpart B (55 FR 32836, 32847, August 10, 1990). If the proposed exemption is granted, the restrictions of section 406(a)(1)(A) and (D) and section 406(b) of the Act, and the sanctions resulting from the application of section 4975 of the Code, by reason of section 4975(c)(1)(A), (D), (E) and (F) of the Code, shall not apply to the sale (the Sale) of an 8.828121% partnership interest (the Interest) in the Julien J. Studley N Street Partnership, a general partnership (the JJS Partnership), by the Plan to Studley, Inc. (the Employer), a party in interest with respect to the Plan, provided that the following conditions are satisfied:
(a) The Sale is a one-time transaction for cash;
(b) The terms and conditions of the Sale are at least as favorable to the Plan as those that the Plan could obtain in an arm's length transaction with an unrelated third party;
(c) The Interest is sold for $900,000;
(d) The Sale is consummated within two weeks after the date a final exemption regarding the Sale is published in the
(e) If, (1) within seven years of the date of the Sale of the Interest to the Employer, (i) the Employer sells the Interest, (ii) JJS Partnership sells its interest in N19 Associates LLC (N19 Associates), or (iii) N19 Associates sells its building on N Street, Washington, DC, and (2) the net amount realized by the Employer in respect of the Interest upon and by reason of such sale, exceeds the sum of (i) the $900,000 price paid for the Interest, and (ii) any capital contributed by the Employer to the JJS Partnership in respect of the Interest after the date of the Sale and any other funds paid or advanced by the Employer to, or on behalf of, the JJS Partnership in respect of the Interest after the date of the Sale, the Employer will contribute such excess amount to the Plan within two weeks of its receipt by the Employer;
(f) The Plan pays no commissions, fees, or other expenses in connection with the Sale; and
(g) The Plan has not waived or released and does not waive or release any claims, demands, and/or causes of
1. The Studley, Inc. Section 401(k) Profit Sharing Plan (the Plan) is sponsored by Studley, Inc. (the Employer or the Applicant), located in New York, New York. Julien Studley (Mr. Studley) was the founder of the Employer. Pursuant to a buyout, all of his shares in the Employer not held in an employee benefit plan were purchased on December 12, 2002, by the Employer, at which time Mr. Studley resigned as a voting member from the Employer's Board of Directors. He remained a non-voting member until June 2004. Since then, Mr. Studley has not held any position with, or interest in, the Employer (other than shares held in employee benefit plans). The Employer is in the business of providing commercial real estate advisory, brokerage and related services.
The Plan had 61 participants and beneficiaries, as of November 14, 2011. Based on the most recently available audited financial statements, the total value of the Plan's assets was $26,830,211, as of December 31, 2010. The Plan's trustee is T. Rowe Price Trust Company. The trust agreement indicates that the trustee takes direction from the named fiduciary (the Named Fiduciary), which is the Employer. The Plan has a non-participant directed profit sharing component in which it holds real estate investments, as well as a 401(k) component which is participant directed.
2. Among the assets of the Plan is an 8.828121% interest (the Interest) in the Julien J. Studley N Street Partnership (JJS Partnership), a general partnership in which the Employer and the Plan are both general partners. The Applicant represents that there are currently eight other members in the JJS Partnership in addition to the Employer and the Plan. No other employee benefit plans are members of the JJS Partnership.
The managing partners of the JJS Partnership are Mr. Studley and Mr. Peter Speier, and neither the Plan nor the Employer has management responsibilities. The JJS Partnership was formed and capitalized on or about December 28, 1976. The Applicant represents that the Interest was acquired by the Plan in 1982 for $45,000 and is held under an ancillary trust agreement (the Ancillary Trust Agreement), with Mitchell Steir and Michael Colacino as trustees.
3. The Applicant represents that the JJS Partnership was formed for the purpose of holding an interest in an entity known as N19 Associates. The JJS Partnership holds a 32% interest in N19 Associates, which owns a building on N Street in Washington, DC (the Building). The Plan's effective interest in the Building is 2.825%, which is 8.828121% of 32%.
4. The NYRO opened an investigation of the Plan and found that the Plan's interest in the JJS Partnership is an illiquid and hard-to-value asset.
5. The Applicant represents that N19 Associates is controlled by Melvin and Edward Lenkin, who are not affiliated with the Employer or the JJS Partnership. The JJS Partnership has commenced litigation against the Lenkins based, in part, upon their refusal to provide current information regarding the Building. Due to the disagreement among the parties, the Applicant represents, among other things, that JJS Partnership has been unable to obtain and provide to the Plan the information that would enable the Plan to obtain a current appraisal of the Interest by an independent appraiser. The most recently available independent appraisal assigns the Interest a value of $670,000, as of November 3, 2006, which reflects a 25% minority discount by reason of the Plan's holding a minority, non-controlling interest. This was the value for the Interest used in the Plan's audited financial statements as of December 31, 2010.
6. The Applicant represents that the most recent expression of interest from an unrelated party [i.e., Goldstar Real Estate Fund II, LP (Goldstar)] in purchasing the Building received by the JJS Partnership on August 2, 2010 was $45 million. However, the potential sale of the Building to Goldstar could not be consummated in the absence of a current independent appraisal of the Building, which is currently not obtainable due to the lack of cooperation among the parties, as described in Representation 5, above. Therefore, the Employer proposes to purchase the Interest from the Plan for $900,000 on the following basis: After deducting N19 Associates' mortgage and other liabilities and expenses associated with the sale, a $45 million purchase price for the Building would result in $900,000 of net proceeds to the Plan in respect of the Interest. It is represented that this price is very favorable to the Plan because it does not reflect any discount for the fact that the JJS Partnership and the Plan hold only minority, non-controlling interests, and the discounting of minority, non-controlling interests is a recognized principle of valuation.
The Applicant represents that according to its available records, the Plan has received approximately $167,690 in cash distributions from the JJS Partnership during the time it has
7. In addition, the Employer has included in the terms of the proposed Sale a “true-up” provision that the Employer will contribute an additional amount to the Plan if (a) within seven years of the date of the Sale of the Interest to the Employer, (i) the Employer sells the Interest, (ii) JJS Partnership sells its interest in N19 Associates, or (iii) N19 Associates sells the Building, and (b) the net amount realized by the Employer in respect of the Interest upon and by reason of such Sale, exceeds the sum of (i) the $900,000 price paid for the Interest, and (ii) any capital contributed by the Employer to the JJS Partnership in respect of the Interest after the date of the Sale and any other funds paid or advanced by the Employer to, or on behalf of, the JJS Partnership in respect of the Interest after the date of the Sale. The Employer will contribute such excess amount to the Plan within two weeks of its receipt by the Employer. Such contribution will be allocated to the Plan accounts of participants who were invested in the Interest at the time of the Sale.
8. The Applicant represents that the requested exemption for the Sale of the Plan's Interest to the Employer is in the interest of the Plan because it will enable the participants and beneficiaries to realize the value of the Interest and receive requested distributions in respect of their investment therein. The Applicant also represents that the requested exemption is also protective of the rights of the participants and beneficiaries of the Plan because the Sale price reflects the best information available to the Employer of the Interest's current fair market value, with no discount taken for a minority, non-controlling interest. Moreover, according to the Applicant, the “true-up” provision gives the participants and beneficiaries of the Plan protection against a down market and allows their full participation in any up market for the next seven years.
The Applicant also represents that the Sale of the Interest will be a one-time transaction for cash, and the Plan will incur no fees, commissions, or other expenses in connection with the Sale. Further, the Employer will bear the costs of the exemption application and notification of interested persons.
9. In consideration of the following conditions, the Department has tentatively determined that the Sale will satisfy the statutory criteria for an exemption under section 408(a) of the Act: (a) The Sale will be a one-time transaction for cash; (b) the terms and conditions of the Sale will be at least as favorable to the Plan as those that the Plan could obtain in an arm's length transaction with an unrelated third party; (c) the Interest will be sold for $900,000; (d) the Sale will be consummated within two weeks after the date a final exemption regarding the Sale is published in the
All comments will be made available to the public. Warning: Do not include any personally identifiable information (such as name, address, or other contact information) or confidential business information that you do not want publicly disclosed. All comments may be posted on the Internet and can be retrieved by most Internet search engines.
Mr. Eric A. Raps of the Department, telephone (202) 693-8532. (This is not a toll-free number.)
[Application No. D-11724]
Based on the facts and representations set forth in the application, the Department is considering granting the following amendment to Prohibited Transaction Exemption 2002-30 (67 FR 39069) under the authority of ERISA section 408(a), section 8477(c)(3) of the Federal Employees' Retirement System Act of 1986 (FERSA) and Code section 4975(c)(2), and in accordance with the procedures set forth in 29 CFR Part 2570, Subpart B (76 FR 66637, 66644, October 27, 2011), as follows:
If the proposed exemption is granted, the restrictions of ERISA section 406(a)(1)(A) and (D) and the sanctions resulting from the application of Code section 4975(a) and (b), by reason of Code section 4975(c)(1)(A) and (D), shall not apply, effective October 1, 2012, to the sale or licensing of certain data and/or analytical tools to a plan by EquiLend, a party in interest with respect to such plan.
This exemption, if granted, would be subject to the following conditions:
(a) The terms of any such sale or licensing are at least as favorable to the plan as the terms generally available in an arm's-length transaction involving an unrelated party;
(b) Any data sold/licensed to the plan will be limited to:
(1) Current and historical data related to transactions, whether or not proposed or occurring on EquiLend's electronic securities lending platform (the Platform) or,
(2) Data derived from current and historical data using statistical or computational techniques; and
(c) Each analytical tool sold/licensed to the plan will be an objective statistical or computational tool designed to permit the evaluation of securities lending activities.
If the proposed exemption is granted, the restrictions of ERISA sections 406(a)(1)(A) and (D) and 406(b), FERSA section 8477(c)(2), and the sanctions resulting from the application of Code section 4975(a) and (b), by reason of Code section 4975(c)(1)(A) and (D) through (F), shall not apply, effective October 1, 2012, to: (1) The participation in the Platform by an equity owner of EquiLend (an Equity Owner), in its capacity as a securities lending agent for a plan (an Owner Lending Agent); (2) the sale or licensing of certain data and/or analytical tools by EquiLend to a plan for which an Equity Owner acts as a securities lending agent; and (3) the provision by an Owner Lending Agent to EquiLend of securities lending data based on off-Platform securities lending transactions conducted by an Owner Lending Agent on behalf of a plan.
This proposed exemption, if granted, would be subject to the following conditions:
(a) In the case of participation in the Platform on behalf of a plan, to the extent an applicable exemption is required, the securities lending transactions conform to the provisions of Prohibited Transaction Class Exemption (PTE) 2006-16 (71 FR 63786 (Oct. 31, 2006)) (or its successor), and/or any applicable individual exemption;
(b) None of the fees imposed by EquiLend for securities lending transactions conducted through the use of the Platform at the direction of an Owner Lending Agent will be charged to a plan;
(c) Each securities lender and securities borrower participating in a securities lending transaction through EquiLend will be notified by EquiLend as to its responsibilities with respect to compliance, as applicable, with ERISA, the Code, and FERSA. This requirement may be met by including such notification in the participation, subscription or other user agreement required to be executed by each participant in EquiLend;
(d) EquiLend will not act as a principal in any securities lending transaction involving plan assets;
(e) Each Owner Lending Agent will provide prior written notice to its plan clients of its intention to participate in EquiLend;
(f)(1) Except as otherwise provided in paragraph (i), the arrangement pursuant to which the Owner Lending Agent utilizes the services of EquiLend on behalf of a plan for securities lending:
(A) Is subject to the prior written authorization of an independent fiduciary (an authorizing fiduciary) as defined in paragraph (b) of Section III). For purposes of subparagraph (f)(1), the requirement that the authorizing fiduciary be independent shall not apply in the case of an Equity Owner Plan;
(B) May be terminated by the authorizing fiduciary, without penalty to the plan, within the lesser of: (i) The time negotiated for such notice of termination by the plan and the Owner Lending Agent, or (ii) five business days. Notwithstanding the foregoing, the requirement for prior written authorization will be deemed satisfied in the case of any plan for which the authorizing fiduciary has previously provided written authorization to the Owner Lending Agent pursuant to PTE 2006-16 (or any predecessor or successor thereto), unless such authorizing fiduciary objects to participation in the Platform in writing to the Owner Lending Agent within 30 days following disclosure of the information described in paragraphs (e) and (g) of this Section to such authorizing fiduciary;
(2) Except as otherwise provided in paragraph (i), each purchase or license of a securities lending-related product from EquiLend on behalf of a plan by an Owner Lending Agent:
(A) Is subject to the prior written authorization of an authorizing fiduciary. For purposes of subparagraph (f)(2), the requirement for prior written authorization shall not apply to any purchase or licensing of an EquiLend securities lending-related product by an Equity Owner Plan if the fee or cost associated with such purchase or licensing is not paid by the Equity Owner Plan; and
(B) May be terminated by the authorizing fiduciary within: (i) The time negotiated for such notice of termination by the plan and the Owner Lending Agent; or (ii) five business days, whichever is lesser, in either case without penalty to the plan, provided that, such authorizing fiduciary shall be deemed to have given the necessary authorization in satisfaction of this subparagraph (f)(2) with respect to each specific product purchased or licensed pursuant thereto unless such authorizing fiduciary objects to the Owner Lending Agent within 15 days after the delivery of information regarding such specific product to the authorizing fiduciary in accordance with paragraph (g) of this exemption; and
(3) Except as otherwise provided in paragraph (i), provision by an Owner Lending Agent to EquiLend of securities lending data based on off-Platform securities lending transactions conducted on behalf of a plan:
(A) Is subject to the prior written authorization of an authorizing fiduciary; and
(B) May be terminated by the authorizing fiduciary with respect to the future provision of data within the lesser of (i) the time negotiated for such notice of termination by the plan and the Owner Lending Agent or (ii) five business days, in either case without penalty to the plan. Notwithstanding the foregoing, the requirement for prior written authorization will be deemed satisfied unless such authorizing fiduciary objects to provision by the Owner Lending Agent to EquiLend of such data in writing to the Owner Lending Agent within 30 days following disclosure of the information described in paragraph (g) of this Section to such authorizing fiduciary.
(g) The authorization(s) described in paragraph (f) of this Section shall not be deemed to have been made unless the Owner Lending Agent has furnished the authorizing fiduciary with any reasonably available information that the Owner Lending Agent reasonably believes to be necessary for the authorizing fiduciary to determine whether such authorization should be made, and any other reasonably available information regarding the matter that the authorizing fiduciary may reasonably request. This includes, but is not limited to: (1) a statement that the Equity Owner, as securities lending agent, has a financial interest in the successful operation of EquiLend, (2) a
(h) Any purchase or licensing of data and/or analytical tools with respect to securities lending activities by a plan pursuant to this Section complies with the relevant conditions of Section I and will be authorized in advance by an authorizing fiduciary in accordance with the applicable procedures of paragraphs (f), (g) and (i);
(i) In the case of a pooled separate account maintained by an insurance company qualified to do business in a state or a common or collective trust fund maintained by a bank or trust company supervised by a state or federal agency (Commingled Investment Fund), the requirements of paragraph (f) of this Section shall not apply, provided that—
(1) The information described in paragraph (g) (including information with respect to any material change in the arrangement) of this Section and a description of the operation of the Platform (including a description of the fee structure paid by securities lenders and borrowers), shall be furnished by the Owner Lending Agent to the authorizing fiduciary (described in paragraph (b) of Section III) with respect to each plan whose assets are invested in the account or fund, not less than 30 days prior to implementation of any such arrangement or material change thereto, or, not less than 15 days prior to the purchase or license of any specific securities lending-related product, and, where requested, upon the reasonable request of the authorizing fiduciary. For purposes of this subparagraph, the requirement that the authorizing fiduciary be independent shall not apply in the case of an Equity Owner Plan;
(2) In the event any such authorizing fiduciary notifies the Owner Lending Agent that it objects to participation in the Platform, or to the purchase or license of any EquiLend securities lending-related tool or product, or to the further provision by an Owner Lending Agent to EquiLend of securities lending data based on off-Platform securities lending transactions conducted on behalf of the plan, the plan on whose behalf the objection was tendered is given the opportunity to terminate its investment in the account or fund, without penalty to the plan, within such time as may be necessary to effect the withdrawal in an orderly manner that is equitable to all withdrawing plans and to the non-withdrawing plans. In the case of a plan that elects to withdraw pursuant to the foregoing, such withdrawal shall be effected prior to the implementation of, or material change in, the arrangement or purchase or license, but any existing arrangement need not be discontinued by reason of a plan electing to withdraw; and
(3) In the case of a plan whose assets are proposed to be invested in the pooled account or fund subsequent to the implementation of the arrangements and which has not authorized the arrangements in the manner described in paragraphs (i)(1) and (i)(2), the plan's investment in the account or fund shall be authorized in the manner described in paragraph (f)(1)(A), (f)(2)(A), and (f)(3)(A);
(j) The Equity Owner, together with its affiliates (as defined in Section III(a)), does not own at the time of the execution of a securities lending transaction on behalf of a plan by the Equity Owner (i.e., in its capacity as Owner Lending Agent) through EquiLend or at the time of the purchase, or commencement of licensing, of data and/or analytical tools by the plan, more than 20% of:
(1) If EquiLend is a corporation, including a limited liability company taxable as a corporation, the combined voting power of all classes of stock entitled to vote or the total value of shares of all classes of stock of EquiLend, or
(2) If EquiLend is a partnership, including a limited liability company taxable as a partnership, the capital interest or the profits interest of EquiLend;
(k) Any information, authorization, or termination of authorization may be provided by mail or electronically; and
(l) No Equity Owner Plan, as defined in Section III(e), will participate in the Platform, other than through a Commingled Investment Fund in which the aggregate investment of all Equity Owner Plans at the time of the transaction constitutes less than 20% of the total assets of such fund. Notwithstanding the foregoing, this prohibition shall not apply to the participation by an Equity Owner Plan as of the date that the aggregate loan balance of all securities lending transactions entered into through EquiLend by all participants outstanding on such date (excluding transactions entered into on behalf of Equity Owner Plans) is equal to or greater than $10 billion; provided that if such aggregate loan balance is later determined to be less than $10 billion, no additional participation by an Equity Owner Plan (other than through a Commingled Investment Fund) shall occur until such time as the $10 billion threshold amount is again met.
For purposes of this proposed exemption:
(a) An “affiliate” of another person means:
(1) Any person directly or indirectly, through one or more intermediaries, controlling, controlled by, or under common control with such other person;
(2) Any officer, director, partner, employee, relative (as defined in ERISA section 3(15)) of such other person; and
(3) Any corporation or partnership of which such other person is an officer, director or partner.
For purposes of this paragraph, the term “control” means the power to exercise a controlling influence over the management or policies of a person other than an individual.
(b) The term “authorizing fiduciary” means, with respect to an Owner Lending Agent, a plan fiduciary who is independent of such Owner Lending Agent. In this regard, an authorizing fiduciary will not be considered independent of an Owner Lending Agent if:
(1) Such fiduciary directly or indirectly controls, is controlled by, or is under common control with the Owner Lending Agent; or
(2) Such fiduciary directly or indirectly receives any compensation or other consideration from the Owner Lending Agent or an affiliate for his or her own personal account in connection with any securities lending transaction described herein; provided that Commingled Investment Funds and Equity Owner Plans maintained by such Owner Lending Agent or an affiliate will not be deemed affiliates of such Owner Lending Agent for purposes of this subparagraph (2).
For purposes of Section II, no Equity Owner or any affiliate may be an authorizing fiduciary except in the case of an Equity Owner Plan. Notwithstanding the foregoing, the requirements for consent by an authorizing fiduciary with respect to participation in the Platform, and the annual right of such fiduciary to terminate such participation, shall be deemed met to the extent that the Owner Lending Agent's proposed utilization of the services of EquiLend on behalf of a plan for securities lending has been approved by an order of a United States district court.
(c) The term “Owner Lending Agent” means an Equity Owner in its capacity as a fiduciary of a plan acting as securities lending agent in connection with the loan of plan assets that are securities.
(d) The term “Equity Owner” means an entity that either directly or through an affiliate owns an equity ownership interest in EquiLend.
(e) The term “Equity Owner Plan” means a plan which is established or maintained by an Equity Owner of EquiLend as an employer of employees covered by such plan, or by its affiliate.
(f) The terms “plan” means:
(1) An “employee benefit plan” within the meaning of ERISA section 3(3), subject to Part 4 of Subtitle B of Title I of ERISA,
(2) A “plan” that is within the meaning of Code section 4975(e)(1) and subject to Code section 4975, or
(3) The Federal Thrift Savings Fund.
1. The applicant is EquiLend, a Delaware limited liability company established on May 16, 2001. As of March 15, 2012, the equity owners of EquiLend were as follows: BlackRock, Credit Suisse, JP Morgan Clearing Corp., JP Morgan Chase, Merrill Lynch, Morgan Stanley, State Street, Goldman Sachs, Northern Trust and UBS, or affiliates of the foregoing entities. The applicant represents that, as of March 15, 2012, each equity owner owned 10 percent of EquiLend.
2. The applicant submitted a request that Prohibited Transaction Exemption 2002-30 (67 FR 39069) (PTE 2002-30) be amended. PTE 2002-30 was originally promulgated on June 6, 2002, and it permits: (1) The sale or licensing of certain data and/or analytical tools to an employee benefit plan by EquiLend; (2) participation in the Platform by an equity owner of EquiLend (an Equity Owner), in its capacity as a securities lending agent for the plan (an Owner Lending Agent); and (3) the sale or licensing of certain data and/or analytical tools by EquiLend to a plan for which an Equity Owner acts as an Owner Lending Agent. Unless otherwise noted, the facts and representations of PTE 2002-30, are integrated herein.
3. The applicant represents that, as permitted under Section I of PTE 2002-30, EquiLend currently sells and/or licenses certain data to plans. Consistent with the terms of the individual exemption, this data is: (A) Historical in nature and relates to transactions proposed or occurring on the system; or (B) derived from current and historical data utilizing statistical or computational techniques. In this regard, the applicant notes that Section I(b) of PTE 2002-30 requires that, with respect to the sale or licensing of certain data and/or analytical tools to an employee benefit plan by EquiLend:
(b) Any data sold/licensed to the plan will be limited to: (1) current and historical data related to transactions proposed or occurring on the Platform or, (2) data derived from current and historical data using statistical or computational techniques.
4. The applicant is seeking to amend Section I(b) of PTE 2002-30, effective October 1, 2012. The applicant notes that Section I(b) of PTE 2002-30 limits the types of data that may be licensed or sold by EquiLend. Specifically, Section I(b) precludes the sale or licensing of data to a plan by Equilend where such data sold/licensed involves the use of current or historical data related to transactions that are proposed or occurring off the Platform. The applicant believes, however, that access to off-Platform securities lending data by plans will further enhance EquiLend's existing client service functionality via the Platform by expanding the information that is available to plans. The applicant states that the addition of additional data to the Platform enhances the ability of a plan to evaluate the performance of lending agents and the returns on lending portfolios.
5. The applicant, therefore, requests that the Department revise Section I(b) of PTE 2002-30 in a manner that would permit, effective October 1, 2012, EquiLend to use, sell or license data relating to transactions occurring off the Platform to plans. If this proposed amendment is granted, Section I(b) of PTE 2002-30 will provide that:
(b) Any data sold/licensed to the plan will be limited to:
(1) Current and historical data related to transactions, whether or not proposed or occurring on EquiLend's electronic securities lending platform (the Platform) or,
(2) Data derived from current and historical data using statistical or computational techniques.
6. In the applicant's view, affected plans would be adequately protected with respect to the sale and licensing by EquiLend of this off-Platform data. In this regard, the applicant notes that Section I(b) of PTE 2002-30 limits the type of data that may be sold and licensed by EquiLend to current and historical data related to securities lending transactions, or data derived from current and historical data using statistical or computational techniques. Further, the applicant notes that the terms of any sale or licensing of data must be at least as favorable to the plan as the terms generally available in an arm's-length transaction involving an unrelated party. The applicant represents that these limitations/conditions are sufficient to ensure that plans would be adequately protected to the extent Section I(b) of PTE 2002-30 is revised to include any current and historical data related to transactions proposed occurring off the Platform.
7. The applicant also seeks to amend Section II of PTE 2002-30, effective October 1, 2012. Section II presently permits: (1) Participation in the Platform by an Equity Owner, in its capacity as an Owner Lending Agent; and (2) the sale or licensing of certain data and/or analytical tools by EquiLend to a plan for which an Equity Owner acts as an Owner Lending Agent. The applicant notes that Section II of the individual exemption does not permit the provision by an Owner Lending Agent to EquiLend of securities lending data based on off-Platform securities lending transactions conducted by an Owner Lending Agent on behalf of a plan.
8. However, for the same reasons stated above, the applicant believes that access to off-Platform securities lending data by plans will further enhance EquiLend's existing client service functionality via the Platform by expanding the information that is available to plans. The applicant, therefore, requests that the Department amend PTE 2002-30 to permit, effective October 1, 2012, the provision by an Owner Lending Agent to EquiLend of securities lending data based on off-Platform securities lending transactions conducted by an Owner Lending Agent on behalf of a plan. The applicant notes that, if this proposed amendment is adopted, the three categories of transactions covered by Section II would be: (1) The participation in the Platform by an Equity Owner, in its capacity as an Owner Lending Agent; (2) the sale or licensing of certain data and/
9. The applicant believes that affected plans would be adequately protected with respect to the proposed amendment to Section II. In this regard, a new condition is proposed in Section II that would be applicable to the new category of transactions that would be covered therein. To the extent an Owner Lending Agent provides to EquiLend data based on off-Platform securities lending transactions conducted on behalf of plans, prior to such provision of data, each Owner Lending Agent will disclose to a plan's authorizing fiduciary who is independent of the Owner Lending Agent and EquiLend (other than in case of an Equity Owner Plan) that such Owner Lending Agent intends to provide to EquiLend data based on off-Platform securities lending transactions conducted on behalf the plan. Thereafter, the plan's authorizing fiduciary must consent to provision of such data by the Owner Lending Agent to EquiLend (such authorizing fiduciary will be deemed to have given the required authorization unless such authorizing fiduciary objects in writing to the provision to EquiLend of data based on off-Platform securities lending transactions conducted on behalf of the plan to the Owner Lending Agent within 30 days after disclosure of such information). This authorization may be terminated with respect to the future provision of data by the authorizing fiduciary without penalty to the plan, within the lesser of: (i) The time negotiated for such notice of termination by the plan and the Owner Lending Agent, or (ii) five business days.
10. The applicant notes that Section II of PTE 2002-30 contains other conditions that are designed to ensure that plans are adequately protected with respect to this amendment, if adopted. Specifically, conditions (a) through (j) of the individual exemption require that:
(A) In the case of participation in the Platform on behalf of a plan, to the extent applicable the procedures regarding the securities lending activities conform to the provisions of PTE 2006-16 (or its successor), and/or any applicable individual exemption;
(B) None of the fees imposed by EquiLend for securities lending transactions conducted through the use of the Platform at the direction of an Owner Lending Agent will be charged to a plan;
(C) Each securities lender and securities borrower participating in a securities lending transaction through EquiLend will be notified by EquiLend as to its responsibilities with respect to compliance, as applicable, with ERISA, the Code, and FERSA;
(D) Equilend will not act as a principal in any security lending transaction involving plan assets;
(E) Each Equity Owner will provide prior written notice to its plan clients of its intention to participate in EquiLend;
(F) The arrangement pursuant to which the Equity Owner utilizes the services of EquiLend on behalf of a plan:
(1) Is subject to the prior written authorization of an authorizing fiduciary;
(2) May be terminated by the authorizing fiduciary, without penalty to the plan, within the lesser of: (i) The time negotiated for such notice of termination by the plan and the Equity Owner, or (ii) five business days;
(G) With certain limited exceptions, each purchase or license of a securities lending-related product from EquiLend is subject to the prior authorization of an authorizing fiduciary;
(H) The Equity Owner will furnish each authorizing fiduciary with any reasonably available information which the Equity Owner reasonably believes to be necessary to determine whether such authorization should be made or renewed;
(I) The provision by an Owner Lending Agent to EquiLend of data based on off-Platform securities lending transactions conducted on behalf of a plan:
(1) Is subject to the prior authorization of an authorizing fiduciary ;
(2) May be terminated by the authorizing fiduciary with respect to the future provision of data, without penalty to the plan, within the lesser of: (i) The time negotiated for such notice of termination by the plan and the Equity Owner, or (ii) five business days; and
(J) The Equity Owner, together with its affiliates, does not own at the time of the execution of a securities lending transaction on behalf of a plan by the Equity Owner through EquiLend or at the time of the purchase, or commencement of licensing, of data and/or analytical tools by the plan, more than 20% of EquiLend.
11. In summary, the applicant represents that this proposed amendment to PTE 2002-30 satisfies the statutory criteria for an administrative exemption contained in ERISA section 408(a) and Code section 4975(c)(2) because, among other things: (a) The proposed amendment to Section I and Section II of PTE 2002-30 will be administratively feasible and protective of and in the best interests of the plans and their participants and beneficiaries because of the conditions set forth originally and for the same reasons as set forth originally in PTE 2002-30; and (b) the proposed amendment to Section II of PTE 2002-30 will be additionally protective of the rights of participants and beneficiaries because each Owner Lending Agent will disclose to a plan's authorizing fiduciary who is independent of the Owner Lending Agent and EquiLend (other than in case of an Equity Owner Plan) that such Owner Lending Agent intends to provide to EquiLend data based on off-Platform securities lending transactions conducted on behalf a plan. Further, the plan's authorizing fiduciary must consent to the provision of such data by the Owner Lending Agent to EquiLend.
The applicant represents that the potentially interested participants and beneficiaries cannot all be identified and therefore the only practical means of notifying such participants and beneficiaries of this proposed exemption is by the publication of this notice in the
Brian Shiker of the Department, telephone (202) 693-8552. (This is not a toll-free number.)
The attention of interested persons is directed to the following:
(1) The fact that a transaction is the subject of an exemption under section 408(a) of the Act and/or section
(2) Before an exemption may be granted under section 408(a) of the Act and/or section 4975(c)(2) of the Code, the Department must find that the exemption is administratively feasible, in the interests of the plan and of its participants and beneficiaries, and protective of the rights of participants and beneficiaries of the plan;
(3) The proposed exemptions, if granted, will be supplemental to, and not in derogation of, any other provisions of the Act and/or the Code, including statutory or administrative exemptions and transitional rules. Furthermore, the fact that a transaction is subject to an administrative or statutory exemption is not dispositive of whether the transaction is in fact a prohibited transaction; and
(4) The proposed exemptions, if granted, will be subject to the express condition that the material facts and representations contained in each application are true and complete, and that each application accurately describes all material terms of the transaction which is the subject of the exemption.
Occupational Safety and Health Administration (OSHA), Labor.
Request for public comments.
OSHA solicits public comments concerning its proposal to extend the Office of Management and Budget's (OMB) approval of the information collection requirements specified in the Standard on 4,4'—Methylenedianiline in Construction (29 CFR 1926.60).
Comments must be submitted (postmarked, sent, or received) by January 15, 2013.
Theda Kenney or Todd Owen, Directorate of Standards and Guidance, OSHA, U.S. Department of Labor, Room N-3609, 200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693-2222.
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent (i.e., employer) burden, conducts a preclearance consultation program to provide the public with an opportunity to comment on proposed and continuing information collection requirements in accord with the Paperwork Reduction Act of 1995 (44 U.S.C. 3506(c)(2)(A)). This program ensures that information is in the desired format, reporting burden (time and costs) is minimal, collection instruments are clearly understood, and OSHA's estimate of the information collection burden is accurate. The Occupational Safety and Health Act of 1970 (the OSH Act) (29 U.S.C. 651
The information collection requirements specified in the 4,4'- Methylenedianiline Standard for Construction (the “MDA Standard”) (29 CFR 1926.60) protect workers from the adverse health effects that may result from their exposure to MDA, including cancer, liver and skin disease. The major paperwork requirements specify that employers must perform initial, periodic, and additional exposure
Employers must label any material or products containing MDA, including containers used to store MDA-contaminated protective clothing and equipment. They also must inform personnel who launder MDA-contaminated clothing of the requirement to prevent release of MDA, while personnel who launder or clean MDA-contaminated protective clothing or equipment must receive information about the potentially harmful effects of MDA. In addition, employers are to post warning signs at entrances or accessways to regulated areas, as well as train workers exposed to MDA at the time of their initial assignment, and at least annually thereafter.
Other paperwork provisions of the MDA Standard require employers to provide workers with medical examinations, including initial, periodic, emergency and follow-up examinations. As part of the medical surveillance program, employers must ensure that the examining physician receives specific written information, and that they obtain from the physician a written opinion regarding the worker's medical results and exposure limitations.
The MDA Standard also specifies that employers are to establish and maintain exposure monitoring and medical surveillance records for each worker who is subject to these respective requirements, make any required record available to OSHA compliance officers and the National Institute for Occupational Safety and Health (NIOSH) for examination and copying, and provide exposure monitoring and medical surveillance records to workers and their designated representatives.
OSHA has a particular interest in comments on the following issues:
• Whether the proposed information collection requirements are necessary for the proper performance of the Agency's functions, including whether the information is useful;
• The accuracy of OSHA's estimate of the burden (time and costs) of the information collection requirements, including the validity of the methodology and assumptions used;
• The quality, utility, and clarity of the information collected; and
• Ways to minimize the burden on employers who must comply; for example, by using automated or other technological information collection and transmission techniques.
The Agency is requesting that it retain its previous burden hour request of 1,029 hours. As reported by the Consumer Price Index (CPI) there was a 9.1% inflation from 2007 to 2010. Therefore, there is an overall increase in capital costs of $5,640 (from $62,838 to $68,478). This adjustment is a result of an increase in the estimated cost of medical examinations from $168 to $183. Also, there is an increase in the estimated cost of laboratory airborne sample analysis from $107 to $117.
The Agency will summarize the comments submitted in response to this notice and will include this summary in the request to OMB to extend the approval of the information collection requirements contained in the Standard.
You may submit comments in response to this document as follows: (1) Electronically at
Because of security procedures, the use of regular mail may cause a significant delay in the receipt of comments. For information about security procedures concerning the delivery of materials by hand, express delivery, messenger, or courier service, please contact the OSHA Docket Office at (202) 693-2350, (TTY (877) 889-5627). Comments and submissions are posted without change at
All submissions, including copyrighted material, are available for inspection and copying at the OSHA Docket Office. Information on using the
David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and Health, directed the preparation of this notice. The authority for this notice is the Paperwork Reduction Act of 1995 (44 U.S.C. 3506
Institute of Museum and Library Services (IMLS), NFAH.
Notice of meeting.
This notice sets forth the agenda of the forthcoming meeting of the National Museum and Library Services Board. This notice also describes the function of the Board. Notice of the meeting is required under the Sunshine in Government Act.
Wednesday, November 14 and Thursday, November 15, 2012.
Twenty-Sixth Meeting of the National Museum & Library Service Board Meeting:
The meeting will be held at the Institute of Museum and Library Services. 1800 M Street NW., 9th Floor, Washington, DC, 20036. Telephone: (202) 653-4676.
Elizabeth Lyons, Program Coordinator for Special Events and Board Liaison, Institute of Museum and Library Services, 1800 M Street NW., 9th Floor, Washington, DC 20036. Telephone: (202) 653-4676.
The National Museum and Library Services Board is established under the Museum and Library Services Act, 20 U.S.C. Section 9101
The Executive Session from 12:30 p.m. until 2:00 p.m. on Wednesday, November 14, 2012, will be closed pursuant to subsections (c)(4) and (c)(9) of section 552b of Title 5, United States Code because the Board will consider information that may disclose: Trade secrets and commercial or financial information obtained from a person and privileged or confidential; and information the premature disclosure of which would be likely to significantly frustrate implementation of a proposed agency action. The Session from 9:00 a.m. until 12:00 p.m. on Thursday, November 15, 2012 is open to the public.
If you need special accommodations due to a disability, please contact: Institute of Museum and Library Services, 1800 M Street NW., 9th Fl., Washington, DC 20036. Telephone: (202) 653-4676; TDD (202) 653-4614 at least seven (7) days prior to the meeting date.
The National Science Board's
Friday, November 16, 2012, at 1:30 p.m. EST, Tuesday, November 20, 2012, at 1:30 p.m. EST.
Discussion of candidates for the 2013 Vannevar Bush Award and 2013 National Science Board Public Service Award.
Closed.
These meetings will be held by teleconference originating at the National Science Board Office, National Science Foundation, 4201Wilson Blvd., Arlington, VA 22230.
Please refer to the National Science Board Web site (
National Science Foundation.
Notice of permits issued under the Antarctic Conservation of 1978, Public Law 95-541.
The National Science Foundation (NSF) is required to publish notice of permits issued under the Antarctic Conservation Act of 1978. This is the required notice.
Nadene G. Kennedy, Permit Office, Office of Polar Programs, Rm. 755, National Science Foundation, 4201 Wilson Boulevard, Arlington, VA 22230.
On August 27, 2012, the National Science Foundation published a notice in the
Philip R. Kylel
Mr. Brandon D. Neff was formerly employed as a contract Condenser Replacement Project Superintendent at Energy Northwest's Columbia Generating Station (CGS or Licensee). The Licensee holds License NPF-21 issued by the U.S. Nuclear Regulatory Commission (NRC) pursuant to Part 50 of Title 10 of the
The NRC's Office of Investigations, Region IV, initiated an investigation from June 3, 2011, through May 14, 2012, at Columbia Generating Station, Richland, Washington. The purpose of the investigation was to review the circumstances surrounding a fitness-for-duty (FFD) matter that occurred at CGS on June 2, 2011. The incident involved Mr. Brandon D. Neff's willful attempt to subvert a FFD drug test. During the investigation, several individuals including: Ms. Hansen, FFD Laboratory Technician II; Ms. Witt, FFD Leader; and Mr. Gloyn, Supervisor of Security Compliance, informed the investigator that on June 2, 2011, Mr. Neff submitted a synthetic urine sample as specimen Y22362385, and documented in writing on the Licensee's Federal Drug Testing Custody and Control Form that the specimen collected was not adulterated in any manner. Through Mr. Neff's own testimony, he admitted to taking prescription medication during the 2011 Memorial Day holiday weekend and that the medication had been prescribed to another individual.
Furthermore, Mr. Neff admitted that he knew the ramifications of taking another individual's medication because he was familiar with the regulatory requirements under 10 CFR part 26, and the licensee's site-wide procedure SWP-FFD-01, “Fitness for Duty Program Requirements” that relate to FFD and drug use. As a result of his decision to take another individual's prescription medication, Mr. Neff took several coordinated steps in an attempt to circumvent a FFD drug test in the event he was selected.
Based on the statements of Mr. Brandon D. Neff and the results of the investigation, it was determined that Mr. Neff had deliberately submitted a synthetic urine sample as a specimen for a FFD drug test and deliberately provided false information by signing the Licensee's Federal Drug Testing Custody and Control Form attesting that the specimen collected was not adulterated in any manner.
In a letter dated September 14, 2012, the NRC provided Mr. Neff the results of the investigation, which was initiated by the NRC's Office of Investigations. The letter informed Mr. Neff that the NRC was considering escalated enforcement action against him for an apparent violation due to failure to provide complete and accurate information to CGS when attesting that the specimen collected during the FFD drug test was not adulterated in any manner. As part of the letter, the NRC offered Mr. Neff a choice to attend a Predecisional Enforcement Conference or to request Alternative Dispute Resolution (ADR) through the use of mediation to resolve any possible disagreement over: (1) Whether the violation occurred; and (2) the appropriate enforcement action. Mr. Neff initially responded that he would like ADR. Mr. Neff, however, did not respond to any NRC staff's subsequent communication attempts.
The NRC concluded that Mr. Neff violated 10 CFR 50.5(a)(2) by deliberately submitting to the Licensee information that he knew to be incomplete and inaccurate in some respect material to the NRC. The NRC concluded that Mr. Neff's actions were deliberate and that he took several coordinated steps to subvert a FFD test in the event that he was selected for a FFD drug test, as a result of his decision to take another individual's prescription medication.
The NRC must be able to rely upon the Licensee, its employees, and contractors to comply with the NRC requirements, including the requirement to maintain a drug-free workplace and a workplace free of the effects of such substances, and to provide information and maintain records that are complete and accurate in all material respects. Mr. Neff's actions, in violating 10 CFR 50.5 and his misrepresentations to the licensee, have raised serious doubts as to whether he can be relied upon to comply with the NRC requirements and to provide complete and accurate information to the NRC or its licensees.
Consequently, I lack the requisite reasonable assurance that Mr. Neff can conduct NRC-licensed activities in compliance with the NRC's requirements, and that the health and safety of the public will be protected if Mr. Neff were permitted at this time to be involved in NRC-licensed activities. Therefore, the public health, safety, and interest require that Mr. Neff be prohibited from any involvement in NRC-licensed activities for a period of 3 years from the effective date of this Order. Additionally, Mr. Neff is required to notify the NRC of his employment in NRC-licensed activities for a period of 1 year following the prohibition period.
Accordingly, pursuant to Sections 103, 161b, 161i, 182 and 186 of the Atomic Energy Act of 1954, as amended, and the Commission's regulations in 10 CFR 2.202, 10 CFR 50.5, and 10 CFR 150.20.
1. Mr. Brandon D. Neff is prohibited for 3 years, from the effective date of this Order, from engaging in NRC-licensed activities. NRC-licensed activities are those activities that are conducted pursuant to a specific or general license issued by the NRC, including, but not limited to, those activities of Agreement State licensees conducted pursuant to the authority granted by 10 CFR 150.20.
2. This Order shall be effective 30 days following its publication in the
3. If Mr. Neff is currently involved with an NRC licensee other than Columbia Generating Station, or engaged in any other NRC-licensed activities, he must immediately cease those activities, and inform the NRC of the name, address, and telephone number of the employer, and provide a copy of this order to the employer.
4. For a period of 1 year after the 3-year period of prohibition has expired, Mr. Neff shall, within 20 days of acceptance of his first employment offer involving NRC-licensed activities or his becoming involved in NRC-licensed activities, as defined in paragraph IV.1 above, provide notice to the Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, of the name, address, and telephone number of the employer or the entity where he is, or will be, involved in the NRC-licensed activities. In the notification, Mr. Neff shall include a statement of his commitment to compliance with regulatory requirements and the basis why the Commission should have confidence that he will now comply with applicable NRC requirements.
The Director, Office of Enforcement, may, in writing, relax or rescind any of the above conditions upon demonstration by Mr. Brandon D. Neff of good cause.
In accordance with 10 CFR 2.202, Mr. Brandon D. Neff must, and any other person adversely affected by this Order may, submit an answer to this Order within 30 days of its publication in the
All documents filed in the NRC adjudicatory proceedings, including a request for hearing, a petition for leave to intervene, any motion or other document filed in the proceeding prior to the submission of a request for hearing or petition to intervene, and documents filed by interested governmental entities participating under 10 CFR 2.315(c), must be filed in accordance with the NRC E-Filing rule (72 FR 49139; August 28, 2007). The E-Filing process requires participants to submit and serve all adjudicatory documents over the Internet, or in some cases to mail copies on electronic storage media. Participants may not submit paper copies of their filings unless they seek an exemption in accordance with the procedures described below.
To comply with the procedural requirements of E-Filing, at least 10 days prior to the filing deadline, the participant should contact the Office of the Secretary by email at
Information about applying for a digital ID certificate is available on the NRC's public Web site at
If a participant is electronically submitting a document to the NRC in accordance with the E-Filing rule, the participant must file the document using the NRC's online, Web-based submission form. In order to serve documents through the Electronic Information Exchange System, users will be required to install a Web browser plug-in from the NRC's Web site. Further information on the Web-based submission form, including the installation of the Web browser plug-in, is available on the NRC's public Web site at
Once a participant has obtained a digital ID certificate and a docket has been created, the participant can then submit a request for hearing or petition for leave to intervene. Submissions should be in Portable Document Format (PDF) in accordance with NRC guidance available on the NRC's public Web site at
The E-Filing system also distributes an email notice that provides access to the document to the NRC's Office of the General Counsel and any others who have advised the Office of the Secretary that they wish to participate in the proceeding, so that the filer need not serve the documents on those participants separately. Therefore, applicants and other participants (or their counsel or representative) must apply for and receive a digital ID certificate before a hearing request/petition to intervene is filed so that they can obtain access to the document via the E-Filing system.
A person filing electronically using the agency's adjudicatory E-Filing system may seek assistance by contacting the NRC Meta System Help Desk through the “Contact Us” link located on the NRC's Web site at
Participants who believe that they have a good cause for not submitting documents electronically must file an exemption request, in accordance with 10 CFR 2.302(g), with their initial paper filing requesting authorization to continue to submit documents in paper format. Such filings must be submitted by: (1) First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemaking and Adjudications Staff; or (2) courier, express mail, or expedited delivery service to the Office of the Secretary, Sixteenth Floor, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852, Attention: Rulemaking and Adjudications Staff. Participants filing a document in this manner are responsible for serving the document on all other participants. Filing is considered complete by first-class mail as of the time of deposit in the mail, or by courier, express mail, or expedited delivery service upon depositing the document with the provider of the service. A presiding officer, having granted an exemption request from using E-Filing, may require a participant or party to use E-Filing if the presiding officer subsequently determines that the reason for granting the exemption from use of E-Filing no longer exists.
Documents submitted in adjudicatory proceedings will appear in the NRC's electronic hearing docket, which is available to the public at
If a person other than Mr. Brandon D. Neff requests a hearing, that person shall set forth with particularity the manner in which his interest is adversely affected by this Order and shall address the criteria set forth in 10 CFR 2.309(d).
If a hearing is requested by Mr. Neff or a person whose interest is adversely affected, the Commission will issue an Order designating the time and place of any hearings. If a hearing is held, the issue to be considered at such hearing shall be whether this Order should be sustained. In the absence of any request for hearing or ADR, or written approval of an extension of time in which to request a hearing, the provisions
For the Nuclear Regulatory Commission.
Securities and Exchange Commission (the “Commission”).
Notice of an application for an order under section 6(c) of the Investment Company Act of 1940, as amended (the “Act”), for an exemption from section 15(a) of the Act and rule 18f-2 under the Act.
Highland Associates, Inc. (the “Adviser”) and Financial Investors Trust (the “Trust”), on behalf of the Redmont Resolute Fund I and Redmont Resolute Fund II (the “Redmont Funds”).
An order granting the application will be issued unless the Commission orders a hearing. Interested persons may request a hearing by writing to the Commission's Secretary and serving applicants with a copy of the request, personally or by mail. Hearing requests should be received by the Commission by 5:30 p.m. on December 4, 2012, and should be accompanied by proof of service on the applicants, in the form of an affidavit or, for lawyers, a certificate of service. Hearing requests should state the nature of the writer's interest, the reason for the request, and the issues contested. Persons who wish to be notified of a hearing may request notification by writing to the Commission's Secretary.
Elizabeth M. Murphy, Secretary, U.S. Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090. Applicants: c/o JoAnn Strasser, Thompson Hine LLP, 41 South High Street, 17th Floor, Columbus OH 43215.
Deepak T. Pai, Senior Counsel, at (202) 551-6876, or Mary Kay Frech, Branch Chief, at (202) 551-6821 (Division of Investment Management, Office of Investment Company Regulation).
The following is a summary of the application. The complete application may be obtained via the Commission's Web site by searching for the file number, or an applicant using the Company name box, at
1. The Trust, a Delaware statutory trust, is registered under the Act as an open-end management investment company and is comprised of individual series, including the Redmont Funds, each with its own investment objective, policies and restrictions.
2. Under the terms of the Advisory Agreement, the Adviser is responsible for the overall management of each Redmont Fund's business affairs and selecting investments according to their respective investment objectives, policies and restrictions. For the investment management services that it provides to a Redmont Fund, the Adviser receives the fee specified in the Advisory Agreement. The Advisory Agreement also permits the Adviser to retain one or more subadvisers for the purpose of managing the investments of all or a portion of the assets of the Redmont Funds. Pursuant to this authority, the Adviser may enter into investment subadvisory agreements with unaffiliated investment subadvisers (“Subadvisers”) to provide investment advisory services to the Redmont Funds (each, a “Subadvisory Agreement” and together, the “Subadvisory Agreements”).
3. Applicants request an order to permit the Adviser, subject to Board approval, to enter into and materially amend Subadvisory Agreements without obtaining shareholder approval.
4. Funds will inform shareholders of the hiring of a new Subadviser pursuant to the following procedures (“Modified Notice and Access Procedures”): (a) Within 90 days after a new Subadviser is hired for any Fund, that Fund will send its shareholders either a Multi-manager Notice or a Multi-manager Notice and Multi-manager Information Statement;
A “Multi-manager Information Statement” will meet the requirements of Regulation 14C, Schedule 14C and Item 22 of Schedule 14A under the Exchange Act for an information statement. Multi-manager Information Statements will be filed electronically with the Commission via the EDGAR system.
1. Section 15(a) of the Act provides, in relevant part, that it is unlawful for any person to act as an investment adviser to a registered investment company except pursuant to a written contract that has been approved by the vote of a majority of the company's outstanding voting securities. Rule 18f-2 under the Act provides that each series or class of securities in a series investment company affected by a matter must approve that matter if the Act requires shareholder approval.
2. Section 6(c) of the Act provides that the Commission may exempt any person, security, or transaction or any class or classes of persons, securities, or transactions from any provisions of the Act, or from any rule thereunder, if such exemption is necessary or appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Act. Applicants state that the requested relief meets this standard.
3. Applicants assert that the shareholders expect the Adviser and the Board to select the Subadvisers for the Funds that are best suited to achieve each Fund's investment objective. Applicants assert that, from the perspective of the investor, the role of the Subadvisers is substantially equivalent to that of the individual portfolio managers employed by the Adviser. Applicants state that requiring shareholder approval of each Subadvisory Agreement would impose costs and unnecessary delays on the Funds, and may preclude the Adviser from acting promptly in a manner considered advisable by the Board. Applicants note that the Advisory Agreement and any Subadvisory Agreement with an Affiliated Subadviser will remain subject to section 15(a) of the Act and rule 18f-2 under the Act, including the requirement for shareholder voting.
Applicants agree that any order granting the requested relief will be subject to the following conditions:
1. Before a Fund may rely on the requested order, the operation of the Fund in the manner described in the application will be approved by a majority of the Fund's outstanding voting securities, as defined in the Act, or in the case of a Fund whose public shareholders purchase shares on the basis of a prospectus containing the disclosure contemplated by condition 2 below, by the initial shareholder(s) before offering shares of that Fund to the public.
2. Each Fund relying on the requested order will disclose in its prospectus the existence, substance, and effect of any order granted pursuant to the application. Each Fund will hold itself out to the public as utilizing the Manager of Managers Structure. The prospectus will prominently disclose that the Adviser has ultimate responsibility (subject to oversight by the Board) to oversee the Subadvisers and recommend their hiring, termination, and replacement.
3. Funds will inform shareholders of the hiring of a new Subadviser within 90 days after the hiring of the new Subadviser pursuant to the Modified Notice and Access Procedures.
4. The Adviser will not enter into a subadvisory agreement with any Affiliated Subadviser without such agreement, including the compensation to be paid thereunder, being approved by the shareholders of the applicable Fund.
5. At all times, at least a majority of the Board will be Independent Trustees, and the nomination of new or additional Independent Trustees will be placed within the discretion of the then-existing Independent Trustees.
6. Whenever a subadviser change is proposed for a Fund with an Affiliated Subadviser, the Board, including a majority of the Independent Trustees, will make a separate finding, reflected in the applicable Board minutes, that such change is in the best interests of the Fund and its shareholders, and does not involve a conflict of interest from which the Adviser or the Affiliated Subadviser derives an inappropriate advantage.
7. The Adviser will provide general management services to each Fund, including overall supervisory responsibility for the general management and investment of each Fund's assets and, subject to review and approval of the Board, will: (a) Set each Fund's overall investment strategies; (b) evaluate, select and recommend Subadvisers to manage all or a part of each Fund's assets; (c) allocate and, when appropriate, reallocate each Fund's assets among one or more Subadvisers; (d) monitor and evaluate the performance of Subadvisers; and (e) implement procedures reasonably designed to ensure that the Subadvisers comply with each Fund's investment objective, policies and restrictions.
8. No trustee or officer of the Trust or a Fund, or director, manager, or officer of the Adviser, will own directly or indirectly (other than through a pooled investment vehicle that is not controlled by such person), any interest in a Subadviser, except for (a) ownership of interests in the Adviser or any entity that controls, is controlled by, or is under common control with the Adviser, or (b) ownership of less than 1% of the outstanding securities of any class of equity or debt of any publicly traded company that is either a Subadviser or an entity that controls, is controlled by, or is under common control with a Subadviser.
9. In the event the Commission adopts a rule under the Act providing substantially similar relief to that in the order requested in the application, the requested order will expire on the effective date of that rule.
For the Commission, by the Division of Investment Management, under delegated authority.
Notice is hereby given, pursuant to the provisions of the Government in the Sunshine Act, Public Law 94-409, that the Securities and Exchange Commission will hold a Closed Meeting on Wednesday, November 14, 2012 at 9:30 a.m.
Commissioners, Counsel to the Commissioners, the Secretary to the Commission, and recording secretaries will attend the Closed Meeting. Certain staff members who have an interest in the matters also may be present.
The General Counsel of the Commission, or his designee, has certified that, in his opinion, one or more of the exemptions set forth in 5 U.S.C. 552b(c)(4), (8), (9)(A)(i) and (ii), and 17 CFR 200.402(a)(4), (8), (9)(A)(i) and (ii), permit consideration of the scheduled matter at the Closed Meeting.
Commissioner Walter, as duty officer, voted to consider the item listed for the Closed Meeting in a closed session, and determined that no earlier notice was possible.
The subject matter of the Closed Meeting will be an examination of a financial institution.
At times, changes in Commission priorities require alterations in the scheduling of meeting item.
For further information and to ascertain what, if any, matters have been added, deleted or postponed, please contact: The Office of the Secretary at (202) 551-5400.
On March 1, 2012 and April 23, 2012, NASDAQ OMX PHLX LLC (“Phlx” or “Exchange”) filed with the Securities and Exchange Commission (the “Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Exchange Act” or “Act”)
On April 30, 2012, the Commission suspended the proposals and instituted proceedings to determine whether to approve or disapprove the proposals.
The Commission received no comment letters on the proposals. This order approves the proposed rule changes, as modified by Amendments No. 1, and approves, as a one-year pilot program, those fees which the Exchange proposes to implement on a pilot basis.
The Exchange's first proposal amended Complex Order fees and rebates for adding and removing liquidity in its Select Symbols.
Phlx's proposal to amend the Fee for Removing Liquidity increased the Complex Order Fees for Removing Liquidity for the Directed Participant, Market Maker, Firm, Broker-Dealer, and Professional
The proposal also provided a new volume incentive to Market Makers. The Exchange has four categories of Market Makers—Specialists,
In its second proposal, the Exchange did not propose to amend any of the fees for the Complex Order Directed Participant and Market Maker Fees for Removing Liquidity in Select Symbols. Rather, the Exchange provided further justification for the differential between the fees paid by Directed Participants and Market Makers.
As discussed more fully below, in its proposals and in its subsequent letter in support of its proposals, the Exchange advanced several arguments as to why the proposal to increase the fee for removing liquidity for Complex Orders to $0.32 per contract for Directed Participants, and to $0.37 per contract for non-directed Market Makers, and the corresponding increase in the differential between these two fees from $0.02 to $0.05 per contract, was not unreasonable or unfairly discriminatory. First, the Exchange stated that Directed Participants enter into payment for order flow agreements (“PFOF”) with OFPs so that OFPs will direct order flow to them to execute against.
In its order suspending the two proposals and instituting proceedings to determine whether to approve or disapprove the proposals, the Commission noted several areas of concern. For example, the Commission questioned whether discrimination on the basis of whether a Market Maker has an off-exchange arrangement to pay an OFP to direct its orders to that Market Maker is a “fair” basis for discrimination among exchange members with respect to the fees charged by the Exchange, and whether a flat $0.05 fee differential appropriately reflects potential differences that may exist in payment for order flow arrangements between Market Makers and OFPs.
During the course of the proceedings, the Exchange amended its filings to implement the fee for removing liquidity for Directed Participants and other Market Makers on a one-year pilot basis, and to state that the proposed fees would be operative on December 3, 2012. The Exchange also represented that it would provide the Commission with certain publicly available data and data analyses, on a monthly basis, over the course of the pilot program that would enable the Commission to better evaluate the effects of the fee proposals. As part of the amendment, the Exchange also represented that, prior to and at the time of a complex order transaction, Market Makers, including Directed Participants, are unaware of the identity of the contra-party to the transaction. The Exchange stated that Rule 707 is intended to prohibit coordinated actions between Directed Participants and OFPs, and that the Exchange proactively
After careful consideration, and as discussed below, the Commission finds that the proposed rule changes are consistent with the requirements of the Act and the rules and regulations thereunder applicable to a national securities exchange. In particular, the Commission finds that the proposals are consistent with Section 6(b)(4) of the Act, which requires that the rules of a national securities exchange “provide for the equitable allocation of reasonable dues, fees, and other charges among its members and issuers and other persons using its facilities;”
Phlx argues in part that the Commission should rely on competitive forces to determine whether the proposed fees are reasonable and not unfairly discriminatory. Phlx states that competition should determine fee changes, noting that the “Congress directed that exchanges' fee changes be deemed immediately effective for the expressed purpose of promoting price competition between markets.”
Phlx represents that the options markets operate in an intensely competitive environment, and that it and the other options exchanges are engaged in an intense competition on price (and other dimensions of competition) to attract order flow from directed and other order flow providers.
Phlx asserts that, in vibrant markets such as the options markets, participants who view one pricing scheme as unpalatable are free to move to another market or markets with favorable pricing.
The Commission disagrees with the Exchange's assertion that the existence of competition alone is adequate to determine whether the fees are reasonable, not unfairly discriminatory, and an equitable allocation of fees among members under the Exchange Act. The Commission's market-based approach to evaluating whether certain market data fees are consistent with the Exchange Act incorporates two parts.
Applying this approach to the Exchange's proposal, the Commission finds under the first part of the analysis that the Exchange was subject to significant competitive forces in setting the terms of its proposal. There currently are ten registered national securities exchanges that trade listed options. The Commission has previously found that there is significant competition for order flow in the options markets.
Under the second part of the analysis, the Commission does not at this time find that there is a substantial countervailing basis to find that the terms of the fees and fee differential fail to meet the requirements of the Exchange Act or the rules thereunder. The Commission notes that it received no comments in opposition to the proposed rule changes. The fees for removing liquidity as proposed distinguish between Directed Participants and all other Market Makers (or other members), and would provide the Directed Participants a lower fee than other Market Makers when the Directed Participants interact with order flow that has been directed to them. The Exchange argues in part that Directed Participants that execute against order flow in the complex market that has been directed to them do not have a 40% guaranteed allocation, unlike in the leg market,
For orders involving Directed RSQTs or SQTs, the contacts remaining in the Directed Order, if any, shall be allocated automatically as follows: The Directed RSQT or SQT shall be allocated a number of contracts that is the greater of the proportion of the aggregate size at the NBBO associated with such Directed SQT or RSQT's quote, the specialist's quote, other SQT and RSQT quotes, and non-SQT ROT limit orders entered on the book via electronic interface at the disseminated price represented by the size of the Directed RSQT or SQT's quote at the NBBO, or 40% of the remaining contracts.
The Commission has previously approved as consistent with the Act rules of exchanges that provide directed Market Makers a 40% guaranteed allocation when they interact with directed order flow, based upon their status as directed Market Makers.
When approving the proposals that provided a guaranteed allocation to directed market makers, the Commission found that the guaranteed allocation for directed market makers would not affect the incentives of the trading crowd to compete aggressively for orders based on price.
The Commission has carefully considered the potential impact of the fees for removing liquidity on Directed Participants and other Market Makers and the $0.05 fee differential on competition between Directed Participants and other Market Makers that are competing to execute against the same order flow, and on the extent of price improvement provided to directed customer Complex Orders. The data provided by Phlx does not show any statistical significant adverse impact of the proposed fee and fee differential on the competitiveness of the market for directed customer Complex Orders on Phlx, or the extent of price improvement for directed customer Complex Orders.
With respect to rates of customer Complex Order interaction, for the period prior to the introduction of the new fees (March 2011-February 2012), the average order interaction by Directed Participants was 14.98%. For March and April 2012, when the lower Directed Participant (as compared to the fee assessed to other Market Makers) fee was in effect, the statistics show that order interaction by Directed Participants averaged 14.02% and 15.64%, respectively. These figures reflect the rates of Complex Order interaction as averaged among Directed Participants, i.e., the rate of Complex Order interaction for any given Directed Participant could, in fact, be much higher.
With respect to price improvement data, Phlx produced data for directed customer Complex Orders receiving price improvement, showing the breakdown by contra side participant type, and the average amount of price improvement for such order flow, also by contra side participant type. This data was produced for November 2011 to May 2012, using the week before the standard expirations in each month. The data that has been submitted shows that, for directed customer Complex Orders that received price improvement, Directed Participants interacted with those orders 7.8% of the time, and provided average price improvement of $7.90 per contract, during the time that the suspended fees were not in effect (November 2011-February 2012, and May 2012), and 11.8% of the time, with an average price improvement amount of $4.70 per contract, during the time that the suspended fees were in effect (March-April 2012). For directed customer Complex Orders that received price improvement, other Market Makers interacted with those orders 86.74% during the time that the suspended fees were not in effect (November 2011-February 2012, and May 2012) and 7.8% of the time during the time that the suspended fees were in effect (March-April 2012), and provided average price improvement of $6.14 and $5.15 per contract, respectively, for the same respective time periods.
Phlx also produced data showing the percentage of directed and non-directed customer Complex Orders that received price improvement, and the average amount of price improvement. This data was produced for November 2011 to May 2012, using the week before the standard expirations in each month. The data that has been submitted shows that non-directed customer Complex Orders received price improvement 17.2% of the time while the suspended fees were not in effect (November 2011-February 2012, and May 2012), with an average price improvement of $3.29 per contract. During the time the suspended fees were in effect (March-April 2012), non-directed Customer Complex orders received price improvement 13% of the time, with an average price improvement of $3.39 per contract. Directed customer Complex Orders received price improvement 29.6% of the time while the suspended fees were not in effect (November 2011-February 2012, and May 2012), with an average price improvement of $6.26 per contract. During the time the suspended fees were in effect (March-April 2012), directed Customer Complex orders received price improvement 30.5% of the time, with an average price improvement of $5.10 per contract.
In providing this data, Phlx used a definition of price improvement that compared the execution price with the limit price of the incoming order. In the data to be provided by Phlx as part of the pilot, Phlx will measure price improvement by comparing the Phlx best bid or offer at the time of the incoming order to the execution price of the order.
However, the suspended fees that are at issue were only in place for two months and thus were only analyzed over that period.
This data and analysis will allow the Exchange and the Commission to further evaluate during the course of the pilot program the impact of the fees for removing liquidity for Directed Participants and other Market Makers and the $0.05 fee differential on competition between Directed Participants and other Market Makers and the extent of price improvement for Complex Orders over a longer time period with a larger data set.
In its original filing, the Exchange also pointed to the existence of non-exchange sponsored PFOF arrangements as a basis for the fees and fee differential. Specifically, Phlx argued that the fee differential is fair, equitable and not unfairly discriminatory because it is intended “to * * * reflect the increased costs that are incurred by such Market Makers that enter into order flow arrangements at a cost and without the benefit of a guaranteed allocation.”
In support of its argument, Phlx has represented that it is aware that non-exchange-sponsored PFOF arrangements exist, and that the rates paid by Market Makers under these arrangements, in many cases, “exceed [Phlx's] own exchange-sponsored payment for order flow fee and also exceed the rebates that [Phlx] provides for adding or removing liquidity from the exchange.”
The Commission does not believe that this argument provides a reasonable basis to find that the fees and fee differential are consistent with the Act. As outlined above, pursuant to this argument, Phlx would be setting its fees, and discriminating among market participants, based on the existence of non-exchange sponsored PFOF arrangements. The record, however, does not contain any representations regarding the amounts of payments made by Directed Participants pursuant to such arrangements or whether such payments are made, whether these off-exchange PFOF arrangements are standardized, and whether the terms and amounts are the same between different OFPs and Directed Participants. As such, the Exchange has not substantiated the details of such off-exchange PFOF arrangements. The Commission believes it is likely that the terms of such arrangements could vary considerably between different Directed Participants and OFPs. Essentially, pursuant to this argument, Phlx could be discriminating in its fees for a specified amount based on payments potentially made off-exchange that may vary widely. The Commission therefore does not believe that this argument provides a basis to support a finding that the fees and fee differential are reasonable, equitably allocated, and not unfairly discriminatory. Nevertheless, for the reasons discussed above, the Commission finds that the proposed rule changes are consistent with 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 email to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
Amendments No. 1 revised the proposed rule changes to, among other things, specify that the portion of the proposed rule change relating to fees for removing liquidity for Complex Orders for Directed Participants and other Market Makers, and the accompanying $0.05 fee differential, will be operative on a one-year pilot basis, and that such fees would be operative on December 3, 2012. Phlx also committed to provide the Commission, on a monthly basis, with publicly available data and data analyses studying the impact of the fees for removing liquidity for complex orders for Directed Participants and other Market Makers upon inter and intra-market competition, and upon market quality. The Exchange represented that it would provide such information as the Commission may request regarding this fee pilot, including information with respect to rates of order interaction with Customer Complex Orders and rates of price improvement. Receiving data and analysis from the Exchange during the duration of the pilot period will allow the Commission (and the Exchange) to continue to assess the impact, if any, of the proposed rule changes during the pilot period. Accordingly, the Commission finds good cause, pursuant to Section 19(b)(2) of the Act,
For the foregoing reasons, the Commission finds that the proposed rule changes, as modified by Amendments No. 1, are consistent with the Act and the rules and regulations thereunder applicable to a national securities exchange, and, in particular, with Sections 6(b)(4), 6(b)(5), and 6(b)(8) of the Act.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange proposes to amend the fee schedule applicable to Members
The text of the proposed rule change is available at the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these 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 modify the “Options Pricing” section of its fee schedule effective immediately, in order to: (i) Increase the TCV improvement requirements for the Grow with Us pricing plan; (ii) modify the rebates provided by the Exchange for Customer
The Exchange currently offers its Grow with Us pricing program to certain orders that add or remove liquidity, as further explained below, by providing a Member with enhanced rebates (and lower execution fees) to the extent such Member shows a minimum of 5 basis points of total consolidated volume (“TCV”)
The Exchange has found that normal variance in trading behavior can cause an improvement of greater than 5 basis points from its Members. As such, the Exchange proposes to increase the requirement for the minimum improvement from 5 basis points of TCV to a more significant improvement of 10 basis points of TCV.
(ii) Customer Rebates for Adding Liquidity in Penny Pilot Securities
The Exchange currently provides rebates for Customer orders that add liquidity to the BATS Options order book in Penny Pilot Securities pursuant to a tiered pricing structure, as described below. In order to make a broader based and more inclusive rebate structure, the Exchange proposes to modify this tiered pricing structure and the rebates associated therewith as well as modify the rebates associated with the Grow with Us pricing program.
The Exchange currently provides a rebate of $0.30 per contract for Customer orders that add liquidity to the BATS Options order book to the extent a Member of BATS Options does not qualify for a higher rebate based on their average daily volume (“ADV”).
The Exchange proposes to adjust the existing volume tiers, to add an additional volume tier, and to modify the rebates paid for Customer orders that add liquidity to the BATS Options order book in Penny Pilot Securities.
The Exchange proposes to decrease the lower volume tier level from an ADV equal to or greater than 0.30% of average TCV to an ADV equal to or greater than 0.25% of average TCV. The Exchange also proposes to lower the upper volume tier level from an ADV equal to or greater than 1% of average TCV to an ADV equal to or greater than 0.75% of average TCV. Lastly, the Exchange proposes to add an additional volume tier level at an ADV equal to or greater than 1.25% of average TCV. This proposal would result in three distinct discounted volume tiers for Customer orders that add liquidity to BATS Options in Penny Pilot Securities, as follows: greater than or equal to 0.25%, but less than 0.75%; greater than or equal to 0.75%, but less than 1.25%; and equal to or greater than 1.25%.
The Exchange proposes to increase its rebate for any Member that qualifies for the lower tier applicable to Members with an ADV equal to or greater than 0.25% of average TCV but not the 0.75% of average TCV tier from a rebate of $0.42 per contract to a rebate of $0.43 per contract for Customer orders that add liquidity to BATS Options in Penny Pilot Securities. The Exchange proposes to increase its rebate for any Member that qualifies for the middle tier applicable to Members with an ADV equal to or greater than 0.75% of average TCV but not the 1.25% of average TCV tier from a rebate of $0.44 per contract to a rebate of $0.46 per contract for Customer orders that add liquidity to BATS Options in Penny Pilot Securities. The Exchange proposes to add a rebate for Members that qualify for the proposed upper tier applicable to Members with an ADV equal to or greater than 1.25% of average TCV of $0.47 per contract for Customer orders that add liquidity to BATS Options in Penny Pilot Securities.
As part of the Grow with Us pricing program, the Exchange also proposes to reduce its rebate for any Member that does not qualify for the lower tier applicable to Members with an ADV equal to or greater than 0.25% of average TCV but achieves a 10 basis point increase over its previous High Water Mark from a rebate of $0.38 per contract to a rebate of $0.31 per contract for Customer orders that add liquidity to BATS Options in Penny Pilot Securities. The Exchange proposes to reduce the rebate for any Member that qualifies for the lower tier applicable to Members with an ADV equal to or greater than 0.25% of average TCV but not the 0.75% of average TCV tier that achieves at least a 10 basis point increase over its previous High Water Mark from a rebate of $0.45 per contract to a rebate of $0.44 per contract for Customer orders that add liquidity to BATS Options in Penny Pilot Securities. The Exchange proposes to increase its rebate for any Member that qualifies for the middle tier applicable to Members with an ADV equal to or greater than 0.75% of average TCV but not the 1.25% of average TCV tier that achieves at least a 10 basis point increase over its previous High Water Mark from a rebate of $0.46 per contract to a rebate of $0.47 per contract for Customer orders that add liquidity to BATS Options in Penny Pilot Securities.
(iii) Customer Fees for Removing Liquidity in Penny Pilot Securities
The Exchange currently charges fees for Customer orders that remove liquidity from the BATS Options order book in Penny Pilot Securities pursuant to a tiered pricing structure, as described below. The Exchange proposes to modify this tiered pricing structure and the fees associated therewith as well as modify the fees associated with the Grow with Us pricing program.
The Exchange currently charges Members with an ADV less than 0.30% of TCV with a fee of $0.44 per contract for Customer orders that remove liquidity from the BATS Options order book in Penny Pilot Securities. The Exchange currently charges Members with an ADV greater than 0.30% of TCV but less than 1.0% of TCV with a fee of $0.40 per contract for Customer orders that remove liquidity from the BATS Options order book in Penny Pilot Securities. The Exchange currently charges Members with an ADV greater than than 1.0% of TCV with a fee of $0.36 per contract for Customer orders that remove liquidity from the BATS Options order book in Penny Pilot Securities. Finally, the Exchange currently offers its Grow with Us pricing program to Customer orders that remove liquidity by reducing the fees charged to a Member to the extent such Member shows a minimum of 5 basis points TCV improvement over the Member's previous High Water Mark. Under the current pricing structure, any Member that does not qualify for the lower tier applicable to Members with an ADV equal to or greater than 0.30% of average TCV but achieves at least a 5 basis point increase over its previous High Water Mark is charged a fee of $0.42 per contract for Customer orders that remove liquidity from the BATS Options order book in Penny Pilot Securities. A Member that qualifies for the lower tier applicable to Members with an ADV equal to or greater than 0.30% of average TCV but not the 1% of average TCV tier that achieves at least a 5 basis point increase over its previous High Water Mark is charged a fee of $0.38 per contract for Customer orders that remove liquidity from the BATS Options order book in Penny Pilot Securities. A Member that qualifies for the highest tier applicable to Members with an ADV equal to or greater than 1% of average TCV that achieves at least a 5 basis point increase over its previous High Water Mark is charged a fee of $0.36 per contract for Customer orders that remove liquidity from the BATS Options order book in Penny Pilot Securities.
The Exchange proposes to adjust the existing volume tiers, to add an
The Exchange proposes to decrease the lower volume tier level from an ADV equal to or greater than 0.30% of average TCV to an ADV equal to or greater than 0.25% of average TCV. The Exchange also proposes to lower the upper volume tier level from an ADV equal to or greater than 1% of average TCV to an ADV equal to or greater than 0.75% of average TCV. Lastly, the Exchange proposes to add an additional volume tier level at an ADV equal to or greater than 1.25% of average TCV. This proposal would result in three distinct discounted volume tiers for Customer orders that remove liquidity from BATS Options in Penny Pilot Securities, as follows: greater than or equal to 0.25%, but less than 0.75%; greater than or equal to 0.75%, but less than 1.25%; and equal to or greater than 1.25%.
The Exchange proposes to increase its fee for any Member that does not qualify for the lower tier applicable to Members with an ADV equal to or greater than 0.25% of average TCV from a fee of $0.44 per contract to $0.45 per contract for Customer orders that remove liquidity from BATS Options in Penny Pilot Securities. The Exchange proposes to increase its fee for any Member that qualifies for the lower tier applicable to Members with an ADV equal to or greater than 0.25% of average TCV but not the 0.75% of average TCV tier from a fee of $0.40 per contract to $0.44 per contract for Customer orders that remove liquidity from BATS Options in Penny Pilot Securities. The Exchange proposes to add a fee for any Member that qualifies for the middle tier applicable to Members with an ADV equal to or greater than 0.75% of average TCV but not the 1.25% of average TCV tier from a fee of $0.43 per contract for Customer orders that remove liquidity from BATS Options in Penny Pilot Securities. The Exchange proposes to increase the fee for any Member that qualifies for the proposed upper tier applicable to Members with an ADV equal to or greater than 1.25% of average TCV from $0.36 per contract to $0.42 for Customer orders that remove liquidity from BATS Options in Penny Pilot Securities.
As part of the Grow with Us pricing program, the Exchange also proposes to increase its fee for any Member that does not qualify for the lower tier applicable to Members with an ADV equal to or greater than 0.25% of average TCV but achieves a 10 basis point increase over its previous High Water Mark from a fee of $0.42 per contract to a fee of $0.44 per contract for Customer orders that remove liquidity from BATS Options in Penny Pilot Securities. The Exchange proposes to increase the fee for any Member that qualifies for the lower tier applicable to Members with an ADV equal to or greater than 0.25% of average TCV but not the 0.75% of average TCV tier that achieves at least a 10 basis point increase over its previous High Water Mark from a fee of $0.38 per contract to a rebate [sic] of $0.43 per contract for Customer orders that remove liquidity from BATS Options in Penny Pilot Securities. The Exchange proposes to add a fee for any Member that qualifies for the middle tier applicable to Members with an ADV equal to or greater than 0.75% of average TCV but not the 1.25% of average TCV tier that achieves at least a 10 basis point increase over its previous High Water Mark of $0.42 per contract for Customer orders that remove liquidity from BATS Options in Penny Pilot Securities.
The Exchange currently provides a rebate of $0.22 per contract for Professional, Firm, and Market Maker orders that add liquidity to the BATS Options order book in Penny Pilot Securities and are removed by a Customer order. The Exchange currently provides a rebate of $0.32 per contract for Professional, Firm, and Market Maker orders that add liquidity to the BATS Options order book in Penny Pilot Securities and are removed by a Professional, Firm, or Market Maker order.
In order to further incentivize liquidity on BATS Options, the Exchange proposes to increase its rebate for Professional, Firm, and Market Maker orders that add liquidity to the BATS Options order book in Penny Pilot Securities and are removed by a Customer order from $0.22 per contract to $0.25 per contract. The Exchange also proposes to increase its rebate for Professional, Firm, and Market Maker orders that add liquidity to the BATS Options order book in Penny Pilot Securities and are removed by a Professional, Firm, or Market Maker order from $0.32 per contract to $0.35 per contract.
The Exchange currently charges a fee of $0.45 per contract for Professional, Firm, and Market Maker orders that remove liquidity from BATS Options in Penny Pilot Securities, where the Member does not qualify for a lower charge based on TCV improvement. The Exchange currently charges a fee of $0.44 per contract for Professional, Firm, and Market Maker orders that remove liquidity from BATS Options in Penny Pilot Securities where the Member shows a minimum of 5 basis points of TCV improvement over their previous High Water Mark.
The Exchange proposes to increase its fees for Professional, Firm, and Market Maker orders that remove liquidity from BATS Options in Penny Pilot Securities where the Member does not qualify for a lower charge based on TCV improvement from $0.45 per contract to $0.47 per contract. The Exchange also proposes to increase its fees for Professional, Firm, and Market Maker orders that remove liquidity from BATS Options in Penny Pilot Securities where the Member shows a minimum of 10 basis points of TCV improvement, as proposed above, over their previous High Water Mark from $0.44 per contract to $0.46 per contract.
The Exchange's NBBO Setter Program is a program intended to incentivize aggressive quoting on BATS Options by providing an additional rebate upon execution for all orders that add liquidity that set either the NBB or NBO (the “NBBO Setter Rebate”),
The Exchange also applies its Grow with Us pricing program to the NBBO Setter Rebate. Accordingly, any Member that does not qualify for NBBO Setter Rebates applicable to Members with an ADV equal to or greater than 0.30% of average TCV but achieves at least a 5 basis point increase over its previous High Water Mark receives NBBO Setter Rebates of $0.03 per contract for qualifying executions. Similarly, any Member that qualifies for the lower tier
The Exchange proposes to adjust the existing volume tiers, to add an additional volume tier, and to modify the rebates paid as part of the NBBO Setter Rebate program.
The Exchange proposes to decrease the lower volume tier level from an ADV equal to or greater than 0.30% of average TCV to an ADV equal to or greater than 0.25% of average TCV. The Exchange also proposes to lower the upper volume tier level from an ADV equal to or greater than 1% of average TCV to an ADV equal to or greater than 0.75% of average TCV. Lastly, the Exchange proposes to add an additional volume tier level at an ADV equal to or greater than 1.25% of average TCV. This proposal would result in three distinct discounted volume tiers for the NBBO Setter Rebate, as follows: greater than or equal to 0.25%, but less than 0.75%; greater than or equal to 0.75%, but less than 1.25%; and equal to or greater than 1.25%.
The Exchange proposes to decrease its NBBO Setter Rebate for executions of Professional, Firm, and Market Maker orders that qualify for the NBBO Setter Rebate by any Member that qualifies for the lower tier applicable to Members with an ADV equal to or greater than 0.25% of average TCV but not the 0.75% of average TCV from $0.06 per contract to $0.03 per contract. The Exchange also proposes to decrease its NBBO Setter Rebate for executions of Professional, Firm, and Market Maker orders that qualify for the NBBO Setter Rebate by any Member that qualifies for the lower tier applicable to Members with an ADV equal to or greater than 0.75% of average TCV but not the 1.25% of average TCV from $0.10 per contract to $0.06 per contract. The Exchange proposes to add an NBBO Setter Rebate for executions of Professional, Firm, and Market Maker orders that qualify for the NBBO Setter Rebate by any Member that qualifies for the highest tier applicable to Members with an ADV equal to or greater than 1.25% of average TCV of $0.10 per contract.
The Exchange proposes to eliminate its current NBBO Setter Rebate of $0.03 for a Member that does not qualify for the lower tier but does achieve an increase over its previous High Water Mark and under current pricing receives a Grow with Us benefit. The Exchange proposes to decrease its rebate for executions of Professional, Firm, and Market Maker orders that qualify for the NBBO Setter Rebate by a Member that qualifies for the lower tier applicable to Members with an ADV equal to or greater than 0.25% of average TCV but not the 0.75% of average TCV that also show a minimum of 10 basis points TCV improvement over their previous high water mark, as proposed above, from $0.08 per contract to $0.05 per contract. The Exchange also proposes to add a rebate for executions of Professional, Firm, and Market Maker orders that qualify for the NBBO Setter Rebate by a Member that qualifies for the middle tier applicable to Members with an ADV equal to or greater than 0.75% of average TCV but not the 1.25% of average TCV that also show a minimum of 10 basis points TCV improvement over their previous high water mark, as proposed above, of $0.08 per contract.
The Exchange currently charges a fee of $0.80 per contract for Professional, Firm, and Market Maker orders that remove liquidity from BATS Options in non-Penny Pilot Securities. The Exchange proposes to increase the fee for Professional, Firm, and Market Maker orders that remove liquidity from BATS Options in non-Penny Pilot Securities from $0.80 per contract to $0.84 per contract.
The Exchange currently provides a rebate of $0.75 per contract for Customer orders that add liquidity to BATS Options in non-Penny Pilot Securities. The Exchange also currently provides a rebate of $0.70 per contract for Professional, Firm, and Market Maker orders that remove liquidity from BATS Options in non-Penny Pilot Securities.
The Exchange proposes to increase the rebate for Customer orders that add liquidity to BATS Options in non-Penny Pilot Securities from $0.75 per contract to $0.80 per contract. The Exchange also proposes to decrease the rebate for Professional, Firm, and Market Maker orders that add liquidity to BATS Options in non-Penny Pilot Securities from $0.70 per contract to $0.60 per contract.
In order to further incentivize aggressive liquidity by incenting displayed size of contracts, the Exchange implemented the Enhanced NBBO Setter Rebate on June 1, 2012. The Enhanced NBBO Setter Rebate provides twice the rebate for executions that qualify for an NBBO Setter Rebate and result from an order with a displayed size that equals or exceeds 25 contracts. Due to limited customer participation, however, the Exchange proposes to eliminate the Enhanced NBBO Setter Rebate altogether. Over the implementation period, participation has been low, and eliminating the Enhanced NBBO Setter Rebate will act to simplify the Exchange's fee schedule while eliminating an underutilized pricing program.
The Exchange proposes to change pricing with respect to orders routed to away options exchanges. The Exchange currently charges certain flat rates for routing to other options exchanges that have been placed into groups based on the approximate cost of routing to such venues. The grouping of away options exchanges is based on the cost of transaction fees assessed by each venue as well as costs to the Exchange for routing (i.e., clearing fees, connectivity and other infrastructure costs, membership fees, etc.) (collectively, “Routing Costs”).
The Exchange currently has two categories for the Nasdaq Options Market (“NOM”) under which it charges: (i) A fee of $0.50 per contract for Customer orders and $0.57 per contract for Professional, Firm, or Market Maker orders routed to and executed at NOM in all options other than Specified Symbols;
Based on recent changes to NOM pricing,
As of November 1, ARCA is also adjusting its pricing structure to more closely resemble that of NOM in non-Penny Pilot Securities.
The Exchange generally imposes routing fees that approximate the Exchange's Routing Costs, however, in order to maintain some level of consistency in its fee schedule, the Exchange does not always adjust its routing fees when an away options exchange adjusts its pricing. Because the Exchange doesn't always adjust its routing fees to be perfectly in line with away options exchanges, over time, the Exchange can end up charging less for executions at the away options exchanges than are required to cover its Routing Costs. Currently, this is the case for several of the away options exchange groupings. As such, the Exchange is proposing the following:
• To increase the fees for Customer orders executed at NYSE MKT LLC (“AMEX”), BOX Options Exchange LLC (“BOX”), Chicago Board Options Exchange, Inc. (“CBOE”), NASDAQ OMX BX, Inc. (“BX Options”), International Securities Exchange, LLC (“ISE”) (Classic issues), and PHLX (Classic issues) from $0.10 per contract to $0.11 per contract.
• To increase the fees for Professional, Firm, and Market Maker orders executed at AMEX, BOX, CBOE, BX Options, ISE (Classic issues), and PHLX (Classic issues) from $0.55 per contract to $0.57 per contract.
• To increase the fees for Professional, Firm, and Market Maker orders executed at ISE in Make/Take issues from $0.55 per contract to $0.57 per contract.
• To increase the fees for Customer orders executed at C2, ARCA in Make/Take issues, PHLX in Make/Take issues, and NOM in Penny Pilot Securities from $0.50 per contract to $0.52 per contract.
• To increase the fees for Professional, Firm, and Market Maker orders executed at C2, ARCA in Make/Take issues, PHLX in Make/Take issues, and NOM in Penny Pilot Securities from $0.55 per contract to $0.57 per contract.
The Exchange believes that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder that are applicable to a national securities exchange, and, in particular, with the requirements of Section 6 of the Act.
The Exchange believes that continuing to provide additional financial incentives to Members that demonstrate an increase over their previous High Water Mark offers an additional, flexible way to achieve financial incentives from the Exchange and encourages Members to add increasing amounts of liquidity to BATS Options each month. The Grow with Us pricing program, therefore, is reasonable in that it rewards a Member's growth patterns. Such increased volume increases potential revenue to the Exchange, and will allow the Exchange to continue to provide and potentially expand the incentive programs operated by the Exchange. The increased liquidity also benefits all investors by deepening the BATS Options liquidity pool, offering additional flexibility for all investors to enjoy cost savings, supporting the quality of price discovery, promoting market transparency and improving investor protection. The Grow with Us program is also fair and equitable and not unreasonably discriminatory in that it is available to all Members, even for Members that do not meet the Exchange's volume based tiers. More specifically, the heightened requirement to achieve a 10 basis point, rather than 5 basis point, improvement over a Member's previous High Water Mark is reasonable because this higher level will incentivize growth by Members of BATS Options with a more meaningful threshold. The proposed increase to the basis point requirement is fair and equitable and not unreasonably discriminatory due to the fact that Grow with Us pricing is available to all Members. As noted above, the Exchange believes that this pricing structure is reasonable and not unreasonably discriminatory because the Exchange is incentivizing Members to increase their activity on BATS Options, to the benefit of other BATS Options participants.
Volume-based rebates and fees such as the ones maintained by BATS Options, and as amended by this proposal, have been widely adopted in the cash equities markets, and are equitable because they are open to all Members on an equal basis and provide additional benefits or discounts that are reasonably related to the value to an exchange's market quality associated with higher levels of market activity, such as higher levels of liquidity provision and/or growth patterns, and introduction of higher volumes of orders into the price and volume discovery processes. Accordingly, the Exchange believes that the proposed changes to the tiered pricing structure are not unfairly discriminatory because they are consistent with the overall goals of enhancing market quality. Similarly, the Exchange believes that continuing to base its tiered fee structure based on overall TCV, rather than a static number of contracts irrespective of overall volume in the options industry, is a fair and equitable approach to pricing.
Specifically, the proposals to adjust the thresholds of existing volume tiers, add additional volume tiers, and to modify the rebates paid for Customer orders that add liquidity to the BATS Options order book in Penny Pilot Securities are reasonable in that they are consistent with the aforementioned goal of promoting market quality because they reward Members for contributing to the growth of and liquidity available on BATS Options, thereby furthering the price discovery process. The Exchange believes that the proposed adjustment to the tiered pricing structure is reasonable, fair and equitable because the threshold has been lowered to permit additional Members to qualify for the lowest tier. With respect to the proposed reduction of the rebate for Members that do not qualify for tiered pricing on Customer orders in Penny Pilot Securities, but that do qualify for Grow with Us pricing, the Exchange
The Exchange also believes that the proposed increase to rebates paid for Professional, Firm or Market Maker orders in Penny Pilot Securities is reasonable in that it will further incentivize Members to add liquidity to BATS Options and will help to offset proposed increases in fees. The Exchange further believes that the proposed increase to rebates for such orders is fair and equitable and not unreasonably discriminatory because such rebates are available to all Members that submit Professional, Firm or Market Maker orders to the Exchange.
Despite the increases in fees for all orders that remove liquidity (Customer, Professional, Firm and Market Maker orders) in Penny Pilot Securities, the Exchange believes that its proposed fee structure is reasonable as the Exchange's standard fees in Penny Pilot Securities remain generally equivalent to standard fees charged by other markets with similar fee structures, such as NYSE Arca and NOM. The increase in fees is also reasonable because the Exchange has also proposed to increase the majority of the rebates available for orders that qualify for volume-based tier or the Grow with Us program. Similarly, the Exchange believes that the increases are fair and equitable because the various programs offered by the Exchange to receive reduced fees and enhanced rebates provide all Members with several different ways to offset the increase in fees or receive a reduction in fees. As noted above, the Exchange believes that such volume-based tiers are fair and equitable and not unreasonably discriminatory because they are consistent with the overall goals of enhancing market quality. While Professional, Firm and Market Maker orders will be assessed comparably higher transaction fees than those assessed to other Customer orders, as proposed, the Exchange does not believe that this pricing is unreasonably discriminatory because the securities markets generally, and the Exchange in particular, have historically aimed to improve markets for investors and develop various features within the market structure for customer benefit. The Exchange also notes that Professional, Firm and Market Maker orders qualify for additional rebates under the Exchange's NBBO Setter Program, which is not applicable to Customer orders.
The Exchange's proposals to modify the NBBO Setter Program's rebates are necessary because such modifications align with the other modifications to the Exchange's tier structure (i.e., by creating a third tier). Although some rebates provided under the NBBO Setter Program, as amended, will be less than under the previous structure, this change is reasonable due to the increased rebate provided to all Professional, Firm and Market Maker orders. In particular, the elimination of the $0.03 rebate for orders eligible for the NBBO Setter Program submitted by Members that do not qualify for the lowest tier but that do qualify for Grow with Us pricing is reasonable because such members will receive an additional $0.03 rebate on all of their Professional, Firm and Market Maker orders. Despite the fact that Customer orders are not eligible for NBBO Setter Rebates, the proposed modifications to NBBO Setter Rebates are fair and equitable and not unreasonably discriminatory because in many cases, Customer orders that do not set the NBBO are eligible for even higher rebates than certain Professional, Firm, and Market Maker orders that did set the NBBO and receive a NBBO Setter Rebate.
As explained above, the Exchange believes that elimination of the Enhanced NBBO Setter Rebate is reasonable, fair and equitable and not unreasonably discriminatory because this enhanced rebate program has not been widely utilized and eliminating the Enhanced NBBO Setter Rebate will act to simplify the Exchange's fee schedule while also allowing the Exchange to allocate resources devoted to the program to other pricing programs.
The Exchange believes that its proposed modifications to fees and rebates for non-Penny Pilot Securities are reasonable in light of the benefits to Members to the extent the corresponding rebates, which are still significantly higher than typical rebates available for adding liquidity, incentivize aggressive quoting that will result in better execution prices, as described in further detail below. The Exchange also believes that providing financial incentives to achieve aggressive quoting and incentivize liquidity providers to narrow the spread while charging more to those who realize the economic benefit of that narrower spread is a fair and equitable approach to pricing. The Exchange's proposal to increase fees and to reduce rebates for Professional, Firm and Market Maker orders in non-Penny Pilot Securities is reasonable, fair and equitable for several reasons, including that the proposed fee is only a slight increase to existing fees and that the Exchange has proposed other changes to the fee schedule in which Professional, Firm, and Market Maker orders will receive additional rebates. The proposal to increase the rebate for Customer orders in non-Penny Pilot Securities, in turn, is reasonable because it is intended to encourage Members to submit Customer orders in non-Penny Pilot Securities to the Exchange. Finally, the Exchange notes that in non-Penny Pilot Securities it is continuing to charge more for, and rebating less to, non-Customer orders than Customer orders, and the proposed changes will increase the gap between such orders. The Exchange believes that this proposed pricing structure for non-Penny Pilot Securities is not unreasonably discriminatory because it accounts for the difference of assumed information and sophistication level between the different trading capacities. Since Professional, Firm and Market Maker capacity members are assumed to have more informed (and hence less desirable to counterparties) orders, those orders have a slightly higher transaction cost associated with them. The Exchange further notes that the charges and rebates to all non-Customer orders is equivalent regardless of capacity and therefore non-discriminatory.
In the current U.S. options market, many of the contracts are quoted in pennies. Under this pricing structure, the minimum penny tick increment equates to a $1.00 economic value difference per contract, given that a single standardized U.S. option contract covers 100 shares of the underlying stock. Where contracts are quoted in $0.05 increments, the value per tick is $5.00 in proceeds to the investor transacting in these contracts. Liquidity rebate and access fee structures on the make-take exchanges, including BATS, for securities quoted in penny increments are commonly in the $0.30 to $0.45 range. A $0.30 rebate in a penny quoted security is a rebate
As explained above, the Exchange generally attempts to approximate the cost of routing to other options exchanges, including other applicable costs to the Exchange for routing. The Exchange believes that this pricing model, based on approximate Routing Costs is a reasonable, fair and equitable approach to pricing. As noted above, in order to maintain some level of consistency in its fee schedule, the Exchange does not always adjust its routing fees when an away options exchange adjusts its pricing, and thus, over time, the Exchange can end up charging less for executions at the away options exchanges than are required to cover its Routing Costs. The proposed increases to fees, therefore, are reasonable, fair and equitable because they will generally allow the Exchange to provide routing services at levels that allow the Exchange to cover applicable Routing Costs rather than subsidizing routing by Exchange Members. The Exchange believes that its routing fees are not unreasonably discriminatory because they apply equally to all Members and are intended to provide a service to Members that is generally at the same cost that the Exchange incurs for routing. Also, although routing options are available to all Members, Members are not required to use the Exchange's routing services, but instead, the Exchange's routing services are completely optional. Members can manage their own routing to different options exchanges or can utilize a myriad of other routing solutions that are available to market participants.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. Particularly with respect to routing fees, the proposed changes will assist the Exchange in recouping costs for routing orders to other options exchanges on behalf of its participants, and absent such change, the Exchange would be subsidizing routing to other options exchanges by Exchange participants. The Exchange also notes that Users may choose to mark their orders as ineligible for routing to avoid incurring routing fees.
No written comments were solicited or received.
Pursuant to Section 19(b)(3)(A)(ii) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend 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 email to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (
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”),
CME proposes to amend certain of its rules to comply with the Commodity Futures Trading Commission's Part 22 Regulations. The text of the proposed rule change is available at the CME's Web site at
In its filing with the Commission, CME 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 III below. CME has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
CME is registered as a derivatives clearing organization (“DCO”) with the Commodity Futures Trading Commission (“CFTC”) and operates a substantial business clearing futures and swaps contracts subject to the jurisdiction of the CFTC. CME proposes to make changes to CME Rules 802 and 901; CME Rules 8G04, 8G802, 8H04 and 8H802 to comply with the CFTC's Part 22 Regulations. The compliance date for these Regulations is November 14, 2012.
The proposed rule changes are intended, among other things, to implement CFTC requirements regarding the protection of cleared swaps customer contracts and collateral which became effective on April 9, 2012. DCOs like CME are required to comply with these requirements by November 14, 2012, as set forth in Part 22 of the CFTC Regulations.
The proposed rule changes also set forth new requirements for post-default cleared swaps customer account processing. Under the proposed process, upon the default of a clearing member, CME would cease netting of settlement variation within the operationally commingled account and calculate obligations to CME separately for each customer. As further set forth in the rule, each cleared swaps customer would then be required to pay directly to CME any obligations to CME associated with its cleared swaps positions. Where appropriate, similar rules have been adopted in the related sections of the default rules of each of CME's three financial safeguard packages: base products, interest rate swaps (“IRS”) and credit default swaps (“CDS”).
The proposed changes to CME Rules 802 and 901 can be summarized as follows:
• Rule 802.A harmonizes the definition of a clearing member default with those in Rules 8G802.A and 8H802.A.
• Rule 802.B clarifies the approach the Clearing House may take in liquidating any open contracts of a defaulted clearing member, including book entry that offsets open commodity contracts on the books of the defaulting clearing member; liquidation in the open market; and/or one or more private auctions amongst qualified market participants invited by the Clearing House to submit confidential bids.
• Rule 802.G sets forth new requirements for post-default cleared swaps customer account processing, with the Clearing House treating positions and collateral of a defaulting clearing member's cleared swaps customers in accordance with Part 22 of the Commission's regulations. The rule also requires the Clearing House to cease netting of settlement variation in the cleared swaps customer account class upon a clearing member default and discusses the processes that the Clearing House would use to manage such customer accounts.
• New Rule 901.P provides that each Clearing Member would be required to use systems and appropriate procedures to accurately track and provide to the Clearing House the positions and collateral of each of its cleared swaps customers.
The proposed changes to CME Rules 8G802 and 8G04 can be summarized as follows:
• Rule 8G802.A clarifies the rights of CME for the use of an IRS Clearing Member's and its customer's collateral in the event of a default of an IRS Clearing Member in conformity with the Part 22 regulations. Rule 8G802.A.1(i) would also harmonize the definition of a clearing member default with rules 802.A and 8H802.A.
• Rule 8G802.B sets forth amended procedures for establishing a close out
• Rule 8G802.G is amended to remove the customer mutualization within the customer account class for IRS to conform to the Part 22 Regulations.
• Rule 8G802.I sets forth the new requirements for cleared swaps customer account processing with CME after the default of an IRS Clearing Member treating positions and collateral of a defaulting clearing member's cleared swaps customers in accordance with Part 22 of the Commission's regulations. The rule also requires CME to cease netting of settlement variation in the cleared swaps customer account class upon an IRS Clearing Member default and establishes processes for CME to use to manage such customer accounts.
• New Rule 8G04.5 provides that each IRS Clearing Member would be required to use systems and appropriate procedures to accurately track and provide to CME the IRS positions and collateral of each of its cleared swaps customers.
• The IRS Manual is also being revised to make conforming changes related to the Part 22 regulations.
The proposed changes to CME Rules 8H802 and 8H04.12 can be summarized as follows:
• Rule 8H802.A clarifies the rights of CME for the use of a CDS Clearing Member's and its customer's collateral in the event of a default of a CDS Clearing Member in conformity with the Part 22 Regulations.
• Rule 8H802.B sets forth amended procedures for establishing a close out value for CDS contracts to be consistent with Part 22. Section B.3 of the rule would provide for revised netting and offset provisions for the final settlement cycle upon a CDS Termination Event.
• Rule 8H802.G is amended to remove the customer mutualization of the customer account class for CDS to conform to the Part 22 regulations.
• Rule 8H802.I sets forth the new requirements for cleared swaps customer account processing with CME after the default of a CDS Clearing Member treating positions and collateral of a defaulting clearing member's cleared swaps customers in accordance with Part 22 of the Commission's regulations. The rule also requires CME to cease netting of settlement variation in the cleared swaps customer account class upon the default of a CDS Clearing Member and establishes processes for CME to use to manage such customer accounts.
• New Rule 8H04.12 provides that each CDS Clearing Member would be required to use systems and appropriate procedures to accurately track and provide to CME the CDS positions and collateral of each of its cleared swaps customers.
• The CDS Manual is also being revised to make conforming changes related to the Part 22 Regulations.
CME proposes to make these rule changes effective on November 14, 2012. CME also made a filing, CME Submission 12-347, with its primary regulator, the CFTC, with respect to the proposed rule changes.
CME believes the proposed changes are consistent with the requirements of the Exchange Act including Section 17A. The rule changes are being proposed to comply directly with the CFTC's Part 22 Regulations, which are designed to protect investors, or in CME's view, are critical in facilitating CME's compliance with Part 22 (e.g., the new provisions for post-default cleared swaps customer account processing that require the Clearing House to cease netting of settlement variation in the cleared swaps customer account class and require each cleared swaps customer to pay directly to CME any obligations to CME associated with its cleared swaps positions).
CME does not believe that the proposed rule change will have any impact, or impose any burden, on competition.
CME has not solicited, and does not intend to solicit, comments regarding this proposed rule change. CME has not received any unsolicited written comments from interested parties.
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 email to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
All submissions should refer to File Number SR-CME-2012-43. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (
All comments received will be posted without change; the Commission does not edit personal identifying information from submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-CME-2012-43 and should be submitted on or before December 7, 2012.
Section 19(b) of the Act
In its filing, CME requested that the Commission approve this proposed rule change on an accelerated basis for good cause shown. CME cites as the reason for this request that the proposed changes are necessary to facilitate CME's compliance with new CFTC regulations that become effective on November 14, 2012.
The Commission finds good cause, pursuant to Section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to extend the Cabinet Trading Pilot program in Rule 1059. The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to extend the pilot program in Commentary .02 of Exchange Rule 1059, Accommodation Transactions, which sets forth specific procedures for engaging in cabinet trades, to allow the Commission adequate time to consider permanently allowing transactions to take place on the Exchange in open outcry at a price of at least $0 but less than $1 per option contract.
On December 30, 2010, the Exchange filed an immediately effective proposal that established the pilot program being extended by this filing. The pilot program allowed transactions to take place in open outcry at a price of at least $0 but less than $1 per option contract until June 1, 2011.
The Exchange believes that allowing a price of at least $0 but less than $1 will better accommodate the closing of options positions in series that are worthless or not actively traded, particularly due to recent market conditions which have resulted in a significant number of series being out-of-the-money. For example, a market participant might have a long position in a call series with a strike price of $100 and the underlying stock might now be trading at $30. In such an instance, there might not otherwise be a market for that person to close-out its position even at the $1 cabinet price (
The Exchange hereby seeks to extend the pilot period for such $1 cabinet trading until June 1, 2013. The Exchange seeks this extension to allow the procedures to continue without interruption.
The Exchange believes that the proposed rule change is consistent with the provisions of Section 6 of the Act,
The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act, as amended.
Written comments were neither solicited nor received.
The proposed rule change is effective upon filing pursuant to Section 19(b)(3)(A) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend 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. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or 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 email to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
All submissions should refer to File Number
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On May 1, 2012, The NASDAQ Stock Market LLC (“NASDAQ” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Section 19(b)(2) of the Act
The Commission finds it appropriate to designate a longer period within which to issue an order approving or disapproving the proposed rule change so that it has sufficient time to consider the proposal and the issues that commenters have raised concerning the proposal.
Accordingly, the Commission, pursuant to Section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Exchange Act” or “Act”),
The Exchange is proposing to amend its Fee and Rebate Schedule (the “Fee Schedule”) issued pursuant to Exchange
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange is proposing to change its Fee Schedule to (i) create separate definitions of ADV for orders executed using Auto-Ex Mode versus Order Delivery Mode to include within the Auto-Ex Mode ADV calculation shares of NMS stocks with quoted prices less than one dollar, (ii) create a fixed per share rebate for Midpoint Peg Zero Display Reserve Orders,
The Exchange uses the ADV
In addition, the Exchange notes that both EDGX Exchange Inc. (“EDGX”) and BATS Exchange Inc. (“BATS”) have similar rebate structures and do not exclude securities priced below one dollar in the calculation of volume thresholds used to determine rebates payable for orders executed at one dollar or above.
Midpoint Peg Zero Display Reserve Orders
The Exchange also proposes a fixed per share rebate of $0.0017 for Midpoint Peg Zero Display Reserve Orders
Finally, the Exchange is correcting typographical inconsistencies within the Fee Schedule by correcting endnote references, renumbering endnotes, and updating the heading in Section I.
The Exchange intends to make the proposed modifications, which are effective upon filing, operative as of the commencement of trading on November 1, 2012. Pursuant to Exchange Rule 16.1(c), the Exchange will “provide ETP Holders with notice of all relevant dues, fees, assessments and charges of the Exchange” through the issuance of a Regulatory Circular of the changes to the Fee Schedule and will post a copy of the rule filing on the Exchange's Web site (
The Exchange believes that the proposed ADV definition changes are consistent with the provisions of Section 6(b) of the Act,
In addition, the Exchange believes the fixed per share rebate for Midpoint Peg Zero Display Reserve Orders is consistent with Section 6(b)(5) of the Act in that it is equitably allocated and not unfairly discriminatory because all ETP Holders are eligible to submit (or not submit) these types of orders, and may do so at their discretion during the course of the month.
Lastly, the Exchange believes correcting the typographical inconsistencies and updating the heading in Section I in the Fee Schedule are reasonable in that they provide clarity to ETP holders to how the Exchange's fee and rebate structure operates by clarifying important cross-references. The corrections are equitable and not unfairly discriminatory in that the Fee Schedule applies to all ETP Holders.
Finally, the Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues. In such an environment, the Exchange must continually review, and consider adjusting, its fees and rebates to remain competitive with other exchanges. For the reasons described above, the Exchange believes that the proposed rule change reflects this competitive environment.
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.
The Exchange has neither solicited nor received written comments on the proposed rule change.
The proposed rule change has taken effect upon filing pursuant to Section 19(b)(3)(A)(ii) of the Exchange 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 email to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for Web site viewing and printing in the Commission's Public Reference Room, 100 F Street NE., Washington, DC 20549, on official business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of the filing also will be available for inspection and copying at the principal office of the Exchange. All comments received will be posted without change; the Commission does not edit personal identifying information from submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-NSX-2012-18 and should be submitted on or before December 7, 2012.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to extend the Cabinet Trading Pilot program in Rule 1059. The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to extend the pilot program in Commentary .02 of Exchange Rule 1059, Accommodation Transactions, which sets forth specific procedures for engaging in cabinet trades, to allow the Commission adequate time to consider permanently allowing transactions to take place on the Exchange in open outcry at a price of at least $0 but less than $1 per option contract.
On December 30, 2010, the Exchange filed an immediately effective proposal that established the pilot program being extended by this filing. The pilot program allowed transactions to take place in open outcry at a price of at least $0 but less than $1 per option contract until June 1, 2011.
The Exchange believes that allowing a price of at least $0 but less than $1 will better accommodate the closing of options positions in series that are worthless or not actively traded, particularly due to recent market conditions which have resulted in a significant number of series being out-of-the-money. For example, a market
The Exchange hereby seeks to extend the pilot period for such $1 cabinet trading until June 1, 2013. The Exchange seeks this extension to allow the procedures to continue without interruption.
The Exchange believes that the proposed rule change is consistent with the provisions of Section 6 of the Act,
The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act, as amended.
Written comments were neither solicited nor received.
The proposed rule change is effective upon filing pursuant to Section 19(b)(3)(A) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend 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. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or 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 email to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The NASDAQ Stock Market LLC proposes to modify Chapter XV, Section 2, governing pricing for NASDAQ members using the NASDAQ Options Market (“NOM”), NASDAQ's facility for executing and routing standardized equity and index options. While changes pursuant to this proposal are effective upon filing, the Exchange has designated the proposed amendment to be operative on November 1, 2012.
The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The purpose of this filing is to recoup costs that the Exchange incurs for routing and executing certain orders in equity options to the International Securities Exchange, LLC (“ISE”).
The Exchange's Pricing Schedule at Chapter XV, Section 2(4) currently includes the following fees for routing Customer, Firm, Market Maker and Professional orders to away markets:
The Exchange is proposing to amend the ISE Select Symbol Customer Routing Fee from $0.31 to $0.35 per contract when routing Select Symbols to ISE. ISE amended its fee for removing liquidity for Priority Customer orders from $0.20 to $0.25 per contract.
Nasdaq Options Services LLC (“NOS”), a member of the Exchange, is the Exchange's exclusive order router.
As with all fees, the Exchange may adjust these Routing Fees in response to competitive conditions by filing a new proposed rule change.
NASDAQ believes that its proposal to amend its rules is consistent with Section 6(b) of the Act
The Exchange believes that the proposed Customer ISE Select Symbols Routing Fee is reasonable because the Exchange seeks to recoup costs incurred by the Exchange when routing Customer orders to ISE in Select Symbols on behalf of NOM Options Participants.
NASDAQ does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. In addition, a NOM Options Participant may designate an order as not available for routing to avoid routing fees.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) 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 email to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend Chapter XV, Section 2 entitled “BX Options Market—Fees and Rebates.” Specifically, the Exchange proposes to amend a Customer fee for routing options to the International Securities Exchange, LLC (“ISE”). While changes pursuant to this proposal are effective upon filing, the Exchange has designated the proposed amendment to be operative on November 1, 2012.
The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The purpose of this filing is to recoup costs that the Exchange incurs for routing and executing certain orders in equity options to ISE. The Exchange's Pricing Schedule at Chapter XV, Section 2(4) currently includes the following fees for routing Customer, Firm, Market Maker, Broker-Dealer and Professional orders to away markets:
The Exchange is proposing to amend the ISE (Select Symbols) Customer Routing Fee from $0.31 to $0.35 per contract when routing Select Symbols to ISE. ISE amended its fee for removing liquidity for Priority Customer orders from $0.20 to $0.25 per contract.
Nasdaq Options Services LLC (“NOS”), a member of the Exchange, is the Exchange's exclusive order router.
As with all fees, the Exchange may adjust these Routing Fees in response to competitive conditions by filing a new proposed rule change.
BX believes that its proposal to amend its rules is consistent with Section 6(b) of the Act
The Exchange believes that the proposed Customer ISE Select Symbols Routing Fee is reasonable because the Exchange seeks to recoup costs incurred by the Exchange when routing Customer orders to ISE in Select Symbols on behalf of BX Options Participants. Each destination market's transaction charge varies and there is a standard clearing charge for each transaction incurred by the Exchange along with other administrative and technical costs that are incurred by the Exchange. The Exchange believes that the proposed Customer Routing Fee would enable the Exchange to recover the remove fee assessed to BX Options Participants by ISE in Select Symbols, plus clearing and other administrative and technical fees for the execution of certain Customer orders routed to ISE. The Exchange also believes that the proposed Customer Routing Fee is equitable and not unfairly discriminatory because the Exchange would assess the ISE Select Symbol Customer Routing Fee uniformly to all Customer orders that are routed to ISE.
BX does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. In addition, a BX Options Participant may designate an order as not available for routing to avoid routing fees.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) 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 email 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.
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of DIAS Holding, Inc. because it has not filed any periodic reports since the period ended September 30, 2009.
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of EarthBlock Technologies, Inc. because it has not filed any periodic reports since the period ended December 31, 2007.
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of Ensurapet, Inc. because it has not filed any periodic reports since the period ended December 31, 2008.
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of FIIC Holdings, Inc. because it has not filed any periodic reports since the period ended September 30, 2007.
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of Gold Star Tutoring Services, Inc. because it has not filed any periodic reports since the period ended September 30, 2009.
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of GeM Solutions, Inc. because it has not filed any periodic reports since the period ended March 31, 2007.
It appears to the Securities and Exchange Commission that there is a lack of current and accurate information concerning the securities of GPS Industries, Inc. because it has not filed any periodic reports since the period ended March 31, 2009.
The Commission is of the opinion that the public interest and the protection of investors require a suspension of trading in the securities of the above-listed companies. Therefore, it is ordered, pursuant to Section 12(k) of the Securities Exchange Act of 1934, that trading in the securities of the above-listed companies is suspended for the period from 9:30 a.m. EST on November 14, 2012, through 11:59 p.m. EST on November 28, 2012.
By the Commission.
Small Business Administration.
Notice of Reporting Requirements Submitted for OMB Review.
Under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35), agencies are required to submit proposed reporting and recordkeeping requirements to OMB for review and approval, and to publish a notice in the
Submit comments on or before December 17, 2012. If you intend to comment but cannot prepare comments promptly, please advise the OMB Reviewer and the Agency Clearance Officer before the deadline.
Address all comments concerning this notice to:
Curtis Rich, Agency Clearance Officer, (202) 205-7030.
U.S. Small Business Administration.
Amendment 11.
This is an amendment of the Presidential declaration of a major disaster for the State of Louisiana (FEMA—4080—DR), dated 08/31/2012.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
The notice of the President's major disaster declaration for the State of Louisiana, dated 08/31/2012 is hereby amended to extend the deadline for filing applications for physical damages as a result of this disaster to 11/29/2012.
All other information in the original declaration remains unchanged.
Acting under the authority of and in accordance with section 1(b) of Executive Order 13224 of September 23, 2001, as amended by Executive Order 13268 of July 2, 2002, and Executive Order 13284 of January 23, 2003, I hereby determine that the individual known as Qari Zakir, also known as Abdul Rauf, committed, or poses a significant risk of committing, acts of terrorism that threaten the security of U.S. nationals or the national security, foreign policy, or economy of the United States.
Consistent with the determination in section 10 of Executive Order 13224 that “prior notice to persons determined to be subject to the Order who might have a constitutional presence in the United States would render ineffectual the blocking and other measures authorized in the Order because of the ability to transfer funds instantaneously,” I determine that no prior notice needs to be provided to any person subject to this determination who might have a constitutional presence in the United States, because to do so would render ineffectual the measures authorized in the Order.
This notice shall be published in the
Federal Aviation Administration (FAA), DOT.
Notice of petition for exemption received.
This notice contains a summary of a petition seeking relief from specified requirements of 14 CFR. The purpose of this notice is to improve the public's awareness of, and participation in, this aspect of FAA's regulatory activities. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before December 6, 2012.
You may send comments identified by Docket Number FAA-2012-0954 using any of the following methods:
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Theresa White, ANM-113, Standardization Branch, Federal Aviation Administration, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA 98057-3356; email
This notice is published pursuant to 14 CFR 11.85.
In accordance with Part 211 of Title 49 Code of Federal Regulations (CFR), this document provides the public notice that by a document dated July 25, 2012, the Peninsula Corridor Joint Powers Board (PCJPB or Caltrain) has petitioned the Federal Railroad Administration (FRA) for a waiver of compliance from certain provisions of the Federal railroad safety regulations contained at 49 CFR part 215. FRA assigned the petition Docket Number FRA-2012-0067.
Caltrain seeks a waiver of compliance from the Railroad Freight Car Safety Standards contained in 49 CFR 215.303-
Caltrain states that the purpose of this petition is to allow Caltrain to operate the subject cars for transportation of decorations during the annual Holiday Trains, which is a successful community supported event. Caltrain stated that the principal business owner of these two cars is PCJPB and the operator and maintainer is TransitAmerica Services, Inc. Each car has been inspected and determined to be safe for continued operation. These two cars were built on August 1, 1953. The maximum speed is 50 mph. The territorial limits are Caltrain Main Track #1 and #2 between Milepost 0 and Milepost 52, as well as Caltrain yard tracks. These two cars will not be interchanged.
A copy of the petition, as well as any written communications concerning the petition, is available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested party desires an opportunity for oral comment, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate Docket Number and may be submitted by any of the following methods:
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Communications received by December 31, 2012 will be considered by FRA before final action is taken. Comments received after that date will be considered as far as practicable.
Anyone is able to search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the 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
In accordance with Part 211 of Title 49 Code of Federal Regulations (CFR), this document provides the public notice that by a document dated August 14, 2012, the City of Oshkosh, WI (the City), has petitioned the Federal Railroad Administration (FRA) for a waiver of compliance from certain provisions of the Federal railroad safety regulations contained at 49 CFR Part 222-Use of Locomotive Horns at Public Highway-Rail Grade Crossings. FRA assigned the petition Docket Number FRA-2012-0074.
The City is seeking a waiver from the provisions of 49 CFR Section 222.9-
A copy of the petition, as well as any written communications concerning the petition, is available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested party desires an opportunity for oral comment, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate docket number and may be submitted by any of the following methods:
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Communications received by December 31, 2012 will be considered by FRA before final action is taken. Comments received after that date will be considered as far as practicable.
Anyone is able to search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the 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
In accordance with Part 211 of Title 49 Code of Federal Regulations (CFR), this document provides the public notice that by a document dated June 18, 2012, the Port Authority Trans-Hudson Corporation (PATH) has petitioned the Federal Railroad Administration (FRA) for a waiver of compliance from certain provisions of the Federal railroad safety regulations related to periodic brake equipment maintenance found in 49 CFR 238.309(b)(2), which requires brake equipment maintenance at the 1104-day interval.
PATH is asking for an extension of 6 months to complete these processes for all equipment overhauls. PATH states that the material and inventory necessary to complete the required maintenance will not be available from the vendor (WABTEC) in sufficient time for completion. FRA assigned the petition Docket Number FRA-2012-0060.
A copy of the petition, as well as any written communications concerning the petition, is available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested party desires an opportunity for oral comment, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate docket number and may be submitted by any of the following methods:
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Communications received by December 31, 2012 will be considered by FRA before final action is taken. Comments received after that date will be considered as far as practicable.
Anyone is able to search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the 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
In accordance with Part 211 of Title 49 Code of Federal Regulations (CFR), this document provides the public notice that by a document dated September 24, 2012, Long Island Rail Road (LIRR) has petitioned the Federal Railroad Administration (FRA) for a waiver of compliance from certain Federal hours of service requirements for train employees engaged in commuter or intercity rail passenger transportation contained at 49 CFR 228.405(a)(3). FRA assigned the petition Docket Number FRA-2012-0079.
In its petition, LIRR seeks a waiver allowing the series of at most 14 consecutive calendar days to reset after a general pick, or after a large timetable revision. A general pick, as described by LIRR, is a biannual event allowing train employees to bid on jobs with jobs being
In support of the request, LIRR explained that after the first general pick, about 20 employees were required to take 1 or 2 workdays off to avoid violating Federal requirements. As a result, employees suffered financially, and employee availability was reduced, disrupting LIRR's ability to provide timely and efficient service for its customers. LIRR argues that allowing the 14 consecutive calendar-day series to reset after a general pick, or a large timetable revision, will prevent any future employee financial losses and disruptions in LIRR's ability to provide optimum service to its customers.
A copy of the petition, as well as any written communications concerning the petition, is available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested party desires an opportunity for oral comment, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate Docket Number and may be submitted by any of the following methods:
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Communications received by December 31, 2012 will be considered by FRA before final action is taken. Comments received after that date will be considered as far as practicable.
Anyone is able to search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the 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
In accordance with Part 211 of Title 49 Code of Federal Regulations (CFR), this document provides the public notice that by a document dated October 9, 2012, the Albany Port Railroad (APRR) and the United Transportation Union (UTU) have jointly petitioned the Federal Railroad Administration (FRA) for an extension of their waiver of compliance from certain provisions of the Federal hours of service laws contained at 49 U.S.C. 21103(a)(4). FRA assigned the petition Docket Number FRA-2012-0068.
In the petition, APRR and UTU seek relief from 49 U.S.C. 21103(a)(4), which in part requires a train employee to receive 48 hours off duty after initiating an on-duty period for 6 consecutive days. Specifically, APRR and UTU seek an extension of the waiver to allow a train employee to initiate an on-duty period for 6 consecutive days followed by 24 hours off duty. In support of the request, APRR explained they have four train employees of which three work a single regular assignment Monday through Friday, beginning at 6 a.m. and usually ending at 1 p.m. The remaining employee holds a relief position and works for the other three employees when they require a day off. Finally, APRR states that the work is always performed within the confines of the Albany Port, which consists of yard tracks with a speed of 5 mph.
A copy of the petition, as well as any written communications concerning the petition, is available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested party desires an opportunity for oral comment, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate docket number and may be submitted by any of the following methods:
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Communications received by December 31, 2012 will be considered by FRA before final action is taken. Comments received after that date will be considered as far as practicable.
Anyone is able to search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the 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
On October 31, 2012, Aiken Railway Company, LLC (AIKR), a noncarrier, filed a verified notice of exemption under 49 CFR 1150.31 to lease from Norfolk Southern Railway Company (NSR), and to operate, two segments of rail line referred to as the SA Line and the AB Line. The SA Line extends 12.45 miles between milepost SA 63.45 at or near Warrenville, SC, and milepost SA 51.0 at or near Oakwood, SC. The AB Line extends 6.45 miles between milepost AB 23.75 at or near Aiken, SC, and milepost AB 17.3 at or near Seclay, SC. This transaction is related to a notice of exemption filed on November 5, 2012, in which Western Carolina Railway Service Corporation (WCRS), and Steven C. Hawkins and Cheryl R. Hawkins (collectively, the Hawkins) seek Board approval to continue in control of AIKR upon AIKR's becoming a Class III rail carrier.
As a result of this transaction, and pursuant to a lease agreement between AIKR and NSR, AIKR will provide freight rail service over the lines. As consideration for the lease, AIKR has agreed to bring the lines (except for a sub-segment between mileposts SA 51.0 and SA 55.0) up to the Federal Railroad Administration's Class 1 standards. AIKR states that the lines connect only with NSR and that it will interchange with NSR in Aiken, SC. AIKR states that the transaction does not, however, impose any interchange commitments.
The effective date of this exemption is November 30, 2012. AIKR states that it expects to commence operations on December 1, 2012, more than 30 days after the notice of exemption was filed. The effective date of the related continuance in control exemption in Docket No. FD 35691, however, is December 5, 2012. WCRS and the Hawkins are reminded that they are not authorized to control AIKR until the continuance in control exemption becomes effective on December 5, 2012.
AIKR certifies that its projected annual revenues as a result of this transaction will not exceed those that would qualify it as a Class III rail carrier. AIKR further certifies that its projected annual revenues as a result of this transaction will not exceed $5 million.
If the verified notice contains false or misleading information, the exemption is void
An original and ten copies of all pleadings, referring to Docket No. FD 35665 must be filed with the Surface Transportation Board, 395 E Street SW., Washington, DC 20423-0001. In addition, a copy of each pleading must be served on J. Marshall Lawson, 4840 Forest Drive, Suite 6B, PMB-295, Columbia, SC 29206-4810.
Board decisions and notices are available on our Web site at
By the Board, Rachel D. Campbell, Director, Office of Proceedings.
In accordance with section 999(a)(3) of the Internal Revenue Code of 1986, the Department of the Treasury is publishing a current list of countries which require or may require participation in, or cooperation with, an international boycott (within the meaning of section 999(b)(3) of the Internal Revenue Code of 1986).
On the basis of the best information currently available to the Department of the Treasury, the following countries require or may require participation in, or cooperation with, an international boycott (within the meaning of section 999(b)(3) of the Internal Revenue Code of 1986).
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 2013.
The rate will be in effect for the period beginning on January 1, 2013, and ending on December 31, 2013.
Inquiries should be directed to the E-Commerce Division, Financial Management Service, Department of the Treasury, 401 14th Street SW., Washington, DC 20227 (Telephone: 202-874-9428).
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 2013 reflects the average investment rates for the 12-
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13(44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 2063, U.S. Departing Alien Income Tax Statement.
Written comments should be received on or before January 15, 2013 to be assured of consideration.
Direct all written comments to Yvette Lawrence, Internal Revenue Service, Room 6129, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for additional information or copies of the form and instructions should be directed to Martha R. Brinson at Internal Revenue Service, Room 6129, 1111 Constitution Avenue NW., Washington, DC 20224, or at (202) 622-3869, or through the Internet at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13(44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Nonaccrual-Experience Method of Accounting Under Section 448(d)(5).
Written comments should be received on or before January 15, 2013 to be assured of consideration.
Direct all written comments to Yvette Lawrence, Internal Revenue Service, Room 6129, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for additional information or copies of the regulations should be directed to Martha R. Brinson at Internal Revenue Service, Room 6129, 1111 Constitution Avenue NW., Washington, DC 20224, or at (202) 622-3869, or through the Internet at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning the Extended Carryback of Losses to or From a Consolidated Group.
Written comments should be received on or before January 15, 2013 to be assured of consideration.
Direct all written comments to Yvette Lawrence, Internal Revenue Service, Room 6129, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for additional information or copies of the regulations should be directed to Martha R. Brinson at Internal Revenue Service, Room 6129, 1111 Constitution Avenue NW., Washington, DC 20224, or at (202) 622-3869, or through the Internet at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Corporations; Consolidated Returns-Special Rules Relating To Dispositions and Deconsolidations of Subsidiary Stock (§§ 1.337(d)-2 and 1.1502-20).
Written comments should be received on or before January 15, 2013 to be assured of consideration.
Direct all written comments to Yvette Lawrence, Internal Revenue Service, Room 6129, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for additional information or copies of the regulations should be directed to Martha R. Brinson at Internal Revenue Service, Room 6129, 1111 Constitution Avenue NW., Washington, DC 20224, or at (202) 622-3869, or through the Internet at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Centers for Medicare & Medicaid Services (CMS), HHS.
Final rule with comment period.
This major final rule with comment period addresses changes to the physician fee schedule, payments for Part B drugs, 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 provisions of the Affordable Care Act by establishing a face-to-face encounter as a condition of payment for certain durable medical equipment (DME) items. In addition, it implements statutory changes regarding the termination of non-random prepayment review. This final rule with comment period also includes a discussion in the Supplementary Information regarding various programs . (See the Table of Contents for a listing of the specific issues addressed in this final rule with comment period.)
In commenting, please refer to file code CMS-1590-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.
(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.)
If you intend to deliver your comments to the Baltimore address, please call telephone number (410) 786-7195 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.
• Interim final work, practice expense, and malpractice RVUs (including physician time, direct practice expense (PE) inputs, and the equipment utilization rate assumption) for new, revised, potentially misvalued, and certain other CY 2013 HCPCS codes as indicated in the sections that follow and listed in Addendum C to this final rule with comment period; and
• The appropriate direct PE inputs for establishing nonfacility PE RVUs for CPT code 63650 (Percutaneous implantation of neurostimulator electrode array, epidural).
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 Code of Federal Regulations (CFR). Information on the regulations impact appears throughout the preamble and, therefore, is not discussed exclusively in section VIII. of this final rule with comment period.
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:
In the past, the Addenda referred to throughout the preamble of our annual PFS proposed and final rules with comment period were included in the printed
Throughout this final rule with comment period, we use CPT codes and descriptions to refer to a variety of services. We note that CPT codes and descriptions are copyright 2012 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association (AMA). Applicable Federal Acquisition Regulations (FAR) and Defense Federal Acquisition Regulations (DFAR) apply.
This major final rule with comment period revises payment policies under the Medicare Physician Fee Schedule (PFS) and makes other policy changes related to Medicare Part B payment. These changes are applicable to services furnished in CY 2013. It also implements provisions of the Affordable Care Act by establishing a face-to-face encounter as a condition of payment for certain durable medical equipment (DME) items. In addition, it implements statutory changes regarding the termination of non-random prepayment review.
The Social Security Act (Act) requires us to establish payments under the PFS based on national uniform relative value units (RVUs) and the relative resources used in furnishing a service. The Act requires that national RVUs be established for physician work, practice expense (PE), and malpractice expense. In this major final rule with comment period, we establish payment rates for CY 2013 for the PFS, payments for Part B drugs, and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and in the relative value of services. It also implements provisions of the Affordable Care Act by establishing a face-to-face encounter as a condition of payment for certain durable medical equipment (DME) items, and by removing certain regulations regarding the termination of non-random prepayment review. It also establishes new claims-based data reporting requirements for therapy services to implement a provision in the Middle Class Tax Relief and Jobs Creation Act (MCTRCA). In addition, this rule:
• Identifies Potentially Misvalued Codes to be Evaluated.
• Establishes Additional Multiple Procedure Payment Reductions (MPPR).
• Expands Medicare Telehealth Services.
• Implements Regulatory Changes Regarding Payment for Technical Component of Certain Physician Pathology Services to Conform to Statute.
• Requires the Inclusion of Specific Information on Claims for Therapy Services.
• Establishes New Transitional Care Management Services.
• Clarifies Services Included in the Certified Registered Nurse Anesthetists Scope of Benefit.
• Modifies Ordering Requirements for Portable X-ray Services.
• Updates the Ambulance Fee Schedule.
• Sets Part B Drug Payment Rates for 2013.
• Addresses Ambulance Coverage—Physician Certification Statement.
• Updates policies regarding the—
++ Physician Compare Web site.
++ Physician Quality Reporting System.
++ Electronic Prescribing (eRx) Incentive Program.
++ Electronic Health Record (EHR) Incentive Program.
++ Medicare Shared Savings Program.
• Discusses Budget Neutrality for the Chiropractic Demonstration.
• Addresses Implementation of the Physician Value-Based Payment Modifier and the Physician Feedback Reporting Program.
• Establishes Medicare Coverage of Hepatitis B Vaccine.
• Updates Existing Standards for e-prescribing under Medicare Part D and Lifting the LTC Exemption.
The statute requires that we establish by regulation each year payment amounts for all physicians' service. These payment amounts are required to be adjusted to reflect the variations in
Several changes affect the specialty distribution of Medicare expenditures. This final rule with comment period reflects the Administration's priority to improve payment for primary care services. As described in Section II.N, in the absence of Congressional action, an overall reduction of 26.5 percent will be imposed in the conversion factor used to calculate payment for physicians' services on or after January 1, 2013 due to the Sustainable Growth Rate (SGR). To isolate the impact of changes that we are proposing in this final rule with comment period, we analyze and discuss the policies' impact with a constant conversion factor. In the absence of a change in the conversion factor, payments to primary care specialties will increase and payments to select other specialties will decrease due to several changes in how we calculate payments for CY 2013.
The largest payment increase for primary care specialties overall will result from a new payment for managing a beneficiary's care when the beneficiary is discharged from an inpatient hospital, a SNF, an outpatient hospital observation, partial hospitalization services, or a community mental health center. Payments to primary care specialties also will increase due to redistributions from changes in payments for services furnished by other specialties. Because of the budget-neutral nature of this system, decreases in payments for one service result in increases in payments in others.
Payments to primary care specialties are also impacted by the completion of the 4-year transition to new PE RVUs using the new Physician Practice Information Survey (PPIS) data that was adopted in the CY 2010 PFS final rule with comment period. The projected impacts of using the new PPIS data are generally consistent with the impacts discussed in the CY 2012 final rule with comment period (76 FR 72452).
Several types of providers are projected to see decreases in Medicare PFS payments, mainly as a result of the potentially misvalued codes initiative. We have received numerous new codes with new values and revised codes with new values for CY 2013 as a result of our ongoing misvalued codes initiative, an effort to improve payment accuracy. Many of the new and revised codes that we valued on an interim basis for CY 2013 originated with the potentially misvalued codes initiative. Reductions for pathology, neurology, and independent laboratories are a result of the misvalued code initiative. In the case of independent laboratories, we note that independent laboratories receive the majority of the Medicare revenue from the Clinical Lab Fee Schedule, which is unaffected by the misvalued code initiative. Radiation therapy centers will see an overall decrease of 9 percent primarily as a result of the PPIS transition discussed above and a change in the interest rate assumption used to calculate PE. Radiation oncology sees a 7 percent decrease for the same reasons as radiation therapy centers.
We note that throughout this final rule with comment period, unless otherwise noted, the term “practitioner” is used to describe both physicians and nonphysician practitioners (such as physician assistants, nurse practitioners, clinical nurse specialists, certified nurse-midwives, psychologists, or clinical social workers) who are permitted to bill Medicare under the PFS for their services. Since January 1, 1992, Medicare has paid for physicians' services under section 1848 of the Act, “Payment for Physicians' Services.” The Act requires that CMS make payments under the PFS using 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, PE, and malpractice expense. Before the establishment of the resource-based relative value system, Medicare payment for physicians' services was based on reasonable charges.
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.
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 (HHS). 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, in part, on our review of recommendations received from the American Medical Association/Specialty Society Relative Value Update Committee (AMA RUC).
Initially, only the physician work RVUs were resource-based, and the PE and malpractice RVUs were based on average allowable charges. Section 121 of the Social Security Act Amendments of 1994 (Pub. L. 103-432), and 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 and required us to develop resource-based PE RVUs for each physicians' service. We were to consider general categories of expenses (such as office rent and wages of personnel, but excluding malpractice expenses) comprising PEs.
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. Separate PE RVUs are established for procedures that can be furnished in both a nonfacility setting, such as a physician's office, and a facility setting, such as a hospital outpatient department (HOPD). The difference between the facility and nonfacility RVUs reflects the fact that a facility typically receives separate payment from Medicare for its costs of furnishing the service, apart from payment under the PFS. The nonfacility
This resource-based system was based on two significant sources of actual PE data. Panels of physicians, practice administrators, and nonphysician health professionals (for example, registered nurses (RNs)), who were nominated by physician specialty societies and other groups identified the direct inputs required for each physicians' service. (We have since refined and revised these inputs based on recommendations from the AMA RUC.) Aggregate specialty-specific information on hours worked and PEs was obtained from the AMA's Socioeconomic Monitoring System (SMS).
Section 212 of the Balanced Budget Refinement Act of 1999 (BBRA) (Pub. L. 106-113) directed us 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 CY 2007 PFS final rule with comment period (71 FR 69624), we revised the methodology for calculating direct PE RVUs from the top-down to the bottom-up methodology beginning in CY 2007. We adopted a 4-year transition to the new PE RVUs. This transition was completed in CY 2010. Direct PE RVUs were calculated for CY 2013 using this methodology, unless otherwise noted.
In the CY 2010 PFS final rule with comment period, we updated the practice expense per hour (PE/HR) data that are used in the calculation of PE RVUs for most specialties (74 FR 61749). For this update, we used the Physician Practice Information Survey (PPIS) conducted by the AMA. The PPIS is a multispecialty, nationally representative, PE survey of both physicians and nonphysician practitioners (NPPs) using a survey instrument and methods highly consistent with those used prior to CY 2010. We note that in CY 2010, for oncology, clinical laboratories, and independent diagnostic testing facilities (IDTFs), we continued to use the supplemental survey data to determine PE/HR values (74 FR 61752). Beginning in CY 2010, we provided for a 4-year transition for the new PE RVUs using the updated PE/HR data. In CY 2013, the final year of the transition, PE RVUs are calculated based on the new data.
Section 4505(f) of the BBA amended section 1848(c) of the Act to require that we implement resource-based malpractice RVUs for services furnished on or after CY 2000. The resource-based malpractice RVUs were implemented in the PFS final rule with comment period published November 2, 1999 (64 FR 59380). The malpractice RVUs were based on malpractice insurance premium data collected from commercial and physician-owned insurers.
Section 1848(c)(2)(B)(i) of the Act requires that we review all RVUs no less often than every 5 years. Prior to CY 2013, we conducted separate periodic reviews of work RVUs and PE RVUs. The First Five-Year Review of Work RVUs was published on November 22, 1996 (61 FR 59489) and was effective in 1997. The Second Five-Year Review of Work RVUs 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 Work RVUs was published in the CY 2007 PFS final rule with comment period (71 FR 69624) and was effective on January 1, 2007. The Fourth Five-Year Review of Work RVUs was published in the CY 2012 PFS final rule with comment period (76 FR 73026).
Initially refinements to the direct PE inputs relied on input from the AMA RUC-established the Practice Expense Advisory Committee (PEAC). Through March 2004, the PEAC provided recommendations to CMS for more than 7,600 codes (all but a few hundred of the codes included in the AMAs Current Procedural Terminology (CPT) codes). As part of the CY 2007 PFS final rule with comment period (71 FR 69624), we implemented a new bottom-up methodology for determining resource-based PE RVUs and transitioned the new methodology over a 4-year period. A comprehensive review of PE was undertaken prior to the 4-year transition period for the new PE methodology from the top-down to the bottom-up methodology, and this transition was completed in CY 2010. In CY 2010, we also incorporated the new PPIS data to update the specialty-specific PE/HR data used to develop PE RVUs, adopting a 4-year transition to PE RVUs developed using the PPIS data.
In the CY 2012 PFS final rule with comment period (76 FR 73057), we finalized a proposal to consolidate reviews of work and PE RVUs under section 1848(c)(2)(B) of the Act and reviews of potentially misvalued codes under section 1848(c)(2)(K) of the Act into one annual process.
In the CY 2005 PFS final rule with comment period (69 FR 66236), we implemented the first Five-Year Review of the malpractice RVUs (69 FR 66263). Minor modifications to the methodology were addressed in the CY 2006 PFS final rule with comment period (70 FR 70153). The second Five-Year Review and update of resource-based malpractice RVUs was published in the CY 2010 PFS final rule with comment period (74 FR 61758) and was effective in CY 2010.
In addition to the Five-Year Reviews, beginning for CY 2009, CMS and the AMA RUC have identified and reviewed a number of potentially misvalued codes on an annual basis based on various identification screens. This annual review of work and PE RVUs for potentially misvalued codes was supplemented by the amendments to Section 1848 of the Act, as enacted by section 3134 of the Affordable Care Act, which requires the agency to periodically identify, review and adjust values for potentially misvalued codes with an emphasis on the following categories: (1) Codes and families of codes for which there has been the fastest growth; (2) codes or families of codes that have experienced substantial changes in PEs; (3) codes that are recently established for new technologies or services; (4) multiple codes that are frequently billed in conjunction with furnishing a single service; (5) codes with low relative values, particularly those that are often billed multiple times for a single treatment; (6) codes which have not been subject to review since the implementation of the fee schedule (the so-called `Harvard valued codes'); and (7) other codes determined to be appropriate by the Secretary.
Budget neutrality (BN) typically requires that expenditures not increase or decrease as a result of changes or revisions to policy. However, section 1848(c)(2)(B)(ii)(II) of the Act requires
To calculate the payment for each physicians' service, the components of the fee schedule (work, PE, and malpractice RVUs) are adjusted by geographic practice cost indices (GPCIs). The GPCIs reflect the relative costs of physician work, PE, and malpractice 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:
Payment = [(RVU work × GPCI work) + (RVU PE × GPCI PE) + (RVU malpractice × GPCI malpractice)] × CF.
The CY 2012 PFS final rule with comment period (76 FR 73026) implemented changes to the PFS and other Medicare Part B payment policies. It also finalized many of the CY 2011 interim RVUs and implemented interim RVUs for new and revised codes for CY 2012 to ensure that our payment systems are updated to reflect changes in medical practice and the relative values of services. In the CY 2012 PFS final rule with comment period, we announced the following for CY 2012: the total PFS update of −27.4 percent; the initial estimate for the sustainable growth rate (SGR) of −16.9 percent; and the conversion factor (CF) of $24.6712. These figures were calculated based on the statutory provisions in effect on November 1, 2011, when the CY 2012 PFS final rule with comment period was issued.
A correction notice was issued (77 FR 227) to correct several technical and typographical errors that occurred in the CY 2012 PFS final rule with comment period.
On December 23, 2011, the Temporary Payroll Tax Cut Continuation Act of 2011 (TPTCCA) (Pub. L. 112-78) was signed into law. Section 301 of the TPTCCA specified a zero percent update to the PFS from January 1, 2012 through February 29, 2012. As a result, the CY 2012 PFS conversion factor was revised to $34.0376 for claims with dates of service on or after January 1, 2012 through February 29, 2012. In addition, the TPTCCA extended several provisions affecting Medicare services furnished on or after January 1, 2012 through February 29, 2012, including:
• Section 303—the 1.0 floor on the physician work geographic practice cost index;
• Section 304—the exceptions process for outpatient therapy caps;
• Section 305—the payment to independent laboratories for the technical component (TC) of physician pathology services furnished to certain hospital patients, and
• Section 307—the 5 percent increase in payments for mental health services.
On February 22, 2012, the Middle Class Tax Relief and Job Creation Act of 2012 (Pub. L. 112-96) (MCTRJCA) was signed into law. Section 3003 of the MCTRJCA extended the zero percent PFS update to the remainder of CY 2012. As a result of the MCTRJCA, the CY 2012 PFS CF was maintained as $34.0376 for claims with dates of service on or after March 1, 2012 through December 31, 2012. In addition:
• Section 3004 of MCTRJCA extended the 1.0 floor on the physician work geographic practice cost index through December 31, 2012;
• Section 3006 continued payment to independent laboratories for the TC of physician pathology services furnished to certain hospital patients through June 30, 2012; and
• Section 3005 extended the exceptions process for outpatient therapy caps through CY 2012 and made several other changes related to therapy claims and caps.
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, amended section 1848(c)(2)(C)(ii) of the Act to require us to develop a methodology for a resource-based system for determining PE RVUs for each physician's service. We develop PE RVUs by looking at the direct and indirect physician practice resources involved in furnishing each service. Direct expense categories include clinical labor, medical supplies, and medical equipment. Indirect expenses include administrative labor, office expense, and all other expenses. The sections that follow provide more detailed information about the methodology for translating the resources involved in furnishing each service into service-specific PE RVUs. In addition, we note that 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 otherwise been if the adjustments were not made. Therefore, 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. We refer readers to the CY 2010 PFS final rule with comment period (74 FR 61743 through 61748) for a more detailed explanation of the PE methodology.
We use a “bottom-up” approach to determine the direct PE by adding the costs of the resources (that is, the clinical staff, equipment, and supplies) typically involved with furnishing 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 RUC. For a detailed explanation of the bottom-up direct PE methodology, including examples, we refer readers to the Five-Year Review of Work Relative Value Units Under the PFS and Proposed Changes to the Practice Expense Methodology proposed notice (71 FR 37242) and the CY 2007 PFS final rule with comment period (71 FR 69629).
We use survey data on indirect PEs incurred per hour worked in developing the indirect portion of the PE RVUs. Prior to CY 2010, we primarily used the practice expense per hour (PE/HR) by specialty that was obtained from the
The PPIS is a multispecialty, nationally representative, PE survey of both physicians and NPPs using a consistent survey instrument and methods highly consistent with those used for the SMS and the supplemental surveys. The PPIS gathered information from 3,656 respondents across 51 physician specialty and healthcare professional groups. We believe the PPIS is the most comprehensive source of PE survey information available to date. Therefore, we used the PPIS data to update the PE/HR data for the CY 2010 PFS for almost all of the Medicare-recognized specialties that participated in the survey.
When we began using the PPIS data beginning in CY 2010, we did not change the PE RVU methodology itself or the manner in which the PE/HR data are used in that methodology. We only updated the PE/HR data based on the new survey. Furthermore, as we explained in the CY 2010 PFS final rule with comment period (74 FR 61751), because of the magnitude of payment reductions for some specialties resulting from the use of the PPIS data, we finalized a 4-year transition (75 percent old/25 percent new for CY 2010, 50 percent old/50 percent new for CY 2011, 25 percent old/75 percent new for CY 2012, and 100 percent new for CY 2013) from the previous PE RVUs to the PE RVUs developed using the new PPIS data.
Section 1848(c)(2)(H)(i) of the Act requires us to use the medical oncology supplemental survey data submitted in 2003 for oncology drug administration services. Therefore, the PE/HR for medical oncology, hematology, and hematology/oncology reflects the continued use of these supplemental survey data.
We do not use the PPIS data for reproductive endocrinology and spine surgery since these specialties currently are not separately recognized by Medicare, nor do we have a method to blend these data with Medicare-recognized specialty data. Similarly, we do not use the PPIS data for sleep medicine since there is not a full year of Medicare utilization data for that specialty given when the specialty code was created.
Supplemental survey data on independent labs, from the College of American Pathologists, were implemented for payments in CY 2005. Supplemental survey data from the National Coalition of Quality Diagnostic Imaging Services (NCQDIS), representing independent diagnostic testing facilities (IDTFs), were blended with supplementary survey data from the American College of Radiology (ACR) and implemented for payments in CY 2007. Neither IDTFs nor independent labs participated in the PPIS. Therefore, we continue to use the PE/HR that was developed from their supplemental survey data.
Consistent with our past practice, the previous indirect PE/HR values from the supplemental surveys for medical oncology, independent laboratories, and IDTFs were updated to CY 2006 using the MEI to put them on a comparable basis with the PPIS data.
Previously, we have established PE/HR values for various specialties without SMS or supplemental survey data by crosswalking them to other similar specialties to estimate a proxy PE/HR. For specialties that were part of the PPIS for which we previously used a crosswalked PE/HR, we instead use the PPIS-based PE/HR. We continue previous crosswalks for specialties that did not participate in the PPIS. However, beginning in CY 2010 we changed the PE/HR crosswalk for portable x-ray suppliers from radiology to IDTF, a more appropriate crosswalk because these specialties are more similar to each other for physician time.
For registered dietician services, the resource-based PE RVUs have been calculated in accordance with the final policy that crosswalks the specialty to the “All Physicians” PE/HR data, as adopted in the CY 2010 PFS final rule with comment period (74 FR 61752) and discussed in more detail in the CY 2011 PFS final rule with comment period (75 FR 73183).
There were five specialties whose utilization data were newly incorporated into ratesetting for CY 2012. In accordance with the final policies adopted in the CY 2012 final rule with comment period (76 FR 73036), we use proxy PE/HR values for these specialties by crosswalking values from other, similar specialties as follows: Speech Language Pathology from Physical Therapy; Hospice and Palliative Care from All Physicians; Geriatric Psychiatry from Psychiatry; Intensive Cardiac Rehabilitation from Cardiology, and Certified Nurse Midwife from Obstetrics/gynecology.
For CY 2013, there are two specialties whose utilization data will be newly incorporated into ratesetting. We proposed to use proxy PE/HR values for these specialties by crosswalking values from other specialties that furnish similar services as follows: Cardiac Electrophysiology from Cardiology; and Sports Medicine from Family Practice. These proposed changes are reflected in the “PE HR” file available on the CMS Web site under the supporting data files for the CY 2013 PFS final rule with comment period at
We did not receive any comments regarding our proposal to use these proxy PE/HR values for these specialties, and we continue to believe that the values crosswalked from other specialties that furnish similar services are appropriate. Therefore, we are finalizing our CY 2013 proposals to update the PE/HR data as reflected in the “PE HR” file available on the CMS Web site under the supporting data files for the CY 2013 PFS final rule with comment period at
As provided in the CY 2010 PFS final rule with comment period (74 FR 61751), CY 2013 is the final year of the 4-year transition to the PE RVUs calculated using the PPIS data. Therefore, the CY 2013 PE RVUs are developed based entirely on the PPIS data, except as noted in this section.
To establish PE RVUs for specific services, it is necessary to establish the direct and indirect PE associated with each service.
The relative relationship between the direct cost portions of the PE RVUs for any two services is determined by the relative relationship between the sum of the direct cost resources (that is, the clinical staff, equipment, and supplies) typically involved with furnishing the services. The costs of these resources are calculated from the refined direct PE inputs in our PE database. For example, if one service has a direct cost sum of $400 from our PE database and another service has a direct cost sum of $200, the direct portion of the PE RVUs of the first service would be twice as much as the direct portion of the PE RVUs for the second service.
Section II.A.2.b. of this final rule with comment period describes the current data sources for specialty-specific indirect costs used in our PE calculations. We allocated the indirect costs to the code level on the basis of the direct costs specifically associated with a code and the greater of either the clinical labor costs or the physician work RVUs. We also incorporated the
• For a given service, we use the direct portion of the PE RVUs calculated as previously described and the average percentage that direct costs represent of total costs (based on survey data) across the specialties that furnish the service to determine an initial indirect allocator. For example, if the direct portion of the PE RVUs for a given service was 2.00 and direct costs, on average, represented 25 percent of total costs for the specialties that furnished the service, the initial indirect allocator would be 6.00 since 2.00 is 25 percent of 8.00 and 6.00 is 75 percent of 8.00.
• Next, we add the greater of the work RVUs or clinical labor portion of the direct portion of the PE RVUs to this initial indirect allocator. In our example, if this service had work RVUs of 4.00 and the clinical labor portion of the direct PE RVUs was 1.50, we would add 6.00 plus 4.00 (since the 4.00 work RVUs are greater than the 1.50 clinical labor portion) to get an indirect allocator of 10.00. In the absence of any further use of the survey data, the relative relationship between the indirect cost portions of the PE RVUs for any two services would be determined by the relative relationship between these indirect cost allocators. For example, if one service had an indirect cost allocator of 10.00 and another service had an indirect cost allocator of 5.00, the indirect portion of the PE RVUs of the first service would be twice as great as the indirect portion of the PE RVUs for the second service.
• Next, we next incorporate the specialty-specific indirect PE/HR data into the calculation. As a relatively extreme example for the sake of simplicity, assume in our previous example that, based on the survey data, the average indirect cost of the specialties furnishing the first service with an allocator of 10.00 was half of the average indirect cost of the specialties furnishing the second service with an indirect allocator of 5.00. In this case, the indirect portion of the PE RVUs of the first service would be equal to that of the second service.
For procedures that can be furnished in a physician's office, as well as in a hospital or facility setting, we establish two PE RVUs: facility and nonfacility. The methodology for calculating PE RVUs is the same for both the facility and nonfacility RVUs, but is applied independently to yield two separate PE RVUs. Because Medicare makes a separate payment to the facility for its costs of furnishing a service, the facility PE RVUs are generally lower than the nonfacility PE RVUs.
Diagnostic services are generally comprised of two components: a professional component (PC) and a technical component (TC), each of which may be furnished independently or by different providers, or they may be furnished together as a “global” service. When services have PC and TC components that can be billed separately, the payment for the global component equals the sum of the payment for the TC and PC. This is a result of using a weighted average of the ratio of indirect to direct costs across all the specialties that furnish the global components, TCs, and PCs; that is, we apply the same weighted average indirect percentage factor to allocate indirect expenses to the global components, PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum to the global under the bottom-up methodology.)
For a more detailed description of the PE RVU methodology, we refer readers to the CY 2010 PFS final rule with comment period (74 FR 61745 through 61746).
First, we create a setup file for the PE methodology. The setup file contains the direct cost inputs, the utilization for each procedure code at the specialty and facility/nonfacility place of service level, and the specialty-specific PE/HR data from the surveys.
Sum the costs of each direct input.
Create indirect allocators.
There are two situations where this formula is modified:
• If the service is a global service (that is, a service with global, professional, and technical components), then the indirect allocator is: indirect percentage (direct PE RVUs/direct percentage) + clinical PE RVUs + work RVUs.
• If the clinical labor PE RVUs exceed the work RVUs (and the service is not a global service), then the indirect allocator is: indirect percentage (direct PE RVUs/direct percentage) + clinical PE RVUs.
(
For presentation purposes in the examples in Table 1, the formulas were divided into two parts for each service.
• The first part does not vary by service and is the indirect percentage (direct PE RVUs/direct percentage).
• The second part is either the work RVUs, clinical PE RVUs, or both depending on whether the service is a global service and whether the clinical PE RVUs exceed the work RVUs (as described earlier in this step).
Apply a scaling adjustment to the indirect allocators.
Calculate the indirect practice cost index.
The final PE BN adjustment is calculated by comparing the results of Step 18 to the current pool of PE RVUs. This final BN adjustment is required in order to redistribute RVUs from step 18 to all PE RVUs in the PFS and because certain specialties are excluded from the PE RVU calculation for ratesetting purposes, but all specialties are included for purposes of calculating the final BN adjustment. (See “Specialties excluded from ratesetting calculation” later in this section.)
•
In the CY 2013 PFS proposed rule, we proposed to calculate the specialty mix for low volume services (fewer than 100 billed services in the previous year) using the same methodology we used for non-low volume services. We currently use the survey data from the dominant specialty for these low volume services. We proposed to calculate a specialty mix for these services rather than use the dominant specialty in order to smooth year-to-year fluctuations in PE RVUs due to changes in the dominant specialty. However, the PE RVUs for the affected HCPCS codes were inadvertently displayed in Addendum B for the CY 2013 PFS proposed rule using our previously established methodology of using the dominant specialty for these services. While we received comments on our proposal, including some suggesting alternative methods for handling low volume services, we do not believe that it would be appropriate to make changes to the current methodology since the correct impact of the proposed calculation was not reflected in the displayed PE RVUs. We appreciate the commenters' perspective on the proposal, and will take those comments into account as we consider the best methodology for calculating the specialty mix for low volume services in future rulemaking.
•
•
•
•
We also make adjustments to volume and time that correspond to other payment rules, including special multiple procedure endoscopy rules and multiple procedure payment reductions (MPPR) including the final ophthalmology and cardiovascular diagnostic services MPPR discussed in section II.B.4. of this final rule with comment period. We note that section 1848(c)(2)(B)(v) of the Act exempts certain reduced payments for multiple imaging procedures and multiple therapy services from the budget-neutrality calculation under section 1848(c)(2)(B)(ii)(II) of the Act. These MPPRs are not included in the development of the RVUs.
For anesthesia services, we do not apply adjustments to volume since the average allowed charge is used when simulating RVUs and therefore includes all discounts. A time adjustment of 33 percent is made only for medical direction of two to four cases since that it is the only occasion where time units are duplicative.
•
The equipment cost per minute is calculated as:
• Fixed rate loans of $50,000 or more must not exceed Prime plus 2.25 percent if the maturity is less than 7 years, and Prime plus 2.75 percent if the maturity is 7 years or more.
• For loans between $25,000 and $50,000, maximum rates must not exceed Prime plus 3.25 percent if the maturity is less than 7 years, and Prime plus 3.75 percent if the maturity is 7 years or more.
• For loans of $25,000 or less, the maximum interest rate must not exceed Prime plus 4.25 percent if the maturity is less than 7 years, and Prime plus 4.75 percent, if the maturity is 7 years or more.
Based on that recommendation, for CY 2013, we proposed to use a “sliding scale” approach based on the current SBA maximum interest rates for different categories of loan size (price of the equipment) and maturity (useful life of the equipment). Additionally, we proposed to update this assumption through annual PFS rulemaking to account for fluctuations in the Prime rate and/or changes to the SBA's formula to determine maximum allowed interest rates.
We support CMS's proposal to use more accurate interest rate information because this will improve the accuracy of practice expense payment rates and redistribute dollars from overvalued codes to undervalued codes.
The AMA RUC commented:
The RUC appreciates that CMS intends to adopt the RUC recommendation of implementing a “sliding scale” for the interest rate utilized in computing equipment costs.
Other commenters, also supported the proposal. However, while physician organizations that represent specialties that provide medical equipment intensive services and medical equipment manufacturers generally acknowledged that the interest rate used in the calculation had not been updated in over 12 years, they did not support the specific proposed update approach. These commenters assertions included: The proposal is “overly complicated” to administer since the interest rates vary by loan size and maturity, and interest rates can fluctuate; the SBA loan program is designed to encourage loans to small businesses so the SBA rates are below market rates unrelated to the cost of capital for physician practices; the proposed methodology may be inconsistent with the statute since it does not reflect relative resources; CMS should factor in the opportunity cost for practices that pay cash for the equipment (a weighted average cost of capital (WACC) approach) using WACC measures available in the private sector; CMS should transition this policy given the investments in equipment that have already been made; CMS should use a multiyear average of the Prime rate rather than the most recent Prime rate in the calculation; and, CMS should only update the interest rate every few years to help ensure more stable practice expenses.
Additionally, we disagree that the maximum SBA loan rates are not sufficient as an assumption for the rate at which a typical physician practice would obtain financing, nor did the commenters offer nationally representative data indicating that this is the case.
We agree with commenters that, in an ideal world, the interest rate assumption used in the equipment calculation would explicitly factor in the opportunity costs for practices that pay cash for the equipment (a WACC approach) and not just the cost of financing. However, as with the interest rates typically charged to physicians for medical equipment financing, we are unaware of any nationally representative data source that would provide the opportunity cost for physician practices deciding on purchasing medical equipment. Some commenters suggested we use proprietary WACC measures designed for industry and company stock valuations. We do not believe it would be appropriate to use proprietary measures in this calculation, nor do we believe that measures developed to value the stock prices of individual medical equipment companies or the medical device industry are necessarily applicable to the opportunity costs of
We also do not believe that our proposal is overly complicated to administer. The Prime rate is readily available, as are the SBA loan maximums. As such, we believe our proposal is a very transparent approach. We stated that we would update the rate through our annual PFS rulemaking process. In response to comments on this aspect of our proposal, we are clarifying that we generally intend to update the interest rate calculation through future rulemaking when we broadly update one or more of the other direct practice expense inputs, such as pricing or labor wage rates, to maintain relatively between the practice expense components. Given that we do not anticipate updating the interest rate assumption every year, we do not believe it is necessary to use a rolling average in the calculation. Periodic updates using the most recent Prime rate will balance commenters' desire for stability in the PE RVUs with the need to maintain appropriate relativity under the PFS. We also do not believe a transition is appropriate in this situation. We believe it is important to update the interest rate assumptions to appropriately adjust the relativity of equipment in relation to other PE inputs and the relation of equipment intensive services to other services on the PFS.
In summary, we are finalizing without modification our proposal to use a “sliding scale” approach based on the current SBA maximum interest rates for different categories of loan size (price of the equipment) and maturity (useful life of the equipment). We will update the interest rate assumption through PFS rulemaking to account for fluctuations in the Prime rate and/or changes to the SBA's formula to determine maximum allowed interest rates. We are clarifying that we generally intend to update the interest rate calculation through future rulemaking only in years when we broadly update one or more of the other direct practice expense inputs. Accordingly, we anticipate updating the interest rate calculation less frequently than annually.
The effects of this policy on direct equipment inputs are reflected in the CY 2013 direct PE input database, available on the CMS Web site under the downloads for the CY 2013 PFS final rule with comment period at
In this section, we discuss other specific CY 2013 proposals and changes related to direct PE inputs for specific services. The changes we proposed and are finalizing are included in the final rule CY 2012 direct PE database, which is available on the CMS Web site under the supporting data files for the CY 2012 PFS final rule with comment period at
It has come to our attention that the pacemaker follow-up system (EQ138) associated with two interrogation device management service codes does not have minutes allocated in the direct PE input database. Based on our analysis of these services, we believed that 10 minutes should be allocated to the equipment for each of the following CPT codes: 93294 (Interrogation device evaluation(s) (remote), up to 90 days; single, dual, or multiple lead pacemaker system with interim physician analysis, review(s) and report(s)), and 93295 (Interrogation device evaluation(s) (remote), up to 90 days; single, dual, or multiple lead implantable cardioverter-defibrillator system with interim physician analysis, review(s) and report(s)). Therefore, the direct PE input database was modified to allocate 10 minutes to the pacemaker follow-up system for CPT codes 93294 and 93295.
It has come to our attention that the direct PE input database includes 15 minutes of clinical labor time in the nonfacility setting allocated for a CORF social worker/psychologist (L045C) associated with HCPCS code G0424 (Pulmonary rehabilitation, including exercise (includes monitoring), one hour, per session, up to two sessions per day). Based on our analysis of this service, we believed that these 15 minutes should be added to the 15 minutes currently allocated to the Respiratory Therapist (L042B) associated with this service. Therefore, we proposed to modify the direct PE input database to allocate 15 additional minutes to the Respiratory Therapist (L042B) (for a total of 30 minutes) and to delete the CORF social worker/psychologist (L045C) associated with HCPCS code G0424.
After consideration of the comments we received, we are finalizing the modification of the direct PE labor inputs for this service to allocate 15 additional minutes to the Respiratory Therapist (L042B) (for a total of 30 minutes) and to delete the CORF social worker/psychologist (L045C) associated with HCPCS code G0424.
For CY 2011, the CPT Editorial Panel converted Category III CPT codes 0160T and 0161T to Category I status (CPT codes 90867 (Therapeutic repetitive transcranial magnetic stimulation (TMS) treatment; initial, including cortical mapping, motor threshold determination, delivery and management), and 90868 (Therapeutic repetitive transcranial magnetic stimulation (TMS) treatment; subsequent delivery and management, per session)), which were contractor priced on the PFS. For CY 2012, the CPT Editorial Panel modified CPT codes 90867 and 90868, and created CPT code 90869 ((Therapeutic repetitive transcranial magnetic stimulation (TMS) treatment; subsequent motor threshold re-determination with delivery and management.) In the CY 2012 PFS final rule with comment period, we established interim final values based on refinement of RUC-recommended work RVUs, direct PE inputs, and malpractice risk factor crosswalks for these services (76 FR 73201).
Subsequent to the development of interim final PE RVUs, it came to our attention that the application of our usual PE methodology resulted in anomalous PE values for these services. As we explain in section II.A.2.c.2 of this final rule with comment period, for a given service, we use the direct costs associated with a service (clinical staff, equipment, and supplies) and the average percentage that direct costs represent of total costs (based on survey data) across the specialties that furnish the service to determine an initial indirect allocator.
For services almost exclusively furnished by one specialty, the average percentage of indirect costs relative to direct costs would ordinarily be used to determine the initial indirect allocator. For specialties that typically incur significant direct costs relative to indirect costs, the initial indirect allocator for their services is generally lower than for the specialties that typically incur lower direct costs relative to indirect costs. Relative to direct costs, the methodology generally allocates a greater proportion of indirect PE to services furnished by psychiatrists, for example, than to services furnished by specialties that typically incur significant direct costs, such as radiation oncologists. In the case of TMS, however, the direct costs incurred by psychiatrists reporting the codes far exceed the direct costs typical to any other service predominantly furnished by psychiatrists. This drastic difference in the direct costs of TMS relative to most other services furnished by psychiatrists, results in anomalous PE values since code-level indirect PE allocation relies on typical resource costs for the specialties that furnish the service. In other words, the amount of indirect PE allocated to TMS services is
Historically, we have contractor-priced (meaning our claims processing contractors develop payment rates) for services with resource costs that cannot be appropriately valued within the generally applicable PE methodology used to price services across the PFS. Because there is no mechanism to develop appropriate payment rates for these services within our current methodology, we proposed to contractor price these codes for CY 2013.
In our proposal, we pointed out that the direct costs incurred by psychiatrists reporting the codes far exceed the direct costs typical to any other service predominantly furnished by psychiatrists. The commenter objected to this assertion and claimed it was made without any empirical support. We made that assertion based on comparing the direct practice expense input costs for transcranial magnetic stimulation services and the current direct practice expense input costs in the direct PE database for services predominantly furnished by the specialty based on Medicare claims data. In our examination of 20 frequently billed psychiatry services (where greater than half of the Medicare allowed services were reported by psychiatrists), the total direct costs (clinical labor, disposable medical supplies, or medical equipment) in the direct PE input database summed to under $10 for all but 3 of these 20 services. Examples of these services include CPT codes 90807 (Individual psychotherapy, insight oriented, behavior modifying and/or supportive, in an office or outpatient facility, approximately 45 to 50 minutes face-to-face with the patient; with medical evaluation and management services), 90862 (Pharmacologic management, including prescription, use, and review of medication with no more than minimal medical psychotherapy), and 90845 (Psychoanalysis). For the three where the direct PE input costs summed to greater than $10, HCPCS code M0064 (Brief office visit for the sole purpose of monitoring or changing drug prescriptions used in the treatment of mental psychoneurotic and personality disorders), and CPT codes 90865 (Narcosynthesis for psychiatric diagnostic and therapeutic purposes (eg, sodium amobarbital (Amytal) interview)), and 90870 (Electroconvulsive therapy (includes necessary monitoring)), the service with the highest direct cost sum was $32.24. In contrast, the transcranial magnetic stimulation services treatment delivery (CPT code 90867) included direct PE inputs that summed to direct costs of $145.19. The disparity between the TMS direct costs and the direct costs in other frequent psychiatry codes was the basis for our assertion that the direct costs for this service far exceeded the direct costs typical to any other service predominantly furnished by psychiatrists. Thus, we continue to believe our decision to contractor price these codes is the proper one.
After consideration of these public comments, we are finalizing our proposal to contractor price CPT codes 90867, 90868, and 90869 for CY 2013.
Stakeholders have recently brought to our attention that CPT code 63650 (Percutaneous implantation of neurostimulator electrode array, epidural) is frequently furnished in the physician office setting but is not priced in that setting. We note that the valuation of a service under the PFS in particular settings does not address whether those services are medically reasonable and necessary in the case of individual patients, including being furnished in a setting appropriate to the patient's medical needs and condition. However, because these services are being furnished in the nonfacility setting, we believed that CPT code 63650 should be reviewed to establish appropriate nonfacility inputs. We proposed to review CPT code 63650 and requested recommendations from the AMA RUC and other public commenters on the appropriate physician work RVUs (as measured by time and intensity), and facility and nonfacility direct PE inputs for this service. We understand that disposable leads comprise a significant resource cost for this service and are currently separately reportable to Medicare for payment purposes when the service is furnished in the physician office setting. Disposable medical supplies are not considered prosthetic devices paid under the Durable Medical Equipment, Prosthetic/Orthotic, and Supplies (DMEPOS) fee schedule and generally are incorporated as nonfacility direct PE inputs to PE RVUs. We sought comment on establishing nonfacililty PE RVUs for CPT code 63650.
After consideration of the comments we received regarding our proposal to establish nonfacility PE RVUs for CPT code 63650 (Percutaneous implantation of neurostimulator electrode array, epidural), we continue to believe that it would be appropriate to do so since these services are being furnished in the nonfacility setting. The AMA RUC expects to review the direct PE inputs for this service during CY 2013. We anticipate receiving recommendations from the AMA RUC for the CY 2014 PFS, and we request comments from other stakeholders regarding the appropriate direct PE inputs for this service
To value services under the PFS, section 1848(c) of the Act requires the Secretary to determine relative values for physicians' services based on three components: work; practice expense (PE); and malpractice. Section 1848(c)(1)(A) of the Act defines the work component to include “the portion of the resources used in furnishing the service that reflects physician time and intensity in furnishing the service.” In addition, section 1848(c)(2)(C)(i) of the Act specifies that “the Secretary shall determine a number of work relative value units (RVUs) for the service based on the relative resources incorporating physician time and intensity required in furnishing the service.”
As discussed in detail in sections II.B.1.b. and II.B.1.c. of this final rule with comment period, the statute also defines the PE and malpractice components and provides specific guidance in the calculation of the RVUs for each of these components. Section 1848(c)(1)(B) of the Act defines the PE component as “the portion of the resources used in furnishing the service that reflects the general categories of expenses (such as office rent and wages of personnel, but excluding malpractice expenses) comprising practice expenses.” Section 1848(c)(1)(C) of the Act defines the malpractice component as “the portion of the resources used in furnishing the service that reflects malpractice expenses in furnishing the service.” Clause (ii) and clause (iii) of section 1848 (c)(2)(C) of the Act specify that PE and malpractice expense RVUs shall be determined based on the relative PE/malpractice expense resources involved in furnishing the service.
Section 1848(c)(2)(B) of the Act directs the Secretary to conduct a periodic review, not less often than every 5 years, of the RVUs established under the PFS. On March 23, 2010, the Affordable Care Act was enacted, further requiring the Secretary to periodically identify and review potentially misvalued codes and make appropriate adjustments to the relative values of those services identified as being potentially misvalued. Section 1848(c)(2)(K) to the Act requires the Secretary to periodically identify potentially misvalued services using certain criteria and to review and make appropriate adjustments to the relative values for those services. Section 1848(c)(2)(L) of the Act requires the Secretary to develop a process to validate the RVUs of certain potentially misvalued codes under the PFS, identified using the same criteria used to identify potentially misvalued codes, and to make appropriate adjustments.
As discussed in section I.B.1.a. of this final rule with comment period, each year we develop and propose appropriate adjustments to the RVUs, taking into account the recommendations provided by the American Medical Association Specialty Society Relative Value Scale Update Committee (AMA RUC), the Medicare Payment Advisory Commission (MedPAC), and others. For many years, the AMA RUC has provided us with recommendations on the appropriate relative values for new, revised, and potentially misvalued PFS services. We review these recommendations on a code-by-code basis and consider these recommendations in conjunction with the recommendations of other public commenters, and with analyses of data sources, such as claims data, to inform the decision-making process as authorized by the law. We may also consider analyses of physician time, work RVUs, or direct PE inputs using other data sources, such as Department of Veteran Affairs (VA) National Surgical Quality Improvement Program (NSQIP), the Society for Thoracic Surgeons (STS), and the Physician Quality Reporting Initiative (PQRI) databases. In addition to considering the most recently available data, we also assess the results of physician surveys and specialty recommendations submitted to us by the AMA RUC. We conduct a clinical review to assess the appropriate RVUs in the context of contemporary medical practice. We note that section 1848(c)(2)(A)(ii) of the Act authorizes the use of extrapolation and other techniques to determine the RVUs for physicians' services for which specific data are not available, in addition to taking into account the
In its March 2006 Report to the Congress, MedPAC noted that “misvalued services can distort the price signals for physicians' services as well as for other health care services that physicians order, such as hospital services.” In that same report MedPAC postulated that physicians' services under the PFS can become misvalued over time for a number of reasons: For example, MedPAC stated, “when a new service is added to the PFS, it may be assigned a relatively high value because of the time, technical skill, and psychological stress that are often required to furnish that service. Over time, the work required for certain services would be expected to decline as physicians become more familiar with the service and more efficient in furnishing it.” That is, the amount of physician work needed to furnish an existing service may decrease as physicians build experience furnishing that service. Services can also become overvalued when PEs decline. This can happen when the costs of equipment and supplies fall, or when equipment is used more frequently than is estimated in the PE methodology, reducing its cost per use. Likewise, services can become undervalued when physician work increases or PEs rise. In the ensuing years since MedPAC's 2006 report, additional groups of potentially misvalued services have been identified by the Congress, CMS, MedPAC, the AMA RUC, and other stakeholders.
In recent years, CMS and the AMA RUC have taken increasingly significant steps to address potentially misvalued codes. As MedPAC noted in its March 2009 Report to Congress, in the intervening years since MedPAC made the initial recommendations, “CMS and the AMA RUC have taken several steps to improve the review process.” Most recently, section 1848(c)(2)(K)(ii) of the Act directed the Secretary to specifically examine, as determined appropriate, potentially misvalued services in seven categories as follows:
• Codes and families of codes for which there has been the fastest growth;
• Codes and families of codes that have experienced substantial changes in PEs;
• Codes that are recently established for new technologies or services;
• Multiple codes that are frequently billed in conjunction with furnishing a single service;
• Codes with low relative values, particularly those that are often billed multiple times for a single treatment;
• Codes which have not been subject to review since the implementation of the PFS (the so-called `Harvard-valued codes'); and
• Other codes determined to be appropriate by the Secretary.
Section 1848(c)(2)(K)(iii) of the Act also specifies that the Secretary may use existing processes to receive recommendations on the review and appropriate adjustment of potentially misvalued services. In addition, the Secretary may conduct surveys, other data collection activities, studies, or other analyses, as the Secretary determines to be appropriate, to facilitate the review and appropriate adjustment of potentially misvalued services. This section also authorizes the use of analytic contractors to identify and analyze potentially misvalued codes, conduct surveys or collect data, and make recommendations on the review and appropriate adjustment of potentially misvalued services. Additionally, this section provides that the Secretary may coordinate the review and adjustment of any RVU with the periodic review described in section 1848(c)(2)(B) of the Act. Finally, section 1848(c)(2)(K)(iii)(V) of the Act specifies that the Secretary may make appropriate coding revisions (including using existing processes for consideration of coding changes) which may include consolidation of individual services into bundled codes for payment under the PFS.
In addition to these requirements, section 3003(b)(1) of the Middle Class Tax Relief and Job Creation Act of 2012 (MCTRJCA) (Pub. L. 112-96), requires that the Secretary conduct a study that examines options for bundled or episode-based payment to cover physicians' services currently paid under the PFS under section 1848 of the Act for one or more prevalent chronic conditions or episodes of care for one or more major procedures. In conducting the study, the Secretary shall consult with medical professional societies and other relevant stakeholders. Additionally, the study shall include an examination of related private payer payment initiatives. This section also requires that not later than January 1, 2013, the Secretary submit to certain committees of the Congress a report on the study. The report shall include recommendations on suitable alternative payment options for services paid under the PFS and on associated implementation requirements.
Bundling is one method for aligning incentives for hospitals, post-acute care providers, physicians, and other practitioners to partner closely across all specialties and settings that a patient may encounter to improve the patient's experience of care. The typical goals of developing an effective bundled payment system are to improve quality, reduce costs, and promote efficiency. Current work on bundling services paid under the PFS to date has been limited to targeting specific codes and sets of codes and repackaging those codes into “bundles.” As detailed above, through the potentially misvalued codes initiative we are currently identifying for review codes that are frequently billed together and codes with low relative values billed in multiples. Many of the codes identified through these screens have been referred to the CPT Editorial Panel for the development of a comprehensive or bundled code, and several bundled codes have already been created and valued. However, we believe that we now need to move beyond this “repackaging” of codes and examine the potential of a larger bundled payment within the PFS. In response to section 3003(b)(1) of the MCTRJCA, we have consulted with medical professional societies, private payers, healthcare system administrators, and other stakeholders; met with other CMS staff involved in other bundling initiatives; and performed an extensive literature review. Additionally, we have had representatives of specialty groups such as radiation oncologists volunteer to work with us to create a bundled payment for their services. If we were to engage in a bundling project for radiation therapy, we would want to do more than provide a single episode payment for the normal course of radiation therapy that aggregates the sum of the individual treatments. Radiation therapy has many common side effects that can vary based on the type of cancer the patient has and how it is being treated. Common side effects associated with radiation therapy include fatigue, skin problems, eating problems, blood count changes, emotional issues such as depression, etc* * * If we were to engage in a bundling project that includes radiation therapy, we would be interested in exploring whether it could also include treating and managing the side effects
We will continue to examine options for bundled or episode-based payments and will include our recommendations and implementation options in our report to the Congress. Following completion of this report, we will look forward with interest to the view of stakeholders that are interested in testing some of these concepts within the PFS.
In accordance with our statutory mandate, we have identified and reviewed numerous potentially misvalued codes in all seven of the categories specified in section 1848(c)(2)(K)(ii) of the Act, and we plan to continue our work examining potentially misvalued codes in these areas over the upcoming years. In the current process, we identify potentially misvalued codes for review, and request recommendations from the AMA RUC and other public commenters on revised work RVUs and direct PE inputs for those codes. The AMA RUC, through its own processes, identifies potentially misvalued codes for review, and through our public nomination process for potentially misvalued codes established in the CY 2012 PFS final rule, other individuals and stakeholder groups submit nominations for review of potentially misvalued codes as well.
Since CY 2009, as a part of the annual potentially misvalued code review and Five-Year Review processes, we have reviewed over 1,000 potentially misvalued codes to refine work RVUs and direct PE inputs. We have adopted appropriate work RVUs and direct PE inputs for these services as a result of these reviews.
Our prior reviews of codes under the potentially misvalued codes initiative have included codes in all seven categories specified in section 1848(c)(2)(K)(ii) of the Act, listed above. A more detailed discussion of the extensive prior reviews of potentially misvalued codes is included in the CY 2012 PFS final rule with comment period (76 FR 73052 through 73055).
In the CY 2012 final rule with comment period, under the potentially misvalued codes category of “Other codes determined to be appropriate by the Secretary,” we finalized our proposal to review a list of the highest PFS expenditure services, by specialty, that had not been recently reviewed (76 FR 73059 through 73068). In the CY 2012 final rule with comment period we also finalized policy to consolidate the periodic reviews of physician work and PE at the same time (76 FR 73055 through 73958), and established a process for the annual public nomination of potentially misvalued services to replace the Five-Year review process (76 FR 73058 through 73059). Below we discuss the CY 2013 PFS proposals that support our continuing efforts to appropriately identify, review, and adjust values for potentially misvalued codes.
In addition to identifying and reviewing potentially misvalued codes, section 1848(c)(2)(L) of the Act specifies that the Secretary shall establish a formal process to validate RVUs under the PFS. The validation process may include validation of work elements (such as time, mental effort and professional judgment, technical skill and physical effort, and stress due to risk) involved with furnishing a service and may also include validation of the pre-, post-, and intra-service time components of work. The Secretary is directed, as part of the validation, to validate a sampling of the work RVUs of codes identified through any of the seven categories of potentially misvalued codes specified by section 1848(c)(2)(K)(ii) of the Act. Furthermore, the Secretary may conduct the validation using methods similar to those used to review potentially misvalued codes, including conducting surveys, other data collection activities, studies, or other analyses as the Secretary determines to be appropriate to facilitate the validation of RVUs of services.
In the CY 2011 PFS proposed rule (75 FR 40068) and CY 2012 PFS proposed rule (76 FR 42790), we solicited public comments on possible approaches, methodologies, and data sources that we should consider for a validation process. A summary of the comments along with our responses are included in the CY 2011 PFS final rule with comment period (75 FR 73217) and the CY 2012 PFS final rule with comment period (77 FR 73054 through 73055). In September 2012 we entered into two contracts to assist us in validating RVUs of potentially misvalued codes; the implementation details for these contracts are currently under development. Contractors will explore models for the validation of physician work under the PFS, both for new and existing services. We plan to discuss these models further in future rulemaking.
We applied the concept of payment for a global surgical package under the PFS at its inception on January 1, 1992 (56 FR 59502). For each global surgical procedure, we establish a single payment, which includes payment for a package of all related services typically furnished by the surgeon furnishing the procedure during the global period. Each global surgery is paid on the PFS as a single global surgical package. Each global surgical package payment rate is based on the work necessary for the typical surgery and related pre- and post-operative work. The global period may include 0, 10, or 90 days of post-operative care, depending on the procedure. For major procedures, those with a 90-day global period, the global surgical package payment also includes services typically furnished the day prior to the day of surgery.
Some global surgical packages have been valued by adding the RVU of the surgical procedure and all pre- and post-operative evaluation and management (E/M) services included in the global period. Others have been valued using magnitude estimation, in which case the overall RVU for the surgical package was determined without factoring in the specific RVUs associated with the E/M services in the global period. The number and level of E/M services identified with a global surgery payment are based on the typical case. Even though a surgical package may have been developed with several E/M services included, a physician is not required to furnish each pre- or post-operative visit to bill for the global surgical package.
Similar to other bundled services on the PFS, when a global surgery code is billed, the bundled pre- and post-operative care is not separately payable; surgeons or other physicians billing a surgical procedure, cannot separately bill for the E/M services that are included in the global surgical package.
The use of different methodologies for valuing global surgical packages since 1992 has created payment rates that reflect a wide range of E/M services within the post-operative period. This is especially true among those with 90-day global periods. More recently reviewed codes tend to have fewer E/M services in the global period, and the work RVUs of those E/M services are often
In 2005, the HHS Office of Inspector General (OIG) examined whether global surgical packages are appropriately valued. In its report on eye and ocular surgeries, “National Review of Evaluation and Management Services Included in Eye and Ocular Adnexa Global Surgery Fees for Calendar Year 2005” (A-05-07-00077), the OIG reviewed a sample of 300 eye and ocular surgeries, and counted the actual number of face-to-face services in the surgeons' medical records to establish whether the surgeon furnished post-operative E/M services. The OIG findings show that surgeons typically furnished fewer E/M services in the post-operative period than were identified with the global surgical package payment for each procedure. A smaller percentage of surgeons furnished more E/M services than were identified with the global surgical package payment. The OIG could only review the number of face-to-face services and was not able to review the level of the E/M services that the surgeons furnished due to a lack of documentation in surgeons' medical records. The OIG concluded that the RVUs for the global surgical package are too high because they include the work of E/M services that are not typically furnished within the global period for the reviewed procedures.
Following the 2005 report, the OIG continued to investigate E/M services furnished during the global surgical period. In May 2012, the OIG published a report titled “Musculoskeletal Global Surgery Fees Often Did Not Reflect the Number of Evaluation and Management Services Provided” (A-05-09-00053). For this investigation, the OIG sampled 300 musculoskeletal global surgeries and again found that, for the majority of sampled surgeries, physicians furnished fewer E/M services than were identified as part of the global period for that service. Once again, a smaller percentage of surgeons furnished more E/M services than were identified with the global surgical package payment. The OIG concluded that the RVUs for the global surgical package are too high because they include the work of E/M services that are not typically furnished within the global period for the reviewed procedures.
In both reports, the OIG recommended that we adjust the number of E/M services identified with the global surgical payments to reflect the number of E/M services that are actually being furnished. Under the PFS, we do not ask surgeons to detail the component bundled services on their claim when billing for the global surgical package as we do providers furnishing bundled services under other Medicare payment systems. Since it is not necessary for a surgeon to identify the level or CPT code of the E/M services actually furnished during the global period, there is very limited documentation on the frequency or level of post-operative services. Without sufficient documentation, a review of the medical record cannot accurately determine the number or level of E/M services furnished in the post-operative period. This is an area of concern, and is discussed in more detail later in this section.
As noted above, section 1848(c)(2)(K) of the Act, which codified and expanded the potentially misvalued codes initiative that CMS had begun, requires that the Secretary identify and review potentially misvalued services with an emphasis on several categories, and recognizes the Secretary's discretion to identify additional potentially misvalued codes. Several of the categories of potentially misvalued codes support better valuation of global surgical package codes. We have made efforts to prioritize the review of RVUs for services on the PFS that have not been reviewed recently or for services where there is a potential for misuse. One of the priority categories for review of potentially misvalued codes is services that have not been subject to review since the implementation of the PFS (the so-called “Harvard-valued codes”). In the CY 2009 PFS proposed rule, we requested that the AMA RUC engage in an ongoing effort to review the remaining Harvard-valued codes, focusing first on the high-volume codes (73 FR 38589). For the Fourth Five-Year Review (76 FR 32410), we requested that the AMA RUC review services that have not been reviewed since the original implementation of the PFS with utilization greater than 30,000 (Harvard-valued—Utilization > 30,000). In the CY 2013 PFS proposed rule, we proposed to review Harvard-valued services with annual allowed charges that totaled at least $10,000,000 (Harvard-valued—Allowed charges ≥$10,000,000), and requested recommendations from the AMA RUC and other public commenters on appropriate values for these services (77 FR 44741).
Of the more than 1,000 identified potentially misvalued codes, just over 650 are surgical services with a global period of 0, 10, or 90 days. We have completed our review of 450 of these potentially misvalued surgical codes. As we stated in the CY 2013 PFS proposed rule, these efforts are important, but we believe the usual review process does not go far enough to assess whether the valuation of global surgical packages reflects the number and level of post-operative services that are typically furnished. To support our statutory obligation to identify and review potentially misvalued services and to respond to the OIG's concern that global surgical package payments are misvalued, we believe that we should gather more information on the E/M services that are typically furnished with surgical procedures. Information regarding the typical work involved in surgical procedures with a global period is necessary to evaluate whether certain surgical procedures are appropriately valued. While the AMA RUC reviews and recommends RVUs for services on the PFS, we complete our own assessment of those recommendations, and may adopt different RVUs. However, for procedures with a global period, the lack of detail in claims data and documentation restrict our ability to review and assess the appropriateness of their RVUs.
In the CY 2013 proposed rule, we requested comments on methods of obtaining accurate and current data on E/M services furnished as part of a global surgical package. We stated that we were especially interested in and invited comments on a claims-based data collection approach that would include reporting E/M services furnished as part of a global surgical package, as well as other valid, reliable, generalizable, and robust data to help us identify the number and level of E/M services typically furnished in the global surgical period for specific procedures.
The following is summary of the comments we received regarding the methods of obtaining accurate and current data on E/M services furnished as part of a global surgical package proposal.
In response to our request for comments on methods of obtaining accurate and current data on E/M services furnished as part of a global surgical package, some commenters stated that they believe post-operative work is appropriately surveyed, vetted and valued by the AMA RUC during its ongoing reviews of surgical procedures, and therefore, claims-based reporting is unnecessary in order to verify that the number of visits assigned to global surgical procedures is accurate. Some commenters stated that if CMS has concerns with a specific code, or group of codes, regarding the number of E/M visits valued within the physician work RVU, CMS should work with the AMA RUC to review these services. One commenter noted that there are 4,258 CPT codes on the PFS with a global period, but that only 271 of these CPT codes are billed more than 10,000 times annually, and most of the 271 CPT codes have been reviewed by CMS and the AMA RUC since 2005.
In addition to the broader comments on measuring post-operative work, we also received a comment from the AMA RUC noting that the hospital and discharge management services included in the global period for many surgical procedures may have been inadvertently removed from the time file in 2007. With its comment letter, the AMA RUC sent us a revised time file with updated post-operative visits for the services that may be incorrectly displayed with zero visits. We are reviewing this file, and if appropriate, we intend to propose modifications to the physician time file in the CY 2014 PFS proposed rule. We note that should time have been removed from the physician time file inadvertently, it would not have affected the physician work RVUs or direct practice expense inputs for these services. It would have a small impact on the indirect allocation of practice expense at the specialty level, which we will review when we explore this potential time file change.
In the CY 2012 PFS final rule, we finalized a public nomination process for potentially misvalued codes (76 FR 73058). Under the previous Five-Year Reviews for PE and work, we invited the public to nominate potentially misvalued codes for review. To allow for public input and to preserve the public's ability to identify and nominate potentially misvalued codes for review under our annual potentially misvalued codes initiative, we established a process by which the public can submit codes, along with documentation supporting the need for review, on an annual basis. Stakeholders may nominate potentially misvalued codes for review by submitting the code with supporting documentation during the 60-day public comment period following the release of the annual PFS final rule with comment period. Supporting documentation for codes nominated for the annual review of potentially misvalued codes may include the following:
• 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; and physician time.
• Evidence of an anomalous relationship between the code being proposed for review and other codes.
• 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, such as a misleading vignette, survey, or flawed crosswalk assumptions in a previous evaluation.
• Prices for certain high cost supplies or other direct PE inputs that are used to determine PE RVUs are inaccurate and do not reflect current information.
• Analyses of physician time, work RVU, or direct PE inputs using other data sources (for example, Department of Veteran Affairs (VA) National Surgical Quality Improvement Program (NSQIP), the Society for Thoracic Surgeons (STS), and the Physician Quality Reporting System (PQRS) databases).
• National surveys of physician time and intensity from professional and management societies and organizations, such as hospital associations.
Under this newly established process, after we receive the nominated codes during the 60-day comment period following the release of the annual PFS final rule with comment period, we evaluate the supporting documentation and assess whether the submitted codes appear to be potentially misvalued codes appropriate for review under the annual process. In the following year's PFS proposed rule, we publish the list of nominated codes, and propose -which nominated codes will be reviewed as potentially misvalued. We encourage the public to submit nominations for potentially misvalued codes in the 60-day comment period following the publication of this CY 2013 PFS final rule with comment period.
In the 60 days following the release of the CY 2012 PFS final rule with comment period, we received nominations and supporting documentation for review of the codes listed above in Table 4. A total of 36 CPT codes were nominated. The majority of the nominated codes were codes for which we finalized RVUs in the CY 2012 PFS final rule. That is, the RVUs were interim in CY 2011 and finalized for CY 2012, or proposed in either the Fourth Five-Year Review of Work or the CY 2012 PFS proposed rule and finalized for CY 2012. In the CY 2013 proposed rule, we noted that under this annual public nomination process it would be highly unlikely that we would determine that a nominated code is appropriate for review under the potentially misvalued codes initiative if it had been reviewed in the years immediately preceding its nomination since we believe that the best information on the level of physician work and PE inputs already would have been available through that recent review. We stated that, nonetheless, we would evaluate the supporting documentation for each nominated code to ascertain whether the submitted information demonstrated that the code is potentially misvalued.
CPT codes 33282 (Implantation of patient-activated cardiac event recorder) and 33284 (Removal of an implantable, patient-activated cardiac event recorder) were nominated for review as potentially misvalued codes. The requestor stated that CPT codes 33282 and 33284 are misvalued in the nonfacility setting because these CPT codes currently are only priced in the facility setting even though physicians furnish these services in the office setting. The requestor asked that we establish appropriate payment for the services when furnished in a physician's office. Specifically, the requestor asked that CMS establish nonfacility PE RVUs for these services. In the CY 2013 proposed rule, we stated that we do not consider the lack of pricing in a particular setting as an indicator of a potentially misvalued code. However, given that these services are now furnished in the nonfacility setting, we believe that CPT codes 33282 and 33284 should be reviewed to establish appropriate nonfacility inputs. We noted, as did the requestor, that the valuation of a service under the PFS in a particular setting does not address whether those services and the setting in which they are furnished are medically reasonable and necessary for a patient's medical needs and condition. We proposed to review CPT codes 33282 and 33284 and requested recommendations from the AMA RUC and other public commenters on the appropriate physician work RVUs (as measured by time and intensity), and facility and nonfacility direct PE inputs for these services.
Like CPT codes 33282 and 33284, stakeholders requested that we establish appropriate payment for CPT code 63650 (Percutaneous implantation of neurostimulator electrode array, epidural) when furnished in an office
The following is a summary of the comments we received in response to our proposal to review the physician work, facility, and nonfacility direct PE inputs for CPT codes 33282 and 33284.
Another commenter recommended that CMS finalize the proposal to revalue CPT codes 33282 and 33284 in order to establish nonfacility PE RVUs. The commenter stated that the lack of nonfacility PE RVUs prevents physicians from furnishing these services in the office for select patients for whom this setting of care is safe and appropriate. This commenter recommended that CMS maintain the existing work RVUs, and focus the revaluation on the nonfacility PE inputs. The commenter requested that CMS remain flexible in its approach to nominated codes and allow for more expeditious review of codes by not requiring full provider surveys.
We acknowledge that commenters support the current work and facility RVUs, however, it is our policy generally to review the physician work, facility, and nonfacility direct PE inputs for each service together to ensure consistency in the inputs used to value the service. Based on information provided by the requestor and the 2011 nonfacility utilization for this code, we believe it is appropriate to review this service for nonfacility PE inputs. As explained above, we intend to review the work and facility inputs as well. Additionally, we note that the physician work and facility PE inputs for these two services have not been reviewed in over a decade, so we believe it is reasonable to assess whether the inputs on which the current payment rates are based accurately reflect the resources involved in furnishing these services today. Accordingly, we are finalizing our proposal to review the physician work, and facility and nonfacility direct practice expense inputs for CPT codes 33282 and 33284, and request comments on the appropriate physician work, and facility and nonfacility direct practice expense inputs for these services.
Traditionally, we have received recommendations from the AMA RUC on the appropriate physician work, PE, and malpractice inputs for services CMS plans to review and revalue. However, we understand that the AMA RUC may not issue recommendations for all codes under review by CMS. In addition to requesting recommendations from the AMA RUC on services we intend to review, we request and encourage recommendations on these services from other public commenters as well. We acknowledge the requestor's comment that CMS remain flexible in its approach to nominated codes and not require full practitioner surveys for CPT codes 33282 and 33284. We understand that practitioner surveys regarding work, malpractice, and PE are not always available, practical, or reliable. We encourage commenters to submit the best data available on the appropriate valuation and inputs for the services under review, including the information listed above under supporting documentation for the nomination of potentially misvalued codes.
In the CY 2013 proposed rule, we stated that we did not consider CPT codes 36819 (Arteriovenous anastomosis, open; by upper arm basilic vein transposition) and 36825 (Creation of arteriovenous fistula by other than direct arteriovenous anastomosis (separate procedure); autogenous graft) to be potentially misvalued because these codes were last reviewed and valued for CY 2012 and the supporting documentation did not provide sufficient evidence to demonstrate that the codes should be reviewed as potentially misvalued for CY 2013 or CY 2014. The following is a summary of the comments we received in response to our proposal not to review CPT codes 36819 and 36825 as potentially misvalued codes.
CPT code 53445 (Insertion of inflatable urethral/bladder neck sphincter, including placement of pump, reservoir, and cuff) was nominated for review as a potentially misvalued code. CPT code 53445 was identified through the site-of-service anomaly potentially misvalued code screen for CY 2008. We completed our review and established RVUs for this
CPT code 77336 (Continuing medical physics consultation, including assessment of treatment parameters, quality assurance of dose delivery, and review of patient treatment documentation in support of the radiation oncologist, reported per week of therapy) was nominated for review as a potentially misvalued code. The requestor stated that CPT code 77336 is misvalued because changes in the technique for furnishing continuing medical physics consultations have resulted in changes to the knowledge required, time, and effort expended, and complexity of technology associated with the tasks performed by the physicist and other staff. Additionally the requestor stated that the direct PE inputs no longer accurately reflect the resources used to deliver this service and may be undervalued. CPT code 77336 was last reviewed for CY 2003. In the CY 2013 proposed rule, we stated that after evaluating the detailed supporting information that the commenter provided, we believed there may have been changes in technology and other PE inputs since we last reviewed the service, and that further review is warranted. As such, we proposed to review CPT code 77336 as potentially misvalued and requested recommendations from the AMA RUC and other public commenters on the direct PE inputs for this service and for the other services within this family of CPT codes.
The following is a summary of the comments we received in response to our proposal to review CPT code 77336 as potentially misvalued.
CPT code 94762 (Noninvasive ear or pulse oximetry for oxygen saturation; by continuous overnight monitoring (separate procedure)) was nominated for review as a potentially misvalued code. Requestors stated that CPT code 94762 is misvalued because the time currently allocated to the various direct PE inputs does not accurately reflect current practice. Requestors also stated that independent diagnostic testing facilities are not appropriately accounted for in the current indirect PE methodology. In the CY 2013 proposed rule, we stated that, in response to these stakeholder concerns, we reviewed the PE inputs for CPT code 94762, which was last reviewed for CY 2010. We believed that CPT code 94762 is misvalued, and we proposed changes to the PE inputs for CY 2013. We stated that, following clinical review, we believed that the current time allocated to clinical labor and supplies appropriately reflects current practice. However, we believed that 480 minutes (8 hours) of equipment time for the pulse oximetry recording slot and pulse oximeter with printer are more appropriate for this overnight monitoring procedure code. As such, we proposed this refinement to the direct PE inputs for CPT code 94762 for CY 2013. These proposed adjustments were reflected in the CY 2013 proposed direct PE input database, available on the CMS Web site under the downloads for the CY 2013 PFS final rule with comment period at
The following is a summary of the comments received regarding the proposed direct PE adjustments to CPT code 94762.
Based on these comments and our clinical review, we are adopting these direct PE inputs, including our adjusted allocation of equipment minutes, on an interim basis for CY 2013. These values are reflected in the CY 2013 PFS direct PE input database available under downloads for the CY 2013 PFS final rule with comment period on the CMS Web site at:
In the CY 2013 proposed rule, we stated that we did not consider the nominated codes that were last reviewed and valued for CY 2012 to be potentially misvalued because the supporting documentation did not provide sufficient evidence to demonstrate that the codes should be reviewed as potentially misvalued for CY 2013 or CY 2014. The supporting documentation for these services generally mirrored the public comments previously submitted, to which CMS has already responded. Below is a summary of the comments we received in response to our proposal to not review the CPT codes listed above in Table 4 not discussed above.
As mentioned above, in the last several annual PFS proposed rules we have identified lists of potentially misvalued codes for review. We believe it is imperative that we continue to identify new lists of potentially misvalued codes for review to appropriately identify, review, and adjust values for potentially misvalued codes for CY 2013.
For many years, we have been reviewing `Harvard-valued' CPT codes through the potentially misvalued code initiative. The RVUs for Harvard-valued CPT codes have not been reviewed since they were originally valued in the early 1990s at the beginning of the PFS. While the principles underlying the relative value scale have not changed, over time the methodologies we use for valuing services on the PFS have changed, potentially disrupting the relativity between the remaining Harvard-valued codes and other codes on the PFS. At this time, nearly all CPT codes that were Harvard-valued and had Medicare utilization of over 30,000 allowed services per year have been reviewed. In the CY 2013 PFS proposed rule, we proposed to review Harvard-valued services with annual Medicare allowed charges of $10 million or greater. The CPT codes meeting these criteria have relatively low Medicare utilization (as we have reviewed the services with utilization over 30,000), but account for significant Medicare spending annually and have never been reviewed. In the CY 2013 proposed rule, we noted that several of the CPT codes meeting these criteria have already been identified as potentially misvalued through other screens and were scheduled for review for CY 2013. We also recognized that other codes meeting these criteria had been referred by the AMA RUC to the CPT Editorial Panel. We stated that, in these cases, we were not proposing re-review of these already identified services, but for the sake of completeness, we included those codes as a part of this category of potentially misvalued services. In our proposal, we recognized that the relatively low Medicare utilization for these services may make gathering information on the appropriate physician work and direct PE inputs difficult. We requested recommendations from the AMA RUC and other public commenters, and stated that we appreciate efforts expended to provide RVU and input recommendations to CMS for these lower volume services. Because survey sample sizes could be small for these lower volume services, we encouraged the use of valid and reliable alternative data sources and methodologies when developing recommended values. In sum, we proposed to review Harvard-valued CPT codes with annual allowed charges of $10 million or more as a part of the potentially misvalued codes initiative. In the CY 2013 proposed rule, we stated that the following codes met the criteria for this screen and proposed to review these CPT codes as potentially misvalued services.
The following is summary of the comments we received in response to our proposal to review Harvard-valued CPT codes with annual allowed charges of $10 million or more as a part of the potentially misvalued codes initiative.
In the CY 2013 proposed rule, we noted that several codes that met the criteria for this potentially misvalued code screen were currently under review for CY 2013 and others were scheduled for review by the CPT Editorial Panel. CPT codes 13152 (Repair, complex, eyelids, nose, ears and/or lips; 2.6 cm to 7.5 cm), 52353 (Cystourethroscopy, with ureteroscopy and/or pyeloscopy; with lithotripsy (ureteral catheterization is included)), 64450 (Injection, anesthetic agent; other peripheral nerve or branch), 92286 (Special anterior segment photography with interpretation and report; with specular endothelial microscopy and cell count), and 95860 (Needle electromyography; 1 extremity with or without related paraspinal areas) were reviewed for CY 2013. A discussion of the interim final values for those services is in section III.M.3. of this final rule with comment period. CPT code 92982 (Percutaneous transluminal coronary balloon angioplasty; single vessel) has been deleted by the CPT Editorial Panel for CY 2013. We have updated the list of CPT codes meeting this potentially misvalued code screen to show the review status of the codes, and to remove the three CPT codes mentioned above that do not meet the parameters of the screen. We are finalizing the list of Harvard-valued CPT codes with annual allowed charges of $10 million or more in Table 6, and for CY 2014, we will review the services not already reviewed. We request public comments on the appropriate work RVUs and direct practice expense inputs for these services.
Improving the accuracy of procedure time assumptions used in PFS ratesetting continues to be a high priority of the potentially misvalued codes initiative. Procedure time is a critical measure of the resources typically used in furnishing particular services to Medicare beneficiaries, and procedure time assumptions are an important component in the development of work and PE RVUs. Discussions in the academic community have indicated that certain procedure times used for PFS ratesetting are overstated (McCall, N., J. Cromwell, et al. (2006). “Validation of physician survey estimates of surgical time using operating room logs.”
In recent years, CMS and the AMA RUC have taken steps to consider the accuracy of available data regarding procedure times used in the valuation of the physician work component of PFS payment. Generally, the AMA RUC derives estimates of physician work time from survey responses, and the AMA RUC reviews and analyzes those responses as part of its process for developing a recommendation for physician work. These procedure time assumptions are also used in determining the appropriate direct PE input values used in developing nonfacility PE RVUs. Specifically, physician intra-service time serves as the basis for allocating the appropriate number of minutes within the service period to account for the time used in furnishing the service to the patient. The number of intra-service minutes, or occasionally a particular proportion thereof, is allocated to both the clinical staff that assists the physician in furnishing the service and to the equipment used by either the physician or the staff in furnishing the service. This allocation reflects only the time the beneficiary receives treatment and does not include resources used immediately prior to or following the service. Additional minutes are often allocated to both clinical labor and equipment resources in order to account for the time used for necessary preparatory tasks immediately preceding the procedure or tasks typically performed immediately following it. For codes without physician work, the procedure times assigned to the direct PE inputs for such codes assume that the clinical labor performs the procedure. For these codes, the number of intra-service minutes assigned to clinical staff is independent and not based on any physician intra-service time assumptions. Consequently, the procedure time assumptions for these kinds of services have not been subject to all of the same mechanisms recently used by the AMA RUC and physician community in providing recommendations to CMS, and by CMS in the valuation of the physician work component of PFS payment. These
For CY 2012, a series of radiation treatment services were reviewed as part of the potentially misvalued code initiative. Among these were intensity modulated radiation therapy (IMRT) delivery services and stereotactic body radiation therapy (SBRT) delivery services reported with CPT codes 77418 (Intensity modulated treatment delivery, single or multiple fields/arcs, via narrow spatially and temporally modulated beams, binary, dynamic MLC, per treatment session) and 77373 (Stereotactic body radiation therapy, treatment delivery, per fraction to 1 or more lesions, including image guidance, entire course not to exceed 5 fractions), respectively. CPT code 77418 (IMRT treatment delivery) had been identified as potentially misvalued based on Medicare utilization data that indicated both fast growth in utilization and frequent billing with other codes. We identified this code as potentially misvalued in the CY 2009 PFS proposed rule (73 FR 38586). CPT code 77373 (SBRT treatment delivery) had been identified as potentially misvalued by the RUC as a recently established code describing services that use new technologies. There is no physician work associated with either of these codes since other codes are used to bill for planning, dosimetry, and radiation guidance. Both codes are billed per treatment session. Because the physician work associated with these treatments is reported using codes distinct from the treatment delivery, the primary determinant of PE RVUs for these codes is the number of minutes allocated for the procedure time to both the clinical labor (radiation therapist) and the resource-intensive capital equipment included as direct PE inputs.
In the CY 2012 PFS final rule with comment period, we received and accepted without refinement PE recommendations from the AMA RUC for these two codes. (We received the recommendation for CPT code 77418 (IMRT treatment delivery) too late in 2010 to be evaluated for CY 2011 and it was therefore included in the CY 2012 rulemaking cycle.) The AMA RUC recommended minor revisions to the direct PE inputs for the code to eliminate duplicative clinical labor, supplies, and equipment to account for the frequency with which the code was billed with other codes. For CPT code 77373 (SBRT treatment delivery), the RUC recommended no significant changes to the direct PE inputs.
Subsequent to the publication of the final rule, the AMA RUC and other stakeholders informed CMS that the direct PE input recommendation forwarded to CMS for IMRT treatment delivery (CPT code 77418) inadvertently omitted seven equipment items typically used in furnishing the service. These items had been used as direct PE inputs for the code prior to CY 2012. There is broad agreement among stakeholders that these seven equipment items are typically used in furnishing the services described by CPT code 77418. We were unable to reincorporate the items for CY 2012. These omitted items are listed in Table 7. In consideration of the comments from the AMA RUC and other stakeholders, we proposed to include the seven equipment items omitted from the RUC recommendation for CPT code 77418. These proposed adjustments were reflected in the CY 2013 proposed direct PE input database, available on the CMS Web site under the downloads for the CY 2013 PFS proposed rule with comment period at
It has come to our attention that there are discrepancies between the procedure time assumptions used in establishing nonfacility PE RVUs for these services and the procedure times made widely available to Medicare beneficiaries and the general public. Specifically, the direct PE inputs for IMRT treatment delivery (CPT code 77418) reflect a procedure time assumption of 60 minutes. These procedure minutes were first assigned to the code for CY 2002 based on a recommendation from the AMA RUC indicating that the typical treatment time for the IMRT patient was 40 to 70 minutes. The most recent RUC recommendation that CMS received for CY 2012 rulemaking supported the procedure time assumption of 60 minutes.
Information available to Medicare beneficiaries and the general public indicates that IMRT sessions typically last between 10 and 30 minutes. For example, the American Society for Radiation Oncology (ASTRO) publishes a patient fact sheet that explains that for all external beam radiation therapy, including IMRT, “treatment is delivered in a series of daily sessions, each about 15 minutes long.” [“Radiation Therapy for Prostate Cancer: Facts to Help Patients Make an Informed Decision” available for purchase at
The direct PE inputs for SBRT treatment delivery (CPT code 77373) reflect a procedure time assumption of 90 minutes. These procedure minutes were first assigned to the code for CY 2007 based on a recommendation from the AMA RUC. The most recent RUC recommendation that CMS received for CY 2012 rulemaking supported continuing that procedure time assumption.
In 2012, information available to Medicare beneficiaries and the general public states that SBRT treatment typically lasts no longer than 60 minutes. For example, the American College of Radiology (ACR) and the Radiological Society of North America (RSNA) Web site,
Given the importance of the procedure time assumption in the development of RVUs for these services, using the best available information is critical to ensuring that these services are valued appropriately. We believe medical societies and practitioners strive to offer their cancer patients accurate information regarding the IMRT or SBRT treatment experience. Therefore, we believe that the typical procedure time for IMRT delivery is between 10 and 30 minutes and that the
While we generally have not used publicly available resources to establish procedure time assumptions, we believe that the procedure time assumptions used in setting payment rates for the Medicare PFS should be derived from the most accurate information available. In the case of these services, we believe that the need to reconcile the discrepancies between our existing assumptions and more accurate information outweighs the potential value in maintaining relativity offered by only considering data from one source. We proposed to adjust the procedure time assumption for IMRT delivery (CPT code 77418) to 30 minutes. We proposed to adjust the procedure time assumption for SBRT delivery (CPT code 77373) to 60 minutes. These procedure time assumptions reflect the maximum number of minutes reported as typical in publicly available information. We note that in the case of CPT code 77418, the `accelerator, 6-18 MV' (ER010) and the `collimator, multileaf system w-autocrane' (ER017) are used throughout the procedure and currently have no minutes allocated for preparing the equipment, positioning the patient, or cleaning the room. Since these clinical labor tasks are associated with related codes typically reported at the same time, we also proposed to allocate minutes to these equipment items to account for their use immediately before and following the procedure. All of these proposed adjustments are reflected in the CY 2013 proposed direct PE input database, available on the CMS Web site under the downloads for the CY 2013 PFS final rule with comment period at
While we recognize that using these procedure time assumptions will result in payment reductions for these particular services, we believe such changes are necessary to appropriately value these services. Recent attention from popular media sources like the
We received many comments regarding our proposal to change the direct PE inputs for CPT codes 77418 and 77373 based on amended procedure time assumptions and consideration of the comments from the AMA RUC and other stakeholders to include the seven equipment items omitted from the previous AMA RUC recommendation for CPT code 77418. The following is summary of the comments we received and our responses to those comments.
We also note that the direct PE inputs for codes describing imaging guidance services that are typically reported at the same time-include minutes for the radiation therapist to prepare the room, position the patient, and clean the room. Similarly, the proposed direct PE inputs for CPT code 77373 incorporate clinical labor and equipment minutes that exceed the minutes assumed for the procedure itself: 24 minutes of additional nurse time, 24 minutes of additional time for the radiation therapist, and 15 additional minutes for the medical physicist for pre-service and post-service tasks. On the basis of these tasks, the equipment associated with the code has also been allocated 24 minutes beyond the procedure time assumption for pre-service and post-service work. Therefore, we do not agree with commenters who suggested that our proposed revisions are inappropriate because the procedure time reported in the patient education materials may underestimate the procedure time assumptions used in developing direct PE inputs. Instead, we believe that the typical procedure time described in the patient education material is generally equivalent to the minutes incorporated in the service period for performing the procedure. We already have incorporated additional minutes of clinical labor time into the direct PE inputs for both CPT codes 77418 and 77373 to account for tasks like preparing the equipment and cleaning the room in addition to the minutes allocated for the procedure time assumptions. This reflects the direct PE inputs used for most services, where we allocate minutes to clinical labor and medical equipment for preparatory or follow-up tasks in addition to the equipment time allocated based on the procedure time assumption. While many commenters stated that the procedure times reported in the publicly available information do not include necessary preparatory or follow-up tasks, we received no comments with specific objections to the number of minutes allocated for such tasks in conjunction with our proposal.
Since MedPAC's March 2006 Report to the Congress, CMS has implemented a potentially misvalued codes initiative
Additionally, we do not agree with the commenters' assertion that if time is distorted across the PFS, it is likely to be distorted with consistent proportionality. While the distortions may be relatively consistent for surveys taken at similar times or data gathered through similar methods, the procedure time assumptions used in developing practice expense inputs have not originated from consistent sources. The 60 minute procedure time assumption for IMRT treatment delivery, for example, was originally developed based on a specialty society survey for CY 2002.
Through our misvalued codes initiative and other efforts, we strive to prioritize and review values for codes each year and work toward achieving greater calibration of values across the PFS over time.
Several other commenters suggested that the payment decrease expected to result from this proposal will force patients into the more expensive hospital setting and patients will be steered toward treatment options that result in greater financial returns. These commenters stated that this migration will increase costs both to the Medicare program and to patients through higher co-insurance payments. Others suggested that significant differences between nonfacility PFS and OPPS payment are likely to result in consolidation of free-standing cancer centers and hospitals that will reduce competition, inhibit access to care, and undermine focused care for cancer patients.
We understand commenters' concerns regarding the inadvertent impact that financial incentives may make on the usual site of service for particular services. We believe that utilizing the most accurate cost inputs possible is a reasonable approach to mitigating the impact of such potential incentives.
As a result of the comments we received regarding our proposal to change the procedure time assumptions used in determining direct PE inputs for CPT codes 77418 and 77373, we are finalizing our proposals to adjust the procedure time assumption for IMRT delivery (CPT code 77418) to 30 minutes and to adjust the procedure time assumption for SBRT delivery (CPT code 77373) to 60 minutes. These codes continue to include clinical labor time for preparatory and follow-up tasks in addition to revisions to the procedure times. Based on comments received regarding additional updates to the direct PE inputs for these services, we are also adjusting other direct PE inputs for these services on an interim final basis for CY 2013. Based on comments received on our proposal, we are incorporating a second radiation therapist for CPT code 77418. The second therapist will be allocated 30 minutes of service period time, consistent with the first. Furthermore, we are incorporating a new equipment
These two IMRT and SBRT treatment delivery codes are PE only codes and are fairly unique in that the resulting RVUs are largely comprised of resources for staff and equipment based on the minutes associated with clinical labor. There are several other codes on the PFS established through the same methodology. As we previously stated, we believe that the procedure time assumptions for these kinds of services have not been subject to all of the same mechanisms recently used by CMS in the valuation of the physician work component of PFS payment. In light of observations about publicly available procedure times for CPT codes 77418 (IMRT treatment delivery) and 77373 (SBRT treatment delivery) and public awareness of potential adverse financial incentives associated with IMRT treatment delivery in particular, we believe that similar codes may be potentially misvalued.
Therefore, consistent with the requirement in section 1848(c)(2)(K)(ii) of the Act to examine other codes determined to be appropriate by the Secretary, we proposed to review and make adjustments to CPT codes with stand-alone procedure time assumptions used in developing nonfacility PE RVUs. These procedure time assumptions are not based on physician time assumptions. We prioritized for review CPT codes that have annual Medicare allowed charges of $100,000 or more, include direct equipment inputs that amount to $100 or more, and have PE procedure times of greater than 5 minutes. We did not propose to include in this category services with payment rates subject to the OPPS cap (as specified in the statute under section 1848(b)(4) of the Act and listed in Addendum G to this proposed rule) or services with PE minutes established through code descriptors. (For example, an overnight monitoring code might contain 480 minutes of monitoring equipment time to account for 8 hours of overnight monitoring.) The CPT codes meeting these criteria appear in Table 8. We recognized that there are other CPT codes that are valued in the same manner. We may consider evaluating those services as potentially misvalued codes in future rulemaking.
For the services in Table 8, we requested recommendations from the AMA RUC and other public commenters on the appropriate direct PE inputs for these services. We encourage the use of valid and reliable alternative data sources when developing recommended values, including electronic medical records (with personally-identifiable information redacted) and other independent data sources. We note that many of the CPT codes in Table 8 have been identified through other potentially misvalued code screens and have been recently reviewed. Given our concerns with the inputs for the recently reviewed IMRT and SBRT direct PE inputs discussed above, we believe it is necessary to re-review other recently reviewed services with stand-alone PE procedure time.
While we assume that the AMA RUC deliberated on the procedure time assumptions used in developing the direct PE input recommendations for these services, we do not believe that extensive committee discussions would mitigate the need for more extensive review of these services as potentially misvalued since the assumptions that were developed through discussion could benefit from the objective data of many kinds.
Based on the comments we received, we are finalizing our proposal to review and make adjustments to CPT codes with stand-alone procedure time assumptions used in developing nonfacility PE RVUs.
Each year when we publish the PFS proposed and final rules, we publish on the CMS Web site several files that support annual PFS ratesetting. One of these supporting files is the physician time file, which lists the physician time associated with the HCPCS codes on the PFS. The physician time file associated with the CY 2013 PFS final rule with comment period is available on the CMS Web site under the downloads for the CY 2013 PFS final rule with comment period at
As we stated in the CY 2013 PFS proposed rule, in our review of potentially misvalued codes and their inputs, we became aware of several HCPCS codes that have anomalous times in our physician time file. Physician work is a measure of physician time and intensity, so there should be no services that have payable physician work RVUs but no time in the physician time file, and there should be no payable services with time in the physician time file and no physician work RVUs. For CY 2013 we proposed to make the physician time file changes detailed below to address these anomalous time file entries.
CPT code 94014 (Patient-initiated spirometric recording per 30-day period of time; includes reinforced education, transmission of spirometric tracing, data capture, analysis of transmitted data, periodic recalibration and physician review and interpretation) has a physician work RVU of 0.52 and for CY 2012 was listed with 0 physician time. CPT code 94014 is a global service that includes CPT code 94015 (Patient-initiated spirometric recording per 30-day period of time; recording (includes hook-up, reinforced education, data transmission, data capture, trend analysis, and periodic recalibration)) (the technical component), and CPT code 94016 (Patient-initiated spirometric recording per 30-day period of time; physician review and interpretation only) (the professional component). We stated that we believe it is appropriate for the physician time of CPT code 94014 to match the physician time of the code's component professional service—CPT code 94016. As such, for CPT code 94014 for CY 2013, we proposed to assign 2 minutes of pre-service evaluation time, and 20 minutes of intra-service time, which matches the times associated with CPT code 94016.
HCPCS codes G0117 (Glaucoma screening for high risk patients furnished by an optometrist or ophthalmologist) and G0118 (Glaucoma screening for high risk patient furnished under the direct supervision of an optometrist or ophthalmologist) both have physician work RVUs (0.45, and 0.17, respectively), but neither code was included in the CY 2012 physician time file. HCPCS codes G0117 and G0118 have a PFS procedure status indicator of T indicating that these services are only paid if there are no other services payable under the PFS billed on the same date by the same provider.
In the CY 2002 PFS final rule (66 FR 55274), we crosswalked the physician work of HCPCS code G0117 from CPT code 99212 (Level 2 office or other outpatient visit, established patient), and we crosswalked the physician work of HCPCS code G0118 from CPT code 99211 (Level 1 office or other outpatient visit, established patient). Based on these finalized physician work crosswalks, we proposed to assign HCPCS code G0117 physician times matching CPT code 99212, and HCPCS code G0118 physician times matching CPT code 99211. Specifically, we proposed 2 minutes of pre-service time, 10 minutes of intra-service time, and 4 minutes of immediate post-service time for HCPCS code G0117, and 5 minutes of intra-service time, and 2 minutes of immediate post-service time for HCPCS code G0118.
HCPCS code G0128 (Direct (face-to-face with patient) skilled nursing services of a registered nurse provided in a comprehensive outpatient rehabilitation facility, each 10 minutes beyond the first 5 minutes) currently has a physician work RVU (0.08), but was not listed in the CY 2012 physician time file. In the CY 2013 proposed rule we stated that, after review of this HCPCS code, we do not believe that HCPCS code G0128 describes a service that includes physician work. Time for a registered nurse to furnish the service is included in the PE for the code. As such, for CY 2013, we proposed to remove the physician work RVU for HCPCS code G0128. HCPCS code G0128 continues to have PE and malpractice expense RVUs.
HCPCS codes G0245 (Initial physician evaluation and management of a diabetic patient with diabetic sensory neuropathy resulting in a loss of protective sensation (LOPS) which must include: (1) The diagnosis of LOPS; (2) a patient history; (3) a physical examination that consists of at least the following elements: (a) Visual inspection of the forefoot, hindfoot and toe web spaces; (b) evaluation of a protective sensation; (c) evaluation of foot structure and biomechanics; (d) evaluation of vascular status and skin integrity; and (e) evaluation and recommendation of footwear; and (4) patient education), G0246 (Follow-up physician evaluation and management of a diabetic patient with diabetic sensory neuropathy resulting in a loss of protective sensation (LOPS) to include at least the following: (1) A patient history; (2) a physical examination that includes: (a) Visual inspection of the forefoot, hindfoot and toe web spaces; (b) evaluation of protective sensation; (c) evaluation of foot structure and biomechanics; (d) evaluation of vascular status and skin integrity; and (e) evaluation and recommendation of
In the CY 2003 PFS final rule (67 FR 79990), we crosswalked the physician work of HCPCS code G0245 from CPT code 99202 (Level 2 office or other outpatient visits, new patient), we crosswalked the physician work of HCPCS code G0246 from CPT code 99212, and we crosswalked the physician work of HCPCS code G0257 from CPT code 11040 (Debridement; skin; partial thickness). Based on these finalized physician work crosswalks, we proposed to assign HCPCS code G0245 physician times matching CPT code 99202, HCPCS code G0246 physician times matching CPT code 99212, and HCPCS code G0247 physician times matching CPT code 11040. Specifically, for HCPCS code G0245 we proposed 2 minutes of pre-service time, 15 minutes of intra-service time, and 5 minutes of immediate post-service time. For HCPCS code G0246 we proposed 2 minutes of pre-service time, 10 minutes of intra-service time, and 4 minutes of immediate post-service time. For HCPCS code G0247 we proposed 7 minutes of pre-service time, 10 minutes of intra-service time, and 7 minutes of immediate post-service time.
HCPCS code G0250 (Physician review, interpretation, and patient management of home INR (International Normalized Ratio) testing for patient with either mechanical heart valve(s), chronic atrial fibrillation, or venous thromboembolism who meets Medicare coverage criteria; testing not occurring more frequently than once a week; billing units of service include 4 tests) has a physician work RVU of 0.18 but was not listed in the CY 2012 physician time file. HCPCS code G0250 has a procedure status indicator of R on the PFS indicating that coverage of this service is restricted. In the CY 2003 final rule (67 FR 79991), we assigned HCPCS code G0250 a work RVU of 0.18, which corresponds to the work RVU of CPT code 99211. While we did not articulate this as a direct crosswalk in the CY 2003 final rule, after clinical review we believe that HCPCS code G0250 continues to require similar work as CPT code 99211, and should have the same amount of physician time as CPT code 99211. As such, we proposed to assign HCPCS code G0250 the same physician time as CPT code 99211. Specifically, for HCPCS code G0250 we proposed 5 minutes of intra-service time and 2 minutes of immediate post-service time.
During our annual review of new, revised, and potentially misvalued CPT codes, the assessment of physician time used to furnish a service is an important part of the clinical review when determining the appropriate work RVU for a service. However, the time in the physician time file is not used to automatically adjust the physician work RVUs outside of that clinical review process. As such, the proposed addition of physician time to the HCPCS codes discussed above will have no impact on the current physician work RVUs for these services.
The time data in the physician time file is used in the PE methodology described in section II.A.2. In creating the indirect practice cost index (IPCI), we calculate specialty-specific aggregate pools of indirect PE for all PFS services for that specialty by adding the product of the indirect PE/HR for the specialty, the physician time for the service, and the specialty's utilization for the service across all services furnished by the specialty. The proposed addition of physician time to the HCPCS codes discussed above will affect the aggregate pools of indirect PE at the specialty level. However because the services discussed above have low utilization and low total time, the impact of the physician time changes on the IPCI is negligible, and likely would have a modest impact if any on the PE RVUs at the individual code level.
Below is a summary of the comments we received on our proposed changes for PFS services with physician work and no listed time in the physician time file.
There are a number of services that have no physician work RVUs, yet include time in the physician time file. Many of these services are not payable under the PFS or are contractor priced services where the physician time is not used to nationally price the services on the PFS. We did not propose to remove the physician time from the time file for these services as the time has no effect on the calculation of RVUs for the PFS. However, there are several CPT codes, listed in Table 9, that are payable under the PFS and have no physician work RVUs yet include time in the physician time file. We proposed to remove the physician time from the time file for these seven CPT codes.
As mentioned above and as discussed in section II.A.2. of this final rule with comment period, to create the IPCI used in the PE methodology, we calculated specialty-specific aggregate pools of indirect PE for all PFS services for that specialty by adding the product of the indirect PE/HR for the specialty, the physician time for the service, and the specialty's utilization for the service across all services performed by the specialty. As we stated in the CY 2013 PFS proposed rule, the proposed removal of physician time from the CPT codes discussed above will affect the aggregate pools of indirect PE at the specialty level. However because the services discussed above have low utilization and/or low total time, the impact of the physician time changes on the IPCI is negligible, and likely will have a modest impact if any on the PE RVUs at the individual code level.
Below is a summary of the comments we received on our proposed changes for PFS services with no physician work and listed time in the physician time file.
Medicare has long employed multiple procedure payment reduction (MPPR) policies to adjust payment to more appropriately reflect reduced resources involved with furnishing services that are frequently furnished together. Under these policies, we reduce payment for the second and subsequent services within the same MPPR category furnished in the same session or same day. These payment reductions reflect efficiencies that typically occur in either the practice expense (PE) or professional work or both when services are furnished together. With the exception of a few codes that are always reported along with another code, the Medicare PFS values services independently to recognize relative resources involved when the service is the only one furnished in a session. While our general policy for MPPRs precedes the Affordable Care Act, MPPRs address the fourth category of potentially misvalued codes identified in section 1848(c)(2)(K) of the Act which is “multiple codes that are frequently billed in conjunction with furnishing a single service” (see 75 FR 73216).
For CY 2013, we proposed to continue our work to recognize resource efficiencies when certain services are furnished together. We proposed to apply an MPPR to the technical component (TC) of certain cardiovascular and ophthalmology diagnostic tests. As discussed in the CY 2012 final rule with comment period (76 FR 73079), we are also proceeding with applying the current MPPR policy for imaging services to services furnished in the same session by physicians in the same group practice.
Medicare has a longstanding policy to reduce payment by 50 percent for the second and subsequent surgical procedures furnished to the same beneficiary by a single physician or physicians in the same group practice on the same day, largely based on the presence of efficiencies in the PE and pre- and post-surgical physician work. Effective January 1, 1995, the MPPR policy, with this same percentage reduction, was extended to nuclear medicine diagnostic procedures (CPT codes 78306, 78320, 78802, 78803, 78806, and 78807). In the CY 1995 PFS final rule with comment period (59 FR 63410), we indicated that we would consider applying the policy to other diagnostic tests in the future.
Consistent with recommendations of MedPAC in its March 2005 Report to the Congress on Medicare Payment Policy, for CY 2006 PFS, we extended the MPPR policy to the TC of certain
The imaging MPPR policy originally applied to computed tomography (CT) and computed tomographic angiography (CTA), magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA), and ultrasound services within 11 families of codes based on imaging modality and body region and only applied to procedures furnished in a single session involving contiguous body areas within a family of codes, not across families. Additionally, the MPPR policy originally applied to TC-only services and to the TC of global services, but not to professional component (PC) services.
There have been several revisions to this policy since it was originally adopted. Under the current imaging MPPR policy, full payment is made for the TC of the highest paid procedure, and payment for the TC is reduced by 50 percent for each additional procedure subject to this MPPR policy. We originally planned to phase in the imaging MPPR policy over a 2-year period, with a 25 percent reduction in CY 2006 and a 50 percent reduction in CY 2007 (70 FR 70263). However, the Deficit Reduction Act of 2005 (DRA) (Pub. L. 109-171) amended the statute to place a cap on the PFS payment amount for most imaging procedures at the amount paid under the hospital outpatient prospective payment system (OPPS). In view of this new OPPS payment cap, we decided in the PFS final rule with comment period for CY 2006 that it would be prudent to retain the imaging MPPR at 25 percent while we continued to examine the appropriate payment levels (71 FR 69659). The DRA also exempted reduced expenditures attributable to the imaging MPPR policy from the PFS BN provision. Effective July 1, 2010, section 1848(b)(4)(C) of the Act increased the MPPR on the TC of imaging services under the policy established in the CY 2006 PFS final rule with comment period from 25 to 50 percent. Section 1848(c)(2)(B)(v)(IV) of the Act exempted the reduced expenditures attributable to this further change from the PFS BN provision.
In the July 2009 U.S. Government Accountability Office (GAO) report entitled,
In its March 2010 report, MedPAC noted its concerns about mispricing of services under the PFS. MedPAC indicated that it would explore whether expanding the unit of payment through packaging or bundling would improve payment accuracy and encourage more efficient use of services. In the CYs 2009 and 2010 PFS proposed rules (73 FR 38586 and 74 FR 33554, respectively), we stated that we planned to analyze nonsurgical services commonly furnished together (for example, 60 to 75 percent of the time) to assess whether an expansion of the MPPR policy could be warranted. MedPAC encouraged us to consider duplicative physician work, as well as PE, in any expansion of the MPPR policy.
Section 1848(c)(2)(K) of the Act specifies that the Secretary shall identify potentially misvalued codes by examining multiple codes that are frequently billed in conjunction with furnishing a single service, and review and make appropriate adjustments to their relative values. As a first step in applying this provision, in the CY 2010 final rule with comment period, we implemented a limited expansion of the imaging MPPR policy to additional combinations of imaging services.
Effective January 1, 2011, the imaging MPPR applies regardless of code family; that is, the policy applies to multiple imaging services furnished within the same family of codes or across families. This policy is consistent with the standard PFS MPPR policy for surgical procedures that does not group procedures by body region. The current imaging MPPR policy applies to CT and CTA, MRI and MRA, and ultrasound procedures furnished to the same beneficiary in the same session, regardless of the imaging modality, and is not limited to contiguous body areas.
As we noted in the CY 2011 PFS final rule with comment period (75 FR 73228), while section 1848(c)(2)(B)(v)(VI) of the Act specifies that reduced expenditures attributable to the increase in the imaging MPPR from 25 to 50 percent (effective for fee schedules established beginning with 2010 and for services furnished on or after July 1, 2010) are excluded from the PFS BN adjustment, it does not apply to reduced expenditures attributable to our policy change regarding additional code combinations across code families (noncontiguous body areas) that are subject to BN under the PFS. The complete list of codes subject to the CY 2011 MPPR policy for diagnostic imaging services is included in Addendum F.
As a further step in applying the provisions of section 1848(c)(2)(K) of the Act, on January 1, 2011, we implemented an MPPR for therapy services. The MPPR applies to separately payable “always therapy” services, that is, services that are only paid by Medicare when furnished under a therapy plan of care. As we explained in the CY 2011 PFS final rule with comment period (75 FR 73232), the therapy MPPR does not apply to contractor-priced codes, bundled codes, and add-on codes. The complete list of codes subject to the MPPR policy for therapy services is included in Addendum H.
This MPPR for therapy services was first proposed in the CY 2011 proposed rule (75 FR 44075) as a 50 percent payment reduction to the PE component of the second and subsequent therapy services for multiple “always therapy” services furnished to a single beneficiary in a single day. It applies to services furnished by an individual or group practice or “incident to” a physician's service. However, in response to public comments, in the CY 2011 PFS final rule with comment period (75 FR 73232), we adopted a 25 percent payment reduction to the PE component of the second and subsequent therapy services for multiple “always therapy” services furnished to a single beneficiary in a single day.
Subsequent to publication of the CY 2011 PFS final rule with comment period, section 3 of the Physician Payment and Therapy Relief Act of 2010 (PPTRA) (Pub. L. 111-286) revised the payment reduction percentage from 25 percent to 20 percent for therapy services for which payment is made under a fee schedule under section 1848 of the Act (which are services furnished
This MPPR policy applies to multiple units of the same therapy service, as well as to multiple different “always therapy” services, when furnished to the same beneficiary on the same day. The MPPR applies when multiple therapy services are billed on the same date of service for one beneficiary by the same practitioner or facility under the same National Provider Identifier (NPI), regardless of whether the services are furnished in one therapy discipline or multiple disciplines, including physical therapy, occupational therapy, or speech-language pathology.
The MPPR policy applies in all settings where outpatient therapy services are paid under Part B. This includes both services that are furnished in the office setting and paid under the PFS, as well as institutional services that are furnished by outpatient hospitals, home health agencies, comprehensive outpatient rehabilitation facilities (CORFs), and other entities that are paid for outpatient therapy services at rates based on the PFS.
In its June 2011 Report to Congress, MedPAC highlighted continued growth in ancillary services subject to the in-office ancillary services exception. The in-office ancillary exception to the general prohibition under section 1877 of the Act as amended by the Ethics in Patient Referrals Act, also known as the Stark law, allows physicians to refer Medicare beneficiaries for designated health services, including imaging, radiation therapy, home health care, durable medical equipment, clinical laboratory tests, and physical therapy, to entities with which they have a financial relationship under specific conditions. MedPAC recommended that we apply a MPPR to the PC of diagnostic imaging services furnished by the same practitioner in the same session as one means to curb excess self-referral for these services. The GAO already had made a similar recommendation in its July 2009 report.
In continuing to apply the provisions of section 1848(c)(2)(K) of the Act regarding potentially misvalued codes that result from “multiple codes that are frequently billed in conjunction with furnishing a single service,” in the CY 2012 final rule (76 FR 73071), we expanded the MPPR to the PC of Advanced Imaging Services (CT, MRI, and Ultrasound), that is, the same list of codes to which the MPPR on the TC of advanced imaging already applied (see Addendum F). Thus, this MPPR policy now applies to the PC and the TC of certain diagnostic imaging codes. Specifically, we expanded the payment reduction currently applied to the TC to apply also to the PC of the second and subsequent advanced imaging services furnished by the same physician (or by two or more physicians in the same group practice) to the same beneficiary in the same session on the same day. However, in response to public comments, in the CY 2012 PFS final rule with comment period, we adopted a 25 percent payment reduction to the PC component of the second and subsequent imaging services.
Under this policy, full payment is made for the PC of the highest paid advanced imaging service, and payment is reduced by 25 percent for the PC for each additional advanced imaging service furnished to the same beneficiary in the same session. This policy was based on the expected efficiencies in furnishing multiple services in the same session due to duplication of physician work, primarily in the pre- and post-service periods, but with some efficiencies in the intraservice period.
This policy is consistent with the statutory requirement for the Secretary to identify, review, and adjust the relative values of potentially misvalued services under the PFS as specified by section 1848(c)(2)(K) of the Act. This policy is also consistent both with our longstanding policy on surgical and nuclear medicine diagnostic procedures, under which we apply a 50 percent payment reduction to second and subsequent procedures. Furthermore, it was responsive to continued concerns about significant growth in imaging spending, and to MedPAC (March 2010 and June 2011) and GAO (July 2009) recommendations regarding the expansion of MPPR policies under the PFS to account for additional efficiencies.
In the CY 2012 proposed rule (76 FR 42812), we also invited public comment on the following MPPR policies under consideration. We noted that any proposals would be presented in future rulemaking and subject to further public comment:
• Apply
Such an approach would be based on the expected efficiencies due to duplication of clinical labor activities, supplies, and equipment time when multiple services are furnished together. This approach would apply to approximately 530 HCPCS codes, including the 119 codes to which the current imaging MPPR applies. Savings would be redistributed to other PFS services as required by the statutory PFS BN provision.
•
Such an approach would be based on efficiencies due to duplication of physician work primarily in the pre- and post-service periods, with smaller efficiencies in the intraservice period, when multiple services are furnished together. This approach would apply to approximately 530 HCPCS codes, including the 119 codes to which the current imaging MPPR applies. Savings would be redistributed to other PFS services as required by the statutory PFS BN provision.
•
Such an approach would be based on the expected efficiencies due to duplication of clinical labor activities, supplies, and equipment time when multiple services are furnished together. The approach would apply to approximately 700 HCPCS codes, including the approximately 560 HCPCS codes that are currently subject to the OPPS cap. The savings would be redistributed to other PFS services as required by the statutory PFS BN provision.
As indicated previously, effective January 1, 1995, we implemented an MPPR for six nuclear medicine codes. Under the current policy, full payment is made for the highest paid procedure, and payment is reduced by 50 percent for the second procedure furnished to the same beneficiary on the same day. As noted in the CY 2013 proposed rule (77 FR 44748), due to a technical error, the MPPR is not being applied to CPT codes 78306 (Bone imaging; whole body) when followed by CPT code 78320 (Bone imaging; SPECT). We will apply the MPPR to these procedures effective January 1, 2013. We received the following comment on this provision:
As indicated in the CY 2012 final rule (76 FR 73077-73079), we finalized a policy to apply the MPPR to the PC and TC of the second and subsequent advanced imaging procedures furnished to the same beneficiary in the same session by a single physician or by multiple physicians in the same group practice. Due to operational limitations, we did not apply this MPPR to multiple physicians in the same group practice during CY 2012. In addition, after we issued the CY 2012 final rule with comment period, some commenters stated that they had not commented on the application of the MPPR to physicians in the same group practice because that policy was not explicit in the CY 2012 proposed rule discussion expanding the MPPR for advanced imaging to the PC. As noted in the CY 2013 proposed rule (77 FR 44748), we have resolved the operational problems and, therefore, for services furnished on or after January 1, 2013 we will apply the MPPR to both the PC and the TC of advanced imaging procedures to multiple physicians in the same group practice (same group NPI). Under this policy, the MPPR will apply when one or more physicians in the same group practice furnish services to the same beneficiary, in the same session, on the same day. This policy is consistent with other PFS MPPR policies for surgical and therapy procedures and, effective January 1, 2013, for diagnostic cardiovascular and ophthalmology procedures. We continue to believe that the typical efficiencies achieved when the same physician is furnishing multiple procedures also accrue when different physicians in the same group furnish multiple procedures involving the same beneficiary in the same session. While we agree with commenters that most physicians would not change the way they practice in order to avoid application of the MPPR, we believe application of the imaging MPPR to physicians in the same group practice will ensure that there is no financial incentive for physicians in a group practice to change their behavior to split imaging interpretation services for a beneficiary among different physicians in the group. It is our intention to apply this and future MPPRs to services furnished by one or more physicians in the same group unless we determine for a specific MPPR that the efficiencies associated with an individual physician furnishing multiple procedures do not extend to multiple physicians in the same group practice. We received the following comments on this provision:
Commenters maintained that CMS assumes efficiencies exist, but has not presented any clinical evidence or comprehensive resource use analysis to justify claims of efficiency. Commenters do not believe that substantial economy of time or of effort exist. According to commenters, each physician who reviews a beneficiary's imaging results must review the beneficiary's medical history, examine the imaging results, make diagnoses, draft a report, and enter communications with other physicians in the beneficiary's medical chart. Commenters note that none of these actions would take less time or effort when performed by a second physician in the same practice. Commenters do not believe this proposal reflects the true costs incurred by a practice when multiple physicians furnish advanced imaging services to the same beneficiary on the same day. Another commenter noted that cognitive medicine, such as diagnostic imaging cannot have global efficiencies, as every observer needs to independently investigate, collect data, formulate an educated opinion, and furnish a professional assessment.
Commenters maintained that clinical best practice dictates that the images are read by subspecialized, fellowship-trained radiologists, trained to read specific body parts. For example, they stated, radiologists are trained to read either breast, musculoskeletal, body, neurology or oncology images. Commenters indicated that the proposal would penalize or disincentivize practices from having the most appropriate radiologist read the study, which may subject beneficiaries to undue risks.
Commenters also noted that beneficiaries suffering from life-threatening conditions such as trauma, heart attacks, and cancer often require multiple imaging scans to accurately and fully assess extent of injury and monitor disease progression and/or any improvements in condition. This is not uncommon in an urban hospital serving high acuity beneficiaries. Commenters maintained that as the complexity of the
A commenter noted that multi-modality images on a beneficiary are not always interpreted at the same time or by the same physician. According to the commenter, the beneficiary encounter that includes multiple TCs is not directly related to the performance of the PCs by the interpreting physician(s). The commenter indicated that through the use of teleradiology, the interpretations often take place at separate locations and by separate physicians. Finally, the commenter noted that this process allows differently specialized radiologists to interpret different images.
A commenter maintained that CMS' reliance on both the July 2009 GAO report and the March 2010 MedPAC report to support its MPPR policies is fundamentally flawed because such sources do not appear to justify the proposals. The commenter noted that CMS also cites the June 2011 MedPAC report as further support for its MPPR application to the PC of diagnostic imaging services furnished by the same physician in the same session. The commenter indicated that the report's policy recommendation is for a multiple procedure payment reduction to the professional component of diagnostic imaging services furnished by the same practitioner in the same session. The commenter stated that it could be unfair to apply the MPPR to physicians who share a practice.
A commenter recommended that CMS focus on applying the results of the Medicare Imaging Demonstration, and pursuing options to encourage use of appropriateness criteria, as the best solution to any problems of under or overutilization of imaging.
We disagree that radiologists are routinely trained to only read organ specific or technology specific images. Radiologists receive broad training that allows them to provide services across multiple technologies and organ systems. Some may choose to more narrowly focus their practice, but in the typical radiology practice across the country, many radiologists continue to provide a broad range of imaging interpretation services.
We agree with the commenter that higher complexity patients may require multiple scans. However, we disagree that this higher complexity negates the efficiencies that are seen with less complex patients. Duplication in technical component, such as greeting and gowning, would continue irrespective of patient complexity. Higher complexity patients, receiving multiple scans, provide greater support for the proposed MPPR policy changes. Since interpretation of an image builds on the clinical framework that the radiologist(s) develops for each patient as she reviews each scan, we believe that interpretation of multiple additional scans require diminishing marginal effort.
Finally, while we agree with commenters that most physicians would not change the way they practice in order to avoid application of the MPPR, we believe application of the imaging MPPR to physicians in the same group practice will ensure that there is no financial incentive for physicians in a group practice to change their behavior to split imaging interpretation services for a beneficiary among different physicians in the group.
It is our intention to apply this and future MPPR policies to services furnished by one or more physicians in the same group. Future modifications may be appropriate if we collect or are provided with data that indicates that the efficiencies associated with an individual physician furnishing multiple procedures do not extend to multiple physicians in the same group practice.
We disagree that we have misinterpreted GAO and MedPAC policy recommendations. MedPAC's June 2011 recommendation for an MPPR on the professional component of imaging services is silent on application to the group practice, but since then, MedPAC has not opposed our proposal to apply the MPPR on the PC and TC of diagnostic imaging to physicians in the same group practice. Finally, the Medicare Imaging Demonstration is designed to test whether the use of decision support systems can improve quality of care by diminishing patient exposure to potentially harmful radiation caused by unnecessary over-utilization of advanced imaging services. The 2-year demonstration has recently completed its first year. The demonstration is a separate initiative and does not specifically address MPPR policy.
• Physicians use the 59 modifier appropriately to bypass the MPPR when multiple services are furnished to the same beneficiary in separate sessions on the same day. However, the 59 modifier is also used for the Correct Coding Initiative (CCI) edits, creating a conflict between the two different uses of the modifier. For example, if an MRA of the head and brain are furnished to the same beneficiary on the same day, it may be appropriate to report modifier 59 to bypass the CCI edit. However, the modifier 59 may also be interpreted to bypass the MPPR, which would not be appropriate if the services were furnished in the same session. They stated that this presents a quandary for both radiology practices and Medicare Administrative Contractors.
• CMS has provided no guidance on what constitutes a separate session for professional interpretation, other than “scans interpreted at widely different times,” leaving radiology practices vulnerable to differing interpretations by Medicare contractors, including Recovery Audit Contractors.
• Whether CMS' use of the word “encounter” is synonymous with “session.”
• Multiple physicians furnishing the PC on different studies to the same beneficiary on the same day should constitute separate sessions by definition.
• Software programs in use for medical billing do not adequately capture interpretation times, and therefore, do not track whether the PC was performed in the same or different sessions and when the 59 modifier is appropriate. Commenters expressed concern that they will not be able to routinely identify when a Medicare beneficiary has had multiple imaging scans on the same day, especially if reports are generated in different locations, by different physicians, at different times of day. Radiology workflow systems triage studies to subspecialty radiologists who each separately interpret the studies and generate reports. Billing systems submit separate claims for each study. If two physicians read studies on the same beneficiary, coders and billing systems will have significant difficulty attaching the 59 modifier to the appropriate study, even if they are able to recognize that the 59 modifier should be applied. Hospital-based radiologists rely on data feeds provided by their hospitals' information systems. These data-feeds typically include beneficiary demographic information but not image interpretation times. Because they are unable to track the time of interpretation, coders and billers will be required to re-create the timing of interpretative sessions to determine whether or not the interpretation occurred in the same session.
• Radiologists in small practices, or rural hospitals and imaging facilities, are more likely to have only a few radiologists in the office. Frequently in small practices, there will be instances where beneficiaries have multiple advanced imaging services that are in clinically separate sessions, but interpreted by the individual members of the same small group of radiologists. It is not clear that there will be a way for coders, CMS contractors and auditors to understand and validate that these separate encounters constitute separate sessions.
• Contrary to CMS' claim, commenters expect there would be frequent circumstances requiring the use of the 59 modifier, that is, a distinct procedural service.
Alternatively, we may consider modifying the MPPR policy to apply to procedures furnished on the same day, rather than in the same session. This would resolve some of the operational difficulties with the use of “session” and conform to the policy for all other MPPRs. If we were to modify this MPPR to apply to procedures furnished on the same day rather than in the same session, we would do so through future rulemaking and subject to public comment.
As noted above, we continue to examine whether it would be appropriate to apply MPPR policies to other categories of services that are frequently billed together, including the TC for diagnostic services other than advanced imaging services. For CY 2013, we examined other diagnostic services to determine whether there typically are efficiencies in the technical component when multiple diagnostic services are furnished together on the same day. We have conducted an analysis of the most frequently furnished code combinations for all diagnostic services using CY 2011 claims data. Of the several areas of diagnostic tests that we examined, we found that billing patterns and PE inputs indicated that multiple cardiovascular and ophthalmology diagnostic procedures, respectively, are frequently furnished together and that there is some duplication in PE inputs when this occurs. For cardiovascular diagnostic services, we reviewed the code pair/combinations with the highest utilization in the CPT code ranges of 75600 through 75893, 78414 through 78496, and 93000 through 93990. For ophthalmology diagnostic services, we reviewed the code pair/combinations with the highest utilization in the CPT code ranges of 76510 through 76529 and 92002 through 92371. The cardiovascular and ophthalmology diagnostic code combinations identified as most frequently billed together are listed in Tables 14 and 15.
Under the resource-based PE methodology, specific PE inputs of clinical labor, supplies, and equipment are used to calculate PE RVUs for each individual service. When multiple diagnostic tests are furnished to the same beneficiary on the same day, most of the clinical labor activities and some supplies are not furnished twice. We have identified the following clinical labor activities that typically would not be duplicated for subsequent procedures:
• Greeting and gowning the patient.
• Preparing the room, equipment and supplies.
• Education and consent.
• Completing diagnostic forms.
• Preparing charts.
• Taking history.
• Taking vitals.
• Preparing and positioning the patient.
• Cleaning the room.
• Monitoring the patient.
• Downloading, filing, identifying and storing photos
• Developing film.
• Collating data.
• Quality Assurance documentation.
• Making phone calls.
• Reviewing prior X-rays, lab and echocardiograms.
We analyzed the CY 2011 claims data for the most frequently billed cardiovascular and ophthalmology diagnostic code combinations to determine the level of duplication present when multiple services are furnished to the same beneficiary on the same day. Our MPPR determination excludes the clinical staff minutes associated with the activities that are not duplicated for subsequent procedures. For purposes of this analysis, we retained the higher number of minutes for each duplicated clinical activity, regardless of the code in the pair with which those clinical labor minutes were associated. For example, if code A and B had 6 and 3 minutes, respectively, of clinical labor for preparing and positioning the beneficiary, we removed 3 minutes. If code A and B had 2 and 4 minutes, respectively, of clinical labor for preparing room, equipment and supplies, we removed 2 minutes. The lower number of minutes was removed, regardless of the code. If one code had no minutes for a particular clinical labor activity, then no minutes were removed for that activity. Equipment time and indirect costs are allocated based on clinical labor time; therefore, these inputs were reduced accordingly. While we observed that some supplies are duplicated, we did not factor these into our calculations because they were low cost and had little impact on our estimate of the level of duplication for each code pair.
When we removed the PE inputs for activities that are not duplicated, and adjusted the equipment time and indirect costs, we found support for payment reductions ranging from 8 to 57 percent for second and subsequent cardiovascular procedures (volume-adjusted average reduction across all code pairs of 25 percent); and payment reductions ranging from 9 to 62 percent for second and subsequent ophthalmology procedures (volume-adjusted average reduction across all code pairs of 32 percent). Because we found a relatively wide range of reductions by code pair, we believed that an across-the-board reduction of 25 percent for second and subsequent procedures (which is approximately the average reduction supported by our analysis) would be appropriate. In the CY 2013 proposed rule (77 FR 44748-44752), we proposed to apply an MPPR to TC-only services and to the TC portion of global services for the procedures listed in Tables 12 and 13. The MPPR would apply independently to second and subsequent cardiovascular services and to second and subsequent ophthalmology services. We proposed to make full payment for the TC of the highest priced procedure and to make payment at 75 percent (that is, a 25 percent reduction) of the TC for each additional procedure furnished by the same physician (or physicians in the same group practice, that is, the same group practice NPI) to the same beneficiary on the same day. We did not propose to apply an MPPR to the PC for cardiovascular and ophthalmology services at this time.
We believe that the proposed MPPR percentage represents an appropriate reduction for the typical delivery of multiple cardiovascular and ophthalmology services on the same day. Because the reduction is based on discounting the specific PE inputs that are not duplicated for second and subsequent services, the proposal is consistent with our longstanding policies on surgical, nuclear medicine diagnostic procedures, and advanced imaging procedures, which apply a 50 percent reduction to second and subsequent procedures, and our more recent policy on therapy services, which applies a 20 or 25 percent reduction depending on the setting.
Furthermore, it is consistent with section 1848(c)(2)(K) of the Act, which specifies that the Secretary shall identify potentially misvalued codes by examining multiple codes that are frequently billed in conjunction with furnishing a single service, and review and make appropriate adjustments to their relative values.
Finally, it is responsive to continued concerns about significant growth in spending on imaging and other diagnostic services, and to MedPAC (March 2010) and GAO (July 2009) recommendations regarding the expansion of MPPR policies under the PFS to account for additional efficiencies. Savings resulting from this proposal would be redistributed to other PFS services as required by the general statutory PFS BN provision.
In summary, we proposed that for services furnished on or after January 1, 2013, we will apply the MPPR to nuclear medicine procedures to CPT code 78306 (Bone imaging; whole body) when followed by CPT code 78320 (Bone imaging; SPECT). We will apply the MPPR to the PC and the TC of advanced imaging procedures when furnished by multiple physicians in the same group practice (same group NPI). Therefore, the MPPR will apply when
The following is a summary of the comments we received on this proposal to apply the MPPR to diagnostic cardiovascular and ophthalmology procedures:
In the PFS proposed rule for CY 2012 (76 FR 42812-42813), CMS solicited comments on whether the MPPR should be applied to the TC of all diagnostic tests, rather than just imaging procedures. In response, MedPAC examined Part B claims data from 2010 to look for diagnostic tests that are frequently furnished more than once on the same day by the same physician for the same beneficiary. MedPAC found that several surgical pathology codes are frequently billed with more than one unit of service on the same date. For example, one-third of the claims for CPT code 88305 (Level IV, surgical pathology, gross and microscopic examination) contained more than one unit of service for that code. In addition, 57 percent of the claims for CPT code 88342 (immunohistochemistry, each antibody) contained more than one unit of service for that code. In these cases, it appears that multiple specimens from the same beneficiary were examined at the same time by the same pathologist. MedPAC indicated that CMS should analyze whether there are efficiencies in practice expense or physician work that occur when multiple units of the same test are performed at the same time. If so, MedPAC suggested that CMS should consider applying the MPPR policy to these services or creating bundled codes that include multiple units of the same test. MedPAC noted that these services account for a substantial and growing amount of Medicare spending. In 2010, Medicare spent $1.3 billion on CPT code 88305 and $241 million on CPT code 88342.
MedPAC noted that it has recommended expanding the MPPR to both the TC and PC of all imaging services to account for efficiencies in practice expense and physician work that occur when multiple studies are furnished in the same session.
A few additional commenters either agreed with the principle of applying the MPPR to cardiovascular and ophthalmology services or concurred with our findings that efficiencies exist when multiple diagnostic services are furnished on the same beneficiary on the same day. Those commenters agreed that the application of the MPPR to the additional cardiovascular and ophthalmic diagnostic procedures is an appropriate way to recognize such efficiencies.
As examples, commenters referenced the sample payment reduction calculations in the proposed rule for cardiovascular and ophthalmology services. Concerning CPT code 93306 (transthoracic echocardiography) and CPT code 78452 (myocardial perfusion single-photon emission computed tomography (SPECT)), commenters noted that different physicians, each supported by separately specialized clinical staff perform the service in different rooms on two different types of equipment.
Commenters indicated that clinical teams for each test independently greet and gown the patient, provide education, obtain consent, review previous exam results and studies and position the patient for the test. Commenters noted that the patient is positioned multiple times on different exam tables. According to commenters, two different clinical staff will independently review prior x-ray, laboratory, echocardiography studies, and other studies. Also, separate notes are made in the patient's records, different diagnostic forms are completed, and different quality assurance regulatory compliance information must be documented for each test. Commenters noted that two different rooms with different specialized equipment in two different parts of the facility are prepared and cleaned for the two unique and different services. Finally, two different machines are utilized by two differently credentialed support staff to acquire independent and unrelated clinical testing data.
Concerning CPT code 92235 (Fluorescein Angiography) and CPT code 92250 (Fundus Photography), commenters maintained that the proposal was based on an erroneous understanding of how services vary. Commenters noted that ophthalmic diagnostic tests are not equivalent to x-ray or fluoroscopic imaging, where the technician simply repositions the same device over a nearby area of the patient's body. Commenters noted that ophthalmic diagnostic tests range from imaging to psychophysical tests using a number of different technologies and instruments that require patient participation by responding to various stimuli to achieve an objective functional measurement of the anatomical structures within the eye. For such tests the patient must be taken to a second instrument and positioned, substantially reducing any redundancy in direct practice expenses.
Another commenter indicated that visual field testing equipment, and other eye diagnostic equipment, do not share interfaces, space or patient information. The commenter noted that each machine requires independent input from the testing technician; including patient name, date, birth date, verification of the eye being tested, and there is no shared registration of data between the two services.
According to the commenter, visual field testing requires a dedicated space and is typically not performed at the same time as other diagnostic tests. Patients need a quiet area away from other testing and patients to complete the test. Both eyes are tested, each with their own input and varying lenses that must be inserted into the equipment. The commenter maintained that these tests require substantial clinical staff time, patient instruction and interaction. Ophthalmology patients are typically elderly, often visually impaired and in need of mobility and positioning assistance in order to perform diagnostic eye testing. Finally, the commenter highlighted that the AMA RUC recently removed clinical staff time from some of the codes reviewed in our analysis.
Commenters disagreed that diagnostic test resource utilization for multiple diagnostic tests is comparable to those required for multiple surgeries. Commenters noted that surgical procedures generally have a 90-day global period where more than 50 percent of the payment is related to postoperative care. Commenters also noted that in large multi-specialty practice, technical resources are located in different physical locations.
Commenters recommended that CMS conduct its study with a new methodology that takes into account both the frequency and the different types of clinical staff, and the different types of rooms involved in the services that are performed together on the same day.
Finally, commenters noted that CMS' own analysis reveals payment reductions as low as 8 percent, indicating that a payment reduction of 25 percent would be excessive for some of these services. A commenter expressed concern that taking this “average” approach would have the effect of discouraging cardiologists and ophthalmologists from performing certain low overhead diagnostic procedures as the payment will be far less than the practice costs. The commenter suggested that in previous cases the identified savings were closer to the mean on average and would not result in such dramatic effects. Other commenters recommended that the MPPR reduction percentage should be code-specific up to a maximum reduction of 25 percent.
Concerning CPT code 93306 (transthoracic echocardiography) and CPT code 78452 (myocardial perfusion single-photon emission computed tomography (SPECT)) referenced by commenters, we agree that some cardiovascular centers might choose to employ two differently specialized technicians; that is, nuclear medicine and echocardiography; to allow two different clinical staff to independently perform the studies; and to locate the different specialized equipment in two different parts of the practice. However, we continue to believe that is not the typical cardiovascular center or practice. We believe that the typical cardiovascular center performing these diagnostic tests commonly cross-train technicians to perform both procedures and that a single cardiologist often performs both tests for a single patient. In addition, we continue to believe that much of the pre-service work such as greeting and gowning the patient and reviewing medical records and previous images is redundant. We believe that some of the equipment used in the top code pairs is portable and can be used in the treatment room or other diagnostic room. We also do not believe that multiple rooms dedicated to individual testing equipment is typical such that room preparation, greeting and gowning, and cleaning the room are never duplicated. Overall, commenters provided general descriptions of practices using multiple rooms and technicians to furnish these services, without sufficient information supporting a multiple room, dedicated clinical labor model as typical outside the facility setting. We would review generalizable, robust data demonstrating that an extensive practice model of multiple rooms dedicated to individual tests and distinct dedicated technicians trained is typical practice.
Concerning CPT code 92235 (Fluorescein Angiography) and CPT code 92250 (Fundus Photography), we acknowledge that these tests are not equivalent to other imaging procedures. However, we believe there are still efficiencies when furnished to the same patient due to some duplication of clinical labor. Concerning visual field testing, we agree that this is an interactive test, requiring the technician to teach the patient how to perform the test; however, the most intense instruction only occurs the first time a patient has visual field testing. Although not considered in our analysis, we also note that once a patient is diagnosed with glaucoma the patient usually undergo visual field testing for the rest of their life, and their familiarity with the test reduces the clinical labor associated with providing this service overtime. As for the other ophthalmology tests, we understand them to be mostly passive with minimal patient instruction.
Commenters expressed concerns that there is wide variation in the potential efficiencies among different code pairs; that such variability precludes broad application of a single percentage reduction; and, that establishing new combined codes is the only mechanism for capturing accurate payment for multiple imaging services. In general, we believe that MPPR policies capture efficiencies when several services of the same type are furnished in the same session and that it is appropriate to apply a single percentage reduction to second and subsequent procedures to capture those efficiencies. Because of the myriad potential combinations of diagnostic services, establishing new combined codes for each combination of advanced imaging scans is unwieldy and impractical. An MPPR policy reflects efficiencies in the aggregate, such as common patient history, application of multiple tests to the same anatomical structures by the same clinical labor, frequently with the same modality, for the same patient.
As previously noted, we found support for payment reductions ranging from 8 to 57 percent for second and subsequent cardiovascular procedures (volume-adjusted average reduction across all code pairs of 25 percent); and payment reductions ranging from 9 to 62 percent for second and subsequent ophthalmology procedures (volume-adjusted average reduction across all code pairs of 32 percent). Based on this analysis, and because we found a relatively wide range of reductions by code pair, we believed that an across-the-board reduction of 25 percent for second and subsequent procedures, which is approximately the average reduction supported by our analysis, would be appropriate. Based on subsequent public comments, we have conducted additional analysis on ophthalmology code pairs discussed below. In response to comment that this MPPR application to ophthalmic and cardiovascular diagnostic testing is not the same as the MPPR for global surgery,
The commenter requested that any ophthalmic tests that had their time reduced because of duplication with an office visit should be removed from the list of codes subject to the MPPR. Specifically, the commenter requested that the three visual field tests CPT codes 92081, 92082 and 92083 and CPT code 92235 (Fluorescein angiography) and CPT code 92286 (Internal eye photography) for which minutes were reduced that were not reflected in the CMS analysis should be removed from the list. Additionally, the commenter indicated that CPT codes 92133, 92134 and 92285 all had their clinical staff labor times previously reduced during the AMA RUC consideration and should not be included in the MPPR.
Commenters also expressed concern about CPT codes that have recently been reviewed or are in the process of being reviewed under the various misvalued services screens. Commenters noted that these codes have already been subjected to a process where duplicative minutes have been reduced. Therefore, they requested that any codes for procedures where the AMA RUC has reviewed the PE inputs in the last 2 years be removed from this proposed list of services.
We disagree that recently reviewed codes should be exempt from the MPPR. However, we agree that the analysis establishing an MPPR should be based on the most current practice expense data available, and that the recent clinical labor reductions made to the subject codes should be taken into account. Therefore, based on our revised analysis, we are reducing the final MPPR on ophthalmology services from 25 percent to 20 percent to more accurately reflect the new data.
Commenters further noted that every other code pair is reported together at or below 40 percent of the time, with over half below 20 percent. They stated that not only are these services not commonly billed together, they are not performed on contiguous body parts and are not always performed on the same type of equipment or even in the same room. Further, the services would sometimes be performed by different physicians in the same group practice.
In addition, commenters indicated that a broader analysis of the claims data for all the analyzed codes pairs for cardiovascular and ophthalmology suggest that only roughly four percent of the code combinations are typically performed together on the same date of service. Given that these services are rarely performed on the same day
Commenters maintained that efficiencies in practice expense are potentially created only when the two services are similar, use the same instrument, and are commonly performed together. Commenters indicated, however, that for more low-volume code pairs, the practice will not have the same level of familiarity, including the office equipment set up, to conduct these services. Commenters further noted that the differences between these services are such that even if all these services were commonly billed together, physician staff could not provide noticeable efficiencies.
The frequency of code combinations reviewed for cardiovascular services ranged from 260 to 207,573 and for ophthalmology services from 4,193 to 553,502. Although utilization was low for some code combinations reviewed, we examined the top highest frequency code combinations for each of the five code groups examined (three for cardiovascular and two for ophthalmology). The frequency with which a code combination is furnished does not diminish the potential efficiencies in clinical labor activities that will occur when that code combination is furnished. All MPPR policies (surgery, diagnostic imaging and therapy) apply to all code combinations of procedures subject to the policy, regardless of the frequency that the code combination was furnished. Therefore, we believe it is appropriate to apply the MPPR regardless of the frequency which the code combination is billed. Applying the MPPR to code combinations furnished infrequently will have a minimal effect on overall payments for imaging services. Finally, we based our final recommended percent reduction on the volume-adjusted average reduction observed in our code pair analysis, which ensures that when the MPPR is applied, the reduction adjustment is more likely to reflect the actual reduction for the code pair. MPPR policies have been consistently applied to all multiple procedures and are not restricted to those with the highest frequency of billings.
Another commenter noted that ultrasound services have never experienced rapid growth, but rather, have experienced only moderate growth. The commenter cited GAO's September 2008 report to Congress that found that after the implementation of DRA cap, which for vascular ultrasound services resulted in reductions of greater than 40 percent, the disparity in utilization between ultrasound and expensive, advanced imaging modalities continued to grow. The commenter noted that this is reflected by the Congressional Budget Office's (CBO) December 2008 recommendations to Congress in which it excluded ultrasound and other inexpensive imaging modalities from its policy recommendations on advanced imaging services. Commenters concluded that imaging has absorbed numerous payment reductions and that it is illogical to target procedures for reduction that do not demonstrate a pattern of rapid growth.
Another commenter noted that CPT codes 93293 (Transtelephonic rhythm strip pacemaker evaluation(s) single, dual, or multiple lead pacemaker system, includes recording with and without magnet application with analysis, review and report(s) by a physician or other qualified health care professional, up to 90 days), 93296 (Interrogation device evaluation(s) (remote), up to 90 days; single, dual, or multiple lead pacemaker system or implantable cardioverter-defibrillator system, remote data acquisition(s), receipt of transmissions and technician review, technical support and distribution of results), and 93299 (Interrogation device evaluation(s), (remote) up to 30 days; implantable cardiovascular monitor system or implantable loop recorder system, remote data acquisition(s), receipt of transmissions and technician review, technical support and distribution of results) describe the TC for remote interrogation of the devices, meaning that the patient is not physically present when the service is furnished. The commenter questioned how it is possible for efficiencies to exist in the rare circumstance these services were furnished on the same date as a cardiovascular diagnostic service. The commenter indicated that the inclusion of these codes demonstrates a lack of understanding of how diagnostic services are furnished to beneficiaries.
The commenter further noted that, due to the relatively low payment rates for ultrasound procedures, they are one of the most cost-effective diagnostic imaging modalities. The commenter indicated that analyses performed by GAO in 2008 and others have shown that lower cost imaging modalities such as ultrasound have declined in use relative to more expensive imaging modalities, negatively impacting the quality and cost of their health care.
The commenter concluded that payment reductions to ultrasound services have threatened the ability to furnish such services. Therefore, the commenter requested removal of all ultrasound procedures from the list of procedures subject to the MPPR on cardiovascular services.
Another commenter noted that the June 2011 MedPAC report focused on advanced diagnostic imaging services and supported increasing, rather than decreasing, the payments for ultrasound services. The commenter indicated that the report suggests reforming the Medicare fee-for-service system to encourage the use of high-value services and discourage the use of low-value services. In describing what is meant by low-valued services, MedPAC points to situations where two services may be equally safe and effective, yet one is more expensive than the other. The commenter indicates that this is the situation with ultrasound as compared to other, more expensive imaging services. Finally, the commenter noted that the report suggested that services that can potentially harm patients, for example, overexposure to radiation, should be considered low-value. The commenter indicates that ultrasound, which is non-ionizing, poses less risk to patients than other modalities.
Commenters urged CMS to be mindful of this work and to fully take into account the AMA RUC review of the code pairs. Commenters found it contradictory for CMS to utilize the AMA RUC process and accept the PE payment principle, only to disregard the methodology in applying an MPPR; and suggested that duplication of work in services performed on the same date of service should be addressed at the individual code level rather than through an MPPR.
Another commenter recommended that CMS ask the AMA RUC to review the codes and make code-specific recommendations and claimed that implementing payment reductions that are not specific does a disservice to the entire AMA RUC process and all of the physicians who are paid under the PFS.
Commenters disputed the assumption that an MPPR is a valid and accurate mechanism to value services when performed on the same date of service. Commenters indicated that, historically, the AMA RUC has recognized that efficiencies can be gained when services are commonly performed by the same physician on the same date of service, but only when explicit criteria are met. The commenters indicated that the proposal fails to meet these criteria because the services are not commonly billed together, are not analogous services performed on contiguous body parts, and applies to both individual physicians and physicians in the same group practice.
Commenters maintained that the vague justification for selecting particular codes in the CY 2013 rule stands in stark contrast to the AMA RUC. According to commenters, the AMA RUC process set a clear and
As noted previously, although less precise than creating new comprehensive codes to capture each unique combination of diagnostic services that could be performed together, we believe that an MPPR policy appropriately addresses efficiencies present when multiple diagnostic services are furnished together. Moreover, we believe it would be unwieldy and impractical to develop unique codes and values for the myriad of procedure combinations that could be furnished together. In addition, we believe that the expansion of the MPPR policy to the TC of diagnostic cardiovascular and ophthalmology services is consistent with both the GAO and MedPAC recommendations. Finally, we already have discussed information on the determination of frequently billed services in response to comments on this rule concerning the most frequently billed cardiovascular and ophthalmology diagnostic code combinations used in our analysis.
Another commenter noted that payment rates for x-rays under the OPPS are significantly higher than payment rates under the PFS. The commenter indicated that application of the MPPR in a non-hospital setting will cause procedures to shift to the hospital setting. The commenter recommended paying the lower of (1) full payment under the OPPS rate for procedure with the higher fee, and 50 percent of the OPPS rate for the second procedure, or (2) full payment for both procedures under the PFS.
As explained previously, section 1848(c)(2)(K)(i) of the Act requires the Secretary to identify services within several specific categories as being potentially misvalued and to make appropriate adjustments to their relative values. One of the specific categories listed under section 1834(c)(2)(K)(ii) of the Act is “multiple codes that are frequently billed in conjunction with furnishing a single service.” Although some code pair combinations will occur infrequently, the codes subject to the MPPR are frequently found in groups of multiple codes that are billed in conjunction with furnishing a single service. Section 1848(c)(2)(K)(ii) of the Act specifies that we should examine not only individual codes, but also families of codes. We believe the MPPR policy contributes to fulfilling our statutory obligations under section 1848(c) of the Act by more appropriately valuing combinations of imaging services furnished to patients and paid under the PFS.
As previously noted, Medicare has a long-standing policy of applying an MPPR to surgical procedures. While the various MPPRs have been adopted through notice and comment rulemaking as administrative actions, the Congress has acknowledged our authority to adopt MPPRs by directly modifying several of them, and by exempting the payment changes relating to several others from budget neutrality adjustment under the PFS. For example, section 5102(a) of the DRA exempted from the PFS budget neutrality adjustment the changes in expenditures resulting from the MPPR on the TC of diagnostic imaging. Section 3135(b) of the Affordable Care Act increased the MPPR reduction percentage on the TC of diagnostic imaging from 25 to 50 percent. Sections 3 and 4 of the PPATRA decreased the MPPR reduction percentage on the PE of therapy services from 25 to 20 percent for therapy services furnished in office settings, and exempted from budget neutrality the change in expenditures resulting from the MPPR on therapy services from budget neutrality.
We appreciate the commenter's suggestions concerning alternate payment methodologies, that is, payments based on the OPPS rate, and we will consider them further for possible rulemaking in the future.
The commenter urged us to exclude the following codes from the MPPR on cardiovascular services: CPT codes 93303 and 93304 (Congenital transthoracic echocardiography); CPT code 93308 (Limited non-congenital code used for follow-up studies); and CPT codes 93320, 93321 and 93325 (Spectral and Color Doppler). The commenter maintained that excluding these codes would have no demonstrable effect on Medicare utilization of cardiology services since cardiologists treating adult patients rarely bill the congenital echocardiography codes to Medicare. The commenter noted that because most adult non-congenital transthoracic echocardiography studies that are billed to Medicare have been bundled into CPT code 93306 (including non-congenital echocardiography CPT codes 93307, 93320 and 93325), the significant decrease in payment for the subject codes would disproportionately impact pediatric cardiologists.
The commenter further noted that state Medicaid agencies and private sector health insurance payors use Medicare guidelines and RVU valuations to establish their own payment protocols. Therefore, the repercussions of these reductions will extend across all payor sources for pediatric cardiology practices and have a materially significant impact on the financial viability of many practices. Finally, the commenter indicated that the inclusion of the subject codes in the proposed MPPR would exacerbate the current shortage of available fellowship positions that recruit medical residents into pediatric cardiology, and will impair their ability to provide patient access to this life-saving specialty care, especially to medically underserved areas.
We considered the specific scenarios presented by the commenter's in the context of MPPR methodology and identified the same or similar efficiencies regardless of whether the multiple diagnostic procedures were targeted at abnormal flow in response to congenital structural abnormalities or were targeted at functional abnormalities in response to primary vascular disease. We also noted that, whereas practitioners who perform more services that are reported separately will be impacted more by the MPPR, practitioners who report more services that have recently been bundled together will have a similar impact due to the efficiencies that were considered by CMS in the valuation of those new bundled codes. Finally, we note that the codes are not specific to pediatric patients so it is not possible to exclude them for pediatric cardiologists alone.
In response to the commenters concerns that other insurers may adopt our policies, we do not modify Medicare payment policy based on the fact that Medicaid and other payors may adopt such policies. We understand that other payors have their own unique payment systems and consider the appropriateness of CMS valuations in their decisions to accept, modify or ignore our payments. We continue to believe that the MPPR policy that we are
• Create a disincentive for specialists to provide efficient, high quality and continuous care to their patients. Penalize the use of the appropriate sub-specialist, resulting in generalist physicians conducting multiple reads, leading to a degradation of diagnostic interpretation quality.
• Have a negative impact on investment in new advanced imaging technology and stifle innovation. New equipment offers more precise images and the addition of highly-trained personnel to a medical practice is integral to high quality patient care. Inhibit staff training and the addition of staff in a state of uncertainty.
• Lead to a forced reduction in necessary services, compromising patient access to life-saving diagnostic imaging services in all settings, including independent practices, community hospitals, and large academic medical centers.
• Drive more services out of physicians' offices and into more expensive hospital settings, fragment care, and increase patient costs.
• Reduce the efficiency of patient care and inconvenience patients because many would be scheduled for multiple procedures over multiple days instead of just one day. This would particularly disadvantage patients with serious medical conditions, such as multiple traumas, heart attacks, strokes, and cancer, who require frequent and multiple imaging.
• Disproportionally affect radiologists in academic medical centers who are often part of large group practices and who furnish care to a more complex patient population. These patients are often suffering from acute trauma or undergoing treatment for cancer and are more likely to have multiple examinations on the same day.
• Contradict the goal to focus more on preventive care, as diagnostic tests enable the early detection of potentially serious conditions.
For the ordering and scheduling of cardiovascular or ophthalmology services for Medicare beneficiaries, we require that Medicare-covered services be appropriate to beneficiary needs. We would not expect the adoption of an MPPR for the TC of diagnostic cardiovascular and ophthalmology services to result in services being furnished on separate days by one physician merely so that the physician may garner increased payment. We agree with the commenters who noted that such an unprofessional response on the part of practitioners would be inefficient and inappropriate care for the beneficiary. We will monitor access to care and patterns of delivery for cardiovascular and ophthalmology services to beneficiaries, with particular attention focused on identifying any clinically inappropriate changes in timing of the delivery of such services.
In summary, after consideration of the public comments received, we are adopting our CY 2013 proposal to apply an MPPR to the TC of diagnostic cardiovascular and ophthalmology services, with a modification to apply a 20 percent reduction for diagnostic ophthalmology services rather than the 25 percent reduction we had proposed. The reduction percentage for diagnostic cardiovascular services remains at 25 percent, as proposed. We continue to believe that efficiencies exist in the TC of multiple diagnostic cardiovascular and ophthalmology services and we will continue to monitor code combinations for possible future adjustments to the reduction percentage applied through this MPPR policy.
Specifically, beginning in CY 2013 we are adopting an MPPR that applies a 25 percent reduction to the TC of second and subsequent diagnostic cardiovascular, and a 20 percent reduction to the TC of second and subsequent diagnostic ophthalmology services, furnished by the same physician (or physicians in the same group practice) to the same beneficiary, on the same day. In Table 10, we provide examples illustrating the current and CY 2013 payment amounts:
No changes have been made to the proposed list for diagnostic ophthalmology services. We have revised the proposed list for diagnostic cardiovascular services by removing codes deleted for CY 2013, add-on codes, and remote monitoring codes, and adding global codes corresponding to technical-only codes already on the list:
The complete list of services subject to the MPPR for the TC of diagnostic cardiovascular and ophthalmology services is shown in Addendum X. The PFS budget neutrality provision is applicable to the new MPPR for the TC of diagnostic cardiovascular and ophthalmology services. Therefore, the estimated reduced expenditures for such services have been redistributed to increase payment for other PFS services. We refer readers to section VIII.C. of this final rule with comment period for further discussion of the impact of this policy.
We are proposing to add the new codes in Table 16 to the list of procedures subject to the OPPS cap, effective January 1, 2013. Some of these codes are replacement codes for codes deleted for CY 2013. These procedures meet the definition of imaging under section 5102(b) of the DRA. These codes are being added on an interim final basis and their addition as procedures subject to the OPPS cap is open to public comment in this final rule with comment period.
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, which amended section 1848(c) of the Act, required us to implement resource-based malpractice RVUs for services furnished beginning in 2000. Therefore, initial implementation of resource-based malpractice RVUs occurred in 2000.
The statute also requires that we review and, if necessary, adjust RVUs no less often than every 5 years. The first review and update of resource-based malpractice RVUs was addressed in the CY 2005 PFS final rule with comment period (69 FR 66263). Minor modifications to the methodology were addressed in the CY 2006 PFS final rule with comment period (70 FR 70153). In the CY 2010 PFS final rule with comment period, we implemented the second review and update of malpractice RVUs. For a discussion of the second review and update of malpractice RVUs, see the CY 2010 PFS proposed rule (74 FR 33537) and final rule with comment period (74 FR 61758).
As explained in the CY 2011 PFS final rule with comment period (75 FR 73208), malpractice RVUs for new and revised codes effective before the next Five-Year Review of Malpractice (for example, effective CY 2011 through CY 2014, assuming that the next review of malpractice RVUs occurs for CY 2015) are determined either by a direct crosswalk to a similar source code or by a modified crosswalk to account for differences in work RVUs between the new/revised code and the source code. For the modified crosswalk approach, we adjust (or “scale”) the malpractice RVU for the new/revised code to reflect the difference in work RVU between the source code and the new/revised work value (or, if greater, the clinical labor portion of the fully implemented PE RVU) for the new code. For example, if the proposed work RVU for a revised code is 10 percent higher than the work RVU for its source code, the malpractice RVU for the revised code would be increased by 10 percent over the source code malpractice RVU. This approach presumes the same risk factor for the new/revised code and source code but uses the work RVU for the new/revised code to adjust for risk-of-service.
As we indicated in the CY 2013 PFS proposed rule, we will continue our current approach for determining malpractice RVUs for new/revised codes. In section II.M.2. of this final rule with comment period, we have published a list of new/revised codes and the malpractice crosswalk(s) used for determining their malpractice RVUs. These malpractice RVUs for new/revised codes will be implemented for CY 2013 on an interim final basis and the malpractice crosswalks are subject to public comment. We will respond to comments and finalize the malpractice crosswalks for the majority of these codes in the CY 2014 PFS final rule with comment period.
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, practice expense (PE), and malpractice). While requiring that the PE and MP GPCIs reflect the full relative cost differences, section 1848(e)(1)(A)(iii) of the Act requires that the work GPCIs reflect only one-quarter of the relative cost differences compared to the national average. In addition, section 1848(e)(1)(G) of the Act sets a permanent 1.5 work GPCI floor for services furnished in Alaska beginning January 1, 2009, and section 1848(e)(1)(I) of the Act sets a permanent 1.0 PE GPCI floor for services furnished in frontier states beginning January 1, 2011.
Section 1848 (e)(1)(E) of the Act provides for a 1.0 floor for the work GPCIs, which was set to expire at the end of 2011. The statute was amended by section 303 of the Temporary Payroll
Since the 1.0 work GPCI floor provided in section 1848 (e)(1)(E) of the Act is set to expire prior to the implementation of the CY 2013 updates to the PFS, the proposed CY 2013 work GPCIs and summarized geographic adjustment factors (GAFs) published in addendums D and E of this CY 2013 PFS proposed rule do not reflect the 1.0 work GPCI floor for CY 2013. As required by section 1848 (e)(1)(G) and section1848 (e)(1)(I) of the Act, the 1.5 work GPCI floor for Alaska and the 1.0 PE GPCI floor for frontier states are applicable in CY 2013 and are reflected in addendums D and E.
In the CY 2012 PFS final rule with comment period, we made several refinements to the GPCIs (76 FR 73081 through 73092), including revising the sixth GPCI update to reflect the most recent data, with modifications. Specifically, we finalized our proposal to change the GPCI cost share weights for CY 2012 to reflect the most recent rebased and revised Medicare Economic Index (MEI). As a result, the cost share weight for the work GPCI (as a percentage of the total) was changed from 52.466 percent to 48.266 percent, and the cost share weight for the PE GPCI was revised from 43.669 percent to 47.439 percent with a change in the employee compensation component from 18.654 to 19.153 percentage points. The cost share weight for the office rent component of the PE GPCI was changed from 12.209 percent to 10.223 percentage points (fixed capital with utilities), and the medical equipment, supplies, and other miscellaneous expenses component was changed from 12.806 percent to 9.968 percentage points. In addition, we finalized the weight for purchased services at 8.095 percentage points, of which 5.011 percentage points are adjusted for geographic cost differences. Lastly, the cost share weight for the malpractice GPCI was revised from 3.865 percent to 4.295 percent. Table 17 displays the cost share weights that were finalized in the CY 2012 final rule with comment period. Note that the employee compensation; office rent; purchased services; and equipment supplies and other cost share weights sum to the total PE GPCI cost share weights of 47.439 percent.
We also finalized several other policies in the CY 2012 final rule with comment period including the use of 2006 through 2008 American Community Survey (ACS) two-bedroom rental data as a proxy for the relative cost difference in physician office rent. In addition, we created a purchased services index to account for labor-related services within the “all other services” and “other professional expenses” MEI components. In response to public commenters who recommended that we use Bureau of Labor Statistics (BLS) Occupational Employment Statistics (OES) data to capture the “full range” of occupations included in the offices of physician industry to calculate the nonphysician employee wage component (also referred to as the employee wage index) of the PE GPCI, we finalized a policy of using 100 percent of the total wage share of nonphysician occupations in the offices of physicians' industry to calculate the nonphysician employee wage component of the PE GPCI.
Concurrent with our CY 2012 rulemaking cycle, the Institute of Medicine released the final version of its first of two anticipated reports entitled
As we anticipated in the CY 2013 proposed rule, the Institute of Medicine's second report, entitled “
CY 2013 is the final year of the sixth GPCI update and, because we will propose updates next year, we did not include any proposals related to the GPCIs for the CY 2013 PFS. In response to public inquiries about exceptions to the calculated GPCIs, we provided a brief discussion about the permanent 1.0 PE floor for frontier states, the 1.5 work floor for Alaska, the GPCIs for the Puerto Rico payment locality, and the expiration of the GPCI 1.0 work floor required under section 1848 (e)(1)(E) of the Act. We also discussed recommendations from the first Institute of Medicine report that were not addressed during CY 2012 rulemaking in the CY 2013 proposed rule. We have included this discussion below.
Section 1848(e)(1)(G) of the Act sets a permanent 1.5 work GPCI floor for services furnished in Alaska beginning January 1, 2009. Therefore, the 1.5 work floor for Alaska will remain in effect in CY 2013. In addition, section 1848(e) (1)(I) of the Act establishes a 1.0 PE GPCI floor for physicians' services furnished in frontier states effective January 1, 2011. In accordance with section 1848(e)(1)(I) of the Act,
As noted in the CY 2013 proposed rule, we have received inquiries from representatives of the Puerto Rico medical community regarding our policies for determining the GPCIs for the Puerto Rico payment locality. While we did not make any proposals related to the GPCIs for Puerto Rico, in response to those inquiries, we provided the following discussion regarding the GPCIs assigned to the Puerto Rico payment locality. We anticipate recalculating all the GPCIs in the seventh GPCI update, currently anticipated to be implemented for CY 2014.
As noted above, we are required by section 1848(e)(1)(A) of the Act to develop separate GPCIs to measure relative resource cost differences among localities compared to the national average for each of the three fee schedule components: Work, PE and malpractice expense. To calculate these GPCI values, we rely on three primary data sources. We currently use the 2006-2008 BLS OES data to calculate the work GPCI, the nonphysician employee wage component of PE GPCI, and the labor costs associated with the purchased services component of PE GPCI. We use 2006-2008 ACS data to calculate the office rent component of the PE GPCI. Finally, we use 2006-2007 malpractice premium data to calculate the malpractice GPCI. For all localities, including Puerto Rico, we assume equipment, supplies, and other expenses are purchased in a national market and that the costs do not vary by geographic location. Therefore, we do not use data on the price of equipment, supplies, and expenses across localities in calculating PE GPCIs. With the exception of the malpractice GPCI, we have current data from the applicable sources allowing us to calculate the work and PE GPCIs for the Puerto Rico payment locality. The 2006-2008 BLS OES data and rental values derived from the 2006-2008 ACS indicate that the costs associated with operating a physician practice in Puerto Rico are the lowest among all payment localities.
To calculate the malpractice GPCI for the various Medicare PFS localities, we collect malpractice insurance market share and premium data from state departments of insurance and from state rate filings. As discussed in our contractor's report (Final Report on the Sixth Update of the Geographic Practice Cost Index for the Medicare Physician Fee Schedule page. 41), for the fourth, fifth, and sixth GPCI updates we were not able to collect this data for the Puerto Rico payment locality. Therefore, we carried over the malpractice GPCI value of 0.249 from previous GPCI updates when malpractice premium data were last available. It is important to note that we have a source for more current malpractice premium data for Puerto Rico for use in the upcoming seventh GPCI update. We are working with the relevant officials in Puerto Rico to acquire these data for use in future rulemaking.
For a detailed discussion regarding the methodology used to calculate the various components of the Puerto Rico GPCIs, we referred readers to our contractor's report from November of 2010 entitled “Final Report on the Sixth Update of the Geographic Practice Cost Index for the Medicare Physician Fee Schedule” available on our Web site at
In the CY 2013 proposed rule, we also encouraged comments from stakeholders regarding potential data sources that may be available for calculating the Puerto Rico malpractice GPCI.
The work GPCIs are designed to capture the relative costs of physician labor by Medicare PFS locality. Previously, the work GPCIs were developed using the median hourly earnings from the 2000 Census of workers in seven professional specialty occupation categories that we used as a proxy for physicians' wages. Physicians' wages are not included in the occupation categories because Medicare payments are a key determinant of physicians' earnings. That is, including physicians' wages in the work GPCIs would effectively make the indices dependent upon Medicare payments. As required by law, the work GPCIs reflect one quarter of the relative wage differences for each locality compared to the national average. The work GPCI updates in CYs 2001, 2003, 2005, and 2008 were based on professional earnings data from the 2000 Census. For the sixth GPCI update in CY 2011, we used the 2006 through 2008 BLS OES data as a replacement for the 2000 Census data.
Although we did not propose any changes to the data or methodology used to calculate the work GPCI for CY
At our request, the Institute of Medicine conducted a study of the geographic adjustment factors in Medicare payment. It is a comprehensive empirical study of the geographic adjustment factors established under sections 1848(e) (GPCI) and 1886(d)(3)(E) (hospital wage index) of the Act. These adjustments are designed to ensure Medicare payments reflect differences in input costs across geographic areas. The factors the Institute of Medicine evaluated include the following:
• Accuracy of the adjustment factors;
• Methodology used to determine the adjustment factors; and
• Sources of data and the degree to which such data are representative.
Within the context of the U.S. healthcare marketplace, the Institute of Medicine also evaluated and considered the—
• Effect of the adjustment factors on the level and distribution of the health care workforce and resources, including—
++ Recruitment and retention taking into account mobility between urban and rural areas;
++ Ability of hospitals and other facilities to maintain an adequate and skilled workforce; and
++ Patient access to providers and needed medical technologies;
• Effect of adjustment factors on population health and quality of care; and
• Effect of the adjustment factors on the ability of providers to furnish efficient, high value care.
The Institute of Medicine's first report entitled “
• Recommendation 2-1: The same labor market definition should be used for both the hospital wage index and the physician geographic adjustment factor. Metropolitan statistical areas and statewide non-metropolitan statistical areas should serve as the basis for defining these labor markets.
• Recommendation 2-2: The data used to construct the hospital wage index and the physician geographic adjustment factor should come from all health care employers.
• Recommendation 5-1: The GPCI cost share weights for adjusting fee-for-service payments to practitioners should continue to be national, including the three GPCIs (work, PE, and liability insurance) and the categories within the PE (office rent and personnel).
• Recommendation 5-2: Proxies should continue to be used to measure geographic variation in the physician work adjustment, but CMS should determine whether the seven proxies currently in use should be modified.
• Recommendation 5-3: CMS should consider an alternative method for setting the percentage of the work adjustment based on a systematic empirical process.
• Recommendation 5-4: The PE GPCI should be constructed with the full range of occupations employed in physicians' offices, each with a fixed national weight based on the hours of each occupation employed in physicians' offices nationwide.
• Recommendation 5-5: CMS and the Bureau of Labor Statistics should develop an agreement allowing the Bureau of Labor Statistics to analyze confidential data for CMS.
• Recommendation 5-6: A new source of information should be developed to determine the variation in the price of commercial office rent per square foot.
• Recommendation 5-7: Nonclinical labor-related expenses currently included under PE office expenses should be geographically adjusted as part of the wage component of the PE. This report can be accessed on the Institute of Medicine 's Web site at
As previously noted in this section, the Institute of Medicine also considered the role of Medicare payments on matters such as the distribution of the healthcare workforce, population health, and the ability of providers to produce high-value, high-quality health care in its final report July 17, 2012. We were not able to evaluate the recommendations contained in the Institute of Medicine's Phase II report, in time for discussion in the proposed rule. The Phase II report can be accessed on the Institute of Medicine's Web site at
In the CY 2012 PFS final rule with comment period, we addressed three of the recommendations offered by the Institute of Medicine in its Phase I report. Specifically, the final CY 2012 GPCIs utilized the full range of nonphysician occupations in the employee wage calculation consistent with Institute of Medicine recommendation 5-4. Additionally, we created a new purchased service index to account for nonclinical labor related expenses similar to Institute of Medicine recommendation 5-7. Lastly, we have consistently used national cost share weights to determine the appropriate weight attributed to each GPCI component, which is supported by Institute of Medicine recommendation 5-1 (76 FR 73081 through 73092). In order to facilitate a public discussion regarding the Institute of Medicine's remaining Phase I recommendations, we provided a summary analysis of these recommendations in the CY 2013 proposed rule, which has also been included in this final rule with comment period below. We provided our technical analyses of the remaining Institute of Medicine Phase I recommendations in a report released on the PFS Web site at
(A)
The current PFS locality structure was developed and implemented in 1997. There are currently 89 total PFS localities; 34 localities are statewide areas (that is, only one locality for the entire state). There are 52 localities in the other 16 states, with 10 states having 2 localities, 2 states having 3 localities, 1 state having 4 localities, and 3 states having 5 or more localities. The District of Columbia, Maryland, and Virginia suburbs, Puerto Rico, and the Virgin Islands are additional localities that make up the remainder of the total of 89 localities. The development of the current locality structure is described in detail in the CY 1997 PFS proposed rule (61 FR 34615) and the subsequent final rule with comment period (61 FR 59494).
Prior to 1992, Medicare payments for physicians' services were made under the reasonable charge system. Payments were based on the charging patterns of physicians. This resulted in large differences among types of services, geographic payment areas, and physician specialties. Recognizing this, the Congress replaced the reasonable charge system with the Medicare PFS in the Omnibus Budget Reconciliation Act (OBRA) of 1989, effective January 1, 1992. Payments under the fee schedule are based on the relative resources used in furnishing services and vary among areas as resource costs vary geographically as measured by the GPCIs.
Payment localities were established under the reasonable charge system by local Medicare carriers based on their knowledge of local physician charging patterns and economic conditions. These localities changed little between the inception of Medicare in 1967 and the beginning of the PFS in 1992. As a result, a study was begun in 1994 that resulted in a comprehensive locality revision, which was implemented in 1997 (61 FR 59494).
The revised locality structure reduced the number of localities from 210 to the current 89 and the number of statewide localities increased from 22 to 34. The revised localities were based on locality resource cost differences as reflected by the GPCIs. A full discussion of the methodology can be found in the CY 1997 PFS final rule with comment period (61 FR 59494). The current 89 fee schedule areas are defined alternatively by state boundaries (for example, Wisconsin), metropolitan areas (for example, Metropolitan St. Louis, MO), portions of a metropolitan area (for example, Manhattan), or rest-of-state areas that exclude metropolitan areas (for example, Rest of Missouri). This locality configuration is used to calculate the GPCIs that are in turn used to calculate payments for physicians' services under the PFS.
As was stated in the CY 2011 final rule with comment period (75 FR 73261), we require that changes to the PFS locality structure be done in a budget neutral manner within a state. For many years, we have sought consensus for any locality changes among the professionals whose payments would be affected. We have also considered more comprehensive changes to locality configurations. In 2008, we issued a draft comprehensive report detailing four different locality configuration options (
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For a detailed discussion of the public comments on the contractor's 2008 draft report detailing four different locality configurations, we refer readers to the CY 2010 PFS proposed rule (74 FR 33534) and subsequent final rule with comment period (74 FR 61757). There was no public consensus on the options, although a number of commenters expressed support for Option 3 (separate MSAs from statewide localities) because the commenters believed this alternative would improve payment accuracy and could mitigate potential reductions to rural areas compared to Option 1 (CMS CBSAs).
In response to some public comments regarding the third of the four locality options, we had our contractor conduct an analysis of the impacts that would result from the application of Option 3. Those results were displayed in the final locality report released in 2011. The final report, entitled “
The Institute of Medicine recommends altering the current locality structure that was originally based on areas set by local contractors and, in 1996, reduced from 210 to current 89 using a systematic iterative methodology. Rather than using the current uniform fee schedule areas in adjusting for relative cost differences as compared to the national average, the Institute of Medicine recommends a three-tiered system for defining fee schedule areas. In the first tier, the
To understand why the employee wage index would vary by county under the Institute of Medicine's recommendation, consider the three steps that would be required to calculate the employee wage index. The first step calculates the average hourly wage (AHW) for workers employed in each MSA or residual (rest of state) area. The wages of workers in each occupation are weighted by the number of workers employed in physicians' offices nationally. The second step applies a commuting-based smoothing adjustment to create area index wages for each county. The commuting-adjusted county index wages are equal to a weighted average of the AHW values calculated in the first step, where the weights are county-to-MSA out-commuting patterns. The Institute of Medicine's out-commuting-based weights equal the share of health care workers that live in a county where a physician's office is located who commute out of the county to work in a physician's office in each MSA. The third step sets each physician's employee index wage equal to the estimated area index wage (calculated in Step 2) of the county in which the physician's office is located. Because the out-commuting adjustment envisioned by the Institute of Medicine in the second step varies by county, the employee wage index value—and thus the PE GPCI as a whole—would also potentially vary by county depending on the smoothing option chosen. If implemented, the number of employee wage index payment areas could potentially increase from 89 to over 3,000.
The Institute of Medicine's second tier of fee schedule areas would use an MSA-based approach. The Institute of Medicine proposes using the MSA-based system for the work GPCI, the office rent index and the purchased services index of the PE GPCI, and the MP GPCI. An MSA is made up of one or more counties, including the counties that contain the core urban area with a population of 50,000 or more, as well as surrounding counties that exhibit a high degree of social and economic integration (as measured by commuting patterns) with the urban core. MSAs are designed to be socially and economically integrated units based on the share of workers who commute to work within the urban core of each MSA. Implementing an MSA-based locality structure would expand the number of fee schedule areas from 89 to upwards of 400 plus additional MSAs for U.S. territories (for example, Virgin Islands, American Samoa, Guam, Northern Marianna Islands).
In its third payment area tier, the Institute of Medicine proposes creating a national payment area for the “equipment, supplies and other” index. We currently do not adjust PEs associated with supplies and equipment since we believe they are typically purchased in a national market. Thus, this approach is equivalent to using a national fee schedule area to define this index. The Institute of Medicine proposes no change to the fee schedule area used to compute the “equipment, supplies and other” index.
Based on our contractor's analysis, there would be significant redistributive impacts if we were to implement a policy that would reconfigure the PFS localities based on the Institute of Medicine's three-tiered recommendation. Many rural areas would see substantial decreases in their corresponding GAF and GPCI values as higher cost counties are removed from current “rest of state” payment areas. Conversely, many urban areas, especially those areas that are currently designated as “rest of state” but reside within higher cost MSAs, would experience increases in their applicable GPCIs and GAFs.
The localities used to calculate the GPCIs have been a subject of substantial discussion and debate since the implementation of the PFS. The intensity of those discussions has increased since the last comprehensive update to the locality structure in 1997. Physicians and other suppliers in areas such as Santa Cruz County, California and Prince William County, Virginia have expressed concern that the current locality structure does not appropriately capture economic and demographic shifts that have taken place since the last PFS locality update. On the other hand, rural practitioners have argued that revisions to the current PFS payment localities will reduce their payments and exacerbate the problems of attracting physicians and other practitioners to rural areas. In the past, we have also heard concerns from representatives of some statewide localities regarding the potential implications of adopting an alternative locality structure that would change their current statewide payment area (74 FR 33536).
The Institute of Medicine stated in its Phase I report regarding its locality recommendation that, “While the payment areas would stay the same for the HWI (hospital wage index), implementing this recommendation would mean that the GPCI payment areas would expand from 89 to 441 areas, which would be a significant change. The impact of the change in payment areas will be assessed in the Phase II report.” (“
• The effect of the adjustment factors on the level and distribution of the health care workforce and resources, including—
++ Recruitment and retention taking into account mobility between urban and rural areas;
++ Ability for hospitals and other facilities to maintain an adequate and skilled workforce;
++ Patient access to providers and needed medical technologies;
++ Effect of adjustment factors on population health and quality of care; and
++ Effect of adjustment factors on the ability of providers to furnish efficient, high value care.
To fully assess the broader public policy implications associated with the Institute of Medicine's locality recommendation, we must first fully assess and analyze the recommendations contained in the Institute of Medicine's Phase II report. Accordingly, we believe that it would be premature to make any statements about potential changes we would consider making to the PFS localities at this time. Any changes to PFS fee schedule areas would be made through future notice and comment rulemaking.
In the event that we develop a specific proposal for changing the locality configuration during future rulemaking, we would provide detailed analysis on the impact of the changes for physicians in each county. We would also provide opportunities for public input (for example, Town Hall meetings or Open Door Forums), as well as opportunities for public comments afforded by the rulemaking process.
While we did not propose to change the current locality configuration for CY 2013, we requested public comments regarding the Institute of Medicine's recommended three-tiered PFS payment locality definition. In addition, as stated above we, made our technical analyses of the Institute of Medicine locality recommendations, specific to the Phase I report, available on the CMS Web site at
The following is a summary of the comments we received regarding the Institute of Medicine's recommended three-tiered PFS payment locality definition.
A few commenters supported the Institute of Medicine's recommendation to move toward an MSA-based locality configuration and urged us to make updating the PFS locality configuration a priority in CY 2013. Commenters supporting an MSA-based locality configuration contend that significant economic and demographic shifts have occurred since the last reconfiguration, making the current locality assignments outdated. One state medical association expressed disappointment that we did not propose an MSA-based locality structure for CY 2013. The commenter urged us “to adopt a transition plan to update the PFS localities” and stressed that the “transition plan must take into account the negative impact on physicians practicing in rural areas and work to mitigate the reductions in these regions.”
(B)
The Institute of Medicine recommends altering the data used to calculate the employee wage index. Specifically, Institute of Medicine recommends using wage data for workers in the healthcare industry rather than wage data for workers across all-industries. Although all-industry wage data has the largest sample size, the Institute of Medicine “* * * is concerned that the [all-industry] sample does not represent physician offices.” BLS OES occupation wage data by MSA, however, are not publicly available for the healthcare industry. Using healthcare-industry wages would require the use of confidential BLS OES data. While CMS could potentially secure access to the confidential BLS OES data, the general public may not be able to. Although the Institute of Medicine recommends that CMS secure an agreement with BLS to use the confidential wage data, the current employee wage index relies on publicly-available all-industry wage data.
In the CY 2013 proposed rule we requested comments on the use of confidential employee wage index data rather than the publicly available all-industry wage data. However, we did not receive specific comments as to whether we should pursue the acquisition of confidential employee wage index data (as a replacement for the publically available all-industry wage data) for purposes of determining the employee wage index component of the PE GPCI.
Regardless of whether healthcare-industry or all-industry wage data is used, the Institute of Medicine recommends following the current approach adopted by CMS in CY 2012 for calculating the employee wage index. This approach constructs the employee wage index as a weighted average of occupation wages for the full-range of occupations employed in physicians' offices, where the weights are equal to the fixed national weight based on the hours of each occupation employed in physicians' offices nationwide. We adopted this approach for calculating the GPCI employee wage index in the CY 2012 PFS final rule with comment period (76 FR 73088).
Proxies should continue to be used to measure geographic variation in the physician work adjustment, but CMS should determine whether the seven proxies currently in use should be modified (Geographic Adjustment in Medicare Payment, Phase I: Improving Accuracy page 5-36) and; Recommendation 5-3: CMS should consider an alternative method for setting the percentage of the work adjustment based on a systematic empirical process. (Geographic Adjustment in Medicare Payment, Phase I: Improving Accuracy pages 5-36 thru 5-37)
The Institute of Medicine recommends replacing the current work GPCI methodology with a regression-based approach. We currently use three steps to calculate the work GPCI. These steps include:
(1) Selecting the proxy occupations and calculating an occupation-specific index for each proxy;
(2) Assigning weights to each proxy-occupation index based on each occupation's share of total national wages to create an aggregate proxy-occupation index; and
(3) Adjusting the aggregate proxy-occupation index by a physician inclusion factor to calculate the final work GPCI.
By using this approach, the current methodology reduces the circularity problem that occurs when work GPCI values are based on direct measurements of physician earnings. Because physician earnings are made up of both wages and a return on investment from ownership of the physician practice, calculating the work GPCI using physician earnings information would assign areas where physician practices are more profitable higher work GPCI values. Although the Institute of Medicine recommends that we continue to use proxy occupations in the work GPCI methodology, its regression-based approach alters each of the three steps described above.
To modify the first step, the Institute of Medicine recommends that we empirically evaluate the validity of seven proxy occupations we currently use. The current proxy occupations in the work GPCI are intended to represent highly educated, professional employee categories. Although the Institute of Medicine recommends re-evaluating the proxy occupations used in the work GPCI, it does not define specific criteria to use for this purpose.
To modify the second step, the Institute of Medicine recommends using a regression-based approach to weight the selected proxy occupation indices based on their correlation with physician earnings. This Institute of Medicine proposal would replace the current approach where occupations are weighted by the size of their share of total national wages. Such an approach presumes that wages for proxy occupations are not related to physician profits.
Finally, the Institute of Medicine proposes an empirically-based approach to determine the inclusion factor for work. The inclusion factor for work refers to section 1848(e)(1)(A)(iii) of the Act requiring that the work GPCI reflect only 25 percent of the difference between the relative value of physicians' work effort in each locality and the national average of such work effort. Therefore, under current law, only one quarter of the measured regional variation in physician wages is incorporated into the work GPCI. The Institute of Medicine recommends calculating an inclusion factor based on the predicted values of the regression described above. Under the Institute of Medicine's approach, the inclusion factor is larger when the proxy occupations have a higher correlation with physicians' earnings and smaller when the proxy occupations have a lower correlation with physicians' earnings. We note that using such an empirical approach to weight the proxy occupation indices and to estimate the inclusion factor requires the identification of a viable source of physician wage information in addition to the wage information of proxy occupations to accurately measure regional variation in physician wages.
We requested comments on the Institute of Medicine's recommendations to revise the work GPCI methodology.
The following is a summary of the comments we received regarding the Institute of Medicine's recommendations to revise the work GPCI methodology.
(D)
The Institute of Medicine recommends the development of a new source of data to determine the variation in the price of commercial office rent per square foot. However, the Institute of Medicine does not explicitly recommend where the data should come from or how it should be collected. Before coming to this recommendation, the Institute of Medicine identified and evaluated several public and commercially available sources of data to determine whether an accurate alternative is available to replace the residential rent data currently used as a proxy to measure regional variation in physicians' cost to rent office space in the PE GPCI; these sources include rental data from the U.S. Department of Housing and Urban Development, American Housing Survey, General Services Administration, Basic Allowance for Housing (U.S. Department of Defense), U.S. Postal Service, MGMA (MGMA), and REIS, Inc. The Institute of Medicine concluded that these sources had substantial limitations, including lack of representativeness of the market in which physicians rent space, small sample size, low response rates, and sample biases. Although we agree that a suitable source for commercial office rent data would be preferable to the use of residential rent data in our PE office rent methodology, we have still been unable to identify an adequate commercial rent source that sufficiently covers rural and urban areas.
We will continue to evaluate possible commercial rent data sources for potential use in the office rent calculation. To that end, we encouraged public commenters to notify us of any publicly available commercial rent data sources, with adequate data representation of urban and rural areas that could potentially be used in the calculation of the office rent component of PE. However, we did not receive comments on specific data sources for commercial rent for purposes of determining the office rent component of the PE GPCI.
We appreciate the comments received on the Institute of Medicine's recommendations regarding the PFS locality structure and the data sources and methodology used to calculate GPCI values. We will consider the commenters' suggestions as we continue to evaluate options for reconfiguring the PFS locality structure and as we implement the seventh update to the GPCIs scheduled for CY 2014. We also look forward to conducting a full review and assessment of the Institute of Medicine's additional PFS locality recommendations (as discussed in their Phase II report), as well as the MedPAC study on the physician work GPCI under the PFS that is required by section 3004 of the MCTRJCA.
Prior to January 1, 1999, Medicare coverage for services delivered via a telecommunications system was limited to services that did not require a face-to-face encounter under the traditional model of medical care. Examples of these services included interpretation of an x-ray, or electrocardiogram, or electroencephalogram tracing, and cardiac pacemaker analysis.
Section 4206 of the BBA provided for coverage of, and payment for, consultation services delivered via a telecommunications system to Medicare beneficiaries residing in rural health professional shortage areas (HPSAs) as defined by the Public Health Service Act. Additionally, the BBA required that a Medicare practitioner (telepresenter) be with the patient at the time of a teleconsultation. Further, the BBA specified that payment for a teleconsultation had to be shared between the consulting practitioner and the referring practitioner and could not exceed the fee schedule payment which would have been made to the consultant for the service furnished. The BBA prohibited payment for any telephone line charges or facility fees associated with the teleconsultation. We implemented this provision in the CY 1999 PFS final rule with comment period (63 FR 58814).
Effective October 1, 2001, section 223 of the Medicare, Medicaid and SCHIP Benefits Improvement Protection Act of 2000 (Pub. L. 106-554) (BIPA) added a new section, 1834(m), to the Act which significantly expanded Medicare telehealth services. Section 1834(m)(4)(F)(i) of the Act defines
As specified in regulations at § 410.78(b), we generally require that a telehealth service be furnished via an interactive telecommunications system. Under § 410.78(a)(3), an interactive telecommunications system is defined as multimedia communications equipment that includes, at a minimum, audio and video equipment permitting two-way, real time interactive communication between the patient and the practitioner at the distant site. Telephones, facsimile machines, and electronic mail systems do not meet the definition of an interactive telecommunications system. An interactive telecommunications system is generally required as a condition of payment; however, section 1834(m)(1) of the Act does allow the use of asynchronous “store-and-forward” technology in delivering these services when the originating site is a federal telemedicine demonstration program in Alaska or Hawaii. As specified in regulations at § 410.78(a)(1), store and forward means the asynchronous transmission of medical information from an originating site to be reviewed at a later time by the practitioner at the distant site.
Medicare telehealth services may be furnished to an eligible telehealth individual notwithstanding the fact that the individual practitioner furnishing the telehealth service is not at the same location as the beneficiary. An eligible telehealth individual means an individual enrolled under Part B who receives a telehealth service furnished at an originating site. Under the BIPA, originating sites were limited under section 1834(m)(3)(C) of the Act to specified medical facilities located in specific geographic areas. The initial list of telehealth originating sites included the office of a practitioner, a critical access hospital (CAH), a rural health clinic (RHC), a federally qualified health center (FQHC) and a hospital (as defined in Section 1861(e) of the Act). More recently, section 149 of the Medicare Improvements for Patients and Providers Act of 2008 (Pub. L. 110-275) (MIPPA) expanded the list of telehealth originating sites to include hospital-based renal dialysis centers, skilled nursing facilities (SNFs), and community mental health centers (CMHCs). In order to serve as a telehealth originating site, these sites must be located in an area designated as a rural health professional shortage area (HPSA), in a county that is not in a metropolitan statistical area (MSA), or must be an entity that participates in a federal telemedicine demonstration project that has been approved by (or receives funding from) the Secretary of Health and Human Services as of December 31, 2000. Finally, section 1834(m) of the Act does not require the eligible telehealth individual to be presented by a practitioner at the originating site.
As noted previously, Medicare telehealth services can only be furnished to an eligible telehealth beneficiary in an originating site. An originating site is defined as one of the specified sites where an eligible telehealth individual is located at the time the service is being furnished via a telecommunications system. In general, originating sites must be located in a rural HPSA or in a county outside of an MSA. The originating sites authorized by the statute are as follows:
• Offices of a physician or practitioner;
• Hospitals;
• CAHs;
• RHCs;
• FQHCs;
• Hospital-Based or Critical Access Hospital-Based Renal Dialysis Centers (including Satellites);
• SNFs;
• CMHCs.
• Initial inpatient consultations;
• Follow-up inpatient consultations;
• Office or other outpatient visits;
• Individual psychotherapy;
• Pharmacologic management;
• Psychiatric diagnostic interview examination;
• End-stage renal disease (ESRD) related services;
• Individual and group medical nutrition therapy (MNT);
• Neurobehavioral status exam;
• Individual and group health and behavior assessment and intervention (HBAI);
• Subsequent hospital care;
• Subsequent nursing facility care;
• Individual and group kidney disease education (KDE);
• Individual and group diabetes self-management training (DSMT); and
• Smoking cessation services.
In general, the practitioner at the distant site may be any of the following, provided that the practitioner is licensed under state law to furnish the service via a telecommunications system:
• Physician;
• Physician assistant (PA);
• Nurse practitioner (NP);
• Clinical nurse specialist (CNS);
• Nurse-midwife;
• Clinical psychologist;
• Clinical social worker;
• Registered dietitian or nutrition professional.
Practitioners furnishing Medicare telehealth services submit claims for telehealth services to the Medicare contractors that process claims for the service area where their distant site is located. Section 1834(m)(2)(A) of the Act requires that a practitioner who furnishes a telehealth service to an eligible telehealth individual be paid an amount equal to the amount that the practitioner would have been paid if the service had been furnished without the use of a telecommunications system. Distant site practitioners must submit the appropriate HCPCS procedure code for a covered professional telehealth service, appended with the -GT (Via interactive audio and video telecommunications system) or -GQ (Via asynchronous telecommunications system) modifier. By reporting the -GT or -GQ modifier with a covered telehealth procedure code, the distant site practitioner certifies that the beneficiary was present at a telehealth originating site when the telehealth service was furnished. The usual Medicare deductible and coinsurance policies apply to the telehealth services reported by distant site practitioners.
Section 1834(m)(2)(B) of the Act provides for payment of a facility fee to the originating site. To be paid the originating site facility fee, the provider or supplier where the eligible telehealth individual is located must submit a claim with HCPCS code Q3014 (Telehealth originating site facility fee), and the provider or supplier is paid according to the applicable payment methodology for that facility or location. The usual Medicare deductible and coinsurance policies apply to HCPCS code Q3014. By submitting HCPCS code Q3014, the originating site certifies that it is located in either a rural HPSA or non-MSA county or is an entity that participates in a federal telemedicine demonstration project that has been approved by (or receives funding from) the Secretary of Health and Human Services as of December 31, 2000 as specified in section 1834(m)(4)(C)(i)(III) of the Act.
As previously described, certain professional services that are commonly furnished remotely using telecommunications technology, but that do not require the patient to be present in-person with the practitioner when they are furnished, are covered and paid in the same way as services delivered without the use of telecommunications technology when the practitioner is in-person at the medical facility furnishing care to the patient. Such services typically involve circumstances where a practitioner is able to visualize some aspect of the patient's condition without the patient being present and without the interposition of a third person's judgment. Visualization by the practitioner can be possible by means of x-rays, electrocardiogram or electroencephalogram tracings, tissue samples, etc. For example, the interpretation by a physician of an actual electrocardiogram or electroencephalogram tracing that has been transmitted via telephone (that is, electronically, rather than by means of a verbal description) is a covered physician's service. These remote services are not Medicare telehealth services as defined under section 1834(m) of the Act. Rather, these remote services that utilize telecommunications technology are considered physicians' services in the same way as services that are furnished in-person without the use of telecommunications technology; they are paid under the same conditions as in-person physicians' services (with no requirements regarding permissible originating sites), and should be reported in the same way (that is, without the -GT or -GQ modifier appended).
As noted previously, in the December 31, 2002
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Some examples of clinical benefit include the following:
• Ability to diagnose a medical condition in a patient population without access to clinically appropriate in person diagnostic services.
• Treatment option for a patient population without access to clinically appropriate in-person treatment options.
• Reduced rate of complications.
• Decreased rate of subsequent diagnostic or therapeutic interventions
• Decreased number of future hospitalizations or physician visits.
• More rapid beneficial resolution of the disease process treatment.
• Decreased pain, bleeding, or other quantifiable symptom.
• Reduced recovery time.
Since establishing the process to add or remove services from the list of approved telehealth services, we have added the following to the list of Medicare telehealth services: individual and group HBAI services; psychiatric diagnostic interview examination; ESRD services with 2 to 3 visits per month and 4 or more visits per month (although we require at least 1 visit a month to be furnished in-person by a physician, CNS, NP, or PA in order to examine the vascular access site); individual and group MNT; neurobehavioral status exam; initial and follow-up inpatient telehealth consultations for beneficiaries in hospitals and skilled nursing facilities (SNFs); subsequent hospital care (with the limitation of one telehealth visit every 3 days); subsequent nursing facility care (with the limitation of one telehealth visit every 30 days); individual and group KDE; and individual and group DSMT (with a minimum of 1 hour of in-person instruction to ensure effective injection training), and smoking cessation services.
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 2012 will be considered for the CY 2014 proposed rule. Each request for adding a service to the list of Medicare telehealth services must include any supporting documentation the requester wishes us to consider as we review the request. Because we use the annual PFS rulemaking process as a vehicle for making changes to the list of Medicare telehealth services, requestors should be advised that any information submitted is subject to public disclosure for this purpose. For more information on submitting a request for an addition to the list of Medicare telehealth services, including where to mail these requests, we refer readers to the CMS Web site at
We received a request in CY 2011 to add alcohol and/or substance abuse and brief intervention services as Medicare telehealth services effective for CY 2013. The following presents a discussion of this request, and our proposals for additions to the CY 2013 telehealth list.
The American Telemedicine Association submitted a request to add alcohol and/or substance abuse and brief intervention services, reported by CPT codes 99408 (Alcohol and/or substance (other than tobacco) abuse structured screening (for example, AUDIT, DAST), and brief intervention (SBI) services; 15 to 30 minutes) and 99409 (Alcohol and/or substance (other than tobacco) abuse structured screening (for example, AUDIT, DAST), and brief intervention (SBI) services; greater than 30 minutes) to the list of approved telehealth services for CY 2013 on a category 1 basis.
We note that we assigned a status indicator of “N” (Noncovered) to CPT codes 99408 and 99409 as explained in the CY 2008 PFS final rule with comment period (72 FR 66371). At the time, we stated that because Medicare only provides payment for certain screening services with an explicit benefit category, and these CPT codes incorporate screening services along with intervention services, we believed that these codes were ineligible for payment under the PFS. We continue to believe that these codes are ineligible for payment under PFS and, additionally, under the telehealth benefit. We do not believe it would be appropriate to make payment for claims using these CPT codes for the services furnished via telehealth, but not when furnished in person. Because CPT codes 99408 and 99409 are currently assigned a noncovered status indicator, and because we continue to believe this assignment is appropriate, we did not propose adding these CPT codes to the list of Medicare Telehealth Services for CY 2013.
However, we created two parallel G-codes for 2008 that allow for appropriate Medicare reporting and payment for alcohol and substance abuse assessment and intervention services that are not furnished as screening services, but that are furnished in the context of the diagnosis or treatment of illness or injury. The codes are HCPCS code G0396 (Alcohol and/or substance (other than tobacco) abuse structured assessment (for example, AUDIT, DAST) and brief intervention, 15 to 30 minutes) and HCPCS code G0397, (Alcohol and/or substance (other than tobacco) abuse structured assessment (for example, AUDIT, DAST) and intervention greater than 30 minutes). Since these codes are used to report comparable alcohol and substance abuse services under certain conditions, we believed that it would be appropriate to consider the ATA's request as it applies to these services when appropriately reported by the G-codes. The ATA asked that CMS consider this request as a category 1 addition based on the similarities between these services and CPT codes 99406 (Smoking and tobacco use cessation counseling visit; intermediate, greater than 3 minutes up to 10 minutes) and 99407 (Smoking and tobacco use cessation counseling visit; intensive, greater than 10 minutes). We agree that the interaction between a practitioner and a beneficiary receiving alcohol and substance abuse assessment and intervention services is similar to their interaction in smoking cessation services. We also believe that the interaction between a practitioner and a beneficiary receiving alcohol and substance abuse assessment and intervention services is similar to the assessment and intervention elements of CPT code 96152 (health and behavior intervention, each 15 minutes, face-to-face; individual), which also is currently on the telehealth list.
Therefore, we proposed to add HCPCS codes G0396 and G0397 to the list of telehealth services for CY 2013 on a category 1 basis. Consistent with this proposal, we also proposed to revise our regulations at § 410.78(b) and § 414.65(a)(1) to include alcohol and substance abuse assessment and intervention services as Medicare telehealth services.
Under our existing policy, we add services to the telehealth list on a category 1 basis when we determine that they are similar to services on the existing telehealth list with respect to the roles of, and interactions among, the beneficiary, physician (or other practitioner) at the distant site and, if necessary, the telepresenter. As we stated in the CY 2012 proposed rule (76 FR 42826), we believe that the category 1 criteria not only streamline our review process for publically requested services that fall into this category, the criteria also expedite our ability to identify codes for the telehealth list that resemble those services already on this list.
During CY 2012, CMS added coverage for several preventive services through the national coverage determination (NCD) process as authorized by section 1861(ddd) of the Act. These services add to Medicare's existing portfolio of preventive services that are now
• Screening and behavioral counseling interventions in primary care to reduce alcohol misuse, reported by HCPCS codes G0442 (Annual alcohol misuse screening, 15 minutes) and G0443 (Brief face-to-face behavioral counseling for alcohol misuse, 15 minutes).
• Screening for depression in adults, reported by HCPCS code G0444 (Annual Depression Screening, 15 minutes).
• Screening for sexually transmitted infections (STIs) and high-intensity behavioral counseling (HIBC) to prevent STIs, reported by HCPCS code G0445 (High-intensity behavioral counseling to prevent sexually transmitted infections, face-to-face, individual, includes: education, skills training, and guidance on how to change sexual behavior, performed semi-annually, 30 minutes).
• Intensive behavioral therapy for cardiovascular disease, reported by HCPCS code G0446 (Annual, face-to-face intensive behavioral therapy for cardiovascular disease, individual, 15 minutes).
• Intensive behavioral therapy for obesity, reported by HCPCS code G0447 (Face-to-face behavioral counseling for obesity, 15 minutes).
We believe that the interactions between practitioners and beneficiaries receiving these services are similar to individual KDE services reported by HCPCS code G0420 (Face-to-face educational services related to the care of chronic kidney disease; individual, per session, per one hour), individual MNT reported by HCPCS code G0270 (Medical nutrition therapy; reassessment and subsequent intervention(s) following second referral in the same year for change in diagnosis, medical condition or treatment regimen (including additional hours needed for renal disease), individual, face-to-face with the patient, each 15 minutes); CPT code 97802 (Medical nutrition therapy; initial assessment and intervention, individual, face-to-face with the patient, each 15 minutes); and CPT code 97803 (Medical nutrition therapy; re-assessment and intervention, individual, face-to-face with the patient, each 15 minutes), and HBAI reported by CPT code 96150 (Health and behavior assessment (for example, health-focused clinical interview, behavioral observations, psychophysiological monitoring, health-oriented questionnaires), each 15 minutes face-to-face with the patient; initial assessment); CPT code 96151 (Health and behavior assessment (for example, health-focused clinical interview, behavioral observations, psychophysiological monitoring, health-oriented questionnaires), each 15 minutes face-to-face with the patient re-assessment); CPT code 96152 (Health and behavior intervention, each 15 minutes, face-to-face; Individual); CPT code 96153 (Health and behavior intervention, each 15 minutes, face-to-face; Group (2 or more patients)); CPT code 96154 (Health and behavior intervention, each 15 minutes, face-to-face; family (with the patient present)), all services that are currently on the telehealth list.
Therefore, we proposed to add HCPCS codes G0442, G0443, G0444, G0445, G0446, and G0447 to the list of telehealth services for CY 2013 on a category 1 basis. We note that all coverage guidelines specific to the services would continue to apply when these services are furnished via telehealth. For example, when the national coverage determination requires that the service be furnished to beneficiaries in a primary care setting, the qualifying originating telehealth site must also qualify as a primary care setting. Similarly, when the national coverage determination requires that the service be furnished by a primary care practitioner, the qualifying primary distant site practitioner must also qualify as primary care practitioner. For more detailed information on coverage requirements for these services, we refer readers to the Medicare National Coverage Determinations Manual, Pub. 100-03, Chapter 1, Section 210, available at
After consideration of the public comments received, we are finalizing our CY 2013 proposal to add HCPCS codes G0396, G0397, G0442, G0443, G0444, G0445, G0446, and G0447 to the list of telehealth services for CY 2013 on a category 1 basis. We note that all coverage guidelines specific to the services will continue to apply when these services are furnished via telehealth. For example, when the national coverage determination requires that the service be furnished to beneficiaries in a primary care setting, the telehealth originating site must also qualify as a primary care setting under the terms of the national coverage determination. Similarly, when the national coverage determination requires that the service be furnished by a primary care practitioner, the distant site practitioner who furnishes the telehealth service must also qualify as primary care practitioner under the terms of the national coverage
In the CY 2012 PFS final rule with comment period (76 FR 73103), we finalized our proposal to change the code descriptors for initial inpatient telehealth consultation G-codes to reflect telehealth consultations furnished to emergency department patients in addition to inpatient telehealth consultations effective January 1, 2012. However, we did not amend the description of the services within the regulation at § 414.65(a)(1)(i). Therefore, we proposed to make a technical revision to our regulation at § 414.65(a)(1)(i) to reflect telehealth consultations furnished to emergency department patients in addition to hospital and SNF inpatients.
We received no comments regarding our proposal to make this technical revision. Therefore, we are finalizing our proposal to make a technical revision to our regulation at § 414.65(a)(1)(i) to reflect telehealth consultations furnished to emergency department patients in addition to hospital and SNF inpatients.
Section 1834(m)(2)(B) 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 2013 is 0.8 percent. Therefore, for CY 2013, the payment amount for HCPCS code Q3014 (Telehealth originating site facility fee) is 80 percent of the lesser of the actual charge or $24.43. The Medicare telehealth originating site facility fee and MEI increase by the applicable time period is shown in Table 18.
Section 542(c) of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554) provided payment to independent laboratories furnishing the technical component (TC) of physician pathology services to fee-for-service Medicare beneficiaries who are inpatients or outpatients of a covered hospital for a 2-year period beginning on January 1, 2000. This section was subsequently amended by section 732 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173), section 104 of division B of the Tax Relief and Health Care Act of 2006 (MIEA-TRHCA) (Pub. L. 109-432), section 104 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 (MMSEA) (Pub. L. 110-173), section 136 of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275), section 3104 of the Affordable Care Act (Pub. L. 111-148), section 105 of the Medicare and Medicaid Extenders Act of 2010 (MMEA) (Pub. L. 111-309), section 305 of the Temporary Payroll Tax Cut Continuation Act of 2011 (Pub. L. 112-78) and section 3006 of the Middle Class Tax Relief and Job Creation Act of 2012 (Pub. L. 112-96) to continue payment to independent laboratories furnishing the technical component (TC) of physician pathology services to fee-for-service Medicare beneficiaries who are inpatients or outpatients of a covered hospital for various time periods. As discussed in detail below, Congress most recently acted to continue this payment through June 30, 2012. The TC of physician pathology services refers to the preparation of the slide involving tissue or cells that a pathologist interprets. The professional component (PC) of physician pathology services refers to the pathologist's interpretation of the slide.
When the hospital pathologist furnishes the PC service for a hospital patient, the PC service is separately billable by the pathologist. When an independent laboratory's pathologist furnishes the PC service, the PC service is usually billed with the TC service as a combined or global service.
Historically, any independent laboratory could bill the Medicare contractor under the PFS for the TC of physician pathology services for hospital patients even though the payment for the costs of furnishing the pathology service (but not its interpretation) was already included in the bundled inpatient stay payment to the hospital. In the CY 2000 PFS final rule with comment period (64 FR 59408 and 59409), we stated that this policy has contributed to the Medicare program paying twice for the TC service: (1) To the hospital, through the inpatient prospective payment rate, when the patient is an inpatient; and (2) To the independent laboratory that bills the Medicare contractor, instead of the hospital, for the TC service. While the policy also permits the independent laboratory to bill for the TC of physician pathology services for hospital outpatients, in this case, there generally would not be duplicate payment because we would expect the hospital to not also bill for the pathology service, which would be paid separately to the hospital only if the hospital were to specifically bill for it. We further indicated that we would implement a policy to pay only the hospital for the TC of physician pathology services furnished to its inpatients.
Therefore, in the CY 2000 PFS final rule with comment period, we revised § 415.130(c) to state that for physician pathology services furnished on or after January 1, 2001 by an independent laboratory, payment is made only to the hospital for the TC of physician pathology services furnished to a hospital inpatient. Ordinarily, the provisions in the PFS final rule with comment period are implemented in the following year. However, the change to § 415.130 was delayed 1-year (until January 1, 2001), at the request of the industry, to allow independent laboratories and hospitals sufficient time to negotiate arrangements.
Full implementation of § 415.130 was further delayed by section 542 of the
Section 136 of the MIPPA extended the payment through CY 2009. Section 3104 of the Affordable Care Act amended the prior legislation to extend the payment through CY 2010. Section 105 of the MMEA extended the payment through CY 2011. Subsequent to the publication of the CY 2012 PFS final rule with comment period, section 305 of the Temporary Payroll Tax Cut Continuation Act of 2011 extended the payment through February 29, 2012 and section 3006 of the Middle Class Tax Relief and Job Creation Act of 2012 extended the payment through June 30, 2012.
In the CY 2012 PFS final rule with comment period, we finalized our policy that an independent laboratory may not bill the Medicare contractor for the TC of physician pathology services furnished after December 31, 2011, to a hospital inpatient or outpatient (76 FR 73278 through 73279, 73473). As discussed above, subsequent to publication of that final rule with comment period, Congress acted to continue payment to independent laboratories through June 30, 2012. Therefore, the policy that we finalized in the CY 2012 PFS final rule with comment period was superseded by statute for 6 months. To be consistent with the statutory changes and our current policy, we proposed conforming changes to § 415.130(d) such that we continued payment under the PFS to independent laboratories furnishing the TC of physician pathology services to fee-for-service Medicare beneficiaries who are inpatients or outpatients of a covered hospital on or before June 30, 2012 (77 FR 44763). Independent laboratories may not bill the Medicare contractor for the TC of physician pathology services furnished after June 30, 2012, to a hospital inpatient or outpatient. We received no public comments on the proposed conforming changes so we are finalizing the revisions to § 415.130(d) without modification.
Section 1833(g) of the Act applies annual, per beneficiary, limitations (therapy caps) on expenses considered incurred for outpatient therapy services under Medicare Part B. There is one therapy cap for outpatient occupational therapy (OT) services and another separate therapy cap for physical therapy (PT) and speech-language pathology (SLP) services combined. Although therapy services furnished in an outpatient hospital setting have been exempt from the application of the therapy caps, section 3005(b) of the MCTRJCA amended section 1833(g) of the Act to include therapy services furnished in an outpatient hospital setting in the therapy caps. This provision is in effect from October 1, 2012 through December 31, 2012.
The therapy cap amounts are updated each year based on the Medicare Economic Index (MEI). The annual change in the therapy cap amount for CY 2013 is computed by multiplying the cap amount for CY 2012 by the MEI for CY 2013 and rounding to the nearest $10. This amount is added to the CY 2012 cap, which is $1,880, to obtain the CY 2013 cap amount. The MEI for CY 2013 is 0.8 percent, resulting in a therapy cap amount for CY 2013 of $1,900.
An exceptions process to the therapy caps has been in effect since January 1, 2006. Since originally authorized by section 5107 of the Deficit Reduction Act (DRA), which amended section 1833(g)(5) of the Act, the exceptions process for the therapy caps has been extended through subsequent legislation (MIEA-TRHCA, MMSEA, MIPPA, the Affordable Care Act, MMEA, and TPTCCA). Last amended by section 3005 of the MCTRJCA, the Agency's authority to provide for an exception process to therapy caps expires on December 31, 2012. To request an exception to the therapy caps, therapy suppliers and providers use the KX modifier on claims for services after the beneficiary's services for the year have exceeded the therapy cap. Use of the KX modifier indicates that the services are reasonable and necessary and that there is documentation of medical necessity in the beneficiary's medical record.
Section 3005 of the MCTRJCA also required two additional changes to Medicare policies for outpatient therapy services. Effective for services furnished from October 1 through December 31, 2012, after a beneficiary's incurred expenses for PT and SLP services combined exceed the threshold of $3,700 during the calendar year, section 1833(g)(5)(C) of the Act, as amended by 3005(a)(5) of the MCTRJCA, requires that we apply a manual medical review process as part of the therapy caps exceptions process. Similar to the therapy caps, there is a separate $3,700 threshold for OT services. All requests for exceptions to the therapy caps for services after the $3,700 threshold is reached are subject to manual medical review. The manual medical review process is being phased in over a 3-month period. Unlike the therapy caps, exceptions are not automatically granted for therapy services above the $3,700 threshold based upon the therapist's determination that they services are reasonable and necessary. To request an exception to the therapy caps for services after the threshold is reached, the provider sends a request for an exception to the Medicare contractor. The contractor then uses the coverage and payment requirements contained within Pub. 100-02, Medicare Benefit Policy Manual, section 220 and applicable medical review guidelines, and any relevant local coverage determinations to make decisions as to whether an exception is approved for the services. For more information on the manual medical review process, go to
Section 3005(g) of the MCTRJCA requires CMS to implement, beginning on January 1, 2013, “* * * a claims-based data collection strategy that is designed to assist in reforming the Medicare payment system for outpatient therapy services subject to the limitations of section 1833(g) of the Act. Such strategy shall be designed to provide for the collection of data on patient function during the course of therapy services in order to better understand patient condition and outcomes.”
In 2011, more than 8 million Medicare beneficiaries received outpatient therapy services, including
Section 4541 of the Balanced Budget Act of 1997 (Pub. L. 105-33) (BBA) amended section 1833(g) of the Act to impose financial limitations on outpatient therapy services (the “therapy caps” discussed above) in an attempt to limit Medicare expenditures for therapy services. Prior to the BBA amendment, these caps had applied to services furnished by therapists in private practice, but the BBA expanded the caps effective January 1, 1999, to include all outpatient therapy services except those furnished in hospital outpatient departments. Since that time, the Congress has amended the statute several times to impose a moratorium on the application of the caps or has required us to implement an exceptions process for the caps. The therapy caps have only been in effect without a moratorium or an exceptions process for less than 2 years. (See the discussion about the therapy cap exceptions process above.) Almost from the inception of the therapy caps, Congress and the Agency have been exploring potential alternatives to the therapy caps.
In the CY 2011 PFS final rule with comment period (75 FR 73232-73242), we adopted a MPPR of 25 percent applicable to the practice expense (PE) component of the second and subsequent therapy services furnished to a beneficiary when more than one of these services is furnished in a single session. This reduction applies to nearly 40 therapy service codes. (For a list of therapy service codes to which this policy applies, see Addendum H.) The Physician Payment and Therapy Relief Act of 2010 (PPATRA) subsequently revised the reduction to 20 percent for the second and subsequent therapy services furnished to a beneficiary in an office setting, leaving the 25 percent reduction in place for therapy services furnished to a beneficiary in institutional settings. We adopted this MPPR as part of our directive under section 1848(c)(2)(K) of the statute, as added by section 3134(a) of the Affordable Care Act, to identify and evaluate potentially misvalued codes. By taking into consideration the expected efficiencies in direct PE resources that occur when services are furnished together, this policy results in more appropriate payment for therapy services. Although we did not adopt this MPPR policy specifically as an alternative to the therapy caps, paying more appropriately for combinations of therapy services that are commonly furnished in a single session reduces the number of beneficiaries impacted by the therapy caps in a given year. For more details on the MPPR policy, see section II.B.4. of this final rule with comment period.
The therapy cap is a uniform dollar amount that sets a limit on the total value of services furnished unrelated to the specific services furnished or the beneficiary's condition or needs. A uniform cap does not deter unnecessary care or encourage efficient practice for low complexity beneficiaries. In fact, it may even encourage the provision of services up to the level of the cap. Conversely, a uniform cap without an exceptions process restricts necessary and appropriate care for certain high complexity beneficiaries. Recognizing these limitations in a uniform dollar value cap, we have been studying therapy practice patterns and exploring ways to refine payment for these services as an alternative to therapy caps.
On November 9, 2004, the Secretary delivered the Report to Congress, as required by the BBA as amended by the BBRA, “Medicare Financial Limitations on Outpatient Therapy Services.” This report included two utilization analyses. Although these analyses provided details on utilization, neither specifically identified ways to improve therapy payment. In the report, we indicated that further study was underway to assess alternatives to the therapy caps. The report and the analyses are available on the CMS Web site at
Since 2004, we have periodically updated the utilization analyses and posted other reports on the CMS Web site. These reports highlighted the expected effects of limiting services in various ways and presented plans to collect data about beneficiary condition, including functional limitations, using available tools. Through these efforts, we have made progress in identifying the types of outpatient therapy services that are billed to Medicare, the demographics of the beneficiaries who utilize these services, the HCPCS codes used to bill the services, the allowed and paid amounts of the services, the providers of these services, the therapy utilization patterns among states in which the services are furnished, and the type of practitioner furnishing services.
From these and other analyses in our ongoing research effort, we have concluded that without the ability to define the services that are typically needed to address specific clinical cohorts of beneficiaries (those with similar risk-adjusted conditions), it is not possible to develop payment policies that encourage the delivery of reasonable and necessary services while discouraging the provision of services that do not produce a clinical benefit. Although there is widespread agreement that beneficiary condition and functional limitations are critical to developing and evaluating an alternative payment system for therapy services, a system for collecting such data uniformly does not exist. Currently diagnosis information is available from Medicare claims. However, we believe that the diagnosis on the claim is a poor predictor for the type and duration of therapy services required. Additional work is needed to develop an appropriate system for classifying clinical cohorts to determine therapy needs.
A 5-year CMS project titled “Development of Outpatient Therapy Payment Alternatives” (DOTPA) is expected to provide some of this information. The purpose of the DOTPA project is to identify a set of measures that we could collect routinely and reliably to support the development of payment alternatives to the therapy caps. Specifically, the measures being collected are assessed for administrative feasibility and usefulness in identifying beneficiary need for outpatient therapy services and the outcomes of those services. The data collection processes have just been completed and a final DOTPA report is expected in late CY 2013. In addition to developing alternatives to the therapy caps, the DOTPA project reflects our interest in
Section 3005(g) of MCTRJCA requires CMS to implement a claims-based data collection strategy on January 1, 2013 to gather information on beneficiary function and condition, therapy services furnished, and outcomes achieved. This information will be used in assisting us in reforming the Medicare payment system for outpatient therapy services. By collecting data on beneficiary function over an episode of therapy services, we hope to better understand the Medicare beneficiary population who uses therapy services, how their functional limitations change as a result of therapy services, and the relationship between beneficiary functional limitations and furnished therapy.
The long-term goal is to develop an improved payment system for Medicare therapy services. The desired payment system would pay appropriately and similarly for efficient and effective services furnished to beneficiaries with similar conditions and functional limitations that have potential to benefit from the services furnished. Importantly, such a system would not encourage the furnishing of medically unnecessary or excessive services. At this time, the data on Medicare beneficiaries' use and outcomes from therapy services from which to develop an improved system does not exist. This data collection effort is the first step towards collecting the data needed for this type of payment reform. Once the initial data have been collected and analyzed, we expect to identify gaps in information and determine what additional data would be needed to develop a new payment policy. Without a better understanding of the diversity of beneficiaries receiving therapy services and the variations in type and volume of treatments provided, we lack the information to develop a comprehensive strategy to map the way to an improved payment policy. While this claims-based data collection is only the first step in a long-term effort, it is an essential step.
In the CY 2013 proposed rule, we proposed to implement section 3005(g) of MCTRJCA by requiring that claims for therapy services include nonpayable G-codes and modifiers. Through the use of these codes and modifiers, we proposed to capture data on the beneficiary's functional limitations (a) At the outset of the therapy episode, (b) at specified points during treatment and (c) at discharge from the outpatient therapy episode of care. In addition, the therapist's projected goal for functional status at the end of treatment would be reported on the first claim for services and periodically throughout an episode of care.
Specifically, as proposed, G-codes would be used to identify what type of functional limitation is being reported and whether the report is on the current status, projected goal status or discharge status. Modifiers would indicate the severity/complexity of the functional limitation being tracked. The difference between the reported functional status at the start of therapy and projected goal status represents any progress the therapist anticipates the beneficiary would make during the course of treatment/episode of care. We proposed that these reporting requirements would apply to all therapy claims, including those for services above the therapy caps and those that include the KX modifier (described above).
By tracking any changes in functional limitations throughout the therapy episode of care and at discharge, we would have information about the therapy services furnished and the outcomes of such services. The ICD-9 diagnosis codes reported on the claim form would provide some information on the beneficiary's condition.
We proposed that these claims-based data collection requirements would apply to services furnished under the Medicare Part B outpatient therapy benefit and PT, OT, and SLP services under the Comprehensive Outpatient Rehabilitation Facilities (CORF) benefit. We also proposed to include therapy services furnished personally and “incident to” the services of physicians or nonphysician practitioners (NPPs). As we explained in the proposed rule, this broad applicability would include therapy services furnished in hospitals, critical access hospitals (CAHs), skilled nursing facilities (SNFs), CORFs, rehabilitation agencies, home health agencies (when the beneficiary is not under a home health plan of care), and in private offices of therapists, physicians and NPPs.
When used in this section “therapists” means all practitioners who furnish outpatient therapy services, including physical therapists, occupational therapists, and speech-language pathologists in private practice and those therapists who furnish services in the institutional settings, physicians and NPPs (including, physician assistants (PAs), nurse practitioners (NPs), clinical nurse specialists (CNSs), as applicable.) The term “functional limitation” generally encompasses both the terms “activity limitations” and “participation restrictions” as described by the International Classification of Functioning, Disability and Health (ICF). (For information on ICF, see
The CY 2013 proposal was based upon an option for claims-based data collection that was developed as part of the Short Term Alternatives for Therapy Services (STATS) project under a contract with CMS, which provided three options for alternatives to the therapy caps that could be considered in the short-term before completion of the DOTPA project. In developing options, the STATS project drew upon the analytical expertise of CMS contractors and the clinical expertise of various outpatient therapy stakeholders to consider policies and available claims data. The options developed were:
• Capturing additional clinical information regarding the severity and complexity of beneficiary functional impairments on therapy claims in order to facilitate medical review and at the same time gather data that would be useful in the long term to develop a better payment mechanism;
• Introducing additional claims edits regarding medical necessity to reduce overutilization; and
• Adopting a per-session bundled payment, the amount of which would vary based on beneficiary characteristics and the complexity of evaluation and treatment services furnished in a therapy session.
Although we did not propose to adopt any of these alternatives at that time, we discussed and solicited public comments on all aspects of these options during the CY 2011 rulemaking. (See 75 FR 40096 through 40100 and 73284 through 73293.) In developing the CY 2013 claims-based data collection proposal, we used the feedback received from the CY 2011 rulemaking.
We noted in the proposal that the proposed claims-based data collection system using G-codes and severity modifiers builds upon current Medicare requirements for therapy services. Section 410.61 requires that a therapy plan of care (POC) be established for every beneficiary receiving outpatient therapy services. This POC must include: the type, amount, frequency, and duration of services to be furnished to each beneficiary, the diagnosis and the anticipated goals. Section 410.105(c) contains similar requirements for services furnished in the CORF setting. We have long encouraged therapists, through our manual provisions, to express the POC-required goals for each beneficiary in functional terms and require that goals be based on measureable assessments or objective data and relate to identified functional impairments. See Pub 100-02, Chapter 15, Section 220.1.2. We also noted that the evaluation and the goals developed as part of the POC would be the foundation for the initial reporting under the proposed system.
The following is a summary of the comments we received regarding the general approach proposed in the CY 2013 PFS proposed rule to require nonpayable G-codes and modifiers on therapy claims to implement the new statutory requirement.
With regard to how those treating beneficiaries should comply with the data collection system, we expect therapists to report the G-code for the functional limitation that most closely relates to the functional limitation being treated. As a result of comments on the proposed rule, we are clarifying in this final rule with comment period that if the therapy services being furnished are not intended to treat a functional limitation, the therapist should use the G-code for “other” and the modifier representing zero.
We proposed that therapists would report G-codes and modifiers on Medicare claims for outpatient therapy services. We discussed and sought comment on two types of G-codes in the proposed rule—generic and categorical. Table 19 shows the proposed generic G-codes and Table 20 shows the categorical codes discussed in the proposed rule.
The proposed G-codes differ from the three separate pairs of G-codes discussed in the CY 2011 PFS rulemaking. The CY 2011 discussion included these three pairs of G-codes, all of which reflect specific ICF terminology:
• Impairments of Body Functions and/or Impairments of Body Structures;
• Activity Limitations and Participation Restrictions; and
• Environmental Factors Barriers.
In the CY 2013 PFS proposed rule, we indicated that we were not proposing to use these specific G-codes because we found them to be potentially redundant and confusing. Instead we chose to use G-codes to define “functional limitations” synonymously with the ICF terminology “activity limitations and participation restrictions.” We noted that requiring separate reporting on three elements would have imposed a greater burden on therapists without providing a meaningful benefit in the value of the data provided. We added that because environmental barriers as discussed in CY 2011 are contextual, we did not believe collecting information on them would contribute to developing an improved payment system.
To create the select categories of G-codes discussed in the proposed rule (See Table 20) we used the two most frequently reported functional limitations in the DOTPA project by each of the three therapy disciplines. We noted that should we decide to use a system with category-specific reporting, we would expect to develop specific nonpayable G-codes for select categories of functional limitations in the final rule. We explained that if one of the select categories of functional limitations describes the functional limitation being reported, that G-code set would be used to report the current, projected goal, and discharge status of the beneficiary. When reporting a functional limitation not described by one of categorical G-codes, one of the generic G-codes previously described would be used.
We sought input from therapists on categories of functional limitations, such as those described in this section. We specifically requested comments regarding the following questions: Would data collected on categories of functional limitations provide more meaningful data on therapy services than that collected through use of the generic G-codes in our proposal? Should we choose to implement a system that is based on at least some select categories of functional limitation, which functional limitations should we collect data on in 2013? Is it more, less or the same burden to report on categories of functional limitations or generic ones? The categories of functional limitations described above are based on the ICF categories, but these ICF categories also have subcategories. Should we use subcategories for reporting? Are there specific conditions not covered by these ICF categories? Would we need to have G-codes for the same categories of secondary limitations? We sought public comment on whether these proposed G-codes allow adequate reporting on beneficiary's functional limitations. We also noted that we would particularly appreciate receiving specific suggestions for any missing elements.
The following is a summary of the comments we received on the G-codes, generic and categorical, whether these proposed G-codes allow adequate reporting on beneficiary's functional limitations, and specific suggestions for any missing elements.
Others told us that there were many conditions and situations that our system did not address and that some of these beneficiaries did not exhibit functional limitations that could be easily measured or reported. They cited, as examples, beneficiaries seen for lymphedema management, wound care, wheelchair assessment/fitting, cognitive impairments, and incontinence training.
Accordingly, we are replacing the two of the categorical codes relating to SLP with seven categorical codes and one “other” code for SLP. (See Table 21.) The seven categorical codes mirror the seven most frequently reported NOMS categories and should be used when appropriate. For all other SLP treatments, the “SLP Other” category should be used.
For functional limitations not defined by the specific categorical codes and for therapy services that are not addressing a particular functional limitation; the “other” G-codes should be used. As we begin collecting data in this initial year, we will continue to assess the need for additional G-codes, refinement of existing ones, and examine ways to address those situations for which beneficiaries do not have functional limitations.
We have addressed in this final rule with comment period those areas for which we have adequate information to do so at this time and for which an additional burden will not be created. We will continue to refine this system through further notice and comment rulemaking in future years.
We proposed that, using a set of G-codes with appropriate modifiers, the therapist would report the beneficiary's primary functional limitation defined as the most clinically relevant functional limitation at the time of the initial therapy evaluation and the establishment of the POC. The projected goal would also be reported at this time. At specified intervals during treatment, claims would also include the current functional status and the goal functional status, which would not typically change during therapy, except as described below. On the final claim for an episode of care, the therapist would report the status at this time for this functional limitation and the goal status.
Early results from the DOTPA project suggest that most beneficiaries have more than one functional limitation at treatment outset. In fact, only 21 percent of the DOTPA assessments reported just one functional limitation. Slightly more than half (54 percent) reported two, three or four functional limitations.
To the extent that the DOTPA finding is typical, the therapist may need to make a determination as to which functional limitation is primary for reporting purposes. In cases where this is unclear, the therapist may choose the functional limitation that is most clinically relevant to a successful outcome for the beneficiary, the one that would yield the quickest and/or greatest mobility, or the one that is the greatest priority for the beneficiary. In all cases, this primary functional limitation should reflect the predominant limitation that the furnished therapy services are intended to address.
We sought comment on specific issues regarding reporting data on a secondary limitation. Specifically, we requested comments regarding whether reporting on secondary functional limitations should be required or optional.
The following is a summary of the comments we received on the percentage of Medicare therapy beneficiaries with more than one functional limitation at the outset of therapy and whether reporting on secondary functional limitations should be required or optional.
We also explained that in situations where treatment continues after the treatment goal is achieved and reporting ended on the primary functional limitation, reporting will be required for another functional limitation. Thus, reporting on more than one functional limitation may be required for some patients, but not simultaneously. Instead, once reporting on the primary functional limitation is complete, the therapist will begin reporting on a subsequent functional limitation using another set of G-codes. If this additional functional limitation is not described by one of the specific categorical codes, one of the three “other” codes should be used depending on the circumstances.
In response to the comments, we are making several modifications in the G-codes that we proposed, as noted in the responses to comments above. To summarize, the G-codes, and their long descriptors, that will be used for reporting functional limitations of beneficiaries are listed in Table 21. There are 11 G-codes that describe categorical functional limitation, including seven for SLP services, and three more general G-codes for functional limitations that do not fit within one of the 11 categories. The general categorical codes would be used when none of the specific categories apply or when an assessment tool is used that yields a composite score that combines several or many functional measures, such as is done with the FOTO Patient Inquiry tool, for example. Two of these general G-code sets are to be used for “other” PT and OT services and one for “other” SLP services. In addition, we deleted the requirement to report a G-code to signal that no reporting was required and thus deleted the G-code that would have been used for this. (For discussion about the comments on this G-code and our decision to remove this reporting requirement, see section II.F.2.(b).(6).) Therapists would use the code that best describes the functional limitation that is primary to the therapy plan of care.
We proposed that for each functional G-code used on a claim, a modifier would be required to report the severity/complexity for that functional limitation. We proposed to adopt a 12-point scale to report the severity or complexity of the functional limitation involved. The proposed modifiers are listed in Table 22.
We noted that there are many valid and reliable measurement and assessment tools that therapists use to inform their clinical decision-making and to quantify functional limitations, including the four assessment tools we discussed in CY 2011 PFS rulemaking that produce functional scores—namely, the Activity Measure—Post Acute Care (AM-PAC) tool, the FOTO Patient Inquiry, OPTIMAL, and NOMS. We list these four tools as recommended for use by therapists, though not required, in the outpatient therapy IOM provision of the Benefits Policy Manual, Chapter 15, Section 220.3C “
In assessing the ability of therapists to provide the required severity information regardless of what assessment tool or combination of tools they use, if any, we considered the comments received on the CY 2011 PFS proposed rule discussion. These indicated that we needed greater granularity in our severity scale so that the changes in functional limitation over the course of therapy could be more accurately reflected. Specifically, most commenters on the CY 2011 proposed rule favored the 7-point scale over the 5-point ICF-based scale. They indicated that they preferred a scale with more severity levels and equal increments since it would allow the therapist to document smaller changes that many therapy beneficiaries make towards their goals.
Believing that neither the 5- or 7-point scales would be adequate for this reporting system, we developed and proposed a 12-point scale that we believed was an enhancement over the 7-point scale. We thought it addressed concerns that those commenting on the CY 2011 options had raised regarding the 7-point scale. We thought that a more sensitive rating scale (one with more increments) had the advantage of demonstrating the progress of beneficiaries with conditions that improve slowly, such as those recovering from strokes or with spinal cord injuries. In addition, we believed that the proposed scale's 10-percentage point increments would make it easier for therapists to convert composite and overall scores from assessment instruments or other measurement tools to this scale.
The following is a summary of the comments we received regarding our proposal for a 12-point scale to capture the severity/complexity of beneficiaries' functional limitations.
Because there will be many cases for which one single functional measurement tool is not available or clinically inappropriate, therapists can use their clinical judgment in the assignment of the appropriate modifier. Therapists will need to document in the medical record how they made the modifier selection so that the same process can be followed at succeeding assessment intervals.
In response to the comments, we are adopting the following 7-point severity/complexity scale to report the severity of the beneficiary's functional impairment, which is based upon the scale developed as part of the STATs project.
In the proposed rule we noted that therapists frequently use assessment tools to quantify beneficiary function. FOTO and NOMS are two such assessment tools in the public domain that can be used to determine a score for an assessment of beneficiary function. Therapists could use the score produced by such instruments to select the appropriate modifier for reporting the beneficiary's functional status. Although we recommend the use of four of these functional assessment instruments to determine beneficiary functional limitation in the IOM, we did not propose to require the use of a particular functional assessment tool to determine the severity/complexity modifier. We explained our reasons for not doing so in the proposed rule saying “Some tools are proprietary, and others in the public domain cannot be modified to explicitly address this data collection project. Further, this data collection effort spans several therapy disciplines. Requiring a specific instrument could create burdens for therapists that would have to be considered in light of any potential improvement in data accuracy, consistency and appropriateness that such an instrument would generate.” We noted that we might reconsider this decision once we have more experience with claims-based data collection on beneficiary function associated with furnished therapy services. We sought public comment on the use of assessment tools. In particular, we were interested in feedback regarding the benefits and burdens associated with use of a specific tool to assess beneficiary functional limitations. We requested that those favoring a requirement to use a specific tool provide information on the preferred tool and describe why the tool is preferred.
The following is a summary of the comments we received regarding the use of assessment tools and the benefits and burdens associated with use of a specific tool to assess beneficiary functional limitations.
Commenters found the following potential drawbacks to our proposal to allow therapists to choose the assessment tool(s) (or use their professional judgment) to determine the complexity/severity modifier. Commenters stated that the current proposal would collect individual level data that is not comparable among groups of beneficiaries or providers. Commenters also stated that gathering data on beneficiary condition, functional limitation, and progression necessitates the use of one standardized collection tool by all therapists. One commenter revealed that the same beneficiary could obtain widely distinct modifier scores depending on the tool used. Further, a commenter acknowledged that there are over 400 different measurement tools used by physical therapists, many of which only measure one domain of function. Additionally, another commenter urged us to provide more instruction on how each tool interfaces with the complexity/severity scale and provide crosswalks and guidance for each tool to promote consistency in the data collected.
Commenters suggested the following alternatives to our proposal to address the potential drawbacks they identified. Commenters supported endorsing a small number of standardized tools with proven validity, reliability, and responsiveness that would be distinct for each therapy discipline. The American Speech-Language and Hearing Association (ASHA) urged we adopt NOMS and a 7-point severity scale specifically for SLP to recognize the distinctiveness of the discipline and record meaningful outcomes for SLP beneficiaries. Many commenters supported the use of FOTO stating that it measures a broad scope of conditions reliably, results in a composite score, and creates little undue burden to report. Those commenters also stated that FOTO is already the tool of choice for their respective providers.
Two commenters suggested developing a list of approved tools for specific beneficiary populations and settings. Another commenter suggested assigning G-codes to specific assessment tools so that the data could be compared. As a future alternative, a few commenters proposed developing core items that could be used in any tool to standardize data collection. MedPAC suggested that “CMS consider developing an instrument that collects the necessary information that would allow Medicare to categorize beneficiaries by condition and severity in order to pay appropriately” and pointed to the “Reason for Therapy” form used in the DOTPA study as a starting point, noting that it is “concise, easy to assess and document for clinicians, and collects information on function and limitations across three therapy disciplines.”
We appreciate the comments providing information on the benefits of using specific tools, such as NOMS and FOTO. However, at this time we do not believe that they are sufficiently widely used to require the use of one of these tools. In this final rule with comment period, we are not requiring the use of a specific assessment tool. We are continuing to encourage, but not require, the use of assessment tools in the IOM.
We did, however, adopt G-codes and a modifier scale for SLP that are consistent with NOMS so it is possible to move to a standardized tool for SLP in the future. We will consider the possibility using coding to identify the specific functional assessment tool used in subsequent refinements. As noted above, therapists can also use their professional judgment in determining the percentage of functional limitations in conjunction with objective data from evaluations and assessments and the subjective reports from beneficiaries.
We proposed that the therapist's projected goal for the beneficiary's functional status at the end of treatment would be reported on the first claim for services, periodically throughout an episode of care, and at discharge from therapy.
The following is a summary of the comments regarding goal reporting.
At this time, we intend to use the projected goal to have an understanding of therapists' ability to project the likely progress a beneficiary will make. We ultimately may employ these data to help us develop proposals to improve payment for therapy services, but do not anticipate using the goal data for purposes of payment or coverage decisions. In cases where the therapist does not expect improvement, such as for those individuals receiving maintenance therapy, the reported projected goal status will be the same as current status. We appreciate that commenters raised concerns about
We proposed to require claims-based reporting in conjunction with the initial service at the outset of a therapy episode, at established intervals during treatment, and at discharge. As proposed, the number of G-codes required on a particular claim would have varied from one to four, depending on the circumstances. We provided the following (Table 24) graphic example of which codes would have been used for periodic reporting. This example represents a therapy episode of care occurring over an extended period, such as might be typical for a beneficiary receiving therapy for the late effects of a stroke. We chose to use an example with a much higher than average number of treatment days in order to show a greater variety of reporting scenarios.
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The following is a summary of comments on the frequency of reporting at the outset.
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A treatment day is defined as a calendar day in which treatment occurs resulting in a billable service. Often a treatment day and a therapy “session” (or “visit”) may be the same, but the two terms are not interchangeable. For example, a beneficiary might receive certain services twice a day, although this is a rare clinical scenario, these two different sessions (or visits) on the same day by the same discipline are counted as one treatment day.
We explained that the proposal would require that on the claim for service on or before the 10th treatment day or the 30th calendar day after treatment day one, the therapist would only report the G-code and the appropriate modifier to show the beneficiary's current functional status at the end of this reporting period under the proposal. We added that the next reporting period begins on the next treatment day and that the time period between the end of one reporting period and the next treatment day does not count towards the 30-calendar day period. On the claim for services furnished on this date, the therapist would report both the G-code and modifier showing the current functional status at this time along with the G-code and modifier reflecting the projected goal that was identified at the outset of the therapy episode. This process would continue until the beneficiary concludes the course of therapy treatment.
Further, we proposed that on a claim for a service that does not require specific reporting of a G-code with modifier (that is, on a claim for therapy services within the time period for which reporting is not required), GXXX7 would be used. By using this code, the therapist would be confirming that the claim does not require specific functional reporting. This is the only G-code that we proposed to be reported without a severity modifier.
As we noted in the proposed rule, we proposed the 10/30 frequency of reporting to be consistent with our existing timing requirements for progress reports. These timing requirements are included in the
We noted that the proposal required that the same reporting periods be used for both the primary and secondary functional limitation. We added that the therapist can accomplish this by starting them at the same time or if the secondary functional limitation is added at some point in treatment, the primary functional limitation's reporting period must be re-started by reporting GXXX1 and GXXX2 at the same time the new secondary functional limitation is added using GXXX4 and GXXX5.
Further, for those therapy treatment episodes lasting longer periods of time, the periodic reporting of the G-codes and associated modifiers would reflect any progress that the beneficiary made toward the identified goal. In summary, we proposed to require the reporting of G-codes and modifiers at episode outset (evaluation or initial visit), and once every 10th treatment day or at least every 30 calendar days, whichever time period is less, and at discharge.
We noted that we believed it was important that the requirements for this reporting system be consistent with the requirements for documenting any progress in the medical record as specified in our manual. Given the current proposal for claims-based data collection, we believe it is an appropriate time to reassess the manual requirements. We sought comment on whether it would be appropriate to modify the periodicity of the progress report requirement in the IOM to one based solely on the number of treatment days, such as six or ten. We noted that if a timing modification was made for progress reporting, a corresponding change would be made in the functional reporting interval.
The following is a summary of the comments we received on our proposal to require reporting every 10 treatment days or 30 calendar days, whichever is less, and whether it would be appropriate to modify the progress report requirement in the IOM to one based solely on the number of treatment days, such as six or ten, and the clinical impact of such a change.
A few commenters urged us to eliminate the requirement for functional status reporting at the visit subsequent to the progress report because a beneficiary's status probably would remain the same unless there is a significant gap between visits.
We received many comments concerning the reporting of GXXX7; which we proposed to be used to indicate that the therapist confirms functional reporting not required. These commenters stated that the reporting of GXXX7, which is required for claims with dates of services when a functional status measure is not collected, would be unnecessary and burdensome, especially for daily billers. They urged us to require reporting only when a functional status is required to be reported. Further commenters stated
After assessing the comments, we agree that reporting a G-code (GXXX7) to tell us that no reporting is required would not provide meaningful data and would pose an additional burden for therapists and therapy providers. When proposed, we believed it would be convenient for therapists to use the code to indicate that this was a claim for therapy services that did not require the functional reporting because it would assist them in complying with the reporting requirements and would assist us in enforcing them. When we reassessed the issue based on feedback from commenters, it was clear that the “no report due” code would not aid us in enforcing the requirements as we would still have to verify that claims with the proposed GXXX7 were in fact claims that did not require reporting. Since commenters pointed out that not only would it not assist them, but would in fact burden them, we have decided not to include this code. Accordingly, we are also modifying our proposal to remove the requirement to report a “no report due” code on claims when functional reporting is not due, such as between the first and the tenth day of service. We expect these changes will significantly reduce the frequency of required reporting during a therapy episode and believe they will appropriately simplify the claims-based reporting system.
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Although collection of discharge data is important in achieving our goals, we recognize that data on functional status at the time therapy concludes is sometimes likely to be incomplete for some beneficiaries receiving outpatient therapy services. The DOTPA project has found this to be true. There are various reasons as to why the therapist would not be able to report functional status using G-codes and modifiers at the time therapy ends. Sometimes, beneficiaries may discontinue therapy without alerting their therapist of their intention to do so; simply because they feel better; they can no longer fit therapy into their life, work, or social schedules; a physician told them further therapy was not necessary; or their transportation is unavailable. Whatever the reason, there would be situations where the therapy ends without the planned discharge visit taking place. In these situations, we said that we would not require the reporting at discharge. However, we encourage therapists to include discharge reporting whenever possible on the final therapy claim for services.
Since the therapist is typically reassessing the beneficiary during the therapy episode, the data critical to the severity/complexity of the functional measure may be available even when the final therapy session does not occur. In these instances, the G-codes and modifiers appropriate to discharge should be reported when the final claim for therapy services has not already been submitted.
We sought feedback on how often the therapy community finds that beneficiaries discontinue therapy without the therapist knowing in advance that it is the last treatment session and other situations in which the discharge data would not be available for reporting.
The following is a summary of the comments we received regarding the proposal to require reporting of the G-code/modifier functional data at the conclusion of treatment so that we have a complete set of data for the therapy episode of care.
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The following is a summary of the comments we received regarding the proposal that in addition to reporting at the intervals discussed above, the G-code and related modifier would be required to be reported when a formal and medically necessary re-evaluation of the beneficiary results in an alteration of the goals in the beneficiary's POC.
In summary, we maintain that claims-based reporting should occur at the outset of therapy episode, on or before every 10 treatment days throughout the course of therapy, and at the time of discharge from therapy. Additionally, functional reporting is also required at the time the beneficiary's condition changes significantly enough to clinically warrant a re-evaluation such that a HCPCS/CPT code for a re-evaluation or a repeat evaluation is billed.
We proposed to require that documentation of the information used for reporting under this system must be included in the beneficiary's medical record. As proposed, the therapist would need to track in the medical record the G-codes and the corresponding severity modifiers that were used to report the status of the functional limitations at the time reporting was required. Including G-codes and related modifiers in the medical record creates an auditable record, assists in improving the quality of data CMS collects, and allows therapists to track assessment and functional information. In the proposed rule, we provided the example of a situation where the therapist selects the mobility functional limitation of “walking and moving” as the primary functional limitation and determines that at therapy outset the beneficiary has a 60 percent limitation and sets the goal to reduce the limitation to 5 percent. We noted that the therapist uses GXXX1-XH to report the current status of the functional impairment and GXXX2-XB to report the goal. Additionally, we said that the therapist should note in the beneficiary's medical record that the functional limitation is “walking and moving” and document the G-codes and severity modifiers used to report this functional limitation on the claim for therapy services.
The following is a summary of comments we received concerning our documentation requirements.
In the proposed rule, we noted that except for the addition of the proposed G-codes and the associated modifiers, nothing in this proposal would modify other existing requirements for submission of therapy claims. We noted in the proposed rule that, in addition to the new G-codes and modifiers used for the claims-based data collection system, the therapy modifiers—GO, GP, and GN, would still be required on claims to indicate that the therapy services are furnished under an OT, PT, or SLP plan of care, respectively; and, therefore, we are designating these nonpayable G-codes as “always therapy.” We noted in the proposed rule that institutional claims for therapy services would require that a charge be included on the service line for each one of these G-codes used in the required functional reporting. We also noted that this charge would not be used for payment purposes and would not affect processing. Further, we noted claims for professional services do not require that a charge be included for these nonpayable G-codes, but that reporting a charge for the nonpayable G-codes would not affect claims processing. To illustrate this policy, for each nonpayable G-code on the claim, that line of service would also need to contain one of the severity modifiers, the corresponding GO, GP, or GN therapy modifier to indicate the respective OT, PT, or SLP therapy discipline and related POC; and the date of service it references. For each line on the institutional claim submitted by hospitals, SNFs, rehabilitation agencies, CORFs and HHAs, a charge of one penny, $0.01, can be added. For each line on the professional claim submitted by private practice therapists and physician/NPPs, a charge of $0.00 can be added. We believe that many therapists submitting professional claims are already submitting nonpayable G-code quality measures under the PQRS and will be familiar with the parameters of nonpayable G-codes on claims for Medicare services.
Finally, we noted that Medicare does not process claims that do not include a billable service. As a result, reporting under this claims-based data collection system would need to be included on the same claim as a furnished service that Medicare covers.
We did not receive any comments specifically on the claims requirements so we are finalizing these as proposed.
In accordance with section 3005(g) of the MCTRJCA, we proposed to implement these data reporting requirements on January 1, 2013. We recognized that with electronic health records and electronic claims submission, therapists might encounter difficulty in including this new data on claims. To accommodate those that may experience operational or other difficulties with moving to this new reporting system and to assure smooth transition, we proposed a testing period from January 1, 2013 until July 1, 2013. We noted that we would expect that all those billing for outpatient therapy services would take advantage of this testing period and would begin attempting to report the new G-codes and modifiers as close to January 1, 2013, as possible, in preparation for required reporting beginning on July 1, 2013. Taking advantage of this testing period would help to minimize potential problems after July 1, 2013, when claims without the appropriate G-codes and modifiers would be returned unpaid.
The following is a summary of comments we received concerning our implementation of the new system on January 1, 2013 with enforcement beginning after July 1, 2013.
To implement the claims-based data collection system required by MCTRJCA and described above, we proposed to amend the regulations establishing the conditions for payment governing outpatient and CORF PT, OT, and SLP services to add a requirement that the claims include information on beneficiary functional limitations. In addition, we proposed to amend the POC requirements set forth in the regulations for outpatient therapy services and CORFs to require that the therapy goals, which must be included in the POC, are consistent with the beneficiary's functional limitations and goals reported on claims for services.
Specifically, we proposed to amend the regulations for outpatient OT, PT, and SLP (§ 410.59, § 410.60, and § 410.62, respectively) by adding a new paragraph (a)(4) to require that claims submitted for services furnished contain
We also proposed to amend the POC requirements set forth at § 410.61(c) to require that the therapy goals, which must be included in the treatment plan, must be consistent with those reported on claims for services. This requirement is in addition to those already existing conditions for the POC.
To achieve consistency in the provision of PT, OT, and SLP services across therapy benefits, we proposed to amend § 410.105 to include the same requirements for these services furnished in CORFs. These proposed revisions would require that the goals specified in the treatment plan be consistent with the beneficiary functional limitations and goals reported on claims for services and that claims submitted for services furnished contain specified information on beneficiary functional limitations, respectively. The requirements do not apply to respiratory therapy services.
We did not receive any comments on the proposed regulatory changes and are finalizing the changes as proposed.
Section 3005(g) of the MCTRJCA requires us to consult with relevant stakeholders as we propose and implement this reporting system. In the CY 2013 PFS proposed rule, we indicated that we are meeting this requirement through the publication of this proposal and specifically by soliciting public comment on the various aspects of our proposal. In addition, we noted that we would meet with key stakeholders and discuss this issue in Open Door Forums over the course of the summer.
During the CY 2013 proposed rule comment period, we met with the various therapy professional associations and provider groups in order to solicit their comments on the various aspects of this proposal. At the CMS Physicians, Nurses & Allied Health Professionals Open Door Forum on July 17, 2012, we discussed the provisions of the proposed rule, including these requirements. We also discussed this proposed rule at the CMS Hospital & Hospital Quality Open Door Forum on July 18, 2012. In developing the final rule, we took into consideration many of the critical issues that were raised by the various stakeholders in these meetings and Forums. Accordingly, we believe we have met our obligation to consult with relevant stakeholders in proposing and implementing the required claims-based data collection strategy, and in developing our final policies, we have taken into consideration the various needs of stakeholders affected by this effort.
In recent years, we have recognized primary care and care coordination as critical components in achieving better care for individuals, better health for individuals, and reduced expenditure growth. Accordingly, we have prioritized the development and implementation of a series of initiatives designed to improve payment for, and encourage long-term investment in, primary care and care management services. These initiatives include the following programs and demonstrations:
• The Medicare Shared Savings Program (described in “Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations; Final Rule” which appeared in the
++ The testing of the Pioneer ACO model, designed for experienced health care organizations (described on the Center for Medicare and Medicaid Innovation's (Innovation Center's) Web site at
++ The testing of the Advance Payment ACO model, designed to support organizations participating in the Medicare Shared Savings Program (described on the Innovation Center's Web site at
• The Primary Care Incentive Payment (PCIP) Program (described on the CMS Web site at
• The patient-centered medical home model in the Multi-payer Advanced Primary Care Practice (MAPCP) Demonstration designed to test whether the quality and coordination of health care services are improved by making advanced primary care practices more broadly available (described on the CMS Web site at
• The Federally Qualified Health Center (FQHC) Advanced Primary Care Practice demonstration (described on the CMS Web site at
• The Comprehensive Primary Care (CPC) initiative (described on the Innovation Center's Web site at
In coordination with these initiatives, we also continue to explore other potential refinements to the PFS that would appropriately value primary care and care coordination within Medicare's statutory structure for fee-for-service physician payment and quality reporting. We believe that improvements in payment for primary care and recognizing care coordination initiatives are particularly important as EHR technology diffuses and improves the ability of physicians and other providers of health care to work together to improve patient care. We view these potential refinements to the PFS as part of a broader strategy that relies on input and information gathered from the initiatives described above, research and demonstrations from other public and private stakeholders, the work of all parties involved in the potentially misvalued code initiative, and from the public at large.
In the CY 2012 PFS proposed rule (76 FR 42793 through 42794), we initiated a discussion to gather information about how primary care services have evolved to focus on preventing and managing chronic conditions. We also proposed to review evaluation and management (E/M) services as potentially misvalued and suggested that the American Medical Association Relative (Value) Update Committee (AMA RUC) might consider changes in the practice of chronic conditions management and care coordination as key reason for undertaking this review. In the CY 2012 PFS final rule with comment period (76 FR 73062 through 73065), we did not finalize our proposal to review E/M codes due to consensus from an overwhelming majority of commenters that a review of E/M services using our current processes could not appropriately value the evolving practice of chronic care coordination at the time, and therefore, would not accomplish the agency's goal of paying appropriately for primary care services. We stated that we would continue to consider ongoing research projects, demonstrations, and the numerous policy alternatives suggested by commenters. In addition, in the CY 2012 PFS proposed rule (76 FR 42917 through 42920), we initiated a public
• 99495 Transitional Care Management Services with the following required elements:
++ Communication (direct contact, telephone, electronic) with the patient and/or caregiver within 2 business days of discharge.
++ Medical decision making of at least moderate complexity during the service period.
++ Face-to-face visit, within 14 calendar days of discharge.
• 99496 Transitional Care Management Services with the following required elements:
++ Communication (direct contact, telephone, electronic) with the patient and/or caregiver within 2 business days of discharge.
++ Medical decision making of high complexity during the service period.
++ Face-to-face visit, within 7 calendar days of discharge.
We discuss these codes in greater detail below.
Under current PFS policy, care coordination is a component of E/M services which are generally reported using E/M CPT codes. The pre- and post-encounter non-face-to-face care management work is included in calculating the total work for the typical E/M services, and the total work for the typical service is used to develop RVUs for the E/M services. In the CY 2012 PFS proposed rule, we highlighted some of the E/M services that include substantial care coordination work. Specifically, we noted that the vignettes that describe a typical service for mid-level office/outpatient services (CPT codes 99203 and 99213) include furnishing care coordination, communication, and other necessary care management related to the office visit in the post-service work. We also highlighted vignettes that describe a typical service for hospital discharge day management (CPT codes 99238 and 99239), which include furnishing care coordination, communication, and other necessary management related to the hospitalization in the post-service work.
The payment for non-face-to-face care management services is bundled into the payment for face-to-face E/M visits. Moreover, Medicare does not pay for services that are furnished to parties other than the beneficiary and which Medicare does not cover, for example, communication with caregivers. Accordingly, we do not pay separately for CPT codes for telephone calls, medical team conferences, prolonged services without patient contact, or anticoagulation management services.
However, the physician community continues to tell us that the care coordination included in many of the E/M services, such as office visits, does not adequately describe the non-face-to-face care management work involved in primary care. Because the current E/M office/outpatient visit CPT codes were designed to support all office visits and reflect an overall orientation toward episodic treatment, we agree that these E/M codes may not reflect all the services and resources required to furnish comprehensive, coordinated care management for certain categories of beneficiaries such as those who are returning to a community setting following discharge from a hospital or SNF stay. As part of our multi-year strategy to recognize and support primary care and care management, we proposed in the CY 2013 PFS proposed rule (77 FR 44776-44780) to create a HCPCS G code to describe care management involving the transition of a beneficiary from care furnished by a treating physician during a hospital stay (inpatient, outpatient observation services, or outpatient partial hospitalization), SNF stay, or community mental health center (CMHC) partial hospitalization program to care furnished by the beneficiary's primary physician in the community. We also solicited comment on how care furnished in these settings might be incorporated into the current fee-for-service structure of the PFS.
Specifically, this HCPCS G code would describe all non-face-to-face services related to the TCM furnished by the community physician or qualified nonphysician practitioner within 30 calendar days following the date of discharge from an inpatient acute care hospital, psychiatric hospital, long-term care hospital, skilled nursing facility, and inpatient rehabilitation facility; hospital outpatient for observation services or partial hospitalization services; and a partial hospitalization program at a CMHC to community-based care. The post-discharge TCM service includes non-face-to-face care management services furnished by clinical staff member(s) or office-based case manager(s) under the supervision of the community physician or qualified nonphysician practitioner. We based the concept of this proposal, in part, on our policy for care plan oversight services. We currently pay physicians for the non-face-to-face care plan oversight services furnished for beneficiaries under care of home health agencies or hospices. These beneficiaries require complex and multidisciplinary care modalities that involve: Regular physician development and/or revision of care plans, subsequent reports of patient status, review of laboratory and other studies, communication with other health professionals not employed in the same practice who are involved in the patient's care, integration of new information into the care plan, and/or adjustment of medical therapy. Physicians furnishing these services bill HCPCS codes G0181 or G0182 (See the Medicare benefit manual, 100-02, Chapter 15, Section 30 for detailed description of these services.)
For CY 2013, we proposed to create a new code to describe post-discharge TCM services. This service was proposed to include:
• Assuming responsibility for the beneficiary's care without a gap.
++ Obtaining and reviewing the discharge summary.
++ Reviewing diagnostic tests and treatments.
++ Updating of the patient's medical record based on a discharge summary to incorporate changes in health conditions and on-going treatments related to the hospital or nursing home stay within 14 business days of the discharge.
• Establishing or adjusting a plan of care to reflect required and indicated elements, particularly in light of the services furnished during the stay at the specified facility and to reflect result of communication with beneficiary.
++ An assessment of the patient's health status, medical needs, functional status, pain control, and psychosocial needs following the discharge.
• Communication (direct contact, telephone, electronic) with the beneficiary and/or caregiver, including education of patient and/or caregiver within 2 business days of discharge based on a review of the discharge summary and other available information such as diagnostic test results, including each of the following tasks:
++ An assessment of the patient's or caregiver's understanding of the medication regimen as well as education to reconcile the medication regimen differences between the pre- and post-hospital, CMHC, or SNF stay.
++ Education of the patient or caregiver regarding the on-going care plan and the potential complications that should be anticipated and how they should be addressed if they arise.
++ Assessment of the need for and assistance in establishing or re-establishing necessary home and community based resources.
++ Addressing the patient's medical and psychosocial issues, and medication reconciliation and management.
When indicated for a specific patient, the post-discharge transitional care service was also proposed to include:
• Communication with other health care professionals who will (re)assume care of the beneficiary, education of patient, family, guardian, and/or caregiver.
• Assessment of the need for and assistance in coordinating follow up visits with health care providers and other necessary services in the community.
• Establishment or reestablishment of needed community resources.
• Assistance in scheduling any required follow-up with community providers and services.
The proposed post-discharge transitional care HCPCS G code was described as follows:
GXXX1 Post-discharge transitional care management with the following required elements:
• Communication (direct contact, telephone, electronic) with the patient or caregiver within 2 business days of discharge.
• Medical decision making of moderate or high complexity during the service period.
• To be eligible to bill the service, physicians or qualified nonphysician practitioners must have had a face-to-face E/M visit with the patient in the 30 days prior to the transition in care or within 14 business days following the transition in care.
The post-discharge transitional care services HCPCS G code we proposed would be used by the community physician or qualified nonphysician practitioner to report the services furnished in the community to ensure the coordination and continuity of care for patients discharged from a hospital (inpatient stay, outpatient observation, or outpatient partial hospitalization), SNF stay, or CMHC. The post-discharge transitional care service would parallel the discharge day management service for the community physician or qualified nonphysician practitioner and complement the E/M office/outpatient visit CPT codes.
We proposed that the post-discharge transitional care service HCPCS G code would be used to report physician or qualifying nonphysician practitioner services for a patient whose medical and/or psychosocial problems requires moderate or high complexity medical decision-making during transitions in care from hospital (inpatient stay, outpatient observation, and partial hospitalization), SNF stay, or CMHC settings to community-based care. The Evaluation and Management Guidelines define decision-making of moderate and high medical complexity. In general, moderate complexity medical decision-making includes multiple diagnoses or management options, moderate complexity and amount of data to be reviewed, a moderate amount and/or complexity of data to be reviewed; and a moderate risk of significant complications, morbidity, and/or mortality. High complexity decision-making includes an extensive number of diagnoses or management options, an extensive amount and/or complexity of data to be reviewed, and high risk of significant complications, morbidity, and/or mortality (See Evaluation and Management Services Guide, Centers for Medicare & Medicaid Services, December 2010.) We proposed that the post-discharge transitional care HCPCS code (GXXX1) would be payable only once in the 30 days following a discharge, per patient per discharge, to a single community physician or qualified nonphysician practitioner (or group practice) who assumes responsibility for the patient's post-discharge TCM services. The service would be billable only at 30 days post discharge or thereafter. The post-discharge TCM service would be distinct from services furnished by the discharging physician or qualified nonphysician practitioner reporting CPT codes 99238 (Hospital discharge day management, 30 minutes or less); 99239 (Hospital discharge day management, more than 30 minutes); 99217 (Observation care discharge day management); or Observation or Inpatient Care services, CPT codes 99234 -99236; as appropriate.
We proposed to pay only one claim for the post-discharge transitional care GXXX1 billed per beneficiary at the conclusion of the 30 day post-discharge period Given the elements of the service and the short window of time following a discharge during which a physician or qualifying nonphysician practitioner will need to perform several tasks on behalf of a beneficiary, we stated our belief that it would be unlikely that two or more physicians or practitioners would have had a face-to-face E/M contact with the beneficiary in the specified window of 30 days prior or 14 days post discharge and have furnished the proposed post-discharge TCM services listed above. Therefore, we did not believe it necessary to take further steps to identify a beneficiary's community physician or qualified nonphysician practitioner who furnished the post-discharge TCM services. We proposed to pay only one claim for the post-discharge transitional care GXXX1 billed per beneficiary at the conclusion of the 30 day post-discharge period. Post-discharge TCM services relating to any subsequent discharges for a beneficiary in the same 30-day period would be included in the single payment. Practitioners billing this post-discharge transitional care code accept responsibility for managing and coordinating the beneficiary's care over the first 30 days after discharge.
• 99495 Transitional Care Management Services with the following required elements:
++ Communication (direct contact, telephone, electronic) with the patient and/or caregiver within 2 business days of discharge.
++ Medical decision making of at least moderate complexity during the service period.
++ Face-to-face visit, within 14 calendar days of discharge.
• 99496 Transitional Care Management Services with the following required elements:
++ Communication (direct contact, telephone, electronic) with the patient and/or caregiver within 2 business days of discharge.
++ Medical decision making of high complexity during the service period.
++ Face-to-face visit, within 7 calendar days of discharge.
We discuss these codes in greater detail and respond to these specific recommendations below.
A few commenters from the medical community did not specifically recommend adopting the CPT TCM codes. For example, one major medical society supported our proposal on the grounds, among other considerations, that it was consistent with the “general direction of organized medicine, as evidenced by the fact that the AMA's CPT Editorial Panel has created two new codes for transitional care management.” This commenter then expressed support for several of the several elements in our proposed G code which differ from the CPT TCM codes, such as our “proposal to keep the required post-discharge face-to-face E/M separately reportable.” (We discuss this issue in further detail later in this section.)
We explicitly constructed this proposal as a payment for non-face-to-face post-discharge TCM services separate from payment for E/M or other medical visits. However, we believe that it is important to ensure that the community physician or qualified nonphysician practitioner furnishing post-discharge TCM services either already have or establish, soon after discharge, a relationship with the beneficiary. As such, we proposed that the community physician or qualified nonphysician practitioner reporting post-discharge TCM GXXX1 should already have a relationship with the beneficiary, or establish one soon after discharge, prior to furnishing TCM and billing this code. Therefore, we specifically proposed that the community physician or qualified nonphysician practitioner reporting a TCM G-code must have billed an E/M visit for that beneficiary within 30 days prior to the hospital discharge (the start of post-discharge TCM period), or must conduct an E/M office/outpatient visit (99201 to 99215) within the first 14 days of the 30-day post-discharge period of TCM services. In either case, the E/M visit would be separately billed under our G-code proposal. While we proposed that the post-discharge TCM code would not include a face-to-face visit, and that physicians or qualified nonphysician practitioners would bill and be paid for this care management service separately from a medical visit, we sought comments about whether we should require a face-to-face visit when billing for the post-discharge TCM service: That is, whether we should bundle a required visit into the reporting and payment for the TCM codes. We were also concerned about whether beneficiaries would understand their coinsurance liability for the post-discharge transitional care service when they did not visit the physician's or qualified nonphysician practitioner's office.
We also share the commenters' concerns about beneficiaries who may have limited mobility or otherwise have difficulty travelling to a physician office in the period following a discharge. We note that the final CPT TCM codes, 99495 and 99496, which we are adopting in this final rule with comment period, requires a face-to-face visit, but does not specify the location/setting for that portion of the service. The AMA RUC states in its recommendation that, “each code includes a timely face-to-face visit which typically occurs in the office, but can also occur at home or other location where the patient resides.” Finally, we agree with those commenters who stated that beneficiaries would understand their coinsurance liability better if the TCM services included a required E/M visit as part of the service.
We also sought comments regarding whether we should incorporate such a required visit on the same day into the payment for the proposed code. We considered several reasons for requiring a face-to-face visit on the same day as the date of discharge. We wondered whether, with a face-to-face visit immediately after discharge, the plan of care would be more accurate given that the patient's medical or psychosocial condition may have changed from the time the practitioner last met with the patient and the practitioner could better develop a plan of care through an in-person visit and discussion. On the other hand, we contemplated several scenarios where it is not possible for a beneficiary to get to the physician's or qualified nonphysician practitioner's office and welcomed comment on whether an exception process would be appropriate if we were to finalize a same day face-to-face visit as a requirement for billing the post-discharge TCM code.
In addition, we note that the CPT TCM code prefatory language provides that the TCM service period “commences upon the date of discharge and continues for the next 29 days.” Subsequent CPT TCM language indicates that the first visit must occur within 7 or 14 calendar days of the date of discharge depending on the level of decision-making. We are unclear as to whether the CPT TCM prefatory language intends to allow the first visit to occur on the same date as discharge. We note that there is a distinction between the discharge day management and TCM services, and we wish to avoid any implication that the E/M services furnished on the day of discharge as part of the discharge management service could be considered to meet the requirement for the TCM service that the physician or nonphysician practitioner must conduct an E/M service within 7 or 14 days of discharge. Therefore, we will specify that the E/M service required for the CPT TCM codes cannot be furnished by the same physician or nonphysician practitioner on the same day as the discharge management service.
Pre-service care coordination activities include:
• Communicate with other professionals and with patient or patient's family.
Intra-service care coordination activities include:
• Discuss aftercare treatment with the patient, family and other healthcare professionals;
• Provide care coordination for the transition including instructions for aftercare to caregivers;
• Order/arrange for post discharge follow-up professional services and testing; and
• Inform the primary care or referring physician or qualified nonphysician practitioner of discharge plans.
Post-service care coordination activities include:
• Provide necessary care coordination, telephonic or electronic communication assistance, and other necessary management related to this hospitalization; and
• Revise treatment plan(s) and communicate with patient and/or caregiver, as necessary.
The hospital and nursing facility discharge management codes also include a number of other pre-, intra and post-service activities.
We certainly recognize that the services of physicians and other practitioners providing discharge management services are crucial to the overall success of TCM services. These codes have been valued by the AMA/RUC in the past, and these valuations have been reviewed and accepted by us. At this time, we are not aware of any substantive evidence that these codes are systematically undervalued.
Further, we proposed that a physician or qualified nonphysician practitioner billing for a procedure with a 10- or 90-day global period would not also be permitted to bill HCPCS code GXXX1 in conjunction with that procedure because any follow-up care management would be included in the post-operative portion of the global period.
We proposed that the TCM code would be payable only once in the 30 days following a discharge, per patient per discharge, to a single community physician or qualified nonphysician practitioner (or group practice) who assumes responsibility for the patient's post-discharge TCM. We expressed our belief that, given the elements of the TCM service and the short time period during which they must be furnished, it would be unlikely that two or more physicians would meet the requirements for billing the TCM code.
After considering all these comments, and for the reasons stated above we are adopting the CPT TCM codes subject to the modifications described in our responses to comments on the issues discussed above. In summary, these specific modifications are: Our decision not to restrict the billing of the CPT TCM codes to established patients, our clarification of the post-discharge service period, and our prohibition against billing a discharge day management service on the same day that a required E/M visit is furnished under the CPT TCM codes for the same patient. We will provide guidance to contractors and revise the relevant manual provisions in order to implement these policies.
Below are the requirements of the CPT TCM codes as modified for Medicare purposes in this final rule.
• 99495 Transitional Care Management Services with the following required elements:
++ Communication (direct contact, telephone, electronic) with the patient and/or caregiver within 2 business days of discharge.
++ Medical decision making of at least moderate complexity during the service period.
++ Face-to-face visit, within 14 calendar days of discharge.
• 99496 Transitional Care Management Services with the following required elements:
++ Communication (direct contact, telephone, electronic) with the patient and/or caregiver within 2 business days of discharge.
++ Medical decision making of high complexity during the service period.
++ Face-to-face visit, within 7 calendar days of discharge.
CPT codes 99495 and 99496 are used to report transitional care management services. These services are for a patient whose medical and/or psychosocial problems require moderate or high complexity medical decision making during transitions in care from an inpatient hospital setting (including acute hospital, rehabilitation hospital, long-term acute care hospital), partial hospital, observation status in a hospital, or skilled nursing facility/nursing facility, to the patient's community setting (home, domiciliary, rest home, or assisted living). Transitional care management commences upon the date of discharge and continues for the next 29 days.
Transitional care management is comprised of one face-to-face visit within the specified time frames, in combination with non-face-to-face services that may be performed by the physician or other qualified health care professional and/or licensed clinical staff under his or her direction. It is our expectation that the services in the two lists of non-face-to-face services below will be routinely provided as part of transitional care management service unless the practitioner's reasonable assessment of the patient indicates that a particular service is not medically indicated or needed.
Non-face-to-face services provided by clinical staff, under the direction of the physician or other qualified health care professional, may include:
• Communication (direct contact, telephone, electronic) with the patient and/or caregiver within 2 business days of discharge.
• Communication with home health agencies and other community services utilized by the patient.
• Patient and/or family/caretaker education to support self-management, independent living, and activities of daily living.
• Assessment and support for treatment regimen adherence and medication management.
• Identification of available community and health resources.
• Facilitating access to care and services needed by the patient and/or family.
Non-face-to-face services provided by the physician or other qualified health care provider may include:
• Obtaining and reviewing the discharge information (for example, discharge summary, as available, or continuity of care documents).
• Reviewing need for or follow-up on pending diagnostic tests and treatments.
• Interaction with other qualified health care professionals who will assume or reassume care of the patient's system-specific problems.
• Education of patient, family, guardian, and/or caregiver.
• Establishment or reestablishment of referrals and arranging for needed community resources.
• Assistance in scheduling any required follow-up with community providers and services.
Transitional care management requires a face-to-face visit, initial patient contact, and medication reconciliation within specified time frames. The first face-to-face visit is part of the transitional care management service and not reported separately. Additional E/M services after the first face-to-face visit may be reported separately. Transitional care management requires an interactive contact with the patient or caregiver, as appropriate, within 2 business days of discharge. The contact may be direct (face-to-face), telephonic, or by electronic means. telephonic, or by electronic means. Medication reconciliation and management must occur no later than the date of the face-to-face visit.
Medical decision making and the date of the first face-to-face visit are used to select and report the appropriate transitional care management code. For 99496, the face-to-face visit must occur within 7 calendar days of the date discharge and medical decision making must be of high complexity. For 99495, the face-to-face visit must occur within 14 calendar days of the date of discharge and medical decision making must be of at least moderate complexity.
Medical decision making is defined by the E/M Services Guidelines. The medical decision making over the service period reported is used to define the medical decision making of transitional care management. Documentation includes the timing of the initial post discharge communication with the patient or caregivers, date of the face-to-face visit, and the complexity of medical decision making.
(The E/M Services Guidelines define levels of medical decision making on the basis of the following factors:
• The number of possible diagnoses and/or the number of management options that must be considered;
• The amount and/or complexity of medical records, diagnostic tests, and/or other information that must be obtained, reviewed, and analyzed; and
• The risk of significant complications, morbidity, and/or mortality as well as comorbidities associated with the patient's presenting problem(s), the diagnostic procedure(s), and/or the possible management options.
Only one individual may report these services and only once per patient within 30 days of discharge. Another transitional care management service may not be reported by the same individual or group for any subsequent discharge(s) within the 30 days. The same individual may report hospital or observation discharge services and transitional care management. The same individual should not report transitional care management services provided in the post-operative period for a service with a global period.
A physician or other qualified health care professional who reports codes 99495, 99496 may not report care plan oversight services (99339, 99340, 99374-99380), prolonged services without direct patient contact (99358, 99359), anticoagulant management (99363, 99364), medical team conferences (99366-99368), education and training (98960-98962, 99071, 99078), telephone services (98966-98968, 99441-99443), end stage renal disease services (90951-90970), online medical evaluation services (98969, 99444), preparation of special reports (99080), analysis of data (99090, 99091), complex chronic care coordination services (99481X-99483X), medication therapy management services (99605-99607), during the time period covered by the transitional care management services codes.
It is very important to emphasize that we consider the non-face-to-face services to be furnished by physicians, qualified health care professionals, and clinical staff to be intrinsic, indeed essential, components of the TCM codes. To support the non-face-to-face services, the TCM service requires a face-to-face visit, initial patient contact, and medication reconciliation within specified time frames. The first face-to-face visit is part of the TCM service and may not be reported separately. Additional reasonable and necessary E/M services required for managing the beneficiary's clinical issues in addition to the face-to-face visit may be reported separately.
Despite the importance of the face-to-face service that is a required element of the CPT TCM codes, the non-face-to-face services such as communication, referrals, education, identification of community resources, and medication management constitute the truly essential features that distinguish TCM from those services that are predominantly or exclusively face-to-face in nature.
We are adopting these new CPT TCM codes to provide a separate reporting mechanism for the community physician for these services in the context of the broader CMS multi-year strategy to recognize and support primary care and care management. Therefore, we plan to monitor the use of the transitional care management billing codes. We wish to emphasize again that the policies we are finalizing in this final rule may be short-term payment strategies that may be modified and/or revised over time to be consistent with broader primary care and care management initiatives. Because CPT TCM codes 99495 and 99496 are new codes, they will be valued and designated as interim final in this final rule with comment period and subject to public comment.
We would also note that this proposal coincides with our discussion under section III.J. of this final rule with comment period on the Value-based Payment Modifier and Physician Feedback Reporting Program which discusses hospital admission measures and a readmission measure as outcome measures for the proposed value-based payment modifier adjustment beginning in CY 2015.
To establish a physician work relative value unit (RVU) for the proposed post-discharge TCM, HCPCS code GXXX1, we compared GXXX1 with CPT code 99238 (Hospital discharge day management; 30 minutes or less) (work RVU = 1.28). We recognized that, unlike CPT code 99238, HCPCS code GXXX1 is not a face-to-face visit. However, we believed that the physician time and intensity involved in post-discharge community care management is most equivalent to CPT code 99238 which, like the proposed new G code, involves a significant number of care management services. Therefore, we proposed a work RVU of 1.28 for HCPCS code GXXX1 for CY 2013. We also proposed the following physician times: 8 minutes pre-evaluation; 20 minutes intra-service; and 10 minutes immediate post-service. In addition, we proposed to crosswalk the clinical labor inputs from CPT code 99214 (Level 4 established patient office or other outpatient visit) to proposed HCPCS code GXXX1. For malpractice expense, we proposed a malpractice crosswalk of CPT code 99214 for HCPCS code GXXX1 for CY 2013. We believe the malpractice risk factor for CPT code 99214 appropriately reflects the relative malpractice risk associated with furnishing HCPCS code GXXX1. In our proposal, we noted that, as with other services paid under the PFS, the 20 percent beneficiary coinsurance would apply to the post-discharge TCM service as would the Part B deductible.
With regard to PE, another commenter recommended that we assign clinical staff type RN/LPN only for the clinical staff work for the TCM codes because those are the only two clinical staff types who furnish clinical staff TCM activities. A commenter noted that this proposal largely ignores equipment costs (for example, computer, electronic health record, and telephone) that are essential to furnishing this service, and urged us to reconsider whether 1.41 is an appropriate practice expense RVU amount. Another commenter noted that our source code for practice expense, CPT code 99214, is for moderate complexity decision-making and that we should consider the greater costs associated with a patient of high complexity. One commenter agreed with our proposed malpractice value.
We appreciate comments suggesting that we value our proposed G-code, GXXX1, comparable to CPT codes G0180 and G0181. However, because we not finalizing the proposed G-codes and instead are adopting the CPT TCM codes on an interim final basis in this final rule with comment period, we believe that the AMA RUC recommendation, which reflects the services we included in the proposed G-code as well as a face-to-face visit, is a more basis for appropriate valuation. In response to comments noting that the discharge day management source code, CPT code 99238, for GXXX1, does not contain sufficient time for the receiving physician and that the time does not reflect differences in the complexity of decision-making, we note that we are adopting AMA RUC recommended times as modified in the preceding paragraph on an interim final basis, with refinement, which include a longer time than the proposed time of 30 minutes, and those times are specific to the level of complexity. We also note that there is a significant amount of clinical labor time incorporated in the practice expense calculation for these codes. In summary, we are assigning a work RVU of 2.11 to CPT TCM code 99495 with intra-service time of 40 minutes, and a work RVU of 3.05 with intra-service time of 50 minutes. The work RVUs included in Addendum B to this final rule with comment period reflect these interim final values. The physician time file associated with this PFS final rule with comment period is available on the CMS Web site in the Downloads section for the CY 2013 PFS final rule with comment period at
Consistent with our policy discussed in section II.C.1. of this final rule with comment period for assigning malpractice RVUs, we developed malpractice RVUs for the new CPT TCM codes. For CPT code 99495, the AMA RUC recommended a malpractice risk factor crosswalk to CPT code 99214, resulting in a malpractice RVU of 0.14 for CPT code 99495. For CPT code 99496, the AMA RUC recommended a malpractice risk factor crosswalk to CPT code 99215, resulting in a malpractice RVU of 0.20 for CPT code 99496. We are accepting the AMA RUC's recommended malpractice crosswalks for CPT codes 99495 and 99496 on an interim final basis. We appreciate comments in support of our proposed malpractice value for our non-face-to-face G-code, GXXX1, of 0.09. We believe that the interim final malpractice crosswalks recommended by the AMA RUC provide appropriate malpractice values for the CPT TCM codes, which include a face-to-face visit.
For practice expense, we are accepting the AMA RUC-recommended practice expense inputs for these codes with one refinement to clinical labor time for CPT code 99496. We are refining the 60 minutes of recommended clinical labor time for a RN/LPN nurse blend dedicated to non-face-to-face care management activities from 60 minutes to 70 minutes. We believe that the total clinical labor staff time and physician intra-service work time that the AMA RUC-recommended for non-face-to-face care management activities was accurate, but that the proportionality between physician work and clinical staff time should be refined to reflect greater clinical staff time. In response to the comment on appropriate clinical staff type for non-face-to-face care management services, we note that we are accepting the AMA RUC recommended clinical labor staff type of an RN/LPN for conducting non-face-to-face care coordination activities. The AMA RUC did not include additional costs for computer, EHR, and telephone in their recommendations. We believe accounting for the infrastructure required to furnish advanced primary care services is an issue we will consider as we pursue the broader HHS and CMS multi-year strategy to recognize and support primary care and care management under the MPFS.
The CY 2013 final rule with comment period direct PE input database reflects these inputs and is available on the CMS Web site under the supporting data files for the CY 2013 PFS final rule with comment period at
For BN calculations, we estimated that physicians or qualified nonphysician practitioners would furnish post-discharge TCM services for 10 million discharges in CY 2013. We estimated that this number roughly considers the total number of hospital inpatient and SNF discharges, hospital outpatient observation services and partial hospitalization patients that may require moderate to high complexity decision-making following discharge.
The next step is to determine how many of these discharges will be readmissions in CY 2013. Since the patient would only be eligible for one TCM service associated with a hospital discharge and the later readmission, we are not counting the readmission in our utilization estimate. The AMA RUC used an estimate of 19.6 percent. We disagree with this estimate. More recent work by MedPAC indicates that the all cause readmission rate was closer to 15 percent in CY 2011.
The AMA RUC also cited a variety of factors that it believes will reduce the number of billings from the universe of discharges, including the number of patients requiring moderate or high complexity decision-making based on the percentage of high cost Medicare patients in the Medicare population, the number of patients currently seen within 14 days of discharge, discharges where the primary care physician didn't know patient was in the hospital, cases where the patient couldn't be contacted or seen, cases where the patient died, cases where the patient changed doctors or didn't see the primary care doctor, and cases for which physicians will not furnish the TCM service as rapidly as we have assumed. The AMA RUC provided assumptions about the number of discharges it believes will not result in the billing of a TCM service. We have posted the AMA RUC calculation on our Web site at
In considering this and similar comments, we examined the current distribution of the inpatient, observation, and nursing facility evaluation and management codes. Within each of these families, we also examined the severity of the presenting problems and the level of complexity of the medical decision-making to help differentiate the codes. We found that 85 percent of Hospital Observation and Initial and Subsequent Hospital Care services (CPT codes 99218-99233) were at Level 2 or Level 3, generally indicating moderate to high severity and complexity. We note that over 90 percent of place of service designations for the discharge codes are inpatient or outpatient hospital. We found that 43 percent of Nursing Facility Care services (CPT codes 99304-99310) were at Level 2 or Level 3, generally indicating moderate to high severity and complexity. Although less relevant for the TCM policy, we also examined the Office or Other Outpatient visits (CPT codes 99201-99213) as a point of comparison and found that 41 percent of services were at Level 4 or Level 5, generally indicating moderate to high severity and complexity.
In light of the data on the current severity and complexity levels of the evaluation and management services, and after consideration of the factors included in the AMA RUC estimate and removing 15 percent for readmissions, we believe that two-thirds of the discharges reflected in the discharge day management codes, are likely to result in TCM claims. This represents approximately 5.7 million claims [=10 million discharges * (1−.15) for readmissions * (
We disagree with the RUC that 60 percent of those claims will be for 99495 and 40 percent for 99496. In looking at the relationship between the moderate and high Hospital Observation and Initial and Subsequent Hospital Care services (CPT codes 99218-99233) and the relationship between the moderate and high Nursing Facility Care services (99304-99310), we believe a more reasonable estimate is that 75 percent of the TCM claims will be for 99495 and 25 percent for 99496.
Because the practice expense RVUs for the transitional care codes will vary depending on whether or not the service is billed in a facility or non-facility setting, we also need to further refine the estimate to determine the proportion of TCM services that will be paid at the facility rate versus the non-facility rate. After examining the facility and non-facility distribution of the 99214 and 99215 visit codes billed by primary care specialties, we believe that 92 percent of the TCM services will be billed in the non-facility setting.
Lastly, we agree with the RUC that 26 percent of patients had at least one visit within 7 calendar days of discharge and 44 percent had one within 14 days of discharge. Because these are existing visits that will potentially now be billed as part of the TCM service, we partially offset the cost of the TCM services with the cost of the existing visits assumed to be billed as part of the CPT TCM code.
For the comments requesting that we also offset the cost of the CPT TCM codes in our BN calculation with savings from reduced readmissions, there are currently many efforts underway to reduce hospital readmissions. We do not believe that it would be possible to isolate the effect of payment for TCM services on the readmission rate. Furthermore, the statute does not permit costs or savings from outside of the physician fee schedule to be used in the physician fee schedule BN calculation.
For purposes of the Primary Care Incentive Payment Program (PCIP), we proposed to exclude the post discharge TCM services from the total allowed charges used in the denominator calculation to determine whether a physician is a primary care practitioner. Under section 1833(x) of the Act, the PCIP provides a 10 percent incentive payment for primary care services within a specific range of E/M services when furnished by a primary care practitioner. Specific physician specialties and qualified nonphysician practitioners can qualify as primary care practitioners if 60 percent of their PFS allowed charges are primary care services. As we explained in the CY 2011 PFS final rule (75 FR 73435-73436), we do not believe the statute authorizes us to add codes (additional services) to the definition of primary care services. However, to avoid inadvertently disqualifying community primary care physicians who follow their patients into the hospital setting, we finalized a policy to remove allowed charges for certain E/M services furnished to hospital inpatients and outpatients from the total allowed charges in the PCIP primary care percentage calculation.
In the proposed rule, we also proposed that the TCM code should be treated in the same manner as those services for the purposes of PCIP because post-discharge TCM services are a complement in the community setting to the hospital-based discharge day management services already
As we discussed above, we are committed to considering new options and developing future proposals for payment of primary care services under the MPFS. Such options would promote comprehensive and continuous assessment, care management, and attention to preventive services that constitute effective primary care by establishing appropriate payment when physicians furnish such services. One potential method for ensuring that any targeted payment for primary care services would constitute a minimum level of care coordination and continuous assessment under the MPFS would be to pay physicians for services furnished in an “advanced primary care practice” that has implemented a medical home model supporting patient-specific care. The medical home model has been the subject of extensive study in medical literature. Since 2007, the AMA, American Academy of Family Physicians (AAFP), the American Academy of Pediatrics (AAP), the American College of Physicians (ACP), and the American Osteopathic Association (AOA), and many other physician organizations have also endorsed “Joint Principles of the Patient-Centered Medical Home.” In February 2011, the AAFP, the AAP, the ACP, and AOA also published formal “Guidelines for Patient-Centered Medical Home (PCMH) Recognition and Accreditation Programs” to develop and promote the concept and practice of the PCMH. (These guidelines are available at
The medical home concept emphasizes establishing an extensive infrastructure requiring both capital investments and new staffing, along with sophisticated processes, to support continuous and coordinated care with an emphasis on prevention and early diagnosis and treatment. The literature, reports, and guidelines dealing with the medical home concept define the requisite elements or functions that constitute this infrastructure and processes in various ways. For example, the Innovation Center's CPC initiative identified a set of five “comprehensive primary care functions,” which form the service delivery model being tested and the required framework for practice transformation under the CPC initiative. In the proposed rule (77 FR 44780), we discussed these five “comprehensive primary care functions” as an appropriate starting point for discussing the incorporation of the comprehensive primary care services delivered in advanced primary care practices (practices implementing a medical home model) into the MPFS. These five
In the proposed rule, we also discussed the need to establish a set of parameters to determine whether or not a clinical practice could be considered an advanced primary care practice (medical home) in the event that we were to establish an enhanced payment for primary care services furnished to Medicare beneficiaries in an advanced primary care practice environment. (77 FR 44781-44782) Specifically, we discussed two possible approaches to determining whether a practice has implemented all the necessary functions to be considered an advanced primary care practice or medical home. One approach would be to recognize one or more of the nationally available accreditation programs currently in use by major organizations that provide accreditation for advanced primary care practices, frequently credentialed as “PCMHs.” We identified four national models that provide accreditation for organizations wishing to become an advanced primary care practice; the Accreditation Association for Ambulatory Health, The Joint Commission, the NCQA, and the Utilization Review Accreditation Commission (URAC). Alternatively, we could develop our own criteria using, for example, the five functions of comprehensive primary care used in the CPC initiative and described above, to determine what constitutes advanced primary care for purposes of Medicare payment. We would then need to develop a process for determining whether specific physician practices meet the criteria for advanced primary care. This could include creating our own processes for review or could include using existing accrediting bodies to measure compliance against advanced primary care criteria determined by CMS.
We also discussed another potential issue surrounding comprehensive primary care services delivered in an advanced primary care practice, specifically attribution of a beneficiary to an advanced primary care practice. (77 FR 44782) In a fee-for-service environment we would need to determine which practice is currently serving as the advanced primary care practice for the beneficiary to ensure appropriate payment. One method of attribution could be that each beneficiary prospectively chooses an advanced primary care practice. Other attribution methodologies might examine the quantity and type of E/M or other designated services furnished to that beneficiary by the practice. We welcomed input on the most appropriate approach to the issue of how to best determine the practice that is functioning as the advanced primary care practice for each beneficiary. We emphasized that we would not consider proposals that would restrict a beneficiary's free choice of practitioners.
In summary, we stated our belief that targeting primary care management payments to advanced primary care practices could have many merits, including ensuring a basic level of care coordination and care management. We recognize that the advanced primary care model has demonstrated efficacy in improving the value of health care in several contexts, and we are exploring whether we can achieve these outcomes for the Medicare population through several demonstration projects. Careful analysis of the outcomes of these demonstration projects will inform our understanding of how this model of care affects the Medicare population and of potential PFS payment mechanisms for these services. At the same time, we also believe that there are many policy and operational issues to be considered when nationally implementing such a program within the PFS. Therefore, we generally invited broad public comment on the accreditation and attribution issues discussed above and any other aspect, including payment, of integrating an advanced primary care model into the PFS.
We received many helpful and informative comments on the issues we discussed in relation to recognizing advanced primary care practices, especially on the criteria and processes that should be used to identify such practices. We welcome these comments because we are actively considering such an advanced primary care practice model in the near future after a complete assessment of the results of ongoing demonstrations and policy and operational considerations.
We also received many comments recommending that we adopt the complex care coordination codes developed by the AMA's C3W for CY 2013. As discussed in section III.M.3.a. of this final rule with comment period, on an interim final basis for CY 2013, we are assigning CPT codes 99487, 99488, and 99489 a PFS procedure status indicator of B (Payments for covered services are always bundled into payment for other services, which are 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 bundled (for example, a telephone call from a hospital nurse regarding care of a patient). We will consider these codes, as well as other payment approaches as we continue our multi-year strategy to recognize and support primary care and care management.
The AMA CPT Editorial Panel has created new CPT codes to replace the codes used to bill for molecular pathology services that will be deleted at the end of CY 2012. The new codes describe distinct molecular pathology tests and test methods. CPT divided these molecular pathology codes into Tiers. Tier 1 codes describe common gene-specific and genomic procedures. Tier 2 codes capture reporting for less common tests. Each Tier 2 code represents a group of tests that the CPT Editorial Panel believes involve similar technical resources and interpretive work. The CPT Editorial Panel created 101 new molecular pathology CPT codes for CY 2012 and another 14 new molecular pathology codes for CY 2013.
We stated in our notice for the Clinical Laboratory Fee Schedule (CLFS) Annual Public Meeting held on July 16, 2012 (77 FR 31620) that we were following our regular process to determine the appropriate basis and payment amounts for new clinical diagnostic laboratory tests, including molecular pathology tests, under the CLFS for CY 2013. However, we also stated that we understand stakeholders in the molecular pathology community continue to debate whether Medicare should pay for molecular pathology tests under the CLFS or the PFS. Medicare pays for clinical diagnostic laboratory tests through the CLFS and for services that ordinarily require physician work through the PFS. We stated that we believed we would benefit from additional public comments on whether these tests are clinical diagnostic laboratory tests that should be paid under the CLFS or whether they are physicians' services that should be paid under the PFS. Therefore, we solicited public comment on this issue in the CY 2013 PFS proposed rule (77 FR 44782 and 44783), as well as public comment on pricing policies for these tests under the CLFS during the CLFS Annual Public Meeting process.
In the PFS proposed rule, we first discussed and requested public comment on whether these molecular pathology CPT codes describe services
As detailed in section II.B.1. of this final rule with comment period, Medicare establishes payment under the PFS by setting RVUs for work, practice expense (PE), and malpractice expense for services that ordinarily require physician work. To establish RVUs for physician work, we conduct a clinical review of the relative physician work (time by intensity) required for each PFS service. This clinical review includes the review of RVUs recommended by the American Medical Association/Specialty Society Relative Value Scale Update Committee (AMA RUC) and others. The AMA RUC-recommended work RVUs for a service typically are based in part on results of a survey conducted by the relevant specialty society. CMS establishes PE RVUs under a resource-based PE methodology that considers the cost of direct inputs, as well as indirect PE costs. The AMA RUC, through the Practice Expense Subcommittee, recommends direct PE inputs to CMS, and the relevant specialty societies provide pricing information for those direct inputs to CMS. After we determine the appropriate direct PE inputs, the PE methodology is used to develop PE RVUs. Physician work and PE RVUs for each CPT code are constructed to reflect the typical case; that is, they reflect the service as it is most commonly furnished (71 FR 69629). CMS establishes resource-based malpractice expense RVUs using weighted specialty-specific malpractice insurance premium data collected from commercial and physician-owned insurers, last updated for the CY 2010 final rule (74 FR 61758). For most services paid under the PFS, beneficiary cost-sharing is 20 percent of the fee schedule payment amount.
CMS establishes a payment rate for new clinical diagnostic laboratory tests under the CLFS by either crosswalking or gap-filling. Crosswalking is used when a new test code is comparable to an existing test code, multiple existing test codes, or a portion of an existing test code on the CLFS. Under this methodology, the new test code is assigned the local fee schedule amounts and the national limitation amount (NLA) of the existing test, with payment made at the lesser of the local fee schedule amount or the NLA. Gap-filling is used when no comparable test exists on the CLFS. In the first year a test is gap-filled, contractor-specific amounts are established for the new test code using the following sources of information: Charges for the test and routine discounts to charges; resources required to perform the test; payment amounts determined by other payers; and charges, payment amounts, and resources required for other tests that may be comparable or otherwise relevant. For the second year, the NLA is calculated, which is the median of the carrier-specific amounts. See § 414.508. Services paid under the CLFS do not account for any physician work, although tests paid under the CLFS can involve assessment by a laboratory technician/technologist, a chemist, molecular biologist, or a geneticist—none of which are health care professional occupations that meet the statutory definition of a physician. Although payments can vary geographically due to contractor discretion across locality areas (which are the same localities used for the GPCIs under the PFS), payments cannot exceed a NLA, nor are they adjusted once rates are determined (apart from inflation updates as required by statute). In the CY 2008 PFS final rule with comment period, we adopted a prospective reconsideration process for new tests paid under the CLFS, allowing a single year for Medicare and stakeholders to review pricing for new tests after a payment is initially established through crosswalking, and in certain circumstances, up to 2 years for Medicare and stakeholders to review pricing for new tests after a payment is initially established through gap-filling (72 FR 66275 through 66279, 66401 through 66402). Finally, in almost all circumstances, there is no beneficiary cost-sharing for clinical laboratory diagnostic tests paid on the CLFS.
For a handful of clinical laboratory services paid under the CLFS, we allow an additional payment under the PFS for the professional services of a pathologist when they meet the requirements for a clinical consultation service as defined in § 415.130(c). The PFS pays for services that ordinarily require the work of a physician and, with regard to pathology services, explicitly pays for both the professional and technical component of the services of a pathologist as defined in § 415.130(b), including surgical pathology, cytopathology, hematology, certain blood banking services, clinical consultations, and interpretive clinical laboratory services.
Molecular pathology tests are currently billed using combinations of longstanding CPT codes that describe each of the various steps required to perform a given test. This billing method is called “stacking” because different “stacks” of codes are billed depending on the components of the furnished test. Currently, all of the stacking codes are paid through the CLFS; and one stacking code, CPT code 83912 (molecular diagnostics; interpretation and report), is paid on both the CLFS and the PFS. Payment for the interpretation and report of a molecular pathology test when furnished and billed by a physician is made under the PFS using the professional component (PC, or modifier 26) of CPT code 83912 (83912-26). Payment for the interpretation and report of a molecular pathology test when furnished by nonphysician laboratory professional is bundled into payment made under the CLFS using CPT code 83912.
As we stated in the CY 2013 PFS proposed rule (77 FR 44783), since the creation of new molecular pathology CPT codes, there has been significant debate in the stakeholder community regarding whether these new molecular pathology CPT codes describe physicians' services that ordinarily require physician work and would be paid under the PFS, or whether they describe clinical diagnostic laboratory tests that would be paid on the CLFS. In the CY 2013 PFS proposed rule (77 FR 44783), we stated that there is little agreement on whether the technical component and/or professional component (interpretation and report) of these services are ordinarily furnished by a physician or a nonphysician laboratory professional. Additionally, we stated that some stakeholders have suggested that interpretation and report by any health care professional is generally not necessary for these services, as the laboratory result reporting is becoming more automated.
In the CY 2012 PFS final rule with comment period (76 FR 73190), we stated that for CY 2012, Medicare would continue to use the existing stacking codes for the reporting and payment of these molecular pathology tests, and that the new molecular pathology CPT codes would not be valid for payment for CY 2012. We did this because we were concerned that we did not have sufficient information to know whether the new molecular pathology CPT codes describe clinical diagnostic laboratory tests or services that ordinarily require physician work. In the PFS proposed
• Do each of the 101 molecular pathology CPT codes describe services that are ordinarily furnished by a physician?
• Do each of these molecular pathology CPT codes ordinarily require interpretation and written report?
• What is the nature of that interpretation and does it typically require physician work?
• Who furnishes interpretation services and how frequently?
In the CY 2013 PFS proposed rule, we also proposed to price all of the new molecular pathology CPT codes through a single fee schedule, either the CLFS or the PFS. We stated that after meeting with stakeholders and reviewing each CPT code, we believed that there are a discrete number of laboratory methods used to generate results across molecular pathology tests. For example, two different tests (represented by different CPT codes) may be run using the same testing methodologies, but using different genes. However, there are very different processes for establishing payment rates under the PFS and the CLFS. As discussed above, Medicare sets payment under the CLFS by either crosswalking or gap-filling and, after the prospective reconsideration process we do not adjust the payment amount further (apart from inflation updates as required by statute). In contrast, Medicare sets payment under the PFS through a set of resource-based methodologies for physician work, PE, and malpractice expense, and payment can be reviewed and adjusted as the resources required to furnish a service change. We stated that we were concerned that establishing different prices for comparable laboratory services across two different payment systems would create a financial incentive to choose one test over another simply because of its fee schedule placement. We stated that we were also concerned that the differences in prices would become more pronounced over time, as we continue to review the values for physician work and PE inputs on the PFS relative to established CLFS prices. Therefore, largely because of the homogeneity of the laboratory methodologies behind these procedure test codes, we stated that we believe that it is appropriate for all new molecular pathology CPT codes to be priced on the same fee schedule using the same methodology. We invited public comment on that proposal.
As we considered public comment on whether these molecular pathology CPT codes describe services that ordinarily require physician work, we wanted to ensure that there was a payment mechanism in place to pay for these CPT codes for CY 2013, either on the PFS or the CLFS. We stated that, because we believe that these molecular pathology CPT codes may be clinical diagnostic laboratory tests payable on the CLFS, comments and recommendations from the public on the appropriate basis for establishing payment amounts on the CLFS would be discussed and received through the CY 2013 CLFS Annual Public Meeting process. More information on these tests is available on the CMS Web site at
As a parallel to determining the appropriate basis and payment amounts for the molecular pathology CPT codes as clinical diagnostic laboratory tests through the CLFS Annual Public Meeting process, we also proposed payment for these codes under the PFS for CY 2013. In the CY 2013 PFS proposed rule, we stated that the AMA RUC and the College of American Pathologists (CAP) provided CMS with recommendations for physician work RVUs and PE inputs for most of the molecular pathology CPT codes. We did not have recommendations on physician work RVUs or direct PE inputs for a small number of codes, which represent tests that are patented, and therefore the methodology used to furnish the test is proprietary and was unavailable to the AMA RUC or CMS to support developing appropriate work and direct PE inputs. As we stated in the PFS proposed rule, the AMA RUC-recommended physician work RVUs range from 0.13 to 2.35, with a median work RVU of 0.45. The AMA RUC-recommended physician intra-service times (which, for these codes, equals the total times) range from 7 minutes to 80 minutes, with a median intra-service time of 18 minutes. We noted that the physician work RVU for CPT code 83912-26 and all but one of the other clinical diagnostic laboratory services for which CMS recognizes payment for clinical interpretation is 0.37. Table 27 lists AMA RUC-recommended physician work RVUs and times, as well as the AMA RUC-estimated CY 2013 utilization for these codes. This table contains the AMA RUC's estimated CY 2013 utilization for all 115 molecular pathology codes effective for CY 2013 and recommended physician work RVUs and times only for those codes that CAP believes are ordinarily performed by a physician. These values are listed for reference only and were not used for PFS rate-setting.
As we stated in the PFS proposed rule, molecular pathology tests can be furnished in laboratories of different types and sizes (for example, a large commercial laboratory, academic or research laboratory, typically hospital-based, or potentially, a pathology group practice), and tests may be furnished in small or large batches. Also, although there are largely homogenous methods across the different tests considered here, we recognize that for a specific test, the combination of methods may vary across different laboratories. When developing direct PE input recommendations for CMS, CAP and the AMA RUC made assumptions about the typical laboratory setting and batch size to determine the typical direct PE inputs for each service. Given that many of these services are furnished by private laboratories, it was challenging for CAP and the AMA RUC to provide recommendations on the typical inputs for many services, and not possible for other services. We posted the AMA RUC- and CAP-recommended direct PE inputs on the CMS Web site in the files supporting the CY 2013 PFS proposed rule at
As we discussed in the CY 2013 PFS proposed rule, in addition to recommendations on physician work and direct PE inputs, the AMA RUC provided CMS with recommended utilization crosswalks for most of the molecular pathology tests. When there are coding changes, the utilization crosswalk tracks Medicare utilization from an existing code to a new code. The existing code utilization figures are drawn from Medicare Part B claims data. We use utilization crosswalk assumptions to ensure PFS budget neutrality and to create PE RVUs
We stated that if we were to finalize payment for molecular pathology tests under the PFS, we did not believe that we could propose national payment rates, because the following questions remained:
• If these services are furnished by a physician, what are the appropriate physician work RVUs and times relative to other similar services?
• Where and how are each of these services typically furnished—for example, what is the typical laboratory setting and batch size?
• What is the correct projected utilization for each of these services?
In the CY 2013 PFS proposed rule, we stated that, given these major areas of uncertainty, if CMS determined that new molecular pathology CPT codes should be paid under the PFS for CY 2013, we would propose to allow the Medicare contractors to price these codes because we do not believe that we have sufficient information to engage in accurate national pricing and because the price of tests can vary locally. As previously discussed, this proposal was parallel to the CLFS Annual Public Meeting process through which we received comments and recommendations on the appropriate basis for establishing a payment amount for these molecular pathology tests as clinical diagnostic laboratory tests under the CLFS. We stated that if we decided to finalize payment for these new codes under the PFS, we would consider modifying § 415.130 as appropriate to provide for payment to a pathologist for molecular pathology tests.
Finally, we stated that, after reviewing comments received on the proposals contained within the CY 2013 PFS proposed rule (77 FR 44782 through 44787), and after hearing the discussion at the CLFS Annual Public Meeting and reviewing comments and recommendations during the public meeting process, we would determine the appropriate basis for establishing payment amounts for the new molecular pathology CPT codes. We stated that we would publish our final decision in the CY 2013 PFS final rule with comment period and, at the same time the final rule is published, post final payment determinations for any molecular pathology tests that will be paid under the CLFS.
A summary of the comments received on the questions and proposals discussed in the CY 2013 PFS proposed rule, followed by our responses and conclusions are below.
We received the following comments in response to our questions on whether these molecular pathology CPT codes describe services that are ordinarily furnished by a physician; whether the services require interpretation and written report and, if so, who ordinarily furnishes that interpretation and how frequently; what is the nature of that interpretation and does it typically require physician work; and the broader question of whether these codes describe physicians' services that should be paid under the PFS or if they describe clinical diagnostic laboratory tests that should be paid under the CLFS; as well as our proposal to price all molecular pathology CPT codes through a single fee schedule:
In contrast, other commenters noted that the molecular pathology CPT codes were developed as global services, including both professional (physician work) and technical components together, and so the CPT codes inherently include physician work. They noted that many of the clinical vignettes developed as a part of the CPT and AMA RUC processes demonstrate the incorporation of the technical steps and the professional services by a pathologist associated with each code.
There was little agreement among commenters on whether molecular pathology tests require any interpretation and whether that interpretation is ordinarily furnished by a physician. Several commenters noted that molecular pathology tests can be divided into three groups based on interpretation requirements. The first group includes tests that require interpretation by a physician to generate a beneficiary-specific result, which, they stated, includes tests that utilize fluorescence in situ hybridization or immunohistochemistry technology. The second group includes tests that require interpretation by a nonphysician qualified healthcare professional to produce a beneficiary-specific result, which, they stated, includes many of the genetic tests assigned to Tier 1 and Tier 2 CPT codes. The third group includes tests that do not require interpretation by either a physician or health care professional because the test system produces the beneficiary-specific result, which, they stated, includes multi-analyte assays with algorithmic analyses (MAAAs) and in vitro diagnostic kits for genetic tests that have been assigned Tier 1 and Tier 2 CPT codes.
Other commenters noted that each of the tests represented by the new molecular pathology CPT codes ordinarily requires interpretation and report. Several commenters explained that even clearly negative results, in
There was also little agreement among commenters as to whether the interpretation and report associated with these molecular pathology tests is ordinarily performed by a physician. Many commenters stated that clinical molecular diagnostics is a rapidly evolving diagnostic subspecialty that requires both technical and medical knowledge to interpret test results for use in beneficiary care. They explained that these molecular pathology tests require review by an expert who is well-versed in the interpretation of molecular pathology test results, who has the medical knowledge to place the results in a clinical context, and who can guide decisions about beneficiary treatment options and care management. They contended that selecting the best treatment path for an individual beneficiary's disease state is a key facet of molecular pathology and depends upon the pathologist's clinical expertise in the disease area. Commenters stated that, with molecular pathology, it is medically necessary for the pathologist to provide the referring physician with clinical insight about how the result should be interpreted based on the technique used and on the beneficiary's history and medical condition. They contended that this differs from other laboratory subspecialties where the ordering physician typically has the expertise to interpret test results. These commenters stated that interpretation and report of a molecular pathology test is ordinarily furnished by a physician.
In contrast, other commenters noted that, regardless of the nature of the interpretation for a molecular pathology test, doctoral-level geneticists are qualified and credentialed to perform the interpretation. The commenters stated that physician interpretation is not typical. They stated that in some laboratories, physicians may interpret test results when circumstances require a broader clinical review. They went on to note that among 367,370 molecular pathology allowed services with interpretation and report paid by Medicare in 2010, approximately 80 percent of the services did not require a physician interpretation.
Commenters who stated that molecular pathology tests ordinarily require the interpretation of a physician also stated that the molecular pathology tests should be paid under the PFS. Generally, these commenters contended that it is medically necessary for a physician to interpret the molecular pathology test results, guide the beneficiary's treatment, assess the beneficiary's progress, and prepare the final report for the beneficiary's record. As such, the commenter stated molecular pathology, as a field, is fundamentally different from laboratory medicine. They reasoned that complex tests that require physician interpretation to be clinically meaningful belong on the PFS. Additionally, some commenters stated that these services should be paid under the PFS because the resources involved in furnishing molecular pathology tests are changing rapidly. They pointed out that only the PFS currently allows the valuation of the codes to be continuously reviewed and scrutinized, taking into account changing technology and increased efficiencies as technology is adopted and becomes more widespread. They noted that placing the CPT codes for these molecular pathology tests on the PFS will enable the healthcare system to capture those savings. Finally, some commenters who stated that the molecular pathology tests should be paid under the PFS also thought that CMS should establish CLFS payment for laboratory interpretation and report of a molecular pathology test.
Commenters who stated that molecular pathology tests do not ordinarily require the interpretation of a physician also stated that the molecular pathology tests should be paid under the CLFS. Generally, these commenters contended that if a service is not ordinarily furnished by a physician, then CMS is precluded from paying for the service under the PFS. They explained that, as stated by the regulation at § 415.130(b), allowable physician pathology tests can only be paid if they first meet the threshold criteria of § 415.102(a)(1) (“The services are personally furnished for an individual beneficiary by a physician”) and § 415.102(a)(3) (“The services ordinarily require performance by a physician.”) Additionally, some commenters stated that the tests described by the new molecular pathology CPT codes will continue to be performed exactly as they were prior to the coding change and that there is no reason why the tests should not continue to be paid under the CLFS. Finally, some commenters who stated that the molecular pathology tests should be paid under the CLFS also suggested that CMS should establish PFS payment for physician interpretation and report of a molecular pathology test.
Finally, in response to our proposal to price all molecular pathology CPT codes through a single fee schedule, most commenters stated that CMS should assess each CPT code independently and include the molecular pathology tests that require physician work on the PFS, and the molecular pathology tests that do not require physician work on the CLFS. However, as stated above, some commenters stated that all the molecular pathology CPT codes include physician work, and should all be placed together on the PFS, while others stated that none of the molecular pathology CPT codes require physician work, and all should be placed together on the CLFS. Finally, as stated above, some commenters suggested that the tests should be paid under the CLFS with a PFS payment for physician interpretation and report of a molecular pathology test whereas others stated that the tests should be paid under the PFS with a CLFS payment for laboratory interpretation and report of a molecular pathology test.
We do not agree with some commenters that these codes inherently include physician work because they were developed as global services. We have a long-standing policy of dividing a global diagnostic service into a professional and technical component to separately capture the resources involved in the professional work and technical component of the test. We are not convinced that a physician must be involved in performing portions of the technical component. We believe that some molecular pathology tests are automated and do not require interpretation. Where the laboratory processes are not automated, laboratory personnel, including doctoral-level geneticists, can produce accurate molecular pathology test results. Although there might be occasions when a physician furnishes some of the technical component of a clinical laboratory test paid under the CLFS, we do not believe that performance by a physician changes the nature of the work. Rather, we believe it would still be appropriate to make payment for the technical work as part of the CLFS payment for the test. One commenter provided a claims analysis demonstrating that physicians are the most common entity to bill CPT code 89312 in the 2009 claims data; that there are more individual pathologists submitting claims for molecular pathology services than there are independent laboratories submitting claims for molecular pathology services. We believe this speaks to the different business structures in the pathology and laboratory communities. We would expect numerous different pathologists working in a hospital-based academic or research laboratory to bill for their professional services interpreting and reporting on a molecular pathology test independently under their NPI or group NPI using CPT code 83912-26. We would expect commercial laboratories to bill CPT code 83912 for interpretation and report by a nonphysician laboratory professional, like a doctoral-level geneticist, for a great volume of tests under a single laboratory NPI. We do not believe this analysis of the typical provider supports an assessment of whether interpretation is ordinarily required for furnishing molecular pathology services.
Finally, while we considered the differences in methodology for pricing under the CLFS versus the PFS, including the ability to apply a budget neutrality adjustment under the PFS, we do not believe that the differences in payment methodologies should be a definitive basis for deciding to choose a specific fee schedule. Rather, the statute requires Medicare to pay using separate methodologies for physicians' services and for clinical diagnostic laboratory tests. Ultimately, we believe the primary criterion for determining the appropriate payment methodology is the identification of a service as one or the other.
Therefore, for CY 2013, we are assigning a PFS procedure status indicator of X (Statutory exclusion. These codes represent an item or service that is not within the statutory definition of “physicians' services” for PFS payment purposes (for example, ambulance services). No RVUs are shown for these codes and no payment may be made under the PFS to the molecular pathology CPT codes listed in Table 27, because payment will be made for these tests under the CLFS. More information on the CLFS determination of the appropriate basis for payment (crosswalk or gap-filling) for these tests is available on the CMS Web site at
While we do not believe the molecular pathology tests are ordinarily performed by physicians, we do believe that, in some cases, a physician interpretation of a molecular pathology test may be medically necessary to provide a clinically meaningful, beneficiary-specific result. In order to make PFS payment for that physician interpretation, on an interim basis for CY 2013, we have created HCPCS G-code G0452 (molecular pathology procedure; physician interpretation and report) to describe medically necessary interpretation and written report of a molecular pathology test, above and beyond the report of laboratory results. This professional component-only HCPCS G-code will be considered a “clinical laboratory interpretation service,” which is one of the current categories of PFS pathology services under the definition of physician pathology services at § 415.130(b)(4). Section § 415.130(b)(4) of the regulations and section 60 of the Claims Processing Manual (IOM 100-04, Ch. 12, section 60.E.) specify certain requirements for billing the professional component of certain clinical laboratory services including that the interpretation (1) must be requested by the patient's attending physician, (2) must result in a written narrative report included in the patient's medical record, and (3) requires the exercise of medical judgment by the consultant physician. We note that a hospital's standing order policy can be used as a substitute for the individual request by a patient's attending physician. The current CPT code for interpretation and report, 83912-26, is included on the current list of clinical laboratory interpretation services but will be deleted at the end of CY 2012.
We will monitor the utilization of this service and collect data on billing patterns to ensure that G0452 is only being used when interpretation and report by a physician is medically necessary and is not duplicative of laboratory reporting paid under the CLFS. In the near future, we intend to reassess whether this HCPCS code is necessary, and if so, in conjunction with which molecular pathology tests. A discussion of the work and direct PE inputs for HCPCS G-code G0452 can be found later in this section. We note that physicians can continue to receive payment for the current clinical pathology consultation CPT codes 80500 (Clinical pathology consultation; limited, without review of a patient's history and medical records) and 80502 (Clinical pathology consultation; comprehensive, for a complex diagnostic problem, with review of patient's history and medical records) if the pathology consultation services relating to a molecular pathology test meet the definition of those codes.
We do not believe it is appropriate to establish a HCPCS G-code on the CLFS for the interpretation and report of a molecular pathology test by a doctoral-level scientist or other appropriately trained nonphysician health care professional. The new molecular pathology CPT codes consolidate the services previously reported using the CLFS stacking codes, including the CLFS stacking code for laboratory interpretation and report of a molecular pathology test (CPT code 83912). As such, we believe that payment for the interpretation and report service would be considered part of the overall CLFS payment for the molecular pathology CPT codes. In addition, geneticists and other nonphysician laboratory personnel do not have a Medicare benefit category that allows them to bill and be paid for their interpretation services; therefore, they cannot bill or receive PFS payment for HCPCS code G0452.
In response to our questions about the appropriate physician work RVUs and times, utilization crosswalks, and direct PE inputs for the molecular pathology services described by the CPT codes, as
Commenters stated that they are concerned that contractor pricing would lack the breadth of input, external scrutiny, and relativity utilized in the development of the AMA RUC recommendations. Commenters also believe that contractor pricing would add administrative complexities and costs, and that variations in contractor pricing would be disruptive. Also, commenters stated that contractor pricing could result in movement of sites of testing to the highest paying regions in order to maximize Medicare payment for individual services. Furthermore, commenters suggested that the variation in the costs of these tests is related to differences in laboratory facilities, equipment, and/or test methodologies, and that the variation is not geographically based; therefore, contractor pricing is not appropriate.
Regarding the utilization estimates for the new molecular pathology CPT codes, the AMA RUC noted that its utilization projections were based on the utilization of CPT code 83912 (molecular diagnostics; interpretation and report), which includes interpretation on both the physician fee schedule (83912-26) and the clinical laboratory fee schedule (83912), when interpretation by technical laboratory personnel, such as a geneticist, accompanies performance of the molecular pathology test represented by other “stacking” codes on a claim. The AMA RUC noted that utilization of this service has been growing rapidly and provided updated utilization assumptions based on 2011 Medicare allowed charges for CPT code 83912. These utilization assumptions, and the AMA RUC-recommended physician work RVUs and times, for all 115 codes are included in Table 27 for reference. However, we note that because these services are not payable under the PFS, these values were not used for rate-setting.
Under section 1861(ddd) of the Act, as amended by section 4105 of the Affordable Care Act, CMS is authorized to add coverage of “additional preventive services” if certain statutory criteria are met as determined through the national coverage determination (NCD) process, including that the service meets all of the following criteria: (1) They must be reasonable and necessary for the prevention or early detection of illness or disability, (2) they must be recommended with a grade of A or B by the United States Preventive Services Task Force (USPSTF), and (3) they must be appropriate for individuals entitled to benefits under Part A or enrolled under Part B. After reviewing the USPSTF recommendations for the preventive services, conducting evidence reviews, and considering public comments under the NCD process, we determined that the above criteria were met for the services listed in Table 28. Medicare now covers each of the following preventive services:
• Screening and Behavioral Counseling Interventions in Primary Care to Reduce Alcohol Misuse, effective October 14, 2011;
• Screening for Depression in Adults, effective October 14, 2011;
• Screening for Sexually Transmitted Infections (STIs) and High Intensity Behavioral Counseling (HIBC) to Prevent STIs, effective November 8, 2011;
• Intensive Behavioral Therapy for Cardiovascular Disease, effective November 8, 2011; and
• Intensive Behavioral Therapy for Obesity, effective November 29, 2011.
Table 28 lists the HCPCS G-codes created for reporting and payment of these services. The Medicare PFS payment rates for these services are discussed below. The NCD process establishing coverage of these preventive services was not complete at the time of publication of the CY 2012 PFS final rule with comment period, so we could not include interim RVUs for these preventive services in the addenda to our CY 2012 final rule with comment period. However, we were able to include these HCPCS G-codes with national payment amounts for these services in the CY 2012 PFS national relative value files, which were effective January 1, 2012. From the effective date of each service to December 31, 2011, the payment amount for these codes was established by the Medicare Administrative Contractors.
Two new HCPCS codes, G0442 (Annual alcohol misuse screening, 15 minutes), and G0443 (Brief face-to-face behavioral counseling for alcohol misuse, 15 minutes), were created for the reporting and payment of screening and behavioral counseling interventions in primary care to reduce alcohol misuse.
As we explained in the proposed rule, we believe that the screening service described by HCPCS code G0442 requires similar physician work as CPT code 99211 (Level 1 office or other outpatient visit, established patient). Accordingly, we proposed a work RVU of 0.18 for HCPCS code G0442 for CY 2013, the same work RVU as CPT code 99211. For physician time, we proposed 15 minutes, which is the amount of time specified in the HCPCS code descriptor for G0442. We proposed a malpractice expense crosswalk to CPT code 99211. The proposed direct PE inputs were reflected in the CY 2013 proposed direct PE input database, available on the CMS Web site under the downloads for the CY 2013 PFS proposed rule at
After consideration of the public comments we received, we are finalizing our CY 2013 proposal to establish a work RVU of 0.18 and a time of 15 minutes for HCPCS code G0442. For malpractice expense, we are finalizing our proposed crosswalk for HCPCS code G0442 to CPT code 99211. We are also finalizing the direct PE inputs as proposed. The direct PE inputs associated with this code are included in the CY 2013 direct PE input database, available on the CMS Web site under the downloads for the CY 2013 PFS final rule with comment period at
As we explained in the proposed rule, we believe that the behavioral counseling service described by HCPCS code G0443 requires similar work as CPT code 97803 (Medical nutrition therapy; re-assessment and intervention, individual, face-to-face with the patient, each 15 minutes). Accordingly, we proposed a work RVU of 0.45 for HCPCS code G0443 for CY 2013, the same work RVU as CPT code 97803. For physician time, we proposed 15 minutes, which is the amount of time specified in the HCPCS code descriptor for G0443. For malpractice expense, we proposed a malpractice expense crosswalk to CPT code 97803. The proposed direct PE inputs are reflected in the CY 2013 proposed direct PE input database, available on the CMS Web site under the downloads for the CY 2013 PFS proposed rule at
After consideration of the public comments that we received, we are finalizing the proposed work RVU of 0.45 and a time of 15 minutes for HCPCS code G0443. For malpractice expense, we are finalizing our proposed crosswalk to for HCPCS code G0443 to CPT code 97803. We are also finalizing the direct PE inputs as proposed. The direct PE inputs associated with this code are included in the CY 2013 direct PE input database, available on the CMS Web site under the downloads for the CY 2013 PFS final rule with comment period at
After consideration of the public comments we received, we are finalizing the proposed a work RVU of 0.18, and a time of 15 minutes for HCPCS G0444 code. For malpractice expense, we are finalizing our proposed crosswalk for HCPCS G0444 code. For malpractice expense, we are finalizing our proposed crosswalk for HCPCS code G0444 to CPT code 99211. We are also finalizing the direct PE inputs as proposed. The direct PE inputs associated with this code are included in the CY 2013 direct PE input database, available on the CMS Web site under the downloads for the CY 2013 PFS final rule with comment period at
After consideration of the public comments we received, we are finalizing the proposed a work RVU of 0.45 and a time of 30 minutes for HCPCS code G0445. For malpractice expense, we are finalizing our proposed crosswalk for HCPCS code G0445 to CPT code 97803. We are also finalizing the direct PE inputs as proposed. The direct PE inputs associated with this code are included in the CY 2013 direct PE input database, available on the CMS Web site under the downloads for the CY 2013 PFS final rule with comment period at
Based upon the comments we received, we are finalizing the proposed rate for HCPCS code G0446. It will be valued with a work RVU of 0.45, and with a time of 15 minutes. For malpractice expense, we are finalizing our proposed crosswalk for HCPCS code G0446 to CPT code 97803. We are also finalizing the direct PE inputs as proposed. The direct PE inputs associated with this code are included in the CY 2013 direct PE input database, available on the CMS Web site under the downloads for the CY 2013 PFS final rule with comment period at
After the consideration of the public comments we received, we are finalizing the proposed work RVU of 0.45 and a time of 15 minutes for HCPCS G0447 code. For malpractice expense, we are finalizing our proposal to crosswalk HCPCS code G0447 to CPT code 97803. We are also finalizing the direct PE inputs as proposed. The direct PE inputs associated with this code are included in the CY 2013 direct PE input database, available on the CMS Web site under the downloads for the CY 2013 PFS final rule with comment period at
The benefit category for services furnished by a certified registered nurse anesthetist (CRNA) was added in section 1861(s)(11) of the Act by section 9320 of the Omnibus Budget Reconciliation Act (OBRA) of 1986. Since this benefit was implemented on January 1, 1989, CRNAs have been eligible to bill Medicare directly for services within this benefit category. Section 1861(bb)(2) of the Act defines a CRNA as “a certified registered nurse anesthetist licensed by the State who meets such education, training, and other requirements relating to anesthesia services and related care as the Secretary may prescribe. In prescribing such requirements the Secretary may use the same requirements as those established by a national organization for the certification of nurse anesthetists.”
Section 410.69(b) defines a CRNA as a registered nurse who: (1) Is licensed as a registered professional nurse by the State in which the nurse practices; (2) meets any licensure requirements the State imposes with respect to nonphysician anesthetists; (3) has graduated from a nurse anesthesia educational program that meets the standards of the Council on Accreditation of Nurse Anesthesia Programs, or such other accreditation organization as may be designated by the Secretary; and (4) meets one of the following criteria: (i) Has passed a certification examination of the Council on Certification of Nurse Anesthetists, the Council on Recertification of Nurse Anesthetists, or any other certification organization that may be designated by the Secretary; or (ii) is a graduate of a program described in paragraph (3) of
Section 1861(bb)(1) of the Act defines services of a CRNA as “anesthesia services and related care furnished by a certified registered nurse anesthetist (as defined in paragraph (2)) which the nurse anesthetist is legally authorized to perform as such by the State in which the services are furnished.” CRNAs are paid at the same rate as physicians for furnishing such services to Medicare beneficiaries. Payment for services furnished by CRNAs only differs from physicians in that payment to CRNAs is made only on an assignment-related basis (§ 414.60) and supervision requirements apply in certain circumstances.
At the time that the Medicare benefit for CRNA services was established, anesthesia practice, for anesthesiologists and CRNAs, largely occurred in the surgical setting and services other than anesthesia (medical and surgical) were furnished in the immediate pre- and post-surgery timeframe. The scope of “anesthesia services and related care” as delineated in section 1861(bb)(1) of the Act reflected that practice. As anesthesiologists and CRNAs have moved into other practice settings, questions have arisen regarding what services are encompassed under the benefit category's characterization of “anesthesia and related care.” As an example, some CRNAs now offer chronic pain management services that are separate and distinct from a surgical procedure. We recently received additional information about upcoming changes to CRNA curricula to include specific training regarding chronic pain management services. Such changes in CRNA practice have prompted questions as to whether these services fall within the scope of section 1861(bb)(1) of the Act.
As we noted in the CY 2013 proposed rule (77 FR 44788), Medicare Administrative Contractors (MACs) have reached different conclusions as to whether the statutory benefit category description of “anesthesia services and related care” encompasses the chronic pain management services furnished by CRNAs. The scope of the benefit category determines the scope of services for which a physician, practitioner, or supplier may receive Medicare payment. In order for the specific services to be paid by Medicare, the services must be reasonable and necessary for treatment of the patient's illness or injury.
To address what is included in the benefit category for CRNAs in the CY 2013 proposed rule, we assessed our current regulations and subregulatory guidance, and determined that the existing guidance does not specifically address whether chronic pain management is included in the CRNA benefit. In the Internet Only Manual (Pub 100-04, Ch 12, Sec 140.4.3), we discuss the medical or surgical services that fall under the “related care” language stating: “These may include the insertion of Swan Ganz catheters, central venous pressure lines, pain management, emergency intubation, and the pre-anesthetic examination and evaluation of a patient who does not undergo surgery.” Some have interpreted the reference to “pain management” in this language as authorizing direct payment to CRNAs for chronic pain management services, while others have taken the view that the services highlighted in the manual language are services furnished in the perioperative setting and refer only to acute pain management associated with the surgical procedure.
After assessing in the proposed rule (see 77 FR 44788) the information available to us, we concluded that chronic pain management was an evolving field, and we recognized that certain states have determined that the scope of practice for a CRNA should include chronic pain management to meet health care needs of their residents and ensure their health and safety. We also found that several states, including California, Colorado, Missouri, Nevada, South Carolina, and Virginia, were debating whether to include pain management in the CRNA scope of practice. After determining that the scope of practice for CRNAs was evolving and that there was not a clear answer on pain management specifically, we proposed to revise our regulations at § 410.69(b) to define the statutory benefit for CRNA services with deference to state scope of practice laws. Specifically, we proposed to add the following language: “Anesthesia and related care includes medical and surgical services that are related to anesthesia and that a CRNA is legally authorized to perform by the state in which the services are furnished.” We explained that this proposed definition would set a Medicare standard for the services that can be furnished and billed by CRNAs while allowing appropriate flexibility to meet the unique needs of each state. The proposal also dovetailed with the language in section 1861(bb)(1) of the Act requiring the state's legal authorization to furnish CRNA services as a key component of the CRNA benefit category. Finally, we stated that the proposed benefit category definition was also consistent with our policy to recognize state scope of practice as defining the services that can be furnished and billed by other NPPs.
The following is a summary of the comments we received regarding the proposal to revise our regulations at § 410.69(b) to define the statutory description of CRNA services. We received a significant volume of comments from specialty groups, individual physicians, and practitioners, including CRNAs and Student Registered Nurse Anesthetists (SRNAs), educational program directors, and patients, who strongly supported defining the CRNA benefit broadly. There were also many commenters who strongly opposed this proposal, including specialty groups, individual physicians and practitioners, patients, educational program directors, and a patient advocacy group.
Other commenters referenced preamble text in our 1992 final rule, which states “we describe related care services as * * * pain management services, and other services not directly connected with the anesthesia service or associated with the surgical service” and noted that historically, related care services have been recognized as a different class of anesthesia services, which may or may not be related to anesthesia. One commenter requested that we define “related care” separately from anesthesia, as “medical and surgical services not directly related to anesthesia, including but not limited to the insertion of arterial lines, central venous pressure lines, and Swan Ganz catheters, acute and chronic pain management and emergency intubation, and that a CRNA is legally authorized to perform by the state in which the services are furnished.”
Some commenters pointed to Medicare policies allowing other advanced practice nurses such as nurse practitioners or clinical nurse specialists to furnish and bill for physicians' services as support for recognizing a similar interpretation of the scope of CRNA practice. Commenters stated that CRNAs should be able to practice to the full extent of state law. Commenters cited the Institute of Medicine report [The Future of Nursing: Leading Change, Advancing Health, 11/17/10] that stated that nurses should be able to practice to the full extent of their education and training.
Our proposal to define related care as “related to anesthesia” resulted in various views as to whether this would include pain management and other services. Some stated that it restricted the benefit category, but others believed that it expanded it. The commenters further stated that there are no chronic, long-term, anesthesia related services that occur outside the operating room or recovery room where the practice of anesthesia is appropriate. Others stated that chronic pain management services are outside the scope of perioperative related care defined in the Act, and that chronic pain is not related to anesthesia.
Some commenters pointed to the long period of time during which CRNAs have furnished chronic pain services with no documented differences in
We note that we did not address the services that CRNAs are trained and qualified to furnish in our proposal or in this final rule with comment period. Our proposal and this final rule merely define what services are included in the scope of the Medicare benefit established in section 1861(bb)(1) of the Act. The definition that we are adopting uses the state scope of practice as a proxy for what the term “anesthesia and related care” in section 1861(bb)(1) of the Act means and thus leaves decisions about what services constitute anesthesia and related care to be resolved by the state. This appropriately recognizes the actions of state bodies formed specifically to address the issue of what constitutes the scope of practice for a CRNA. We believe that determining whether or not CRNAs are adequately trained and can safely furnish chronic pain management is an appropriate decision for state bodies. This proposal is consistent with the Institute of Medicine's report on advanced practice nursing, which recommends that Medicare should “include coverage of advanced practice registered nurse services that are within the scope of practice under applicable state law, just as physicians' services are now covered.”
We agree with commenters that it also is the responsibility of individual practitioners (physicians and CRNAs) to ensure that they are adequately trained and qualified to furnish any and all procedures that they furnish.
After consideration of all comments, we are finalizing our proposal with modification to revise our regulations at § 410.69(b) to define “Anesthesia and related care” under the statutory benefit for CRNA services as follows: “Anesthesia and related care means those services that a certified registered nurse anesthetist is legally authorized to perform in the state in which the services are furnished.” We will continue to monitor the state scope of practice laws for CRNAs in order to insure that the use of state scope of practice as a proxy to define “anesthesia services and related care” is consistent with the goals and needs of Medicare program.
Portable x-ray suppliers furnish diagnostic imaging services at a beneficiary's location. These services are most often furnished in residences, including private homes and alternative living facilities (for example, nursing homes) rather than in a traditional clinical setting (for example, a doctor's office or hospital). The supplier transports mobile diagnostic imaging equipment to the beneficiary's location, sets up the equipment, and administers the test onsite. The supplier may interpret the results itself or it may furnish the results to an outside physician for interpretation. Portable x-ray services may avoid the need for expensive ambulance transport of frail beneficiaries to a radiology facility or hospital.
Our Medicare Conditions for Coverage (CfC) regulations require that “portable x-ray examinations are performed only on the order of a doctor of medicine (MD) or doctor of osteopathy (DO) licensed to practice in the state * * *” (§ 486.106(a)). With the exception of portable x-ray services, Medicare payment regulations at § 410.32(a) allow physicians, as defined in section 1861(r) of the Act, and certain nonphysician practitioners at § 410.32(a)(2) to order diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests as long as those nonphysician practitioners are operating within the scope of their authority under state law and within the scope of their Medicare statutory benefit. Physicians other than an MD or DO recognized to order diagnostic tests under § 410.32(a) include the following limited-license practitioners: Doctor of optometry, doctor of dental surgery and doctor of dental medicine, and doctor of podiatric medicine. Nonphysician practitioners authorized to order diagnostic tests under § 410.32(a)(2) include nurse practitioners, physician assistants, clinical nurse specialists, certified nurse-midwives, clinical psychologists, and clinical social workers. Nonphysician practitioners have become an increasingly important component of clinical care, and we believe that delivery systems should take full advantage of all members of a healthcare team, including nonphysician practitioners.
Although current Medicare regulations limit the ordering of portable x-ray services to a MD or a DO, the Office of the Inspector General (OIG) in its December 2011 report entitled
We proposed to revise our current regulations, which limit ordering of portable x-ray services to only a MD or DO, to allow other physicians and nonphysician practitioners acting within the scope of their Medicare benefit and state law to order portable x-ray services. Specifically, we proposed revisions to the CfC at § 486.106(a) and § 486.106(b) to permit portable x-ray services to be ordered by a physician or nonphysician practitioner in accordance with the ordering policies for other diagnostic services under § 410.32(a).
This proposed change would allow a MD or DO, as well as a nurse practitioner, clinical nurse specialist, physician assistant, certified nurse-midwife, doctor of optometry, doctor of dental surgery and doctor of dental medicine, doctor of podiatric medicine, clinical psychologist, and clinical social worker to order portable x-ray services within the scope of their authority under state law and the scope of their Medicare benefit. Although all of these physicians and nonphysician practitioners are authorized to order
With regard to clinical social workers, under section 1861(hh) of the Act, the scope of their Medicare benefit is further limited to services “for the diagnosis and treatment of mental illnesses.” Therefore, the proposed change to our regulations to allow clinical social workers to order portable x-ray services in the same way that they are permitted to order other diagnostic tests under § 410.32(a) would not allow clinical social workers to order portable x-ray services. Portable x-ray services fall within the scope of the Medicare benefit for the remaining nonphysician and limited-license practitioners, including clinical psychologists. As noted above, we believe state scope of practice laws might limit ordering of portable x-ray services by clinical psychologists or other practitioners. Additionally, certain other practitioners are unlikely to have a reason to order portable x-ray services, such as doctors of optometry. We have no evidence to suggest that clinical psychologists or other limited license or nonphysician practitioners are ordering significant numbers of x-rays, CTs, and MRIs under § 410.32(a) authority at this time. We do not expect any marked change in ordering patterns following the change in regulation to allow for ordering of portable x-ray services.
With regard to the request for FY 2011 data on portable x-ray ordering by select nonphysician practitioners, we do not believe this or any recent data on portable x-ray ordering patterns for limited-license or nonphysician practitioners would be meaningful information regarding future potential ordering patterns for portable x-ray services because these practitioners are not permitted to order portable x-ray services under the current regulation. We believe our proposal is consistent with our current regulations that generally allow nonphysician practitioners to order diagnostic services, and the agency's interest in having delivery systems take full advantage of all members of a healthcare delivery team. We describe below our intention to design monitoring systems that will capture excessive ordering.
The OIG report concluded, and CMS concurred, that CMS should recoup payment for portable x-ray services identified under the report as ordered by limited-license physicians and nonphysician practitioners, other than a MD or DO in accordance with our regulations at § 410.32(c) and § 486.106 since this was consistent with this recommendation. We will continue our recoupment efforts in response to the OIG report. However, we have instructed our payment contractors that the ordering of portable x-ray services should not be made a priority for additional medical review activity beyond claims identified in the OIG audit.
After considering the public comments received, we are finalizing our CY 2013 proposal to revise the CfC at § 486.106(a) and § 486.106(b) to permit portable x-ray services to be ordered by physicians or nonphysician practitioners in accordance with the general ordering policies for other diagnostic services as specified under § 410.32(a). Therefore, effective for services furnished on or after January 1, 2013, the following practitioners will be permitted to order portable x-rays in accordance with Medicare regulations and subject to their scope of practice under state law and their applicable Medicare statutory benefit: A physician (including an MD or a DO, doctor of optometry, doctor of dental surgery and doctor of dental medicine, and doctor of podiatric medicine), or a nurse practitioner, clinical nurse specialist, physician assistant, certified nurse-midwife, or clinical psychologist, where the ordering of portable x-ray services is within the scope of their practice under state law. As discussed above, although clinical social workers are permitted to order diagnostic tests under § 410.32(a)(2), the scope of their Medicare benefit is limited to services for the diagnosis and treatment of mental illnesses. As such, we do not believe these nonphysician practitioners would need to order portable x-ray services. We also are finalizing revisions to the language included under § 410.32(c) specific to portable x-ray services to recognize the same authority for physicians and nonphysician practitioners to order diagnostic tests as is prescribed for other diagnostic services under § 410.32(a). Finally, we are finalizing two technical corrections that we proposed to make in the CY 2013 PFS proposed rule. One is to § 410.32(d)(2), where we currently cite paragraph (a)(3) for the definition of a qualified nonphysician practitioner. The definition of a qualified nonphysician practitioner is currently found in paragraph (a)(2), while paragraph (a)(3) does not exist; therefore, we are correcting the citation. The second technical correction is in § 410.32(b)(2)(iii) to better reflect the statutory authority to furnish neuropsychological testing in addition to psychological testing. We did not receive any comments on these proposed technical corrections. The documentation requirement for this paragraph remains unchanged.
Although we believe it is appropriate to finalize policy to allow nonphysician practitioners and limited-license practitioners to order portable x-ray services within the scope of their authority under state law and the scope of their Medicare statutory benefit given overall changes in health care delivery practice patterns since the beginning of the Medicare program, we remain concerned about the OIG's recent findings. The OIG observed other questionable billing patterns for portable x-ray services in addition to ordering by nonphysician practitioners. Of specific note was the observation that some portable x-ray suppliers are furnishing services on the same day that the beneficiary also receives services in a clinical setting, such as the physician office or hospital. Under current regulations at § 486.106(a)(2), the order for portable x-ray services must include a statement concerning the condition of the beneficiary which indicates why portable x-ray services are necessary. If, on the same day that a portable x-ray service was furnished, the patient was able to travel safely to a clinical setting, we believe the statement of need for portable x-ray services could be questionable. We also are concerned that the OIG observed some portable x-ray suppliers billing for multiple trips to a facility on the same day Medicare makes a single payment for each trip the portable x-ray supplier makes to a particular location. We make available several modifiers to allow the portable x-ray supplier to indicate the number of beneficiaries served on a single trip to a facility. We expect portable x-ray suppliers to use those modifiers and not to bill multiple trips to the same facility on a single day when only one trip was made. Additionally, we strongly encourage portable x-ray suppliers to make efficient use of resources and consolidate trips, to the extent it is clinically appropriate to do so, rather than making multiple trips on the same day.
In conjunction with our proposal to expand the scope of physicians and nonphysician practitioners who can order portable x-ray services, we intend to develop, as needed, monitoring standards predicated by these and other OIG findings. In addition, we will be conducting data analysis of ordering patterns for portable x-ray and other diagnostic services to determine if additional claims edits, provider audits, or fraud investigations are required to prevent abuse of these services and to allow for the collection of any potential
In the proposed rule (77 FR 44791), we solicited comments and suggestions for updating the current regulations at 42 CFR Part 486, Subpart C—Conditions for Coverage: Portable X-Ray Services through future rulemaking. Below are our responses to public comments on suggestions for future rulemaking at 42 CFR Part 486, Subpart C—Conditions for Coverage: Portable X-Ray Services.
Section 1848(c)(2)(B) of the Act requires that we review RVUs for physicians' services no less often than every 5 years. Under section 1848(c)(2)(K) of the Act (as added by section 3134 of the Affordable Care Act), we are required to identify and revise RVUs for services identified as potentially misvalued. To facilitate the review and appropriate adjustment of potentially misvalued services, section 1848(c)(2)(K)(iii) specifies that the Secretary may use existing processes to receive recommendations; conduct surveys, other data collection activities, studies, or other analyses as the Secretary determined to be appropriate; and use analytic contractors to identify and analyze potentially misvalued services, conduct surveys or collect data. In accordance with section 1848(c)(2)(K)(iii) of the Act, we identify potentially misvalued codes, and develop and propose appropriate adjustments to the RVUs, taking into account the recommendations provided by the AMA RUC, the Medicare Payment Advisory Commission (MedPAC), and other public commenters.
For many years, the AMA RUC has provided CMS with recommendations on the appropriate relative values for PFS services. Over the past several years, CMS and the AMA RUC have identified and reviewed a number of potentially misvalued codes on an annual basis, based on various identification screens for codes at risk for being misvalued. This annual review of work RVUs and direct PE inputs for potentially misvalued codes was further bolstered by the Affordable Care Act mandate to examine potentially misvalued codes, with an emphasis on the following categories specified in section 1848(c)(2)(K)(ii) (as added by section 3134 of the Affordable Care Act):
• Codes and families of codes for which there has been the fastest growth.
• Codes or families of codes that have experienced substantial changes in practice expenses.
• Codes that are recently established for new technologies or services.
• Multiple codes that are frequently billed in conjunction with furnishing a single service.
• Codes with low relative values, particularly those that are often billed multiple times for a single treatment.
• Codes which have not been subject to review since the implementation of the RBRVS (the “Harvard-valued” codes).
• Other codes determined to be appropriate by the Secretary.
In addition to providing recommendations to CMS for work RVUs, the AMA RUC's Practice Expense Subcommittee reviews, and then the AMA RUC recommends, direct PE inputs (clinical labor, medical supplies, and medical equipment) for individual services. To guide the establishment of malpractice RVUs for new and revised codes before each Five-Year Review of Malpractice, the AMA RUC also provides malpractice crosswalk recommendations, that is, “source” codes with a similar specialty mix of practitioners furnishing the source code and the new/revised code.
CMS reviews the AMA RUC recommendations on a code-by-code basis. For AMA RUC recommendations regarding physician work RVUs, after conducting a clinical review of the codes, we determine whether we agree with the recommended work RVUs for a service (that is, whether we agree the AMA RUC-recommended valuation is accurate). If we disagree, we determine an alternative value that better reflects our estimate of the physician work for the service.
Because of the timing of the CPT Editorial Panel decisions, the AMA RUC recommendations, and our rulemaking cycle, we publish these work RVUs in the PFS final rule with comment period as interim final values, subject to public comment. Similarly, we assess the AMA RUC's recommendations for direct PE inputs and malpractice crosswalks, and establish PE and malpractice interim final values, which are also subject to comment. We note that, with respect to interim final PE RVUs, the aspect of our valuation that is open for public comment for a new, revised, or potentially misvalued code is the direct PE inputs and not the other elements of the PE valuation methodology, such as the indirect cost allocation methodology, that also contribute to establishing the PE RVUs for a code.
If we receive public comments on the interim final work RVUs for a specific code indicating that refinement of the interim final work value is warranted based on sufficient and new information from the commenters concerning clinical aspects of the physician work associated with the service (57 FR 55917) that were not already considered in making the interim valuation or the AMA RUC deliberations, we refer the service to a refinement panel, as discussed in further detail in section III.M.1.a. of this final rule with comment period.
In the interval between closure of the comment period and the subsequent year's PFS final rule with comment period, we consider all of the public comments on the interim final work, PE, and malpractice RVUs for the new, revised, and potentially misvalued codes and the results of the refinement panel, if applicable. Finally, we address the interim final RVUs (including the interim final direct PE inputs) by providing a summary of the public comments and our responses to those comments, including a discussion of any changes to the interim final work or
We conducted a clinical review of each code identified in this section and reviewed the current and recommended work RVUs, intensity, and time to furnish the pre-service, intra-service, and post-service activities, as well as other components of the service that contribute to the value. Our clinical review generally includes, but is not limited to, a review of information provided by the AMA RUC and other public commenters, medical literature, and comparative databases, as well as a comparison with other codes within the Medicare PFS, consultation with other physicians and healthcare professionals within CMS and the Federal Government, and the views based on clinical experience of the physicians on the PFS clinical review team. We also assessed the methodology and data used to develop the recommendations submitted to us by the AMA RUC and other public commenters and the rationale for the recommendations. As we noted in the CY 2011 PFS final rule with comment period (75 FR 73328 through 73329), there are a variety of methodologies and approaches used to develop work RVUs, including building block, survey data, crosswalk to key reference or similar codes, and magnitude estimation. The building block methodology is used to construct, or deconstruct, the work RVU for a CPT code based on component pieces of the code. Components may include pre-, intra-, or post-service time and post-procedure visits, or, when referring to a bundled CPT code, the components could be considered to be the CPT codes that make up the bundled code. Magnitude estimation refers to a methodology for valuing physician work that determines the appropriate work RVU for a service by gauging the total amount of physician work for that service relative to the physician work for similar service across the physician fee schedule without explicitly valuing the components of that work. The resource-based relative value system (RBRVS) has incorporated into it cross-specialty and cross-organ system relativity. This RBRVS requires assessment of relative value and takes into account the clinical intensity and time required to perform a service. In selecting which methodological approach will best determine the appropriate value for a service, we consider the current and recommended physician work and time values, as well as the intensity of the service, all relative to other services.
Several years ago, to aid in the development of pre-service time recommendations for new and revised CPT codes, the AMA RUC created standardized pre-service time packages. The packages include pre-service evaluation time, pre-service positioning time, and pre-service scrub, dress and wait time. Currently there are six pre-service time packages for services typically furnished in the facility setting, reflecting the different combinations of straightforward or difficult procedure, straightforward or difficult patient, and without or with sedation/anesthesia. Currently there are two pre-service time packages for services typically furnished in the nonfacility setting, reflecting procedures without and with sedation/anesthesia care.
We have developed several standard building block methodologies to appropriately value services when they have very common billing patterns. As we have discussed in past rulemaking, most recently in the CY 2012 PFS final rule with comment period (76 FR 73107 through 73108), in cases where a service is typically furnished to a beneficiary on the same day as an evaluation and management (E/M) service, we believe that there is overlap between the two services in some of the activities furnished during the pre-service evaluation and post-service time. We believe that at least one-third of the physician time in both the pre-service evaluation and post-service period is duplicative of work furnished during the E/M visit. Accordingly, in cases where we believe that the AMA RUC has not adequately accounted for the overlapping activities in the recommended work RVU and/or times, we adjust the work RVU and/or times to account for the overlap. The work RVU for a service is the product of the time involved in furnishing the service times the intensity of the work. Pre-service evaluation time and post-service time both have a long-established intensity of work per unit of time (IWPUT) of .0224, which means that 1 minute of pre-service evaluation or post-service time equates to .0224 of a work RVU. Therefore, in many cases where we remove 2 minutes of pre-service time and 2 minutes of post-service time from a procedure to account for the overlap with the same day E/M service, we also remove a work RVU of .09 (4 minutes × .0224 IWPUT) if we do not believe the overlap in time has already been accounted for in the work RVU. We continue to believe this adjustment is appropriate. The AMA RUC has recognized this valuation policy and, in many cases, addresses the overlap in time and work when a service is typically provided on the same day as an E/M service.
We appreciate the creation and use of these standardized pre-service time packages. However, we believe that services that involve only a local anesthetic agent do not typically involve the same amount of pre-service time as procedures involving sedation or non-local anesthesia care. We request that the AMA RUC consider assigning services that require only local anesthesia without sedation to the “no sedation/anesthesia care” pre-service time package, or that the AMA RUC create one or more new pre-service time packages to reflect the pre-service time typically involved in furnishing local anesthesia without sedation.
For many CPT codes that are typically billed on the same day as an E/M service, the recommendations from the AMA RUC state that the AMA RUC reviewed the work associated with the procedure, and adjusted the pre-service and/or post-service time to account for the work that is furnished as a part of the E/M service. For many codes, the AMA RUC made this adjustment from the pre-service evaluation time included in the AMA RUC-selected pre-service time package. However, as we noted above, we believe that the pre-service time packages for procedures with sedation or anesthesia care may overstate the time involved in furnishing services that involve only local or topical anesthesia without sedation. As a result, though the AMA RUC may have removed some pre-service time from the package to account for the same day E/M service, in a few instances, consistent with our established same day E/M reduction methodology discussed above, we further reduced the AMA RUC-recommended pre-service evaluation time to fully account for the overlapping time with the same day E/M service.
In this section, we address the interim final values published in the CY 2012 PFS final rule with comment period (76 FR 73026 through 73474), as subsequently corrected in the January 4, 2012 (77 FR 227 through 232) correction notice; and the proposed values published in the CY 2013 PFS proposed
As discussed in the 1993 PFS final rule with comment period (57 FR 55938), we adopted a refinement panel process to assist us in reviewing the public comments on CPT codes with interim final work RVUs for a year and in developing final work values for the subsequent year. We decided the panel would be comprised of a multispecialty group of physicians who would review and discuss the work involved in each procedure under review, and then each panel member would individually rate the work of the procedure. We believed establishing the panel with a multispecialty group would balance the interests of the specialty societies who commented on the work RVUs with the budgetary and redistributive effects that could occur if we accepted extensive increases in work RVUs across a broad range of services.
Depending on the number and range of codes that are subject to refinement in a given year, we establish refinement panels with representatives from four groups of physicians: Clinicians representing the specialty most identified with the procedures in question; physicians with practices in related specialties; primary care physicians; and contractor medical directors (CMDs). Typical panels have included 8 to 10 physicians across the four groups.
Following the addition of section 1848(c)(2)(K) to the Act by Section 3134 of the Affordable Care Act, which authorized the Secretary to review potentially misvalued codes and make appropriate adjustments to the RVUs, we reassessed the refinement panel process. As detailed in the CY 2011 PFS final rule with comment period (75 FR 73306), we believed that the refinement panel process may provide an opportunity to review and discuss the proposed and interim final work RVUs with a clinically diverse group of experts, who then provide informed recommendations. Therefore, we indicated that we would continue the refinement process, but with administrative modification and clarification. We also noted that we would continue using the established composition that includes representatives from the four groups of physicians—clinicians representing the specialty most identified with the procedures in question, physicians with practices in related specialties, primary care physicians, and CMDs.
One change relates to the calculation of the refinement panel results. The basis of the process is that following discussion of the information but without an attempt to reach a consensus, each member of the panel votes independently. Historically, the refinement panel's recommendation to change a work value or to retain the interim value had hinged solely on the outcome of a statistical test on the ratings (an F-test of panel ratings among the groups of participants). Over time, we found the statistical test used to evaluate the RVU ratings of individual panel members became less reliable as the physicians in each group tended to select a previously discussed value, rather than developing a unique value, thereby reducing the observed variability needed to conduct a robust statistical test. In addition, reliance on values developed using the F-test also occasionally resulted in rank order anomalies among services (that is, a more complex procedure is assigned lower RVUs than a less complex procedure). As a result, we eliminated the use of the statistical F-test and instead indicated that we would use the median work value of the individual panel members' ratings. We said that this approach would simplify the refinement process administratively, while providing a result that reflects the summary opinion of the panel members based on a commonly used measure of central tendency that is not significantly affected by outlier values. At the same time, we clarified that we have the final authority to set the RVUs, including making adjustments to the work RVUs resulting from the refinement process, and that we will make such adjustments if warranted by policy concerns (75 FR 73307).
As we continue to strive to make the refinement panel process as effective an efficient as possible, we would like to remind readers that the refinement panels are not intended to review every code for which we did not propose to accept the AMA RUC-recommended RVUs. Rather the refinement panels are designed for situations where there is new information available that might provide a reason for a change in work values and for which a multi-specialty panel of physicians might provide input that would assist us in making work RVU decisions. To facilitate the selection of services for the refinement panels, we would like to remind specialty societies seeking reconsideration of proposed or interim final work RVUs, including consideration by a refinement panel, to specifically state they are requesting refinement panel review in their public comment letters.
Furthermore we have asked commenters requesting refinement panel review to submit sufficient new information concerning the clinical aspects of the work assigned for a service to indicate that referral to the refinement panel is warranted (57 FR 55917). We note that the majority of the information presented during the CY 2012 refinement panel discussions was duplicative of the information provided to the AMA RUC during its development of recommendations. As detailed in section III.B. of this final rule with comment period, we consider information and recommendations from the AMA RUC when assigning proposed and interim final RVUs to services. Thus, if the only information that a commenter has to present is information already considered by the AMA RUC, referral to a refinement panel is not appropriate. To facilitate selection of codes for refinement, we request that commenters seeking refinement panel review of work RVUs submit supporting information that has not already been considered the AMA RUC in creating recommended work RVUs or by CMS in assigning proposed and interim final work RVUs. We can make best use of our resources as well as those of the specialties involved and physician volunteers, by avoiding duplicative consideration of information by the AMA RUC, CMS, and a refinement panel. To achieve this goal, CMS will continue to critically evaluate the need to refer codes to refinement panels in future years, specifically considering any new information provided by commenters.
We referred to the CY 2012 refinement panel 17 CPT codes with interim final work values for which we
• One to two clinicians representing the commenting organization;
• One to two primary care clinicians nominated by the American Academy of Family Physicians and the American College of Physicians;
• Four contractor medical directors (CMDs); and
• One to two clinicians with practices in related specialties who were expected to have knowledge of the services under review.
The panel process was designed to capture each participant's independent judgment and his or her clinical experience which informed and drove the discussion of the refinement code during the refinement panel proceedings. Following the discussion, each voting participant rated the physician work of the refinement code and submitted those ratings to CMS individually and confidentially, with no attempt to achieve consensus among the panel members. As finalized in the CY 2011 PFS final rule with comment period (75 FR 73307), we reviewed the ratings from each panel member and determined the median value for each service that was reviewed by the refinement panel.
We note that the individual codes reviewed by the CY 2012 refinement panel, and their final work RVUs are discussed in section III.B.1.b. of this final rule with comment period. Also, see Table 29 for the refinement panel ratings and the final work RVUs for the codes reviewed by the CY 2012 refinement panel.
In this section, we discuss all code families for which we received a comment on an interim final physician work value in CY 2012 PFS final rule with comment period or on a proposed value in the CY 2013 PFS proposed rule. Refer to Addendum B for a comprehensive list of all final values.
For discussion on CY 2013 interim final work values for CPT code 11056 refer to section III.M.3. of this final rule with comment period.
For discussion on CY 2013 interim final work values for CPT code 11719 refer to section III.M.3. of this final rule with comment period.
For discussion on CY 2013 interim final work values for CPT codes 12035 through12057 refer to section III.M.3. of this final rule with comment period.
As detailed in the CY 2012 final rule with comment period (76 FR 73112), for CY 2012, the CPT Editorial Panel deleted 24 skin substitute codes and established a 2-tier structure with 8 new codes (CPT codes 15271 through 15278) to report the application of skin substitute grafts, which are distinguished according to the anatomic location and surface area rather than by product description.
We assigned a work RVU of 0.33 to CPT code 15272 (Application of skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm; each additional 25 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure)) on an interim final basis for CY 2012. After clinical review of CPT code 15272, we believed that a work RVU of 0.33 accurately reflected the work associated with this service. The AMA RUC reviewed the survey results for CPT code 15272 and recommended the survey 25th percentile work RVU of 0.59 for this service. However, we believed this value overstated the work of this procedure when compared to the base CPT code 15271 (Application of skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area). We believed that CPT code 15272 is similar in intensity to CPT code 15341 (Tissue cultured allogeneic skin substitute; each additional 25 sq cm, or part thereof (List separately in addition to code for primary procedure)), and that the primary factor distinguishing the work of these two services is the
We assigned a work RVU of 0.50 to CPT code 15276 (Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm; each additional 25 sq cm wound surface area, or part thereof (List separately in addition to code for primary procedure)) on an interim final basis for CY 2012 based on our clinical review of the work associated with this service. The AMA RUC reviewed the survey results for CPT code 15276 and recommended a work RVU of 0.59, which corresponds to the AMA RUC's recommended work RVU for CPT code 15272. We disagreed with the AMA RUC that these two CPT codes should be valued the same. We assigned an interim final work RVU of 0.33 to CPT code 15272 but believed that the work associated with CPT code 15276, which describes work on the face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, is more intense than the work associated with CPT code 15272, which describes work on the trunk, arms, and legs. Accordingly, we noted that our interim final work RVU for CPT code 15276 accurately captured the work associated with this service and established the appropriate relativity between the services. Therefore, we assigned a work RVU of 0.50 to CPT code 15276 on an interim final basis for CY 2012.
CPT code 26341 (Manipulation, palmar fascial cord (ie, Dupuytren's cord), post enzyme injection (eg, collagenase), single cord) was created by the CPT Editorial Panel along with CPT code 20517 to describe a technique for treating Dupuytren's contracture by injecting an enzyme into the Dupuytren's cord for full finger extension and manipulation, effective January 1, 2012.
As detailed in the CY 2012 final rule with comment period, we assigned an interim final work RVU of 0.91 to CPT code 26341 (76 FR 73192). After reviewing survey results for CPT code 26341, the AMA RUC recommended a work RVU of 1.66, which corresponds to the survey 25th percentile value. After clinical review of CPT code 26341, we believed the service described by CPT code 26341 is analogous to that of CPT code 97140 (Manual therapy techniques (eg, mobilization/manipulation, manual lymphatic drainage, manual traction), 1 or more regions, each 15 minutes), which has a work RVU of 0.43. However, since CPT code 97140 has no post-service visits (global period = XXX), while CPT code 26341 includes 1 CPT code 99212 (level 2 office or outpatient visit) (global period = 010), we added the work RVU of 0.48 for CPT code 99212, to the work RVU of 0.43 for CPT code 97140 to obtain the work RVU of 0.91 for CPT code 26341.
For discussion on interim final work values for CPT codes 29581, 29582, 29583, and 29584 refer to section III.M.3. of this final rule with comment period.
In the CY 2012 final rule with comment period, we assigned an interim final work RVU of 13.75 for CPT code 32096 (Thoracotomy, with diagnostic biopsy(ies) of lung infiltrate(s) (eg, wedge, incisional), unilateral) (76 FR 73193). As we noted, the CPT Editorial Panel reviewed the lung resection family of codes and deleted eight, revised five, and created 18 new codes to describe thoracoscopic procedures effective January 1, 2013. For the wedge resection procedures, the revisions were based on three tiers; first, the approach, thoracotomy or thoracoscopy; second, the target to remove nodules or infiltrates; and lastly the intent, diagnostic or therapeutic (for nodules only, all infiltrates will be removed for diagnostic purposes).
As we noted in the CY 2012 final rule with comment period, after clinical review of CPT code 32096, we believed a work RVU of 13.75 accurately reflected the work associated with this service compared to other related services. The AMA RUC reviewed the survey results, compared the code to other services, and concluded that the survey 25th percentile work RVU of 17.00 appropriately accounted for the work and physician time required to perform this procedure. We determined that the work associated with CPT code 32096 was similar in terms of physician time and intensity to CPT code 44300 (Placement, enterostomy or cecostomy, tube open (eg, for feeding or decompression) (separate procedure)). Therefore, we assigned the same work RVU to CPT code 32096 as that of CPT code 44300 on an interim final basis for CY 2012.
As detailed in the CY 2012 final rule with comment period, we assigned an interim final work RVU of 13.75 for CPT code 32097 (Thoracotomy, with diagnostic biopsy(ies) of lung nodule(s) or mass(es) (eg, wedge, incisional), unilateral) (76 FR 73194). We noted that after clinical review of CPT code 32097, we believed a work RVU of 13.75 accurately reflected the work associated with this service compared to other related services. We also noted that the AMA RUC had reviewed the specialty society survey results, compared the code to other services, and recommended the survey 25th percentile work RVU of 17.00. We stated that we determined that the work associated with CPT code 32097 was similar to CPT code 32096, to which we assigned a work RVU of 13.75 on an interim final basis for CY 2012.
As detailed in the CY 2012 final rule with comment period, we assigned an interim final work RVU of 12.91 to CPT code 32098 (Thoracotomy, with biopsy(ies) of pleura) (76 FR 73194). We noted that after clinical review, we believed a work RVU of 12.91 accurately reflected the work associated with this service as compared to other related services. After reviewing survey results and comparing the code to other services, the AMA RUC recommended the survey 25th percentile work RVU of 14.99. We noted that the work associated with CPT code 32098 was similar in terms of physician time and intensity to CPT code 47100 (Biopsy of liver, wedge) and therefore we believed that crosswalking to the work RVU of CPT code 47100 appropriately accounted for the work associated with CPT code 32098. Therefore, we assigned a work RVU of 12.91 to CPT code 32098 on an interim final basis for CY 2012.
We assigned a work RVU of 13.75 for CPT code 32100 (Thoracotomy; with exploration) on an interim final basis in the CY 2012 final rule with comment period (76 FR 73194). After clinical review of CPT code 32100, we believed a work RVU of 13.75 accurately reflected the work associated with this service as compared to other related services. The AMA RUC reviewed the specialty society survey results, compared the code to other services, and recommended a work RVU of 17.00. We noted that the affected specialty society and AMA RUC asserted that CPT code 32100 should be valued the same as CPT codes 32096 and 32097 because they believe that the work is similar for these three services. We noted that we assigned a work RVU of 13.75 to CPT codes 32096 and 32097, and therefore a work RVU of 13.75 to CPT code 32100 as well.
We assigned a work RVU of 15.75 for CPT code 32505 (Thoracotomy; with therapeutic wedge resection (eg, mass, nodule), initial) on an interim final basis in the CY 2012 final rule with comment period (76 FR 73194). We noted that after clinical review of CPT code 32505, we believed a work RVU of 15.75 accurately reflected the work associated with this service compared to other related services. After reviewing the survey results, comparing the code to other services, the AMA RUC recommended the survey 25th percentile work RVU of 18.79. We explained that we assigned the interim final work RVU of 15.75 in recognition of the greater physician work and intensity involved in CPT 32505 as compared to CPT code 32096. We valued the additional 30 minutes of intra-service work associated with CPT code 32505 at 2.00 work RVUs. Accordingly, we assigned a work RVU of 15.75 for CPT code 32505 on an interim final basis for CY 2012.
For discussion on interim final work values for CPT codes 32663, 32668 through 32673 refer to section III.M.3. of this final rule with comment period.
In the Fourth Five-Year Review of Work (76 FR 32445), we discussed CPT code 36247 (Selective catheter placement, arterial system; initial third order or more selective abdominal, pelvic, or lower extremity artery branch, within a vascular family) and proposed a CY 2012 work RVU of 6.29 and a global period change from 90 days (Major surgery with a 1-day pre-operative period and a 90-day postoperative period included in the fee schedule amount) to XXX (the global concept does not apply). In the CY 2012 PFS final rule with comment period (76 FR 73132), we agreed with commenters to the Fourth Five-Year Review of Work that our discussion of the global period was incorrect and should have indicated a change in global period from XXX to 000 (Minor procedure-includes RVUs for pre- and post-operative procedures on the same day). We stated that, based on comments received, we referred CPT code 36247 to the CY 2011 multi-speciality refinement panel for further review. The refinement panel median value was a work RVU of 7.00, the AMA RUC-recommended value. We went on to state that upon clinical review, we believed that our proposed work RVU of 6.29 was more appropriate. We stated that we observed a significant decrease in the physician times reported for this service that argue for a lower work RVU, notwithstanding that the survey was conducted for a 0-day global period, which includes an E/M service on the same day. Therefore, we assigned work RVUs of 6.29 and a global period of 000 to CPT code 36247 on an interim basis for CY 2012 and invited additional public comment on this code in the CY 2012 final rule with comment period.
As detailed in the CY 2012 final rule with comment period (76 FR 73196), the CPT Editorial Panel created four bundled renal angiography services (CPT codes 36251, 36252, 36253, and 36254), effective January 1, 2012.
We assigned a work RVU of 5.35 to CPT code 36251 (Selective catheter placement (first-order), main renal artery and any accessory renal artery(s) for renal angiography, including arterial puncture and catheter placement(s), fluoroscopy, contrast injection(s), image postprocessing, permanent recording of images, and radiologic supervision and interpretation, including pressure gradient measurements when performed, and flush aortogram when performed; unilateral) on an interim final basis for CY 2012 based upon our
We assigned an interim final work RVU of 6.99 to CPT code 36252 (Selective catheter placement (first-order), main renal artery and any accessory renal artery(s) for renal angiography, including arterial puncture and catheter placement(s), fluoroscopy, contrast injection(s), image postprocessing, permanent recording of images, and radiologic supervision and interpretation, including pressure gradient measurements when performed, and flush aortogram when performed; bilateral), for CY 2012 after clinical review. The AMA RUC reviewed the survey results, compared the code to other services, and concluded that the work value for CPT code 36252 should be directly crosswalked to CPT code 43272 (Endoscopic retrograde cholangiopancreatography (ERCP); with ablation of tumor(s), polyp(s), or other lesion(s) not amenable to removal by hot biopsy forceps, bipolar cautery or snare technique), which has a work RVU of 7.38. Although the AMA RUC recommended a work RVU of 7.38 for CPT code 36252, we found that the intensity of this service is more similar to CPT code 58560 (Hysteroscopy, surgical; with division or resection of intrauterine septum (any method)), which has a work RVU of 6.99. Accordingly, we assigned an interim final work RVU of 6.99 to CPT code 36252 for CY 2012.
As discussed in the CY 2012 final rule with comment period (76 FR 73197), for CPT code 37192 (Repositioning of intravascular vena cava filter, endovascular approach inclusive of vascular access, vessel selection, and all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance (ultrasound and fluoroscopy)), we assigned a work RVU of 7.35 to CPT code 37192, with a refinement to 45 minutes of intra-service time, on an interim final basis for CY 2012.
After clinical review of CPT code 37192, we believed a work RVU of 7.35 accurately reflected the work associated with this service. The AMA RUC reviewed the survey results, compared the code to other services, and concluded that the survey 75th percentile intra-service time of 60 minutes and the 25th percentile of work RVU of 8.00 accurately described the physician work involved in the service. We determined that the work associated with CPT code 37192 is similar to CPT code 93460 (Catheter placement in coronary artery(s) for coronary angiography, including intraprocedural injection(s) for coronary angiography, imaging supervision and interpretation; with right and left heart catheterization including intraprocedural injection(s) for left ventriculography, when performed), which has a work RVU of 7.35, 48 minutes pre-service time, 50 minutes intra-service time, and 30 minutes post-service time. By comparing the times assigned to those of CPT code 93460, we determined that the survey median intra-service time of 45 minutes appropriately accounted for the time required to furnish the intra-service work of CPT code 37192. Therefore, we assigned it a work RVU of 7.35, with a refinement to 45 minutes of intra-service time on an interim final basis for CY 2012. A complete listing of the times associated with this code is available on the CMS Web site at:
As discussed in the CY 2012 final rule with comment period (76 FR 73197), for CPT code 37193 (Retrieval (removal) of intravascular vena cava filter, endovascular approach inclusive of vascular access, vessel selection, and all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance (ultrasound and fluoroscopy)), we assigned a work RVU of 7.35 to CPT code 37193, with a refinement to 45 minutes of intra-service time, on an interim final basis for CY 2012. After clinical review of CPT code 37193, we believed a work RVU of 7.35 accurately reflected the work associated with this service. The AMA RUC reviewed the survey results, compared the code to other services, and concluded that the survey 75th percentile intra-service time of 60 minutes and the 25th percentile of work RVU of 8.00 accurately described the physician work involved in the service. We believed that the work associated with CPT code 37193 is similar to CPT code 93460 (Catheter placement in coronary artery(s) for coronary angiography, including intraprocedural injection(s) for coronary angiography, imaging supervision and interpretation; with right and left heart catheterization including intraprocedural injection(s) for left ventriculography, when performed), which has a work RVU of 7.35, 48 minutes pre-service time, 50 minutes intra-service time, and 30 minutes post-service time. Based upon these times, we believed that the survey median intra-service time of 45 minutes appropriately accounted for the time required to furnish the intra-service work associated with CPT code 37193. Therefore, we assigned a work RVU of 7.35 to CPT code 37193, with a refinement to 45 minutes of intra-service time, on an interim final basis for CY 2012. A complete listing of the times associated with this code is available on the CMS Web site at:
On an interim final basis, we assigned a work RVU of 3.09 to CPT codes 38230 (Bone marrow harvesting for transplantation; allogeneic) and 38232 (Bone marrow harvesting for transplantation; autologous) for CY 2012 (76 FR 73197). In the CY 2012 final rule with comment period we noted that for CY 2012, the CPT Editorial Panel split CPT code 38230 into two separate CPT codes: 38230 and 38232 to more accurately reflect current medical practice. We noted that we changed the global period from 010 to 000 for CPT code 38230, and assigned a global period of 000 to CPT code 38232, as these services rarely required overnight hospitalization and physician follow-up in the days following the procedure.
We noted that after clinical review of CPT codes 38230 and 38232, we believed that a work RVU of 3.09 appropriately accounted for the work associated with these services. The AMA RUC reviewed the survey results and, after comparison to similar CPT codes, the AMA RUC recommended the survey median work RVU of 4.00 for CPT code 38230, and the survey median work RVU of 3.50 for CPT code 38232. Notwithstanding the AMA-RUC recommendation, we noted that the work for these services is very similar and should be valued the same. In CY 2011, CPT code 38230 had a work RVU of 4.85 with a ten-day global period that included a CPT code 99213 (Level 3 office or outpatient visit, established patient), and a CPT code 99238 (discharge day management service). We explained that we considered converting the value of CPT code 38230 from a 10-day global period to a 0-day global period by subtracting the work RVUs for CPT code 99213 (work RVU=0.97) and CPT code 99238 (work RVU=1.28), but believed that the resulting work RVU of 2.60 would result in this code being valued too low compared to other similar services. Instead, we found that the CPT code 38230 survey 25th percentile work RVU of 3.09 accurately captured the intensity of this service with the revised global period. Therefore, we assigned a work RVU of 3.09 to CPT code 38230 on an interim final basis for CY 2012. Since, as explained above, we believed that CPT code 38232 should have the same work RVU as CPT code 38230, we also assigned a work RVU of 3.09 to CPT code 38230 on an interim final basis for CY 2012.
As detailed in the CY 2012 final rule with comment period (76 FR 73198), the CPT Editorial Panel deleted CPT codes 49080 and 49081and created three new CPT codes, 49082, 49083, and 49084, effective January 1, 2012, to more accurately describe the current medical practice.
After clinical review, we assigned a work RVU of 2.00 to CPT codes 49083 (Abdominal paracentesis (diagnostic or therapeutic); with imaging guidance) and 49084 (Peritoneal lavage, including imaging guidance, when performed) on an interim final basis for CY 2012. The AMA RUC recommended a work RVU of 2.00 for CPT code 49083 and a work RVU of 2.50 for CPT code 49084. We agreed with the AMA RUC-recommended work RVU of 2.00 for CPT code 49083, but disagreed that CPT 49084 should be valued more. Instead, we believed that CPT code 49084 requires similar work to code 49083 and should be valued the same. Therefore, we assigned a work RVU of 2.00 to CPT codes 49083 and 49084 on an interim final basis for CY 2012.
CPT code 62370 (Electronic analysis of programmable, implanted pump for intrathecal or epidural drug infusion (includes evaluation of reservoir status, alarm status, drug prescription status)); with reprogramming and refill (requiring physician's skill)) newly created by the CPT Editorial Panel for CY 2012, was assigned an interim final work RVU of 0.90 for CY 2012 as discussed in the CY 2012 final rule with comment period (76 FR 73199).
As we noted in the CY 2012 final rule with comment period, after clinical review of CPT code 62370, we believed that a work RVU of 0.90 accurately accounted for the work associated with this service. We noted that after a comparison to similar services, the AMA RUC recommended a work RVU of 1.10 for CPT code 62370 based on a crosswalk to CPT code 56605 (Biopsy of vulva or perineum (separate procedure); 1 lesion) however, we believed that a work RVU of 1.10 for CPT code 62370 was too high compared to similar services in this family. Instead, we found CPT code 62370 to be similar in intensity and complexity to CPT code 93281 (Programming device evaluation (in person) with iterative adjustment of the implantable device to test the function of the device and select optimal permanent programmed values with physician analysis, review and report; multiple lead pacemaker system), which has a work RVU of 0.90. We noted that this value, which is between the specialty society survey 25th percentile and median work RVU, appropriately reflected the work of CPT code 62370. Therefore, we assigned a work RVU of 0.90 to CPT code 62370 on an interim final basis for CY 2012.
For discussion on CY 2013 interim final work values for CPT code 74174 refer to section III.M.3. of this final rule with comment period.
For discussion on CY 2013 interim work values for CPT codes 88120-88121, refer to section III.M.3. of this final rule with comment period.
For discussion on interim work values for CPT codes 90845 and 90869, refer to section III.M.3. of this final rule with comment period.
As detailed in the CY 2012 final rule with comment period (76 FR 73202), for the Fourth Five-Year Review, we identified CPT code 92070 through the Harvard-Valued—Utilization over 30,000 screen as a potentially misvalued code. Upon review of this service, the CPT Editorial Panel deleted CPT code 92070 and created two new CPT codes (92071 and 92072) to distinguish reporting of fitting of contact lens for treatment of ocular surface disease and fitting of contact lens for management of keratoconus.
We assigned an interim final work RVU of 0.61, with refinement to time as noted above to CPT code 92071 (Fitting of contact lens for treatment of ocular surface disease) for CY 2012. We
On an interim final basis for CY 2012, we assigned a work RVU of 0.35 to CPT code 92587 (Distortion product evoked otoacoustic emissions; limited evaluation (to confirm the presence or absence of hearing disorder, 3-6 frequencies) or transient evoked otoacoustic emissions, with interpretation and report) as detailed in the CY 2012 final rule with comment period (76 FR 73202). We identified CPT code 92587 as a potentially misvalued code through the Fastest Growing screen. The specialty society surveyed this service to create a new recommendation for CY 2011. However, after reviewing the survey data, it concluded that more than one service is represented by this code and requested the service be referred back to the CPT Editorial Panel for further clarification. As a result, the CPT Editorial Panel created CPT code 92558 (Distortion product evoked otoacoustic emissions; comprehensive diagnostic evaluation (quantitative analysis of outer hair cell function by cochlear mapping, minimum of 12 frequencies), with interpretation and report) to describe evoked otoacoustic emissions screening, and revised CPT codes 92587 and 92588 clarify the otoaucoustic emissions evaluations, effective January 1, 2012. After clinical review of CPT code 92587, we believed that the survey 25th percentile work RVU of 0.35 accurately described the work associated with this service. The HCPAC reviewed the survey results, and after a comparison to similar CPT codes, recommended a work RVU of 0.45 for CPT code 92587, which was between the survey 25th percentile and median values. We believed that CPT code 92587 was similar in time and intensity to CPT code 97124 (Therapeutic procedure, 1 or more areas, each 15 minutes; massage, including effleurage, petrissage and/or tapotement (stroking, compression, percussion)), which has a work RVU of 0.35, and that the survey 25th percentile value appropriately reflected the relativity of this service. Therefore, we assigned a work RVU of 0.35 to CPT code 92587 on an interim final basis for CY 2012.
On an interim final basis for CY 2012, we assigned a work RVU of 0.55 to CPT code 92588 (Distortion product evoked otoacoustic emissions; comprehensive diagnostic evaluation (quantitative analysis of outer hair cell function by cochlear mapping, minimum of 12 frequencies), with interpretation and report) (76 FR 73202). After clinical review of CPT code 92588, we believed that the survey 25th percentile work RVU of 0.55 accurately described the work associated with this service. The HCPAC reviewed the survey results, and after a comparison to similar CPT codes, recommended the survey median work RVU of 0.62 for CPT code 92588. We believed that CPT code 92588 is similar in work to CPT code 92570 (Acoustic immittance testing, includes tympanometry (impedance testing), acoustic reflex threshold testing, and acoustic reflex decay testing), which has a work RVU of 0.55, and that the survey 25th percentile work RVU of 0.55 appropriately reflected the relativity of this service. Therefore, we assigned a work RVU of 0.55 to CPT code 92588 on an interim final basis for CY 2012.
For CY 2012, we assigned the following interim final work RVUs for the following CPT codes: 2.72 for CPT code 93451 (Right heart catheterization including measurement(s) of oxygen saturation and cardiac output, when performed), 4.75 for CPT code 93452 (Left heart catheterization including intraprocedural injection(s) for left ventriculography, imaging supervision and interpretation, when performed), 6.24 for CPT code 93453 (Combined right and left heart catheterization including intraprocedural injection(s) for left ventriculography, imaging supervision and interpretation, when performed), 4.79 for CPT code 93454 (Catheter placement in coronary artery(s) including intraprocedural injection(s) for coronary angiography, imaging supervision and interpretation), 5.54 for CPT code 93455 (with catheter placement(s) in bypass graft(s) (internal mammary, free arterial, venous grafts) including intraprocedural injection(s) for bypass graft angiography with catheter placement(s) in bypass graft(s) (internal mammary, free arterial, venous grafts) including intraprocedural injection(s) for bypass graft angiography), 6.15 for CPT code 93456 (Catheter placement in coronary artery(s) including intraprocedural injection(s) for coronary angiography, imaging supervision and interpretation with right heart catheterization), 6.89 for CPT code 93457 (Catheter placement in coronary artery(s) including intraprocedural injection(s) for coronary angiography, imaging supervision and interpretation with catheter placement(s) in bypass graft(s) (internal mammary, free arterial, venous grafts) including intraprocedural injection(s) for bypass graft angiography and right heart catheterization), 5.85 for CPT code 93458 (Catheter placement in coronary artery(s) including intraprocedural injection(s) for coronary angiography, imaging supervision and interpretation with left heart catheterization including intraprocedural injection(s) for left ventriculography, when performed), 6.60 for CPT code 93459 (Catheter placement in coronary artery(s) including intraprocedural injection(s) for coronary angiography, imaging supervision and interpretation with left heart catheterization including intraprocedural injection(s) for left ventriculography, when performed, catheter placement(s) in bypass graft(s) (internal mammary, free arterial, venous grafts) with bypass graft angiography), 7.35 for CPT code 93460 (Catheter placement in coronary artery(s) including intraprocedural injection(s) for coronary angiography, imaging supervision and interpretation with right and left heart catheterization including intraprocedural injection(s) for left ventriculography, when performed), 8.10 for CPT code 93461 (Catheter placement in coronary artery(s) including intraprocedural injection(s) for coronary angiography, imaging supervision and interpretation with right and left heart catheterization including intraprocedural injection(s) for left ventriculography, when
As discussed in the CY 2012 final rule with comment period (76 FR 73202), the AMA RUC reviewed these codes again for CY 2012 and reiterated its previous recommendations, maintaining that there are negligible work efficiencies gained in the bundling of these services. However, we continued to believe that there would be efficiencies when these services are performed together that should be reflected in the values assigned. In lieu of a more specific estimate from the AMA RUC, and using the best information available to us at the time, we noted that we believed it was appropriate to assign as interim final for CY 2012 the AMA RUC CY 2011 recommendation with a 10 percent reduction in work to reflect the efficiencies described above.
CPT code 94060 (Bronchodilation responsiveness, spirometry as in 94010, pre- and post-bronchodilator administration) was assigned an interim final work RVU of 0.26 in the CY 2012 final rule with comment period (76 FR 73206). After CPT code 94060 was identified for review because it was on the Multispecialty Points of Comparison List, and also was identified as potentially misvalued through Codes Reported Together 75 percent or More screen, the CPT Editorial Panel reviewed the code and created CPT codes 94060, 94726 (Plethysmography for determination of lung volumes and, when performed, airway resistance), 94727 (Gas dilution or washout for determination of lung volumes and, when performed, distribution of ventilation and closing volumes), 94728 (Airway resistance by impulse
For CY 2012, we assigned a work RVU of 0.26 to CPT codes 94060, 94726, 94727, and 94728 on an interim final basis (76 FR 73206). After clinical review, we determined that CPT codes 94060, 94726, 94727, and 94728, involve similar work and should have the same work RVUs. We noted that CPT code 94240 (Functional residual capacity or residual volume: helium method, nitrogen open circuit method, or other method) (work RVU=0.26) was deleted and the utilization associated with that service would be captured under the CPT codes 94726 and 92727. We also noted that we believed that a work RVU of 0.26 appropriately reflected the work associated with CPT codes 94060, 94726, 94727, and 94728 and that the AMA RUC had recommended the same work RVU (0.31) for all four codes, based upon each survey's 25th percentile work RVU. We explained that this value was further supported by CPT code 97012 (Application of a modality to 1 or more areas; traction, mechanical), which has a work RVU of 0.25) and which had similar time and intensity. Therefore, we assigned a work RVU of 0.26 to CPT codes 94060, 94726, 94727, and 94728 on an interim final basis for CY 2012.
After clinical review of CPT code 94729 (Diffusing capacity (eg, carbon monoxide, membrane) (List separately in addition to code for primary procedure)), we believed that a work RVU of 0.17 accurately reflected the work associated with this service. Based on a comparison to similar services, the AMA RUC recommended a work RVU of 0.19. We believed that CPT code 94010 (Spirometry, including graphic record, total and timed vital capacity, expiratory flow rate measurement(s), with or without maximal voluntary ventilation), which has a work RVU of 0.17, was similar in time and intensity to CPT code 94729, and that the codes should have the same work RVUs. Therefore, we assigned a work RVU of 0.17 to CPT code 94729 on an interim final basis for CY 2012.
Furthermore, for CY 2013, we received no public comments on the CY 2012 interim final work RVUs for CPT codes 94780 and 94781. We believe these values continue to be appropriate and are finalizing them without modification.
For discussion on interim work values for CPT codes 95938 and 95939, refer to section III.M.3. of this final rule with comment period.
For CY 2012, the CPT Editorial Panel revised CPT code 96110 (Developmental screening, with interpretation and report, per standardized instrument form) to reflect current practice and avoid use of inaccurate terms associated with this code. For CY 2012 we created HCPCS code G0451 (Development testing, with interpretation and report, per standardized instrument form) to replace CPT code 96110, which is discussed in the CY 2012 final rule with comment period (76 FR 73265). In the CY 2012 final rule correction notice (77 FR 227), we noted that the discussion of CPT codes 96110 and G0451 was omitted from the CY final rule with comment period due to an inadvertent error, and we included our intended discussion in subsequent the correction notice. Additionally, we corrected the PFS status indicator in Addendum B for CPT code 96110 to N (Non-covered service. These codes are noncovered services. Medicare payment is not made for these codes. If RVUs are shown, they are not used for Medicare payment.), from X (Statutory exclusion. These codes represent an item or service that is not within the statutory definition of “physicians' services” for PFS payment purposes (for example, ambulance services). No RVUs are shown for these codes and no payment may be made under the PFS.). The discussion and information in this section reflects the changes made in CY 2012 final rule correction notice.
The CPT Editorial Panel revised the long descriptor for CPT code 96110 from (Developmental testing; limited (for example, Developmental Screening Test II, Early Language Milestone Screen), with interpretation and report) to (Developmental screening, with interpretation and report, per standardized instrument form), effective January 1, 2012. With this change, we believed that the services described by CPT code 96110 consisted of screening services, and thus was not within the scope of benefits of the Medicare program, as defined by the Act. Therefore, we assigned CPT code 96110 a PFS procedure status indicator of N. To continue to make payment under the PFS for the testing services described
In this section, we address interim final direct PE inputs as presented in the CY 2012 PFS final rule with comment period and displayed in the final CY 2012 direct PE database available on the CMS Web site under the downloads at
On an annual basis, the AMA RUC provides CMS with recommendations regarding direct PE inputs, including clinical labor, supplies, and equipment, for new, revised, and potentially misvalued codes. We review the AMA RUC-recommended direct PE inputs on a code-by-code basis, including the recommended facility PE inputs and/or nonfacility PE inputs, as clinically appropriate for the code. We determine whether we agree with the AMA RUC's recommended direct PE inputs for a service or, if we disagree, we refine the PE inputs to represent inputs that better reflect our estimate of the PE resources required for the service in the facility and/or nonfacility settings. We also confirm that CPT codes should have facility and/or nonfacility direct PE inputs, and make changes based on our clinical judgment and any PFS payment policies that would apply to the code.
As we explained in the CY 2012 PFS final rule (76 FR 73212), we generally only establish interim final direct PE inputs for services when we receive direct PE input recommendations in the context of new, revised or potentially misvalued codes. However, for CY 2012, we established interim final direct PE inputs for several codes for which we did not receive direct PE recommendations. In the case of these codes, we believed it was necessary to establish new interim final direct PE inputs in order to maintain appropriate relativity among those codes and other related codes or between the PE, work and malpractice components of the PFS payment for the codes.
In the CY 2012 PFS final rule with comment period (76 FR 73213), we addressed the general nature of some of our common refinements to the AMA RUC-recommended direct PE inputs as well as the reasons for refinements to particular inputs. In the following subsections, we respond broadly to comments we received regarding common refinements we made based on established principles or policies. Following those discussions, we summarize and respond to comments received regarding other refinements to particular codes.
We note that the interim final direct PE inputs for CY 2012 that are being finalized for CY 2013 are displayed in the final CY 2013 direct PE input database, available on the CMS Web site under the downloads for the CY 2013 PFS final rule at
We also note that for several codes for which we established interim final direct PE inputs for CY 2012, we either made proposals in the CY 2013 PFS proposed rule with comment period as a result of those comments or we are establishing CY 2013 interim final direct PE inputs for the services based on new recommendations from the AMA RUC. We acknowledge receipt of those comments here and we note that those comments were taken into consideration in the development of CY 2013 PFS proposals and our consideration of the CY 2013 AMA RUC direct PE input recommendations.
Prior to CY 2010, the AMA RUC did not generally provide CMS with recommendations regarding equipment time inputs. In CY 2010, in the interest of ensuring the greatest possible degree of accuracy in allocating equipment minutes, we requested that the AMA
In general, the equipment time inputs correspond to the intra-service portion of the clinical labor times. We have clarified that assumption to consider equipment time as the sum of the times within the intra-service period when a clinician is using the piece of equipment, plus any additional time the piece of equipment is not available for use for another patient due to its use during the designated procedure. In addition, when a piece of equipment is typically used during additional visits included in a service's global period, the equipment time should also reflect that use.
We believe that certain highly technical pieces of equipment and equipment rooms are less likely to be used during all of the pre-service or post-service tasks performed by clinical labor on the day of the procedure (the clinical labor service period) and are typically available for other patients even when one member of clinical staff may be occupied with a pre-service or post-service task related to the procedure.
Some commenters have repeatedly objected to CMS' rationale for refinement of equipment minutes on this basis. We acknowledge the comments we received that reiterate those objections to this rationale and refer readers to our extensive discussion regarding those objections in the CY 2012 PFS final rule with commenter period (76 FR 73182). In following paragraphs we address new comments on this policy.
We also note that there are hundreds of services in the direct PE input database that include more than one type of staff in the clinical labor inputs. For many services, for example, minutes are allocated for a standard nurse blend staff type for pre-service and post-service tasks, while technologists are only allocated intra-service period minutes. There is no standing CMS policy that would prevent consideration of dividing clinical labor tasks among different types of clinical labor in the direct PE input database.
In response to the commenter's second assertion, these refinements are far from arbitrary. We have consistently applied these principles in refining the direct PE inputs for services as we review equipment inputs through the potentially misvalued code initiative and our review of new and revised codes since the AMA RUC started providing equipment minute recommendations to CMS in 2010. We believe that imprecise allocation of equipment minutes may be a significant factor in certain potentially misvalued codes. We understand the importance of relativity within the equipment category of direct practice expenses and seek public comment on whether it might be necessary to consider making corresponding refinements to equipment minutes for services across the fee schedule for the sake of maintaining relativity.
Finally, as a general statement, differences in payment rates between different payment systems do not necessarily indicate a lack of appropriate relativity within each system. There can be legitimate reasons why a payment rate should vary in different payment systems (for example, higher indirect costs, different payment bundles). Nevertheless, excessive differences in payment rates between payment systems can be one indication of the need to examine the relativity between services in one or both systems. While we continue to examine this issue, we do not believe that it would be appropriate to establish or maintain inaccurate direct PE inputs for these services based on comparisons between the PFS and OPPS payment rates.
We will continue to work to improve the accuracy of the equipment minutes as reflected in the direct PE input database and will address any further improvements in future rulemaking.
After consideration of these comments, we are finalizing the current interim final direct PE inputs as refined based on this policy. The direct PE inputs are displayed in the final CY 2013 direct PE input database, available on the CMS Web site under the downloads for the CY 2013 PFS final rule at
Some direct PE inputs are directly affected by revisions in physician time. Specifically, changes in the intra-service portions of the physician time and changes in the number or level of postoperative visits associated with the global periods result in corresponding changes to direct PE inputs. While the direct PE input recommendations generally correspond to the physician time values associated with services, we believe that in some cases inadvertent discrepancies between physician time values and direct PE inputs should be refined in the establishment of interim final direct PE inputs. In other cases, CMS refinement of recommended interim final physician times prompts necessary adjustments in the direct PE inputs. In the context of our establishment of interim final direct PE inputs for CY 2013, we explain those refinements in section III.M.3.b of this final rule with comment period.
After consideration of these comments, we are finalizing the current interim final direct PE inputs as refined based on this policy. The direct PE inputs are displayed in the final CY 2013 direct PE input database, available on the CMS Web site under the downloads for the CY 2013 PFS final rule at
In establishing interim final direct PE inputs for 2012, CMS refined the AMA RUC's recommendation for CPT codes 15271 (Application of skin substitute graft to trunk, arms, legs, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area), 15273 (Application of skin substitute graft to trunk, arms, legs, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children), 15275 (Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area up to 100 sq cm; first 25 sq cm or less wound surface area), and 15277 (Application of skin substitute graft to face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits, total wound surface area greater than or equal to 100 sq cm; first 100 sq cm wound surface area, or 1% of body area of infants and children) to allocate the full service period minutes to the basic instrument pack (EQ137) by reducing the equipment allocation by 3 minutes to account for the overlapping time for cleaning the room and the pack.
CMS also refined the recommended direct PE inputs for CPT codes 15273 and 15275 by not including the post-op incision care (suture) pack (SA054) in each code because the code itself does not describe post-op care.
In establishing interim final direct PE inputs for 2012, CMS refined the AMA RUC's recommendation for CPT code 20527 (Injection, enzyme (eg, collagenase), palmar fascial cord (ie, dupuytren's contracture)) by including a minimum multi-specialty visit pack (SA048) as a direct PE input for the service.
After consideration of this comment, we are finalizing the direct PE inputs for CPT code 20527 as established as interim final with the additional refinement of removing the supply item discussed above. The direct PE inputs are displayed in the final CY 2013 direct PE input database, available on the CMS Web site under the downloads for the CY 2013 PFS final rule at
In establishing interim final direct PE inputs for 2012, CMS refined the AMA RUC's recommendation for CPT code 22525 (Percutaneous vertebral augmentation, including cavity creation (fracture reduction and bone biopsy included when performed) using mechanical device, 1 vertebral body, unilateral or bilateral cannulation (eg, kyphoplasty); each additional thoracic or lumbar vertebral body (list separately in addition to code for primary procedure))by not including additional clinical labor and equipment time for preparing the room, equipment, and supplies since the CPT code 22525 is an add-on code and time for those tasks is already included in the base code.
After consideration of these comments, we are finalizing the direct PE inputs for CPT code 22525 as established as interim final with the additional refinement of assigning the appropriate labor codes.
In establishing interim final direct PE inputs for 2012, CMS refined the AMA RUC's recommendation for CPT code 26341 (Manipulation, palmar fascial cord (ie, dupuytren's cord), post enzyme injection (eg, collagenase), single cord) by including a minimum multi-specialty visit pack (SA048) as a direct PE input for the service period in the nonfacility and the same pack in both settings to account for the post-service office visit included in the global period.
After consideration of this comment, we are finalizing the direct PE inputs for CPT code 26341 as established as interim final. The direct PE inputs are displayed in the final CY 2013 direct PE input database, available on the CMS Web site under the downloads for the CY 2013 PFS final rule at
In establishing interim final direct PE inputs for 2012, CMS refined the AMA RUC's recommendations for CPT codes 32405 (Biopsy, lung or mediastinum, percutaneous needle) and 47000 (Biopsy of liver, needle; percutaneous) by removing minutes allocated to the CT room (EL007) since these services are typically billed with radiological supervision and interpretation (S&I) services.
After consideration of this comment, we are finalizing the direct PE inputs for CPT codes 32405 and 47000 as established as interim final with the additional refinement of including the CT room as a direct PE input for the services, with the reduction of 9 minutes to account for the overlapping number of minutes allocated in the S&I code.
In establishing interim final direct PE inputs for 2012, CMS refined the AMA RUC's recommendations for CPT codes 36200 (Introduction of catheter, aorta), 36246 (Selective catheter placement, arterial system; initial second order abdominal, pelvic, or lower extremity artery branch, within a vascular family), and 36247 (Selective catheter placement, arterial system; initial third order or more selective abdominal, pelvic, or lower extremity artery branch, within a vascular family) by reducing the number of clinical labor minutes allocated for preparing the room, equipment, and supplies used in the service to the standard number of minutes allocated to clinical labor for those tasks.
After consideration of this comment, we are finalizing the direct PE inputs for CPT codes 36200, 36246, and 36247 as established as interim final. The direct PE inputs are displayed in the final CY 2013 direct PE input database, available on the CMS Web site under the downloads for the CY 2013 PFS final rule at
In establishing interim final direct PE inputs for 2012, CMS refined the AMA RUC's recommendations for CPT code 49083 (Abdominal paracentesis (diagnostic or therapeutic); with imaging guidance) by reducing the number of clinical labor minutes recommended for a series of tasks to correspond with the standard minutes as allocated across PFS services. Additionally, CMS refined the minutes allocated to the equipment associated with the service based on the standard allocation of minutes for highly technical and resource-intensive equipment.
After consideration of this comment, we are finalizing the direct PE inputs for CPT code 49083 as established as interim final, with the additional refinement of allocating 32 minutes for the equipment used in the service. The direct PE inputs are displayed in the final CY 2013 direct PE input database, available on the CMS Web site under the downloads for the CY 2013 PFS final rule at
In establishing interim final direct PE inputs for 2012, CMS refined the AMA RUC's recommendations for CPT code 51736 (Simple uroflowmetry (ufr) (eg, stop-watch flow rate, mechanical uroflowmeter)) by adding the following supplies to the direct PE inputs for the service based on CMS clinical review: paper towel (SK082), disinfectant spray (SM012), and sanitizing cloth wipe (SM022).
After consideration of this comment, we are finalizing the direct PE inputs for CPT code 51741 as established as interim final, with the additional refinement of removing the three supply items and one equipment item identified above. The direct PE inputs are displayed in the final CY 2013 direct PE input database, available on the CMS Web site under the downloads for the CY 2013 PFS final rule at
(9) Nervous: Extracranial Nerves, Peripheral Nerves, and Autonomic Nervous System (CPT Codes 64633, 64635)
In establishing interim final direct PE inputs for 2012, CMS refined the AMA RUC's recommendations for CPT code 64633 (Destruction by neurolytic agent, paravertebral facet joint nerve(s), with imaging guidance (fluoroscopy or ct); cervical or thoracic, single facet joint) and 64635 (Destruction by neurolytic agent, paravertebral facet joint nerve(s), with imaging guidance (fluoroscopy or ct); lumbar or sacral, single facet joint) by not including the recommended radiofrequency probe kit (SA100) as a supply item. As we explained in the CY 2012 PFS final rule (76 FR 73214), the very expensive disposable item had not previously been included as a direct PE input for predecessor codes that described the same services, and the recommendation did not include any information suggesting that such a significant resource cost had become typical in furnishing the services. At that time, we noted that the direct PE inputs for these codes were considered interim for CY 2012, and we would consider any submitted information regarding the use of this supply in furnishing these services prior to finalizing the direct PE inputs for CY 2013.
CMS also refined the recommended direct PE inputs for CPT codes 64633 and 64635 by allocating equipment minutes in the facility setting for the exam table (EF023) and the exam light (EQ168) based on the post-service office visits included in the global periods.
After consideration of these comments, we are finalizing the direct PE inputs for CPT code 64633 and 64635 as established as interim final, with the additional refinement of establishing this equipment item, “radiofrequency kit for destruction by
In establishing interim final direct PE inputs for 2012, CMS refined the direct PE inputs for CPT codes 72120 (Radiologic examination, spine, lumbosacral; bending views only, 2 or 3 views) and 72170 (Radiologic examination, pelvis; 1 or 2 views) by reducing the number of minutes allocated to the clinical labor for cleaning the room and equipment to one.
After consideration of these comments, we are finalizing the direct PE inputs for CPT codes 72120 and 72170, with the additional refinement of allocating two additional minutes to the clinical labor and the associated equipment inputs for cleaning the room and equipment. The direct PE inputs are displayed in the final CY 2013 direct PE input database, available on the CMS Web site under the downloads for the CY 2013 PFS final rule at
In establishing interim final direct PE inputs for 2012, CMS refined the AMA RUC's recommendations for CPT codes 78226 (Hepatobiliary system imaging, including gallbladder when present;), 78227(Hepatobiliary system imaging, including gallbladder when present; with pharmacologic intervention, including quantitative measurement(s) when performed), 78579 (Pulmonary ventilation imaging (eg, aerosol or gas)), 78580 (Pulmonary perfusion imaging (eg, particulate)), 78582 (Pulmonary ventilation (eg, aerosol or gas) and perfusion imaging), 78597 (Quantitative differential pulmonary perfusion, including imaging when performed), and 78598 (Quantitative differential pulmonary perfusion and ventilation (eg, aerosol or gas), including imaging when performed) by refining equipment time allocations as described in section III.M.2.b above.
CMS also refined the recommended direct PE inputs for CPT codes 78226, 78227, 78579, 78580, 78582, 78597, 78598 by examining all of the educational tasks included in the AMA RUC's recommendation and refining the sum of those times to a total number of minutes considered accurate under CMS clinical review. The AMA RUC recommendation included 6 minutes of education by the nuclear medicine technologist. CMS refined the total number of minutes allocated for educational tasks to 4.
CMS also refined the recommended direct PE inputs for CPT codes 78226, 78227, 78579, 78580, 78582, 78597, 78598 by examining all of the cleaning tasks included in the AMA RUC's recommendation and refining the sum of those times to a total number of minutes considered accurate under CMS clinical review. The AMA RUC recommendation included 13 minutes of cleaning tasks by a nuclear medicine technologist. CMS refined the total number of minutes allocated for educational tasks to 10.
After consideration of these comments, we are finalizing the direct PE inputs for CPT codes 78226, 78227, 78579, 78580, 78582, 78597, 78598 with the additional refinement of allocating 1 additional clinical labor minute for patient education tasks and an additional 3 minutes to the clinical labor and equipment items to account for mandatory cleaning tasks. The direct PE inputs are displayed in the final CY 2013 direct PE input database, available on the CMS Web site under the downloads for the CY 2013 PFS final
In establishing interim final direct PE inputs for 2012, CMS refined the AMA RUC's recommendations for CPT code 94728 (Airway resistance by impulse oscillometry) by adding the body plethysmograph autobox (EQ044) as direct equipment input for the service based on the item's inclusion as a direct PE input for related services.
After consideration of these comments, we are finalizing the direct PE inputs for CPT code 94728 with the additional refinement of removing the equipment item discussed above as a direct PE input for the service. The direct PE inputs are displayed in the final CY 2013 direct PE input database, available on the CMS Web site under the downloads for the CY 2013 PFS final rule at
In establishing interim final direct PE inputs for 2012, CMS refined the AMA RUC's recommendations for CPT code 96413 (Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug) by not including the 6 clinical labor minutes in the pre-service period for completing pre-service diagnostic and referral forms and coordinating pre-surgery services since these tasks are not generally allocated for services without global periods.
CMS refined the recommended direct PE inputs for CPT code 96416 by not including the 4 minutes assigned to the clinical labor for reviewing the charts and obtain chemotherapy-related medical history. This refinement reflected that CMS clinical review concluded that these tasks are already accounted for in the clinical labor minutes assigned to CPT code 96413 and would typically not be repeated when CPT code 96416 is reported.
CMS also refined the recommended direct PE inputs for CPT code 96416 by examining all of the tasks described in the AMA RUC's recommendation for monitoring the patient and removing the minutes that overlap with monitoring included in CPT code 96413. This refinement assumed no monitoring was necessary beyond the monitoring time already associated with CPT code 96413.
After consideration of these comments, we are finalizing the direct PE inputs for CPT codes 96413 and 96416 with the additional refinements of including an additional 6 minutes of clinical labor time in the pre-service period for CPT code 96413 and including an additional 11 minutes of clinical labor time in the service period for CPT code 96416. We also note that the minutes allocated to the equipment inputs will increase based on our standard allocation policies. The direct PE inputs are displayed in the final CY 2013 direct PE input database, available on the CMS Web site under the downloads for the CY 2013 PFS final rule at
For all other CY 2012 new, revised, or potentially misvalued codes with CY 2012 interim final RVUs that are not specifically discussed in this final rule with comment period, we are finalizing, without modification, the interim final direct PE inputs that we initially adopted for CY 2012.
Consistent with our malpractice methodology described in section III.C.1. of this final rule with comment period, for the CY 2012 PFS final rule, we assigned malpractice RVUs for CY 2012 new and revised codes by utilizing crosswalks to source codes that have a similar malpractice risk-of-service. After reviewing the AMA RUC-recommended malpractice source code crosswalks for CY 2012 new and revised codes, we accepted nearly all of them on an interim final basis for CY 2012. As detailed in the CY 2012 final rule with comment period (76 FR 73264 through 73265), for four CPT codes describing multi-layer compression systems, we assigned a malpractice crosswalk different from the malpractice crosswalk recommended by the AMA RUC and HCPAC.
In the CY 2012 PFS final rule with comment period, for CPT codes 29581 (Application of multi-layer compression
Additionally, for CY 2012 we created HCPCS G-code G0451 (Development testing, with interpretation and report, per standardized instrument form) to replace CPT code 96110 (Developmental screening, with interpretation and report, per standardized instrument form). For CY 2012, we assigned CPT code 96110 as the malpractice source code crosswalk for HCPCS code G0451.
In accordance with our malpractice methodology, we adjusted the malpractice RVUs for the CY 2012 new/revised codes for the difference in work RVUs (or, if greater, the clinical labor portion of the fully implemented PE RVUs) between the source codes and the new/revised codes to reflect the specific risk-of-service for the new/revised codes. The interim final malpractice crosswalks were listed in Table 22 of the CY 2012 PFS final rule with comment period (76 FR 73266 through 73268).
We received no comments on the CY 2012 interim final malpractice crosswalks and are finalizing them without modification for CY 2013. The malpractice RVUs for these services are reflected in Addendum B of this CY 2013 PFS final rule with comment period.
For all other new, revised, or potentially misvalued codes with CY 2012 interim final RVUs or CY 2013 proposed RVUs that are not specifically discussed in this final rule with comment period, we received no public comments and, as such, we are finalizing, without modification, the interim final or proposed work and direct PE inputs we initially adopted in the CY 2012 final rule with comment period or the CY 2013 proposed rule, respectively. The time values for all codes appear on the CMS Web site at
As previously discussed in section III.M.2 of this final rule with comment period, on an annual basis the AMA RUC and HCPAC, along with other public commenters, provide CMS with recommendations regarding physician work values for new and revised CPT codes. This section discusses services for which CMS disagreed with the recommended physician work RVU or time values for CY 2013 new or revised CPT codes, services that had interim or interim final values in CY 2012 and will continue to have interim or interim final values for CY 2013, as well as the physician work and time values for new and revised HCPCS G-codes. The interim or interim final work RVUs for all codes in this section, including those where CMS agreed with the recommended work RVU, appear in Table 2 at the start of this section. Unless otherwise indicated, we agreed with the time values recommended by the AMA RUC or HCPAC for all codes addressed in this section. The time values for all codes appear on the CMS Web site at:
We note that in addition to the CPT codes discussed in this section, the CPT Editorial created, and the AMA RUC reviewed, many new CPT codes for molecular pathology tests. These services will be payable on the Medicare Clinical Laboratory Fee Schedule and are discussed in detail in section III.I of this CY 2013 PFS final rule with comment period.
CPT code 10120 was identified as potentially misvalued using the Harvard-valued—Utilization over 30,000 screen.
After clinical review of CPT code 10120 (Incision and removal of foreign body, subcutaneous tissues; simple) we believe that the specialty society survey 25th percentile work RVU of 1.22 accurately reflects the work of this service. Medicare claims data from 2011 indicate that this service is typically furnished to the beneficiary by the provider on the same day as an E/M visit. We believe that some of the activities furnished during the pre- and post-service period of the procedure code and the E/M visit overlap. After review, we believe that the AMA RUC appropriately accounted for this overlap in its recommendation of pre-service time, but failed to account for the overlap in post-service time. To account for this overlap, we reduced the AMA RUC-recommended post-service time for this procedure by one-third, from 5 minutes to 3 minutes. We believe that 3 minutes accurately reflects the post-service time involved in furnishing this procedure and is more in line with similar services. Because we reduced the AMA RUC-recommended procedure time for this code by 2 minutes, given a standard post-service work intensity of .0224 RVUs per minute, we believe that the specialty society survey 25th percentile work RVU of 1.22 is more appropriate for this service than the AMA RUC-recommended work RVU of 1.25. In sum, on an interim final basis for CY 2013, we are assigning a work RVU of 1.22 to CPT code 10120, with a refinement to the AMA RUC-recommended time. A complete list of the interim final times associated with this procedure is available on the CMS Web site at
CPT code 11056 was identified for review because it is on the multispecialty points of comparison (MPC) list—a list of CPT codes commonly used as reference codes in the valuation of other codes.
We reviewed CPT code 11056 (Paring or cutting of benign hyperkeratotic lesion (eg, corn or callus); 2 to 4 lesions) in CY 2012, and accepted the HCPAC-recommended work RVU of 0.50, the specialty society survey 25th percentile value, on an interim basis for CY 2012. At that time, we requested that the specialty society re-review CPT code 11056 along with related CPT codes 11055 (Paring or cutting of benign hyperkeratotic lesion (eg, corn or callus); single lesion) and 11057 (Paring or cutting of benign hyperkeratotic lesion (eg, corn or callus); more than 4 lesions) to ensure appropriate relativity between the three services (76 FR 73190). The specialty society declined to survey CPT codes 11055 or 11057, and, in its recommendations to CMS, the AMA RUC noted that there are no apparent rank order anomalies among the three services.
For CY 2013, we reviewed CPT codes 11055, 11056, and 11057 together. After clinical review, we did not have evidence that the relativity of the services to each other had changed over time, and since the HCPAC and CMS agreed that the work associated with CPT code 11056 had decreased, we believe it is appropriate to reduce the work of CPT codes 11055 and 11057 relative to the decrease in work of CPT code 11056. In CY 2012, the HCPAC recommended that CPT code 11056 be reduced from a CY 2011 work RVU of 0.61 to a CY 2012 work RVU of 0.50. Therefore, to maintain relativity, we are reducing CPT code 11055 from a work RVU of 0.43 to a work RVU of 0.35, and we are reducing CPT code 11057 from a work RVU of 0.79 to a work RVU of 0.65 on an interim final basis for CY 2013.
Regarding physician time, CPT codes 11055 and 11057 currently (CY 2012) are assigned 2 minutes of pre-service time and 5 minutes of post-service time. Before it was reviewed by the HCPAC for CY 2012, CPT code 11056 was also assigned 2 minutes of pre-service time and 5 minutes of post service time. Through its review, the HCPAC recommended adjusting the time of CPT code to include 7 minutes of pre-service time and 2 minutes of post-service time, and we agreed. We believe that these are also the appropriate pre- and post- service times for CPT codes 11055 and 11057. On an interim final basis for CY 2013, we are refining the times of CPT codes 11055 and 11057 to 7 minutes of pre-service time and 2 minutes of post-service time. We believe the current intra-service times of 4 minutes for CPT code 11055 and 15 minutes for CPT code 11057 remain appropriate. A complete list of the interim final times associated with these procedures is available on the CMS Web site at
For CY 2013 CPT codes 11300 through 11313, which describe procedures related to the shaving of epidermal or dermal lesions, were surveyed by their related specialty society to establish current relative values for these procedures. The specialty society and the AMA RUC reviewed the survey results for CPT codes 11300 through 11313 and recommended the survey 25th percentile work RVU for nearly all the codes in the family. After clinical review, we believe that the survey 25th percentile for all the codes in the family reflects the appropriate relativity of the services both within the family, as well as relative to other services on the PFS. On an interim final basis for CY 2013 we are assigning a work RVU of 0.60 for CPT code 11300 (Shaving of epidermal or dermal lesion, single lesion, trunk, arms or legs; lesion diameter 0.5 cm or less); a work RVU of 0.90 for CPT code 11301 (Shaving of epidermal or dermal lesion, single lesion, trunk, arms or legs; lesion diameter 0.6 to 1.0 cm); a work RVU of 1.05 for CPT code 11302 (Shaving of epidermal or dermal lesion, single lesion, trunk, arms or legs; lesion diameter 1.1 to 2.0 cm); a work RVU of 1.25 for CPT code 11303 (Shaving of epidermal or dermal lesion, single lesion, trunk, arms or legs; lesion diameter over 2.0 cm); a work RVU of 0.80 for CPT code 11305 (Shaving of epidermal or dermal lesion, single lesion, scalp, neck, hands, feet, genitalia; lesion diameter 0.5 cm or less); a work RVU of 0.96 for CPT code 11306 (Shaving of epidermal or dermal lesion, single lesion, scalp, neck, hands, feet, genitalia; lesion diameter 0.6 to 1.0 cm); a work RVU of 1.20 for CPT code 11307 (Shaving of epidermal or dermal lesion, single lesion, scalp, neck, hands, feet, genitalia; lesion diameter 1.1 to 2.0 cm); a work RVU of 1.46 for CPT code 11308 (Shaving of epidermal or dermal lesion, single lesion, scalp, neck, hands, feet, genitalia; lesion diameter over 2.0 cm); a work RVU of 0.80 for CPT code 11310 (Shaving of epidermal or dermal lesion, single lesion, face, ears, eyelids, nose, lips, mucous membrane; lesion diameter 0.5 cm or less); a work RVU of 1.10 for CPT code 11311 (Shaving of epidermal or dermal lesion, single lesion, face, ears, eyelids, nose, lips, mucous membrane; lesion diameter 0.6 to 1.0 cm); a work RVU of 1.30 for CPT code 11312 (Shaving of epidermal or dermal lesion, single lesion, face, ears, eyelids, nose, lips, mucous membrane; lesion diameter 1.1 to 2.0 cm); and a work RVU of 1.68 for CPT code 11313 (Shaving of epidermal or dermal lesion, single lesion, face, ears, eyelids, nose, lips, mucous membrane; lesion diameter over 2.0 cm).
CPT codes 12031, 12051, and 13101 were identified as potentially misvalued using the Harvard-valued—Utilization over 30,000 screen. As a result of this screen, in the Fourth Five-Year Review of Work, we reviewed the family of intermediate wound repair CPT codes (12031 through 12057), along with two complex wound repair codes (13100 and 13101).
In the Fourth Five-Year Review, we disagreed with the AMA RUC-recommended work RVUs for the larger of the intermediate wound repair codes: CPT codes 12035 (Repair, intermediate, wounds of scalp, axillae, trunk and/or extremities (excluding hands and feet); 12.6 cm to 20.0 cm), 12036 (Repair, intermediate, wounds of scalp, axillae, trunk and/or extremities (excluding hands and feet); 20.1 cm to 30.0 cm), 12037 (Repair, intermediate, wounds of scalp, axillae, trunk and/or extremities (excluding hands and feet); over 30.0 cm), 12045 (Repair, intermediate, wounds of neck, hands, feet and/or external genitalia; 12.6 cm to 20.0 cm), 12046 (Repair, intermediate, wounds of neck, hands, feet and/or external genitalia; 20.1 cm to 30.0 cm), 12047 (Repair, intermediate, wounds of neck, hands, feet and/or external genitalia; over 30.0 cm), 12055 (Repair, intermediate, wounds of face, ears, eyelids, nose, lips and/or mucous membranes; 12.6 cm to 20.0 cm), 12056 (Repair, intermediate, wounds of face, ears, eyelids, nose, lips and/or mucous membranes; 20.1 cm to 30.0 cm) and 12057 (Repair, intermediate, wounds of face, ears, eyelids, nose, lips and/or mucous membranes; over 30.0 cm) (76 FR 32431 through 32432). As discussed in the CY 2012 PFS final rule with comment period, after review by the refinement panel, we maintained the proposed RVUs published in the Fourth Five-Year Review of Work (76 FR 73113 through 73114). We stated that we would hold these codes interim for another year rather than finalizing the codes, so that we could review these larger intermediate wound repair codes alongside the family complex wound repair codes, which we anticipated reviewing for CY 2013.
In the Fourth Five-Year Review of Work, we stated that we would maintain the current (CY 2011) work RVUs and times for complex wound repair CPT codes 13100 (Repair, complex, trunk; 1.1 cm to 2.5 cm) and 13101 (Repair, complex, trunk; 2.6 cm to 7.5 cm), and requested that the AMA RUC review the entire set of codes in the complex wound repair family together to assess the appropriate gradation of the work RVUs in the family (76 FR 32434 through 32435). For CY 2013, we received new recommendations from the AMA RUC on CPT codes 13100 and 13101, as well as recommendations on the rest of the CPT codes in the complex wound repair family CPT codes 13100 through 13102, 13120 through 13122, 13131 through 13133, and 13150 through 13153, excluding CPT code 13150 (Repair, complex, eyelids, nose, ears and/or lips; 1.0 cm or less), which the AMA RUC referred to the CPT Editorial Panel for deletion in CY 2014. We agree with the AMA RUC recommendations for all the codes in the complex wound repair family, except one. After reviewing CPT code 13152 (Repair, complex, eyelids, nose, ears and/or lips; 2.6 cm to 7.5 cm), we believe that the AMA RUC-recommended work RVU of 5.34 is too high relative to similar CPT code 13132 (Repair, complex, forehead, cheeks, chin, mouth, neck, axillae, genitalia, hands and/or feet; 2.6 cm to 7.5 cm), which has an AMA RUC-recommended work RVU of 4.78, and CPT code 13151 (Repair, complex, eyelids, nose, ears and/or lips; 1.1 cm to 2.5 cm), which has an AMA RUC-recommended work RVU of 4.34. We believe that the specialty society 25th percentile work RVU of 4.90 more appropriately reflects the relative work involved in furnishing this service. On an interim final basis for CY 2013, we are assigning a work RVU of 4.90 to CPT code 13152.
The AMA RUC referred CPT code 13150 to the CPT Editorial Panel for deletion in CY 2014. Because of this, the AMA RUC did not review this service with the other codes in this family. For CY 2013, we believe it is appropriate to reduce the work RVU of CPT code 13150 proportionate to the other services in the family, so that the value of CPT code 13150 maintains appropriate proportionate rank order for CY 2013. For CY 2013, the work RVUs
After reviewing the family of complex wound repair CPT codes for CY 2013, we re-reviewed the larger intermediate wound repair codes that we had been holding interim since the Fourth Five-Year Review of Work. We reviewed CPT codes 12035 through 12037, 12045 through 12047, and 12055 through 12057 in relation to each other, the other intermediate wound repair CPT codes (12031 through 12034, 12041 through 12044, and 12051 through 12054), the complex wound repair CPT codes, and other PFS services, and we continue to believe that the current interim values are appropriate relative to the other services. Therefore, on an interim final basis for CY 2013, are maintaining the following current (CY 2012) work values: A work RVU of 3.50 for CPT code 12035; a work RVU of 4.23 for CPT code 12036; a work RVU of 5.00 for CPT code 12037; a work RVU of 3.75 for CPT code 12045; a work RVU of 4.30 for CPT code 12046; a work RVU of 4.95 for CPT code 12047; a work RVU of 4.50 for CPT code 12055; a work RVU of 5.30 for CPT code 12056, and a work RVU of 6.00 for CPT code 12057.
We also believe that it is appropriate to maintain the current (CY 2012) times for these procedures, as we believe that they reflect the time involved in furnishing these procedures and that they are well-aligned with each other and with the simple and complex wound repair CPT codes. One exception to this is CPT code 12045 (Repair, intermediate, wounds of neck, hands, feet and/or external genitalia; 12.6 cm to 20.0 cm), which includes 10 minutes of pre-service evaluation time, while CPT codes 12046 (Repair, intermediate, wounds of neck, hands, feet and/or external genitalia; 20.1 cm to 30.0 cm) and 12047 (Repair, intermediate, wounds of neck, hands, feet and/or external genitalia; over 30.0 cm) both include 9 minutes of pre-service evaluation time. We believe it is appropriate to reduce the pre-service evaluation time of CPT code 12045 to match the pre-service evaluation time of CPT codes 12046 and 12047. Therefore, for CY 2013, we are assigning an interim final pre-service evaluation time of 9 minutes to CPT 12045. A complete list of the interim final times associated with these procedures is available on the CMS Web site at
For CY 2013, the CPT Editorial Panel created CPT code 22586 (Arthrodesis, pre-sacral interbody technique, including disc space preparation, discectomy, with posterior instrumentation, with image guidance, includes bone graft when performed, l5-s1 interspace). The specialty societies related to this CPT code that participate in the AMA RUC declined to survey this new CPT code and the AMA RUC issued no work RVU recommendation to us for this service for CY 2013. A related specialty society that does not participate in the AMA RUC conducted a survey of its members regarding the physician work and time associated with this procedure and submitted a recommendation to CMS. In determining the appropriate value for this CPT code, we reviewed the survey results and recommendations submitted to us, literature on the procedure, and the Medicare claims data. Ultimately, we used a building block approach based on Medicare 2011 same day billing combinations to develop the interim final value for this procedure.
New CPT code 22586 is a bundled lumbar arthrodesis procedure that includes grafting, posterior instrumentation, and fixation. To value this service we used CPT code 22558 (Arthrodesis, anterior interbody technique, including minimal discectomy to prepare interspace (other than for decompression); lumbar) as a reference service, as it is a similar procedure but it does not include additional grafting, instrumentation, and fixation. To assess the appropriate relative work increase from unbundled CPT code 22558 to the new bundled CPT code 22586, we used Medicare claims data to assess which grafting, instrumentation, and fixation services are commonly billed with CPT code 22558 and how often. We used those data to create a utilization weighted work RVU for the grafting component of CPT code 22586, the instrumentation component of the 22586, and the fixation component of 22586. We added those components to the base service of CPT code 22558 to create a work RVU of 28.12. We believe this work RVU reflects the appropriate incremental difference in work between the base reference CPT code 22558 and new CPT code 22586. For CY 2013 we are assigning a work RVU of 28.12 to CPT code 22586 for CY 2013, and we request additional public input on the appropriate valuation of this service.
We assigned CPT code 22586 a global period of 90 days, which is consistent with similar service. Regarding physician time for CPT code 22586, after reviewing the physician time and post-operative visits for similar services, we believe this service includes 40 minutes of pre-service evaluation time, 20 minutes of pre-service positioning time, 20 minutes of pre-service scrub, dress and wait time, 180 minutes of intra-service time, and 30 minutes of immediate post-service time. In the post-operative period, we believe the typical case for this service includes 2 CPT code 99231 visits, 1 CPT code
For CY 2013, the CPT Editorial Panel created two new CPT codes for total shoulder revision, CPT code 23473 (Revision of total shoulder arthroplasty, including allograft when performed; humeral or glenoid component) and 23474 (Revision of total shoulder arthroplasty, including allograft when performed; humeral and glenoid component). The specialty society surveyed these codes along with the other codes in this family, which include CPT codes 23331 (Removal of foreign body, shoulder; deep (eg, neer hemiarthroplasty removal)), 23332 (Removal of foreign body, shoulder; complicated (eg, total shoulder)), and 23472 (Arthroplasty, glenohumeral joint; total shoulder (glenoid and proximal humeral replacement (eg, total shoulder))). After reviewing the survey responses, the AMA RUC concluded that the descriptors for CPT codes 23331 and 23332 needed revision. The AMA RUC referred CPT codes 23331 and 23332 to the CPT Editorial Panel for further clarification and recommended that we maintain the current (CY 2012) work RVUs of 7.63 for CPT code 23331, and 12.37 for CPT code 23332 for CY 2013. The AMA RUC recommended the survey 25th percentile work RVU for the three other services in this family: A work RVU of 22.13 for CPT code 23472; a work RVU of 25.00 for CPT code 23473; and a work RVU of 27.21 for CPT code 23474. We are accepting these work RVUs on an interim basis for CY 2013, and will review CPT codes 23472, 23473, and 23474 alongside CPT codes 23331 and 23332 after the codes descriptors are changed, to ensure consistency within this family of CPT codes.
For CY 2013, the CPT Editorial Panel created two new CPT codes for revision of a total elbow arthroplasty, CPT code 24370 (Revision of total elbow arthroplasty, including allograft when performed; humeral or ulnar component) and CPT code 24371 (Revision of total elbow arthroplasty, including allograft when performed; humeral and ulnar component). The specialty society surveyed these CPT codes along with component CPT codes 24160 (Implant removal; elbow joint) and 24363 (Arthroplasty, elbow; with distal humerus and proximal ulnar prosthetic replacement (eg, total elbow)). After reviewing the survey responses, the AMA RUC concluded that the descriptor for CPT code 24160 needs revision. The AMA RUC referred CPT code 24160 to the CPT Editorial Panel for revision of the descriptor and recommended that we maintain the current (CY 2012) work RVU of 8.00 for CPT code 24160 for CY 2013. The AMA RUC recommended the survey 25th percentile work RVU for the three other services in this family: a work RVU of 22.00 for CPT code 24363; a work RVU of 23.55 for CPT code 24370; and a work RVU of 27.50 for CPT code 24371. We are accepting these work RVUs on an interim basis for CY 2013, and will review CPT codes 24363, 24370, and 24371 alongside CPT code 24160 after the code descriptor is changed, to ensure consistency within this family of CPT codes. For CY 2013, we are refining the AMA RUC-recommended post-service time of CPT code 24363 to 20 minutes, from 30 minutes, to match the post-service times of CPT code 24370 and 24371. A complete list of the interim final times associated with these procedures is available on the CMS Web site at
For CY 2013, the CPT Editorial Panel revised the descriptor of CPT code 29581, and created CPT codes 29582, 29583, and 29584 to describe the application of multi-layer compression to the upper and lower extremities. The CPT Editorial Panel and AMA RUC concluded that the revisions to the descriptor for CPT code 29581 were editorial only, and the AMA RUC related specialty society (Society for Vascular Surgery) believed that resurveying CPT code 29581 was not necessary. As such, the AMA RUC recommended “No Change” for CPT code 29581. For CY 2012, CPT codes 29582, 29583, and 29584 were surveyed through the American Physical Therapy Association (the expected dominant providers of the services), and the HCPAC reviewed the results and issued recommendations to CMS for these three CPT codes.
We discussed CPT codes 29581 (Application of multi-layer compression system; leg (below knee), including ankle and foot), 29582 (Application of multi-layer compression system; thigh and leg, including ankle and foot, when performed), 29583 (Application of multi-layer compression system; upper arm and forearm), and 29584 (Application of multi-layer compression system; upper arm, forearm, hand, and fingers) in the CY 2012 final rule with comment period (76 FR 73192 through 73193). In the CY 2012 PFS final rule with comment period, we stated that after clinical review, we believed that CPT code 29581, in relation to CPT codes 29582 through 29584, described a similar service from a resource perspective and should be valued similarly to those codes. We stated that we believed a work RVU of 0.60 for CPT code 29581 is inappropriately high in relation to the HCPAC-reviewed codes 29582, 29583, and 29584. We believed that the HCPAC-recommended work RVUs of 0.35 for CPT code 29682, 0.25 for CPT code 29583, and 0.35 for CPT code 29584 accurately reflected the work associated with these services. Additionally, we stated that we believed that the clinical conditions treated by CPT codes 29581 and 29583 are essentially the same, namely the treatment of venous ulcers and lymphedema. We stated that we recognized that there would be mild differences and variation in the application of a multi-layer compression system to the upper extremity versus the lower extremity, which is accounted for in the intra-service times of the codes. As such, we believed that a work RVU of 0.25 appropriately accounts for the work associated with CPT code 29581.
Ultimately, we stated that we believed that a survey that addressed all 4 CPT codes together as a family and gathers responses from all clinicians who furnish the services described by CPT codes 29581 through 29584 would help us to further consider the appropriate gradation in valuation of these 4 services. We assigned a work RVU of 0.25 to CPT code 29581 on an interim basis for CY 2012, and anticipated reviewing CPT code 29581 along with CPT codes 29582, 29583, and 29584 with new survey data for CY 2013.
In response to the CY 2012 PFS final rule with comment period, commenters stated that they believe the CPT Editorial Panel revisions to CPT code 29581 were editorial only and resurveying CPT code 29581 was unnecessary, and no changes should be made to the work RVU for this code. Commenters disagreed with our methodology to value CPT code 29581 similar to HCPAC-reviewed codes 29582, 29583, and 29584, stating that the beneficiaries who receive services under CPT code 29581 are more complex. Commenters noted that the work descriptor for CPT code 29581 includes evaluation and cleansing of the venous ulcer, while there is no such parallel service for CPT codes 29582, 29583, and 29584. Commenters argued that CPT code 29581 was reviewed by the AMA RUC in April 2009 and those survey results should not be invalided by crosswalking CPT code 29581 to HCPAC-reviewed codes 29582, 29583, and 29584. Commenters noted that no completed RUC survey data was submitted to the HCPAC for CPT codes 29582, 29583 or 29584—a single specialty presented crosswalk values to the HCPAC, and they were accepted. Commenters recommended we maintain the 2009 valued AMA RUC work RVU of 0.60 for CPT code 29581.
In response to our assertion that a survey that addressed all 4 CPT codes together as a family and gathers responses from all clinicians who furnish the services described by CPT codes 29581 through 29584 would help assure the appropriate gradation in valuation of these 4 services, the AMA RUC noted that when CPT codes 29582, 29583, and 29584 were created no physician (MD/DO) specialty societies had an interest in surveying the codes, so they were surveyed and reviewed by only the HCPAC. The AMA RUC noted that another survey process would not mean that these codes would be surveyed together as we had requested.
In response to comments received, we referred CPT code 29581 to the CY 2012 multi-specialty refinement panel for further review. The refinement panel median work RVU for CPT code 29581 was 0.50. Typically, we finalize the work values for CPT codes after reviewing the results of the refinement panel. However, for CY 2012 we assigned interim RVUs for CPT codes 29581, 29582, 29583, and 29584 and requested additional information, with the intention of re-reviewing the services for CY 2013 with the new information we had received, and setting interim final values at that time. We recognize that CPT code 29581 received only editorial changes; however, we continue to believe the HCPAC-reviewed codes 29582, 29583, and 29584 describe similar services. While the services are performed by different specialties, they do involve similar work. For example, prior to the application of the compression bandage, CPT code 29581 includes the work furnishing a physical exam to assesses adequate arterial flow, the presence of infection, the degree of swelling, and the size/depth of the lower extremity ulcer, while CPT code 29583 includes
CPT codes 29824, 29826, 29827, and 29828 were identified as potentially misvalued through the Codes Reported Together 75 percent or More screen. CPT code 29826 was also identified as potentially misvalued through the Harvard-valued—Utilization over 30,000 screen, and CPT code 29828 was also identified for additional review because it was on the New Technology list.
We reviewed CPT code 29826 (Arthroscopy, shoulder, surgical; decompression of subacromial space with partial acromioplasty, with coracoacromial ligament (ie, arch) release, when performed (list separately in addition to code for primary procedure)) for CY 2012 and agreed with the AMA RUC recommended work RVU of 3.00, which was the specialty society survey 25th percentile work RVU (76 FR 73193). For CY 2013, the AMA RUC reviewed CPT codes 29824 (Arthroscopy, shoulder, surgical; distal claviculectomy including distal articular surface (mumford procedure)) and 29827 (Arthroscopy, shoulder, surgical; with rotator cuff repair), however the specialty society did not survey these CPT codes. Without survey information, the AMA RUC affirmed that the current work RVU of 8.82 for CPT code 29824 and the current work RVU of 15.59 for CPT code 29827 are correct and not overlapping with CPT code 29826. For CY 2013, the AMA RUC also reviewed CPT code 29828 (Arthroscopy, shoulder, surgical; biceps tenodesis), which, as stated above, was on the New Technology list. The specialty society surveyed CPT code 29828, and the AMA RUC recommended the current a work RVU of 13.16, which was between the survey 25th percentile and median work RVU. As we have stated many times, we believe families of services should be reviewed together to ensure relativity between the services and consistency in inputs. We do not find the AMA RUC's affirmation that the work RVUs of CPT codes 29824 and 29827 have not changed to be sufficient evidence that the current RVUs continue to accurately reflect the work associated with furnishing those services. We request additional information from commenters on the appropriate values for these services. To clarify, we do not believe the specialty society needs to resurvey CPT codes 29826 and 29828, however we would welcome data on the valuation of CPT codes 29824 and 29827. We anticipate re-reviewing this family of services together for CY 2014. On an interim basis for CY 2013, we are assigning the current (CY 2012) work RVUs to these four services: A work RVU of 8.98 to CPT code 29824; a work RVU of 3.00 to CPT code 29826; a work RVU of 15.59 to CPT code 29827; and a work RVU of 13.16 to CPT code 29828.
CPT code 31231 was identified for review because it is on the MPC list. After clinical review of CPT code 31231 (Nasal endoscopy, diagnostic, unilateral or bilateral (separate procedure)) we believe that the current work RVU of 1.10, the survey 25th percentile value and the AMA RUC recommendation accurately reflects the work associated with this procedure. Medicare claims data from 2011 indicate that this service is typically furnished to the beneficiary on the same day as an E/M visit. We believe that some of the activities furnished during the pre- and post-service period of the procedure code and the E/M visit overlap. After review, we believe that the AMA RUC appropriately accounted for this overlap in its recommendation of pre-service time, but failed to account for the overlap in post-service time. To account for this overlap, we reduced the AMA RUC-recommended post-service time for this procedure by one-third, from 5 minutes to 3 minutes. We believe 3 minutes accurately reflects the post-service time involved in furnishing this procedure, and is more in line with similar services. A complete list of the
For CY 2013, the CPT Editorial Panel created CPT codes 31647, 31648, 31649, and 31651 to replace 0250T, 0251T and 0252T; as well as CPT codes 31660 and 31661 to replace 0276T and 0277T.
After clinical review, we agree with the AMA RUC-recommended work RVU of 4.40 for CPT code 31647 (Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with balloon occlusion, when performed, assessment of air leak, airway sizing, and insertion of bronchial valve(s), initial lobe) and the AMA RUC recommended work RVU of 1.58 for CPT code 31651 (Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with balloon occlusion, when performed, assessment of air leak, airway sizing, and insertion of bronchial valve(s), each additional lobe (list separately in addition to code for primary procedure[s])) which is the associated add-on code for CPT code 31647. We also agree with the AMA RUC-recommended RVU of 4.20 for CPT code 31648 (Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with removal of bronchial valve(s), initial lobe), which is somewhat less work than CPT code 31647. We do not agree with the AMA RUC-recommended work RVU of 2.00 for CPT code 31649 (Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with removal of bronchial valve(s), each additional lobe (list separately in addition to code for primary procedure)). CPT code 31647 has a higher work RVU than CPT code 31648, so to maintain the appropriate relativity between these services, we believe that the add-on code associated with CPT code 31647 (which is CPT code 31651) should have a higher RVU than the add-on code associated with CPT code 31648 (which is CPT code 31649). As such, we believe that the survey 25th percentile work RVU of 1.44 for CPT code 31649 places these services in the appropriate rank-order. On an interim final basis for CY 2013 we are assigning a work RVU of 4.40 to CPT code 31647; a work RVU of 4.20 to CPT code 31648; a work RVU of 1.44 to CPT code 31649; and a work RVU of 1.58 to CPT code 31651.
After reviewing CPT codes 31660 (Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with bronchial thermoplasty, 1 lobe) and 31661 (Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with bronchial thermoplasty, 2 or more lobes) we believe that the specialty society survey 25th percentile work RVUs of 4.25 for CPT code 31660 and 4.50 for CPT code 31661 appropriately reflect the relativity of these services to each other and to other fee schedule services. The AMA RUC recommended the specialty society survey median work RVUs of 4.50 for CPT code 31660 and 5.00 for CPT code 31661. On an interim final basis for CY 2013, we are assigning a work RVU of 4.25 for CPT code 31660 and a work RVU of 4.50 to CPT code 31661.
CPT codes 32420, 32421, 32422, and 32551 were identified as potentially misvalued through the Harvard-valued—Utilization over 30,000 screen. For CY 2013, the CPT Editorial Panel deleted CPT codes 32420, 32421, and 32422 and replaced them with CPT codes 32554, 32555, 32556, and 32557.
After clinical review of CPT code 32551 (Tube thoracostomy, includes connection to drainage system (eg, water seal), when performed, open (separate procedure)), we believe that the current work RVU of 3.29 appropriately reflects the work associated with service. The AMA RUC recommended the specialty society survey 25th percentile work RVU of 3.50, however we believe that an increase in work RVU is not warranted for this service, especially considering
After clinical review of CPT codes 32554 (Thoracentesis, needle or catheter, aspiration of the pleural space; without imaging guidance), 32555 (Thoracentesis, needle or catheter, aspiration of the pleural space; with imaging guidance), and 32556 (Pleural drainage, percutaneous, with insertion of indwelling catheter; without imaging guidance) we agree with the AMA RUC-recommended work RVUs. On an interim final basis for CY 2013, we are assigning a work RVU of 1.82 to CPT code 32554; a work RVU of 2.27 to CPT code 32555, and a work RVU of 2.50 to CPT code 32556.
After clinical review of CPT code 32557 (Pleural drainage, percutaneous, with insertion of indwelling catheter; with imaging guidance), we believe that a work RVU of 3.12 appropriately reflects the work of this service. The AMA RUC recommended a work RVU of 2.50 for CPT code 32556 and a work RVU of 3.62 for CPT code 32557. We believe the AMA RUC-recommended work RVU of 3.62 overstates the difference between CPT codes 32556 and 32557. The specialty societies that surveyed CPT code 32556 recommended to the AMA RUC a work RVU of 3.00 for CPT code 32556 and a work RVU of 3.62 for CPT code 32557. We believe this difference in work RVU of 0.62 more accurately captures the relative difference between these two services. Therefore, since we assigned CPT code 32556 an interim final work RVU of 2.50, we believe a work RVU of 3.12 appropriately reflects the work of CPT code 32557. On an interim final basis for CY 2013, we are assigning a work RVU of 3.12 to CPT code 32557.
Additionally, on an interim final basis for CY 2013, we are refining the AMA RUC recommended pre-service evaluation time to 13 minutes from 15 minutes for CPT codes 32555 and 32557 to match the pre-service evaluation times of CPT codes 32554 and 32556. A complete list of the times associated with these procedures is available on the CMS Web site at
The CPT Editorial Panel reviewed the lung resection family of codes and deleted 8 codes, revised 5 codes, and created 18 new codes for CY 2012. During our clinical review for the CY 2012 PFS final rule with comment period, we were concerned with the varying differentials in the AMA RUC-recommended work RVUs and times between some of the open surgery lung resection codes and their endoscopic analogs. Rather than assign alternate interim final RVUs and times in this large restructured family of codes, we accepted the AMA RUC recommendations on an interim basis and requested that the AMA RUC re-review the surgical services along with their endoscopic analogs.
In the CY 2012 PFS final rule with comment period we made this request on a code-by-code basis. However, there was an inadvertent typographical error in our request—we referred to “open heart surgery analogs”, instead of just “open surgery analogs”. For example, we stated, “For CPT code 32663 (Thoracoscopy, surgical; with lobectomy (single lobe)), the AMA RUC recommended a work RVU of 24.64. Upon clinical review, we have determined that it is most appropriate to accept the AMA RUC recommended work RVU of 24.64 on a provisional basis, pending review of the open heart surgery analogs, in this case CPT code 32480. We are requesting the AMA RUC look at the incremental difference in RVUs and times between the open and laparoscopic surgeries and recommend a consistent valuation of RVUs and time for CPT code 32663 and other services within this family with this same issue. Accordingly, we are assigning a work RVU of 24.64 for CPT code 32663 on an interim basis for CY 2012” (76 FR 73195).
In response to this request, the specialty society noted that these are not open heart surgery codes and therefore are not relevant. The AMA RUC requested further information from CMS on why these services should be reviewed as part of a family. We understand that our request would have been more clear if we had referred to “open surgery codes” instead of “open heart surgery codes” and if we had written “endoscopic procedures” instead of “laparoscopic surgeries”. With this clarification, we re-request public comment on the appropriate work RVU and time values for the interim codes in the table above. These codes are discussed in greater detail in the CY 2012 PFS final rule with comment period, pages 73193 through 73195. For CY 2013, we are maintaining the current (CY 2012) values for these services on an interim basis. We intend
The CPT Editorial Panel deleted four Category III codes (0256T through 0259T) and approved nine CPT codes (33361 through 33369) to report transcatheter aortic valve replacement (TAVR) procedures for CY 2012.
On May 1, 2012, CMS issued a National Coverage Determination (NCD) covering TAVR under Coverage with Evidence Development (CED). The NCD identifies numerous detailed requirements, including that covered TAVR requires a cardiothoracic surgeon and an interventional cardiologist. Under this CED, coverage is limited to services furnished under specific conditions targeted to developing data on the safety and efficacy of the service for Medicare beneficiaries. Like their predecessor Category III codes (0256T through 0259T), the new Category I CPT codes 33361 through 33365 require the work of an interventional cardiologist and cardiothoracic surgeon to jointly participate in the intra-operative technical aspects of TAVR as co-surgeons. Claims processing instructions for the CED (CR 7897 transmittal 2552) require each physician to bill with modifier-62 indicating that co-surgery payment applies. Medicare pays each co-surgeon 62.5 percent of the fee schedule amount. The three add-on cardiopulmonary bypass support services (CPT codes 33367 through 33369) are only reported by the cardiothoracic surgeon; therefore the AMA RUC-recommended work RVUs for those services reflect only the work of one physician. The AMA RUC-recommended work RVUs for each of the co-surgery CPT codes (33361 through 33365) reflect the combined work of both physicians, irrespective of the co-surgery payment policy. We debated whether it was appropriate to continue our co-surgery payment policy at 62.5 percent of the physician fee schedule amount for each physician for these codes if the work value reflected 100 percent of the work for two physicians. Ultimately, we decided to set work RVU values to reflect the total physician work of the procedures, and to continue to follow our co-surgery payment policy allowing the services to be billed by two physicians, in part because co-surgery is a requirement under Medicare policy for these services. We are not sure this is the appropriate long-term payment policy. We intend to reassess payment for this family of codes when we review national coverage for TAVR. For the time package, the AMA RUC accounted for the time each physician separately spends obtaining consent and reviewing the procedure with the patient. We are concerned that time for each physician to obtain consent and review the procedure with the patient is inconsistent with a framework for valuing the service as a single service.
After clinical review of CPT code 33361 (Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; percutaneous femoral artery approach), we believe that the specialty society survey 25th percentile work RVU of 25.13 appropriately captures the total work of the service. The AMA RUC recommended the survey median work RVU of 29.50. Regarding physician time, for CPT 33361, as well as CPT codes 33362 through 33364, we believe 45 minutes of pre-service evaluation time, which is the survey median time, is more consistent with the work of this service than the AMA RUC-recommended pre-service evaluation time of 50 minutes. Accordingly, we are assigning a work RVU of 25.13 to CPT code 33361, with a refinement of 45 minutes of pre-service evaluation time, on an interim basis for CY 2013. A complete listing of the times associated with this code is available on the CMS Web site at:
After clinical review of CPT code 33362 (Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open femoral artery approach), we believe that the specialty society survey 25th percentile work RVU of 27.52 appropriately captures the total work of the service. The AMA RUC recommended the survey median work RVU of 32.00. Like CPT code 33361, we also believe 45 minutes of pre-service evaluation time is more appropriate for this service than the AMA RUC-recommended pre-service evaluation time of 50 minutes. Accordingly, we are assigning a work RVU of 27.52 to CPT code 33362, with a refinement to 45 minutes of pre-service evaluation time, on an interim basis for CY 2013. A complete listing of the times associated with this code is available on the CMS Web site at
After clinical review of CPT code 33363 (Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open axillary artery approach), we believe that the specialty society survey 25th percentile work RVU of 28.50 appropriately captures the
After clinical review of CPT code 33364 (Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; open iliac artery approach), we believe that the specialty society survey 25th percentile work RVU of 30.00 more appropriately captures the total work of the service. The AMA RUC reviewed the survey results and recommended the survey median work RVU of 34.87. Like CPT codes 33361 through 33363, we also believe 45 minutes of pre-service evaluation time is more appropriate for this service than the AMA RUC-recommended time of 50 minutes. Accordingly, we are assigning a work RVU of 30.00 to CPT code 33364, with a refinement to 45 minutes of pre-service evaluation time, on an interim basis for CY 2013. A complete listing of the times associated with this code is available on the CMS Web site at:
After clinical review of CPT code 33365 (Transcatheter aortic valve replacement (TAVR/TAVI) with prosthetic valve; transaortic approach (eg, median sternotomy, mediastinotomy), we believe a work RVU of 33.12 accurately reflects the work associated with this service. The AMA RUC reviewed the survey results and recommended the survey median work RVU of 37.50. After clinical review, we determined that the work associated with this service is very similar to reference CPT code 33410 (Replacement, aortic valve, with cardiopulmonary bypass; with stentless tissue valve) (work RVU = 46.41), which has a 90-day global period that includes inpatient hospital and office visits. Because CPT code 33365 has a 0-day global period that does not include post-operative visits, we calculated the value of the pre-operative and post-operative visits in the global period of CPT code 33410, which totaled 13.29 work RVUs, and subtracted that from the total work RVU of 46.41 for CPT code 33410 to determine the appropriate work RVU for CPT code 33365. With regard to time, we decided to maintain the 50 minutes of pre-service evaluation time because we believe that the procedure described by CPT code 33365 involves more pre-service evaluation time since it is performed by surgically opening the chest via median sternotomy. Accordingly, we are assigning a work RVU of 33.12 for CPT code 33365 on an interim basis for CY 2013.
CPT codes 33405, 33430, and 33533 were identified as potentially misvalued through the High Expenditure Procedure Code screen.
When reviewing these services, the specialty society utilized data from the Society of Thoracic Surgeons (STS) National Adult Cardiac Database in developing recommended times and RVUs for CPT codes 33405 (Replacement, aortic valve, with cardiopulmonary bypass; with prosthetic valve other than homograft or stentless valve), 33430 (Replacement, mitral valve, with cardiopulmonary bypass), and 33533 (Coronary artery bypass, using arterial graft(s); single arterial graft), and did not conduct a survey of physician work and time. After reviewing the mean procedure times for these services in the STS database alongside other information relating to the value of these services, the specialty society and AMA RUC concluded that CPT codes 33405 and 33430 are valued appropriately and that the current work RVUs of 41.32 for CPT code 33405, and 50.93 for CPT code 33430 should be maintained. After reviewing the mean procedure time for CPT code 33533 in the STS database alongside other information relating to the value of the service, the specialty society and AMA RUC concluded that the work associated with CPT code 33553 had increased since this service was last reviewed. The AMA RUC recommended a work RVU of 34.98 for CPT code 33533, which is a direct crosswalk to CPT code 33510 (Coronary artery bypass, vein only; single coronary venous graft).
We believe the STS database, which captures outcome data in addition to time and visit data, is a useful resource in the valuation of PFS services. However, the AMA RUC recommendations on these services show only the STS database mean time for CPT codes 33405, 33430, and 33533. We are interested in seeing the distribution of times, including the 25th percentile, median, and 75th percentile values (which are the data points reported on the specialty society surveys), in addition to any other information STS believes would be relevant to the valuation of the services, such as case-mix, or time data for similar services. The STS database is a robust source of information and we believe it would be helpful to review additional data points for these three services beyond the mean time provided by the AMA RUC. In order to complete our clinical review of these services, we would like to see the distribution of procedure times for CPT codes 33405, 33430, and 33533. We are also interested in more information on the methodology used to develop the recommended work RVUs based on the time data, and, using that methodology, the different RVUs that correspond to the 25th percentile, median, and 75th percentile time data. We previously have expressed our concerns regarding the manner in which data derived from the STS database was used (71 FR 37224 through 37225). We are committed to reviewing and evaluating all services using an approach that maintains the appropriate relativity among fee schedule services. For CY 2013 we are maintaining the current work RVUs for these services on an interim basis. We will consider additional time and other data submitted in response to comments on this final rule with comment period in the CY 2014 PFS final rule with comment period. Specifically, we are maintaining a work RVU of 41.32 for CPT code 33405; a work RVU of 50.93 for CPT code 33430; and a work RVU of 33.75 for CPT code 33533.
In CY 2011, CPT codes 35475 and 35476 were identified in the CMS High Expenditure Procedure Codes Screen.
After clinical review of CPT code 35475 (Transluminal balloon angioplasty, percutaneous; brachiocephalic trunk or branches, each vessel), we believe a work RVU of 5.75 appropriately captures the work of the service. To develop a recommended value for this service, the AMA RUC started with the work RVU of CPT code 37224 (Revascularization, endovascular, open or percutaneous, femoral, popliteal artery(s), unilateral; with transluminal angioplasty) (work RVU of 9.00), which the AMA RUC believed was a comperable service to CPT code 35475, then removed RVUs to account for overlap in work resulting from same day billing with CPT codes 36147 (Introduction of needle and/or catheter, arteriovenous shunt created for dialysis (graft/fistula); initial access with complete radiological evaluation of dialysis access, including fluoroscopy, image documentation and report (includes access of shunt, injection[s] of contrast, and all necessary imaging from the arterial anastomosis and adjacent artery through entire venous outflow including the inferior or superior vena cava)) and 75962 (Transluminal balloon angioplasty, peripheral artery other than renal, or other visceral artery, iliac or lower extremity, radiological supervision and interpretation). Using these calculations, the AMA RUC recommended a work RVU of 6.60 for CPT code 35475. We agree with this approach, but believe that CPT code 37220 (Revascularization, endovascular, open or percutaneous, iliac artery, unilateral, initial vessel; with transluminal angioplasty) (work RVU 8.15) is more similar to CPT code 35475 and therefore a better starting point for the reductions. After accounting for overlap with other services typically reported with CPT code 35475, we determined that a work RVU of 5.75 is appropriate for this service. Accordingly, we are assigning a work RVU of 5.75 to CPT code 35475 on an interim final basis for CY 2013.
After clinical review of CPT code 35476 (Transluminal balloon angioplasty, percutaneous; venous), we believe a work RVU of 4.71 more appropriately captures the work of the service. The AMA RUC reviewed the survey results and recommended a work RVU of 5.50, the survey 25th percentile value. We determined that the work associated with CPT code 35476 was similar in terms of physician time and intensity to CPT code 37191 (Insertion of intravascular vena cava filter, endovascular approach including vascular access, vessel selection, and radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance (ultrasound and fluoroscopy), when performed), which has a work RVU of 4.71. We believe the work RVU of 4.71 appropriately captures the relative difference between this service and CPT code 35475. Therefore, we are assigning a work RVU of 4.71 for CPT code 35476 on an interim final basis for CY 2013.
CPT codes 36221 through 32668 were identified as potentially misvalued through the Codes Reported Together 75 percent or More screen. For CY 2012, the AMA RUC requested that CPT Editorial Panel create eight new codes to bundle selective catheter placement with radiological supervision and interpretation, including angiography. Additionally, the specialty society recognized that non-invasive vascular imaging has replaced diagnostic angiography as a screening test.
After clinical review of CPT code 36221(Non-selective catheter placement, thoracic aorta, with angiography of the extracranial carotid, vertebral, and/or intracranial vessels, unilateral or bilateral, and all associated radiological supervision and interpretation, includes angiography of the cervicocerebral arch, when performed), we believe a work RVU of 4.17 more appropriately captures the work of the service, with refinement of 30 minutes to the post-service time. The AMA RUC reviewed the survey results, and after a comparison to similar CPT codes, recommended a value of 4.51 work RVUs and a post-service time of 40 minutes. The AMA RUC used a direct crosswalk to the two component codes being bundled, CPT code 32600 (Introduction of catheter, aorta) (work RVU = 3.02) and CPT code 75650 (Angiography, cerviocerebral, catheter, including vessel origin, radiological supervision and interpretation) (work RVU = 1.49) and the recommended value of 4.51 is the sum of the RVUs for these component codes. We believe that that there are efficiencies gained when services are bundled. We believe crosswalking to the work RVU of CPT code 32550 (Insertion of indwelling tunneled pleural catheter with cuff), which has a work RVU of 4.17, appropriately accounts for the physician time and intensity with CPT code 36221. Additionally, we believe that the survey post-service time of 30 minutes more accurately accounts for the time involved in furnishing this service than the AMA RUC-recommended post-service time of 40 minutes. Therefore, we are assigning a work RVU of 4.17 with refinement to time for CPT code
After clinical review of CPT code 36222 ((Non-selective catheter placement, thoracic aorta, with angiography of the extracranial carotid, vertebral, and/or intracranial vessels, unilateral or bilateral, and all associated radiological supervision and interpretation, includes angiography of the cervicocerebral arch, when performed).), we believe the survey 25th percentile work RVU of 5.53 appropriately captures the work of this service, particularly the efficiencies when two services are bundled together. The AMA RUC recommended the survey median work RVU of 6.00. Like CPT code 36221, we believe the survey post-service time of 30 minutes is more appropriate than the AMA RUC-recommended post-service time of 40 minutes. We are assigning a work RVU of 5.53 with refinement to time for CPT code 36222 as interim final for CY 2013. A complete listing of the times associated with this code is available on the CMS Web site at:
After clinical review of CPT code 36223 (Selective catheter placement, common carotid or innominate artery, unilateral, any approach, with angiography of the ipsilateral intracranial carotid circulation and all associated radiological supervision and interpretation, includes angiography of the extracranial carotid and cervicocerebral arch, when performed), we believe a work RVU value of 6.00, the survey 25th percentile value, appropriately captures the work of the service, particularly efficiencies when two services are bundled together. The AMA RUC reviewed the survey results, and after a comparison to similar CPT codes, recommended a work RVU of 6.50. Like many of the other CPT codes in this family, we believe the survey post-service time of 30 minutes is more appropriate than the AMA RUC-recommended time of 40 minutes. We are assigning a work RVU of 6.00 with refinement to time for CPT code 36223 as interim final for CY 2013. A complete listing of the times associated with this code is available on the CMS Web site at:
After clinical review of CPT code 36224 (Selective catheter placement, internal carotid artery, unilateral, with angiography of the ipsilateral intracranial carotid circulation and all associated radiological supervision and interpretation, includes angiography of the extracranial carotid and cervicocerebral arch, when performed), we believe a work RVU of 6.50, the survey 25th percentile value, appropriately captures the work of the service, particularly efficiencies when two services are bundled together. We believe 30 minutes of post-service times more appropriately accounts for the work of this service. The AMA RUC reviewed the survey results, and after a comparison to similar CPT codes, recommended a value of 7.55 and a post-service time of 40 minutes for CPPT code 36224. Accordingly, we are assigning a work RVU of 6.50 with refinement to time for CPT code 36224 as interim final for CY 2013. A complete listing of the times associated with this code is available on the CMS Web site at:
After clinical review of CPT code 36225 (Selective catheter placement, subclavian or innominate artery, unilateral, with angiography of the ipsilateral vertebral circulation and all associated radiological supervision and interpretation, includes angiography of the cervicocerebral arch, when performed), we believe that this code should be valued the same as the CPT code 36223, to which we are assigning a work RVU of 6.00. Comparable to CPT code 36223, we also believe 30 minutes of post-service times more appropriately accounts for the work of this service. The AMA RUC reviewed the survey results and recommended the survey median work RVU of 6.50 and a post-service time of 40 minutes for CPT code 36225. We are assigning a work RVU of 6.00 with refinement to time for CPT code 36225 as interim final for CY 2013. A complete listing of the times associated with this code is available on the CMS Web site at:
After clinical review of CPT code 36226 (Selective catheter placement, vertebral artery, unilateral, with angiography of the ipsilateral vertebral circulation and all associated radiological supervision and interpretation, includes angiography of the cervicocerebral arch, when performed), we believe that this CPT code should be valued the same as CPT code 36224, which has a work RVU as 6.50. Comparable to CPT code 36224, we also believe 30 minutes of post-service times more appropriately accounts for the work of this service. The AMA RUC reviewed the survey results, and after a comparison to similar CPT codes, recommended a value of 7.55 and a post-service time of 40 minutes for CPT code 36226. We are assigning a work RVU of 6.50 with refinement to time for CPT code 36226 as interim final for CY 2013.
After clinical review of CPT code 36227 (Selective catheter placement, external carotid artery, unilateral, with angiography of the ipsilateral external carotid circulation and all associated radiological supervision and interpretation (list separately in addition to code for primary procedure)), we determined that there are efficiencies gained when services are bundled, and identified a work RVU of 2.09 for this service. This work RVU reflects the application of a very conservative estimate of 10 percent for the work efficiencies that we would expect to occur when multiple component codes are bundled together to the sum of the work RVUs for the component codes. The AMA RUC reviewed the survey results, and after a comparison to similar CPT codes, recommended a value of 2.32 for CPT code 36227. The AMA RUC used a direct crosswalk to the two component codes being bundled, CPT code 36218 (Selective catheter placement, arterial system; additional second order, third order, and beyond, thoracic or brachiocephalic branch, within a vascular family (list in addition to code for initial second or third order vessel as appropriate) (work RVU= 1.01) and CPT code 75660 (Angiography, external carotid, unilateral, selective, radiological supervision and interpretation) (work RVU = 1.31). We are assigning a work RVU of 2.09 as the interim final value of CPT code 36227 for CY 2013.
CPT codes 38240, 38241, 38242, and 38243 were revised by the CPT Editorial Panel for CY 2013.
After clinical review, we agree with the AMA RUC-recommended work RVUs for CPT codes 38241 (Hematopoietic progenitor cell (hpc); autologous transplantation), 38242 (Allogeneic lymphocyte infusions), and 38243 (Hematopoietic progenitor cell (hpc); hpc boost). On an interim final basis for CY 2013 we are assigning a work RVU of 3.00 to CPT code 38241; a work RVU of 2.11 to CPT code 38242; and a work RVU of 2.13 to CPT code 38243.
After clinical review, we believe CPT code 38240 should have the same work RVU as CPT code 38241, because we believe the two services involve the same amount of work. The AMA RUC recommended a work RVU of 4.00 for CPT code 38240. On an interim final basis for CY 2013 we are assigning CPT code 38240 a work RVU of 3.00.
The CPT Editorial Panel created CPT code 44705 (Preparation of fecal microbiota for instillation, including assessment of donor specimen) for CY 2013. The AMA RUC recommended a work RVU of 1.42, which is a direct crosswalk to CPT code 99203 (Level 3 office or other outpatient visit, new patient). This service is currently (CY 2012) reported under CPT code 44799 (Unlisted procedure, intestine), as is the instillation of the microbiota. Within Medicare, payment for the preparation of the donor specimen would only be made if the specimen is ultimately used for the treatment of a beneficiary as Medicare is not authorized to pay for any costs not directly related to the diagnosis and treatment of a beneficiary. Because of this policy, we believe it is appropriate to bundle the preparation and instillation into one payable HCPCS code. For CY 2013, we have created HCPCS code G0455 (Preparation with instillation of fecal microbiota by any method, including assessment of donor specimen). HCPCS code G0455 will replace new CPT code 44705 (Preparation of fecal microbiota for instillation, including assessment of donor specimen) which will have a PFS procedure status indicator of I (Not valid for Medicare purposes), and includes both the work of preparation and instillation of the microbiota.
After reviewing the preparation and instillation work associated with this procedure, we believe that CPT code 99213 (Level 3 office or other outpatient visit, established patient) is an appropriate crosswalk for the work and time of HCPCS code G0455. Therefore, on an interim final basis for CY 2013, we are assigning a work RVU of 0.97 to HCPCS code G0455. A list of the interim final times associated with this procedure is available on the CMS Web site at
In CY 2011, we received comments regarding a potential relativity problem between CPT codes 47600 (Cholecystectomy;) and 47605 (Cholecystectomy; with cholangiography), as CPT code 47600
In their review of these CPT codes, the specialty societies indicated and the AMA RUC agreed that the typical patient undergoing an open cholecystectomy is scheduled and started with a laparoscopic approach and is then converted to the open procedure. We are concerned that the vignettes associated with these procedures imply that the work of the failed laparoscopic approach is included in the work of the cholecystectomy. We request that the AMA RUC review the vignettes for these services.
CPT codes 47562 and 47563 were identified as potentially misvalued through the High Expenditure Procedure Code screen.
Though these service were identified by CMS as potentially misvalued, the related specialty societies declined to survey CPT codes 47562 (Laparoscopy, surgical; cholecystectomy) and 47563 (Laparoscopy, surgical; cholecystectomy with cholangiography), because, they said, the codes had been resurveyed many times, with CPT code 47563 last surveyed and reviewed as recently as the Fourth Five-Year Review (CY 2011). The AMA RUC Relativity Assessment Workgroup concluded that these services have not changed since last reviewed and that resurveying the codes would not produce different values. The AMA RUC reaffirmed the current (CY 2012) work RVU of 11.76 for CPT code 47562 and the current (CY 2012) work RVU of 11.47 for CPT code 47563.
After clinical review, we noticed a rank-order anomaly in these services similar to the rank-order problem discussed above for CPT codes 47600 and 47605. CPT code 47563, which includes cholangiography, is currently (CY 2012) valued lower than CPT code 47562 which describes the same procedure without cholangiography. After reviewing these two services, we agree with the AMA RUC that the recently-reviewed current work RVU of 11.47 for CPT code 47563 continues to accurately reflect the work of this service. As discussed above, we believe that a work RVU of 1.00 reflects the incremental difference between cholecystectomy with cholangiography and cholecystectomy alone. Therefore, we believe that CPT code 47562 should be valued 1.00 RVU lower than CPT code 47563. On an interim final basis for CY 2013, we are assigning a work RVU of 10.47 to CPT code 47562 and a work RVU of 11.47 to CPT code 47563.
Regarding physician time, we changed the pre-service time of CPT code 47562 to match the pre-service time of CPT code 47563, leading to small increase in pre-service time for the service. A complete listing of the interim final times assigned to these services is available on the CMS Web site at
CPT code 52235 was identified as potentially misvalued under the Harvard-valued—Utilization over 30,000 screen. CPT codes 52234, 52240, and 52351 through 52355 were identified as a part of this family for review.
After clinical review, we agreed with the AMA RUC-recommended work RVUs for the majority of codes in this family. However, we disagreed with the AMA RUC-recommended work RVUs for CPT codes 52353 (Cystourethroscopy, with ureteroscopy and/or pyeloscopy; with lithotripsy (ureteral catheterization is included)), 52354 (Cystourethroscopy, with ureteroscopy and/or pyeloscopy; with biopsy and/or fulguration of ureteral or renal pelvic lesion), 52355 (Cystourethroscopy, with ureteroscopy and/or pyeloscopy; with resection of ureteral or renal pelvic tumor), and 52240 (Cystourethroscopy, with fulguration (including cryosurgery or laser surgery) and/or resection of; large bladder tumor(s)). For CPT codes,
After reviewing CPT code 52240, we believe this service should be valued the same as CPT code 52353, as the services have the same times and describe very similar procedures. Therefore, on an interim final basis for CY 2013, we are assigning a work RVU of 7.50 to CPT code 52240.
Regarding physician time, we refined the AMA RUC-recommended pre-service time for CPT code 52224 (Cystourethroscopy, with fulguration (including cryosurgery or laser surgery) or treatment of minor (less than 0.5 cm) lesion(s) with or without biopsy) from 32 minutes to 29 minutes to match the pre-service time of CPT code 52214 (Cystourethroscopy, with fulguration (including cryosurgery or laser surgery) of trigone, bladder neck, prostatic fossa, urethra, or periurethral glands) which has very similar pre-service work. A complete list of the interim final times associated with these procedures is available on the CMS Web site at
The CPT Editorial Panel created CPT code 64615 and revised CPT codes 64612, 64613, and 64614 for CY 2013.
When the AMA RUC and related specialty societies reviewed CPT codes 64613 (Chemodenervation of muscle(s); neck muscle(s) (eg, for spasmodic torticollis, spasmodic dysphonia)) and 64614 (Chemodenervation of muscle(s); extremity and/or trunk muscle(s) (eg, for dystonia, cerebral palsy, multiple sclerosis)), they determined that both CPT codes should be divided into additional codes, and referred CPT codes 64613 and 64614 to the CPT Editorial Panel. The AMA RUC recommended the survey median work RVU of 1.41 for CPT code 64612 (Chemodenervation of muscle(s); muscle(s) innervated by facial nerve, unilateral (eg, for blepharospasm, hemifacial spasm)), a decrease from the current work RVU of 2.01, and recommended the survey median work RVU of 1.85 for new CPT code 64615 (Chemodenervation of muscle(s); muscle(s) innervated by facial, trigeminal, cervical spinal and accessory nerves, bilateral (eg, for chronic migraine)). We are accepting the AMA RUC-recommended work RVUs for CPT codes 64612 and 64615 on an interim basis, and will review these services alongside CPT codes 64613 and 64614 (or their successor CPT codes) after they are reviewed by the CPT Editorial Panel.
The AMA RUC requested a change in the global period of CPT code 64615 from 10 days to 0 days. We believe that a global period of 10 days is most appropriate for this service, and maintains consistency within this family of CPT codes, as the other services in this family also have 10-day global periods.
CPT code 65222 was identified as potentially misvalued under the Harvard-valued—Utilization over 30,000 screen.
Medicare claims data from 2011 indicate that CPT code 65222 (Removal of foreign body, external eye; corneal, with slit lamp) is typically furnished to the beneficiary on the same day as an E/M visit. We believe that some of the activities furnished during the pre- and post-service period of the procedure code and the E/M visit overlap. After review, we do not believe that the AMA RUC appropriately accounted for this overlap in its recommendation of pre- and post-service time. To account for this overlap, we reduced the AMA RUC-recommended pre-service evaluation time by one-third, from 7 minutes to 5 minutes, and the AMA RUC-recommended post-service time by one-third, from 5 minutes to 3 minutes. We believe that 5 minutes of pre-service evaluation time and 3 minutes of post-service time accurately reflect the time involved in furnishing the pre- and
CPT code 67810 was identified as potentially misvalued under the Harvard-valued—Utilization over 30,000 screen.
Medicare claims data from 2011 indicate that CPT code 67810 (Incisional biopsy of eyelid skin including lid margin) is typically furnished to the beneficiary on the same day as an E/M visit. We believe that some of the activities furnished during the pre- and post-service period of the procedure code and the E/M visit overlap. After review, we believe that the AMA RUC appropriately accounted for this overlap in its recommendation of pre-service time, but that the AMA RUC-recommended post-service time, while reduced from the survey time, is still high relative to similar services performed on the same day as an E/M service. To better account for this overlap, and to value this service relative to similar services, we reduced the AMA RUC-recommended post-service time for this procedure by one-third, from 5 minutes to 3 minutes.
After reviewing CPT code 67810 and assessing the overlap in time and work, we agree with the AMA RUC-recommended work RVU of 1.18 for this service, which is a decrease from the CY 2012 work RVU of 1.48. In sum, on an interim final basis for CY 2013, we are assigning a work RVU of 1.18 to CPT code 67810, with a refinement to the AMA RUC recommended time. A complete list of the interim final times associated with this procedure is available on the CMS Web site at
CPT code 68200 was identified as potentially misvalued under the Harvard-valued—Utilization over 30,000 screen.
Medicare claims data from 2011 indicate that CPT code 68200 (Subconjunctival injection) is typically furnished to the beneficiary on the same day as an E/M visit. We believe that some of the activities furnished during the pre- and post-service period of the procedure code and the E/M visit overlap. After review, we believe that the AMA RUC appropriately accounted for this overlap in its recommendation of pre-service time, but that the AMA RUC did not adequately account for the overlap in the post-service time. To better account for the overlap in post-service time, we reduced the AMA RUC-recommended post-service time for this procedure by one-third, from 5 minutes to 3 minutes.
After reviewing CPT code 68200 and assessing the overlap in time and work, we agree with the AMA RUC-recommended work RVU of 0.49 for this service. In sum, on an interim final basis for CY 2013, we are assigning a work RVU of 0.49 to CPT code 68200, with a refinement to the AMA RUC recommended time. A complete list of the interim final times associated with this procedure is available on the CMS Web site at
CPT code 69200 was identified as potentially misvalued under the Harvard-valued—Utilization over 30,000 screen.
Medicare claims data from 2011 indicate that CPT code 69200 (Removal foreign body from external auditory canal; without general anesthesia) is typically furnished to the beneficiary on the same day as an E/M visit. We believe that some of the activities furnished during the pre- and post-service period of the procedure code and the E/M visit overlap. To account for this overlap, we removed one-third of the pre-service evaluation time from the pre-service time package, reducing the pre-service evaluation time from 7 minutes to 5 minutes. Additionally, we reduced the AMA RUC-recommended post-service time for this procedure by one-third, from 5 minutes to 3 minutes.
After reviewing CPT code 69200 and assessing the overlap in time and work, we agree with the AMA RUC-recommended work RVU of 0.77 for this service. In sum, on an interim final basis for CY 2013, we are assigning a work RVU of 0.77 to CPT code 69200, with a refinement to the AMA RUC recommended time. A complete list of the interim final times associated with this procedure is available on the CMS Web site at
CPT codes 74175 and 72191 were identified as potentially misvalued through the Codes Reported Together 75 percent or More screen. The CPT Editorial Panel created CPT code 74174, which bundles the work of CPT codes 74175 and 72191, for CY 2012.
We reviewed CPT code 74174 (Computed tomographic angiography, abdomen and pelvis, with contrast material(s), including noncontrast images, if performed, and image postprocessing) for CY 2012. We stated in the CY 2012 PFS final rule with comment period that we are accepting the AMA RUC-recommended work RVU of 2.20 for CPT code 74174 on an interim basis, and request that the AMA RUC review the component CPT codes: 74175 (Computed tomographic angiography, abdomen, with contrast material(s), including noncontrast images, if performed, and image postprocessing) and 72191 (Computed tomographic angiography, pelvis, with contrast material(s), including noncontrast images, if performed, and image postprocessing) (76 FR 73200).
In response to this request, some commenters stated that the AMA RUC operates under the premise that the values assigned to all the service paid under the PFS are assumed to be accurate and therefore, our request to review the physician work component of CPT codes 74175 and 72191 is unnecessary. Commenters noted that CPT codes 74175 and 72191 were used as important building blocks in the work valuation of CPT code 74174, and that the AMA RUC considered their individual values, which in many ways equates to an AMA RUC review. Commenters stated that to review individual codes solely because they are bundled to create a new code, risks rank-order anomalies within families, which could threaten the relativity of the values for services on the PFS. Therefore, commenters stated that they believe an AMA RUC review of CPT codes 74175 and 72191 is unnecessary.
The AMA RUC Relativity Assessment Workgroup referred component CPT codes 74175 and 72191 to the PE Subcommittee of the AMA RUC to review the direct practice expense inputs, but the AMA RUC did not review the physician work or time.
We have stated many times our belief that when codes are bundled, the new codes should be reviewed along with their component codes to ensure consistency in RVUs and inputs. Therefore, we reviewed CPT codes 74174, 72191, and 74175 for CY 2013. During this review, we saw an anomalous relationship between the physician times assigned to these services. CPT code 74174 describes computed tomographic angiography (CTA) of both the abdomen and pelvis together. This CPT code includes 5 minutes of pre-service time, 30 minutes of intra-service time, and 5 minutes of post-service time, which is in line with several other similar bundled CPT codes. CPT code 74175 describes CTA of the abdomen only, and includes 10 minutes of pre-service time, 30 minutes of intra-service time, and 10 minutes of post-service time. Similarly, CPT code 72191 describes CTA of the pelvis only, and includes 9 minutes of pre-service time, 30 minutes of intra-service time, and 10 minutes of post-service time. We
CPT code 75896 was identified as potentially misvalued through the Codes Reported Together 75 percent or More screen.
The associated specialty societies and the AMA RUC intend to survey and review CPT code 75896 (Transcatheter therapy, infusion, other than for thrombolysis, radiological supervision and interpretation) and related CPT code 75898 (Angiography through existing catheter for follow-up study for transcatheter therapy, embolization or infusion, other than for thrombolysis) for CY 2014. The AMA RUC recommended carrier pricing these two services for CY 2014. Currently (CY 2012) both codes have a national payment rate for the professional component of the service, and the technical component of the service is contractor priced. We believe it is appropriate to maintain the current national price on the professional component, and to contractor price the technical component until we are able to establish a national price that appropriately values the practice expenses associated with this service. Therefore, on an interim basis for CY 2013, we are assigning a work RVU of 1.31 to the professional component of CPT code 75896, and a work RVU of 1.65 to the professional component of CPT code 75898. The technical component and global billing for both CPT codes will be contractor priced. We anticipate reviewing these services again after reviewing the AMA RUC recommendations for these services in CY 2014.
CPT code 76830 was identified as potentially misvalued through the High Expenditure Procedure Code screen.
We reviewed CPT code 76830 (Ultrasound, transvaginal) and believe that the current work RVU of 0.69 continues to accurately reflect the work of this services. The AMA RUC also recommended maintaining the current work RVU of this service. We are refining the AMA RUC-recommended post-service time for this procedure from 10 minutes to 8 minutes to match the post-service time of CPT code 76817 (Ultrasound, pregnant uterus, real time with image documentation, transvaginal), which, we believe, involves very similar post-service work. In sum, on an interim final basis for CY 2013, we are assigning a work RVU of 0.69 to CPT code 76830, with a refinement to the AMA RUC recommended time. A complete list of the interim final times associated with this procedure is available on the CMS Web site at
CPT code 77003 was identified as potentially misvalued through the High Expenditure Procedure Code screen.
We reviewed CPT code 77003 (Fluoroscopic guidance and localization of needle or catheter tip for spine or paraspinous diagnostic or therapeutic injection procedures (epidural or subarachnoid)), and believe it is necessary to review this service alongside very similar CPT codes 77001 (Fluoroscopic guidance for central venous access device placement, replacement (catheter only or complete), or removal (includes fluoroscopic guidance for vascular access and catheter manipulation, any necessary contrast injections through access site or catheter with related venography radiologic supervision and interpretation, and radiographic documentation of final catheter position) (list separately in addition to code for primary procedure)) and 77002 (Fluoroscopic guidance for needle placement (eg, biopsy, aspiration, injection, localization device)) to determine the appropriate relative value for this high volume, high expenditure procedure code. The AMA RUC reviewed CPT code 77003 for CY 2013 and concluded that the current work RVU of 0.60 is appropriate for this service. It is our understanding that the AMA RUC does not intend to review CPT codes 77001 and 77002. We anticipate reviewing CPT codes 77001, 77002, and 77003 together in CY 2013 for CY 2014 and request public
CPT code 77301 was identified as potentially misvalued through the High Expenditure Procedure Code screen.
We reviewed CPT code 77301 (Intensity modulated radiotherapy plan, including dose-volume histograms for target and critical structure partial tolerance specifications) and do not believe the work associated with this procedure has changed. The AMA RUC also recommended the current work RVU of 7.99 for this service. On an interim final basis for CY 2013 we are assigning a work RVU of 7.99 to CPT code 77301. Regarding the physician time for this service, CPT code 77301 currently (CY 2012) includes 30 minutes of pre-service time, 131 minutes of intra-service time, and 35 minutes of post-service time. The AMA RUC recommended moving the pre-service time associated with this procedure into the intra-service period. We do not believe this is appropriate, as we think the physician work associated with those 30 minutes is pre-service work and should remain in the pre-service period. Therefore, we are assigning an interim final pre-service evaluation time of 30 minutes, intra-service time of 130 minutes, and post-service time of 35 minutes to CPT code 77301 for CY 2013.
The AMA CPT Editorial Panel has created new CPT codes to replace the codes used to bill for molecular pathology services that will be deleted at the end of CY 2012. The new codes describe distinct molecular pathology tests and test methods. The CPT Editorial Panel created 101 new molecular pathology CPT codes for CY 2012 and another 14 new molecular pathology codes for CY 2013. As discussed in detail in section III.I. of this CY 2013 PFS final rule with comment period, these new molecular pathology CPT codes will be paid on the CLFS for CY 2013.
One of the molecular pathology CPT codes that is being deleted for CY 2012 is payable on the PFS: CPT code 83912-26 (Molecular diagnostics; interpretation and report). To replace this CPT code, we have created HCPCS code G0452 (molecular pathology procedure; physician interpretation and report) to describe medically necessary interpretation and written report of a molecular pathology test, above and beyond the report of laboratory results. This professional component-only HCPCS G-code will be considered a “clinical laboratory interpretation service,” which is one of the current categories of PFS pathology services under the definition of physician pathology services at § 415.130(b)(4). Section § 415.130(b)(4) of the regulations and section 60 of the Claims Processing Manual (IOM 100-04, Ch. 12, section 60.E.) specify certain requirements for billing the professional component of certain clinical laboratory services including that the interpretation (1) Must be requested by the patient's attending physician, (2) must result in a written narrative report included in the patient's medical record, and (3) requires the exercise of medical judgment by the consultant physician. We note that a hospital's standing order policy can be used as a substitute for the individual request by a patient's attending physician. The current CPT code for interpretation and report, 83912-26, is included on the current list of clinical laboratory interpretation services but will be deleted at the end of CY 2012.
As discussed in section III.I. of this CY 2013 PFS final rule with comment period, we reviewed the work associated with this procedure, and we believe it is appropriate to directly crosswalk the work RVUs and times of CPT code 83912-26 to HCPCS code G0452, because we do not believe this coding change reflects a change in the service or in the resources involved in furnishing the service. Accordingly, we are assigning a work RVU of 0.37, with 5 minutes of pre-service time, 10 minutes of intra-service time, and 5 minutes of post-service time to HCPCS code G0452 on an interim final basis for CY 2013.
The CPT Editorial Panel created CPT codes 86152 and 86153 to replace CPT Category III codes 0279T and 0280T.
CPT code 86153 (Cell enumeration using immunologic selection and identification in fluid specimen (eg, circulating tumor cells in blood); physician interpretation and report, when required) will be payable on the PFS for the physician interpretation and report of CPT code 86152 (Cell enumeration using immunologic selection and identification in fluid specimen (eg, circulating tumor cells in blood)) which will be payable on the Clinical Laboratory Fee Schedule (CLFS). Like HCPCS code G0452 discussed above, CPT code 86153 is a professional component-only CPT code that will be considered a “clinical laboratory interpretation service,” which is one of the current categories of PFS pathology services under the definition of physician pathology services at § 415.130(b)(4). This code must be billed with the “26” modifier to be paid under the PFS.
After reviewing CPT code 86153, we believe that the AMA RUC-recommended work RVU of 0.69 appropriately accounts for the work of this service. Accordingly, we are assigning a work RVU of 0.69 to CPT code 86153 on an interim final basis for CY 2013. Regarding physician time, the AMA RUC recommended 20 minutes of intra-service time and 5 minutes of post-service time for CPT code 86153. We believe that all the work of this service belongs in the intra-service period, and that 20 minutes accurately captures the time involved in furnishing this service. Therefore, we are assigning 0 minutes pre-service time, 20 minutes intra-service time, and 0 minutes post-service time to CPT code 86153 on an interim final basis for CY 2013.
The CPT Editorial Panel created CPT codes 88120 (Cytopathology, in situ hybridization (eg, FISH), urinary tract specimen with morphometric analysis, 3-5 molecular probes, each specimen; manual) and 88121 (Cytopathology, in situ hybridization (eg, FISH), urinary tract specimen with morphometric analysis, 3-5 molecular probes, each specimen; using computer-assisted technology) to describe in situ hybridization testing using urine samples, effective for CY 2011. Prior to CY 2011, all in situ hybridization testing was billed using CPT codes 88365 (In situ hybridization (eg, FISH), each probe), 88367 (Morphometric analysis, in situ hybridization (quantitative or semi-quantitative) each probe; using computer-assisted technology), and 88368 (Morphometric analysis, in situ hybridization (quantitative or semi-quantitative) each probe; manual). The appropriate code would be billed one time for each probe used in the performance of the test, regardless of the medium of the specimen (that is, blood, tissue, tumor, bone marrow, or urine). We stated in the CY 2012 PFS proposed rule that because the descriptors for the new CPT codes 88120 and 88121 include the use of approximately 4 probes, and existing CPT codes 88367 and 88368 include only 1 probe, we were concerned about potential payment discrepancies between the new and existing codes (76 FR 42795 through 42796). Unlike the new codes for urinary tract specimens, the existing codes (for all other specimens) allow for multiple units of each code to be billed. We asked the AMA RUC to review the work and PE for existing CPT codes 88365, 88367, and 88368 alongside CPT codes 88120 and 88121 to ensure the appropriate relativity between these two sets of services (76 FR 73153 through 73154).
In response to that request, the College of American Pathologists (CAP) indicated that they would develop a CPT Assistant article clarifying the appropriate usage of each code. The AMA RUC stated that it intends to review these services in CY 2013 for CY 2014, after CY 2012 utilization data are available to assess how these services are being billed. We agree with this approach, and are maintaining the current (CY 2012) work RVUs of 1.20 for CPT code 88120, and 1.00 for CPT code 88121, as interim until we review CPT codes 88120 and 88121 alongside CPT codes 88365, 88367, and 88368 for CY 2014.
We have received information from stakeholders that the current (CY 2012) descriptor for HCPCS code G0416 (Surgical pathology, gross and
In preparation for the Fourth Five-Year Review of Work, we received comments indicating that psychiatry/psychotherapy CPT codes 90801 through 90880 may be potentially misvalued. In response to these comments, we requested that the AMA RUC review these services. Ultimately, the AMA RUC concluded that the entire section of psychiatry/psychotherapy services would benefit from re-structuring within CPT. After a year of analysis, the CPT Editorial Panel replaced the current psychiatry/psychotherapy CPT codes with a new structure that allows for the separate reporting of E/M codes, eliminates the site-of-service differential, establishes CPT codes for crisis, and creates a series of add-on CPT codes to psychotherapy to describe interactive complexity and medication management.
We appreciate all the work that has been completed to date by the CPT Editorial Panel, AMA RUC, and involved specialty societies in revising this family of CPT codes. Below we discuss the specific CY 2013 work RVUs for the new psychotherapy family of CPT codes. We note that related specialty societies have not yet surveyed some of the new CPT codes, namely, the new CPT codes for psychotherapy for crisis, interactive complexity, and pharmacologic management. The AMA RUC and HCPAC have recommended contractor pricing for these services until the surveys are complete. After the specialty societies have completed the survey process for all the codes in the new code set, we intend to review the values for all codes in the family again. It is our policy to value a family of codes together to ensure more accurate valuation and proper relativity. We will take into consideration the AMA RUC and HCPAC recommendations, specialty society recommendations, public comments, Medicare utilization data, and other available information. For CY 2013, our general approach was to maintain the current CPT code values, or adopt values that approximate the values for the current CPT codes after adjusting for differences in code structure between CY 2012 and 2013, for all psychiatry services on an interim basis, pending a final review of the values for the entire family of CPT codes.
The first major change in the new coding framework involves changes to the CPT codes for initial psychiatric evaluation. For CY 2013, the CPT Editorial Panel is deleting CPT codes 90801 (Psychiatric diagnostic interview examination) (work RVU = 2.80) and 90802 (Interactive psychiatric diagnostic interview examination using play equipment, physical devices, language interpreter, or other mechanisms of communication) (work RVU = 3.01), and replacing them with new CPT codes 90791 (Psychiatric diagnostic evaluation) and 90792 (Psychiatric diagnostic evaluation with medical service). CPT code 90791 describes psychiatric diagnostic evaluation without medical work. We are assigning an interim work RVU of 2.80, the work RVU of deleted CPT code 90801, to this service for CY 2013. CPT code 90792 describes psychiatric diagnostic evaluation involving medical work. We are assigning an interim work RVU of 2.96 to this service for CY 2013. Currently (CY 2012) the psychotherapy with E/M services are valued on average 0.16 work RVUs higher than the psychotherapy without E/M services. We believe this is the appropriate differential between the diagnostic evaluation with medical services and diagnostic evaluation without medical services CPT codes. Therefore, to assign a work RVU to CPT code 90792, which includes medical services, we added 0.16 work RVUs to the work RVU of CPT code 90791, which does not include medical services.
Regarding coding and payment for these CPT codes, we note that CPT
We previously have addressed the delivery of mental health services to caregivers in Chapter 1, section 70.1 of the Medicare National Coverage Determinations Manual, Pub. 100-03, which provides guidance specifically for current CPT code 90846 (family psychotherapy without the patient present). It states that, “In certain types of medical conditions, including when a patient is withdrawn and uncommunicative due to a mental disorder or comatose, the physician may contact relatives and close associates to secure background information to assist in diagnosis and treatment planning. When a physician contacts their patient's relatives or associates for this purpose, expenses of such interviews are properly chargeable as physician's services to the patient on whose behalf the information was secured. A physician may also have contacts with a patient's family and associates for purposes other than securing background information. In some cases, the physician will provide counseling to members of the household. Family counseling services are covered only where the primary purpose of such counseling is the treatment of the patient's condition. For example, two situations where family counseling services would be appropriate are as follows: (1) Where there is a need to observe the patient's interaction with family members; and/or (2) where there is a need to assess the capability of and assist the family members in aiding in the management of the patient. Counseling principally concerned with the effects of the patient's condition on the individual being interviewed would not be reimbursable as part of the physician's personal services to the patient.” Therefore, we believe that CPT codes 90791 and 90792 may be used for diagnosis through a relative or close associate providing direct care for the patient when the focus of the service is gathering additional information about the beneficiary, and cannot substitute for an evaluation of the beneficiary. We are concerned that multiple diagnostic evaluations with family members should not replace a detailed evaluation of the beneficiary, and we intend to monitor the frequency of billing for diagnostic evaluations per patient.
The second major change in the new coding framework involves psychotherapy procedure codes without medical services, which we typically expect will be billed by clinical psychologists and licensed clinical social workers. For CY 2013, the CPT Editorial Panel created stand-alone psychotherapy CPT codes 90832 (Psychotherapy, 30 minutes with patient and/or family member), 90834 (Psychotherapy, 45 minutes with patient and/or family member), and 90837 (Psychotherapy, 60 minutes with patient and/or family member), that are not site-of-service specific. These services are currently reported using outpatient and interactive outpatient, and inpatient and interactive inpatient psychotherapy CPT codes. To assign interim work RVUs to these services that approximate the current values for these services under the current CPT coding structure, we assigned each new stand-alone psychotherapy CPT code the work RVU of the current corresponding inpatient psychotherapy code. Specifically, we are assigning an interim work RVU of 1.25 to CPT code 90832, which is the current work RVU of CPT code 90816 (Individual psychotherapy, insight oriented, behavior modifying and/or supportive, in an inpatient hospital, partial hospital or residential care setting, approximately 20 to 30 minutes face-to-face with the patient;); an interim work RVU of 1.89 to CPT code 90834, which is the current work RVU of CPT code 90818 (Individual psychotherapy, insight oriented, behavior modifying and/or supportive, in an inpatient hospital, partial hospital or residential care setting, approximately 45 to 50 minutes face-to-face with the patient;); and an interim work RVU of 2.83 to CPT code 90837, which is the current work RVU of CPT code 90821 (Individual psychotherapy, insight oriented, behavior modifying and/or supportive, in an inpatient hospital, partial hospital or residential care setting, approximately 75 to 80 minutes face-to-face with the patient;). For CY 2013, the additional work involved in psychotherapy with higher interactive complexity will be captured using an interactive complexity add-on CPT code, discussed below.
Regarding coding and payment for these psychotherapy CPT codes, we note that the CY 2012 CPT codes describe time spent face-to-face with the patient, while the CY 2013 CPT codes describe time spent with the patient and/or family member. As discussed above in relation to CPT codes 90791 and 90792, Medicare only pays for services provided to diagnose or treat a Medicare beneficiary. Obtaining information from relatives or close associates is appropriate in some circumstances, but should not substitute for direct treatment of the beneficiary. We would expect psychotherapy to be billed only when the beneficiary is present for a significant portion of the service.
The third major change in the new coding framework involves psychotherapy services furnish alongside an E/M service. For CY 2013, the CPT Editorial Panel created CPT codes 90833 (Psychotherapy, 30 minutes with patient and/or family member when performed with an evaluation and management service (list separately in addition to the code for primary procedure)), 90836 (Psychotherapy, 45 minutes with patient and/or family member when performed with an evaluation and management service (list separately in addition to the code for primary procedure)) and 90838 (Psychotherapy, 60 minutes with patient and/or family member when performed with an evaluation and management service (list separately in addition to the code for primary procedure)). These services are currently reported using outpatient and interactive outpatient, and inpatient and interactive inpatient psychotherapy with E/M CPT codes. For CY 2013, physicians and qualified nonphysician practitioners that can bill for E/M services will now bill for psychotherapy with evaluation and management using the existing E/M structure and a choice of one add-on psychotherapy time-based code, 30, 45 or 60 minutes. At this time, we believe that the work involved in furnishing the psychotherapy add-on CPT codes is very similar to the work of furnishing the stand-alone psychotherapy CPT codes (CPT codes 90832, 90834, and 90837). We believe the difference in work between the psychotherapy add-on codes and stand-alone psychotherapy CPT codes is not in the intensity of the services; rather, it is in amount of time involved in furnishing them. The AMA RUC has recommended, and we agree, that the psychotherapy add-on CPT codes include 12 minutes less time than the stand-alone psychotherapy CPT codes. The psychotherapy add-on CPT codes are furnished alongside an E/M service, so some of the activities in the stand-alone psychotherapy CPT codes should not be included in the psychotherapy add-on CPT codes because those activities (reviewing the record, coordinating care, and some documentation and reporting activities)
Like the stand-alone psychotherapy services, we note that the CY 2012 CPT codes describe time spent face-to-face with the patient, while the CY 2013 CPT codes describe time spent with the patient and/or family member. As discussed above, Medicare only pays for services provided to diagnose or treat a Medicare beneficiary. Obtaining information from relatives or close associates is appropriate in some circumstances, but should not substitute for direct treatment of the beneficiary. We would expect psychotherapy to be billed only when the beneficiary is present for a significant portion of the service.
Additionally, the CY 2013 coding structure includes a new add-on CPT code for interactive complexity, CPT code 90785 (Interactive complexity (list separately in addition to the code for primary procedure)). The interactive complexity add-on CPT code, when billed with a psychotherapy service, replaces the CY 2012 CPT codes for interactive psychotherapy. As stated above, this service has not yet been surveyed by the related specialty societies, and the AMA RUC recommended contractor pricing this service for CY 2013. However, given that services involving interactive complexity are nationally priced in the CY 2012 coding structure, we believe we have enough information to assign interim work RVUs for CPT code 90785 for CY 2013. In the 2012 coding structure, there are CPT codes for outpatient and inpatient psychotherapy services and corresponding CPT codes for outpatient and inpatient interactive psychotherapy services. For both the outpatient and inpatient services, the interactive service has a work RVU that is 0.11 RVUs higher than the corresponding service that is not interactive. We believe this reflects the current value of interactive services. Therefore, we are assigning an interim work RVU of 0.11 to CPT code 90785 for CY 2013. We are assigning this service 0 minutes of physician time because the work RVU of 0.11 reflects only the incremental difference in intensity of the base procedure; the time of this service is captured in the time of the procedure with which it is billed.
Regarding coding and payment for CPT code 90785, the CPT prefatory language for this service states that psychiatric procedures may be reported with interactive complexity for “* * * Use of play equipment, other physical devices, interpreter or translator to communicate with the patient to overcome barriers to therapeutic or diagnostic interaction between the physician or other qualified health care professional and a patient who is not fluent in the same language as the physician or other qualified health care professional, or has not developed, or has lost, either the expressive language communication skills to explain his/her symptoms and response to treatment, or the receptive communication skills to understand the physician or other qualified health care professional if he/she were to use typical language for communication.” Given this language, we would like to clarify that CPT code 90785 generally should not be billed solely for the purpose of translation or interpretation services. Federal laws prohibit discrimination, which in this case would take the form of higher beneficiary payments and copayments for the same service, based on disability or ethnicity. Billing for this service solely for translation or interpretation related to a beneficiary's disability could implicate section 504 of the Rehabilitation Act of 1973 and the Americans with Disabilities Act, and billing for this service solely for translation or interpretation related to foreign language could implicate Title VI of the Civil Rights Act of 1964.
The CPT Editorial Panel has created two new CPT codes for psychotherapy when a patient is in crisis, CPT codes 90839 (Psychotherapy for crisis; first 60 minutes) and 90840 (Psychotherapy for crisis; each additional 30 minutes (list separately in addition to code for primary service)). As these CPT codes have not yet been surveyed, the AMA RUC has recommended contractor pricing for CPT codes 90839 and 90840 for CY 2013. We agree and are assigning CPT codes 90839 and 90840 a PFS procedure status of C (Contractors price the code. Contractors establish RVUs and payment amounts for these services on an interim basis for CY 2013.
Additionally, for CY 2013, the CPT Editorial Panel has deleted CPT code 90862 (Pharmacologic management, including prescription, use, and review of medication with no more than minimal medical psychotherapy). For CY 2013, psychiatrists will now bill the appropriate E/M code when furnishing pharmacologic management services. The CPT Editorial Panel also created CPT add-on code 90863 (Pharmacologic management, including prescription and review of medication, when performed with psychotherapy services (list separately in addition to the code for primary procedure) to describe medication management by a nonphysician when furnished with psychotherapy. We understand from our past meetings with stakeholders that the ability to prescribe medicine is predicated upon first providing evaluation and management (E/M) services. We have discussed in previous rulemaking that Medicare does not recognize clinical psychologists to bill E/M services because they are not authorized to furnish those services under their state scope of practice (62 FR 59057). While clinical psychologists have been granted prescribing privileges in Louisiana and New Mexico, they are not licensed or authorized under their State scope of practice to furnish the full range of traditional E/M services. CPT code 90862 describes pharmacologic management, including prescription, use, and review of medication with no more than minimal medical psychotherapy. This descriptor reference to “medical psychotherapy” implies that the service furnished under CPT code 90862 is an E/M service, and therefore, clinical psychologists cannot bill Medicare for CPT code 90862. We also believe that clinical psychologists would continue to be precluded from billing Medicare for pharmacologic management services under new CPT code 90863, even in the absence of the reference to “medical psychotherapy” because pharmacologic management services require some knowledge and ability to perform evaluation and management services. Even though clinical psychologists in Louisiana and New Mexico have been granted prescribing privileges, clinical psychologists in those and other states are not licensed or authorized to furnish E/M services. Accordingly, on an interim basis for CY 2013, we are assigning CPT code 90863 a PFS procedure status indicator of I (Not valid for Medicare purposes. Medicare uses another code for the reporting of and the payment for these services.). We invite public comment on our interim assignment of this procedure status.
Finally, under the new coding structure, existing psychotherapy CPT codes 90845 (Psychoanalysis), 90846 (Family psychotherapy (without the
The AMA RUC and HCPAC-recommended RVUs are listed in the table at the start of this section. Regarding physician time, we accepted the AMA RUC-recommended times for all the new CPT codes in this family. We are maintaining the current work RVUs and times for existing CPT codes 90845, 90846, 90847, and 90853 on an interim basis until we are able to review all the recommended values for this family of CPT codes. Regarding the utilization crosswalk, we made some refinements to the AMA RUC-recommended utilization crosswalks for the new psychotherapy CPT codes, based on our understanding of how these services will be billed for CY 2013. We will re-review these assumptions when we review all recommended values for this family of CPT codes. The CY 2013 physician time file and utilization crosswalk are available on the CMS Web site at
CPT code 92980 (Transcatheter placement of an intracoronary stent(s), percutaneous, with or without other therapeutic intervention, any method; single vessel) was identified for review because it is on the MPC list. After reviewing CPT code 92980, the related specialty societies believed that the family of percutaneous coronary intervention (PCI) codes should be revised to better reflect current practice, and referred the family of codes to the CPT Editorial Panel for review.
The CPT Editorial Panel approved 13 new PCI CPT codes for CY 2013 to replace the 6 existing codes. In the current (CY 2012) coding structure, CPT code 92980 describes the placement of a coronary stent in a single vessel, and add-on CPT code 92981 describes placement of a stent in each additional vessel. As currently described, a single vessel includes one artery and all its branches. Under this coding convention, if a physician placed a stent in one artery and one branch to that artery, the physician would bill only CPT code 92980. If that physician placed a stent in one artery and one branch of that artery, then went on to place a stent in a second artery and one branch of that artery, the physician would bill CPT code 92980 along with add-on CPT code 92981.
The CY 2013 coding structure creates more codes and more granular coding. For CY 2013, the placement of a stent in an artery is billed using a base code, and the placement of a stent in a branch of that artery is billed using an add-on code. Stenting each new artery is billed using a new base code and stenting each branch is billed using an add-on to that base code. If a physician placed a stent in one artery and one branch of that artery, and then went on to place a stent in a second artery and one branch of that second artery, the physician would bill two base code/add-on pairs.
The CPT Panel made similar changes to the current codes for angioplasty and atherectomy and added new codes for atherectomy with stenting, any revascularization of a coronary artery bypass graft, and any revascularization procedure through a chronic total occlusion of any coronary artery or graft. The CPT Panel created a separate base code for each procedure for each new artery and an add-on code for each branch within that artery. Finally, the CPT Panel created a new code for any revascularization procedure for an acute coronary artery occlusion during an acute myocardial infarction. This final code does not have an add-on code.
We believe that this revised coding structure represents a CPT trend toward identifying greater granularity in codes describing the most intense and difficult work. As we discuss in section III.B.1. of this final rule with comment period, the agency has an interest in pursuing additional bundling in the PFS payment structure. Bundling is one method for structuring payment that can improve payment accuracy and efficiency. We believe that unbundling the placement of branch-level stents in a fee-for-service system may encourage increased placement of stents. To eliminate that incentive, on an interim final basis for CY 2013, we are rebundling the work associated with the placement of a stent in an arterial branch into the base code for the placement of a stent in an artery.
Specifically, we are bundling the work of CPT code 92921 (Percutaneous transluminal coronary angioplasty; each additional branch of a major coronary artery (list separately in addition to code for primary procedure)) into CPT code 92920 (Percutaneous transluminal coronary angioplasty; single major coronary artery or branch); we are bundling the work of CPT code 92925
To bundle the work of each new add-on code into its respective base code, we used the AMA RUC-recommended utilization crosswalk to determine what percentage of the base code utilization would be billed with the add-on code, and added that percentage of the add-on code AMA RUC-recommended work RVU to the base code AMA RUC-recommended work RVU. For example, the AMA RUC estimated that CPT code 92920 would have 26,848 Medicare allowed services in CY 2013, and that corresponding add-on CPT code 92921 would have 7,368 Medicare allowed services in CY 2013. Therefore, the AMA RUC estimates that CPT code 92920 will be billed without add-on CPT code 92921 for 73 percent of the Medicare allowed services, and that CPT code 92920 will be billed with add-on CPT code 92921 for 27 percent of the allowed services (7,368/26,848). To account for the additional work involved in 27 percent of the allowed services, we added a work RVU of 1.10 (27.44 percent of a work RVU of 4.00 for CPT code 92921) to the work RVU of 9.00 for CPT code 92920, to get to a work RVU of 10.10 for the combined service. We followed this methodology to establish the combined work RVUs for all the new base code/add-on code pairs. Based this methodology, we are assigning the following interim final work RVUs for CY 2013: a work RVU of 10.10 to CPT code 92920; a work RVU of 11.99 to CPT code 92924; a work RVU of 11.21 to CPT code 92928; a work RVU of 12.54 to CPT code 92933; a work RVU of 11.20 to CPT code 92937; and a work RVU of 12.56 to CPT code 92943. On an interim final basis for CY 2013, add-on CPT codes 92921, 92925, 92929, 92934, 92938, and 92944 will have a PFS procedure status indicator of B (Bundled code. Payments for covered services are always bundled into payment for other services, which are 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 bundled) and will not be separately payable.
We did not use this methodology directly to establish a work RVU for CPT code 92941 (Percutaneous transluminal revascularization of acute total/subtotal occlusion during acute myocardial infarction, coronary artery or coronary artery bypass graft, any combination of intracoronary stent, atherectomy and angioplasty, including aspiration thrombectomy when performed, single vessel), which does not have a specific corresponding add-on code. After reviewing this service alongside the other services in this family, like the AMA RUC, we believe CPT code 92941 should have the same work RVU as CPT code 92943 to preserve the appropriate rank order of the services in this family. As we stated above, we are assigning a work RVU of 12.56 to CPT code 92943. Therefore, on an interim final basis for CY 2013 we are assigning a work RVU of 12.56 to CPT code 92941, with the AMA RUC-recommended intra-service time of 70 minutes.
The AMA RUC recommended RVUs for these services are listed in the table above. The CY 2013 physician time file and utilization crosswalk are available on the CMS Web site at
CPT codes 93651 and 93652 were identified as potentially misvalued through the Codes Reported Together 75 percent or More screen. The CPT Editorial Panel deleted CPT codes 93651 and 93652, and replaced them with new CPT codes 93653 through 93657 for CY 2013.
We reviewed new CPT codes 93653 (Comprehensive electrophysiologic evaluation including insertion and repositioning of multiple electrode catheters with induction or attempted induction of an arrhythmia with right atrial pacing and recording, right ventricular pacing and recording, his recording with intracardiac catheter ablation of arrhythmogenic focus; with treatment of supraventricular tachycardia by ablation of fast or slow atrioventricular pathway, accessory atrioventricular connection, cavo-tricuspid isthmus or other single atrial focus or source of atrial re-entry), 93654 (Comprehensive electrophysiologic evaluation including insertion and repositioning of multiple electrode catheters with induction or attempted induction of an arrhythmia with right atrial pacing and recording, right ventricular pacing and recording, his recording with intracardiac catheter ablation of arrhythmogenic focus; with treatment of ventricular tachycardia or focus of ventricular ectopy including intracardiac electrophysiologic 3d mapping, when performed, and left ventricular pacing and recording, when performed), and 93656 (Comprehensive electrophysiologic evaluation including transseptal catheterizations, insertion and repositioning of multiple electrode catheters with induction or attempted induction of an arrhythmia with atrial recording and pacing, when possible, right ventricular pacing and recording, his bundle recording with intracardiac catheter ablation of arrhythmogenic focus, with treatment of atrial fibrillation by ablation by pulmonary vein isolation). We believe that the survey 25th percentile work RVUs of 15.00 for CPT code 93653, 20.00 for CPT code 93654, and 20.02 for CPT code 93656 accurately account for the work involved in furnishing these services. The AMA RUC recommended these values as well, with 180 minutes of intra-service time for CPT code 93653, and 240 minutes of intra-service time for CPT codes 93654 and 93656. We agree with these values. Accordingly, we are assigning a work RVU of 15.00 for CPT code 93653, a work RVU of 20.00 for 93654, and a work RVU of 20.02 for CPT code 93656, with no refinements to the AMA RUC-recommended time, on an interim final basis for CY 2013.
After reviewing CPT codes 93655 (Intracardiac catheter ablation of a discrete mechanism of arrhythmia which is distinct from the primary ablated mechanism, including repeat diagnostic maneuvers, to treat a spontaneous or induced arrhythmia (list separately in addition to code for primary procedure)) and 93657 (Additional linear or focal intracardiac catheter ablation of the left or right atrium for treatment of atrial fibrillation remaining after completion of pulmonary vein isolation (list separately in addition to code for primary procedure)), we believe these CPT codes have a very similar level of intensity as their related base codes: CPT codes 93653, 93654, and 93656. CPT codes 93653, 93654, and 93656 are all valued at 5.00 RVUs per 1 hour of intra-service time. We believe this is the appropriate increment for CPT codes 93655 and 93657 as well, which include 90 minutes of intra-service time. Therefore, we believe that a work RVU of 7.50 accurately accounts for the work of these services and reflects the appropriate relativity within this family of CPT codes. The AMA RUC recommended a work RVU of 9.00 for CPT code 93655 and a work RVU of 10.00 for CPT code 93657. We are assigning a work RVU of 7.50 to CPT codes 93655 and 93657 with no refinements to the AMA RUC-recommended time, on an interim final basis for CY 2013.
CPT codes 93925 and 93926 were identified by the AMA RUC as potentially misvalued because the time and PE inputs for these services had never been reviewed by the AMA RUC and these services have utilization of 500,00 service per year.
After reviewing CPT codes 93925 (Duplex scan of lower extremity arteries or arterial bypass grafts; complete bilateral study) and 93926 (Duplex scan of lower extremity arteries or arterial bypass grafts; unilateral or limited study), we believe that the specialty society survey 25th percentile work RVUs of 0.80 for CPT code 93925, and 0.50 for CPT code 93926 accurately account for the work involved in furnishing these services and appropriately captures the increase in work since these services were last valued. We believe that the AMA RUC-recommended the survey median work RVUs of 0.90 for CPT code 93925 and 0.70 for 93926 overstate the increase in value for these services and that those values are too high relative to similar services. Regarding physician time, we have refined the AMA RUC-recommended pre-service and post-service times from 5 minutes to 3 minutes to align with similar CPT codes 93922 (Limited bilateral noninvasive physiologic studies of upper or lower extremity arteries, (e.g., for lower extremity: ankle/brachial indices at distal posterior tibial and anterior tibial/dorsalis pedis arteries plus bidirectional, doppler waveform recording and analysis at 1-2 levels, or ankle/brachial indices at distal posterior tibial and anterior tibial/dorsalis pedis arteries plus volume plethysmography at 1-2 levels, or ankle/brachial indices at distal posterior tibial and anterior tibial/dorsalis pedis arteries with, transcutaneous oxygen tension measurement at 1-2 levels)) and 93923
The CPT Editorial Panel created CPT codes 95782 and 95783 for CY 2013 to describe the physician work involved in pediatric polysomnography for children 5 years of age or younger.
We reviewed CPT codes 95782 and 95783 and determined that the specialty society survey 25th percentile work RVUs of 2.60 for CPT code 95782 (Polysomnography; younger than 6 years, sleep staging with 4 or more additional parameters of sleep, attended by a technologist) and 2.83 for CPT code 95783 (Polysomnography; younger than 6 years, sleep staging with 4 or more additional parameters of sleep, with initiation of continuous positive airway pressure therapy or bi-level ventilation, attended by a technologist) appropriately reflect the work involved in furnishing these services. CPT codes 95782 and 95783 were previously reported under CPT codes 95810 (Polysomnography; age 6 years or older, sleep staging with 4 or more additional parameters of sleep, attended by a technologist) and 95811 (Polysomnography; age 6 years or older, sleep staging with 4 or more additional parameters of sleep, with initiation of continuous positive airway pressure therapy or bilevel ventilation, attended by a technologist). These CPT codes (95810 and 95811) have revised descriptors for CY 2013 indicating age 6 years and older. CPT code 95810 has a CY 2012 work RVU of 2.50, and CPT code 95811 has a CY 2012 work RVU of 2.60. We believe the increase from these current work RVUs to the CY 2013 work RVUs of 2.60 for CPT code 95782 and 2.83 for CPT code 95783 reflect the incremental difference in work between the existing services for ages 6 years and older and new services for younger than 6 years. The AMA RUC recommended the specialty society survey median work RVUs of 3.00 for CPT code 95782 and 3.20 for CPT code 95783. We are assigning a work RVU of 2.60 to CPT code 95782 and a work RVU of 2.83 to CPT code 95783 on an interim final basis for CY 2013.
CPT codes 95860, 95861, 95863, and 95864 were identified as potentially misvalued through the Codes Reported Together 75 percent or More screen. The related specialty societies submitted a code change proposal to the CPT Editorial Panel to bundle the services commonly reported together. In response, for CY 2012, the CPT Panel created three add-on codes (CPT codes 95885 through 95887), and for CY 2013, the Panel created seven new codes (CPT codes 95907 through 95913) that bundle the work of multiple nerve conduction studies into each individual code.
We first reviewed CPT codes 95885 (Needle electromyography, each extremity, with related paraspinal areas, when performed, done with nerve conduction, amplitude and latency/velocity study; limited (list separately in addition to code for primary procedure)), 95886 (Needle electromyography, each extremity, with related paraspinal areas, when performed, done with nerve conduction, amplitude and latency/velocity study; complete, five or more muscles studied, innervated by three or more nerves or four or more spinal levels (list separately in addition to code for primary procedure)), and 95887 (Needle electromyography, non-extremity (cranial nerve supplied or axial) muscle(s) done with nerve conduction, amplitude and latency/velocity study (list separately in addition to code for primary procedure)) for the CY 2012 PFS final rule with comment period. We stated that we were accepting the AMA RUC-recommended work RVUs and times on an interim basis, pending review of the other electromyography services (76 FR 73207). For CY 2013 we were able to review these services alongside the related electromyography services and nerve conduction tests. After reviewing these services, we agree with the AMA RUC-recommended times and RVUs for needle electromyography CPT codes 95860 through 95870 (all listed in the table above). We also agree with the AMA RUC-recommendations for the CY 2012 needle electromyography add-on CPT code 95885, however we do not agree with the AMA RUC recommendations for the other two CY 2012 needle electromyography add-on CPT codes 95886 and 95887.
After review, we determined that the AMA RUC-recommended work RVU of 0.35 for CPT code 95885 was appropriate and was well-aligned with CPT code 95870 (Needle electromyography; limited study of muscles in 1 extremity or non-limb (axial) muscles (unilateral or bilateral), other than thoracic paraspinal, cranial nerve supplied muscles, or sphincters), to which we are assigning a work RVU of 0.37; the services involve similar work and both include 15 minutes of intra-service time. We believe that CPT codes 95886 and 95887 involve the same level of work intensity as CPT code 95885. To determine the appropriate RVU for CPT codes 95886 and 95887 relative to 95885, we increased the work RVU in proportion to the increase in time for the services. Under this methodology, because we are assigning a work RVU of 0.35 and 15 minutes of intra-service time to CPT code 95885, we believe it is appropriate to assign a work RVU of 0.70 to CPT code 95886, which has an intra-service time of 30 minutes; and a work RVU of 0.47 to CPT code 95887, which has an intra-service time of 20 minutes. The AMA RUC recommended a work RVU of 0.92 for CPT code 95886 and a work RVU of 0.73 for CPT code 95887. We are assigning a work RVU of 0.70 to CPT code 95886 and a work RVU of 0.47 to CPT code 95887 on an interim final basis for CY 2013.
We reviewed new CPT codes 95907 (Nerve conduction studies; 1-2 studies), 95908 (Nerve conduction studies; 3-4 studies), 95909 (Nerve conduction studies; 5-6 studies), 95910 (Nerve conduction studies; 7-8 studies), 95911 (Nerve conduction studies; 9-10 studies), 95912 (Nerve conduction studies; 11-12 studies), and 95913 (Nerve conduction studies; 13 or more studies) and found that the progression of the survey 25th percentile work RVUs and survey median times appropriately reflect the relativity of these services. The two CPT codes in the nerve conduction studies series that describe the fewest nerve conduction studies, 95907 and 95908, are the exception to this trend, as the survey 25th percentile work RVUs are too low relative to other fee schedule services. For CPT code 95907, the survey 25th percentile work RVU is 0.48, but we believe that the survey median and AMA RUC recommended work RVU of 1.00 is more appropriate for this service. For CPT code 95908, the survey 25th percentile work RVU is 1.00, however CPT code 95908 should be valued between CPT code 95907 and 95909, which has a survey 25th percentile work RVU of 1.50. We believe a work RVU of 1.25, half-way between the work RVU of CPT codes 95907 and 95909, accurately reflects the work of this service relative to other services in this series. The AMA RUC recommended the survey median values for most of the services in the series, and used a crosswalk methodology to develop a work RVU recommendation for CPT codes 95908 and 95909. In sum, on an interim final basis for CY 2013, we are assigning a work RVU of 1.00 to CPT code 95907; a work RVU of 1.25 to CPT code 95908; a work RVU of 1.50 to CPT codes 95909; a work RVU of 2.00 to CPT codes 95910; a work RVU of 2.50 to CPT code 95911; a work RVU of 3.00 to CPT code 95912; and a work RVU of 3.56 to CPT code 95913. We are refining the AMA RUC-recommended intra-service time for CPT code 95908 from 25 minutes to the survey median time of 22 minutes, and for CPT code 95909 from 35 minutes to the survey median time of 30 minutes, so that all the CPT codes in this series are valued using the survey median intra-service time. A complete list of the interim final times assigned to these procedures is available on the CMS Web site at
CPT code pairs 95925 with 95926, and 95928 with 95929, were identified as potentially misvalued through the Codes Reported Together 75 percent or More screen. For CY 2012, the CPT Editorial Panel created CPT code 95938 to capture the reporting of CPT codes 95925 and 95926 together, and CPT codes 95939 to capture the reporting of CPT codes 95928 with 95929. The related specialty societies surveyed CPT codes 95938 and 95939 and the AMA RUC sent us recommendations on those services for the CY 2012 PFS final rule with comment period.
We reviewed CPT codes 95938 (Short-latency somatosensory evoked potential study, stimulation of any/all peripheral nerves or skin sites, recording from the central nervous system; in upper and lower limbs) and 95939 (Central motor evoked potential study (transcranial motor stimulation); in upper and lower limbs) for the CY 2012 PFS final rule with comment period. In that rule, we stated that we were accepting the AMA RUC-recommended values on an interim basis, and requested that the AMA RUC review the component CPT codes 95925 (Short-latency somatosensory evoked potential study, stimulation of any/all peripheral nerves or skin sites, recording from the central nervous system; in upper limbs), 95926 (Short-latency somatosensory evoked potential study, stimulation of any/all peripheral nerves or skin sites, recording from the central nervous system; in lower limbs), 95928 (Central motor evoked potential study (transcranial motor stimulation); upper limbs), and 95929 (Central motor evoked potential study (transcranial motor stimulation); lower limbs) (76 FR 73207 through 73208).
In response to this request, the AMA RUC Relativity Assessment Workgroup referred component CPT codes 95925, 95926, 95928, and 95929 to the PE Subcommittee of the AMA RUC to review the direct practice expense inputs, but the AMA RUC decided not to review the physician work or time.
When reviewing the physician work and time for the two new bundled CPT codes and their component codes, we saw unlikely relationships between the physician times assigned to these services, especially CPT codes 95928, 95929, and 95939. Given these time anomalies, we are also concerned the current (CY 2012) work RVUs do not reflect the appropriate relativity of the services. CPT code 95939 describes an evoked potential study in both the upper and lower limbs together, and is assigned 30 minutes of intra-service time. CPT code 95928 describes an evoked potential study in the upper limbs only, and is assigned 60 minutes of intra-service time. CPT code 95929 describes an evoked potential study in the lower limbs, and is assigned 55 minutes of intra-service time. We do not believe that an evoked potential study on the upper or lower limbs alone takes twice as long as an evoked potential study on both the upper and lower limbs.
Additionally, CPT code 95938 describes an evoked potential study in both the upper and lower limbs together, and is assigned 30 minutes of intra-service time. CPT code 95925 describes an evoked potential study in the upper limbs only and is assigned 15 minutes of intra-service time. CPT code 95926 describes an evoked potential study in the lower limbs and is assigned 15 minutes of intra-service time. We note that the intra-service times of CPT codes 95925 and 95926 are significantly different from the intra-service times of CPT codes 95928 and 95929 for very similar procedures, but somehow the new bundled procedure codes for both have 30 minutes of intra-service time. We conclude that there are valuation and time inaccuracies, both across the evoked potential study codes and relative to the new bundled codes. For example, for CPT codes 95925 and 95926, we do not believe that the correct intra-service time for CPT code 95938 can be the sum of the intra-service times of CPT codes 95925 and 95926, as we are confident that there efficiencies to be recognized when performing these services together.
Given these anomalous relationships, we request public comments on the appropriate work and time values for these services. We are maintaining the current (CY 2012) work RVUs and times for CPT codes 95925, 95926, 95928, 95929, 95938, and 95939 on an interim basis for CY 2013, and anticipate re-reviewing these services for CY 2014.
Effective January 1, 2013, the CPT Editorial Panel is deleting CPT code 95920 (Intraoperative neurophysiology testing, per hour (List separately in addition to code for primary procedure)), and is replacing it with CPT codes 95940 (Continuous intraoperative neurophysiology monitoring in the operating room, one on one monitoring requiring personal attendance, each 15 minutes) and CPT code 95941 (Continuous intraoperative neurophysiology monitoring, from outside the operating room (remote or nearby) or for monitoring of more than one case while in the operating room, per hour). Currently remote monitoring is billed under the PFS using CPT code 95920, though the code does not specify whether the physician is present in the same room with a patient or monitoring from a remote location, nor does the code descriptor indicate whether the code may be billed for the monitoring of one patient or more than one simultaneously. Some carriers have established local coverage determinations (LCDs) to address these issues and more tightly define the circumstances under which CPT code 95920 may be billed.
The CPT prefatory language for CPT code 95941 states: “* * * One or more simultaneous cases may be reported * * * Report 95941 for all remote or non-one on one monitoring time connected to each case regardless of overlap with other cases.” Given this language, we are concerned that CPT code 95941 allows a practitioner to bill individual beneficiaries for monitoring more than one beneficiary for the same work during the same time interval. To resolve this concern, we have created HCPCS code G0453 (Continuous intraoperative neurophysiology monitoring, from outside the operating room (remote or nearby), per patient, (attention directed exclusively to one patient) each 15 minutes (list in addition to primary procedure)), effective January 1, 2013. HCPCS code G0453 may be billed only for undivided attention by the monitoring physician to a single beneficiary, not for simultaneous attention by the monitoring physician to more than one patient. HCPCS code G0453 may be billed in multiple units to account for the cumulative time spent monitoring, that is, 15 minutes of continuous attendance followed by another 15 minutes later in the procedure would constitute one half hour of monitoring, and CPT code G0453 would be billed with a unit of 2. HCPCS code G0453 will replace CPT code 95941, which will have a PFS procedure status indicator of I (Not valid for Medicare purposes. Medicare uses another code for the reporting of and the payment for these services) for CY 2013. CPT code 95940, which describes continuous intraoperative neurophysiology monitoring in the operating room for one patient at a time, will be payable on the PFS for CY 2013, with a PFS procedure status indicator of A (Active).
After reviewing CPT code 95940, we agree with the AMA RUC that a work RVU of 0.60 accurately accounts for the work involved in furnishing this procedure. We are assigning a work RVU of 0.60 to CPT code 95940 on an interim final basis for CY 2013. Also, we agree with the AMA RUC that a work RVU of 2.00 accurately accounts for the work for involved in furnishing 60 minutes of continuous intraoperative neurophysiology monitoring from outside the operating room. Accordingly, we are assigning a work RVU of 0.50 to HCPCS code G0453, which describes 15 minutes of monitoring from outside the operating room, on an interim final basis for CY 2013.
For CY 2013, we are creating two HCPCS codes in order to provide a payment mechanism for negative pressure wound therapy services furnished to beneficiaries through means unrelated to the durable medical equipment benefit: G0456 (Negative pressure wound therapy. (e.g. vacuum assisted drainage collection) using a mechanically-powered device, not durable medical equipment, including provision of cartridge and dressing(s), topical application(s), wound assessment, and instructions for ongoing care, per session; total wound(s) surface area less than or equal to 50 square centimeters) and G0457 (Negative pressure wound therapy. (e.g. vacuum assisted drainage collection) using a mechanically-powered device, not durable medical equipment, including provision of cartridge and dressing(s), topical application(s), wound assessment, and instructions for ongoing care, per session; total wound(s) surface area greater than 50 sq cm). The two new codes will be contractor priced on an interim basis for CY 2013. We request comments on the appropriate value for this service.
The CPT editorial panel created CPT codes 99485 and 99486 for CY 2013, to describe the non-face-to-face services provided by physician to supervise interfacility care of critically ill or critically injured pediatric patients.
We reviewed CPT codes 99485 (Supervision by a control physician of interfacility transport care of the critically ill or critically injured pediatric patient, 24 months of age or younger, includes two-way communication with transport team before transport, at the referring facility and during the transport, including data interpretation and report; first 30 minutes) and 99486 (Supervision by a control physician of interfacility transport care of the critically ill or critically injured pediatric patient, 24 months of age or younger, includes two-way communication with transport team before transport, at the referring facility and during the transport, including data interpretation and report; each additional 30 minutes (list separately in addition to code for primary procedure)), and we believe these services are bundled into other services and are not separately payable. We believe these services are similar to CPT codes 99288 (Physician or other qualified health care professional direction of emergency medical systems (ems) emergency care, advanced life support), which is also bundled on the PFS. The AMA RUC recommended a work RVU of 1.50 for CPT code 99485 and a work RVU of 1.30 for CPT code 99486. On an interim final basis for CY 2013, we are assigning CPT codes 99485 and 99486 a PFS procedure status indicator of B (Payments for covered services are always bundled into payment for other services, which are 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 bundled.
The CPT Editorial Panel created CPT codes 99487, 99488, and 99489 for CY 2013 to describe complex chronic care coordination services that are patient-centered management and support services.
In section II.H. of this CY 2013 PFS final rule with comment period, we discuss our broader HHS and CMS multi-year strategy to recognize and support primary care and care management under the PFS and commitment to exploring payment approaches and developing proposals to promote primary care within a fee-for-service payment structure. We intend to consider CPT codes 99487 (Complex chronic care coordination services; first hour of clinical staff time directed by a physician or other qualified health care professional with no face-to-face visit, per calendar month), 99488 (Complex chronic care coordination services; first hour of clinical staff time directed by a physician or other qualified health care professional with one face-to-face visit, per calendar month), and 99489 (Complex chronic care coordination services; each additional 30 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month (list separately in addition to code for primary procedure)) as part of that larger discussion. At this time, we believe these services are bundled into the services to which they are incident and are not separately payable. The AMA RUC recommended a work RVU of 1.00 for CPT code 99487, a work RVU of 2.50 for CPT code 99488, and a work RVU of 0.50 for CPT code 99489. On an interim final basis for CY 2013, we are assigning CPT codes 99487, 99488, and 99489 a PFS procedure status indicator of B (Payments for covered services are always bundled into payment for other services, which are 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 bundled).
The CPT Editorial Panel created CPT codes 99495 and 99496 for CY 2013 to describe transitional care provided to patients from an inpatient setting to a home setting over a 30-day period.
CPT codes 99495 (Transitional care management services with the following required elements: Communication (direct contact, telephone, electronic) with the patient and/or caregiver within 2 business days of discharge medical decision making of at least moderate complexity during the service period face-to-face visit, within 14 calendar days of discharge) and 99496 (Transitional care management services with the following required elements: Communication (direct contact, telephone, electronic) with the patient and/or caregiver within 2 business days of discharge medical decision making of high complexity during the service period face-to-face Visit, within 7 calendar days of discharge) are discussed in detail in section III.H of this CY 2013 PFS final rule with comment period. In sum, after clinical review, we are assigning a work RVU of 2.11 with 40 minutes of intra-service time to CPT code 99495, and a work RVU of 3.05 with 50 minutes of intra-service time to CPT codes 99496 on an interim final basis for CY 2013.
Effective January 1, 2013, we have created HCPCS code G0454 (Physician documentation of face-to-face visit for Durable Medical Equipment determination performed by Nurse Practitioner, Physician Assistant or Clinical Nurse Specialist) for payment to a physician who documents that a PA, NP, or CNS practitioner has performed a face-to-face encounter for the list of specified DME covered items. As discussed in section IV.C. of this CY 2013 PFS final rule with comment period, for HCPCS code G0454, we are finalizing a work RVU of 0.18, with 5 minutes of intra-service time and 2 minutes of post-service time, which is a crosswalk to CPT code 99211 (Level 1 office or other outpatient visit, established patient). We believe these values appropriately capture the work and time involved in furnishing this service.
For all other CY 2013 new, revised and potentially misvalued CPT codes not specifically discussed previously, we agree with the AMA RUC/HCPAC recommended work RVUs and times and are setting as interim final the work RVUs listed in Table 30.
The AMA RUC provides CMS with recommendations regarding direct PE inputs, including clinical labor, supplies, and equipment, for new, revised, and potentially misvalued codes. We review the AMA RUC-recommended direct PE inputs on a code-by-code basis, including the recommended facility PE inputs and/or nonfacility PE inputs, as clinically appropriate for the code. We determine whether we agree with the AMA RUC's recommended direct PE inputs for a service or, if we disagree, we refine the PE inputs to represent inputs that better reflect our estimate of the PE resources required to furnish the service in the facility and/or nonfacility settings. We also confirm that CPT codes should have facility and/or nonfacility direct PE inputs and make changes based on our clinical judgment and any PFS payment policies that would apply to the code.
We have accepted for CY 2013, as interim and without refinement, the direct PE inputs based on the recommendations submitted by the AMA RUC for the codes listed in Table KK6. For the remainder of the AMA RUC's direct PE recommendations, we have accepted the PE recommendations submitted by the AMA RUC as interim, but with refinements. These codes and the refinements to their direct PE inputs are listed in Table KK7. In some cases, we have maintained the interim status of direct PE inputs for certain code beyond the year of the initial recommendation. In those cases, we address the associated direct PE inputs in this section, along with the interim direct PE inputs, established through our review of AMA RUC recommendations.
We note that the final CY 2013 PFS direct PE input database reflects the refined direct PE inputs that we are adopting on an interim basis for CY 2013. That database is available under downloads for the CY 2013 PFS final rule with comment period on the CMS Web site at:
While Table KK7 details the CY 2013 refinements of the AMA RUC's direct PE recommendations at the code-specific level, we discuss the general nature of some common refinements and the reasons for particular refinements in the following section.
Some direct PE inputs are directly affected by revisions in physician time described in section III.B.3. and III.M.3.a. of this final rule with comment period. Specifically, changes in the intra-service portions of the physician time and changes in the number or level of postoperative visits associated with the global periods result in corresponding changes to direct PE inputs.
For equipment associated with the intra-service period in the nonfacility setting, we generally allocate time based on the typical number of minutes a piece of equipment is being used and, therefore, not available for use with another patient during that period. In general, we allocate these minutes based on the description of typical clinical labor activities. To the extent that we are making changes in the clinical labor times associated with the intra-service portion of procedures, we have adjusted the corresponding equipment minutes associated with the codes.
These refinements are reflected in the final CY 2013 PFS direct PE input database and detailed in Table 73.
In general, the equipment time inputs reflect the sum of the times within the intra-service period when a clinician is using the piece of equipment, plus any additional time the piece of equipment is not available for use for another patient due to its use during the designated procedure. While some services include equipment that is typically unavailable during the entire clinical labor service period, certain highly technical pieces of equipment and equipment rooms are less likely to be used by a clinician for all tasks associated with a service and therefore are typically available for other patients during the pre-service and post-service components of the service period. We adjust those equipment times accordingly. We refer interested stakeholders to our extensive discussion of these policies in the CY 2012 PFS final rule (76 FR 73182-73183). We are refining the CY 2013 AMA RUC direct PE recommendations to conform to these equipment time policies. These refinements are reflected in the final CY 2013 PFS direct PE database and detailed in Table 73.
In the CY 2012 PFS final rule (76 FR 73043-73049), we finalized a standard package of direct PE inputs for services where moderate sedation is considered inherent in the procedure. We are refining the CY 2013 AMA RUC direct PE recommendations to conform to these policies. These refinements are reflected in the final CY 2013 PFS direct PE database and detailed in Table 73.
In general, the minutes associated with certain clinical labor tasks are standardized depending on the type of procedure, its typical setting, its global period, and the other procedures with which it is typically reported. In the case of some services, the RUC has recommended a numbers of minutes either greater or less than time typically allotted for certain tasks. In those cases, CMS clinical staff has reviewed the deviations from the standards to determine their clinical appropriateness. Where CMS clinical judgment considers that the standard number of minutes generally accommodates the range of minutes likely to be typical for such activities, the recommended exceptions have not been accepted, and we have refined the interim final direct PE inputs to match the standard times for those tasks. Each of those refinements appears in Table 73.
The CPT Editorial Panel created CPT code 44705 (Preparation of fecal microbiota for instillation, including assessment of donor specimen) and the AMA RUC recommended nonfacility direct PE inputs for this service for CY 2013. As discussed in section III.M.3.a. of this final rule, Medicare payment for the preparation of the donor specimen would only be made if the specimen is ultimately used for the treatment of a beneficiary. Because of this policy, we believe it is appropriate to bundle the preparation and instillation into one payable HCPCS code. For CY 2013, we have created HCPCS code G0455 (Preparation with instillation of fecal microbiota by any method, including assessment of donor specimen). HCPCS code G0455 will replace new CPT code 44705 (Preparation of fecal microbiota for instillation, including assessment of donor specimen) which will have a PFS procedure status indicator of I (Not valid for Medicare purposes), and includes both the work of preparation and instillation of the microbiota.
In order to establish direct PE inputs for this service that includes both the preparation and instillation, we examined the AMA RUC recommendations for CPT code 44705 and incorporated an additional 17 minutes of clinical labor time in the service period to account for pre-service activities like greeting and gowning the beneficiary, obtaining the vital signs, providing pre-education/obtaining consent, preparing the room and equipment, and preparing the patient and post-service activities like cleaning the room and providing home care instructions to the beneficiary, based on the amount of time allocated for those services in the direct PE inputs for evaluation and management services. We note that we have also included a minimum multi-specialty visit pack (SA048) as a supply input for the code and otherwise crosswalked the AMA RUC-recommended supply and equipment inputs from CPT code 44705.
Generally, we only establish interim final direct PE inputs for services when the RUC has provided a new recommendation. However, in some cases, we believe it is necessary to establish new interim final direct PE inputs for codes not recently reviewed by the RUC in order to maintain appropriate relativity between the PE and work components of PFS payment or among those codes and other related codes. For example, this situation can occur when either the physician work of particular codes has been reviewed without parallel review of the direct PE inputs or when the direct PE inputs of certain codes have been reviewed without parallel review of the direct PE inputs of closely related codes. We addressed the issue in detail in the CY 2012 PFS final rule (76 FR 73212).
Over the past several years, AMA CPT has created codes for diagnostic radiology services that describe CT and computed tomographic angiography (CTA) of the abdomen and pelvis combined while maintaining the current component codes that describe CT and CTA of each region separately. In reviewing both the physician work and the direct PE inputs for these services, we have consistently requested that recommendations for appropriate valuation of these services consider the whole code set at once.
In response to this request, commenters contended that the AMA RUC operates under the premise that the values of all the services paid on the PFS are assumed to be accurate and therefore, our request to review component codes is unnecessary and that reviewing and possibly revaluing individual codes solely because they are bundled to create a new code, risks rank-order anomalies within families, which could threaten the relativity of the values of the PFS services. One commenter suggested that our requests would create an endless cycle of review.
We continue to believe that code sets that include component and combined codes should be reviewed for appropriate revaluing as whole sets instead of in fragments. In fact, we believe that disjointed review, as opposed to comprehensive review, is itself the most likely cause of rank order anomalies and “endless cycles of review.” The Act requires CMS to conduct periodic reviews of PFS services [1848(c)(2)(B)] and make appropriate adjustments to misvalued codes [1848(c)(2)(K)]. In consideration of these obligations, we believe that the relative values for these codes must be considered as a whole set instead of in fragments. In the interest of examining the direct PE inputs of these services as a comprehensive set, we have reviewed the direct PE inputs for all of the abdomen and pelvis CT codes and all of the abdomen and pelvis CTA codes as two individual sets. We have started from the basis that the most recently developed AMA RUC recommendation represents the most current information regarding typical medical practice. For each set of codes, we have established a common set of disposable supplies and medical equipment. We established clinical labor minutes that reflect the fundamental assumption that the component codes should include a base number of minutes for particular tasks and that the number of minutes in the combined codes should reflect efficiencies that occur when the regions are examined together.
We are establishing the direct PE input for each of these services on an interim basis for CY 2013, and we have displayed particular refinements to the most recent AMA RUC recommendations or current direct PE inputs for the codes in Table 73.
Regarding the supply item called “computer media, optical disk 2.6gb” (SK016), we note that the most recent AMA RUC recommendation included the item with a quantity of 1 as a disposable supply. When reviewing the item in the direct PE input database, we noted that its quantity for other similar codes is 0.1. We believe that quantity better reflects the resource costs of storing digital images for these services. We also note that the item is currently priced at $68.75 in the direct PE input database, and we believe that price may be significantly higher than typical prices. Therefore, we are seeking comment on the appropriate quantity and price for the item, which will be set at a quantity of 0.1 for these services on an interim basis for CY 2013.
Finally, we note that the direct PE inputs for these services will not be finalized until the associated work RVUs are finalized, consistent with our established policies regarding the concurrent review of work and direct practice expense inputs.
When clinically appropriate, the AMA RUC generally recommends the use of supply and equipment items that already exist in the direct PE database for new, revised, and potentially misvalued codes. Some recommendations include supply or equipment items that are not currently in the direct PE database. In these cases, the AMA RUC has historically recommended a new item be created and has facilitated CMS' pricing of that item by working with the specialty societies to provide sales invoices to us. We appreciate the contributions of the AMA RUC in that process.
We received invoices for several new supply and equipment items for CY 2013. We have accepted the majority of these items and added them to the direct PE database. For CY 2013, we could not price the new equipment for CPT code 78072 (Parathyroid planar imaging (including subtraction, when performed); with tomographic (SPECT), and concurrently acquired computed tomography (CT) for anatomical localization). We received a recommendation to create a new equipment item in the direct PE database called “gamma camera system, single-dual head SPECT/CT” for use in furnishing this service in the nonfacility setting. In order to facilitate pricing the new item, the AMA RUC forwarded information from the specialty society, but that information only included a letter from the device manufacturer that offered a price quote. While we recognize that the resource costs for the equipment is significant, we do not believe that a letter from the manufacturer is adequate documentation for establishing a price for a new equipment item. In many cases when we cannot adequately price a newly recommended item, we have included the item in the direct PE input database without an associated price. While doing so means that the item does not contribute to the calculation of the
The AMA RUC submitted direct PE input recommendations for CPT code 86153 (Cell enumeration using immunologic selection and identification in fluid specimen (eg, circulating tumor cells in blood); physician interpretation and report, when required) that describes a laboratory physician interpretation code. As we discuss in section III.M.3.a. of this final rule with comment period, CPT code 86153 is a professional component-only CPT code that will be considered a “clinical laboratory interpretation service,” which is one of the current categories of PFS pathology services under the definition of physician pathology services at § 415.130(b)(4). This code must be billed with the “26” modifier to be paid under the PFS. Therefore, CPT code 86153-26 should be valued exclusively without direct practice expense inputs. Therefore, we are not accepting the recommended direct PE inputs for CPT code 86153.
For surgical pathology CPT codes 88300, 88302, 88304, 88305, 88307, 88309 (Surgical Pathology, Levels I through VI), the AMA RUC recommended creating several new supply and equipment items in direct PE input database that we will not incorporate for CY 2013 in addition to several new direct PE inputs that we are adopting on an interim basis. The new supply items that we will not incorporate were called “specimen, solvent, and formalin disposal cost,” and “courier transportation costs.” We do not believe that specimen and supply disposal or courier costs for transporting specimens are appropriately considered as disposable medical supplies. Instead, we believe the costs described by these recommendations are incorporated into the PE RVUs for these services through the indirect PE allocation. We note that the current direct PE inputs for these and similar services across the PFS do not include these kinds of costs as disposable supplies.
In addition to the recommendation to include these new supply items, the AMA RUC recommended that we create new equipment items called “equipment maintenance cost,” “Copath System with maintenance contract,” and “Copath software” as direct PE inputs for these codes. Our standard equipment cost per minute calculation includes a maintenance factor to incorporate costs related to maintenance in amortizing the cost of the equipment itself. Therefore, we will not incorporate separate maintenance costs for particular items. Regarding the “Copath” system and software equipment, the AMA RUC forwarded materials from a manufacturer that included a description of a computer system that is used to interface with other data systems to provide inbound demographic information and export laboratory results and billing information. Based on the way those functionalities were presented in this information, we believe that this computer system and associated software reflects an indirect practice expense since the clerical and other administrative functionality seem central to its purpose. We note that no similar equipment is currently included as a direct PE input for these services. All direct PE inputs for these services are interim for CY 2013 and open to comment. We would consider additional information regarding whether this computer system and associated software might be considered a direct cost as medical equipment associated with furnishing the technical component of these surgical pathology services for CY 2014 rulemaking. We are especially interested in understanding the clinical functionality of the equipment in relation to the services being furnished.
In addition to this information, we are also seeking additional public comment regarding the appropriate assumptions regarding the direct PE inputs for these services. We note that the AMA RUC recommendations for these potentially misvalued codes were developed based on an underlying assumption regarding the typical number of blocks used each time a service is reported. The number of blocks assumed to be used has significant impact on the quantity of other supplies and the number of clinical labor and equipment minutes assigned as direct PE inputs to each code. After conducting an initial clinical review of these direct PE inputs, we are concerned that the number of blocks assumed for each code may be inaccurate. For 88300, no blocks are assumed. For 88302, one block is assumed. For 88304 and 88305, the assumed number of blocks typically used is 2. For 88307, the assumed number of blocks is 12 and for 88309, the typical number of blocks is assumed to be 18. We are accepting the AMA RUC's recommended direct PE inputs that derive from these assumptions on an interim basis for CY 2013, but we are seeking independent evidence regarding the appropriate number of blocks to assume as typical for each of these services. We are requesting public comment regarding the appropriate number of blocks and urge the AMA RUC and interested medical specialty societies to provide corroborating, independent evidence that the number of blocks assumed in the current direct PE input recommendations is typical prior to finalizing the direct PE inputs for these services.
The CPT Editorial Panel created CPT codes 88120 (Cytopathology, in situ hybridization (eg, FISH), urinary tract specimen with morphometric analysis, 3-5 molecular probes, each specimen; manual) and 88121 (Cytopathology, in situ hybridization (eg, FISH), urinary tract specimen with morphometric analysis, 3-5 molecular probes, each specimen; using computer-assisted technology) to describe in situ hybridization testing using urine samples, effective for CY 2011.
As we explain in section III.M.3.a. of this final rule with comment period, we believe that the work and direct PE inputs for existing CPT codes 88365, 88367, and 88368 should be reviewed alongside CPT codes 88120 and 88121 to ensure the appropriate relativity between these two sets of services (76 FR 73153 through 73154). The AMA RUC has stated that it intends to do so after CY 2012 utilization data are available to assess how these services are being billed. We agree with this approach, and are maintaining the interim status for the direct PE inputs for CPT code 88120 and 88121 until we review CPT codes 88120 and 88121 alongside CPT codes 88365, 88367, and 88368 for CY 2014.
Distinct from that forthcoming review, stakeholders have informed us of two separate issues related to the interim direct PE inputs for these services. Two stakeholders have examined the AMA RUC recommendations and found miscalculations in the recommended equipment minutes. The information we
These stakeholders also suggested that CMS should increase the price of the supply “UroVysion test kit” (SA105) by building in an “efficiency factor” to account for the kits that are purchased by practitioners and used in tests that fail. The stakeholders provided documentation suggesting that a certain failure rate is inherent in the procedure.
The prices associated with supply inputs in the direct PE input database reflect the price per unit of each supply. Since the current PE methodology relies on the inputs for each service reflecting the typical direct practice expense costs for each service, and the supply costs for the failed tests are not used in furnishing PFS services, we do not believe that the methodology accommodates a failure rate in allocating the cost of disposable medical supplies. Therefore, we are not adjusting the price input for “UroVysion test kit” (SA105) in the direct PE input database.
For CY 2013, the CPT Editorial Panel has replaced the current psychiatry/psychotherapy CPT codes with a new structure that allows for the separate reporting of E/M codes, eliminates the site-of-service differential, establishes CPT codes for crisis, and creates a series of add-on CPT codes to psychotherapy to describe interactive complexity and medication management. As we note in section III.M.3.a. of this final rule with commenter period, because related specialty societies have not yet surveyed some of the new CPT codes, namely, the new CPT codes for psychotherapy for crisis, interactive complexity, and pharmacologic management, we anticipate re-reviewing the values for all the codes in the family in the near future. For CY 2013, our general approach is to maintain the current values, or as close to the current values as possible, given the consolidation of multiple CY 2012 CPT codes into a single CY 2013 CPT code, for these service on an interim basis, pending re-review.
The AMA RUC submitted direct PE input recommendations for codes in this family that included significant reductions in the direct PE costs associated with the predecessor codes. For most of the new codes, we believe that accepting these recommended reductions in direct practice expense conforms to our general approach of maintaining the current values for these services since many practitioners who furnish these services will now report concurrent medical evaluation and management services with PE values that will offset the differences in total PE values between the new and old psychotherapy codes. However, for practitioners who do not furnish medical evaluation and management services, there are no corresponding PE value increases to offset the recommended reductions in the direct PE inputs for these codes. Therefore, instead of accepting the recommended direct PE inputs for the new CPT codes that describe services primarily furnished by practitioners who do not also report medical evaluation and management services, we will crosswalk the PE RVUs from the CY 2012 codes that describe the same services. We believe this crosswalk will effectively maintain the total value of the services, pending a comprehensive review of the code family. The CPT codes with CY 2013 PE RVU crosswalks are: 90791 (Psychiatric diagnostic evaluation), 90832 (Psychotherapy, 30 minutes with patient and/or family member), 90834 (Psychotherapy, 45 minutes with patient and/or family member), and 90837 (Psychotherapy, 60 minutes with patient and/or family member). For CY 2013, we are crosswalking the PE RVUs developed for the predecessor codes for CY 2012. We note that the PE RVUs used for these services will correspond with the CY 2013 fully implemented values instead of the transition values since this interim policy is to maintain the current values relative to the new coding structure for the services, not exempt the services from the final year of the PPIS transition, as described in section III.A. of this final rule with comment period. The values in Addendum C reflect the interim PE RVUs for these codes.
The AMA RUC submitted direct PE input recommendations for CPT code 91112 (Gastrointestinal transit and pressure measurement, stomach through colon, wireless capsule, with interpretation and report). The recommendations reflect an assumption that the patient data receiver would be typically used for 7200 minutes, or 5 days, for each service. However, product information available on the device manufacturer's Web site specifies a 24 to 48 hour capsular passage time. Based on this information and CMS clinical review, we believe that assigning 2880 minutes to the data receiver is appropriate based on the assumption that 2 days reflects the maximum typical time for passage of the capsule. We also note that while the AMA RUC's recommendation included the capsule and standardized meal as separate disposable items, the submitted invoice priced the items together, so the new supply item created in the direct PE input database reflects the combined items as a single disposable supply.
Effective January 1, 2013, the CPT Editorial Panel is deleting CPT code 95920 (Intraoperative neurophysiology testing, per hour (List separately in addition to code for primary procedure)), and is replacing it with CPT codes 95940 (Continuous intraoperative neurophysiology monitoring in the operating room, one on one monitoring requiring personal attendance, each 15 minutes) and CPT code 95941 (Continuous intraoperative neurophysiology monitoring, from outside the operating room (remote or nearby) or for monitoring of more than one case while in the operating room, per hour).
As we note in section III.M.3.a. of this final rule with comment period, we have created HCPCS code G0453 (Continuous intraoperative neurophysiology monitoring, from outside the operating room (remote or nearby), per patient, (attention directed exclusively to one patient) each 15 minutes (list in addition to primary procedure)), effective January 1, 2013 to replace CPT code 95941 for Medicare purposes. CPT code 95941 will have a PFS procedure status indicator of I (Not valid for Medicare purposes. Medicare uses another code for the reporting of
The AMA RUC provided direct PE input recommendations for CPT codes 95940 and 95941. However, we do not believe that these services are furnished to patients outside of facility settings. Medicare makes payment for technical inputs (labor, supplies, equipment, capital, and overhead) to the facility when services are performed in a facility setting. For these services, the patient would receive this service in the ASC or hospital setting and payment for any technical services, including those for remote monitoring, should be included in the facility payment. We do not believe it would be appropriate to incorporate nonfacility direct PE inputs or develop nonfacility PE RVUs for CPT code 95940 and newly created HCPCS code G0453 for CY 2013. We do not believe that these services incur PFS direct practice expense costs when furnished to patients in the facility setting. Therefore, we are developing facility PE RVUs for this service based on no direct PE inputs.
The AMA RUC submitted direct PE input recommendations for new CPT codes describing pediatric polysomonography: 95782 (Polysomnography, younger than 6 years, 4 or more) and 95783 (Polysomnography, younger than 6 years, w/cpap). We note that in addition to refining minutes assigned to certain labor tasks based on CMS clinical judgment, we have not accepted the AMA RUC's recommendation to create a new equipment item `crib' for use in these services. We do not believe that a crib would typically be used in this service, and we have incorporated the bedroom furniture including a hospital bed and a reclining chair as typical equipment for this service.
The AMA RUC provided new direct PE input recommendations for CPT codes 96920(Laser treatment for inflammatory skin disease (psoriasis); total area less than 250 sq cm), 96921 (Laser treatment for inflammatory skin disease, (psoriasis); between 250 sq cm to 500 sq cm), and 96922 (Laser treatment for inflammatory skin disease, (psoriasis); over 500 sq cm).
Included in the new direct PE inputs for these services was a disposable laser tip (SF028). This disposable item, priced at $290 in the direct PE input database, was not previously included as a direct PE input for these services. The recommendation did not provide a rationale as to why this highly priced disposable should be included as a direct PE input for these existing services when the codes have not previously included this item or any similarly priced disposable supply. Therefore, we are refining the RUC recommendation by removing the supply item SF028 from 96920, 96921, and 96922. We note that the direct PE inputs for these codes are interim for CY 2013, and we will consider any additional information and public comments regarding the typical use of this supply in furnishing these services prior to finalizing the direct PE inputs for CY 2014.
The CPT Editorial Panel created CPT codes 99495 and 99496 for CY 2013 to describe transitional care provided to patients from an inpatient setting to a home setting over a 30-day period. The AMA RUC submitted direct PE input recommendations for these services that we are accepting with the following refinements.
As discussed in detail in section III.H of this CY 2013 PFS final rule with comment, we agree with the AMA RUC recommendation to include 45 minutes of RN/LPN time for CPT code 99495 for dedicated to non-face-to-face care management activities. However, for CPT code 99496, we are refining the 60 minutes of recommended clinical labor time for a RN/LPN nurse blend dedicated to non-face-to-face care management activities from 60 minutes to 70 minutes. We believe that the total clinical labor staff time and physician intra-service work time that the AMA RUC-recommended for non-face-to-face care management activities was accurate for both codes, but that the proportionality between physician work and clinical staff time should be refined to reflect greater clinical staff time in 99496.
We also note that we are refining the AMA RUC recommendation by incorporating the clinical labor inputs for dedicated to non-face-to-face care management activities as facility inputs.
According to our malpractice methodology discussed in section III.C.1 of this CY 2013 PFS final rule with comment period, we have assigned malpractice RVUs for CY 2013 new and revised codes by utilizing a crosswalk to a source code with a similar malpractice risk-of-service. We have reviewed the AMA RUC-recommended malpractice source code crosswalks for CY 2013 new and revised codes, and we are accepting all of them on an interim final basis for CY 2013.
For CY 2013, we created several HCPCS G-codes. HCPCS code G0452 (Molecular pathology procedure; physician interpretation and report) was created to replace CPT code 83912 (Molecular diagnostics; interpretation and report), which is deleted effective January 1, 2013. We believe CPT code 83912 has a similar malpractice risk-of-service as HCPCS code G0452. Therefore, we are assigning an interim final malpractice crosswalk of CPT code 83912 to HCPCS code G0452 on an interim final basis for CY 2013.
For CY 2013, we created HCPCS code G0453 (Continuous intraoperative neurophysiology monitoring, from outside the operating room (remote or nearby), per patient, (attention directed exclusively to one patient), each 15 minutes) to replace new CPT code 95941 (Continuous intraoperative neurophysiology monitoring, from outside the operating room (remote or nearby) or for monitoring of more than one case while in the operating room, per hour) which will have a PFS procedure status indicator of I (Not valid for Medicare purposes. Medicare uses another code for the reporting of and the payment for these services) for CY 2013, as discussed in section III.M.3.a. of this CY 2013 PFS final rule with comment period. The AMA RUC recommended a malpractice crosswalk of CPT code 95920 (Intraoperative neurophysiology testing, per hour (List separately in addition to code for primary procedure)) for CPT code 95941. We believe CPT code 95920 has a similar malpractice risk-of-service as HCPCS code G0453. Therefore, we are assigning an interim final malpractice crosswalk of CPT code 95920 to HCPCS code G0453 for CY 2013.
For CY 2013, we created HCPCS code G0454 (Physician documentation of face-to-face visit for Durable Medical Equipment determination performed by Nurse Practitioner, Physician Assistant or Clinical Nurse Specialist) for payment to a physician who documents that a PA, NP, or CNS practitioner has performed a face-to-face encounter for the list of specified DME covered items. As discussed in section IV.C. of this CY 2013 PFS final rule with comment period, we have assigned HCPCS code G0454 a work RVU of 0.18, which is a crosswalk to CPT code 99211 (Level 1 office or other outpatient visit, established patient). We believe CPT code 99211 has a similar malpractice risk-of-service as HCPCS code G0454. Therefore, we are assigning an interim final malpractice crosswalk of CPT code 99211 to HCPCS code G0454 for CY 2013.
For CY 2013, we created HCPCS code G0455 (Preparation with instillation of fecal microbiota by any method, including assessment of donor specimen) to replace new CPT code 44705 (Preparation of fecal microbiota for instillation, including assessment of donor specimen) which will have a PFS procedure status indicator of I (Not valid for Medicare purposes. Medicare uses another code for the reporting of and the payment for these services) for CY 2013, as discussed in section III.M.3.a. of this CY 2013 PFS final rule with comment period. The AMA RUC recommended a malpractice crosswalk of CPT code 91065 (Breath hydrogen test (eg, for detection of lactase deficiency, fructose intolerance, bacterial overgrowth, or oro-cecal gastrointestinal transit) for CPT code 44705. We believe CPT code 91065 has a similar malpractice risk-of-service as HCPCS code G0455. Therefore, we are assigning an interim final malpractice crosswalk of CPT code 91065 to HCPCS code G0455 for CY 2013.
In accordance with our malpractice methodology, we have adjusted the malpractice RVUs of the CY 2013 new/revised codes for the difference in work RVUs (or, if greater, the clinical labor portion of the fully implemented PE RVUs) between the source code and the new/revised codes to reflect the specific risk-of-service for the new/revised codes. Table 75 lists the CY 2012 new/revised HCPCS codes and their respective source codes used to set the interim final CY 2013 malpractice RVUs. Revised CPT codes that are crosswalked to themselves (that is, CPT code 11300 to 11300) are not listed. The malpractice RVUs for these services are reflected in Addendum B of this CY 2013 PFS final rule with comment period.
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
As discussed in the CY 2010 PFS final rule with comment period (74 FR 61961), the statute provides the Secretary with clear discretion to decide whether physician-administered drugs should be included or excluded from the definition of “physicians' services.” Accordingly, we removed 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 the levels of allowed expenditures and actual expenditures beginning with CY 2010, and for all subsequent years. Furthermore, in order to effectuate fully the Secretary's policy decision to remove drugs from the definition of physicians' services, we removed physician-administered drugs from the calculation of allowed and actual expenditures for all prior years.
Thus, for purposes of determining allowed expenditures, actual expenditures for all years, and SGRs beginning with CY 2010 and for all subsequent years, we specified 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, nurse practitioners, 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.
• Additional preventive services.
• Pulmonary rehabilitation.
• Cardiac rehabilitation.
• Intensive cardiac rehabilitation.
• Kidney disease education services.
• Personalized prevention plan services.
Our preliminary estimate of the CY 2013 SGR is—19.7 percent. We first estimated the CY 2013 SGR in March 2012, and we made the estimate available to the MedPAC and on our Web site. Table 76 shows the March 2012 estimate and our current estimates of the factors included in the CY 2013
Our current estimate of the CY 2012 SGR is 5.1 percent. Table 77 shows our preliminary estimate of the CY 2012 SGR that was published in the CY 2012 PFS final rule with comment period (76 FR 73269) and our current estimate. The majority of the difference between the preliminary estimate and our current estimate of the CY 2012 SGR is explained by adjustments to reflect intervening legislative changes that have occurred since publication of the CY 2012 final rule with comment period.
The SGR for CY 2011 is 4.7 percent. Table 78 shows our preliminary estimate of the CY 2011 SGR from the CY 2011 PFS final rule with comment period, our revised estimate from the CY 2012 PFS final rule with comment period, and the final figures determined using the best available data as of September 1, 2012.
All of the figures used to determine the CY 2013 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 2013 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 87.7 percent of total allowed charges included in the SGR in CY 2013 and are updated using the percent change in the MEI. As discussed in section C, the percent change in the MEI for CY 2013 is 0.8 percent. Diagnostic laboratory tests are estimated to represent approximately 12.3 percent of Medicare allowed charges included in the SGR for CY 2013. Medicare payments for these tests are updated by the Consumer Price Index for Urban Areas (CPI-U), which is 1.7 percent for CY 2013. Section 1833(h)(2)(A)(iv(l) of the Act requires that the CPI-U update applied to clinical laboratory tests be reduced by a multi-factor productivity adjustment (MFP adjustment) and, for each of years 2011 through 2015, by 1.75 percentage
We estimate that the weighted average increase in fees for physicians' services in CY 2013 under the SGR (before applying any legislative adjustments) will be 0.3 percent.
This factor is our estimate of the percent change in the average number of fee-for-service enrollees from CY 2012 to CY 2013. Services furnished 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 3.6 percent from CY 2012 to CY 2013. Table 80 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 2013 becomes known.
We estimate that the growth in real GDP per capita from CY 2012 to CY 2013 will be 0.7 percent (based on the annual growth in the 10 year moving average of real GDP per capita (2004 through 2013)). Our past experience indicates that there have also been changes in estimates of real GDP per capita growth made before the year begins and the actual change in real GDP per capita growth 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 CY 2013.
The statutory and regulatory provisions that will affect expenditures in CY 2013 relative to CY 2012 are estimated to have an impact on expenditures of −23.3 percent. The impact is primarily due to the expiration of the physician fee schedule update specified in statute for CY 2012 only.
A more detailed discussion of our revised estimates of the four elements of the CY 2012 SGR follows.
This factor was calculated as a weighted-average of the CY 2012 changes in fees that apply for the different types of services included in the definition of physicians' services for the SGR in CY 2012.
We estimate that services paid using the PFS account for approximately 90.3 percent of total allowed charges included in the SGR in CY 2012. These services were updated using the CY 2012 percent change in the MEI of 0.6 percent. We estimate that diagnostic laboratory tests represent approximately 12.3 percent of total allowed charges included in the SGR in CY 2012. For CY 2012, diagnostic laboratory tests received an update of 0.7 percent.
Table 81 shows the weighted-average of the MEI and laboratory price changes for CY 2011.
After considering the elements described in Table 81, we estimate that the weighted-average increase in fees for physicians' services in CY 2012 under the SGR was 0.6 percent. Our estimate of this factor in the CY 2012 PFS final rule with comment period was 0.6 percent (76 FR 73271).
We estimate that the average number of Medicare Part B fee-for-service enrollees (excluding beneficiaries enrolled in Medicare Advantage plans) increased by 1.6 percent in CY 2012. Table 82 illustrates how we determined this figure.
Our estimate of the 1.6 percent change in the number of fee-for-service enrollees, net of Medicare Advantage enrollment for CY 2012 compared to CY 2011, is different than our original estimate of an increase of 3.5 percent in the CY 2012 PFS final rule with comment period. (76 FR 73271). While our current projection based on data from 8 months of CY 2012 differs from our original estimate of 3.5 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 2012 fee-for-service enrollment.
We estimate that the growth in real GDP per capita will be 0.7 percent for CY 2012 (based on the annual growth in the 10-year moving average of real GDP per capita (2003 through 2012)). Our past experience indicates that there have also been differences between our estimates of real per capita GDP growth made prior to the year's end and the actual change in this factor. Thus, it is possible that this figure will change further as complete actual information on CY 2012 economic performance becomes available to us in CY 2013.
The statutory and regulatory provisions that affected expenditures in CY 2012 relative to CY 2011 are estimated to have an impact on expenditures of 2.8 percent. This is primarily an effect of the statutory requirements surrounding the temporary physician fee schedule update in CY 2012.
A more detailed discussion of our final revised estimates of the four elements of the CY 2011 SGR follows.
This factor was calculated as a weighted average of the CY 2011 changes in fees that apply for the different types of services included in the definition of physicians' services for the SGR in CY 2011.
We estimate that services paid under the PFS account for approximately 90.7 percent of total allowed charges included in the SGR in CY 2011. These services were updated using the CY 2011 percent change in the MEI of 0.4 percent. We estimate that diagnostic laboratory tests represent approximately 9.3 percent of total allowed charges included in the SGR in CY 2011. For CY 2011, diagnostic laboratory tests received an update of −1.8 percent.
Table 83 shows the weighted-average of the MEI and laboratory price changes for CY 2011.
After considering the elements described in Table 83, we estimate that the weighted-average increase in fees for physicians' services in CY 2011 under the SGR (before applying any legislative adjustments) was 0.2 percent. This figure is a final one based on complete data for CY 2011.
We estimate the change in the number of fee-for-service enrollees (excluding beneficiaries enrolled in MA plans) from CY 2010 to CY 2011 was 1.0 percent. Our calculation of this factor is based on complete data from CY 2011. Table 84 illustrates the calculation of this factor.
We estimate that the growth in real per capita GDP was 0.6 percent in CY 2011 (based on the annual growth in the 10-year moving average of real GDP per capita (2002 through 2011)). This figure is a final one based on complete data for CY 2011.
Our final estimate for the net impact on expenditures from the statutory and regulatory provisions that affect expenditures in CY 2011 relative to CY 2010 is 2.8 percent. This is primarily an effect of the statutory requirements surrounding the temporary physician fee schedule update in CY 2011.
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. As discussed previously, allowed expenditures are equal to actual expenditures in a base period updated each year by the 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. As discussed previously, section 1848(f)(3) specifies that the SGR (and, in turn, allowed expenditures) for the upcoming CY (CY 2013 in this case), the current CY (that is, CY 2012) and the preceding CY (that is, CY 2011) 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 CY 2011 allowed expenditures in this final rule with comment).
Table 85 shows the historical SGRs corresponding to each period through CY 2013. Note that these figures have been revised to reflect a correction to the historical clinical laboratory expenditure data.
Consistent with section 1848(d)(4)(E) of the Act, Table 85 includes our second revision of allowed expenditures for CY 2011, a recalculation of allowed expenditures for CY 2012, and our initial estimate of allowed expenditures for CY 2013. To determine the UAF for CY 2013, the statute requires that we use allowed and actual expenditures from April 1, 1996 through December 31, 2012 and the CY 2013 SGR. Consistent with section 1848(d)(4)(E) of the Act, we will be making further revisions to the CY 2012 and CY 2013 SGRs and CY 2012 and CY 2013 allowed expenditures. Because we have incomplete actual expenditure data for CY 2012, 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.
We are using figures from Table 85 in the following statutory formula:
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 0.006 (0.6 percent) is between −0.07 and 0.03, the UAF for CY 2013 will be 0.006.
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 0.006 yields 1.006.
The Medicare Economic Index (MEI) is required by section the fourth sentence of 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 current form of the MEI was detailed in the CY 2011 PFS final rule with comment period (75 FR 73262) which updated the cost structure of the index from a base year of 2000 to 2006.
The MEI measures the weighted-average annual price change for various inputs needed to furnish 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 2006 base year weights, is comprised of two broad categories: (1) Physician's own time; and (2) physician's practice expense (PE).
The physician's compensation (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 practice expense (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 expenses; medical materials and supplies; professional liability insurance; medical equipment; medical materials and supplies; and other professional expenses.
Table 86 presents a listing of the MEI cost categories with associated weights and percent changes for price proxies for the 2013 update. The CY 2013 final MEI update is 1.8 percent and reflects a 1.9 percent increase in physician's own time and a 1.7 percent increase in physician's PE. Within the physician's PE, the largest increase occurred in chemicals, which increased 7.1 percent,
For CY 2013, the increase in the MEI is 0.8 percent, which reflects an increase in the non-productivity adjusted MEI of 1.8 percent and a productivity adjustment of 1.0 percent (which is based on the 10-year moving average of economy-wide private nonfarm business multifactor productivity). The Bureau of Labor Statistics (BLS) is the agency that publishes the official measure of private non-farm business multi-factor productivity (MFP). Please see
From May 2012 through September 2012, the MEI Technical Advisory Panel conducted a technical review of the MEI, including analyses of the inputs, input weights, price-measurement proxies, and productivity adjustment. Details regarding the Panel's work and documents such as transcripts, meeting summaries, and presentations can be found at the following Web site:
The Panel concluded its public work on July 11, 2012 and submitted a final report complete with its recommendations to the Secretary of Health and Human Services on August 27, 2012.
The CY 2013 PFS CF is $25.0008. The CY 2012 national average anesthesia CF is $15.93.
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 less productivity times the UAF, which is calculated as specified under section 1848(d)(4)(B) of the Act.
Generally, 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.
We note section 101 of the Medicare Improvements and Extension Act, Division B of the Tax Relief and Health Care Act of 2006 (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 Medicare, Medicaid, and SCHIP Extension Act of 2007 (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 CY 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 CYs 2007, 2008, and 2009 had never applied. Section 1011(a) of the DODAA and section 5 of the TEA specified a zero percent update for CY 2010, effective January 1, 2010 through March 31, 2010. Section 4 of the Continuing Extension Act of 2010 (CEA) extended the zero percent update for CY 2010 through May 31, 2010. Subsequently, section 101(a)(2) of the PACMBPRA provided for a 2.2 percent update to the CF, effective from June 1, 2010 to November 30, 2010. Section 2 of the Physician Payment and Therapy Relief Act of 2010 (Pub. L. 111-286) extended the 2.2 percent through the end of CY 2010. Section 101 of the MMEA provided a zero percent update for CY 2011, effective January 1, 2011 through December 31, 2011, and specified that the CFs for CY 2012 and subsequent years must be computed as if the increases in previous years had never applied. Section 301 of the Temporary Payroll Tax Cut Continuation Act of 2011 (TPTCCA) provided a zero percent update effective January 1, 2012 through February 29, 2012, and specified that the CFs for subsequent time periods must be computed as if the increases in previous years had never applied. Section 3003 of the Middle Class Tax Relief and Job Creation Act of 2012 (Job Creation Act) provided a zero percent update for effective March 1, 2012 through December 31, 2012, and specified that the CFs for subsequent time periods must be computed as if the increases in previous years had never applied. Therefore, under current law, the CF that would be in effect in CY 2012 had the prior increases specified above not applied is $24.6712.
In addition, when calculating the PFS CF for a year, 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 by more than $20 million from what it would have been in the absence of these changes. If this threshold is exceeded, we must make adjustments to preserve budget neutrality. We estimate that CY 2012 RVU changes would result in an increase in Medicare physician expenditures of more than $20 million. Accordingly, we are decreasing the CF by −0.1% to offset the estimated increase in Medicare physician expenditures due to the CY 2012 RVU changes. We calculate the CY 2013 PFS CF to be $25.0008. This final rule with comment period announces a reduction to payment rates for physicians' services in CY 2013 under the SGR formula. These payment rates are currently scheduled to be reduced under the SGR system on January 1, 2013. The total reduction in the conversion factor between CY 2012 and CY 2013 under the SGR system will be −26.5 percent. By law, we are required to make these reductions in accordance with section 1848(d) and (f) of the Act, and these reductions can only be averted by an Act of Congress. While Congress has provided temporary relief from these reductions every year since 2003, a long-term solution is critical. We will continue to work with Congress to fix this untenable situation so doctors and beneficiaries no longer have to worry about the stability and adequacy of their payments from Medicare under the Physician Fee Schedule.
We illustrate the calculation of the CY 2013 PFS CF in Table 87.
We note payment for services under the PFS will be calculated as follows:
We calculate the anesthesia CF as indicated in Table 88. Anesthesia services do not have RVUs like other PFS services. Therefore, we account for any necessary RVU adjustments through an adjustment to the anesthesia CF to simulate changes to RVUs. More specifically, if there is an adjustment to the work, 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. Information regarding the anesthesia work, PE, and malpractice shares can be found at the following:
The anesthesia CF in effect in CY 2012 is $21.52. As explained previously, in order to calculate the CY 2013 PFS CF, the statute requires us to calculate the CFs for all previous years as if the various legislative changes to the CFs for those years had not occurred. Accordingly, under current law, the anesthesia CF in effect in CY 2012 had statutory increases not applied is $15.60. The percent change from the anesthesia CF in effect in CY 2012 to the CF for CY 2013 is -26.0 percent. We illustrate the calculation of the CY 2013 anesthesia CF in Table 88.
Section 146(a) of the Medicare Improvements for Patients and Providers Act of 2008 (Pub. L. 110-275) (MIPPA) amended section 1834(l)(13)(A) of the Act to specify that, effective for ground ambulance services furnished on or after July 1, 2008 and before January 1, 2010, the ambulance fee schedule amounts for ground ambulance services shall be increased as follows:
• For covered ground ambulance transports that originate in a rural area or in a rural census tract of a metropolitan statistical area, the fee schedule amounts shall be increased by 3 percent.
• For covered ground ambulance transports that do not originate in a rural area or in a rural census tract of a metropolitan statistical area, the fee schedule amounts shall be increased by 2 percent.
Sections 3105(a) and 10311(a) of the Affordable Care Act further amended section 1834(l)(13)(A) of the Act to extend the payment add-ons described above for an additional year, such that these add-ons also applied to covered ground ambulance transports furnished on or after January 1, 2010 and before January 1, 2011. In the CY 2011 PFS final rule (75 FR 73385 and 73386, 73625), we revised § 414.610(c)(1)(ii) to conform the regulations to this statutory requirement.
Section 106(a) of the MMEA again amended section 1834(l)(13)(A) of the Act to extend the payment add-ons described above for an additional year, such that these add-ons also applied to covered ground ambulance transports furnished on or after January 1, 2011 and before January 1, 2012. In the CY 2012 End-Stage Renal Disease Prospective Payment System (ESRD PPS) final rule (76 FR 70228, 70284 through 70285, 70315), we revised § 414.610(c)(1)(ii) to conform the regulations to this statutory requirement. However, in doing so, paragraphs (c)(1)(ii)(A) and (B) were inadvertently deleted from the Code of Federal Regulations. Thus, in the proposed rule, we proposed to reinstate paragraphs (c)(1)(ii)(A) and (B) as further revised below. We did not receive any comments on this proposal. Therefore, we are finalizing our proposal to reinstate paragraphs (c)(1)(ii)(A) and (B), as further revised below to conform to subsequent legislation.
Subsequently, section 306(a) of the Temporary Payroll Tax Cut Continuation Act of 2011 (Pub. L. 112-78) (TPTCCA) amended section 1834(l)(13)(A) of the Act to extend the payment add-ons described above through February 29, 2012; and section 3007(a) of the Middle Class Tax Relief and Job Creation Act of 2012 (Pub. L. 112-96) (MCTRJCA) further amended section 1834(l)(13)(A) to extend these payment add-ons through December 31, 2012. Thus, these payment add-ons also apply to covered ground ambulance transports furnished on or after January 1, 2012 and before January 1, 2013. In the proposed rule, we proposed to revise § 414.610(c)(1)(ii) to conform the regulations to these statutory requirements. We did not receive any comments on this proposal. Accordingly, we are finalizing our proposal to revise § 414.610(c)(1)(ii) to conform to the statutory requirements described above. These statutory requirements are self-implementing. A plain reading of the statute requires only a ministerial application of the mandated rate increase, and does not require any substantive exercise of discretion on the part of the Secretary.
Section 146(b)(1) of the MIPPA amended the designation of rural areas for payment of air ambulance services. This section originally specified that any area that was designated as a rural area for purposes of making payments under the ambulance fee schedule for air ambulance services furnished on December 31, 2006, must continue to be treated as a rural area for purposes of making payments under the ambulance fee schedule for air ambulance services furnished during the period July 1, 2008 through December 31, 2009.
Sections 3105(b) and 10311(b) of the Affordable Care Act amended section 146(b)(1) of MIPPA to extend this provision for an additional year, through December 31, 2010. In the CY 2011 PFS final rule (75 FR 73385 through 86, 73625 through 26), we revised § 414.610(h) to conform the regulations to this statutory requirement.
Section 106(b) of the MMEA amended section 146(b)(1) of MIPPA to extend this provision again through December 31, 2011. In the CY 2012 ESRD PPS final rule (76 FR 70284 through 70285, 70315), we revised § 414.610(h) to conform the regulations to this statutory requirement.
Subsequently, section 306 (b) of the TPTCCA amended section 146(b)(1) of MIPPA to extend this provision through February 29, 2012; and section 3007(b) of the MCTRJCA further amended section 146(b)(1) of MIPPA to extend this provision through December 31, 2012. Thus, we proposed to revise § 414.610(h) to conform the regulations to these statutory requirements. We did not receive any comments on this proposal. Therefore, we are finalizing our proposal to revise § 414.610(h) to conform to the statutory requirements described above. These statutory requirements are self-implementing. A plain reading of the statute requires only
Section 414 of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA) added paragraph (12) to section 1834(l) of the Act, which specified that in the case of ground ambulance services furnished on or after July 1, 2004, and before January 1, 2010, for which transportation originates in a qualified rural area (as described in the statute), the Secretary shall provide for a percent increase in the base rate of the fee schedule for such transports. The statute requires this percent increase to be based on the Secretary's estimate of the average cost per trip for such services (not taking into account mileage) in the lowest quartile of all rural county populations as compared to the average cost per trip for such services (not taking into account mileage) in the highest quartile of rural county populations. Using the methodology specified in the July 1, 2004 interim final rule (69 FR 40288), we determined that this percent increase was equal to 22.6 percent. As required by the MMA, this payment increase was applied to ground ambulance transports that originated in a “qualified rural area”; that is, to transports that originated in a rural area included in those areas comprising the lowest 25th percentile of all rural populations arrayed by population density. For this purpose, rural areas included Goldsmith areas (a type of rural census tract).
Sections 3105(c) and 10311(c) of the Affordable Care Act amended section 1834(l)(12)(A) of the Act to extend this rural bonus for an additional year through December 31, 2010. In the CY 2011 PFS final rule (75 FR 73385 through 73386 and 73625), we revised § 414.610(c)(5)(ii) to conform the regulations to this statutory requirement.
Section 106(c) of the MMEA again amended section 1834(l)(12)(A) of the Act to extend the rural bonus described above for an additional year, through December 31, 2011. Therefore, in the CY 2012 ESRD PPS final rule (76 FR 70284 through 70285, 70315), we revised § 414.610(c)(5)(ii) to conform the regulations to this statutory requirement.
Subsequently, section 306 (c) of the TPTCCA amended section 1834(l)(12)(A) of the Act to extend this rural bonus through February 29, 2012; and section 3007(c) of the MCTRJCA further amended section 1834(l)(12)(A) of the Act to extend this rural bonus through December 31, 2012. Therefore, we are continuing to apply the 22.6 percent rural bonus described above (in the same manner as in previous years), to ground ambulance services with dates of service on or after January 1, 2012 and before January 1, 2013 where transportation originates in a qualified rural area.
This rural bonus is sometimes referred to as the “Super Rural Bonus” and the qualified rural areas (also known as “super rural” areas) are identified during the claims adjudicative process via the use of a data field included on the CMS-supplied ZIP Code File.
In the proposed rule, we proposed to revise § 414.610(c)(5)(ii) to conform the regulations to the statutory requirements set forth at section 306(c) of the TPTCCA and section 3007(c) of the MCTRJCA. We did not receive any comments on this proposal. Accordingly, we are finalizing our proposal to revise § 414.610(c)(5)(ii) to conform the regulations to these statutory requirements. These statutory requirements are self-implementing. Together, these provisions require a one-year extension of the rural bonus (which was previously established by the Secretary) through December 31, 2012, and do not require any substantive exercise of discretion on the part of the Secretary.
Section 1847A of the Act requires use of the average sales price (ASP) payment methodology for payment for drugs and biologicals described in section 1842(o)(1)(C) of the Act furnished on or after January 1, 2005. The ASP methodology applies to most drugs furnished incident to a physician's service, many drugs furnished under the DME benefit, certain oral anti-cancer drugs, and oral immunosuppressive drugs.
If the ASP payment limit for a drug or biological exceeds the WAMP or AMP by a threshold percentage, section 1847A(d)(3)(C) of the Act authorizes the Secretary to substitute the lesser of the widely available market price for the drug or biological, or 103 percent of the average manufacturer price as determined under section 1927(k)(1) of the Act.
The applicable threshold percentage is specified in section 1847A(d)(3)(B)(i) of the Act as 5 percent for CY 2005. For CY 2006 and subsequent years, section 1847A(d)(3)(B)(ii) of the Act authorizes the Secretary to specify the threshold percentage for the WAMP or the AMP, or both. In the CY 2006 (70 FR 70222), CY 2007 (71 FR69680), CY 2008 (72 FR 66258), CY 2009 (73 FR 69752), and CY 2010 (74 FR 61904) PFS final rules with comment period, we specified an applicable threshold percentage of 5 percent for both the WAMP and AMP. We based this decision on the fact that data was too limited to support an adjustment to the 5 percent threshold. Beginning in CY 2011, we treated the WAMP and AMP based adjustments to the applicable threshold percentages separately.
After soliciting and reviewing comments, we finalized proposals to continue the 5 percent WAMP threshold for CY 2011 (75 FR 73469), and CY 2012 (76 FR 73287). For CY 2013, we again had no additional information from OIG studies or other sources that led us to consider an alternative threshold. When making comparisons to the WAMP, we proposed that the applicable threshold percentage remain at 5 percent until such time that a change in the threshold amount is warranted, and we proposed to update § 414.904(d)(3)(iv) accordingly. As mentioned above, the threshold has remained at 5 percent since 2005. Our proposal will eliminate the need for annual rulemaking until a change is warranted.
For CY 2013, we did not propose any WAMP based price substitutions. As we noted in the CY 2011 PFS final rule with comment period (75 FR 73470) and reiterated in CY 2012 PFS final rule with comment period (76 FR 73287), we understand that there are complicated operational issues associated with the WAMP based substitution policy, and we continue to proceed cautiously in this area. We remain committed to providing stakeholders, including providers and manufacturers of drugs impacted by potential price substitutions with adequate notice of our intentions, including the opportunity to provide input with regard to the processes for substituting the WAMP for the ASP.
The AMP threshold has remained at 5 percent since 2005. As with the WAMP threshold, we had no information that led us to believe that the 5 percent threshold percentage for AMP-based price substitution is inappropriate or should be changed for CY 2013. We proposed that the applicable threshold percentage remain at 5 percent until such time that a change in the threshold amount is warranted, and we proposed to update § 414.904(d)(3)(iii) accordingly. Our proposal eliminates the need for annual rulemaking until a change is warranted.
In the CY 2012 PFS rule, we specified that the substitution of AMP for ASP will be made only when the ASP exceeds the AMP by 5 percent in 2 consecutive quarters immediately prior to the current pricing quarter, or three of the previous four quarters immediately prior to the current quarter, and that matching sets of NDCs had to be used in the comparison (76FR 73289 through 73295). The value of the AMP based price substitution must also be less than the ASP payment limit that is calculated for the quarter in which the substitution is applied. Also, the price substitution remains in effect for one quarter.
We did not apply the price substitution policy in April 2012 because access concerns led us to reconsider whether it was prudent to proceed with price substitution during a developing situation that was related to a drug shortage that had not met the definition of a public health emergency under section 1847A(e) of the Act. In light of recent concerns about drug shortages, the resulting impact on patient care, beneficiary and provider access, as well as the potential for shortages to suddenly affect drug prices for the provider, under the authority in section 1847A(d)(3)(C) of the Act, we proposed adding § 414.904(d)(3)(ii)(C), which would prevent the AMP price substitution policy from taking effect if the drug and dosage form represented by the HCPCS code are reported by the FDA on their Current Drug Shortage list (or other FDA reporting tool that identifies shortages of critical or medically necessary drugs) to be in short supply at the time that ASP payment limits are being finalized for the next quarter. Further, we also clarified that this proposal to add to the safeguards finalized in CY 2012 only applied to calculations under the AMP-based price substitution policy. Our proposal intended to continue the cautious approach described in previous rules and to strike a balance between operational requirements associated with receiving manufacturers' ASP reports, calculating the payment limits, and posting stable payment limits that will be used to pay claims. We believe that this approach also addresses concerns about access to care, known program issues identified by the OIG, and provides an opportunity for some modest program savings. However, we did not propose any other changes to the safeguards, timing, or notification that identifies the codes that will be substituted each quarter. We asked for comments on our approach as well as comments regarding additional specific safeguards for the AMP price substitution policy.
Additional Part B drug-related comments that are outside the scope of this rule are listed in section 3 below.
This section discusses payment policies regarding billing for certain drugs under Medicare Part B. In 2010 and 2011, we issued two change requests (CRs 7109 and 7397) that summarized a number of longstanding drug payment policy and billing requirements. We considered these CRs to be merely clarifying, rather than changing, our policy. However, one item in the CRs, which stated that pharmacies may not bill for drugs that are used incident to physician's service, has caused some concern. Specifically, we understood that some nonphysician suppliers—operating in part on the basis of erroneous guidance from a Medicare contractor—have been submitting claims for drugs that they have shipped to physicians' offices for use in refilling implanted intrathecal pumps. In light of concern over its potential effect on suppliers, we delayed implementation of the most recently updated CR (CR 7397 Transmittal 2437, April 4, 2012) until January 1, 2013 so that we could undertake rulemaking, evaluate public comments on this issue, and determine whether CR 7397 should be implemented as planned, revised, or rescinded.
Implanted pumps may qualify as Durable Medical Equipment (DME); however, unlike external pumps used to administer drugs, implanted pumps are typically refilled in a physician's office. The implanted intrathecal pump is refilled by injecting the drug into a pump's reservoir, which lies below the patient's skin. The reservoir is connected to the pump, which delivers the drug to the intrathecal space through a tunneled catheter. The procedure of refilling an intrathecal pain pump is a service that is typically performed by the physician because of risk and complexity.
To be covered by Medicare Part A or Part B, an item or service must fall within one or more benefit categories within such Parts, and must not be otherwise excluded from coverage. Drugs and biologicals paid under Medicare Part B drugs fall into three basic categories as follows:
•
•
•
Depending on the circumstances, drugs used to refill an implanted intrathecal pump can be paid under either the “incident to” or the DME benefit category or Medicare Part D. The CMS Benefit Policy Manual (100-02 Chapter 15 Section 50.3) states that drugs paid under the “incident to” provision are of a form that is not usually self-administered; are furnished by a physician; and are administered by the physician, or by auxiliary personnel employed by the physician and under the physician's personal supervision. Section 60.1 A requires that “to be covered, supplies, including drugs and biologicals, must represent an expense to the physician or legal entity billing.” In what we believe is a typical situation, when physicians' services are used to refill an intrathecal pump, the “incident to” requirements can be met because, consistent with our guidance and longstanding policy, the physician or other professional employed by his or her office performs a procedure to inject the drug into the implanted pump's reservoir (that is, the drug is not self-administered), and the drug represents a cost to the physician because he or she has purchased it.
Conversely, we believe that in the typical situation, payment to a pharmacy or other nonphysician supplier under the DME benefit for a drug dispensed for use in the physician's office is both inappropriate and inconsistent with existing guidance. For example, DME prosthetics, orthotics, and supplies (POS) policy does not permit payment for prosthetics dispensed prior to the procedure that makes necessary the use of the device. Moreover, in the case of prescription drugs used in conjunction with DME, our guidance is clear that the entity that dispenses the drug needs to furnish it directly to the patient for whom a prescription is written. An arrangement whereby a pharmacy (or supplier) ships
We note that payment to pharmacies (or suppliers) for drugs used to refill an implanted pump can be made under the DME benefit category where the drug is directly dispensed to a patient and the implanted pump is refilled without a physician's service. However, it is our understanding that implanted pumps are rarely refilled without utilizing the service of a physician.
In the proposed rule, we stated our concern about stakeholders' reports that, due to incorrect guidance from a contractor, Medicare payment policy on this issue has been applied in an inconsistent manner. We stated that we consider the contractor's guidance to be erroneous. This inconsistency has permitted supplier claims for drugs dispensed by pharmacies to physicians' offices to be paid in some jurisdictions and denied in others. We understand that the inconsistent application of our payment policy has influenced the business and professional practices of pharmacies/DME suppliers that prepare drugs for implanted pumps. We stated that we do not believe that payment for drugs used to refill implanted DME should continue to be made because such action is not supported under long standing policy and, as discussed above, is not appropriate.
We proposed to clarify that we consider drugs used by a physician to refill an implanted item of DME to be within the “incident to” benefit category and not the DME benefit category. Therefore, for the drug to be paid under Part B, the physician must buy and bill for the drug, and a non-physician supplier that has shipped the drug to the physician's office may not do so. We asked for comments on this proposal and its potential impact on beneficiaries and providers.
Under the incident to provision, we associate payment for the drug with the physician's professional service, and the drug is a key component of the billable procedure that is paid incident to a physician's professional service. As we have described earlier, when an implanted article of DME is refilled in the physician's office, the drug required for the service must meet the three conditions of the incident to benefit described in the Claims Processing manual, Chapter 15, Section 50.1, where the drug or biological must be of a form that is not usually self-administered; must be furnished by the physician; and must be administered by the physician, or by auxiliary personnel employed by the physician and under the physician's personal supervision. Based on discussion with stakeholders, it is our understanding that most refills of implanted DME that are done in the physician's office meet these conditions. In contrast, under the DME benefit category, a pharmacist dispenses the drug as a supply necessary for the effective use an item of DME (including, an implanted pump) and a physician's service is not utilized for the drug administration process.
In addition, we disagree with the commenter's assertion that by sending a drug to the physician's office for a specific patient, it is furnishing the drug directly to the patient, because such delivery would not be made without the physician's being at the delivery location to administer the drug in his or her office. It is notable that the commenter neglected to describe what happens to the drug that it asserts is delivered “directly” to the patient at the physician's office if the patient cannot receive a pump refill at the time of such delivery. Presumably the physician's office or the pharmacy, rather than the patient, would be responsible for the storage of the drug until it could be safely used or for disposal or return of an unused and unopened dose, which would indicate that at no time did the patient take “delivery” of the drug. In any event, in light of the physician's integral role in receipt and administration of the drug, the DME benefit category does not appropriately apply to this situation. Moreover, the incident to benefit category does not permit pharmacy billing for the incident to drug. Pharmacy/DME supplier dispensed drugs that are to be used incident to a physician's service do not meet the “incident to” conditions because the pharmacist does not refill the implanted pump.
However, we believe that it is important to preserve the potential for paying a pharmacy for a drug that is used to refill implanted pumps in certain limited instances where a physician's service is not used. Although patients and caregivers do not typically refill implanted pumps, it is our understanding that in rare situations persons other than a physician (as defined by section 1861(r) of the Act) could refill the pump, for example, when a patient cannot be transported to a physician's office, but a suitably trained individual is available at the home. We believe that this situation is very uncommon, but we also believe that in certain situations, for example in remote locations, it may facilitate the administration of refills of implanted durable medical equipment in situations where a beneficiary cannot be transported to the office, but a qualified individual is available to fill the pump and the drug is dispensed directly to the patient at home. In these situations, the drug is not being administered by the physician, and therefore the drug cannot be billed incident to a physician's service. As there is no service incident to a physician's service and the drug is being dispensed directly to the beneficiary in the home for use in an implanted item of DME, the pharmacy may bill and be paid for the drug.
With respect to the assertion about ALJ decisions, we are persuaded only that they are evidence that our payment policy has been applied inconsistently, and do not consider them to be indicators of what the correct payment policy is or should be.
That being said, we wish to respond to these comments as fully as we can, in the interest of transparency. We do not agree with the suggestions that the buy and bill approach for obtaining drugs used by physician for refilling implanted pumps in the office is strictly prohibited, because if it were, our payment policy for drugs used to refill implanted DME, with which the majority of physician offices and pharmacies already comply, would have raised concerns from stakeholders across the country long before we issued the two CRs last year.
Further, we disagree that our policy is in conflict with laws pertaining to controlled substances. First, we note that our policy is not specific to controlled substances, and the comments do not persuade us to adopt a different policy for controlled substances used by a physician to refill an implanted item of DME from the Part B payment policy for all other controlled substances administered incident to a physician's professional service. It has long been our policy that drugs furnished incident to a physician's professional service must be purchased and billed by the physician, and in general physicians buy and bill for controlled substances furnished under the incident to benefit without being in violation of DEA requirements. We have consulted with DEA about the issue of controlled substances used in implanted DME, and they have confirmed our understanding of DEA rules as discussed below.
It is our understanding from discussions with the DEA that it is a criminal violation of the law when a DEA-registered pharmacy dispenses a controlled substance and knowingly or intentionally delivers that substance to any person other than the patient or a member of the patient's household. We understand that the DEA provides for registration of entities, including pharmacies, as DEA registered manufacturer/distributors that may distribute controlled substances to providers under conditions outlined by the DEA. We understand that the DEA's “5 percent rule” may apply to pharmacies that are not manufacturers and that wish to provide these drugs to the office; however, we also understand that the 5 percent rule may not apply to situations where a drug must be compounded from bulk chemicals. In
Thus, we believe pharmacies can be in compliance with the DEA regulations in providing controlled substances to physicians who can then bill Medicare under the “incident to” benefit category. Indeed, we are concerned that current practices described by some commenters are inconsistent with DEA regulations. Some commenters described dispensing activities that appear to deliver the drugs to the office on behalf of the patient (that is, “dispensing for a patient”) in a manner that may not be consistent with DEA regulations, which require that controlled substances be dispensed directly to the patient, and not to an agent, person, or other entity that is acting on the patient's behalf. We also have concerns about the ad hoc record keeping methods (like delivery logs) for controlled substance prescription delivery that were described in some comments. Such an approach does not appear to comply with practices that are required by the DEA for transfers or sales of drug between registrants. This process involves the use of DEA Form 222 and related record keeping that is described in DEA regulation.
We also note that not all of the drugs used in implanted pumps are drugs are controlled substances. Some of the analgesics (for example, ziconitide and clonidine) often used in implanted pumps are not opiates, and are not always used in conjunction with opiates. Agents used to treat spasiticy (baclofen) are also not opiates. These medications are not controlled substances, and the DEA provisions discussed above do not apply.
With respect to comments about conflicts with FDA guidance, we cannot make statements about when the FDA may require that compounding pharmacies be considered manufacturers; as noted above, this is outside of CMS's scope of authority and expertise. Nevertheless, we disagree that our proposed clarification would, in itself, require that compounding pharmacies be considered manufacturers. The FDA Compliance Policy Guidance on pharmacy compounding (
Finally, many of the comments pertaining to State law involved dispensing activities. However, our proposal did not address, and we do not take a position now, with respect to whether a pharmacy should dispense or distribute a drug used by a physician to refill an implanted item of DME in the physician office. We understand that State laws pertaining to dispensing of prescriptions may be problematic because they are not uniform across States and the interpretation of all requirements may vary. However, the comments did not foreclose the possibility that an appropriately registered and licensed pharmacy could sell the drug to the physician's office, for example when the pharmacy does not act as a dispenser of a prescription, but acts as a distributor of a drug. In response to the state board of pharmacy's comment, we note that the comment appears to indicate that prescriptions in the state must be dispensed in accordance with DEA requirements. As stated above, we believe it is possible to comply with DEA requirements under the buy-and-bill method.
Our approach also minimizes program integrity concerns and avoids a situation where billing for a procedure and an item necessary for the procedure is done by two different entities that may submit claims with two dates of service. Such corresponding services are difficult to match during claims processing and the presumption that a drug that has been dispensed in advance of the pump refill will always be administered to the beneficiary may not always be correct. In other words, our approach minimizes the opportunity for fraud and abuse caused by splitting up payment for related components of a service between providers that bill separately.
Further, as noted above and as borne out by our experience administering and overseeing the Medicare program, the buy and bill approach does not appear to be problematic in a majority of the country. Therefore, in considering these comments, we continue to believe that it is appropriate for Medicare payment policy to be uniform, in spite of the fact that suppliers in certain states may need to adjust their regulatory standing with the state in order to comply with our payment rules. As stated above, inconsistent application of the policy has influenced the business and professional practices of pharmacies/DME suppliers that prepare drugs for implanted pumps. Specifically, pharmacies that have been allowed to bill directly to Medicare have marketed this approach to physicians at the expense of pharmacies that have not been allowed to direct bill. Inconsistent application of the policy has given a distinct economic advantage to some pharmacies relative to others that we do not believe is equitable. A uniform policy is more fair and predictable for beneficiaries and health care providers, and is easier to administer and oversee and, as stated above, is consistent with longstanding Medicare law and regulations and minimizes the potential for fraud and abuse.
Nevertheless, if a physician does not have a cost for these drugs, the physician does not meet the requirements to bill for these drugs under Medicare Part B as an “incident to” drug. As explained above, these drugs are also not billable under Part B as DME supplies because the drugs are not being furnished directly to the beneficiary. However, these drugs may be payable to the pharmacy under Part D if the ingredients that are being compounded independently meet the definition of a Part D drugs—generally a commercial FDA approved drug product.
We have considered the implications of the proposed clarification on patient care and Medicare providers (including physicians and pharmacies). Review of the comments also indicated that the issue is not national, but does affect the south central region of the contiguous United States more than other regions and therefore we believe that providers in most states follow the proposed approach and most states' laws do not create insurmountable barriers for physician offices that administer refills of implanted DME equipment to obtain drugs. We do not believe that major revisions to policy should be based on
Comments about the potential impact to beneficiaries included suggestions that some practices would charge beneficiaries up front, that some physicians might convert medication regimens to the oral route—which may not be as well tolerated or as efficacious, or that access could be impaired.
We do not believe we should incorporate a change or permit continued inconsistent application of our policies based on erroneous guidance. As we have stated above and in the proposed rule, the erroneous guidance significantly conflicts with longstanding national policies for drugs provided incident to physicians' services and items furnished under the DME benefit.
Based on the comments, we understand that many pharmacies that prepare drugs used to refill implanted pumps and the providers with whom they have a relationship are unaffected by the policy clarification in the CRs and this rule. Based on publicly available information, we understand that some pharmacies that prepare doses of intrathecally administered medications for Medicare beneficiaries (including some of the commenters who opposed our clarification) are already registered with the DEA as drug distributors. We understand that these entities can receive orders for controlled substances via the DEA 222 form and can sell (that is, distribute) the individually prepared doses to the physician provider, who in turn administers the drug and bills Medicare Part B.
As discussed above, our approach also minimizes program risk that arises from billing for a procedure and an item necessary for the procedure by two different entities that may submit claims with two dates of service. We believe fraud and abuse risk is minimized by requiring the same entity to bill for the drug and its administration.
We are concerned by comments that suggested that some practices may charge Medicare patients up front. We would like to remind physicians that Medicare providers who accept assignment may not charge up front, and note that section 1842(o)(3)(A) of the Act requires these drugs to be paid on an assignment-related basis. Also, the routine use of advance beneficiary notices (ABNs) is not allowed (See the Medicare Claims Processing Manual, chapter 30, Section 40.3.6 at
Moreover, in addition to the other indications discussed elsewhere, our claims processing structure indicates that these drugs generally are billed by physicians incident to their professional service. CMS Change Request 2227 dated July 22, 2002 required that “bills for implanted DME * * * accessories and supplies for the implanted DME must be billed to local carriers.” This instruction removed claims processing for drugs used to refill implanted DME from the DME MAC environment (where pharmacy-based Part B claims are typically submitted) and assigned the responsibility to the local carrier, now referred to as a Medicare Administrative Contractor (MAC) (where physicians' claims are typically submitted). This instruction, now 10 years old, indicates that we have long intended that payment for drugs used to refill implanted pumps in the physician's office be received primarily by the physician's office rather than non-physician providers/DME suppliers.
Finally, we wish to clarify one other point. In the proposed rule, we stated that in the case of drugs used to refill an implantable item of DME, “the physician must buy and bill for the drug, and a nonphysician supplier that has shipped the drug to the physician's office may not do so (except as may be permitted pursuant to a valid reassignment).” Our reference to a “valid reassignment” was intended to refer only to the fact that in certain limited cases, as specified in section 1842(b)(6) of the Act and its implementing regulations, a physician may reassign a claim for Medicare payment. To the extent that our reference to a “valid reassignment” in the proposed rule implied that a physician could permissibly reassign a claim for a drug used to refill an implanted item of DME to a pharmacy supplier, it was in error.
We maintain that CR 7397 (and its predecessor CR 7109) does not change longstanding Part B drug payment policy for drugs paid under section 1847A of the Act, in particular, that a drug provided incident to a physician's service must represent an expense to the physician. Neither laws nor regulations that authorize such payment have been changed since the erroneous guidance was brought to CMS' attention. Corresponding instructions in the Benefit Policy Manual (Publication 100-02, Chapter 15, sections 50.3 and 60.1) also have not changed. The instructions in the CRs that clarified that payment for drugs furnished incident to the filling or refilling of an implanted pump or reservoir are determined under section 1847A of the Act and pharmacies (including DME suppliers that utilize pharmacists to dispense medications) may not bill Medicare Part B for drugs provided to a physician for administration to a Medicare beneficiary also have not changed. We believe that these facts confirm that our policy clarification is consistent with longstanding statute, regulation, and manual instructions that pertain to Medicare national policy and that our policy remains the appropriate one.
In addition to comments requesting us to delay AMP-based price substitution that were discussed at the end of Section 1.c., we received comments pertaining to the creation of unique HCPCS codes for new branded drugs and biologicals, the payment amount for part B drugs, supply and dispensing fees, concerns about the timeliness of claims processing and claims denials, payment incentives that would decrease the impact of drug shortages, the duration of the quarterly AMP-based price substitution, notice of price substitution for manufacturers, and safeguards for WAMP-based price substitution.
In the proposed rule, we stated that we are not proposing any other changes to the safeguards, timing or notification procedures for the AMP-based price substitution. Comments on these and other issues listed in the paragraph above are outside the scope of this rule, and therefore, are not addressed in this final rule with comment period.
Sections 1832, 1834, and 1861 of the Act establish that the provision of durable medical equipment, prosthetic, orthotics, and supplies (DMEPOS) is a covered benefit under Part B of the Medicare program.
Section 1834(a)(11)(B)(i) of the Act, as redesignated by the Affordable Care Act, authorizes us to require, for Specified Covered Items, that payment may only be made under section 1834(a) of the Act if a physician has communicated to the supplier a written order for the item, before delivery of the item. Section 1834(h)(3) of the Act states that section 1834(a)(11) applies to prosthetic devices, orthotics, and prosthetics in the same manner as it applies to items of durable medical equipment (DME). In a December 7, 1992 final rule (57 FR 57675), we implemented this provision in § 410.38(g), for DME items and § 410.36(b) for prosthetic devices, orthotics, and prosthetics. Together these sections state that as a requirement for payment, CMS, a
Section 6407(b) of the Affordable Care Act amended section 1834(a)(11)(B) of the Act. The Affordable Care Act added language to the Act that requires for certain items of DME, a physician documenting that a physician, a physician assistant (PA), a nurse practitioner (NP), or a clinical nurse specialist (CNS) has had a face-to-face encounter with the beneficiary pursuant to the written order. Under section 1834(h)(3) of the Act, the items that require a written order verifying a face to face encounter may also include prosthetic devices, orthotics, and prosthetics. The encounter must occur during the 6 months prior to the written order for each item or during such other reasonable timeframe as specified by the Secretary.
We have made a series of modifications to the rule based on response to comments. As a result of comments, we are implementing several changes and clarifications to limit burden and still protect the Medicare Trust Funds. We have clarified that this requirement will begin only for new orders written after the effective date. We believe it is important to apply this requirement prospectively and not retroactively. To allow sufficient time for implementation, the effective date of this provision is July 1, 2013. Therefore, covered items ordered on or after July 1, 2013 will require a face-to-face encounter. Additionally, we have modified the timeline to require that a face-to-face encounter occur within 6 months before the written order. We have also added an additional criterion to remove items from the list of covered items. This is discussed in further detail below.
We had proposed to revise § 410.38(g) to require, as a condition of payment for certain covered items of DME, that a physician must have documented and communicated to the DME supplier that the physician or a PA, an NP, or a CNS has had a face-to-face encounter with the beneficiary no more than 90 days before the order is written or within 30 days after the order is written. As described in the CY 2013 PFS proposed rule (77 FR 44794), we outlined the rationale for the 90 days before or 30 days after the order was written.
During the face-to-face encounter, the physician, a PA, NP, or CNS must have evaluated the beneficiary, conducted a needs assessment for the beneficiary or treated the beneficiary for the medical condition that supports the need for each covered item of DME. As a matter of practice, this information would be part of the beneficiary's medical record and include the identity of the practitioner who provided the face-to-face assessment. We believe that requiring a face-to-face encounter to document the medical condition that supports the need for the covered item of DME reduces the risk of fraud, waste, and abuse since these visits help ensure that a beneficiary's condition warrants the covered item of DME.
Section 1834(a)(11)(B)(ii) of the Act, as amended by section 6407(b) of the Affordable Care Act, states that a physician must document that the physician, a PA, NP, or CNS has had a face-to-face encounter (other than with respect to encounters in which “incident to” services are involved) with the beneficiary. “Incident to” services are defined in section
The following is a summary of the comments we received regarding the documentation of a face-to-face encounter and the timeframe in which it must occur.
We will monitor the implementation of this rule to ensure there are no unintended consequences that negatively impact the practitioner, supplier, and beneficiary communities. In addition, we do not believe the new timeframe will have a significant impact
In response to comments, we removed language that allowed the face-to-face encounter to occur 30 days after the written order and modified the timeframe to now be within the 6 months preceding the written order. We believe that this will allow suppliers to deliver medically necessary DME while trying to eliminate the possibility that the face-to-face encounter will never be conducted.
In the proposed rule, we noted that a face-to-face encounter may be accomplished via a telehealth encounter if all Medicare telehealth requirements as defined under section 1834(m) of the Act and the implementing regulations in § 410.78 and § 414.65 are met as described in more detail in the CY 2013 PFS proposed rule (77 FR 44794). Further, a single face-to-face encounter, including those facilitated through the appropriate use of telehealth, can support the need for multiple covered items of DME as long as it is clearly documented in the pertinent medical record that the beneficiary was evaluated or treated for a condition that supports the need for each covered item, during the specified timeframe.
As described in more detail in the CY 2013 PFS proposed rule (77 FR 44795), we proposed requirements for a written order as a condition of payment. For purposes of this final rule with comment period, which is focused on implementing section 1834(a)(11)(B) of the Act and reducing fraud, waste, and abuse, an order without minimum elements would be considered incomplete and would not support a claim for payment.
The following is a summary of the comments we received regarding the written order proposal.
As a result of the comments, we are requiring at a minimum, the written order contains: (1) The beneficiary name; (2) the item of DME ordered; (3) the signature of the prescribing practitioner; (4) prescribing practitioner NPI; (5) the date of the order. Orders should still comply with standards of practice and therefore may be more detailed.
As noted previously, section 1834(h)(3) of the Act incorporates by cross reference prosthetic devices, orthotics, and prosthetics to the items encompassed by section 1834(a)(11)(B) of the Act. At this time, we are not implementing the proposed changes to § 410.36(b) to require documentation of a face-to-face encounter for prosthetic devices, orthotics, and prosthetics that, according to § 410.36(b), require a written order before delivery in this final rule. We intend to use future rulemaking to determine which prosthetic devices, orthotics, and prosthetics, require, as a condition of payment, a written order before delivery supported by documentation of a face-to-face encounter with the beneficiary consistent with section 1834(a)(11)(B)(ii) of the Act.
The following is a summary of comments we received regarding prosthetic devices, orthotics, and prosthetics.
Several commenters noted that when CMS considers whether to apply the new face-to-face encounter requirements to enteral nutrition, CMS should be mindful of the existing requirements and not impose redundant requirements or request duplicative information.
We also stated in the proposed rule that none of our proposals superseded any regulatory requirements that more specifically address a face-to-face encounter requirement for a particular item of DME.
The statute requires that a physician document that the physician or a PA, NP or CNS has had a face-to-face encounter with the beneficiary. As described in the CY 2013 PFS proposed rule (77 FR 44795), we proposed two options for how this could be done.
The following is a summary of the comments we received regarding the physician documentation proposal.
We do caution, however, that some templates provide limited options and/or space for the collection of information such as by using “check boxes,” predefined answers, and limited space to enter information. We discourage the use of such templates. Our experience with claim review shows that `limited space' templates often fail to capture sufficient detailed clinical information to demonstrate that all coverage and coding requirements are met. Furthermore, physicians or practitioners should be aware that templates designed to gather selected information primarily for reimbursement purposes are often insufficient to demonstrate that all coverage and coding requirements are met. These `limited space' documents often do not provide sufficient comprehensive information to adequately show that the medical necessity criteria for the item/service have been met.
As a result of the comments, the submission of the pertinent portion of the medical record documented by the physician is sufficient to document that the face-to-face encounter has occurred, when the physician conducts the face-to-face encounter. Documentation of the face-to-face encounter must include an evaluation of the beneficiary, needs assessment for the beneficiary, or treatment of the beneficiary for the medical condition that supports the need for each covered item of DME. A written order is still required for these covered items of DME.
As described in the CY 2013 PFS proposed rule (77 FR 44795), we had considered four options for the physician documentation of a face-to-
The following is a summary of the comments we received regarding how physician documentation requirements should be handled when the face-to-face encounter with the beneficiary is conducted by a PA, NP, or CNS.
As a result of the comments, we are requiring the physician documenting the face-to-face encounter performed by a NP, PA or CNS, must sign or cosign the pertinent portion of the medical record indicating the occurrence of a face-to-face encounter for the beneficiary for the date of the face-to-face encounter, thereby documenting that the beneficiary was evaluated or treated for a condition relevant to an item of DME on that date of service. Other signature requirements described in the manual, such as those for determining a legible signature remain in force. This option provides evidence that the physician reviewed the relevant documentation to support that a face-to-face encounter occurred for that date of service. A signed order (in contrast to a signed medical record) would not satisfy the requirement described in this option that the physician “sign/cosign the pertinent portion of the medical record.”
Since the supplier submits the claims for the covered items of DME, the supplier must have access to the documentation of the face-to-face encounter. All documentation to support the appropriateness of the item of DME ordered, including documentation of the face-to-face encounter, must be available to the supplier. As with certain other items and services submitted for Medicare payment, we require the entity submitting the claim to maintain access to the written order and supporting documentation relating to written orders for covered items of DME and provide them to us upon our request or at the request of our contractors.
As described in CY 2013 PFS proposed rule (77 FR 44795), we had considered four options for the supplier notification of the face-to-face encounter.
The following is a summary of the comments we received regarding the supplier notification proposal.
As a result of the comments received, we are not requiring a particular method of supplier notification. Instead, since this is a condition of payment, we only require that the supplier must have all documentation to support the claim upon request. We believe this will limit the burden on practitioners and suppliers while helping to ensure beneficiary access to DME.
Section 1834(a)(11)(B)(i) of the Act (as redesignated by the Affordable Care Act authorizes us to specify covered items that require a written order prior to delivery of the item. Under section 1834(a)(11)(B)(ii) of the Act, these orders must be written pursuant to a physician documenting that a face-to-face encounter has occurred. Accordingly, to reduce the risk of fraud, waste, and abuse, we proposed a list of Specified Covered Items that would require a written order prior to delivery. Our final list of Specified Covered Items is in Table 89. In future years, updates to this list will appear annually in the
As highlighted in the January 2007 Government Accountability Office (GAO) report entitled, “Improvements Needed to Address Improper Payments for Medical Equipment and Supplies,” it is estimated that there were $700 million in improper payments across the spectrum of DMEPOS from April 1, 2005, through March 31, 2006. GAO did not specifically recommend the use of DME face-to-face encounters as a remedial action in its report. However, the GAO did recommend making improvements to address improper payments in the DMEPOS arena. This final rule with comment period is one way in which we are working to prevent DME improper payments.
Though we initially considered making all items encompassed by section 1834(a)(11)(B) of the Act (including prosthetic and orthotic items described in section 1834(h)(3) of the Act) subject to a face-to-face encounter requirement, we have first proposed a more limited criteria- driven list to balance a comprehensive face-to-face requirement to prevent fraud, waste, and abuse while mitigating any undue negative effect on practitioners and suppliers by including all items. We welcomed comments on limiting the associated burden of this proposed rule by refining the number of items subject to a face-to-face encounter, while still protecting the Medicare Trust Funds.
The following is a summary of the comments we received regarding the covered items proposal.
We use a criterion driven approach to select these items and are implementing this provision in accordance with the statute. We do not believe that this requirement will delay a beneficiary from getting necessary care particularly with the longer timeframe. In addition, we will monitor the implementation of this rule to ensure there are no unintended consequences that negatively impact the practitioner, supplier, and beneficiary communities.
Additionally, commenters recommended any items necessary to ensure a safe discharge from an inpatient stay and preserve continuity of care, including wheelchairs, infusion pumps, hospital beds and accessories, negative pressure wound therapy (NPWT), and ambulatory items, be excluded from the list of Specified Covered Items.
Commenters stated that the need for glucometers and nebulizers (E0570, E0575, E0580) for this population is obvious; if translated to office or clinic visits needed to monitor then in the absence of the availability of this equipment, or even the extra time it will take physicians and nurse practitioners to obtain the extra documentation to order these items. This represents a significant amount of unnecessary time and cost with poorer patient outcomes.
Many commenters expressed the view that a face-to-face encounter for speech generating device (SGD) should be excluded since it will adversely affect an aphasia patient's ability to obtain the equipment required for function communication. They believe the face-to-face encounter requirement is an undue hardship for people needing a speech generating device. A SGD already requires a Certificate of Medical Necessity before ordering.
Commenters noted the current proposed list of Specified Covered Items includes equipment that have a fee schedule amount well below $1000, including accessories to the primary equipment. To require a separate face-to-face encounter to document need for an accessory for primary equipment already vetted in a previous face-to-face encounter and currently in the possession of the beneficiary seems unduly burdensome. To that point, commenters stated, that wheelchair accessories should not be included on the Specified Covered Item list. Section 410.38(c)(3)(ii) states that accessories for PMDs may be ordered by the physician/treating practitioner without conducting a face-to-face encounter with the beneficiary.
For a beneficiary who is discharged from the hospital, the face-to-face encounter may occur in that setting. This mitigates the concern of items needed to safely discharge the beneficiary.
We are removing items from the covered list of items where regulations explicitly state that a face-to-face encounter is not necessary such as power wheelchair accessories. We used a criteria-driven approach in order to create this list, and speech generating devices specifically are items meet one of our criteria. There are items below $1,000 on the list because these items still have an aggregate effect on the Medicare Trust Funds. While commenters recommended we remove individual items, we are not convinced that any of our criteria are inappropriate.
As a result of the comments, we are maintaining our criteria-driven list, however, we are removing items from the covered list of items where regulations explicitly state that a face-to-face encounter is not necessary.
As described in the CY 2013 PFS proposed rule (77 FR 44796), we described our proposed criteria, as well as the reasons we selected these criteria. We first noted that our proposed list of Specified Covered Items contains DME items only. We intended to use future rulemaking to apply section 1834(a)(11)(B)(ii) of the Act to add prosthetics and orthotics. We believe that our proposed current focus on DME items is an appropriate way of balancing our goals of reducing fraud, waste, and abuse and limiting burden on beneficiaries and the supplier community. We also proposed to focus initially on DME items for several reasons.
We welcomed comments on limiting the associated burden of this proposed regulation by refining the number of items subject to a face-to-face encounter, while still meeting the requirements of the statute.
The proposed list of Specified Covered Items contains items that meet at least one of the following four criteria: (1) Items that currently require a written order prior to delivery per instructions in our Program Integrity Manual; (2) items that cost more than $1,000; (3) items that we, based on our experience and recommendations from the Durable Medical Equipment Medicare Administrative Contractors, believe are particularly susceptible to fraud, waste, and abuse; (4) items determined by CMS as vulnerable to fraud, waste and abuse based on reports of the HHS Office of Inspector General, Government Accountability Office or other oversight entities. We are adding a criterion to remove any items where regulations explicitly state that a face-to-face encounter is not necessary. As described in the CY 2013 PFS proposed rule (77 FR 44796), we outlined each of these criteria.
Our final list of Specified Covered Items is in Table 89 of this final rule with comment period. We further proposed to update this list of Specified Covered Items annually to add any new items that are described by a HCPCS code for the following types of DME:
Note that the list does not include power mobility devices (PMDs), which are subject to already existing face-to-face requirements, as previously discussed. In addition, we proposed to add to the list any item of DME that in the future appears on the DMEPOS Fee Schedule with a price ceiling at or greater than $1,000. Items not included in one of the proposed automatic pathways would be added to the list of Specified Covered Items through notice and comment rulemaking.
Through updates in the
The DME list of Specified Covered Items are as follows, the original list was at 77 FR 44798:
We understand that there is a burden associated with the requirement placed on the physician to document that a face-to-face encounter has occurred between a PA, a NP or a CNS, and the beneficiary. As discussed in section III.M.3 of this final rule with comment period, we are establishing work and malpractice RVUs for HCPCS codes for G0454 by crosswalking to the work and malpractice RVUs for CPT code 99211 ((Level 1 office or other outpatient visit, established patient). With regard to practice expense RVUs, we are not including any direct practice expense inputs for clinical labor, disposable medical supplies, or equipment in the direct PE input database for this code; practice expense RVUs will reflect resources for overhead costs only. The work, malpractice, and practice expense RVUs for HCPCS code G0454 are reflected in Addendum B of this CY 2013 PFS final rule with comment period
This code is to compensate a physician who documented that a PA, a NP, or a CNS practitioner has performed a face-to-face encounter for the list of Specified Covered Items. This G-code becomes effective when this provision of the regulation becomes effective. We believe that the existing Evaluation and Management (E&M) codes are sufficient for practitioners furnishing face-to-face encounters. This new G-code will be specifically designed and mapped only for a physician who completes the documentation of the face-to-face encounter furnished by a PA, NP, or CNS. Only a physician who does not bill an associated E&M code for the beneficiary in question would be eligible for this G-code. If multiple written orders for covered items of DME originate from one visit, the physician can receive the G-code payment only once for documenting that the face-to-face encounter has occurred. The G-code would be mapped so that only eligible DME items would be covered. Upon request, we will need to see documentation of the face-to-face encounter in order to verify the appropriateness of the G-code payment.
The following is a summary of the comments we received regarding the physician payment proposal.
Medical review is the process performed by Medicare contractors to ensure that billed items or services are covered and are reasonable and necessary as specified under section 1862(a)(1)(A) of the Act. We enter into contractual agreements with contractors to perform medical review functions. On December 8, 2003, the Congress enacted the MMA. Section 934 of the MMA amended section 1874A of the Act by adding a new subsection (h)—regarding random prepayment reviews and non-random prepayment complex medical reviews and requiring us to establish termination dates for non-random prepayment complex medical reviews. Although section 934 of the MMA set forth requirements for random prepayment review, our contractors do not perform random prepayment review. However, our contractors do perform non-random prepayment complex medical review.
On September 26, 2008, we published a final rule in the
On March 23, 2010, the Congress enacted the Patient Protection and Affordable Care Act (Pub. L. 111-148) and the Health Care and Education Reconciliation Act of 2010 (HCERA) (Pub. L. 111-152) (together known as the Affordable Care Act). Section 1302 of the HCERA, repealed section 1874A(h) of the Act.
Section 1302 of the HCERA repealed section 1874A(h) of the Act, and therefore, removed the statutory basis for our regulation. Thus, we proposed to remove the regulatory provisions in 42 CFR part 421, subpart F, that require contractors to terminate a provider or supplier from non-random prepayment complex medical review no later than 1 year following the initiation of the medical review or when the provider or supplier has reduced its initial error rate by 70 percent or more. As a result of this proposal, contractors would not be required to terminate non-random prepayment medical review by a prescribed time but would instead terminate each medical review when the provider or supplier has met all Medicare billing requirements as evidenced by an acceptable error rate as determined by the contractor.
The following is a summary of the public comments received and our responses:
After reviewing the public comments, we are finalizing these provisions as proposed. We believe we need to do so in order to balance protection of the integrity of the Medicare Trust Fund and reduction of improper payments against limiting provider burden.
We proposed to revise § 410.40(d)(2) by incorporating nearly the same provision found at § 410.40(d)(3)(v) to clarify that a physician certification statement (PCS) does not, in and of itself, demonstrate that a non-emergency, scheduled, repetitive ambulance service is medically necessary for Medicare coverage. The Medicare ambulance benefit at section 1861(s)(7) of the Act allows for coverage of an “ambulance service where the use of other methods of transportation is contraindicated by the individual's condition, but * * * only to the extent provided in regulations.” In other words, the definition of the benefit itself embodies the clinical medical necessity requirement that other forms of transportation must be contraindicated by a beneficiary's condition. Section 410.40(d) interprets the medical necessity requirement. Notably, even aside from the requirements of section 1861(s)(7), section 1862(a)(1)(A) of the Act dictates that any service that is not medically necessary under the Act and regulations is not a covered benefit.
Despite these statutory provisions and the language of the present regulation at § 410.40(d)(2) that we believe already requires both medical necessity and a PCS, some courts have recently concluded that § 410.40(d)(2) establishes that a sufficiently detailed and timely order from a beneficiary's physician, to the exclusion of any other medical necessity requirements, conclusively demonstrates medical necessity with respect to nonemergency, scheduled, repetitive ambulance services.
Absent explicit statutorily-based exceptions, we have consistently maintained that the Secretary is the final arbiter of whether a service is reasonable and necessary and qualifies for Medicare coverage. For example, in HCFA Ruling 93-1, we said “[i]t is HCFA's ruling that no presumptive weight should be assigned to the treating physician's medical opinion in determining the medical necessity of inpatient hospital or SNF services under section 1862(a)(1) of the Act. A physician's opinion will be evaluated in the context of the evidence in the complete administrative record. Even though a physician's certification is required for payment, coverage decisions are not made based solely on this certification; they are made based on objective medical information about the patient's condition and the services received. This information is available from the claims form and, when necessary, the medical record which includes the physician's certification.”
Medical necessity is not just an integral requirement of Medicare's ambulance benefit in particular, but, as noted above, section 1862(a)(1)(A) of the Act dictates that services must be reasonable and necessary to qualify for any Medicare coverage. Numerous U.S. Circuit Courts of Appeal have held that PCSs or certificates of medical necessity do not, in and of themselves, conclusively demonstrate medical necessity. The same applies in the context of non-emergency, scheduled, repetitive ambulance services—the PCS is not, in and of itself, the sole determinant of medical necessity, and, as we discuss below, we believe the existing regulation at § 410.40(d)(2) already demonstrates that. To erase any doubt, however, we proposed a revision to § 410.40(d)(2) to explicitly clarify this principle.
Since being finalized in the February 27, 2002
The preamble to the February 27, 2002 final rule (Medicare Program; Fee Schedule for Payment of Ambulance Services and Revisions to the Physician Certification Requirements for Coverage of Nonemergency Ambulance Services (67 FR 9100)) and the 1999 final rule with comment (FRC) (Medicare Program; Coverage of Ambulance Services and Vehicle and Staff Requirements (64 FR 3637)) support this interpretation.
For example, in describing comments regarding medical necessity and physician certification in the 1999 FRC, we said: “[t]wo ambulance suppliers commented that physicians are unaware of the coverage requirements for
In the section of the February 27, 2002 final rule preamble describing the PCS requirements, we said: “[i]n all cases, the appropriate documentation must be kept on file and, upon request, presented to the carrier or intermediary. It is important to note that the presence of the signed physician certification statement does not necessarily demonstrate that the transport was medically necessary. The ambulance supplier must meet all coverage criteria for payment to be made.” (67 FR 9100, 9111) Although we incorporated that passage into the final rule only at § 410.40(d)(3)(v), we intended, and we believe our intent was clear from the preamble narrative, that the principle apply equally to all nonemergency ambulance transports.
The OIG report entitled “Medicare Payments for Ambulance Transports” (OEI-05-02-00590) (January 2006) also supports our position. Based on its analysis of a sample of calendar year 2002 claims, the OIG reported that “27 percent of ambulance transports to or from dialysis facilities did not meet Medicare's coverage criteria.” The OIG added “the ongoing and repetitive nature of dialysis treatment makes transports to and from such treatment vulnerable to abuse. Although the condition of some patients warrants repetitive, scheduled ambulance transports for dialysis treatment, many dialysis transports do not meet coverage criteria.” The OIG recommended that we instruct our contractors to implement prepayment edits with respect to dialysis transports and have them request wide-ranging documents when conducting postpayment medical review. The fact that we agreed with the OIG's recommendations demonstrated our belief that the PCS was not the sole determinant of medical necessity. Likewise, the fact that the OIG mentioned our ambulance coverage regulations, including the PCS requirement, but did not recommend altering or clarifying the regulations with respect to medical necessity demonstrated that we were of like mind; that, while a physician certifies with respect to medical necessity, the Secretary is the final arbiter of whether a service is medically necessary.
Accordingly, we proposed to revise § 410.40(d)(2) to add nearly the same provision presently found at § 410.40(d)(3)(v), except for the reference to a “signed return receipt” that does not pertain to non-emergency, scheduled, repetitive ambulance services. We proposed to accomplish this by redesignating the current language as § 410.40(d)(2)(i), and adding the clarifying language to a new § 410.40(d)(2)(ii). The proposed § 410.40(d)(2)(ii) clarifies that a signed physician certification statement does not, in and of itself, demonstrate that an ambulance transport was reasonable and necessary. Rather, for all ambulance services, providers, and suppliers must retain on file all appropriate documentation and present such documentation upon request to a Medicare contractor. A CMS contractor may use such documentation to assess, among other things, whether the service satisfied Medicare's medical necessity, eligibility, coverage, benefit category, or any other criteria necessary for Medicare payment to be made. For example, the patient's condition must be such that other means of transportation would be contraindicated, and the services provided must be reasonable and necessary for the diagnosis or treatment of illness or injury.
We also proposed to fix the typographical error “fro,” which should be “from”, in the existing § 410.40(c)(3)(ii).
The following is a summary of the comments received on the physician certification statement proposal and our responses:
After reviewing the public comments, we are finalizing the revisions to § 410.40(c)(3)(ii) and § 410.40(d)(2) as proposed.
Section 10331(a)(1) of the Affordable Care Act requires that, by no later than January 1, 2011, we develop a Physician Compare Internet Web site with information on physicians enrolled in the Medicare program under section 1866(j) of the Act, as well as information on other eligible professionals who participate in the Physician Quality Reporting System (PQRS) under section 1848 of the Act.
CMS launched the first phase of Physician Compare (
Section 10331(a)(2) of the Affordable Care Act also requires that, no later than January 1, 2013, and for reporting periods that begin no earlier than January 1, 2012, we implement a plan for making publicly available through Physician Compare, information on physician performance that provides comparable quality and patient experience measures. This plan is outlined below.
To the extent that scientifically sound measures are developed and are available, we are required to include, to the extent practicable, the following types of measures for public reporting:
• Measures collected under the PQRS.
• An assessment of patient health outcomes and functional status of patients.
• An assessment of the continuity and coordination of care and care transitions, including episodes of care and risk-adjusted resource use.
• An assessment of efficiency.
• An assessment of patient experience and patient, caregiver, and family engagement.
• An assessment of the safety, effectiveness, and timeliness of care.
• Other information as determined appropriate by the Secretary.
As required under section 10331(b) of the Affordable Care Act, in developing and implementing the plan, we must include, to the extent practicable, the following:
• Processes to ensure that data made public are statistically valid, reliable, and accurate, including risk adjustment mechanisms used by the Secretary.
• Processes for physicians and eligible professionals whose information is being publicly reported to have a reasonable opportunity, as determined by the Secretary, to review their results before posting to Physician Compare.
• Processes to ensure the data published on Physician Compare provides a robust and accurate portrayal of a physician's performance.
• Data that reflects the care provided to all patients seen by physicians, under both the Medicare program and, to the extent applicable, other payers, to the extent such information would provide a more accurate portrayal of physician performance.
• Processes to ensure appropriate attribution of care when multiple physicians and other providers are involved in the care of the patient.
• Processes to ensure timely statistical performance feedback is provided to physicians concerning the data published on Physician Compare.
• Implementation of computer and data infrastructure and systems used to support valid, reliable, and accurate reporting activities.
Section 10331(d) of the Affordable Care Act requires us to consider input from multi-stakeholder groups in selecting quality measures for Physician Compare, which we seek to accomplish through rulemaking and focus groups. In developing the plan for making information on physician performance publicly available through Physician Compare, section 10331(e) of the Affordable Care Act requires the Secretary, as the Secretary deems appropriate, to consider the plan to transition to value-based purchasing for physicians and other practitioners that was developed under section 131(d) of the Medicare Improvements for Patients and Providers Act of 2008.
We are required, under section 10331(f) of the Affordable Care Act, to submit a report to the Congress by January 1, 2015, on Physician Compare development, and include information on the efforts and plans to collect and publish data on physician quality and efficiency and on patient experience of care in support of value-based purchasing and consumer choice. Section 10331(g) of the Affordable Care Act provides that any time before that date, we may continue to expand the information made available on Physician Compare.
We believe section 10331 of the Affordable Care Act supports our overarching goals of providing consumers with quality of care information to make informed decisions about their healthcare, while encouraging clinicians to improve on the quality of care they provide to their patients. In accordance with section 10331 of the Affordable Care Act, we intend to utilize Physician Compare to publicly report physician performance results.
In implementing our plan to publicly report physician performance, we will
We previously finalized a decision to make public on Physician Compare the performance rates on the quality measures that group practices submit under the 2012 PQRS group practice reporting option (GPRO) (76 FR 73417). Therefore, we are targeting to post performance information collected through the GPRO web interface for group practices participating in the 2012 PQRS GPRO on Physician Compare in 2013 or early 2014. Specifically, we will make public performance information for measures included in the 2012 PQRS GPRO that meet the minimum sample size, and that prove to be statistically valid and reliable. As we previously established, if the minimum threshold is not met for a particular measure, or the measure is otherwise deemed not to be suitable for public reporting, the group's performance rate for that measure will be suppressed and not publicly reported. We previously established a minimum threshold of 25 patients for reporting performance information on Physician Compare (76 FR 73418). Although we considered keeping the threshold for reporting performance data on Physician Compare at 25 patients, we proposed to change the minimum patient sample size, from 25 patients to 20 patients, beginning with data collected for services furnished in 2013 (77 FR 44803).
The following is summary of the comments we received regarding the new minimum patient sample size proposal:
We appreciate the comment that this reduction may increase participation; however we note that this proposal only relates to Physician Compare. While the decreased threshold may increase participation for other quality reporting programs, we do not believe it will have an impact on Physician Compare.
We believe this threshold of 20 patients to be sufficient to protect patient privacy for reporting on the site, and should thus be applied to every measure reported on Physician Compare. Currently, this is the reliability threshold being finalized for both the Value-Based Modifier (VBM) and the proposed PQRS criteria for reporting measure groups. As we work to align quality initiatives and minimize reporting burden on physicians and other healthcare professionals, we will finalize our proposal to reduce the reporting threshold from 25 to 20 patients.
In the Shared Savings Program final rule (76 FR 67948), we finalized Accountable Care Organization (ACO) public reporting provisions in the interest of promoting greater transparency regarding the ACOs participating in the program. We finalized requirements for ACOs to publicly report certain data, as well as data that we would publicly report. Because ACO providers/suppliers that are eligible professionals are considered to be group practices for purposes of qualifying for a PQRS incentive under the Shared Savings Program, we indicated that performance on quality measures reported by ACOs at the ACO TIN level, on behalf of their ACO providers/suppliers who are eligible professionals, using the GPRO web interface would be reported on Physician Compare in the same way as for the groups that report under the PQRS.
In April 2012, we added functionality to Physician Compare allowing users to search for group practices in preparation for the addition of 2012 PQRS GPRO data. A full Web site redesign is slated for early 2013 to further prepare the site for the introduction of quality data and ACO information. With each enhancement, we work to improve the usability and functionality of the site, providing consumers with more tools to help them make informed healthcare decisions.
In CY 2012, we intend to enhance the accuracy of “administrative” information displayed on the eligible professional's profile page, and to add additional data. By administrative data, we are referring to information about eligible professionals that is pulled from the Provider Enrollment, Chain, and Ownership System (PECOS) and other readily available external data sources. Specifically, we intend to add whether a physician or other health care professional is accepting new Medicare patients, board certification information, and to improve the foreign language and hospital affiliation data. We also intend to include the names of those eligible professionals who participated in the Medicare EHR Incentive Program, as authorized by section 1848(o)(3)(D) of the Act, and the names of those eligible professionals who satisfactorily participated under the PQRS GPRO for 2011. We will continue to update the names of those eligible professionals and group practices who satisfactorily participated under the PQRS, and those who are successful electronic prescribers under the eRx Incentive Program based on the most recent program year data available.
In support of the HHS-wide Million Hearts Initiative, we proposed to post the names of the eligible professionals who report the PQRS Cardiovascular Prevention measures group (77 FR 44803). This is consistent with the requirements under section 10331 of the Affordable Care Act to provide information about physicians and other eligible professionals who participate in the PQRS.
The following is a summary of the comments received regarding the proposal to post the names of eligible professionals who report the PQRS Cardiovascular Prevention measures group in support of the Million Hearts Initiative:
Consistent with Affordable Care Act requirements, it is our intent to phase in an expansion of Physician Compare over the next several years by incorporating quality measures from a variety of sources, as technically feasible. For our next phase, we proposed to make public on Physician Compare, performance rates on the quality measures that group practices submit through the GPRO web interface under the 2013 PQRS GPRO and the Medicare Shared Savings Program (77 FR 44803). We indicated that we anticipated the 2013 PQRS GPRO web interface measures data would be posted no sooner than 2014. These data would include measure performance rates for measures included in the 2013 PQRS GPRO web interface that met the proposed minimum sample size of 20 patients, and that proved to be statistically valid and reliable.
When technically feasible, and targeted for posting on the site in 2014, we proposed to publicly report composite measures that reflect group performance across several related measures (77 FR 44803). As an initial step we intend to develop disease module level composite scores for PQRS GPRO measures. Under the Medicare Shared Savings Program, ACOs are required to report on composite measures for Diabetes Mellitus (DM) and Coronary Artery Disease (CAD) (76 FR 67891). Accordingly, in an effort to align the PQRS GPRO measures with the GPRO measures under the Shared Savings Program, we proposed to add composite measures for DM and CAD into the PQRS starting in reporting year 2013. We also indicated we would consider future development of composites for the remaining disease level modules within the GPRO web interface. As more data are added to Physician Compare over time, we stated we would consider adding additional disease level composites across measure types as technically feasible and statistically valid.
The following is a summary of the comments received regarding our proposal to post performance rates on the quality measures that group practices submit through the GPRO web interface under the 2013 PQRS GPRO and the Medicare Shared Savings Program, and to report composite measures at the disease module level for 2013 GPRO data:
Consistent with the requirement under section 10331(a)(2) of the Affordable Care Act to implement a plan to make comparable information on patient experience of care measures publicly available, we proposed to post patient experience survey-based measures from the Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) (77 FR 44804). As discussed in section G.6.c. of this final rule with comment period, we proposed to collect the
These measures capture patients' experiences with clinicians and their staff, and patients' perception of care. We proposed, no earlier than 2014, to publicly report 2013 patient experience data for all group practices participating in the 2013 PQRS GPRO, not limited to those groups participating via the GPRO web interface, on Physician Compare. At least for 2013, we noted that we intended to administer and collect patient experience survey data on a sample of the group practices' beneficiaries. As we intend to administer and collect the data for these surveys, we indicated that we did not anticipate any notable burden on the groups.
For ACOs participating in the Shared Savings Program, consistent with the PQRS proposal to publicly report patient experience measures on Physician Compare starting in 2013, we proposed to publicly report patient experience data in addition to the measure data reported through the GPRO web interface (77 FR 44804). Specifically, the patient experience measures that would be reported for ACOs include the CAHPS measures in the Patient/Caregiver Experience domain finalized in the Shared Savings Program final rule (76 FR 67889):
For patient experience data reported under either the PQRS GPRO or the Medicare Shared Savings Program, we also considered an alternative option of providing confidential feedback to group practices and ACOs using 2013 patient experience data before publicly reporting patient experience data on Physician Compare (77 FR 44804). In lieu of publicly reporting the patient experience data relating to 2013 PQRS GPRO and ACOs participating in the Shared Savings Program, we considered using the 2013 results as a baseline to be shared confidentially with the group practices and ACOs, during which time the group practices and ACOs would have the opportunity to review their data, and implement changes to improve patient experience scores. Under this alternative option, program year 2014 patient experience data would be the first to be publicly reported on Physician Compare, and we would publicly report 2014 patient experience data for ACOs and group practices participating in the 2014 PQRS GPRO on Physician Compare no earlier than 2015. We invited public comment on our proposal to begin publicly reporting patient experience data for program year 2013, and also the alternative option of delaying public reporting of patient experience of care data on Physician Compare until program year 2014 in order to give group practices and ACOs the opportunity to make changes to the processes used in their practices based on the review of their data from program year 2013 (77 FR 44804).
The following is a summary of the comments we received regarding our proposal to publicly report patient experience data:
Understanding the strong desire from consumers for these data, and given our commitment to public reporting, we are finalizing our proposal to target the reporting of patient experience data, collected no earlier than 2013, on Physician Compare in 2014, if technically feasible, for groups of one hundred or more eligible professionals reporting via the GPRO web interface, including ACOs participating in the Shared Savings Program. The requirement regarding posting of ACO data is finalized at § 425.308. We believe that by limiting this posting requirement to group practices and ACOs participating via the GPRO web interface, and by allowing group practices and ACOs to preview their data during a 30-day preview period, we are able to address the concerns of the provider community while making this data available to healthcare consumers and meeting the mandates set forth by the Affordable Care Act. Due to patient privacy and confidentiality, we will not implement the suggestion that groups have the opportunity to resurvey patients prior to the posting of results.
We are dedicated to supporting group practices in the reporting of these important data. Thus, we are finalizing a policy under which CMS will
As we continue to improve administrative and provider level data, we proposed posting the names of those physicians who earned a PQRS Maintenance of Certification Program Incentive as data becomes available, and targeted for 2014 (77 FR 44804).
The following is a summary of the comments we received related to posting the names of physicians who earned a PQRS Maintenance of Certification Program Incentive:
We considered allowing measures that have been developed and collected by approved and vetted specialty societies to be reported on Physician Compare, as deemed appropriate, and as they are found to be scientifically sound and statistically valid (77 FR 44804). We proposed including additional claims-based process, outcome and resource use measures on Physician Compare, and noted that we intend to align measure selection for Physician Compare with measures selected for the Value Based Modifier (VBM) (section III.K).
We received several comments related to reporting measures developed and collected by specialty societies. The following is a summary of the comments we received:
We will work to ensure that any specialty society data included on Physician Compare is approved, vetted, scientifically sound, and statistically reliable. As with PQRS measures and other measures posted on Physician Compare, any measures under consideration will be subjected to the Measures Application Partnership (MAP) pre-rulemaking process prior to being considered for posting on the site. Please note that such measures will be addressed in future rulemaking.
We received comments related to our proposed alignment of Physician Compare with the VBM. The following is a summary of the comments we received:
We proposed to include group level ambulatory care sensitive condition admission measures of potentially preventable hospitalizations developed by the HHS Agency for Healthcare Research and Quality (AHRQ) that meet the proposed minimum sample size of 20 patients, and that prove to be statistically valid and reliable (measure details are available at
We received comments related to our proposal to post group level ambulatory care sensitive condition admission measures of potentially preventable hospitalizations developed by AHRQ. The following is a summary of the comments we received:
We also proposed to publicly report performance rates on quality measures included in the 2015 PQRS and VBM for individual eligible professionals (77 FR 44804). We indicated, however, that further details on what measures would be included in the 2015 reporting period will be addressed in future rulemaking. We also proposed that public reporting of 2015 PQRS and administrative claims-based quality measures for individuals would occur no earlier than 2016.
We received several comments related to the posting of individual-level measures on Physician Compare. The following is a summary of the comments we received:
For all measures publicly reported on Physician Compare, we proposed to post a standard of care, such as those endorsed by the National Quality Forum (77 FR 44804). Such information would serve as a standard for consumers to measure individual provider, and group level data.
We received comments related to our proposal to post a standard of care on Physician Compare. The following is a summary of the comments we received:
We received several comments not directly related to our proposals which are summarized below.
We are equally committed to including only the most accurate, statistically reliable and valid quality of care measure data on Physician Compare when those data are publicly reported. We are committed to ensuring that these data are comparable and presented appropriately regardless of the mechanism through which they are collected, and that they accurately reflect performance. We will ensure these data are updated in a timely fashion as technically feasible, and will provide a 30-day preview period for physicians and group practices to view their data prior to it being posted on the site.
We are committed to making Physician Compare a constructive tool for Medicare beneficiaries, successfully meeting the Affordable Care Act mandate, and in doing so, providing consumers with information needed to make informed healthcare decisions. We have developed a plan, and started to implement that plan with a phased approach to adding physician quality data to Physician Compare. We believe this staged approach to public reporting of physician quality information allows consumers access to information that is currently available while we continue to develop the infrastructure necessary to support additional types of data and information on physicians' quality measure performance. Implementation of subsequent phases of the plan will need to be developed and addressed in future notice and comment rulemaking, as needed.
There are several healthcare quality improvement programs that affect physician payments under the Medicare PFS. The National Quality Strategy establishes three aims for quality improvement across the nation: Better health, better healthcare, and lower costs. This strategy, the first of its kind, outlines a national vision for quality improvement and creates an opportunity for programs to align quality measurement and incentives
This section contains the requirements for the Physician Quality Reporting System (PQRS). The PQRS, as set forth in section 1848(a), (k), and (m) of the Act, is a quality reporting program that provides incentive payments and payment adjustments to eligible professionals based on whether or not they satisfactorily report data on quality measures for covered professional services furnished during a specified reporting period. We note that, in developing these requirements, it was our goal to align program requirements between these quality reporting programs, such as the eRx Incentive Program, EHR Incentive Program, Medicare Shared Savings Program, and value-based payment modifier, wherever possible. We believe that alignment of these quality reporting programs will lead to greater overall participation in these programs, as well as minimize the reporting burden on eligible professionals.
Please note that, during the comment period following the proposed rule, we received comments that were not related to our specific proposals for PQRS in the CY 2013 Medicare PFS proposed rule. While we appreciate the commenters' feedback and intend to use these comments to better develop PQRS, these comments will not be specifically addressed in this CY 2013 Medicare PFS final rule, as they are beyond the scope of this rule. However, we will take these comments into consideration when developing policies and program requirements for future years.
The regulation governing the PQRS is located at § 414.90. The program requirements for years 2007-2012 of the PQRS that were previously established, as well as information on the PQRS, including related laws and established requirements, are available at
There are two ways an eligible professional can participate in the PQRS: (1) As an individual or (2) as part of a group practice participating in the PQRS group practice reporting option (GPRO).
As defined at § 414.90(b), the term “eligible professional” means any of the following: (1) A physician; (2) a practitioner described in section 1842(b)(18)(C) of the Act; (3) a physical or occupational therapist or a qualified speech-language pathologist; or (4) a qualified audiologist. For more information on which professionals are eligible to participate in the PQRS, we refer readers to the “List of Eligible Professionals” download located in the “How to Get Started” section of the PQRS CMS Web site at
We proposed to modify § 414.90(b) to define group practice as “a single Tax Identification Number (TIN) with 2 or more eligible professionals, as identified by their individual National Provider (NPI), who have reassigned their Medicare billing rights to the TIN” (77 FR 44806). We proposed to change the number of eligible professionals comprising a PQRS group practice from 25 or more to 2 or more to allow all groups of smaller sizes to participate in the GPRO. We believe that expanding the scope of group practices eligible to participate under the program will lead to greater program participation. To participate in the GPRO, a group practice would be required to meet this proposed definition at all times during the reporting period for the program year in which the group practice is selected to participate in the GPRO.
We solicited public comments on the proposed definition of group practice. The following is a summary of the comments we received regarding this proposal.
When determining program requirements, we considered factors other than alignment with the Value-based Payment Modifier. For example, aside from alignment, we adopted policies that we believe will increase overall participation in PQRS, as well as increase the likelihood that eligible professionals will meet the criteria for satisfactory reporting for the 2013 and 2014 PQRS incentives and 2015 and 2016 PQRS payment adjustments. We believe that expanding the definition of group practices to groups of 2 or more eligible professionals will help to achieve these goals, because we are providing group practices with additional ways to participate in PQRS.
Please note that, for group practices participating in PQRS through other Medicare programs (such as but limited to those group practices participating as Accountable Care Organizations (ACOs) under the Medicare Shared Savings Program), certain provisions in this section may not apply. For information on how to participate in PQRS through other Medicare programs, please refer to the requirements for those respective programs.
We noted that this web-based functionality is still being developed by CMS. Therefore, in the event this web-based functionality would not be available in time to accept self-nomination statements for the 2013 PQRS, we proposed that, in lieu of submitting self-nomination statements via the web, a group practice would be required to submit its self-nomination statement via a letter accompanied by an electronic file submitted in a format specified by CMS (such as a Microsoft excel file) (77 FR 44807). We proposed that this self-nomination statement would be mailed to the following address: Centers for Medicare & Medicaid Services, Center of Clinical Standards and Quality, Quality Measurement and Health Assessment Group, 7500 Security Boulevard, Mail Stop S3-02-01, Baltimore, MD 21244-1850. If mailing the self-nomination statement, we would require that this self-nomination statement be received by no later than 5 p.m. Eastern Standard Time on January 31 of the year in which the group practice wishes to participate in the GPRO.
We invited public comment on the proposed method for submitting a GPRO self-nomination statement. The following is a summary of the comments we received on this proposal.
As for our proposed contingency plan for accepting self-nomination statements via mail in the event the web-based functionality was not be available in time to accept self-nomination statements for the 2013 PQRS, or in the event we experience issues with accepting self-nomination statements via the web, we are also finalizing that proposal. While we expect that we will have the web system operational, we believe it is appropriate to have an alternative submission process available as a back-up. Therefore, if the web-based functionality is unavailable in time to accept self-nomination statements for the 2013 PQRS, or in the event we experience issues with accepting self-nomination statements via the web, in lieu of submitting self-nomination statements via the web, a group practice is required to submit its self-nomination statement via a letter accompanied by an electronic file submitted in a format specified by CMS (such as a Microsoft excel file), and a mailed to the following address: Centers for Medicare & Medicaid Services, Center of Clinical Standards and Quality, Quality Measurement and Health Assessment Group, 7500 Security Boulevard, Mail Stop S3-02-01, Baltimore, MD 21244-1850.
Although we proposed to require that this self-nomination statement be received by no later than 5 p.m. Eastern Standard Time on January 31 of the year in which the group practice wishes to participate in the GPRO, we believe it is appropriate to provide group practices with additional time to submit this information and self-nominate under the PQRS. Additional time for submissions may also address concerns raised by commenters about the potential for increased number of self-nomination statements and efficiency of the web portal with regard to avoiding delays. As we discuss in greater detail below in response to comments we received, we also believe it would be helpful to afford group practices additional time with regard to selecting its reporting mechanism, which group practices must include in the self-nomination statement. Therefore, we are finalizing a deadline of October 15 of the year in which the group practice wishes to participate in the GPRO. We believe this is an appropriate amount of time for group practices under the PQRS. Moreover, we note that this deadline aligns with the final policies we are adopting for the value-based payment modifier. For those group practices for whom the value-based payment modifier will apply, this extended deadline will provide groups with additional time to make decisions with regard to participation under the PQRS.
We solicited public comment on our proposal to lock-in a group practice's reporting mechanism choice at the time of self-nomination. The following is summary of the comments we received regarding this proposal.
Please note that the ability to elect the administrative claims-based reporting mechanism will not be available until the summer of the applicable reporting period. Therefore, should a group practice self-nominate earlier, if the group practice elects to use the administrative claims-based reporting mechanism, the group practice would have to visit the Web page to elect the administrative claims-based reporting mechanism.
Please note that, for group practices participating in PQRS through other Medicare programs (such as but limited to those group practices participating as Accountable Care Organizations (ACOs) under the Medicare Shared Savings Program), certain provisions in this section may not apply. For information on how to participate in PQRS through other Medicare programs, please refer to
We invited public comment on this proposal. The following is summary of the comments we received regarding this proposal not to allow group practices who change their TINs to continue to participate in the GPRO for the applicable program year.
We invited public comment on the proposed selection process for group practices wishing to participate in the GPRO. The following is summary of the comments we received regarding this proposed opt-out period for group practices that have elected to participate in PQRS under the GPRO.
Unlike using the traditional PQRS reporting mechanisms (that is, claims, registry, EHRs, GPRO web interface) to satisfy the reporting requirements for the 2015 and 2016 payment adjustments, we proposed that eligible professionals and group practices wishing to use the proposed administrative claims reporting
• If technically feasible, submission of this statement via the web; and
• If technically feasible, submission of an eligible professional's or group practice's intent to register to use the administrative claims-based reporting mechanism by placing a G-code on at least 1 Medicare Part B claim.
In the event the two proposed options are not technically feasible, we also considered allowing for submission of the registration statement by submitting a mailed letter to CMS at Centers for Medicare & Medicaid Services, Center of Clinical Standards and Quality, Quality Measurement and Health Assessment Group, 7500 Security Boulevard, Mail Stop S3-02-01, Baltimore, MD 21244-1850. However, we noted that using this mailing option would be a more burdensome and time-intensive process for CMS.
The eligible professional would be required to complete this election process by January 31 of the applicable payment adjustment reporting period (for example, by January 31, 2013 for the 2015 payment adjustment). However, we noted that we proposed that we may extend this deadline based on the submission method that we finalized. For example, because processing mailed letters would take the longest to process (out of the 3 methods), we anticipated that if we were to include the option of mailed letters, the deadline for submitting a mailed registration letter would be January 31 of the applicable payment adjustment reporting period. Since it would be more efficient to process registration statements received via the web or via a G-code on a claim, we anticipated that we would be able to extend the registration deadline to as late as December 31 of the applicable payment adjustment reporting period. Once an eligible professional makes an election to participate in PQRS using the administrative claims-based reporting mechanism for the PQRS payment adjustments, the eligible professional would be assessed under the administrative claims-based reporting mechanism.
For group practices participating in the GPRO, we proposed that these group practices would use the 3 methods described above (mailed letter, web, or G-code submission) and have the same deadline as eligible professionals wishing to elect to use the administrative claims-based reporting mechanism for an applicable payment adjustment. In the alternative, we proposed that a group practice participating in the GPRO would be required to elect to use the administrative claims-based reporting mechanism in its self-nomination statement. We proposed to provide less time for group practices to elect to use the administrative claims-based reporting mechanism because it is necessary for CMS to receive this information in the beginning of the applicable reporting period to indicate to CMS how these group practices should be analyzed throughout the reporting period. This early notification is especially important for large group practices, which may have hundreds or thousands of eligible professionals to track as a group practice. Therefore, we felt it was appropriate to request that a group practice elect to use the administrative claims-based reporting mechanism when the group practice self-nominates.
We further proposed that an eligible professional or group practice would be required to make this election for each payment adjustment year the eligible professional or group practice seeks to be analyzed under this mechanism. For example, if the eligible professional seeks to report under the administrative claims mechanism for the 2015 and 2016 payment adjustments, the eligible professional would be required to make this election by the applicable deadline, for the 2015 payment adjustment and again by the applicable deadline, for the 2016 payment adjustment. We invited public comment on the proposed election requirement for eligible professionals and group practices electing to participate in the 2015 and 2016 payment adjustments using the administrative claims-based reporting mechanism.
We invited public comment on the process for electing the administrative claims-based reporting option for eligible professionals and group practices. The following is a summary of the comments received on this proposed process and on the proposed election requirement.
Therefore, based on the comments received, we are finalizing the following election process for eligible professionals and group practices wishing to use the administrative claims-based reporting option for the 2015 PQRS payment adjustment. We note that we are changing the name of this process from a registration to an election process. We believe using the term election process is more appropriate, as individuals and group practices would be electing to be analyzed under a reporting mechanism, not registering to participate in PQRS
• We proposed three methods of accepting this election: Via the web, a G-code on claims, or, if neither were technically feasible, via U.S. mail. We are finalizing submission of the administrative claims election statement via the web, because we believe that this is the most efficient method of accepting these elections. However, in the event that we experience issues with accepting election statements via the web, we are finalizing a back-up method of accepting elections via U.S. mail. In the event the we experience issues with accepting election statements via the web, eligible professionals and group practices may elect to be analyzed under the administrative claims-based reporting mechanism by submitting a mailed letter to CMS at Centers for Medicare & Medicaid Services, Center of Clinical Standards and Quality, Quality Measurement and Health Assessment Group, 7500 Security Boulevard, Mail Stop S3-02-01, Baltimore, MD 21244-1850.
• The final deadline for submitting the administrative claims election statement to participate using the administrative claims reporting mechanism for the 2015 PQRS payment adjustment for both individual eligible professionals, and group practices is October 15, 2013. Group practices will be able to make this election under its self-nomination statement. As we discussed above, we are finalizing a later deadline so that eligible professionals and group practices have more time to determine which reporting mechanism would be more advantageous for their respective practices. We note that, should we encounter issues with accepting election statements via the web, we may extend the deadline for submitting these administrative claims election statements to account for any time the web may not be properly functioning.
We are modifying newly created § 414.90(h) to indicate this election requirement for individual eligible professionals and group practices who wish to use the administrative claims-based reporting option for the 2015 PQRS payment adjustment.
Please note that, for group practices participating in PQRS through other Medicare programs, the administrative claims-based reporting mechanism may not be a reporting option for reporting PQRS measures. For example, under the Medicare Shared Savings Program, eligible professionals within Accountable Care Organizations (ACOs) must report for purposes of the PQRS using the GPRO web interface (77 FR 67870). Therefore, group practices participating within ACOs participating in the PQRS under the Medicare Shared Savings Program cannot participate in the traditional PQRS or report using the administrative claims-based reporting mechanism.
For the PQRS incentives, we previously established 12 and 6-month reporting periods for satisfactorily reporting PQRS quality measures at § 414.90(f)(1). Under section 1848(a)(8)(C)(iii) of the Act, we are authorized to specify the quality reporting period (reporting period) for a payment adjustment year. We proposed to modify the regulation to establish the reporting periods for the PQRS payment adjustments for 2015 and beyond (77 FR 44808). Please note that we are re-designating § 414.90(f) as § 414.90(g) and making technical changes to change the structure of the regulation and to improve the readability of the regulation. Newly designated § 414.90(g)(1) indicates the reporting periods available for the PQRS incentives.
For the 2016 payment adjustment, to coincide with the reporting periods for the 2014 incentive, we proposed to modify the regulation at newly designated § 414.90(h) to specify a 12-month (January 1, 2014-December 31, 2014) and, for individual eligible professionals reporting measures groups via registry only, a 6-month (July 1, 2014-December 31, 2014) reporting period for the 2016 payment adjustments.
We invited public comment on our proposed reporting periods for the 2015 and 2016 payment adjustments. The following is a summary of the comments we received on our proposals.
With respect to the commenter's concern that a 6-month reporting period may not provide as accurate of a picture of the quality of care provided than the 12-month period, we generally agree with the commenter. However, our desire to align the reporting periods of the 2013 and 2014 PQRS incentive and 2015 and 2016 PQRS payment adjustments, and afford additional reporting options, outweighs this interest. We also note that the 6-month reporting period will only be available for individual eligible professionals reporting measures groups via registry.
We invited public comment on our proposal to establish a 12-month reporting period for payment adjustments occurring in 2017 and beyond. The following is a summary of the comments we received on this proposal.
As a result, we need to determine whether eligible professionals have satisfactorily reported under the PQRS based on a reporting period that occurs prior to 2017. For the reasons stated above, for the PQRS payment adjustments occurring in 2017 and beyond, we are finalizing 12-month reporting periods that fall 2 years prior to the application of the respective payment adjustment year. For example, the reporting period for the 2017 PQRS payment adjustment will be CY 2015 (that is, January 1, 2015-December 31, 2015). We are finalizing newly created § 414.90(e) to specify a 12-month reporting period for the 2017 PQRS payment adjustments and beyond.
This section addresses the following reporting mechanisms: Claims, registry, EHR (including direct EHR products and EHR data submission vendor), GPRO web interface, and administrative claims. We previously established at § 414.90(f)(2) that eligible professionals reporting individually may use the claims, registry, and EHR-based reporting mechanisms. We proposed to modify § 414.90 to allow group practices comprised of 2-99 eligible professionals to use the claims, registry, and EHR-based reporting mechanisms as well, because we recognized the need to provide varied reporting criteria for smaller group practices, particularly since we proposed to expand the definition of group practice (77 FR 44808). For example, we noted that a smaller group practice may not have a sufficiently varied practice to be able to meet the proposed satisfactory reporting criteria for the GPRO web interface that would require a smaller group practice to report on all of the PQRS quality measures we proposed. We proposed changes to § 414.90, which we proposed to re-designate § 414.90(g) and § 414.90(h).
We invited public comment on this proposal to make the claims, registry, and EHR-based reporting options applicable to group practices of 2-99 eligible professionals. The following is summary of the comments we received regarding this proposal.
As for the registry-based reporting mechanism, we are finalizing our proposal to extend the registry-based reporting mechanism to groups practices comprised of 2-99 eligible professionals participating in PQRS via the GPRO for 2013 and beyond.
For group practices of 2-99 eligible professionals using direct EHR and EHR data submission vendor products, we are delaying availability of this option until 2014 to coincide with when the EHR Incentive Program introduces its group practice reporting option for meeting the clinical quality measures (CQM) objective for achieving meaningful use (77 FR 54076 through 54078). Therefore, in this final rule, we are adopting the EHR-based reporting options for groups of 2-99 eligible professionals participating in PQRS via the GPRO for 2014 and beyond.
As for extending use of the registry and EHR-based reporting mechanisms for GPRO group practices of 100 of more eligible professionals, we agree with the commenters that extending the registry and EHR-based reporting mechanisms would provide more opportunities for large specialty group practices to participate in PQRS. Therefore, based on the comments received, we are finalizing the registry-based reporting mechanism for 2013 and beyond and the EHR-based reporting mechanisms for 2014 and beyond for groups of 100 or more eligible professionals under the GPRO as well as those group practices with 2-99 eligible professionals under the GPRO.
Therefore, we are finalizing § 414.90(g) and § 414.90(h) to indicate that the registry-based reporting mechanism will be available for use by eligible professionals and group practices beginning in 2013 and the EHR-based reporting mechanisms (direct EHR product and EHR data submission vendor) will be available for use by eligible professional and group practices beginning in 2014 to report for the PQRS incentives and payment adjustments.
Eligible professionals that wish to report data on PQRS quality measures via claims for the incentives and for the payment adjustments must submit quality data codes (QDCs) on claims to CMS for analysis. QDCs for the eligible professional's selected PQRS (individual or measures groups) quality measures that are reported on claims may be submitted to CMS at any time during the reporting period for the respective program year. However, as required by section 1848(m)(1)(A) of the Act, all claims for services furnished during the reporting period, would need to be processed by no later than the last Friday occurring 2 months after the end of the reporting period, to be included in the program year's PQRS analysis. For example, all claims for services furnished during a reporting period that occur during calendar year 2013 would need to be processed by no later than the last Friday of the second month after the end of the reporting period, that is, processed by February 28, 2014 for the reporting periods that end December 31, 2013. In addition, after a claim has been submitted and processed, we proposed at re-designated § 414.90(g)(2)(i)(A) and newly added § 414.90(h)(2)(i)(A) to indicate that EPs cannot submit QDCs on claims that were previously submitted and processed (for example, for the sole purpose of adding a QDC for the PQRS).
We invited public comment on our proposed requirements for using the claims-based reporting mechanism for the incentives and for the payment adjustments for 2013 and beyond. The following is a summary of the comments we received regarding these proposals.
For 2013 and beyond, we proposed that registries wishing to submit data on PQRS quality measures for a particular reporting period would be required to be qualified for each reporting period the registries wish to submit quality measures data (77 FR 44808). This qualification process is necessary to verify that registries are able to submit data on PQRS quality measures on behalf of eligible professionals and group practices to CMS. Registries who wish to become qualified to report PQRS quality measures for a reporting period undergo (1) a self-nomination process and (2) a qualification process regardless of whether the registry was qualified the previous program year.
• The name of the registry.
• The reporting period start date the registry will cover.
• The measure numbers for the PQRS quality measures on which the registry is reporting.
We noted that CMS is currently developing the functionality to accept registry self-nomination statements via the web and anticipate development of this functionality to be complete for registries to submit their self-
We invited public comment on our proposals related to the registry self-nomination process. The following is a summary of these comments.
We are also finalizing the deadline of January 31. Although we agree that submitting a self-nomination statement via U.S. mail would require more time to complete than submitting the self-nomination statement via the web, we do not believe an extended submission deadline is warranted since registries (such as those participating in PQRS in 2012) are familiar with submitting self-nomination statements by January 31 via U.S. mail. Beginning 2013, registries wishing to indicate their intent to submit PQRS measure data on behalf of eligible professionals are required to submit a self-nomination statement for each year in which the registry seeks to participate in PQRS. Please note that when submitting self-nomination statements via the web, registries are required to meet CMS' security and system requirements. Should a registry wishing to self-nominate encounter issues using the web, the registry may contact the QualityNet Help Desk for assistance in submitting a self-nomination statement.
• Be in existence as of January 1 the year prior to the program year in which the registry seeks qualification (for example, January 1, 2012, to be qualified to submit data in 2013).
• Have at least 25 participants by January 1 the year prior to the program year in which the registry seeks qualification (for example, January 1, 2012, to be qualified for the reporting periods occurring in 2013).
• Provide at least 1 feedback report to participating eligible professionals and group practices for each program year in which the registry submits data on PQRS quality measures on behalf of eligible professionals and group practices. This feedback reporting would be based on the data submitted by the registry to CMS for the applicable reporting period or periods occurring during the program year. For example, if a registry was qualified for the reporting periods occurring in 2013, the registry would be required to provide a feedback report to all participating eligible professionals and group practices based on all 12 and 6-month reporting periods for the 2013 incentive and the 12-month reporting period for 2015 payment adjustment. Although we proposed to require that qualified registries provide at least 1 feedback report to all participating eligible professionals and group practices, we encouraged registries to provide an additional, interim feedback report, if feasible, so that an eligible professional may determine what steps, if any, are needed to meet the criteria for satisfactory reporting.
• For purposes of distributing feedback reports to its participating eligible professionals and group practices, the registry must collect each participating eligible professional's email address and have documentation from each participating eligible professional authorizing the release of his or her email address.
• Not be owned or managed by an individual, locally-owned, single-specialty group (for example, single-specialty practices with only 1 practice location or solo practitioner practices would be precluded from becoming a qualified PQRS registry).
• Participate in all ongoing PQRS mandatory support conference calls and meetings hosted by CMS for the
• Be able to collect all needed data elements and transmit to CMS the data at the TIN/NPI level for at least 3 measures.
• Be able to calculate and submit measure-level reporting rates and/or, upon request, the data elements needed to calculate the reporting rates by TIN/NPI.
• Be able to calculate and submit, by TIN/NPI, a performance rate (that is, the percentage of a defined population who receive a particular process of care or achieve a particular outcome based on a calculation of the measure's numerator and denominator specifications) for each measure on which the eligible professional (as identified by the TIN/NPI) or group practice reports and/or, upon request, the Medicare beneficiary data elements needed to calculate the reporting rates.
• Be able to separate out and report on Medicare Part B FFS patients.
• Report the number of eligible instances (reporting denominator).
• Report the number of instances a quality service is performed (reporting/performance numerator).
• Report the number of performance exclusions, meaning the quality action was not performed for a valid reason as defined by the measure specification.
• Report the number of reported instances, performance not met, meaning the quality action was not performed for any valid reason as defined by the measure specification. Please note that an eligible professional receives credit for reporting, not performance.
• Be able to transmit data on PQRS quality measures in a CMS-approved XML format.
• Comply with a CMS-specified secure method for data submission, such as submitting the registry's data in an XML file through an identity management system specified by CMS or another CMS-approved method, such as use of appropriate Nationwide Health Information Network specifications, if technically feasible.
• Submit an acceptable “validation strategy” to CMS by March 31 of the reporting year the registry seeks qualification (for example, if a registry wishes to become qualified for reporting in 2013, this validation strategy would be required to be submitted to CMS by March 31, 2013). A validation strategy details how the registry will determine whether eligible professionals and group practices have submitted accurately and on at least the minimum number (80 percent) of their eligible patients, visits, procedures, or episodes for a given measure. Acceptable validation strategies often include such provisions as the registry being able to conduct random sampling of their participant's data, but may also be based on other credible means of verifying the accuracy of data content and completeness of reporting or adherence to a required sampling method.
• Perform the validation outlined in the strategy and send the results to CMS by June 30 of the year following the reporting period (for example, June 30, 2014, for data collected in the reporting periods occurring in 2013).
• 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 and group practices, as well as the registry's disclosure of quality measure results and numerator and denominator data and/or patient-specific data on Medicare beneficiaries on behalf of eligible professionals and group practices who wish to participate in the PQRS.
• 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 measure results and numerator and denominator data and/or patient-specific data on Medicare beneficiaries to CMS for the purpose of PQRS participation. This documentation would be required to be obtained at the time the eligible professional signs up with the registry to submit PQRS quality measures data to the registry and would be required to meet any applicable laws, regulations, and contractual business associate agreements.
• Upon request and for oversight purposes, provide CMS access to review the Medicare beneficiary data on which PQRS registry-based submissions are founded or provide to CMS a copy of the actual data.
• Provide CMS a signed, written attestation statement via mail or email which states that the quality measure results and any and all data including numerator and denominator data provided to CMS are accurate and complete.
• Use PQRS measure specifications and the CMS provided measure calculation algorithm, or logic, to calculate reporting rates or performance rates unless otherwise stated. We will provide registries a standard set of logic to calculate each measure and/or measures group they intend to report for each reporting period.
• Provide a calculated result using the CMS-supplied measure calculation logic and XML file format for each measure that the registry intends to calculate. The registries may be required to show that they can calculate the proper measure results (that is, reporting and performance rates) using the CMS-supplied logic and send the calculated data back to CMS in the specified format. The registries will be required to send in test files with fictitious data in the designated file format.
• Describe to CMS the cost for eligible professionals and group practices that the registry charges to submit PQRS and/or eRx Incentive Program data to CMS.
• Agree to verify the information and qualifications for the registry prior to posting (includes names, contact, measures, cost, etc.) and furnish/support all of the services listed for the registry on the CMS Web site.
• Agree that the registry's data for Medicare beneficiaries may be inspected or a copy requested by CMS and provided to CMS under our oversight authority.
• Be able to report consistent with the satisfactory reporting criteria requirements for the PQRS incentives and payment adjustments.
In addition to meeting all the requirements specified previously for the reporting of individual quality measures via registry, for registries that intend to report on PQRS measures groups, we proposed that these registries, regardless of whether or not registries were qualified in previous years, would be required to:
• 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 relevant reporting period.
• If the registry is reporting using the measures group option for 20 patients, the registry on behalf of the eligible professional may include non-identifiable data for non-Medicare beneficiaries as long as these patients meet the denominator of the measure and the eligible professional includes a majority of Medicare Part B patients in their cohort of 20 patients for the measures group.
We intend to post the final list of registries qualified for each reporting period by the summer of each year in which the reporting periods occur on
The registry qualification process we proposed was largely the same process we established to qualify registries for the reporting periods occurring in 2012. We proposed a similar process to the 2012 qualification process because, registries are already familiar with this qualification process, so we felt there would be a greater likelihood that registries wishing to be qualified to report quality measures data for a particular reporting period would be able to pass the qualification process. We felt this would provide eligible professionals with more qualified registry products from which to choose.
We invited public comment on our proposals related to the qualification process for registries. The following is a summary of the comments we received regarding these proposals.
We note that, although we are not requiring that a registry's validation strategy be tested to become qualified to submit PQRS quality measures data on behalf of its eligible professionals, this testing process will still be available for registries to test their respective validation strategies. It is important for registries to undergo this testing process to check whether they will be able to submit quality measures data accurately to CMS after the applicable reporting period.
Based on the comments received and for the reasons stated previously, we are finalizing the registry qualification process for 2014 and beyond, as proposed, with the exception that we are not finalizing the requirement that a registry perform the validation outlined in its strategy and send the results to CMS by June 30 of the year following the reporting period.
In proposing registry disqualification, we considered other alternatives, such as placing registries in a probationary
We invited public comment as to the threshold of grossly inaccurate data for the purpose of disqualifying a registry. The following is a summary of the comments we received regarding this proposal.
We note that, although no longer required, registries have an opportunity during the year to test its validation and submission strategy with CMS prior to submitting the data that CMS will use to determine whether its eligible professionals or group practices have met the criteria for satisfactory reporting for the PQRS incentives and/or payment adjustments. We strongly encourage registries to undergo this testing process, as it will help to alleviate issues that may occur when submitting PQRS quality measures data to CMS.
Based on the comments received and for the reasons stated, we are modifying § 414.90(b) to indicate that we are finalizing the proposed disqualification process for registries. Should CMS decide to disqualify a registry, please note that our decision to disqualify a registry is final.
We did not receive public comment on our proposal to modify the definition of a direct electronic health record (EHR) product (77 FR 44811). Therefore, we are modifying § 414.90(b) to define a direct electronic health record (EHR) product as “an electronic health record vendor's product and version that submits data on Physician Quality Reporting System measures directly to CMS,” as proposed.
• Transmitted in a CMS-approved XML format utilizing a Clinical Document Architecture (CDA) standard such as Quality Reporting Data Architecture (QRDA) level 1 and
• In compliance with a CMS-specified secure method for data submission, such as submitting the direct EHR vendor's data (for testing) through an identity management system specified by CMS or another approved method.
CMS would therefore no longer post a list of qualified EHR vendors and their products on the CMS Web site. Therefore, eligible professionals would need to work with their respective EHR vendor to determine whether their specific EHR product has undergone any testing with the PQRS and/or whether their EHR product can produce and transmit the data in the CMS-specified form and manner. While we no longer believe that this process is necessary, we invited public comment as to whether CMS should continue to require that direct EHR products undergo self-nomination and qualification processes prior to being authorized to submit quality measures data to CMS for PQRS reporting purposes.
We proposed to not continue the qualification requirement (that is, no longer propose this process for future years of the program) because we believe adequate checks are in place to ensure that a direct EHR product is able to submit quality measures data for the PQRS. For example, to the extent possible, we intend to align with the Medicare EHR Incentive Program for our criteria for satisfactory reporting and measures available for reporting under the EHR-based reporting mechanism. The Medicare EHR Incentive Program requires that an eligible professional submit clinical quality measures using EHR technology certified under the program established by the Office of the National Coordinator for Health Information Technology (ONC). We anticipated that ONC's certification process could include testing related to the reporting of the proposed PQRS EHR measures indicated in Tables 32 and 33, since we proposed to align the PQRS EHR-based measures with the measures available for reporting under the EHR Incentive Program. We invited public comment as to whether, in lieu of qualification, CMS should require that direct EHR products that would be used to submit data on PQRS quality measures for a respective reporting period be classified as certified under the program established by ONC.
The following is summary of the comments we received regarding our proposal to discontinue the qualification process for direct EHR products as well as our proposal to require CEHRT in lieu of PQRS qualification.
Nonetheless, we share the commenter's concern to provide guidance to eligible professionals on choosing EHR products. Therefore, based on the comments received, we are also finalizing to the requirement that a direct EHR product be certified by ONC as Certified EHR Technology (CEHRT), and therefore meet the definition of CEHRT in ONC's regulations (see 45 CFR 170.102), to submit PQRS measures. (For the 2014 Edition EHR certification criteria, please refer to 77 FR 54163). While the process for certifying EHR technology may not be distinctly tailored for reporting PQRS quality measures, we note that we are making efforts to align, to the maximum extent possible, the measures and reporting criteria with the EHR Incentive Program, which requires eligible professionals to use CEHRT. For example, it is our intention to further align the EHR measures available for reporting by eligible professionals and group practices under PQRS and the EHR Incentive Program, so that the specifications of these measures will be the same. Therefore, beginning in 2014, ONC's certification process would test the submission of data on CQMs available for reporting under the EHR Incentive Program and, consequently, since the measures would be the same, data on PQRS quality measures that are reportable via an EHR.
We understand that CEHRT may provide more capabilities than needed to report PQRS quality measures. However, we note that most of these capabilities are intertwined with the direct EHR product's ability to capture data on quality measures and therefore necessary. The certified health information technology product list (CHPL) includes all EHR technology that has been certified, and it can be found at
• Transmitted in a CMS-approved XML format utilizing a Clinical Document Architecture (CDA) standard such as Quality Reporting Data Architecture (QRDA) level 1 and
• In compliance with a CMS-specified secure method for data submission, such as submitting the direct EHR vendor's data (for testing) utilizing an identity management system specified by CMS or another approved method (77 FR 44811).
In addition, upon request and for oversight purposes, we proposed that the vendor would still be expected to provide CMS access to review the Medicare beneficiary data on which PQRS direct EHR-based submissions are founded or provide to CMS a copy of the actual data.
We invited public comment on these additional proposed requirements for direct EHR products. The following is a summary of comments we received on this proposal.
In summary, we are finalizing the requirements for submitting quality measures data via a direct EHR product, as proposed, with the following exception: We are not finalizing our proposal to allow CMS access to review the Medicare beneficiary data on which PQRS direct EHR-based submissions are founded or provide to CMS a copy of the actual data. In addition, we note that the EHR Incentive Program has provided an additional format for transmitting quality measures data to CMS from CEHRT. In addition to finalizing the submission of quality measures data using the QRDA Category I format, the EHR Incentive Program also finalized the QRDA Category III transmission format (77 FR 54075). In our proposal, we proposed to require that eligible professionals and group practices using CEHRT transmit quality measures data in a CMS-approved XML format utilizing a Clinical Document Architecture (CDA) standard, and used QRDA Category I as an example. Since
We invited public comment but received no comments on this proposed definition of EHR data submission vendor product. However, we are modifying this definition to indicate that a data submission vendor is not necessarily an EHR product. Rather, according to stakeholder feedback, an EHR data submission vendor is any entity that is able to receive and transmit to CMS quality measures data extracted from an EHR product on behalf of the eligible professional. Therefore, we are modifying § 414.90(b) to define an “electronic health record (EHR) data submission vendor” as “an entity that receives and transmits data on Physician Quality Reporting System measures from an EHR product to CMS.”
We invited public comment on our proposal to, beginning 2014, not require qualification of EHR data submission vendor products. We also invited public comment as to whether CMS should continue to require that EHR data submission vendors undergo these self-nomination and qualification processes prior to being authorized to submit quality measure data to CMS on an eligible professional's behalf for PQRS reporting purposes.
We proposed to not continue the qualification requirement (that is, no longer propose this process for 2014 and future years of the program) because we felt adequate checks were in place to ensure that an EHR data submission vendor is able to submit quality measures data for the PQRS. For example, to the extent possible, we intend to align with the Medicare EHR Incentive Program for our criteria for satisfactory reporting and measures available for reporting under the EHR-based reporting mechanism. The Medicare EHR Incentive Program requires that an eligible professional submit clinical quality measures using EHR technology certified under the program established by the Office of the National Coordinator for Health Information Technology (ONC). We anticipated that the ONC's certification process could include testing related to the reporting of the proposed PQRS EHR measures indicated in Table 95, since we proposed to align the PQRS EHR-based measures with the measures available for reporting under the EHR Incentive Program. We invited public comment as to whether, in lieu of qualification, CMS should require that direct EHR products that would be used to submit data on PQRS quality measures for a respective reporting period be classified as CEHRT under the program established by the ONC.
The following is a summary of comments we received regarding our
Nonetheless, we share the commenter's concern that discontinuing the qualification process would place additional burden on providers when trying to determine which EHR data submission vendor to enter into an agreement with. Therefore, based on the comments received and for the reasons we are requiring that direct EHR products be CEHRT beginning in 2014, we are also finalizing a requirement that a vendors EHR product be certified under the program established by ONC as Certified EHR Technology (CEHRT), and therefore meet the definition of CEHRT in ONC's regulations (see 45 CFR 170.102), to submit PQRS measures. We understand that CEHRT may provide more capabilities than needed to report PQRS quality measures. However, we note that most of these capabilities are intertwined with the EHR product's ability to capture data on quality measures and therefore necessary.
• Transmitted in a CMS-approved XML format utilizing a Clinical Document Architecture (CDA) standard such as Quality Reporting Data Architecture (QRDA) level 1 and for EHR data submission vendor products that intend to report for purposes of the proposed PQRS-Medicare EHR Incentive Program Pilot, if the aggregate data are transmitted in a CMS-approved XML format.
• In compliance with a CMS-specified secure method for data submission (77 FR 44812).
In addition, upon request and for oversight purposes, we proposed that the vendor would still be expected to provide CMS access to review the Medicare beneficiary data on which PQRS direct EHR-based submissions are founded or provide to CMS a copy of the actual data.
We invited public comment on these proposed requirements for EHR data submission vendors. The following is a summary of the comments we received on this proposal.
In addition, we note that in addition to finalizing the submission of quality measures data using the QRDA Category I format, the EHR Incentive Program also finalized the QRDA Category III transmission format (77 FR 54075). In our proposal, we proposed to require that eligible professionals and group practices using CEHRT transmit quality measures data in a CMS-approved XML format utilizing a Clinical Document Architecture (CDA) standard, and used QRDA Category I as an example. Since it was our intent to align with the EHR Incentive Program, who finalized transmission of quality measures data using the QRDA Category I and QRDA Category III formats, we are also requiring that quality measures data submitted via CEHRT for purposes of reporting for PQRS beginning in 2014 be transmitted using the QRDA Category I and QRDA Category III formats. We note that, although we are requiring that products be able to transmit data using the QRDA Category I and III formats, for purposes of reporting PQRS quality measures data to CMS, eligible
The GPRO web interface is a reporting mechanism established by CMS that is used by group practices that are selected to participate in the GPRO. For 2013 and beyond, we proposed to modify newly designated § 414.90(g) and § 414.90(h) to identify the GPRO web interface as a reporting mechanism available for reporting under the PQRS by group practices comprised of 25 or more eligible professionals (77 FR 45055). Consistent with the GPRO satisfactory reporting criteria we established for the 2012 PQRS (76 FR 73338), as well as the GPRO satisfactory reporting criteria we proposed for 2013 and beyond, we proposed to limit reporting via the GPRO web interface during a respective reporting period to group practices composed of at least 25 eligible professionals (that is, this reporting option would not be available to group practices that contain 2-24 eligible professionals) and selected to participate in the GPRO for the year under which the reporting period occurs (77 FR 44812). For example, a group practice wishing to submit quality measure data via the GPRO web interface for 2013 must be a group practice selected to participate in the GPRO for the 2013 program year. We believe it is necessary to limit use of the GPRO web interface to group practices comprised of at least 25 eligible professionals selected to participate in the GPRO because the 18 measures (including 2 composite measures, for a total of 22 measures) that are proposed to be reportable via the GPRO web interface (as specified in Table 33 of the proposed rule) reflect a variety of disease modules: Patient/caregiver experience, care coordination/patient safety, preventive health, diabetes, hypertension, ischemic vascular disease, heart failure, and coronary artery disease.
We believe that the reporting of the 18 proposed measures spanning across various settings would lend this reporting mechanism to larger group practices that are more likely to be multi-specialty practices (which are typically group practices consisting of more than 24 eligible professionals). The GPRO web interface was modeled after the CMS Physician Group Practice (PGP) demonstration, and this demonstration was originally intended for large group practices. From our experience with the PGP demonstration, we believe a group practice comprised of 25 eligible professionals is the smallest group practice that could benefit from use of the GPRO web interface as a reporting mechanism. We also do not believe that excluding group practices comprised of 2-24 eligible professionals from using the GPRO web interface as a reporting mechanism would harm these smaller group practices because we proposed to expand the reporting options for small group practices by proposing to allow groups composed of 2-99 eligible professionals to report using the claims, qualified registry, EHR, and administrative claims-based reporting mechanisms.
We proposed to provide group practices that are selected to participate in the GPRO using GPRO web interface reporting option with access to the GPRO web interface by no later than the first quarter of the year following the end of the reporting period under which the group practice intends to report (77 FR 44813). For example, for group practices selected for the GPRO for the 2013 incentive using the GPRO web interface tool, we proposed to provide group practices selected to participate in the GPRO with access to the GPRO web interface by no later than the first quarter of 2014 for purposes of reporting for the applicable 2013 reporting period for the incentive. In addition, we noted that if CMS encountered operational issues with the use of the GPRO web interface, we reserved the right to use a similar tool for group practices to use in lieu of reporting via the GPRO web interface.
We invited public comment on our proposed requirements for group practices using the GPRO web interface for 2013 and beyond. We received the following comment on these proposals:
Based on the comments received, we are finalizing, as proposed, requirements for group practices using the GPRO web interface for 2013 and beyond. We are also modifying § 414.90(g)(3) and § 414.90(h)(3) to indicate that the GPRO web interface will be a reporting mechanism available for use by group practices for the PQRS incentives and payment adjustments.
For purposes of reporting for the 2015 and 2016 PQRS payment adjustments only, we proposed to modify § 414.90(h) to allow eligible professionals and group practices to use an administrative claims reporting mechanism (77 FR 45056). The administrative claims reporting mechanism builds off of the traditional PQRS claims-based reporting mechanism. Under the traditional PQRS claims-based reporting mechanism, eligible professionals and group practices wishing to report data on PQRS quality measures via claims for the incentives and for the payment adjustments must submit quality data codes (QDCs) on claims to CMS for analysis. Under the proposed administrative claims reporting mechanism, unlike the traditional claims-based reporting option, an eligible professional or group practice would not be required to submit QDCs on claims to CMS for analysis (77 FR 44813). Rather, CMS would analyze every eligible professional's or group practice's patient's Medicare claims to determine whether the eligible professional or group practice has performed any of the clinical quality actions indicated in the proposed PQRS quality measures in Table 63 of the CY 2013 PFS proposed rule. We proposed that, for purposes of assessing claims for quality measures under this option, all claims for services furnished that occur during the 2015 and/or 2016 PQRS payment adjustment reporting period would need to be processed by no later than 60 days after the end of the respective 2015 and 2016 payment adjustment reporting periods (that is, December 31, 2013 and December 31, 2014).
We invited public comment on our proposed requirements for using the administrative claims-based reporting mechanism for the 2015 and 2016 payment adjustments. The following is summary of the comments we received regarding these proposals.
Based on the comments received, we are finalizing, as proposed, the administrative claims-based reporting mechanism for reporting for the 2015 payment adjustment only. We are not finalizing the administrative claims-based reporting mechanism for the 2016 PQRS payment adjustment, as we will revisit the necessity of having this reporting option available for the 2016 PQRS payment adjustment next year. We are modifying § 414.90(h)(2) and § 414.90(h)(3) to indicate that the administrative claims-based reporting mechanism is available for use by eligible professionals and group practices for the 2015 PQRS payment adjustment.
For 2013 and 2014, in accordance with § 414.90(c)(3), eligible professionals that satisfactorily report data on PQRS quality measures are eligible to receive an incentive equal to 0.5 percent of the total estimated Medicare Part B allowed charges for all covered professional services furnished by the eligible professional or group practice during the applicable reporting period. This section contains the criteria for satisfactory reporting for the 2013 and 2014 incentives, which are the last two incentives authorized under the PQRS.
According to the “2010 Physician Quality Reporting System and eRx Reporting Experience and Trends,” available for viewing in the “downloads” section of the main page the PQRS Web site (
We invited public comment on the proposed criteria for satisfactory reporting of individual measures by individual eligible professionals via claims for the 2013 and 2014 incentives. The following is a summary of the comment we received regarding these proposed criteria:
We note that section 1848(m)(3)(A)(ii) of the Act provides that, to meet the criteria for satisfactory reporting under PQRS, an eligible professional would be required to report on at least 3 measures for at least 80 percent of the cases in which the respective measure is reportable under the system. Although we have the authority under section 1848(m)(3)(D) of the Act to revise the criteria for satisfactory reporting, for registry-based reporting, we have largely followed these reporting criteria for the PQRS incentives. According to the “2010 Physician Quality Reporting System and eRx Reporting Experience and Trends,” eligible professionals are more likely to meet the requirements for a PQRS incentive using the satisfactory reporting criteria for the registry-based reporting mechanism than claims. In fact, in 2010, approximately 87 percent of the eligible professionals reporting individual PQRS quality measures via registry were eligible and met the criteria for satisfactory reporting for the 2010 incentive. Since eligible professionals have had success with using these satisfactory reporting criteria, we believe such criteria are appropriate and see no reason to change the criteria for satisfactory reporting via registry that has been in place since 2010. Therefore, for those reasons and our desire to maintain the same reporting criteria we established for individual eligible professionals for the 2012 PQRS incentive (76 FR 73331), we proposed the following criteria for satisfactory reporting of PQRS individual measures for individual eligible professionals using the registry-based reporting mechanism for the 12-month reporting periods for the 2013 and 2014 incentives, respectively: Report at least 3 measures AND report each measure for at least 80 percent of the eligible professional's Medicare Part B FFS patients seen during the reporting period to which the measure applies (77 FR 44814). Measures with a zero percent performance rate will not be counted.
We invited but received no public comment on the proposed criteria for satisfactory reporting of individual measures by individual eligible professionals via a registry for the 2013 and 2014 incentives. Therefore, we are finalizing these criteria as proposed. These criteria are specified in Tables 25 and 26 below.
• As required by the Stage 1 final rule, eligible professionals must report on three Medicare EHR Incentive Program core or alternate core measures, plus three additional measures. The EHR Incentive Program's core, alternate core, and additional measures can be found in Table 6 of the EHR Incentive Program's Stage 1 final rule (75 FR 44398) or in Tables 32 and 33 of the CY 2013 PFS proposed rule. We referred readers to the discussion in the Stage 1 final rule for further explanation of the requirements for reporting those CQMs (75 FR 44398 through 44411).
Under this proposal, eligible professionals using these reporting
In addition, we noted that section 1848(m)(3)(A)(ii) of the Act provides that, to meet the criteria for satisfactory reporting under PQRS, an eligible professional would be required to report on at least 3 measures for at least 80 percent of the cases in which the respective measure is reportable under the system. Although we have the authority under section 1848(m)(3)(D) of the Act to revise the criteria for satisfactory reporting, for EHR-based reporting, we noted that we have largely kept these reporting criteria for the 2010-2012 incentives. As some eligible professionals succeeded with these criteria, we proposed the following similar criteria for the 12-month reporting period for the 2013 incentive: Report at least 3 measures AND report each measure for at least 80 percent of the eligible professional's Medicare Part B FFS patients seen during the reporting period to which the measure applies (77 FR 44814). Measures with a zero percent performance rate will not be counted.
We received no public comment on the satisfactory reporting criterion we proposed for individual PQRS measures using a direct EHR or EHR data submission vendor product for the 2013 PQRS incentive: Report at least 3 measures for at least 80 percent of the cases in which the respective measure is reportable under the system. Therefore, for the reasons previously stated, we are finalizing the criterion.
We invited public comment on the proposed criteria for the satisfactory reporting of individual PQRS measures using a direct EHR or EHR data submission vendor product for the 2013 PQRS incentive. The following is a summary of those comments.
• Option 1a: Select and submit 12 clinical quality measures available for EHR-based reporting from Tables 32 and 33 of the proposed rule, including at least 1 measure from each of the following 6 domains—(1) patient and family engagement, (2) patient safety, (3) care coordination, (4) population and public health, (5) efficient use of healthcare resources, and (6) clinical process/effectiveness.
• Option 1b: Submit 12 clinical quality measures composed of all 11 of the proposed Medicare EHR Incentive Program core clinical quality measures specified in Table 95 plus 1 menu clinical quality measure from Tables 32 and 33 of the proposed rule. We noted it was our intention to finalize the reporting criteria that aligns with the criteria that would be established for meeting the CQM component of meaningful use beginning with CY 2014 for the Medicare EHR Incentive Program. Furthermore, to the extent that the final criteria for meeting the CQM component of achieving meaningful use differ from what was proposed, we noted that our intention was to align with the reporting criteria the EHR Incentive Program ultimately established (77 FR 44814). Therefore, eligible professionals who participate in both PQRS and the EHR Incentive Program would be able to use one reporting criterion, during overlapping reporting periods, to satisfy the satisfactory reporting criteria under PQRS and the CQM component of meaningful use under the Medicare EHR Incentive Program.
In addition to this proposed criterion, we had proposed under the Medicare EHR Incentive Program that, beginning with CY 2014, eligible professionals who participate in both the Physician Quality Reporting System and the Medicare EHR Incentive Program may satisfy the CQM component of meaningful use if they submit and satisfactorily report PQRS clinical quality measures under the PQRS EHR reporting option using Certified EHR Technology (77 FR 13748). Since this language suggested that the Medicare EHR Incentive Program may defer to the satisfactory reporting criteria for the EHR-based reporting mechanism that we will establish for 2014, we proposed the following reporting criteria for the 12-month reporting period for the 2014 incentive that largely conform to the criteria set forth under section
We received no comments regarding the following proposed criteria using a direct EHR or EHR data submission vendor product for the 2014 incentive: Report at least 3 measures AND report each measure for at least 80 percent of the eligible professional's Medicare Part B FFS patients seen during the reporting period to which the measure applies. However, in an effort to streamline reporting requirements for the 2014 PQRS incentives, we only wish to finalize one reporting criterion to meet the criteria for satisfactory reporting for the 2014 PQRS incentive using an EHR-based reporting mechanism. Therefore, since the EHR Incentive Program did not finalize this proposed reporting criterion, we are not finalizing this proposed criterion. We understand that not finalizing this criterion would eliminate a reporting option previously available to eligible professionals. We note however, that this EHR-based reporting criterion was not widely used by eligible professionals. In fact, according to the 2010 PQRS and eRx Experience Report, less than 1% of eligible professionals participating in PQRS did so using the EHR-based reporting mechanism. Therefore, we do not believe eligible professionals will be harmed by our decision not to finalize this criterion. Furthermore, we believe that eligible professionals that have used the EHR-based reporting mechanism in the past will gravitate towards using reporting criterion that aligns with the EHR Incentive Program, as eligible professionals using aligned criterion will have the ability to submit one set of quality measures data to achieve the requirements under both PQRS and the EHR Incentive Program. Nonetheless, we are streamlining the criteria in 2014, and not 2013, in order to give eligible professionals an additional year to adjust their practice workflows to account for this change.
We invited public comment on the proposed criteria for satisfactory reporting on PQRS measures via EHR for the 2014 PQRS incentive that were proposed under the EHR Incentive Program for 2014. The following is summary of the comments we received regarding these proposals.
We note that, despite this distinction in the way the eligible professional's submitted data is analyzed, we are still achieving our goal of aligning the criteria for satisfactory reporting under PQRS with the criteria for meeting the CQM component of achieving meaningful use under the EHR Incentive Program. Eligible professionals will still be able to report the same set of data in the same form and manner to satisfy the requirements for both programs. The only distinction lies in the analysis performed by the two programs. For example, let's pretend an eligible professional, in 2014, uses CEHRT to report 9 measures covering 3 domains, and only 1 measure applies to the eligible professional's practice (that is, the eligible professional has patients that are eligible for inclusion in only 1 measure's denominator). The eligible professional will have met the criteria for meeting the CQM component of achieving meaningful use in 2014, because the eligible professional would have reported 9 measures covering at least 3 domains and reported the measures (1 measure, in this example) for which there is patient data and the remaining required measures as “zero denominators” as displayed by the
We understand that there may be instances where no measures apply to an eligible professional. For those eligible professionals for which no measures available for reporting used the EHR-based reporting mechanisms apply, for 2014, we strongly encourage those eligible professionals to meet the criteria for satisfactory reporting using an alternative reporting option.
Based on the comments received and for the reasons we stated above, we are finalizing the following criteria for satisfactory reporting of individual PQRS measures using direct EHR or EHR data submission vendor products for the 2014 PQRS incentive: Report 9 measures covering at least 3 domains, as specified in Table 95. If an eligible professional's CEHRT does not contain patient data for at least 9 measures covering at least 3 domains, then the eligible professional must report the measures for which there is patient data.
We note that the EHR Incentive Program established the requirements, should an eligible professional's CEHRT not contain patient data for at least 9 measures covering at least 3 domains, the eligible professional must report the measures for which there is patient data and report the remaining required measures as “zero denominators” as displayed by the eligible professional's CEHRT. If there are no measures applicable to the eligible professional's scope of practice and patient population, eligible professionals must still report 9 measures even if zero is the result in either the numerator or denominator of the measure. If all applicable measures have a value of zero from their CEHRT, then eligible professional must report any 9 measures (77 FR 54058). For PQRS, we are only concerned with the reporting of measures that are relevant to an eligible professional's practice. Therefore, we are not accepting the reporting of “zero denominators.” Therefore, to meet the criteria for satisfactory reporting for the 2014 PQRS incentive using this criterion, an eligible professional must report on at least 1 applicable measure (that is, at least 1 of the 9 measures that the eligible professional reports using an EHR-based reporting mechanism must not have a “zero denominator”).
In the CY 2012 Medicare PFS final rule, we established the following criteria for satisfactorily reporting PQRS measures groups for the 12-month reporting period for the 2012 incentive (76 FR 73335):
• Report at least 1 PQRS measures group, AND report each measures group for at least 30 Medicare Part B FFS patients. Measures groups containing a measure with a 0 percent performance rate will not be counted; OR
• Report at least 1 PQRS measures group, AND report each measures group for at least 50 percent of the eligible professional's Medicare Part B FFS patients seen during the reporting period to whom the measures group applies; BUT report each measures group on no less than 15 Medicare Part B FFS patients seen during the reporting period to which the measures group applies. Measures groups containing a measure with a 0 percent performance rate will not be counted.
We received stakeholder feedback that it is difficult for some specialties to meet the 30 Medicare Part B FFS patient threshold. Therefore, based on our authority under section 1848(m)(3)(D) of the Act to revise the reporting criteria for satisfactory reporting, we proposed the following criteria for the satisfactorily reporting PQRS measures groups for individual eligible professionals using the claims-based reporting mechanism for the 12-month reporting periods for the 2013 and 2014 incentives: Report at least 1 measures group AND report each measures group for at least 20 Medicare Part B FFS patients. Measures groups containing a measure with a zero percent performance rate will not be counted (77 FR 44815).
We invited public comment on the proposed criterion for satisfactory reporting of measures groups via claims for the 2013 and 2014 incentives. The following is summary of the comments we received regarding this proposal.
In the CY 2012 Medicare PFS final rule, we established the following criteria for satisfactorily reporting PQRS measures groups for the 12-month reporting period for the 2012 incentive (76 FR 73337):
• Report at least 1 PQRS measures group AND report each measures group for at least 30 Medicare Part B FFS patients. Measures groups containing a measure with a 0 percent performance rate will not be counted; OR
• Report at least 1 PQRS measures group, AND report each measures group for at least 80 percent of the eligible professional's Medicare Part B FFS patients seen during the reporting period to whom the measures group applies; BUT report each measures group on no less than 15 Medicare Part B FFS patients seen during the reporting period to which the measures group applies. Measures groups containing a measure with a 0 percent performance rate will not be counted.
In addition, we established the following criteria for satisfactorily reporting PQRS measures groups for the 6-month reporting period for the 2012 incentive (76 FR 73337): Report at least 1 PQRS measures group, AND report each measures group for at least 80 percent of the eligible professional's Medicare Part B FFS patients seen during the reporting period to whom the measures group applies; BUT report each measures group on no less than 8 Medicare Part B FFS patients seen during the reporting period to which the measures group applies. Measures groups containing a measure with a 0 percent performance rate will not be counted.
We received stakeholder feedback that it is difficult for some specialties to meet the 30 Medicare Part B FFS patient threshold. Therefore, based on our authority under section 1848(m)(3)(D) of the Act to revise the reporting criteria for satisfactory reporting, we proposed the following criteria for satisfactory reporting of PQRS measures groups for individual eligible professionals using the registry-based reporting mechanism for the 2013 and 2014 incentives:
(1) For the 12-month reporting periods for the respective 2013 and 2014 incentives, report at least 1 measures group, AND report each measures group for at least 20 patients, a majority of which must be Medicare Part B FFS patients. Measures groups containing a measure with a 0 percent performance rate would not be counted.
(2) For the 6-month reporting period for the respective 2013 and 2014
We noted that, while we still proposed to require that an eligible professional report on at least 20 patients, we understood that a patient's personal identification information may be stripped when data is collected via a qualified registry. Therefore, we understood that it may be difficult to distinguish Medicare and non-Medicare patients. Given this difficulty and that the eligible professionals generally would be attempting to report data on Medicare patients, we felt the reporting of some non-Medicare patients could serve as a proxy for the reporting of Medicare patients whose data is not easily distinguishable as data on Medicare patients under this reporting mechanism.
Finally, we noted that our proposals would satisfy the requirement under section 1848(m)(5)(F) of the Act that we provide for alternative reporting periods and criteria for satisfactory reporting with regard to measures groups and registry-based reporting.
We invited public comment on the proposed criteria for satisfactory reporting of measures groups by individual eligible professionals via registry for the 2013 and 2014 incentives. The following is summary of the comments we received regarding these proposals.
Tables 90 and 91 provide a summary of the final criteria for the satisfactory reporting of PQRS quality measures for the 2013 and 2014 incentives.
This section addresses the criteria for satisfactory reporting for group practices participating in the GPRO for the 2013 and 2014 incentives, which are the last two incentives authorized under the Physician Quality Reporting System. Please note that, in addition to offering the GPRO web interface that we've previously included under the program, we proposed new criteria for group practices under the GPRO that allow group practices to use the claims, registry, and EHR-based reporting mechanisms (77 FR 44819). In prior program years, large group practices have been successful in reporting quality measures data via the GPRO web interface. We proposed new criteria under the claims, qualified registry, and EHR-based reporting mechanisms because we felt that smaller groups may benefit from different reporting criteria and also other reporting mechanisms. Since the introduction of smaller group practices composed of 25-99 eligible professionals under the GPRO was fairly recent, and given that we proposed to modify the definition for group practice such that the PQRS GPRO would include, beginning in 2013, group practices composed of 2-24 eligible professionals, we proposed additional criteria for reporting because we felt it might be more practicable for smaller group practices to report on PQRS quality measures via claims, qualified registry, or direct EHR or EHR data submission vendor versus the GPRO web interface, which was designed for use by larger group practices.
In the proposed rule we discussed how we are assigning beneficiaries in 2012 to group practices for purposes of reporting on the PQRS quality measures via the GPRO web interface. We proposed to continue using this same assignment methodology for 2013 and subsequent years because it is already in place operationally.
However, as an alternative way to assign beneficiaries to groups for the GPRO web interface, in the proposed rule we also discussed and invited comments on using the assignment and sampling methodology utilized under the more recently implemented Medicare Shared Savings Program (76 FR 6700). The Medicare Shared Savings Program uses an approach that is generally similar to and is based on the approach previously used by the PGP Transition demonstration, but that was revised to reflect both our experiences under the demonstration and specific statutory requirements for the Medicare Shared Savings Program. In particular, the attribution method used by the Medicare Shared Savings Program emphasizes primary care services furnished by physicians. More information regarding the assignment methodology that is used in the Shared Savings Program can be found on the program Web site at
Consistent with that two-step methodology, in order for a beneficiary to be eligible for assignment to a group practice, the beneficiary must have received at least one primary care service from a physician within the group practice during the reporting period. Accordingly, we would identify beneficiaries who received at least one primary care service from any group practice physician (regardless of specialty) participating in the group practice during the reporting period. Under the first assignment step, we would assign the beneficiary to the group practice if the beneficiary had at least one primary care service furnished by a primary care physician at the participating group practice, and more primary care services (measured by Medicare allowed charges) furnished by primary care physicians in the participating group practice than furnished by primary care physicians at any other group or solo practice.
The second step applies only for those beneficiaries who do not receive any primary care services from a primary care physician during the reporting period. We would assign the beneficiary to the participating group practice in this step if the beneficiary had at least one primary care service furnished by a group practice physician regardless of specialty, and more primary care services were furnished by group practice eligible professionals (measured by Medicare allowed charges) at the participating group practice than at any other group or solo practice We would then pull samples of beneficiaries for the relevant measures/modules from this population of assigned beneficiaries to populate the GPRO web interface. In other words, the GPRO web interface would be populated based on a sample of the group practice assigned beneficiary population. Group practices would need to complete the tool for the first 411 or 218 consecutively ranked and assigned beneficiaries in the order in which they appear in the group's sample for each domain, measures set, or individual measure if a separate denominator is required such as in the case of preventive care measures which may be specific to one sex. If the pool of eligible assigned beneficiaries is less than 411 or 218, the group practice would report on 100 percent of assigned beneficiaries for the domain, measure set, or individual measure. The GPRO web interface would need to be completed for all domains, measure sets, and measures described in Table 96.
We considered making this change to the assignment method beginning with the 2013 PQRS GPRO web interface so that the rules used to assign
We invited public comment whether to continue to use the PQRS-established methodology for assigning beneficiaries, or, in the alternative, to use the assignment and sampling methodology utilized under the Medicare Shared Savings Program. The following is summary of the comments we received regarding these proposals.
The satisfactory reporting criteria we proposed for the GPRO web interface for groups of 25-99 eligible professionals and for large group practices for the 2013 and 2014 incentives were consistent with the reporting criteria we established for the 2012 PQRS incentive (76 FR 73339). We proposed these same criteria because the thresholds proposed for these criteria were based on analysis performed on group reporting based on the Medicare Care Management Performance (MCMP) and PGP demonstrations used to determine reasonable thresholds for group practice reporting. We also note that there are the same criteria used for ACOs participating in the Medicare Shared Savings Program. Therefore, we believed the satisfactory reporting criteria that for the GPRO web interface for the 2013 and 2014 incentives were appropriate criteria and reasonable for groups to meet.
Furthermore, we proposed using Medicare Part B claims data for dates of service on or after January 1 and submitted and processed by approximately the last Friday in October of the applicable 12-month reporting period under which the group practice participates in the GPRO to assign Medicare beneficiaries to each group practice. For example, for a group practice participating under the GPRO for the reporting periods occurring in 2013, for the sampling model, we proposed that we would assign beneficiaries on which to report based on Medicare Part B claims with dates of service beginning January 1, 2013 and processed by October 25, 2013 (77 FR 44820).
We invited but received no public comment on the proposed satisfactory reporting criteria on PQRS quality measures via the GPRO web interface. Therefore, we are finalizing these proposals as proposed. These criteria are specified in Tables 27 and 28.
We proposed to have the claims, registry, and EHR reporting mechanisms available for group practices of 2-99 eligible professionals to use to report PQRS quality measures (77 FR 44820). For these group practices, we proposed alternative criteria to those proposed under the GPRO web interface for satisfactory reporting for the 2013 and 2014 incentives using the claims, registry, and EHR-based reporting mechanisms that mirror the criteria we proposed for individual reporting for the claims, registry, and EHR-based reporting mechanisms from the 2013 and 2014 incentives. We noted that the criteria we proposed for the 2013 and 2014 incentives using the claims, registry, and EHR-based reporting mechanisms are similar to the criteria
Therefore, based on our authority under section 1848(m)(3)(C) of the Act, we proposed the following satisfactory reporting criteria via claims for group practices comprised of 2-99 eligible professionals under the GPRO for the 2013 and 2014 incentives via claims: Report at least 3 measures AND report each measure for at least 50 percent of the group practice's Medicare Part B FFS patients seen during the reporting period to which the measure applies. Measures with a zero percent performance rate will not be counted.
For those group practices that chose to report using a qualified registry, we proposed the following satisfactory reporting criteria via qualified registry for group practices comprised of 2-99 eligible professionals under the GPRO for the 2013 and 2014 incentives: Report at least 3 measures AND report each measure for at least 80 percent of the group practice's Medicare Part B FFS patients seen during the reporting period to which the measure applies. Measures with a zero percent performance rate will not be counted.
For group practices comprised of 2-99 eligible professionals that chose to report PQRS quality measures via EHR, we proposed the following 2 options for the satisfactory reporting criteria via a direct EHR product or EHR data submission vendor for group practices comprised of 2-99 eligible professionals under the GPRO for the 2013 incentive:
We noted that at the time of the CY 2013 PFS proposed rule, that we had proposed under the Medicare EHR Incentive Program 2 options for meeting the CQM component of achieving meaningful use beginning with CY 2014 (see 77 FR 13746-13748). To align our EHR-based reporting requirements with those proposed under the Medicare EHR Incentive Program at the time, we proposed the following criteria for satisfactory reporting using the EHR-based reporting mechanism for the 12-month reporting period for the 2014 incentive:
•
•
We also considered proposing the following satisfactory reporting criteria for the 2014 PQRS incentive for groups of 2-99 that was similar to the satisfactory reporting criteria being proposed for the 2013 PQRS incentive via EHR: report at least 3 measures, AND report each measure for at least 80 percent of the group practice's Medicare Part B FFS patients seen during the reporting period to which the measure applies. Measures with a zero percent performance rate will not be counted (77 FR 44821). We invited public comment on this alternative considered.
We invited public comment on the proposed criteria for satisfactory reporting of individual measures by group practices via claims, registry, or EHR for the 2013 and 2014 incentives. The following is a summary of general comments we received.
The commenters believe that establishing these proposals would lead to greater overall program participation.
However, we finalized for the EHR Incentive Program two group reporting options beginning in 2014 for the CQM component of achieving meaningful use, one of which is the following: Medicare EPs who satisfactorily report PQRS CQMs using CEHRT under the PQRS GPRO would be considered to have satisfied their CQM reporting requirement as a group for the Medicare EHR Incentive Program (77 FR 54076
Although we proposed three reporting criteria for the satisfactory reporting of PQRS measures via an EHR-based reporting mechanism under the GPRO for the 2014 PQRS incentive, we are only finalizing one GPRO EHR reporting criterion. Similar to the reasoning we provided to streamline the reporting criteria for reporting measures groups via registry for the 2013 and 2014 PQRS incentives, it is our desire to provide one streamlined reporting option via EHR for group practices participating in the GPRO.
We note that we believe these proposed criteria meet the requirements for group practice reporting specified in section 1848(m)(3)(C) of the Act. Section 1848(m)(3)(C) requires that the criterion for group reporting use a statistical sampling model, such as the model used in the PGP demonstration. We note that, although these criteria depart from the model used in the PGP demonstration, we believe that these criteria still meet the statistical sampling model requirement in that the group practices would still be required to report the measures on a sample of their patients. Rather than CMS choosing which sample of patients the group practice must report, with these criteria, the group practice decides to submit quality measures data on a sample of 100 percent of its patients. We note that although reporting on 100 percent of patients is not a sample, for data collection purposes, CMS would only collect data on the group practice's patients to which the EHR measures apply. Therefore, even though a group practice would report on 100 percent of patients to which the measure applies, not all of the EHR measures would necessarily apply to all of the group practice's patients. Since the group practice is then only providing information on its patients to whom the measure is applicable, we believe the proposed EHR reporting criteria would still meet the statistical sampling model requirement.
A summary of the final criteria for satisfactory reporting for group practices selected to participate in the GPRO for the 2013 and 2014 incentives is specified in Tables 92 and 93:
For the proposed criteria for satisfactory reporting for the 2013 and 2014 incentives described in this section, we proposed that eligible professionals and group practices may not combine different satisfactory reporting criteria under different reporting mechanisms to meet the requirements of satisfactory reporting for the 2013 and 2014 incentives (77 FR 44824). For example, an eligible professional may not meet the requirements for the 2013 incentive by reporting on 2 applicable PQRS quality measures via EHR and 1 applicable PQRS quality measure via qualified registry, because the eligible professional did not meet the criteria for satisfactory reporting under at least one reporting mechanism. Similarly, a group practice would be required to select a single reporting mechanism for the entire group practice. For example, for a group practice consisting of 4 eligible professionals, the group practice would not be able to meet the requirements for the 2014 incentive by reporting 2 individual measures via qualified registry and 1 measure via the direct EHR submission method.
For individual eligible professionals and group practices reporting on individual measures and/or measures groups, we noted that, although an eligible professional or group practice could meet more than one criterion for satisfactory reporting, only one incentive payment will be made to the eligible professional or group practice. For example, if an eligible professional meets the criteria for satisfactory reporting of individual measures via claims and measures groups via claims for the 2013 incentive, the eligible professional would nonetheless only be entitled to one incentive payment. CMS would consider the eligible professional to be incentive eligible under whichever reporting criterion yields the greatest bonus.
We invited but received no public comment on our proposed analysis of the criteria for satisfactory reporting for the 2013 and 2014 incentives. Therefore, we are finalizing this analysis rule.
Section 1848(a)(8) of the Social Security Act, as added by section 3002(b) of the Affordable Care Act, provides that for covered professional services furnished by an eligible professional during 2015 or any subsequent year, if the eligible professional does not satisfactorily report data on quality measures for covered professional services for the quality reporting period for the year, the fee schedule amount for services furnished by such professional during the year shall be equal to the applicable percent of the fee schedule amount that would otherwise apply to such services. The applicable percent for 2015 is 98.5 percent. For 2016 and subsequent years, the applicable percent is 98.0 percent.
This section contains the final criteria for satisfactory reporting for purposes of the 2015 and 2016 payment adjustments for eligible professionals and group practices, as well as some discussion of what we are considering for the payment adjustments for 2017 and beyond.
As stated previously, the majority of eligible professionals currently are not participating in the PQRS. Yet, the payment adjustment will apply to all eligible professionals who are not satisfactory reporters during the reporting period for the year. Therefore, we noted that in implementing the PQRS payment adjustment, we seek to achieve two overarching policy goals. First, and foremost, we sought to increase participation in the PQRS and to implement the payment adjustment in a manner that will allow eligible professionals who have never participated in the program to familiarize themselves with the program. Second, we sought to align the reporting requirements under the PQRS with the quality reporting requirements of various CMS programs, such as the physician value-based payment modifier discussed in section III.K of this final rule with comment period.
This section addresses the criteria for satisfactory reporting for the 2015 and 2016 payment adjustments using the claims, registry, EHR-based, and GPRO web interface reporting mechanisms. First, we proposed that for purposes of the 2015 and 2016 payment adjustments (which would be based on data reported during 12 and 6-month reporting periods that fall within 2013 and 2014, respectively), an eligible professional or group practice would meet the requirement to satisfactorily report data on quality measures for covered professional services for the 2015 and 2016 payment adjustments by meeting the requirement for satisfactory reporting for the 2013 and 2014 incentives respectively (77 FR 44824). That is, we proposed the exact same
For individual eligible professionals also participating in the EHR Incentive Program, we noted that it is our intention to align our proposed criteria for satisfactory reporting for the 2015 and 2016 PQRS payment adjustments with the criteria for meeting the CQM component of meaningful use applicable during the 2015 and 2016 PQRS payment adjustment reporting periods. For eligible professionals participating in PQRS and the EHR Incentive Program using a direct EHR product or EHR data submission vendor that is CEHRT, we noted that since we proposed to align our proposed EHR criteria for satisfactory reporting for the 2013 and 2014 PQRS incentives with the proposed criteria for meeting the CQM component of meaningful use for CYs 2013 and 2014 if these proposals were established and we meet our goal of aligning the two programs, an eligible professional that met the CQM component of meaningful use during the PQRS 2015 and 2016 payment adjustment reporting periods occurring in CYs 2013 and 2014 respectively using a direct EHR product or EHR data submission vendor that is CEHRT would meet the requirements for satisfactory reporting for the 2015 and 2016 PQRS payment adjustments by submitting a single set of data.
We invited public comment on our proposals related to applying the satisfactory reporting criteria established for the 2013 and 2014 PQRS incentives for eligible professionals and group practices using the GPRO to the respective 2015 and 2016 PQRS payment adjustments. The following is a summary of the comments we received on these proposals.
In addition, as a result of the overarching goals we have articulated above about encouraging participation and concern about eligible professionals' familiarity and experience with the program, we proposed the following alternative criteria for satisfactory reporting during the 12-month reporting periods for the 2015 and 2016 payment adjustments for eligible professionals and group practices: Report 1 (applicable) measure or measures group using the claims, registry or EHR-based reporting mechanisms. We noted that this particular proposed alternative criterion for satisfactory reporting was significantly less stringent than the satisfactory reporting criteria we have proposed for the 2013 and 2014 incentives. However, we stressed that we were proposing less stringent criteria only to ease eligible professionals and group practices who have not previously participated in PQRS into reporting into the mechanics of reporting quality measures under PQRS. As indicated in the proposed rule, for the 2017 PQRS payment adjustment and beyond, we anticipate eliminating these alternative proposed criteria and establishing criteria that more closely resemble the proposed satisfactory reporting criteria for the 2013 and 2014 incentives (77 FR 44826).
For group practices, section 1848(m)(3)(C) requires that the criterion for group reporting use a statistical sampling model, such as the model used in the PGP demonstration, we noted that we believed that the proposed reporting criteria met this standard, as the group practice would decide on which sample of patients to report (77 FR 44825). Under the proposed criteria, the group practice would select the sample number, meaning the group could choose to report on all applicable patients or a certain number of patients to which the particular measure applied. We noted that, although the group practice could choose the sample, we expected that the sample the group practice selects would represent a sufficient picture of the beneficiaries the group practice sees.
We invited public comments on these proposed criteria for satisfactory reporting for the 2015 and 2016 payment adjustments for eligible professionals and group practices using the claims, registry, EHR-based reporting mechanisms. The following is a summary of the comments we received regarding these proposed criteria.
Based on the comments received and for the reasons previously stated, we are finalizing the proposed criteria for satisfactory reporting for the 2015 PQRS payment adjustment—Report 1 measure or measures group during the applicable payment adjustment reporting period. Therefore, an individual eligible professional will meet the criteria for satisfactory reporting for the 2015 payment adjustment if the eligible
Although we did not propose using the GPRO web interface as a reporting mechanism to report 1 measure to meet the criteria for satisfactory reporting for the 2015 PQRS payment adjustment, we did propose this criterion for the other three traditional reporting mechanisms (claims, registry, and EHR). We anticipated that it would be sufficient to establish this criterion for these three other reporting mechanisms (claims, registry, and EHR) for the 2015 PQRS payment adjustment. However, as we previously stated, we are not finalizing the claims-based reporting mechanism for group practices participating in the GPRO. We are also not finalizing the EHR-based reporting mechanism for group practices participating in the GPRO until 2014. Therefore, since the registry-based reporting mechanism will be the only reporting mechanism under which group practices would be able to use this criterion, we are expanding this criterion for use under the GPRO web interface. Therefore, a group practice will not be subject to the 2015 payment adjustment if the group practice meets the criteria for satisfactory reporting by reporting 1 applicable measure using a qualified registry or the GPRO web interface reporting mechanism during the CY 2013 payment adjustment reporting period.
We are not finalizing these proposed criteria for the 2016 payment adjustment at this time, as we intend to revisit whether we should establish more stringent satisfactory reporting criteria beginning with the 2016 payment adjustment. We believe that, rather than maintaining this criterion for the 2016 PQRS payment adjustment, it may be more preferable to adopt a phased approach to moving towards reporting criteria that is identical to or similar to the criteria for satisfactory reporting for the 2013 and 2014 PQRS incentives. However, as we explained above, we are finalizing one criterion for satisfactory reporting for the 2016 PQRS payment adjustment: Meet the criteria for satisfactory reporting for the 2014 PQRS incentive.
Unlike the traditional PQRS claims-based reporting mechanism, the administrative claims-based reporting mechanism we proposed does not require an eligible professional to submit quality data codes (QDCs) on Medicare Part B claims (77 FR 44825). Rather, using the administrative claims-based reporting mechanism only requires that an eligible professional or group practice submit Medicare claims to CMS. Since CMS, rather than the eligible professional or group practice, is performing the analysis and collecting the data provided in an eligible professional's or group practice's Medicare claims for an eligible professional's or group practice's Medicare beneficiaries, we believe it is appropriate to propose a reporting threshold that is more stringent than that proposed for the 2013 and 2014 incentives that use traditional PQRS reporting mechanisms. Therefore, we proposed the following criteria for satisfactory reporting for the 12-month reporting periods for the 2015 and 2016 payment adjustments (that occur in 2013 and 2014 respectively) for eligible professionals and group practices using the administrative claims-based reporting mechanism: Report ALL measures in Table 63 of the proposed rule for 100 percent of the cases in which the measures apply.
Section 1848(m)(3)(C) requires that the criterion for group reporting use a statistical sampling model, such as the model used in the PGP demonstration. We noted that, although these criteria depart from the model used in the PGP demonstration, similar to our arguments for the satisfactory reporting criteria we proposed for group practices using the claims, registry, and EHR-based reporting mechanisms, we believe that these criteria would still meet the statistical sampling model requirement in that the group practices would still be required to report the measures on a sample of their patients. We noted that, with these proposed criteria, the group practice would provide claims data to CMS on 100 percent of its patients for which the measure applies. We note that although reporting on 100 percent of patients is not a sample, for data collection purposes, CMS would only collect data on the group practice's patients to which the administrative claims measures apply. Therefore, the applicable measures will determine the sample size for which the group would report. Since the group practice is then only providing information on its applicable patients, we believe these reporting criteria would still meet the statistical sampling model requirement.
We invited public comment on these proposed criteria for eligible professionals and group practices using the administrative claims-based reporting mechanism. The following is a summary of comments received on these proposed criteria.
In addition, when developing proposals for reporting criteria for the 2015 and 2016 PQRS payment adjustments, we considered satisfactory reporting options that would encourage eligible professionals and group practices to report for the 2013 and/or 2014 incentives but, should eligible professionals or group practices come up shy of meeting the 2013 and/or 2014 incentive reporting criteria, would still allow an eligible professional to meet the criteria for satisfactory reporting for the 2015 and/or 2016 payment adjustments (77 FR 44825). In lieu of more lenient satisfactory reporting criteria we proposed for the 2015 and 2016 payment adjustment, for example, to report at least 1 measure or measures group or to elect the administrative claims-based reporting option, we considered the option of defaulting those eligible professionals who report but fail to meet the criteria for satisfactory reporting using the proposed criteria for the 2013 and/or 2014 incentives to the administrative claims-based reporting option. We would therefore analyze the claims of all eligible professionals who report at least 1 measure under a traditional reporting method during the respective 2015 and 2016 payment adjustment reporting periods under the administrative claims-based reporting option. We considered this proposal because it is our intention to encourage eligible professionals to report PQRS measures using the proposed reporting criteria for the 2013 and 2014 PQRS incentives. However, given our concern about new eligible professionals' familiarity and experience with the program, we stated that we felt it was necessary to propose an alternative, less stringent reporting option.
We invite public comment on this alternative, and the following is a summary of the comments we received.
In summary, eligible professionals and group practices have 3 options for meeting the criteria for satisfactory reporting for the 2015 PQRS payment adjustment:
• Meet the criteria for the 2013 PQRS incentive;
• Report 1 applicable measure or, for eligible professionals only, measures group; or
• Elect to be analyzed under the administrative claims-based reporting mechanism.
Eligible professionals and group practices have 1 option for meeting the criteria for satisfactory reporting for the 2016 PQRS payment adjustment: Meet the criteria for satisfactory reporting for the 2016 PQRS payment adjustment.
As noted in § 414.90(b), an eligible professional is assessed at the TIN/NPI level and a group practice selected to participate in the GPRO is assessed at the TIN level. As there is a 1-year lapse in time between the end of a proposed respective payment adjustment reporting period and when an eligible professional is expected to receive a PQRS payment adjustment for not meeting the requirements for satisfactory reporting for the respective payment adjustment, we understand that an eligible professional may change his or her TIN/NPIs during this lapse of time. Likewise, a group practice selected to participate in the GPRO may change its TIN during this lapse in time. In the proposed rule (77 FR 44825-44826). We noted that we believed this could raise issues with regard to the subsequent application of the payment adjustment and concerns about the potential for abuse (for example, “gaming the system”).
Accordingly, we invited public comment this issue, including what parameters, if any, CMS should impose regarding the changes in TIN/NPIs and compositions of group practices with regard to the payment adjustment. We received the following comment regarding this issue.
This section focuses on the PQRS quality measures we are making available for reporting under PQRS using the claims, registry, EHR (direct EHR or EHR data submission vendor product), GPRO web interface, and/or administrative claims-based reporting mechanisms. Below, we address the comments we received regarding these measures. We note, however, that many commenters provided comments related to measure specifications and suggestions for additional measures. For the measure specifications for these proposed PQRS measures, please note that we do not use the rulemaking process to change measure specifications. Measure specifications are determined by the measure developers and owners. Therefore, suggestions on changes to measure specifications should be addressed to the respective measure developer and/or owner.
In addition, we note that we received some comments in which commenters suggested additional measures. However, as we have noted in prior program years, we do not generally adopt measures in the final measure set that were not proposed in the proposed rule (though we do take them in consideration for possible use in future years of the program). In addition, we note that we undergo a pre-rulemaking process—including the requirement that measure owners and developers submit these measures for inclusion in the PQRS measure set in our annual PQRS Call for Measures and have these measures subsequently reviewed by the MAP—prior to proposing measures in rulemaking. Since these proposed measures have not gone through our various vetting channels, we cannot include these newly suggested measures that arise from the comments provided.
We also received comments asking whether PQRS measures applied to certain specialties. Please note that these questions are not typically addressed in rulemaking. We urge the commenters to contact the QualityNet Help Desk for assistance with finding applicable measures.
Under section 1848(k)(2)(C)(i) of the Act, the PQRS 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 (currently, that is the National Quality Forum, or NQF). However, in the case of a specified area or medical topic determined appropriate by the Secretary for which a feasible and practical measure has not been endorsed by the NQF, section 1848(k)(2)(C)(ii) of
The statutory requirements under section 1848(k)(2)(C) of the Act, subject to the exception noted previously, 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 for 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 process of 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 for purposes of the PQRS.
In addition to section 1848(k)(2)(C) of the Act, section 1890A of the Act, which was added by section 3014(b) of the Affordable Care Act, requires that the entity with a contract with the Secretary under subsection 1890(a) of the Act (currently that, is the NQF) convene multi-stakeholder groups to provide input to the Secretary on the selection of certain categories of quality and efficiency measures. These categories are described in section 1890(b)(7)(B) of the Act, and include such measures as the quality measures selected for reporting under the PQRS. Pursuant to section 3014 of Affordable Care Act, the NQF convened multi-stakeholder groups by creating the Measure Applications Partnership (MAP). Section 1890(A)(a) of the Act requires that the Secretary establish a pre-rulemaking process in which the Secretary must make publicly available by December 1st of each year a list of the quality and efficiency measures that the Secretary is considering for selection through rulemaking for use in the Medicare program. Once we have made this list available to the public, the NQF must provide CMS with the MAP's input on selecting measures by February 1st of each year. The list of measures under consideration for 2012 is available at
We received the following comments regarding these statutory requirements for the selection of PQRS quality measures:
As we noted above, section 1848(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). We may select measures under this exception if there is a specified area or medical topic for which a feasible and practical measure has not been endorsed by the entity. Under this exception, aside from NQF endorsement, we requested that stakeholders apply the following considerations when submitting measures for possible inclusion in the PQRS measure set:
• 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.
• Measures that address gaps in the quality of care delivered to Medicare beneficiaries.
• Address Gaps in the PQRS measure set.
• Measures impacting chronic conditions (chronic kidney disease, diabetes mellitus, heart failure, hypertension and musculoskeletal).
• Measures applicable across care settings (such as, outpatient, nursing facilities, domiciliary, etc.).
• Broadly applicable measures that could be used to create a core measure set required of all participating eligible professionals.
• Measures groups that reflect the services furnished to beneficiaries by a particular specialty.
On October 7, 2011, we ended a Call for Measures that solicited new measures for possible inclusion in the PQRS for 2013 and beyond. During the Call for Measures, we solicited measures that were either NQF-endorsed or fell under the exception specified in section 1848(k)(2)(C)(ii) of the Act.
Although the deadline to submit measures for consideration for the 2013 PQRS program year has ended, we invited public comment on future considerations related to the selection of new PQRS quality measures. The following is a summary of the comments received.
This section focuses on the proposed PQRS individual Measures available for reporting via claims, registry, and/or EHR-based reporting for 2013 and beyond. To align with the proposed measure domains provided in the EHR Incentive Program (77 FR 13743), we classify all proposed measures against six domains based on the National Quality Strategy's six priorities, as follows (77 FR 44827):
(1)
(2)
(3)
(4)
(5)
(6)
We invited but received no public comment on these domains.
Please note that the PQRS quality measure specifications for any given proposed PQRS individual quality measure may differ from specifications for the same quality measure used in prior years. For example, for the proposed PQRS quality measures that were selected for reporting in 2012, please note that detailed measure specifications, including the measure's title, for the proposed individual PQRS quality measures for 2013 and beyond may have been updated or modified during the NQF endorsement process or for other reasons. In addition, due to our desire to align measure titles with the measure titles that were proposed for 2013, 2014, 2015, and potentially subsequent years of the EHR Incentive Program, we note that the measure titles for measures available for reporting via EHR may change. To the extent that the EHR Incentive Program updates its measure titles to include version numbers (77 FR 13744), we intend to use these version numbers to describe the PQRS EHR measures that will also be available for reporting for the EHR Incentive Program. We will continue to work toward complete alignment of measure specifications across programs whenever possible.
Through NQF's measure maintenance process, NQF endorsed measures are
We would continue to use the rulemaking process to adopt changes to measures that we consider to substantially change the nature of the measure. We believe that this proposal adequately balances our need to incorporate NQF updates to NQF-endorsed measures in the most expeditious manner possible, while preserving the public's ability to comment on updates that so fundamentally change an endorsed measure that it is no longer the same measure that we originally adopted.
We invite public comment on this proposal. The following is a summary of comments we received on this proposal to allow for altering of a measure that has been finalized in rulemaking, provided that the updates do not substantially change the nature of the measure.
We note that CMS does not usually make unilateral changes to measures. These minor changes are usually addressed in collaboration with stakeholder feedback—measure developers, measure owners, eligible professionals reporting the respective measures, etc. Therefore, to the extent that we received comments related to minor changes to the proposed PQRS measures, we did not address these comments in this final rule. Commenters are encouraged to contact the respective measures owners regarding these issues.
To receive more information on the proposed measures contained in this section, including the measure specifications for these proposed measures, please contact the respective measure owners. Contact information for the measure owners of these proposed PQRS measures is available at the PQRS Web site at
In 2011, the Department of Health and Human Services (HHS) started the Million Hearts Initiative, which is an initiative to prevent 1 million heart attacks and strokes in 5 years. We are dedicated to this initiative and seek to encourage eligible professionals to join in this endeavor. Therefore, based on our desire to support the Million Hearts Initiative and maintain our focus on cardiovascular disease prevention, we proposed individual PQRS Core Measures that were specified in Table 94 of the CY 2013 MPFS proposed rule for 2013 and beyond (77 FR 44827). These measures were the same measures we finalized under the 2012 PQRS in the CY 2012 Medicare PFS final rule (76 FR 73345). Please note that, although we proposed that certain measures serve as core PQRS quality measures, we did not propose to require that eligible professionals report on these proposed PQRS core measures. We invited public comment on the proposed PQRS core measures for 2013 and beyond. We did not receive public comment on the majority of measures we proposed to classify as PQRS core measures.
The following is a summary of the comments we received on the proposed PQRS core measures for 2013 and beyond and our proposal regarding the “core” designation.
• Preventive Care and Screening: Cholesterol-Fasting Low Density Lipoprotein (LDL) Test Performed AND Risk-Stratified Fasting LDL
The commenter does not believe that this measure should be a core measure because it is only available for reporting using the EHR-based reporting mechanism.
Table 94 provides a summary of the HHS Million Hearts measures we are finalizing for 2013 and beyond. Please note that, although we strongly encourage that eligible professionals report these measures, eligible professionals are not required to report these specific measures for the purposes of meeting the criteria for satisfactory reporting for the PQRS incentives or payment adjustments.
This section contains individual PQRS quality measures we proposed for 2013 and beyond (77 FR 44830) and the final measure set we are adopting in this final rule with comment period. Please note that, in large part, we proposed to retain most of the quality measures we finalized for reporting for the 2012 PQRS (76 FR 42865 through 42872). However, in 2013 and 2014, we proposed to include new measures, as well as remove measures that were available for reporting under the 2012 PQRS (not re-propose certain measures for 2013 and beyond). Table 97 of the CY 2013 PFS proposed rule contains the list of measures we proposed to be available for reporting under the PQRS for 2013 and beyond that were available under the 2012 PQRS (77 FR 44841). Tables 30 and 33 of the CY 2013 PFS proposed rule contains the list of new measures we proposed to be available for reporting under the PQRS beginning in 2013 and 2014 respective that were not available under the 2012 PQRS (77 FR 44831 and 77 FR 44942). Tables 31 and 34 of the CY 2013 PFS proposed rule contains the list of measures we did not propose for reporting under PQRS beginning in 2013 and 2014 respectively that are available for reporting under the 2012 PQRS (77 FR 44837 and 77 FR 44953).
We note that we received several comments related to the addition of measures we did not propose for inclusion in PQRS. We note the need to be transparent and provide the public with an opportunity to provide comment on the measures we include in PQRS prior to finalizing these measures in the PQRS measure set. Since we did not propose including these measures for reporting under PQRS, we are not addressing these comments in this final rule. However, we will use the comments we have received when selecting measures to be included in PQRS for future program years.
The following is a summary of the comments we did receive regarding prior program measures we did not propose to include under PQRS in 2013 or 2014:
• Chronic Wound Care: Use of Compression System in Patients with Venous Ulcers. One commenter states that the MAP recommended that the measure be submitted for NQF endorsement.
• Health Information Technology (HIT): Adoption/Use of Electronic Health Records (EHR).
One commenter suggested that this measure be retained until a majority of eligible professionals have adopted EHR systems. Another commenter disagreed with CMS' contention that this measure is redundant to have an eligible professional report on whether or not s/he has adopted an EHR. The commenter believed that the measure is only redundant in the instances where the eligible professional is using direct EHR reporting. The commenter suggested that CMS follow the same protocol as other PQRS measures by designating measure #124 available only to those eligible professional who report using claims or registry reporting.
With respect to the commenter's request that this measure be retained until a majority of eligible professionals have adopted EHR systems, we do not believe we need to retain this measure for reporting for this purpose as we are encouraging eligible professionals to adopt EHR systems in other ways. For example, we are aligning our EHR reporting criteria with the criteria for meeting the CQM component of meaningful use such that eligible professionals reporting quality measures data via an EHR may satisfy the requirements for satisfactory reporting under PQRS and achieving meaningful use under the EHR Incentive Program by submitting one set of data.
With respect to the commenter who disagreed that the measure is redundant, we respectfully disagree with the commenter. Measures in PQRS generally provide that the eligible professional perform some sort of clinical quality action. For example, with respect to the HHS Million Hearts measure set that we are finalizing, the measure set indicates that an eligible professional asks certain questions of beneficiaries and perform certain procedures that we believe would help prevent heart disease. This measure does not do this; rather, the measure merely asks the eligible professional in indicate to CMS whether or not the eligible professional has adopted an EHR system. We do not believe this measure provides meaningful information to CMS anymore, as there are other PQRS requirements and CMS programs that more appropriately address the adoption and use of EHR systems. For these reasons, we will not extend the reporting of this measure for claims or registry-based reporting as the commenter requested.
• Stroke and Stroke Rehabilitation: Computed Tomography (CT) and Magnetic Resonance Imaging (MRI).
• Coronary Artery Disease (CAD): Symptom and Activity Assessment.
The commenter is concerned that this measure is paired with PQRS Measure #242 (CAD: Symptom Management), and therefore should be remain in PQRS for reporting to coincide with the reporting of measure #242.
We prioritize the recommendation the MAP provides for the inclusion of measures in the PQRS measure set over our desire to retain the manner we have suggested that eligible professionals reporting these CAD measures in 2012. Since this measure was reviewed by the MAP and not recommended for inclusion in the PQRS measure set beginning 2013, we are not retaining this measure for reporting in PQRS. Measure #242 will therefore be reportable as a standalone measure. The description on how to report Measure #242 will be found in the Measures Specifications Manual that will be published for 2013 that will be available on the PQRS Web site at
• Emergency Medicine: Community-Acquired Pneumonia (CAP): Assessment of Oxygen Saturation.
• Referral for Otologic Evaluation for Patients with Acute or Chronic Dizziness.
The commenter urged CMS to consider retiring Measure 188: Referral for Otologic Evaluation for Patients with Congenital or Traumatic Deformity of the Ear in lieu of retiring Measure 190: Referral for Otologic Evaluation for Patients with Acute or Chronic Dizziness, because Measure 100 relates to a relatively uncommon condition seen in audiology practices.
• Emergency Medicine: Community-Acquired Pneumonia (CAP): Assessment of Mental Status.
• Heart Failure: Patient Education.
• Hypertension (HTN): Plan of Care.
• Hypertension (HTN): Blood Pressure Measurement.
• Prostate Cancer: Three Dimensional (3D) Radiotherapy.
• Heart Failure: Warfarin Therapy for Patients with Atrial Fibrillation.
• Preventive Care and Screening: Unhealthy Alcohol Use—Screening.
With respect to the individual measures we proposed to include for reporting in PQRS beginning in 2013 or 2014, we did not receive public comments on a majority of the measures we proposed for inclusion in PQRS (specific measures we did receive comments on are addressed below). Therefore, based on the reasons previously stated in the CY 2013 PFS proposed rule, we are finalizing these measures, as proposed. These measures either meet the requirement that the measures available in the PQRS measure set be NQF endorsed or address an exception to NQF endorsement, such as filling a gap in the PQRS measure set. The following is a summary of the comments we did receive on certain proposed individual measures:
• Melanoma: Coordination of Care—The inclusion of this measure would expand the number of measures relevant to dermatologists.
• Melanoma: Continuity of Care—Recall System—The inclusion of this measure would expand the number of measures relevant to dermatologists.
• Melanoma: Overutilization of Imaging Studies in Melanoma—The inclusion of this measure would expand the number of measures relevant to dermatologists.
For the following measures, one commenter supported the following proposed measures for inclusion in PQRS as they are relevant to ophthalmologists:
• Age-Related Macular Degeneration (AMD): Dilated Macular Examination.
• Diabetic Retinopathy: Documentation of Presence or Absence of Macular Edema and Level of Severity of Retinopathy.
• Diabetic Retinopathy: Communication with the Physician Managing On-going Diabetes Care.
One commenter applauds the decision to incorporate the following measures for reporting in PQRS:
• Cardiac Stress Imaging Not Meeting Appropriate Use Criteria: Preoperative Evaluative in Low-Risk Surgery Patients.
• Cardiac Stress Imaging Not Meeting Appropriate Use Criteria: Routine Testing After Percutaneous Coronary Intervention (PCI).
• Cardiac Stress Imaging Not Meeting Appropriate Use Criteria: Testing in Asymptomatic, Low-Risk Patients.
The commenter believes these measures collect data on three most common areas on inappropriate imaging, allowing CMS to more accurately capture information on the overall value of cardiac diagnostic imaging for beneficiaries. Another commenter specifically supported the measure titled “Cardiac Stress Imaging Not Meeting Appropriate Use Criteria: Testing in Asymptomatic, Low-Risk Patients.”
• Participation by a Hospital, Physician or Other Clinician in a Systematic Clinical Database Registry that Includes Consensus Endorsed Quality.
• Atrial Fibrillation and Atrial Flutter: Chronic Anticoagulation Therapy—The commenter also requested that the measure owner information on this measure should be updated to indicate that AMA-PCPI/ACCF/AHA is the current measure owner.
• Pediatric Kidney Disease: Adequacy of Volume Management—The commenter also requested that the measure owner information on this measure should be updated to indicate that AMA-PCPI is the current measure owner.
• Adult Major Depressive Disorder (MDD): Coordination of Care of Patients With Co-morbid Conditions.
However, the commenter opposed our proposal that this measure be paired, since the measure owner did not support the following second part of the measure: “who have a follow-up attempt within 60 days of original communication by the physician treating MDD to elicit a response from the other physician.”
• Referral for Otologic Evaluation for Patients with Congenital or Traumatic Deformity of the Ear.
The commenter requests retiring this measure in lieu of retiring Measure 190: Referral for Otologic Evaluation for Patients with Acute or Chronic Dizziness, because Measure 100 relates to a relatively uncommon condition seen in audiology practices.
• Diabetic Retinopathy: Communication with the Physician Managing On-going Diabetes Care
Since the activity addressed in the measure relates to communication and coordination with diabetes patients, the measure is more appropriately classified in the Care Coordination domain.
Please note that we are making the following changes to certain proposed measures for the following reasons:
A list of the measures we are finalizing for PQRS beginning in 2013 or 2014 is contained in Table 95. Please note that the titles of the measures may change slightly from CMS program and/or CMS program year based on specifications updates. We intend to continue to work toward complete alignment of measure specifications across programs whenever possible.
We have previously discussed our measure proposals for group practices using the GPRO web interface in the proposed rule (77 FR 44954). A summary of these proposed measures for group practices using the GPRO web interface can be found in Table 35 of the CY 2013 PFS proposed rule (77 FR 44960). We proposed (77 FR 44959) 18 measures—including 2 composite measures for diabetes (5 component measures) and CAD (2 component measures), for a total of 22 measures—for reporting under the PQRS using the GPRO web interface for 2013 and beyond to align with the quality measures available for reporting under the Medicare Shared Savings Program (76 FR 67890). Because of our desire to align with measures available for reporting under the Medicare Shared Savings Program, we did not propose to retain the 13 measures specified in Table 36 of the CY 2013 PFS proposed rule for purpose of reporting via the GPRO web interface beginning in 2013 (77 FR 44963). We invited public comment on the proposed PQRS quality measures available for reporting under the GPRO web interface for 2013 and beyond. We did not receive public comment on a majority of the measures we proposed for reporting in the GPRO web interface. The following is a summary of the comments we did receive regarding the proposed measures for the GPRO web interface:
We also proposed to have the following measure available for reporting occurring in 2013 and beyond: CG-CAHPS Clinician/Group Survey: Getting timely care, appointments and information; How well your doctors communicate; Patients' rating of doctor; Access to specialists; Health promotion and education; Shared decision making; Courteous and helpful office staff; Care coordination; Between visit communication; Educating patients about medication adherences; and Stewardship of patient resources (77 FR 44964).
The final measures available for reporting using the GPRO web interface beginning in 2013 and listed in Table 96:
We proposed the following 20 measures groups for reporting in the PQRS beginning with reporting periods occurring in 2013: Diabetes Mellitus; Chronic Kidney Disease (CKD); Preventive Care; Coronary Artery Bypass Graft (CABG); Rheumatoid Arthritis (RA); Perioperative Care; Back Pain; Hepatitis C; Heart Failure (HF); Coronary Artery Disease (CAD); Ischemic Vascular Disease (IVD); HIV/AIDS; Asthma; Chronic Obstructive Pulmonary Disease (COPD); Inflammatory Bowel Disease (IBD); Sleep Apnea; Dementia; Parkinson's Disease; Hypertension; Cardiovascular Prevention; and Cataracts (77 FR 44964). These 20 proposed measures groups are also available for reporting under the PQRS in 2012.
Beginning in 2013, we proposed the oncology measures group for reporting under the PQRS that provides measures available for reporting related to breast cancer and colon cancer. We believe it is important to measure cancer care (77 FR 44964).
We proposed the following 4 measures groups for inclusion in the PQRS beginning with reporting periods occurring in 2014: Osteoporosis; Total Knee Replacement; Radiation Dose; and Preventive Cardiology. These measures groups address conditions that the measures groups established in 2012 do not address.
Therefore, we proposed to finalize a total of 26 measures groups for inclusion in PQRS.
We invited public comment on these proposed PQRS measures groups. The following is a summary of the comments we received regarding these proposed measures groups:
In addition, in 2012, the PQRS included a community-acquired pneumonia (CAP) measures group among others. We did not propose to include this measures group again in the PQRS measure set for the 2013 PQRS or subsequent years because measures contained within this measures group were not recommended for retention by the Measure Applications Partnership. We received no comments regarding our decision not to continue inclusion this measures group for reporting in PQRS beginning in 2013.
We also proposed, as identified in Table 47 of the CY 2013 PFS proposed rule, to change the composition of the Coronary Artery Disease (CAD) measures group from what was finalized for 2012 (77 FR 44970). Specifically, we proposed to remove PQRS measure #196: Coronary Artery Disease (CAD): Symptom and Activity Assessment and replace this measure with PQRS measure #242: Coronary Artery Disease (CAD): Symptom Management in the CAD measures group, because the measure #196 was not recommended for retention by the Measure Applications Partnership (77 FR 44964). On the other hand, measure #242 was recommended for retention by the Measure Applications Partnership. We received no comments regarding our proposal to change the composition of the CAD measures group. Therefore, we are finalizing the CAD measures group, as proposed.
Based on the comments received and for the reasons previously stated, we are finalizing the following 26 measures groups indicated in Tables 97 through 122. Descriptions of the measures within each measures group are provided in Tables 97 through 122. Please note that some of the proposed measures included within a final PQRS quality measures group may also be available for reporting as an individual measure. In addition, please note that the Osteoporosis and Preventive Cardiology measures groups contain composite measures. Since composite measures must be reported as a group, similar to reporting measures within a measures group, we felt it was appropriate to classify these two composite measures as measures groups.
We proposed 19 measures—including 15 process and 4 outcome measures derived from administrative claims—for eligible professionals and group practices that report using administrative claims for the 2015 and 2016 payment adjustments (see Table 63 of the CY 2013 PFS proposed rule, 77 FR 44981). Our proposals on how to attribute beneficiaries to groups of physicians that elect the administrative claims option were discussed in the value-based payment modifier in section III.K. of the proposed rule. We considered all of the 28 process measures included in the program year 2010 individual Physician Feedback reports that can be calculated using administrative claims but proposed only a subset of the measures that were included in the program year 2010 individual Physician Feedback reports. We proposed this subset of measures for both the PQRS payment adjustment and the value-based modifier because we believe these measures are clinically meaningful, focus on highly prevalent conditions among beneficiaries, have the potential to differentiate physicians, and be statistically reliable (77 FR 44980). We also sought comment on whether to include any of the remaining 13 measures included in the program year 2010 individual Physician Feedback Reports (77 FR 44998) (see Table 65 of the CY 2013 PFS proposed rule, 77 FR 45000). The utilization of the administrative claims measures will allow PQRS to implement different reporting options which capture a wider venue of participants without using the traditional methods of reporting.
We invited public comment on these proposed measures. The following is a summary of the comments we received regarding the proposed measures for eligible professionals and group practices that report using the administrative claims-based reporting mechanism for the 2015 and/or 2016 PQRS payment adjustments. Please note that, since we are not finalizing an administrative claims-based reporting option for the 2016 PQRS payment adjustment, they will only be available for the purpose of reporting for the 2015 PQRS payment adjustment.
We are not finalizing NQF 0021 measure titled “Annual Monitoring for Beneficiaries on Persistent Medications,” for the Administrative Claims option. The measure steward, NCQA, has withdrawn this measure from consideration during NQF Steering Committee review and will update and resubmit the measure at a later date. Instead, we will substitute NQF 0022 “Use of High Risk Medicines in the
A substantial number of commenters from the consumer advocacy and physician value community supported all four of the outcome measures as moving quality measurement in the forward direction and in particular singled out the use of composite scores as a method to increase reliability.
We believe an effective Administrative Claims option and a meaningful value-based payment modifier in the long-run will place greater emphasis on outcome measures and we believe it is important to include outcome measures that highlight key areas for achieving better care for beneficiaries.
With regard to the suggestions to replace these outcome measures for four recently endorsed AMA-PCPI care coordination measures that were recently NQF endorsed, we note that these suggested care coordination measures are all process measures, and they will be considered for the claims option of the PQRS program in 2014 in future rulemaking.
Therefore, based on the comments received, as specified in Tables 123 and 124, we are finalizing 17 measures, comprised of 14 process and 3 outcome measures (2 of which are PQI composite measures), for inclusion in the PQRS administrative claims-based measure set for reporting for the 2015 PQRS payment adjustment only.
We proposed that new and previously qualified entities wishing to become qualified to provide their members with an opportunity to earn the 2013 and/or 2014 Maintenance of Certification Program incentives undergo a self-nomination and qualification process (77 FR 44982). Once qualified, we proposed that the entity would be able to submit data on behalf of its eligible professionals.
• Provide detailed information regarding the Maintenance of Certification Program with reference to the statutory requirements for such program.
• Indicate the organization sponsoring the Maintenance of Certification Program, and whether the Maintenance of Certification Program is sponsored by an American Board of Medical Specialties (ABMS) board. If not an ABMS board, indicate whether and how the program is substantially equivalent to the ABMS Maintenance of Certification Program process.
• Indicate that the program is in existence as of January 1 the year prior to the year in which the entity seeks to be qualified for the Maintenance of Certification Program incentive. For example, to be qualified for the 2013 Maintenance of Certification Program incentive, the entity would be required to be in existence by January 1, 2012.
• Indicate that the program has at least one (1) active participant.
• The frequency of a cycle of Maintenance of Certification for the specific Maintenance of Certification Program of the sponsoring organization, including what constitutes “more frequently” for both the Maintenance of Certification Program itself and the practice assessment for the specific Maintenance of Certification Program of the sponsoring organization.
• Confirmation from the board that the practice assessment will occur and be completed in the year the physician is participating in the Maintenance of Certification Program Incentive.
• What was, is, or will be the first year of availability of the Maintenance of Certification Program practice assessment for completion by an eligible professional.
• What data is collected under the patient experience of care survey and how this information would be provided to CMS.
• Describe how the Maintenance of Certification program monitors that an eligible professional has implemented a quality improvement process for their practice.
• Describe the methods, and data used under the Maintenance of Certification Program, and provide a list of all measures used in the Maintenance of Certification Program for the year prior to which the entity seeks to be qualified for the Maintenance of Certification Program incentive (for example, measures used in 2012 for the 2013 Maintenance of Certification Program incentive), including the title and descriptions of each measure, the owner of the measure, whether the measure is NQF endorsed, and a link to a Web site containing the detailed specifications of the measures, or an electronic file containing the detailed specifications of the measures.
We invited but received no public comment on our proposed self-nomination process for entities who wish to be qualified for the 2013 and 2014 Maintenance of Certification Program incentive. Therefore, we are finalizing the self-nomination process for boards wishing to participate in the Maintenance of Certification Program incentive, as proposed.
• The name, NPI and applicable TINs of eligible professionals who would like to participate for the 2013 and/or 2014 Maintenance of Certification Program incentives.
• Attestation from the board that the information provided to CMS is accurate and complete.
• The board has signed documentation from eligible professional(s) that the eligible professional wishes to have the information released to us.
• Information from the patient experience of care survey.
• Information certifying the eligible professional has participated in a Maintenance of Certification Program for a year, “more frequently” than is required to qualify for or maintain board certification status, including the year the physician met the board certification requirements for the Maintenance of Certification Program, and the year the eligible professional participated in the Maintenance of Certification Program “more frequently” than is required to maintain or qualify for board certification.
• Information certifying the eligible professional has completed the Maintenance of Certification Program practice assessment at least one time each year the eligible professional participates in the Maintenance of Certification Program Incentive.
We proposed this self-nomination and qualification process because the process is identical to the self-nomination and qualification process finalized for the 2011 and 2012 Maintenance of Certification Program incentives and we felt such requirements remain appropriate. Because the incentives only run through 2014, we felt it was important to keep the requirements consistent with what has been required for the 2011 and 2012 Maintenance of Certification Program incentives.
We invited public comment on the proposed qualification process for entitles entities who wish to be qualified for the 2013 and 2014 Maintenance of Certification Program incentive. The following is summary of the comments we received regarding these proposals.
Based on the comments received and for the reasons discussed above, we are finalizing the qualification process for boards wishing to become qualified to participate in the Maintenance of Certification Program incentive. However, boards that were previously qualified as a Maintenance of Certification Program entity or newly participating boards that utilize a previously qualified registry for their Maintenance of Certification Program data will not need to undergo the qualification process annually. Rather, these entities will be qualified after these entities complete their self-nomination statements. However, please note that previously qualified boards or boards that use a previously qualified registry must still self-nominate to participate in the Maintenance of Certification Program incentive for each year the boards wish to participate. For boards wishing to newly become qualified, we note that, due to a delay in the availability of the testing tool to qualify the boards, this qualification process will occur later in time for 2013. Please note that we are also making technical changes in § 414.90(d) due to changes in the composition of § 414.90(c) to specify the incentive amounts for the 2013 and 2014 PQRS incentives. We are also making a technical change at § 414.90(d)(1)(iii)(B)(2)(i), as this section incorrectly references (d)(2)(11); the correct reference is (d)(1)(iii).
We established an informal review process for 2012 and beyond in the CY 2012 Medicare PFS final rule (76 FR 73390). In this final rule with comment period, we addressed the additional parameters we proposed for eligible professionals and group practices subject to a PQRS payment adjustment requesting an informal review. For eligible professionals and group practices that are subject to the payment adjustments that wish to request an informal review, in addition to the requirements we previously established, we proposed the following:
• An eligible professional electing to utilize the informal review process must request an informal review by February 28 of the year in which the payment adjustment is being applied. For example, if an eligible professional requests an informal review related to the 2015 payment adjustment, the eligible professional would be required to submit his/her request for an informal review by February 28, 2015. We felt this deadline provided ample time for eligible professionals and group practices after their respective claims begin to be adjusted due to the payment adjustment.
• Where we find that the eligible professional or group practice did satisfactorily report for the payment adjustment, we would to cease application of the payment adjustment and reprocess all claims that have been erroneously adjusted to date (77 FR 44983).
We invited public comment on our proposals for the PQRS informal review process. The following is a summary of the comments we received regarding the proposed additional parameters for the PQRS informal review process.
Based on the comments received and for the reasons stated previously, we are finalizing these additional parameters for the PQRS informal review process as it relates to the PQRS payment adjustments. We are finalizing changes to § 414.90 to reflect the PQRS informal review process for the PQRS incentives and payment adjustments.
We established the requirements for the 2013 and 2014 eRx Incentive Program in the CY 2012 Medicare PFS final rule (76 FR 73393). This section addresses additional final requirements for the 2013 and 2014 eRx Incentive Program.
Please note that, during the comment period following the proposed rule, we received comments that were not related to our specific proposals for the eRx Incentive Program in the CY 2013 Medicare PFS proposed rule. While we appreciate the commenters' feedback and intend to use these comments to better develop the eRx Incentive Program, these comments will not be specifically addressed in this CY 2013 Medicare PFS final rule.
Under § 414.92(b) a group practice is one that, defined at § 414.90(b), that is participating in the Physician Quality Reporting System; or in a Medicare-approved demonstration project or other Medicare program, under which Physician Quality Reporting System requirements and incentives have been incorporated; and has indicated its desire to participate in the electronic prescribing group practice option. Please note that the definition of group practice for the eRx Incentive Program is therefore tied to the definition of group practice under PQRS. Since we are changing the definition of group practice in PQRS to allow groups of 2-24 eligible professionals to participate
In addition, we would like to clarify the requirement under § 414.92(b) that a group practice under the eRx Incentive Program must be “participating in the Physician Quality Reporting System”. We developed this definition in light of our goals for group practices to report under both programs, as well as operational considerations for administering the group practice reporting option under the PQRS and ERx Incentive Program. In particular, we expect that group practices participating in the eRx Incentive Program as a group practice will also be participating in PQRS as a group practice. With regard to “participation,” we note that we have never required nor indicated that group practices under the eRx GPRO must report PQRS quality measures to demonstrate participation in the PQRS for purposes of this definition. In the past, we have required that group practices wishing to participate in the eRx Incentive Program under the group practice reporting option (eRx GPRO) must complete a self-nomination statement stating the group practice's intent to participate in PQRS as a group practice. We have viewed that as an example of “participation.” However, because we believe submission of a self-nomination statement for PQRS as an extra administrative step we have required in order for group practices to participate in the eRx GPRO, in 2013, we no longer view completion of a self-nomination statement to participate in PQRS under the PQRS group practice reporting option (PQRS GPRO) as necessary to demonstration “participation” by group practices under the eRx Incentive Program. Therefore, the statement to be “participating in the Physician Quality Reporting System” is merely an indication but not a requirement that we expect that group practices participating in the eRx Incentive Program as a group practice will also be participating in PQRS as a group practice.
In the CY 2012 Medicare PFS final rule (76 FR 73394), we established that a group practice wishing to participate in the eRx Incentive Program under the eRx GPRO must self-nominate via the web. However, we proposed an alternative submission mechanism for self-nomination by groups participating in the Medicare Shared Savings Program, Pioneer ACO, PGP Demonstration, or other Medicare-approved demonstration project or other Medicare program (77 FR 44983). Specifically, we proposed that the participating TINs within these groups that wish to participate in the eRx Incentive Program using the eRx GPRO would be required to submit a self-nomination statement by sending a letter indicating its intent to participate in the eRx Incentive Program under the eRx GPRO. We also proposed that the group practice would be required to submit an XML file describing the eligible professionals included in the group practice. We proposed this alternative submission mechanism for group practices that are participating as groups in the Medicare Shared Savings Program, Pioneer ACO, or PGP Demonstration because it is not technically feasible for CMS to receive this information from these group practices via the web. We invited public comment on this proposed alternative mechanism for submitting self-nomination statements for groups participating in the Medicare Shared Savings Program, Pioneer ACO, and PGP demonstration and the proposed requirement to provide an XML file to CMS for the types of group practices identified above that want to participate in the eRx Incentive Program using the eRx GPRO. We received no comments regarding these proposed alternative methods related to the self-nomination process for group practices participating in the Medicare Shared Savings Program, Pioneer ACO, and PGP demonstration that wish to participate in the eRx Incentive Program using the eRx GPRO. Therefore, we are finalizing an alternative self-nomination process for these aforementioned groups. However, as we believe that it would be more efficient to accept self-nomination statements electronically, we will not accept these self-nomination statements via U.S. mail. Rather, we will accept these self-nomination statements via email. We are also not finalizing the requirement that these group practices provide an XML file to CMS. The XML file typically provides CMS with a list of the eligible professionals (defined by their individual rendering National Provider Identification numbers or NPIs) within the group practice. Since we do not need NPI-level information to analyze group practice reporting, we no longer need this XML file.
In addition, in the CY 2012 PFS final rule with comment period, we stated we would accept self-nomination statements for group practices that want to participate in the GPROs for PQRS and the eRx Incentive Program via the web (76 FR 73315 and 76 FR 73394). We note that this Web page is only available for those group practices who wish to submit a self-nomination statement to participate in both the PQRS and eRx Incentive Program under the respective GPROs. Therefore, it will not be technically feasible to accept self-nomination statements via this Web page from group practices who wish to submit a self-nomination statement to participate in the eRx GPRO only. Group practices wishing to submit a separate GPRO self-nomination statement to participate in the eRx Incentive Program only must follow the alternative self-nomination process that group practices participating in the Medicare Shared Savings Program using the eRx GPRO follow (76 FR 73395).
We also note that, in the CY 2012 Medicare PFS final rule, we established a deadline of January 31 of the applicable program year (for example, January 31, 2013 for the 2013 program year) for group practices to submit a self-nomination statement to participate in the eRx GPRO (76 FR 73316). Although, as discussed in section III.G, we have extended the deadline for group practices wishing to participate in the GPRO in PQRS to the Fall of the applicable program year (for example, Fall 2013 for the 2013 program year), for operational reasons, group practices wishing to participate in the eRx Incentive Program under the eRx GPRO for 2013 must submit its self-nomination statement by January 31, 2013 as finalized in the CY 2012 Medicare PFS final rule. We understand that having two separate deadlines for submitting GPRO self-nomination statements for PQRS and the eRx Incentive Program may cause confusion for group practices who have submitted self-nomination statements for PQRS and eRx simultaneously in previous years. However, because the 2014 6-month payment adjustment reporting period (that is, January 1, 2013-June 30, 2013) occurs prior to Fall 2013, we must maintain a deadline of January 31, 2013 for those group practices wishing to participate in the eRx Incentive Program as a group practice using the eRx GPRO for reporting periods occurring 2013.
We realize that having two separate self-nomination dates of January 31, 2013 and Fall 2013 for self-nominating to participate in the GPRO for the eRx Incentive Program and PQRS respectively may cause additional administrative concerns, such as situations where a group practice may change its TIN between June 30, 2013
We proposed to add another criterion for becoming a successful electronic prescriber under the program for the 2013 Incentive for groups of 2-24 eligible professionals that may now participate in the eRx Incentive Program using the eRx GPRO in 2013 (77 FR 44983-44984). (For the other criteria we previously adopted for the eRx GPRO, please see 76 FR 73407). Specifically, we proposed the following criterion for being a successful electronic prescriber for group practices participating in the eRx GPRO comprised of 2-24 eligible professionals for purposes of the 2013 eRx incentive: Report the electronic prescribing measure's numerator code during a denominator-eligible encounter for at least 225 times during the 12-month 2013 incentive reporting period (January 1, 2013-December 31, 2013). We proposed a lower criterion for group practices participating under the eRx GPRO with 2-24 eligible professionals because we understand that their smaller sizes necessitate a lower reporting threshold. We proposed this reporting threshold because this reporting threshold is familiar to group practices, as this was the threshold established for group practices comprised of 11-25 eligible professionals that participated in the GPRO II in 2011 (75 FR 73509).
We invited public comment on our proposed criterion for being a successful electronic prescriber for the 2013 incentive for groups comprised of 2-24 eligible professionals. The following is a summary of the comments we received on this proposal.
For the suggestion to adopt a percentage threshold, we prefer to establish a reporting count as the established criteria for becoming a successful electronic prescriber for larger groups utilize a reporting count rather than a percentage. Therefore, we would like to remain consistent in the reporting criteria that were previously established for larger group practices participating in the eRx GPRO.
For the tiered approach, we believe that adding several tiers for reporting for smaller group practices would add to the complexity of the eRx Incentive Program. To streamline the requirements for becoming a successful electronic prescriber for the eRx Incentive Program, we prefer one criterion for all group practices of 2-24 eligible professionals using the eRx GPRO. We believe that the proposed threshold of 75 offered by commenters is reasonable, particularly because the eRx Incentive Program previously required group practices of 2-10 eligible professionals participating in the eRx GPRO II to report the electronic prescribing measure at least 75 times (75 FR 73509). We note that our proposed threshold of reporting the electronic prescribing measure was also consistent with criteria we established under GPRO II in 2011, but we understand the desire to lower the threshold to 75. We believe that the reporting threshold of 75 also achieves the program goal of ensuring that eligible professionals are generating prescriptions electronically. Therefore, based on the comments received, we are finalizing a lower threshold for reporting the electronic prescribing measure of 75 rather than 225. To be a successful electronic prescriber for the 2013 incentive, group practices comprised of 2-24 eligible professionals that are participating in the eRx GPRO must report the electronic prescribing measure at least 75 times during the applicable 12-month reporting period (that is, January 1, 2013-December 31, 2013) for the 2013 incentives.
We proposed to change the minimum group practice size from 25 to 2 accordingly with PQRS and proposed to add another criterion for being a successful electronic reporter under the program for the 2014 payment adjustment (77 FR 44984). (For the other criteria we previously adopted for the eRx GPRO Reporting Option, please see 76 FR 73412-73414). Specifically, we proposed the following criterion for being a successful electronic prescriber for purposes of the 2014 payment adjustment for group practices comprised of 2-24 eligible professionals participating under the eRx GPRO: Report the electronic prescribing measure's numerator code at least 225 times for the 6-month 2014 payment adjustment reporting period (January 1, 2013-June 30, 2013). We proposed this lower criterion for group practices participating under the eRx GPRO with 2-24 eligible professionals because we understand that their smaller sizes necessitate a lower reporting threshold. In addition, we noted that this reporting threshold is familiar to group practices, as this was the threshold established for group practices comprised of 11-25 eligible professionals that participated in the GPRO II in 2011 (75 FR 73509).
We invited public comment on the proposed criterion for being a successful electronic prescriber for the 2014 eRx payment adjustment for the 6-month payment adjustment reporting period for group practices composed of 2-24 eligible professionals. The following is a summary of comments we received regarding this proposal.
In addition to these comments, some commenters supported our proposed criteria to report the electronic prescribing measure at least 225 times to become a successful electronic prescriber for the 2013 incentive but believed that this 225 threshold is too high for the 2014 payment adjustment, as group practices will only have 6 months as opposed to 12 months to meet this threshold. The commenters added that the threshold is especially high for dermatologists who may not see this many Medicare Part B patients during the 6-month 2014 payment adjustment reporting period.
We understand that, in certain instances, it is permissible for an eligible professional to have their Medicare Part B claims reprocessed. However, we raised concerns about eligible professionals resubmitting claims for the sole reason of attaching a G-code for purposes of reporting under the eRx Incentive Program (rather than reporting such data at the time the claim was initially submitted). Therefore, we proposed to modify § 414.92 to indicate that under the eRx Incentive Program, if an eligible professional re-submits a claims for reprocessing, the eligible professional may not attach a G-code at that time. The following is a summary of comments we received on this proposal.
Section 1848(a)(5)(B) of the Act provides that the Secretary may, on a case-by-case basis, exempt an eligible professional from the application of the payment adjustment, if the Secretary determines, subject to annual renewal, that compliance with the requirement for being a successful electronic prescriber would result in a significant hardship. In the CY 2012 final rule with comment period, we finalized, as set forth at § 414.92(c)(2)(ii)(B), four circumstances under which an eligible professional or eRx GPRO can request consideration for a significant hardship exemption for the 2013 and 2014 eRx payment adjustments (76 FR 73413):
• The eligible professional or group practice practices in a rural area with limited high speed internet access.
• The eligible professional or group practice practices in an area with limited available pharmacies for electronic prescribing.
• The eligible professional or group practice is unable to electronically prescribe due to local, state, or Federal law or regulation.
• The eligible professional or group practice has limited prescribing activity, as defined by an eligible professional generating fewer than 100 prescriptions during a 6-month reporting period.
We have received feedback from stakeholders requesting significant hardship exemptions from application of the payment adjustment based on participation in the EHR Incentive Program, a program which requires a certain level of electronic prescribing activity. Under the EHR Incentive Program, eligible professionals
• Eligible professionals or group practices who achieve meaningful use during certain eRx payment adjustment reporting periods.
• Eligible professionals or group practices who demonstrate intent to participate in the EHR Incentive Program and adoption of Certified EHR Technology.
The following is a summary of general comments we received regarding our proposal to add these two additional significant hardship exemption categories for the 2013 and 2014 payment adjustments:
With respect to the argument that eligible professionals have had adequate time to acquire systems capable for electronic prescribing, we note that although the eRx Incentive Program was established in 2009, and has transitioned from bonus incentives to payment adjustments beginning in 2012, we believe that with the establishment of the EHR Incentive Program, which also includes an electronic prescribing objective, eligible professionals and group practices choosing to participate in the eRx Incentive Program and the EHR Incentive Program may have had difficulties with regard to searching for products that had the capabilities to meet requirements for both programs. As we noted in the proposed rule (77 FR 44984), we received stakeholder feedback regarding the difficulties of choosing, purchasing, and setting up an EHR system that is capable for use for both programs. Therefore, we believe that these significant hardship exemption categories are appropriate for eligible professionals and group practices such as these.
Under Stage 1 of meaningful use for the EHR Incentive Program, an eligible professional is required to meet certain objectives and associated measures to achieve meaningful use. One of these objectives is for the eligible professional to generate and transmit permissible prescriptions electronically, and the measure of whether the eligible professional has met this objective is more than 40 percent of all permissible prescriptions written by the eligible professional are transmitted electronically using Certified EHR Technology (§ 495.6(d)(4)). We note that the EHR Incentive Program and the eRx Incentive Program share a common goal of encouraging electronic prescribing and the adoption of technology that enables eligible professionals to electronically prescribe. This goal is advanced under each program via the respective program requirements—the electronic prescribing objective under the EHR Incentive Program and the requirement that an EP be a “successful electronic prescriber” under the eRx Incentive Program. Indeed, both programs require that the eligible professionals indicate their electronic prescribing activity. Under the EHR Incentive Program, an eligible professional must attest to the percentage of his or her permissible prescriptions that were generated and transmitted electronically using Certified EHR Technology during the applicable EHR reporting period, which must exceed 40 percent. Under the eRx Incentive Program, to avoid the payment adjustment, an eligible professional must be a successful electronic prescriber, which is achieved by the reporting of the eRx quality measure a certain number of instances during the applicable reporting period (each instance of reporting of the eRx quality measure, which includes reporting of specific quality data codes, signifies that the professional generated an electronic prescription for a specified service or encounter). In most cases, we believe the electronic prescribing objective of meaningful use would be a more rigorous standard for eligible professionals to meet than the standard adopted under the eRx Incentive Program (as demonstrated via the reporting of the eRx quality measure). In addition, there seems to be no added benefit with regard to reporting (presumably lower) electronic prescribing activity under the eRx Incentive Program given that the identical goals (encouraging electronic prescribing) of both programs would have been fulfilled through the eligible professional's achievement of meaningful use. For those reasons, we believe it may pose a significant hardship for eligible professionals who are meaningful EHR users to additionally comply with the requirements of being a successful electronic prescriber under the eRx Incentive program.
For the reasons stated, under this proposed significant hardship category, we proposed that individual eligible professionals (and every eligible professional member of a group practice using the eRx GPRO for the 2014 payment adjustment only) would need to achieve meaningful use of Certified EHR Technology for a continuous 90-day EHR reporting period (as defined for the EHR Incentive Program) that falls within the 6-month reporting period (January 1-June 30, 2012) for the 2013 eRx payment adjustment or the 12- or 6-month reporting periods (January 1-December 31, 2012 or January 1-June 30, 2013, respectively) for the 2014 eRx payment adjustment to be eligible for this significant hardship exemption (77 FR 44985). We also proposed that for purposes of the 2013 and 2014 eRx payment adjustments this hardship exemption category would apply to individual EPs and group practices (that is, every member of the group) who instead achieve meaningful use of Certified EHR Technology for an EHR reporting period that is the full CY 2012.
We invited public comment on this proposed significant hardship exemption category. The following is a summary of the comments received related to the proposed significant hardship exemption category: Eligible professionals or group practices who achieve meaningful use during the 2013 and 2014 payment adjustment reporting periods.
We cannot expand this significant hardship exemption category for the 2014 payment adjustment to include eligible professionals who achieve meaningful use during the last 6 months of 2013 (July 1, 2013-December 31, 2013) because the last 6 months of 2013 do not coincide with the 2014 payment adjustment reporting period.
Based on the comments received and for the reasons previously stated, we are finalizing this significant hardship exemption category—eligible professionals or group practices who achieve meaningful use during the 2013 and 2014 payment adjustment reporting periods—as follows: To qualify for a significant hardship exemption under this category for the 2013 payment adjustment, an eligible professional (or every eligible professional in a group practice participating in the eRx GPRO for the 2013 payment adjustment) must have achieved meaningful use of Certified EHR Technology under the EHR Incentive Program for a continuous 90-day EHR reporting period that fell within the 12-month (January 1, 2011-December 31, 2011) or 6-month (January 1, 2012-June 30, 2012) payment adjustment reporting period or for an EHR reporting period that is the full CY 2012. To qualify for a significant hardship exemption under this category for the 2014 payment adjustment, an eligible professional (or every eligible professional in a group practice participating in the eRx GPRO) must achieve meaningful use of Certified EHR Technology under the EHR Incentive Program for a continuous 90-day EHR reporting period that falls within the 12-month (January 1, 2012-December 31, 2012) or 6-month (January 1, 2013-June 30, 2013) payment adjustment reporting period or for an EHR reporting period that is the full CY 2012.
We note that we finalized at § 414.92(c)(2)(ii)(A)(
When an eligible professional or eligible professional in a group practice first adopts CEHRT, we understand significant changes may be required with regard to how the eligible professional's practice operates. Further, necessary steps are involved in fully implementing CEHRT once it has been adopted, including: Installation, configuration, customization, training, workflow redesign and the establishment of connectivity with entities that facilitate electronic health
Therefore, for the 2013 and 2014 payment adjustments, we proposed a significant hardship exemption category to address this situation (77 FR 44985). We believe, however, that for this category it is necessary for eligible professionals and group practices to show they intend to participate in the EHR Incentive Program for the first time and have adopted CEHRT. Therefore, to be eligible for consideration for an exemption under this proposed significant hardship exemption category for the 2013 and 2014 payment adjustments, we proposed that eligible professionals or group practices must register to participate in the Medicare or Medicaid EHR Incentive Programs and adopt CEHRT by a date specified by CMS. We further note that, given the nature of the significant hardship at issue under this category, this proposal would be limited to eligible professionals and group practices (that is, every individual eligible professional of the group practice): (1) Who have not previously adopted CEHRT or received an incentive payment under the Medicare or Medicaid EHR Incentive Programs; and (2) who attempt to participate in the Medicare or Medicaid EHR Incentive Programs from January 2, 2012 through October 15, 2012, or the effective date of the final rule (which includes the 6-month 2013 eRx payment adjustment reporting period of January 1, 2012-June 30, 2012) for the 2013 eRx payment adjustment, or during the 6-month payment adjustment reporting period for the 2014 eRx payment adjustment (January 1, 2013 through June 30, 2013).
For eligible professionals or group practices who intend to adopt EHR technology in the future or have not yet taken the steps required to apply for this significant hardship exemption, we believe that mere intent to adopt CEHRT or attest at a later date does not sufficiently demonstrate that an eligible professional will adopt CEHRT to participate in the Medicare or Medicaid EHR Incentive Programs. Unlike those eligible professionals who would have registered for the Medicare or Medicaid EHR Incentive Programs and have adopted CEHRT available for immediate use, we would have to monitor and provide oversight over those eligible professionals who have not yet taken these steps to participate in the Medicare or Medicaid EHR Incentive Programs. We also do not believe that such eligible professionals or group practices would necessarily be facing a significant hardship as contemplated in this proposed exemption category. Accordingly, all of the proposed requirements to qualify for an exemption under this significant hardship exemption category would need to be met by the time the eligible professional requests an exemption. In section III.H1.5.b. below, we discuss the proposed deadlines and procedures for requesting consideration of an exemption under this proposed significant hardship exemption category.
We invited public comment on this proposed significant hardship exemption category for the 2013 and 2014 payment adjustments. The following is a summary of the comments received specific to this proposed significant hardship exemption category: Eligible professionals or group practices who demonstrate intent to participate in the EHR Incentive Program and adoption of Certified EHR Technology.
For the 2013 payment adjustment, it was our intent to apply this significant hardship exemption category to eligible professionals or group practices that adopt CEHRT as well as demonstrate intent to participate in the EHR Incentive Program during a certain timeframe in 2012. We proposed that, for the 2013 payment adjustment, an eligible professional would be required to meet the qualifications for this significant hardship exemption category by October 15, 2012 or the effective date of this final rule, whichever is later.
For the 2014 payment adjustment, it was our intent to apply this significant hardship exemption category to eligible professionals or group practices that adopt CEHRT, as well as demonstrate intent to participate in the EHR Incentive Program during a certain timeframe in 2013. We proposed that an eligible professional would be required to meet the qualifications for this significant hardship exemption category by the end of the 6-month 2014 payment adjustment reporting period (January 1, 2013-June 30, 2013). We established this deadline as it coincides with the deadline for requesting exemptions
Based on the comments received and for the reasons stated above, we are finalizing this significant hardship exemption category—eligible professionals or group practices who demonstrate intent to participate in the EHR Incentive Program and adoption of Certified EHR Technology. However, to provide CMS with additional time to gather information on who qualifies for a significant hardship exemption under this category, we are extending the proposed deadline. For the 2013 payment adjustment, this significant hardship exemption category would apply to eligible professionals (or every eligible professional in a group practice participating in the eRx GPRO) who demonstrate intent to participate in the EHR Incentive Program by registering for the program between January 2, 2012 and January 31, 2013 and adopt Certified EHR Technology. We note that eligible professionals who achieved meaningful use of Certified EHR Technology under the EHR Incentive Program for an EHR reporting period that ended on or before June 30, 2012, or for an EHR reporting period that is the full CY 2012, are not eligible for this significant hardship exemption category (nor is a group practice participating in the eRx GPRO eligible if any of its member eligible professionals achieved meaningful use during those timeframes).
For the 2014 payment adjustment, this significant hardship exemption category applies to eligible professionals (or every eligible professional in a group practice participating in the eRx GPRO) who demonstrate intent to participate in the EHR Incentive Program by registering for the program between January 1, 2013 and June 30, 2013 and adopting Certified EHR Technology. Eligible professionals who achieve meaningful use of Certified EHR Technology under the EHR Incentive Program for an EHR reporting period that ends on or before June 30, 2013, or for an EHR reporting period that is the full CY 2013, are not eligible for this significant hardship exemption category (nor is a group practice participating in the eRx GPRO eligible if any of its member eligible professionals achieve meaningful use during those timeframes). Please note that, should the deadline for submitting requests for the four previously established significant hardship exemption categories be extended for any reason, it is our intent that the deadline for this significant hardship exemption category would be extended accordingly with all other significant hardship exemption categories to the 2014 payment adjustment.
In the CY 2012 final rule with comment period, we established a process whereby eligible professionals would submit significant hardship exemptions for the existing significant hardship exemption categories for the eRx payment adjustments (76 FR 54963). Unfortunately, for submitting these proposed significant hardship exemptions for the 2013 payment adjustment, it would not be operationally feasible to accept significant hardship exemption requests in the manner we previously established. Therefore, we proposed that, to request a significant hardship under the two proposed significant hardship exemption categories for the 2013 eRx payment adjustment, CMS would analyze the information provided to us in the Registration and Attestation System under the EHR Incentive Program to determine whether the eligible professional or group practice (that is, every EP member of the group practice) has either (1) achieved meaningful use under the EHR Incentive Program during the applicable reporting periods we noted previously, or (2) registered to participate in the EHR Incentive Program via the Registration and Attestation system for the EHR Incentive Program (located at
We also proposed that eligible professionals would be required to submit this significant hardship request by October 15, 2012 or the effective date of the final rule for this provision, whichever is later. For those eligible professionals who request a significant hardship exemption based on achieving meaningful use under the EHR Incentive Program during the 12- or 6-month reporting periods for the 2013 payment adjustment, we also proposed that the eligible professional would be required to have attested under the EHR Incentive Program by October 15th of 2012 (or if later, the effective date of the final rule), to qualify for a significant hardship exemption for the 2013 payment adjustment. For those eligible professionals requesting a significant hardship exemption for the 2013 eRx payment adjustment under the second proposed significant hardship exemption category (that is, intent to participate in the EHR Incentive Program and adoption of CEHRT), we proposed that these eligible professionals who intend to participate in the EHR Incentive Program from January 1, 2011 through October 15, 2012 or the effective date of the final rule would be required to register for the EHR Incentive Program and adopt CEHRT by the same deadline noted above, to qualify for a significant hardship exemption for the 2013 payment adjustment. We note that we proposed a later deadline of October 15, 2012 (or the effective date of the final rule, if later) for the submission of these requests because the deadline for submitting requests under other previously established significant hardship exemption categories to the 2013 eRx payment adjustment (June 30, 2012) has passed and other similar dates we might choose would likely have passed by the time the final rule is effective.
For submitting exemption requests for the two significant hardship exemption categories for the 2014 payment adjustment, we proposed the following method for submitting a request for a significant hardship exemption: Via the Communication Support Page (which is the method established for submitting the established significant hardship exemption categories).
In addition, we considered accepting significant hardship exemption requests for the two proposed significant hardship exemption categories for the 2014 payment adjustment by CMS receiving eligible professionals' information through the Registration and Attestation System for the EHR Incentive Program (similar to our proposed submission process for the
We proposed that the deadline for submitting these significant hardship exemption requests for the 2014 payment adjustment would be June 30, 2013, which is the same deadline established for submitting a significant hardship exemption request for the existing significant hardship exemption categories. Additionally, and consistent with our proposal for the 2013 payment adjustment, we proposed that an eligible professional or group practice (that is, all members of the practice) that achieves meaningful use under the EHR Incentive Program during the 6- or 12-month reporting periods for the 2014 payment adjustment would be required to attest by June 30, 2013. Similarly, for eligible professionals requesting a significant hardship exemption for the 2014 payment adjustment under the second proposed significant hardship exemption category (that is, intent to participate in the EHR Incentive Program and adoption of CEHRT), we proposed that eligible professionals who intend to participate in the EHR Incentive Program during the last 6 months of 2013 would be required to register for the EHR Incentive Program and adopt CEHRT by June 30, 2013, to qualify for a significant hardship exemption for the 2014 payment adjustment. We noted that we understood that these deadlines may exclude some eligible professionals who attested or registered for the EHR Incentive Program at later dates, but these deadlines were necessary to avoid the reprocessing of claims. We note, however, that these proposed deadlines would not extend any deadlines applicable under the EHR Incentive Program. That is, for purposes of the EHR Incentive Program, an eligible professional would still be required to attest to being a meaningful user by the deadline established under the EHR Incentive Program, even if such deadline fell prior to the proposed eRx Incentive program significant hardship exemption deadline.
We noted that we only proposed submission of requests for significant hardship exemptions under these two categories under an individual eligible professional level only because it is not technically feasible for us to operationally analyze information on the EHR Incentive Program's Registration and Attestation page using the TIN, as the information stored in this system is stored by NPI. However, we stated we would not preclude eligible professionals in an eRx GPRO for 2012 from submitting requests for significant hardship exemptions under these two categories. Therefore, to allow the submission of significant hardship requests for the 2013 eRx payment adjustment under these two proposed categories, we proposed that eligible professionals within an eRx GPRO must each request a significant hardship exemption under these two categories.
We invited public comment on this proposed process for submitting significant hardship exemption requests under these two proposed categories. The following is a summary of the comments received related to these proposals.
We received no public comment regarding the proposed deadline for qualifying for an exemption under these two additional significant hardship exemption categories for the 2014 payment adjustment. Based on the reasons stated previously, we are finalizing this proposal. We note, however, that in the event that the deadlines for requesting a significant hardship exemption under the four previously established exemption categories are extended, we intend to extend this deadline to coincide with the deadline for requesting exemptions under these other four categories. Additionally, we may extend this deadline should we run into operational concerns, such as receiving data from the EHR Incentive Program's Registration and Attestation page.
With respect to extending the deadline to submit exemption requests under the four previously established significant hardship exemption categories for the 2013 payment adjustment, we will allow the extension of the deadline to request exemptions under these four previously established exemption categories to January 31, 2013. We finalized a deadline of June 30, 2012 to submit requests for exemptions under these four significant hardship categories primarily to avoid having to reprocess claims. Since we are extending this deadline to January 31, 2013, we anticipate that, in some cases, particularly in instances where eligible professionals submit significant hardship exemption requests closer towards the deadline, we may not be able to complete our review of the requests before the claims processing systems updates are made to begin reducing eligible professionals' and group practices' PFS amounts in 2013. In such cases, if we ultimately approve the eligible professional or group practice's request for a significant hardship exemption after January 1, 2013, we would need to reprocess all claims for services furnished up to that point in 2013 that were paid at the reduced PFS amount, which we anticipate may take several months. To avoid the reprocessing of claims, we encourage eligible professionals who would be submitting a significant hardship exemption request under these four significant hardship exemption categories to do so as soon as possible, rather than waiting until the deadline to submit such a request.
We note that we would like to be able to process all such requests before we begin making the claims processing systems changes to adjust eligible professionals' or group practices' payments starting on January 1, 2013 or 2014. However, we anticipate that, in some cases, particularly in instances where eligible professionals submit significant hardship exemption requests closer towards the deadline, we may not be able to complete our review of the requests before the claims processing systems updates are made to begin reducing eligible professionals' and group practices' PFS amounts in 2013. In such cases, if we ultimately approve the eligible professional or group practice's request for a significant hardship exemption after January 1, 2013 or 2014, we would need to reprocess all claims for services furnished up to that point in 2013 that were paid at the reduced PFS amount, which we anticipate may take several months. To avoid the reprocessing of claims, we encourage eligible professionals who would be submitting a significant hardship exemption request under these two categories to do so as soon as possible, rather than waiting until the deadline to submit such a request.
Tables 125 and 126 provide a summary of the significant hardship exemption categories that are available to eligible professionals and group practices for the 2013 and 2014 payment adjustments.
To better facilitate issues surrounding the issuance of incentives and payment adjustments, we proposed to establish an informal review process for the eRx Incentive Program (77 FR 44987). We proposed an informal review process similar to the informal review process established for the PQRS (76 FR 73390), because eligible professionals and group practices are already familiar with this process. We proposed the informal review process would only be available for the 2013 incentive payments and the 2014 payment adjustment.
For an informal review regarding the 2013 incentive, we proposed that an eligible professional or group practice must request an informal review within 90 days of the release of his or her feedback report, irrespective of when an eligible professional or group practice actually accesses his/her feedback report.
For an informal review regarding the 2014 payment adjustment, we proposed that an eligible professional or group practice must request an informal review by January 31, 2013 (77 FR 44988). We believed this deadline would provide ample time for eligible professionals and group practices to discover that their respective claims are being adjusted due to the 2014 payment adjustment and seek informal review.
We proposed that the request be submitted in writing and summarize the concern(s) and reasons for requesting an informal review. In his or her request for an informal review, an eligible professional may also submit other information to assist in the review. We proposed that an eligible professional may request an informal review through the web. We believe use of the web would provide a more efficient way for CMS to record informal review requests, as the web would guide the eligible professional through the creation of an informal review requests. For example, the web-based tool would prompt an eligible professional of any necessary information he or she must provide. Should it be technically not feasible to receive requests for informal reviews via the web, we proposed that an eligible professional would be able to request an informal review via email (77 FR 44988).
We further proposed that we would make our determination and provide the eligible professional or group practice with a written response to his or her request for an informal review within 90 days of receiving the request.
Based on our informal review and once we have made a determination, we proposed that we would provide the eligible professional or group practice a written response. Where we find that the eligible professional or group practice did successfully report for the 2013 incentive, we would provide the eligible professional or group practice with the applicable incentive payment. Where we find that the eligible professional or group practice did successfully report (that is, meet criteria for being a successful electronic prescriber) for purposes of the 2014 payment adjustment, we would cease application of the 2014 payment adjustment and reprocess all claims that have been adjusted. We further proposed that decisions based on the informal review would be final, and there would be no further review or appeal.
We invited public comment on our proposals for the eRx Incentive Program informal review process for the 2013 incentive and the 2014 payment adjustment. The following is a summary of comments we received on these proposals:
To summarize what we have finalized, we are establishing an informal review process for the 2012 and 2013 eRx incentives and 2013 and 2014 eRx payment adjustments. As such, we are also finalizing our proposed modifications to § 414.92 that address the informal review process we are establishing. Eligible professionals and group practices wishing to request an informal review must do so via email. For the 2012 eRx incentive and 2013 eRx incentives, eligible professionals and group practices must submit a request for an informal review 90 days after the receipt of the
The Medicare EHR Incentive Program provides incentive payments to eligible professionals (EPs) who demonstrate meaningful use of certified EHR technology (CEHRT). EPs who fail to demonstrate meaningful use will be subject to payment adjustments beginning in 2015. We established a phased approach to meaningful use, which we expect will include three stages (77 FR 53973), and all EPs are currently in Stage 1. In the CY 2012 Medicare PFS final rule, we established the PQRS-Medicare EHR Incentive Pilot in an effort to pilot the electronic submission of CQMs for the Medicare EHR Incentive Program and move towards the alignment of quality reporting requirements between Stage 1 of the Medicare EHR Incentive Program and the PQRS (76 FR 73422). We refer readers to the final rule for further explanation of the requirements of the Pilot (76 FR 73422-73425). Specifically, we established that an EP participating in the PQRS-Medicare EHR Incentive Pilot would be able to report clinical quality measures (CQMs) data extracted from Certified EHR Technology via use of a PQRS qualified direct EHR product or PQRS qualified EHR data submission vendor (76 FR 73422). We proposed to modify § 495.8 to extend this Pilot for CY 2013 as it was finalized for CY 2012. We also proposed to remove from § 495.8(a)(2)(v) the cross-reference to § 495.6(d)(10) to conform to the proposed changes to § 495.6(d) that were included in the EHR Incentive Program—Stage 2 NPRM (77 FR 53976). This proposal includes the following:
• For 2013 only, EPs intending to participate in the PQRS-Medicare EHR Incentive Pilot may use a PQRS qualified EHR data submission vendor that would submit CQM data extracted from the EP's CEHRT to CMS. Under this option, identical to the submission process used for the Pilot in 2012, the PQRS qualified EHR data submission vendor would calculate the CQMs from the EP's CEHRT and then submit the calculated results to CMS on the EP's behalf via a secure portal for purposes of this Pilot.
• For 2013 only, identical to the submission process used for the Pilot in 2012, EPs intending to participate in the PQRS-Medicare EHR Incentive Pilot may use a PQRS qualified direct EHR product to submit CQM data directly from his or her CEHRT to CMS via a secure portal using the infrastructure of the PQRS EHR-based reporting mechanism.
In addition, for 2013, we proposed to extend the use of attestation as a reporting method for the CQM component of meaningful use for the EHR Incentive Program. For 2013, EPs would be able to continue to report by attesting CQM results as calculated by CEHRT, as they did for 2011 and 2012. For further explanation of the CQM reporting criteria for EPs and reporting by attestation, we refer readers to the EHR Incentive Program—Stage 2 final rule (77 FR 54049 through 54089) and the EHR Incentive Program—Stage 1 final rule (75 FR 44386-44411, 44430-44434).
We invited public comment on our proposal to extend to 2013 the PQRS-Medicare EHR Incentive Pilot as it was established for 2012 as well as reporting CQMs by attestation. The following is a summary of the comments we received regarding our proposals.
Under section 1899 of the Act, CMS has established a Medicare Shared Savings Program (Shared Savings Program) to facilitate coordination and cooperation among providers to improve the quality of care for Medicare Fee-For-Service (FFS) beneficiaries and reduce the rate of growth in healthcare costs. Eligible groups of providers and suppliers, including physicians, hospitals, and other healthcare providers, may participate in the Shared Savings Program by forming or participating in an Accountable Care Organization (ACO). The final rule implementing the Shared Savings Program appeared in the
Section 1899(b)(3)(D) of the Act affords the Secretary discretion to “* * * incorporate reporting requirements and incentive payments related to the physician quality reporting initiative (PQRI), under section 1848 of the Act, including such requirements and such payments related to electronic prescribing, electronic health records, and other similar initiatives under section 1848 * * *” and permits the Secretary to “use alternative criteria than would otherwise apply [under section 1848 of the Act] for determining whether to make such payments.” Under this authority, we incorporated certain Physician Quality Reporting System (PQRS) reporting requirements and incentive payments into the Shared Savings Program (76 FR 67902). In the Shared Savings Program final rule, we finalized the following requirements with regard to PQRS incentive payments under the Shared Savings Program: (1) The 22 GPRO quality measures identified in Table 1 of the final rule (76 FR 67889-67890); (2) reporting via the GPRO web interface (76 FR 67893); (3) criteria for satisfactory reporting (76 FR 67900); and (4) January 1 through December 31 as the reporting period. The regulation governing the incorporation of PQRS incentives and reporting requirements under the Shared Savings Program is set forth at § 425.504.
Under § 425.504(a)(1), ACOs, on behalf of their ACO provider/suppliers who are eligible professionals, must submit the measures determined under § 425.500 using the GPRO web interface established by CMS, to qualify on behalf
As discussed in section III.G of this final rule with comment period, as required by section 1848(a)(8) of the Act, a payment adjustment will apply under the PQRS beginning in 2015. For eligible professionals who are not satisfactory reporters, the PFS amount for covered professional services furnished by the eligible professional during 2015 shall be equal to 98.5 percent (and 98 percent for 2016 and each subsequent year) of the fee schedule amount that would otherwise apply to such services. Therefore, consistent with our authority under section 1899(b)(3)(D) of the Act, we proposed to amend § 425.504 to incorporate reporting requirements for the PQRS payment adjustment under the Shared Savings Program for eligible professionals that are ACO providers/suppliers (77 FR 44989).
We proposed to incorporate requirements for the PQRS payment adjustment that are consistent with requirements for PQRS incentives that we previously adopted in the Shared Savings Program final rule. Specifically, for purposes of the PQRS payment adjustment, we proposed to incorporate the same PQRS GPRO under the Shared Savings Program that is currently used for purposes of the PQRS incentive under the Shared Savings Program. Under this proposal, eligible professionals that are ACO providers/suppliers would constitute a group practice that would report quality measures via the GPRO data collection tool for purposes of both the PQRS incentive under the Shared Savings Program and the PQRS payment adjustment under the Shared Savings Program (77 FR 44989).
For purposes of the payment adjustment, we proposed to use the final GPRO quality measures adopted under the Shared Shavings Program that appear in Table 1 of the Shared Savings Program final rule (76 FR 67899-67890). We further proposed to incorporate the same criteria for satisfactory reporting that were finalized for the PQRS incentive under the Shared Savings Program, which are described in the Shared Savings Program final rule (76 FR 67900). Specifically:
• An ACO on behalf of its eligible professionals must report on all measures included in the GPRO data collection tool under the Shared Savings Program final rule.
• Beneficiaries would be assigned to the ACO using the methodology described in § 425.400. As a result, the GPRO tool would be populated based on a sample of the ACO-assigned beneficiary population. ACOs must complete the tool for the first 411 consecutively ranked and assigned beneficiaries in the order in which they appear in the group's sample for each domain, measures set, or individual measure if a separate denominator is required such as in the case of preventive care measures which may be specific to one sex. If the pool of eligible assigned beneficiaries is less than 411, the ACO must report on 100 percent of assigned beneficiaries for the domain, measures set, or individual measure.
• The GPRO data collection tool must be completed for all domains, measure sets and measures described in Table 1 of the of the Shared Savings Program final rule (76 FR 67889-67890).
Under this proposal, ACOs would need to satisfactorily report the 22 GPRO quality measures identified in Table 1 of the Shared Savings Program final rule (76 FR 67889-67890) and would not need to report the other 11 Shared Savings Program quality performance measures for purposes of satisfactory reporting for the PQRS payment adjustment. However, under this proposal, the ACO would still be required to satisfy the ACO quality performance standards for purposes of determining eligibility for shared savings, as described in § 425.502.
We note that the proposal that ACOs report the same quality measures for purposes of satisfactory reporting for both the PQRS payment adjustment and incentive payments under the Shared Savings Program was consistent with the proposal under the traditional PQRS GPRO Web Interface reporting option that the criteria for satisfactory reporting for the payment adjustments align with the satisfactory reporting requirements for the incentive payments (77 FR 44824).
While satisfactorily reporting one measure would be required for purposes of avoiding the 2015 PQRS payment adjustment under the Medicare Shared Savings Program, we note that ACOs are still required to report all 22 GPRO measures for purposes of the PQRS incentive under the Shared Savings Program and for purposes of assessing ACOs' quality performance under the Shared Savings Program and determining the percentage of shared savings that ACOs are eligible to receive. In addition, under the Shared Savings Program regulations at § 425.500(e)(3), ACOs are required to report on all of the quality measures established by CMS, and the failure to report on those quality measures accurately, completely, and timely may subject the ACO to termination or other sanctions. Therefore, we expect PQRS eligible professionals who are ACO providers/suppliers to meet the satisfactory reporting criteria for the 2015 PQRS payment adjustment, since they would need to continue to report beyond the one measure for purposes of the PQRS incentive payment and Shared Savings Program shared savings. Satisfactory reporting criteria for the PQRS payment adjustment under the Shared Savings Program for 2016 and beyond will be discussed in future rulemaking.
Although we proposed to use the same timeframe of January 1 through December 31 that we adopted for the PQRS incentive under the Shared Savings Program as the reporting period for the PQRS payment adjustment, we proposed that the timing of the reporting period would differ for purposes of the PQRS payment adjustment (77 FR 44990). Specifically, we proposed that the reporting period for the payment adjustment would fall 2 years prior to when the payment adjustment would be assessed. For example, under the Shared Savings Program, the reporting period for the 2015 payment adjustment would be from January 1, 2013 through December 31, 2013.
We also noted that this policy results in overlapping reporting periods for both the PQRS incentive and payment adjustment. For example, the measure data collected for the 2013 calendar year reporting period (January 1, 2013-December 31, 2013) would be used for purposes of both the Physician Quality Reporting System 2013 incentive and 2015 payment adjustment under the Shared Savings Program. We believed that using the same reporting period for purposes of both the incentive and payment adjustment would result in less reporting burden and that ACOs would perceive this as more efficient than requiring one set of measures reported during one timeframe for purposes of the PQRS incentive and another set during another timeframe for purposes of the payment adjustment.
It is necessary for us to use a reporting period that precedes the year in which the payment adjustment is applicable to avoid retroactive payments and the reprocessing of claims. In addition, it is not operationally feasible for us to use a full calendar year reporting period that falls closer to the year in which the payment adjustment is applicable because we need sufficient time to determine if the requirements for satisfactory reporting have been met and to adjust our claims systems prior to the start of the applicable year. We note that the length and timing of the reporting period that we are finalizing for the PQRS payment adjustment under the Shared Savings Program is consistent with the one finalized for the traditional PQRS (76 FR 73392).
Since the publication of the Shared Savings Program final rule, we have received a number of inquiries regarding whether ACO participant TINs need to self-nominate or register to participate in PQRS GPRO under the Shared Savings Program, since there are such registration and self-nomination requirements under the traditional PQRS GPRO. We wish to clarify that no registration or self-nomination is required for ACO providers/suppliers that are eligible professionals to earn a PQRS incentive or avoid the payment adjustment under the Shared Savings Program.
Finally, just as ACO providers/suppliers that are eligible professionals in an ACO may only participate under their ACO participant TIN as a group practice under the PQRS GPRO under the Shared Savings Program for purposes of receiving an incentive under that TIN (76 FR 67903), we proposed that ACO providers/suppliers that are eligible professionals within an ACO must participate under the ACO participant TIN as a group practice under the PQRS GPRO under the Shared Savings Program for purposes of the PQRS payment adjustment (77 FR 44990). Thus, ACO providers/suppliers who are eligible professionals may not seek to avoid the payment adjustment by reporting either as an individual under the traditional PQRS or under the traditional PQRS GPRO.
We recognize that some eligible professionals may move across programs and reporting options from year to year. For instance, an eligible professional that is an ACO provider/supplier and participates in the PQRS under the Shared Savings Program in 2013 may later exit the Shared Savings Program and participate in PQRS individual reporting in 2014. Alternatively, a group practice participating in the traditional PQRS GPRO in 2013 may be an ACO participant in 2014. In instances in which eligible professionals change their PQRS reporting option from year to year, we believe that as long as the eligible professional satisfactorily reported for purposes of the payment adjustment during the applicable reporting period, then the eligible professional should not be subject to the payment adjustment even if the eligible professional was reporting under a different reporting method than at the time the payment adjustment would be assessed.
Accordingly, we are finalizing the proposed amendment to the regulations at § 425.504(b) with two modifications. We have revised § 425.504(b)(2)(ii) to provide that an ACO, on behalf of its ACO providers/suppliers who are eligible professionals, must satisfactorily report one of the GPRO measures during the reporting period according to the method of submission established by CMS under the Shared Savings Program for purposes of the 2015 Physician Quality Reporting System payment adjustment. Satisfactory reporting criteria for the PQRS payment adjustment under the Shared Savings Program for 2016 and beyond will be discussed in future rulemaking.
Please note that, in this final rule with comment period, we also address final policies for ACO data to be publicly reported on Physician Compare in section III.G. of this final rule with comment period and under Medicare Shared Savings Program regulations at § 425.308. ACOs and the Value-Based Modifier are discussed in section III.I of this final rule with comment period.
Section 651 of MMA requires the Secretary to conduct a demonstration for up to 2 years to evaluate the feasibility and advisability of expanding coverage for chiropractic services under Medicare. Current Medicare coverage for chiropractic services is limited to treatment by means of manual manipulation of the spine to correct a subluxation described in section 1861(r)(5) of the Act provided such treatment is legal in the state or jurisdiction where performed. The demonstration expanded Medicare coverage to include: “(A) care for neuromusculoskeletal conditions typical among eligible beneficiaries; and (B) diagnostic and other services that a chiropractor is legally authorized to perform by the State or jurisdiction in which such treatment is provided.” The demonstration was conducted in four geographically diverse sites, two rural and two urban regions, with each type including a Health Professional Shortage Area (HPSA). The two urban sites were 26 counties in Illinois and Scott County, Iowa, and 17 counties in Virginia. The two rural sites were the States of Maine and New Mexico. The demonstration, which ended on March 31, 2007, was required to be budget neutral as section 651(f)(1)(B) of MMA mandates the Secretary to ensure that “the aggregate payments made by the Secretary under the medicare program do not exceed the amount which the Secretary would have paid under the medicare program if the demonstration projects under this section were not implemented.”
In the CY 2006, 2007, and 2008 PFS final rules with comment period (70 FR 70266, 71 FR 69707, 72 FR 66325, respectively), we included a discussion of the strategy that would be used to assess budget neutrality (BN) and the method for adjusting chiropractor fees in the event the demonstration resulted in costs higher than those that would occur in the absence of the demonstration. We stated that BN would be assessed by determining the change in costs based on a pre-post comparison of total 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 for other services.
In the CY 2010 PFS final rule with comment period (74 FR 61926), we discussed the evaluation of this demonstration conducted by Brandeis University and the two sets of analyses used to evaluate BN. In the “All Neuromusculoskeletal Analysis,” which compared the total Medicare costs of all beneficiaries who received services for a neuromusculoskeletal condition in the demonstration areas with those of beneficiaries with similar characteristics from similar geographic areas that did not participate in the demonstration, the total effect of the demonstration on Medicare spending was $114 million higher costs for beneficiaries in areas that participated in the demonstration. In the “Chiropractic User Analysis,” which compared the Medicare costs of beneficiaries who used expanded chiropractic services to treat a neuromusculoskeletal condition in the demonstration areas, with those of beneficiaries with similar characteristics who used chiropractic services as was currently covered by Medicare to treat a neuromusculoskeletal condition from similar geographic areas that did not participate in the demonstration, the total effect of the demonstration on Medicare spending was a $50 million increase in costs.
As explained in the CY 2010 PFS final rule, we based the BN estimate on the “Chiropractic User Analysis” because of its focus on users of chiropractic services rather than all Medicare beneficiaries with neuromusculoskeletal conditions, as the latter included those who did not use chiropractic services
As explained in the CY 2010 PFS final rule (74 FR 61927), because the costs of this demonstration were higher than expected and we did not anticipate a reduction to the PFS of greater than 2 percent per year, we finalized a policy to recoup $50 million in expenditures from this demonstration over a 5-year period, from CYs 2010 through 2014 (74 FR 61927). Specifically, we are recouping $10 million for each such year through adjustments to the chiropractic CPT codes. Payment under the PFS for these codes will be reduced by approximately 2 percent. We believe that spreading this adjustment over a longer period of time will minimize its potential negative impact on chiropractic practices.
For the CY 2012 PFS, our Office of the Actuary (OACT) estimated chiropractic expenditures to be approximately $470 million, which reflected the statutory 29.4 percent reduction to physician payments scheduled to take effect that year. As noted above, the statute was subsequently amended to impose a zero percent update for CY 2012 instead of the 29.4 percent reduction. OACT now estimates CY 2012 chiropractic expenditures to be approximately $630 million. We are currently recouping $10 million through adjustments to the chiropractic CPT codes in CY 2012, and the percent of this reduction is approximately 1.5 percent.
We are continuing the implementation of the required BN adjustment by recouping $10 million in CY 2013. Our Office of the Actuary estimates chiropractic expenditures in CY 2013 will be approximately $470 million based on Medicare spending for chiropractic services for the most recent available year and reflecting an approximate 30.9 percent reduction to physician payments scheduled to take effect under current law. To recoup $10 million in CY 2013, the payment amount under the PFS for the chiropractic CPT codes (CPT codes 98940, 98941, and 98942) will be reduced by approximately 2 percent. We are reflecting this reduction only in the payment files used by the Medicare contractors to process Medicare claims rather than through adjusting the relative value units (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.
Therefore, as finalized in the CY 2010 PFS regulation and reiterated in the CYs 2011-2012 PFS regulations, we are implementing this methodology and recouping from the chiropractor fee schedule codes set forth above. Our methodology meets the statutory requirement for BN and appropriately impacts the chiropractic profession that is directly affected by the demonstration.
The following is a summary of the comments we received and our responses.
Regardless of the differences in the costs associated with the demonstration areas, the evaluation conducted by Brandeis University found that expanding coverage for chiropractic services under the demonstration resulted in increased Medicare expenditures, and the Secretary must recoup these costs in order to meet the budget neutrality requirement of the law.
In response to the comment suggesting that the data from this demonstration should not be used to estimate the cost of a national rollout of the expansion of chiropractic services, we note the following. At the time of the final Report to Congress on the Chiropractic Services Demonstration, we estimated the costs of a national rollout of the expansion of chiropractic services. We based our estimate on the best available data at the time which
After consideration of the public comments received, we are continuing the implementation of the required budget neutrality adjustment by recouping $10 million in CY 2013 by reducing the payment amount under the PFS for chiropractic codes (that is, CPT codes 98940, 98941, and 98942) by approximately 2 percent.
Section 1848(p) of the Act requires that we establish a value-based payment modifier and apply it to specific physicians and groups of physicians the Secretary determines appropriate starting January 1, 2015 and to all physicians and groups of physicians by January 1, 2017. On or after January 1, 2017, the section 1848(p)(7) of the Act provides the Secretary discretion to apply the value-based payment modifier to eligible professionals as defined in section 1848(k)(3)(B) of the Act. Based on our initial experience with the program, we will consider whether to expand the application of the value-based payment modifier to additional eligible professionals as permitted by the Act.
We proposed to apply the value-based payment modifier (a) to groups of physicians of 25 or more eligible professionals, (b) to align quality measurement for purposes of the value-based payment modifier with the reporting requirements for data on quality measures under the Physician Quality Reporting System (PQRS), and (c) to implement the value-based payment modifier so that it does not affect payment for those groups that satisfactorily report information on quality measures under the PQRS unless the group of physicians expressly elect further assessment using a quality-tiering option. The statute requires the value-based payment modifier to be budget neutral.
We are finalizing our overall approach to the value-based payment modifier in which the value-based payment modifier adjustment is based on participation in the PQRS. Although we are refining many of the proposed value-based payment modifier policies in response to comments received, the major change from our proposals is that we will apply the value-based payment modifier to groups of physicians of 100 or more eligible professionals rather than to groups of physicians of 25 or more eligible professionals. We believe this change in policy is necessary in order for us to gain additional experience with, and to be able to produce data to enhance physician acceptance of, our methodologies and approach. We emphasize that even with this change we are committed to applying the value-based payment modifier to all physicians and groups of physicians by 2017 as required by Section 1848(p) of the Act. We urge solo practitioners and physicians in smaller groups to participate in the PQRS now, because when we propose in future rulemaking to apply the value-based payment modifier to smaller groups and solo practitioners, we anticipate basing the quality composite on PQRS quality data reported by such physicians. We also anticipate that we would propose to increase the amount of payment at risk under the value-based payment modifier as we gain additional experience with the methodologies used to assess the quality of care furnished, and the cost of care, by physicians and groups of physicians.
In the CY 2013 PFS proposed rule, we stated that the value-based payment modifier has the potential to help transform Medicare from a passive payer to an active purchaser of higher quality, more efficient and effective healthcare by providing upward payment adjustments under the PFS to high performing physicians (and groups of physicians) and downward adjustments for low performing physicians (and groups of physicians) (77 FR 44993). We recognize, however, that physicians are at the forefront of care delivery and that changes in payment policy can directly affect the medical care that physicians furnish to Medicare beneficiaries. Consistent with the National Quality Strategy, our aim is to promote preventive care and improve, rather than impede, the care that beneficiaries currently receive, especially for the chronically ill and those with the most complicated cases.
We explained in the CY 2013 PFS proposed rule (77 FR 42908) that Medicare is beginning to implement value-based payment adjustments for other types of services, including inpatient hospital services. We have also outlined in reports to Congress strategies to implement value-based purchasing for skilled nursing facilities, home health services, and ambulatory surgical center services. In implementing value-based purchasing initiatives generally, we would meet the following goals:
• Recognize and reward high quality care and quality improvements.
++ Value-based payment systems and public reporting should rely on a mix of standards, processes, outcomes, and patient experience measures, including measures of care transitions and changes in patient functional status. Across all programs, we would move as quickly as possible to the use of outcome and patient experience measures. To the extent practicable and appropriate, we believe these outcome and patient experience measures should be adjusted for risk or other appropriate patient population or provider characteristics.
++ To the extent possible, and recognizing differences in payment system readiness and statutory requirements and authorities, measures should be aligned across Medicare and Medicaid's public reporting and payment systems. We would seek to evolve a focused core set of measures appropriate to each specific provider category that reflects the level of care and the most important areas of service and measures for that provider.
++ The collection of information should minimize the burden on providers to the extent possible. As part of that effort, we will continuously seek to align our measures with the adoption of meaningful use standards for health information technology (HIT), so the collection of performance information is part of care delivery.
++ To the extent practicable, the measures we use should be nationally endorsed by a multi-stakeholder organization. Measures should be aligned with best practices among other payers and the needs of the end users of the measures.
• Promote more efficient and effective care through the use of evidence based measures, less rework and duplication, and less fragmented care.
++ Providers should be accountable for the costs of care, being both rewarded for reducing unnecessary expenditures and responsible for excess expenditures.
++ In reducing excess expenditures, providers should continually improve and maintain the quality of care they deliver.
++ To the extent possible, and recognizing differences in payers' value-based purchasing initiatives, providers should redesign care processes to deliver higher quality and more efficient care to their entire patient population.
Because of the centrality of physicians to high-quality, efficient, patient-
Given this long range objective, we proposed that the following specific principles should govern the implementation of the value-based payment modifier.
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We solicited comments on these principles as guides to our implementation of the value-based payment modifier. The following is a summary of the comments we received and our response.
One commenter stated that the proposed value-based modifier program was designed for large multispecialty group practices, not small single specialty groups. Another commenter indicated that long term care physicians currently lack the infrastructure to be able to achieve the proposed principles within the timeline proposed. Other commenters were concerned about the lag between the performance year (2013) and the application of the payment adjustment (2015) and urged CMS to further explore ways to realistically achieve the goal cited under “Focus on actionable information.” One of the commenters also raised several concerns related to group reporting of the quality data.
Some of the commenters' recommendations included providing the Physician Feedback reports to all physicians sooner so they have information before implementation of the value-based payment modifier; making group reporting optional; expanding the reporting options for large groups; and evaluating the implementation proposals on small single specialty group practices and settings such as long term care settings.
In the proposed rule, we described our proposals for each component of the value-based payment modifier (77 FR 44995). In this final rule with comment period, we discuss our proposed policies for each component of the value-based payment modifier, the comments received, our responses to the comments, and a brief statement of our final policy.
Section 1848(p)(4)(B)(iii) of the Act requires the Secretary to apply the value-based payment modifier to items and services furnished under the Medicare Physician Fee Schedule beginning on January 1, 2015, for specific physicians and groups of physicians the Secretary determines appropriate, and beginning not later than January 1, 2017 for all physicians and groups of physicians. For purposes of the value-based payment modifier we are finalizing in this final rule with comment period, physicians are defined in section 1861(r) of the Act to include
We proposed to apply the value-based payment modifier beginning in calendar year 2015 to all groups of physicians with 25 or more eligible professionals (77 FR 44995). For purposes of establishing group size, we proposed to use the definition of an eligible professional as specified in section 1848(k)(3)(B) of the Act. This section defines an eligible professional as any of the following: (1) A physician; (2) a practitioner described in section 1842(b)(18)(C) of the Act; (3) a physical or occupational therapist or a qualified speech-language pathologist; or (4) a qualified audiologist. We proposed to define a group of physicians as “a single Tax Identification Number (TIN).” We chose this definition in order to align with the reporting requirements for group practices and the definitions used in the PQRS. We also proposed to assess whether a group of physicians has 25 or more eligible professionals at the time the group of physicians is selected to participate under the PQRS GPRO.
In addition, we proposed to apply the value-based payment modifier to the Medicare paid amounts for the items and services billed under the PFS at the TIN level so that beneficiary cost-sharing would not be affected. We also proposed to apply it to the items and services billed by physicians under the TIN, not to other eligible professionals that also may bill under the TIN. Application of the value-based payment modifier at the TIN level means that we would not “track” or “carry” an individual physician's performance from one TIN to another TIN. In other words, if a physician changes groups from TIN A in the performance period (calendar year 2013) to TIN B in the payment adjustment period (calendar year 2015), we would apply TIN B's value-based payment modifier to the physician's payments for items and services billed under TIN B during 2015. We made this proposal for two reasons (77 FR 44995). First, payment at the group practice (TIN level) promotes shared accountability for the quality of care furnished at the group practice level. Second, we believed it will be more straightforward for groups of physicians to understand how the value-based payment modifier affects their TIN's payment in the payment adjustment period if all physicians billing under the TIN received the same value-based payment modifier.
On the other hand, a few commenters suggested we apply the value-based payment modifier to additional physicians, such as those in groups of 10 or more. This suggestion was based on a view that increasing participation in the value-based payment modifier for the first 2 years of the program could facilitate a smoother transition to all physicians in 2017 (as required by law) and gain physician participation in the first few years. Another commenter recommended that CMS allow smaller practices to participate in the modifier in 2015 if they meet certain criteria, such as being Meaningful Users (MU) of certified Electronic Health Records (EHRs), or practicing in a rural state or other area where there are relatively few groups with 25 or more eligible professionals (for example, Health Professional Shortage Areas). These commenters reasoned that incorporating smaller practices into the value-based payment modifier would encourage all physicians, not only larger groups, to focus on high-quality, affordable care, reinforcing current private and other payers' payment incentives. Commenters stated a belief that a broader definition of physician group is imperative if the value-based payment modifier is to promote value on a wide scale, given that most physicians practice in groups of less than 10 physicians. Further, they argued that it would be feasible to include smaller practices in the value-based payment modifier because many of these smaller practices are participating in the EHR Incentive Program and they are currently reporting many of the same measures that are available to eligible professionals under the PQRS. In addition, it was also noted that some states with a high proportion of rural and other under-served areas may have comparatively few groups of 25 or more eligible professionals and thus be under-represented in the value-based payment modifier unless smaller groups are included.
In response to the comments, we are finalizing that beginning in calendar year 2015 we will apply the value-based payment modifier to groups of physicians of 100 or more eligible professionals. We also are finalizing the following proposed policies related to the definition of a group and group size:
• For purposes of establishing group size only, we use the definition of an eligible professional as specified in section 1848(k)(3)(B) of the Act;
• We apply the value-based payment modifier to the Medicare paid amounts for the items and services billed under the PFS at the TIN level so that beneficiary cost-sharing is not be affected; and
• We apply the value-based payment modifier to the items and services billed by physicians under the TIN, not to other eligible professionals that also may bill under the TIN.
• We identify the groups of physicians subject to the value-based payment modifier (groups of 100 or more eligible professionals) based on a query of PECOS on October 15, 2013, and we remove any groups from this October 15 list if, based on a claims analysis, the group of physicians did not have 100 or more eligible professionals that submitted claims during the performance period.
We explained in the proposed rule that our proposals would allow groups of 25 or more eligible professionals to decide how the value-based payment modifier would be applied to their PFS payments (77 FR 44995). We proposed that in light of our desire to align CMS quality improvement programs, the value-based payment modifier methodology relies, in part, on the data submitted on quality measures by groups of physicians through the PQRS. We explained that quality measurement is necessary, but not sufficient, for quality improvement and a focus on value. Thus, we proposed to categorize groups of physicians eligible for the value-based payment modifier into two categories depending upon whether they had met the criteria for satisfactory reporting of data on the PQRS GRPO quality measures for the 2013 and 2014 incentive payments under the PQRS or the criteria for satisfactory reporting using the administrative claims-based reporting mechanism, which was proposed for the 2015 and 2016 PQRS payment adjustment. For those groups of physicians that met either of these PQRS satisfactory reporting criteria and requested that their value-based payment modifier be calculated using a quality-tiering approach, we proposed to use the performance rates on the quality measures reported through any of these PQRS reporting mechanisms available to them.
We proposed that the second category include those groups of physicians with 25 or more eligible professionals that have not met the PQRS satisfactory reporting criteria identified above (77 FR 44996). Because we would not have quality measure performance rates on which to assess the quality of care furnished by these groups, we proposed to apply a value-based payment modifier of −1.0 percent, meaning they would receive 99.0 percent of the paid amounts for the items and services billed under the PFS in CY 2015.
We explained that we were concerned, however, that some groups of physicians may attempt to submit data on PQRS quality measures and fail to meet the criteria for satisfactory reporting for the PQRS incentive and thus be placed into the second category of groups of physicians and, therefore, be subject to the −1.0 percent value-based payment modifier downward adjustment. To address this issue, we solicited comments on whether to assess performance on the measures included in the PQRS administrative claims-based reporting option as a default if a group of physicians attempts to participate in one of the PQRS GPRO reporting mechanisms and does not meet the PQRS criteria for satisfactory reporting.
Based upon the comments received, we are adopting our proposed policy, with one modification, to categorize groups of physicians eligible for the value-based payment modifier into two categories. Specifically, the first category of groups of physicians includes those that (a) have self-nominated for the PQRS as a group and reported at least one measure or (b) have elected the PQRS administrative claims option for CY 2013 We note that groups in category (a) also include those groups that have self-nominated and have met the satisfactory reporting criteria for the PQRS incentive payment. The value-based payment modifier for the groups of physicians in this first category (both (a) and (b)) will be 0.0 percent, meaning no payment adjustment will be applied to physicians in these groups for CY2015. For those groups of physicians within this first category that have requested that their value-based payment modifier be based on quality-tiering and have either met the satisfactory reporting criteria for the PQRS incentive or have chosen the administrative claims-based option, we will use the performance rates on the quality measures reported through these reporting mechanisms (that is, GPRO registries, web-interface, or administrative claims) to calculate their value-based payment modifier. Otherwise, we will use the group's performance on the administrative claims measures for quality-tiering, because although the group self-nominated and reported at least one measure, we would not have sufficient quality information to construct a quality composite under the quality-tiering approach.
The second category includes those groups of physicians with 100 or more eligible professionals that do not fall within either of the two subcategories of category 1 described above. The value-based payment modifier for these groups of physicians will be −1.0 percent in CY 2015.
We proposed that, starting in 2017, we would apply the value-based payment modifier to all physicians and groups of physicians as required by the statute (77 FR 44996). We also solicited comments on whether we should offer individual physicians and groups of physicians with fewer than 25 eligible professionals an option that their value-based payment modifier be calculated using a quality-tiering approach starting in 2015 (77 FR 44996). If we did so, we indicated that we could calculate a value-based payment modifier for groups of physicians with as few as two
As discussed above, we are adopting a policy to apply the value-based payment modifier to groups of physicians of 100 or more eligible professionals. We will not offer smaller groups of physicians and individual physicians the ability to elect quality-tiering for the 2015 value-based payment modifier as suggested by some commenters. Although we recognize that we must apply the value-based payment modifier to all physicians and groups of physicians starting January 1, 2017, we believe it is important to phase-in the value-based payment modifier to larger groups of physicians as we gain experience with the methodologies used in the value-based payment modifier. We want to emphasize, however, that in future rulemaking we anticipate proposing for smaller groups and for individual physicians a value-based payment modifier structure similar to the policies we are adopting for groups of physicians of 100 or more eligible professionals. Importantly, we expect the value-based payment modifier structure for smaller groups and individuals would also be aligned with the PQRS. Thus, we strongly encourage smaller groups of physicians and individual physicians to participate in the PQRS so that they can prepare themselves and their practices for the application of value-based payment modifier in later years.
We also solicited comments on whether we should develop a value-based payment modifier option for hospital-based physicians to elect to be assessed based on the performance of the hospital at which they are based (77 FR 44996). In particular, hospital performance could be assessed using the measure rates for the quality measures in the Inpatient Quality Reporting (IQR) and the Outpatient Quality Reporting (OQR) programs. We solicited comments on which IQR and OQR measures (and applicable reporting period) would be appropriate to include in such an option and a way to identify and verify whether physicians are hospital-based.
The following is a summary of the comments we received regarding whether we should develop a value-based payment modifier option for hospital-based physicians.
Some commenters urged CMS to be judicious when selecting measures from the IQR and OQR programs to ensure that hospitalist care is measured in a valid way. Some potential areas for performance measures were identified, such as to include transitions of care/discharges and common diagnoses like congestive heart failure (CHF), acute myocardial infarction (AMI), pneumonia and stroke. A number of these commenters requested that physicians and group practices should be able to identify themselves as “hospitalists” ensuring that they are compared to like-groups within the value-based payment modifier. Some commenters were concerned that our proposed beneficiary attribution approach and our total per capita cost measures could result in hospitalists being inaccurately measured, as they could be attributed the total cost of the patients' stay at a hospital, when the hospitalist may have only been responsible for discharging the patient. Therefore, a commenter recommended that an attribution methodology be developed to accurately capture the role of hospitalists in patient care.
We solicited comments on how best to ascertain whether a group of physicians subject to the value-based payment modifier requests the option that their value-based payment modifier be calculated using a quality-tiering approach (77 FR 44996). We are seeking to establish a system that is as simple as possible to reduce administrative burden on physicians and enable these groups of physicians to indicate how they plan to submit data on quality measures through the PQRS for purposes of the value-based payment modifier. We described three possible approaches to accomplish these objectives: (a) Build off of the self-nomination process that we have proposed for groups of physicians to participate in the PQRS GPRO and which requires groups to submit a self-nomination application by January 31, 2013 for the 2013 performance period, (b) create a separate web-based registration system that permits groups of physicians to, throughout calendar year 2013, request that their value-based payment modifier be calculated using the quality-tiering approach, or (c) require that groups of physicians submit a letter (in a prescribed format) to CMS in a timely manner.
We want to emphasize that if a group of physicians with 100 or more eligible professionals does not self-nominate to participate in the PQRS GPRO or elect the administrative claims option for groups for CY 2013, its value-based payment modifier in CY 2015 will be −1.0 percent.
We proposed that groups of physicians that are participating in the Medicare Shared Savings Program or the testing of the Pioneer ACO model, assuming they meet the PQRS satisfactory reporting criteria, would not have the option that their value-based payment modifier be calculated using the quality-tiering approach (77 FR 44996-44997). We made this proposal because we were mindful that the physicians and groups of physicians that are, or will be, participating in the Shared Savings Program and the testing of the Pioneer ACO model have made sizable investments to redesign care processes based on the incentives created by these programs and did not wish to unintentionally disturb these investments. Therefore, we solicited comments on ways to structure the value-based payment modifier starting in 2017 so it does not create incentives that conflict with the goals of the Shared Savings Program and the Pioneer ACO model. We also solicited comments on whether groups of physicians that are participating in these two initiatives should have the option that their value-based payment modifier be calculated using a quality-tiering approach and applied to their payments under the PFS starting in 2015.
In sum, we will not apply the value-based payment modifier for 2015 and 2016 to groups of physicians that are participating in the Medicare Shared Savings Program, the testing of the Pioneer ACO model, or other similar Innovation Center or CMS initiatives.
We previously finalized CY 2013 as the initial performance period for the value-based payment modifier that will be applied in CY 2015 (76 FR 73436). This means that we will use performance on quality and cost measures during CY 2013 to calculate the value-based payment modifier that we would apply to items and services for which payment is made under the PFS during CY 2015. Likewise, we proposed that performance on quality and cost measures in CY 2014 be used to calculate the value-based payment modifier that is applied to items and services for which payment is made under the PFS during CY 2016 (77 FR 44997).
As we explained in the CY 2012 PFS final rule with comment period (76 FR 73435), we explored different options to close the gap between the performance period (that is, 2013) and the payment adjustment period (that is, 2015), but found that none of them would have permitted sufficient time for physicians and groups of physicians to report measures or have their financial performance measured over a meaningful period, or for us to calculate
In this section we discuss our policies to align quality measure reporting for the value-based payment modifier with the PQRS reporting methods, and to expand the range of quality measures that we will use for the value-based payment modifier.
In the proposed rule we proposed to categorize groups of physicians eligible for the value-based payment modifier into two categories depending upon their participation in the PQRS (77 FR 44997). We further elaborated on these proposals and proposed that groups of physicians subject to the value-based payment modifier would be able to submit data on quality measures using one of the following proposed PQRS reporting mechanisms: PQRS GPRO using the web-interface, claims, registries, or EHRs; or PQRS administrative claims-based option. We also sought comment on which PQRS reporting mechanisms we should offer to individual physicians if we were to apply the value-based payment modifier to their payments under the PFS starting in 2015 and 2016.
In summary, we are finalizing and clarifying our proposal that the groups
We proposed to include all individual measures in the PQRS GPRO web-interface, claims, registries, and EHR reporting mechanisms for 2013 and beyond for the value-based payment modifier. We proposed to include the measures in the PQRS administrative claims-based reporting option as well (77 FR 44998). We also proposed that four of the quality measures in the PQRS administrative claims-based reporting option (the four outcome measures) be used in the value-based payment modifier for all groups of physicians subject to the value-based payment modifier (77 FR 45001-02). Finally, we solicited comments on the quality measures that we should propose for individual physicians if we were to provide individual physicians the ability to elect to have the value-based payment modifier apply to their payments under the PFS starting in 2015 or 2016 (77 FR 44998). In addition, we sought comment on the inclusion of community level measures in the value-based payment modifier (77 FR 45002).
In addition as we described above in section III.G.6, we plan on expanding the specialty measures available in the PQRS in order to more accurately measure the performance on quality of care furnished by specialists. The expansion of the GPRO to registries in 2013 and to EHRs in 2014 means that sub-specialists may participate in the PQRS as members of a group practice, such that the group can report data on measures of broad applicability. We believe group reporting can ameliorate the commenters' concerns that the current set of PQRS measures does not capture all of the clinical care that some specialists and sub-specialists furnish. We also recognize that the rules governing the PQRS are flexible in terms of the quality measures physicians and groups of physicians report and the methods by which they report them. Although some commenters stated this flexibility would lead to “cherry-picking” measures, we believe these two features of the PQRS are beneficial given that the first principle governing the value-based payment modifier is to encourage greater reporting of information for quality purposes by physicians and groups of physicians.
Section 1848(p)(3) of the Act requires us to evaluate costs, to the extent practicable, based on a composite of appropriate measures of costs. In the CY 2012 PFS final rule with comment period (76 FR 73434), we finalized use of total per capita cost measures and per capita cost measures for beneficiaries with four specific chronic conditions (chronic obstructive pulmonary disease, heart failure, coronary artery disease, and diabetes) for the value-based payment modifier. Total per capita costs include payments under both Part A and Part B. Total per capita costs do not include Medicare payments under Part D for drug expenses. We proposed to use at least a 60-day claims run out with a completion factor from our Office of the Actuary (for example, claims paid through March 1 of the year following December 31, the close of the performance period) to calculate the total per capita cost measures (77 FR 45002).
As described more fully in the composite scoring methodology discussion below, we proposed to make cost comparisons among groups of physicians using a similar beneficiary attribution methodology such that we make “apples to apples” comparisons. We believe that this would be an appropriate approach to using the total per capita cost measure in the value-based payment modifier. We sought comment on these proposals.
The following is a summary of the comments we received regarding these proposals.
One commenter expressed concerns that the value-based payment modifier was based on “crude” per capita measures, while a number of specialists expressed concern that the cost measures are inappropriate for some specialties, particularly single specialty practices. A number of specialists objected to basing physician cost measures on total amount billed per patient, since the specialist is assumed to be held responsible for care and treatment decisions of the patient for which they have little control and for which they have limited ability to modify their practice to reduce costs. Commenters indicated that attribution of no costs or little costs to specialists is possible under any attribution method since the majority of specialists do not treat one of the four chronic conditions, so measuring costs using per capita measures would not create incentives to change behavior. Some commenters stated that Medicare Part A costs should be excluded from cost comparisons, because physicians cannot control Part A (for example, hospital) costs. A number of specialists supported CMS working closely with physicians to refine the cost measures prior to implementation of the value-based payment modifier.
As a result of the comments and for the reasons we articulated previously, we are finalizing the total per capita cost measures and per capita cost measures for beneficiaries with four specific chronic conditions (COPD, coronary artery disease, diabetes, and heart failure) in the 2015 value-based payment modifier and to use at least a 60-day claims run out.
Section 1848(p)(3) of the Act requires that “* * * costs shall be evaluated, to
Payment standardization removes local or regional price differences that may cause cost variation a physician cannot influence through practicing efficient care. In Medicare, an effective payment standardization methodology would exclude Medicare geographic adjustment factors such as the geographic practice cost index (GPCI) and the hospital wage index so that, for example, per capita costs for beneficiaries in Atlanta, Georgia can be compared to those of beneficiaries in Lincoln, Nebraska. Payment standardization, therefore, allows fair comparisons of resource use costs for physicians to those of peers who may practice in locations or facilities where Medicare payments are higher or lower.
With industry input, we developed a Medicare payment standardization methodology that excludes such geographic payment rate differences. We update this methodology annually to reflect any change in CMS payment systems. We proposed to use the same standardization methodology as in the 2011 Physician Feedback reports and the Medicare Spending per Beneficiary (MSPB) measure that is used in CMS' feedback reports to hospitals (77 FR 45003).
The following is a summary of the comments we received regarding the payment standardization proposal.
Multiple commenters expressed concern about the Geographic Price Cost Indices (GPCIs). They stated that the GPCI results in downward adjustments that do not reflect the actual cost of physician practice. Some commenters referred to concerns about CMS cost measurement methodology issues that were raised in the May 2011 and July 2012 Institute of Medicine reports that questioned CMS policies regarding geographic adjustment.
As a result of the comments and for the reasons specified above, we are finalizing our proposal to apply the CMS payment standardization methodology, and any annual updates to the methodology, to the cost measures used for the value-based payment modifier.
Section 1848(p)(3) of the Act requires that costs be adjusted to “* * * take into account risk factors[,] such as socioeconomic and demographic characteristics, ethnicity, and health status of individuals (such as to recognize that less healthy individuals may require more intensive interventions) and other factors determined appropriate by the Secretary.”
Risk adjustment accounts for differences in patient characteristics not directly related to patient care, but that may increase or decrease the costs of care. In the Physician Feedback reports, after standardizing per capita costs for geographic factors, we also adjusted them based on the unique mix of patients attributed to the physician or group of physicians. Costs for beneficiaries with high risk factors (such as a history of chronic diseases, disability, or increased age) are adjusted downward, and costs for beneficiaries with low risk factors are adjusted upward. Thus, for individual physicians or physician groups who have a higher than average proportion of patients with serious medical conditions or other higher-cost risk factors, risk adjusted per capita costs are lower than the unadjusted costs, because costs of higher-risk patients are adjusted downward. Similarly, for individual physicians or physician groups who treated comparatively lower-risk patients, risk adjusted per capita costs were higher than unadjusted costs, because costs for lower-risk patients were adjusted upwards.
We proposed to use the HCC model, which assigns prior year ICD-9-CM diagnosis codes to 70 high-cost clinical conditions (each with similar disease characteristics and costs) to capture medical condition risk (77 FR 45003-45004). The HCC risk scores also incorporate patient age, gender, reason for Medicare eligibility (age or disability), and Medicaid eligibility status, which is in part a proxy for socioeconomic status and reflects the greater resources typically used by beneficiaries eligible for both Medicare and Medicaid. The risk adjustment model also includes the beneficiary's end stage renal disease (ESRD) status. More information about the risk adjustment model is on the CMS Web site at
We proposed to use the same risk adjustment model for risk adjusting total per capita costs and the total per capita costs for beneficiaries with four chronic diseases (coronary artery disease, COPD, diabetes, and heart failure) as we have used for the group and individual 2010 Physician Feedback reports.
The following is a summary of the comments we received regarding the risk adjustment proposal.
Many commenters expressed concerns about the proposed risk adjustment method. Some commenters indicated that they had long-standing concerns with the HCC risk adjuster that should be addressed before the value-based payment modifiers is applied to small and mid-sized practices, and they urged CMS to consider new approaches that have been suggested by MedPAC and by the Medicare Episode Grouper contractor. Some concerns about the HCC model that commenters expressed include that it does not fare as well with acute costs associated with surgeries that are not predictable. Some commenters argued that socioeconomic factors and compliance are not adequately captured in the model, and that the Medicaid dual eligible status alone does not capture these differences in risk. Commenters suggested including different factors to capture socioeconomic status, including poverty status, education, literacy, race, ethnicity, English proficiency, homelessness, and religion. A number of commenters urged that CMS do further analysis in testing and refining risk adjusters that address comorbid conditions or new disease onset, and suggested that CMS work with physician groups.
Commenters did not present evidence that the risk adjustment model systematically disadvantages physicians or groups that see certain patient types, nor did they present reliable data sources we could use in our risk adjustment model to account for recommended factors such as socioeconomic status, education, literacy, English proficiency, homelessness, and religion. We agree with commenters that patient compliance could be a relevant issue, but commenters did not present a method about how to incorporate such compliance into the risk adjustment model using existing beneficiary data.
After consideration of the comments and for the reasons discussed above, we are finalizing our proposed approach to risk adjustment of the cost measures included in the value-based payment modifier.
Calculation of administrative claims-based quality and cost measure performance rates requires us to attribute Medicare beneficiaries to groups of physicians. We proposed to use a plurality of care method to attribute beneficiaries to a group of physicians (77 FR 45005). In this method, we attributed Medicare FFS beneficiaries to the group practice that billed a larger share of office and other outpatient Evaluation and Management (E/M) services (based on dollars) than any other group of physician practice (that is, the plurality). In addition, beneficiaries had to have at least two E/M services furnished by the group of physicians.
We sought comments on two possible alternative attribution approaches for the value-based payment modifier (77 FR 45005). First, we sought comment on whether we should use an attribution approach based on the methodology used in the Medicare Shared Savings Program to assign a beneficiary to an Accountable Care Organization (ACO). As discussed in the CY 2013 proposed FFS rule (77 FR 44819), this attribution approach would involve a two-step process that emphasizes primary care services furnished by a physician or group of physicians. Second, we sought comment on whether we instead should apply the “degree of involvement” attribution method. We used the “degree of involvement” method to attribute beneficiaries for cost purposes to individual physicians in the CY 2010 Physician Feedback reports. Under this attribution method, we classified the patients for which a physician submitted at least one Medicare FFS Part B claim into three categories (directed, influenced, and contributed) based on the amount of physician involvement with the patient.
The following is a summary of the comments we received regarding the attribution proposal.
Although commenters were more favorable of the plurality of care or plurality of primary care method than the degree of involvement attribution method, some commenters expressed concerns about using an attribution method based on plurality of care. Some commenters agreed with CMS that the plurality of care method, which depends on E/M frequency, would not work for certain specialists, with one commenter stating that plurality unfairly attributes costs to certain specialties over others and other commenters agreeing with CMS that plurality will not be applicable to single specialty groups. One commenter expressed concern that the plurality method may be too restrictive for some practices. Another commenter noted that plurality of care attribution in the performance year is a problem when used with risk adjustment that is based on claims that are submitted in years prior to the performance year, and noted that multiple attribution or degree of involvement may alleviate some, but not all, of the issues. One commenter asked how the plurality of care method accommodates specialists who do not furnish the plurality of a patient's care.
CMS asked for comment on the plurality of primary care attribution approach that is similar to what is used in the Shared Savings Program. Although fewer commenters discussed this method than the plurality of care method, most who did discuss this method expressed general support for this approach, either as their preferred attribution method or one that was at least at the same level of acceptability as the plurality of care method. Some commenters stated that, while the plurality of care method would be consistent with the attribution method proposed for the PQRS GPRO web-interface, the plurality of primary care attribution method is comparable to that used in the Shared Savings Program and would create consistency across these programs. One specialist group indicated that a patient that sees a specialist for management of chronic conditions and receives a plurality of primary care services from the specialist would be appropriately attributed under this method. One medical center supported the Shared Savings Program-like approach over the plurality of care method because most group reporting measures are primary care based, so attribution under this method would be to the primary care physician whereas, under plurality of care attribution, the beneficiaries could be assigned incorrectly to higher cost specialists.
We recognize that certain large single specialty groups—such as those limited to emergency medicine, diagnostic radiology, pathology, and anesthesiology—will not be attributed beneficiaries under this attribution methodology. Indeed, neither the plurality of care attribution methodology nor the Shared Savings Program methodology would attribute beneficiaries to certain single specialty groups. However, after we have had the opportunity to examine the issue further and gain more experience with the value-based payment modifier we anticipate addressing this issue in future rulemaking. We believe that as we continue to phase in the value-based payment modifier, we will refine our attribution methods to assign beneficiaries to these physicians and groups of physicians within these specialties.
A number of commenters expressed either concern or confusion about the degree of involvement attribution method. Several commenters suggested that CMS use data from the Physician Feedback reports to examine the impact of different methods on groups' cost and quality scores. Some commenters questioned how the degree of involvement classification would translate into how much would be attributed to a physician or a group. One commenter indicated that the degree of involvement method would be problematic in many cases and would need to evolve over time, with consideration for physicians who see patients at multiple facilities. Emergency physicians expressed concern about their ability to influence overall costs through coordination, although they might be attributed the costs under this method.
As a result of the comments, we are not finalizing the proposed plurality of care method, but instead, as described above, we will apply the same attribution rule as that used for the Medicare Shared Savings Program and the PQRS GPRO web interface. This methodology is described at
Section 1848(p)(2) of the Act requires that quality of care be evaluated, to the extent practicable, based on a composite of measures of the quality of care furnished. Likewise, section 1848(p)(3) of the Act requires that costs in the value-based payment modifier be evaluated, to the extent practicable, based on a composite of appropriate measures of costs.
We proposed to align the quality measures used in the value-based payment modifier with the national priorities established in the National Quality Strategy (77 FR 45006). The National Quality Strategy outlined six priorities including:
• Make care safer by reducing harm caused in the delivery of care (patient safety).
• Ensure that care engages each person and family as partners (patient experience).
• Promote effective communication and coordination of care (care coordination).
• Promote the most effective prevention and treatment practices for leading causes of mortality (clinical care).
• Work with communities to promote wide use of best practice to enable healthy living (population/community health).
• Make quality care more affordable for individuals, families, employers, and governments by developing and spreading new health care delivery models (efficiency).
We proposed to classify each of the quality measures that we proposed for the value-based payment modifier into one of these six domains. We proposed to weight each domain equally to form a quality of care composite. We believe this is a straightforward approach that recognizes the importance of each domain. Within each domain, we proposed to weight each measure equally so that groups of physicians have equal incentives to improve care delivery on all measures. To the extent that a domain does not contain quality measures, the remaining domains would be equally weighted to form the quality of care composite. For example, if only three domains contain quality information, each domain would be weighted at 33.3 percent to form the quality composite while the remaining three domains would not be included.
In terms of the cost composite, we finalized in the CY 2012 PFS final rule (76 FR 73434) five per capita cost measures: Total per capita costs (Parts A and B) and total per capita costs for beneficiaries with four chronic diseases (diabetes, CAD, COPD, heart failure). We proposed to group these five per capita cost measures into two separate domains: Total overall costs (one measure) and total costs for beneficiaries with specific conditions (four measures). A separate domain for costs for beneficiaries with specific conditions highlights our desire to incentivize efficient care for beneficiaries with these conditions.
Similar to the quality of care composite, we proposed to weight each cost domain equally to form the cost composite and within the cost domains we proposed to weight each measure equally. In those instances in which we cannot calculate a particular cost measure, for example, due to too few cases, we proposed to weight the remaining cost measures in the domain equally.
Comments on our proposed domains and weighting methodology were also mixed. One commenter expressed support for our proposal to equally weight domains, but recommended that attention be given to the number of measures in each domain so that they were weighted to support our policy
We also received varying views on how to weight various measures. One commenter suggested that quality outcome measures should receive more weight than other measure types; another comment suggested that outcome measures be weighted lower than the PQRS measures as the latter are likely to be more direct indicators of a physician's performance, particularly for specialty physicians. Alternatively, one commenter suggested that CMS weight existing PQRS measures within the efficiency domain for those who successfully report or assess costs on a measure-by-measure basis.
We agree with the commenters' recommendation that we continue to monitor and examine our policy to form the quality and cost composites. We believe this monitoring will be facilitated with the data reported by those participating in value-based payment modifier and the PQRS programs. As part of this monitoring, we will be able to examine whether the quality and cost composites are masking performance variation within a group as suggested by the commenters.
Accordingly, we are finalizing our proposal to construct the quality composite by classifying each group's quality measures into one of the six National Quality Strategy domains, to weight each measure equally within each domain, and to weight the domains equally to form the quality composite. Likewise, we are finalizing our proposals to construct the cost composite by classifying each group's per capita cost measures into two domains—all patients and all patients with four specific chronic conditions, to weight each measure equally within each domain, and to weight the domains equally to form the cost composite.
We proposed a scoring approach that focuses on how the group of physicians' performance differs from the benchmark on a measure-by-measure basis because we proposed to provide flexibility to groups of physicians as to the quality measures they report (77 FR 45007). We explained that the scoring methodology needs to be able to compare “apples to apples.” For each quality and cost measure, we proposed to divide the difference between a group of physicians' performance rate and the benchmark by the measure's standard deviation. The benchmarks, as further described below, are the national means of the quality or cost measure. This step produces a score for each measure that is expressed in standardized units.
We proposed that the benchmark for each quality measure be the national mean of each measure's performance rate during the performance period (77 FR 45008). We proposed to unify the calculation of the benchmark by weighting the performance rate of each physician and group of physicians submitting data on the quality measure by the number of beneficiaries used to calculate the performance rate so that group performance is weighted appropriately.
In addition, we proposed that the benchmarks for quality measures in the PQRS administrative claims-based reporting option be the national mean of each quality measure's performance rate calculated at the TIN level. We proposed to calculate the national mean by including all TINs of groups of physicians with 25 or more eligible professionals. We proposed to weight the TIN's performance rate by the number of beneficiaries used to calculate the quality measure.
To help groups of physicians understand how their quality measure performance affects their quality of care composite score, we proposed to publish the previous years' performance rates (and standardized scores) on each quality measure.
Other commenters reported concerns about the proposed national benchmark and, as an alternative, suggested that comparisons should be within regions, physician or to some other appropriate peer group, for example, considering patient risk. One commenter encouraged CMS to set performance standards higher in subsequent years.
Some commenters suggested that CMS explore and conduct analyses on a variety of benchmarking options. For example, one suggested that CMS examine the advantages of initially using a regional or blended benchmark that gradually moves to a national benchmark. In their view, this could be a means to encourage physician buy-in while not disadvantaging certain regions
One commenter suggested that for a pay-for-performance system to be effective, it must have clarity and credibility with front-line practitioners. This commenter observed that under our proposals, physicians receiving a payment adjustment are unlikely to understand why their payments are getting adjusted and what they need to do to improve their value modifier.
Because we are allowing flexibility on the quality measures that groups of physicians can report, we believe the most appropriate peer group consists of other physicians and physician groups reporting the same measure regardless of specialty. Under this approach, we expect physicians and physician groups will report data on the quality measures that best reflect the care they furnish.
We also believe that the optional nature of the quality-tiering approach to calculating the value-based payment modifier will encourage physician buy-in while not disadvantaging certain regions based on their historical performance levels, thus we will not develop regional benchmarks for each quality measure.
Further, we believe transparency is a key component to establish credibility among physicians, namely, physicians need to understand why their payments are being adjusted in order to improve their performance. Thus, we are modifying our proposal to establish benchmarks based on the year prior to the performance year so that groups of physicians have information on national benchmarks prior to the end of the performance year. For example, the benchmark for the 2013 performance year will be based on 2012. We intend that these benchmarks would be available publicly to inform a group of physicians' choice of PQRS reporting method for the applicable performance year.
Accordingly, we are finalizing our proposal for national benchmarks and we will unify the calculation of the benchmark by weighting the performance rate of each physician and group of physicians submitting data (through any PQRS reporting method) on the quality measure by the number of beneficiaries used to calculate the performance rate. In addition, the benchmarks for quality measures in the PQRS administrative claims-based reporting option are the national mean of each quality measure's performance rate calculated at the TIN level. We will weight the TIN's performance rate by the number of beneficiaries used to calculate the quality measure. We also will use the year prior to the performance year as the year for calculating the benchmark. If a measure is new to the PQRS, we will be unable to calculate a benchmark, and hence, performance on that measure will not be included in the quality composite. We will be considering the effects of our policies over the next several years as we implement this program and may consider changes and refinements through future rulemaking.
To ensure fair cost comparisons that identify groups of physicians that are outliers (both high and low), we proposed that the methodology used to attribute beneficiaries to a group of physicians be the same as the methodology used to attribute beneficiaries in the peer group (77 FR 45008). We explained that we seek to compare like groups of physicians that use the same cost attribution methodology to ensure we are making “apples to apples” comparisons among groups of physicians. As discussed above, we are finalizing a cost attribution methodology that we use in the Medicare Shared Savings Program and that relies on a two-step process. We sought comment, however, on whether the cost measure peer groups should change if we adopted the “degree of involvement” methodology for groups of physicians other than groups of physicians using the PQRS GPRO web-interface to submit data on quality measures. We also solicited comments on establishing cost benchmarks on a quality measure-by-quality measure basis.
We believe it is crucial that the value-based payment modifier be based on quality of care and cost composites that reliably measure performance. Statistical reliability is defined as the extent to which variation in the measure's performance rate is due to variation in the quality (or cost) furnished by the physicians (or group of physicians) rather than random variation due to the sample of cases observed. Potential reliability values range from zero to one, where one (highest possible reliability) signifies that all variation in the measure's rates is the result of variation in differences in performance across physicians (or groups of physicians). Generally, reliabilities in the 0.40-0.70 range are often considered moderate and values greater than 0.70 high.
Therefore, we proposed to establish a minimum number of cases in order for a quality or cost measure to be included in the quality of care or cost composite (77 FR 45009). To the extent that a group of physicians fails to meet the minimum number of cases for a particular measure, the measure would not be counted and the remaining measures in the domain would be given equal weight. To the extent that we cannot develop either a reliable quality of care composite or cost composite because we do not have reliable domain information, we proposed that we would not calculate a value-based payment modifier and payment would not be affected.
Based on an analysis of the individual CY 2010 Physician Feedback reports and on recent literature, we proposed a minimum case size of 20 for both quality and cost measures to ensure high statistical reliability. We explained that the average reliability of the total per capita cost measure assessed at the individual level for physicians in all specialties was high (greater than 0.70) when the minimum case size was 20 or more. We also stated that reliability was high for nine of the 15 administrative claims based quality measures that we are proposing for purposes of the value-
Section 1848(p) of the Act does not specify the amount of physician payment that should be subject to the adjustment for the value-based payment modifier; however, section 1848(p)(4)(C) of the Act requires the payment modifier be implemented in a budget neutral manner. Budget neutrality means that payments will increase for some groups of physicians based on high performance and decrease for others based on low performance, but the aggregate amount of Medicare spending in any given year for physicians' services will not change as a result of application of the value-based payment modifier.
In making proposals about the amount of Medicare payment made under the PFS at risk for the value-based payment modifier, we considered that there are two other payment adjustments affecting physicians' Medicare payment in 2015 that could further decrease physician payments in 2016. Specifically, under the PQRS, a physician who does not submit data on quality measures to meet the satisfactory reporting criteria for the PQRS payment adjustment during the applicable reporting period in 2013 will have his or her fee schedule amount reduced by 1.5 percent for services furnished in 2015. This PQRS downward payment adjustment to the fee schedule will increase to 2 percent in 2016 (and thereafter) based on reporting periods that fall in CY 2014 (and thereafter, reporting period or periods that fall two years prior to the year in which the PQRS payment adjustment is assessed). The second payment adjustment is for physicians who do not achieve meaningful EHR use under the EHR Incentive program. Section 1848(a)(7) of the Act provides for a downward payment adjustment of 1 percent in 2015, 2 percent in 2016, and 3 percent in 2017 . We note that the adjustment in 2015 for not achieving meaningful use is increased by 1 percentage point (to −2 percent) if the physician was subject to the eRx Incentive Program payment adjustment for 2014.
As discussed above, we have finalized our policy to allow groups of physicians of 100 or more eligible professionals to elect whether to have their value-based payment modifier based on the quality-tiering methodology. For those groups that elect quality-tiering, we proposed that the maximum payment adjustment be −1.0 percent for poor performance (75 FR 45010). We stated that due to the budget neutrality requirement, we did not propose the exact amount of the upward payment adjustments for high performance under the quality-tiering approach because the upward payment adjustments (in the aggregate) will have to balance the downward payment adjustments in order to achieve budget neutrality. Thus, we proposed to determine the projected aggregate amount of downward payment adjustments and then calculate the upward payment adjustment factor based on the amount of the projected aggregate upward payment adjustments.
For groups of physicians subject to the value-based payment modifier that have not met the PQRS criteria for satisfactory reporting as described above (including those groups that have not participated in any of the PQRS reporting mechanisms), we proposed to set their value-based payment modifier at −1.0 percent (77 FR 45010). We arrived at our proposal for a −1.0 percent downward adjustment using the following rationale: Section 1848(p)(1) of the Act requires us to differentiate payment based on a comparison of quality of care furnished compared to cost. Because we do not have performance rates on which to assess the quality of care furnished by these groups, we can differentiate payment based on costs only rather than quality and cost as required by statute. Due to the fact that the value-based payment modifier is just starting in 2015, we do not wish to apply a greater downward payment adjustment for non-satisfactory reporters than we are proposing for the low quality/high cost groups that request that their value-based payment modifier be calculated using a quality-tiering approach.
In contrast, however, we received many comments suggesting that the
Related to this, some commenters expressed concern that since the upward payment adjustment was yet unspecified, there was little incentive or clarity in terms of the advantages and risks for participating in the program. One commenter sought clarity on whether budget neutrality meant that groups that elect quality-tiering would be “vying to receive an upward modifier adjustment from a pool of funds derived from groups that received the −1.0 percent adjustment or would be competing against one another.
We also appreciate concerns expressed about the uncertain of the amount of the upward payment adjustment; however, given statutory requirements for budget neutrality, we have not identified a way to specify an upward amount until all downward adjustments have been determined. We are open to comments on how we might be able to provide an upward payment amount for future rulemaking. We also wish to clarify that the total amount of upward payment adjustments is a fixed amount that is equal the amount made available through downward payment adjustments.
In summary, we are finalizing our proposal to establish a −1.0 value-based payment modifier adjustment for those groups of physicians of 100 or more eligible professionals that fall into category 2, which are those that neither (a) self-nominate for the PQRS as a group and report at least one measure nor (b) elect the PQRS administrative claims option for CY 2013. We also are finalizing our proposal to limit the downside payment adjustment for groups of physicians that elect the quality-tiering option at −1.0 percent.
Section 1848(p)(1) of the Act requires the Secretary to establish a payment modifier that provides for differential payment to a physician or group of physicians under the fee schedule based upon the quality of care furnished compared to cost during a performance period. As noted previously, the statute requires that quality of care furnished and cost shall be evaluated, to the extent practicable, based on composites of quality of care furnished and cost.
In making our proposals, we developed two models that compare the quality of care furnished to costs: A quality-tiering model and a total performance score model. We proposed the quality-tiering model for the value-based payment modifier, and solicited comments on the total performance score model (77 FR 44010-12).
The quality-tiering model compares the quality of care composite with the cost composite to determine the value-based payment modifier. To make this comparison, we proposed to classify the quality of care composites scores into high, average, and low quality of care categories based on whether they are statistically above, not different from, or below the mean quality composite score. We seek to ensure that those groups of physicians classified as high or low performers have performance that is meaningfully different from average performance (to be sure that no group of physicians is disadvantaged for performance only slightly different from the benchmark) and is precisely measured (to ensure that no group of physicians is disadvantaged by an inaccurate performance assessment). We proposed to assess meaningful differences as those performance scores that are at least one standard deviation from the mean. We proposed to assess precision by requiring a group of physicians' score to be statistically different from the mean at the 5.0 percent level of significance (that is, a 95 percent confidence interval).
Likewise, we proposed to identify those groups of physicians that have cost composite scores that are statistically different from the mean cost composite score of all groups of physicians. We proposed to classify these groups of physicians into high, average, and low cost categories based on whether they are significantly above, not different from, or below the mean cost composite score as described above with reference to quality composite. We proposed to assess meaningful differences as those performance scores that are at least one standard deviation from the mean and we proposed to assess precision at the 5.0 percent level of significance.
We proposed to compare quality of care composite classification with the cost composite classification to determine the value-based payment modifier adjustment according to the amounts in Table 126.
We proposed to establish the upward payment adjustment factor (“x”) after the performance period has ended based on the aggregate amount of downward payment adjustments. We also proposed to aggregate the downward payment adjustments in Table 126 with the downward adjustment for groups of physicians subject to the value-based payment modifier that are not satisfactory PQRS reporters and then to solve for the upward payment
We also proposed that the scoring methodology provide a greater upward payment adjustment (+1.0x) for groups of physicians that care for high-risk patients (as evidenced by the average HCC risk score of the attributed beneficiary population) and submit data on PQRS quality measures through PQRS via the GPRO using the web-interface, claims, registries, or EHRs. We proposed to increase the upward payment adjustment to +3x (rather than +2x) for groups of physicians classified as high quality/low cost and to +2x (rather than +1x) for groups of physicians that are either high quality/average cost or average quality/low cost if the group of physicians' attributed patient population has an average risk score that is in the top 25 percent of all beneficiary risk scores. In other words, we did not propose this additional upward payment adjustment (+1.0x) for groups of physicians that select the PQRS administrative claims-based reporting option.
A second approach to scoring the value-based payment modifier is a total performance score approach. We sought comment on this approach. This approach allows us to develop a unique value-based payment modifier for each group of physicians. This approach results in a range of continuous payment adjustments rather than the thresholds proposed in the quality tier approach. This method would be similar to the approach we use in the Hospital Value-Based Purchasing program where we use a linear exchange function to develop a unique payment for each hospital. This approach results in a continuous array of unique value-based payment modifiers such that there are no longer cut-off points between high and low performing groups of physicians.
We also received many comments supporting the total performance score methodology. Several commenters expressed their view that this methodology better aligned with the hospital value-based purchasing methodology than did quality-tiering or that it would be most appropriate for hospital-based physicians.
Many of these commenters suggested that the total performance score methodology: (1) Offered greater incentives for groups to participate in the program or to improve their performance because they could be rewarded for either achievement or improvement; and (2) avoided “cut off problems” where groups are placed in high and low performing categories that occur under the quality-tiering approach. One commenter offered their view that applying a cutoff such as one standard deviation is crude in that a physician performing at 0.99 standard deviations below the mean would be considered average while another performing at 1.01 standard deviations below the mean would be considered low. Another commenter observed that since quality-tiering applies to only physician groups above or below one standard deviation, the methodology effectively removes two-thirds of practices from its effects. Another suggested that a focus on outliers does little to improve care as variation in performance within groups is hidden.
Commenters also noted that CMS might not have sufficient historical data on all physicians to implement this methodology, and suggested that it could evolve from quality-tiering over time.
In other cases, commenters suggested alternatives to distinguishing groups by statistical comparison. For example, one commenter suggested that CMS explore a concept of “meaningful clinical difference” that is used in the domain of patient self-reported health status.
Section 1848(p)(10) of the Act provides that there shall be no administrative or judicial review under section 1869 of the Act, section 1878 of the Act, or otherwise of the following:
• The establishment of the value-based payment modifier;
• The evaluation of the quality of care composite, including the establishment of appropriate measure of the quality of care;
• The evaluation of costs composite, including establishment of appropriate measures of costs;
• The dates of implementation of the value-based payment modifier;
• The specification of the initial performance period and any other performance period;
• The application of the value-based payment modifier; and
• The determination of costs.
Despite the preclusion of administrative and judicial review, we believe it is useful for groups of physicians to understand how their payment under the PFS could be changed by the value-based payment modifier. We also believe that an informal mechanism is needed for groups of physicians to review and to identify any possible errors prior to application of the value-based payment modifier.
Therefore, we intend to disseminate Physician Feedback reports containing calendar year 2013 data in the fall of 2014 to groups of physicians subject to these policies; these reports would be the basis of the value-based payment modifier in 2015. We proposed that these reports would contain, among other things, the quality and cost measures and measure performance and benchmarks used to score the composites, and quality of care and cost composite scores, and the value-based payment modifier amount (77 FR 45012).
After the dissemination of the Physician Feedback reports in the fall of 2014, we proposed that physicians would be able to email or call a technical help desk to inquire about their report and the calculation of the value-based payment modifier. We envisioned this process to help educate and inform physicians about the value-based payment modifier, especially for those groups of physicians that have elected that their value-based payment modifier be calculated using a quality-tiering approach.
In anticipation of the reports that we would produce in 2014, in the fall of 2013 we plan to produce and disseminate Physician Feedback reports at the TIN level to all groups of physicians with 25 or more eligible professionals based on 2012 data. These reports will include a “first look” at the methodologies we proposed in this rule for the value-based payment modifier. We view these reports as a way to help educate groups of physicians about how the value-based payment modifier could affect their payment under the PFS.
A number of commenters noted the importance of making feedback reports available in a timely manner, and expressed concerns about the usefulness of data that are not current. For example, commenters reported that untimely data are not actionable and assessing payments on such data offer little incentive for change. One commenter suggested that data need to be timely or penalties should otherwise be waived.
We also received comments expressing support for the availability of technical assistance, for example, through a technical help desk as well as an appeals or review process. One commenter suggested that CMS establish corrective action plans or some means to assist poorer performers before applying a payment adjustment. One commenter disagreed with the “limited distribution of physician feedback reports prior to implementation of the value based modifier” and suggested we provide feedback reports to all physicians in advance of payment adjustments.” In addition, some commenters urged CMS to consider adopting a Corrective Action Plan, or similar program, for outliers/poor performers prior to applying the value-based payment modifier.
Section 1848(n) of the Act requires us to provide confidential reports to physicians that measure the resources involved in furnishing care to Medicare FFS beneficiaries. Section 1848(n)(1)(A)(iii) of the Act also authorizes us to include information on the quality of care furnished to Medicare FFS beneficiaries. In September 2011, we produced and disseminated confidential feedback reports to physician groups that participated in the PQRS Group Practice Reporting Option (GPRO) in 2010, and in March 2012 we produced and disseminated reports to physicians practicing in the following states: Iowa, Kansas, Missouri, and Nebraska.
In the CY 2013 PFS proposed rule, we discussed that, in the fall of 2012, we plan to disseminate Physician Feedback reports to physicians in nine states (California, Iowa, Illinois, Kansas,
In the fall of 2013, we plan to produce and disseminate Physician Feedback reports at the TIN level to all groups of physicians with 25 or more eligible professionals. These reports will include a “first look” at the methodologies that we have adopted in this final rule for the value-based payment modifier.
In addition, section 1848(n) of the Act requires that we use the episode-based costs in the Physician Feedback reports beginning in 2013 for the reports based on 2012 data. As discussed above in relation to the value-based payment modifier, we plan to include episode-based cost measures for several episode types in future Physician Feedback reports. In addition, we plan to consider adjusting the format and organization of the reports, to the extent practicable, to address the best practices outlined in the American Medical Association's Guidelines for Reporting Physician Data. We believe that this dissemination plan satisfies our obligations under the section 1848(p)(4)(B)(ii)(II) of the Act to provide information to physicians and groups of physicians about the quality of care furnished to Medicare FFS beneficiaries.
In the fall of 2014, we plan to disseminate Physician Feedback reports based on 2013 data that show the amount of the value-based payment modifier and the basis for its determination. We plan to provide these reports to all groups of physicians (at the TIN level) with 25 or more eligible professionals even though groups of physicians with 25 to 99 eligible professionals will not be subject to the value-based payment modifier in 2015. We are examining whether we can provide reports to groups of physicians with fewer than 25 eligible professionals and individual level reports as well. These reports will contain, among other things, performance on the quality and cost measures used to score the composites and the value-based payment modifier amount. As discussed above, we anticipate providing an opportunity for review and correction as outlined in our value-based payment modifier proposals above.
We received many comments on our future plans for the Physician Feedback reports. A summary of the comments and our responses to those comments are provided below.
• Work with national and state medical specialty societies to ensure that physicians understand these reports.
• Work with medical specialty societies to improve the Physician Feedback reports.
• Further increase physician awareness of and education for the value-based payment modifier and Physician Feedback Program.
• Provide a mechanism for interpretation of feedback reports and meaningful dialogue between physicians, specialty society staff, and CMS.
Section 1861(s)(10)(B) of the Act authorizes Medicare Part B coverage of hepatitis B vaccine and its administration if furnished to an individual who is at high or intermediate risk of contracting hepatitis B. High and intermediate risk groups are defined in regulations at § 410.63.
On December 23, 2011, the United States Centers for Disease Control and Prevention (CDC) published a Morbidity and Mortality Weekly Report (MMWR), which included an article entitled “Use of Hepatitis B Vaccination for Adults with Diabetes Mellitus: Recommendations of the Advisory Committee on Immunization Practices (ACIP).” The article stated that “In the United States, since 1996, a total of 29 outbreaks of HBV [Hepatitis B virus] infection in one or multiple long-term care (LTC) facilities, including nursing homes and assisted-living facilities, were reported to CDC; of these, 25 involved adults with diabetes receiving assisted blood glucose monitoring. These outbreaks prompted the Hepatitis Vaccines Work Group of the Advisory Committee on Immunization Practices (ACIP) to evaluate the risk for HBV infection among all adults with diagnosed diabetes.”
“HBV is highly infectious and environmentally stable; HBV can be transmitted by medical equipment that is contaminated with blood that is not visible to the unaided eye. Percutaneous exposures to HBV occur as a result of assisted monitoring of blood glucose and other procedures involving instruments or parenteral treatments shared between persons. Lapses in infection control during assisted blood glucose monitoring that have led to HBV transmission include multipatient use of finger stick devices designed for single-patient use and inadequate disinfection and cleaning of blood glucose monitors between patients. Breaches have been documented in various settings, including LTC facilities, hospitals, community health centers, ambulatory surgical centers, private offices, homes, and health fairs.” Additionally, in analyses of persons without hepatitis B-related risk behaviors (that is, injection-drug use, male sex with a male, and sex with multiple partners), persons aged 23 through 59 years with diabetes had 2.1 times the odds of developing acute hepatitis B as those without diabetes; and the odds for hepatitis B infection were 1.5 times as likely for persons aged 60 and older. (MMWR, December 23, 2011).
Based on the Hepatitis Vaccines Work Group findings, ACIP recommended that:
• Hepatitis B vaccination should be administered to unvaccinated adults with diabetes mellitus who are aged 19 through 59 years.
• Hepatitis B vaccination may be administered at the discretion of the treating clinician to unvaccinated adults with diabetes mellitus who are aged 60 years and older.
Based on the ACIP recommendations, we proposed to modify § 410.63(a)(1), High Risk Groups, by adding new paragraph “(viii) Persons diagnosed with diabetes mellitus.” Since HBV can be transmitted by medical equipment (that is, finger stick devices and blood glucose monitors) that is contaminated with blood that is not visible to the unaided eye, we believe that persons diagnosed with diabetes mellitus should be added to the high risk group. Since lapses in infection control have been reported in both community and facility settings, the increased risk of contracting HBV is not limited to the facility setting. We believe that expanding coverage of Hepatitis B vaccinations and administration to those diagnosed with diabetes mellitus is supported by the findings and evidence reviewed by the Hepatitis Vaccines Work Group and the ACIP recommendations. Hepatitis B vaccination is a preventive measure that needs to occur before exposure. It is difficult to predict which diabetics will eventually be exposed in the circumstances that we discussed above. Therefore, we proposed to expand coverage for hepatitis B vaccine and its
We received 15 public comments that supported the proposed rule to expand coverage of hepatitis B vaccination and its administration to individuals diagnosed with diabetes mellitus. We did not receive any public comments that opposed our proposed expansion. In addition to their support of our proposal, below is a summary of additional comments received and our responses.
Based on the overwhelming support of the public comments received, we are implementing this rule as proposed.
Section 101 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) amended title XVIII of the Act to establish a voluntary prescription drug benefit program at section 1860D-4(e) of the Act. Among other things, these provisions required the adoption of Part D e-prescribing standards. Prescription Drug Plan (PDP) sponsors and Medicare Advantage (MA) organizations offering Medicare Advantage-Prescription Drug Plans (MA-PD) are required to establish electronic prescription drug programs that comply with the e-prescribing standards that are adopted under this authority. There is no requirement that prescribers or dispensers implement e-prescribing. However, prescribers and dispensers who electronically transmit prescription and certain other information for covered drugs prescribed for Medicare Part D eligible beneficiaries, directly or through an intermediary, are required to comply with any applicable standards that are in effect. The Medicare Part—D e-prescribing Program adopts standards that allow Eligible Professionals (EP) to participate in the eRx Incentive Payment program and Other CMS programs that require the reporting of electronic prescribing transactions.
For a further discussion of the statutory basis for this final rule and the statutory requirements at section 1860D-4(e) of the Act, please refer to section I. (Background) of the E-Prescribing and the Prescription Drug Program proposed rule, published February 4, 2005 (70 FR 6256).
CMS utilized several rounds of rulemaking to adopt standards for the Part D e-prescribing program. Its first rule, which was published on November 7, 2005 (70 FR 67568), adopted three standards that were collectively referred to as the “foundation” standards. One of these standards, the National Council for Prescription Drug Programs (NCPDP) SCRIPT Standard, Implementation Guide, Version 5, Release 0 (Version 5.0), May 12, 2004 (excluding the Prescription Fill Status Notification Transaction and its three business cases; Prescription Fill Status Notification Transaction—Filled, Prescription Fill Status Notification Transaction—Not Filled, and Prescription Fill Status Notification Transaction—Partial Fill), hereafter referred to as the NCPDP SCRIPT 5.0, is the subject of several of the changes effectuated by this and prior final rules. We issued a subsequent rule on April 7, 2008 (73 FR 18918) that adopted additional standards which are referred to as “final” standards. One of these standards, Version 1.0 of the NCPDP Formulary and Benefit standard, Implementation Guide, Version 1, Release 0, hereafter referred to as the NCPDP Formulary and Benefit 1.0) is also the subject of another of the changes effectuated by this final rule. Please see the “Initial Standards Versus Final Standards” discussion at 70 FR 67568 in the November 7, 2005 rule for a more detailed discussion about “foundation” and “final” standards.
While prescribers and dispensers who electronically transmit prescription and certain other information for covered drugs prescribed for Medicare Part D eligible beneficiaries, directly or through an intermediary, are generally required to comply with any applicable Part D e-prescribing standards that are in effect at the time of their transmission, the early versions of the NCPDP SCRIPT standard did not support the complexities of the prescribing process for patients in long term care facilities where the prescribing process involves not only a prescriber and a pharmacy, but also a facility and its staff. As such, we exempted such entities from use of the NCPDP SCRIPT standard. That exemption, currently found at § 423.160(a)(3)(iv), provides an exemption for entities transmitting prescriptions or prescription-related information where the prescriber is required by law to issue a prescription for a patient to a non-prescribing provider (such as a nursing facility) that in turn forwards the prescription to a dispenser.
For a more detailed discussion, see the November 7, 2005 final rule (70 FR 67583).
Transaction standards are periodically updated to take new knowledge, technology and other considerations into account. As CMS adopted specific versions of the standards when it adopted the foundation and final e-prescribing standards, there was a need to establish a process by which the standards could be updated or replaced over time to ensure that the standards did not hold back progress in the industry. CMS discussed these processes in its November 7, 2005 final rule (70 FR 67579).
The discussion noted that the rulemaking process will generally be used to retire, replace or adopt a new e-prescribing standard, but it also provided for a simplified “updating
In contrast to the extensive updating that was done to the NCPDP SCRIPT standard in the Part D e-prescribing program, the original NCPDP Formulary and Benefit 1.0 is still in place as the official Part D e-prescribing standard.
As described in the CY 2013 Physician Fee Schedule proposed rule (77 FR 45022-45023) we proposed to finalize our recognition of NCPDP SCRIPT 10.6 as a backward compatible version of the official Part D e-prescribing standard NCPDP SCRIPT 8.1, effective from the effective date of the final rule through October 31, 2013, but, in response to the comments that were received to the interim final rule with comment, we also proposed to retire NCPDP SCRIPT 8.1 effective October 31, 2013, and we proposed to adopt NCPDP SCRIPT 10.6 as the official Part D e-prescribing standard effective November 1, 2013. For further discussion on our NCPDP SCRIPT updating proposals please see CY 2013 Physician Fee Schedule proposed rule (77 FR 45022 through 45025).
As such, we proposed to revise § 423.160(b)(2)(ii) so as to limit its application to transactions on or before October 31, 2013 and add a new § 423.160(b)(2)(iii) to require that, as of November 1, 2013, providers and dispensers would use NCPDP SCRIPT 10.6 for the following electronic transactions that convey prescription or prescription related information:
• Get message transaction.
• Status response transaction.
• Error response transaction.
• New prescription transaction.
• Prescription change request transaction.
• Prescription change response transaction.
• Refill prescription request transaction.
• Refill prescription response transaction.
• Verification transaction.
• Password change transaction.
• Cancel prescription request transaction.
• Cancel prescription response transaction
• Fill status notification.
Furthermore, we proposed to amend § 423.160(b)(1) by adding a new 423.160(b)(1)(iii) to amend the information about which subsequent requirements in the section are applicable to which timeframes and amend § 423.160(b)(1)(ii) to limit its application to transactions on or before October 31, 2013.
The following is a summary of the comments we received regarding the finalization of NCPDP SCRIPT 10.6 as a backward compatible version of NCPDP SCRIPT 8.1, the proposed retirement of NCPDP SCRIPT 8.1, and the proposed adoption of NCPDP SCRIPT 10.6 as the official Part D E-Prescribing standard. We received comments on all three proposals.
In light of the overwhelmingly positive comments that we received in response to our proposals to finalize the NCPDP SCRIPT 10.6 as a Backward Compatible Version of NCPDP SCRIPT 8.1 as of the effective date of this final rule, and retire NCPDP SCRIPT 8.1 and adopt NCPDP SCRIPT 10.6 as the official Part D e-Prescribing Standard
Formulary and Benefits standards provide a uniform means for pharmacy benefit payers (including health plans and PBMs) to communicate a range of formulary and benefit information to prescribers via point-of-care (POC) systems. These include:
• General formulary data (for example, therapeutic classes and subclasses);
• Formulary status of individual drugs (that is, which drugs are covered);
• Preferred alternatives (including any coverage restrictions, such as quantity limits and need for prior authorization); and
• Copayment (the copayments for one drug option versus another).
The NCPDP Formulary and Benefits Standard 1.0 enables the prescriber to consider this information during the prescribing process, and make the most appropriate drug choice without extensive back-and-forth administrative activities with the pharmacy or the health plan.
As discussed above, the November 7, 2005 final rule (70 FR 67579) established the process of updating an official Part D e-prescribing standard with the recognition of “backward-compatible” versions of the official standard in instances in which the user of the later version can accommodate users of the earlier version of the adopted standard without modification. In these instances, notice and comment rulemaking could be waived, and use of either the new or old version of the adopted standard would be considered compliant with the adopted standard upon the effective date of the newer version's incorporation by reference in the
One of the major improvements between Version 1.0 and 3.0 involved the addition of Text message support for “Coverage and Copay Information,” the addition of the “Text Message Type (A46-1S)” field and the addition of “Optional Prior Authorization Lists.” Theses list were added for use in conveying prior authorization requirements.
Other improvements included conversion of certain elements from optional to mandatory. Version 3.0 also provides for “Formulary Status List Headers,” which are fields that allow the sender to specify a default formulary status for non-listed drugs. Subsequent versions also allowed for the omission of “Formulary Status Detail” records when the non-listed formulary policies are used exclusively to convey the status of a drug on a formulary.
Changes to a standard may also involve removing fields that are not widely used in industry. The removed fields are often replaced by new fields that better serve the business needs of the industry. For example, the following items have been removed through the various updates that led up to Version 3.0: “Classification List” and references to it (such as Drug Classification Information), “Coverage Information Detail—Medical Necessity (MN),” “Coverage Information Detail-Resource Link-Summary Level (RS),” and the Classification ID in the Cross Reference Detail.
In place of these deleted fields, the following fields were added or amended to ultimately result in Version 3.0: The “Formulary Status existing value 2” field was changed to “On Formulary/Non-Preferred,” and “The file load also enables payers to specify a single coverage-related text message for each drug” field was changed to “A payer may send multiple quantity limits, step medications, text messages and resource links for the same drug.”
We reviewed Version 3.0, and based on our findings, we have determined that NCPDP Formulary and Benefits 3.0 maintains full functionality of the official adopted Part D e-prescribing standard NCPDP Formulary and Benefits 1.0, and would permit the successful communication of the applicable transaction with entities that continue to use Version 1.0.
While we would usually use the “backward compatible” waiver of notice and comment procedures that are described above to recognize Version 3.0 as a backward compatible version of the officially adopted Version 1.0, this would have to be done in an interim final rule with comment. As we cannot combine proposals and elements of a final rule in one rule, we elected this one time to formally propose recognizing a subsequent standard as a backward compatible version of an adopted standard through full notice and comment rulemaking to avoid having to publish two rules contemporaneously. We therefore proposed to recognize the use of either Version 1.0 or 3.0 as compliant with the adopted Version 1.0 effective 60 days after the publication of a final rule.
As noted above, according to the November 7, 2005 final rule (70 FR 67580), entities that voluntarily adopt later versions of standards that are recognized as backward compatible versions of the official Part D e-prescribing standard must still accommodate the earlier official Part D e-prescribing standard without modification. Therefore, as we used full notice and comment in place of the backward compatible methodology in this one instance, we also proposed to require users of 3.0 to support users who are still using Version 1.0 until such time as Version 1.0 is officially retired as a Part D e-prescribing standard and Version 3.0 is adopted as the official Part D e-prescribing standard.
To effectuate these proposals, we proposed to revise § 423.160(b)(5) by placing the existing material in a new subsection (b)(5)(i), and creating a second new subsection (b)(5)(ii) to reflect the use of Version 3.0. as a backward compatible version of the official Part D e-prescribing standard, effective 60 days after the publication of the final rule through October 31, 2013. We further proposed revising § 423.160(b)(5) by adding a new section § 423.160(b)(5)(iii) to cover Formulary and Benefit transactions on or after November 1, 2013 We also needed to add an end date of January 15, 2013 to § 423.160(b)(5)(i). We solicited comments on our proposals, the timing
The following is a summary of the comments we received regarding our proposal to recognize NCPDP Formulary and Benefit Standard 3.0 as a backward compatible version of the NCPDP Formulary and Benefit Standard 1.0, the proposed retirement of NCPDP Formulary and Benefit Standard 1.0 and the proposed adoption of NCPDP Formulary and Benefit Standard 3.0.
As a result of the comments, It is our intention to keep NCPDP Formulary and Benefits Version 1.0 as the official standard for the Medicare Part D eprescribing program and hold off on finalizing Verison 3.0 until future rulemaking.
In our November 16, 2007 proposed rule (72 FR 64902-64906), we discussed the inability of NCPDP SCRIPT versions 5.0 and 8.1 to support the workflows and legal responsibilities in the long-term care setting, that is, entities transmitting prescriptions or prescription-related information where the prescriber is required by law to issue a prescription for a patient to a non-prescribing provider (such as a nursing facility) that in turn forwards the prescription to a dispenser (“three-way prescribing communications” between facility, physician, and pharmacy). As such, such entities were provided with an exemption from the requirement to use the NCPDP SCRIPT standard in transmitting such prescriptions or prescription-related information. On July 1, 2010 we published an IFC (75 FR 38029) in which we conveyed that we would consider removing the LTC exemption when there was an NCPDP SCRIPT standard that could address the unique needs of long-term care settings. We noted that NCPDP SCRIPT Version 10.6 was available, and that we believed that it addressed the concerns of the LTC industry regarding their ability to successfully support their workflows when e-prescribing. We solicited comments on the impact and timing of adopting version 10.6 as the official Part D e-prescribing standard and the removal of the long-term care facility exemption from the NCPDP SCIPT standard. For further background discussion on our proposal to lift the LTC exemption please refer to the proposed rule (77 FR 45024-45025).
We proposed to eliminate the current exemption at § 423.160(a)(3)(iv) upon adoption of NCPDP SCRIPT 10.6 as the official Part D e-prescribing standard, which, as described above, was proposed to take place on November 1, 2013.
We solicited comments on lifting the Long Term Care exemption, effective November 1, 2013 in conjunction with the effective date of NCPDP SCRIPT 10.6. We also solicited comments regarding the impact of these proposed effective dates on industry and other interested stakeholders, and whether an earlier or later effective date should be adopted.
The following is summary of the comments we received regarding the proposal.
They stated that while they are supportive of moving to NCPDP SCRIPT 10.6 and encourage LTC providers to move toward a single standard, they fully expect that those entities currently using HL7 or propriety messaging will need additional time to make the transition. They also recommend an extended transition period to ensure that both vendors and providers are ready for the new requirements.
Section 4104(c) of the Affordable Care Act amended section 1833(b) of the Act to waive the Part B deductible for colorectal cancer screening tests that become diagnostic in the course of the procedure or visit. Specifically, section 1833(b) of the Act waives the deductible for “colorectal screening tests regardless of the code that is billed for the establishment of a diagnosis as a result of the test, or the removal of tissue or other matter or other procedure that is furnished in connection with, as a result of, and in the same clinical encounter as a screening test.” We note that in the proposed rule, we referred in this discussion to section 1833(b)(1) of the Act; however, the relevant amendment was a new sentence added at the end of section 1833(b). We have corrected the reference in this final rule with comment period. To implement this statutory provision, we proposed in the PFS proposed rule for CY 2011 that “all surgical services furnished on the same date as a planned screening colonoscopy, planned flexible sigmoidoscopy, or barium enema be considered to be furnished in connection with, as a result of, and in the same clinical encounter as the screening test.” After receiving public comment, this proposal was finalized in the CY 2011 final rule with comment period (75 FR 73431) and the policy was implemented, effective January 1, 2011. However, we neglected to amend our regulations to reflect this policy.
When a screening test becomes a diagnostic service, we instruct the practitioner to bill the procedure that is actually furnished and to append the PT modifier to the diagnostic procedure code that is reported. By use of this modifier, the practitioner signals that the procedure meets the criteria for the deductible to be waived.
In the CY 2013 PFS proposed rule, we proposed to amend our regulations at § 410.160, Part B annual deductible, to include colorectal screening tests that become diagnostic services in the list of services for which the deductible does not apply. Specifically, we proposed to add a new § 410.160(b)(8) to read, “Beginning January 1, 2011, a surgical service furnished on the same date as a planned colorectal cancer screening test as described in § 410.37.”
The following is summary of the comments we received regarding the proposal to amend our regulations to the policy we adopted for CY 2011 to implement the statutory amendment that waives the Part B deductible for a colorectal cancer screening test that becomes diagnostic.
We also believe that the language of the Act is consistent with applying the deductible to pathology services. By the use of the term a “colorectal screening test regardless of the code that is billed,” the statute waives the deductible for procedures that, in and of themselves, begin as colorectal screening tests. As noted above,
In regard to the commenter's concern about using “same day,” instead of “same clinical encounter,” this too is the policy we established through notice and comment rulemaking for CY 2011. We believe it would be exceedingly rare for a beneficiary to have additional procedures on the same date as a screening colorectal cancer test or a “screening turned diagnostic” colorectal procedure that are not in the same clinical encounter. Therefore, we believe “same day” is the practical equivalent of “same clinical encounter.” To the extent there is a difference between these two terms, the language we proposed would provide broader rather than more limited waiver of the deductible as the commenter asserted. Given the practical equivalence between the language in the statute and in the proposed regulation, and the fact that our claims processing system can easily distinguish “same day” but not “same clinical encounter,” we will not modify our policy or the proposed regulation language as the commenter suggests.
Based upon the comments we received, and further review of the policy we established to implement the statute, we are finalizing the proposed amendment to the regulation as initially proposed. Specifically, we will amend the regulation at § 410.160, Part B annual deductible, to include colorectal screening tests that become diagnostic services in the list of services for which the Part B deductible does not apply and will add a new § 410.160(b)(8), which will read, “Beginning January 1, 2011, a surgical service furnished on the same date as a planned colorectal cancer screening test as described in § 410.37.”
Section 103 of the BIPA amended section 1861(pp)(1)(C) of the Act to permit coverage of screening colonoscopies for individuals not at high risk for colorectal cancer who meet certain requirements. To conform our regulations to section 1861(pp)(1)(C) of the Act, we proposed to modify § 410.37(a)(1)(iii) of our regulations to define “Screening colonoscopies” by removing the phrase “In the case of an individual at high risk for colorectal cancer” from this paragraph.
We also proposed to delete paragraph (g)(1) from this section since Medicare no longer receives claims for dates of service between January 1, 1998 and June 30, 2001, making this paragraph obsolete. We also proposed to redesignate paragraphs (g)(2) through (g)(4) and make technical changes to newly redesignated paragraph (g)(1) by replacing the reference to paragraph (g)(4) with a reference to newly redesignated paragraph (g)(3).
Finally, we will delete paragraph (g)(1) from this section since Medicare no longer receives claims for dates of service between January 1, 1998 and June 30, 2001, making this paragraph obsolete, will redesignate paragraphs (g)(2) through (g)(4) and make technical changes to newly redesignated paragraph (g)(1) by replacing the reference to paragraph (g)(4) with a reference to newly redesignated paragraph (g)(3).
Section 1877 of the Act prohibits a physician from referring a Medicare beneficiary for certain designated health services (DHS) to an 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 Level II 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:
• Dialysis-related drugs furnished in or by an ESRD facility (§ 411.355(g)).
• Preventive screening tests, immunizations, or vaccines (§ 411.355(h)).
The definition of DHS at § 411.351 excludes services that are reimbursed by Medicare as part of a composite rate (unless the services are specifically identified as DHS and are themselves payable through a composite rate, such as home health and inpatient and outpatient hospital services).
EPO and other dialysis-related drugs furnished by an ESRD facility (except drugs for which there are no injectable equivalents or other forms of administration) are currently being paid under the ESRD PPS (effective January 1, 2011) promulgated in the final rule published on August 12, 2010 in the
The Code List was last updated in Addendum J of the CY 2012 PFS final rule with comment period.
We received no public comments relating to the Code List that became effective January 1, 2012.
The updated, comprehensive Code List effective January 1, 2013, appears on our Web site at
Additions and deletions to the Code List conform it to the most recent publications of CPT and HCPCS Level II and to changes in Medicare coverage policy and payment status.
Tables 127 and 128 identify the additions and deletions, respectively, to the comprehensive Code List that become effective January 1, 2013. Tables 127 and 128 also identify the additions and deletions to the list of codes used to identify the items and services that may qualify for the exception in § 411.355(g) (regarding 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 127, we specify additions that reflect new CPT and HCPCS codes that become effective January 1, 2013, or that became effective since our last update, including those additions that reflect changes in Medicare coverage policy or payment status. Table 128 reflects the deletions necessary to conform the Code List to the most recent publications of the CPT and HCPCS, and to changes in Medicare coverage policy and payment status.
We will consider comments regarding the codes listed in Tables 127 and 128. Comments will be considered if we receive them by the date specified in the
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.
In the CY 2013 PFS proposed rule, we solicited public comment on each of the section 3506(c)(2)(A)-required issues for the following information collection requirements (ICRs). No PRA-related comments were received.
As a condition of payment for certain covered items of DME, § 410.38(g) specifies that a physician must have documented and communicated to the DME supplier that the physician or physician assistant (PA), nurse practitioner (NP), or clinical nurse specialist (CNS) has had a face-to-face encounter with the beneficiary no more than 6 months before the order is written.
In the proposed rule, we proposed that when the face-to-face encounter is performed by a physician, the submission of the pertinent portion(s) of the beneficiary's medical record (portions containing sufficient information to document that the face-to-face encounter meets our requirements) would be considered sufficient and valid documentation of the face-to-face encounter when submitted to the supplier and made available to CMS or its agents upon request. While we believe that many of the practitioners addressed in this final rule with comment period are already conducting a needs assessment and evaluating or treating the beneficiary for conditions relevant to the covered item of DME, this final rule with comment period may require some changes in their procedures to ensure that their documentation fulfills Medicare's regulatory requirements. Suppliers should already be receiving written orders and documentation to support the appropriateness of certain items of DME.
To promote the authenticity and comprehensiveness of the written order and as part of our efforts to reduce the risk of waste, fraud, and abuse, as a condition of payment, a written order must include the following: (1) The beneficiaries' name; (2) the item of DME ordered; (3) the signature of the prescribing practitioner; (4) the prescribing practitioner NPI; and (5) the date of the order.
To determine costs, we utilized the Bureau of Labor Statistics mean hourly rates for the professional, analyzed for the year that the original data was received. The hourly rate for a physician, including fringe benefits and overhead is estimated at $118 per hour. The hourly rate, including fringe benefits and overhead, for a NP, PA, or CNS is estimated at $55 per hour. The hourly rate for administrative assistant, including fringe benefits and overhead, is estimated at $23 per hour.
Physicians are now required to document the face-to-face encounter if it was performed by a PA, NP, or CNS. To allow payment for this documentation, a G code is established for this service. Since the effective date for this regulation is July 1, 2013, only 6 months of year 1 are included in calendar year 2013. Likewise, it was assumed that about 500,000 of these documentation services would be billed in year 1. We estimate the time for a physician to review each one of these encounters that results in an order is 10 minutes. Therefore, we estimate that the physician documentation burden to review and document when a PA, NP or CNS performed the face-to-face encounter in year 1 would be nearly 83,333 hours and a total of 483,333 hours over 5 years. The associated cost in year 1 is nearly $9.8 million and over 5 years has associated costs of nearly $57.03 million based on the growth rate of the Medicare population. The increase is slightly more than five-fold because the number of Medicare beneficiaries would increase over time. The average annual burden over 5-years for 580,000 claims (2,900,000/5) is 96,667 hours at a cost of $11,406,667.
We assume it will take 3 minutes for a PA, NP, or CNS to prepare the medical record for the review of the face-to-face encounter. For the 500,000 orders used in the previous estimate, this creates a total of 25,000 hours at a cost of about $1.4 million in year 1 and nearly 145,000 hours over 5 years at a cost of nearly $8 million based on the growth rate of the Medicare population. Though consistent with previous estimates, we believe that using a PA, NP, or CNS hourly rate creates a high burden impact estimate since most of these tasks would more than likely be completed by administrative personnel. We invited but received no public comments on our estimates related to the appropriateness of these estimates. The average annual burden over 5-years for 580,000 claims (2,900,000/5) is 29,000 hours at a cost of $1,595,000.
This final rule with comment period creates only a minimal change in the normal course of business activities in regards to recordkeeping. Although we believe the documentation of a needs assessment, evaluation, and/or treatment of a beneficiary for a condition relevant to an item of DME is a common practice, it is possible that
This regulation requires that the supplier have access to the documentation of the face-to-face encounter (required when CMS conducts an audit), CMS already accounts for the audit burden associated with the exchange of documentation for claims subject to prepayment review (approved under OCN 0938-0969). As a business practice we recognize that some suppliers may receive the documentation of the face-to-face for all applicable claims, voluntarily.
We believe that the requirements that are set out in this final rule with comment period meet the utility and clarity standards. We invited but received no public comments on this assumption and on ways to minimize the burden on affected parties. The recordkeeping requirement in § 410.38(g)(5) and the requirement to maintain and make the supplier's order/additional documentation available to CMS upon request is subject to the PRA, but we believe that these requirements are usual and customary business practices as defined in 5 CFR 1320.3(b)(2) and, therefore, the associated burden is exempt from the PRA.
We are making several program revisions to the Physician Quality Reporting System for reporting periods that occur in 2013 and 2014, and, therefore, we are making several revisions to § 414.90. All of the requirements and burden estimates are currently approved by OMB under OCN 0938-1059, and are not subject to additional OMB review under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
First, we are revising § 414.90(e)—Use of Consensus-based Quality Measures. We are redesignating § 414.90(e) as § 414.90(f) and then revising newly designated § 414.90(f) to broadly define our use of consensus-based quality measures. The current regulation at § 414.90(e) (now redesignated as § 414.90(f)) states that we will publish a final list of measures every year. However, we finalized measures for 2013 and beyond this year. While § 414.90(e) (now redesignated as § 414.90(f)) contains information collection requirements regarding the input process and the endorsement of consensus-based quality measures, this rule would not revise any of the information collection requirements or burden estimates that are associated with those provisions.
Second, we are revising § 414.90(b)—Definitions under the Physician Quality Reporting System. Specifically, we are revising the definition of “group practice” to include groups of 2-24 eligible professionals in the definition. We are revising the definition of “qualified registry” to indicate CMS' authority to disqualify registries. We are also eliminating the definition of “qualified electronic health record product” to more specifically address the EHR-based reporting mechanisms available under PQRS as “direct electronic health record (EHR) product” and “electronic health record (EHR) data submission vendor.” We are also adding the definition of “administrative claims,” which is a newly-established reporting mechanism available under PQRS for the purpose of reporting quality measures for the 2015 and 2016 PQRS payment adjustments. In addition, we are adding the definition of “group practice reporting option (GPRO) web-interface.” While the GPRO web-interface was available as a reporting mechanism in CY 2012, we had not previously included a definition for the GPRO web-interface. While § 414.90(b) contains information collection requirements regarding the input process and the endorsement of consensus-based quality measures, this rule would not revise any of the information collection requirements or burden estimates that are associated with § 414.90(b).
Third, we are revising § 414.90(g) (formerly designated as 414.90(f))—Requirements for the Incentive Payments. In this final rule, we are redesignating 414.90(f) as 414.90(g) and making changes to newly designated § 414.90(g) to indicate the applicable incentive amounts and requirements for the 2013 and 2014 PQRS incentives. While § 414.90(e) (newly designated in this final rule as § 414.90(f)) contains information collection requirements regarding the input process and the endorsement of consensus-based quality measures, this rule would not revise any of the information collection requirements or burden estimates that are associated with those provisions.
Fourth, we are adding § 414.90(e)—Requirements for the Payment Adjustments. We are adding § 414.90(e) to indicate the applicable adjustment amounts and requirements for the 2015 and 2016 PQRS payment adjustments. While § 414.90(e) contains information collection requirements regarding the input process and the endorsement of consensus-based quality measures, this rule would not revise any of the information collection requirements or burden estimates that are associated with those provisions. The impact of this revision to the current information collection requirements or burden estimates that are associated with those provisions are described here:
The preamble of this final rule with comment period discusses the background of the PQRS, provides information about the measures and reporting mechanisms that will be available to eligible professionals and group practices who choose to participate in the 2013 and 2014 PQRS, and provides the criteria for satisfactory reporting in CYs 2013 and 2014 (for the 2013 and 2014 PQRS incentives and the 2015 and 2016 PQRS payment adjustments).
According to the 2010 Reporting Experience Report, a total of $391,635,495 in PQRS incentives was paid by CMS for the 2010 program year, which encompassed 168,843 individual eligible professionals. In 2010, eligible professionals earned a 2.0 percent incentive (that is, a bonus payment equal to 2.0 percent of the total allowed part B charges for covered professional services under the PFS furnished by the eligible professional in the reporting period) for satisfactory reporting under PQRS. For 2013 and 2014, eligible professionals can earn a 0.5 percent incentive for satisfactory reporting, a reduction of 1.5 percent from 2010. Therefore, based on 2010, we would expect that approximately $97 million (approximately
The average incentive distributed to each eligible professional in 2010 was $2,157. Taking into account the 1.5 percent incentive reduction from 2.0 percent in 2010 to 0.5 percent in 2013 and 2014, we estimate that the average amount per eligible professional earning an incentive in 2013 and 2014 would be $539. Therefore, we estimated that we would distribute approximately $162 million ($539 × 300,000 eligible professionals) and $216 million ($539 × 400,000 eligible professionals) in incentive payments in 2013 and 2014, respectively. We believe these incentive payments will help offset the cost to
We noted that the total burden associated with participating in PQRS is the time and effort associated with indicating intent to participate in PQRS, if applicable, and submitting PQRS quality measures data. When establishing these burden estimates, we assumed the following:
• The requirements for reporting for the PQRS 2013 and 2014 incentives and payment adjustments for 2015 and beyond would be established as proposed in this 2013 Medicare PFS final rule with comment period.
• For an eligible professional using the claims, registry, or EHR-based reporting mechanisms and group practices using the registry or EHR-based reporting mechanisms, that the eligible professional or group practice would report on 3 measures.
• With respect to labor costs, we believe that a billing clerk would handle the administrative duties associated with participating, while a computer analyst would handle duties related to reporting PQRS quality measures. According to the Bureau of Labor Statistics, the mean hourly wage for a billing clerk is approximately $16/hour whereas the mean hourly wage for a computer analyst is approximately $40/hour.
For an eligible professional who wishes to participate in PQRS as an individual using the traditional reporting mechanisms, the eligible professional need not indicate his/her intent to participate. Instead, the eligible professional may simply begin reporting quality measures data. Therefore, these burden estimates for individual eligible professionals participating in PQRS are based on the reporting mechanism the individual eligible professional chooses. However, we believe a new eligible professional or group practice would spend 5 hours—which includes 2 hours to review the PQRS measures list, review the various reporting options, and select a reporting option and measures on which to report and 3 hours to review the measure specifications and develop a mechanism for incorporating reporting of the selected measures into their office work flows. Therefore, we believe that the initial administrative costs associated with participating in PQRS would be approximately $80 ($16/hour × 5 hours).
In 2010, approximately 200,000 of the roughly 245,000 eligible professionals (or 84 percent) of eligible professionals used the claims-based reporting mechanism. We believe that although the number of eligible professionals or group practices using the claims-based reporting mechanism will increase in 2013 and 2014, we anticipated that the percentage of eligible professionals or group practices using the claims-based reporting mechanism will decrease slightly as eligible professionals and group practices transition towards using the EHR-based reporting mechanism. Therefore, we estimated that the percentage of PQRS participants using the claims-based reporting mechanism will decrease as we anticipate that more eligible professionals would use the registry and EHR-based reporting mechanisms. For these reasons, we estimated that approximately 320,000 eligible professionals would participate in PQRS using the traditional claims-based reporting mechanism by 2014.
With respect to an eligible professional who participated in PQRS via claims, the eligible professional must gather the required information, select the appropriate quality data codes (QDCs), and include the appropriate QDCs on the claims they submitted for payment. PQRS will collect QDCs as additional (optional) line items on the existing HIPAA transaction 837-P and/or CMS Form 1500 (OCN 0938-0999). Based on our experience with the Physician Voluntary Reporting Program (PVRP), we continue to estimate that the time needed to perform all the steps necessary to report each measure via claims would range from 0.25 minutes to 12 minutes, depending on the complexity of the measure. Therefore, the time spent reporting 3 measures would range from 0.75 minutes to 36 minutes. Using an average labor cost of $40/hour, we estimated that the time cost of reporting for an eligible professional via claims would range from $0.50 (0.75 minutes × $40/hour) to $24.00 (36 minutes × $40/hour) per reported case. With respect to how many cases an eligible professional would report when using the claims-based reporting mechanism, we established that an eligible professional would need to report on 50 percent of the eligible professional's applicable cases. The actual number of cases on which an eligible professional reports would vary depending on the number of the eligible professional's applicable cases. However, in prior years, when the reporting threshold was 80 percent, we found that the median number of reporting cases for each measure was 9. Since we reduced the reporting threshold to 50 percent, we estimated that the average number of reporting cases for each measure would be reduced to 6. Based on these estimates, we estimated that the total cost of reporting for an eligible professional choosing the claims-based reporting mechanism would range from ($0.50/per reported case × 6 reported cases) $3.00 to ($24.00/reported case × 6 reported cases) $144.
We note that, for the 2015 PQRS payment adjustments, we are finalizing an administrative claims reporting option for eligible professionals and group practices. The burden associated with reporting using the administrative claims reporting option is the time and effort associated with using this option. To submit quality measures data for PQRS using the administrative claims reporting option, an eligible professional or group practice would need to (1) register as an administrative claims reporter for the applicable payment adjustment and (2) report quality measures data. With respect to registration, we believe it would take approximately 2 hours to register to participate in PQRS as an administrative claims reporter. Therefore, we estimated that the cost of undergoing the administrative claims selection process would be ($16/hour × 2 hours) $32.
With respect to reporting, we noted that any burden associated with reporting would be negligible, as an eligible professional or group practice would not be required to attach reporting G-codes on the claims they submitted. Rather, CMS would bear the burden of calculating the measures rates from claims data submitted by the eligible professional or group practice. We note that there would be no additional burden on the eligible professional or group practice to submit these claims, as the eligible professional or group practice would have already submitted these claims for reimbursement purposes.
In 2010, approximately 40,000 of the roughly 245,000 eligible professionals (or 16 percent) of eligible professionals used the registry-based reporting mechanism. We believe the number of eligible professionals and group practices using the registry based reporting mechanism would remain the same, as we believe the decision for an eligible professional or group practice to purchase a registry would not likely be solely to report PQRS quality measures data to CMS. Rather, we believe that eligible professionals use registries for functions other than PQRS and therefore would obtain a registry solely for PQRS reporting by CY 2014.
In 2010, only 14 of the roughly 245,000 eligible professionals (or <1 percent) of eligible professionals used the EHR-based reporting mechanism. We believe the number of eligible professionals and group practices using the EHR-based reporting mechanism would increase as eligible professionals become more familiar with EHR products. In particular, we believe eligible professionals and group practices would transition from using the claims-based to the EHR-based reporting mechanisms. We estimated that approximately 40,000 eligible professionals (4 percent), whether participating as an individual or part of a group practice, would use the EHR-based reporting mechanism in CY 2014.
With respect to an eligible professional or group practice who participated in PQRS via a qualified registry, direct EHR product, or EHR data submission vendor product, we believe there would be little to no burden associated for an eligible professional to report PQRS quality measures data to CMS, because the selected reporting mechanism would submit the quality measures data for the eligible professional. While we noted that there may be start-up costs associated with purchasing a qualified registry, direct EHR product, or EHR data submission vendor, we believe that an eligible professional or group practice would not purchase a qualified registry, direct EHR product, or EHR data submission vendor product solely for the purpose of reporting PQRS quality measures. Therefore, we have not included the cost of purchasing a qualified registry, direct EHR, or EHR data submission vendor product in our burden estimates.
Unlike eligible professionals who choose to report individually, we noted that we proposed that eligible professionals choosing to participate as part of a group practice under the GPRO would need to indicate their intent to participate in PQRS as a group practice. The total burden for group practices who submit PQRS quality measures data via the GPRO web-interface would be the time and effort associated with submitting this data. To submit quality measures data for PQRS, a group practice would need to (1) be selected to participate in the PQRS GPRO and (2) report quality measures data. With respect to the administrative duties for being selected to participate in PQRS as a GPRO, we believe it would take approximately 6 hours—including 2 hours to decide to participate in PQRS as a GPRO; 2 hours to self-nominate, and 2 hours to undergo the vetting process with CMS officials—for a group practice to be selected to participate in PQRS GPRO for the applicable year. Therefore, we estimated that the cost of undergoing the GPRO selection process would be ($16/hour × 6 hours) $96.
With respect to reporting PQRS quality measures using the GPRO web-interface, the total reporting burden is the time and effort associated with the group practice submitting the quality measures data (that is, completing the data collection interface). Based on burden estimates for the PGP demonstration, which uses the same data submission methods, we estimated the burden associated with a group practice completing the data collection interface would be approximately 79 hours. Therefore, we estimated that the report cost for a group practice to submit PQRS quality measures data for an applicable year would be ($40/hour × 79 hours) $3,160.
Eligible professionals who wish to qualify for an additional 0.5 percent Maintenance of Certification Program incentive would need to “more frequently” than is required to qualify for or maintain board certification status participate in a qualified Maintenance of Certification Program for the year in which the eligible professionals seek to qualify for this additional incentive and successfully complete a qualified Maintenance of Certification Program practice assessment for the applicable year. Although we understand that there is a cost associated with participating in a Maintenance of Certification Board, we believe that most of the eligible professionals attempting to earn this additional incentive would already be enrolled in a Maintenance of Certification Board for reasons other than earning the additional Maintenance of Certification Program incentive. Therefore, the burden to earn this additional incentive would depend on what a certification board establishes as “more frequently” and the time needed to complete the practice assessment component. We expect that the amount of time needed to complete a qualified Maintenance of Certification Program practice assessment would be spread out over time since a quality improvement component is often required. With respect to the practice assessment component, according to an informal poll conducted by ABMS in 2012, the time an individual spent to complete the practice assessment component of the Maintenance of Certification ranged from 8-12 hours.
Aside from the burden of eligible professionals and group practices participating in PQRS, we believe that registry and EHR vendor products incur costs associated with participating in PQRS.
Based on the number of registries that have self-nominated to become a qualified PQRS registry in prior program years, we estimated that approximately 50 additional registries would self-nominate to be considered a qualified registry for PQRS. With respect to qualified registries, the total burden for qualified registries who submitted PQRS quality measures data would be the time and effort associated with submitting this data. To submit quality measures data for the proposed PQRS program years, a registry would need to (1) become qualified for the applicable year and (2) report quality measures data on behalf of its eligible professionals. With respect to administrative duties related to the qualification process, we estimated that it would take a total of 10 hours—including 1 hour to complete the self-nomination statement, 2 hours to interview with CMS, 2 hours to calculate numerators, denominators, and measure results for each measure the registry wished to report using a CMS-provided measure flow, and 5 hours to complete an XML submission—to become qualified to report PQRS quality measures data. Therefore, we estimated that it would cost a registry approximately ($16.00/hour × 10 hours) $160 to become qualified to submit PQRS quality
With respect to the reporting of quality measures data, the burden associated with reporting is the time and effort associated with the registry calculating quality measures results from the data submitted to the registry by its eligible professionals, submitting numerator and denominator data on quality measures, and calculating these measure results. We believe, however, that registries already perform these functions for its eligible professionals irrespective of participating in PQRS. Therefore, we believe there is little to no additional burden associated with reporting PQRS quality measures data. Whether there is any additional reporting burden would vary with each registry, depending on the registry's level of knowledge with submitting quality measures data for PQRS.
With respect to EHR products, the total burden for direct EHR products and EHR data submission vendors who submit PQRS quality measures data would be the time and effort associated with submitting this data. To submit quality measures data for PQRS, a direct EHR product or EHR data submission vendor would need to report quality measures data on behalf of its eligible professionals. Please note that since we are not continuing to require direct EHR products and EHR data submission vendors to become qualified to submit PQRS quality measures data, there is no burden associated with a qualification process for direct EHR products and EHR data submission vendor products. With respect to reporting quality measures data, we believe the burden associated with the EHR vendor programming its EHR product(s) to extract the clinical data that the eligible professional would need to submit to CMS will depend on the vendor's familiarity with PQRS and the vendor's system and programming capabilities. Since we believe that an EHR vendor would be submitting data for reasons other than reporting under PQRS, we believe there would be no additional burden for an EHR vendor to submit quality measures data for PQRS reporting.
We invited but received no public comments on our estimates related to the impact of the collection of information requirements related to PQRS. However, we believe that the estimated changes from the requirements and burden estimates currently approved by OMB under OCN 0938-1059 are due to a combination of all revisions being made at § 414.90(b), newly designated § 414.90(f), and newly created§ 414.90(e), rather than just one outstanding provision. Therefore, please note that we have combined all impacts of the collection of information requirements related to PQRS in this section, in lieu of separating these impacts as it was proposed. Otherwise, our burden estimates remain unchanged.
While § 414.90 contains information collection requirements regarding the PQRS payment adjustments, this rule will not revise any of the information collection requirements or burden estimates that are associated with those provisions, except for the provisions that would allow the administrative claims reporting option. Otherwise, all of the requirements and burden estimates are currently approved by OMB under OCN 0938-1083 and are not subject to additional OMB review under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Specifically, although we are finalizing the criteria to report 1 measure or measures group for the 2015 PQRS payment adjustment, we do not expect eligible professional and group practices to stop reporting when they have met this threshold. Rather, since the reporting period for the 2013 PQRS incentive and 2015 PQRS payment adjustment coincide, we expect that all eligible professionals and group practices who use the traditional PQRS reporting mechanisms—claims, registry, EHR, and GPRO web interface—will attempt to report PQRS quality measures to meet the criteria for the 2013 PQRS Incentive. Therefore, the burden estimates for the 2013 PQRS incentive apply to the 2015 PQRS payment adjustment.
With respect to the 2016 PQRS payment adjustment, we did not finalize the criteria to report 1 measure or measures group. Therefore, at this time, eligible professionals and group practices using the traditional PQRS reporting mechanisms—claims, registry, EHR, and GPRO web interface must meet the criteria for the 2014 PQRS incentive for the 2016 PQRS payment adjustment. Therefore, the burden estimates for the 2014 PQRS incentive apply to the 2016 PQRS payment adjustment.
We note that, for the 2015 PQRS payment adjustment, we are finalizing an administrative claims reporting option for eligible professionals and group practices. The burden associated with reporting using the administrative claims reporting option is the time and effort associated with using this option. To submit quality measures data for PQRS using the administrative claims reporting option, an eligible professional or group practice would need to (1) elect to use the administrative claims-based reporting mechanism for the applicable payment adjustment and (2) be analyzed under the administrative claims-based reporting mechanism. With respect to election, we believe it would take approximately 2 hours to register to participate in PQRS as an administrative claims reporter. Therefore, we estimated that the cost of undergoing the administrative claims selection process would be ($16/hour × 2 hours) $32.
With respect to reporting, we noted that any burden associated with reporting would be negligible, as an eligible professional or group practice would not be required to attach reporting G-codes on the claims they submitted. Rather, CMS would calculate the administrative claims measures rates from claims submitted by group practices and eligible professionals. We note that there would be no additional burden on the eligible professional or group practice to submit these claims, as the eligible professional or group practice would have already submitted these claims for reimbursement purposes.
The requirements for the eRx Incentive Program for 2012-2014 were established in the CY 2012 Medicare PFS final rule. Although we made proposals related to the eRx Incentive Program in the CY 2013 Medicare PFS, these proposals have no additional burden or impact on the public. Therefore, this rule does not revise the requirements or burden estimates approved by OMB under OCN 0938-1059. We invited but received no public comment on our proposed impact analysis and are therefore finalizing the analysis for the collection of information requirements associated with the Electronic Prescribing (eRx) Incentive Program.
While this final rule with comment period will impose collection of information requirements that are set out in the regulatory text (see above), this rule also sets out information collection requirements that are set out only in the preamble. Following is a discussion of the preamble-specific information collections, all of which have already received OMB approval.
The discussion of average sales price (ASP) issues in section III.B.1 of this final rule with comment period rule does not contain any new information collection requirements with respect to payment for Medicare Part B drugs and biologicals under the ASP methodology. Drug manufacturers are required to submit ASP data to us on a quarterly basis. The ASP reporting requirements are set forth in section 1927(b) of the Act. The burden associated with this requirement is the time and effort required by manufacturers of Medicare Part B drugs and biologicals to calculate, record, and submit the required data to CMS. All of the requirements and burden estimates are currently approved by OMB under OCN 0938-0921, and are not subject to additional OMB review under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
As explained previously, the burden estimates related to PQRS are under OCN 0938-1083. However, we note that, to meet the criteria for the 2013 and 2014 PQRS incentives, we are requiring that group practices using the GPRO web interface complete a CAHPS survey. This would require the collection of information to obtain the patient experience data that will be included in the quality information reported by eligible professionals. The data collected in the survey will be scored and reported via Physician Compare on the cms.gov Web site. The information collection—a survey—will be targeted to Fee-for-service Medicare beneficiaries who have received care in the prior 12 months from the physician group practices participating in Physician Quality Reporting. The survey will be administered in English and Spanish, and beneficiaries may have assistance to complete the survey or designate a proxy respond on their behalf.
Administering the CAHPS survey is different from the estimates provided from reporting measures, as beneficiaries must actively participate in the reporting of data by completing these surveys. According to estimates we have performed with respect to administering this survey, we anticipate that it will take approximately 39.53 hours to administer the CAHPS survey. We estimate that the cost per response will be $7,673.50. We understand the estimated cost is high. However, as we indicate in Section G in this final rule, CMS will assume the expense of administering the CAHPS survey. A summary of the burden estimates for administering the CAHPS survey is provided below:
If you comment on these information collection and recordkeeping requirements, please submit your comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: CMS Desk Officer, [CMS-1590-FC]; Fax: (202) 395-6974; or Email:
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 us 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 assign interim RVUs to any new codes based on a review of the AMA RUC recommendations for valuing these services. We also assign interim RVUs to certain codes for which we did not receive specific AMA RUC recommendations, but that are components of new combined codes. We set interim RVUs for the component codes in order to conform them to the value of the combined code. Finally, we assign interim RVUs to certain codes for which we received AMA RUC recommendations for only one component (work or PE) but not both. By reviewing these AMA 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. We are also able to determine, on an interim final basis, whether the codes will be subject other payment policies. 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 Medicare contractor establish a payment rate for these new codes. We believe both of these alternatives are 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 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 previously outlined 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.C. of this final rule with comment period discusses the identification and review of potentially misvalued codes by the AMA RUC, as well as our review and decisions regarding the AMA RUC recommendations. Similar to the AMA RUC recommendations for new and revised codes previously discussed, due to the timing of the AMA RUC 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, on an interim final basis for CY 2013. 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
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)).
Because of the large number of public comments we normally receive on
This final rule with comment period is necessary in order to make payment and policy changes under the Medicare PFS and to make required statutory changes under the Middle Class Tax Relief and Job Creation Act of 2012 (MCTRJCA), the Affordable Care Act, and other statutory changes. This final rule with comment period also is necessary to make changes to Part B drug payment policy and other related Part B related policies.
We have examined the impact of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (February 2, 2012), 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 (March 22, 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 Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). We estimate, as discussed below in this section, that the PFS provisions included in this proposed rule will redistribute more than $100 million in 1 year. Therefore, we estimate that this rulemaking is “economically significant” as measured by the $100 million threshold, and hence also a major rule under the Congressional Review Act. Accordingly, we have prepared a RIA 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 entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of $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 that 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 $10 million or less based on SBA size standards. Approximately 95 percent of physicians are considered to be small entities. There are over 1 million physicians, other practitioners, and medical suppliers that receive Medicare payment under the PFS.
Because we acknowledge that many of the affected entities are small entities, the analysis discussed throughout the preamble of this proposed rule constitutes our regulatory flexibility analysis for the remaining provisions and addresses comments received on these issues.
In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This 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 for Medicare payment regulations and has fewer than 100 beds. We are not preparing an analysis for section 1102(b) of the Act because we have determined, and the Secretary certifies, that this proposed rule would 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 also requires that agencies assess anticipated costs and benefits on State, local, or tribal governments or on the private sector before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2012, that threshold is approximately $139 million. This final rule with comment period would have no consequential spending effect on state, local, or tribal governments or on the private sector.
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. Since this regulation does not impose any costs on state or local governments, the requirements of Executive Order 13132 are not applicable.
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 would use to minimize the burden on small entities. As indicated elsewhere in this final rule with comment period, we proposed to implement a variety of changes to our regulations, payments, or payment
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 by more than $20 million from what expenditures would have been in the absence of these changes. If this threshold is exceeded, we make adjustments to preserve BN.
Our estimates of changes in Medicare revenues for PFS services compare payment rates for CY 2012 with final payment rates for CY 2013 using CY 2011 Medicare utilization as the basis for the comparison. To the extent that there are year-to-year changes in the volume and mix of services furnished by physicians, the actual impact on total Medicare revenues would be different from those shown in Tables 134 (CY 2013 PFS Final Rule with Comment Period Estimated Impact on Total Allowed Charges by Specialty) and 135 (CY 2013 PFS Final Rule with Comment Period Estimated Impact on Total Allowed Charges by Specialty by Selected Policy). 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 and would depend on the mix of services the physician furnishes. The average change in total revenues would be less than the impact displayed here because physicians furnish services to both Medicare and non-Medicare patients and specialties may receive substantial Medicare revenues for services that are not paid under the PFS. For instance, independent laboratories receive approximately 85 percent of their Medicare revenues from clinical laboratory services that are not paid under the PFS.
Tables 134 and 135 show the payment impact on PFS services. We note that these impacts do not include the effect of the January 2013 conversion factor changes under current law. The annual update to the PFS conversion factor is calculated based on a statutory formula that measures actual versus allowed or “target” expenditures, and applies a sustainable growth rate (SGR) calculation intended to control growth in aggregate Medicare expenditures for physicians' services. This update methodology is typically referred to as the “SGR” methodology, although the SGR is only one component of the formula. Medicare PFS 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 to eventually bring actual expenditures back in line with targets. If actual expenditures exceed allowed expenditures, the update is reduced. If actual expenditures are less than allowed expenditures, the update is increased. By law, we are required to apply these updates in accordance with section 1848(d) and (f) of the Act, and any negative updates can only be averted by an Act of the Congress. While the Congress has provided temporary relief from negative updates for every year since 2003, a long-term solution is critical. We are committed to working with the Congress to permanently reform the SGR methodology for Medicare PFS updates. We provide our most recent estimate of the SGR and physician update for CY 2013 in section III.N. of this final rule with comment period.
The following is an explanation of the information represented in Table 134:
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Table 135 shows the estimated impact of selected policies in this final rule with comment period on total allowed charges, by specialty. The following is an explanation of the information represented in Table 135:
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The most widespread specialty impacts of the RVU changes are generally related to several factors. First, as discussed in section III.A.2. of this final rule with comment period, we are currently implementing the final year of the 4-year transition to new PE RVUs using the PPIS data that were adopted in the CY 2010 PFS final rule with comment period. This impact appears in column C of Table 135. The impacts of the final year of the transition are generally consistent with the impacts that would be expected based on the impacts displayed in the CY 2012 final rule with comment period. The second factor is the post-discharge transitional care management policy, under which we will pay for care coordination in the 30 days following an inpatient hospital, outpatient hospital observation services or partial hospitalization, SNF, or CMHC discharge from the treating physician in the hospital to the beneficiary's primary physician in the community. We estimate that CPT codes 99495 and 99496 for TCM will redistribute approximately $0.6 billion in allowed charges to primary care specialties under the physician fee schedule (estimated using the CY 2012 CF), with approximately 20 percent of that representing redistributed beneficiary coinsurance. The redistributive effect of this policy appears on column F of Table 135.
Column E in Table 135 also reflects updates to the proposed interest rate assumption used in the medical equipment calculation in the PE RVU methodology. Other final rule policies, including the multiple procedure payment reduction policy for the technical component of diagnostic cardiovascular and ophthalmological procedures, as well as new values for new and revised codes are included in Column D. Column G in Table 135 isolates the impact of revisions to equipment inputs and prices for certain radiation therapy services. Table 135 shows the same information as provided in Table 134, but rather than isolating the policy impact on physician work, PE, and malpractice separately, Table 135 shows the impact of varied final policies on total RVUs.
Column E of Table 134 and column H of Table 135 display the estimated CY 2013 combined impact on total allowed charges by specialty of all the RVU and MPPR changes. These impacts range from an increase of 7 percent for family practice to a decrease of 14 percent for independent laboratory. We have received numerous new codes with new values and revised codes with new values for CY 2013 as a result of our ongoing misvalued codes initiative. Many of the new and revised codes that we valued on an interim basis for CY 2013 originated with the potentially misvalued codes initiative. Reductions for pathology, neurology, and independent laboratories are a result of the potentially misvalued code initiative. In the case of independent laboratories, we note that independent laboratories receive the majority of the Medicare revenue from the Clinical Lab Fee Schedule, which is unaffected by the potentially misvalued code initiative. Again, these impacts are estimated prior to the application of the negative CY 2013 Conversion Factor (CF) update applicable under the current statute.
Table 136 (Impact of Final Rule with Comment Period on CY 2013 Payment for Selected Procedures) shows the estimated impact on total payments for selected high volume procedures of all of the changes discussed previously. We have included CY 2013 payment rates with and without the effect of the CY 2013 negative PFS CF update for comparison purposes. We selected these procedures because they are the most commonly furnished by a broad spectrum of physician specialties. There are separate columns that show the change in the facility rates and the nonfacility rates. For an explanation of facility and nonfacility PE, we refer readers to Addendum A of this final rule with comment period.
As discussed in section III.E.3 of this final rule with comment period, we are finalizing our proposal to add several new codes to the list of Medicare telehealth services. While we expect these changes to increase access to care in rural areas, based on recent utilization of similar services already on the telehealth list, we estimate no significant impact on PFS expenditures from the additions.
As discussed in section III.K.1. of this final rule with comment period, we clarified that “anesthesia and related care”, with respect to the statutory benefit category for CRNAs under Section 1861(bb)(2) of the Social Security Act, means those services that a certified registered nurse anesthetist is legally authorized to perform in the state in which the service is furnished.
Our final rule clarification recognizes local variation in state scope of practice, which does not diverge significantly from current practice. Therefore, we estimate no significant budgetary impact from this proposed change.
As discussed in section III.K.2. of this final rule with comment period, we are finalizing our proposal to revise our current regulation that limits ordering of portable x-ray services to only a doctor of medicine or a doctor of osteopathy to allow other physicians and nonphysician practitioners (acting within the scope of state law and their Medicare benefit) to order portable x-ray services. We estimated no significant impact on PFS expenditures from the additions.
As discussed in section III.E. of this final rule with comment period, we are required to review and revise the GPCIs at least every 3 years and phase in the adjustment over 2 years (if there has not been an adjustment in the past year). For CY 2013, we did not propose any revisions related to the data or methodologies used to calculate the GPCIs. However, since the 1.0 work GPCI floor provided in section 1848 (e)(1)(E) of the Act is set to expire prior to the implementation of the CY 2013 PFS, the CY 2013 physician work GPCIs and summarized geographic adjustment factors (GAFs) published in addendums D and E of this CY 2013 PFS final rule with comment period do not reflect the 1.0 work GPCI floor for CY 2013. As required by section 1848 (e)(1)(G) and section1848 (e)(1)(I) of the Act, the 1.5 work GPCI floor for Alaska and the 1.0 PE GPCI floor for frontier states are applicable in CY 2013.
As discussed in section III.A. of this final rule with comment period, section 306 of the TPTCCA and section 3007 of the MCTRJCA required the extension of certain add-on payments for ground ambulance services, and the extension of certain rural area designations for purposes of air ambulance payment, through CY 2012. As further discussed in section III.A. of this final rule with comment period, this legislation is self-implementing, and we proposed to amend the regulation text at § 414.610 only to conform the regulations to these self-implementing statutory requirements. As a result, we did not make any policy proposals associated with these legislative provisions and there is no associated regulatory impact.
As discussed in section III of this final rule with comment period, we proposed to update the AMP-based price substitution policy that would allow Medicare to pay based off lower market prices for those drugs and biologicals that consistently exceed the applicable threshold percentage. Our impact analysis is unchanged from last year (76 FR 73462): based on estimates published in various OIG reports cited in the CY 2012 PFS final rule with comment period (76 FR 73290-1), we believe that this proposal will generate minor savings for the Medicare program and its beneficiaries since any substituted prices would be for amounts less than the calculated 106 percent of the ASP.
Our policy clarification regarding Pharmacy Billing for Part B Drugs Administered Incident to a Physician's Services, which is discussed in section III of this final rule with comment period states that only physicians and not pharmacies (or DME suppliers) are allowed to bill Medicare under Part B for drugs administered to beneficiaries in physicians' offices. We do not believe that this clarification will significantly impact the quantity or payment amount for Part B drugs that are administered through implanted DME and or the procedures used to refill such pumps because it is a clarification of current policy.
The majority of changes regarding the impact between the proposed and the final result from the change in timeframe, from 90 days before the written order or 30 days after to six months before the written order. Moreover, the effective date for this regulation is July 1, 2013; therefore, only 6 months of year 1 (calendar year 2013) are included in this analysis. . We estimated the overall economic impact of this provision on the health care sector to be a cost of $30.2 million in the first year approximately half of which would be in CY 2013. The 5 year impact is $172.3 million. This overall impact is composed of additional administrative paperwork costs to private sector providers; a slight increase in Medicare spending, consisting of additional costs and some offsetting savings; and additional opportunity and out-of-pocket costs to Medicare beneficiaries. We believe there are likely to be other benefits and cost savings that result from the DME face-to-face requirement; however, many of those benefits cannot be quantified. For instance, we expect to see savings in the form of reduced fraud, waste, and abuse, including a reduction in improper Medicare fee-for-service payments (note that not all improper payments are fraudulent). Our detailed cost and benefit analysis is explained below. We specifically solicited comments on the potential increased costs and benefits associated with this provision.
The following is a summary of the comments we received regarding the potential increased costs and benefits associated with this provision.
Response: CMS believes that this is an important requirement aimed at reducing waste, fraud and abuse. CMS utilized a criterion driven approach to select these items and did not receive sufficiently detailed alternative criteria to those proposed to be implementable. CMS will monitor the effects of this requirement on reducing waste, fraud and abuse and monitor beneficiary access to care.
The definition of small entity in the RFA includes non-profit organizations. Most suppliers and providers are small entities as that term is used in the RFA. Likewise, the vast majority of physician and NP practices are considered small businesses according to the Small Business Administration's size standards with total revenues of $10 million or less in any 1 year. While the economic costs and benefits of this rule are substantial in the aggregate, the economic impacts on individual entities will be relatively small. We estimate that 90 to 95 percent of DME suppliers and practitioners who order DME are small entities under the RFA definition. Physicians and other professionals would receive extra payments for some of the costs imposed, and other costs (for example, for additional practitioner visits) would be reimbursed by Medicare under regular payment rules. The rationale behind requiring a face-to-face encounter is to reduce inappropriate claims from those DME suppliers who have been abusing or defrauding the program. The impact on these suppliers could be significant; however, since we believe that the purpose of the statute and this regulation is to reduce abusive and fraudulent DME sales, we do not view the burden placed on those providers and suppliers in the form of lost revenues as a condition that we must mitigate. We believe that the effect on legitimate suppliers and practitioners would be minimal.
We believe that most practitioners are already seeing the beneficiary no more than 6 months prior to the written order. However, this regulation potentially requires increased documentation.
Although we have no quantitative data for a specific dollar figure for the additional DME that may now be authorized in accordance with § 410.38(g), nor can we determine if there would be cost avoidance and a reduction of unnecessary DME, we acknowledge the potential for this provision to surpass the economically significant threshold. We do not believe that this final rule with comment period would significantly affect the number of legitimate written orders for DME. However, we would expect a decline in fraudulent, wasteful and abusive orders, thereby causing a decrease in the amount paid for DME overall.
The covered items of DME as outlined in III.C, including the list of specified covered items, contains items that meet at least one of the following four criteria: (1) Items that currently require a written order prior to delivery per instructions in our Program Integrity Manual; (2) items that cost more than $1,000; (3) items that we, based on our experience and recommendations from the DME MACs, believe are particularly susceptible to fraud, waste, and abuse; (4) items determined by CMS as vulnerable to fraud, waste and abuse based on reports of the HHS Office of Inspector General, the Government Accountability Office or other oversight entities. CMS will not include items on the covered list of items that are cited in statute explicitly as not having a face-to-face encounter requirement. A summary of comments regarding the criteria is available in III.C.
We also have estimated the number of different covered Medicare items subject to this final rule with comment period at approximately 155 HCPCS codes for items of DME. As new products enter the market this number could increase, which could increase the impact. In addition, we propose a G-code to pay physicians for documenting the encounter conducted by a PA, a NP, or a CNS.
We anticipated there would be an impact as a result of additional office visits for the face-to-face encounter and the additional time spent by physicians to document the face-to-face encounters with a beneficiary when it is furnished by a PA, a NP, or a CNS.
In our estimate of overall cost we included the estimates from section III, of this final rule with comment period (Collection of Information Requirements section). These are estimated at $11.2 million in year 1 and $ 64.8 million over 5 years. These are driven by the physician documenting face-to-face encounters with a beneficiary when it is furnished by a PA, a NP, or a CNS, including the time to communicate the practitioners' findings to physicians so they can complete the necessary documentation.
Medicare would incur additional costs associated with this final rule with comment period related to additional face-to-face encounters in the form of office visits, and additional payment for time spent documenting the face-to-face encounter if furnished by the PA, NP or CNS and not by the physician directly. Subsequently, a G-Code is being created to allow Medicare payment to physicians for documenting the face-to-face encounters that are furnished by a PA, NP, and CNS, and is included in this final rule with comment period.
From a programmatic standpoint we believe that there would be 375,000 additional office visits billed and 500,000 G code claims for the documentation in year 1. It is difficult to determine how many PAs, NPs or CNSs wrote orders for covered items of DME and while we lack exact empirical data, in order to provide an estimate, we assumed that 5 percent of the orders for covered items of DME were written by a PA, NP or CNS. For the purpose of this estimate, we assumed that each order requires a separate face-to-face encounter, recognizing fully that the estimate might be inflated.
While we believe that currently the majority of practitioners evaluate beneficiaries before ordering DME, some may not, and therefore, a certain number of beneficiaries would be required to have a new visit in order to fulfill the face-to-face encounter requirement. Actuarial estimates indicated approximately 2.5 percent of those obtaining covered items of DME in a given year did not see a practitioner in the 6 months preceding the order. This percentage changed due to the modified timeframe from the proposed rule. We estimated that 250,000 beneficiaries would not see their practitioners in the 6 months prior to the written order. We assumed that 1.5 visits per year per affected beneficiary would be required to cover the DME services that currently fail to meet the face-to-face requirement. The range would be about one to three; possibly less than one if many beneficiaries choose not to meet the requirement or reschedule services. DME claims for beneficiaries who failed to meet the physician contact requirements averaged 3 line items per beneficiary. However, about 40 percent of these line items occur on the same date and so probably refer to the same event and could be authorized during a single visit. Some additional coordination is probable for DME purchases within a narrow time frame. To estimate the impact of the additional office visits, we assumed 375,000 additional office visits (1.5 visits * 250,000 beneficiaries). We also assumed that the average cost for these office visits is around $65, which is consistent with a mid-level office visit under the PFS. This represents the total amount that the practitioners would receive, either from Medicare or the beneficiary, who is responsible for the 20 percent coinsurance.
Physicians are now required to document the face-to-face encounter if it was furnished by a PA, NP, or CNS. In order to allow payment for this documentation, a G code is established for this service. There are approximately 10 million DME users and it we assumed that roughly 5 percent of face-to-face encounters are actually furnished by these other practitioner types, thereby requiring documentation of the encounter. Therefore, we assumed that about 500,000 of these documentation services would be billed. As discussed in section III.M.3 of this final rule with comment period, we are establishing work and malpractice RVUs for HCPCS codes for G0454 by crosswalking to the work and malpractice RVUs for CPT code 99211 (Level 1 office or other outpatient visit, established patient). With regard to practice expense RVUs, we are not including any direct practice expense inputs for clinical labor, disposable medical supplies, or equipment in the direct PE input database for this code; practice expense RVUs will reflect resources for overhead costs only. The work, malpractice, and practice expense RVUs for HCPCS code G0454 are reflected in Addendum B of this CY 2013 PFS final rule with comment period
Therefore the estimated gross cost is estimated to be $10 million in CY 2013 and $115 million over 5 years; note that there are also savings to Medicare that must be netted against the cost of additional practitioner office visits, which are described later in the Benefits section. There is a high degree of uncertainty surrounding this estimate because it was difficult to predict how physicians and beneficiaries would respond to the new requirement.
This provision would assist in providing better documentation which may help to lower the error rate and thus reduce improper payments, including those stemming from waste, fraud and abuse. Since there is a large amount of potential variation in the amount of time that a face-to-face encounter may take for an item of DME, as a proxy our estimate is based on the amount of time needed for a mid-level visit to evaluate a beneficiary (E&M code 99213). The time allotted for this visit to furnish the face-to-face evaluation under a 99213 is 15 minutes. We solicited comments as to the appropriateness of E&M Code 99213 as a proxy measure of time required for a face-to-face encounter but did not receive any public comments.
Based on actual data, projecting these historical patterns in light of the draft regulation was not straight-forward. Some line items may be bundled (perhaps because they were used together). Beneficiaries may also change their behavior in response to the regulation. For example, beneficiaries who would be required to visit a physician in order for Medicare to pay for a new piece of equipment may substitute this visit for a later visit that would have been for a routine service. In this situation, the overall number of visits would not increase. Moreover, some beneficiaries may choose not to pursue the DME item at that time. On
The requirement for a face-to-face encounter with a beneficiary in a certain time period as a condition of payment for DME is a new statutory requirement. It is not subject to the physician fee schedule budget neutrality requirement under section 1848(c)(2)(B)(ii)(II) of the Act. However, by regulation, we are making an additional payment through a new G-code for physician work documenting the face-to-face encounters that are performed by a PA, NP, and CNS. This additional regulatory spending is subject to the physician fee schedule budget neutrality requirement under section 1848(c)(2)(B)(ii)(II) of the Act.
From a programmatic standpoint, approximately 2.5 percent of those obtaining covered items of DME in that year did not see a practitioner in the 6 months preceding the order. We estimated that 250,000 beneficiaries would not see their practitioners in the 6 months prior to the written order for the covered item. As mentioned above, we assumed that 1.5 visits per year per affected beneficiary would be required to cover the DME services that currently fail to meet the face-to-face requirement. The range would be about one to three; possibly less than one if many beneficiaries chose not to meet the requirement or reschedule services. DME claims for beneficiaries who failed to meet the physician contact requirements averaged 3 line items per beneficiary. However, about 40 percent of these line items occur on the same date and so probably refer to the same event and could be authorized during a single visit. Some additional coordination is probable for DME purchases within a narrow time frame. There are effects on travel time and cost for these beneficiaries. We estimate that there will be an additional 375,000 office visits as a number of beneficiaries would not have seen their practitioner in the six months prior to the written order for the covered item. If it takes a beneficiary 1.25 hours to go to a practitioner, the total estimate is approximately 468,750 hours of time for this final rule with comment period. We assumed that an average trip requires one hour and 15 minutes (1.25 hours) (45 minutes of round trip travel time and 30 minutes in the doctor's office—half for waiting and half for time with the staff). As a proxy we use $20 to estimate the cost per hour including loss of leisure time and travel cost for a beneficiary to see a practitioner. This is consistent with previous estimates of beneficiary leisure time as proposed in the May 4, 2011 proposed rule entitled “Medicare & Medicaid Programs; Influenza Vaccination Standard for Certain Medicare & Medicaid Participating Providers and Suppliers” (76 FR 25469). This creates an economic cost of nearly $9,375,000 in year 1 and $52.5 million over 5 years. There will be additional out of pocket expenses at the 20 percent Medicare Part B coinsurance. We estimated this cost to be $5 million in year 1 and $25 million over 5 years.
There would be quantifiable benefits from an expected reduction in Medicare DME services provided. In addition, we anticipated additional, qualitative benefits from a decrease in waste, fraud, and abuse, which would decrease the number of services. Further, requiring that there be a face-to-face evaluation of the beneficiary helps ensure appropriate orders are based on the individual's medical condition, which increases the quality of care that the beneficiary receives. It is difficult to measure how much waste, fraud, and abuse will be prevented as a result of this final rule with comment period since it is impossible to determine what would have happened in the absence of the final rule with comment period. This provision is expected to improve physician's documentation of DME, and therefore, will help reduce improper payments and move the agency towards its strategic goal to reduce the Medicare fee-for-service error rate for DME items, which has a higher error rate than other Medicare services. Fraud is an improper payment, but not all improper payments are fraud.
Therefore, creating a measure of how much this final rule with comment period would save in terms of a reduction in waste, fraud and abuse is not possible. With that stated, in 2009 Medicare paid $1.7 billion for DME items covered by this proposed rule, and we estimated that $1.9 billion would be paid for covered items in 2012, and $9.9 billion over 5 years. Preventing waste, fraud and abuse by changing behavior that results in just a small percentage reduction in inappropriate or unnecessary ordering of DME services will generate Medicare savings. This is an area where savings
We project Medicare savings from reduced DME services; these savings partially offset the costs of additional physician office visits and documentation payments described earlier in the impact analysis. The year-to-year Medicare savings from reduced DME services is as follows:
Based on an analysis of 2007 DME claims, approximately 1 percent of total DME spending was for those beneficiaries who had little contact with their physician during the year. The gross savings to Medicare has been reduced from the estimated savings in the proposed rule due to the change in timeframe from 90 days to 6 months. We believe that some beneficiaries who would not order a DME service because they did not have face-to-face visit within 90 days prior to the written order, would likely have a face-to-face visit within the 6-month timeframe. For this subset of spending we assumed that there would be a 20 percent reduction in spending due to the face-to- face requirement. We found similar reductions in DME expenditures among managed care enrollees compared to fee-for service (FFS) beneficiaries in the Medical Expenditure Panel Survey. This assumption is fairly speculative but we think it is modest compared to the estimates of improper payments across Medicare services including DME. The savings would occur because some beneficiaries would not choose to go to the physician to authorize the DME item, some physicians would not order the items that would otherwise have been provided in the absence of the regulation, and some suppliers would not be able to achieve a payment that might have occurred through an unnecessary sale or outright fraud.
The overall net impact to Medicare of the DME face-to-face encounter policy is $5 million in the first year and $30 million over the first 5 years.
This regulation produced an extra benefit that is difficult to quantify, but is an extremely positive one in terms of greater practitioner involvement. By increasing practitioner interactions with beneficiaries before ordering DME, beneficiaries would receive more appropriate DME and benefit from higher quality care. Beneficiaries would also benefit from reduced out-of-pocket costs by not having to pay for unnecessary DME. This accomplished the objective of achieving greater practitioner accountability noted in the provisions of and the amendments made by section 6407 and other sections of the Affordable Care Act.
In this final rule with comment period, we considered a variety of options and sought comments on these options in other sections of this final rule with comment period. We expected public comment on how to limit the burden associated with the supplier being notified that a face-to-face encounter has occurred. We proposed several options for the physician documentation of a face-to-face encounter furnished by that physician. We believe just submitting the medical record for the applicable date of service would create the least cost while still producing the desired benefits. We had also proposed different options for how the physician must document the face-to-face encounter if performed by a NP, PA, or CNS. In this final rule with comment period we establish that physicians must document a face-to-face encounter furnished by a PA, NP or CNS by signing or cosigning the pertinent portion of the medical record thereby documenting that the beneficiary was evaluated or treated for a condition relevant to an item of DME on that date of service.
Finally, there are other possible periods of time that could be set as the window within which face-to-face encounters must occur. We believe the 6 month timeframe for the face-to-face to occur helps to best limit burden.
We estimated no significant budgetary impact. We believe that the overall costs for most providers and suppliers would remain the same unless they are subject to non-random prepayment complex medical review for an extended period of time.
We estimated no significant budgetary impact.
Section IV.N.2. of this final rule with comment period addresses the background of the Physician Compare Web site. As described in section IV.N.2. of this final rule with comment period, we are developing aspects of the Physician Compare Web site using a phased approach. In the first phase, which was completed in 2011, we posted the names of those eligible professionals who satisfactorily participated in the 2009 Physician Quality Reporting System. The second phase of the plan, which was completed in 2012, included posting the names of eligible professionals who were successful electronic prescribers under the 2009 eRx Incentive Program, as well as eligible professionals (EPs) who participated in the EHR Incentive Program. The next phase of the plan included posting of performance information with respect to the 2012 Physician Quality Reporting System GPRO measures which is targeted to be completed in 2013.
We are finalizing proposals to include performance information for the 2013 Physician Quality Reporting System GPRO web interface measures data, and targeted posting this data in 2014, in addition to 2013 patient experience data for group practices participating in the 2013 Physician Quality Reporting System GPRO. As reporting of physician performance rates and patient experience data on the Physician Compare Web site would be performed directly by us using the data that we collect under the 2012 Physician Quality Reporting System GPRO and other data collection methods, we did not anticipate any notable impact on eligible professionals with respect to the posting of information on the Physician Compare Web site.
We invited but received no public comment on the Regulatory Impact Analysis related to Physician Compare and are therefore finalizing this analysis.
According to the 2010 Reporting Experience Report, a total of $391,635,495 in Physician Quality Reporting System (PQRS) incentives was paid by CMS for the 2010 program year, which encompassed 168,843 individual eligible professionals. In 2010, eligible professionals earned a 2.0 percent incentive (that is, a bonus payment equal to 2.0 percent of the total allowed part B charges for covered professional services under the PFS furnished by the eligible professional during the reporting period) for satisfactory reporting under the PQRS. For 2013 and 2014, eligible professionals can earn a 0.5 percent incentive for satisfactory reporting, a reduction of 1.5 percent from 2010. Therefore, based on 2010, which is the latest year in which PQRS has full participation data, we would expect that approximately $97 million (approximately
The average incentive distributed to each eligible professional in 2010 was $2,157. Taking into account the 1.5 percent incentive reduction from 2.0 percent in 2010 to 0.5 percent in 2013 and 2014, we estimated that the average amount per eligible professional earning an incentive in 2013 and 2014 would be $539. Therefore, we estimate that the PQRS would distribute approximately $162 million ($539 × 300,000 eligible professionals) and $216 million ($539 × 400,000 eligible professionals) in incentive payments in 2013 and 2014, respectively. We believe these incentive payments will help offset the cost to eligible professionals for participating in the PQRS for the applicable year. Please note that, beginning 2015, incentive payments for satisfactory reporting in the PQRS will cease and payment adjustments for not satisfactorily reporting will commence.
We note that the total burden associated with participating in the PQRS is the time and effort associated with indicating intent to participate in the PQRS, if applicable, and submitting PQRS quality measures data. When establishing these burden estimates, we assumed the following:
• The requirements for reporting for the PQRS 2013 and 2014 incentives and payment adjustments for 2015 and beyond would be established as proposed in this 2013 Medicare PFS final rule with comment period.
• For an eligible professional or group practice using the claims, registry, or EHR-based reporting mechanisms, we assume that the eligible professional or group practice would report on 3 measures.
• With respect to labor costs, we believe that a billing clerk will handle the administrative duties associated with participating, while a computer analyst will handle duties related to reporting PQRS quality measures. According to the Bureau of Labor Statistics, the mean hourly wage for a billing clerk is approximately $16/hour whereas the mean hourly wage for a computer analyst is approximately $40/hour.
For an eligible professional who wished to participate in the PQRS as an individual, the eligible professional need not indicate his/her intent to participate, if using the traditional reporting mechanisms. The eligible professional may simply begin reporting quality measures data. Therefore, these burden estimates for individual eligible professionals participating in the PQRS are based on the traditional reporting mechanism the individual eligible professional chooses. However, we believe a new eligible professional or group practice would spend 5 hours—which includes 2 hours to review the PQRS measures list, review the various reporting options, and select a reporting option and measures on which to report and 3 hours to review the measure specifications and develop a mechanism for incorporating reporting of the selected measures into their office work flows. Therefore, we believe that the initial administrative costs associated with participating in the PQRS would be approximately $80 ($16/hour × 5 hours).
With respect to the reporting of quality measures data, we believe the burden associated with reporting was the time and effort associated with the registry calculating quality measures results from the data submitted to the registry by its eligible professionals, submitting numerator and denominator data on quality measures, and calculating these measure results. We believe, however, that registries already perform these functions for its eligible professionals irrespective of participating in the PQRS. Therefore, we believe there would be little to no additional burden associated with reporting PQRS quality measures data. Whether there is any additional reporting burden will vary with each registry, depending on the registry's level of savvy with submitting quality measures data for the PQRS.
We invited but received no public comment on the Regulatory Impact Analysis related to PQRS and are therefore finalizing this analysis.
Please note that the requirements for becoming a successful electronic prescriber for the 2013 incentive and 2014 payment adjustment were established in the CY 2012 MPFS final rule with comment period. The final provisions contained in this CY 2013 MPFS final rule with comment period would make additional changes to the requirements for the 2013 incentive and 2014 payment adjustment for group practices. Specifically, CMS is finalizing a new criterion for being a successful electronic prescriber for the 2013 incentive and 2014 payment adjustments for group practices of 2-24 eligible professionals given that CMS is modifying the definition of group practice. However, we note that any additional impact as a result of this additional requirement would be minimal, as it is our understanding the eligible professionals who would use this new reporting option are already participating in the eRx Incentive Program as individual eligible professionals.
For the reasons stated, the final changes would have no additional impact other than the impact of the 2013 and 2014 payment adjustments described in the CY 2012 MPFS final rule with comment period. We invited but received no public comment on the Regulatory Impact Analysis related to the eRx Incentive Program and are therefore finalizing this analysis.
Please note that the requirements for participating in the Medicare Shared Saving Program and the impacts of these requirements were established in the final rule for the Medicare Shared Savings Program that appeared in the
We invited but received no public comment on the Regulatory Impact Analysis related to the Medicare Shared Savings Program and are therefore finalizing this analysis.
Please note that the requirements for reporting clinical quality measures (CQMs) to achieve meaningful use under the EHR Incentive Program were established in a standalone final rule published on July 28, 2010 (75 FR 44544) and September 4, 2012 (77 FR 53968). The requirements contained in this CY 2013 MPFS final rule with comment period merely propose methods to report CQMs for purposes of achieving meaningful use under the EHR Incentive Program. Therefore, the impacts of the extension of the use of attestation and the PQRS-Medicare EHR Incentive Pilot to report CQMs were absorbed in the impacts discussion published in the EHR Incentive Program final rules published on July 28, 2010 and September 4, 2012.
We invited but received no public comment on the Regulatory Impact Analysis related to The Medicare EHR Incentive Program and are therefore finalizing this analysis.
As discussed in section III of this final rule with comment period, we continue the recoupment of the $50 million in expenditures from this demonstration in order to satisfy the BN requirement in section 651(f)(1)(B) of the MMA. We initiated this recoupment in CY 2010 and this will be the fourth year. As discussed in the CY 2010 PFS final rule with comment period, we finalized a policy to recoup $10 million each year through adjustments to the PFS for all chiropractors in CY s 2010 through 2014. To implement this required BN adjustment, we are recouping $10 million in CY 2013 by reducing the payment amount under the PFS for the chiropractic CPT codes (that is, CPT codes 98940, 98941, and 98942) by approximately 2 percent.
The Physician Value-Based Payment Modifier and the Physician Feedback Program final policies discussed in section IV.I. of this final rule with comment period would not impact CY 2013 physician payments under the PFS. However, we expect that our proposals to use the PQRS quality measures in the Physician Feedback reports and in the value-based payment modifier to be implemented in CY 2015 may result in increased participation in the PQRS in CY 2013. We anticipate that as we approach implementation of the value-based payment modifier, physicians would increasingly participate in the PQRS to determine and understand how the value-based payment modifier could affect their payments.
As discussed in section III of this final rule with comment period, section 1861(s)(10)(B) of the Act authorizes Medicare coverage of hepatitis B vaccine and its administration if furnished to an individual who is at high or intermediate risk of contracting hepatitis B, as determined by the Secretary under regulations. Our current regulations are established at 42 CFR 410.63. We proposed to modify § 410.63(a)(1) by adding persons diagnosed with diabetes mellitus to the high risk group. While it is estimated that approximately 23 percent of non-institutionalized Medicare beneficiaries are diagnosed with diabetes mellitus, it is unclear how many of these beneficiaries would obtain these services. Therefore, the estimated impact of adding persons diagnosed with diabetes mellitus to the high risk group eligible for coverage of hepatitis B vaccine and its administration is unknown for CY 2013.
The e-prescribing standard updates that are adopted in this final rule with comment period impose no new requirements as the burden of using the updated standards is anticipated to be the same as using the old standards. We believe that prescribers and dispensers that are now e-prescribing largely invested in the hardware, software, and connectivity necessary to e-prescribe. We do not anticipate that the retirement of NCPDP SCRIPT 8.1 in favor of NCPDP SCRIPT 10.6 will result in significant costs. Nor do we believe that the eventual retirement of the NCPDP Formulary and Benefit 1.0 and the adoption of the updates for NCPDP Formulary and Benefits 3.0 as the official Part D standard will result in significant costs.
The removal of the LTC exception to the NCPDP SCRIPT standard would impose a small burden on the LTC industry. LTC entities who use and developed proprietary solutions may need to invest in software programming updates if they had not already incorporated the Part D e-prescribing standards in their solutions. It is reasonable to assume that a small number of proprietary solutions would have to be modified to enable adherence to the adopted e-prescribing standards. Other costs may be incurred through staff training on the use of the e-prescribing standards and the use of any e-prescribing solution adopted by a LTC facility. Additional training cost may involve prescribers and dispensers learning the new workflows that an electronic prescription may or may not require.
This final rule with comment period contains a range of policies, including some provisions related to specific statutory provisions. The preceding preamble provided descriptions of the statutory provisions that are addressed, identified those policies when discretion has been exercised, presented rationale for our final policies 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 that many of the changes adopted in this final rule with comment period, including the refinements of the PQRS with its focus on measuring, submitting, and analyzing quality data; establishing the value-based payment modifier to adjust physician payment beginning in CY 2015; creating a separate payment for post-discharge transitional care management services in the 30 days after a beneficiary has been discharged from an inpatient hospital admission, from outpatient observation services and partial hospitalization program, from a SNF, or from a CMHC; improved accuracy in payment through revisions to the inputs used to calculate payments under the PFS for certain radiation therapy services; capital interest rate assumptions; multiple procedure payment reduction for ophthalmology and cardiovascular diagnostic tests; revised values for many services identified through the misvalued codes initiative, and revisions to payment for Part B drugs would have a positive impact and improve the quality and value of care furnished to Medicare beneficiaries.
Most of the aforementioned policy changes could result in a change in beneficiary liability as it relates to coinsurance (which is 20 percent of the fee schedule amount if applicable for the particular provision after the beneficiary has met the deductible). To illustrate this point, as shown in Table 136, the CY 2012 national payment amount in the nonfacility setting for CPT code 99203 (Office/outpatient visit, new) is $105.18 which means that in CY 2012 a beneficiary would be responsible for 20 percent of this amount, or $21.04. Based on this final rule with comment period, using the current (CY 2012) CF of 34.0376, the CY 2013 national payment amount in the nonfacility setting for CPT code 99203, as shown in Table 136, is $107.80, which means that, in CY 2013, the proposed beneficiary coinsurance for this service would be $21.56. Payment amounts and associated coinsurance would be lower using the current law CY 2013 CF with the negative SGR adjustment.
The transitional care management policy would also have an impact on beneficiary coinsurance for those beneficiaries who have a hospital visit in CY 2013 and require moderate to high complexity decision-making by their community physician in the 30 days post discharge. Prior to the new TCM policy discussed in section III.H. of this final rule with comment period such a recently discharged beneficiary may have had an established patient follow-up visit with their community physician. The CY 2013 national payment amount in the nonfacility setting for CPT code 99215 (Office/outpatient visit, established), the highest level of an established patient office visit, is $142.96, which means that a beneficiary would be responsible for 20 percent of this amount, or $28.59. Under the new transitional care management policy, if a beneficiary received the highest level transitional care management visit, 99496, which has a national payment amount of $231.11, the beneficiary would be responsible for 20 percent of this amount, or $46.22
As required by OMB Circular A-4 (available at
The analysis in the previous sections, together with the remainder of this preamble, provides an initial “Regulatory Flexibility Analysis.”
In accordance with the provisions of Executive Order 12866, this regulation 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.
Administrative practice and procedure, Health facilities, Health professions, Kidney diseases, Medicare, Reporting and recordkeeping requirements.
Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements.
Administrative practice and procedure, Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements.
Administrative practice and procedure, Emergency medical services, Health facilities, Health maintenance organizations (HMO), Health professionals, Incorporation by reference, Medicare, Penalties, Privacy, Reporting and recordkeeping requirements.
Administrative practice and procedure, Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements.
Grant programs—health, Health facilities, Medicare, Reporting and recordkeeping requirements, X-rays.
Administrative practice and procedure, Electronic health records, Health facilities, Health professions, Health maintenance organizations (HMO), Medicaid, Medicare, Penalties, Privacy, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services amend 42 CFR chapters IV as set forth below:
Secs. 1102, 1834, 1871, 1881, and 1893 of the Social Security Act (42 U.S.C. 1302. 1395m, 1395hh, and 1395ddd.
(b) * * *
(8) Claims for drugs payable administered by a physician as defined in section 1861(r) of the Social Security Act to refill an implanted item of DME may only be paid under Part B to the physician as a drug incident to a physician's service under section 1861(s)(2)(A). These drugs are not payable to a pharmacy/supplier as DME under section 1861(s)(6) of the Act.
The revisions and addition read as follows:
(b) * * *
(2) * * *
(iii) Diagnostic psychological and neuropsychological testing services when—
(c) * * *
(2) These services are ordered by a physician as provided in paragraph (a) or by a nonphysician practitioner as provided in paragraph (a)(2) of this section.
(d) * * *
(2) * * *
(i)
(e) Diagnostic laboratory tests furnished in hospitals and CAHs. The provisions of paragraphs (a) and (d)(2) through (d)(4) of this section, inclusive, of this section apply to all diagnostic laboratory test furnished by hospitals and CAHs to outpatients.
(g)(1)
(2)
(ii) The list of Specified Covered Items includes the following:
(A) Any item described by a
(
(
(
(
(
(B) Any item of durable medical equipment that appears on the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Fee Schedule with a price ceiling at or greater than $1,000.
(C) Any other item of durable medical equipment that CMS adds to the list of Specified Covered Items through the notice and comment rulemaking process in order to reduce the risk of fraud, waste, and abuse.
(iii) The list of specific covered items excludes the following:
(A) Any item that is no longer covered by Medicare.
(B) Any HCPCS code that is discontinued.
(3)
(A) The physician must document and communicate to the DME supplier that the physician or a physician assistant, a nurse practitioner, or a clinical nurse specialist has had a face-to-face encounter with the beneficiary on the date of the written order up to 6 months before the date of the written order.
(B) During the face-to-face encounter the physician, a physician assistant, a nurse practitioner, or a clinical nurse specialist must conduct a needs assessment, evaluate, and/or treat the beneficiary for the medical condition that supports the need for each covered item of DME ordered.
(C) The face-to-face encounter must be documented in the pertinent portion of the medical record (for example, history, physical examination, diagnostic tests, summary of findings, diagnoses, treatment plans or other information as it may be appropriate). Physician must sign or cosign the pertinent portion of the medical record indicating the occurrence of a face-to-face encounter for the beneficiary for the date of the face-to-face encounter when performed by a physician assistant, a nurse practitioner, or a clinical nurse specialist. For purposes of this paragraph (g), a face-to-face encounter does not include DME items and services furnished from an “incident to” service.
(ii) For purposes of this paragraph (g), a face-to-face encounter may occur via telehealth in accordance with all of the following:
(A) Section 1834(m) of the Act.
(B)(
(
(4)
(i) Beneficiary's name.
(ii) Item of DME ordered.
(iii) Signature of the prescribing practitioner.
(iv) Prescribing practitioner NPI.
(v) The date of the order.
(5)
(ii) Upon request by CMS or its agents, a supplier must submit additional documentation to CMS or its agents to support and substantiate that a face-to-face encounter has occurred.
The addition reads as follows:
(d) * * *
(2) * * *
(ii) In all cases, the provider or supplier must keep appropriate documentation on file and, upon request, present it to the contractor. The presence of the signed physician certification statement does not alone demonstrate that the ambulance
(a) * * *
(4) Claims submitted for furnished services contain prescribed information on patient functional limitations.
(a) * * *
(4) Claims submitted for furnished services contain prescribed information on patient functional limitations.
(c)
(a) * * *
(4) Claims submitted for furnished services contain prescribed information on patient functional limitations.
The addition reads as follows:
(a) * * *
(1) * * *
(viii) Persons diagnosed with diabetes mellitus.
(b) * * *
(b)
The revision and addition read as follows:
(c) * * *
(1) * * *
(ii) Prescribes the type, amount, frequency, and duration of the services to be furnished, and indicates the diagnosis and anticipated rehabilitation goals that are consistent with the patient function reporting on the claims for services.
(d) Claims submitted for physical therapy, occupational therapy or speech-language-pathology services, contain prescribed information on patient functional limitations.
(b) * * *
(8) Beginning January 1, 2011, a surgical service furnished in connection with, as a result of, and in the same clinical encounter as a planned colorectal cancer screening test. A surgical service furnished in connection with, as a result of, and in the same clinical encounter as a colorectal cancer screening test means—a surgical service furnished on the same date as a planned colorectal cancer screening test as described in § 410.37.
Secs. 1102, 1871, and 1881(b)(l) of the Social Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(l)).
(a) * * *
(1) The Medicare payment amount for office or other outpatient visits, subsequent hospital care services (with
(i)
(ii)
The revisions and additions read as follows:
(b) * * *
(c)
(1) There are any quality measures that have been established under the Physician Quality Reporting System that are applicable to any such services furnished by such professional (or in the case of a group practice under paragraph (i) of this section, such group practice) for such reporting period; and
(2) If the eligible professional (or in the case of a group practice under paragraph (j) of this section, the group practice) satisfactorily submits (as determined under paragraph (g) of this section for the eligible professional and paragraph (i) of this section for the group practice) to the Secretary data on such quality measures in accordance with the Physician Quality Reporting System for such reporting period, in addition to the amount otherwise paid under section 1848 of the Act, there also must be paid to the eligible professional (or to an employer or facility in the cases described in section 1842(b)(6)(A) of the Act or, in the case of a group practice under paragraph (i) of this section, to the group practice) from the Federal Supplementary Medical Insurance Trust Fund established under section 1841 of the Act an amount equal to the applicable quality percent (as specified in paragraph (c)(3) of this section) of the eligible professional's (or, in the case of a group practice under paragraph (i) of this section, the group practice's) total estimated allowed charges for all covered professional services furnished by the eligible professional (or, in the case of a group practice under paragraph (i) of this section, by the group practice) during the reporting period.
(3) The applicable quality percent is as follows:
(i) For 2007 and 2008, 1.5 percent.
(ii) For 2009 and 2010, 2.0 percent.
(iii) For 2011, 1.0 percent.
(iv) For 2012, 2013, and 2014, 0.5 percent.
(4) For purposes of this paragraph (c)—
(i) The eligible professional's (or, in the case of a group practice under paragraph (i) of this section, the group practice's) total estimated allowed charges for covered professional services furnished during a reporting period are determined based on claims processed in the National Claims History (NCH) no later than 2 months after the end of the applicable reporting period;
(ii) In the case of the eligible professional who furnishes covered professional services in more than one practice, incentive payments are separately determined for each practice based on claims submitted for the eligible professional for each practice;
(iii) Incentive payments to a group practice under this paragraph must be in lieu of the payments that would otherwise be made under the Physician Quality Reporting System to eligible professionals in the group practice for meeting the criteria for satisfactory reporting for individual eligible professionals. For any program year in which the group practice (as identified by the TIN) is selected to participate in the Physician Quality Reporting System group practice reporting option, the eligible professional cannot individually qualify for a Physician Quality Reporting System incentive payment by meeting the requirements specified in paragraph (g) of this section.
(iv) Incentive payments earned by the eligible professional (or in the case of a group practice under paragraph (i) of this section, by the group practice) for a particular program year will be paid as a single consolidated payment to the TIN holder of record.
(d)
(1) In order to qualify for the additional incentive payment described in paragraph (d) of this section, an eligible professional must meet all of the following requirements:
(i) Satisfactorily submits data on quality measures for purposes of this section for the applicable incentive year.
(ii) Have such data submitted on their behalf through a Maintenance of Certification program (as defined in paragraph (b) of this section) that meets:
(A) The criteria for a registry (as specified by CMS); or
(B) An alternative form and manner determined appropriate by the Secretary.
(iii) The eligible professional, more frequently than is required to qualify for or maintain board certification status—
(A) Participates in a maintenance of certification program (as defined in paragraph (b) of this section) for a year; and
(B) Successfully completes a qualified maintenance of certification program practice assessment (as defined in paragraph (b) of this section) for such year.
(2) In order for an eligible professional to receive the additional incentive payment, a Maintenance of Certification Program must submit to the Secretary, on behalf of the eligible professional, information—
(i) In a form and manner specified by the Secretary, that the eligible professional has successfully met the requirements of paragraph (d)(1)(iii) of this section, which may be in the form of a structural measure.
(ii) If requested by the Secretary, on the survey of patient experience with care.
(iii) As the Secretary may require, on the methods, measures, and data used under the Maintenance of Certification Program and the qualified Maintenance of Certification Program practice assessment.
(e)
(1) The applicable percent is as follows:
(i) For 2015, 98.5 percent; and
(ii) For 2016 and each subsequent year, 98 percent.
(2) [Reserved.]
(f)
(1) Be such measures selected by the Secretary from measures that have been endorsed by the entity with a contract with the Secretary under section 1890(a) of the Act.
(2) 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 entity with a contract under section 1890(a) of the Act, the Secretary may 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.
(3) For each quality measure adopted by the Secretary under this paragraph, the Secretary ensures that eligible professionals have the opportunity to provide input during the development, endorsement, or selection of quality measures applicable to services they furnish.
(g)
(1)
(i) The 12-month period from January 1 through December 31 of such program year.
(ii) A 6-month period from July 1 through December 31 of such program year.
(A) For 2011, such 6-month reporting period is not available for EHR-based reporting of individual Physician Quality Reporting System quality measures.
(B) For 2012 and subsequent program years, such 6-month reporting period from July 1 through December 31 of such program year is only available for registry-based reporting of Physician Quality Reporting System measures groups by eligible professionals.
(2)
(i)
(A) If an eligible professional re-submits a Medicare Part B claim for reprocessing, the eligible professional may not attach a G-code at that time for reporting on individual Physician Quality Reporting System measures or measures groups.
(B) [Reserved]
(ii)
(iii)
(iv)
(v) Although an eligible professional may attempt to qualify for the Physician Quality Reporting System incentive payment by reporting on both individual Physician Quality Reporting System quality measures and measures groups, using more than one reporting mechanism (as specified in paragraph (g)(2) of this section), or reporting for more than one reporting period, he or she will receive only one Physician Quality Reporting System incentive payment per TIN/NPI combination for a program year.
(3)
(i)
(ii)
(iii)
(iv)
(v) Although a group practice may attempt to qualify for the Physician Quality Reporting System incentive payment by using more than one reporting mechanism (as specified in paragraph (g)(3) of this section), or reporting for more than one reporting period, the group practice will receive only one Physician Quality Reporting System incentive payment for a program year.
(h)
(1) For purposes of this paragraph (h), the reporting period for the payment adjustment, with respect to a payment adjustment year, is the 12-month period from January 1 through December 31 that falls 2 years prior to the year in which the payment adjustment is applied.
(i) For the 2015 and 2016 PQRS payment adjustments only, an alternative 6-month reporting period, from July 1-December 31 that fall 2 years prior to the year in which the payment adjustment is applied, is also available.
(ii) [Reserved]
(2)
(i)
(A) If an eligible professional re-submits a Medicare Part B claim for reprocessing, the eligible professional may not attach a G-code at that time for reporting on individual Physician Quality Reporting System measures or measures groups.
(B) [Reserved]
(ii)
(iii)
(iv)
(v)
(A) Elect to participate in the Physician Quality Reporting System using the administrative claims reporting option.
(B) Reporting Medicare Part B claims data for CMS to determine whether the eligible professional has performed services applicable to certain individual Physician Quality Reporting System quality measures.
(3)
(i)
(ii)
(iii)
(iv)
(v)
(A) Elect to participate in the Physician Quality Reporting System using the administrative claims reporting option.
(B) Reporting Medicare Part B claims data for CMS to determine whether the group practice has performed services applicable to certain individual Physician Quality Reporting System quality measures.
(i)
(1) Meet the participation requirements specified by CMS for the Physician Quality Reporting System group practice reporting option.
(2) Report measures in the form and manner specified by CMS.
(3) Meet other requirements for satisfactory reporting specified by CMS.
(4) Meet other requirements for satisfactory reporting specified by CMS.
(5) Meet participation requirements.
(i) If an eligible professional, as identified by an individual NPI, has reassigned his or her Medicare billing rights to a group practice (as identified by the TIN) selected to participate in the Physician Quality Reporting System group practice reporting option for a program year, then for that program year the eligible professional must participate in the Physician Quality Reporting System via the group practice reporting option.
(ii) If, for the program year, the eligible professional participates in the Physician Quality Reporting System as part of a group practice (as identified by the TIN) that is not selected to participate in the Physician Quality Reporting System group practice reporting option for that program year, then the eligible professional may individually participate and qualify for a Physician Quality Reporting System incentive by meeting the requirements specified in paragraph (g) of this section under that TIN.
(j)
(1) To request an informal review for the PQRS incentives, an eligible professional (or in the case of reporting under paragraph (g) of this section, group practices) must submit a request to CMS via the Web within 90 days of the release of the feedback reports. The request must be submitted in writing or via email and summarize the concern(s) and reasons for requesting an informal review and may also include information to assist in the review.
(i) CMS will provide a written response within 90 days of the receipt of the original request.
(ii) All decisions based on the informal review will be final.
(iii) There will be no further review or appeal.
(2) To request an informal review for the PQRS payment adjustments, an eligible professional or group practices must submit a request to CMS via the Web by February 28 of the year in which the eligible professional is receiving the applicable payment adjustment. The request must be submitted in writing and summarize the concern(s) and reasons for requesting an informal review and may also include information to assist in the review.
(i) CMS will provide a timely, written response after the receipt of the original request.
(ii) All decisions based on the informal review will be final.
(iii) There will be no further review or appeal.
The revision and addition reads as follows:
(c) * * *
(2) * * *
(ii) * * *
(A) * * *
(
(
(f) * * *
(2)
(i) * * *
(A) If an eligible professional re-submits a Medicare Part B claim for reprocessing, the eligible professional may not attach a G-code at that time for reporting on the electronic prescribing measure.
(B) [Reserved]
(g)
(1) To request an informal review for the 2012 and 2013 incentives, an eligible professional or group practice must submit a request to CMS via email within 90 days of the release of the feedback reports. The request must be submitted in writing and summarize the concern(s) and reasons for requesting an informal review and may also include information to assist in the review.
(2) To request an informal review for the 2013 and 2014 payment adjustments, an eligible professional or group practices must submit a request to CMS via email by February 28 of the year in which the eligible professional is receiving the applicable payment adjustment. The request must be submitted in writing and summarize the concern(s) and reasons for requesting an informal review and may also include information to assist in the review.
(3) CMS will provide a written response of CMS' determination.
(i) All decisions based on the informal review will be final.
(ii) There will be no further review or appeal.
(c) * * *
(1) * * *
(ii) For services furnished during the period July 1, 2008 through December 31, 2012, ambulance services originating in—
(A) Urban areas (both base rate and mileage) are paid based on a rate that is 2 percent higher than otherwise is applicable under this section; and
(B) Rural areas (both base rate and mileage) are paid based on a rate that is 3 percent higher than otherwise is applicable under this section.
(5) * * *
(ii) For services furnished during the period July 1, 2004 through December 31, 2012, the payment amount for the ground ambulance base rate is increased by 22.6 percent where the point of pickup is in a rural area determined to be in the lowest 25 percent of rural population arrayed by population density. The amount of this increase is based on CMS's estimate of the ratio of the average cost per trip for the rural areas in the lowest quartile of population compared to the average cost per trip for the rural areas in the highest quartile of population. In making this estimate, CMS may use data provided by the GAO.
(h)
(d) * * *
(3) * * *
(ii) Payment at 103 percent of the average manufacturer price for a billing code will be applied at such times when all of the following criteria are met:
(A) The threshold for making price substitutions, as defined in paragraph (d)(3)(iii) of this section is met.
(B) 103 percent of the average manufacturer price is less than the 106 percent of the average sales price for the quarter in which the substitution would be applied.
(C) Beginning in 2013, the drug and dosage form described by the HCPCS code is not identified by the FDA to be in short supply at the time that ASP calculations are finalized.
(iii) The applicable percentage threshold for average manufacturer price comparisons is 5 percent and is reached when—
(A) The average sales price for the billing code has exceeded the average manufacturer price for the billing code by 5 percent or more in 2 consecutive quarters, or 3 of the previous 4 quarters immediately preceding the quarter to which the price substitution would be applied; and
(B) The average manufacturer price for the billing code is calculated using the same set of National Drug Codes used for the average sales price for the billing code.
(iv) The applicable percentage threshold for widely available market price comparisons is 5 percent.
(a)
(b)
(1) The application of the value-based payment modifier.
(2) Performance and payment adjustment periods.
(3) Reporting mechanisms for the value-based payment modifier.
(4) Alignment of PQRS quality of care measures with the quality measures for the value-based payment modifier.
(5) Additional measures for groups of physicians.
(6) Cost measures.
(7) Attribution for quality of care and cost measures.
(8) Scoring methods for the value-based payment modifier.
(9) Benchmarks for quality of care measures.
(10) Benchmarks for cost measures.
(11) Composite scores.
(12) Reliability of measures.
(13) Payment adjustments.
(14) Value-based payment modifier quality-tiering scoring methodology.
(15) Limitation of review.
(16) Inquiry process.
As used in this subpart, unless otherwise indicated—
(a) The value-based payment modifier is applicable to physicians:
(1) For CY 2015, in groups with 100 or more eligible professionals based on the performance period described at § 414.1215(a).
(2) [Reserved]
(b)
(2) [Reserved]
(c)
(a) The performance period is calendar year 2013 for value-based payment modifier adjustments made in the calendar year 2015 payment adjustment period.
(b) The performance period is calendar year 2014 for value-based payment modifier adjustments made in the calendar year 2016 payment adjustment period.
Groups of physicians subject to the value-based payment modifier may submit data on quality measures as specified under the Physician Quality Reporting System and in § 414.90(g) for which they are eligible and § 414.90(h)(3)(vi) administrative claims.
All of the quality measures for which groups of physicians are eligible to report under the Physician Quality Reporting System starting in CY 2013 are used to calculate the value-based payment modifier program to the extent the group of physicians submits data on such measures.
The value-based payment modifier includes the following additional quality measures for all groups of physicians subject to the value-based payment modifier:
(a) A composite of rates of potentially preventable hospital admissions for heart failure, chronic obstructive pulmonary disease, and diabetes. The rate of potentially preventable hospital admissions for diabetes is a composite measure of uncontrolled diabetes, short term diabetes complications, long term diabetes complications and lower extremity amputation for diabetes.
(b) A composite of rates of potentially preventable hospital admissions for dehydration, urinary tract infections, and bacterial pneumonia.
(c) Rates of an all-cause hospital readmissions measure.
Costs for groups of physicians subject to the value-based payment modifier are assessed based on the following 6 cost measures:
(a) Total per capita costs for all attributed beneficiaries; and
(b) Total per capita costs for all attributed beneficiaries with diabetes, coronary artery disease, chronic obstructive pulmonary disease, or heart failure.
(c) Total per capita costs include all fee-for-service payments made under Medicare Part A and Part B.
(1) Payments under Medicare Part A and Part B will be adjusted using CMS' payment standardization methodology to ensure fair comparisons across geographic areas.
(2) The CMS-HCC model (and adjustments for ESRD status) is used to adjust standardized payments for each cost measure; that is—
(i) Total per capita costs; and
(ii) Total per capita costs for beneficiaries with the following conditions: coronary artery disease, COPD, diabetes, and heart failure.
Beneficiaries are attributed to groups of physicians subject to the value-based payment modifier using a method generally consistent with the method of assignment of beneficiaries under § 425.402 of this chapter.
For each quality of care and cost measure, a standardized score is calculated for each group of physicians subject to the value-based payment modifier by dividing—
(a) The difference between their performance rate and the benchmark, by
(b) The measure's standard deviation.
(a) The benchmark for quality of care measures reported through the PQRS using the claims, registries, EHR, or web interface is the national mean for that measure's performance rate (regardless of the reporting mechanism) during the year prior to the performance period. In calculating the national benchmark, individuals' and groups of physicians' performance rates are weighted by the number of beneficiaries used to calculate the individuals' or group of physician's performance rate.
(b) The benchmark for each quality of care measure reported through the PQRS using the administrative claims option is the national mean for that measure's performance rate during the year prior to the performance period.
The benchmark for each cost measure is the national mean of the performance rates calculated among all groups of physicians for which beneficiaries are attributed to the group of physicians and are subject to the value-based payment modifier. In calculating the national benchmark, groups of physicians' performance rates are weighted by the number of beneficiaries used to calculate the group of physician's performance rate.
(a)(1) The standardized score for each quality of care measure is classified into one of the following equally weighted domains to determine the quality composite:
(i) Patient safety.
(ii) Patient experience.
(iii) Care coordination.
(iv) Clinical care.
(v) Population/community health.
(vi) Efficiency.
(2) If a domain includes no measure or does not reach the minimum case size in § 414.1265, the remaining domains are equally weighted to form the quality of care composite.
(b)(1) The standardized score for each cost measure is grouped into two separate and equally weighted domains to determine the cost composite:
(i) Total per capita costs for all attributed beneficiaries (one measures); and
(ii) Total per capita costs for all attributed beneficiaries with specific conditions: Diabetes, coronary artery disease, chronic obstructive pulmonary disease, or heart failure (four measures).
(2) Measures within each domain are equally weighted.
To calculate a composite score for a quality or cost measure based on claims, a group of physicians subject to the value-based payment modifier must have 20 or more cases for that measure.
(a) In a performance period, if a group of physicians has fewer than 20 cases for a measure, that measure is excluded from its domain and the remaining measures in the domain are given equal weight.
(b) In a performance period, if a reliable quality of care composite or cost composite cannot be calculated, payments shall not be adjusted under the value-based payment modifier.
(a)
(1) Such group does neither self-nominates for the PQRS GPRO and reports at least one measure nor elects the PQRS administrative claims option for CY 2013 as defined in § 414.90(h);
(i) Such adjustment will be −1.0 percent.
(ii) [Reserved]
(2) Such group elects that its value-based payment modifier be calculated using a quality-tiering approach, and is determined to have poor performance (low quality and high costs),
(i) Such adjustment will not exceed −1.0 percent as specified in § 414.1275.
(ii) [Reserved]
(b)
(1) Self-nominates for the PQRS GPRO and reports at least one measure; or
(2) Elects the PQRS administrative claims option for CY 2013 as defined in § 414.90(h).
(c)
(a) The value-based payment modifier amount for a group of physicians subject to the value-based payment modifier that elects the quality-tiering approach is based upon a comparison of the composite of quality of care measures and a composite of cost measures.
(b) Quality composite and cost composite are classified into high, average, and low categories based on whether the composites are statistically above, not different from, or below the mean composite scores.
(1) Quality composites that are one or more standard deviations above the mean are classified into the high category. Quality composites that are one or more standard deviations below the mean are classified into the low category.
(2) Cost composites that are one or more standard deviations below the mean are classified into the low category. Cost composites that are one or more standard deviations above the mean are classified into the high category.
(c) The following value-based payment modifier percents apply:
(d) Groups of physicians subject to the value-based payment modifier that have an attributed beneficiary population with an average risk score in the top 25 percent of the risk scores of beneficiaries nationwide and elect the quality-tiering approach, receive a greater upward payment adjustment as follows:
(1) Classified as high quality/low cost receive an upward adjustment of +3x (rather than +2x); and
(2) Classified as either high quality/average cost or average quality/low cost receive an upward adjustment of +2x (rather than +1x).
(a) There shall be no administrative or judicial review under section 1869 of the Act, section 1878 of the Act, or otherwise of all of the following:
(1) The establishment of the value-based payment modifier.
(2) The evaluation of the quality of care composite, including the establishment of appropriate measure of the quality of care.
(3) The evaluation of costs composite, including establishment of appropriate measures of costs.
(4) The dates of implementation of the value-based payment modifier.
(5) The specification of the initial performance period and any other performance period.
(6) The application of the value-based payment modifier.
(7) The determination of costs.
(b) [Reserved.]
After the dissemination of the annual Physician Feedback reports, a group of physicians may contact CMS to inquire about its report and the calculation of the value-based payment modifier.
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
Sec. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
Sections 1102, 1106, 1860D-1 through 1860D-42, and 1871 of the Social Security Act (42 U.S.C. 1302, 1306, 1395w-101 through 1395w-152, and 1395hh).
The revisions and additions read as follows:
(a) * * *
(3) * * *
(iv) Until November 1, 2014, entities transmitting prescriptions or prescription-related information where the prescriber is required by law to issue a prescription for a patient to a non-prescribing provider (such as a nursing facility) that in turn forwards the prescription to a dispenser are exempt from the requirement to use the NCPDP SCRIPT Standard adopted by this section in transmitting such prescriptions or prescription-related information. As of November 1, 2014, such entities will be required to use the adopted NCPCP SCRIPT standard(s).
(b) * * *
(1) * * *
(i) Before April 1, 2009 the standards specified in paragraphs (b)(2)(i), (b)(3), (b)(4), (b)(5), and (b)(6) of this section.
(ii) From April 1, 2009 until January 14, 2013, the standards specified in paragraphs (b)(2)(ii), (b)(3)-(b)(4), (b)(5) and (b)(6) of this section.
(iii) From January 15, 2013 until October 31, 2013 the standards specified in paragraphs (b)(2)(ii), (b)(3)-(b)(4), (b)(5) and (b)(6) of this section.
(2) * * *
(iii) The National Council for Prescription Drug Programs SCRIPT standard, Implementation Guide Version 10.6 approved November 12, 2008 (incorporated by reference in paragraph (c)(1)(v) of this section), to provide for the communication of a prescription or related prescription related information between prescribers and dispensers for the following:
(A) Get message transaction.
(B) Status response transaction.
(C) Error response transaction.
(D) New prescription transaction.
(E) Prescription change request transaction.
(F) Prescription change response transaction.
(G) Refill prescription request transaction.
(H) Refill prescription response transaction.
(I) Verification transaction.
(J) Password change transaction.
(K) Cancel prescription request transaction.
(L) Cancel prescription response transaction.
(M) Fill status notification.
Secs. 1102, 1106, 1871, and 1899 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
(e)
(b)
(2)(i) ACO providers/suppliers that are eligible professionals within an ACO may only participate under their ACO participant TIN as a group practice under the Physician Quality Reporting System Group Practice Reporting Option of the Shared Savings Program for purposes of the 2015 Physician Quality Reporting System payment adjustment under the Shared Savings Program.
(ii) Under the Shared Savings Program, an ACO, on behalf of its ACO providers/suppliers who are eligible professionals, must satisfactorily report one of the measures determined under Subpart F of this part during the reporting period for a year, as defined in paragraph (b)(6) of this section, according to the method of submission established by CMS under the Shared Savings Program for purposes of the 2015 Physician Quality Reporting System payment adjustment.
(3) If an ACO, on behalf of its ACO providers/suppliers who are eligible professionals, does not satisfactorily report for purposes of a 2015 Physician Quality Reporting System payment adjustment, each ACO supplier/provider who is an eligible professional, will receive a payment adjustment, as described in paragraph (b)(5) of this section.
(4) ACO participant TINs and individual ACO providers/suppliers who are eligible professionals cannot satisfactorily report for purposes of a 2015 Physician Quality Reporting System payment adjustment outside of the Medicare Shared Savings Program.
(5) For eligible professionals subject to the 2015 Physician Quality Reporting System payment adjustment under the Medicare Shared Savings Program, the Medicare Part B Physician Fee Schedule amount for covered professional services furnished during the program year is equal to the applicable percent of the Medicare Part B Physician Fee Schedule amount that would otherwise apply to such services under section 1848 of the Act.
(i) The applicable percent for 2015 is 98.5 percent.
(ii) The applicable percent for 2016 and subsequent years is 98.0 percent.
(6) The reporting period for a year is the calendar year from January 1 through December 31 that occurs 2 years prior to the program year in which the payment adjustment is applied.
Secs. 1102, 1138, and 1871 of the Social Security Act (42 U.S.C. 1302, 1320b-8, and 1395hh) and section 371 of the Public Health Service Act (42 U.S.C. 273).
All portable X-ray services performed for Medicare beneficiaries are ordered by a physician or a nonphysician practitioner as provided in § 410.32(a) of this chapter or by a nonphysician practitioner as provided in § 410.32(a)(2) and records are properly preserved.
(a)
(1) The portable X-ray test was ordered by a licensed physician or a nonphysician practitioner acting within the State scope of law; and
(2) Such physician or nonphysician practitioner's written, signed order specifies the reason a portable X-ray test is required, the area of the body to be exposed, the number of radiographs to be obtained, and the views needed; it also includes a statement concerning the condition of the patient which indicates why portable X-ray services are necessary.
(b)
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
(a) * * *
(2) * * *
(v)
(A) Submission of data extracted from the EP's certified EHR technology through a Physician Quality Reporting System qualified EHR data submission vendor; or
(B) Submission of data extracted from the EP's certified EHR technology, which must also be through a Physician Quality Reporting System qualified EHR.
(Catalog of Federal Domestic Assistance Program No. 93.773, Medicare—Hospital Insurance; and Program No. 93.774, Medicare—Supplementary Medical Insurance Program)
1.
2.
3.
4.
5.
A.
(1) The Labor-Management Reporting and Disclosure Act of 1959, as amended, 29 U.S.C. § 401,
(2) Section 701 (Standards of Conduct for Labor Organizations) of the Civil Service Reform Act of 1978 (5 U.S.C. § 7120), Section 1017 of the Foreign Service Act of 1980 (22 U.S.C. § 4117), and Section 220(a)(1) of the Congressional Accountability Act of 1995 (2 U.S.C. 1351(a)(1)), and the regulations pertaining to such sections at 29 CFR parts 457-459; with the exception of the authority granted to the Administrative Review Board in Secretary's Order 02-2012.
(3) Section 1209 of the Postal Reorganization Act of 1970, 39 U.S.C. § 1209.
(4) The employee protection provisions of the Federal Transit law, as codified at 49 U.S.C. 5333(b), and related provisions.
(5) The employee protection provisions certified under Sections 405(a), (b), (c), and (e) of the Rail Passenger Service Act of 1970, 45 U.S.C. 565(a), (b), (c), and (e).
(6) Executive Order 13496 (Notification of Employee Rights Under Federal Labor Laws) of January 30, 2009.
(7) Section 211(a) of the Labor Management Relations Act, 29 U.S.C. 181(a) (“Compilation of Collective Bargaining Agreements, etc.; Use of Data”).
(8) Such additional Federal acts that from time to time may assign to the Secretary or the Department of Labor duties and responsibilities similar to those listed under subparagraphs (1)-(7) of this paragraph, as directed by the Secretary.
B.
6.
A. The submission of reports and recommendations to the President and the Congress concerning the administration of the statutory provisions and Executive Orders listed above is reserved to the Secretary.
B. Nothing in this Order shall limit or modify the delegation of authority and assignment of responsibility to the Administrative Review Board by Secretary's Order 02-2012.
C. Except as expressly provided in Section 5, nothing in this Order shall limit or modify the provisions of any other Order, including Secretary's Order 4-2006 (Office of Inspector General).
7.
8.
1.
2.
3.
4.
5.
a. Final decisions of the Administrator of the Wage and Hour Division or an authorized representative of the Administrator, and final decisions of Administrative Law Judges (“ALJs”), under the following:
(1) The Davis-Bacon Act, 40 U.S.C. § 3141 et seq.; any laws now existing or which may be subsequently enacted, providing for prevailing wages determined by the Secretary of Labor in accordance with or pursuant to the Davis-Bacon Act; the Contract Work Hours and Safety Standards Act, 40 U.S.C. § 3701 et seq. (except matters pertaining to safety); the Copeland Act, 40 U.S.C. § 3145; Reorganization Plan No. 14 of 1950; and 29 CFR parts 1, 3, 5, 6, Subpart C and D.
b. Final decisions of the Administrator of the Wage and Hour Division or an authorized representative of the Administrator, and decisions of ALJs, arising under the McNamara-O'Hara Service Contract Act, as amended, 41 U.S.C. § 6701 et seq.; the Contract Work Hours and Safety Standards Act, 40 U.S.C. § 3701 et seq. (except matters pertaining to safety) where the contract is also subject to the McNamara-O'Hara Service Contract Act; and 29 CFR parts 4, 5, 6, Subparts B, D, E.
c. Decisions and recommended decisions by ALJs as provided for or pursuant to the following laws and implementing regulations:
(1) Age Discrimination Act of 1975, 42 U.S.C. § 6103;
(2) Title VI of the Civil Rights Act of 1964, 42 U.S.C. 2000d-l; 29 CFR Part 31;
(3) Civil Service Reform Act of 1978, 5 U.S.C. § 7120; 29 CFR Part 458, sections 458.70, 458.72, 458.76, 458.81, 458.82, 458.88, 458.90, 459.91, and 458.93;
(4) Clean Air Act, 42 U.S.C. § 7622; 29 CFR Part 24;
(5) Comprehensive Environmental Response, Compensation and Liability Act of 1980, 42 U.S.C. § 9610; 29 CFR Part 24;
(6) Congressional Accountability Act of 1995, 2 U.S.C. 1351(a)(1); 29 CFR Part 458, sections 458.70, 458.72, 458.76, 458.81, 458.82, 458.88, 458.90, 459.91, and 458.93;
(7) Consumer Financial Protection Act of 2010, Section 1057 of the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010, 12 U.S.C. § 5567, Public Law 111-203;
(8) Consumer Product Safety Improvement Act of 2008, 15 U.S.C. § 2087; 29 CFR Part 1983;
(9) Title IX of the Education Amendments of 1972, 20 U.S.C. § 1682; 29 CFR Part 36;
(10) Employee Polygraph Protection Act of 1988, 29 U.S.C. § 2005(a); 29 CFR Part 801, Subpart E;
(11) Energy Reorganization Act of 1974, as amended, 42 U.S.C. § 5851; 29 CFR Part 24;
(12) Equal Access to Justice Act, 5 U.S.C. § 504; 29 CFR Part 16;
(13) Executive Order No. 11246, as amended, 3 CFR part 339 (1964-1965 Comp.); reprinted in 42 U.S.C. 2000e app.; 41 CFR Parts 60-1 and 60-30;
(14) Fair Labor Standards Act of 1938, as amended, 29 U.S.C. 203(m); 29 CFR Part 531, sections 531.4, 531.5;
(15) Fair Labor Standards Act of 1938, as amended, 29 U.S.C. 211(d); 29 CFR Part 530, Subpart E;
(16) Fair Labor Standards Act of 1938, as amended, 29 U.S.C. 214(c) 29 CFR Part 525, section 525.22;
(17) Fair Labor Standards Act of 1938, as amended, 29 U.S.C. 216(e); 29 CFR Part 580;
(18) Fair Labor Standards Act of 1938, as amended by the Affordable Care Act, 29 U.S.C. 218C, Public Law 111-148, section 1558;
(19) Federal Railroad Safety Act, 49 U.S.C. § 20109; 29 CFR Part 1982;
(20) Federal Unemployment Tax Act, 26 U.S.C. 3303(b)(3), 3304(c);
(21) Federal Unemployment Tax Act (addressing agreements under the Trade Act of 1974, as amended), 26 U.S.C. 3302(c)(3); 20 CFR Part 617;
(22) Federal Water Pollution Control Act, 33 U.S.C. 1367; 29 CFR Part 24;
(23) Foreign Service Act of 1980, 22 U.S.C. § 4117; 29 CFR Part 458, sections 458.70, 458.72, 458.76, 458.81, 458.82, 458.88, 458.90, 459.91, 458.92, and 458.93;
(24) Immigration and Nationality Act, as amended, 8 U.S.C. 1182(m); 20 CFR Part 655, Subpart E;
(25) Immigration and Nationality Act, as amended, 8 U.S.C. 1182(m); 20 CFR Part 655, Subpart M;
(26) Immigration and Nationality Act, as amended, 8 U.S.C. 1182(n); 20 CFR Part 655, Subpart I;
(27) Immigration and Nationality Act, as amended, 8 U.S.C. 1184(c)(14), 20 CFR Part 655, Subpart A, 29 CFR Part 503, Subpart C;
(28) Immigration and Nationality Act, as amended, 8 U.S.C. 1188(b)(2), 20 CFR Part 655, Subpart A, 29 CFR Part 503, Subpart C;
(29) Immigration and Nationality Act, as amended, 8 U.S.C. 1288(c) and (d); 20 CFR Part 655, Subpart G;
(30) Immigration and Nationality Act, as amended, 8 U.S.C. 1188(g)(2); 29 CFR Part 501, Subpart C;
(31) Labor-Management Reporting and Disclosure Act of 1959, 29 U.S.C. 481(h); 29 CFR Part 417, sections 417.6, 417.7, 417.9(c), 417.13, 417.14, and 417.15;
(32) Longshore and Harbor Workers' Compensation Act, 33 U.S.C. 907(j)(2); 20 CFR Part 702;
(33) Migrant and Seasonal Agricultural Worker Protection Act, 29
(34) Motor Vehicle and Highway Safety Improvement Act of 2012, Section 31307 of the Moving Ahead for Progress in the 21st Century Act, 49 U.S.C. § 30171;
(35) National Apprenticeship Act, 29 U.S.C. § 50; 29 CFR Parts 29 and 30;
(36) National Transit Systems Security Act of 2007, 6 U.S.C. § 1142; 29 CFR Part 1982;
(37) Notification of Employee Rights Under Federal Labor Laws, 29 CFR Part 471;
(38) Older Americans Senior Community Service Employment Program, 42 U.S.C. § 3056, 20 CFR 641.900;
(39) Part B of the Black Lung Benefits Act, 30 U.S.C. §§ 921-924; Section 3(d)(3) of the Black Lung Consolidation of Administrative Responsibility Act (2002); 20 CFR Part 410 (2011);
(40) Pipeline Safety Improvement Act of 2002, 49 U.S.C. 60129; 29 CFR Part 1981;
(41) Program Fraud Civil Remedies Act of 1986, 31 U.S.C. § 3803; 29 CFR Part 22;
(42) Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5177(a) and 5189a; 20 CFR Part 625;
(43) Section 423(d)(1) of the Black Lung Benefits Act, 30 U.S.C. 933(d)(1); 20 CFR Part 726;
(44) Section 428 of the Black Lung Benefits Act, 30 U.S.C. § 938;
(45) Seaman's Protection Act, 46 U.S.C. § 2114;
(46) Section 402 of the FDA Food Safety Modernization Act, Public Law 111-353, 21 U.S.C. 399d;
(47) Section 503 of the Rehabilitation Act of 1973, as amended, 29 U.S.C. § 793; 41 CFR Part 60-741, Subpart B;
(48) Section 504 of the Rehabilitation Act of 1973, as amended, 29 U.S.C. § 794; 29 CFR Part 32;
(49) Safe Drinking Water Act, 42 U.S.C. 300j-9(i); 29 CFR Part 24;
(50) Sarbanes-Oxley Act of 2002, 18 U.S.C. 1514A, as amended by Sections 922 and 929A of the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010, Public Law 111-203, 29 CFR Part 1980;
(51) Single Audit Act of 1984, as amended, 31 U.S.C. § 7501 et seq.; OMB Circular No. A-133, as amended; 29 CFR Part 96;
(52) Social Security Act, 42 U.S.C. § 503; 20 CFR Parts 601 and 602;
(53) Solid Waste Disposal Act, 42 U.S.C. § 6971; 29 CFR Part 24;
(54) Surface Transportation Assistance Act, 49 U.S.C. § 31105; 29 CFR Part 1978;
(55) Toxic Substances Control Act, 15 U.S.C. § 2622; 29 CFR Part 24;
(56) Trade Act of 1974, as amended, 19 U.S.C. § 2101-2321; 20 CFR Part 617;
(57) Unemployment Compensation for Federal Civilian Employees Program, 5 U.S.C. § 8501-8508; 20 CFR Part 609;
(58) Unemployment Compensation for Ex-Servicemembers Program, 5 U.S.C. § 8521-8525; 20 CFR Part 614;
(59) Vietnam Era Veterans Readjustment Assistance Act, as amended, 38 U.S.C. §§ 4211, 4212; 41 CFR Part 60-250, Subpart B, and Part 60-300, Subpart B;
(60) Wagner-Peyser Act, as amended, 29 U.S.C. § 49; 20 CFR Part 658;
(61) Walsh-Healey Public Contracts Act, as amended, 41 U.S.C. § 38; 41 CFR Part 50-203;
(62) Welfare to Work Act, 20 CFR 645.800(c);
(63) Wendell H. Ford Aviation Investment and Reform Act for the 21st Century, 49 U.S.C. § 42121; 29 CFR Part 1979;
(64) Workforce Investment Act of 1998, as amended, 29 U.S.C. § 2936; 20 CFR 667.830;
(65) Workforce Investment Act of 1998, as amended, 29 U.S.C. § 2938; 29 CFR Part 37 (see 37.110-112); and
(66) Any laws or regulation subsequently enacted or promulgated that provide for final decisions by the Secretary of Labor upon appeal or review of decisions, or recommended decisions, issued by ALJs, and any Federal law that extends or supplements unemployment compensation and provides for final decisions by the Secretary of Labor.
The Board shall not have jurisdiction to pass on the validity of any portion of the Code of Federal Regulations that has been duly promulgated by the Department of Labor and shall observe the provisions thereof, where pertinent, in its decisions. The Board also shall not have jurisdiction to review decisions to deny or grant exemptions, variations, and tolerances and does not have the authority independently to take such actions. In issuing its decisions, the Board shall adhere to the rules of decision and precedent applicable under each of the laws enumerated in Sections 5(a), 5(b), and 5(c) of this Order, until and unless the Board or other authority explicitly reverses such rules of decision or precedent. The Board's authority includes the discretionary authority to review interlocutory rulings in exceptional circumstances, provided such review is not prohibited by statute.
6.
a. The Board shall consist of a maximum of five Members, one of whom the Secretary shall designate as Chair, and a second of whom the Secretary shall designate as Vice-Chair. The Members of the Board shall be appointed by the Secretary of Labor, and shall be selected upon the basis of their qualifications and competence in matters within the authority of the Board.
b. Except as provided in Section 6(c), the Board shall sit, hear cases, render decisions, and perform all other related functions in panels of two or three Members, as may be assigned by the Chair, unless the Chair specifically directs that an appeal or review will be decided by the full Board.
c. Except as otherwise provided by law or duly promulgated regulation (see, e.g., 29 CFR Parts 7 and 8), if the petitioner(s) and the respondent(s) (or the appellant(s) and the appellees(s)) consent to disposition by a single Member, the Chair may determine that the decision shall be by a single Member. Upon an affirmative determination, the Chair of the Board shall, in his or her discretion, designate himself, herself, or any other Member of the Board to decide such an appeal under Section 8.
d. The Vice-Chair shall preside at meetings in the absence of the Chair. In the event of the vacancy of the Chair's position, the Vice-Chair shall assume all of the Chair's authority and shall act as Chair.
e. The Vice-Chair shall be responsible for the operational management of the Board and its affairs.
7.
a. Members of the Board shall be appointed for a term of two years or less.
b. Appointment of a Member of the Board to a term not to exceed a specified time period shall not affect the authority of the Secretary to remove, in his or her sole discretion, any Member at any time.
c. Vacancies in the membership of the Board shall not impair the authority of the remaining Member(s) to exercise all the powers and duties of the Board.
8.
9.
10.
11.
12.