| Page Range | 52823-53395 | |
| FR Document |
| Page and Subject | |
|---|---|
| 82 FR 52942 - Sunshine Act Meeting Notice | |
| 82 FR 52896 - Sunshine Act Meeting Notice | |
| 82 FR 52902 - Sunshine Act Meetings | |
| 82 FR 52949 - Product Change-Priority Mail Express, Priority Mail, & First-Class Package Service Negotiated Service Agreement | |
| 82 FR 52863 - Internet Communication Disclaimers; Extension of Comment Period | |
| 82 FR 52826 - Airworthiness Criteria: Glider Design Criteria for DG Flugzeugbau GmbH Model DG-1000M Glider | |
| 82 FR 52926 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies | |
| 82 FR 52906 - Federal Reserve Bank Services | |
| 82 FR 52965 - Petition for Exemption; Summary of Petition Received | |
| 82 FR 52944 - Standard Review Plan for Spent Fuel Dry Storage Systems and Facilities | |
| 82 FR 52895 - Agency Information Collection Activities; Comment Request; Fast Response Survey System (FRSS) 109: Teachers' Use of Technology for School and Homework Assignments-Preliminary Activities | |
| 82 FR 52967 - Bureau of the Fiscal Service; Senior Executive Service; Combined Performance Review Board (PRB) | |
| 82 FR 52964 - 60-Day Notice of Proposed Information Collection: Refugee Biographic Data | |
| 82 FR 52875 - Proposed Submission of Information Collection for OMB Review; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery | |
| 82 FR 52846 - Disposal of Consumer Report Information and Records | |
| 82 FR 52902 - Privacy Act of 1974; Systems of Records | |
| 82 FR 52869 - Updates Concerning Non-Geostationary, Fixed-Satellite Service Systems and Related Matters | |
| 82 FR 52963 - U.S. Advisory Commission on Public Diplomacy; Notice of Meeting | |
| 82 FR 52965 - Wisconsin Central Ltd.-Discontinuance of Service Exemption-in Oneida and Marinette Counties, Wis. | |
| 82 FR 52901 - Proposed Settlement Agreement, Clean Air Act Title V Permit Appeal | |
| 82 FR 52899 - Clean Water Act Class II: Proposed Administrative Settlement, Penalty Assessment and Opportunity To Comment Regarding Enel Green Power North America, Inc. | |
| 82 FR 52881 - Meeting of the Columbia Basin Partnership Task Force of the Marine Fisheries Advisory Committee | |
| 82 FR 52881 - Marine Fisheries Advisory Committee Meeting | |
| 82 FR 52933 - Meetings Announcement for the Physician-Focused Payment Model Technical Advisory Committee Required by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) | |
| 82 FR 52934 - Delegation of Authority | |
| 82 FR 52935 - Center for Substance Abuse Prevention; Notice of Meeting | |
| 82 FR 52882 - Fisheries Off West Coast States; Pacific Coast Groundfish Fishery; Application for an Exempted Fishing Permit | |
| 82 FR 52849 - Fraser River Sockeye and Pink Salmon Fisheries; Inseason Orders | |
| 82 FR 52871 - Atlantic Coastal Fisheries Cooperative Management Act Provisions; American Lobster Fishery; Control Date for Lobster Conservation Management Areas | |
| 82 FR 52876 - Notice of Public Meeting of the Louisiana Advisory Committee for a Meeting To Hear Public Testimony Regarding Civil Rights and Voter Accessibility in the State | |
| 82 FR 52877 - Notice of Public Meeting of the Minnesota Advisory Committee | |
| 82 FR 52851 - Fisheries of the Northeastern United States; Amendment 6 to the Tilefish Fishery Management Plan | |
| 82 FR 52906 - Notice of Agreement Filed | |
| 82 FR 52877 - Federal Economic Statistics Advisory Committee Meeting | |
| 82 FR 52905 - Agency Information Collection Activities: Submission for OMB Review; Comment Request | |
| 82 FR 52939 - Carton-Closing Staples From China; Scheduling of the Final Phase of an Antidumping Duty Investigation | |
| 82 FR 52944 - Advisory Committee On Reactor Safeguards (ACRS); Meeting of the Acrs Subcommittee on Planning And Procedures; Notice of Meeting | |
| 82 FR 52936 - Environmental Assessment and Finding of No Significant Impact for the Issuance of Depredation Permits for Double-Crested Cormorants | |
| 82 FR 52830 - Airworthiness Directives; General Electric Company Turbofan Engines | |
| 82 FR 52894 - Agency Information Collection Activities: Comment Request | |
| 82 FR 52896 - MHK Distributed and Alternate Applications Forum | |
| 82 FR 52945 - License Transfer From Exelon Generation Company, LLC to James A. FitzPatrick Nuclear Power Plant | |
| 82 FR 52965 - Notice of Determinations; Culturally Significant Objects Imported for Exhibition Determinations: “Birds of a Feather: Joseph Cornell's Homage to Juan Gris” Exhibition | |
| 82 FR 52963 - Notice of Determinations; Culturally Significant Objects Imported for Exhibition Determinations: “Michel Sittow: Estonian Painter at the Courts of Renaissance Europe” Exhibition | |
| 82 FR 52964 - Notice of Determinations; Culturally Significant Objects Imported for Exhibition Determinations: “Outliers and American Vanguard Art” Exhibition | |
| 82 FR 52889 - Patent and Trademark Financial Transactions | |
| 82 FR 52949 - Investor Advisory Committee Meeting | |
| 82 FR 52966 - Cooper Tire & Rubber Company, Grant of Petition for Decision of Inconsequential Noncompliance | |
| 82 FR 52884 - Endangered and Threatened Species; Take of Anadromous Fish | |
| 82 FR 52927 - Agency Information Collection Activities; Proposed Collection; Comment Request; Infant Formula Requirements | |
| 82 FR 52848 - Treatment of Certain Transfers of Property to Foreign Corporations; Correction | |
| 82 FR 52888 - Determination of Overfishing or an Overfished Condition | |
| 82 FR 52935 - Center for Scientific Review; Notice of Closed Meetings | |
| 82 FR 52890 - Agency Information Collection Activities Under OMB Review | |
| 82 FR 52898 - Combined Notice of Filings | |
| 82 FR 52879 - Export Trade Certificate of Review | |
| 82 FR 52943 - Request for Information-Interagency Arctic Research Policy Committee, Chaired by the National Science Foundation | |
| 82 FR 52942 - Notice of Lodging of Consent Decree Under the Clean Air Act | |
| 82 FR 52894 - Meeting of the Historically Black Colleges and Universities Capital Financing Advisory Board | |
| 82 FR 52941 - Importer of Controlled Substances Application: Anderson Brecon, Inc. | |
| 82 FR 52971 - Agency Information Collection Activity: Community Residential Care Recordkeeping Requirements | |
| 82 FR 52862 - Emergency Preparedness Requirements for Small Modular Reactors and Other New Technologies | |
| 82 FR 52934 - Agency Information Collection Request. 60-Day Public Comment Request | |
| 82 FR 52970 - Agency Information Collection Activity: Funeral Arrangements | |
| 82 FR 52972 - Agency Information Collection Activity: Ethics Consultation Feedback Tool (ECFT) | |
| 82 FR 52972 - Agency Information Collection Activity Under OMB Review: Regulation for Submission of Evidence | |
| 82 FR 52939 - Alaska Native Claims Selection | |
| 82 FR 52938 - Agency Information Collection Activities; Use and Occupancy Under the Mining Laws | |
| 82 FR 52937 - Initial Classification and Extension of the Proposed Classification and Segregation for State In Lieu Selection, Montana | |
| 82 FR 52880 - President's Advisory Council on Doing Business in Africa | |
| 82 FR 52946 - Wolf Creek Generating Station: Consideration of Approval of Transfer of License | |
| 82 FR 52968 - Proposed Collection; Comment Request for Regulation Project | |
| 82 FR 52962 - Self-Regulatory Organizations; ICE Clear Europe Limited; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating to Amendments to the ICE Clear Europe Delivery Procedures | |
| 82 FR 52958 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of a Longer Period for Commission Action on a Proposed Rule Change, as Modified by Amendment No. 1, To List and Trade Shares of the GraniteShares Silver Trust Under NYSE Arca Rule 8.201-E | |
| 82 FR 52953 - Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to the Access and Redistribution Fee | |
| 82 FR 52955 - Self-Regulatory Organizations; Nasdaq BX, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to the Access and Redistribution Fee | |
| 82 FR 52959 - Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Its Index Options Rules To Be More Clear and Conformed More Closely to Those of the Options Clearing Corporation (“OCC”) and Other Exchanges | |
| 82 FR 52950 - Self-Regulatory Organizations; Nasdaq PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to the Access and Redistribution Fee | |
| 82 FR 52958 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of a Longer Period for Commission Action on Proposed Rule, as Modified by Amendment No. 1 Thereto, to List and Trade Shares of the GraniteShares Palladium Trust under NYSE Arca Rule 8.201-E | |
| 82 FR 52927 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies | |
| 82 FR 52874 - Information Collection Request, Volunteer Program | |
| 82 FR 52943 - Draft Environmental Impact Statement-South Mall Campus Master Plan | |
| 82 FR 52969 - Proposed Collection; Comment Request for Form 4419. | |
| 82 FR 52970 - Proposed Collection; Comment Request for Deductions and Reductions in Earnings and Profits (or Accumulated Profits) With Respect to Certain Foreign Deferred Compensation Plans Maintained by Certain Foreign Corporations or by Foreign Branches of Domestic Corporations | |
| 82 FR 52878 - Approval of Subzone Status; Lockheed Martin Corporation, Space Systems Company; Littleton, Colorado | |
| 82 FR 52878 - Foreign-Trade Zone 15-Kansas City, Missouri Application for Expansion Under Alternative Site Framework | |
| 82 FR 52878 - Approval of Subzone Status; Gulfstream Aerospace Corporation; Dallas, Texas | |
| 82 FR 52935 - Agency Information Collection Activities: Crewman's Landing Permit | |
| 82 FR 52880 - Draft National Procedure for Permit Applications To Retain Releasable Rehabilitated Marine Mammals for Public Display | |
| 82 FR 53374 - Health Education Assistance Loan (HEAL) Program | |
| 82 FR 52873 - Verdeca LLC; Availability of a Petition for Determination of Nonregulated Status of Soybean Genetically Engineered for Increased Yield | |
| 82 FR 52838 - Airworthiness Directives; the Boeing Company Airplanes | |
| 82 FR 52941 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension With or Without Change of a Currently Approved Collection; Investigator Integrity Questionnaire-ATF F 8620.7 | |
| 82 FR 52848 - Benefits Payable in Terminated Single-Employer Plans; Interest Assumptions for Paying Benefits | |
| 82 FR 52832 - Airworthiness Directives; Airbus Airplanes | |
| 82 FR 52868 - Alaska; Hunting and Trapping in National Preserves | |
| 82 FR 52863 - International Services Surveys: BE-120 Benchmark Survey of Transactions in Selected Services and Intellectual Property With Foreign Persons | |
| 82 FR 52823 - Miscellaneous Corrections | |
| 82 FR 52835 - Airworthiness Directives; The Boeing Company Airplanes | |
| 82 FR 52827 - Airworthiness Directives; Rockwell Collins, Inc. Traffic Surveillance System Processing Unit | |
| 82 FR 52844 - Airworthiness Directives; Bombardier, Inc., Airplanes | |
| 82 FR 52976 - Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program | |
| 82 FR 52840 - Airworthiness Directives; 328 Support Services GmbH (Type Certificate Previously Held by AvCraft Aerospace GmbH; Fairchild Dornier GmbH; Dornier Luftfahrt GmbH) Airplanes |
Animal and Plant Health Inspection Service
Farm Service Agency
Census Bureau
Economic Analysis Bureau
Foreign-Trade Zones Board
International Trade Administration
National Oceanic and Atmospheric Administration
Patent and Trademark Office
Energy Efficiency and Renewable Energy Office
Federal Energy Regulatory Commission
Centers for Medicare & Medicaid Services
Children and Families Administration
Food and Drug Administration
National Institutes of Health
Substance Abuse and Mental Health Services Administration
U.S. Customs and Border Protection
Fish and Wildlife Service
Land Management Bureau
National Park Service
Alcohol, Tobacco, Firearms, and Explosives Bureau
Drug Enforcement Administration
Federal Aviation Administration
National Highway Traffic Safety Administration
Fiscal Service
Internal Revenue Service
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription.
Nuclear Regulatory Commission.
Final rule.
The U.S. Nuclear Regulatory Commission (NRC) is amending its regulations to make miscellaneous corrections. The amendments include correcting references, an address and a misspelling. The amendments will also make references to persons in one part of the NRC's regulations gender neutral. This document is necessary to inform the public of these non-substantive amendments to the NRC's regulations.
This rule is effective December 15, 2017. The material incorporated by reference was previously approved by the Director of the Federal Register.
Please refer to Docket ID NRC-2017-0170 when contacting the NRC about the availability of information for this final rule. You may obtain publicly-available information related to this final rule by any of the following methods:
•
•
•
Dawn Forder, Office of Nuclear Material Safety and Safeguards, telephone: 301-415-3407, email:
The NRC is amending its regulations in parts 2, 9, 40, 50, 61, 71, 73, and 110 of title 10 of the
Under the Administrative Procedure Act (5 U.S.C. 553(b)), an agency may waive publication in the
The NRC has determined that this final rule is the type of action described in 10 CFR 51.22(c)(2), which categorically excludes from environmental review rules that are corrective or of a minor, nonpolicy nature and do not substantially modify existing regulations. Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this rule.
This final rule does not contain a collection of information as defined in the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the document requesting or requiring the collection displays a currently valid OMB control number.
The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal agencies to write documents in a clear, concise, and well-organized manner. The NRC has written this document to be consistent with the Plain Writing Act as well as the Presidential Memorandum, “Plain Language in Government Writing,” published June 10, 1998 (63 FR 31883).
The NRC has determined that the corrections in this final rule do not constitute backfitting and are not inconsistent with any of the issue finality provisions in 10 CFR part 52. The amendments are non-substantive in nature, including correcting references, correcting an address and correcting a misspelling. They impose no new requirements and make no substantive changes to the regulations. The corrections do not involve any provisions that would impose backfits as defined in 10 CFR chapter I, or would be inconsistent with the issue finality provisions in 10 CFR part 52. For these reasons, the issuance of the rule in final form would not constitute backfitting or represent a violation of any of the issue finality provisions in 10 CFR part 52. Therefore, the NRC has not prepared any additional documentation for this correction rulemaking addressing backfitting or issue finality.
Administrative practice and procedure, Antitrust, Byproduct material, Classified information, Confidential business information, Freedom of information, Environmental protection, Hazardous waste, Nuclear energy, Nuclear materials, Nuclear power plants and reactors, Penalties, Reporting and recordkeeping requirements, Sex discrimination, Source material, Special nuclear material, Waste treatment and disposal.
Administrative practice and procedure, Courts, Criminal penalties, Freedom of information, Government employees, Privacy, Reporting and recordkeeping requirements, Sunshine Act.
Criminal penalties, Exports, Government contracts, Hazardous materials transportation, Hazardous waste, Nuclear energy, Nuclear materials, Penalties, Reporting and recordkeeping requirements, Source material, Uranium, Whistleblowing.
Administrative practice and procedure, Antitrust, Classified information, Criminal penalties, Education, Fire prevention, Fire protection, Incorporation by reference, Intergovernmental relations, Nuclear power plants and reactors, Penalties, Radiation protection, Reactor siting criteria, Reporting and recordkeeping requirements, Whistleblowing.
Criminal penalties, Hazardous waste, Indians, Intergovernmental relations, Low-level waste, Nuclear energy, Nuclear materials, Penalties, Reporting and recordkeeping requirements, Waste treatment and disposal, Whistleblowing.
Criminal penalties, Hazardous materials transportation, Incorporation by reference, Intergovernmental relations, Nuclear materials, Packaging and containers, Penalties, Radioactive materials, Reporting and recordkeeping requirements.
Criminal penalties, Exports, Hazardous materials transportation, Incorporation by reference, Imports, Nuclear energy, Nuclear materials, Nuclear power plants and reactors, Penalties, Reporting and recordkeeping requirements, Security measures.
Administrative practice and procedure, Classified information, Criminal penalties, Exports, Incorporation by reference, Imports, Intergovernmental relations, Nuclear energy, Nuclear materials, Nuclear power plants and reactors, Penalties, Reporting and recordkeeping requirements, Scientific equipment.
For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 552 and 553, the NRC is adopting the following amendments to 10 CFR parts 2, 9, 40, 50, 61, 71, 73, and 110:
Atomic Energy Act of 1954, secs. 29, 53, 62, 63, 81, 102, 103, 104, 105, 161, 181, 182, 183, 184, 186, 189, 191, 234 (42 U.S.C. 2039, 2073, 2092, 2093, 2111, 2132, 2133, 2134, 2135, 2201, 2231, 2232, 2233, 2234, 2236, 2239, 2241, 2282); Energy Reorganization Act of 1974, secs. 201, 206 (42 U.S.C. 5841, 5846); Nuclear Waste Policy Act of 1982, secs. 114(f), 134, 135, 141 (42 U.S.C. 10134(f), 10154, 10155, 10161); Administrative Procedure Act (5 U.S.C. 552, 553, 554, 557, 558); National Environmental Policy Act of 1969 (42 U.S.C. 4332); 44 U.S.C. 3504 note. Section 2.205(j) also issued under 28 U.S.C. 2461 note.
Atomic Energy Act of 1954, sec. 161 (42 U.S.C. 2201); Energy Reorganization Act of 1974, sec. 201 (42 U.S.C. 5841); 44 U.S.C. 3504 note.
Subpart A also issued under 31 U.S.C. 9701.
Subpart B also issued under 5 U.S.C. 552a.
Subpart C also issued under 5 U.S.C. 552b.
Atomic Energy Act of 1954, secs. 62, 63, 64, 65, 69, 81, 83, 84, 122, 161, 181, 182, 183, 184, 186, 187, 193, 223, 234, 274, 275 (42 U.S.C. 2092, 2093, 2094, 2095, 2099, 2111, 2113, 2114, 2152, 2201, 2231, 2232, 2233, 2234, 2236, 2237, 2243, 2273, 2282, 2021, 2022); Energy Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); Uranium Mill Tailings Radiation Control Act of 1978, sec. 104 (42 U.S.C. 7914); 44 U.S.C. 3504 note.
Atomic Energy Act of 1954, secs. 11, 101, 102, 103, 104, 105, 108, 122, 147, 149, 161, 181, 182, 183, 184, 185, 186, 187, 189, 223, 234 (42 U.S.C. 2014, 2131, 2132, 2133, 2134, 2135, 2138, 2152, 2167, 2169, 2201, 2231, 2232, 2233, 2234, 2235, 2236, 2237, 2239, 2273, 2282); Energy Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); Nuclear Waste Policy Act of 1982, sec. 306 (42 U.S.C. 10226); National Environmental Policy Act of 1969 (42 U.S.C. 4332); 44 U.S.C. 3504 note; Sec. 109, Pub. L. 96-295, 94 Stat. 783.
(e) Applications for a design certification, combined license, manufacturing license, operating license or standard design approval that propose nuclear reactor designs which differ significantly from light-water reactor designs that were licensed before 1997. Or use simplified, inherent, passive, or other innovative means to accomplish their safety functions will be approved only if:
(b) * * *
(2) * * *
(ix) * * *
(B)
Atomic Energy Act of 1954, secs. 53, 57, 62, 63, 65, 81, 161, 181, 182, 183, 223, 234 (42 U.S.C. 2073, 2077, 2092, 2093, 2095, 2111, 2201, 2231, 2232, 2233, 2273, 2282); Energy Reorganization Act of 1974, secs. 201, 206, 211 (42 U.S.C. 5841, 5846, 5851); Low-Level Radioactive Waste Policy Amendments Act of 1985, sec. 2 (42 U.S.C. 2021b); 44 U.S.C. 3504 note.
Atomic Energy Act of 1954, secs. 53, 57, 62, 63, 81, 161, 182, 183, 223, 234, 1701 (42 U.S.C. 2073, 2077, 2092, 2093, 2111, 2201, 2232, 2233, 2273, 2282, 2297f); Energy Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); Nuclear Waste Policy Act of 1982, sec. 180 (42 U.S.C. 10175); 44 U.S.C. 3504 note.
Atomic Energy Act of 1954, secs. 53, 147, 149, 161, 170D, 170E, 170H, 170I, 223, 229, 234, 1701 (42 U.S.C. 2073, 2167, 2169, 2201, 2210d, 2210e, 2210h, 2210i, 2273, 2278a, 2282, 2297f); Energy Reorganization Act of 1974, secs. 201, 202 (42 U.S.C. 5841, 5842); Nuclear Waste Policy Act of 1982, secs. 135, 141 (42 U.S.C. 10155, 10161); 44 U.S.C. 3504 note.
Section 73.37(b)(2) also issued under Sec. 301, Public Law 96-295, 94 Stat. 789 (42 U.S.C. 5841 note).
Atomic Energy Act of 1954, secs. 11, 51, 53, 54, 57, 62, 63, 64, 65, 81, 82, 103, 104, 109, 111, 121, 122, 123, 124, 126, 127, 128, 129, 133, 134, 161, 170h, 181, 182, 183, 184, 186, 187, 189, 223, 234 (42 U.S.C. 2014, 20710, 2073, 2074, 2077, 2092, 2093, 2094, 2095, 2111, 2112, 2133, 2134, 2139, 2141, 2151, 2152, 2153, 2154, 2155, 2156, 2157, 2158, 2160C, 2160D, 2201, 2210H, 2231, 2232, 2233, 2234, 2236, 2237, 2239, 2273, 2282); Energy Reorganization Act of 1974, secs. 201 (42 U.S.C. 5841); Administrative Procedure Act (5 U.S.C. 552,
Section 110.1(b) also issued under 22 U.S.C. 2403; 22 U.S.C. 2778a; 50 App. U.S.C. 2401
For the Nuclear Regulatory Commission.
Federal Aviation Administration (FAA), DOT.
Airworthiness design criteria.
These airworthiness design criteria are for the DG Flugzeugbau GmbH model DG-1000M glider. The Administrator finds the design criteria, which make up the certification basis for the DG-1000M glider, acceptable.
These airworthiness design criteria are effective December 15, 2017.
Mr. Jim Rutherford, AIR-692, Federal Aviation Administration, Policy & Innovation Division, Small Airplane Standards Branch, 901 Locust, Room 301, Kansas City, MO 64106, telephone (816) 329-4165, facsimile (816) 329-4090.
On May 18, 2011, DG Flugzeugbau GmbH submitted an application for type validation of the DG-1000M glider in accordance with the Technical Implementation Procedures for Airworthiness and Environmental Certification Between the FAA and the European Aviation Safety Agency (EASA), dated May 05, 2011. This model is a variant of the DG-1000T powered glider and will be added to existing Type Certificate No. G20CE. The model DG-1000M is a two-seat, mid-wing, self-launching, powered glider with a retractable engine and fixed-pitch propeller. It is constructed from carbon and glass fiber reinforced plastic, and features a conventional T-type tailplane. The glider also features a 65.6 foot (20 meter) wingspan and a maximum weight of 1,742 pounds (790 kilograms).
The EASA type certificated the DG-1000M powered glider under Type Certificate Number (No.) EASA.A.072 on March 17, 2011. The associated EASA Type Certificate Data Sheet (TCDS) No. EASA.A.072 defines the DG Flugzeubau GmbH certification basis submitted to the FAA for review and acceptance.
The applicable requirements for glider certification in the United States can be found in FAA Advisory Circular (AC) 21.17-2A, “Type Certification—Fixed-Wing Gliders (Sailplanes), Including Powered Gliders,” dated February 10, 1993. AC 21.17-2A has been the basis for certification of gliders and powered gliders in the United States for many years. AC 21.17-2A states that applicants may utilize the Joint Aviation Requirements (JAR)-22, “Sailplanes and Powered Sailplanes,” or another accepted airworthiness criteria, or a combination of both, as the accepted means for showing compliance for glider type certification.
The certification basis is based on JAR-22, amendment 6, dated August 01, 2001. In addition to JAR-22 requirements, the applicant will comply with other requirements from the certification basis referenced in EASA TCDS No. EASA.A.072, including an equivalent safety finding.
Notice of proposed airworthiness design criteria for the DG Flugzeugbau GmbH model DG-1000M glider was published in the
Applicable Airworthiness Criteria under § 21.17(b).
Based on the Special Class provisions of § 21.17(b), the following airworthiness requirements form the FAA Certification Basis for this design:
1. 14 CFR part 21, effective February 1, 1965, including amendments 21-1 through 21-92 as applicable.
2. JAR-22, amendment 6, dated August 01, 2001.
3. EASA Equivalent Safety Finding to JAR 22.207(c)—Stall warning. (FAA issued corresponding Equivalent Level of Safety (ELOS) Memorandum No. ACE-07-01A, dated April 02, 2012, as an extension to an existing ELOS finding).
4. “Standards for Structural Substantiation of Sailplane and Powered Sailplane Parts Consisting of Glass or Carbon Fiber Reinforced Plastics,” Luftfahrt-Bundesamt (LBA) document no. I4-FVK/91, issued July 1991.
5. “Guideline for the analysis of the electrical system for powered sailplanes,” LBA document no. I334-MS 92, issued September 15, 1992.
6. Operations allowed: VFR-Day, and “Cloud Flying” where “Cloud Flying” is considered flying in Instrument Meteorological Conditions (IMC) and requires an Instrument Flight Rules (IFR) clearance in the United States. This is permissible provided the pilot has the appropriate rating per 14 CFR 61.3, the glider contains the necessary equipment specified under 14 CFR 91.205, and the pilot complies with IFR requirements.
7. EASA Type Certificate Data Sheet No. EASA.A.072, Issue 03, dated March 17, 2011.
8. Date of application for FAA Type Certificate: May 18, 2011.
Federal Aviation Administration (FAA), DOT.
Final rule.
We are adopting a new airworthiness directive (AD) for certain Rockwell Collins, Inc. TSS-4100 Traffic Surveillance System Processing Units that incorporate TSSA-4100 Field Loadable Software (FLS) Rockwell Collins part numbers 810-0052-002/-003/-010/-011/-012/-100/-101 and are installed on airplanes. This AD was prompted by five instances of air traffic control observing coasting (extrapolated stale data) of automatic dependent surveillance-broadcast data (position/velocity data). This AD requires installing the TSSA-4100 FLS upgrades on the TSS-4100 units. We are issuing this AD to address the unsafe condition on these products.
This AD is effective December 20, 2017.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of December 20, 2017.
For service information identified in this final rule, contact Rockwell Collins, Inc., Collins Aviation Services, 400 Collins Road NE., M/S 164-100, Cedar Rapids, IA 52498-0001; telephone: 888-265-5467 (U.S.) or 319-265-5467; fax: 319-295-4941 (outside U.S.); email:
You may examine the AD docket on the Internet at
Paul Rau, Aerospace Engineer, Wichita Aircraft Certification Office, FAA, 1801 Airport Road, Room 100, Wichita, Kansas 67209; phone: 316-946-4149; fax: 316-946-4107; email:
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Rockwell Collins, Inc. TSS-4100 Traffic Surveillance System Processing Units that incorporate TSSA-4100 Field Loadable Software (FLS) Rockwell Collins part numbers 810-0052-002/-003/-010/-011/-012/-100/-101 and are installed on airplanes. The NPRM published in the
We gave the public the opportunity to participate in developing this final rule. The following presents the comments received on the NPRM and the FAA's response to each comment.
The Air Line Pilots Association (ALPA) requested we reduce the compliance time for the AD actions. The ALPA requested this change because of the high number of reports the FAA received and because the equipment is installed on a variety of airframe types that may operate in heavily trafficked airspace.
We disagree with this comment. We considered the variety of airframe types and operations when we determined the compliance time for the proposed AD. We proposed within 12 months or 750 hours time-in-service (TIS), whichever occurs first, and we expect that airframes with the heaviest usage will require compliance in less than 4 months after the effective date of the AD. Reducing the compliance time would create an additional burden not supported by the risk assessments.
We have not changed this AD based on this comment.
Bombardier, Inc. requested we delay the effective date of this AD until January 1, 2020, when the requirements of 14 CFR 91.225 take effect. In November 2017, Bombardier, Inc. plans to release service information for CRJ airplane models that will change the affected TSSA-4100 FLS part numbers to different part numbers that are not included the applicability of the AD. Because of the heavy usage of the CRJ airplanes and the 750 hours TIS of the AD, most CRJ airplanes will require compliance with the AD by the end of 2017. Also, Bombardier, Inc. states that air traffic controllers cannot use ADS-B data as a primary source until 2020; as such, the mid-air collision risk does not seem clear to them.
We disagree with this comment. Based on the stated usage, a delay of the effective date until January 1, 2020, could result in airplanes accumulating an additional 5,000 hours TIS beyond the 750 hours TIS compliance proposed in the NPRM. The risk assessment does not support that significant of an increase in the compliance time for this AD. The stale or coasting Mode S altitude data interferes with proper TCAS operation, potentially resulting in an incorrect RA or RA modification. ADS-B operation is not required for that unsafe condition to exist. As of August
We have not changed this AD based on this comment.
Delta Air Lines, Inc. requested we change the language in this AD to allow the use of subsequent FLS part numbers for compliance with this AD. They request, for example, we add the words, “or subsequent” or “any subsequent FLS part number that complies with the intent of this AD” to allow the use of future part numbers that may comply with the AD actions.
We disagree with this comment. RCPN 810-0052-013 or 810-0052-102 are the only part numbers currently available that comply with this AD. We cannot use language “or subsequent” or similar language because we cannot approve documents or materials that do not currently exist. The AD only applies to the FLS part numbers listed in the Applicability, paragraph (c) of this AD, so future software upgrades not listed in paragraph (c) of this AD are not affected by this AD. Operators may request an alternative method of compliance (AMOC) to use future FLS part numbers if they become available using the procedures found in 14 CFR 39.19.
We have not changed this AD based on this comment.
Bombardier, Inc. requested that we allow AD credit for operators who have already completed the replacement of the affected part numbers using parts found in aircraft illustrated parts catalogs (AIPCs) not identified in the Applicability, paragraph (c) of this AD. Certain AIPCs already allow operators to replace some of the affected TSSA-4100 FLS part numbers with part numbers not identified in the Applicability, paragraph (c) of this AD.
We disagree with this comment. We recognize that other instructions for upgrade of the TSSA-4100 exist. However, the actions of this AD must be completed using the service information cited in the AD and incorporated by reference into the AD. Operators may request an AMOC, using the procedures found in 14 CFR 39.19, to use service information other than those referenced in this AD. If, as of the effective date of this AD, the affected TSSA-4100 FLS part numbers identified in the Applicability, paragraph (c) of this AD, are not installed on the airplane, the AD does not apply to that airplane. Therefore, if before the effective date of this AD, operators replaced the affected TSSA-4100 FLS part numbers with part numbers not identified in the Applicability, paragraph (c) of this AD, using the AIPC, they do not require credit for compliance with this AD because this AD does not apply to those airplanes.
We have not changed this AD based on this comment.
Delta Air Lines, Inc. and Bombardier, Inc. requested we add Bombardier, Inc. Models CS 100 (BD-500-1A10) and CS300 (BD-500-1A11) airplanes and remove Bombardier, Inc. Models Global 5000 (BD-700-1A11) and Challenger 605 (CL-600-2B16) from the Applicability, paragraph (c) of this AD. The C series include the TSSA-4100 system; however, the Global 5000 and the Challenger 605 do not have the affected part numbers installed.
We agree with this comment. The list of possible affected airplanes is intended to include airplanes known to have the TSS-4100 installed. The Bombardier C series airplanes were inadvertently omitted, and we added them to the Applicability, paragraph (c) of this AD. The Global 5000 without the Global Vision Flight Deck and the Challenger 605 did not include the installation of the TSS-4100, and we removed them from the Applicability, paragraph (c) of this AD. However, this AD applies specifically to TSS-4100 units, RCPN 822-2132-001, that incorporate TSSA-4100 FLS RCPN 810-0052-002/-003/-010/-011/-012/-100/-101 installed on airplanes. If the TSS-4100 unit with the affected part numbers is installed, for example, through an avionics upgrade, on an airplane not listed in paragraph (c) of this AD, the AD would apply to that airplane.
Bombardier, Inc. requested we change the language in the Unsafe Condition, paragraph (e) of this AD, to more accurately describe the instances of coasting errors. The five observed coasting errors were not observed on the TSS-4100 units but on different units with similar software.
We agree with this comment. We did include more descriptive language in the preamble of the NPRM and this final rule. We added similar language to the Unsafe Condition in paragraph (e) of this AD to clarify the specific units where coasting error were observed.
We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this final rule with the changes described previously and minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM.
We also determined that these changes will not increase the economic burden on any operator or increase the scope of this final rule.
We reviewed Rockwell Collins Service Information Letter, TSSA-4100-SIL-10-1, Revision No. 9, dated March 31, 2017; and Rockwell Collins Service Information Letter, TSSA-4100-SIL-10-1, Revision No. 10, dated July 10, 2017. The service letters both describe procedures for determining the part number of the affected FLS and the installation procedure for updating the FLS; however, Revision No. 10 contains minor editorial changes not included Revision No. 9. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We estimate that this AD affects 1,000 products installed on airplanes of U.S. registry.
We estimate the following costs to comply with this AD:
According to the manufacturer, some of the costs of this proposed AD may be covered by the manufacturer, thereby reducing the cost impact on affected individuals. We do not control manufacturer coverage for affected individuals. As a result, we have included all costs in our cost estimate.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to small airplanes and domestic business jet transport airplanes to the Director of the Policy and Innovation Division.
This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(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.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective December 20, 2017.
None.
Rockwell Collins, Inc. TSSA-4100 Field Loadable Software (FLS) Rockwell Collins part numbers (RCPNs) 810-0052-002, -003, -010, -011, -012, -100, or -101 found on TSS-4100 Traffic Surveillance System Processing Units, (RCPN) 822-2132-001 installed on airplanes.
(1) The FLS RCPNs 810-0052-002, -003, -010, -011, -012, -100, or -101 found on TSS-4100 Traffic Surveillance System Processing Units are known to be installed on but not limited to the airplanes listed in paragraphs (c)(1)(i) through (14) of this AD and are certificated in any category.
(2) Earlier revision levels of the Rockwell Collins, Inc. service information and service information issued by airplane manufacturers before the effective date of this AD may have specified the installation of FLS with different FAA-approved part numbers than the part numbers listed in paragraph (c) of this AD. If, before December 20, 2017 (the effective date of this AD), a part number that is different than the TSSA-4100 RCPNs listed in paragraph (c) of this AD is installed on the airplane, this AD does not apply to that airplane.
Joint Aircraft System Component (JASC)/Air Transport Association (ATA) of America Code 34, Navigation.
This AD was prompted by five instances of air traffic control observing coasting (extrapolated stale data) automatic dependent surveillance-broadcast data (ADS-B position/velocity data) on a related Rockwell Collins, Inc. platform that shares a common architecture with the TSS-4100 Traffic Surveillance System Processing Units. We are issuing this AD to prevent erroneous extrapolation of position/velocity and altitude data that could result in misleading position and/or altitude being reported by the airplane and possibly lead to mid-air collision.
Comply with this AD within the compliance times specified, unless already done.
Within the next 12 months after December 20, 2017 (the effective date of this AD) or within the next 750 hours time-in-service after December 20, 2017 (the effective date of this AD), whichever occurs first, upgrade the TSSA-4100 FLS to RCPN 810-0052-013 or 810-0052-102, as applicable, following Rockwell Collins Service Information Letter, TSSA-4100-SIL-10-1, Revision No. 9, dated
(1) The Manager, Wichita ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in paragraph (i) of this AD.
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
For more information about this AD, contact Paul Rau, Aerospace Engineer, Wichita ACO, FAA, 1801 Airport Road, Room 100, Wichita, Kansas 67209; phone: 316-946-4149; fax: 316-946-4107; email:
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.
(i) Rockwell Collins Service Information Letter, TSSA-4100-SIL-10-1, Revision No. 9, dated March 31, 2017.
(ii) Rockwell Collins Service Information Letter, TSSA-4100-SIL-10-1, Revision No. 10, dated July 10, 2017.
(3) For service information identified in this AD, contact Rockwell Collins, Inc., Collins Aviation Services, 400 Collins Road NE., M/S 164-100, Cedar Rapids, IA 52498-0001; telephone: 888-265-5467 (U.S.) or 319-265-5467; fax: 319-295-4941 (outside U.S.); email:
(4) You may view this service information at FAA, Policy and Innovation Division, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call (816) 329-4148. It is also available on the internet at
(5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Federal Aviation Administration (FAA), DOT.
Final rule; request for comments.
We are adopting a new airworthiness directive (AD) for certain General Electric Company (GE) CF34-8C1, CF34-8C5, CF34-8C5A1, and CF34-8C5B1 engines. This AD requires an inspection of the bleed air manifold link rod assemblies and the supply, return, and drain fuel fittings on the operability bleed valve (OBV). This AD was prompted by an engine fire that occurred as a result of malfunctions related to the OBV. We are issuing this AD to address the unsafe condition on these products.
This AD is effective November 30, 2017.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of November 30, 2017.
We must receive comments on this AD by January 2, 2018.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this final rule, contact General Electric Company, GE-Aviation, Room 285, 1 Neumann Way, Cincinnati, OH 45215, phone: 513-552-3272; fax: 513-552-3329; email:
You may examine the AD docket on the Internet at
John Frost, Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7756; fax: 781-238-7199; email:
We learned that significant fuel leaks, some resulting in engine fires, have occurred on multiple occasions due to malfunctions related to the OBVs. These valves typically dump operability air into the bleed plenum attached to the engine inner nacelle. The fuel fitting threads have pulled out of the valve body which has led to significant fuel leaks on at least four occasions. On two occasions, these leaks resulted in uncontrolled fires, resulting in significant damage to one of the affected airplanes. This condition, if not corrected, could result in failure of the OBV, engine fire, and damage to the airplane. We are issuing this AD to correct the unsafe condition on these products.
We reviewed GE Service Bulletin (SB) CF34-8C-AL S/B 75-0019, Revision 01, dated October 24, 2017. The SB describes procedures for inspecting the OBV. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We reviewed GE CF34-8C SB 75-0019 R00, dated August 4, 2017. The SB describes procedures for inspecting the OBV.
We are issuing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.
This AD requires inspection of the bleed air manifold link rod assemblies and the supply, return, and drain fuel fittings on the OBVs.
We consider this AD interim action. We will consider further rulemaking action depending on the results of the investigation.
An unsafe condition exists that requires the immediate adoption of this AD without providing an opportunity for public comments prior to adoption. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because the compliance time for the required action is shorter than the time necessary for the public to comment and for us to publish the final rule. Therefore, we find good cause that notice and opportunity for prior public comment are impracticable. In addition, for the reason stated above, we find that good cause exists for making this amendment effective in less than 30 days.
This AD is a final rule that involves requirements affecting flight safety and was not preceded by notice and an opportunity for public comment. However, we invite you to send any written data, views, or arguments about this final rule. Send your comments to an address listed under the
We will post all comments we receive, without change, to
We estimate that this AD affects 1,282 engines installed on airplanes of U.S. registry.
We estimate the following costs to comply with this AD:
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to engines, propellers, and associated appliances to the Manager, Engine and Propeller Standards Branch, Policy and Innovation Division.
This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(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.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective November 30, 2017.
None.
This AD applies to General Electric Company (GE) CF34-8C1, CF34-8C5, CF34-8C5A1, and CF34-8C5B1 engines with serial numbers: 965101 through 965670 inclusive; 194101 through 194999 inclusive; and 195101 through 195653 inclusive.
Joint Aircraft System Component (JASC) Code 7531, Compressor bleed governor.
This AD was prompted by an engine fire that occurred as a result of malfunctions related to the operability bleed valve (OBV). We are issuing this AD to prevent failure of the OBV. The unsafe condition, if not corrected, could result in failure of the OBV, engine fire, and damage to the airplane.
Comply with this AD within the compliance times specified, unless already done.
(1) Inspect the bleed air manifold link rod assemblies and the OBV supply, return, and drain fuel fittings within 500 flight hours after the effective date of this AD.
(2) Use the Accomplishment Instructions, paragraph 3.B., in GE Service Bulletin (SB) CF34-8C-AL S/B 75-0019 Revision 01, dated October 24, 2017, to do the inspection. Replace parts that fail this inspection according to the following criteria:
(i) Replace any OBV that fails the inspection with a part eligible for installation before further flight.
(ii) Replace any additional hardware that fails inspection within 50 flight cycles. The engine can be returned to service each day for up to the 50 flight cycles if the OBV rosan rings and fittings are examined each day for fuel leaks and looseness based on the criteria in Table 1 of GE SB CF34-8C-AL S/B 75-0019 Revision 01, dated October 24, 2017.
(3) The reporting instructions in paragraphs 3.B.(3), 3.B.(5)(e), 3.B.(6)(e), and 3.B.(8) of GE SB CF34-8C-AL S/B 75-0019 Revision 01, dated October 24, 2017, are not required by this AD.
You may take credit for the actions that are required by paragraph (g) of this AD if you performed these actions before the effective date of this AD using GE CF34-8C SB 75-0019 R00, dated August 4, 2017.
(1) The Manager, ECO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in paragraph (j) of this AD. You may email your request to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
For more information about this AD, contact John Frost, Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7754; fax: 781-238-7199; email:
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.
(i) General Electric Company (GE) Service Bulletin CF34-8C-AL S/B 75-0019 Revision 01, dated October 24, 2017.
(ii) Reserved.
(3) For GE service information identified in this AD, contact General Electric Company, GE-Aviation, Room 285, 1 Neumann Way, Cincinnati, OH 45215, phone: 513-552-3272; fax: 513-552-3329; email:
(4) You may view this service information at FAA, FAA, Engine & Propeller Standards Branch, 1200 District Avenue, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7125.
(5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
We are adopting a new airworthiness directive (AD) for certain Airbus Model A300 B4-600R series airplanes; Model A300 B4-603, B4-620, and B4-622 airplanes; Model A300 C4-605R Variant F airplanes; and Model A300 F4-605R airplanes. This AD was prompted by a determination that the top stringer joints at rib 18 are an area of uniform stress distribution, which indicates that cracks may develop in adjacent stringers at the same time. This AD requires an inspection of the upper wing skin and top stringer joints, and modification of the stringer joint couplings if necessary. We are issuing this AD to address the unsafe condition on these products.
This AD is effective December 20, 2017.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of December 20, 2017.
For service information identified in this final rule, contact Airbus SAS, Airworthiness Office—EAW, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
You may examine the AD docket on the Internet at
Dan Rodina, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-2125; fax 425-227-1149.
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Airbus Model A300 B4-600R series airplanes; Model A300 B4-603, B4-620, and B4-622 airplanes;
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2017-0023, dated February 10, 2017 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Model A300 B4-600R series airplanes; Model A300 B4-603, B4-620, and B4-622 airplanes; Model A300 C4-605R Variant F airplanes; and Model A300 F4-605R airplanes. The MCAI states:
In response to the FAA Part 26 rule change concerning Widespread Fatigue Damage (WFD), all wing structural items of the A300-600 design deemed potentially susceptible to WFD were assessed. The top stringer joints at Rib 18 were highlighted as an area of uniform stress distribution, indicating that cracks may develop in adjacent stringers at the same time which is known as Multi Element Damage (MED). Each affected stringer joint consists of three main load transferring parts: An overlapping flange, two straps attached through the stringer web and a strap on the top flange. All the components of the joint are attached with fasteners. The fastener holes were the subject of a MED WFD analysis, which showed that cracking could occur from a number of the holes in the joint on stringers 11, 12, 13, 14, 15, 16, 17, and 18.
This condition, if not detected and corrected, could reduce the structural integrity of the wing.
Prompted by the conclusion of the WFD analysis, Airbus issued Service Bulletin (SB) A300-57-6118 to provide modification instructions. The modification will both re-life via oversizing and inspect via non-destructive test a defined number of stringer joint fastener holes at Rib 18. This modification will delay the onset of cracking at the stringer joint, providing it is completed at the specified time and will delay the requirement for subsequent inspection.
For the reasons described above, this [EASA] AD requires a detailed visual inspection (DVI) [for damage, including cracking] of the upper wing skin and the top stringer joints at Rib 18, [and corrective action if necessary] and modification of the stringer joint couplings at Rib 18, on both wings [as applicable].
The modification includes a related investigative action,
You may examine the MCAI in the AD docket on the Internet at
We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM and the FAA's response to each comment.
FedEx supported the intent of the NPRM, but requested that we update the parts cost in the Costs of Compliance section of the proposed AD to reflect the cost of two parts kits. FedEx noted that the proposed AD listed the parts cost for only one kit. FedEx pointed out that operators may need to modify both wings and could therefore need two parts kits per airplane.
We agree with the commenter's request. We have revised the Costs of Compliance section of this final rule to reflect two parts kits, each costing $4,770.
Airbus requested that we correct a reference to “Airbus Model A300 C4-605 Variant F” airplanes in paragraph (g)(2) of the proposed AD. The correct model name is “A300 C4-605R Variant F” airplanes.
We agree with the commenter's request. We have corrected the typographical error in this AD.
We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD with the changes described previously and minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM.
We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.
Airbus has issued Service Bulletin A300-57-6118, Revision 01, dated January 31, 2017. This service information describes procedures for an inspection of the upper wing skin and top stringer joints at rib 18, and modification of the stringer joint couplings. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We estimate that this AD affects 65 airplanes of U.S. registry.
We estimate the following costs to comply with this AD:
We have received no definitive data that will allow us to provide cost estimates for certain on-condition actions specified in this AD.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.
We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under 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.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective December 20, 2017.
None.
This AD applies to Airbus Model A300 B4-605R, B4-622R, B4-603, C4-605R Variant F, B4-620, B4-622, and F4-605R airplanes, certificated in any category, all serial numbers except Model A300 F4-605R airplanes that have embodied Airbus modification 12699 in production.
Air Transport Association (ATA) of America Code 57, Wings.
This AD was prompted by a determination that the top stringer joints at rib 18 are an area of uniform stress distribution, which indicates that cracks may develop in adjacent stringers at the same time. We are issuing this AD to detect and correct damage (including cracking) at the stringer joints, which could reduce the structural integrity of the wing.
Comply with this AD within the compliance times specified, unless already done.
For the purposes of this AD, the definitions in paragraphs (g)(1) through (g)(5) of this AD apply.
(1) Group 1 airplanes are defined as Airbus Model A300 B4-603, B4-605R, B4-620, B4-622, and B4-622R airplanes.
(2) Group 2 airplanes are defined as Airbus Model A300 C4-605R Variant F and F4-605R (if in pre-modification 12699 configuration) airplanes.
(3) Short range (SR) is defined as airplanes with an average flight time of less than 1.5 flight hours per flight cycle.
(4) Long range (LR) is defined as airplanes with an average flight time equal to or higher than 1.5 flight hours per flight cycle.
(5) For determining the “short range” and “long range” airplanes, the average flight time is the total accumulated flight hours, counted from take-off to touch-down, divided by the total accumulated flight cycles at the effective date of this AD.
Not before exceeding the applicable lower thresholds as specified in table 1 to paragraph (h) of this AD, and within the compliance times specified in paragraphs (h)(1), (h)(2), (h)(3), and (h)(4) of this AD, as applicable: Accomplish a detailed visual inspection for damage (including cracking) of the upper wing skin and top stringer joints at rib 18 on both wings, do all applicable corrective actions, and do the applicable modification, including related investigative and corrective actions, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A300-57-6118, Revision 01, dated January 31, 2017, except as required by paragraph (i) of this AD. Do all applicable modifications, related investigative actions, and corrective actions before further flight.
(1) For Group 1, LR airplanes: Inspect at the time specified in paragraph (h)(1)(i) or (h)(1)(ii) of this AD, whichever occurs later.
(i) Before exceeding 32,500 flight cycles or 70,300 flight hours, whichever occurs first since first flight of the airplane.
(ii) Within 700 flight cycles, 1,500 flight hours, or 12 months, whichever occurs first after the effective date of this AD.
(2) For Group 1, SR airplanes: Inspect at the time specified in paragraphs (h)(2)(i) or (h)(2)(ii) of this AD, whichever occurs later.
(i) Before exceeding 35,100 flight cycles or 52,600 flight hours, whichever occurs first since the first flight of the airplane.
(ii) Within 700 flight cycles or 1,000 flight hours, or 12 months, whichever occurs first after the effective date of this AD.
(3) For Group 2, LR airplanes: Inspect before exceeding 35,000 flight cycles or 75,700 flight hours, whichever occurs first since the first flight of the airplane.
(4) For Group 2, SR airplanes: Inspect before exceeding 37,800 flight cycles or 56,700 flight hours, whichever occurs first since the first flight of the airplane.
Where Airbus Service Bulletin A300-57-6118, Revision 01, dated January 31, 2017, specifies to contact Airbus for appropriate action, and specifies that action as “RC” (Required for Compliance): Before further flight, accomplish corrective actions in accordance with the procedures specified in paragraph (k)(2) of this AD.
This paragraph provides credit for actions required by paragraph (h) of this AD, if those actions were performed before the effective date of this AD using Airbus Service Bulletin A300-57-6118, dated June 30, 2015.
The following provisions also apply to this AD:
(1)
(2)
(3)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA AD 2017-0023, dated February 10, 2017, for related information. This MCAI may be found in the AD docket on the Internet at
(2) For more information about this AD, contact Dan Rodina, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-2125; fax 425-227-1149.
(3) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (m)(3) and (m)(4) of this AD.
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(i) Airbus Service Bulletin A300-57-6118, Revision 01, dated January 31, 2017.
(ii) Reserved.
(3) For service information identified in this AD, contact Airbus SAS, Airworthiness Office—EAW, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
(4) You may view this service information at the FAA, Transport Standards Branch, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.
(5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Federal Aviation Administration (FAA), DOT.
Final rule.
We are adopting a new airworthiness directive (AD) for certain The Boeing Company Model 737-200, -200C, -300, -400, and -500 series airplanes. This AD was prompted by an evaluation by the design approval holder (DAH) indicating that the fuselage crown skin panels are subject to widespread fatigue damage (WFD). This AD requires repetitive inspections, replacement, and applicable on-condition actions for certain fuselage crown skin panels. We are issuing this AD to address the unsafe condition on these products.
This AD is effective December 20, 2017.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of December 20, 2017.
For service information identified in this final rule, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; Internet
You may examine the AD docket on the Internet at
Jennifer Tsakoumakis, Aerospace Engineer, Airframe Section, FAA, Los Angeles ACO Branch, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5264; fax: 562-627-5210; email:
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain The Boeing Company Model 737-200, -200C, -300, -400, and -500 series airplanes. The NPRM published in the
We are issuing this AD to detect and correct cracking in the fuselage crown skin panels. Multiple adjacent cracks in the fuselage crown skin could link up and lead to decompression or loss of structural integrity of the airplane.
We gave the public the opportunity to participate in developing this final rule. We have considered the comments received.
Boeing concurred with the NPRM.
Aviation Partners Boeing stated that accomplishing Supplemental Type Certificate (STC) ST01219SE does not affect the ability to accomplish the actions specified in the NPRM.
We concur with the commenter. We have redesignated paragraph (c) of the proposed AD as paragraph (c)(1) and added paragraph (c)(2) to this AD to state that installation of STC ST01219SE does not affect the ability to accomplish the actions required by this AD. Therefore, for airplanes on which STC ST01219SE is installed, a “change in product” alternative method of compliance (AMOC) approval request is not necessary to comply with the requirements of 14 CFR 39.17.
We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this final rule with the changes described previously and minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM.
We also determined that these changes will not increase the economic burden on any operator or increase the scope of this final rule.
We reviewed Boeing Alert Service Bulletin 737-53A1358, dated April 27, 2017. This service information describes procedures for repetitive inspections, replacement, and applicable on-condition actions for certain fuselage crown skin panels. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We estimate that this AD affects 200 airplanes of U.S. registry. We estimate the following costs to comply with this AD:
We have received no definitive data that will enable us to provide cost estimates for the on-condition actions specified in this AD.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.
This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(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.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective December 20, 2017.
None.
(1) This AD applies to The Boeing Company Model 737-200, -200C, -300, -400, and -500 series airplanes, certificated in any category, as identified in Boeing Alert Service Bulletin 737-53A1358, dated April 27, 2017.
(2) Installation of Supplemental Type Certificate (STC) ST01219SE (
Air Transport Association (ATA) of America Code 53, Fuselage.
This AD was prompted by an evaluation by the design approval holder indicating that the fuselage crown skin panels are subject to widespread fatigue damage. We are issuing this AD to detect and correct cracking in the fuselage crown skin panels. Multiple adjacent cracks in the fuselage crown skin could link up and lead to decompression or loss of structural integrity of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Except as required by paragraph (h) of this AD: At the applicable times specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 737-53A1358, dated April 27, 2017, do all applicable actions identified as “RC” (required for compliance) in, and in accordance with, the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1358, dated April 27, 2017.
(1) For purposes of determining compliance with the requirements of this AD, the phrase “the effective date of this AD” may be substituted for “the original issue date of this service bulletin,” as specified in Boeing Alert Service Bulletin 737-53A1358, dated April 27, 2017.
(2) Where Boeing Alert Service Bulletin 737-53A1358, dated April 27, 2017, specifies contacting Boeing, and specifies that action as RC: This AD requires using a method approved in accordance with the procedures specified in paragraph (j) of this AD.
(3) Part 7 of Boeing Alert Service Bulletin 737-53A1358, dated April 27, 2017, specifies post-modification airworthiness limitation inspections in compliance with 14 CFR 25.571(a)(3) at the modified locations to support compliance with 14 CFR 121.1109(c)(2) or 129.109(b)(2). Although Part 7 is identified as RC, this AD does not require accomplishment of Part 7. As airworthiness limitations, these inspections are required by maintenance and operational rules. It is therefore unnecessary to mandate them in this AD. Deviations from these inspections require FAA approval, but do not require approval of an alternative method of compliance.
(1) Replacement of a skin panel, in accordance with Part 8 of the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1358, dated April 27, 2017, except as required by paragraph (h)(2) of this AD, terminates the actions specified in Parts 1, 4, and 6 of the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1358, dated April 27, 2017, as required by paragraph (g) of this AD, for that replaced skin panel only. To be acceptable as terminating action, the replacement may not be done prior to the applicable time specified in Table 4 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 737-53A1358, dated April 27, 2017.
(2) Completion of a structural repair manual repair to repair cracking, in accordance with Part 2 of the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1358, dated April 27, 2017, except as required by paragraph (h)(2) of this AD, terminates the repetitive inspections specified in Part 1 of the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1358, dated April 27, 2017, as required by paragraph (g) of this AD, for that repair location only.
(3) Completion of a “Category C repair” to repair cracking, in accordance with Part 3 of the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1358, dated April 27, 2017, except as required by paragraph (h)(2) of this AD, terminates the repetitive inspections specified in Part 1 of the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1358, dated April 27, 2017, as required by paragraph (g) of this AD, for that repair location only.
(4) Completion of a “Change Category C Repair to SB Repair,” in accordance with Part 6 of the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1358, dated April 27, 2017, except as required by paragraph (h)(2) of this AD, terminates the inspections specified in Part 4 of the Accomplishment Instructions of Boeing Alert Service Bulletin 737-53A1358, dated April 27, 2017, as required by paragraph (g) of this AD, for that repair location only.
(1) The Manager, Los Angeles ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in paragraph (k) of this AD. Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Los Angeles ACO Branch, to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
(4) Except as required by paragraphs (h)(2) and (h)(3) of this AD: For service information that contains steps that are labeled as RC, the provisions of paragraphs (j)(4)(i) and (j)(4)(ii) of this AD apply.
(i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. If a step or substep is labeled “RC Exempt,” then the RC requirement is removed from that step or substep. An AMOC is required for any deviations to RC steps, including substeps and identified figures.
(ii) Steps not labeled as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the RC steps, including substeps and identified figures, can still be done as specified, and the airplane can be put back in an airworthy condition.
For more information about this AD, contact Jennifer Tsakoumakis, Aerospace Engineer, Airframe Section, FAA, Los Angeles ACO Branch, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5264; fax: 562-627-5210; email:
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.
(i) Boeing Alert Service Bulletin 737-53A1358, dated April 27, 2017.
(ii) Reserved.
(3) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; Internet
(4) You may view this service information at the FAA, Transport Standards Branch, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.
(5) You may view this service information that is incorporated by reference at the National Archives and Records
Federal Aviation Administration (FAA), DOT.
Final rule.
We are adopting a new airworthiness directive (AD) for all The Boeing Company Model 737-100, -200, -200C, -300, -400, and -500 series airplanes. This AD was prompted by reports of crack indications in the right wing upper aft skin, originating from fastener holes common to the rear spar upper chord. This AD requires repetitive inspections for cracking of the wing upper aft skin, and applicable on-condition actions. We are issuing this AD to address the unsafe condition on these products.
This AD is effective December 20, 2017.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of December 20, 2017.
For service information identified in this final rule, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; Internet
You may examine the AD docket on the Internet at
Payman Soltani, Aerospace Engineer, Airframe Section, FAA, Los Angeles ACO Branch, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5313; fax: 562-627-5210; email:
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all The Boeing Company Model 737-100, -200, -200C, -300, -400, and -500 series airplanes. The NPRM published in the
We are issuing this AD to detect and correct cracking of the wing upper aft skin, which can lead to the inability of a principal structural element to sustain flight load, and adversely affect the structural integrity of the airplane.
We gave the public the opportunity to participate in developing this final rule. We have considered the comments received.
The Boeing Company supported the NPRM.
Aviation Partners Boeing stated that accomplishing the Supplemental Type Certificate (STC) ST01219SE does not affect the actions specified in the NPRM.
We concur with the commenter. We have redesignated paragraph (c) of the proposed AD as paragraph (c)(1) of this AD and added paragraph (c)(2) to this AD to state that installation of STC ST01219SE does not affect the ability to accomplish the actions required by this AD. Therefore, for airplanes on which STC ST01219SE is installed, a “change in product” alternative method of compliance (AMOC) approval request is not necessary to comply with the requirements of 14 CFR 39.17.
We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this final rule with the change described previously and minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM.
We also determined that these changes will not increase the economic burden on any operator or increase the scope of this final rule.
We reviewed Boeing Alert Service Bulletin 737-57A1335, dated May 24, 2017. The service information describes procedures for repetitive inspections for cracking of the wing upper aft skin at and forward of the rear spar upper chord, and applicable on-condition actions. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We estimate that this AD affects 160 airplanes of U.S. registry. We estimate the following costs to comply with this AD:
We have received no definitive data that would enable us to provide cost estimates for the on-condition actions specified in this AD.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.
This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(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.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective December 20, 2017.
None.
(1) This AD applies to all The Boeing Company Model 737-100, -200, -200C, -300, -400, and -500 series airplanes, certificated in any category.
(2) Installation of Supplemental Type Certificate (STC) ST01219SE (
Air Transport Association (ATA) of America Code 57, Wings.
This AD was prompted by reports of crack indications in the right wing upper aft skin, originating from fastener holes common to the rear spar upper chord. We are issuing this AD to detect and correct cracking of the wing upper aft skin, which can lead to the inability of a principal structural element to sustain flight load, and adversely affect the structural integrity of the airplane.
Comply with this AD within the compliance times specified, unless already done.
(1) For airplanes identified as Group 2 in Boeing Alert Service Bulletin 737-57A1335, dated May 24, 2017: Except as required by paragraph (h) of this AD, at the applicable times specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 737-57A1335, dated May 24, 2017, do all applicable actions identified as “RC” (required for compliance) in, and in accordance with, the Accomplishment Instructions of Boeing Alert Service Bulletin 737-57A1335, dated May 24, 2017.
(2) For airplanes identified as Group 1 in Boeing Alert Service Bulletin 737-57A1335, dated May 24, 2017: Within 120 days after the effective date of this AD, inspect the airplane and do all applicable corrective actions using a method approved in accordance with the procedures specified in paragraph (i) of this AD.
(1) For purposes of determining compliance with the requirements of this AD, the phrase “the effective date of this AD” may be substituted for “the original issue date of this service bulletin,” as specified in Boeing Alert Service Bulletin 737-57A1335, dated May 24, 2017.
(2) Where Boeing Alert Service Bulletin 737-57A1335, dated May 24, 2017, specifies contacting Boeing, and specifies that action as RC: This AD requires using a method approved in accordance with the procedures specified in paragraph (i) of this AD.
(1) The Manager, Los Angeles ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in paragraph (j) of this
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Los Angeles ACO Branch, to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
(4) Except as required by paragraph (h)(2) of this AD: For service information that contains steps that are labeled as RC, the provisions of paragraphs (i)(4)(i) and (i)(4)(ii) of this AD apply.
(i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. If a step or substep is labeled “RC Exempt,” then the RC requirement is removed from that step or substep. An AMOC is required for any deviations to RC steps, including substeps and identified figures.
(ii) Steps not labeled as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the RC steps, including substeps and identified figures, can still be done as specified, and the airplane can be put back in an airworthy condition.
For more information about this AD, contact Payman Soltani, Aerospace Engineer, Airframe Section, FAA, Los Angeles ACO Branch, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5313; fax: 562-627-5210; email:
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.
(i) Boeing Alert Service Bulletin 737-57A1335, dated May 24, 2017.
(ii) Reserved.
(3) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; Internet
(4) You may view this service information at the FAA, Transport Standards Branch, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.
(5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
We are adopting a new airworthiness directive (AD) for certain 328 Support Services GmbH Model 328-100 and Model 328-300 airplanes. This AD was prompted by reports of broken bonding wires of certain fuel line clamps. This AD requires repetitive inspections of certain fuel line clamps for discrepancies; repetitive inspections of certain parts for chafing marks; and replacement of any discrepant parts. This AD also includes an optional modification, which is a terminating action for the inspections. We are issuing this AD to address the unsafe condition on these products.
This AD is effective December 20, 2017.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of December 20, 2017.
For service information identified in this final rule, contact 328 Support Services GmbH, Global Support Center, P.O. Box 1252, D-82231 Wessling, Federal Republic of Germany; telephone +49 8153 88111 6666; fax +49 8153 88111 6565; email
You may examine the AD docket on the Internet at
Todd Thompson, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1175; fax 425-227-1149.
We issued a supplemental notice of proposed rulemaking (SNPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain 328 Support Services GmbH Model 328-100 and Model 328-300 airplanes. The SNPRM published in the
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2017-0016, dated January 31, 2017 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain 328 Support Services GmbH Model 328-100 and Model 328-300 airplanes. The MCAI states:
Occurrences of broken bonding wires of the fuel line clamps have been reported on Dornier 328-100 and Dornier 328-300 aeroplanes equipped with fuel line clamps Part Number (P/N) 14C02-10A, or P/N 14C02-12A, or P/N 14C02-16A. The affected fuel line clamps have been installed in accordance with the instructions of Dornier 328 Service Bulletin (SB) SB-328-28-490 or SB-328J-28-241, as applicable, to reduce occurrences of fuel line chafing.
The results of the investigation did not identify design deficiency or production failure of the fuel line clamps. It is assumed that the chafing and breaking of the bonding wires are caused either by excessive vibration, misalignment, excessive installation tolerances or mistakes on installation or a combination thereof.
This condition, if not detected and corrected, could lead to the loss of bonding function and, in combination with a lightning strike, create a source of ignition in a fuel tank, possibly resulting in a fire or explosion and consequent loss of the aeroplane.
To address the unsafe condition, 328 Support Services issued Alert SB (ASB) ASB-328-28-041 (for Dornier 328-100) and ASB-328J-28-018 (for Dornier 328-300), providing inspection instructions.
Consequently, EASA issued AD 2016-0169 [which corresponds to the NPRM] to require a one-time inspection of the fuel line clamps and, depending on findings, replacement. That [EASA] AD also required the reporting of all inspection results to the design approval holder.
Since that [EASA] AD was issued, it was determined that repetitive inspections are necessary and 328 Support Services revised the applicable ASBs accordingly.
For the reason described above, this [EASA] AD retains the requirements of EASA AD 2016-0169, which is superseded, and requires repetitive inspections of all Hydraflow fuel line clamps [
You may examine the MCAI in the AD docket on the Internet at
We gave the public the opportunity to participate in developing this AD. The following presents the comment received on the SNPRM and the FAA's response to that comment.
One commenter, Christoph Thallmayr, stated that 328 Support Services has released Service Bulletin SB-328-28-553, Revision 1, dated July 10, 2017; and Service Bulletin SB-328J-28-322, Revision 1, dated July 10, 2017. The commenter noted that this service information contains instructions for a modification, which is considered a terminating action to the inspections specified in the SNPRM. The commenter requested that we incorporate the terminating action and applicable service information into the final rule.
We agree with the commenter's request. We have added paragraph (l) to this AD to allow operators to accomplish an optional terminating modification, which must be done in accordance with 328 Support Services GmbH Service Bulletin SB-328-28-553, Revision 1, dated July 10, 2017; or Service Bulletin SB-328J-28-322, Revision 1, dated July 10, 2017; as applicable. We also have redesignated subsequent paragraphs accordingly.
We reviewed the relevant data, considered the comment received, and determined that air safety and the public interest require adopting this AD with the changes described previously and minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the SNPRM for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the SNPRM.
We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.
328 Support Services GmbH has issued Alert Service Bulletin ASB-328J-28-018, Revision 2, dated December 12, 2016; and Alert Service Bulletin ASB-328-28-041, Revision 2, dated December 12, 2016. The service information describes procedures for a general visual inspection of all Hydraflow fuel line clamps for worn and missing bonding wires; a general visual inspection of the jet pump outlet, connection part, and fuel lines for chafing marks; a measurement of the depth of the chafing marks; and replacement of discrepant parts. These documents are distinct since they apply to different airplane models.
328 Support Services GmbH has also issued Service Bulletin SB-328-28-553, Revision 1, dated July 10, 2017; and Service Bulletin SB-328J-28-322, Revision 1, dated July 10, 2017. The service information describes procedures for modifying the wing tank distribution system. These documents are distinct since they apply to different airplane models.
This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We estimate that this AD affects 25 airplanes of U.S. registry.
We estimate the following costs to comply with this AD:
We estimate the following costs to do any necessary replacements that would be required based on the results of the required inspections and measurement. We have no way of determining the number of aircraft that might need these replacements:
A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB control number. The control number for the collection of information required by this AD is 2120-0056. The paperwork cost associated with this AD has been detailed in the Costs of Compliance section of this document and includes time for reviewing instructions, as well as completing and reviewing the collection of information. Therefore, all reporting associated with this AD is mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at 800 Independence Ave. SW., Washington, DC 20591, ATTN: Information Collection Clearance Officer, AES-200.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.
We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under 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.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective December 20, 2017.
None.
This AD applies to 328 Support Services GmbH (Type Certificate Previously Held by AvCraft Aerospace GmbH; Fairchild Dornier GmbH; Dornier Luftfahrt GmbH) airplanes, certificated in any category, as identified in paragraphs (c)(1) and (c)(2) of this AD.
(1) Model 328-100 airplanes, all serial numbers.
(2) Model 328-300 airplanes, all serial numbers.
Air Transport Association (ATA) of America Code 28, Fuel.
This AD was prompted by reports of broken bonding wires of certain fuel line clamps. We are issuing this AD to prevent the loss of bonding function, which, in combination with a lightning strike, could create a source of ignition in a fuel tank, possibly resulting in a fire or explosion and consequent loss of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Within 6 months after the effective date of this AD, do a general visual inspection of all Hydraflow fuel line clamps for worn and missing bonding wires; do a general visual inspection of the jet pump outlet, connection part, and fuel lines for chafing marks; and for parts with chafing marks, before further flight, measure the depth of the chafing marks; in accordance with the Accomplishment Instructions of the service information specified in paragraph (g)(1) or (g)(2) of this AD, as applicable. Repeat the inspections thereafter at intervals not to exceed 2,500 flight hours.
(1) 328 Support Services GmbH Alert Service Bulletin ASB-328-28-041, Revision 2, dated December 12, 2016 (for Model 328-100 airplanes).
(2) 328 Support Services GmbH Alert Service Bulletin ASB-328J-28-018, Revision 2, dated December 12, 2016 (for Model 328-300 airplanes).
(1) If any worn or missing bonding wires are found during any inspection required by paragraph (g) of this AD, before further flight, replace all affected clamps, in accordance with the Accomplishment Instructions of the service information specified in paragraph (g)(1) or (g)(2) of this AD, as applicable.
(2) If, during any inspection required by paragraph (g) of this AD, any chafing depth is found that is more than the replacement limits specified in the Accomplishment Instructions of the service information specified in paragraph (g)(1) or (g)(2) of this AD, as applicable, before further flight, replace all affected parts, in accordance with the Accomplishment Instructions of the service information specified in paragraph (g)(1) or (g)(2) of this AD, as applicable.
At the applicable time specified in paragraph (i)(1) or (i)(2) of this AD, report the inspection results, positive or negative, to 328 Support Services, GmbH, Global Support Center, P.O. Box 1252, D-82231 Wessling, Federal Republic of Germany; fax +49 8153 88111 6565; email
(1) If the inspection was done on or after the effective date of this AD: Submit the report within 30 days after the inspection.
(2) If the inspection was done before the effective date of this AD: Submit the report within 30 days after the effective date of this AD.
This paragraph provides credit for the initial inspection, parts replacement, and initial report required by paragraphs (g), (h), and (i) of this AD, if those actions were performed before the effective date of this AD using the service information specified in paragraphs (j)(1) through (j)(4) of this AD.
(1) 328 Support Services GmbH Alert Service Bulletin ASB-328-28-041, dated June 14, 2016.
(2) 328 Support Services GmbH Alert Service Bulletin ASB-328-28-041, Revision 1, dated October 13, 2016.
(3) 328 Support Services GmbH Alert Service Bulletin ASB-328J-28-018, dated June 3, 2016.
(4) 328 Support Services GmbH Alert Service Bulletin ASB-328J-28-018, Revision 1, dated October 13, 2016.
Replacement of clamps as required by paragraph (h) of this AD does not constitute terminating action for the repetitive inspections required by paragraph (g) of this AD for that airplane.
Modification of the wing tank distribution system, in accordance with the Accomplishment Instructions of 328 Support Services GmbH Service Bulletin SB-328-28-553, Revision 1, dated July 10, 2017; or 328 Support Services GmbH Service Bulletin SB-328J-28-322, Revision 1, dated July 10, 2017, as applicable, terminates the actions required by paragraphs (g), (h), and (i) of this AD for the modified airplane.
The following provisions also apply to this AD:
(1)
(2)
(3)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2017-0016, dated January 31, 2017, for related information. This MCAI may be found in the AD docket on the Internet at
(2) For more information about this AD, contact Todd Thompson, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1175; fax 425-227-1149.
(3) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (o)(3) and (o)(4) of this AD.
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(i) 328 Support Services GmbH Alert Service Bulletin ASB-328-28-041, Revision 2, dated December 12, 2016.
(ii) 328 Support Services GmbH Alert Service Bulletin ASB-328J-28-018, Revision 2, dated December 12, 2016.
(iii) 328 Support Services GmbH Service Bulletin SB-328-28-553, Revision 1, dated July 10, 2017.
(iv) 328 Support Services GmbH Service Bulletin SB-328J-28-322, Revision 1, dated July 10, 2017.
(3) For service information identified in this AD, contact 328 Support Services GmbH, Global Support Center, P.O. Box 1252, D-82231 Wessling, Federal Republic of Germany; telephone +49 8153 88111 6666; fax +49 8153 88111 6565; email
(4) You may view this service information at the FAA, Transport Standards Branch, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.
(5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
We are adopting a new airworthiness directive (AD) for certain Bombardier, Inc., Model CL-600-2B16 (CL-604 Variant) airplanes. This AD was prompted by reports of in-service incidents regarding the loss of all air data system information provided to the flightcrew. This AD requires revising the airplane flight manual (AFM) to provide “Unreliable Airspeed” procedures to the flightcrew to stabilize the airplane's airspeed and attitude for continued safe flight and landing. We are issuing this AD to address the unsafe condition on these products.
This AD is effective December 20, 2017.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of December 20, 2017.
For service information identified in this final rule, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; telephone: 514-855-5000; fax: 514-855-7401; email:
You may examine the AD docket on the Internet at
Assata Dessaline, Aerospace Engineer, Avionics and Administrative Services Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone: 516-228-7301; fax: 516-794-5531.
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Bombardier, Inc., Model CL-600-2B16 (CL-604 Variant) airplanes. The NPRM published in the
Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian Airworthiness Directive CF-2017-01, dated January 6, 2017 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Bombardier, Inc., Model CL-600-2B16 (CL-604 Variant) airplanes. The MCAI states:
A number of in-service incidents have been reported on CL-600-2C10 aeroplanes regarding a loss of all air data information provided to the crew. The air data information was recovered as the aeroplane descended to lower altitudes. An investigation determined that the root cause in both events was high altitude icing (ice crystal contamination). If not recognized and addressed, this condition may affect continued safe flight and landing.
Due to similarities in the air data systems, similar events could happen on Bombardier Inc. CL-600-2B16 aeroplanes.
This [Canadian] AD mandates the incorporation of Aircraft Flight Manual (AFM) procedures to guide the crew to stabilize the aeroplanes airspeed and attitude for continued safe flight and landing.
You may examine the MCAI in the AD docket on the Internet at
We gave the public the opportunity to participate in developing this AD. We considered the comment received.
The commenter, Marjolaine Bourget, stated that the “unreliable airspeed” procedures, while provided in the AFM revisions identified in the proposed requirements, were actually introduced in the previous revision of the identified AFMs.
From this statement, we infer that the commenter was requesting that we add a statement that the “unreliable airspeed” procedures were introduced in the previous revision of the identified AFMs. The commenter provided no justification for this request. We acknowledge that the “unreliable airspeed” procedures were introduced in an earlier revision of the identified AFMs. We have revised this AD by adding new paragraph (h) to this AD that provides credit to operators for previously completing the actions required by paragraph (g) of this AD if they used the applicable previous AFM revision.
We reviewed the relevant data, considered the comment received, and determined that air safety and the public interest require adopting this AD as proposed, except for minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM.
Bombardier, Inc., has issued Unreliable Airspeed, of Section 03-15, Instruments System, of Chapter 3, Emergency Procedures, of the following AFMs:
• Bombardier Challenger 604 AFM, Publication No. CH 604 AFM, Revision 103, dated November 28, 2016.
• Bombardier Challenger 605 AFM, Publication No. CH 605 AFM, Revision 41, dated November 28, 2016.
• Bombardier Challenger 650 AFM, Publication No. CH 650 AFM, Revision 6, dated November 28, 2016.
This service information provides revisions to the Emergency Procedures section of the AFM to incorporate a procedure for “Unreliable Airspeed.” These documents are distinct since they apply to different airplane configurations. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We estimate that this AD affects 128 airplanes of U.S. registry.
We also estimate that it takes about 1 work-hour per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD on U.S. operators to be $10,880, or $85 per product.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.
We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under 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.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective December 20, 2017.
None.
This AD applies to Bombardier, Inc., Model CL-600-2B16 (CL-604 Variant) airplanes, certificated in any category; serial numbers 5301 through 5665 inclusive; 5701 through 5988 inclusive; and 6050 through 6080 inclusive.
Air Transport Association (ATA) of America Code 34, Navigation.
This AD was prompted by reports of in-service incidents regarding the loss of all air data system information provided to the flightcrew. We are issuing this AD to provide the flightcrew with procedures for “Unreliable Airspeed” that stabilize the airplane's airspeed and attitude for continued safe flight and landing.
Comply with this AD within the compliance times specified, unless already done.
Within 30 days after the effective date of this AD: Revise the Emergency Procedures section of the AFM to include the information in Unreliable Airspeed, of Section 03-15, Instruments System, of Chapter 3, Emergency Procedures, of the applicable AFM specified in paragraph (g)(1), (g)(2), or (g)(3) of this AD. These revisions incorporate a procedure for “Unreliable Airspeed.” Thereafter, operate the airplane according to the limitation and procedure in the applicable revision.
(1) For airplanes having serial numbers 5301 through 5665 inclusive: Bombardier Challenger 604 AFM, Publication No. CH 604 AFM, Revision 103, dated November 28, 2016.
(2) For airplanes having serial numbers 5701 through 5988 inclusive (marketing designation—Challenger 605): Bombardier Challenger 605 AFM, Publication No. CH 605 AFM, Revision 41, dated November 28, 2016.
(3) For airplanes having serial numbers 6050 through 6080 inclusive (marketing designation—Challenger 650): Bombardier Challenger 650 AFM, Publication No. CH 650 AFM, Revision 6, dated November 28, 2016.
This paragraph provides credit for the actions specified in paragraph (g) of this AD, if those actions were performed before the effective date of this AD using the applicable AFM revision specified in paragraphs (h)(1), (h)(2), and (h)(3) of this AD.
(1) For airplanes having serial numbers 5301 through 5665 inclusive: Bombardier Challenger 604 AFM, Publication No. CH 604 AFM, Revision 102, dated August 30, 2016.
(2) For airplanes having serial numbers 5701 through 5988 inclusive (marketing designation—Challenger 605): Bombardier Challenger 605 AFM, Publication No. CH 605 AFM, Revision 40, dated August 30, 2016.
(3) For airplanes having serial numbers 6050 through 6080 inclusive (marketing designation—Challenger 650): Bombardier Challenger 650 AFM, Publication No. CH 650 AFM, Revision 5, dated August 30, 2016.
The following provisions also apply to this AD:
(1)
(2)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) Canadian Airworthiness Directive CF-2017-01, dated January 6, 2017, for related information for related information. This MCAI may be found in the AD docket on the Internet at
(2) For more information about this AD, contact Assata Dessaline, Aerospace Engineer, Avionics and Administrative Services Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone: 516-228-7301; fax: 516-794-5531.
(3) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (k)(3) and (k)(4) of this AD.
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(i) Bombardier Challenger 604 Airplane Flight Manual (AFM), Publication No. CH 604 AFM, Revision 103, dated November 28, 2016.
(ii) Bombardier Challenger 605 AFM, Publication No. CH 605 AFM, Revision 41, dated November 28, 2016.
(iii) Bombardier Challenger 650 AFM, Publication No. CH 650 AFM, Revision 6, dated November 28, 2016.
(3) For service information identified in this AD, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; telephone: 514-855-5000; fax: 514-855-7401; email:
(4) You may view this service information at the FAA, Transport Standards Branch, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.
(5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Federal Trade Commission.
Confirmation of rule.
The Federal Trade Commission has completed its regulatory review of its rule regarding Disposal of Consumer Report Information and Records as part of the Commission's systematic review of all current Commission rules and guides, and has determined to retain the Rule in its current form.
This action is effective on November 15, 2017.
Relevant portions of the proceeding, including this document, are available at
Tiffany George, (202) 326-3040, Attorney, Division of Privacy and Identity Protection, Federal Trade Commission, Washington, DC 20580.
In September 2016, the Federal Trade Commission (“FTC” or “Commission”) requested comments on its rule regarding Disposal of Consumer Report Information and Records (“Disposal Rule” or “Rule”), as part of its comprehensive regulatory review program. Specifically, the Commission sought comments on the Rule's costs and benefits, and on whether it should modify the Rule to account for changes in technology or information destruction standards.
After considering the comments, the Commission has determined to retain the Rule without amendment. Most of the commenters who addressed the issue supported the Rule's current provisions. A few commenters recommended expanding the Rule's provisions. Because the Commission has not seen any evidence of problematic acts or practices that any proposed modification would address, it has determined not to amend the Rule at this time.
This document provides background, analyzes the comments, and further explains the Commission's decision.
The Fair and Accurate Credit Transactions Act (“FACTA” or “Act”) was enacted in 2003. In part, the Act amended the Fair Credit Reporting Act (“FCRA”) by requiring that any person that maintains or otherwise possesses consumer information, or any compilation of consumer information, derived from consumer reports for a business purpose, properly dispose of any such information or compilation. The Act also required the Commission and other federal agencies to promulgate rules regarding the proper disposal of consumer report information and records.
Pursuant to the Act's directive, the Commission promulgated the Disposal Rule in 2004, which became effective on June 1, 2005.
The Rule includes several examples of what the Commission believes constitute reasonable measures to protect consumer information in connection with its disposal, including policies and procedures that require (1) the burning, pulverizing, or shredding of papers or (2) the destruction or erasure of electronic media containing consumer information so that the information cannot practicably be read or reconstructed. These examples are intended to provide covered entities with guidance on how to comply with
In September 2016, the Commission published a Notice seeking comment on the Rule as part of the Commission's ongoing comprehensive regulatory review program.
The Commission received 11 comments in response to the Notice during the comment period.
All of the commenters addressing the issue supported the Rule overall. Indeed, none of the commenters advocated repealing the Rule or narrowing its scope. For example, NADA stated that “the Disposal Rule is well-established and working effectively and we do not believe it needs to be changed or amended in any significant way.”
Commenters differed on whether the Commission should expand the Rule's scope. Two organizations supported expanding the Rule. For example, NAID recommended that the Commission “add provisions and clarity to provide direction (and enforcement) related to . . . emerging issues” caused by advances in technology, such as the applicability of the Rule to third-party hardware providers (
Most trade associations argued against expansion of the Rule, asserting that laws and guidance currently in place sufficiently protect consumers. For instance, CDIA stated “[t]here is no net benefit in requiring consumer reporting agencies to incur the additional costs and burdens of applying the Disposal Rule to aggregate information, blind data, or otherwise de-identified data when such a change would not address any identified consumer harm or provide consumers with additional protection.”
The Commission agrees with the commenters who stated that the Rule should continue as it is and that it is not necessary to expand the Rule. No commenter who supported expansion of the Rule provided any evidence of problematic acts or practices that remain unaddressed with the scope of the current Rule.
As to NAID's comment requesting clarity on emerging issues relating to advances in technology including the applicability of the Rule to third-party service providers, the Commission notes that the Rule already applies to “[a]ny person who maintains or otherwise possesses consumer information for a business purpose” and requires “reasonable measures to protect against unauthorized access to or use of the information in connection with its disposal.”
As to the commenters that were concerned that the definition of “consumer information” is too limiting, the Commission notes that the definition—which excludes “aggregate information” and “blind data”—is not limited to information that identifies a consumer by name only. The Statement of Basis and Purpose to the final Rule noted that the terms “aggregate information” and “blind data” are intended to have the same meaning as in the Commission's Gramm-Leach-Bliley Act Rule regarding the Privacy of Consumer Financial Information, 16 CFR part 313 (the “GLB Privacy Rule”). The GLB Privacy Rule in turn defines aggregate information or blind data as information “that does not contain personal identifiers such as account numbers, names, or addresses.”
Thus, the rulemaking record makes clear that the definition of “consumer information” is not unduly limited. It may include other information that can be used to identify an individual. The Commission does not believe it is necessary to amend the Rule on this point.
In light of the comments received, the Commission concludes that a continuing need exists for the Rule and that costs imposed on businesses are reasonable. The Commission has determined to retain the Rule without amendment at this time. The Commission will continue to monitor changes in technology and industry
By direction of the Commission.
Internal Revenue Service (IRS), Treasury.
Correcting amendment.
This document contains corrections to final regulations (TD 9803) that were published in the
This correction is effective on November 15, 2017 and is applicable on or after December 16, 2016.
Lynlee Baker at (202) 317-6937 (not a toll-free number).
The final regulations (TD 9803) that are the subject of this correction are issued under section 367 of the Internal Revenue Code.
As published, the final regulations published in the
Income taxes, Reporting and recordkeeping requirements.
Accordingly, 26 CFR part 1 is corrected by making the following correcting amendment:
26 U.S.C. 7805 * * *
(e)
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 2017. 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, 2017.
Daniel S. Liebman (
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 terminated 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 2017.
The December 2017 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 2017, these 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 2017, 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.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary orders; inseason orders.
NMFS publishes Fraser River salmon inseason orders to regulate treaty and non-treaty (all citizen) commercial salmon fisheries in U.S. waters. The orders were issued by the Fraser River Panel (Panel) of the Pacific Salmon Commission (Commission) and subsequently approved and issued by NMFS during the 2017 salmon fisheries within the U.S. Fraser River Panel Area. These orders established fishing dates, times, and areas for the gear types of U.S. treaty Indian and all citizen commercial fisheries during the period the Panel exercised jurisdiction over these fisheries.
The effective dates for the inseason orders are set out in this document under the heading Inseason Orders.
Peggy Mundy at 206-526-4323.
The Treaty between the Government of the United States of America and the Government of Canada concerning Pacific Salmon was signed at Ottawa on January 28, 1985, and subsequently was given effect in the United States by the Pacific Salmon Treaty Act (Act) at 16 U.S.C. 3631-3644.
Under authority of the Act, Federal regulations at 50 CFR part 300, subpart F, provide a framework for the implementation of certain regulations of the Commission and inseason orders of the Commission's Fraser River Panel for U.S. sockeye and pink salmon fisheries in the Fraser River Panel Area.
The regulations close the U.S. portion of the Fraser River Panel Area to U.S. sockeye and pink salmon tribal and non-tribal commercial fishing unless opened by Panel orders that are given effect by inseason regulations published by NMFS. During the fishing season, NMFS may issue regulations that establish fishing times and areas consistent with the Commission agreements and inseason orders of the Panel. Such orders must be consistent with domestic legal obligations and are issued by the Regional Administrator, West Coast Region, NMFS. Official notification of these inseason actions is provided by two telephone hotline numbers described at 50 CFR
The following inseason orders were adopted by the Panel and issued for U.S. fisheries by NMFS during the 2017 fishing season. Each of the following inseason actions was effective upon announcement on telephone hotline numbers as specified at 50 CFR 300.97(b)(1) and in 82 FR 19631 (April 28, 2017); those dates and times are listed herein. The times listed are local times, and the areas designated are Puget Sound Management and Catch Reporting Areas as defined in the Washington State Administrative Code at Chapter 220-22.
Washington State and Treaty Indian tribes closed most United States Fraser Panel water fisheries on Sunday, September 3, 2017, in response to concerns that the potential harvest of Fraser River pink salmon would exceed the United States share of the total allowable catch. The Fraser River Panel met Tuesday, September 5, 2017, and confirmed the earlier closure of several fisheries that were previously announced on Thursday, August 31, 2017, Fraser River Panel order number 2017-04. The Panel announced the earlier closure of the following Commercial salmon fisheries in Panel Area waters:
The Assistant Administrator for Fisheries NOAA (AA), finds that good cause exists for the inseason orders to be issued without affording the public prior notice and opportunity for comment under 5 U.S.C. 553(b)(B) as such prior notice and opportunity for comments is impracticable and contrary to the public interest. Prior notice and opportunity for public comment is impracticable because NMFS has insufficient time to allow for prior notice and opportunity for public comment between the time the stock abundance information is available to determine how much fishing can be allowed and the time the fishery must open and close in order to harvest the appropriate amount of fish while they are available.
The AA also finds good cause to waive the 30-day delay in the effective date, required under 5 U.S.C. 553(d)(3), of the inseason orders. A delay in the effective date of the inseason orders would not allow fishers appropriately controlled access to the available fish at that time they are available.
This action is authorized by 50 CFR 300.97, and is exempt from review under Executive Order 12866.
16 U.S.C. 3636(b).
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule.
This final rule implements management measures previously approved for Amendment 6 to the Tilefish Fishery Management Plan and publicizes status quo management measures for 2018. Amendment 6 was developed by the Mid-Atlantic Fishery Management Council to establish management measures and 2017 harvest limits for the blueline tilefish fishery north of the Virginia/North Carolina border. The intended effect of this action is to establish permanent management measures for this fishery, consistent with requirements of the Magnuson-Stevens Act.
This rule is effective December 15, 2017.
Copies of Amendment 6 and the Environmental Assessment (EA), with its associated Finding of No Significant Impact (FONSI) and the Regulatory Impact Review (RIR), are available from the Mid-Atlantic Fishery Management Council, 800 North State Street, Suite 201, Dover, DE 19901. The Amendment 6 EA/FONSI/RIR is also accessible online at:
Douglas Potts, Fishery Policy Analyst, 978-281-9341.
This final rule concurrently approves Amendment 6 to the Tilefish Fishery Management Plan (FMP) on behalf of the Secretary of Commerce and finalizes implementing regulations. The Mid-Atlantic Fishery Management Council developed this amendment to establish management measures for the blueline tilefish fishery in Federal waters north of the Virginia/North Carolina border, consistent with the requirements of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). We published a notice of availability on June 14, 2017 (82 FR 27223), announcing a 60-day period for the public to review and provide comments on whether we, acting on behalf of the Secretary of Commerce, should approve Amendment 6. This comment period ended on August 14, 2017. On June 28, 2017, we published a proposed rule (82 FR 29263) to implement the amendment's specific measures and solicited comments on the proposed measures for a 30-day period that ended on July 28, 2017.
We reviewed all comments received during these comment periods, whether directed at our approval decision or the proposed regulations. See
We are approving all Amendment 6 measures, as outlined in our June 28, 2017, proposed rule. However, given their complexity and novelty, development and implementation of permitting and reporting measures for private recreational vessels will take significantly more time than the other, more traditional management measures in this action. Therefore, we are approving, but delaying implementation of, the recreational permitting and reporting requirements. More information on the approved measures is outlined below.
The management unit for blueline tilefish encompasses the U.S. Exclusive Economic Zone (EEZ) from the North Carolina/Virginia border (36.550278 N. Latitude) extending north to the maritime boundary with Canada. This management unit is consistent with the Council's management unit for golden tilefish.
Amendment 6 establishes the management objectives of the current Tilefish FMP to apply for blueline tilefish as well, with the addition that, “management will reflect blueline tilefish's susceptibility of overfishing and the need of an analytical stock assessment.”
Section 303(a)(10) of the Magnuson-Stevens Act requires that FMPs specify criteria for identifying when the fishery is overfished. Amendment 6 defines stock status determination criteria for blueline tilefish based on the results of the most recent approved stock assessment, which is consistent with all of the Council's other FMPs. The Council anticipates new stock status determination criteria will be established through a stock assessment currently being jointly conducted by the South Atlantic and Mid-Atlantic Fishery Management Councils through the Southeast Data, Assessment, and Review process (SEDAR 50). The assessment report is expected in the fall of 2017.
The Magnuson-Stevens Act also requires all FMPs contain measures that are “necessary and appropriate for the conservation and management of the
A commercial fishing vessel is required to be issued an open-access tilefish commercial vessel permit in order to retain and land blueline tilefish. This is the same vessel permit required for vessels fishing for golden tilefish; a vessel that has this permit already does not need a separate permit. Vessel owners and operators are subject to the current requirements to have an operator permit and to maintain and submit Vessel Trip Reports (VTRs) for each fishing trip.
Fishing vessels that carry recreational anglers for hire are required to have an open-access tilefish charter/party vessel permit in order to fish for, retain, or land blueline tilefish. This is the same charter/party vessel permit for golden tilefish, so a vessel that has this permit already does not need a separate permit. Vessel owners and operators would be subject to the current requirements to have an operator permit and to maintain and submit VTRs for each fishing trip.
A commercial seafood dealer must have a tilefish dealer permit in order to purchase, possess, or receive blueline tilefish harvested from the Tilefish Management Unit. This is the same dealer permit already in use for dealers of golden tilefish in the region.
Details about permit requirements for commercial fishing vessels, party/charter vessels, vessel operators, and commercial dealers, including application forms, are available at:
With this action we approve the Amendment 6 requirement for private recreational vessels to obtain a permit to fish for or retain golden or blueline tilefish in the Tilefish Management Unit. However, additional development work is necessary before we can issue recreational tilefish permits or require private anglers to start reporting their catch. Specific details of a private recreational vessel permit and reporting system will be proposed at a later date with additional opportunity for public comment, consistent with requirements of the Administrative Procedure Act.
Commercial vessels are limited to a maximum possession of 300 lb (136 kg) of blueline tilefish per trip. Blueline tilefish can be gutted, but must be landed with the head and fins naturally attached.
The applicable recreational blueline tilefish possession limit depends on the type of vessel used. Anglers fishing from private vessels are allowed to keep up to three blueline tilefish per person per trip. Anglers fishing from a for-hire vessel that has been issued a valid Tilefish Charter/Party Permit, but does not have a current U.S. Coast Guard safety inspection sticker can retain up to five blueline tilefish per person per trip. Finally, anglers on for-hire vessels that have both a valid Tilefish Charter/Party Permit and a current U.S. Coast Guard safety inspection sticker can retain up to seven blueline tilefish per person per trip.
The recreational fishery for blueline tilefish is open from May 1 through October 31, annually. Recreational anglers are prohibited from fishing for or possessing blueline tilefish outside of this season.
Section 303(a)(15) of the Magnuson-Stevens Act requires FMPs to establish a mechanism for specifying annual catch limits (ACL), implementing regulations, or annual specifications to prevent overfishing. In addition, the Act requires the Council's SSC to provide it with ongoing scientific advice, including recommendations for ABC (see Magnuson-Stevens Act 302(g)(1)(B)). Amendment 6 retains the same ABC control rules and risk policy for blueline tilefish used for other Mid-Atlantic Council stocks, described in the regulations at 50 CFR 648.20 and 648.21.
The ACL process approved for blueline tilefish under Amendment 6 is consistent with the specifications-setting process for other stocks managed by the Council. The Council's SSC will review the available scientific information, the ABC control rule, and other relevant information before making ABC recommendations to the Council for up to three years. The recommendations of the SSC will be reviewed by the existing Tilefish Monitoring Committee, which will provide recommendations to the Council and/or relevant committee to ensure the blueline tilefish specifications are not exceeded and to address any other operational aspects of the fishery. To establish specific harvest limits, the recommended ABC will be allocated to establish separate ACLs for the commercial and recreational sectors of the fishery (73 percent to recreational and 27 percent to commercial). These ACLs may be reduced to account for management uncertainty to establish annual catch targets (ACTs). Finally, anticipated discards are subtracted to determine the total allowable landings (TAL) amount for each sector. The Council would develop other management measures (seasons, trip limits, etc., as described above) that are expected to meet the TAL and not exceed the ACL. If the Council re-establishes a research set-aside program, up to three percent of the TAL may be set aside in such a program.
The Magnuson-Stevens Act requires that FMPs include measures to ensure accountability with ACLs, and NMFS has created guidelines for how management measures might meet this requirement (see § 600.310(g)). This action implements different accountability measures (AMs) to address the particular needs of the commercial and recreational sectors of the fishery.
Commercial blueline tilefish landings will be monitored during the fishing year based on dealer reports and other available information. If we determine the commercial TAL will be exceeded, we will close the commercial blueline tilefish fishery, prohibiting possession or landing blueline tilefish for sale for the remainder of the fishing year, through publication of a notice in the
Catch data for the recreational fishery is much more uncertain than for the commercial fishery. We will compare the three-year moving average of recreational catch to the three-year average of the recreational ACL to
If the most recent estimate of biomass is below the B
If the most recent estimate of biomass is above the biomass threshold, but below the biomass target (B/B
We approve the following EFH definition for different life stages of blueline tilefish based on the best available scientific information:
The Council is currently conducting a comprehensive review of EFH designations and fishery impacts on habitat for all Council-managed species, including blueline tilefish. The EFH Review Fishery Management Action Team will review scientific and technical information on fish habitat and develop recommendations as to whether changes to the existing EFH descriptions and other habitat components of the FMPs are warranted. Based on this review, the Council may choose to modify its FMPs (
Framework adjustments allow the Council to make changes to management measures that were previously considered in the FMP or FMP amendment through a more efficient process than a full FMP amendment. The full list of blueline tilefish management measures that could be changed by framework adjustment were published in the proposed rule and are not repeated here.
Table 1 outlines catch limits for blueline tilefish for the 2017 fishing year. We will count landings of blueline tilefish in or from the Tilefish Management Unit that have already occurred in 2017 against these limits when determining if a harvest limit has been met or exceeded.
The regulations at § 648.292(b)(2) state in part that the previous year's specifications will remain effective unless revised through the specification process and/or the research quota process described in paragraph (b)(3) of the section and NMFS will issue notification in the
We received 42 comments on the notice of availability and proposed rule. The majority of comments were from individuals. Four commenters self-identified as owners of for-hire recreational vessels. One commenter identified as president of a recreational saltwater fishing association with over
Numerous commenters expressed opposition to the proposed tiered recreational possession limits. A dozen commenters said the limits unfairly favored for-hire vessels. Ten commenters stated the three-fish per person limit for private vessels was unreasonably low. Twenty commenters generally opposed any differentiation between aspects of the recreational fishery. Six individuals stated the low limit would increase dead discards of blueline tilefish when anglers target co-occurring species such as golden tilefish or black sea bass. Twenty-five commenters expressed support for the seven-fish per person limit across the board that was in the Council's public hearing draft of the Amendment.
A majority of commenters (26) expressed opposition to the proposed recreational closed season. Twenty commenters noted they typically catch blueline tilefish and black sea bass together and seasons for these species need to be coordinated to avoid excessive discard of either species. Several individuals stated blueline tilefish is one of the few species available during the winter months, and a closure could preclude any recreational fishing during that time.
One commenter expressed opposition to a requirement for another vessel permit for his charter boat. A few commenters noted Virginia already has recreational permit and reporting requirements, and any new requirements may be redundant. One commenter supported the proposed permit for private recreational vessels, suggesting we require vessels get a letter of authorization (LOA) until the new recreational permit is fully implemented.
Apart from the specific comments on the recreational possession limits and closed season addressed above, the recreational fishing association and several individuals submitted matching comments opposing the process by which the Council selected those measures. These 20 commenters feel they did not have an adequate opportunity to express to the Council their opposition to these measures, and, therefore, ask the Secretary to disapprove the Amendment and remand it to the Council for further public input.
Many individuals cited the time and expense that recreational anglers invest to participate in this fishery. These individuals indicated that a closed season, and to a lesser extent low possession limits, could have adverse impact on local businesses.
There are no changes to the measures from the proposed rule.
Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the Administrator, Greater Atlantic Region, NMFS, has determined that this final rule is consistent with Amendment 6, other provisions of the Magnuson-Stevens Act, and other applicable law.
This final rule has been determined to be not significant for purposes of Executive Order 12866. Because this rule is not significant under Executive Order 12866, this rule is not an Executive Order 13771 regulatory action.
The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this action will not have a significant economic impact on a substantial number of small entities. The factual basis for the certification was published in the proposed rule and is not repeated here. No comments were received regarding this certification. As a result, a regulatory flexibility analysis was not required and none was prepared.
Fisheries, Fishing, Reporting and recordkeeping requirements.
For the reasons set out in the preamble, 50 CFR part 648 is amended as follows:
16 U.S.C. 1801
(a) This part implements the fishery management plans (FMPs) for the Atlantic mackerel, squid, and butterfish fisheries (Atlantic Mackerel, Squid, and Butterfish FMP); Atlantic salmon (Atlantic Salmon FMP); the Atlantic sea scallop fishery (Scallop FMP); the Atlantic surfclam and ocean quahog fisheries (Atlantic Surfclam and Ocean Quahog FMP); the NE multispecies and monkfish fisheries ((NE Multispecies FMP) and (Monkfish FMP)); the summer flounder, scup, and black sea bass fisheries (Summer Flounder, Scup, and Black Sea Bass FMP); the Atlantic bluefish fishery (Atlantic Bluefish FMP); the Atlantic herring fishery (Atlantic Herring FMP); the spiny dogfish fishery (Spiny Dogfish FMP); the Atlantic deep-sea red crab fishery (Deep-Sea Red Crab FMP); the golden and blueline tilefish fisheries (Tilefish FMP); and the NE skate complex fisheries (Skate FMP). These FMPs and the regulations in this part govern the conservation and management of the above named fisheries of the Northeastern United States.
The additions and revisions read as follows:
(4) For the golden tilefish fishery, from November 1 through October 31 of the following year.
(2) A person or entity eligible to hold golden tilefish IFQ allocation, who receives temporarily transferred golden tilefish IFQ allocation, as specified at § 648.294(e)(1).
(2) An IFQ allocation permit holder who temporarily transfers golden tilefish IFQ allocation, as specified at § 648.294(e)(1).
(a) * * *
(12)
(A) A commercial vessel must fish under the authorization of a golden tilefish IFQ allocation permit, issued pursuant to § 648.294, to possess, or land golden tilefish in excess of the trip limit as specified under § 648.295(a).
(B) [Reserved]
(ii)
(b)
(a)
(a)
(u)
(1)
(ii)
(iii)
(B) Operate a vessel that takes recreational fishermen for hire to fish for golden or blueline tilefish in the Tilefish Management Unit without a valid tilefish charter/party vessel permit, as required in § 648.4(a)(12)(i).
(2)
(A) The tilefish are being fished for or were harvested in or from the Tilefish Management Unit by a vessel holding a valid tilefish permit under this part, and the operator on board such vessel has been issued an operator permit that is on board the vessel.
(B) The tilefish were harvested by a vessel that has not been issued a tilefish permit and that was fishing exclusively in State waters.
(C) The tilefish were harvested in or from the Tilefish Management Unit by a vessel, other than a charter/party vessel, that is engaged in recreational fishing.
(ii) Land or possess golden or blueline tilefish harvested in or from the Tilefish Management Unit, in excess of either:
(A) The relevant commercial trip limit specified at § 648.295, unless possessing golden tilefish authorized pursuant to a valid tilefish IFQ allocation permit, as specified in § 648.294(a).
(B) The relevant recreational possession limit specified at § 648.296, if engaged in recreational fishing including charter/party vessels.
(iii) Land golden tilefish harvested in or from the Tilefish Management Unit in excess of that authorized under a tilefish IFQ allocation permit as described at § 648.294(a).
(iv) Fish for golden or blueline tilefish inside and outside of the Tilefish Management Unit on the same trip.
(v) Discard golden tilefish harvested in or from the Tilefish Management Unit, as defined in § 648.2, unless participating in recreational fishing, as defined in § 648.2, or while fishing subject to a trip limit pursuant to § 648.295(a).
(vi) Land or possess golden tilefish in or from the Tilefish Management Unit, on a vessel issued a valid tilefish permit under this part, after the incidental golden tilefish fishery is closed pursuant to § 648.295(a)(2), unless fishing under a valid tilefish IFQ allocation permit as specified in § 648.294(a), or engaged in recreational fishing.
(vii) Land or possess blueline tilefish in or from the Tilefish Management Unit, on a vessel issued a valid tilefish permit under this part, after the commercial blueline tilefish fishery is closed pursuant to § 648.295(b)(2), unless engaged in recreational fishing.
(viii) Land or possess blueline tilefish in or from the Tilefish Management Unit, on a vessel issued a valid commercial tilefish permit under this part, that do not have the head and fins naturally attached to the fish.
(3)
(ii) Purchase or otherwise receive for commercial purposes golden or blueline tilefish caught in the EEZ from outside the Tilefish Management Unit unless otherwise permitted under 50 CFR part 622.
(4)
(a)
(1) [Reserved]
(2)
(b)
(1)
(2)
(c)
(1) If an ACL is exceeded with a frequency greater than 25 percent (
(2) The MAFMC may specify more frequent or more specific ACL performance review criteria as part of a stock rebuilding plan following a determination that either the golden tilefish or blueline tilefish stock has become overfished.
(3) Performance reviews shall not substitute for annual reviews that occur to ascertain if prior year ACLs have been exceeded, but may be conducted in conjunction with such reviews.
(a)
(1)
(2)
(b)
(1)
(2)
(c)
(a)
(1)
(2)
(ii) The sum of the TAL and the estimated discards shall be less than or equal to the ACT.
(3)
(4)
(5)
(b)
(1)
(i) Total Allowable Landings (TAL) for both the commercial and recreational sectors for each fishing year, where the sum of the TAL and sector-specific estimated discards shall be less than or equal to the sector ACT;
(ii) Research quota for both the commercial and recreational sectors set from a range of 0 to three percent of the TAL, as described in paragraph (b)(3) of this section;
(iii) Commercial trip limit;
(iv) Commercial minimum fish size;
(v) Recreational possession limit;
(vi) Recreational minimum fish size;
(vii) Recreational season;
(viii) Retention requirements; and/or
(ix) Any other measure needed to ensure the ACLs are not exceeded.
(2)
(3)
(a)
(2)
(b)
(2)
(i)
(ii)
(3)
(4)
(i)
(ii)
(A)
(B)
(
(
(iii)
(a)
(2) Allocations shall be issued in the form of an annual IFQ allocation permit. The IFQ allocation permit shall specify the quota share percentage held by the IFQ allocation permit holder and the total pounds of golden tilefish that the IFQ allocation permit holder is authorized to harvest.
(b)
(4)
(e) * * *
(3) * * *
(ii) A transfer of IFQ allocation or quota share will not be approved by the Regional Administrator if it would result in an entity holding, or having an interest in, a percentage of IFQ allocation exceeding 49 percent of the total golden tilefish adjusted TAL.
(iii) For the purpose of calculating the appropriate IFQ cost recovery fee, if the holder of an IFQ allocation leases additional IFQ allocation, the quantity and value of golden tilefish landings made after the date the lease is approved by the Regional Administrator are attributed to the transferred quota before being attributed to the allocation holder's base IFQ allocation, if any exists. In the event of multiple leases, landings would be attributed to the leased allocations in the order the leases were approved by the Regional Administrator. As described in paragraph (h) of this section, a tilefish IFQ quota share allocation holder shall incur a cost recovery fee, based on the value of landings of golden tilefish authorized under the allocation holder's annual tilefish IFQ allocation, including allocation that is leased to another IFQ allocation permit holder.
(4)
(f)
(g)
(h) * * *
(1)
(2) * * *
(ii)
(A) The ex-vessel value for each pound of golden tilefish landed by an IFQ allocation permit holder shall be determined from Northeast Federal dealer reports submitted to NMFS, which include the price per pound paid to the vessel at the time of dealer purchase.
(B) The cost recovery fee percentage shall not exceed three percent of the total value of golden tilefish landings, as required under section 304(d)(2)(B) of the Magnuson-Stevens Act.
(4) * * *
(i) At any time thereafter, notify the IFQ allocation permit holder in writing that his/her IFQ allocation permit is suspended, thereby prohibiting landings of tilefish above the incidental limit, as specified at § 648.295(a).
(a)
(2)
(b)
(2)
(a)
(b)
(2)
(3)
(c)
(a) * * *
(1) * * *
(xix) Recreational management measures, including the bag limit, minimum fish size limit, seasons, and gear restrictions or prohibitions;
(xx) Golden tilefish IFQ program review components, including capacity reduction, safety at sea issues, transferability rules, ownership concentration caps, permit and reporting requirements, and fee and cost-recovery issues;
(xxi) Blueline tilefish recreational permitting and reporting requirements previously considered by the MAFMC; and
(xxii) Blueline tilefish allocations to the commercial and recreational sectors of the fishery within the range of allocation alternatives considered by the MAFMC in Amendment 6.
(xxiii) Measures that require significant departures from previously contemplated measures or that are otherwise introducing new concepts may require a formal amendment of the FMP instead of a framework adjustment.
Nuclear Regulatory Commission.
Regulatory basis; availability.
The U.S. Nuclear Regulatory Commission (NRC) is making available a regulatory basis document in support of a rulemaking that would develop new emergency preparedness (EP) requirements for small modular reactors (SMRs) and other new technologies (ONTs), such as non-light-water reactors and medical isotope production facilities. The regulatory basis concludes that there is sufficient justification to proceed with rulemaking to develop a clear set of rules and guidance for EP for SMRs and ONTs. The regulatory basis also concludes that the principle of using a dose-at-distance and consequence-oriented approach to determine the appropriate size of an emergency planning zone can be applied to SMRs and ONTs. The NRC is not seeking public comment on this document. There will be an opportunity for formal public comment on the proposed rule when it is published in the
The regulatory basis is available on November 15, 2017.
Please refer to Docket ID NRC-2015-0225 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
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•
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Andrew Carrera, Office of New Reactors, telephone: 301-415-1078, email:
The NRC published the draft regulatory basis in the
The NRC received 57 written comments from governmental and non-governmental organizations and individuals, which are available at
As the NRC continues its ongoing proposed rulemaking effort to implement EP requirements for SMRs and ONTs in parts 50 and 52 of title 10 of the
The NRC may post additional materials relevant to this rulemaking at
For the Nuclear Regulatory Commission.
Federal Election Commission.
Proposed rule; extension of comment period.
On October 10, 2017, the Federal Election Commission reopened the comment period on the Advance Notice of Proposed Rulemaking (“ANPRM”) seeking comment on whether to begin a rulemaking to revise its regulations concerning disclaimers on certain internet communications and, if so, on what changes should be made to those rules. The Commission has decided to extend the comment period for one business day due to technological difficulties.
The comment period for the ANPRM published October 13, 2011 (76 FR 63567), and reopened on October 10, 2017 (82 FR 46937), is extended. Comments must be received on or before November 13, 2017.
All comments must be in writing. Commenters are encouraged to submit comments electronically via the Commission's Web site at
Each commenter must provide, at a minimum, his or her first name, last name, city, state, and zip code. All properly submitted comments, including attachments, will become part of the public record, and the Commission will make comments available for public viewing on the Commission's Web site and in the Commission's Public Records Office. Accordingly, commenters should not provide in their comments any information that they do not wish to make public, such as a home street address, personal email address, date of birth, phone number, social security number, driver's license number, or any information that is restricted from disclosure, such as trade secrets or commercial or financial information that is privileged or confidential.
Mr. Neven F. Stipanovic, Acting Assistant General Counsel, or Ms. Jessica Selinkoff, Attorney, 999 E Street NW., Washington, DC 20463, (202) 694-1650 or (800) 424-9530.
On October 10, 2017, the Commission reopened the comment period on an ANPRM published in the
On behalf of the Commission.
Bureau of Economic Analysis, Commerce.
Notice of proposed rulemaking.
This proposed rule would amend regulations of the Department of Commerce's Bureau of Economic Analysis (BEA) to renew reporting requirements for the mandatory BE-120 Benchmark Survey of Transactions in Selected Services and Intellectual Property with Foreign Persons. This survey will apply to the 2017 fiscal reporting year. The benchmark survey covers the universe of transactions in selected services and intellectual property and is BEA's most comprehensive survey of such transactions. For the 2017 benchmark survey, BEA proposes several changes in the data items collected, the design of the survey form, and the reporting requirements for the survey. This mandatory survey would be conducted under the authority of the International Investment and Trade in Services Survey Act.
Comments on this proposed rule will receive consideration if submitted in writing on or before 5:00 p.m. January 16, 2018.
You can submit comments, identified by RIN 0691-AA87, and referencing the agency name (Bureau of Economic Analysis), by any of the following methods:
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•
•
•
•
Written comments regarding the burden-hour estimates or other aspects of the collection-of-information requirements contained in the proposed rule should be sent to both BEA through any of the methods above and to the Office of Management and Budget (OMB), OIRA, Paperwork Reduction Project 0608-0058, Attention PRA Desk Officer for BEA, via email at
Christopher Stein, Chief, Services Surveys Branch (BE-50), Balance of
The BE-120 Benchmark Survey of Transactions in Selected Services and Intellectual Property with Foreign Persons is a mandatory survey and is typically conducted once every five years by BEA under the authority provided by the International Investment and Trade in Services Survey Act (22 U.S.C. 3101-3108), hereinafter, “the Act.” The Act provides that data reported to BEA on this survey are confidential and may be used only for analytical and statistical purposes. Without prior written permission from the survey respondent, the information cannot be presented in a manner that allows it to be individually identified. An individual respondent's report cannot be used for purposes of taxation, investigation, or regulation. Copies retained by BEA are immune from legal process. Per the Cybersecurity Enhancement Act of 2015, a respondent's data are protected from Cybersecurity risks through security monitoring of the BEA information systems.
Unlike most other BEA surveys conducted pursuant to the Act, a response would be required from persons subject to the reporting requirements of the BE-120, whether or not they are contacted by BEA, to ensure complete coverage of services and intellectual property transactions between U.S. persons (any individual or organization subject to the jurisdiction of the United States) and foreign persons.
In 2012, BEA established regulatory guidelines for collecting data on international trade in services and direct investment (77 FR 24373; April 24, 2012). This proposed rule, unlike most annual or quarterly BEA surveys conducted pursuant to the Act, would amend those regulations to require a response from persons subject to the reporting requirements of the BE-120, whether or not they are contacted by BEA.
The benchmark survey is intended to cover the universe of selected services and intellectual property transactions with foreign persons and is BEA's most comprehensive survey of such transactions. In nonbenchmark years, the universe estimates covering these transactions are derived from the sample data reported on BEA's BE-125 Quarterly Survey of Transactions in Selected Services and Intellectual Property with Foreign Persons. The BE-125 collects similar information but at a more aggregated level of detail by type of service. The data are collected from a sample of respondents. BEA uses cutoff sampling for the BE-125, meaning that respondents must only report on the BE-125 if they have transactions that surpassed a designated reporting threshold; greater than $6 million for sales and/or greater than $4 million for purchases. The same reporters that file on a quarterly basis throughout fiscal year 2017 will also be required to report on the 2017 BE-120 survey. The BE-120 survey is conducted to reconcile reported quarterly data at an annual level for those respondents filing on the BE-125 survey, and also to collect data from companies not subject to filing on an ongoing quarterly basis.
The benchmark data, including data from respondents not subject to filing on an ongoing quarterly basis, will be used, in conjunction with quarterly data collected on the companion BE-125 survey, to produce estimates of selected services components for BEA's international transactions accounts (ITAs), national income and product accounts, and industry accounts. If this information was not collected on the BE-120 survey, BEA would need to expand the scope of the BE-125 quarterly survey by collecting additional data items and reducing reporting thresholds, resulting in an increased number of respondents and a measurable impact on the reporting burden each quarter. The data are needed to monitor U.S. trade in services, to analyze the impact on the U.S. economy and on foreign economies, to compile and improve the U.S. economic accounts, to support U.S. commercial policy on trade in services, to conduct trade promotion, and to improve the ability of U.S. businesses to identify and evaluate market opportunities.
A full list of the services and intellectual property covered by the BE-120 survey can be found in the regulatory text for new § 801.11 at the end of this document.
This proposed rule would amend 15 CFR part 801 by adding new § 801.11 to set forth the reporting requirements for the BE-120 Benchmark Survey of Transactions in Selected Services and Intellectual Property with Foreign Persons.
The proposed changes would amend the regulations and the survey form for the BE-120 benchmark survey. These amendments include changes in data items collected, the design of the survey form, and the reporting requirements for those not subject to reporting on the mandatory schedule(s) of the survey.
BEA proposes to change the reporting requirements for reporters with transactions in covered services below the threshold for mandatory reporting on the schedule(s) of the survey ($2 million in combined sales or $1 million in combined purchases for fiscal year 2017). While responding to benchmark surveys is always mandatory, for the previous BE-120 survey, reporters with transactions below these thresholds were required only to provide a figure for total sales and/or total purchases for all covered transactions. These reporters had the option of providing additional detail for each covered transaction by transaction type, by country, and by affiliation; such additional detail was voluntary rather than required. For the 2017 BE-120, however,
This change will impose minimal additional burden for reporters because the additional information to be reported is information that respondents would have needed to compile or estimate previously in order to apply the reporting requirements. Under the prior approach, reporters would have needed to compile or estimate the dollar amount of their sales to and purchases from foreigners by transaction type in order to determine if their transactions met the threshold for mandatory reporting on the schedules. Under the new approach, BEA is simply requiring that respondents report those transaction totals.
BEA proposes to add and modify some items on the benchmark survey form. Most of the additions are proposed in response to suggestions from data users and would allow BEA to more closely align with international guidelines, and publish more information on U.S. trade in services. Some additions and modifications will allow BEA to align the ITAs more closely with international economic accounting guidelines.
The following items would be added to the benchmark survey:
(1) Mandatory questions will be added to collect information on contract manufacturing services. On the 2011 BE-120 survey, respondents were requested to provide information on transactions related to contract manufacturing services on a voluntary basis. The 2017 BE-120 survey will
(2) Mandatory questions will be added to collect information on trade in services by the location of the U.S. and foreign transactors when the services were supplied. For transactions in selected services, respondents will be required to provide information about the location of the transactors when the services were supplied: (1) Cross-border supply, where both the supplier and the consumer remain in their respective territories; (2) consumption abroad, where the consumer consumes the service outside his or her home territory, and (3) presence of natural persons, where an individual (either the service supplier himself, if he or she is a self-employed person, or his or her employee) is present abroad in order to supply a service.
In addition, BEA proposes to make the following modifications to the survey form:
(1) Mandatory Schedules A and B will be expanded to collect additional detail on intellectual property (IP) transactions. A U.S. person who engages in IP transactions with foreign persons will be required to distribute their receipts and/or payments according to the type of transaction and the type of IP. The covered transaction types are: (1) transactions for the rights to use IP, (2) transactions for the rights to reproduce and/or distribute IP, and (3) transactions for the outright sales or purchases of IP. Reporters will be required to identify the foreign country(ies) involved in the transaction(s) and to distribute the amounts reported for each country according to whether the foreign person is the U.S. person's foreign affiliate, part of the U.S. person's foreign parent group, or an unaffiliated foreign person. The BE-125 survey was modified in 2016 to align with international guidelines by collecting receipts and/or payments according to the above types of transactions and types of IP. Therefore, the proposed modification to the BE-120 is consistent with the change made to the BE-125 survey.
(2) Research and development services will be broken out into two categories: (1) Provision of customized and non-customized R&D services, and (2) other R&D services, including testing. This will allow BEA to align the ITAs with international guidelines and will improve the measurement of investment in R&D in the national income and product accounts.
(3) Engineering, architectural, and surveying services will be broken out into three categories: (1) Architectural services; (2) engineering services; (3) surveying, cartography, certification, testing, and technical inspection services. The current category of industrial engineering services will be dropped and captured within engineering services.
(4) Management, consulting, and public relation services will be broken out into three categories: (1) Market research services; (2) public opinion polling services; and (3) other management, consulting, and public relations services. Trade exhibition and sales convention services would be collected separately.
(5) Database and other information services would be broken out into two components: (1) News agency services, and (2) other information services.
(6) Computer services would be expanded into three categories: (1) Computer software, including end-user licenses and customization services; (2) cloud computing and data storage services; and (3) other computer services.
(7) Several service categories previously collected under “Other selected services” will be collected separately. These services include audiovisual services, artistic-related services, health services, heritage and recreational services, other personal services, disbursements for sales promotion and representation, photographic services (including satellite photography), and space transport services.
(8) Mandatory Schedule C will be modified to only collect related goods details for construction services. On the 2011 BE-120 survey, exports (sales) of three service types are collected on a separate schedule, Schedule C, to allow for reporting of information on the gross operating revenues and related goods exports and foreign expenses. The three categories are: (1) Construction services; (2) engineering, architectural, and surveying services; and (3) mining services. On the 2017 BE-120, only construction services will be collected on Schedule C. Mining services as well as the three new categories that will replace engineering, architectural, and surveying services will be collected on Schedule A.
(9) The identification of transaction types and voluntary reporting of additional detail will be streamlined. On the 2011 BE-120, reporters were sent through a series of check boxes to identify which of the covered transactions (sales or purchases) they had with foreign persons, and to determine if they had amounts which met the thresholds for reporting on the mandatory schedules. Based on the results of this box-checking, reporters were then required to report transactions by country and by affiliation on the mandatory schedule(s), or were given multiple options to voluntarily report this information. This approach resulted in an inefficient use of space on the survey and caused confusion among reporters. With the 2017 BE-120, BEA will streamline the process for identifying which transactions the reporter had and for reporting country and affiliation information. All reporters, regardless of the amount of their transactions in covered services will be required to provide a total dollar amount for their sales and purchases, as applicable, by transaction type. Reporters with transactions below the threshold will then have the option to voluntarily report information on transactions by country and by affiliation on the standard reporting schedules.
In addition, BEA proposes to redesign the format and wording of the survey. The new design would incorporate improvements made to other BEA surveys as well as enhancements from a recent cognitive review conducted with selected survey respondents. Survey instructions and data item descriptions would be changed to improve clarity and ensure the benchmark survey form is more consistent with other BEA surveys.
This proposed rule has been determined to be significant for purposes of E.O. 12866.
This proposed rule does not contain policies with Federalism implications sufficient to warrant preparation of a Federalism assessment under E.O. 13132.
This rule is not subject to the requirements of E.O. 13771 because this rule results in no more than
This proposed rule contains a collection-of-information requirement subject to review and approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3520 (PRA). The requirement will be submitted to OMB for approval as a reinstatement, with change, of a previously approved collection for which approval has expired under OMB control number 0608-0058. Surveys were collected for the 2011 BE-120 in calender years 2012 and 2013. No survey submissions were solicited by BEA after the expiration and discontinuance of the collection in October of 2014.
Notwithstanding any other provisions of law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA unless that collection displays a currently valid OMB control number.
The BE-120 survey, as proposed, is expected to result in the filing of reports from approximately 15,500 respondents. Approximately 11,500 respondents would report mandatory data on the survey, and approximately 4,000 would file exemption claims. The respondent burden for this collection of information would vary from one respondent to another but is estimated to average (1) 23 hours for the 5,000 respondents that file mandatory or voluntary data by country and affiliation for relevant transaction types on the mandatory schedules; (2) 4 hours for the 6,500 respondents that file mandatory data by transaction type but not by country or affiliation—including time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information; and (3) 1 hour for other responses. Thus the total respondent burden for this survey is estimated at 145,000 hours, or about 9.5 hours (145,000 hours/15,500 respondents) per response, compared to 105,000 hours, or about 7 hours (105,000/15,000) for the previous BE-120 benchmark survey in 2011. The increase in burden hours is due to an increase in the size of the respondent universe as well as changes to the content and reporting requirements of the survey.
As part of its continuing effort to reduce paperwork and respondent burden, the Department of Commerce invites the general public and other Federal agencies to comment on proposed and/or continuing information collections, as required by the PRA. Comments are requested concerning: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the burden estimate; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology.
Written comments regarding the burden-hour estimates or other aspects of the collection-of-information requirements contained in the proposed rule should be sent to both BEA and OMB following the instructions given in the
The Chief Counsel for Regulation, Department of Commerce, has certified to the Chief Counsel for Advocacy, Small Business Administration, under the provisions of the Regulatory Flexibility Act, 5 U.S.C. 605(b), that this proposed rulemaking, if adopted, will not have a significant economic impact on a substantial number of small entities. The changes proposed in this rule are discussed in the preamble and are not repeated here.
A BE-120 report would be required of any U.S. person that had sales to, or purchases from, foreign persons in any of the types of selected services or intellectual property listed above. While the survey would not collect data on total sales or other measures of the overall size of the respondents to the survey, historically the respondents to the existing quarterly survey of transactions in selected services and intellectual property and to the previous benchmark surveys have been comprised mainly of major U.S. corporations. A completed benchmark survey, as proposed, would be required from U.S. persons who had transactions in any of the covered services and intellectual property with foreign persons. For U.S. persons who have transactions that exceeded $2 million in combined sales or $1 million in combined purchases for fiscal year 2017, a completed benchmark survey would include data on total sales and/or purchases of each of the covered types of services and intellectual property transactions with totals disaggregated by country and by relationship to the foreign transactor (foreign affiliate, foreign parent group, or unaffiliated). For U.S. persons who have transactions that fall below $2 million in sales or $1 million in purchases for fiscal year 2017, a completed benchmark would include total sales and/or purchases for each type of transaction in which they engaged. This exemption level would exclude most small businesses from mandatory reporting of detail by country and by affiliation. Any small businesses that may be required to report would likely have engaged in a small number of covered transactions, and are therefore expected to be below the expected average burden of 9.5 hours per response. Even if the responses for small businesses took the expected average burden of 9.5 hours per response, that would not constitute a significant impact on any small business or other entity. Because this rule would not have a significant impact on any small entities, an Initial Regulatory Flexibility Analysis is not required and none has been prepared.
Economic statistics, Foreign trade, International transactions, Penalties, Reporting and recordkeeping requirements.
For reasons set forth in the preamble, BEA proposes to amend 15 CFR part 801 as follows:
5 U.S.C. 301; 15 U.S.C. 4908; 22 U.S.C. 3101-3108; E.O. 11961 (3 CFR, 1977 Comp., p. 86), as amended by E.O. 12318 (3 CFR, 1981 Comp. p. 173); and E.O. 12518 (3 CFR, 1985 Comp. p. 348).
Except for surveys subject to rulemaking in §§ 801.7, 801.8, 801.9, 801.10, and 801.11, reporting requirements for all other surveys conducted by the Bureau of Economic Analysis shall be as follows:
(a) Notice of specific reporting requirements, including who is required to report, the information to be reported, the manner of reporting, and the time and place of filing reports, will be published by the Director of the Bureau of Economic Analysis in the
(b) In accordance with section 3104(b)(2) of title 22 of the United States
(c) Persons not notified in writing of their filing obligation by the Bureau of Economic Analysis are not required to complete the survey.
The BE-120 Benchmark Survey of Transactions in Selected Services and Intellectual Property with Foreign Persons will be conducted covering fiscal year 2017. All legal authorities, provisions, definitions, and requirements contained in §§ 801.1 through 801.2 and §§ 801.4 through 801.6 are applicable to this survey. Specific additional rules and regulations for the BE-120 survey are given in paragraphs (a) through (e) of this section. More detailed instructions are given on the report form and in instructions accompanying the report form.
(a)
(1) Completing and returning the BE-120 by the due date of the survey; or
(2) If exempt, by completing the determination of reporting status section of the BE-120 survey and returning it to BEA by the due date of the survey.
(b)
(c)
(2) A U.S. person that had combined sales to foreign persons that were $2 million or less or combined purchases from foreign persons that were $1 million or less in the intellectual property or services categories covered by the survey during its 2017 fiscal year, on an accrual basis, is required to provide the total sales and/or purchases for each type of transaction in which they engaged. The $2 million threshold for sales and the $1 million threshold for purchases should be applied to services and intellectual property transactions with foreign persons by all parts of the consolidated domestic U.S. Reporter. Because the $2 million threshold for sales and $1 million threshold for purchases apply separately to sales and purchases, the mandatory reporting requirement may apply only to sales, only to purchases, or to both.
(i)
(ii)
(3)
(d)
(1) Rights related to the use of a patent, process, or trade secret to produce and/or distribute a product or service;
(2) Outright sales of proprietary rights related to patents, processes, and trade secrets;
(3) Rights to use books, music, etc., including end-user rights related to digital content;
(4) Rights to reproduce and/or distribute books, music, etc.;
(5) Outright sales of proprietary rights related to books, music, etc.;
(6) Rights to use trademarks;
(7) Outright sales of proprietary rights related to trademarks;
(8) Rights to use recorded performances and events, including end-user rights related to digital content;
(9) Rights to reproduce and/or distribute recorded performances and events;
(10) Outright sales of proprietary rights related to recorded performances and events;
(11) Rights to broadcast and record live performances and events;
(12) Rights to reproduce and/or distribute general use computer software;
(13) Outright sales of proprietary rights related to general use computer software;
(14) Fees associated with business format franchising;
(15) Outright sales of proprietary rights related to business format franchising;
(16) Rights to use other intellectual property;
(17) Rights to reproduce and/or distribute other intellectual property;
(18) Outright sales of proprietary rights related to other intellectual property;
(19) Accounting, auditing, and bookkeeping services;
(20) Advertising services;
(21) Auxiliary insurance services;
(22) Computer software, including end-user licenses and customization services;
(23) Cloud computing and data storage services;
(24) Other computer services;
(25) Construction services;
(26) News agency services (excludes production costs related to news broadcasters);
(27) Other information services;
(28) Education services;
(29) Architectural services;
(30) Engineering services;
(31) Surveying, cartography, certification, testing and technical inspection services;
(32) Financial services;
(33) Maintenance services;
(34) Installation, alteration, and training services;
(35) Legal services;
(36) Market research services;
(37) Public opinion polling services;
(38) Other management, consulting, and public relations services;
(39) Merchanting services (net receipts);
(40) Mining services;
(41) Operational leasing;
(42) Trade-related services, other than merchanting services;
(43) Artistic-related services;
(44) Premiums paid on primary insurance;
(45) Losses recovered on primary insurance;
(46) Provision of customized and non-customized research and development services;
(47) Other research and development services;
(48) Telecommunications services;
(49) Health services;
(50) Heritage and recreational services;
(51) Audiovisual and production services;
(52) Contract manufacturing services;
(53) Disbursements for sales promotion and representation;
(54) Photographic services (including satellite photography services);
(55) Space transport services;
(56) Trade exhibition and sales convention services;
(57) Agricultural services;
(58) Waste treatment and depollution services; and
(59) Other selected services n.i.e. (not included elsewhere).
(e)
(2) Sales and purchases of financial instruments, including stocks, bonds, financial derivatives, loans, mutual fund shares, and negotiable CDs. (However, securities brokerage is a service).
(3) Income on financial instruments (interest, dividends, capital gain distributions, etc).
(4) Compensation paid to, or received by, employees.
(5) Penalties and fines and gifts or grants in the form of goods and cash (sometimes called “transfers”).
(f)
National Park Service, Interior.
Regulatory review.
The National Park Service (NPS) intends to initiate a rulemaking process that will consider changes to regulations applicable to Alaska that were promulgated in October 2015.
November 15, 2017.
The final rule that is the subject of this announcement may be found at
Andee Sears, Regional Law Enforcement Specialist, Alaska Regional Office, 240 West 5th Ave., Anchorage, AK 99501. Phone (907) 644-3410. Email:
On October 23, 2015, the NPS published a final rule (Final Rule) to amend its regulations for sport hunting and trapping in national preserves in Alaska (80 FR 65325). The Final Rule provided that the NPS does not adopt State of Alaska management actions or laws or regulations that authorize taking of wildlife, which are related to predator reduction efforts (as defined in the Final Rule). The Final Rule affirmed current State prohibitions on harvest practices by adopting them as federal regulation. The Final Rule also changed procedures for closing an area or restricting an activity in NPS areas in Alaska; updated obsolete subsistence regulations; prohibited obstructing persons engaged in lawful hunting or trapping; and authorized the use of native species as bait for fishing. Pursuant to the Congressional Review Act (CRA), the NPS submitted copies of the final rule to Congress on October 16, 2015. A joint resolution of disapproval was not filed by Congress within the time periods specified by the CRA. The Final Rule became effective on November 23, 2015.
The NPS intends to initiate a rulemaking process that will consider changes to the provisions in the Final Rule that were codified in 36 CFR part 13. Throughout this process, the NPS will consider the purpose of Secretarial Order 3347 (“Conservation Stewardship and Outdoor Recreation”) to advance conservation stewardship and increase outdoor recreation opportunities, including hunting and fishing, for all Americans. The NPS will also identify ways to improve recreational hunting and fishing cooperation, consultation, and communication with State of Alaska wildlife managers. The NPS will comply with all applicable laws governing the rulemaking process, including the requirement to provide an opportunity for public comment on any proposed regulatory changes under 5 U.S.C. 553. The NPS is not accepting comments on this announcement. The public will have an opportunity to comment when a proposed rule is published in the
16 U.S.C. 3124; 54 U.S.C. 100101, 100751, 320102; Sec. 13.1204 also issued under Sec. 1035, Pub. L. 104-333, 110 Stat. 4240.
Federal Communications Commission.
Proposed rule.
The Federal Communications Commission proposes to remove the domestic coverage requirement for non-geostationary-satellite orbit (NGSO), fixed-satellite service (FSS) satellite systems.
Comments are due January 2, 2018. Reply comments are due January 29, 2018.
You may submit comments, identified by IB Docket No. 16-408, by any of the following methods:
•
•
For detailed instructions for submitting comments and additional information on the rulemaking process, see the
Clay DeCell,
This is a summary of the Commission's Further Notice of Proposed Rulemaking (FNPRM), FCC 17-122, adopted September 26, 2017, and released September 27, 2017. The full text of the FNPRM is available at
Pursuant to §§ 1.415 and 1.419 of the Commission's rules, 47 CFR 1.415 and 1.419, interested parties may file comments and reply comments on or before the dates indicated on the first page of this document. Comments may be filed using the Commission's Electronic Comment Filing System (ECFS).
•
•
Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail. All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.
• All hand-delivered or messenger-delivered paper filings for the Commission's Secretary must be delivered to FCC Headquarters at 445 12th St. SW., Room TW-A325, Washington, DC 20554. The filing hours are 8:00 a.m. to 7:00 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes and boxes must be disposed of before entering the building.
• Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9050 Junction Drive, Annapolis Junction, MD 20701.
• U.S. Postal Service first-class, Express, and Priority mail must be addressed to 445 12th Street SW., Washington DC 20554.
The proceeding this FNPRM initiates shall be treated as a “permit-but-disclose” proceeding in accordance with the Commission's
This document contains proposed modified information collection requirements. The Commission, as part of its continuing effort to reduce paperwork burdens, invites the general public and the Office of Management and Budget to comment on the information collection requirements contained in this document, as required by the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198,
The Commission requires NGSO FSS systems to provide continuous coverage of the fifty states, Puerto Rico and the U.S. Virgin Islands. Systems with more localized coverages are prohibited. This
The domestic coverage requirement for NGSO FSS systems could be unnecessary or counterproductive, however. For example, among the several pending applications that request waivers of this requirement, one operator seeks to provide service in remote areas of Alaska as part of an “Arctic Satellite Broadband Mission.” Its satellite system would operate in a highly elliptical orbit chosen to maximize service to the Arctic region, but which prevents coverage of the lower United States. Another operator is currently providing low-latency satellite service to Americans at sea. The equatorial orbit of its system, however, precludes U.S. coverage at high latitudes. Such specialized systems may be authorized by foreign administrations and intended to serve only part of the United States. We do not believe it would serve the public interest to block access to these systems solely because of their specialized coverage areas, given that multiple NGSO FSS systems can share the same frequency bands. Rather, we expect that the most efficient way to encourage widespread service offerings by NGSO FSS systems, including in remote and underserved areas of the United States, would be to allow both general and specialized coverage systems.
We therefore propose to remove the domestic coverage requirement for NGSO FSS systems operating in all permitted spectrum bands, which we believe will afford operators greater flexibility in their system designs. We invite comment on this proposal. Given that this requirement applies to NGSO FSS systems by default, is it appropriate to deny access to every concerned frequency band if a system design does not allow for continuous U.S. coverage? What are the advantages of retaining, or removing, this coverage requirement? For parties that support retaining the domestic coverage requirement, are there particular considerations we should take into account when deciding whether or not to waive it in a particular case?
As required by the Regulatory Flexibility Act (RFA), the Commission has prepared this Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on a substantial number of small entities by the policies and rules proposed in this FNPRM. We request written public comments on this IRFA. Commenters must identify their comments as responses to the IRFA and must file the comments by the deadlines for comments on the FNPRM provided above in DATES. The Commission will send a copy of the FNPRM, including this IRFA, to the Chief Counsel for Advocacy of the Small Business Administration. In addition, the FNPRM and IRFA (or summaries thereof) will be published in the
The FNPRM proposes to delete the requirement that non-geostationary, fixed-satellite service systems provide continuous coverage of the fifty United States, Puerto Rico, and the U.S. Virgin Islands, in order to afford operators greater design flexibility.
The proposed action is authorized under Sections 4(i), 7(a), 10, 303, 308(b), and 316 of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 157(a), 160, 303, 308(b), 316.
The RFA directs agencies to provide a description of, and, where feasible, an estimate of, the number of small entities that may be affected by the proposed rules, if adopted. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A small business concern is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (SBA).
The FNPRM proposes to delete a requirement that non-geostationary, fixed-satellite service systems demonstrate that they will provide continuous domestic coverage. This would reduce paperwork costs for such satellite operators.
The RFA requires an agency to describe any significant, specifically small business, alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): “(1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance and reporting requirements under the rules for such small entities; (3) the use of performance rather than design standards; and (4) an exemption from coverage of the rule, or any part thereof, for such small entities.”
The FNPRM proposes to delete a requirement to demonstrate coverage of the United States. This would wholly eliminate the economic and other impacts of this rule. However, the Commission invites comment on this change and any alternatives.
None.
Satellites.
For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR part 25 as follows:
Interprets or applies 47 U.S.C. 154, 301, 302, 303, 307, 309, 310, 319, 332, 605, and 721, unless otherwise noted.
(b)(1) For all NGSO-like satellite licenses for which the application was filed pursuant to the procedures set forth in § 25.157 after August 27, 2003, authorizing operations in a frequency band for which the Commission has not adopted frequency band-specific service rules at the time the license is granted, the licensee will be required to comply with the following technical requirements, notwithstanding the frequency bands specified in these rule provisions: §§ 25.143(b)(2)(ii) (except NGSO FSS systems), (iii) (except NGSO FSS systems), 25.204(e), 25.210(f), (i).
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Advance notice of proposed rulemaking (ANPR); request for comments.
This document announces that NMFS is considering changes to the lobster management program and may select a control date to restrict the number of permits or traps an individual or business entity may own, with specific emphasis on Lobster Conservation Management Areas (LCMAs) 2 and 3. NMFS may use the existing control date of January 27, 2014, which was published in the
We must receive written comments on or before December 15, 2017.
You may submit comments on this document, identified by
NOAA-NMFS-2013-0169 by any of the following methods:
Peter Burns, Fishery Policy Analyst, 978-281-9144.
NMFS works cooperatively with the states to conserve the American lobster resource within the framework of the Atlantic States Marine Fisheries Commission's Interstate Fishery Management Plan for American Lobster (ISFMP). Through the ISFMP, the Commission adopts fishery conservation and management strategies for the American lobster resource and coordinates the efforts of the states and NMFS to implement these strategies.
The Commission, NMFS, and the affected states have worked to develop a strategy to address the declining SNE stock and control effort in the American lobster fishery. That strategy, which took shape in several addenda to Amendment 3 of the Commission's ISFMP, attempted to achieve this goal while maintaining the historic character of the lobster fishery, which has traditionally been comprised of small owner-operator businesses. As the Commission's ISFMP limited access to the fishery, the Commission was concerned that lobster permits might consolidate among a concentrated number of larger conglomerates. As a result, the Commission's ISFMP introduced the concept of permit restrictions in 2003 in Addendum IV and again in 2005 in Addendum VII. These two addenda contemplated limiting the aggregate number of permits an individual or entity may own in LCMAs 2 and 3.
Concern about fishery consolidation and conglomeration intensified with the advent of the Commission's Trap Transfer Program in 2014. The Trap Transfer Program allows lobster fishermen to buy or sell partial trap allocations up to, but not exceeding, any applicable LCMA trap cap. Attrition in the fishery from the SNE stock decline resulted in a relatively high amount of latent trap effort in the SNE LCMAs. The Commission became concerned that businesses could cheaply purchase and combine latent permits and then activate them by transferring the trap allocation onto the permit or by activating traps that were already associated with a permit under the trap banking provisions of Addendum XVIII. Accordingly, the Commission revisited permit and effort restriction strategies in Addendum XXI in August 2013 and Addendum XXII in October 2013. These addenda limit the number of traps that any one individual or entity may own in LCMAs 2 and 3 and are the focus of this rulemaking action. Under these addenda, permit holders may also purchase traps in excess of the active permit cap and “bank” them. The banked allocation may be used in the future to offset the economic impacts associated with a multi-year schedule of annual trap reductions in LCMAs 2 and 3 that were adopted in Addendum XVIII
In response to the Commission's recommendations for Federal action in Addenda XXI and XXII, NMFS notified the public that we were considering establishing a control date for the purposes of determining the number of traps or permits an individual or entity may hold in LCMAs 2 and 3. The notification, an advance notice of proposed rulemaking (79 FR 4319; January 27, 2014), announced that NMFS could use that publication date, January 27, 2014, or another date for such purpose and that it was developing a rulemaking action to consider the measures set forth in Addenda XXI and XXII.
Subsequently, the Commission announced the results of the 2015 American Lobster Stock Assessment that found the SNE lobster stock was severely depleted, with record low abundance and recruitment failure, due to changing environmental conditions and continued fishing mortality. The Commission then focused its efforts on a new addendum to the ISFMP, Addendum XXV, to address the deteriorating condition of the SNE stock.
NMFS deferred action on Addenda XXI and XXII while the Commission developed draft Addendum XXV during 2016 and 2017, because elements of Addendum XXV could have rendered the measures in the prior addenda unnecessary. In August 2017, the Commission decided to take no further action on Addendum XXV and requested that we advance the measures in Addenda XXI and XXII for Federal rulemaking. In response, we stet this advance notice of proposed rulemaking to reconsider the use of a control date in consideration of the measures in the two addenda.
This document informs the public that NMFS may select January 27, 2014, or another date, as the control date, depending on public comments and input from the Commission. It also gives the public notice that interested participants should locate and preserve records that substantiate and verify their participation in the American lobster fishery. Participation in the fishery after the control date may not be treated the same as participation before the control date. Establishing a control date does not commit NMFS to develop any particular management regime or criteria for participation in these fisheries. Additionally, we may also choose to take no further action to control effort or consolidation in the American lobster fishery. NMFS is seeking specific comments on the appropriateness of using the existing January 27, 2014, control date. The public may also comment on whether another date is better suited as a control date for the lobster fishery.
NMFS is also considering several clarifications to existing regulations:
• Due to enforcement concerns, we are considering modifications to the gear marking requirement for lobster trap trawls with more than three traps to be more consistent with industry practices;
• The Trap Transfer Program currently requires that trap transfers occur in increments of 10. We intend to remove this restriction to allow permit holders to transfer traps in any increment up to the permit cap for the fishing year to allow permit holders to take full advantage of the program;
• NMFS is also considering adding a provision to allow a substitute vessel to haul and fish the traps of a federally-permitted lobster vessel that is inoperable or mechanically impaired. The intent is to allow a Federal permit holder to maintain his or her revenue from lobster fishing while the vessel is repaired or replaced. Currently, the regulations only allow a substitute vessel to bring the trap gear ashore; however, some states already permit the use of a substitute vessel to haul and fish traps under specific circumstances.
Any future action taken by NMFS will be pursuant to the Atlantic Coastal Fisheries Cooperative Management Act and the Magnuson-Stevens Fishery Conservation and Management Act.
This notification and control date do not impose any legal obligations, requirements, or expectation.
16 U.S.C. 1801
Animal and Plant Health Inspection Service, USDA.
Notice.
We are advising the public that the Animal and Plant Health Inspection Service (APHIS) has received a petition from Verdeca LLC seeking a determination of nonregulated status for the new plant variety HB4 soybean designated as IND-00410-5, which has been genetically engineered for increased yield. The petition has been submitted in accordance with our regulations concerning the introduction of certain genetically engineered organisms and products. We are making the Verdeca LLC petition available for review and comment to help us identify potential environmental and interrelated economic issues and impacts that APHIS may determine should be considered in our evaluation of the petition.
We will consider all comments that we receive on or before January 16, 2018.
You may submit comments by either of the following methods:
•
•
Supporting documents and any comments we receive on this docket may be viewed at
The petition is also available on the APHIS Web site at
Dr. John Turner, Director, Biotechnology Risk Analysis Programs, BRS, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 851-3954, email:
Under the authority of the plant pest provisions of the Plant Protection Act (7 U.S.C. 7701
The regulations in § 340.6(a) provide that any person may submit a petition to the Animal and Plant Health Inspection Service (APHIS) seeking a determination that an article should not be regulated under 7 CFR part 340. Paragraphs (b) and (c) of § 340.6 describe the form that a petition for a determination of nonregulated status must take and the information that must be included in the petition.
APHIS has received a petition (APHIS Petition Number 17-223-01p) from Verdeca LLC (Verdeca), seeking a determination of nonregulated status for the new plant variety called HB4 soybean (
As described in the petition, soybean event IND-00410-5 has been genetically engineered to increase yield through the insertion of the
In accordance with § 340.6(d) of the regulations, we are publishing this notice to inform the public that APHIS will accept written comments regarding the petition for a determination of nonregulated status from interested or affected persons for a period of 60 days from the date of this notice. The petition is available for public review, and copies are available as indicated under
After the comment period closes, APHIS will review all written comments received during the comment period and any other relevant information; any substantive issues identified by APHIS based on our review of the petition and our evaluation and analysis of comments will be considered in the development of our decisionmaking documents.
As part of our decisionmaking process regarding a genetically engineered organism's regulatory status, APHIS prepares a plant pest risk assessment (PPRA) to assess its plant pest risk and the appropriate environmental documentation—either an environmental assessment (EA) or an environmental impact statement (EIS)—in accordance with the National Environmental Policy Act (NEPA), to provide the Agency with a review and analysis of any potential environmental impacts associated with the petition request. For petitions for which APHIS prepares an EA, APHIS will publish a separate notice in the
7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.
Farm Service Agency, USDA.
Notice; request for comments.
In accordance with the Paperwork Reduction Act of 1995, the Farm Service Agency (FSA) is requesting comments from all interested individuals and organizations on an extension of a currently approved information collection associated with the Volunteer Program.
We will consider comments that we receive by January 16, 2018.
We invite you to submit comments on this notice. In your comment, include the volume, date, and page number of this issue of the
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You may also send comments to the Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget, Washington, DC 20503. Comments will be available for inspection online at
Copies of the information collection may be requested by contacting Shannon (Logan) Morrison at the above address. Persons with disabilities who require alternative means of communications should contact the USDA Target center at (202)720-2600 (voice).
For specific questions related to collection activities, Ms. Shannon (Logan) Morrison; (202) 401-0165.
Without the information, FSA will be unable to document the services provided by the volunteers. FSA will report the collected information to offices within the Department of Agriculture and the Office of Personnel Management that request information on the Volunteer Program.
FSA continues to use forms AD-2022, AD-2023, AD-2024, and AD-2025 in the Volunteer Program. There is no change to the burden hours since the last OMB approval. Also, FSA will remove the FSA-related burden for form OF301 from the generic information collection request approved under OMB control number 0596-0080; FSA had previously used form OF301, but no longer uses that form.
For the following estimated total annual burden on respondents, the formula used to calculate the total burden hours is the estimated average time per response multiplied by the estimated total annual responses.
We are requesting comments on all aspects of this information to help us to:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;
(3) Evaluate the quality, ability and clarity of the information technology; and
(4) Minimize the burden of the information collection on those who respond through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
All comments received in response to this notice, including names and addresses when provided, will be a matter of public record. Comments will be summarized and included in the submission for Office of Management and Budget Approval.
Architectural and Transportation Barriers Compliance Board.
30-Day Notice and Request for Comments.
In accordance with the Paperwork Reduction Act (PRA), the Architectural and Transportation Barriers Compliance Board (Access Board) invites comment on the proposed extension of its existing generic clearance for the collection of qualitative feedback on agency service delivery, which expires in January 2018. (OMB Control No. 3014-0011, Expiration: Jan. 31, 2018). This information collection was developed as part of a Federal Government-wide effort to streamline the process for seeking feedback from the public on service delivery. In August 2017, the Access Board published a 60-day notice soliciting public comment on the proposed renewal of our generic clearance of qualitative feedback. 82 FR 37421 (Aug. 10, 2017). No comments were received. This notice, as required by the PRA, provides an additional 30 days for public comment.
Submit comments by December 15, 2017.
You may submit comments by any of the following methods:
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Wendy Marshall, Attorney Advisor, Office of General Counsel, U.S. Access Board, 1331 F Street NW., Suite 1000, Washington, DC 20004-1111. Phone: 202-272-0043 (voice). Email:
Under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
With this notice, the Access Board provides notice of its intent to seek renewal of its existing generic clearance for the collection of qualitative feedback on agency service delivery. We anticipate seeking OMB approval for revisions to the type (and number) of information collection activities relative to our existing generic clearance that expires in January 2018. Specifically, the Access Board intends to seek an increase in the number of approved respondents (and burden hours) under the generic clearance, primarily because we expect to solicit feedback from customers across a broader spectrum of agency programs and services that relate to technical assistance, training, and other education and outreach initiatives. To date, we have found the feedback garnered through qualitative customer satisfaction surveys (and similar information collections) to be beneficial, by providing useful insights in experiences, perceptions, opinions, and expectations regarding Access Board services or focusing attention on areas in need of improvement. We thus intend to seek approval for expansion of our current efforts to solicit qualitative customer feedback by seeking input from customers across a broader array of agency programs and services. Online surveys will be used unless the customer contacts the agency by phone for technical assistance or an individual otherwise expresses a preference for another survey format (
Feedback collected under this generic clearance provides useful information, but it does not yield data that can be generalized to the overall population. This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address: The target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential non-response bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior to fielding the study. Depending on the degree of influence the results from such quantitatively-inclined information collections are likely to have, such collections might still be eligible for submission under another type of other generic clearance.
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Illinois Advisory Committee (Committee) will hold a meeting on Wednesday, November 15, 2017, from 9:00a.m. to 1:00p.m. CST, for the purpose of hearing public testimony regarding civil rights and voter access in the state.
The meeting will be held on Wednesday, November 15, 2017, from 9:00 a.m. to 1:00 p.m. CST.
David Barreras, DFO, at
This meeting is free and open to the public. Persons with disabilities requiring reasonable accommodations should contact the Midwest Regional Office prior to the meeting to make appropriate arrangements. Members of the public are invited to make statements during an open comment period. In addition, members of the public may submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be mailed to the Midwestern Regional Office, U.S. Commission on Civil Rights, 55 W. Monroe St., Suite 410, Chicago, IL 60615. They may also be faxed to the Commission at (312) 353-8324, or emailed to Corrine Sanders at
Records generated from this meeting may be inspected and reproduced at the Midwestern Regional Office, as they become available, both before and after the meeting. Records of the meeting will be available via
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act (FACA) that a meeting of the Minnesota Advisory Committee (Committee) to the Commission will be held from 3:00-5:00 p.m. CST Thursday November 30, 2017. The purpose of the meeting is for the Committee to discuss completion of and reporting on their 2017 study of civil rights and policing practices in the State.
The meeting will be held on Thursday, November 30, 2017, from 3:00-5:00 p.m. CST.
Carolyn Allen at
This meeting is available to the public through the following toll-free call-in number: 888-329-8893, conference ID number: 9974470. Any interested member of the public may call this number and listen to the meeting. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and conference ID number.
Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be mailed to the U.S. Commission on Civil Rights, Regional Programs Unit, 55 West Monroe Street, Suite 410, Chicago, IL 60603. They may be faxed to the Commission at (312) 353-8324, or emailed Carolyn Allen at
Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at
Bureau of the Census, Department of Commerce.
Notice of public meeting.
The U.S. Census Bureau is giving notice of a meeting of the Federal Economic Statistics Advisory Committee (FESAC). The Committee advises the Under Secretary for Economic Affairs, the Directors of the Bureau of Economic Analysis (BEA) and the Census Bureau, and the Commissioner of the U.S. Department of Labor's Bureau of Labor Statistics (BLS) on statistical methodology and other technical matters related to the collection, tabulation, and analysis of federal economic statistics. Last minute changes to the agenda are possible, which could prevent giving advance public notice of schedule adjustments. If you plan to attend the meeting, please register by Thursday, December 7, 2017. You may access the online registration form with the following link:
December 15, 2017. The meeting will begin at approximately 9:00 a.m. and adjourn at approximately 4:30 p.m.
The meeting will be held at the U.S. Census Bureau Conference Center, 4600 Silver Hill Road, Suitland, MD 20746.
James R. Spletzer, Designated Federal Official, Department of Commerce, U.S. Census Bureau, Research and Methodology Directorate, Room 5K175, 4600 Silver Hill Road, Washington, DC 20233, telephone 301-763-4069, email:
Members of the FESAC are appointed by the Secretary of Commerce. The Committee advises the Under Secretary for Economic Affairs, the Directors of the BEA and the Census Bureau, and the Commissioner of the Department of Labor's BLS, on statistical methodology and other technical matters related to the collection, tabulation, and analysis of federal economic statistics. The Committee is established in accordance with the Federal Advisory Committee Act (Title 5, United States Code, Appendix 2).
The meeting is open to the public, and a brief period is set aside for public comments and questions. Persons with extensive questions or statements must submit them in writing at least three days before the meeting to the Designated Federal Official named above.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should also be directed to the Designated Federal Official as soon as known, and preferably two weeks prior to the meeting.
Due to increased security, the following measures will be taken: For access to the meeting, please call 301-763-9906 upon arrival at the Census Bureau on the day of the meeting; a photo ID must be presented in order to
An application has been submitted to the Foreign-Trade Zones (FTZ) Board (the Board) by the Greater Kansas City Foreign-Trade Zone, Inc., grantee of FTZ 15, requesting authority to expand its zone under the alternative site framework (ASF) adopted by the Board (15 CFR Sec. 400.2(c)). The application was submitted pursuant to the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u) and the regulations of the Board (15 CFR part 400). It was formally docketed on November 8, 2017.
FTZ 15 was established by the Board on March 13, 1973 (Board Order 93, 38 FR 8622, April 4, 1973) and was reorganized under the ASF on May 16, 2014 (Board Order 1938, 79 FR 30079, May 27, 2014). The zone has a service area that includes Andrew, Bates, Buchanan, Caldwell, Carroll, Cass, Chariton, Clay, Clinton, Cooper, Daviess, DeKalb, Henry, Howard, Jackson, Johnson, Lafayette, Livingston, Pettis, Platte, Ray and Saline Counties, Missouri. The zone currently consists of the following sites:
The applicant is now requesting authority to modify the existing boundaries of Site 3 at the Kansas City International Airport facility by removing a 143.90-acre parcel and adding twelve new parcels totaling 1,273.90 acres. Modified Site 3 would consist of 10,797 acres. The proposed expanded site is within the Kansas City Customs and Border Protection port of entry.
In accordance with the FTZ Board's regulations, Camille Evans of the FTZ Staff is designated examiner to evaluate and analyze the facts and information presented in the application and case record and to report findings and recommendations to the FTZ Board.
Public comment is invited from interested parties. Submissions shall be addressed to the FTZ Board's Executive Secretary at the address below. The closing period for their receipt is January 16, 2018. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to January 29, 2018.
A copy of the application will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230-0002, and in the “Reading Room” section of the FTZ Board's Web site, which is accessible via
For further information, contact Camille Evans at
On September 12, 2017, the Executive Secretary of the Foreign-Trade Zones (FTZ) Board docketed an application submitted by the Metroplex International Trade Development Corporation, grantee of FTZ 168, requesting subzone status subject to the existing activation limit of FTZ 168, on behalf of Gulfstream Aerospace Corporation, in Dallas, Texas.
The application was processed in accordance with the FTZ Act and Regulations, including notice in the
Pursuant to the authority delegated to the FTZ Board's Executive Secretary (15 CFR Sec. 400.36(f)), the application to establish Subzone 168E was approved on November 6, 2017, subject to the FTZ Act and the Board's regulations, including Section 400.13, and further subject to FTZ 168's 1,909-acre activation limit.
On September 25, 2017, the Executive Secretary of the Foreign-Trade Zones (FTZ) Board docketed an application submitted by the City and County of Denver, Colorado, grantee of FTZ 123, requesting subzone status subject to the existing activation limit of FTZ 123, on behalf of Lockheed Martin Corporation, Space Systems Company, in Littleton, Colorado.
The application was processed in accordance with the FTZ Act and Regulations, including notice in the
Notice of Application for an Amended Export Trade Certificate of Review by DFA of California (“DFA”), Application No. 14-4A004.
The Secretary of Commerce, through the International Trade Administration, Office of Trade and Economic Analysis (OTEA), has received an application for an amended Export Trade Certificate of Review (Certificate) from DFA. This notice summarizes the proposed amendment and seeks public comments on whether the amended Certificate should be issued.
Joseph E. Flynn, Director, Office of Trade and Economic Analysis, International Trade Administration, by telephone at (202) 482-5131 (this is not a toll-free number) or email at
Title III of the Export Trading Company Act of 1982 (15 U.S.C. Sections 4001-21) authorizes the Secretary of Commerce to issue Export Trade Certificates of Review. An Export Trade Certificate of Review protects the holder and the members identified in the Certificate from State and Federal government antitrust actions and from private treble damage antitrust actions for the export conduct specified in the Certificate and carried out in compliance with its terms and conditions. Section 302(b)(1) of the Export Trading Company Act of 1982 and 15 CFR 325.6(a) require the Secretary to publish a notice in the
Interested parties may submit written comments relevant to the determination whether an amended Certificate should be issued. If the comments include any privileged or confidential business information, it must be clearly marked and a nonconfidential version of the comments (identified as such) should be included. Any comments not marked as privileged or confidential business information will be deemed to be nonconfidential.
An original and five (5) copies, plus two (2) copies of the nonconfidential version, should be submitted no later than 20 days after the date of this notice to: Office of Trade and Economic Analysis, International Trade Administration, U.S. Department of Commerce, Room 21028, Washington, DC 20230.
Information submitted by any person is exempt from disclosure under the Freedom of Information Act (5 U.S.C. 552). However, nonconfidential versions of the comments will be made available to the applicant if necessary for determining whether or not to issue the amended Certificate. Comments should refer to this application as “Export Trade Certificate of Review, application number 14-4A004.”
1. Add the following new Member of the Certificate within the meaning of section 325.2(1) of the Regulations (15 CFR 325.2(1)): John B. SanFilippo & Sons, Inc.
DFA's proposed amendment of its Export Trade Certificate of Review results in the following membership list:
International Trade Administration, U.S. Department of Commerce.
Notice of an open meeting.
The President's Advisory Council on Doing Business in Africa (PAC-DBIA or Council) will meet to deliberate on analysis of the top three obstacles U.S. companies face in approaching African markets, competing for business opportunities, and operating business activities. Topics may include: Market risk, capital market development, market size, localization requirements, foreign government support to enable competitors, procurement practices, local skilled workforce availability, foreign exchange, trade facilitation, and infrastructure. The final agenda for the meeting will be posted at least one week in advance of the meeting on the Council's Web site at
November 29, 2017, 9:30 a.m. (EST).
The President's Advisory Council on Doing Business in Africa meeting will be broadcast via live webcast on the Internet at
Giancarlo Cavallo or Ashley Bubna, Designated Federal Officers, President's Advisory Council on Doing Business in Africa, Department of Commerce, 1401 Constitution Ave. NW., Room 22004, Washington, DC 20230 telephone: 202-482-2091, email:
Submit statements electronically to Giancarlo Cavallo and Ashley Bubna, Designated Federal Officers, President's Advisory Council on Doing Business in Africa, via email:
Send paper statements to Giancarlo Cavallo and Ashley Bubna, Designated Federal Officers, President's Advisory Council on Doing Business in Africa, Department of Commerce, 1401 Constitution Ave. NW., Room 22004, Washington, DC 20230.
Statements will be provided to the members in advance of the meeting for consideration and also will be posted on the Council Web site (
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; request for comments.
The National Marine Fisheries Service (NMFS) has developed a draft national Procedural Directive clarifying the process for eligible permit applicants to obtain releasable marine mammals for public display purposes under the Marine Mammal Protection Act (MMPA). Releasable marine mammals are those that were successfully rehabilitated by the Marine Mammal Health and Stranding Response Program's network of stranding centers and have been determined by the rehabilitation facility's attending veterinarian to be candidates for return to the wild. NMFS will no longer grant permits for the specific purpose of retaining releasable marine mammals for public display. Instead, applicants will now need to apply for a permit to take (collect) animals from the wild pursuant to the MMPA. Non-releasable animals, on the other hand, may still be obtained through NMFS' administrative procedures.
Comments must be received by December 15, 2017.
The draft Procedural Directive is available in electronic form via the Internet at
Jaclyn Taylor, NMFS, Office of Protected Resources, 301-427-8402,
Section 104 of the MMPA (16 U.S.C. 1361
From 2005-2016, NMFS issued three permits authorizing the retention of releasable marine mammals (rehabilitated animals cleared for release back to the wild) for public display purposes under section 104 of the MMPA and NMFS' implementing regulations at 50 CFR part 216. A permit was required for placement of releasable stranded animals (as opposed to non-releasable animals, which NMFS places in accordance with an administrative process rather than a permit) because NMFS views retention of a releasable marine mammal as the functional equivalent of a take from the wild (
However, NMFS received numerous public comments on the three issued permits asserting that permits to retain releasable marine mammals are in direct contradiction to the purpose of Title IV and section 109(h) of the MMPA, which mandate the rescue and rehabilitation of stranded marine mammals with the goal of releasing the animals to the wild when feasible. Commenters specifically expressed concerns that the process for assessing the actual impact of a take from the wild was largely circumvented.
After evaluation and reconsideration of this permit process and as a result of public comments on the three permits issued, NMFS has developed a new draft Procedural Directive to clarify its interpretation of MMPA regulations and procedures for authorizing releasable rehabilitated marine mammals to be retained for purposes of public display.
In the Procedural Directive, NMFS is proposing to no longer issue permits for the specific purpose of obtaining releasable marine mammals from the National Stranding Network for public display. Instead, would-be applicants must apply for a permit to take (collect) from the wild pursuant to the MMPA. In the event NMFS decides to grant such a permit, the NMFS OPR Director may then, at his or her discretion, require that a releasable rehabilitated marine mammal be substituted for capturing an animal from the wild, in accordance with 50 CFR 216.27.
NMFS believes this approach is more consistent with the statutory provisions governing rehabilitation and release of stranded marine mammals (MMPA section 109(h) and MMPA Title IV), which are separate and distinct from the provisions governing issuance of permits for the take of animals from the wild for purposes of public display (MMPA section 104).
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of open public meeting.
This notice sets forth the proposed schedule and agenda of a forthcoming meeting of the Marine Fisheries Advisory Committee (MAFAC). The members will discuss and provide advice on issues outlined under
The meeting will be held November 28 and 29, 2017, from 8:30 a.m. to 5 p.m., and November 30, from 8:30 a.m. to 3 p.m.
The meeting will be held at the Sheraton Silver Spring Hotel, 8777 Georgia Ave., Silver Spring, MD 20910; 301-589-0800.
Heidi Lovett, MAFAC Assistant Director; 301-427-8034; email:
As required by section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. 2, notice is hereby given of a meeting of MAFAC. The MAFAC was established by the Secretary of Commerce (Secretary), and, since 1971, advises the Secretary on all living marine resource matters that are the responsibility of the Department of Commerce. The complete charter and summaries of prior meetings are located online at
This meeting time and agenda are subject to change.
The meeting is convened to hear presentations and updates and to discuss policies and guidance on the following topics: The importance of timely data for fisheries resiliency; Columbia Basin Partnership Task Force efforts on the conservation and restoration of salmon and steelhead; aquaculture; citizen science; NMFS communications, outreach, and FishWatch; and the budget outlook for FY2018. MAFAC will discuss various administrative and organizational matters, and meetings of subcommittees and working groups will be convened.
The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Heidi Lovett; 301-427-8034 by November 15, 2017.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce.
Notice of open public meeting.
This notice sets forth the proposed schedule and agenda of a forthcoming meeting of the Marine Fisheries Advisory Committee's (MAFAC's) Columbia Basin Partnership Task Force (CBP Task Force). The CBP Task Force will discuss the issues outlined in the
The meeting will be held December 5, 2017, from 8 a.m. to 5 p.m. and on December 6, 2017, from 8 a.m. to 4 p.m.
The meeting will be held at the Davenport Grand Hotel, 333 Spokane Falls Blvd., Spokane, WA 99201; 509-458-3330.
Katherine Cheney; NFMS West Coast Region; 503-231-6730; email:
Notice is hereby given of a meeting of MAFAC's CBP Task Force. The MAFAC was established by the Secretary of Commerce (Secretary) and, since 1971, advises the Secretary on all living marine resource matters that are the responsibility of the Department of Commerce. The complete MAFAC charter and summaries of prior MAFAC meetings are located online at
The meeting time and agenda are subject to change. Updated information will be available on the CBP Task Force Web page above. Meeting topics include progress reports on applying the analytical framework to example species as prototypes and updates on quantitative goal setting, guiding principles, and vision. The meeting is open to the public as observers, and public input will be accepted on December 6, 2017, from 3:30 to 4 p.m., limited to the time available.
The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Katherine Cheney; 503-231-6730, by November 28, 2017.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; receipt of exempted fishing permit applications; request for comments.
NMFS announces the receipt of two exempted fishing permit (EFP) applications. The first application was received from The Nature Conservancy (TNC) for an EFP to test commercial pot fishing gear for selective harvest of lingcod. The lingcod pot gear EFP is intended to provide for the selective harvest of lingcod with fixed gear inside the non-trawl rockfish conservation area (RCA), allowing harvest of lingcod within existing annual catch limits (ACLs) while keeping catch of co-occurring overfished species (
Comments must be received no later than 5 p.m., local time on November 30, 2017.
You may submit comments, identified by 0648-XF799, by any one of the following methods:
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Information relevant to this notice or the EFP applications are available for public review during business hours at the NMFS West Coast Regional Office at 7600 Sand Point Way NE., Seattle, WA 98115, or by requesting them via phone or the email address listed in the
Karen Palmigiano at (206) 526-4491 or
This action is authorized by the Pacific Coast Groundfish Fishery Management Plan (FMP) and implementing regulations at 50 CFR 600.745, which states that EFPs may be used to authorize fishing activities that would otherwise be prohibited.
At its June 2016 meeting, the Pacific Fishery Management Council (Council) received an EFP application from TNC for the use of pot gear to target lingcod within the non-trawl RCA offshore of Washington and Oregon. An initial opportunity for public comment was provided during this meeting. At that time, the Council recommended that NMFS consider issuing the EFP for a period of two years (
In 2014, during preliminary gear testing conducted by TNC and their research partners, catch of lingcod was lower than anticipated. During testing, the gear was only fished in areas open to non-trawl groundfish fishing, which included the area seaward of the non-trawl RCA, in depths ranging from approximately 100-200 fathoms (fm) (54.7-109.4 meters). Applicants hypothesize that low catch of lingcod was primarily due to the non-trawl RCA (a depth-based area closure prohibiting fishing for lingcod with pot gear from approximately 30 fathoms to 100 fathoms), closing depths where lingcod are most commonly found (
Entanglement of humpback whales in pot gear buoy lines is a concern, particularly in the West Coast sablefish pot fishery, which is designated as a Category II fishery in the 2017 List of Fisheries (82 FR 9690, February 8, 2017) due to its occasional interactions with humpback whales; the last of which was documented in 2006. Concerns with regards to the pot gear, similar to sablefish pot gear with regards to the buoy lines, being employed in the proposed EFP are mitigated because the magnitude of the fishing effort permitted under this EFP would be minimal and occur off Oregon, where fewer documented interactions between pot gear and humpback whales has occurred. Therefore, NMFS is proposing to approve the EFP consistent with general requirements following the conclusion of the public comment period. Subsequently, NMFS would issue the actual permits for the EFP to individual participants and TNC as the entity coordinating EFP-related fishing activities as appropriate. NMFS intends to use an adaptive management approach for this EFP in which NMFS may revise requirements and protocols to improve the EFP without issuing another
In accordance with NOAA Administrative Order (NAO) 216-6, a Categorical Exclusion or other appropriate National Environmental Policy Act document would be completed prior to the issuance of any permits under this EFP. Further review and consultation may be necessary before a final determination is made to issue the permits. After publication of this document in the
In September 2017, the Council received an application for an EFP from the West Coast Seafood Processors Association, Environmental Defense Fund, Oregon Trawl Commission, and Midwater Trawlers Cooperative to test if and how the removal of certain gear, time, and area restrictions for the Shorebased IFQ Program may impact the nature and extent of prohibited species bycatch, particularly salmon and eulachon. This EFP is intended to allow participating limited entry groundfish bottom trawl and midwater trawl vessels more flexibility in 2018 to target pelagic rockfish species, such as widow, chilipepper, and yellowtail rockfish. An opportunity for public testimony was provided during the Council meeting, after which the Council recommended the EFP with several changes. Specifically, the Council narrowed the number of exemptions they recommended to include in the EFP. After the Council meeting, the applicants updated their application based on the Council's recommendations and resubmitted a final version of the application to NMFS on October 4, 2017. Copies of the final version of the application are available from NMFS. (See
In late 2016, industry members proposed a trawl gear EFP for 2017 (later known as the 2017 trawl gear EFP) to provide them exemptions to the minimum mesh size requirement and exemptions to the requirement to use selective flatfish trawl shoreward of the trawl RCA north of 42° North latitude (N. lat) for limited entry bottom trawl vessels. Since implementation of the 2017 trawl gear EFP in March 2017, limited entry groundfish bottom trawl vessels have been testing their new gear configurations by targeting midwater pelagic rockfish (primarily widow rockfish and yellowtail rockfish) using modified bottom trawl gear north of 42° N. lat. shoreward of the trawl RCA with minimal impacts on Chinook salmon. As of the end of October 2017, there have been 50 trips taken by 10 vessels, and they have caught a total of four Chinook salmon. Information on gear configurations has been collected, and the data would helpful information any potential modifications or elimination of current gear restrictions.
To continue collecting information on impacts to salmon and eulachon that may arise from the modification or elimination of gear, time, and area regulations, the applicants have requested a 2018 trawl gear EFP that expands upon the 2017 trawl gear EFP. The trawl gear EFP in 2018 would provide participating vessels with several exemptions regarding the required minimum mesh size, the requirement to use selective flatfish trawl gear shoreward of the trawl RCA and north of 42° N. lat., the prohibition on fishing with midwater groundfish trawl gear north of 40°10′ N. lat. in all areas prior to May 15th each year, the prohibition on fishing with midwater groundfish trawl gear south of 40°10′ N. lat. within the boundaries of the trawl RCA (midwater groundfish trawling would still be prohibited shoreward of the RCA and south of 40°10′ N. lat.), the prohibition on bringing a new haul onboard before a previous haul is stowed, and the prohibition on carrying and fishing more than one type of groundfish trawl gear (midwater and bottom trawl gear) on the same trip.
If approved, vessels fishing on an EFP trip with bottom trawl gear would be permitted to use any small footrope gear that meets the definition in regulations at § 660.11 shoreward of the RCA and north of 42° N. lat. similar to what is required south of 40°10′ N. lat. Vessels fishing on an EFP trip with limited entry midwater trawl vessels would be permitted to fish within all areas north of 40°10′ N. lat. and within the boundaries and seaward of the RCA south of 40°10′ N. lat. for the duration of this EFP. These vessels would not be constrained to the primary whiting season dates. All participating groundfish bottom trawl and midwater trawl vessels on an EFP trip would be
NMFS has some concerns with the potential impacts these exemptions may have on protected and prohibited species. The best available data suggests that bycatch rates of Endangered Species Act listed salmon, eulachon, and green sturgeon could increase as a result of the increased effort resulting from this EFP. However, because a targeted fishery for chilipepper, widow, and yellowtail rockfish has not existed in more than a decade and the fishery has changed a lot since this data was collected, this data may not reflect current bycatch rates resulting in its limited utility for predicting current impacts to protected and prohibited species. Thus, NMFS has been working with the applicant to develop an EFP that would meet the applicants' objectives to better target pelagic rockfish species while collecting information about bycatch and minimizing bycatch to the extent practicable. To address NMFS's concerns, the applicants included in their application a requirement to collect bycatch information at the haul level and genetic samples on all salmon caught. Additionally, the applicants proposed and the Council recommended that all salmon caught by vessels participating in this EFP would be subject to a total salmon harvest guideline of 3,547 Chinook salmon. In addition, the Council recommend two sub-harvest guidelines to further help mitigate against potential impacts:
• Prior to May 15th—All vessels fishing on an EFP trip north of 42° N. lat. would be subject to a sub-harvest guideline of 720 Chinook salmon (out of the 3,547 Chinook salmon total harvest guideline) for this area, including seaward, within, and shoreward of the trawl RCA, from the inception of this EFP until 12:01 a.m. on May 15th which corresponds to the start of the Primary whiting season for the Shorebased IFQ fishery. From May 15th through the end of this EFP, all EFP trips taken north of 42° N. lat. would be subject to the remainder of total harvest guideline (3,547 Chinook salmon) for the EFP.
• South of 42° N. lat.—All vessels fishing on an EFP trip south of 42° N. lat. would be subject to a sub-harvest guideline of 80 Chinook salmon (out of the 3,547 Chinook salmon harvest guideline) for this area for the duration of this EFP.
If the overall harvest guideline of 3,547 Chinook salmon for the EFP is reached, the EFP would be shut down. Additionally, if a sub-harvest guideline is reached EFP trips for which that sub-harvest guideline apply would be shut down. For example, if vessels fishing north of 42° N. lat. prior to May 15th catch more than 720 Chinook salmon, the EFP would be shut down until May 15th when it would open back up in this area under the 3,547 Chinook salmon harvest guideline. For the area south of 42° N. lat., if any time during the EFP vessels fishing in this area catch more than 80 Chinook salmon, the EFP activity in the area south of 42° N. lat. would be shut down and would not reopen for the remainder of the EFP.
The applicants have not proposed a specific list of participating vessels, as is traditionally the case, but rather are proposing that NMFS publish a public notice to gauge interest from limited entry groundfish midwater and bottom trawl vessels. Depending on the amount of interest and where vessels may be fishing, NMFS may need to limit participation by time and area to mitigate against potential impacts. Participating vessels that enroll in the EFP would be required to declare into and out of the EFP on a monthly basis by notifying NMFS.
Information collected under the EFP could be used to support the analysis for potential new and modifications to existing gear regulations. With many of the current gear regulations having been in place for more than ten years, it is difficult for NMFS, the Council, and industry to predict the impacts of removing these regulations. In the past ten years, the industry has changed significantly. Reduction in capacity, innovations in gear technologies, and changes in management have all contributed to these changes. This EFP would help demonstrate what potential impacts, if any, today's fleet may have if some of the current gear, area, and time regulations are modified from what is currently in regulation.
Therefore, NMFS is proposing to approve a 2018 trawl gear EFP, covering all the exemptions stated above following the conclusion of the public comment period, review of public comment, and completion of an analysis of the potential impacts. Pending approval, NMFS would issue the permits for the EFP to the vessel owner or designated representative as the “EFP holder.” NMFS intends to use an adaptive management approach in which NMFS may revise requirements and protocols to improve the program without issuing another
In accordance with NAO Administrative Order 216-6, a Categorical Exclusion or other appropriate National Environmental Policy Act document would be completed prior to the issuance of any permits under this EFP. After publication of this document in the
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Applications for four new scientific research permits, two permit modifications, and eight permit renewals.
Notice is hereby given that NMFS has received 14 scientific
Comments or requests for a public hearing on the applications must be received at the appropriate address or fax number (see
Written comments on the applications should be sent to the Protected Resources Division, NMFS, 1201 NE Lloyd Blvd., Suite 1100, Portland, OR 97232-1274. Comments may also be sent via fax to 503-230-5441 or by email to
Rob Clapp, Portland, OR (Tel: 503-231-2314, Fax: 503-230-5441, email:
The following listed species are covered in this notice:
Chinook salmon (
Steelhead (
Chum salmon (
Coho salmon (
Sockeye salmon (
Eulachon (
Green sturgeon (
Scientific research permits are issued in accordance with section 10(a)(1)(A) of the ESA (16 U.S.C. 1531
Anyone requesting a hearing on an application listed in this notice should set out the specific reasons why a hearing on that application would be appropriate (see
The City of Bellingham (COB) is seeking to renew, for five years, a research permit that currently allows them to take juvenile and adult PS Chinook salmon and PS steelhead in Cemetery, Padden, Silver, and Squalicum creeks in Bellingham, WA. The purpose of the COB study is to assess the effectiveness of habitat restoration activities within the City of Bellingham by documenting population trends for salmonids inhabiting these urban creeks. These restoration actions include native riparian and upland plantings, large woody debris and gravel augmentation, re-routing and re-structuring of degraded stream channel, and floodplain re-connection. This research would benefit the affected species by informing future restoration designs, providing data to support future enhancement projects, and helping managers assess salmonid population status in these urban systems. The COB proposes to capture fish using a smolt trap (V-shaped channel-spanning weirs with live boxes) in only one of the aforementioned streams annually. Captured fish would be anesthetized, identified to species, measured, have a tissue sample taken (to determine their origin), and allowed to recover in cool, aerated water before being released back to the stream. The researchers do not intend to kill any listed fish, but some may die as an inadvertent result of the research.
The City of Portland is seeking to modify a permit that currently authorizes them to take juvenile and adult MCR steelhead, UCR spring Chinook salmon, UCR steelhead, SR spring/summer-run Chinook salmon, SR fall-run Chinook salmon, SR steelhead, SR sockeye salmon, LCR Chinook salmon, LCR coho salmon, LCR steelhead, CR chum salmon, UWR Chinook salmon, UWR steelhead, OC coho salmon, and S green sturgeon in the Columbia and Willamette rivers and tributaries (Oregon). The research may also cause them to take adult S eulachon—a species for which there are currently no ESA take prohibitions. The permit modification would not change the methods or scope of the ongoing research, except to increase the number of incidental mortalities authorized for juvenile UWR steelhead from one to five juvenile fish annually. This research is part of the Portland Watershed Management Plan, which aims to improve watershed health in the Portland area. In this program, researchers sample 37 sites annually across all Portland watersheds for hydrology, habitat, water chemistry, and biological communities. The research would benefit listed salmonids by providing information to assess watershed health, status of critical habitat, effectiveness of watershed restoration actions, and compliance with regulatory requirements. The City of Portland proposes to capture juvenile fish using backpack and boat electrofishing, hold fish in a bucket of aerated water, take caudal fin clips for genetic analysis, and release fish at a point near their capture site that would be chosen to minimize the likelihood of recapture. The researchers would avoid contact with adult fish. The researchers do not propose to kill any fish but a small number may die as an unintended result of the activities.
The United States Geological Survey (USGS) is seeking to renew, for five years, a research permit that currently allows them to take adult PS/GB bocaccio, juvenile HCS chum salmon and PS steelhead, and juvenile and adult PS Chinook salmon throughout the marine waters of Puget Sound, Hood Canal, and the Strait of Juan de Fuca (Washington State). The USGS research may also cause them to take adult S eulachon and PS/GB yelloweye rockfish—species for which there are currently no ESA take prohibitions. The purpose of the USGS study is to examine salmonid stage-specific growth, bioenergetics, competition, and predation during the critical early marine growth period. Additionally, unlisted salmonid species, herring, and other forage fish species would be studied. This research would benefit the affected species by quantifying key
The Washington State Department of Natural Resources (WDNR) is seeking to renew, for five years, a research permit that currently allows them to take juvenile PS Chinook salmon, HCS chum salmon, PS steelhead, and OL sockeye salmon throughout the streams of Clallam, Jefferson, and Grays Harbor counties in western Washington State. The purpose of the WDNR study is to determine potential fish presence or absence in streams located on WDNR-managed lands in order to support a region-wide program of road maintenance and abandonment. This research would benefit the affected species by determining which streams with road-related passage barriers contain listed fish and, thus, allow WDNR to focus its resources on road improvements that would best help those species. The WDNR proposes to capture fish using backpack electrofishing equipment and minnow traps. Captured fish would be netted, identified to species, and released. In most cases, the stream survey would terminate when one listed fish is located. The researchers do not intend to kill any listed fish, but some may die as an inadvertent result of the research.
The Northwest Fisheries Science Center (NWFSC) is seeking to renew, for five years, a research permit that currently allows them to take juvenile PS Chinook salmon and PS steelhead. The NWFSC research may also cause them to take adult S eulachon—a species for which there are currently no ESA take prohibitions. Study locations include several bays and estuaries in the Puget Sound that receive effluent from municipal wastewater plants and industrial contaminant sources. The purpose of the NWFSC study is to assess the bioaccumulation and toxic effects of Chemicals of Emerging Concern (CECs) in Chinook salmon. Whole genome and molecular analyses of Chinook salmon would be conducted on various tissues, which would allow for identification of gene pathways and robust mechanism-based diagnostic indices for CEC toxicity. This research would benefit the listed species by identifying degraded estuaries, studying how CECs affect Chinook salmon, and providing information that can be used to mitigate and improve listed species habitat. The NWFSC proposes to capture fish using beach seines. Sampling would occur at seven locations up to two times annually. For each sample event, 40 juvenile Chinook salmon would be euthanized for whole body analysis. The researchers would prioritize using adipose-fin-clipped hatchery fish and unintentional mortalities over natural-origin fish. Excess Chinook salmon (and all other species) would be released immediately after capture. The researchers do not propose to kill any of the listed steelhead or eulachon being captured, but some may die as an unintended result of the activities.
The U.S. Forest Service (USFS) is seeking to renew, for five years, a research permit that currently allows them to take juvenile PS Chinook salmon and PS steelhead in the Nooksack, Sauk, Skagit, and Stillaguamish River drainages of western Washington. The purpose of the USFS study is to expand distributional knowledge of the Salish sucker (
The Coastal Watershed Institute (CWI) is seeking to renew, for five years, a research permit that currently allows them to take juvenile PS Chinook salmon, HCS chum salmon, and PS steelhead in the Elwha River estuary (Washington State). The CWI research may also cause them to take adult S eulachon—a species for which there are currently no ESA take prohibitions. The purpose of the CWI study is to research the nearshore restoration response to the Elwha River dam removals with an emphasis on ecological function of nearshore habitats for juvenile salmon and forage fish. The research would benefit listed species by providing a long-term continuous dataset on how salmonids use local nearshore areas after the dam removals on the Elwha River. This study provides information on how watersheds and fish populations recover after dam removals. The CWI proposes to capture fish using a beach seine. Captured fish would be identified to their lowest taxonomic level. At each sampling event, twenty individuals from each species would be measured and released. Salmonids would be scanned for fin clips and tags. The researchers do not propose to kill any listed fish being captured, but some may die as an inadvertent result of the research.
The Pierce County Department of Public Works and Utilities (PCDPWU) is seeking to renew, for five years, a research permit that currently allows them to take juvenile PS Chinook salmon and PS steelhead in the waterways of Pierce County, Washington. The purpose of the PCDPWU study is to determine the distribution and diversity of anadromous fish species in the waterbodies adjacent to and within the county's levee system. The surveys would help establish listed salmonid presence in waterbodies—information that would be used to assess the impacts
The NWFSC is seeking a two-year research permit to annually take adult PS/GB bocaccio and sub-adult PS Chinook salmon in the Puget Sound near the San Juan Islands (Washington state). The NWFSC research may also cause them to take adult PS/GB yelloweye rockfish—a species for which there are currently no ESA take prohibitions. The purpose of the NWFSC study is to assess the role Chinook salmon residency plays in salmon recovery—including growth, movement patterns, and population structure. This research would benefit the affected species by giving managers information on which populations contribute to the resident PS Chinook salmon population in the San Juan Islands and heling determine the relationship between the Chinook resident life-history type and overall marine survival. These efforts would serve as the foundation for evaluating the relative contribution residents make to the broader ESU—and thereby help managers understand how this behavior type can help salmon recovery. The NWFSC proposes to capture fish using hook and line angling equipment. Captured salmon would be scanned for CWT, measured for length, tissue-sampled (scales and fin clips), and released. Hatchery-origin Chinook salmon would also be anesthetized and gastric lavaged. Fifty adipose-clipped, hatchery-origin subadult Chinook salmon would be intentionally sacrificed annually to obtain otolith samples movement patterns and early growth history may be analyzed. Listed rockfish would be released immediately via rapid submergence to their capture depth to reduce the effects from barotrauma. The researchers do not propose to kill any other captured fish, but some may die as an unintended result of the activities.
The University of Washington (UW) is seeking to renew, for five years, a research permit that currently allows them to take juvenile and adult OL sockeye salmon in Lake Ozette (northwest Washington State). The purpose of the UW study is to investigate the interactions of native predators (
The Oregon Department of Fish and Wildlife (ODFW) is seeking to modify a permit that currently authorizes research in lake, river, backwater, slough, and estuary habitats in the Willamette and Columbia basins (Oregon) and on the Oregon coast. The permit would cover the following projects for four years: (1) Warmwater and Recreational Game Fish Management, (2) District Fish Population Sampling in the Upper Willamette Basin, and (3) Salmonid Assessment and Monitoring in the Deschutes River. These studies provide information on fish population structure, abundance, genetics, disease occurrences, and species interactions, and is used to direct management actions to benefit listed species. The permit modification would not change the methods or scope of the ongoing research, except to add take of juvenile and adult UWR Chinook and UWR steelhead at new research sites in the Tualatin and Yamhill Rivers. The modified permit would authorize take of juvenile UCR spring-run Chinook salmon, UCR steelhead, SR spring/summer-run Chinook salmon, SR fall-run Chinook salmon, SR Basin steelhead, SR sockeye salmon, MCR steelhead, LCR Chinook salmon, LCR coho salmon, LCR steelhead, CR chum salmon, and OC coho salmon; juvenile and adult UWR Chinook salmon and UWR steelhead; and adult S green sturgeon. The ODFW research may also take adult S eulachon—a species for which there are currently no ESA take prohibitions. Researchers would sample fish using boat electrofishing. A subset of captured juveniles would be anesthetized, weighed and measured, allowed to recover, and then released. Most juveniles and all adults would be allowed to swim away after being electroshocked, or they would be netted and released immediately. The ODFW does not intend to kill any of the fish being captured, but a small number may die as an unintended result of the activities.
The NWFSC is seeking a two-year permit that would allow them to take juvenile LCR Chinook salmon, SR fall-run Chinook salmon, SR spring/summer-run Chinook salmon, UCR spring-run Chinook salmon, UWR Chinook salmon, CR chum salmon, LCR coho salmon, SR sockeye salmon, LCR steelhead, MCR steelhead, SR Basin steelhead, UCR steelhead, UWR steelhead, and S green sturgeon. The research may also cause them to take adult S eulachon—a species for which there are currently no ESA take prohibitions. The purpose of the study is to measure contaminant levels in juvenile UWR Chinook salmon in the lower Willamette River (Oregon) near a Superfund site with high levels of pollutants and to evaluate associations between toxins in fish tissues and fish growth and immune response. Study results would support an ongoing Natural Resource Damage Assessment. In addition, the data would be used in Chinook salmon life cycle models to compare how chemical pollution affects UWR Chinook salmon populations relative to other stressors.
The researchers propose to collect fish with beach seines at sites in the lower 20 miles of the Willamette River. The researchers hope to complete all sampling between March and June 2018, but fieldwork could extend to other months and to 2019 if sample size targets are not met in the initial timeframe. The researchers propose to hold fish in buckets, identify and count fish, check fish for passive integrated transponder and coded wire tags, and then immediately release any fish that is not a juvenile Chinook salmon with an intact adipose fin. The researchers propose using a lethal dose of MS-222 to kill natural-origin juvenile Chinook salmon that are between 50 and 80 mm in fork length. The target ESU for contaminant analysis is UWR Chinook, but juvenile Chinook salmon from other ESUs in the Columbia River basin could
The NWFSC researchers used information from past studies to estimate the number of fish needed to obtain enough tissues for statistically robust sample sizes, and to estimate expected mortality rates of fish from non-target ESUs. Based on this information, the NWFSC proposes to intentionally kill up to: 201 natural-origin and 9 hatchery-origin (intact adipose fin) juvenile UWR Chinook salmon; 119 natural-origin and 5 hatchery-origin (intact adipose fin) juvenile LCR Chinook salmon; 4 natural-origin juvenile SR fall-run Chinook salmon; 2 natural-origin juvenile SR spring/summer-run Chinook salmon; and 5 natural-origin juvenile UCR spring-run Chinook salmon. Any Chinook salmon unintentionally killed during the research would be used in lieu of a fish that would otherwise be sacrificed. The NWFSC does not intend to kill any fish that is not a juvenile Chinook salmon, but a small number of individuals from other species may die as an unintended result of the research activities.
Cramer Fish Sciences is seeking a research permit, for two years, that would allow them to take juvenile LCR Chinook, LCR coho, LCR steelhead, and MCR steelhead in the Klickitat, Wind, and White Salmon River subbasins (Washington). The purpose of the research is to determine fish occupancy in stream reaches in lands owned by SDS Lumber Company. Cramer Fish Sciences proposes to capture fish using single-pass backpack electrofishing, identify fish while they are held briefly in hand-held dip nets, and return fish to the stream. The researchers would compare results of the electrofishing surveys with environmental DNA (eDNA) studies done in the same stream reaches, which would provide information on the utility of eDNA analysis for determining fish occupancy. The research would benefit listed fish by affording them protections if they are found in streams that previously were assessed as non-fish bearing. The researchers do not propose to kill any fish but a small number may die as an unintended result of research activities.
Mount Hood Environmental is seeking a research permit, for three years, that would allow them to take juvenile and adult UWR steelhead and UWR Chinook in the Tualatin River (Oregon). The purpose of the research is to determine if salmonids and lamprey are present in the intake channel from the Tualatin River to the Spring Hill Pumping Plant and if these fish are likely to be entrained in the intake. The study would benefit listed fish by providing information to manage and mitigate for potential entrainment of these fish during early life-stages. The researchers propose to work in the intake channel, where they would measure water temperature and velocity, capture fish by seining, trapping, and boat-electrofishing, hold fish in aerated buckets, identify them, and then release them back to the channel. The researchers do not propose to kill any fish but a small number may die as an unintended result of research activities.
This notice is provided pursuant to section 10(c) of the ESA. NMFS will evaluate the applications, associated documents, and comments submitted to determine whether the applications meet the requirements of section 10(a) of the ESA and Federal regulations. The final permit decisions will not be made until after the end of the 30-day comment period. NMFS will publish notice of its final action in the
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice.
This action serves as a notice that NMFS, on behalf of the Secretary of Commerce (Secretary), has found that the following stocks are subject to overfishing or approaching an overfished condition. The Stillaguamish coho salmon stock in Puget Sound is now subject to overfishing. The Klamath River fall Chinook salmon stock on the Northern California coast, the Queets coho salmon stock on the Washington coast, and the Skagit coho salmon stock in Puget Sound are all approaching an overfished condition. The Puerto Rico spiny lobster stock and the Puerto Rico Triggerfishes and Filefishes Complex are both still subject to overfishing. NMFS, on behalf of the Secretary, notifies the appropriate fishery management council (Council) whenever it determines that overfishing is occurring, a stock is in an overfished condition or a stock is approaching an overfished condition.
Regina Spallone, (301) 427-8568.
Pursuant to section 304(e)(2) of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), 16 U.S.C. 1854(e)(2), NMFS, on behalf of the Secretary, must notify Councils, and publish in the
NMFS has determined that the Stillaguamish coho salmon stock in Puget Sound is now subject to overfishing, as the current estimate of fishing mortality (F) exceeds its maximum fishing mortality threshold (MFMT). This determination is based on a 2017 assessment—using data from 2015—produced by the Pacific Fishery Management Council's (Pacific Council) Salmon Technical Team (STT). The Pacific Council manages this stock. Since this stock migrates north, it is also managed under the Pacific Salmon Treaty (Treaty), a bilateral agreement to facilitate management of certain salmon stocks between the United States and Canada. The Pacific Salmon Commission (Commission) implements this Treaty. NMFS has informed the Pacific Council of this determination and that, if exceedance of MFMT for Stillaguamish coho continues, the Council may consider taking further action, consistent with the provisions of the FMP. Due to the international management of this stock, the Pacific Council has limited ability to control ocean fisheries in waters outside their jurisdiction.
NMFS has determined that the Klamath River fall Chinook salmon stock on the Northern California coast,
NMFS has determined that Puerto Rico spiny lobster and the Puerto Rico Triggerfishes and Filefishes Complex are both still subject to overfishing because the 2015 landings exceeded the overfishing limits (OFLs). NMFS is working with the Caribbean Fishery Management Council to implement conservation and management measures to end overfishing on this stock and stock complex.
Proposed collection; comment request.
The United States Patent and Trademark Office (USPTO), as required by the Paperwork Reduction Act of 1995, invites comments on a proposed extension of an existing information collection.
Written comments must be submitted on or before January 16, 2018.
You may submit comments by any of the following methods:
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Requests for additional information should be directed to Matthew Lee, Office of Finance by email to
Customers may submit payments to the USPTO by several methods, including credit card, deposit account, electronic funds transfer (EFT), and paper check transactions. The provisions of 35 U.S.C. 41 and 15 U.S.C. 1113 are implemented in 37 CFR 1.16-1.28, 2.6-2.7, and 2.206-2.209. Under 35 U.S.C. 41 and 15 U.S.C. 1113, the United States Patent and Trademark Office (USPTO) charges processing fees in the form of service charges related to deposit accounts and payments refused.
This information collection includes the Credit Card Payment Form (PTO-2038), which provides the public with a convenient way to submit a credit card payment for fees related to a patent, trademark, or information product. Customers may also submit credit card payments via the USPTO Payment Page when using online systems through the USPTO Web site for paying fees related to patents, trademarks, or information products.
Customers may establish a deposit account for making fee payments online using Financial Manager at the USPTO Web site. Deposit accounts eliminate the need to submit a check, credit card, or other form of payment for each fee transaction with the USPTO. Additionally, in the event that a fee amount due is miscalculated, customers may authorize the USPTO to charge any remaining balance to the deposit account and therefore avoid the potential consequences of underpayment. As customers use their deposit accounts to make payments, they may deposit funds to replenish their accounts by mailing a check to the USPTO, sending funds via wire transfer, or making a deposit online via EFT using Financial Manager at the USPTO Web site. Replenishments may not be made by credit card. Customers may close or withdraw funds from their deposit accounts online using Financial Manager at the USPTO Web site.
In addition to credit cards and deposit accounts, customers may also use EFT to make online fee payments to the USPTO. Customers must first establish a user profile and submit their banking information online through Financial Manager at the USPTO Web site.
Under 37 CFR 1.26 and 2.209, the USPTO may refund fees paid by mistake or in excess of the required amount. For refund requests customers may submit a written request to the Refund Branch of the USPTO Office of Finance.
The USPTO deployed the Financial Manager system allowing customers to add, manage, and report on payment methods in their online user profiles at the USPTO Web site. After establishing a USPTO.gov account username and password, customers may add their credit card, deposit account, and EFT information to their account using the Financial Manager web interface. Customers may then manage and report on these stored payment methods online. The stored payment methods may be used when the customer conducts transactions with the USPTO.
By mail, facsimile, hand delivery, or electronically to the USPTO.
There are service fees for not maintaining the minimum balance required for the deposit account and for returned payments. There is a $25 service charge for deposit accounts that are below the minimum balance at the end of the month. The USPTO estimates that it assesses 3,600 of these low balance charges annually, for a total of $90,000 per year. There is also a $50 service charge for processing a payment refused (including a check returned “unpaid”) or charged back by a financial institution. The USPTO estimates that it assesses 128 of these returned payment charges annually, for a total of $6,400 per year. The total estimated service fees for this collection are $96,400 per year.
Customers may incur postage costs when submitting the Credit Card Payment Form and other paper forms or requests to the USPTO by mail. Customers generally send the Credit Card Payment Form to the USPTO along with other documents related to the fee or service being paid for by credit card, but some customers may submit just the Credit Card Payment Form without additional supporting documents. The USPTO estimates that roughly 5 percent of the 87,874 paper Credit Card Payment Forms submitted annually may be mailed in; approximately 4,394 per year. The USPTO estimates that it will receive an additional 28,922 mailed submissions per year, including Deposit Account Replenishments and Refund Requests, for a total of 33,316 mailed submissions per year. The USPTO estimates that the first-class postage cost for a mailed submission will be $0.49, for a total postage cost of approximately $16,324.84 per year.
The total annual (non-hour) respondent cost burden for this collection in the form of service fees and postage costs is estimated to be approximately $112,724.84 per year.
Comments submitted in response to this notice will be summarized or included in the request for OMB approval of this information collection; they also will become a matter of public record.
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 (including hours and cost) 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,
Commodity Futures Trading Commission.
Notice.
In compliance with the Paperwork Reduction Act of 1995 (PRA), this notice announces that the Information Collection Request (ICR) abstracted below has been forwarded to the Office of Management and Budget (OMB) for review and comment. The ICR describes the nature of the information collection and its expected costs and burden.
Comments must be submitted on or before December 15, 2017.
Comments regarding the burden estimate or any other aspect of the information collection, including suggestions for reducing the burden, may be submitted directly to the Office of Information and Regulatory Affairs (OIRA) in OMB within 30 days of this notice's publication by either of the
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A copy of all comments submitted to OIRA should be sent to the Commodity Futures Trading Commission (the “Commission”) by either of the following methods. The copies should refer to “OMB Control No. 3038-XXXX.”
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• By Hand Delivery/Courier to the same address; or
• Through the Commission's Web site at
A copy of the supporting statements for the collection of information discussed herein may be obtained by visiting
All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to
Eugene Smith, Director, Office of Proceedings, Commodity Futures Trading Commission, (202) 418-5371; email:
In 1984, the Commission promulgated Part 12 of the Commission regulations to administer Section 14. Rule 12.13 provides the standards and procedures for filing a Reparations complaint. Specifically, subparagraph (b) describes the form and content requirements of a complaint. CFTC Form 30 mirrors the requirements set forth in subparagraph (b).
The Commission began utilizing Form 30 in or about 1984. The form was created to assist customers, who are typically
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for the CFTC's regulations were published on December 30, 1981.
There are no capital costs or operating and maintenance costs associated with this collection.
The following appendix will not appear in the Code of Federal Regulations.
Bureau of Consumer Financial Protection.
Notice and request for comment.
In accordance with the Paperwork Reduction Act of 1995 (PRA), the Bureau of Consumer Financial Protection (Bureau) is requesting approval for a new information collection, titled, “Web-Based Quantitative Testing of Point of Sale/ATM (POS/ATM) Overdraft Disclosure Forms”.
Written comments are encouraged and must be received on or before January 16, 2018 to be assured of consideration.
You may submit comments, identified by the title of the information collection, OMB Control Number (see below), and docket number (see above), by any of the following methods:
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Documentation prepared in support of this information collection request is available at
Historically Black Colleges and Universities Capital Financing Board, Office of Postsecondary Education, U.S. Department of Education.
Announcement of an open meeting.
This notice sets forth the agenda, time, and location of an upcoming open meeting of the Historically Black Colleges and Universities Capital Financing Advisory Board (Board). Notice of this meeting is required by Section 10(a)(2) of the Federal Advisory Committee Act and is intended to notify the public of the opportunity to attend.
The Board meeting will be held on Saturday, December 2, 2017, 4:30 p.m.-7:30 p.m., Central Time, in White Rock Rooms 1-2, Level 5, Omni Hotel, 555 S. Lamar St., Dallas, TX 75202.
Adam H. Kissel, Deputy Assistant Secretary for Higher Education Programs and the Designated Federal Official for the Board, U.S. Department of Education, 400 Maryland Avenue SW., Washington, DC 20202; telephone: (202) 453-6808; email:
There will be an opportunity for public comment regarding the Board's activities on Saturday, December 2, 2017, 6:45 p.m.-7:15 p.m. Please be advised that comments cannot exceed five (5) minutes. Members of the public interested in submitting written comments may do so by submitting comments to the attention of Adam H. Kissel, 400 Maryland Avenue SW., Washington, DC, 20202. Comments must be postmarked no later than Saturday, November 25, 2017, to be considered for discussion during the meeting. Comments should pertain to the work of the Board or the Program.
Pursuant to the FACA, 5 U.S.C. App. as amended, Section 10(b), the public may also inspect meeting materials at
Title III, Part D, Section 347, of the Higher Education Act of 1965, as amended in 1998 (20 U.S.C. 1066f).
National Center for Education Statistics (NCES), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a reinstatement of a previously approved information collection.
Interested persons are invited to submit comments on or before January 16, 2018.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact NCES Information Collections at
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Water Power Technologies Office, Office of Energy Efficiency and Renewable Energy, Department of Energy.
Notice of public forum.
This notice serves to announce that the Water Power Technologies Office (WPTO) within the Department of Energy (DOE) intends to hold a marine and hydrokinetic (MHK) Distributed and Alternate Applications Forum (“Forum”) in Washington, DC from December 5-7, 2017. The purpose of the Forum is to gather the latest information on potential high-priority alternative markets for MHK technologies. In order to gather as much data as possible, the Forum will bring together key representatives from potential high-priority markets, MHK technology developers and academia, along with staff from the Department of Energy and its national laboratories who have conducted some preliminary investigation of potential opportunities. This information will ultimately be used to inform WPTO activities and strategy.
DOE will host the Forum from December 5-7, 2017. Each day will run from approximately 7:15 a.m. to 7:00 p.m. DOE will be accepting any comments about the Forum through December 5.
The Forum will be held at The St. Gregory Hotel, 2033 M St. NW., Washington, DC 20024. You may submit comments or questions by email to:
Alexsandra Lemke, Office of Energy Efficiency and Renewable Energy, U.S. Department of Energy, 1000 Independence Ave SW., Washington, DC 20585. Telephone: (720)-648-4381. Email:
The Forum provides a premier opportunity to learn about new applications for marine energy, and how emerging technologies capturing wave and tidal power can help meet the energy needs of a variety of industries. The Forum will bring together experts in marine energy and those from ocean industries who might benefit from local, reliable energy from waves and currents. Speakers will include MHK technology developers and researchers at the forefront of marine energy generation, representatives from industries and communities where marine energy can offer the greatest economic benefit, and government leaders and regulators.
Attendees will both discuss and evaluate high-potential alternate markets for developing marine-energy technologies as well as support DOE in aligning MHK technology R&D initiatives with high-priority opportunities. The event is divided into three days, with each day focusing on distinct topics: December 5th will focus on biofuels and aquaculture (Food and Fuel), December 6th will address the potential markets for subsea sensors, autonomous underwater vehicle recharging, and subsea data centers (Sensors and Data), and December 7th will conclude with desalination of seawater and seawater mineral extraction (Water and Minerals). Participating in these sessions provides attendees the chance to give feedback and input into which markets are best suited to the different marine energy technologies, and how devices can be designed and operated to maximize their benefits for each application. As a result of this forum, the WPTO will produce a report summarizing the opportunities within potential market areas. This is an opportunity for all attendees to provide feedback and input into which markets are best suited to the different marine energy technologies, and how devices can be designed and operated to maximize their benefits for each application.
The event is open to the public based upon space availability. DOE will also accept public comments as described above for purposes of better understanding the marine and hydrokinetic industry along with the alternative markets to be discussed at the Forum. These comments may be submitted at
Participants should limit information and comments to those based on personal experience, individual advice, information, or facts regarding this topic. It is not the object of this session to obtain any group position or consensus from the meeting participants.
Following the meeting, a summary will be compiled by DOE and posted for public comment. For those interested in providing additional public comment, the summary will be posted at
The following notice of meeting is published pursuant to section 3(a) of the
Federal Energy Regulatory Commission.
November 16, 2017, 10:00 a.m.
Room 2C, 888 First Street NE., Washington, DC 20426.
OPEN.
Agenda, * NOTE—Items listed on the agenda may be deleted without further notice.
Kimberly D. Bose, Secretary, Telephone (202) 502-8400. For a recorded message listing items struck from or added to the meeting, call (202) 502-8627.
This is a list of matters to be considered by the Commission. It does not include a listing of all documents relevant to the items on the agenda. All public documents, however, may be viewed on line at the Commission's Web site at
A free webcast of this event is available through
The event will contain a link to its webcast. The Capitol Connection provides technical support for the free webcasts. It also offers access to this event via television in the DC area and via phone bridge for a fee. If you have any questions, visit
Immediately following the conclusion of the Commission Meeting, a press briefing will be held in the Commission Meeting Room. Members of the public may view this briefing in the designated overflow room. This statement is intended to notify the public that the press briefings that follow Commission meetings may now be viewed remotely at Commission headquarters, but will not be telecast through the Capitol Connection service.
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report 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:
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has entered into a Consent Agreement with ENEL Green Power North America, Inc. (EGPNA or Respondent) to resolve violations of the Clean Water Act (CWA), the Clean Air Act (CAA), the Resource Conservation and Recovery Act (RCRA) and the Emergency Planning and Community Right-to-Know Act (EPCRA) and their implementing regulations.
The Administrator is hereby providing public notice of this Consent Agreement and proposed Final Order (CAFO), and providing an opportunity for interested persons to comment on the CWA, CAA, RCRA and EPCRA portions of the CAFO, pursuant to CWA Sections 309(g)(4)(A) and 311(b)(6)(C), 33 U.S.C. 1319(g)(4)(A) and 33 U.S.C. 1321(b)(6)(C). Upon closure of the public comment period, the CAFO and any public comments will be forwarded to the Agency's Environmental Appeals Board (EAB).
Comments are due on or before December 15, 2017.
Submit your comments, identified by Docket ID No. EPA-HQ-2016-0268, to the
Peter W. Moore, Water Enforcement Division, Office of Civil Enforcement (2243-A), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460; telephone: (202) 564-6014; fax: (202) 564-0010; email:
This proposed settlement agreement is the result of voluntary disclosures of CWA, CAA, RCRA and EPCRA violations by EGPNA to the EPA. EGPNA is an electric energy producing company which specializes in producing clean energy from renewable sources (
On October 12, 2012, the EPA and Respondent entered into a corporate audit agreement pursuant to the Agency's policy on
All violations discovered and disclosed by the Respondent are listed in Attachments A and B to the CAFO.
The EPA determined that Respondent satisfactorily completed its audit and has met all conditions set forth in the Audit Policy for the violations identified in Attachment A of the CAFO. Therefore, 100 percent of the gravity-based penalty calculated for the violations identified in Attachment A of the CAFO is being waived.
Attachment B of the CAFO identifies certain CWA violations that did not meet Condition V of the Audit Policy requiring correction of the violation within 60 days of discovery. For these violations, a gravity-based penalty of $22,373 is assessed.
For all violations listed in Attachments A and B, EPA calculated an economic benefit of noncompliance of $54,624. This number was calculated using specific cost information provided by Respondent and use of the Economic Benefit (BEN) computer model.
EGPNA has agreed to pay a total civil penalty of $76,997 for all the violations identified in Attachments A and B of the CAFO. Of this amount, $54,624 is the economic benefit of noncompliance and $22,373 is the gravity-based penalty for the violations listed in Attachment B of the CAFO.
Of this total amount, $633 is attributable to the CAA violations, $49,817 is attributable to the CWA NPDES violations, $23,946 is attributable to the CWA SPCC violations, $907 is attributable to the RCRA violations, and $1,664 is attributable to the EPCRA violations.
The EPA and Respondent negotiated the Consent Agreement in accordance with the Consolidated Rules of Practice, 40 CFR part 22, specifically 40 CFR 22.13(b) and 22.18(b) (
Respondent disclosed that it failed to prepare and implement a Spill Prevention, Control, and Countermeasure (SPCC) Plan in violation of CWA Section 311(j), 33 U.S.C. 1321(j), and the implementing regulations found at 40 CFR part 112, at eighteen (18) facilities located in Idaho, Kansas, Massachusetts, Minnesota, New Hampshire, Nevada, New York, Oklahoma, Texas, Washington, and
Under CWA Section 311(b)(6)(A), 33 U.S.C. 1321(b)(6)(A), any owner, operator, or person in charge of a vessel, onshore facility, or offshore facility from which oil is discharged in violation of CWA Section 311(b)(3), 33 U.S.C. 1321(b)(3), or who fails or refuses to comply with any regulations that have been issued under CWA Section 311(j), 33 U.S.C. 1321(j), may be assessed an administrative civil penalty of up to $177,500 by the EPA. Class II proceedings under CWA Section 311(b)(6), 33 U.S.C. 1321(b)(6), are conducted in accordance with 40 CFR part 22. As authorized by CWA Section 311(b)(6), 33 U.S.C. 1321(b)(6), the EPA has assessed a civil penalty for these violations.
Pursuant to CWA Section 311(b)(6)(C), 33 U.S.C. 1321(b)(6)(C), the EPA will not issue an order in this proceeding prior to the close of the public comment period.
Respondent disclosed that it violated CWA Sections 301(a), 33 U.S.C. 1311(a) and Section 402(a), 33 U.S.C. 1342(a) and implementing regulations found at 40 CFR part 122 at twenty-six (26) facilities located in Georgia, Idaho, Massachusetts, New Hampshire, New York, North Carolina, South Carolina, Vermont, Virginia, and identified in Attachments A and B and listed below.
Under CWA Section 309(a) and (g)(2)(B), 33 U.S.C. 1319(a) and (g)(2)(B), any person who is in violation of any condition or limitation which implements section 301, 302, 306, 307, 308, 318, or 405 of this title in a permit issued by a State under an approved permit program under section 402 or 404 of this title may be assessed an administrative penalty of up to $177,500 by the EPA. Class II proceedings under CWA Section 309(g)(2)(B), 33 U.S.C. 1319(g)(2)(B), are conducted in accordance with 40 CFR part 22. As authorized by CWA Section 309(g)(2)(B), 33 U.S.C. 1319(g)(2)(B), the EPA has assessed a civil penalty for these violations.
Respondent disclosed that it violated CAA Section 110, 42 U.S.C. 7410 and Nevada State Implementation Plan for operating under a Class II Air Quality Operating Permit that imposes emission limits, monitoring, testing, and reporting requirements for failing to maintain records or report significant losses of isobutane during routine maintenance. The facilities are located in the State of Nevada.
Under CAA Section 113(d), 42 U.S.C. 7413(d), the Administrator may issue an administrative penalty order to any person who has violated or is in violation of any applicable requirement or prohibition of the CAA, including any rule, order, waiver, permit, or plan. Proceedings under CAA Section 113(d), 42 U.S.C. 7413(d), are conducted in accordance with 40 CFR part 22. The EPA, as authorized by the CAA, has assessed a civil penalty for these violations.
Respondent disclosed that it failed to comply with RCRA Section 3002 of RCRA, 42 U.S.C. 6922, and the regulations found at 40 CFR part 265, 273, and 279, at sixty (60)) facilities listed in Attachment A of the CAFO when it failed to conduct waste accumulation and storage inspections; maintain proper universal waste disposal and handling practices for spent fluorescent lamps and tubes; and by failing to maintain waste oil in accordance with the regulations. These sixty (60) facilities are located in the following states: California, Connecticut, Georgia, Idaho, Kansas, Maine, Massachusetts, Minnesota, Oklahoma, Nevada, New York, North Carolina, Pennsylvania, South Carolina Vermont, Virginia and Washington, West Virginia.
Under RCRA Section 3008, 42 U.S.C. 6928, the Administrator may issue an order assessing a civil penalty for any past or current violation the RCRA. Proceedings under RCRA Section 3008, 42 U.S.C. 6928, are conducted in accordance with 40 CFR part 22. The EPA, as authorized by the RCRA, has assessed a civil penalty for these violations.
Respondent disclosed that it violated EPCRA Section 302(c), 42 U.S.C. 11002(c), and the implementing regulations found at 40 CFR part 355, at three (3) facilities listed in Attachment
Respondent disclosed that it violated EPCRA Section 311(a), 42 U.S.C. 11021(a), and the implementing regulations found at 40 CFR part 370, at three (3) facilities listed in Attachment A when it failed to submit a Material Safety Data Sheet (MSDS) for a hazardous chemical(s) and/or extremely hazardous substance(s) or, in the alternative, a list of such chemicals, to the LEPCs, SERCs, and the fire departments with jurisdiction over these facilities. These three (3) facilities are located in the following states: Kansas and New Hampshire.
Respondent disclosed that it violated EPCRA Section 312(a), 42 U.S.C. 11022(a), and the implementing regulations found at 40 CFR part 370, at three (3) facilities listed in Attachment A when it failed to prepare and submit emergency and chemical inventory forms to the LEPCs, SERCs, and the fire departments with jurisdiction over these facilities. These three (3) facilities are located in the following states: Kansas and New Hampshire.
Under EPCRA Section 325, 42 U.S.C. 11045, the Administrator may issue an administrative order assessing a civil penalty against any person who has violated applicable emergency planning or right-to-know requirements, or any other requirement of EPCRA. Proceedings under EPCRA Section 325, 42 U.S.C. 11045, are conducted in accordance with 40 CFR part 22. The EPA, as authorized by EPCRA Section 325, 42 U.S.C. 11045, has assessed a civil penalty for these violations.
Environmental protection.
Environmental Protection Agency (EPA).
Notice of Proposed Settlement Agreement; Request for Public Comment.
In accordance with section 113(g) of the Clean Air Act, as amended (“CAA” or the “Act”), notice is hereby given of a proposed settlement agreement to resolve a case filed by Veolia ES Technical Solutions, L.L.C. (“Veolia”) involving EPA actions under the CAA Title V operating permit program. On February, 15, 2017, Veolia filed a petition with the Environmental Appeals Board (“EAB”) challenging the CAA Title V renewal permit issued by EPA Region 5 for the Veolia facility in Sauget, Illinois (“the Facility”) on January 18, 2017. (
Written comments on the proposed settlement agreement must be received by
Submit your comments, identified by Docket ID number EPA-HQ-OGC-2017-0630, online at
John T. Krallman, Air and Radiation Law Office (2344A), Office of General Counsel, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone: (202) 564-0904; email address:
The proposed settlement agreement would resolve the case filed by Veolia involving EPA Region 5's actions under the CAA title V operating permit program. On February 15, 2017, Veolia filed a petition with the Environmental Appeals Board (“EAB”) challenging the CAA Title V renewal permit issued by EPA Region 5 on January 18, 2017 to Veolia's facility in Sauget, Illinois (“the Facility”).
Under the terms of the proposed settlement agreement, among other changes to the permit, Veolia agrees to install activated carbon injection systems (“ACI systems”) on two of its incinerators to control emissions of vapor phase mercury and EPA Region 5 agrees to request a voluntary remand from the EAB of the CAA Title V renewal permit issued on January 18, 2017. If this proposed settlement agreement is finalized, EPA Region 5 will put out a draft CAA Title V permit for separate public notice and comment period. The revised draft CAA Title V renewal permit, which is attached to the proposed settlement agreement, also includes improvements to Veolia's procedures for analyzing hazardous wastes burned in the incinerators. If the final CAA Title V renewal permit for the Facility only contains changes from the revised draft that reflect the inclusion of any final preconstruction permit that has been issued by the Illinois Environmental Protection Agency for the ACI systems or clerical changes from the draft CAA Title V permit attached to the proposed settlement agreement, Veolia agrees that it will not file a petition for review with the EAB or otherwise challenge the final CAA Title V renewal permit for the Facility. The proposed settlement agreement provides that this public notice shall not serve as the notice and comment period for any
For a period of thirty (30) days following the date of publication of this notice, the Agency will accept written comments relating to the proposed settlement agreement from persons who are not named as parties or intervenors to the litigation in question. EPA may withdraw or withhold consent to the proposed settlement agreement if the comments disclose facts or considerations that indicate that such consent is inappropriate, improper, inadequate, or inconsistent with the requirements of the Act.
The official public docket for this action (identified by Docket ID No. EPA-HQ-OGC-2017-0630) contains a copy of the proposed settlement agreement, including the draft CAA Title V renewal permit. The official public docket is available for public viewing at the Office of Environmental Information (OEI) Docket in the EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OEI Docket is (202) 566-1752.
An electronic version of the public docket is available through
It is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing online at
You may submit comments as provided in the
If you submit an electronic comment, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment and with any disk or CD ROM you submit. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. Any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.
Use of the
Thursday, November 16, 2017 at 10:00 a.m.
999 E Street NW., Washington, DC (Ninth Floor).
This meeting will be open to the public.
Judith Ingram, Press Officer, Telephone: (202) 694-1220.
Individuals who plan to attend and require special assistance, such as sign language interpretation or other reasonable accommodations, should contact Dayna C. Brown, Secretary and Clerk, at (202)694-1040, at least 72 hours prior to the meeting date.
Federal Housing Finance Agency.
Notice of a new system of records.
In accordance with the requirements of the Privacy Act of 1974, as amended (Privacy Act), the Federal Housing Finance Agency (FHFA) gives notice of a new proposed Privacy Act system of records. The new proposed
To be assured of consideration, comments must be received on or before December 15, 2017. This new system of records will become effective on December 15, 2017 without further notice unless comments necessitate otherwise. FHFA will publish a new notice if the effective date is delayed to review comments or if changes are made based on comments received.
Submit comments to FHFA, identified by “2017-N-09,” using any one of the following methods:
•
•
•
•
See
Moji Adelekan, Senior Human Resources Specialist at (202) 649-3745; or David A. Lee, Senior Agency Official for Privacy,
This notice informs the public of FHFA's proposal to establish and maintain a new system of records. The proposed new system is being established under FHFA's authority at 12 U.S.C. 4517(h) to hire for mission critical occupation jobs such as examiners, accountants, economists, and specialists in financial markets and in technology. This notice satisfies the Privacy Act requirement that an agency publish a system of records notice in the
As required by the Privacy Act, 5 U.S.C. 552a(r), and pursuant to section 7 of OMB Circular No. A-108, “Federal Agency Responsibilities for Review, Reporting, and Publication under the Privacy Act,” dated December 23, 2016 (81 FR 94424 (Dec. 23, 2016)), prior to publication of this notice, FHFA submitted a report describing the new system of records covered by this notice to the Office of Management and Budget, the Committee on Oversight and Government Reform of the House of Representatives, and the Committee on Homeland Security and Governmental Affairs of the Senate.
The proposed new system of records described above is set forth in its entirety below.
Applicant Tracking System, FHFA-25.
Sensitive but unclassified.
Federal Housing Finance Agency, 400 7th Street SW., Washington, DC 20219; Acendre Inc., 4350 Fairfax Drive, Suite 400, Arlington, VA 22203-1632; and any alternate site used by Federal Housing Finance Agency (FHFA) employees, or individuals, including contractors, assisting such employees.
Office of Human Resources Management, Federal Housing Finance Agency, 400 7th Street SW., Washington, DC 20219.
12 U.S.C. 4515 and 12 U.S.C. 4517(h).
The Applicant Tracking System will be used by FHFA to post and publicize mission critical occupation job openings using FHFA's authority at 12 U.S.C. 4517(h) to hire examiners, accountants, economists, and specialists in financial markets and in technology. The System will be used to receive, store, and process resumes, applications, curriculum vitaes, and similar documents received in response to mission critical occupation job openings, and recruiting and outreach events. In addition, the System will be used to track applicants for such positions.
Applicants for positions at FHFA.
Name; date of birth; race, national origin, color, gender, and disability; business and home addresses; business and personal electronic mail (email) addresses; business, home, cellular, and personal telephone numbers; education records; military status and/or information; and employment experience, status and related information.
Information is provided by applicants.
In addition to those disclosures generally permitted under 5 U.S.C. 552a(b) of the Privacy Act, these records or information contained therein may specifically be disclosed outside FHFA as a routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
(1) To appropriate agencies, entities, and persons when (1) FHFA suspects or has confirmed that there has been a breach of the system of records, (2) FHFA has determined that as a result of the suspected or confirmed breach there is a risk of harm to individuals, FHFA (including its information systems, programs, and operations), the Federal Government, or national security; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with FHFA's efforts to respond to the suspected or confirmed breach or to prevent, minimize, or remedy such harm.
(2) Where there is an indication of a violation or potential violation of law, whether civil, criminal or regulatory in nature, and whether arising by general statute or particular program statute, or by regulation, rule or order issued pursuant thereto, the relevant records in the system of records may be referred, as a routine use, to the appropriate agency, whether federal, state, local, tribal, foreign or a financial regulatory organization charged with the responsibility of investigating or prosecuting such violation or charged with enforcing or implementing a statute, or rule, regulation or order issued pursuant thereto.
(3) To any individual during the course of any inquiry or investigation conducted by FHFA, or in connection with civil litigation, if FHFA has reason to believe that the individual to whom the record is disclosed may have further information about the matters related therein, and those matters appeared to be relevant at the time to the subject matter of the inquiry.
(4) To any individual with whom FHFA contracts to collect, store, or maintain, or reproduce by typing, photocopy or other means, any record within this system for use by FHFA and its employees in connection with their official duties, or to any individual who is utilized by FHFA to perform clerical or stenographic functions relating to the official business of FHFA.
(5) To a Congressional office from the record of an individual in response to an inquiry from the Congressional office made at the request of that individual.
(6) To a court, magistrate, or administrative tribunal in the course of presenting evidence, including disclosures to opposing counsel or witnesses in the course of civil discovery, litigation, or settlement negotiations or in connection with criminal law proceedings or in response to a subpoena from a court of competent jurisdiction.
(7) To the Office of Management and Budget, Department of Justice (DOJ), Department of Labor, Office of Personnel Management, Equal Employment Opportunity Commission, Office of Special Counsel, or other Federal agencies to obtain advice regarding statutory, regulatory, policy, and other requirements related to the purpose for which FHFA collected the records.
(8) To DOJ, (including United States Attorney Offices), or other Federal agency conducting litigation or in proceedings before any court, adjudicative or administrative body, when it is necessary to the litigation and one of the following is a party to the litigation or has an interest in such litigation:
1. FHFA
2. Any employee of FHFA in his/her official capacity;
3. Any employee of FHFA in his/her individual capacity where DOJ or FHFA has agreed to represent the employee; or
4. The United States or any agency thereof, is a party to the litigation or has an interest in such litigation, and FHFA determines that the records are both relevant and necessary to the litigation and the use of such records is compatible with the purpose for which FHFA collected the records.
(9) To the National Archives and Records Administration or other Federal agencies pursuant to records management inspections being conducted under the authority of 44 U.S.C. 2904 and 2906.
(10) To an agency, organization, or individual for the purpose of performing audit or oversight operations as authorized by law, but only such information as is necessary and relevant to such audit or oversight function.
Records are maintained in electronic and paper format. Electronic records are stored in computerized databases. Paper records are stored in locked offices, locked file rooms, locked file cabinets, or safes.
Records may be retrieved by any of the following: Name, email address, or assigned file number. Information may additionally be retrieved by other personal identifiers.
Records are retained and disposed of in accordance with FHFA's approved
Records are safeguarded in a secured environment. Buildings where records are stored have security cameras and 24-hour security guard service. Computerized records are safeguarded through use of access codes and other information technology security measures. Paper records are safeguarded by locked offices, locked file rooms, locked file cabinets, or safes. Access to the records, whether in electronic or paper form, is restricted to those who require the records in the performance of official duties related to the purposes for which the system is maintained.
Direct requests for access to a record to the Privacy Act Officer, Federal Housing Finance Agency, 400 7th Street SW., Washington, DC 20219, or
Direct requests to contest or appeal an adverse determination for a record to the Privacy Act Appeals Officer, Federal Housing Finance Agency, 400 7th Street SW., Washington, DC 20219, or
Direct inquiries as to whether this system contains a record pertaining to an individual to the Privacy Act Officer, Federal Housing Finance Agency, 400 7th Street SW., Washington, DC 20219, or
None.
This is a new system therefore there is no history.
Federal Maritime Commission.
Notice.
The Federal Maritime Commission (Commission) is giving public notice that the agency has submitted to the Office of Management and Budget (OMB) for approval the continuing information collections (extensions with no changes) described in this notice. The public is invited to comment on the proposed information collections pursuant to the Paperwork Reduction Act of 1995.
Written comments must be submitted at the addresses below on or before December 15, 2017 to be assured of consideration.
Comments should be addressed to:
Please send separate comments for each specific information collection listed below, and reference the information collection's title and OMB number in your comments.
Copies of the submission(s) may be obtained by contacting Donna Lee at 202-523-5800 or email:
Pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104-13), the Commission invites the general public and other Federal agencies to comment on proposed information collections. On July 11, 2017, the Commission published a notice and request for comments in the
In response to this notice, comments and suggestions should address one or more of the following points: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (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.
The Commission hereby gives notice of the filing of the following agreement under the Shipping Act of 1984. Interested parties may submit comments on the agreement to the Secretary, Federal Maritime Commission, Washington, DC 20573, within twelve days of the date this notice appears in the
By Order of the Federal Maritime Commission.
Board of Governors of the Federal Reserve System.
Notice.
The Board of Governors of the Federal Reserve System (Board) has approved the private sector adjustment factor (PSAF) for 2018 of $18.9 million and the 2018 fee schedules for Federal Reserve priced services and electronic access. These actions were taken in accordance with the Monetary Control Act of 1980, which requires that, over the long run, fees for Federal Reserve priced services be established on the basis of all direct and indirect costs, including the PSAF.
The new fee schedules become effective January 2, 2018.
For questions regarding the fee schedules: David C. Mills, Deputy Associate Director, (202) 530-6265; Emily Massaro, Financial Services Analyst, (202) 452-2493, Division of Reserve Bank Operations and Payment Systems. For questions regarding the PSAF: Lawrence Mize, Deputy Associate Director, (202) 452-5232; Max Sinthorntham, Senior Financial Analyst, (202) 452-2864, Division of Reserve Bank Operations and Payment Systems. For users of Telecommunications Device for the Deaf (TDD) only, please call (202) 263-4869. Copies of the 2018 fee schedules for the check service are available from the Board, the Federal Reserve Banks, or the Reserve Banks' financial services Web site at
A.
Table 1 summarizes 2016 actual, 2017 estimated, and 2018 budgeted cost-recovery rates for all priced services. Cost recovery is estimated to be 102.6 percent in 2017 and budgeted to be 100.0 percent in 2018.
Table 2 provides an overview of cost-recovery budgets, estimates, and performance for the 10-year period from 2007 to 2016, 2016 actual, 2017 budget, 2017 estimate, and 2018 budget by priced service.
1.
2.
3.
The primary risks to the Reserve Banks' ability to achieve their targeted cost recovery rates are unanticipated volume and revenue reductions and the potential for cost overruns from new and ongoing improvement initiatives. In light of these risks, the Reserve Banks will continue to refine their business and operational strategies to manage operating costs, increase product
4.
• The Reserve Banks will reassign the tier placement of 478 forward and 977 return endpoints in the FedForward® and FedReturn® products, respectively.
• The Reserve Banks will increase all per-item fees for the FedReturn product, except substitute check fees, by 3 percent, rounded to the nearest penny, based on the 2018 tier assignments.
• The Reserve Banks will lower the average daily forward receipt volume thresholds for tiers 1, 2, and 3 of the FedForward product Premium Daily Fee A, B, and C deposit options based on 2018 tier assignments.
• The Reserve Banks will increase fees for their paper check forward and return collection products to encourage depositors to shift volume away from legacy paper-related products. The Reserve Banks will increase the cash letter fee for paper forward deposits from $10 to $15, and increase the per-item fee for paper forward deposits and paper return deposits by $1 to $3.50 and $6.50 respectively.
• The Reserve Banks will increase all fees for the FedImage® product by 10 percent (rounded to the nearest increment based upon the number of decimal places of the current fee).
• The Reserve Banks will increase the base origination and receipt per-item fees from $0.0032 to $0.0035. The Reserve Banks also will increase per-item volume-based discounts by $0.0003 for certain origination discounts (depending on origination volume) and all receipt discounts.
• The Reserve Banks will increase the monthly FedACH Participation Fee from $58 to $65.
• The Reserve Banks will decrease the Tier 3 per-item pre-incentive fee from $0.17 to $0.16 per transaction.
• The Reserve Banks will decrease the Tier 3 per-item incentive fee, which is derived from the Tier 3 per-item pre-incentive fee, from $0.034 to $0.032.
• The Reserve Banks will decrease the payment notification origination surcharge from $0.20 to $0.01.
• The Reserve Banks will keep prices at existing levels for the priced NSS products.
• The Reserve Banks will keep prices at existing levels for the priced Fedwire Securities products.
• The Reserve Banks will provide VPN devices directly to customers and include the provision of the devices in all FedLine Advantage®, FedLine Command®, and both FedLine Direct® packages.
• The Reserve Banks will introduce two new FedComplete® packages: FedComplete 100C Plus and FedComplete 200C Plus. The new FedComplete 100C Plus and 200C Plus packages, which use the same threshold volumes as the existing FedComplete packages, will include the FedLine Command access solution, rather than FedLine Advantage. FedComplete 100C Plus will be priced at $1,375 per month and FedComplete 200C Plus will be priced at $1,900 per month.
• The Reserve Banks will make six additional FedComplete package changes: (1) Add the SameDay ACH origination participation fee and surcharge; (2) remove the FedMail®-FedLine Exchange® Subscriber 5-pack, consistent with the previously announced unbundling of the FedMail service; (3) increase the price of the existing volume overage monthly surcharges for FedForward, from $0.01 to $0.037, FedReturn, from $0.75 to $0.82, FedACH origination, from $0.0025 to $0.0035, and Fedwire Funds origination, from $0.70 to $0.82; (4) implement FedReceipt®, FedACH receipt, and Fedwire Funds receipt monthly surcharges of $0.00005, $0.00035, and $0.082, respectively; (5) implement a threshold limit of 46 items for FedForward Cash Letters; and (6) adjust FedComplete package prices to maintain an effective discount of less than 20 percent compared to the cost of purchasing services separately.
• The Reserve Banks will increase the legacy software fee for FedLine Direct customers that have not converted to new IBM® MQ software. The fee will vary based on the number of customers remaining on the legacy system.
5.
B.
The portion of Federal Reserve assets that will be used to provide priced services during the coming year is determined using information about actual assets and projected disposals and acquisitions. The priced portion of these assets is determined based on the allocation of depreciation and amortization expenses of each asset class. The priced portion of actual Federal Reserve liabilities consists of postemployment and postretirement benefits, accounts payable, and other liabilities. The priced portion of the actual net pension asset or liability is also included on the balance sheet.
The equity financing rate is the targeted ROE produced by the capital asset pricing model (CAPM). In the CAPM, the required rate of return on a firm's equity is equal to the return on a risk-free asset plus a market risk premium. The risk-free rate is based on the three-month Treasury bill; the beta is assumed to be equal to 1.0, which approximates the risk of the market as a whole; and the market risk premium is based on the monthly returns in excess of the risk-free rate over the most recent 40 years. The resulting ROE reflects the return a shareholder will expect when investing in a private business firm.
For simplicity, given that federal corporate income tax rates are graduated, state income tax rates vary, and various credits and deductions can apply, an actual income tax expense is not explicitly calculated for Reserve Bank priced services. Instead, the Board targets a pretax ROE that will provide sufficient income to fulfill the priced services' imputed income tax obligations. To the extent that performance results are greater or less than the targeted ROE, income taxes are adjusted using the effective tax rate.
The increase in the 2018 PSAF to $18.9 million from $16.6 million in 2017 is primarily attributable to a $1.1 million increase in the cost of debt and a $0.8 million increase in the return on equity, both driven by increased imputed funding needs for long-term assets arising from a higher net pension asset balance. System sales tax expenses increased by $0.7 million and were offset, in part, by a $0.3 million decrease in Board of Governors expenses.
Projected 2018 Federal Reserve priced services assets, reflected in table 3, have decreased $186.8 million from 2017. This decrease is primarily due to a $154.0 million decrease in the balance of items in process of collection and a $70.2 million decrease in imputed investments in federal funds, offset by a net increase of $35.7 million in the long-term assets inclusive of net pension asset; Bank premises, furniture, and equipment; and deferred charges. The decrease in net short-term assets to be financed of $3.6 million had a minimal effect on the PSAF. Net credit float (items in process of collection less deferred credit items) decreased by $154.0 million, primarily attributable to the continued effect of new deposit deadlines associated with the Endpoint Cut service deposit deadlines implemented in July 2016, which were intended to reduce float and items in process of collection. The decrease in net credit float had an equivalent effect on the balance of imputed investments in Treasury securities. The resulting balance of 2018 imputed investments in federal funds was sufficient to comply with the PSR policy expectations for Fedwire Funds, and no additional costs were incurred. As shown in table 3, imputed equity for 2018 is $57.8 million, a decrease of $0.7 million from the equity imputed for 2017. In accordance with ASC 715, this amount includes an accumulated other comprehensive loss of $637.2 million.
Table 4 reflects the portion of short- and long-term assets that must be financed with actual or imputed liabilities and equity. Debt and equity imputed to fund the 2018 priced services assets within the observed market leverage ratio produced an equity level that did not meet the FDIC minimum equity requirements. As a result, additional equity was imputed to meet the FDIC requirements, and imputed long-term debt was reduced. The ratio of capital to risk-weighted assets meets the required 10 percent of risk-weighted assets, and equity exceeds 5 percent of total assets (table 6). In 2018, long-term debt and equity was imputed to meet the asset funding requirements and reflects the leverage ratio observed in the market; additional equity of $1.5 million was required (table 5) to meet the market leverage ratio.
Table 5 shows the derivation of the 2018 and 2017 PSAF. Financing costs for 2018 are $1.9 million higher than in 2017. The allocation of equity based on the capital structure observed in the market increased in 2018 to 41.8 percent from 41.6 percent in 2017. The increased equity balance and the slightly higher cost of equity result in a pretax ROE that is $0.7 million higher than the 2017 pretax ROE. Imputed sales taxes increased to $3.9 million in 2018 from $3.2 million in 2017. The priced services portion of the Board's expenses decreased $0.3 million to $5.1 million in 2018. The effective income tax rate used in 2018 was 22.7 percent, the same rate used in 2017.
C.
1.
The decline in Reserve Bank check volume was not as great as previously anticipated. Through August, both total commercial forward and total commercial return check volumes were only 0.4 percent lower than they were during the same period last year. Consistent with anticipated fourth quarter declines, for full-year 2017, the Reserve Banks estimate that their total forward check volume will decline 1.3 percent (compared with a budgeted decline of 5.0 percent) and their total return check volume will decline 1.0 percent (compared with a budgeted decline of 10.1 percent) from 2016 levels.
2.
The Reserve Banks evaluate and set tier assignments annually based on changes in the volume of items received by endpoints. In 2018, the Reserve Banks will reassign the tier placement of 478 forward and 977 return endpoints in the FedForward and FedReturn products, respectively.
Based on these 2018 tier assignments, the Reserve Banks will for the FedReturn deposit options (FedReturn Standard ICL and FedReturn Premium Daily Fee A) increase all per-item fees, except substitute checks, by 3 percent, rounded to the nearest penny. Table 8 shows the 2018 fees.
The Reserve Banks will also lower the average daily receipt volume thresholds for tiers 1, 2, and 3 of the FedForward daily subscription fee premium deposit options (FedForward Premium Daily Fee A, B, and C).
Together, these changes to the Reserve Banks' FedReturn pricing and FedForward Premium Daily Fee volume thresholds are intended to facilitate longer-term cost recovery for the check service while providing price stability for customers that may otherwise experience significant price fluctuations as a result of the Reserve Banks' 2018 tier assignments.
Finally, in light of today's electronic check-processing environment, the Reserve Banks will increase fees to encourage depositors to shift volume away from legacy paper-related products. The Reserve Banks will increase the cash letter fee for paper forward deposits from $10 to $15, and increase the per-item fee for paper forward deposits and paper return deposits by $1 from $2.50 to $3.50 and from $5.50 to $6.50, respectively.
The Reserve Banks estimate that the announced price changes will result in a 0.4 percent average price increase for check customers.
The primary risks to the Reserve Banks' ability to achieve budgeted 2018 cost recovery for the check service include greater-than-expected declines in check volume due to the general reduction in check writing and increased competition from correspondent banks, aggregators, and direct exchanges, which will result in lower-than-anticipated revenue.
D.
1.
2.
The Reserve Banks will increase the base per-item fees for origination and receipt from $0.0032 to $0.0035. The Reserve Banks will also increase per-item volume-based discounts by $0.0003 for origination discounts based on origination volume and all receipt discounts. There are no changes to the existing origination volume discounts based on receipt volume. These changes provide an effective offset with no price change for customers meeting the volume discount thresholds. The Reserve Banks will also increase the monthly FedACH Participation Fee from $58 to $65.
The Reserve Banks estimate that the combined price changes will result in a 3.6 percent average price increase for FedACH customers.
While the Reserve Banks are not budgeted to fully recover costs in 2018, they are expected to fully recover costs following the finalization of the FedACH technology modernization project. To fully recover costs in 2018, fees will need to be significantly increased to cover the increased costs associated with the technology upgrade, which will result in significant overrecovery once the upgrade is complete. Instead the Reserve Banks continue to moderately increase FedACH fees to minimize pricing volatility and promote long-term price stability for customers.
The primary risks to the Reserve Banks' ability to achieve budgeted 2018 cost recovery for the FedACH service are unanticipated cost overruns associated with the FedACH technology modernization project and higher-than-expected support and overhead costs. Other risks include lower-than-expected volume and associated revenue due to unanticipated mergers and acquisitions and loss of market share due to exchanges directly between banks and volume shifts to the private-sector operator.
E.
1.
2.
The Reserve Banks will adjust the incentive pricing fees for the Fedwire Funds Service by decreasing the Tier 3 per-item pre-incentive fee from $0.17 to $0.16.
The Reserve Banks will not change NSS fees for 2018.
The primary risks to the Reserve Banks' ability to achieve budgeted 2018 cost recovery for these services are cost overruns from new initiatives to improve resiliency and operational functionality.
F.
1.
Through August, Fedwire Securities Service online agency transfer volume was 7.9 percent lower than it was during the same period last year. For full-year 2017, the Reserve Banks estimate that Fedwire Securities Service online agency transfer volume will decline 14.7 percent from 2016 levels, compared with a budgeted decline of 11.8 percent. The reduction in volume primarily reflects three market trends. First, JP Morgan Chase is exiting the U.S. government securities clearing and settlement business for its broker-dealer services, which began gradually in 2017 and is targeted to be complete by the end of 2018.
Through August, account maintenance volume was 5.5 percent lower than it was during the same period last year. For full-year 2017, the Reserve Banks estimate that account maintenance volume will decline 5.5 percent from 2016 levels, compared with a budgeted decline of 7.6 percent. The higher-than-expected account maintenance volume is the result of estimated customer account closures not materializing. Through August, the number of agency issues maintained was 3.8 percent lower than the same period last year. For full-year 2017, the Reserve Banks estimate that the number of agency issues maintained will decline 3.1 percent from 2016 levels, compared with a budgeted decline of 2.1 percent.
2.
Revenue is projected to be $27.3 million, a decrease of 3.9 percent from the 2017 estimate. The Reserve Banks also project that 2018 expenses will increase by $0.4 million compared with 2017 expenses, reflecting higher expected operating costs. Higher operating costs in 2018 primarily reflect investments to advance new initiatives to improve resiliency and operational functionality as well as other business and technology initiatives.
The Reserve Banks will not change Fedwire Securities fees for 2018.
The primary risks to the Reserve Banks' ability to achieve budgeted 2018 cost recovery for these services are lower-than-expected volume resulting from the pace of structural changes in government securities settlement, and cost overruns from new initiatives to improve resiliency and operational functionality.
G.
Eight attended access packages offer manual access to critical payment and information services via a web-based interface. The FedMail package provides access to basic information services via email, while the two FedLine Exchange packages are designed to provide certain services, such as the E-Payments Routing Directory, to customers that otherwise do not use FedLine for Federal Reserve Financial Services. The two FedLine Web packages offer online attended access to a range of services, including cash services, FedACH information services, and check services. Three FedLine Advantage packages expand upon the FedLine Web packages and offer attended access to critical transactional services: FedACH, Fedwire Funds, and Fedwire Securities.
Three unattended access packages are computer-to-computer, IP-based interfaces. The FedLine Command package offers an unattended connection to FedACH as well as to most accounting information services. The two remaining options are FedLine Direct packages, which allow for unattended connections at one of two connection speeds to FedACH, Fedwire Funds, and Fedwire Securities transactional and information services and to most accounting information services.
The Reserve Banks will modify the existing monthly fees for FedLine Advantage, Command, and Direct and FedComplete packages to include the price of one or two VPN devices, depending on the package, plus the cost of associated vendor maintenance activities.
VPN devices are being upgraded to Sprint's VPN Managed Solution starting 2018 through 2020 as part of a three-year refresh cycle. New devices will be provisioned to customers, in waves, starting mid-2018.
The Reserve Banks will also introduce two FedComplete packages, FedComplete 100C Plus and FedComplete 200C Plus, priced at $1,375 and $1,900 per month, respectively.
In addition to the changes above for the 2018 FedComplete packages, the Reserve Banks will make six other package changes to maintain consistency with other product offices' product and pricing changes: (1) Add the SameDay ACH origination participation fee and surcharge; (2) remove FedMail-FedLine Exchange Subscriber 5-pack, consistent with the previously announced unbundling of the FedMail service; (3) increase volume overage surcharges for FedForward, from $0.01 to $0.037, FedReturn from $0.75 to $0.82, FedACH origination from $0.0025 to $0.0035, and Fedwire Funds origination from $0.70 to $0.82; (4) implement FedReceipt, FedACH receipt and Fedwire Funds transaction receipt surcharges of $0.00005, $0.00035, and $0.082, respectively; (5) implement a threshold limit of 46 items for FedForward Cash Letters; and (6)
Finally, the Reserve Banks will increase the legacy software fee for FedLine Direct customers that have not converted to new IBM® MQ software. The fee will vary based on the number of customers remaining on the legacy system, up to $80,000/month through 3/31/18 and up to $150,000/month thereafter.
The Reserve Banks estimate that the price changes will result in a 4.3 percent average price increase for FedLine customers. This is primarily driven by the VPN device billing changes.
All operational and legal changes considered by the Board that have a substantial effect on payment system participants are subject to the competitive impact analysis described in the March 1990 policy “The Federal Reserve in the Payments System.”
The 2018 fees, fee structures, and changes in service will not have a direct and material adverse effect on the ability of other service providers to compete effectively with the Reserve Banks in providing similar services. The changes should permit the Reserve Banks to earn a ROE that is comparable to overall market returns and provide for full cost recovery over the long run.
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than December 12, 2017.
1.
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than December 11, 2017.
1.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the
Submit either electronic or written comments on the collection of information by January 16, 2018.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 16, 2018. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
•
Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726,
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, we invite comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
Statutory requirements for infant formula under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) are intended to protect the health of infants and include a number of reporting and recordkeeping requirements. Among other things, section 412 of the FD&C Act (21 U.S.C. 350a) requires manufacturers of infant formula to establish and adhere to quality control procedures, notify us when a batch of infant formula that has left the manufacturers' control may be adulterated or misbranded, and keep records of distribution. We have issued regulations to implement the FD&C Act's requirements for infant formula in parts 106 and 107 (21 CFR parts 106 and 107). We also regulate the labeling of infant formula under the authority of section 403 of the FD&C Act (21 U.S.C. 343). Under our labeling regulations for infant formula in part 107, the label of an infant formula must include nutrient information and directions for use. The purpose of these labeling requirements is to ensure that consumers have the information they need to prepare and use infant formula appropriately.
We have developed an electronic form (Form FDA 3978) that infant formula manufacturers will be able to use to electronically submit reports and notifications in a standardized format to FDA. Manufacturers that prefer to submit paper submissions in a format of their own choosing will still have the option to do so, however. Form FDA 3978 prompts a respondent to include reports and notifications in a standard electronic format and helps the respondent organize their submission to include only the information needed for our review. Draft screenshots of Form FDA 3978 and instructions are available for comment at
We estimate the burden of this collection of information as follows:
In compiling these estimates, we consulted our records of the number of infant formula submissions received in the past. All infant formula submissions may be provided to us in electronic format. The hours per response reporting estimates are based on our experience with similar programs and information received from industry.
We estimate that we will receive 13 reports from 5 manufacturers annually under section 412(d) of the FD&C Act, for a total annual response of 65 reports. Each report is estimated to take 10 hours per response for a total of 650 hours. We also estimate that we receive one notification under § 106.120(b). The notification is expected to take 4 hours per response, for a total of 4 hours.
For exempt infant formula, we estimate that we receive two reports from three manufacturers annually under § 107.50(b)(3) and (4), for a total annual response of six reports. Each report is estimated to take 4 hours per response for a total of 24 hours. We also estimate that we receive one notification annually under § 107.50(e)(2) and that the notification takes 4 hours to prepare.
We estimate that 4 firms submit 36 exemptions annually and that each exemption will take 20 hours to assemble. Therefore, we calculate 36 exemptions × 20 hours = 720 hours as the estimated burden for § 106.96(c), as presented in row 5 of table 1.
We estimate that the infant formula industry annually submits 35 Protein Efficiency Ratio (PER) submissions. For the submission of the PER exemption, we estimate that the infant formula industry submits 34 exemptions per year and that each exemption takes supporting staff 12 hours to prepare. Therefore, we calculate 34 exemptions × 12 hours per exemption = 408 hours to fulfill the requirements of § 106.96(g), as shown in row 6 of table 1.
We estimate that four firms each use one senior scientist or regulatory affairs professional who needs 30 minutes to gather and record the required information for an infant formula registration pursuant to § 106.110. We estimate that the industry annually registers 35 new infant formulas, or an average of 9 registrations per firm. Therefore, we calculate the annual burden as 36 registrations × 0.5 hour per registration = 17.5 (rounded to 18) hours, as shown in row 7 of table 1.
We estimate that four firms each use one senior scientist or regulatory affairs professional who needs 10 hours to gather and record information needed for infant formula submissions pursuant to § 106.120. This estimate includes the time needed to gather and record the information the manufacturer uses to request an exemption under § 106.91(b)(1)(ii), which provides that the manufacturer includes the scientific evidence that the manufacturer is relying on to demonstrate that the stability of the new infant formula will likely not differ from the stability of formula with similar composition, processing, and packaging for which there are extensive stability data. We estimate that 4 firms make submissions for 36 new infant formulas, or an average of 9 submissions per firm. Therefore, to comply with § 106.120, we calculate the annual burden as 36 submissions × 10 hours per submission = 360 hours, as shown in row 8 of table 1. Thus, the total annual reporting burden is 2,188 hours.
We estimate that 21 infant formula plants will test at least every 4 years for radiological contaminants. In addition, we estimate that collecting water for all testing in § 106.20(f)(3) takes between 1 and 2 hours. We estimate that water collection takes an average of 1.5 hours and that water collection occurs separately for each type of testing. We estimate that performing the test will take 1.5 hours per test, every 4 years. Therefore, 1.5 hours per plant × 21 plants = 31.5 (rounded to 32) total hours, every 4 years, as seen in row 1 of table 2. Furthermore, §§ 106.20(f)(4) and 106.100(f)(1) require firms to make and retain records of the frequency and results of water testing. For the 21 plants that are estimated not to currently test for radiological contaminants, this burden is estimated to be 5 minutes per record every 4 years. Therefore, 0.08 hour per record × 21 plants = 1.68 (rounded to 2) hours, every 4 years for the maintenance of records of radiological testing, as seen on row 2 of table 2.
We estimate that five infant formula plants will test weekly for bacteriological contaminants. We estimate that performing the test will take 5 minutes per test once a week. Annually, this burden is 0.08 hours × 52 weeks = 4.16 hours per year, per plant, and 4.16 hours per plant × 5 plants = 20.8 (rounded to 21) total annual hours, as seen on row 3 of table 2. Furthermore, for the five plants that are estimated to not currently test weekly for bacteriological contaminants, this burden is estimated to be 5 minutes per record, every week. Therefore, 0.08 hour per record × 52 weeks = 4.16 hours per plant for the maintenance of records of bacteriological testing. Accordingly, 4.16 hours × 5 plants = 20.8 (rounded to 21) annual hours, as seen on row 4 of table 2.
Sections 106.30(d) and 106.100(f)(2) require that records of calibrating certain instruments be made and retained. We estimate that one senior validation engineer for each of the five plants will need to spend about 13 minutes per week to satisfy the ongoing calibration recordkeeping requirements. Therefore, 5 recordkeepers × 52 weeks = 260 records; 260 records × 0.22 hour per record = 57 hours as the annual burden, as presented in row 5 of table 2.
Sections 106.30(e)(3)(iii) and 106.100(f)(3)) require the recordkeeping of the temperatures of each cold storage compartment. We estimate that five plants will each require one senior validation engineer about 13 minutes per week of recordkeeping. Therefore, 5 recordkeepers × 52 weeks = 260 records; 260 records × 0.22 hours per record = 57 hours as the annual burden, as presented in row 6 of table 2.
Sections 106.30(f) and 106.100(f)(4) require the recordkeeping of ongoing sanitation efforts. We estimate that five plants will each require one senior validation engineer about 12 minutes per week of recordkeeping. Therefore, 5 recordkeepers × 52 weeks = 260 records; 260 records × 0.20 hours per record = 52 hours as the annual burden, as presented in row 7 of table 2.
For §§ 106.35(c) and 106.100(f)(5), we estimate that one senior validation engineer per plant needs 10 hours per week of recordkeeping, with the annual burden for this provision being 520 hours per plant × 5 plants = 2,600 annual hours, as shown in row 8 of table 2. In addition, an infant formula manufacturer revalidates its systems when it makes changes to automatic equipment. We estimate that such changes occur twice a year, and that on each of the two occasions, a team of four senior validation engineers per plant needs to work full time for 4 weeks (4 weeks × 40 hours per week = 160 work hours per person) to provide revalidation of the plant's automated systems sufficient to comply with this section. The annual burden for four senior validation engineers each working 160 hours twice a year is 1,280 hours ((160 hours × 2 revalidations) × 4 engineers = 1,280 total work hours) per plant. Therefore, 640 hours × 5 plants × 2 times per year = 6,400 hours as the annual burden, as shown on row 9 of table 2.
Sections 106.40(d) and 106.100(f)(6) require written specifications for ingredients, containers, and closures. We estimate that one senior validation engineer per plant needs about 10 minutes a week to fulfill the recordkeeping requirements. Therefore, 5 recordkeepers × 52 weeks = 260 records and 260 records × 0.17 hour = 44 hours as the annual burden, as shown in row 10 of table 2.
We estimate that five plants will change a master manufacturing order and that one senior validation engineer for each of the five plants spends about 14 minutes per week on recordkeeping pertaining to the master manufacturing order, as required by §§ 106.50(a)(1) and 106.100(e). Thus, 5 recordkeepers × 52 weeks = 260 records; 260 records × 0.23 hour = 60 hours as the annual burden, as shown in row 11 of table 2.
Sections 106.55(d), 106.100(e)(5)(ii), and 106.100(f)(7)) require recordkeeping of the testing of infant formula for microorganisms. We estimate that five plants each need one senior validation engineer to spend 15 minutes per week on recordkeeping pertaining to microbiological testing. Thus, 5 recordkeepers × 52 weeks = 260 records; 260 records × 0.25 hour per record = 65 hours as the annual burden, as shown in row 12 of table 2.
Section 106.60 establishes requirements for the recordkeeping and labeling of mixed-lot packages of infant formula. Section 106.60(c) requires infant formula diverters to label infant formula packaging (such as packing cases) to facilitate product tracing and to keep specific records of the distribution of these mixed lot cases. We estimate that one worker needs 15 minutes, once a month (0.25 × 12 months) to accomplish this, for an annual burden of 3 hours, as shown in row 13 of table 2.
Sections 106.91(b)(1), (2), and (3) provide ongoing stability testing requirements. We estimate that the stability testing requirements has a burden of 2 hours per plant. Therefore, 2 hours × 4 plants = 8 hours as the annual burden to fulfill the testing requirements, as shown in row 14 of table 2.
Sections 106.91(d) and 106.100(e)(5)(i) provide for recordkeeping of tests required under § 106.91(b)(1), (2), and (3). We estimate that one senior validation engineer per plant will spend about 9 minutes per week of recordkeeping to be in compliance. Thus, 4 recordkeepers × 52 weeks = 208 records; 208 records × 0.15 hour per record = 31.2 (rounded to 31) hours for the annual burden, as shown in rows 15, 16, and 17 of table 2.
We estimate that the ongoing review and updating of audit plans requires a senior validation engineer 8 hours per year, per plant. Therefore, 8 hours × 5 plants = 40 hours for the annual burden, as shown in row 18 of table 2.
We estimate that a manufacturer chooses to audit once per week. We estimate each weekly audit requires a senior validation engineer 4 hours, or 52 weeks × 4 hours = 208 hours per plant. Therefore, burden for updating audit plans is calculated as 208 hours × 5 plants = 1,040 hours for the annual burden, as shown in row 19 of table 2.
We estimate that, as a result of the regulations, the industry as a whole performs one additional growth study per year, in accordance with § 106.96. The regulations require that several pieces of data be collected and maintained for each infant in the growth study. We estimate that the data collection associated with the growth study is assembled into a written report and kept as a record in compliance with §§ 106.96(d) and 106.100(p)(1). Thus, we estimate that one additional growth study report is generated, and that this report requires one senior scientist to work 16 hours to compile the data into a study report. Therefore, one growth study report × 16 hours = 16 hours for the annual burden for compliance with §§ 106.96(b) and (d), 106.100(p)(1) and (q)(1), and 106.121 as shown in row 20 of table 2.
A study conducted according to the requirements of § 106.96(b)(2) must include the collection of anthropometric measurements of physical growth and information on formula intake, and §§ 106.96(d) and 106.100(p)(1) require that the anthropometric measurements be made six times during the growth study. We estimate that in a growth study of 112 infants, 2 nurses or other health professionals with similar experience need 15 minutes per infant at each of the required 6 times to collect and record the required anthropometric measurements. Therefore, 2 nurses × 0.25 hours = 0.50 hour per infant, per visit, and 0.50 hour × 6 visits = 3 hours per infant. For 112 infants in the study, 3 hours × 112 infants = 336 hours for the annual burden, as shown in row 21 of table 2. In addition, we estimate that one nurse needs 15 minutes per infant to collect and record the formula intake information. That is, 0.25 hour × 6 visits = 1.5 hour per infant, and 1.5 hour per infant × 112 infants = 168 hours for the annual burden, as shown in row 22 of table 2.
Section 106.96(b)(4) requires plotting each infant's anthropometric measurements on the Centers for Disease Control-recommended World Health Organization Child Growth Standards. We estimate that it takes 5 minutes per infant to record the anthropometric data on the growth chart at each study visit. Therefore, 112 infants × 6 data plots = 672 data plots, and 672 data plots × 0.08 hour per comparison = 53.75 hours (rounded to 54) for the annual burden, as shown in row 23 of table 2.
Section 106.96(b)(5) requires that data on formula intake by the test group be compared to the intake of a concurrent control group. We estimate that one nurse or other health care professional with similar experience needs 5 minutes per infant for each of the six times anthropometric data are collected. Therefore, 6 comparisons of data × 112 infants = 672 data comparisons and 672 data comparisons × 0.08 hour per comparison = 53.75 hours (rounded to 54) for the annual burden, as shown in row 24 of table 2.
Section 106.96(f) provides that a manufacturer meets the quality factor of sufficient biological quality of the protein by establishing the biological quality of the protein in the infant formula when fed as the sole source of nutrition using an appropriate modification of the PER rat bioassay. Under § 106.96(g)(1), a manufacturer of infant formula may be exempt from this requirement if the manufacturer requests an exemption and provides assurances, as required under § 106.121, that changes made by the manufacturer to an existing infant formula are limited to changing the type of packaging. A manufacturer may also be exempt from this requirement under § 106.100(g)(2), if the manufacturer requests an exemption and provides assurances, as required under § 106.121, that demonstrate to FDA's satisfaction that the change to an existing formula does not affect the bioavailability of the protein. Finally, a manufacturer of infant formula may be exempt from this requirement under § 106.96(g)(3) if the manufacturer requests an exemption and provides assurances, as required under § 106.121(i), that demonstrate that an alternative method to the PER that is based on sound scientific principles is available to show that the formula supports the quality factor for the biological quality of the protein. We estimate that the infant formula industry submits a total of 35 PER submissions: 34 exemption requests and the results of 1 PER study.
A PER study conducted according to the Association of Analytical Communities Official Method 960.48 is 28 days in duration. We estimate that there will be 10 rats in the control and test groups (20 rats total) and that food consumption and body weight will be measured at day 0 and at 7-day intervals during the 28-day study period (a total of 5 records per rat). We further estimate that measuring and recording food consumption and body weight will take 5 minutes per rat. Therefore, 20 rats × 5 records = 100 records; 100 records × 0.08 hour minutes per record = 8 hours to fulfill the requirements of § 106.96(f). Further, we estimate that a report based on the PER study will be generated and that this study report will take a senior scientist 1 hour to generate. Therefore, a total of 9 hours will be required to fulfill the requirements for § 106.96(f): 8 hours for the PER study and data collection, and 1 hour for the development of a report based on the PER study, as shown in rows 25 and 26 of table 2.
We estimate that five firms will expend approximately 20,000 hours per year to fully satisfy the recordkeeping requirements in § 106.100 and that three firms will expend approximately 9,000 hours per year to fully satisfy the recordkeeping requirements in § 107.50(c)(3). Thus, the total recordkeeping burden is 40,232 hours.
We estimate compliance with our labeling requirements in §§ 107.10(a) and 107.20 requires 520 hours annually by five manufacturers.
Notice of public meetings.
This notice announces the next meeting of the Physician-Focused Payment Model Technical Advisory Committee (hereafter referred to as “the Committee”) which will be held in Washington, DC. This meeting will include voting and deliberations on proposals for physician-focused payment models (PFPMs) submitted by members of the public. All meetings are open to the public.
The PTAC meeting will occur on the following dates:
• Monday-Wednesday, December 18-20, 2017, from 9:00 a.m. to 5:00 p.m. ET.
Please note that times are subject to change. If the times change, registrants will be notified directly via email.
The December 18-20, 2017 meeting will be held at the Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201.
Ann Page, Designated Federal Official, at the Office of Health Policy, Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services, 200 Independence Ave. SW., Washington, DC 20201, (202) 690-6870.
The Physician-Focused Payment Model Technical Advisory Committee (“the Committee”) is required by the Medicare Access and CHIP Reauthorization Act of 2015, 42 U.S.C. 1395ee. This Committee is also governed by provisions of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), which sets forth standards for the formation and use of federal advisory committees. In accordance with its statutory mandate, the Committee is to review physician-focused payment model proposals and prepare recommendations regarding whether such models meet criteria that were established through rulemaking by the Secretary of Health and Human Services (the Secretary). The Committee is composed of 11 members appointed by the Comptroller General.
At the December 18-20, 2017 meeting, the Committee will hear presentations on PFPMs that are ready for Committee deliberation. The presentations will be followed by public comment and Committee deliberation. If the Committee completes deliberations, voting will occur on recommendations to the Secretary of Health and Human Services. There will be time allocated for public comment on agenda items. Documents will be posted on the Committee Web site and distributed on the Committee listserv prior to the public meeting. The agenda is subject to change. If the agenda does change, we will inform registrants and update our Web site to reflect any changes.
The meeting is open to the public. The public may also attend via conference call or view the meeting via livestream at
The public may attend the meetings in-person or participate by phone via audio teleconference. Space is limited and registration is preferred in order to attend in-person or by phone. Registration may be completed online at
The following information is submitted when registering:
Persons wishing to attend this meeting must register by following the instructions in the “Meeting Registration” section of this notice. A confirmation email will be sent to registrants shortly after completing the registration process.
If sign language interpretation or other reasonable accommodation for a disability is needed, please contact Angela Tejeda, no later than December 4, 2017. Please submit your requests by email to
The Secretary's Charter for the Physician-Focused Payment Model Technical Advisory Committee is available on the ASPE Web site at
Additional material for this meeting can be found on the PTAC Web site. For updates and announcements, please use the link to subscribe to the PTAC email listserv.
Notice is hereby given that I have delegated to the Assistant Secretary for Children and Families, the following authority vested in the Secretary of Health and Human Services under 45 CFR 95.611(a)(4), pertaining to approval of Federal Financial Participation for the costs of automated data processing affecting multiple programs administered by the Administration for Children and Families (ACF) and the Centers for Medicare and Medicaid Services (CMS).
This delegation of authority applies to the following approval for multi-program State requests for Federal Financial Participation for the costs of automated data processing equipment and services: Requests related to programs under titles IV-B, IV-D and IV-E of the Social Security Act (SSA), administered by ACF; and requests related to programs under titles XIX and XXI of SSA, administered by CMS, when submitted in combination with one or more of the programs under titles IV-B, IV-D and IV-E of the SSA.
The authority may be re-delegated.
These authorities shall be exercised in accordance with established policies, procedures, guidelines and regulations as prescribed by the Secretary.
I hereby affirm and ratify any actions taken by the Assistant Secretary for Children and Families, or his or her subordinates, which involved the exercise of the authorities delegated herein prior to the effective date of this delegation.
This delegation supersedes all existing delegations of these authorities.
This delegation is effective immediately.
Office of the Secretary, HHS.
Notice.
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Comments on the ICR must be received on or before January 16, 2018.
Submit your comments to
When submitting comments or requesting information, please include the document identifier 0990-New-60D and project title for reference., to
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 functions; (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.
The total annual burden hours estimated for this ICR are summarized in the table below.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to Public Law 92-463, notice is hereby given that the Substance Abuse and Mental Health Services Administration's (SAMHSA) Center for Substance Abuse Prevention (CSAP) Drug Testing Advisory Board (DTAB) will meet via web conference on December 6, 2017.
The board will meet in closed session on December 6, 2017, from 10:00 a.m. to 4:00 p.m. EST to discuss proposed revisions to the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Oral Fluid), evaluation of hair as an alternate matrix for drug testing, and future board activities. The meeting will be closed to the public as determined by the Assistant Secretary for Mental Health and Substance Use, SAMHSA, in accordance with 5 U.S.C. 552b(c)(4) and (9)(B), and 5 U.S.C. App. 2, Section 10(d).
The web conference call-in number and access code will only be available to board members, invited guests, and CSAP staff. Registration will be available for members and invited guests online at
Meeting information and a roster of DTAB members may be obtained by accessing the SAMHSA Advisory Committees Web site,
U.S. Customs and Border Protection (CBP), Department of Homeland Security.
60-Day Notice and request for comments; extension of an existing collection of information.
The Department of Homeland Security, U.S. Customs and Border Protection will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). The information collection is published in the
Comments are encouraged and will be accepted (no later than January 16, 2018) to be assured of consideration.
Written comments and/or suggestions regarding the item(s) contained in this notice must include the OMB Control Number 1651-0114 in the subject line and the agency name. To avoid duplicate submissions, please use only
(1)
(2)
Requests for additional PRA information should be directed to CBP Paperwork Reduction Act Officer, U.S. Customs and Border Protection, Office of Trade, Regulations and Rulings, Economic Impact Analysis Branch, 90 K Street NE., 10th Floor, Washington, DC 20229-1177, or via email
CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Fish and Wildlife Service, Interior.
Notice of availability.
This notice advises the public of the completion of an environmental assessment (EA) and finding of no significant impact (FONSI). The EA analyzed the potential impacts of a proposal to make decisions on depredation permit applications for the annual take (
You can obtain a copy of the EA and FONSI by writing to the Division of Migratory Bird Management, 5275 Leesburg Pike, Falls Church, VA 22041. We will also post the EA on our Web site at
Ken Richkus, Deputy Chief, Division of Migratory Bird Management, (703) 358-1730;
The U.S. Fish and Wildlife Service (Service) is the Federal agency delegated the primary responsibility for managing migratory birds. Our authority derives from the Migratory Bird Treaty Act of 1918, as amended (MBTA or Act, 16 U.S.C. 703
The EA serves as a framework for the Service to make timely decisions on depredation permit applications submitted pursuant to 50 CFR 21.41 for the lethal take of cormorants. Based on the scope and environmental consequences identified in the EA, the
The proposed action and the preferred alternative in the EA address the need of the Service to maintain cormorant populations and process depredation permit applications for the lethal take of cormorants to: (1) Alleviate damage at or near aquaculture facilities; (2) protect human health and safety; (3) protect threatened and endangered species (as listed under the Endangered Species Act of 1973, as amended, (16 U.S.C. 1531
Based on the independent analysis within the EA, the Service has found that this action would not constitute a major Federal action significantly affecting the quality of the human environment. A FONSI has been signed for the proposed action of making decisions on depredation permit applications to manage cormorant damage related to human health and safety, aquaculture facilities, protection of threatened and endangered species, and property damage and is now available.
This notice is published under the authority of the National Environmental Policy Act of 1969, as amended (42 U.S.C. 4321
Bureau of Land Management, Interior.
Notice of lands suitable for conveyance.
The Montana Department of Natural Resources and Conservation (State) has filed a petition for classification and application to obtain public lands and the mineral estate in lieu of lands to which the State was entitled, but did not receive, under its Statehood Act. This classification, made under Section 7 of the Taylor Grazing Act of June 8, 1934, partially satisfies the obligation to the State. This Notice also extends the segregation initiated by that application, and the proposed classification published in the
Written comments requesting administrative review regarding the classification of lands and minerals may be submitted to the Secretary of the Interior (Secretary) on or before December 15, 2017. Additional administrative review requirements are found in the
Send requests for administrative review to the Secretary of the Interior, 1849 C Street NW., Room 2134LM, WO-350 (Wilhight), Washington, DC 20240.
Renee Johnson, Branch of Lands, Realty, and Renewable Energy; telephone (406) 896-5028; email
Sections 2275 and 2276 of the Revised Statutes, as amended (43 U.S.C. 851 and 852), provide authority for the State of Montana to receive title to public land in lieu of lands to which it was entitled under the Enabling Act of 1889 (25 Stat. 676) but did not receive because the lands were either encumbered or no longer held in Federal ownership.
Section 7 of the Taylor Grazing Act of June 8, 1934 (43 U.S.C. 315
For a period of 30 days from the date of publication of this Notice, this classification is subject to the exercise of administrative review and modification by the Secretary as provided for under 43 CFR 2461.3. All persons who wish to request that the Secretary conduct an administrative review of the finding that these lands are suitable for conveyance to the State may present their views to the address given in the
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 request to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
The lands/minerals affected by this classification are in Chouteau, Hill, and Custer Counties, Montana, and are described as follows:
The areas described aggregate 2,126.11 acres.
The BLM has examined the lands described above for evidence of valid existing rights and any constraints that would prevent conveyance. No persons other than holders of leases, permits, and rights-of-way, asserted a claim to, or interest in, the lands proposed for classification.
When the selection is certified to the State, the document transferring title will contain the following reservations to the United States:
1. A right-of-way thereon for ditches and canals constructed by the authority of the United States, pursuant to the Act of August 30, 1890, 26 Stat. 391 (43 U.S.C. 945).
2. A right-of-way for a storm water drainage system and all appurtenances thereto, through, over, and upon the land described as tracts DD and FF, T.7N, R.47E, Principal Meridian, Montana, including the right of the United States and its agents, assigns, or employees, to enter upon, maintain, operate, repair, or improve the same, so long as needed or used for or by the United States.
The title will also be taken subject to:
1. Those rights for a power line granted to MDU Resources Group, Inc., its successors or assigns, by right-of-way No. MTM 91401, pursuant to the Act of October 21, 1976 (43 U.S.C. 1761), located in tracts DD and FF, T. 7 N., R. 47 E., Principal Meridian, Montana.
2. Those rights for a power line granted to Northwestern Corporation, its successors or assigns, by right-of-way No. MTM 108329, pursuant to the Act of October 21, 1976 (43 U.S.C. 1761), located in sections 21, 22, 28, and 29, T. 29 N., R. 12. E., Principal Meridian, Montana.
3. Those rights for a water pipeline granted to Loma Sewer and Water, its successors or assigns, by right-of-way No. MTM 93467, pursuant to the Act of October 21, 1976 (43 U.S.C. 1761), located in the E
Right-of-way holders will be afforded the opportunity to modify their existing authorization per 43 CFR 2807.15 prior to official transfer of the lands to the State.
The subject lands contain grazing leases authorized under Section 15 of the Taylor Grazing Act. The holders of the BLM grazing use authorizations received the required 2-year notices as outlined in 43 CFR 4110.4-2(b). The lands will not be conveyed until expiration of the 2-year period or receipt of a waiver from the current holder. State of Montana procedures provide that upon Land Board Approval, the State will offer 10-year grazing leases to the current holders of BLM permits/leases on any transferred lands.
The lands contain no oil and gas, geothermal, or other leases issued under the authority of the Mineral Leasing Act of 1920 (30 U.S.C. 181
This Notice also extends the proposed classification and segregation of the land contained in the State's application, but not yet found suitable for conveyance, for a period of 2 additional years through December 1, 2019. These lands remain segregated from all forms of disposal under the public land laws, including the mining laws, except for the form of land disposal specified in the notice of proposed classification. This publication does not alter the applicability of the public land laws governing the use of the lands under lease, license, or permits or governing the disposal of their mineral and vegetative resources, other than under the mining laws.
The segregative effect of this extension will terminate in one of the following ways:
(1) Classification of the lands within 2 years of publication of this notice of extension of the proposed classification in the
(2) Publication of a notice of termination of the proposed classification in the
(3) An Act of Congress; or
(4) Expiration of the additional 2-year period extending the proposed classification afforded by publication of this Notice.
43 CFR parts 2400 and 2621.
Bureau of Land Management, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the Bureau of Land Management (BLM), are proposing to renew an information collection with revisions.
Interested persons are invited to submit comments on or before January 16, 2018.
Send your comments on this information collection request (ICR) by mail to the U.S. Department of the Interior, Bureau of Land Management, 1849 C Street NW., Room 2134LM, Washington DC 20240, Attention: Jean Sonneman; or by email to Jean Sonneman at
To request additional information about this ICR, contact Adam Merrill by email at
In accordance with the Paperwork Reduction Act of 1995, we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.
We are soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of the BLM; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the BLM enhance the quality, utility, and clarity of the information to be collected; and (5) how might the BLM minimize the burden of this collection on the respondents, including through the use of information technology.
Comments that you submit 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 ICR. 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 the BLM in your comment to withhold your personal-identifying information from public review, we cannot guarantee that we will be able to do so.
An agency may not conduct or sponsor—and a person is not required to respond to—a collection of information unless it displays a currently valid OMB control number. The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Bureau of Land Management, Interior.
Notice of decision approving lands for conveyance.
The Bureau of Land Management (BLM) hereby provides constructive notice that it will issue an appealable decision approving conveyance of the surface and subsurface estates in certain lands to Chugach Alaska Corporation, an Alaska Native regional corporation, pursuant to the Alaska Native Claims Settlement Act of 1971, as amended (ANCSA).
Any party claiming a property interest in the lands affected by the decision may appeal the decision in accordance with the requirements of 43 CFR part 4 within the time limits set out in the
A copy of the decision may be obtained from: Bureau of Land Management, Alaska State Office, 222 West Seventh Avenue, #13, Anchorage, Alaska 99513-7504.
Chelsea Kreiner, BLM Alaska State Office, by phone at 907-271-4205 or by email at
As required by 43 CFR 2650.7(d), notice is hereby given that the BLM will issue an appealable decision to Chugach Alaska Corporation. The decision approves conveyance of the surface and subsurface estates in certain lands pursuant to ANCSA (43 U.S.C. 1601,
The lands are located in the vicinity of Prince William Sound, and aggregate 154.55 acres.
Notice of the decision will also be published once a week for four consecutive weeks in the
Any party claiming a property interest in the lands affected by the decision may appeal the decision in accordance with the requirements of 43 CFR part 4 within the following time limits:
1. Unknown parties, parties unable to be located after reasonable efforts have been expended to locate, parties who fail or refuse to sign their return receipt, and parties who receive a copy of the decision by regular mail which is not certified, return receipt requested, shall have until December 15, 2017 to file an appeal.
2. Parties receiving service of the decision by certified mail shall have 30 days from the date of receipt to file an appeal.
Parties who do not file an appeal in accordance with the requirements of 43 CFR part 4 shall be deemed to have waived their rights. Notices of appeal transmitted by facsimile will not be accepted as timely filed.
United States International Trade Commission.
Notice.
The Commission hereby gives notice of the scheduling of the final phase of antidumping investigation No. 731-TA-1359 (Final) pursuant to the Tariff Act of 1930 (“the Act”) to determine whether an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports of carton-closing staples from China, provided for in subheadings 8305.20.00 and 7317.00.65 of the Harmonized Tariff Schedule of the United States, preliminarily determined by the Department of Commerce to be sold at less than fair value.
November 3, 2017.
Amanda Lawrence (202-205-3185), Office of Investigations, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-
For further information concerning the conduct of this phase of the investigation, hearing procedures, and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A and B (19 CFR part 201), and part 207, subparts A and C (19 CFR part 207).
Additional written submissions to the Commission, including requests pursuant to section 201.12 of the Commission's rules, shall not be accepted unless good cause is shown for accepting such submissions, or unless
In accordance with sections 201.16(c) and 207.3 of the Commission's rules, each document filed by a party to the investigation must be served on all other parties to the investigation (as identified by either the public or BPI service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service.
By order of the Commission.
Bureau of Alcohol, Tobacco, Firearms and Explosives, Department of Justice.
60-day notice.
The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will submit the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Comments are encouraged and will be accepted for 60 days until January 16, 2018.
If you have additional comments, particularly with respect to the estimated public burden or associated response time, have suggestions, need a copy of the proposed information collection instrument with instructions, or desire any additional information, please contact Niki Wiltshire, Personnel Security Division either by mail at Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), Washington, DC 20226, or by telephone at 202-648-9260, or by email at
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
1.
2.
3.
4.
5.
6,
If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., 3E.405A, Washington, DC 20530.
Notice of application.
Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before December 15, 2017. Such persons may also file a written request for a hearing on the application on or before December 15, 2017.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152.
The Attorney General has delegated his authority under the Controlled
In accordance with 21 CFR 1301.34(a), this is notice that on June 10, 2016, Anderson Brecon, Inc., DBA PCI of Illinois, 5775 Logistics Parkway, Rockford, Illinois 61109 applied to be registered as an importer of Ajulemic Acid (7370), a basic class of controlled substance listed in schedule I.
The company plans to import the listed controlled substances in over-encapsulated tablets for clinical trial only. Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of FDA approved or non-approved finished dosage forms for commercial sale.
On November 9, 2017, the Department of Justice lodged a proposed Consent Decree with the United States District Court for the Western District of Washington in
The Consent Decree settles claims brought by the United States for violations of the Clean Air Act and federal regulations promulgated thereunder with respect to refrigeration equipment owned and operated by Defendants on two commercial fishing vessels. Under the Consent Decree, Defendant will undertake measures to prevent future similar violations and pay a civil penalty of $135,000.
The publication of this notice opens a period for public comment on the proposed Consent 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:
We will provide a paper copy of the Consent Decree upon written request and payment of reproduction costs. Please mail your request and payment to: Consent Decree Library, U.S. DOJ—ENRD, P.O. Box 7611, Washington, DC 20044-7611.
Please enclose a check or money order for $55 (25 cents per page reproduction cost) payable to the United States Treasury.
The Legal Services Corporation's Board of Directors will meet telephonically on November 28, 2017. The meeting will commence at 4:00 p.m., EST, and will continue until the conclusion of the Committee's agenda.
John N. Erlenborn Conference Room, Legal Services Corporation Headquarters, 3333 K Street NW., Washington DC 20007.
Members of the public who are unable to attend in person but wish to listen to the public proceedings may do so by following the telephone call-in directions provided below.
• Call toll-free number: 1-866-451-4981;
• When prompted, enter the following numeric pass code: 5907707348
• When connected to the call, please immediately “MUTE” your telephone. Members of the public are asked to keep their telephones muted to eliminate background noises. To avoid disrupting the meeting, please refrain from placing the call on hold if doing so will trigger recorded music or other sound. From time to time, the Chair may solicit comments from the public.
Open.
Katherine Ward, Executive Assistant to the Vice President & General Counsel, at (202) 295-1500. Questions may be sent by electronic mail to
LSC complies with the Americans with Disabilities Act and Section 504 of the 1973 Rehabilitation Act. Upon request, meeting notices and materials will be made available in alternative formats to accommodate individuals with disabilities. Individuals needing other accommodations due to disability in order to attend the meeting in person or telephonically should contact Katherine Ward, at (202) 295-1500 or
National Capital Planning Commission.
Notice of availability; request for comment; notice of public meetings.
The National Capital Planning Commission (NCPC or Commission) has released a Draft Environmental Impact Statement (DEIS) for the Smithsonian Institution's (SI) South Mall Campus Master Plan. The DEIS is available for comment as of the date of this notice.
Submit comments on or before by January 16, 2018. Two public meetings will be held to discuss the DEIS:
1. Monday, December 11, 2017, from 5:00 p.m. to 7:00 p.m.; and
2. Monday, December 18, 2017, from 10:00 a.m.-12:00 p.m.
The public meetings will be held at the National Capital Planning Commission, 401 9th Street NW., Suite 500, Washington, DC 20004.
A copy of the DEIS is available for review at NCPC, or at:
You may submit written comments on the DEIS by either of the methods listed below.
1.
2.
Matthew Flis, Senior Urban Designer at (202) 482-7236 or
No prior registration is required to speak at the meetings. Reasonable accommodations are available upon request to the contact individual noted above.
NCPC, acting as lead federal agency, along with SI, as the project owner, and in cooperation with the National Park Service, has prepared the DEIS to evaluate potential environmental impacts associated with implementing the South Mall Campus Master Plan. The DEIS has been prepared in compliance with the National Environmental Policy Act of 1969, as amended (NEPA). SI proposes to prepare a Master Plan for its South Mall Campus to guide future short-term and long-term renovation and development of the 12-acre campus by establishing holistic planning and design principles. The campus currently includes five principle buildings and four designed gardens, located on the southern side of the National Mall within the monumental core of downtown Washington, DC. The Master Plan would be implemented over a 20 to 30 year period. The purpose of the Master Plan is to guide future short-term and long-term renovation of the South Mall Campus. The Master Plan is needed to meet SI's long-term space requirements, and to address operational deficiencies across the campus that impact visitor use and experience, as well as SI's ability to implement its programs effectively and safely. The project goals are to preserve and protect the historic buildings and features of the campus, improve and expand visitor services and education, create clear accessible entrances and connections between the museums, gardens and surrounding context, and replace aging and inefficient building systems in order to better protect collections and decrease SI's carbon footprint. The DEIS evaluates three master plan action alternatives, along with a no-action alternative.
42 U.S.C. 4371-4375; 1 CFR 602.23(c).
National Science Foundation.
Request for information.
The Interagency Arctic Research Policy Committee (IARPC), chaired by the National Science Foundation, is seeking comment from the public on how best to revise and strengthen the Principles for the Conduct of Research in the Arctic (
Written comments must be submitted no later than January 16, 2018.
Email comments to
For further information contact Renee Crain at 703-292-4482.
All researchers working in the North have an ethical responsibility toward northern communities, their cultures, and the environment. The Interagency Arctic Research Policy Committee (IARPC) developed the
The Principles address the need to promote mutual respect and communication between scientists and northern residents. These Principles are to be observed when carrying out or sponsoring research in the Arctic or when applying the results of this research. Since 1990, new theoretical and methodological approaches to community engagement and Arctic research have emerged necessitating a review and update of the current Principles with an aim to including more language on partnerships and collaborations, including increased engagement with Indigenous scholars, enhanced community-based
IARPC requests input from the public on how best to revise and strengthen the Principles for the Conduct of Research in the Arctic (
IARPC is interested in all suggestions for how to improve the Principles and information about how consultation and collaboration are working. The Working Group leading this effort drafted the following list of questions to consider. We welcome input on these issues and any others the public deems relevant.
• What are the most important 3-5 principles for researchers to follow?
• What elements of the Principles should be retained?
• What are ways in which engagement between researchers and communities can be improved?
• How can the Principles be made more widely known to researchers and to northern residents?
The effort to revise the Principles is intended to collect input from the broadest set of stakeholders on the Principles document to include northern residents, Alaska Native communities, other Arctic Indigenous peoples, researchers, state and federal agency representatives, and others.
The ACRS Subcommittee on Planning and Procedures will hold a meeting on December 6, 2017, 11545 Rockville Pike, Room T-2B3, Rockville, Maryland 20852.
The meeting will be open to public attendance.
The agenda for the subject meeting shall be as follows:
The Subcommittee will discuss proposed ACRS activities and related matters. The Subcommittee will gather information, analyze relevant issues and facts, and formulate proposed positions and actions, as appropriate, for deliberation by the Full Committee.
Members of the public desiring to provide oral statements and/or written comments should notify the Designated Federal Official (DFO), Quynh Nguyen (Telephone 301-415-5844 or Email:
Information regarding changes to the agenda, whether the meeting has been canceled or rescheduled, and the time allotted to present oral statements can be obtained by contacting the identified DFO. Moreover, in view of the possibility that the schedule for ACRS meetings may be adjusted by the Chairman as necessary to facilitate the conduct of the meeting, persons planning to attend should check with the DFO if such rescheduling would result in a major inconvenience.
If attending this meeting, please enter through the One White Flint North building, 11555 Rockville Pike, Rockville, Maryland 20852. After registering with Security, please contact Mr. Theron Brown at 301-415-6207 to be escorted to the meeting room.
Nuclear Regulatory Commission.
Draft NUREG; request for comment.
The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a draft NUREG, NUREG-2215, “Standard Review Plan for Spent Fuel Dry Storage Systems and Facilities.” This Standard Review Plan (SRP) provides guidance to the NRC staff for reviewing Safety Analysis Reports (SARs) for (1) a Certificate of Compliance (CoC) for a dry storage system (DSS) for use at a general license facility, and (2) a specific license for a dry storage facility (DSF) that is either an independent spent fuel storage installation (ISFSI) or a monitored retrievable storage installation (MRS). This draft SRP will replace NUREG-1536, “Standard Review Plan for Dry Cask Storage Systems,” NUREG-1567, “Standard Review Plan for Spent Fuel Dry Storage Facilities, and all Interim Staff Guidance (ISGs) that were used to enhance these NUREGs.
Submit comments by January 2, 2018. Comments received after this date will be considered if it is practical to do so, but the Commission is able to ensure consideration only for comments received before this date.
You may submit comments by any of the following methods:
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For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
Jeremy Smith, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission,
Please refer to Docket NRC-2017-0211 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
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Please include Docket ID NRC-2017-0211 in your comment submission.
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC posts all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment submissions into ADAMS.
The NRC utilizes information that is currently contained in multiple documents (NUREG-1536, NUREG-1567, and numerous ISGs) to assist the NRC staff in its reviews of spent fuel storage applications. The NRC's intent in combining and updating these documents into one document is to assist the NRC staff in its reviews by promoting a consistent regulatory review of a SAR for an ISFSI or a MRS license, or for a CoC; by promoting quality and uniformity of these reviews across each technical discipline; presenting a basis for the review's scope; identifying acceptable approaches to meeting regulatory requirements; and suggesting possible evaluation findings that can be used in the safety evaluation report for applications submitted under part 72 of title 10 of the
By this action, the NRC is requesting public comments on draft NUREG-2215. The NRC invites comments on all portions of this SRP that the commenter thinks the NRC should consider. The NRC will make a final determination regarding issuance of the NUREG after it considers any public comments received in response to this request.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Direct transfer of license; order.
The U.S. Nuclear Regulatory Commission (NRC) is issuing an order approving the transfer of the James A. FitzPatrick Nuclear Power Plant Renewed Facility Operating License No. DPR-59, and the transfer of the generally licensed FitzPatrick Independent Spent Fuel Storage Installation from Exelon Generation Company, LLC to Exelon FitzPatrick, LLC.
The Order was issued on November 7, 2017, and is effective for 1 year.
Please refer to Docket ID NRC-2017-0177 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:
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Booma Venkataraman, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington DC 20555-0001; telephone: 301-415-2934; email:
The text of the Order is attached.
For the Nuclear Regulatory Commission.
Exelon Generation Company, LLC (Exelon Generation) is the owner and operator of the James A. FitzPatrick Nuclear Power Plant (FitzPatrick) and the holder of Renewed Facility Operating License No. DPR-59 and the general license for the FitzPatrick Independent Spent Fuel Storage Installation (ISFSI). FitzPatrick is a General Electric boiling-water reactor located in Oswego County, New York.
By application dated July 24, 2017 (Agencywide Documents Access and Management System (ADAMS) Accession No. ML17206A395), Exelon Generation, and its wholly owned subsidiary, Exelon FitzPatrick, LLC (Exelon FitzPatrick), jointly requested, pursuant to Title 10 of the
Under 10 CFR 50.80, no license, or any right thereunder, shall be transferred, directly or indirectly, through transfer of control of the license, unless the NRC gives its consent in writing. Upon review of the information in the application, and other information before the NRC, and relying upon the representations and agreements contained in the application, the NRC staff has determined that Exelon FitzPatrick is qualified to hold the FitzPatrick renewed facility operating license and the FitzPatrick ISFSI general license. Following completion of the license transfer, Exelon FitzPatrick would acquire ownership of FitzPatrick. Exelon Generation would continue to be responsible for the operation and maintenance of FitzPatrick. The NRC staff has also determined that the transfer of these licenses is otherwise consistent with the applicable provisions of law, regulations, and orders issued by the NRC, pursuant thereto, subject to the condition set forth below.
Upon review of the application for a conforming license amendment to reflect this transfer, the NRC staff has determined that the application for the conforming license amendment complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commission's rules and regulations set forth in 10 CFR chapter I; the facility will operate in conformity with the application, the provisions of the Act, and the rules and regulations of the Commission; there is reasonable assurance that the activities authorized by this amendment can be conducted without endangering the health and safety of the public and that such activities will be conducted in compliance with the Commission's regulations; the issuance of this amendment will not be inimical to the common defense and security or to the health and safety of the public; and the issuance of this amendment will be in accordance with 10 CFR part 51 of the Commission's regulations and all applicable requirements will have been satisfied.
The findings set forth above are supported by an NRC safety evaluation dated November 7, 2017 (ADAMS Accession No. ML17240A069).
Accordingly, pursuant to Sections 161b, 161i, 161o, and 184 of the Atomic Energy Act of 1954, as amended (the Act), 42 U.S.C. 2201(b), 2201(i), 2201(o), and 2234; and 10 CFR 50.80,
Prior to the completion of the license transfer, Exelon FitzPatrick, LLC shall provide satisfactory documentary evidence to the Director of the Office of Nuclear Reactor Regulation that it has obtained the appropriate amount of insurance required of a licensee under 10 CFR part 140 and 10 CFR 50.54(w).
This Order is effective upon issuance.
For further details with respect to this Order, see the application dated July 24, 2017, and the NRC's nonproprietary Safety Evaluation dated November 7, 2017 (ADAMS Accession No. ML17240A069), which are available for public inspection at the Commission's Public Document Room (PDR), located at One White Flint North, Public File Area O1 F21, 11555 Rockville Pike (first floor), Rockville, Maryland. Publicly available documents created or received at the NRC are accessible electronically through ADAMS in the NRC Library at
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Application for indirect transfer of license; opportunity to comment, request a hearing, and petition for leave to intervene.
The U.S. Nuclear Regulatory Commission (NRC) received and is considering approval of an indirect license transfer application filed by Wolf Creek Nuclear Operating Corporation (WCNOC) on September 5, 2017. The WCNOC is the licensed operator of Wolf Creek Generating Station (WCGS). Kansas City Power & Light Company (KCP&L) and Kansas Gas and Electric Company (KG&E) are two of the three non-operating owner licensees, each holding a 47 percent undivided interest in WCGS and 47 percent of the stock of WCNOC. The KCP&L is a subsidiary of Great Plains Energy, Inc. (Great Plains) and KG&E is a subsidiary of Westar Energy, Inc.
Comments must be filed by December 15, 2017. A request for a hearing must be filed by December 5, 2017.
You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):
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For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
Balwant K. Singal, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-3016, email:
Please refer to Docket ID NRC-2017-0217 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
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Please include Docket ID NRC-2017-0217 in your comment submission.
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment submissions into ADAMS.
The NRC is considering the issuance of an order under § 50.80 of title 10 of the
The indirect license transfer will result from the proposed merger transaction involving Great Plains and Westar pursuant to the terms of the Amended Merger Agreement dated July 9, 2017. The WCNOC stated in its letter dated September 5, 2017, that under the Amended Merger Agreement the transaction will occur in the following three simultaneous steps:
In step 1, Great Plains will merge with its wholly-owned subsidiary, which was created to effectuate the transaction, named Monarch Energy Holding, Inc.
In step 2, Westar will merge with a wholly-owned subsidiary of Holdco, named King Energy, Inc. (Merger Sub), which was also created to effectuate the transaction, with Westar continuing as the surviving corporation.
In step 3, each share of common stock of Great Plains and Westar issued and outstanding at that time (subject to certain defined exceptions) will be converted automatically into the right to receive the merger consideration consisting of a number of shares of common stock of Holdco as determined by the applicable exchange ratio specified in the Amended Merger Agreement. Thus the current shareholders of Great Plains and Westar will become the shareholders of Holdco after the transaction.
The current and post-closing ownership structure of the facility is depicted in the simplified organizational charts provided in Figures 1 and 2 of Attachment 1 to the letter dated September 5, 2017.
No physical changes to the WCGS or operational changes are being proposed in the application.
The NRC's regulations at 10 CFR 50.80 state that no license, or any right thereunder, shall be transferred, directly or indirectly, through transfer of control of the license, unless the Commission gives its consent in writing. The Commission will approve an
Within 30 days from the date of publication of this notice, persons may submit written comments regarding the license transfer application, as provided for in 10 CFR 2.1305. The Commission will consider and, if appropriate, respond to these comments, but such comments will not otherwise constitute part of the decisional record. Comments should be submitted as described in the
Within 20 days after the date of publication of this notice, any persons (petitioner) whose interest may be affected by this action may file a request for a hearing and petition for leave to intervene (petition) with respect to the action. Petitions shall be filed in accordance with the Commission's “Agency Rules of Practice and Procedure” in 10 CFR part 2. Interested persons should consult a current copy of 10 CFR 2.309. The NRC's regulations are accessible electronically from the NRC Library on the NRC's Web site at
As required by 10 CFR 2.309(d), the petition should specifically explain the reasons why intervention should be permitted with particular reference to the following general requirements for standing: (1) The name, address, and telephone number of the petitioner; (2) the nature of the petitioner's right under the Act to be made a party to the proceeding; (3) the nature and extent of the petitioner's property, financial, or other interest in the proceeding; and (4) the possible effect of any decision or order which may be entered in the proceeding on the petitioner's interest.
In accordance with 10 CFR 2.309(f), the petition must also set forth the specific contentions which the petitioner seeks to have litigated in the proceeding. Each contention must consist of a specific statement of the issue of law or fact to be raised or controverted. In addition, the petitioner must provide a brief explanation of the bases for the contention and a concise statement of the alleged facts or expert opinion which support the contention and on which the petitioner intends to rely in proving the contention at the hearing. The petitioner must also provide references to those specific sources and documents of which the petitioner intends to rely to support its position on the issue. The petition must include sufficient information to show that a genuine dispute exists with the applicant on a material issue of law or fact. Contentions must be limited to matters within the scope of the proceeding. The contention must be one which, if proven, would entitle the petitioner to relief. A petitioner who fails to satisfy the requirements at 10 CFR 2.309(f) with respect to at least one contention will not be permitted to participate as a party.
Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene. Parties have the opportunity to participate fully in the conduct of the hearing with respect to resolution of that party's admitted contentions, including the opportunity to present evidence, consistent with the NRC's regulations, policies, and procedures.
Petitions must be filed no later than 20 days from the date of publication of this notice. Petitions and motions for leave to file new or amended contentions that are filed after the deadline will not be entertained absent a determination by the presiding officer that the filing demonstrates good cause by satisfying the three factors in 10 CFR 2.309(c)(1)(i) through (iii). The petition must be filed in accordance with the filing instructions in the “Electronic Submissions (E-Filing)” section of this document.
A State, local governmental body, Federally-recognized Indian Tribe, or agency thereof, may submit a petition to the Commission to participate as a party under 10 CFR 2.309(h)(1). The petition should state the nature and extent of the petitioner's interest in the proceeding. The petition should be submitted to the Commission no later than 20 days from the date of publication of this notice. The petition must be filed in accordance with the filing instructions in the “Electronic Submissions (E-Filing)” section of this document, and should meet the requirements for petitions set forth in this section, except that under 10 CFR 2.309(h)(2) a State, local governmental body, or Federally-recognized Indian Tribe, or agency thereof does not need to address the standing requirements in 10 CFR 2.309(d) if the facility is located within its boundaries. Alternatively, a State, local governmental body, Federally-recognized Indian Tribe, or agency thereof may participate as a non-party under 10 CFR 2.315(c).
If a hearing is granted, any person who is not a party to the proceeding and is not affiliated with or represented by a party may, at the discretion of the presiding officer, be permitted to make a limited appearance pursuant to the provisions of 10 CFR 2.315(a). A person making a limited appearance may make an oral or written statement of his or her position on the issues, but may not otherwise participate in the proceeding. A limited appearance may be made at any session of the hearing or at any prehearing conference, subject to the limits and conditions as may be imposed by the presiding officer. Details regarding the opportunity to make a limited appearance will be provided by the presiding officer if such sessions are scheduled.
All documents filed in NRC adjudicatory proceedings, including a request for hearing and petition, any motion or other document filed in the proceeding prior to the submission of a request for hearing or petition, and documents filed by interested governmental entities that request to participate under 10 CFR 2.315(c), must be filed in accordance with the NRC's E-Filing rule (72 FR 49139; August 28, 2007, as amended at 77 FR 46562, August 3, 2012). 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. Detailed guidance on making electronic submissions may be found in the Guidance for Electronic Submissions to the NRC and on the NRC Web site at
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
A person filing electronically using the NRC's adjudicatory E-Filing system may seek assistance by contacting the NRC Electronic Filing Help Desk through the “Contact Us” link located on the NRC's public 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 stating why there is good cause for not filing electronically and 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, 11555 Rockville Pike, Rockville, Maryland 20852, Attention: Rulemaking and Adjudications Staff. Participants filing adjudicatory documents 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
The Commission will issue a notice or order granting or denying a hearing request or intervention petition, designating the issues for any hearing that will be held and designating the Presiding Officer. A notice granting a hearing will be published in the
For further details with respect to this application, see the application dated September 5, 2017.
For the Nuclear Regulatory Commission.
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on November 9, 2017, it filed with the Postal Regulatory Commission a
Securities and Exchange Commission.
Notice of meeting of Securities and Exchange Commission Dodd-Frank Investor Advisory Committee.
The Securities and Exchange Commission Investor Advisory Committee, established pursuant to Section 911 of the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010, is providing notice that it will hold a public meeting. The public is invited to submit written statements to the Committee.
The meeting will be held on Thursday, December 7, 2017 from 9:00 a.m. until 3:30 p.m. (ET). Written statements should be received on or before December 7, 2017.
The meeting will be held in Multi-Purpose Room LL-006 at the Commission's headquarters, 100 F Street NE., Washington, DC 20549. The meeting will be webcast on the Commission's Web site at
Use the Commission's Internet submission form (
Send an email message to
Send paper statements to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
Statements also will be available for Web site viewing and printing in the Commission's Public Reference Room, 100 F Street NE., Room 1503, Washington, DC 20549, on official business days between the hours of 10:00 a.m. and 3:00 p.m. All statements received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly.
Marc Oorloff Sharma, Chief Counsel, Office of the Investor Advocate, at (202) 551-3302, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549.
The meeting will be open to the public, except during that portion of the meeting reserved for an administrative work session during lunch. Persons needing special accommodations to take part because of a disability should notify the contact person listed in the section above entitled
The agenda for the meeting includes: Remarks from Commissioners; a discussion of a recommendation of the Investor as Purchaser Subcommittee regarding electronic delivery of information to retail investors; a discussion regarding retail investor protections and transparency in municipal and corporate bond markets; a discussion regarding cybersecurity risk disclosures (which may include a recommendation of the Investor as Owner Subcommittee); a discussion regarding dual-class share structures (which may include a Recommendation of the Investor as Owner Subcommittee); a discussion regarding retail investor disclosure: What works, what doesn't, and best practices; subcommittee reports; and a nonpublic administrative work session during lunch.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend and conform Sections VIII and XIII of the Exchange's Pricing Schedule, to define key terms; to clarify the rule language; to clarify its application to Extranet Providers, Members, and Non-members in various contexts; and to make conforming changes to the Pricing Schedule's Table of Contents.
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 proposed rule change concerns Section VIII of the Exchange's Pricing Schedule (the “Equities Rule”) and Section XIII of the Exchange's Pricing Schedule (collectively, the “Rules”), currently entitled “Extranet Access Fee.” The Exchange first imposed an Extranet Access Fee in January of 2015.
First, the Exchange is proposing to rename both Rules and to clarify their meaning through the use of defined terms. The Exchange is adding definitions of the terms Equipment Configuration, and Extranet Provider to new subsection (a) of the Rules. The Exchange is also cross-referencing the definition of Distributors currently set forth in Section IX of the Exchange's Pricing Schedule.
The term “Equipment Configuration” will be defined to mean “any line, circuit, router package, or other technical configuration used to provide a connection to the Exchange market data feeds.” The term Equipment Configuration replaces the term “Customer Premises Equipment Configuration” set forth in the current rules. The Exchange believes that the term “Customer Premises Equipment Configuration” is ambiguous and creates confusion about the ownership and location of equipment through which direct access to market data feeds is provided. By referring instead to “Equipment Configuration,” the Exchange intends to specify that the ownership and location of the equipment is inconsequential to the application of access and redistribution fees. Rather, it is the number of configurations that matters, determining the number of monthly access and redistribution fees to be assessed.
For example, if an Extranet Provider supplies market data to five recipients via five configurations, two of which are located in a single Exchange facility (such as Carteret, New Jersey) and three of which are located at different customer facilities, the Extranet Provider will be assessed access and redistribution fees of $5,000 per month. If an Extranet Provider supplies market data to one customer at two separate locations via two configurations—one within a Exchange facility and one located elsewhere—the Extranet Provider will be assessed access and redistribution fees of $2,000 per month. If an Extranet Provider supplies market data to four customers via four configurations all located within an Exchange co-location facility, the Extranet Provider will be assessed $4,000 per month in access and redistribution fees. The Exchange is proposing to define the term “Extranet Provider” as “any entity that has signed the Exchange Extranet Connection Agreement and that establishes a telecommunications connection in the Exchange's co-location facility.” The Exchange requires entities to sign the Exchange Extranet Connection Agreement
Finally, in order to further enhance the clarity of the Exchange's rules, the Exchange is proposing to cross-reference the definition of “Distributor” for purposes of this rule. Section IX of the Exchange's Pricing Schedule currently defines Distributor as:
[A]ny entity that receives a feed or data file of NASDAQ PHLX data directly from NASDAQ PHLX or indirectly through another entity and then distributes it either internally (within that entity) or externally (outside that entity). All distributors shall execute a NASDAQ PHLX distributor agreement.
The Exchange is proposing to renumber and rearrange the existing rule text of the Rules. The first two sentences of existing rule text will become new subsection (b). The Exchange also proposes to improve the clarity of subsection (b) by using the new definitions outlined above and by specifying that the monthly fees referred to are the monthly access and redistribution fees. As described earlier, the third sentence of existing rule text is being modified and moved to paragraph (1) of new subsection (a) as the improved definition of “Equipment Configuration.” The fourth and fifth sentences of existing rule text will move to new subsection (d) with modest textual improvements but no change in application of fees. The sixth sentence of existing rule text will move to the final sentences of subsections (b) and (c) with minor textual enhancements to apply it with equal effect to Extranet Providers and Distributors.
The Exchange also proposes to add new subsection (c) to specify and codify that similarly situated Distributors and Extranet Providers will pay similar fees. Under subsection (b), Extranet Providers are assessed a monthly fee of $1,000 for each Equipment Configuration that offers Exchange market data feeds. Similarly, under proposed subsection (c), the same $1,000 monthly fee applies to Distributors to whom the same Exchange market data feeds are published via a Direct Circuit Connection to the Exchange. The Exchange believes that, as defined, Extranet Providers and Distributors are similarly situated because both entities connect directly to the Exchange, and both provide Exchange market data feeds to their customers via those connections.
For example, a Distributor with two Direct Circuit Connections to the Exchange, both of which emanate from a single Exchange co-location facility (such as Carteret, New Jersey) and both of which receive Exchange market data feeds, will be assessed access and redistribution fees of $2,000 per month. A Distributor with two Direct Circuit Connections to the Exchange that emanate from two separate locations and that receives Exchange market data feeds over each connection will be assessed access and redistribution fees of $2,000 per month. A Distributor with two Direct Circuit Connections to the Exchange that emanate from two separate locations and that receives Exchange market data feeds over only one of the connections will be assessed access and redistribution fees of $1,000 per month.
The Exchange previously assessed and currently assesses this fee in its capacity as operator of Nasdaq Technology Services, which had been considered an Extranet Provider.
Finally, the Exchange proposes to amend the Pricing Schedule's Table of Contents to make conforming changes to Section XIII's title.
The Exchange believes that this proposal is consistent with Section 6(b) of the Act,
The Exchange believes that the application of identical Access and Redistribution fees to Distributors and Extranet Providers as described in the proposed rule change is fair and equitable and non-discriminatory. As stated above, Distributors and Extranet Providers both connect to the Exchange directly for the purpose of re-distributing Exchange market data feeds to their own customers and both enjoy similar benefits in doing so. Likewise, those customers, whether receiving Exchange market data feeds via a Distributor or an Extranet Provider receive that market data feeds in a similar fashion and with similar benefits. Those benefits are considerable: secure, rapid, reliable access to the highest quality market data feeds on the trading of equities and options on the Exchange.
The Commission and the courts have repeatedly expressed their preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. In regulation NMS, while adopting a series of steps to improve the current market model, the Commission highlighted the importance of market forces in determining prices and SRO revenues and, also, recognized that current regulation of the market system “has been remarkably successful in promoting market competition in its broader forms that are most important to investors and listed companies.”
The Exchange believes it is fair and equitable and not discriminatory to apply equal access and redistribution fees to Distributors, as it does to Extranet Providers. As stated above, Distributors and Extranet Providers are similarly situated in that they receive Exchange market data feeds directly from the Exchange and they redistribute that data to their own customers. Likewise, the Exchange believes that the customers of Extranet Providers and of Distributors are similarly situated in the manner in which they receive Exchange market data feeds.
The Exchange believes that it is consistent with an equitable allocation of reasonable dues and fees and not unfairly discriminatory to charge the fees proposed under subsection (c) of Chapters VIII and XIII of the PHLX Pricing Schedule to Extranet Providers and Distributors that are not co-located, but not to charge those same fees to Distributors that are co-located. First, Distributors that are co-located already pay fees set forth in Section X of the Pricing Schedule which include connectivity and access to data. Second, if a co-located Distributor were to send data feeds out of the co-location facility, the feeds would be processed and normalized by the Distributor, as opposed to by the Exchange; in that case, the Distributor would not be using the proximity for which Extranets and Direct Circuit Connection Distributors are being assessed fees under subsection (c) of Chapters VIII and XIII of the PHLX Pricing Schedule.
The Exchange is proposing to enhance the clarity of the language of the Rules to ensure that customers understand the proper application of the Rules as technology has changed and continues to change. The Exchange believes that customers support the continued evolution of its rules, and that regulators do and should support and facilitate this evolution.
The Exchange believes that the proposed rule change will not impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. To the contrary, the Exchange believes that applying equal fees to similarly situated Extranet Providers and Distributors, enhancing the clarity of the Rules, and eliminating ambiguity imposes no burden on competition and is, in fact, pro-competitive. Extranet Providers and Distributors benefit from having a more accurate and complete understanding of the Exchange's services and fees when determining which if any of those competing services to purchase voluntarily.
The Exchange believes that the proposed rule change places no burden on competition because it specifies that identical fees will apply to all similarly situated Distributors and Extranet Providers that provide Exchange market data feeds to their own customers. As described above, such Distributors and Extranet Providers offer the same Exchange market data feeds in the same manner to similarly situated customers. The Exchange offers similar benefits to Distributors and Extranet Providers by offering them such access to Exchange market data feeds.
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.
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: (i) Necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) 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 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 and conform Nasdaq Equities Rule 7025 and Chapter XV, Section 12 of Nasdaq's Options Rules, to define key terms; to improve the rule language; and to specify its application to Extranet Providers and Distributors in various contexts.
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 proposed rule change concerns Nasdaq Rule 7025 (the “Equities Rule”) and Chapter XV, Section 12, of Nasdaq's Options Rules (the “Options Rule,” collectively the “Rules”), currently entitled “Extranet Access Fee.” The Exchange first imposed an Extranet Access Fee in 2004.
First, Nasdaq is proposing to rename both Rules and to clarify their meaning through the use of defined terms. Nasdaq is adding definitions of the terms Equipment Configuration, and Extranet Provider to new subsection (a) of the Rules. Nasdaq is also cross-referencing the definition of Distributors currently set forth in Nasdaq Rule 7019(c).
The term “Equipment Configuration” will be defined to mean “any line, circuit, router package, or other technical configuration used to provide a connection to the Exchange market data feeds.” The term Equipment Configuration replaces the term “Customer Premises Equipment Configuration” set forth in the current rules. Nasdaq believes that the term “Customer Premises Equipment Configuration” is ambiguous and creates confusion about the ownership and location of equipment through which direct access to market data feeds is provided. By referring instead to “Equipment Configuration,” Nasdaq intends to specify that the ownership and location of the equipment is inconsequential to the application of access and redistribution fees. Rather, it is the number of configurations that matters, determining the number of monthly access and redistribution fees to be assessed.
For example, if an Extranet Provider supplies market data to five recipients via five configurations, two of which are located in a single Nasdaq facility (such as Carteret, New Jersey) and three of which are located at different customer facilities, the Extranet Provider will be assessed access and redistribution fees of $5,000 per month. If an Extranet Provider supplies market data to one customer at two separate locations via two configurations—one within a Nasdaq facility and one located elsewhere—the Extranet Provider will be assessed access and redistribution fees of $2,000 per month. If an Extranet Provider supplies market data to four customers via four configurations all located within a Nasdaq co-location facility, the Extranet Provider will be assessed $4,000 per month in access and redistribution fees. Nasdaq is proposing to define the term “Extranet Provider” as “any entity that has signed the Nasdaq Extranet Connection Agreement and that establishes a telecommunications connection in the Exchange's co-location facility.” Nasdaq requires entities to sign the Nasdaq Extranet Connection Agreement
Finally, in order to further enhance the clarity of Nasdaq's rules, Nasdaq is proposing to cross-reference the definition of “Distributor” for purposes of this rule. Rule 7019(c) currently defines Distributor as:
[A]ny entity that receives a feed or data file of Nasdaq data directly from Nasdaq or indirectly through another entity and then distributes it either internally (within that
Nasdaq is proposing to renumber and rearrange the existing rule text of the Rules. The first two sentences of existing rule text will become new subsection (b). Nasdaq also proposes to improve the clarity of subsection (b) by using the new definitions outlined above and by specifying that the monthly fees referred to are the monthly access and redistribution fees. As described earlier, the third sentence of existing rule text is being modified and moved to paragraph (1) of new subsection (a) as the improved definition of “Equipment Configuration.” The fourth and fifth sentences of existing rule text will move to new subsection (d) with modest textual improvements but no change in application of fees. The sixth sentence of existing rule text will move to the final sentences of subsections (b) and (c) with minor textual enhancements to apply it with equal effect to Extranet Providers and Distributors.
Lastly, Nasdaq proposes to add new subsection (c) to specify and codify that similarly situated Distributors and Extranet Providers will pay similar fees. Under subsection (b), Extranet Providers are assessed a monthly fee of $1,000 for each Equipment Configuration that offers Exchange market data feeds. Similarly, under proposed subsection (c), the same $1,000 monthly fee applies to Distributors to whom the same Exchange market data feeds is published via a Direct Circuit Connection to Nasdaq. Nasdaq believes that, as defined, Extranet Providers and Distributors are similarly situated because both entities connect directly to Nasdaq, and both provide Exchange market data feeds to their customers via those connections.
For example, a Distributor with two Direct Circuit Connections to Nasdaq, both of which emanate from a single Nasdaq co-location facility (such as Carteret, New Jersey) and both of which receive Exchange market data feeds, will be assessed access and redistribution fees of $2,000 per month. A Distributor with two Direct Circuit Connections to Nasdaq that emanate from two separate locations and that receives Exchange market data feeds over each connection will be assessed access and redistribution fees of $2,000 per month. A Distributor with two Direct Circuit Connections to Nasdaq that emanate from two separate locations and that receives Exchange market data feeds over only one of the connections will be assessed access and redistribution fees of $1,000 per month.
Nasdaq previously assessed and currently assesses this fee in its capacity as operator of Nasdaq Technology Services, which had been considered an Extranet Provider.
The Exchange believes that this proposal is consistent with Section 6(b) of the Act,
Nasdaq believes that the application of identical Access and Redistribution fees to Distributors and Extranet Providers as described in the proposed rule change is fair and equitable and non-discriminatory. As stated above, Distributors and Extranet Providers both connect to the Exchange directly for the purpose of re-distributing Exchange market data feeds to their own customers and both enjoy similar benefits in doing so. Likewise, those customers, whether receiving Exchange market data feeds via a Distributor or an Extranet Provider receive that market data feeds in a similar fashion and with similar benefits. Those benefits are considerable: Secure, rapid, reliable access to the highest quality market data feeds on the trading of equities and options on the Exchange.
The Commission and the courts have repeatedly expressed their preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. In regulation NMS, while adopting a series of steps to improve the current market model, the Commission highlighted the importance of market forces in determining prices and SRO revenues and, also, recognized that current regulation of the market system “has been remarkably successful in promoting market competition in its broader forms that are most important to investors and listed companies.”
Nasdaq believes it is fair and equitable and not discriminatory to apply equal access and redistribution fees to Distributors, as it does to Extranet Providers. As stated above, Distributors and Extranet Providers are similarly situated in that they receive Exchange market data feeds directly from the Exchange and they redistribute that data to their own customers. Likewise, the Exchange believes that the customers of Extranet Providers and of Distributors are similarly situated in the manner in which they receive Exchange market data feeds.
The Exchange believes that it is consistent with an equitable allocation of reasonable dues and fees and not unfairly discriminatory to charge the fees proposed under Rule 7025 and Section 12(c) of Chapter XV of the Options Rules to Extranet Providers and Distributors that are not co-located, but not to charge those same fees to Distributors that are co-located. First, Distributors that are co-located already pay fees set forth in Rule 7034 which include connectivity and access to data. Second, if a co-located Distributor were to send data feeds out of the co-location facility, the feeds would be processed and normalized by the Distributor as opposed to by the Exchange; in that case, the Distributor would not be using the proximity for which Extranets and Direct Circuit Connection Distributors are being assessed fees under Rule 7025 and Section 12(c) of Chapter XV of the Options Rules.
Nasdaq is proposing to enhance the clarity of the language of the Rules to ensure that customers understand the proper application of the Rules as
The Exchange believes that the proposed rule change will not impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. To the contrary, the Exchange believes that applying equal fees to similarly situated Extranet Providers and Distributors, enhancing the clarity of the Rules, and eliminating ambiguity imposes no burden on competition and is, in fact, pro-competitive. Extranet Providers and Distributors benefit from having a more accurate and complete understanding of Nasdaq's services and fees when determining which if any of those competing services to purchase voluntarily.
Nasdaq believes that the proposed rule change places no burden on competition because it specifies that identical fees will apply to all similarly situated Distributors and Extranet Providers that provide Exchange market data feeds to their own customers. As described above, such Distributors and Extranet Providers offer the same Exchange market data feeds in the same manner to similarly situated customers. Nasdaq offers similar benefits to Distributors and Extranet Providers by offering them such access to Exchange market data feeds.
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.
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: (i) Necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) 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 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 and conform BX Equities Rule 7025 and Chapter XV, Section 3(c) of the Exchange's Options Rules, to define key terms; to clarify the rule language; and to clarify its application to Extranet Providers and Distributors in various contexts.
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
The proposed rule change concerns BX Rule 7025 (the “Equities Rule”) and Chapter XV, Section 3(c) of the Exchange's Options Rules (the “Options Rule,” collectively the “Rules”), currently entitled “Extranet Access Fee.” The Exchange first imposed an Extranet Access Fee in 2009.
First, the Exchange is proposing to rename both Rules and to clarify their meaning through the use of defined terms. The Exchange is adding definitions of the terms Equipment Configuration and Extranet Provider to new subsections 7025(a) of the Equities Rule and Sec. 3(c)(1) of the Options Rule. The Exchange is also cross-referencing the definition of Distributors currently set forth in Exchange Rule 7019(b).
The term “Equipment Configuration” will be defined to mean “any line, circuit, router package, or other technical configuration used to provide a connection to the Exchange market data feeds.” The term Equipment Configuration replaces the term “Customer Premises Equipment Configuration” set forth in the current rules. The Exchange believes that the term “Customer Premises Equipment Configuration” is ambiguous and creates confusion about the ownership and location of equipment through which direct access to market data feeds is provided. By referring instead to “Equipment Configuration,” the Exchange intends to specify that the ownership and location of the equipment is inconsequential to the application of access and redistribution fees. Rather, it is the number of configurations that matters, determining the number of monthly access and redistribution fees to be assessed.
For example, if an Extranet Provider supplies market data to five recipients via five configurations, two of which are located in a single Exchange facility (such as Carteret, New Jersey) and three of which are located at different customer facilities, the Extranet Provider will be assessed access and redistribution fees of $5,000 per month. If an Extranet Provider supplies market data to one customer at two separate locations via two configurations—one within a Exchange facility and one located elsewhere—the Extranet Provider will be assessed access and redistribution fees of $2,000 per month. If an Extranet Provider supplies market data to four customers via four configurations all located within an Exchange co-location facility, the Extranet Provider will be assessed $4,000 per month in access and redistribution fees. The Exchange is proposing to define the term “Extranet Provider” as “any entity that has signed the Exchange Extranet Connection Agreement and that establishes a telecommunications connection in the Exchange's co-location facility.” The Exchange requires entities to sign the Exchange Extranet Connection Agreement
Finally, in order to further enhance the clarity of the Exchange's rules, the Exchange is proposing to cross-reference the definition of “Distributor” for purposes of this rule. Rule 7019(b) currently defines Distributor as:
[A]ny entity that receives a feed or data file of Exchange data directly from the Exchange or indirectly through another entity and then distributes it either internally (within that entity) or externally (outside that entity). All distributors shall execute an Exchange distributor agreement. The Exchange itself is a vendor of its data feed(s) and has executed an Exchange distributor agreement and pays the distributor charge.
The Exchange is proposing to renumber and rearrange the existing rule text of the Rules. The first two sentences of existing rule text will become new subsection 7025(b) of the Equities Rule and Sec. 3(c)(1) of the Options Rule. The Exchange also proposes to improve the clarity of subsection 7025(b) of the Equities Rule and Sec. 3(c)(2) of the Options Rule by using the new definitions outlined above and by specifying that the monthly fees referred to are the monthly access and redistribution fees. As described earlier, the third sentence of existing rule text is being modified and moved, respectively, to paragraphs (1) and (A) of new subsections 7025(a) of the Equities Rule and Sec. 3(c)(1) of the Options Rule as the improved definition of “Equipment Configuration.” The fourth and fifth sentences of existing rule text will move to new subsection 7025(d) of the Equities Rule and Sec. 3(c)(4) of the Options Rule with modest textual improvements but no change in application of fees. The sixth sentence of existing rule text will move to the final sentences of subsections 7025(b) and (c) of the Equities Rule and Sec. 3(c)(2) and (c)(3) of the Options Rule with minor textual enhancements to apply it with equal effect to Extranet Providers and Distributors.
Lastly, the Exchange proposes to add new subsection 7025(c) to the Equities Rule and Sec. 3(c)(3) to the Options Rule to specify and codify that similarly situated Distributors and Extranet Providers will pay similar fees. Under subsection 7025(b) of the Equities Rule and Sec. 3(c)(2) of the Options Rule, Extranet Providers are assessed a monthly fee of $1,000 for each Equipment Configuration that offers Exchange market data feeds. Similarly, under proposed subsection 7025(c) of the Equities Rule and Sec. 3(c)(3) of the Options Rule, the same $1,000 monthly fee applies to Distributors to whom the same Exchange market data feeds are published via a Direct Circuit Connection to the Exchange. The Exchange believes that, as defined, Extranet Providers and Distributors are similarly situated because both entities connect directly to the Exchange, and both provide Exchange market data feeds to their customers via those connections.
For example, a Distributor with two Direct Circuit Connections to the
The Exchange previously assessed and currently assesses this fee in its capacity as operator of Nasdaq Technology Services, which had been considered an Extranet Provider. The Exchange believes that defining Extranet Providers and codifying the fee to Distributors (other than Extranet Providers) is clearer to market participants. The Exchange also understands that Distributors, like Extranet Providers, commonly pass the fee on to their customers and therefore specifying that Distributors employing a Direct Circuit Connection also pay the fee will ensure consistent treatment between users enjoying the same benefits via Extranet Providers on the one hand and Distributors on the other, as described above.
The Exchange believes that this proposal is consistent with Section 6(b) of the Act,
The Exchange believes that the application of identical Access and Redistribution fees to Distributors and Extranet Providers as described in the proposed rule change is fair and equitable and non-discriminatory. As stated above, Distributors and Extranet Providers both connect to the Exchange directly for the purpose of re-distributing Exchange market data feeds to their own customers and both enjoy similar benefits in doing so. Likewise, those customers, whether receiving Exchange market data feeds via a Distributor or an Extranet Provider receive those market data feeds in a similar fashion and with similar benefits. Those benefits are considerable: Secure, rapid, reliable access to the highest quality market data feeds on the trading of equities and options on the Exchange.
The Commission and the courts have repeatedly expressed their preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. In regulation NMS, while adopting a series of steps to improve the current market model, the Commission highlighted the importance of market forces in determining prices and SRO revenues and, also, recognized that current regulation of the market system “has been remarkably successful in promoting market competition in its broader forms that are most important to investors and listed companies.”
The Exchange believes it is fair and equitable and not discriminatory to apply equal access and redistribution fees to Distributors, as it does to Extranet Providers. As stated above, Distributors and Extranet Providers are similarly situated in that they receive Exchange market data feeds directly from the Exchange and they redistribute that data to their own customers. Likewise, the Exchange believes that the customers of Extranet Providers and of Distributors are similarly situated in the manner in which they receive Exchange market data feeds.
The Exchange believes that it is consistent with an equitable allocation of reasonable dues and fees and not unfairly discriminatory to charge the fees proposed under Rule 7025 and Section 3(c) of Chapter XV of the Otpions [sic] Rules to Extranet Providers and Distributors that are not co-located, but not to charge those same fees to Distributors that are co-located. First, Distributors that are co-located already pay fees set forth in Rule 7034 which include connectivity and access to data. Second, if a co-located Distributor were to send data feeds out of the co-location facility, the feeds would be processed and normalized by the Distributor as opposed to by the Exchange; in that case, the Distributor would not be using the proximity for which Extranets and Direct Circuit Connection Distributors are being assessed fees under Rule 7025 and Section 3(c) of Chapter XV of the Options Rules.
The Exchange is proposing to enhance the clarity of the language of the Rules to ensure that customers understand the proper application of the Rules as technology has changed and continues to change. The Exchange believes that customers support the continued evolution of its rules, and that regulators do and should support and facilitate this evolution.
The Exchange believes that the proposed rule change will not impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. To the contrary, the Exchange believes that applying equal fees to similarly situated Extranet Providers and Distributors, enhancing the clarity of the Rules, and eliminating ambiguity imposes no burden on competition and is, in fact, pro-competitive. Extranet Providers and Distributors benefit from having a more accurate and complete understanding of the Exchange's services and fees when determining which if any of those competing services to purchase voluntarily.
The Exchange believes that the proposed rule change places no burden on competition because it specifies that identical fees will apply to all similarly situated Distributors and Extranet Providers that provide Exchange market data feeds to their own customers. As described above, such Distributors and Extranet Providers offer the same Exchange market data feeds in the same manner to similarly situated customers. The Exchange offers similar benefits to Distributors and Extranet Providers by offering them such access to Exchange market data feeds.
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.
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: (i) Necessary or appropriate in the public interest; (ii) for the protection
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 Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On September 12, 2017, NYSE Arca, Inc. (“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 take action on the proposed rule change so that it has sufficient time to consider this proposed rule change, as modified by the recently filed amendment. 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.
On September 12, 2017, NYSE Arca, Inc. (“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 that it is appropriate to designate a longer period within which to take action on the proposed rule change so that it has sufficient time to consider the proposed rule change, as modified by Amendment No. 1. 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 (“Act”),
The Exchange proposes to amend its index options rules to be more clear and conformed more closely to those of the Options Clearing Corporation (“OCC”) and other exchanges.
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 is proposing to amend its index options rules in a number of respects to be more clear and reflective of current market practice, and to be conformed more closely to OCC rules and those of other exchanges in order to minimize the potential for confusion, in addition to other index option rule changes as discussed below.
The Exchange currently assigns the term “closing index value” a meaning which differs from that term's meaning on other exchanges, which presents the potential for needless confusion. Rule 1000A(b)(8) currently provides that the closing index value in respect of a particular index means (a) with respect to P.M.-settled options, the current index value calculated at the close of business on the day of exercise, or, if the day of exercise is not a trading day, on the last trading day before exercise, or (b) with respect to A.M.-settled options, the opening price of each component issue on the primary market on the day of exercise, or, if the day of exercise is not a trading day, on the last trading day before exercise. This definition is proposed to be deleted. The Exchange now proposes to define the term “closing index value” to mean simply the last index value reported on a business day. The new definition tracks the definition of “closing index value” on CBOE, ISE and NOM.
The substantive provisions of the index rules that currently refer to “closing index value” are proposed to be amended as well as discussed below, in light of this amendment to the definition of that term. The use of more consistent terminology across exchanges, both in the definition itself and in substantive provisions using the defined term, should minimize potential for confusion, especially in the context of multiply listed index options. It is in the public interest to avoid use of different terminology across different exchanges to describe the same concept.
The term “current index value” is defined in Rule 1000A(b)(7) in respect of a particular index as “the level of the index that is derived from the reported prices of the underlying securities that are the basis of the index, as reported by the reporting authority for the index.” Other options exchanges define “current index value” in a similar fashion.
However, the Exchange currently uses the term “closing index value” in provisions where other exchanges use the term “current index value.” In order to use more consistent terminology across exchanges, the Exchange proposes to replace the term “closing index value” with the term “current
Current Rule 1000A(b)(8) defining “closing index value” already points to the current index value. Specifically, it defines “closing index value” to mean, with respect to P.M.-settled options, the current index value calculated at the close of business on the day of exercise, or, if the day of exercise is not a trading day, on the last trading day before exercise. In view of the amendment to Rule 1101A(d) discussed below providing generally that the current index value used to settle the exercise of an index options contract is the closing index value (proposed to be defined as the last index value reported on a business day) for the day, the net effect of these amendments with respect to P.M.-settled options is for the most part a change in terminology only, to be consistent with terminology used by other options exchanges. Currently, with respect to P.M.- settled options the relevant value for Rules 1000A(b)(1), (2) and (6) is the “index value calculated at the close of business on the day of exercise”. As amended, the relevant value would be “the last index value reported on a business day”. Both formulations express the same concept. These definitional changes are not intended to change current practice with respect to P.M.-settled options.
The Exchange proposes to add a new definition of A.M. settled index option. Consistent with the CBOE, ISE and NOM definitions of this term, new Rule 1000A(18) would define “A.M. settled index option” as an index option for which the current index value at expiration shall be determined as provided in Rule 1101A(e).
The Exchange proposes to adopt new Rule 1101A(d), Index Values for Settlement, which recites that OCC rules specify that, unless the rules of the Exchange provide otherwise, the current index value used to settle the exercise of an index options contract is the closing index value for the day on which the index options contract is exercised in accordance with OCC rules, or if such day is not a business day, for the most recent business day. Other options exchanges have similar rules.
As an exception to the baseline rule set forth in Rule 1101A(d) regarding settlement based on closing index values, the Exchange proposes to add new Rule 1101A(e) to provide that the last day of trading for A.M.-settled index options shall be the business day preceding the business day of expiration, or, in the case of an option contract expiring on a day that is not a business day, the business day preceding the last day of trading in the underlying securities prior to the expiration date. Under the new rule the current index value at the expiration of an A.M.-settled index option will be determined on the last day of trading in the underlying securities prior to expiration, by reference to the reported level of such index as derived from first reported sale (opening) prices of the underlying securities on the primary market on such day.
Proposed Rule 1101A(e) incorporates one exception. In the event that the primary market for an underlying security is open for trading on that day, but that particular security does not open for trading on that day, the price of that security, for the purposes of calculating the current index value at expiration, will be the last reported sale price of the security.
Finally, new language is added to Rule 1101A(e) which specifically identifies the six A.M.-settled index options that are currently approved for trading on the Exchange.
Rule 1044A, Delivery and Payment, currently provides that in accordance with the applicable Rules of the Options Clearing Corporation, the settlement of index option contracts will be by the delivery of the difference between the closing index value on the day of exercise and the exercise price times the index multiplier. The Exchange proposes to delete this provision, given the proposed amendment to the defined term “closing index value” as discussed above. The Exchange has not found a similar rule on other options exchanges and believes it to be unnecessary given the definitions of put, call and index multiplier, which imply that settlement will be by the delivery of the difference between the closing index value on the day of exercise and the exercise price, times the index multiplier. OCC Bylaws provide for the calculation of the exercise settlement amount by reference the [sic] difference between the aggregate exercise price and the aggregate current index value on the day of the exercise.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange does not believe the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act, as the added clarity and the increased conformity to index rules of other options exchanges and acknowledgement of OCC rules will benefit all market participants trading Exchange listed index options. The proposed rule change does not affect competition in that it conforms the Phlx index rulebook to OCC rules and to existing market practice, and will apply equally to all market participants transacting in index options on the Exchange.
No written comments were either solicited or received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A)(iii) 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: (i) Necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) 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 Brent J. Fields, 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 principal purpose of the proposed rule change is to implement certain amendments and updates to the ICE Clear Europe Delivery Procedures relating to European emissions and UK electricity contracts.
In its filing with the Commission, ICE Clear Europe 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. ICE Clear Europe has prepared summaries, set forth in sections (A), (B), and (C) below, of the most significant aspects of such statements.
ICE Clear Europe proposes to implement certain amendments and updates to the ICE Clear Europe Delivery Procedures relating to European emissions and UK electricity contracts. The proposed amendments are designed (i) to update the Delivery Procedures relating to deliveries under European emissions and UK power contracts to be consistent with current practice and reflect the use of updated delivery forms and processes and (ii) to remove certain references to contracts no longer traded.
In Part A of the Delivery Procedures (relating to European emissions contracts), ICE Clear Europe is modifying the timing for submission of delivery confirmation forms to be consistent with the timing of the expiration of the relevant contracts.
In Part C of the Delivery Procedures (relating to UK electricity contracts), ICE Clear Europe is removing certain references (and related provisions) for contracts that are no longer traded. The amendments also remove references to a pre-delivery authorization process and certain reports that are no longer used, as well as extend the deadline for certain authorization requests, in light of updates to ICE Clear Europe systems. In addition, the amendments modify the timing for submission of certain delivery confirmation forms to be consistent with the timing of the expiration of the relevant contracts.
ICE Clear Europe believes that the proposed amendments are consistent with the requirements of Section 17A of the Act
Section 17A(b)(3)(F) of the Act
ICE Clear Europe does not believe the proposed changes to the rules would have any impact, or impose any burden, on competition not necessary or appropriate in furtherance of the purpose of the Act. ICE Clear Europe is adopting the amendments the Delivery Procedures and Clearing Procedures in order to clarify certain aspects of the exercise and settlement of equity futures and options currently cleared by ICE Clear Europe. ICE Clear Europe does not believe the adoption of related Delivery Procedures and Clearing Procedures amendments would materially affect the cost of clearing these products, adversely affect access to clearing in these products for Clearing Members or their customers, or otherwise adversely affect competition in clearing services.
Written comments relating to the proposed changes to the rules have not been solicited or received. ICE Clear Europe will notify the Commission of any written comments received by ICE Clear Europe.
The foregoing rule change has become effective upon filing pursuant to Section 19(b)(3)(A)
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
All comments
Notice is hereby given of the following determinations: I hereby determine that certain objects to be included in the exhibition “Michel Sittow: Estonian Painter at the Courts of Renaissance Europe,” imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at the National Gallery of Art, Washington, District of Columbia, from on or about January 28, 2018, until on or about May 13, 2018, and at possible additional exhibitions or venues yet to be determined, is in the national interest.
Elliot Chiu in the Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
The foregoing determinations were made pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
The U.S. Advisory Commission on Public Diplomacy will hold a public meeting from 10:00 a.m. until 11:30 p.m., Friday, December 8, 2017, at the Russell Senate Office Building 385 (2 Constitution Ave. NE., Washington, DC 20002).
The public meeting will address the future of public diplomacy training. The session will include presentations from leaders in public diplomacy education and professional development from the Foreign Service Institute, as well as other experts.
This meeting is open to the public, Members and staff of Congress, the State Department, Defense Department, the media, and other governmental and non-governmental organizations. An RSVP is required. To attend and make any requests for reasonable accommodation, email Michelle Bowen at
Since 1948, the U.S. Advisory Commission on Public Diplomacy has represented the public interest by overseeing the United States government's international information, media, cultural, and educational exchange programs. The Commission is a bipartisan and independent body created by Congress to recommend policies and programs in support of U.S. government efforts to inform and influence foreign publics. It is mandated by law to assess the work of the State Department and to report its findings and recommendations to the President, the Congress, the Secretary of State, and the American people.
The Commission consists of seven members appointed by the President, by and with the advice and consent of the Senate. The members of the Commission represent the public interest and shall be selected from a cross-section of educational, communications, cultural, scientific, technical, public service, labor, business, and professional backgrounds. Not more than four members shall be from any one political party. The President designates a member to chair the Commission.
The current members of the Commission are Mr. Sim Farar of California, Chairman; Mr. William Hybl of Colorado, Vice Chairman; Ambassador Penne Korth-Peacock of Texas; Anne Terman Wedner of Illinois; and Ms. Georgette Mosbacher of New York. Two seats on the Commission are currently vacant.
To request further information about the meeting or the U.S. Advisory Commission on Public Diplomacy, contact the Executive Director, Dr. Shawn Powers, at 202-632-6382 or
Notice of request for public comment.
The Department of State is seeking Office of Management and Budget (OMB) approval for the information collection described below. In accordance with the Paperwork Reduction Act of 1995, we are requesting comments on this collection from all interested individuals and organizations. The purpose of this notice is to allow 60 days for public comment preceding submission of the collection to OMB.
The Department will accept comments from the public up to January 16, 2018.
You may submit comments by any of the following methods:
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You must include the DS form number (if applicable), information collection title, and the OMB control number in any correspondence.
Direct requests for additional information regarding the collection listed in this notice, including requests for supporting documents, to Delicia Spruell, PRM/Admissions, 2025 E Street NW., SA-9, 8th Floor, Washington, DC 20522-0908.
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We are soliciting public comments to permit the Department to:
• Evaluate whether the proposed information collection is necessary for the proper functions of the Department.
• Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
The Refugee Biographic Data Sheet describes a refugee applicant's personal characteristics and is needed to match the refugee with a sponsoring voluntary agency for initial reception and placement in the U.S. under the United States Refugee Admissions Program administered by the Bureau of Population, Refugees, and Migration, as cited in the Immigration and Nationality Act and the Refugee Act of 1980. In addition, the information is used to run security checks on refugees by the intelligence and federal law enforcement community before refugees can be permitted to travel to the United States.
Biographic information is collected in a face-to-face intake process with the applicant overseas. An employee of a Resettlement Support Center, under cooperative agreement with PRM, collects the information and enters it into the Worldwide Refugee Admissions Processing System.
Notice is hereby given of the following determinations: I hereby determine that certain objects to be included in the exhibition “Outliers and American Vanguard Art,” imported
Elliot Chiu in the Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
The foregoing determinations were made pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
Notice is hereby given of the following determinations: I hereby determine that certain objects to be included in the exhibition “Birds of a Feather: Joseph Cornell's Homage to Juan Gris,” imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at The Metropolitan Museum of Art, New York, New York, from on or about January 23, 2018, until on or about April 14, 2018, and at possible additional exhibitions or venues yet to be determined, is in the national interest.
Elliot Chiu in the Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
The foregoing determinations were made pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
Surface Transportation Board.
Correction to notice of exemption.
On October 16, 2017, notice of the above exemption was served and published in the
Board decisions and notices are available on our Web site at “
By the Board, Scott M. Zimmerman, Acting Director, Office of Proceedings.
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 Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, this aspect of the 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 involved and must be received on or before December 5, 2017.
Send comments identified by docket number FAA-2017-1046 using any of the following methods:
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Lynette Mitterer, AIR-673, Federal Aviation Administration, 1601 Lind Avenue SW., Renton, WA 98057-3356, email
This notice is published pursuant to 14 CFR 11.85.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Grant of petition.
Cooper Tire & Rubber Company (Cooper), has determined that certain Cooper Mastercraft Courser HSX Tour brand tubeless radial tires do not fully comply with Federal Motor Vehicle Safety Standard (FMVSS) No. 139,
For further information on this decision contact Abraham Diaz, Office of Vehicle Safety Compliance, the National Highway Traffic Safety Administration (NHTSA), telephone (202) 366-5310, facsimile (202) 366-5930.
Notice of receipt of the petition was published in the
S5.5.1
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(b)
In support of its petition, Cooper submitted the following reasoning:
(a) While the 484 tires in the subject population contain an improper plant code on the inboard side of the tire, they are in all other respects properly labeled and meet all performance requirements under the Federal Motor Vehicle Safety Standards. Plant code identification has no bearing on the performance or operation of a tire and does not create a safety concern to either the operator of the vehicle on which the tires are mounted, or the safety of personnel in the tire repair, retread and recycle industry.
(b) Tire registration and traceability could be a concern in some instances where there are plant code errors; however, in this instance, the incorrect plant code is still tied to a Cooper Tire manufacturing facility. Consumers will be able to accurately identify the responsible manufacturer and there will be no issues with registering the tires. Cooper Tire has modified its internal registration systems to allow for the proper registration of the affected tires. Cooper Tire accepts tire registration in a number of ways including electronically via the company's Web site. Cooper Tire's online database has been modified to accept registrations from consumers which include an incorrectly listed UP plant code when the other identifying information (brand, serial week) are accurately reported. Cooper Tire also accepts hard copy tire registration cards, which it
(c) In the event Cooper Tire has to conduct a safety related recall in connection with the 484 subject tires, Cooper Tire will include TINs UT Yl FXJ 1017 to 1117 and UP Yl FXJ 1017 to 1117 in its recall universe, so that there will be no issues with regard to identifying the recall population. Should Cooper Tire receive any affected tires in its service facilities for adjustments, the service technician will record the proper TIN number to accurately record the data.
(d) Cooper Tire has taken steps over the last year to add additional checks in its processes to prevent TIN errors. One of those checks includes implementing software that only allows for the plant to choose the plant code from a drop down menu that includes only its specific plant code. In this instance, however, the molds were transferred from one Cooper Tire facility (Findlay) to another (Texarkana). The Texarkana employee responsible for preparing the mold for use in the Texarkana facility only modified the mold on one side and the error went undetected. The mold containing the error was in production from March 6th through March 15th and when the error was detected on March 30th, the plug error was corrected in the mold to prevent future issues. Responsible Cooper Tire personnel will receive additional training on these processes.
Cooper concluded by expressing the belief that the subject noncompliance is inconsequential as it relates to motor vehicle safety, and that its petition to be exempted from providing notification of the noncompliance, as required by 49 U.S.C. 30118, and a remedy for the noncompliance, as required by 49 U.S.C. 30120, should be granted.
The agency believes that one measure of inconsequentiality to motor vehicle safety is that there is no effect of the noncompliance on the operational safety of the vehicles on which these tires are mounted. Cooper certified and stated that the subject tires meet and/or exceed all performance requirements and all other labeling markings required by FMVSS No. 139, and therefore NHTSA has no reason to believe that there are any operational safety issues for these tires.
The agency also believes it is necessary that consumers be able to readily identify the tire manufacturer for safety reasons. Cooper explained that while the tire identification number (TIN) on the inboard sidewall of the subject tires is marked with the incorrect manufacturer's identification mark (known in the industry as “plant code”) “UP,” instead of the correct code “UT”, the information which identifies the correct manufacturer's identification mark, is properly marked on the outboard sidewall. These tires can also be identified by the Cooper brand name and by the tire size marked on the sidewall of the subject tires.
NHTSA recognizes that Cooper took steps to prevent the possibility that customers would not be able to register their tires because those tires have the incorrect manufacturer's identification mark on them. Cooper worked with CIMS (Computerized Information and Management Services), Inc., to ensure that the electronic registration database could accept the registration regardless of the incorrect code and ensured internal Cooper personnel are trained to manually enter the incorrect codes as well.
Furthermore, Cooper informed the agency that in an effort to prevent reoccurrence of this noncompliance, they have implemented a change to their support software. Specifically, the selection of the plant code is no longer manual, but rather selected from a drop down menu with only one choice “UT.” NHTSA feels that this is important to ensure this noncompliance is corrected on all of Cooper's future production tires since the cumulative effect of recurring noncompliances could result in a safety problem.
NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and 30120(h)) that permit manufacturers to file petitions for a determination of inconsequentiality allow NHTSA to exempt manufacturers only from the duties found in sections 30118 and 30120, respectively, to notify owners, purchasers, and dealers of a defect or noncompliance and to remedy the defect or noncompliance. Therefore, this decision only applies to the subject tires that Cooper no longer controlled at the time it determined that the noncompliance existed. However, the granting of this petition does not relieve equipment distributors and dealers of the prohibitions on the sale, offer for sale, or introduction or delivery for introduction into interstate commerce of the noncompliant tires under their control after Cooper notified them that the subject noncompliance existed.
49 U.S.C. 30118, 30120: delegations of authority at 49 CFR 1.95 and 501.8.
Bureau of the Fiscal Service, Treasury.
Notice of appointments to the Combined Performance Review Board.
This notice announces the appointment of the members of the Combined Performance Review Board (PRB) for the Bureau of the Fiscal Service, the Bureau of Engraving and Printing, the United States Mint, the Alcohol and Tobacco Tax and Trade Bureau, and the Financial Crimes Enforcement Network. The Combined
The membership of the Combined PRB as described in this Notice is effective on October 26, 2017.
Randy L. Thornton, Chief Human Capital Officer, Bureau of the Fiscal Service, (202) 874-5147.
Pursuant to 5 U.S.C. Section 4314(c)(4), this Notice announces the appointment of the following primary and alternate members to the Combined PRB:
5 U.S.C. Section 4314(c)(4).
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Internal Revenue Service, 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 continuing information collections, as required by the Paperwork Reduction Act of 1995. The IRS is soliciting comments concerning the safe harbor for inadvertent normalization violations.
Written comments should be received on or before January 16, 2018 to be assured of consideration.
Direct all written comments to L. Brimmer, Internal Revenue Service, Room 6529, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for additional information or copies of the revenue procedure should be directed to Kerry Dennis, at (202) 317-5751 or Internal Revenue Service, Room 6529, 1111 Constitution Avenue NW., Washington DC 20224, or through the internet, at
The following paragraph applies to all of the collections of information covered by this notice.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Internal Revenue Service, 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. Currently, the IRS is soliciting comments concerning existing Final
Written comments should be received on or before January 16, 2018 to be assured of consideration.
Direct all written comments to L. Brimmer, Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for additional information or copies of the regulations should be directed to LaNita Van Dyke at (202) 371-6009, at Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW., Washington, DC 20224, or through the internet at
The Highway and Transportation Funding Act of 2014 (HATFA), Public Law 113-159, was enacted on August 8, 2014, and was effective retroactively for single employer defined benefit pension plans, optional for plan years beginning in 2013 and mandatory for plan years beginning in 2014. Notice 2014-53 provides guidance on these changes to the funding stabilization rules for single-employer pension plans.
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 Internal Revenue Service, 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. Currently, the IRS is soliciting comments concerning Form 4419, Application for Filing Information Returns Electronically (FIRE).
Written comments should be received on or before January 16, 2018 to be assured of consideration.
Direct all written comments to L. Brimmer, Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for additional information or copies of the form and instructions should be directed to LaNita Van Dyke at (202) 317-6009, at Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW., Washington, DC 20224, or through the internet at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Internal Revenue Service (IRS), Treasury.
The Internal Revenue Service (IRS), 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. The IRS is soliciting comments concerning information collection requirements related to deductions and reductions in earnings and profits (or accumulated profits) with respect to certain foreign deferred compensation plans maintained by certain foreign corporations or by foreign branches of domestic corporations.
Written comments should be received on or before January 16, 2018 to be assured of consideration.
Direct all written comments to L. Brimmer, Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for additional information or copies of the regulation should be directed to Taquesha Cain, at (202) 317-8979 Room 6526, 1111 Constitution Avenue NW., Washington, DC 20224, or through the internet at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Veterans Health Administration, Department of Veterans Affairs.
Notice.
Veterans Health Administration, Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the
Written comments and recommendations on the proposed collection of information should be received on or before January 16, 2018.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Brian McCarthy at (202) 461-6345.
Under the PRA of 1995, Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VHA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VHA's functions, including whether the information will have practical utility; (2) the accuracy of VHA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
38 U.S.C. 111, 1703, 1725, 1728.
By direction of the Secretary.
Veterans Health Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Health Administration, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and it includes the actual data collection instrument.
Comments must be submitted on or before December 15, 2017.
Submit written comments on the collection of information through
Cynthia Harvey-Pryor, Office of Quality, Privacy and Risk (OQPR), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 461-5870 or email
38 CFR 17.63.
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The
By direction of the Secretary.
Veterans Health Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Health Administration, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and it includes the actual data collection instrument.
Comments must be submitted on or before December 15, 2017.
Submit written comments on the collection of information through
Cynthia Harvey-Pryor, Enterprise Records Service (005R1B), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 461-5870 or email
US Code: 38 U.S.C. 1729.
If VA accepts the submitted payment that is less than the billed charges, the third party payer can be subject to rate verification. In the event that rate verification is conducted, the results can be used to negotiate better rates, recoup underpayments, or amend agreements. Absent a third party payer agreement, VA should also be reimbursed billed charges or the amount third party payers would pay to non-government entities.
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The
By direction of the Secretary.
Veterans Health Administration, Department of Veterans Affairs.
Notice.
Veterans Health Administration, Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Written comments and recommendations on the proposed collection of information should be received on or before January 16, 2018.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Brian McCarthy at (202) 461-6345.
Under the PRA of 1995, Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VHA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VHA's functions, including whether the information will have practical utility; (2) the accuracy of VHA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on
38 U.S.C. Part 1 Chapter 5 Section 527.
Ensuring the success of the ethics consultation service also requires ongoing evaluation, by which we mean systematic assessment of the operation and/or outcomes of a program compared to a set of explicit or implicit standards, as a means of contributing to the continuous improvement of the program. Evaluation is an important strategy to improve the process of ethics consultation (
By direction of the Secretary.
Centers for Medicare & Medicaid Services (CMS), HHS.
Final rule.
This major final rule addresses changes to the Medicare physician fee schedule (PFS) and other Medicare Part B payment policies such as changes to the Medicare Shared Savings Program, to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. In addition, this final rule includes policies necessary to begin offering the expanded Medicare Diabetes Prevention Program model.
These regulations are effective on January 1, 2018.
Jessica Bruton, (410) 786-5991, for any physician payment issues not identified below.
Lindsey Baldwin, (410) 786-1694, and Emily Yoder, (410) 786-1804, for issues related to telehealth services and primary care.
Roberta Epps, (410) 786-4503, for issues related to PAMA section 218(a) policy and transition from traditional X-ray imaging to digital radiography.
Isadora Gil, (410) 786-4532, for issues related to the valuation of cardiovascular services, bone marrow services, surgical respiratory services, dermatological procedures, and payment rates for nonexcepted items and services furnished by nonexcepted off-campus provider-based departments of a hospital.
Donta Henson, (410) 786-1947, for issues related to ophthalmology services.
Jamie Hermansen, (410) 786-2064, for issues related to the valuation of anesthesia services.
Tourette Jackson, (410) 786-4735, for issues related to the valuation of musculoskeletal services, allergy and clinical immunology services, endocrinology services, genital surgical services, nervous system services, INR monitoring services, injections and infusions, and chemotherapy services.
Ann Marshall, (410) 786-3059, for issues related to primary care, chronic care management (CCM), and evaluation and management (E/M) services.
Geri Mondowney, (410) 786-1172, for issues related to malpractice RVUs.
Patrick Sartini, (410) 786-9252, for issues related to the valuation of imaging services and malpractice RVUs.
Michael Soracoe, (410) 786-6312, for issues related to the practice expense methodology, impacts, conversion factor, and valuation of pathology and surgical procedures.
Pamela West, (410) 786-2302, for issues related to therapy services.
Corinne Axelrod, (410) 786-5620, for issues related to rural health clinics or federally qualified health centers.
Felicia Eggleston, (410) 786-9287, for issues related to DME infusion drugs.
Rasheeda Johnson, (410) 786-3434, for issues related to initial data collection and reporting periods for the clinical laboratory fee schedule.
Edmund Kasaitis, (410) 786-0477, for issues related to biosimilars.
JoAnna Baldwin, (410) 786-7205, or Sarah Fulton, (410) 786-2749, for issues related to appropriate use criteria for advanced diagnostic imaging services.
Crystal Kellam, (410) 786-7970, for issues related to physician quality reporting system.
Alesia Hovatter, (410) 786-6861, for issues related to Physician Compare.
Alexandra Mugge, (410) 786-4457, for issues related to the EHR incentive program.
Kari Vandegrift, (410) 786-4008, or
Kimberly Spalding Bush, (410) 786-3232, or Fiona Larbi, (410) 786-7224, for issues related to Value-based Payment Modifier and Physician Feedback Program.
Wilfred Agbenyikey, (410) 786-4399, for issues related to MACRA patient relationship categories and codes.
Carlye Burd, (410) 786-1972, or Albert Wesley, (410) 786-4204, for issues related to the Medicare Diabetes Prevention Program expanded model.
In addition, because of the many organizations and terms to which we refer by acronym in this final rule, we are listing these acronyms and their corresponding terms in alphabetical order below:
The PFS Addenda along with other supporting documents and tables referenced in this final rule are available on the CMS Web site at
Throughout this final rule, we use CPT codes and descriptions to refer to a variety of services. We note that CPT codes and descriptions are copyright 2016 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 final rule makes payment and policy changes under the Medicare Physician Fee Schedule (PFS) and implements required statutory changes under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10), Achieving a Better Life Experience Act of 2014 (ABLE) (Pub. L. 113-295), Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. 113-93), and the Consolidated Appropriations Act of 2016 (Pub. L. 114-113). This final rule also makes changes to payment policy and other related policies for Medicare Part B, Part D, and Medicare Advantage.
Section 1848 of the Social Security Act (the Act) requires us to establish payments under the PFS based on national uniform relative value units (RVUs) that account for the relative resources used in furnishing a service. The statute requires that RVUs be established for three categories of resources: Work, practice expense (PE); and malpractice (MP) expense; and, that we establish by regulation each year's payment amounts for all physicians' services paid under the PFS, incorporating geographic adjustments to reflect the variations in the costs of furnishing services in different geographic areas. In this major final rule, we establish RVUs for CY 2018 for the PFS, 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, as well as changes in the statute. In addition, this final rule includes discussions and finalized policies regarding:
• Potentially Misvalued Codes.
• Telehealth Services.
• Establishing Values for New, Revised, and Misvalued Codes.
• Establishing Payment Rates under the PFS for Nonexcepted Items and Services Furnished by Nonexcepted Off-Campus Provider-Based Departments of a Hospital.
• Evaluation & Management (E/M) Guidelines and Care Management Services.
• Care Coordination Services and Payment for Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs).
• Part B Drug Payment: Infusion Drugs Furnished Through an Item of Durable Medical Equipment (DME).
• Solicitation of Public Comments on Initial Data Collection and Reporting Periods for Clinical Laboratory Fee Schedule.
• Payment for Biosimilar Biological Products under Section 1847A of the Act.
• Appropriate Use Criteria for Advanced Diagnostic Imaging Services.
• PQRS Criteria for Satisfactory Reporting for Individual EPs and Group Practices for the 2018 PQRS Payment Adjustment.
• Clinical Quality Measurement for Eligible Professionals Participating in the Electronic Health Record (EHR) Incentive Program for 2016.
• Medicare Shared Savings Program.
• Value-Based Payment Modifier and the Physician Feedback Program.
• MACRA Patient Relationship Categories and Codes.
• Changes to the Medicare Diabetes Prevention Program (MDPP) Expanded Model.
• Physician Self Referral Law: Annual Update to the List of CPT/HCPCS Codes.
• Therapy Caps.
The statute requires that annual adjustments to PFS RVUs may not cause annual estimated expenditures to differ by more than $20 million from what they would have been had the adjustments not been made. If adjustments to RVUs would cause expenditures to change by more than $20 million, we must make adjustments to preserve budget neutrality. These adjustments can affect the distribution of Medicare expenditures across specialties. We have determined that this major final rule is economically significant. For a detailed discussion of the economic impacts, see section V. of this final rule.
Since January 1, 1992, Medicare has paid for physicians' services under section 1848 of the Act, “Payment for Physicians' Services.” The PFS relies on national relative values that are established for work, PE, and MP, which are adjusted for geographic cost variations. These values are multiplied by a conversion factor (CF) to convert the RVUs into payment rates. The concepts and methodology underlying the PFS were enacted as part of the Omnibus Budget Reconciliation Act of 1989 (Pub. L. 101-239, enacted on December 19, 1989) (OBRA ’89), and the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508, enacted on November 5, 1990) (OBRA ’90). The final rule published on November 25, 1991 (56 FR 59502) set forth the first fee schedule used for payment for physicians' services.
We note that throughout this major final rule, unless otherwise noted, the term “practitioner” is used to describe both physicians and nonphysician practitioners (NPPs) who are permitted to bill Medicare under the PFS for services furnished to Medicare beneficiaries.
The work RVUs established for the initial fee schedule, which was implemented on January 1, 1992, were developed with extensive input from the physician community. A research team at the Harvard School of Public Health developed the original work RVUs for most codes under a cooperative agreement with the Department of Health and Human Services (HHS). In constructing the code-specific vignettes used in determining 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.
As specified in section 1848(c)(1)(A) of the Act, the work component of physicians' services means the portion of the resources used in furnishing the service that reflects physician time and intensity. We establish work RVUs for new, revised and potentially misvalued codes based on our review of information that generally includes, but is not limited to, recommendations received from the American Medical Association/Specialty Society Relative Value Scale Update Committee (RUC), the Health Care Professionals Advisory Committee (HCPAC), the Medicare Payment Advisory Commission (MedPAC), and other public commenters; medical literature and comparative databases; as well as a comparison of the work for other codes within the Medicare PFS, and consultation with other physicians and health care professionals within CMS and the federal government. We also assess the methodology and data used to develop the recommendations submitted to us by the RUC and other public commenters, and the rationale for their recommendations. In the CY 2011 PFS final rule with comment period (75 FR 73328 through 73329), we discussed a variety of methodologies and approaches used to develop work RVUs, including survey data, building blocks, crosswalk to key reference or
Initially, only the work RVUs were resource-based, and the PE and MP RVUs were based on average allowable charges. Section 121 of the Social Security Act Amendments of 1994 (Pub. L. 103-432, enacted on October 31, 1994), amended section 1848(c)(2)(C)(ii) of the Act and required us to develop resource-based PE RVUs for each physicians' service beginning in 1998. We were required to consider general categories of expenses (such as office rent and wages of personnel, but excluding malpractice expenses) comprising PEs. The PE RVUs continue to represent the portion of these resources involved in furnishing PFS services.
Originally, the resource-based method was to be used beginning in 1998, but section 4505(a) of the Balanced Budget Act of 1997 (Pub. L. 105-33, enacted on August 5, 1997) (BBA) delayed implementation of the resource-based PE RVU system until January 1, 1999. In addition, section 4505(b) of the BBA provided for a 4-year transition period from the charge-based PE RVUs to the resource-based PE RVUs.
We established the resource-based PE RVUs for each physicians' service in a final rule, published on November 2, 1998 (63 FR 58814), effective for services furnished in CY 1999. Based on the requirement to transition to a resource-based system for PE over a 4-year period, payment rates were not fully based upon resource-based PE RVUs until CY 2002. This resource-based system was based on two significant sources of actual PE data: The Clinical Practice Expert Panel (CPEP) data; and the AMA's Socioeconomic Monitoring System (SMS) data. These data sources are described in greater detail in the CY 2012 final rule with comment period (76 FR 73033).
Separate PE RVUs are established for services furnished in facility settings, such as a hospital outpatient department (HOPD) or an ambulatory surgical center (ASC), and in nonfacility settings, such as a physician's office. The nonfacility RVUs reflect all of the direct and indirect PEs involved in furnishing a service described by a particular HCPCS code. The difference, if any, in these PE RVUs generally results in a higher payment in the nonfacility setting because in the facility settings some costs are borne by the facility. Medicare's payment to the facility (such as the outpatient prospective payment system (OPPS) payment to the HOPD) would reflect costs typically incurred by the facility. Thus, payment associated with those facility resources is not made under the PFS.
Section 212 of the Balanced Budget Refinement Act of 1999 (Pub. L. 106-113, enacted on November 29, 1999) (BBRA) directed the Secretary of Health and Human Services (the Secretary) to establish a process under which we accept and use, to the maximum extent practicable and consistent with sound data practices, data collected or developed by entities and organizations to supplement the data we normally collect in determining the PE component. On May 3, 2000, we published the interim final rule (65 FR 25664) that set forth the criteria for the submission of these supplemental PE survey data. The criteria were modified in response to comments received, and published in the
In the 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 for CY 2010. 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). In CY 2010, we began a 4-year transition to the new PE RVUs using the updated PE/HR data, which was completed for CY 2013.
Section 4505(f) of the BBA amended section 1848(c) of the Act to require that we implement resource-based MP RVUs for services furnished on or after CY 2000. The resource-based MP RVUs were implemented in the PFS final rule with comment period published November 2, 1999 (64 FR 59380). The MP RVUs are based on commercial and physician-owned insurers' malpractice insurance premium data from all the states, the District of Columbia, and Puerto Rico. For more information on MP RVUs, see section II.C. of this final rule.
Section 1848(c)(2)(B)(i) of the Act requires that we review RVUs no less often than every 5 years. Prior to CY 2013, we conducted periodic reviews of work RVUs and PE RVUs independently. We completed 5-year reviews of work RVUs that were effective for calendar years 1997, 2002, 2007, and 2012.
Although refinements to the direct PE inputs initially relied heavily on input from the RUC Practice Expense Advisory Committee (PEAC), the shifts to the bottom-up PE methodology in CY 2007 and to the use of the updated PE/HR data in CY 2010 have resulted in significant refinements to the PE RVUs in recent years.
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 addition to the 5-year reviews, beginning for CY 2009, CMS and the 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, that require the agency to periodically identify, review and adjust values for potentially misvalued codes.
As described in section V.C. of this final rule, in accordance with section 1848(c)(2)(B)(ii)(II) of the Act, if revisions to the RVUs cause expenditures for the year to change by more than $20 million, we make adjustments to ensure that expenditures do not increase or decrease by more than $20 million.
To calculate the payment for each service, the components of the fee schedule (work, PE, and MP RVUs) are adjusted by geographic practice cost indices (GPCIs) to reflect the variations in the costs of furnishing the services. The GPCIs reflect the relative costs of work, PE, and MP 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
Section 1848(b)(2)(B) of the Act specifies that the fee schedule amounts for anesthesia services are to be based on a uniform relative value guide, with appropriate adjustment of an anesthesia CF, in a manner to ensure that fee schedule amounts for anesthesia services are consistent with those for other services of comparable value. Therefore, there is a separate fee schedule methodology for anesthesia services. Specifically, we establish a separate CF for anesthesia services and we utilize the uniform relative value guide, or base units, as well as time units, to calculate the fee schedule amounts for anesthesia services. Since anesthesia services are not valued using RVUs, a separate methodology for locality adjustments is also necessary. This involves an adjustment to the national anesthesia CF for each payment locality.
Practice expense (PE) is the portion of the resources used in furnishing a 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. As required by section 1848(c)(2)(C)(ii) of the Act, we use a resource-based system for determining PE RVUs for each physicians' service. We develop PE RVUs by considering the direct and indirect 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. 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 determine the direct PE for a specific service by adding the costs of the direct resources (that is, the clinical staff, medical supplies, and medical equipment) typically involved with furnishing that 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 generally based on our review of recommendations received from the RUC and those provided in response to public comment periods. For a detailed explanation of the direct PE methodology, including examples, we refer readers to the 5 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 PE/HR by specialty that was obtained from the AMA's SMS. The AMA administered a new survey in CY 2007 and CY 2008, the Physician Practice Expense Information Survey (PPIS). The PPIS is a multispecialty, nationally representative, PE survey of both physicians and NPPs paid under the PFS using a 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 health care professional groups. We believe the PPIS is the most comprehensive source of PE survey information available. 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 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 transitioned its use over a 4-year period from the previous PE RVUs to the PE RVUs developed using the new PPIS data. As provided in the CY 2010 PFS final rule with comment period (74 FR 61751), the transition to the PPIS data was complete for CY 2013. Therefore, PE RVUs from CY 2013 forward are developed based entirely on the PPIS data, except as noted in this section.
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.
Supplemental survey data on independent labs from the College of American Pathologists were implemented for payments beginning 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 beginning 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 these specialties were updated to CY 2006 using the Medicare Economic Index (MEI) to put them on a comparable basis with the PPIS data.
We also 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 the PPIS data with Medicare-recognized specialty data.
Previously, we 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 used the PPIS-based PE/HR. We use crosswalks for specialties that did not participate in the PPIS. These crosswalks have been generally established through notice and comment rulemaking and are available in the file called “CY 2018 PFS Final Rule PE/HR” on the CMS Web site under downloads for the CY 2018 PFS final rule at
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, medical supplies, and medical equipment) typically involved with furnishing each of 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.
We allocate 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 work RVUs. We also incorporate the survey data described earlier in the PE/HR discussion (see section II.B.2.b of this final rule). The general approach to developing the indirect portion of the PE RVUs is as follows:
• 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. That is, the initial indirect allocator is calculated so that the direct costs equal the average percentage of direct costs of those specialties furnishing the service. For example, if the direct portion of the PE RVUs for a given service is 2.00 and direct costs, on average, represent 25 percent of total costs for the specialties that furnish the service, the initial indirect allocator would be calculated so that it equals 75 percent of the total PE RVUs. Thus, in this example, the initial indirect allocator would equal 6.00, resulting in a total PE RVU of 8.00 (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 a work RVU of 4.00 and the clinical labor portion of the direct PE RVU was 1.50, we would add 4.00 (since the 4.00 work RVUs are greater than the 1.50 clinical labor portion) to the initial indirect allocator of 6.00 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 incorporated the specialty-specific indirect PE/HR data into the calculation. In our example, if, 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, 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 facility setting, where Medicare makes a separate payment to the facility for its costs in furnishing a service, 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. In calculating the PE RVUs for services furnished in a facility, we do not include resources that would generally not be provided by physicians when furnishing the service. For this reason, 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). The PC and TC may be furnished independently or by different providers, or they may be furnished together as a global service. When services have separately billable PC and TC components, the payment for the global service equals the sum of the payment for the TC and PC. To achieve this, we use a weighted average of the ratio of indirect to direct costs across all the specialties that furnish the global service, TCs, and PCs; that is, we apply the same weighted average indirect percentage factor to allocate indirect expenses to the global service, PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum to the global.)
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). We also direct interested readers to the file called “Calculation of PE RVUs under Methodology for Selected Codes” which is available on our Web site under downloads for the CY 2018 PFS final rule at
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 calculated from the surveys.
Sum the costs of each direct input.
Create indirect allocators.
We generally use an average of the 3 most recent years of available Medicare claims data to determine the specialty mix assigned to each code. Prior to implementing that policy, we used the most recent year of available claims data to determine the specialty mix assigned to each code.
Under either of these approaches, codes with low Medicare service volume require special attention since billing or enrollment irregularities for a given year can result in significant changes in specialty mix assignment. Prior to adopting the 3-year average of data, for low-volume services (fewer than 100 Medicare allowed services), we assigned the values associated with the specialty that most frequently reported the service in the most recent claims data (dominant specialty). For some time, stakeholders, including the RUC, have requested that we use a recommended “expected” specialty for all low volume services instead of the information contained in the claims data. Currently, in the development of PE RVUs we use “expected specialty” overrides for only several dozen services based on several code-specific policies we established in prior rulemaking. As we stated in the CY 2016 final rule with comment period (80 FR 70894), we hoped that the 3-year average would mitigate the need to use dominant or expected specialty instead of the specialty identified using claims data. Because we incorporated CY 2015 claims data for use in the CY 2017 proposed rates, we believe that the finalized PE RVUs associated with the CY 2017 PFS final rule provided a first opportunity to determine whether service-level overrides of claims data are necessary.
Although we believe that the use of the 3-year average of claims data to determine specialty mix has led to an improvement in the stability of PE and MP RVUs from year to year, after reviewing the RVUs for low volume services, we continue to see possible distortions and wide variability from year to year in PE and MP RVUs for low volume services. Several stakeholders have suggested that CMS implement service-level overrides based on the expected specialty in order to determine the specialty mix for these low volume procedures. The RUC previously supplied us with a list of nearly 2,000 lower volume codes and their suggested specialty overrides. After reviewing the finalized PE RVUs for the CY 2017 PFS final rule, we agree that the use of service-level overrides for low volume services would help mitigate annual fluctuations and provide greater stability in the valuation of these services. While the use of the 3-year average of claims data to determine specialty mix has helped to mitigate some of the year to year variability for low volume services, it has not fully mitigated what appear to be anomalies for many of these lower volume codes.
Therefore, we proposed to use the most recent year of claims data to determine which codes are low volume for the coming year (those that have fewer than 100 allowed services in the Medicare claims data). For codes that fall into this category, instead of assigning specialty mix based on the specialties of the practitioners reporting the services in the claims data, we proposed to instead use the expected specialty that we identify on a list. For CY 2018, we proposed to use a list that was developed based on our medical review of the list most recently recommended by the RUC, in addition to our own proposed expected specialty for certain other low-volume codes for which we have historically used expected specialty assignments. We would display this list as part of the annual set of data files we make available as part of notice and comment rulemaking. We proposed to consider recommendations from the RUC and other stakeholders on changes to this list on an annual basis.
We also proposed to apply these service-level overrides for both PE and MP, rather than one or the other category. We believe that this would simplify the implementation of service-level overrides for PE and MP, and would also address stakeholder concerns about the year-to-year variability for low volume services. We solicited public comment on the proposal to use service-level overrides to determine the specialty mix for low volume procedures, as well as on the proposed list of expected specialty overrides itself, which is largely based on the recommendations submitted by the RUC last year. The proposed list of expected specialty assignments for individual low volume services is available on our Web site under downloads for the CY 2018 PFS proposed rule at
The following is a summary of the public comments received on our proposal to use service-level overrides to determine the specialty mix for low volume procedures and our responses:
• CPT codes 33363 and 33364: The commenter recommended changing the override specialty from cardiology to cardiac surgery.
• CPT codes 33516, 33976 and 35812: The commenter recommended changing the override specialty from thoracic surgery to cardiac surgery.
• CPT codes 35311 and 35526: The commenter recommended changing the override specialty from vascular surgery to cardiac surgery.
• CPT codes 38382, 43108, 43118, 43123, 43360, 43405 and 43425: The commenter recommended changing the override specialty from general surgery to thoracic surgery.
In addition, a different commenter recommended changing the proposed expected specialty for CPT code 43754 from gastroenterology to emergency medicine.
After consideration of comments received, we are finalizing our proposal to use service-level overrides to determine the specialty mix for low volume procedures, with the modifications as discussed in this section. Based on comments, we are also finalizing the use of service-level overrides to determine the specialty mix for no volume procedures. In addition, we are finalizing the proposed list of expected specialty overrides with modifications. We are finalizing the addition of certain CPT codes to the list and updated specialty assignments for certain CPT codes.
For most services the indirect allocator is: Indirect PE percentage * (direct PE RVUs/direct percentage) + work RVUs.
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 PE allocator is: Indirect percentage (direct PE RVUs/direct percentage) + clinical labor 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 PE percentage (direct PE RVUs/direct percentage) + clinical labor PE RVUs.
(
For presentation purposes, in the examples in the download file called “Calculation of PE RVUs under Methodology for Selected Codes”, 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 RVU, clinical labor PE RVU, 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.
•
•
•
•
•
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 (MPPRs). 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 BN 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 we use the average allowed charge when simulating RVUs; therefore, the RVUs as calculated already reflect the payments as adjusted by modifiers, and no volume adjustments are necessary. However, a time adjustment of 33 percent is made only for medical direction of two to four cases since that is the only situation where a single practitioner is involved with multiple beneficiaries concurrently, so that counting each service without regard to the overlap with other services would overstate the amount of time spent by the practitioner furnishing these services.
•
The equipment cost per minute is calculated as:
Stakeholders have often suggested that particular equipment items are used less frequently than 50 percent of the time in the typical setting and that CMS should reduce the equipment utilization rate based on these recommendations. We appreciate and share stakeholders' interest in using the most accurate assumption regarding the equipment utilization rate for particular equipment items. However, we believe that absent robust, objective, auditable data regarding the use of particular items, the 50 percent assumption is the most appropriate within the relative value system. We welcome the submission of data that illustrates an alternative rate.
This section focuses on specific PE inputs. The direct PE inputs are included in the CY 2018 direct PE input database, which is available on the CMS Web site under downloads for the CY 2018 PFS final rule at
In the CY 2017 PFS final rule (81 FR 80179 through 80184), we finalized our proposal to add a professional PACS workstation (ED053) used for interpretation of digital images to a series of CPT codes and to address costs related to the use of film that had previously been incorporated as direct PE inputs for these services. We finalized the following criteria for the inclusion of a professional PACS workstation:
• We did not add the professional PACS workstation to any code that currently lacks a technical PACS workstation (ED050) or lacks a work RVU. We continue to believe that procedures that do not include a technical workstation, or do not have physician work, would not require a professional workstation.
• We did not add the professional PACS workstation to add-on codes. Because the base codes include equipment minutes for the professional PACS workstation, we continue to believe it would be duplicative to add additional equipment time for the professional PACS workstation in the add-on code.
• We also did not add the professional PACS workstation to image guidance codes where the dominant provider is not a radiologist according to the most recent year of claims data, because we believe a single technical PACS workstation would be more typical in those cases.
• We agreed with commenters that because the clinical utility of the PACS workstation is not necessarily limited to diagnostic services, there may be therapeutic codes where it would be reasonable to assume its use to be typical. Based on information provided by commenters and our own medical review, we stated that we believe that the use of the professional PACS workstation is typical for many of the specific codes that were identified. We added the workstation to many of the therapeutic codes requested by commenters, specifically CPT codes listed outside the 70000 series, where we agreed that use of the professional PACS workstation was typical.
• For CPT codes in the 80000 and 90000 series, we expressed our concerns about whether it is appropriate to include the technical PACS workstation in many of these services. PACS workstations were created for imaging purposes, but many of these services that include a technical PACS workstation do not appear to make use of imaging. Although we did not remove the technical PACS workstation from these codes at that time, we did not believe that a professional PACS workstation should be added to these procedures.
Prior to the publication of this CY 2018 PFS proposed rule, a stakeholder expressed concern about our decision not to include the professional PACS workstation in a series of vascular ultrasound codes that use technical PACS workstations. The stakeholder indicated that the vascular ultrasound codes in question do make use of a professional PACS workstation, and that the dominant specialty provider requirement (that is, that the code's dominant specialty provider be diagnostic radiology) would exclude codes for which the professional PACS workstation is typical based on a mistaken assumption. The stakeholder stated that to furnish vascular ultrasound services following the transition from film to digital imaging, both a technical and a professional PACS workstation are required, regardless of whether the practitioner furnishing the service is a radiologist, cardiologist, neurologist, or vascular surgeon.
We appreciate the submission of this additional information regarding the use of the professional PACS workstation in vascular ultrasound codes. Therefore, we solicited comments regarding whether or not the use of the professional PACS workstation would be typical in the following list of CPT and HCPCS codes. The codes brought to our attention by the stakeholder are CPT codes 93880, 93882, 93886, 93888, 93890, 93892, 93893, 93922, 93923, 93924, 93925, 93926, 93930, 93931, 93965, 93970, 93971, 93975, 93976, 93978, 93979, 93980, 93981, 93990, and 76706, and HCPCS code G0365. We considered information submitted in comments to determine whether the professional PACS workstation should be included as a direct PE input for these codes.
The following is a summary of the public comments received regarding whether or not the use of the professional PACS workstation would be typical in the previous list of CPT and HCPCS codes and our responses:
After consideration of comments received, we are finalizing the addition of a professional PACS workstation to the codes listed in Table 4 with the equipment time detailed.
As we noted in the CY 2015 PFS final rule with comment period (79 FR 67640-67641), we continue to make improvements to the direct PE input database to provide the number of clinical labor minutes assigned for each task for every code in the database instead of only including the number of clinical labor minutes for the preservice, service, and postservice periods for each code. In addition to increasing the transparency of the information used to set PE RVUs, this improvement would allow us to compare clinical labor times for activities associated with services across the PFS, which we believe is important to maintaining the relativity of the direct PE inputs. This information would facilitate the identification of the usual numbers of minutes for clinical labor tasks and the identification of exceptions to the usual values. It would also allow for greater transparency and consistency in the assignment of equipment minutes based on clinical labor times. Finally, we believe that the information can be useful in maintaining standard times for particular clinical labor tasks that can be applied consistently to many codes as they are valued over several years, similar in principle to the use of physician preservice time packages. We believe such standards would provide greater consistency among codes that share the same clinical labor tasks and could improve relativity of values among codes. For example, as medical practice and technologies change over time, changes in the standards could be updated simultaneously for all codes with the applicable clinical labor tasks, instead of waiting for individual codes to be reviewed.
The following is a summary of the public comments received regarding the standardization of clinical labor tasks and our responses:
In the following paragraphs, we address a series of issues related to clinical labor tasks, particularly relevant to services currently being reviewed under the misvalued code initiative.
Several years ago, the RUC's PE Subcommittee reviewed the preservice clinical labor times for CPT codes with 0-day and 10-day global periods. The RUC concluded that these codes are assumed to have no preservice clinical staff time (standard time of 0 minutes) unless the specialty can provide evidence that the preservice time is appropriate. In other words, for minor procedures, it is assumed that there is no clinical staff time typically spent preparing for the specific procedure prior to the patient's arrival. However, we note that for CY 2018, 41 of the 53 reviewed codes with 0-day or 10-day global periods include preservice clinical labor of some kind, suggesting that it is typical for clinical staff to prepare for the procedure prior to the patient's arrival. As we review misvalued codes, we believe that the general adherence to values that we have established as standards supports relativity within the PFS. Because 77 percent of the reviewed codes for the current calendar year deviate from the “standard,” we sought comment on the value and appropriate application of the standard in our review of RUC recommendations in future rulemaking. In reviewing the inputs included in the direct PE inputs database, we found that for the 1,142 total 0-day global codes, 741 of them had preservice clinical labor of some kind (65 percent). We also noticed a general correlation between preservice clinical labor time and the recent review. We sought comment specifically on whether the standard preservice clinical labor time of 0 minutes should be consistently applied for 0-day and 10-day global codes in future rulemaking.
The following is a summary of the public comments received regarding whether the standard preservice clinical labor time of 0 minutes should be consistently applied for 0-day and 10-day global codes in future rulemaking and our responses:
After consideration of comments received, we do not believe that the standard preservice clinical labor time of 0 minutes should be consistently applied for 0-day and 10-day global codes in future rulemaking. We look forward to working with stakeholders and seeing their recommendations for preservice clinical labor that maintain relativity among the different kind of procedures classified as 0-day and 10-day globals.
The direct PE inputs for each CPT code paid under the PFS include minutes assigned to a series of standard clinical labor tasks assumed to be typical for the service in question. The minutes assigned to each of these tasks for each CPT code have been developed over several decades, and what was previously considered to be a standard value in the review of the codes has changed over time. Because each year we perform a detailed review of all of the inputs for only several hundred of the over 7,000 CPT codes paid under the PFS, valuation for individual services can be influenced by shifts in review standards over time rather than purely based on changes in practice.
For example, we traditionally assigned a clinical labor time of 3 minutes for the “Obtain vital signs” clinical labor activity, based on the amount of time typically required to check a patient's vitals. Over time, that number of minutes has increased as codes are reviewed. For example, many of the reviewed codes for the current CY 2018 rulemaking cycle have a recommended clinical labor time of 5 minutes for “Obtain vital signs,” based on the understanding that these services are measuring two additional vital signs: the patient's height and weight. We do not have any reason to believe that measuring a patient's height and weight is only typical for services described by recently reviewed codes. Instead, we believe that the review standards have changed, perhaps in conjunction with changes in medical practice, and that the change in the minutes assigned for the “Obtain vital signs” task for newer-reviewed services is detrimental to relativity among PFS services.
Therefore, to preserve relativity among the PFS codes, we proposed to assign 5 minutes of clinical labor time for all codes that include the “Obtain vital signs” task, regardless of the date of last review. We proposed to assign this 5 minutes of clinical labor time for all codes that include at least 1 minute previously assigned to this task. We also proposed to update the equipment times of the codes with this clinical labor task accordingly to match the changes in clinical labor time. For codes that were not recently reviewed and for which we lacked a breakdown of how the equipment time was derived from the clinical labor tasks, we could not determine if the equipment time included time assigned for the “Obtain vital signs” task. In these cases, we proposed to adjust the equipment time of any equipment item that matched the clinical labor time of the full service period to match the change in the “Obtain vital signs” clinical labor time. The list of all codes affected by these proposed vital signs changes to direct PE inputs is available on the CMS Web site under downloads for the CY 2018 PFS proposed rule at
The following is a summary of the public comments received on the list of all codes affected by these proposed vital signs changes to direct PE inputs proposals and our responses:
After consideration of comments received, we are not finalizing our proposal to establish 5 minutes as the new standard for the “Obtain vital signs” clinical labor task. However, since we continue to believe that the review standards associated with the clinical labor time for obtaining vital signs have changed over time, we will assign 5 minutes as the input for all codes that include the “Obtain vital signs” task for CY 2018, as proposed.
Historically, the RUC has submitted a “PE worksheet” that details the recommended direct PE inputs for our use in developing PE RVUs. The format of the PE worksheet has varied over time and among the medical specialties developing the recommendations. These variations have made it difficult for both the RUC's development and our review of code values for individual codes. Beginning for the CY 2019 PFS rulemaking cycle, we understand that the RUC intends to mandate the use of a new PE worksheet for purposes of their recommendation development process that standardizes the clinical labor tasks and assigns them a clinical labor activity code. We believe the RUC's use of the new PE worksheet in developing and submitting recommendations to us would, in turn, help us to simplify and standardize the hundreds of different clinical labor tasks currently listed in our direct PE database.
To help facilitate this transition to the new clinical labor activity codes, we developed a crosswalk to link the old clinical labor tasks to the new clinical labor activity codes. Our crosswalk is for informational purposes only, and would not change either the direct PE input values or the PE RVUs for codes. Instead, we hope that the crosswalk would help us to translate the sprawling, existing data set into a condensed version that would significantly improve the standardization of clinical labor recommendations and improve the ability of commenters to identify concerns with our proposed valuation. For CY 2018 rulemaking, we are displaying two versions of the Labor Task Detail public use file: One version with the old listing of clinical labor tasks, and one with the same tasks as described by the new listing of clinical labor activity codes. These lists are available on the CMS Web site under downloads for the CY 2018 PFS final rule at
During our routine reviews of direct PE input recommendations, we have regularly found unexplained inconsistencies involving the use of scopes and the video systems associated with them. Some of the scopes include video systems bundled into the equipment item, some of them include scope accessories as part of their price, and some of them are standalone scopes with no other equipment included. It is not always clear which equipment items related to scopes fall into which of these categories. We have also frequently found anomalies in the equipment recommendations, with equipment items that consist of a scope and video system bundle recommended, along with a separate scope video system. Based on our review, the variations do not appear to be consistent with the different code descriptions.
To promote appropriate relativity among the services and facilitate the transparency of our review process, during review of recommended direct PE inputs for the CY 2017 PFS proposed rule, we developed a structure that separates the scope and the associated video system as distinct equipment items for each code. Under this approach, we proposed standalone prices for each scope, and separate prices for the video systems that are used with scopes. We proposed to define the scope video system as including: (1) A monitor; (2) a processor; (3) a form of digital capture; (4) a cart; and (5) a printer. We believe that these equipment components represent the typical case for a scope video system. Our model for this system was the “video system, endoscopy (processor, digital capture, monitor, printer, cart)” equipment item (ES031), which we proposed to re-price as part of this separate pricing approach. We obtained current pricing invoices for the endoscopy video system as part of our investigation of these issues involving scopes, which we proposed to use for this re-pricing. We understand that there may be other accessories associated with the use of scopes; we proposed to separately price any scope accessories, and individually evaluate their inclusion or exclusion as direct PE inputs for particular codes as usual under our current policy based on whether they are typically used in furnishing the services described by the particular codes.
We also proposed standardizing refinements to the way scopes have been defined in the direct PE input database. We believe that there are four general types of scopes: Non-video scopes; flexible scopes; semi-rigid scopes, and rigid scopes. Flexible scopes, semi-rigid scopes, and rigid scopes would typically be paired with one of the scope video systems, while the non-video scopes would not. The flexible scopes can be further divided into diagnostic (or non-channeled) and therapeutic (or channeled) scopes. We proposed to identify for each anatomical application: (1) A rigid scope; (2) a semi-rigid scope; (3) a non-video flexible scope; (4) a non-channeled flexible video scope; and (5) a channeled flexible video scope. We proposed to classify the existing scopes in our direct PE database under this classification system, to improve the transparency of our review process and improve appropriate relativity among the services. We planned to propose
We proposed these changes only for the reviewed codes for CY 2017 that made use of scopes, along with updated prices for the equipment items related to scopes utilized by these services. But, we did not propose to apply these policies to codes with inputs reviewed prior to CY 2017. We also solicited comment on this separate pricing structure for scopes, scope video systems, and scope accessories, which we could consider proposing to apply to other codes in future rulemaking. In response to comments, we finalized the addition of a digital capture device to the endoscopy video system (ES031) in the CY 2017 PFS final rule. We finalized our proposal to price the system at $33,391, based on component prices of $9,000 for the processor, $18,346 for the digital capture device, $2,000 for the monitor, $2,295 for the printer, and $1,750 for the cart. We also finalized a price of $16,843.87 for the stroboscopy system scope accessory (ES065). We did not finalize price increases for a series of other scopes and scope accessories, as the invoices submitted for these components indicated that they are different forms of equipment with different product IDs and different prices. We did not receive any data to indicate that the equipment on the newly submitted invoices was more typical in its use than the equipment that we were currently using for pricing.
We did not make further changes to existing scope equipment in CY 2017 in order to allow the RUC's PE Subcommittee the opportunity to provide feedback. However, we believed there was some miscommunication on this point, as the RUC's PE Subcommittee workgroup that was created to address scope systems stated that no further action was required following the finalization of our proposal. Therefore, we made further proposals to continue clarifying scope equipment inputs, and sought comments regarding the new set of scope proposals. We welcomed feedback from all stakeholders, including practitioners with direct experience in the use of scope equipment.
We sought comment on several potential categories of scope system PE inputs. We are considering creating a single scope equipment code for each of the five categories detailed in this rule: (1) A rigid scope; (2) a semi-rigid scope; (3) a non-video flexible scope; (4) a non-channeled flexible video scope; and (5) a channeled flexible video scope. Under the current classification system, there are many different scopes in each category depending on the medical specialty furnishing the service and the part of the body affected. We believe that the variation between these scopes is not significant enough to warrant maintaining these distinctions, and we believe that creating and pricing a single scope equipment code for each category would help provide additional clarity. We sought public comment on the merits of this potential scope organization, as well as any pricing information regarding these five new scope categories.
For CY 2018, we proposed two minor changes to PE inputs related to scopes. We proposed to add an LED light source into the cost of the scope video system (ES031), which would remove the need for a separate light source in these procedures. If this proposal were to be finalized, we would remove the equipment time for the separate light source from CPT codes that include the scope video system. We also proposed an increase to the price of the scope video system of $1,000.00 to cover the expense of miscellaneous small equipment associated with the system that falls below the threshold of individual equipment pricing as scope accessories (such as cables, microphones, foot pedals, etc.) We sought comments on the inclusion of the LED light in the scope video system, and the appropriate pricing of the system with the inclusion of these additional equipment items.
We anticipate adopting detailed changes to scope systems at the code level through rulemaking for CY 2019, because we believe that additional feedback from expert stakeholders will improve the details of the proposed changes. We did not propose any additional pricing changes to scope equipment for CY 2018 due to the proposed reorganization into a single type of scope equipment for each of the five scope categories. However, we would consider updating prices for these equipment items through the public request process for price updates, or based on information submitted as part of RUC recommendations.
The following is a summary of the public comments received on the continued organization of scope equipment and our responses:
After consideration of comments received, we will not finalize our proposal to create and price a single scope equipment code for each of the five categories previously identified. Instead, we are supportive of the recommendation from the commenters to create scope equipment codes on a per-specialty basis for these five, or potentially six, categories of scopes as applicable. Our goal is to create an administratively simple scheme that will be easier to maintain and helps to reduce administrative burden. We look forward to receiving detailed recommendations from expert stakeholders regarding the number of these scope equipment items that would be typically required for each scope category as well as the proper pricing for each scope.
We are not finalizing our proposal to add an LED light source and an increase to the price of the scope video system of $1,000.00 to cover the expense of miscellaneous small equipment associated. We intend to address these changes for CY 2019 in order to incorporate the aforementioned feedback from expert stakeholders.
In the CY 2017 PFS final rule, we finalized work RVUs and direct PE inputs for two new codes related to mechanochemical vein ablation, CPT codes 36473 (Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, mechanochemical; first vein treated) and 36474 (Endovenous ablation therapy of incompetent vein, extremity, inclusive of all imaging guidance and monitoring, percutaneous, mechanochemical; subsequent vein(s) treated in a single extremity, each through separate access sites). Following the publication of the final rule, stakeholders contacted CMS and requested that a Clarivein kit supply item (SA122) be added to the direct PE inputs for CPT code 36474, the add-on code for ablation of subsequent veins. They stated that the Clarivein kit was accidentally omitted from the RUC recommendations, and that an additional kit is necessary to perform the service described by the add-on procedure. We solicited comment regarding the use of multiple kits during procedures described by the base and add-on codes to determine whether or not this supply should be included as a direct PE input for CPT code 36474 for CY 2018.
The following is a summary of the public comments received regarding the use of the Clarivein kit supply in CPT code 36474 for CY 2018 and our responses:
After finalizing the creation of separately billable codes for moderate sedation during the CY 2017 PFS final rule, we received additional recommendations to remove the oxygen gas supply item (SD084) from a series of CPT codes that were previously valued with moderate sedation as an inherent part of the procedure. Because oxygen gas is included in the moderate sedation pack contained within the separately billed moderate sedation codes, we believe that the continued inclusion of the oxygen gas in these codes is a duplicative supply. Therefore, we proposed to remove the oxygen gas from the codes in Table 5.
Subsequent to the publication of the CY 2017 PFS final rule, stakeholders alerted us to several clerical inconsistencies in the direct PE database. We proposed to correct these inconsistencies as described in the proposed rule and reflected in the CY 2018 proposed direct PE input database displayed on the CMS Web site under downloads for the CY 2018 PFS proposed rule at
For CY 2018, we proposed to address the following inconsistencies:
• For CY 2018, we proposed to make direct PE changes for CPT code 96416 (Chemotherapy administration, intravenous infusion technique; initiation of prolonged chemotherapy infusion (more than 8 hours), requiring use of a portable or implantable pump) to improve payment accuracy, in response to a stakeholder inquiry regarding the use of the ambulatory IV pump equipment for this service. We proposed to add 6 additional minutes of RN/OCN clinical labor (L056A), 4 minutes for the “Review charts by chemo nurse regarding course of treatment & obtain chemotherapy-related medical hx” task, and 2 minutes for the “Greet patient and provide gowning” task. We proposed to add 1 quantity of the IV infusion set supply (SC018) and proposed to lower the quantity from 2 to 1 of the 20 ml syringe supply (SC053). We proposed to add 1800 minutes for the new ambulatory IV pump equipment, and we proposed to increase the equipment time of the medical recliner chair (EF009) from 83 minutes to 89 minutes to match the increase in RN/OCN clinical labor. For CY 2018, these proposed direct PE changes would be used to calculate the PE RVU for CPT code 96416. We sought comments on these proposed direct PE refinements.
• We proposed to correct an anomaly in the postservice work time for CPT code 91200 (Liver elastography, mechanically induced shear wave (
• In the process of making updates to our direct PE database, we discovered a series of discrepancies between the finalized direct PE inputs and the values entered into the database from previous calendar years. To reconcile these discrepancies, we proposed the following direct PE refinements:
The proposed PE RVUs displayed in Addendum B on our Web site were calculated with the inputs displayed in the CY 2018 proposed direct PE input database.
The following is a summary of the public comments received on these proposed direct PE refinements and our responses:
We note that the technical correction to the total work time of these codes will not have a direct effect on the calculation of their individual RVUs, as changes to work time affect code valuation at the specialty level, not the service level, in the ratesetting methodology. For additional information, please see section II.B.2.c. of this final rule regarding the allocation of PE to services.
• For CPT code 28122 (Partial excision (craterization, saucerization, sequestrectomy, or diaphysectomy) bone (
• For CPT code 46900 (Destruction of lesion(s), anus (
• For CPT code 47562 (Laparoscopy, surgical; cholecystectomy), the CY 2013 final rule only detailed refining the preservice work time and made no mention of not accepting the RUC recommended postoperative visits. The commenter stated that the work time file should have two 99213 post-operative visits instead of one.
• For CPT code 76948 (Ultrasonic guidance for aspiration of ova, imaging supervision and interpretation), the commenter stated that the CY 2014 final rule did not mention any refinements to the RUC-recommended times for the interim final valuation of this service. For the CY 2015 final rule, the preamble text discussed removing preservice and postservice work times for a different service in this family of codes, CPT code 76945. The commenter stated that it appeared that this refinement was inadvertently applied to both CPT codes 76948 and 76945 in the work time file.
• For CPT code 77767 (Remote afterloading high dose rate radionuclide skin surface brachytherapy, includes basic dosimetry, when performed; lesion diameter up to 2.0 cm or 1 channel), the commenter stated that the CY 2016 NPRM work time file included the RUC-recommended preservice, intraservice and postservice work times but incorrectly summed the total time (listed as CPT dummy code number 7778A). The commenter stated that this error appeared to have been carried forward to the present, since there was no mention of any work time refinements for this code in the CY 2016 final rule.
• For CPT codes (93668 Peripheral arterial disease (PAD) rehabilitation, per session) and 96904 (Whole body integumentary photography, for monitoring of high risk patients with dysplastic nevus syndrome or a history of dysplastic nevi, or patients with a personal or familial history of melanoma), the RUC had recommended and CMS had agreed that these services do not include physician work. However, the commenter stated that the CY 2018 physician work time file
The commenter requested for the work time for these services to be corrected in the CY 2018 Physician Work Time file for the CY 2018 final rule.
After consideration of comments received, we are finalizing the direct PE changes to CPT code 96416 as proposed, the correction to an anomaly in the postservice work time for CPT code 91200 as proposed, and the proposed changes to the direct PE database detailed in Table 6. We are also finalizing technical corrections in physician work times as detailed above in the preceding paragraphs.
In the CY 2011 PFS final rule with comment period (75 FR 73205), we finalized a process to act on public requests to update equipment and supply price and equipment useful life inputs through annual rulemaking, beginning with the CY 2012 PFS proposed rule. For CY 2018, we proposed the following price updates for existing direct PE inputs.
We proposed to update the price of thirteen supplies and one equipment item in response to the public submission of invoices. For the details of these proposed price updates, please refer to section II.H, of this final rule, Table 16: Invoices Received for Existing Direct PE Inputs.
We did not propose to update the price of the blood warmer (EQ072), the cell separator system (EQ084), or the photopheresor system (EQ206) equipment items. The only pricing information that we received for these three equipment items was an invoice that included a hand-written price over redacted information. We were unable to verify the accuracy of this invoice. We are also not proposing to update the price of the DNA image analyzer (ACIS) (EP001) equipment item, due to the inclusion of many components on the submitted invoice that are not part of the price of the DNA image analyzer. We were unable to determine which of these components were included in the cost of the DNA image analyzer, and which of these components were unrelated types of equipment. To price these equipment items accurately, we believe that we need additional information. We continued to use the current price for these equipment items pending the submission of additional pricing information. We welcomed the submission of updated pricing information regarding these equipment items through valid invoices from commenters and other stakeholders.
We also proposed to change the name of the ED050 equipment from the “PACS Workstation Proxy” to the “Technologist PACS workstation.” In the CY 2017 final rule (81 FR 80180-80182), we finalized a policy to add a professional PACS workstation (ED053) to the list of approved equipment items, and we believe that renaming ED050 to the technologist PACS workstation would help to alleviate potential confusion between the two PACS workstations.
We routinely accept public submission of invoices as part of our process for developing payment rates for new, revised, and potentially misvalued codes. Often these invoices are submitted in conjunction with the RUC-recommended values for the codes. For CY 2018, we note that some stakeholders have submitted invoices for new, revised, or potentially misvalued codes after the February 10th deadline established for code valuation recommendations. To be included in a given year's proposed rule, we generally need to receive invoices by the same February 10th deadline. However, we would consider invoices submitted as public comments during the comment period following the publication of the proposed rule, and would consider any invoices received after February or outside of the public comment process as part of our established annual process for requests to update supply and equipment prices.
The following is a summary of the public comments received on updates to prices for new and existing direct PE inputs and our responses:
After consideration of comments received, we are finalizing the updated supply and equipment prices as detailed in Table 16: Invoices Received for Existing Direct PE Inputs.
As we explain in section II.B.2.c.(2) of this final rule, we allocate indirect costs for each code on the basis of the direct costs specifically associated with a code and the greater of either the clinical labor costs or the work RVUs. Indirect expenses include administrative labor, office expense, and all other expenses. For PFS services priced in both the facility and non-facility settings, the difference in indirect PE RVUs between the settings is driven by differences in direct PE inputs for those settings since the other allocator of indirect PE, the work RVU, does not differ between settings. For most services, the direct PE input costs are higher in the nonfacility setting than in the facility setting. As a result, indirect PE RVUs allocated to these services are higher in the nonfacility setting than in the facility setting. When direct PE inputs for a service are very low, however, the allocation of indirect PE RVUs is almost exclusively based on work RVUs, which results in a very small (or no) site of service differential between the total PE RVUs in the facility and nonfacility setting.
Some stakeholders have suggested that for codes in which direct PE inputs for a service are very low, this allocation methodology does not allow for a site of service differential that accurately reflects the relative indirect costs involved in furnishing services in nonfacility settings. Among the services most affected by this anomaly are the primary therapy and counseling services available to Medicare beneficiaries for treatment of behavioral health conditions, including substance use disorders. For example, for the most commonly reported psychotherapy service (CPT code 90834), the difference between the nonfacility and facility PE RVUs is only 0.02 RVUs, which seems unlikely to represent the difference in relative resource costs in terms of administrative labor, office expense, and all other expenses incurred by the billing practitioner for 45 minutes of psychotherapy services when furnished in the office setting versus the facility setting.
We agree with these stakeholders that the site of service differential for these services that is produced by our PE methodology seems unlikely to reflect the relative resource costs for the practitioners furnishing these services in nonfacility settings. For example, we believe the 0.02 RVUs, which translates to approximately $0.72, would be unlikely to reflect the relative administrative labor, office rent, and other overhead involved in furnishing the 45 minute psychotherapy service in a nonfacility setting. Consequently, we believe it would be appropriate to modify the existing methodology for allocating indirect PE RVUs in order to better reflect the relative indirect PE resources involved in furnishing these kinds of services in the nonfacility setting.
In examining the range of services furnished in the nonfacility setting that are most affected by this circumstance, we identified HCPCS codes that describe face-to-face services, have work RVUs greater than zero, and are priced in both the facility and nonfacility setting. From among these codes, we further selected those with the lowest ratio between nonfacility PE RVUs and work RVUs. We selected 0.4 as an appropriate threshold based on several factors, including the range of nonfacility PE RVU to work RVU ratios among the codes identified. Based on these criteria, there were fewer than 50 codes that we identified with a ratio of less than 0.4 nonfacility PE RVUs for each work RVU, most of which are primarily furnished by behavioral health professionals, for a potential modification to our indirect PE allocation methodology.
In considering how to address the anomaly and ensure that an appropriate number of indirect PE RVUs are allocated to these services in the nonfacility setting, we looked at the indirect, nonfacility PE RVU for the most commonly billed physician office visit, CPT code 99213, which is billed by a wide range of physicians and non-physician practitioners under the PFS. We believe that the indirect PE costs allocated to services reported with CPT code 99213, including administrative labor and office rent, would be common for a broad range of physicians and non-physician practitioners across the PFS. We recognize that the services we seek to address are primarily furnished by behavioral health professionals who may be unlikely to incur some of the costs incurred by other practitioners furnishing a broader range of medical services. For instance, a practitioner furnishing a broader range of primary care services likely requires separate office and examination room space, and storage for disposable medical supplies and equipment. Some costs, however, such as those for office staff and records maintenance, would be analogous.
We looked at the relationship between indirect PE and work RVUs for CPT code 99213 as a marker because that is the most commonly and broadly reported PFS code that describes face-to-face office-based services. We compared the relationship between indirect PE and work RVUs for the set of HCPCS codes that we identified using the criteria discussed above and found that for the significant majority of codes, that ratio was at least 0.4 nonfacility PE RVUs for each work RVU. We believe the 0.4 nonfacility PE RVUs can serve as an appropriate marker that appropriately reflects the relative resources involved in furnishing these services.
For the fewer than 50 outlier codes identified using the criteria above, we believe it would be appropriate to establish a minimum nonfacility indirect PE RVU that would be a better reflection the resources involved in furnishing these services. We propose to set the nonfacility indirect PE RVUs for these codes using the indirect PE RVU to work RVU ratio for the most commonly furnished office-based, face-to-face service (CPT 99213) as a marker. Specifically, for each of these outlier codes, we propose to compare the ratio between indirect PE RVUs and work RVUs that result from the preliminary application of the standard methodology to the ratio for the marker code, CPT code 99213. Our proposed change in the methodology would then increase the allocation of indirect PE RVUs to the outlier codes to at least one quarter of the difference between the two ratios. We believe this approach reflects a reasonable minimum allocation of indirect PE RVUs, but we do not currently have empirical data that would be useful in establishing a more precise number.
In developing the proposed PE RVUs for CY 2018, we proposed to implement only one quarter of this proposed minimum value for nonfacility indirect PE for the outlier codes. We recognize that this change in the PE methodology could have a significant impact on the allocation of indirect PE RVUs across all PFS services. In making significant changes to the PE methodology in
The following is a summary of the public comments received on our proposed change to the indirect PE methodology for some office-based services.
After consideration of comments received, we are finalizing our proposed change to the indirect PE methodology for some office-based services.
Section 1848(c) of the Act requires that each service paid under the PFS be composed of three components: Work, PE, and malpractice (MP) expense. As required by section 1848(c)(2)(C)(iii) of the Act, beginning in CY 2000, MP RVUs are resource based. Section 1848(c)(2)(B)(i) of the Act also requires that we review, and if necessary adjust, RVUs no less often than every 5 years. In the CY 2015 PFS final rule with comment period, we implemented the third review and update of MP RVUs. For a comprehensive discussion of the third review and update of MP RVUs see the CY 2015 proposed rule (79 FR 40349 through 40355) and final rule with comment period (79 FR 67591 through 67596).
To determine MP RVUs for individual PFS services, our MP methodology is composed of three factors: (1) Specialty-level risk factors derived from data on specialty-specific MP premiums incurred by practitioners, (2) service level risk factors derived from Medicare claims data of the weighted average risk factors of the specialties that furnish each service, and (3) an intensity/complexity of service adjustment to the service level risk factor based on either the higher of the work RVU or clinical labor RVU. Prior to CY 2016, MP RVUs were only updated once every 5 years, except in the case of new and revised codes.
As explained in the CY 2011 PFS final rule with comment period (75 FR 73208), MP RVUs for new and revised codes effective before the next 5-year review of MP RVUs were determined either by a direct crosswalk from 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 adjusted (or scaled) the MP RVU for the new/revised code to reflect the difference in work RVU between the source code and the new/revised work RVU (or, if greater, the difference in 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 was 10 percent higher than the work RVU for its source code, the MP RVU for the revised code would be increased by 10 percent over the source code MP RVU. Under this approach, the same risk factor was applied for the new/revised code and source code, but the work RVU for the new/revised code was used to adjust the MP RVUs for risk.
In the CY 2016 PFS final rule with comment period (80 FR 70906 through 70910), we finalized a policy to begin conducting annual MP RVU updates to reflect changes in the mix of practitioners providing services (using Medicare claims data), and to adjust MP RVUs for risk, intensity and complexity (using the work RVU or clinical labor RVU). We also finalized a policy to modify the specialty mix assignment methodology (for both MP and PE RVU calculations) to use an average of the 3 most recent years of data instead of a single year of data. Under this approach, for new and revised codes, we generally assign a specialty risk factor to individual codes based on the same utilization assumptions we make regarding the specialty mix we use for calculating PE RVUs and for PFS budget neutrality. We continue to use the work RVU or clinical labor RVU to adjust the MP RVU for each code for intensity and complexity. In finalizing this policy, we stated that the specialty-specific risk factors would continue to be updated through notice and comment rulemaking every 5 years using updated premium data, but would remain unchanged between the 5-year reviews.
In CY 2017, we finalized the eighth GPCI update, which reflected updated MP premium data. We did not propose to use the updated MP premium data to propose updates for CY 2017 to the specialty risk factors used in the calculation of MP RVUs because it was inconsistent with the policy we previously finalized in the CY 2016 PFS
In the CY 2018 PFS proposed rule, we proposed to use the most recent data for the MP RVUs for CY 2018 and to align the update of MP premium data and MP GPCIs to once every 3 years. We sought comment on these proposals, and we also sought comment on methodologies and sources that we might use to improve the next update of MP premium data.
The proposed MP RVUs were calculated based on updated malpractice premium data obtained from state insurance rate filings by a CMS contractor. The methodology used in calculating the proposed CY 2018 review and update of resource based MP RVUs largely paralleled the process used in the CY 2015 update. The calculation requires using information on specialty-specific malpractice premiums linked to specific services based upon the relative risk factors of the various specialties that furnish a particular service. Because malpractice premiums vary by state and specialty, the malpractice premium information must be weighted geographically and by specialty. Accordingly, the proposed MP RVUs were based upon four data sources: CY 2014 and CY 2015 malpractice premium data; CY 2016 and 2017 Medicare payment and utilization data; CY 2017 GPCIs, and CY 2018 proposed work and clinical labor RVUs.
Similar to the previous update, we calculated the proposed MP RVUs using specialty-specific malpractice premium data because they represent the actual expense incurred by practitioners to obtain malpractice insurance. We obtained malpractice premium data exclusively from the most recently available data published in the 2014 and 2015 Market Share Reports accessed from the National Association of Insurance Commissioners (NAIC) Web site. We used information obtained from malpractice insurance rate filings with effective dates in 2014 and 2015. These were the most current data available during our data collection process.
We collected malpractice insurance premium data from all 50 States, the District of Columbia, and Puerto Rico. Rate filings were not available in American Samoa, Guam or the Virgin Islands. Premiums were for $1 million/$3 million, mature, claims-made policies (policies covering claims made, rather than those covering services furnished, during the policy term). A $1 million/$3 million liability limit policy means that the most that would be paid on any claim is $1 million and the most that the policy would pay for claims over the timeframe of the policy is $3 million. We made adjustments to the premium data to reflect mandatory surcharges for patient compensation funds (funds to pay for any claim beyond the statutory amount, thereby limiting an individual physician's liability in cases of a large suit) in states where participation in such funds is mandatory.
We included premium information for all physician and NPP specialties, and all risk classifications available in the collected rate filings. Although we collected premium data from all states, the District of Columbia, and Puerto Rico, not all specialties had distinct premium data in the rate filings from all states. Additionally, for some specialties, MP premiums were not available from the rate filings in any state. Therefore, for specialties for which there were not premium data for at least 35 states, and specialties for which there were not distinct premium data in the rate filings, we crosswalked the specialty to a similar specialty, either conceptually or by available premium data, for which we did have sufficient and reliable data.
For example, for radiation oncology, data were only available from 23 states, and therefore this specialty does not meet our 35-state threshold, which determines whether or not a specialty is deemed to have premium data sufficient to construct a unique risk factor. However, based on the 23 states' worth of rate filings for radiation oncology, the resource costs for the premiums suggests a similar, though slightly lesser average than that of the premiums for diagnostic radiology. We developed the proposed MP RVUs for radiation oncology by crosswalking the risk factor for diagnostic radiology as a similar specialty with similar premium data. We sought comment as to the appropriateness of this and the other crosswalks used in developing MP RVUs.
For the proposed CY 2018 MP RVU update, sufficient and reliable premium data were available for 43 specialty types, representing over 76 percent of allowed Medicare PFS services, which we used to develop specialty specific malpractice risk factors.
Calculation of the proposed MP RVUs conceptually follows the specialty-weighted approach used in the CY 2015 final rule with comment period (79 FR 67591). The specialty-weighted approach bases the MP RVUs for a given service upon a weighted average of the risk factors of all specialties furnishing the service. This approach ensures that all specialties furnishing a given service are accounted for in the calculation of the MP RVUs. The steps for calculating the proposed MP RVUs are described below.
Step (1): Compute a preliminary national average premium for each specialty.
Insurance rating area malpractice premiums for each specialty are mapped to the county level. The specialty premium for each county is then multiplied by its share of the total U.S. population (from the U.S. Census Bureau's 2014 American Community Survey (ACS) estimates). This is in contrast to the method used for creating national average premiums for each specialty in the 2015 update; in that update, specialty premiums were weighted by the total RVU per county, rather than by the county share of the total U.S. population. We refer readers to the CY 2016 PFS final rule with comment period (80 FR 70909) for a discussion of why we have adopted a weighting method based on a share of the total U.S. population. This calculation is then divided by the average MP GPCI across all counties for each specialty to yield a normalized national average premium for each specialty. The specialty premiums are normalized for geographic variation so that the locality cost differences (as
Step (2): Determine which premium class(es) to use within each specialty.
Some specialties had premium rates that differed for surgery, surgery with obstetrics, and non-surgery. These premium classes are designed to reflect differences in risk of professional liability and the cost of malpractice claims if they occur. To account for the presence of different classes in the malpractice premium data and the task of mapping these premiums to procedures, we calculated distinct risk factors for surgical, surgical with obstetrics, and nonsurgical procedures. However, the availability of data by surgery and non-surgery varied across specialties. Consistent with the CY 2015 MP RVU update, because no single approach accurately addressed the variability in premium class among specialties, we employed several methods for calculating average premiums by specialty. These methods are discussed below.
(a) Substantial Data for Each Class: For 10 out of 86 specialties, we determined that there were sufficient data for surgery and non-surgery premiums, as well as sufficient differences in rates between classes. Therefore, we calculated a national average surgical premium and non-surgical premium. We noted that, unlike in the CY 2015 MP RVU update, for CY 2018, there were no specialties that fell under the “unspecified dominates” specialty/surgery class scenario; therefore, we omitted that surgical class category.
(b) Major Surgery Dominates: For 9 surgical specialties, rate filings that included non-surgical premiums were relatively rare. For most of these surgical specialties, the rate filing did not include an “unspecified” premium. When it did, the unspecified premium was lower than the major surgery rate. For these surgical specialties, we calculated only a surgical premium and used the premium for major surgery for all procedures furnished by this specialty.
(c) Blend All Available: For the remaining specialties, there was wide variation across the rate filings in terms of whether or not premium classes were reported and which categories were reported. Because there was no clear strategy for these remaining specialties, we blended the available rate information into one general premium rate. For these specialties, we developed a weighted average “blended” premium at the national level, according to the percentage of work RVUs correlated with the premium classes within each specialty. For example, the surgical premiums for a given specialty were weighted by that specialty's work RVUs for surgical services; the nonsurgical premiums were weighted by the work RVUs for non-surgical services and the unspecified premiums were weighted by all work RVUs for the specialty type.
Step (3): Calculate a risk factor for each specialty.
The relative differences in national average premiums between specialties are expressed in our methodology as a specialty risk factor. These risk factors are an index calculated by dividing the national average premium for each specialty by the national average premium for the specialty with the lowest premiums for which we had sufficient and reliable data, allergy and immunology. For specialties with sufficient surgical and non-surgical premium data, we calculated both a surgical and non-surgical risk factor. For specialties with rate filings that distinguished surgical premiums with obstetrics, we calculated a separate surgical with obstetrics risk factor. For all other specialties, we calculated a single risk factor and applied the specialty risk factor to both surgery and non-surgery services.
We noted that for determining the risk factor for suppliers of TC-only services in the CY 2015 update, we updated the premium data for independent diagnostic testing facilities (IDTFs) that we used in the CY 2010 update. These data were obtained from a survey conducted by the Radiology Business Management Association (RBMA) in 2009; we ultimately used these data to calculate an updated TC specialty risk factor. We applied the updated TC specialty risk factor to suppliers of TC-only services. In the CY 2015 final rule with comment period (79 FR 67595), RBMA voluntarily submitted updated MP premium information collected from independent diagnostic testing facilities (IDTFs) in 2014, and requested that we use the data for calculating the CY 2015 MP RVUs for TC services. We declined to utilize the data and stated that we believe further study is necessary and we would consider this matter and propose any changes through future rulemaking. We believed that data for a broader set of technical component services are needed, and sought comment on appropriate, comparable data sources for such information. We also sought comment on whether the data for IDTFs are comparable and appropriate as a proxy for the broader set of TC services. We endeavor to, in the next update of specialty risk factors, collect more data across a broader set of the technical component services, not just for radiology (as is currently reflected in the RBMA data), but data for services performed by other non-physician practitioners including cytotechnologists, and cardiovascular technologists. In the interim, for CY 2018, we proposed to assign a TC risk factor of 1.0, which corresponds to the lowest physician specialty risk factor.
We assigned the risk factor of 1.0 to the TC services because we did not have comparable professional liability premium data for the full range of clinicians that furnish these services. In lieu of comprehensive, comparable data, we used 1.0 as the default minimum risk factor, though we sought information on the best available data sources for use in the next update, as well as empirical information that would support assignment of an alternative risk factor for these services.
Step (4): Calculate malpractice RVUs for each HCPCS code.
Resource-based MP RVUs were calculated for each HCPCS code that has work or PE RVUs. The first step was to identify the percentage of services furnished by each specialty for each respective HCPCS code. This percentage was then multiplied by each respective specialty's risk factor as calculated in Step 3. The products for all specialties for the HCPCS code were then added together, yielding a specialty-weighted service specific risk factor reflecting the weighted malpractice costs across all specialties furnishing that procedure. The service specific risk factor was multiplied by the greater of the work RVU or PE clinical labor index for that service to reflect differences in the complexity and risk-of-service between services.
Low volume service codes: As we discussed in section II.B. of this final rule, we proposed to use a list of expected specialties instead of the claims-based specialty mix for low volume services in order to address stakeholder concerns about the year to year variability in PE and MP RVUs for low volume services. We solicited comments on the proposal to use these service-level overrides to determine the specialty for low volume procedures, as well as on the list of overrides itself.
The proposed list of codes and expected specialties is available on our Web site under downloads for the CY 2018 PFS proposed rule at
Given that we now annually recalibrate MP RVUs based on claims data, and in light of our proposed introduction of the service-level specialty override for low volume services, we believed that there would no longer be a need to apply service-level MP crosswalks in order to assign a specialty-mix risk factor. Contingent on finalizing this proposal, we also proposed to eliminate general use of an MP-specific specialty-mix crosswalk for new and revised codes. However, we would continue to consider, in conjunction with annual recommendations, specific recommendations from the public and the RUC regarding specialty mix assignments for new and revised codes, particularly in cases where coding changes are expected to result in differential reporting of services by specialty, or where the new or revised code is expected to be low-volume. Absent such information, we would derive the specialty mix assumption for the first year for a new or revised code from the specialty mix used for purposes of ratesetting. In subsequent years when claims data are available, we would assign the specialty based on claims data unless the service does not exceed the low volume threshold (99 or fewer allowed services). If the service is low volume, we would assign the expected specialty, establishing a new expected specialty through rulemaking as needed, which is consistent with our approach for developing PE RVUs.
Step (5): Rescale for budget neutrality.
The statute requires that changes to fee schedule RVUs must be budget neutral. Thus, the last step is to adjust for relativity by rescaling the proposed MP RVUs so that the total proposed resource based MP RVUs are equal to the total current resource based MP RVUs scaled by the ratio of current aggregate MP and work RVUs. This scaling is necessary in order to maintain the work RVUs for individual services from year to year while also maintaining the overall relationship among work, PE, and MP RVUs.
Additional information on our proposed methodology for updating the MP RVUs may be found in our contractor's report, “Interim Report on Malpractice RVUs for the CY 2018 PFS Proposed Rule,” which is available on the CMS Web site under the downloads section of the CY 2018 PFS proposed rule located at
We sought comments on these proposals for calculating the MP RVUs for CY 2018. The following is a summary of the public comments received on our proposals and our responses:
For the the comments that noted differences in which specialties had sufficient data this year, compared to the CY 2015 update, we have determined that this is due to differences in the codes that insurance issuers use to identify the physician speciality on the descriptions on the raw rate filings and/or how these raw data were categorized into CMS specialties. CMS specialty coding information is not available on the raw rate filings, and Insurance Services Office (ISO) codes are only sometimes present. Thus, it is always necessary to use a crosswalk to map malpractice premium data to the CMS specialty classifications. This means that changes in malpractice insurers' premium coding practices or the rate filing categorization process can easily lead to shifts in the number of rate filings across related specialties, which in turn may skew the weighting of the data, which is what we observed in the CY 2018 proposed update.
The Cardiology specialty is illustrative of this issue. In the last update, Cardiology had a surgical risk factor of 6.98 and a non-surgical risk factor of 1.93. In this update, Cardiology did not have sufficient data to compute separate surgical and non-surgical risk factors and was proposed to receive a blended risk factor of 1.90. This change was understandably concerning to several commenters. The reason that Cardiology did not have sufficient data to compute a surgical risk factor was directly due to how the raw rate filings were categorized rather than the data availability itself. In the past, some rate filings that referred to cardiac surgery and interventional cardiology in their specialty descriptions were categorized as Specialty 06: Cardiology, but comparable filings for this year's proposal were categorized as Specialty 78: Cardiac Surgery and C3: Interventional Cardiology. As several commenters suggested, it is possible to mitigate this problem by assigning Cardiology to receive the surgical risk factor of Cardiac Surgery. In the long-term, we understand commenters' concerns and in order to alleviate this issue, we intend to revisit how we categorize all rate filings by specialty. This is particularly important because some physicians may not have updated their specialty codes despite performing surgical and interventional cardiac procedures, and we want to ensure that their rates are properly adjusted if they are still registered as part of the general Cardiology specialty. We also understand that this issue may have occurred for other groups of related specialties and intend to do a comprehensive assessment in the future to avoid potential discrepancies such as those previously described. For these reasons, we are not finalizing our proposal to use the most recent data for the CY 2018 MP RVUs and to align the update of MP premium data and MP GPCIs to once every 3 years. We recognize that, going forward, we need to resolve differences regarding the variances in the descriptions on the raw rate filings as well as how these raw data were categorized to conform with the CMS specialties.
After consideration of the comments received, we are not finalizing our proposal to use the most recent data for the CY 2018 MP RVUs and to align the update of MP premium data and MP GPCIs to once every 3 years. Similar to CY 2017, the CY 2018 MP RVUs will continue to be based on the premium data that was collected for the CY 2015 MP RVU update. For CY 2018, the MP RVUs will be calculated based on the existing specialty risk factors (the same risk factors that were used to calculate the CY 2017 MP RVUs); these specialty risk factors are shown in the CY 2018 Final Rule Malpractice Risk Factors and Premium Amounts by Specialty file located on the CMS Web site under the downloads section of the CY 2018 PFS final rule at
For low volume service codes, we thank the commenters for their support, and we are finalizing the proposal to use a list of expected specialties, instead of a claims-based specialty mix, for low volume, which also includes no volume codes, and to apply these overrides for both PE and MP. We believe that this will simplify the implementation of service-level overrides for PE and MP, and will also address stakeholder concerns about year-to-year variability for low volume services. We refer readers to section II.B. of this final rule for further discussion regarding the low volume service codes.
We note that the next MP update must occur by CY 2020. We continue to believe that updating the MP premium data on a more frequent basis would enable the resulting premiums and RVUs to better reflect market trends in malpractice insurance for different specialties. In principle, more frequent updates are optimal, and we will consider this in future rulemaking.
Many of the commenters expressed concerns regarding the sufficiency of the data. As previously explained, this is not a matter of a lack of sufficient or robust data, but an issue regarding how the rate filings are being classified by specialty. We re-examined the data and after further review, we recognize that going forward we need to resolve differences regarding variances in the descriptions on the raw rate filings as well as how these raw data were categorized to conform with the CMS specialties. Understanding that this is a driver of the fluctuations that were reflected in the updated MP RVUs that we proposed, moving forward we will be able to prioritize reconciling the coding changes and categorizations in the raw rate filings in order to avoid data fluctuations between updates that are not representative of the actual data. We thank the commenters for their detailed feedback, and will continue to take it into consideration as we work to make the MP RVUs as accurate as possible for all specialties. We also note that a few commenters noted concerns regarding potential errors in the proposed MP RVUs for specific codes as a result of the proposed updated specialty risk factors; however, since we are not finalizing those MP RVUs based on the proposed updated specialty risk
The resource based MP RVUs for CY 2018 are shown in Addendum B, which is available on the CMS Web site under the downloads section of the CY 2018 PFS final rule at
Several conditions must be met for Medicare to make payments for telehealth services under the PFS. The service must be on the list of Medicare telehealth services and meet all of the following additional requirements:
• The service must be furnished via an interactive telecommunications system.
• The service must be furnished by a physician or other authorized practitioner.
• The service must be furnished to an eligible telehealth individual.
• The individual receiving the service must be located in a telehealth originating site.
When all of these conditions are met, Medicare pays a facility fee to the originating site and makes a separate payment to the distant site practitioner furnishing the service.
Section 1834(m)(4)(F)(i) of the Act defines Medicare telehealth services to include professional consultations, office visits, office psychiatry services, and any additional service specified by the Secretary, when furnished via a telecommunications system. We first implemented this statutory provision, which was effective October 1, 2001, in the CY 2002 PFS final rule with comment period (66 FR 55246). We established a process for annual updates to the list of Medicare telehealth services as required by section 1834(m)(4)(F)(ii) of the Act in the CY 2003 PFS final rule with comment period (67 FR 79988).
As specified 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 distant site physician or practitioner.
Telephones, facsimile machines, and stand-alone 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 allows the use of asynchronous “store-and-forward” technology when the originating site is part of a federal telemedicine demonstration program in Alaska or Hawaii. As specified in § 410.78(a)(1), asynchronous store-and-forward is the transmission of medical information from an originating site for review by the distant site physician or practitioner at a later time.
Medicare telehealth services may be furnished to an eligible telehealth individual notwithstanding the fact that the practitioner furnishing the telehealth service is not at the same location as the beneficiary. An eligible telehealth individual is an individual enrolled under Part B who receives a telehealth service furnished at a telehealth originating site.
Practitioners furnishing Medicare telehealth services are reminded that these services are subject to the same non-discrimination laws as other services, including the effective communication requirements for persons with disabilities of section 504 of the Rehabilitation Act of 1973 and section 1557 of the Affordable Care Act, as well as and language access for persons with limited English proficiency, as required under Title VI of the Civil Rights Act of 1964 and section 1557 of the Affordable Care Act. For more information, see
Practitioners furnishing Medicare telehealth services submit claims for telehealth services to the Medicare Administrative Contractors (MACs) 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.
Originating sites, which can be one of several types of sites specified in the statute where an eligible telehealth individual is located at the time the service is being furnished via a telecommunications system, are paid a facility fee under the PFS for each Medicare telehealth service. The statute specifies both the types of entities that can serve as originating sites and the geographic qualifications for originating sites. For geographic qualifications, our regulation at § 410.78(b)(4) limits originating sites to those located in rural health professional shortage areas (HPSAs) or in a county that is not included in a metropolitan statistical area (MSA).
Historically, we have defined rural HPSAs to be those located outside of MSAs. Effective January 1, 2014, we modified the regulations regarding originating sites to define rural HPSAs as those located in rural census tracts as determined by the Federal Office of Rural Health Policy of the Health Resources and Services Administration (HRSA) (78 FR 74811). Defining “rural” to include geographic areas located in rural census tracts within MSAs allows for broader inclusion of sites within HPSAs as telehealth originating sites. Adopting the more precise definition of “rural” for this purpose expands access to health care services for Medicare beneficiaries located in rural areas. HRSA has developed a Web site tool to provide assistance to potential originating sites to determine their geographic status. To access this tool, see our Web site at
An entity participating in a federal telemedicine demonstration project that has been approved by, or received funding from, the Secretary as of December 31, 2000 is eligible to be an originating site regardless of its geographic location.
Effective January 1, 2014, we also changed our policy so that geographic status for an originating site would be established and maintained on an annual basis, consistent with other telehealth payment policies (78 FR 74400). Geographic status for Medicare telehealth originating sites for each calendar year is now based upon the status of the area as of December 31 of the prior calendar year.
For a detailed history of telehealth payment policy, see 78 FR 74399.
As noted previously, in the CY 2003 PFS final rule with comment period (67 FR 79988), we established a process for adding services to or deleting services from the list of Medicare telehealth services. This process provides the public with an ongoing opportunity to submit requests for adding services, which are then reviewed by us. Under this process, we assign any submitted request to make additions to the list of telehealth services to one of two categories. Revisions to the criteria that we use to review requests in the second category were finalized in the CY 2012
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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 (for example, due to reduced rate of recurrence of the disease process).
• 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.
The list of telehealth services, including the proposed additions described below, is included in the Downloads section to this final rule at
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. To be considered during PFS rulemaking for CY 2019, qualifying requests must be submitted and received by December 31, 2017. Each request to add 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, requesters 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, see our Web site at
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 for 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 PFS final rule with comment period (76 FR 73098), we believe that the category 1 criteria not only streamline our review process for publicly requested services that fall into this category, but also expedite our ability to identify codes for the telehealth list that resemble those services already on this list.
We received several requests in CY 2016 to add various services as Medicare telehealth services effective for CY 2018. The following presents a discussion of these requests, and our proposals for additions to the CY 2018 telehealth list. Of the requests received, we found that three services were sufficiently similar to services currently on the telehealth list to qualify on a category 1 basis. Therefore, we proposed to add the following services to the telehealth list on a category 1 basis for CY 2018:
We found that the service described by HCPCS code G0296 is sufficiently similar to office visits currently on the telehealth list. We believed that all the components of this service, which include assessment of the patient's risk for lung cancer, shared decision making, and counseling on the risks and benefits of LDCT, can be furnished via interactive telecommunications technology.
We proposed to add CPT codes 90839 and 90840 on a Category 1 basis. We found that these services are sufficiently similar to the psychotherapy services currently on the telehealth list, even though these codes describe patients requiring more urgent care and psychotherapeutic interventions to minimize the potential for psychological trauma. However, we identified one specific element of the services as described in the CPT prefatory language that we concluded may or may not be able to be furnished via telehealth, depending on the circumstances of the particular service. The CPT prefatory language specifies that the treatment described by these codes requires, “mobilization of resources to defuse the crisis and restore safety.” In many cases, we believed that a distant site practitioner would have access (via telecommunication technology, presumably) to the resources at the originating site that would allow for the kind of mobilization required to restore safety. However, we also believed that it would be possible that a distant site practitioner would not have access to such resources. Therefore we proposed to add the codes to the telehealth list with the explicit condition of payment that the distant site practitioner be able to mobilize resources at the originating site to defuse the crisis and restore safety, when applicable, when the codes are furnished via telehealth. “Mobilization of resources” is a description used in the CPT prefatory language. We believed the critical element of “mobilizing resources” is the ability to communicate with and inform staff at the originating site to the extent necessary to restore safety. We solicited comment on whether our assumption that the remote practitioner is able to mobilize resources at the originating site
Although we did not receive specific requests, we also proposed to add four additional services to the telehealth list based on our review of services. All four of these codes are add-on codes that describe additional elements of services currently on the telehealth list and would only be considered telehealth services when billed as an add-on to codes already on the telehealth list. The four codes are:
In the case of CPT codes 96160 and 96161, and HCPCS code G0506, we recognized that these services may not necessarily be ordinarily furnished in-person with a physician or billing practitioner. Ordinarily, services that are typically not considered to be face-to-face services do not need to be on the list of Medicare telehealth services; however, these services would only be considered Medicare telehealth services when billed with a base code that is also on the telehealth list and would not be considered Medicare telehealth services when billed with codes not on the Medicare telehealth list. We believed that by adding these services to the telehealth list it will be administratively easier for practitioners who report these services in association with a visit code that is furnished via telehealth as both the base code and the add-on code would be reported with the telehealth place of service.
We also received requests to add services to the telehealth list that do not meet our criteria for Medicare telehealth services. We did not propose adding the following procedures for physical, occupational, and speech therapy, initial hospital care, and online E/M by physician/qualified healthcare professional to the telehealth list, or changing the requirements for ESRD procedure codes furnished via telehealth, for the reasons noted in the paragraphs that follow.
a. Physical and Occupational Therapy and Speech-Language Pathology Services: CPT Codes—
Section 1834(m)(4)(E) of the Act specifies the types of practitioners who may furnish and bill for Medicare telehealth services as those practitioners under section 1842(b)(18)(C) of the Act. Physical therapists, occupational therapists and speech-language pathologists are not among the practitioners identified in section 1842(b)(18)(C) of the Act. We stated in the CY 2017 PFS final rule (81 FR 80198) that because these services are predominantly furnished by physical therapists, occupational therapists and speech-language pathologists, we did not believe it would be appropriate to add them to the list of telehealth services at this time. In a subsequent submission for 2018, the original requester suggested that we might propose these services to be added to the list so that they can be furnished via telehealth when furnished by eligible distant site practitioners. We considered that possibility; however, since the majority of the codes are furnished by therapy professionals over 90 percent of the time, we believed that adding therapy services to the telehealth list that explicitly describe the services of the kinds of professionals not included on the statutory list of distant site practitioners could result in confusion about who is authorized to furnish and bill for these services when furnished via telehealth. We also noted that several of these services, such as CPT code 97761, require directly physically manipulating the beneficiary, which is not possible to do through telecommunications technology. Therefore, we did not propose adding these codes to the list of Medicare telehealth services.
b. Initial Hospital Care Services: CPT Codes—
We previously considered a request to add these codes to the telehealth list. As we stated in the CY 2011 PFS final rule with comment period (75 FR 73315), while initial inpatient consultation services are currently on the list of approved telehealth services, there are no services on the current list of telehealth services that resemble initial hospital care for an acutely ill patient by the admitting practitioner who has ongoing responsibility for the patient's treatment during the course of the hospital stay. Therefore, consistent with prior rulemaking, we did not propose that initial hospital care services be
The initial hospital care codes describe the first visit of the hospitalized patient by the admitting practitioner who may or may not have seen the patient in the decision-making phase regarding hospitalization. Based on the description of the services for these codes, we believed it is critical that the initial hospital visit by the admitting practitioner be conducted in person to ensure that the practitioner with ongoing treatment responsibility comprehensively assesses the patient's condition upon admission to the hospital through a thorough in-person examination. Additionally, the requester submitted no additional research or evidence that the use of a telecommunications system to furnish the service produces demonstrated clinical benefit to the patient; therefore, we also did not propose adding initial hospital care services to the Medicare telehealth services list on a category 2 basis.
We note that Medicare beneficiaries who are being treated in the hospital setting can receive reasonable and necessary E/M services using other HCPCS codes that are currently on the Medicare telehealth list including those for subsequent hospital care, initial and follow-up telehealth inpatient and emergency department consultations, as well as initial and follow-up critical care telehealth consultations.
Therefore, we did not propose to add the initial hospital care services to the list of Medicare telehealth services for CY 2018.
c. Online E/M by physician/QHP: CPT Code—
As we indicated in the CY 2016 final rule with comment period (80 FR 71061), CPT code 99444 is assigned a status indicator of “N” (Non-covered service). Under section 1834(m)(2)(A) of the Act, Medicare pays the physician or practitioner furnishing a telehealth service an amount equal to the amount that would have been paid if the service was furnished without the use of a telecommunications system. Because CPT code 99444 is currently non-covered, there would be no Medicare payment if this service were furnished without the use of a telecommunications system. Because this code is a non-covered service for which no Medicare payment may be made under the PFS, we did not propose adding online E/M services to the list of Medicare telehealth services for CY 2018.
d. Monthly Capitation Payment (MCP) for ESRD-Related Services for Home Dialysis, by Age: CPT Codes—
In the CY 2004 PFS final rule with comment period (68 FR 63216), we established HCPCS G-codes for ESRD monthly capitation payments (MCPs), which were replaced by CPT codes in CY 2009 (73 FR 69898). The services described by CPT codes 90963 through 90966 were added to the Medicare telehealth list in CY 2005 (69 FR 66276) and CPT codes 90967 through 90970 were added to the Medicare telehealth list in the CY 2017 PFS final rule (81 FR 80194); however, we specified that the required clinical examination of the vascular access site must be furnished face-to-face “hands on” (without the use of an interactive telecommunications system) by a physician, clinical nurse specialist (CNS), nurse practitioner (NP), or physician assistant (PA). The American Telemedicine Association (ATA) submitted a new request for CY 2018 requesting that we allow telehealth coverage of ESRD procedure codes without in-person exam of the catheter access site monthly. Our current policy reflects our understanding that evaluation of the integrity and functionality of the access site is a critical element of the services described by the codes and that this element cannot be performed via telecommunications technology. The requester did not submit evidence to support the assertion that effective examination of the access site can be executed via telecommunications technology. Therefore, for CY 2018, we did not propose any changes to the policy requiring that the MCP practitioner must furnish at least one face-to-face encounter with the home dialysis patient per month for clinical examination of the catheter access site. However, we are interested in more information about current clinically accepted care practices and to what extent telecommunications technology can be used to examine the access site. We are also interested in information about the clinical standards of care regarding the frequency of the evaluation of the access site.
In summary, we proposed adding the following codes to the list of Medicare telehealth services beginning in CY 2018 on a category 1 basis:
The following is a summary of the comments we received regarding the proposed addition of services to the list of Medicare telehealth services:
We believe that the telehealth critical care consultation codes (HCPCS codes G0508 and G0509) more accurately describe the kind of services that can be furnished to patients via telehealth than the initial inpatient hospital visit E/M codes that describe services with elements that can only be furnished in-person. The valuation for HCPCS codes G0508 and G0509 was developed based on our assessment that the overall work (resources in time and intensity) involved in furnishing the services is similar to the in-person critical care service codes, not that all elements of the services are the same. Many services paid under the PFS share similar, if not exactly the same work RVUs, without necessarily describing the exact same elements of the service. For more on the critical care consultation codes in the context of telehealth, please see the CY 2017 PFS final rule (81 FR 80196 through 80197 and 81 FR 80352).
Since several commenters requested that we add MNT and DSMT to the telehealth list, we also wish to remind commenters that codes for both MNT and DSMT are currently on the Medicare telehealth list. The current list of Medicare telehealth services can be viewed on our Web site,
We have required distant site practitioners to report one of two longstanding HCPCS modifiers when reporting telehealth services. Current guidance instructs practitioners to submit claims for telehealth services using the appropriate CPT or HCPCS code for the professional service along with the telehealth modifier GT (via interactive audio and video telecommunications systems). For federal telemedicine demonstration programs in Alaska or Hawaii, practitioners are instructed to submit claims using the appropriate CPT or HCPCS code for the professional service along with the telehealth modifier GQ if telehealth services are performed “via an asynchronous telecommunications system.” By coding and billing these modifiers with a service code, practitioners are certifying that both the broad and code-specific telehealth requirements have been met.
In the CY 2017 PFS final rule (81 FR 80201), we finalized payment policies regarding Medicare's use of a new Place of Service (POS) Code describing services furnished via telehealth. The new POS code became effective January 1, 2017, and we believe its use is redundant with the requirements to apply the GT modifier for telehealth services. We did not propose to implement a change to the modifier requirements during CY 2017 rulemaking because at the time of the CY 2017 PFS proposed rule, we did not know whether the telehealth POS code would be made effective for January 1, 2017. However, we noted in the CY 2017 PFS final rule that, like the modifiers, use of the telehealth POS code certifies that the service meets the telehealth requirements.
Because a valid POS code is required on professional claims for all services, and the appropriate reporting of the telehealth POS code serves to indicate both the provision of the service via telehealth and certification that the requirements have been met, we believe that it is unnecessary to also require the distant site practitioner report the GT modifier on the claim. Therefore, we proposed to eliminate the required use of the GT modifier on professional claims. Because institutional claims do not use a POS code, we proposed for distant site practitioners billing under CAH Method II to continue to use the GT modifier on institutional claims. For purposes of the federal telemedicine demonstration programs in Alaska or Hawaii, we proposed to retain the GQ modifier to maintain the distinction between synchronous and asynchronous telehealth services, as reflected in statute.
The following is a summary of the public comments received on our proposal to eliminate the required use of the GT modifier on professional claims:
We have received numerous requests from stakeholders to expand access to telehealth services. As noted above, Medicare payment for telehealth services is restricted by statute, which establishes the services initially eligible for Medicare telehealth and limits the use of telehealth by defining both eligible originating sites (the location of the beneficiary) and the distant site practitioners who may furnish and bill for telehealth services. Originating sites are limited both by geography and provider setting. We have the authority to add to the list of telehealth services based on our annual process, but cannot change the limitations relating to geography, patient setting, or type of furnishing practitioner because these requirements are specified in statute. For CY 2018, we sought information regarding ways that we might further expand access to telehealth services within the current statutory authority and pay appropriately for services that take full advantage of communication technologies.
In addition to the broad comment solicitation regarding Medicare telehealth services, we also specifically solicited comment on whether to make separate payment for CPT codes that describe remote patient monitoring. We note that remote patient monitoring services would generally not be considered Medicare telehealth services as defined under section 1834(m) of the Act. Rather, like the interpretation by a physician of an actual electrocardiogram or electroencephalogram tracing that has been transmitted electronically, these services involve the interpretation of medical information without a direct interaction between the practitioner and beneficiary. As such, they are paid under the same conditions as in-person physicians' services with no additional requirements regarding permissible originating sites or use of the telehealth place of service code.
We noted we were particularly interested in comments regarding CPT code 99091 (Collection and interpretation of physiologic data (
We also sought comment on other existing codes that describe extensive use of communications technology for consideration for future rulemaking, including CPT code 99090 (Analysis of clinical data stored in computers (
The following is a summary of the public comments received on our proposals and our responses:
A few commenters expressed opposition to making CPT codes 99090 and/or 99091 separately payable, noting that these are generic codes and are duplicative of other codes that are more specific, such as CPT codes 93297 ((Interrogation device evaluation(s), (remote) up to 30 days; implantable cardiovascular monitor system, including analysis of 1 or more recorded physiologic cardiovascular data elements from all internal and external sensors, analysis, review(s) and report(s) by a physician or other qualified health care professional)) and CPT code 93228 (External mobile cardiovascular telemetry with electrocardiographic recording, concurrent computerized real time data analysis and greater than 24 hours of accessible ECG data storage (retrievable with query) with ECG triggered and patient selected events transmitted to a remote attended surveillance center for up to 30 days; review and interpretation with report by a physician or other qualified health care professional)). Several commenters encouraged CMS to wait for the CPT Editorial Panel to complete its work of reviewing and revising the CPT codes and consider valuing the new codes in the future. Of the commenters who were supportive of unbundling and making separate payment for CPT code 99091, a few suggested that CPT code 99091 could be billed in association with chronic care management (CCM) services.
Finally, because we believe the kind of analysis involved in furnishing this service is complementary to CCM and other care management services, for the purposes of Medicare billing, we are allowing that CPT code 99091 can be billed once per patient during the same service period as CCM (CPT codes 99487, 99489, and 99490), TCM (CPT codes 99495 and 99496), and behavioral health integration (BHI) (CPT codes 99492, 99493, 99494, and 99484). We note that under current billing rules, time counted toward the CCM codes generally refers to time spent by clinical staff furnishing care management services; while CPT code 99091 refers to practitioner time. We note that time spent furnishing these services could not be counted towards the required time for both codes for a single month.
We also note that the new separate payment for CPT code 99091 will be excluded from the calculation of the net reduction in expenditures due to changes in coding and valuation for purposes of the misvalued code target, consistent with policies finalized in the CY 2016 PFS final rule with comment period (80 FR 70926). CPT code 99091 describes a service that is newly separately reportable, but for which no corresponding reduction is being made to existing codes and instead reductions under the PFS are being taken exclusively through a budget neutrality adjustment.
We look forward to forthcoming coding changes through the CPT process that we anticipate will better describe the role of remote patient monitoring in contemporary practice and potentially mitigate the need for the additional billing requirements associated with these services.
Section 1834(m)(2)(B) of the Act established the Medicare telehealth originating site facility fee for telehealth services furnished from October 1, 2001 through December 31, 2002, at $20.00. For telehealth services furnished on or after January 1 of each subsequent calendar year, the telehealth originating site facility fee is increased by the percentage increase in the Medicare Economic Index (MEI) as defined in section 1842(i)(3) of the Act. The originating site facility fee for telehealth services furnished in CY 2017 is $25.40. The MEI increase for 2018 is 1.4 percent and is based on the most recent historical update through 2017Q2 (1.8 percent), and the most recent historical MFP through calendar year 2016 (0.4 percent). Therefore, for CY 2018, the payment amount for HCPCS code Q3014 (Telehealth originating site facility fee) is 80 percent of the lesser of the actual charge or $25.76. The Medicare telehealth originating site facility fee and the MEI increase by the applicable time period is shown in Table 8.
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. Section 1848(c)(2)(K) of 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) to the Act also requires the Secretary to develop a process to validate the RVUs of certain potentially misvalued codes under the PFS, using the same criteria used to identify potentially misvalued codes, and to make appropriate adjustments.
As discussed in section II.H. of this final rule, each year we develop appropriate adjustments to the RVUs taking into account recommendations provided by the American Medical Association/Specialty Society Relative Value Scale Update Committee (RUC), the Medicare Payment Advisory Commission (MedPAC), and others. For many years, the 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 analyses of other data, such as claims data, to inform the decision-making process as authorized by law. We may also consider analyses of work 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 System (PQRS) databases. In addition to considering the most recently available data, we assess the results of physician surveys and specialty recommendations submitted to us by the RUC for our review. We also consider information provided by other stakeholders. We conduct a 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 and requires us to take into account the results of consultations with organizations representing physicians who provide the services. In accordance with section 1848(c) of the Act, we determine and make appropriate adjustments to the RVUs.
In its March 2006 Report to the Congress (
As MedPAC noted in its March 2009 Report to Congress (
• Codes that have experienced the fastest growth.
• Codes that have experienced substantial changes in practice expenses.
• Codes that describe new technologies or services within an appropriate time period (such as 3 years) after the relative values are initially established for such codes.
• Codes which are 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 that have not been subject to review since implementation of the fee schedule.
• Codes that account for the majority of spending under the physician fee schedule.
• Codes for services that have experienced a substantial change in the hospital length of stay or procedure time.
• Codes for which there may be a change in the typical site of service since the code was last valued.
• Codes for which there is a significant difference in payment for the same service between different sites of service.
• Codes for which there may be anomalies in relative values within a family of codes.
• Codes for services where there may be efficiencies when a service is furnished at the same time as other services.
• Codes with high intra-service work per unit of time.
• Codes with high practice expense relative value units.
• Codes with high cost supplies.
• Codes as determined 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. 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) that may include consolidation of individual services into bundled codes for payment under the physician fee schedule.
To fulfill our statutory mandate, we have identified and reviewed numerous potentially misvalued codes as 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. As part of our current process, we identify potentially misvalued codes for review, and request recommendations from the RUC and other public commenters on revised work RVUs and direct PE inputs for those codes. The RUC, through its own processes, also identifies potentially misvalued codes for review. Through our public nomination process for potentially misvalued codes established in the CY 2012 PFS final rule with comment period, 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 process, we have reviewed approximately 1,700 potentially misvalued codes to refine work RVUs and direct PE inputs. We have assigned appropriate work RVUs and direct PE inputs for these services as a result of these reviews. 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 PFS final rule with comment period (76 FR 73055 through 73958), we finalized our policy to consolidate the review of physician work and PE at the same time, and established a process for the annual public nomination of potentially misvalued services.
In the CY 2013 PFS final rule with comment period, we built upon the work we began in CY 2009 to review potentially misvalued codes that have not been reviewed since the implementation of the PFS (so-called “Harvard-valued codes”). In CY 2009 (73 FR 38589), we requested recommendations from the RUC to aid in our review of Harvard-valued codes that had not yet been reviewed, focusing first on high-volume, low intensity codes. In the fourth Five-Year Review (76 FR 32410), we requested recommendations from the RUC to aid in our review of Harvard-valued codes with annual utilization of greater than 30,000 services. In the CY 2013 PFS final rule with comment period, we identified specific Harvard-valued services with annual allowed charges that total at least $10,000,000 as potentially misvalued. In addition to the Harvard-valued codes, in the CY 2013 PFS final rule with comment period we finalized for review a list of potentially misvalued codes that have stand-alone PE (codes with physician work and no listed work time and codes with no physician work that have listed work time).
In the CY 2016 PFS final rule with comment period, we finalized for review a list of potentially misvalued services, which included eight codes in the neurostimulators analysis-programming family (CPT 95970-95982). We also finalized as potentially misvalued 103 codes identified through our screen of high expenditure services across specialties.
In the CY 2017 PFS final rule, we finalized for review a list of potentially misvalued services, which included eight codes in the end-stage renal disease home dialysis family (CPT codes 90963-90970). We also finalized as potentially misvalued 19 codes identified through our screen for 0-day global services that are typically billed with an evaluation and management (E/M) service with modifier 25.
In the CY 2012 PFS final rule with comment period (76 FR 73058), we finalized a process for the public to nominate potentially misvalued codes. The public and stakeholders may nominate potentially misvalued codes for review by submitting the code with supporting documentation by February 10 of each year. Supporting documentation for codes nominated for the annual review of potentially misvalued codes may include the following:
• Documentation in 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 work time.
• An anomalous relationship between the code being proposed for review and other codes.
• Evidence that technology has changed physician work.
• 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 work 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) National Database, and the Physician Quality Reporting System (PQRS) databases).
• National surveys of work time and intensity from professional and management societies and organizations, such as hospital associations.
We evaluate the supporting documentation submitted with the nominated codes and assess whether the nominated 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 indicate whether we proposed each nominated code as a potentially misvalued code. The public has the opportunity to comment on these and all other proposed potentially misvalued codes. In that year's final rule, we finalize our list of potentially misvalued codes.
After we issued the CY 2017 PFS final rule, we received a nomination and supporting documentation for one code to be considered as potentially misvalued. We evaluated the supporting documentation for this nominated code to ascertain whether the submitted information demonstrated that the code should be proposed as potentially misvalued.
CPT code 27279 (Arthrodesis, sacroiliac joint, percutaneous or minimally invasive (indirect visualization), with image guidance, includes obtaining bone graft when performed, and placement of transfixing device) was nominated for review as a potentially misvalued code because the current work RVU is potentially undervalued and stakeholders recommended that it should be increased to 14.23. We proposed this code as a potentially misvalued code in the CY 2018 PFS proposed rule.
The following is a summary of the public comments received on whether CPT code 27279 should be reviewed under the misvalued code initiative and our responses:
A few commenters noted that CPT code 27279 is scheduled for review by the RUC in October 2018 as part of its standard review process. As a result, some commenters suggested that CMS should wait until the RUC makes a recommendation regarding the appropriate valuation of the code. Some commenters noted that the RUC intends to review this service in October 2018 and suggested that the timeframe for that review would mean that the code could not be appropriately valued prior to CY 2020.
While we appreciate the comments that included suggestions regarding the specific work RVUs that might represent more appropriate valuation, we agree with those commenters that urged us to wait for the code to be reviewed by the RUC. We note that should the RUC and other relevant stakeholders expedite their review process, we would be able to consider making changes during next year's rulemaking. If the RUC review process is not completed in time, we may not be able to make changes in next year's rulemaking and would wait for the RUC to complete its process before making changes in subsequent rulemaking.
In the CY 2017 PFS final rule, we noted that the assertions by some commenters regarding appropriate values for the dialysis vascular access codes newly created in CY 2017 (CPT codes 36901 through 36909) did not include data that would warrant increases to the work RVUs we proposed and finalized in that rule (81 FR 80290-80297). However, we urged interested stakeholders to consider submitting robust data regarding costs for these and other services (81 FR 80290-80297). We have continued to receive feedback from stakeholders regarding the work valuation of these codes. Stakeholders have expressed concerns regarding the typical patient for these procedures as reflected in the information included in the RUC recommendations for CY 2017 and the importance of appropriate payment for ensuring access to care for Medicare beneficiaries. Therefore, we sought additional comment and requested robust data regarding the potentially misvalued work RVUs for CPT codes 36901 through 36909 and considered alternate work valuations for CY 2018, such as the RUC-recommended work RVUs from CY 2017, or other potential values based on submission of data through the public comment process. We noted that the RUC-recommended work RVUs for these services were displayed in the CY 2017 PFS final rule (81 FR 80290 through 80296).
The following is a summary of the public comments received on CPT codes 36901-36909 and our responses:
The overwhelming majority of commenters suggested we finalize the CY 2017 RUC-recommended work RVUs for CPT codes 36901-36909.
We have received conflicting information about the direct PE inputs for CPT codes 88184 (Flow cytometry, cell surface, cytoplasmic, or nuclear marker, technical component only; first marker) and 88185 (Flow cytometry, cell surface, cytoplasmic, or nuclear marker, technical component only; each additional marker (List separately in addition to code for first marker)). In the CY 2018 PFS proposed rule, we proposed these codes as potentially misvalued so that they can be reviewed again because some stakeholders have suggested the clinical labor and supplies that were previously finalized are no longer accurate.
We received information suggesting that the work RVUs for emergency department visits did not appropriately reflect the full resources involved in furnishing these services. Specifically, stakeholders expressed concerns that the work RVUs for these services have been undervalued given the increased acuity of the patient population and the heterogeneity of the sites, such as freestanding and off-campus emergency departments, where emergency department visits are furnished. Therefore, we sought comment on whether CPT codes 99281-99385 (Emergency department visits for the evaluation and management of a patient) should be reviewed under the misvalued code initiative.
The following is a summary of the public comments received on whether CPT codes 99281-99385 should be reviewed under the misvalued code initiative and our responses:
In contrast, one commenter stated that the problem of under-reimbursement for these services would be better addressed by streamlining the E/M process for documenting the higher level of care. Another commenter stated that given the significant changes to documentation guidelines for E/M services that may be forthcoming in this rule cycle, it is premature and somewhat difficult to advise on potential revaluation of any E/M codes, pending details on how the documentation guideline revisions are resolved.
For over a decade, CMS has collaborated with the RUC to regularly prioritize codes for review by using the categories specified in the statute or as determined appropriate. We generally have referred to these categories as “misvalued code screens.” To supplement ongoing RUC identification of potentially misvalued codes through established screens, CMS regularly uses PFS rulemaking to identify other screens for use in identifying potentially misvalued codes. For example, in recent years, CMS has prioritized the following screens:
• Codes with low work RVUs commonly billed in multiple units per single encounter.
• Codes with high volume and low work RVUs.
• Codes with site-of-service-anomalies.
• E/M codes.
• PFS high expenditure services.
• Services with standalone PE procedure time.
• Services with anomalous time.
• Contractor Medical Director identified potentially misvalued codes.
• Codes with higher total Medicare payments in office than in hospital or ASC.
• Publicly nominated potentially misvalued codes.
• 0-day global services that are typically billed with an evaluation and management (E/M) service with modifier 25.
Although we did not propose a new screen for CY 2018, we continue to believe that it is important to prioritize codes for review under the misvalued code initiative. As a result, we solicited public comment on the best approach for developing screens, as well as what particular new screens we might consider. We will consider these comments for future rulemaking.
The following is a summary of the public comments received on the best approach for developing screens, as well as what particular new screens we might consider and our responses:
Section 502(a)(1) of Division O, Title V of the Consolidated Appropriations Act of 2016 (Pub. L. 114-113) amended section 1848(b) of the Act by establishing a new paragraph (9) of subsection (b). Section 1848(b)(9)(B) of the Act provides for a 7 percent reduction in payments for the technical component (TC) for imaging services made under the PFS that are X-rays (including the technical component portion of a global service) taken using computed radiography technology furnished during CYs 2018 through 2022, and for a 10 percent reduction for the technical component of such imaging services furnished during CY 2023 or a subsequent year. Computed radiography technology is defined for purposes of this paragraph as cassette-based imaging that utilizes an imaging plate to create the image involved. Section 1848(b)(9) of the Act also requires implementation of the reduction in payments through appropriate mechanisms, which can include the use of modifiers. In accordance with section 1848(c)(2)(B)(v)(X) of the Act, the adjustments under section 1848(b)(9)(A) of the Act are exempt from the budget neutrality requirement.
We stated in the CY 2017 PFS proposed rule that because the required reductions in PFS payment for the TC
We proposed that beginning January 1, 2018, this modifier would be required to be used when reporting imaging services for which payment is made under the PFS that are X-rays (including the X-ray component of a packaged service) taken using computed radiography technology. The modifier would be required on claims for the technical component of the X-ray service, including when the service is billed globally because the PFS payment adjustment is made to the technical component regardless of whether it is billed globally, or billed separately using the TC modifier. The modifier must be used to report the specific services that are subject to the payment reduction and accurate use is subject to audit. The use of this proposed modifier to indicate an X-ray taken using computed radiography would result in a 7 percent reduction for CYs 2018 through 2022 and a 10 percent reduction for CY 2023 or a subsequent calendar year to the payments for the TC for such imaging services furnished as specified under section 1848(b)(9)(B) of the Act.
The following is a summary of the public comments received and our responses:
After consideration of the public comments, we are finalizing the proposal without modification.
Sections 1833(t)(1)(B)(v) and (t)(21) of the Act require that certain items and
As part of that discussion, we indicated that, in response to public comments received on the proposed payment policies for nonexcepted items and services, we would issue an interim final rule with comment period (the CY 2017 interim final rule, 81 FR 79720 through 79729) to establish payment policies under the PFS for nonexcepted items and services furnished on or after January 1, 2017. In the following paragraphs, we summarize what we proposed for the payment policies under the PFS for nonexcepted items and services furnished during CY 2018. The CY 2017 interim final rule can be found on the Internet at
Coding and payment policies under the PFS have long recognized the differences between the portions of services for which direct costs generally are incurred by practitioners and the portions of services for which direct costs generally are incurred by facilities. At present, the coding and RVUs established for particular groups of services under the PFS generally reflect such direct cost differences. As described in section II.B of this final rule, we establish separate nonfacility and facility RVUs for many HCPCS codes describing particular services paid under the PFS. For many other services, we establish separate RVUs for the professional component and the technical component of the service described by the same HCPCS code. For other services, we establish RVUs for the different HCPCS codes that segregate and describe the discrete professional and technical aspects of particular services.
Because hospitals with nonexcepted off-campus PBDs that furnish nonexcepted items and services are likely to furnish a broader range of services than other provider or supplier types for which there is a separately valued technical component under the PFS, for CY 2017, we established a new set of payment rates under the PFS that reflected the relative resource costs of furnishing the technical component of a broad range of services to be paid under the PFS specific to the nonexcepted off-campus PBD of a hospital with packaging (bundling) rules that are unique to the hospital outpatient setting under the OPPS.
In principle, the coding and billing mechanisms required to make appropriate payment to hospitals for nonexcepted items and services furnished by nonexcepted off-campus PBDs are parallel to those used to make payment for the technical component services for a range of supplier types paid under the PFS. That is, payments to hospitals are made for the technical aspect of services, while physicians and other practitioners report the professional aspect of these same services. In some cases, the entities reporting the technical aspect of services use the same coding that is used by the individuals reporting the professional services. In other cases, different coding applies. We proposed to maintain this coding and billing mechanism for CY 2018.
Using the relativity among OPPS payments to establish rates for the nonexcepted items and services furnished by nonexcepted off-campus PBDs and billed by hospitals under the PFS was only one aspect of establishing the necessary relativity of these services under the PFS more broadly. It was necessary to estimate the relativity of these services compared to PFS services furnished in other settings paid under the PFS. For CY 2017, we used our best estimate of the more general relativity between the technical component of PFS services furnished in nonexcepted off-campus PBDs and all other PFS services furnished in other settings using the limited information available to us at that time. As described in the CY 2017 interim final rule (81 FR 79722 through 79726), we estimated that for CY 2017, scaling the OPPS payment rates downward by 50 percent would strike an appropriate balance that avoided potentially underestimating the relative resources involved in furnishing services in nonexcepted off-campus PBDs as compared to the services furnished in other settings for which payment was made under the PFS. Specifically, we established site-specific rates under the PFS for the technical component of the broad range of nonexcepted items and services furnished by nonexcepted off-campus PBDs to be paid under the PFS that was based on the OPPS payment amount for the same items and services, scaled downward by 50 percent. We called this adjustment the “PFS Relativity Adjuster.” The PFS Relativity Adjuster refers to the percentage of the OPPS payment amount paid under the PFS for a nonexcepted item or service to the nonexcepted off-campus PBD under this policy.
In developing the CY 2017 interim final rule, we began by analyzing hospital outpatient claims data from January 1 through August 26, 2016, that contained the “PO” modifier signifying that they were billed by an off-campus department of a hospital paid under the OPPS other than a remote location, a satellite facility, or a dedicated emergency department (ED). We noted that the use of the “PO” modifier was a new mandatory reporting requirement for CY 2016. We limited our analysis to those claims billed on the 13X Type of Bill because those claims were used for Medicare Part B billing under the OPPS. We then identified the top (most frequently billed) 25 major codes that were billed by claim line; that is, items and services that were separately payable or conditionally packaged. Specifically, we restricted our analysis to codes with OPPS status indicators “J1”, “J2”, “Q1”, “Q2”, “Q3”, “S”, “T”, or “V”. We did not include separately payable drugs or biologicals in this analysis because those drugs or biologicals were not paid under the PFS under the CY 2017 interim final rule. As such, under the CY 2017 interim final rule, the PFS Relativity Adjuster did not apply to separately payable drugs and biologicals furnished by a nonexcepted off-campus PBD. Similarly, we excluded codes assigned an OPPS status indicator “A” because the services described by those codes were already paid at a rate under a fee schedule other than the OPPS and payment for those nonexcepted items and services was not changed by the rates established under
The most frequently billed service with the “PO” modifier was described by HCPCS code G0463 (Hospital outpatient clinic visit for assessment and management of a patient), which is paid under APC 5012; the total number of CY 2016 claim lines for that service was approximately 6.7 million as of August 2016. In CY 2016, the OPPS payment rate for APC 5012 was $102.12. Because there were multiple CPT codes (CPT codes 99201 through 99215) used under the PFS for billing that service, an exact comparison between the $102.12 OPPS payment rate for APC 5012 and the payment rate for a single CPT code billed under the PFS was not possible. Therefore, for purposes of the analysis, we examined the difference between the nonfacility payment rates and the facility payment rates under the PFS for CPT codes 99213 and 99214, which were the billing codes for a Level III and a Level IV office visit. Although we did not have data to precisely determine the equivalent set of PFS visit codes to use for the comparison, we believed that, based on the distribution of services billed for the visit codes under the PFS and the distribution of the visit codes under the OPPS from the last time period the CPT codes were used under the OPPS in CY 2014, those two codes provided reliable points of comparison. For CPT code 99213, the difference between the nonfacility payment rate and the facility payment rate under the PFS in CY 2016 was $21.86, which was 21 percent of the OPPS payment rate for APC 5012 of $102.12. For CPT code 99214, the difference between the nonfacility payment rate and the facility payment rate under the PFS in CY 2016 was $29.02, which was 28 percent of the OPPS payment rate for APC 5012. However, we recognized that, due to the more extensive packaging that occurred under the OPPS for services provided along with clinic visits relative to the more limited packaging that occurred under the PFS for office visits, those payment rates were not entirely comparable.
We then assessed the next 24 major codes most frequently billed on the 13X claim form by hospitals. We removed HCPCS code 36591 (Collection of blood specimen from a completely implantable venous access device) because, under current PFS policies, the code is used only to pay separately under the PFS when no other service was on the claim. We also removed HCPCS code G0009 (Administration of Pneumococcal Vaccine) because there was no payment for the code under the PFS. For the remaining 22 major codes most frequently billed, we estimated the amount that would have been paid to the physician in the office setting under the PFS for practice expenses not associated with the professional component of the service. As indicated in Table 9, this amount reflected (1) the difference between the PFS nonfacility payment rate and the PFS facility rate, (2) the technical component, or (3) in instances where payment would have been made only to the facility or only to the physician, the full nonfacility rate. This estimate ranged from zero percent to 137.8 percent of the OPPS payment rate for a code. Overall, the average (weighted by claim line volume times rate) of the nonfacility payment rate estimate for the PFS compared to the estimate for the OPPS for the 22 remaining major codes was 45 percent.
As noted with the clinic visits, we recognized that there were limitations to our data analysis, including that OPPS payment rates include the costs of packaged items or services billed with the separately payable code, and therefore the comparison to rates under the PFS was not a one-to-one comparison. Also, we included only a limited number of services, and noted that additional services may have different patterns than the services described. After considering the payment differentials for major codes billed by off-campus departments of hospitals with the “PO” modifier and based on the data limitations of our analysis, we adopted, with some exceptions noted below, a set of PFS payment rates that were based on a 50 percent PFS Relativity Adjuster to the OPPS payment rates (inclusive of packaging) for nonexcepted items and services furnished by nonexcepted off-campus PBDs in the CY 2017 interim final rule. Generally speaking, we arrived at the 50 percent PFS Relativity Adjuster by examining the 45 percent comparison noted above, the ASC payment rate—which was roughly 55 percent of the OPPS payment rate on average—and the payment rate differential for the large number of OPPS and PFS E/M services, as described above. We recognized that the equivalent PFS nonfacility rates may be higher or lower on a code-specific basis than the rates that result from applying the overall PFS Relativity Adjuster to the OPPS payment rates on a code-specific basis. However, we believed that, on the whole, the percentage reduction did not underestimate the overall relativity between the OPPS and the PFS based on the limited data that were available. We were concerned, however, that the 50 percent PFS Relativity Adjuster might overestimate PFS nonfacility payments relative to OPPS payments. For example, if we were able at the time to sufficiently estimate the effect of the packaging differences between the OPPS and PFS, we suspected that the equivalent portion of PFS payments for evaluation and management codes, and for PFS services on average, would likely have been less than 50 percent for the same services. We considered the 50 percent PFS Relativity Adjuster for CY 2017 to be a transitional policy until such time that we had more precise data to better identify and value nonexcepted items and services furnished by nonexcepted off-campus PBDs and billed by hospitals.
We established several significant exceptions to the application of the 50 percent PFS Relativity Adjuster. For example, we did not apply the 50 percent PFS Relativity Adjuster to services that are currently paid under the OPPS based on payment rates from other Medicare fee schedules (including the PFS) on an institutional claim. The items and services that are assigned status indicator “A” in Addendum B to the CY 2017 OPPS/ASC final rule with comment period (available on the CMS Web site at
All nonexcepted items and services furnished by nonexcepted off-campus PBDs and billed by a hospital on an institutional claim with modifier “PN” (Nonexcepted service provided at an off-campus, outpatient, provider-based department of a hospital) are currently paid under the PFS at the rate established in the CY 2017 interim final rule. Specifically, nonexcepted off campus PBDs must report modifier “PN” on each UB-04 claim line to indicate a nonexcepted item or service, and otherwise continue to bill as they currently do. Further billing instructions on the PN modifier can be found in the January 2017 OPPS Quarterly Update (transmittal 3685, Change Request 9930) released December 22, 2016, available on the CMS Web site at
As noted in the CY 2017 interim final rule, we considered the CY 2017 PFS Relativity Adjuster of 50 percent to be a transitional policy until such time that we had more precise data to better identify and value nonexcepted items and services furnished by nonexcepted off-campus PBDs and billed by hospitals. At present, we do not have more precise data than were available when we established the PFS Relativity Adjuster in the CY 2017 interim final rule, and we do not anticipate having such data until after the end of CY 2017, at the earliest. However, in developing a policy for CY 2018, we have continued to explore options for modifying the calculation of the CY 2018 PFS Relativity Adjuster.
There is no consensus among stakeholders regarding the appropriate PFS Relativity Adjuster. Many stakeholders have suggested that making separate facility fee payments to hospitals under the PFS for all services that are separately paid under the OPPS itself undermines site neutral payment because practitioners are only paid a single combined fee for many services when furnished in an office setting, while there are two separate fees (professional and facility) paid when the service is furnished in the hospital setting. We acknowledge that there are many cases where single fees are paid to practitioners for services furnished in an office setting while fees for comparable services when furnished in the hospital setting are paid to both the professional and facility entities. However, we do not agree that this necessarily means that overall payment cannot be site neutral. We point out that the sum of the professional and the facility portions of payment for a service furnished in a nonexcepted off-campus PBD or in a different institutional setting could be equivalent to a single fee paid to the professional in the office setting. In the case of some services, in fact, the single payment made under the PFS at the nonfacility rate exceeds the sum of the separate payments Medicare makes to the professional at the facility rate under the PFS and to the facility under the OPPS. We also note that there are many separately reportable services under the PFS (for example, the vast majority of services described by add-on codes) for which separate payment is made to physician offices but no separate payment is made under either the OPPS or under the site-specific PFS payments made to hospitals billing for nonexcepted items and services furnished by nonexcepted off-campus PBDs. For these reasons, we believe that the overall total payment made for services is more relevant to the goal of site neutrality than the quantity of individual payments made. Nonetheless, we continue to recognize and share stakeholders' concerns regarding the importance of equivalent overall payment for services, regardless of setting.
In considering the appropriate PFS Relativity Adjuster for CY 2018, we continue to believe that claims data from CY 2017, which are not yet available, are needed to guide potential changes to our general approach. In the absence of such data, however, we have continued to consider the appropriate PFS Relativity Adjuster based on the information that is available. In the analysis we used to establish the PFS Relativity Adjuster for CY 2017, we attempted to identify the appropriate value by comparing OPPS and PFS payment rates for services frequently reported in off-campus departments of a hospital and described by the same codes under the two payment systems. As we acknowledged in the CY 2017 interim final rule, that data analysis did not include the most frequently billed service furnished in off-campus departments of a hospital, outpatient clinic visits. Outpatient clinic visits are reported using a single G-code under the OPPS and by one of ten different codes under the PFS.
Consistent with our previously stated concern that the PFS Relativity Adjuster for CY 2017 might be too small, generally resulting in greater overall payments to hospitals for services furnished by nonexcepted off-campus PBDs than would otherwise be paid under the PFS in the non-facility setting, we believed it was appropriate to propose changing the PFS Relativity Adjuster in order to ensure that payment made to these nonexcepted off-campus PBDs better aligns with these services that are the most frequently furnished in this setting.
In the CY 2018 PFS proposed rule, we proposed to revise the PFS Relativity Adjuster for nonexcepted items and services furnished by nonexcepted off-campus PBDs to be 25 percent of the OPPS payment rate. We arrived at this PFS Relativity Adjuster by making a code-level comparison for the service most commonly billed in the off-campus PBD setting under the OPPS: A clinic visit reported using HCPCS code G0463. In order to determine the analogous payment for the technical aspects of this service under the PFS in nonfacility settings, we compared the CY 2017 OPPS national payment rate for HCPCS code G0463 ($102.12) to the difference between the nonfacility and facility PFS payment amounts under the PFS using CY 2016 rates for the weighted average of outpatient visits (CPT codes 99201-99205 and CPT codes 99211-99215) billed by physicians and other professionals in an outpatient hospital department as the place of service.
The proposed PFS Relativity Adjuster of 25 percent was based solely on the comparison for the single service that reflects more than 50 percent of services billed in off-campus PBDs. We continue to recognize that the comparison between the OPPS and PFS rates for other services varies greatly, and that there are other factors, including the specific mix of services furnished by nonexcepted off-campus PBDs, policies related to packaging of codes under OPPS, and payment adjustments like MPPRs and bundling under the PFS that rely on empirical information about whether or not codes are billed on the same day, that contribute to the differences in aggregate payment amounts for a broader range of services. However, for CY 2018, as for CY 2017, we are setting the PFS Relativity Adjuster using currently available data from CY 2016 because we have not had the opportunity to study the CY 2017 claims data that may allow us to consider and incorporate many more factors, including the ones stated above. When we established the PFS Relativity Adjuster for CY 2017 at 50 percent, we stated that we did so with the goal of ensuring adequate payment but remained concerned that the resulting reduction was too conservative. For CY 2018, we were focused on ensuring that we did not overestimate the appropriate overall payment relativity for these nonexcepted items and services. Until
We welcomed stakeholder input with regard to this analysis and the resulting PFS Relativity Adjuster. We also requested comment on whether we should adopt a different PFS Relativity Adjuster, such as 40 percent, that represents a relative middle ground between the CY 2017 PFS Relativity Adjuster, selected to ensure adequate payment to hospitals and our proposed CY 2018 PFS Relativity Adjuster, selected to ensure that hospitals are not paid more than others would be paid through the PFS nonfacility rate. We intend to continue to study this issue and welcomed comments regarding potential future refinements to payment rates for nonexcepted items and services furnished by nonexcepted off-campus PBDs as we gain more experience with these new site-of-service PFS rates.
Finally, we noted that for CY 2018, as in recent years, the annual update to OPPS payments exceeds the annual update to PFS payments. Because we proposed to make a single, across-the-board and, by necessity, imprecise adjustment to OPPS payment rates to establish PFS payment rates for nonexcepted items and services furnished by nonexcepted off-campus PBDs, we expected that the actual difference between OPPS and PFS payment rates for nonexcepted items and services furnished by nonexcepted off-campus PBDs falls in a range which includes our proposed PFS Relativity Adjuster (that is, the actual differential may differ from our proposed PFS Relativity Adjuster). As such, taking into account the differential between the OPPS and PFS annual updates by making an adjustment to the PFS Relativity Adjuster, our proposal for CY 2018 presumed a level of precision in our estimates that is simply not present in our analysis. Therefore, we did not adjust our proposal to reflect the relative updates to PFS and OPPS between CY 2017 and CY 2018, and instead noted that the differential between the OPPS and PFS payment update for CY 2018 is a factor that suggests that the PFS Relativity Adjuster may underestimate PFS nonfacility payment relative to OPPS payments; in future years, we intend to more precisely account for any differential between these two update factors.
For CY 2017, we established class-specific geographic practice cost indices (GPCIs) under the PFS exclusively used to adjust these site-specific, technical component rates for nonexcepted items and services furnished in nonexcepted off-campus PBDs. These class-specific GPCIs are parallel to the geographic adjustments made under the OPPS based on the hospital wage index. We believed it was appropriate to adopt the hospital wage index areas for purposes of geographic adjustment because nonexcepted off-campus PBDs are still considered to be part of a hospital, and the PFS payments to these entities will be limited to the subset of PFS services furnished by hospitals. We also believed it was appropriate, as an initial matter for CY 2017, to adopt the actual wage index values for these hospitals in addition to the wage index areas. The PFS GPCIs that would otherwise currently apply are not based on the hospital wage index areas. For CY 2018, we proposed to continue using the authority under section 1848(e)(1)(B) of the Act to maintain a class-specific set of GPCIs for these site-specific technical component rates that are based both on the hospital wage index areas and the hospital wage index value themselves. For purposes of payment to hospitals, this means that the geographic adjustments used under the OPPS continue to apply.
For most services, the same HCPCS codes are used to describe services paid under both the PFS and the OPPS. There are two notable exceptions that describe high-volume services. The first is the set of codes that describe evaluation and management (E/M) services which are reported under the PFS using the 5 levels of CPT codes describing new or established patient visits (for a total of 10 codes). However, since CY 2014, these visits have been reported under the OPPS using the single HCPCS code G0463 (Hospital Outpatient Clinic Visit) (see 78 FR 75042). We proposed to maintain the current coding and PFS payment rate for HCPCS code G0463 based on the OPPS payment rate modified by the PFS Relativity Adjuster.
The second exception is a set of radiation treatment delivery and imaging guidance services that are reported using different codes under the PFS and the OPPS. CMS established HCPCS Level II G-codes to describe radiation treatment delivery services when furnished in the physician office setting (see 79 FR 67666 through 67667). However, these HCPCS G-codes are not recognized under the OPPS; rather, CPT codes are used to describe these services when furnished in the HOPD. Both sets of codes were implemented for CY 2015 and were maintained for CY 2016. Under the PFS, there is a statutory provision under section 1848(c)(2)(K) of the Act that requires maintenance of the CY 2016 coding and payment inputs for these services for CY 2017 and also for CY 2018. Accordingly, the CY 2018 PFS rates for these services are calculated based on the maintenance of the CY 2016 coding and payment inputs. Because nonexcepted items and services furnished by a nonexcepted off-campus PBD are paid under the PFS starting in CY 2017, and we are required to maintain the CY 2016 coding and payment inputs for these services under the CY 2018 PFS, we proposed to maintain coding and payment amounts for nonexcepted items and services furnished by a nonexcepted off-campus PBD consistent with the payments that would be made to other facilities under the PFS. That is, nonexcepted off-campus PBDs submitting claims for these nonexcepted items and services will continue to bill the HCPCS G-codes established under the PFS to describe radiation treatment delivery services. Under this proposal, the nonexcepted off-campus PBD must append modifier “PN” to each applicable claim line for these nonexcepted items and services, even though the PFS Relativity Adjuster will not apply, on the institutional claim. The payment amount for these services would be set to reflect the technical component rate for the code under the PFS.
In the CY 2017 interim final rule, we adopted the packaging payment rates and MPPR percentage that applied under the OPPS to establish the PFS payment rates for nonexcepted items and services furnished by nonexcepted off-campus PBDs and billed by hospitals. That is, the claims processing logic that was used for payments under the OPPS for comprehensive APCs (C-APCs), conditionally and unconditionally packaged items and services, and major procedures, was incorporated into the newly established PFS rates. We continue to believe it is necessary to incorporate the OPPS payment policies for C-APCs, packaged items and services, and the MPPR in order to maintain the integrity of the PFS Relativity Adjuster because the adjuster is intended, in part, to account for the methodological differences between the OPPS and the PFS rates that would otherwise apply. We also
In order to apply these OPPS payment policies and adjustments to nonexcepted items and services, we proposed that hospitals continue to bill on an institutional claim form that will pass through the Outpatient Code Editor and into the OPPS PRICER for calculation of payment. This approach will yield data based on claims for nonexcepted items and services furnished by nonexcepted off-campus PBDs, which can be used to refine PFS payment rates for these services in future years.
There were several OPPS payment adjustments that we did not adopt in the CY 2017 interim final rule, including, but not limited to, outlier payments, the rural sole community hospital (SCH) adjustment, the cancer hospital adjustments, transitional outpatient payments, the hospital outpatient quality reporting payment adjustment, and the inpatient hospital deductible cap to the cost-sharing liability for a single hospital outpatient service. We believed these payment adjustments were expressly authorized for, and should be limited to, hospitals that are paid under the OPPS for covered OPD services in accordance with section 1833(t) of the Act. We believed that these policies should not apply to nonexcepted items and services furnished by nonexcepted off-campus PBDs, and did not propose that they apply for CY 2018.
For partial hospitalization programs (PHP), which are intensive outpatient psychiatric day treatment programs furnished to patients as an alternative to inpatient psychiatric hospitalization or as a stepdown to shorten an inpatient stay and transition a patient to a less intensive level of care, section 1861(ff)(3)(A) of the Act specifies that a PHP is a program furnished by a hospital, to its outpatients, or by a Community Mental Health Center (CMHC). In the CY 2017 OPPS/ASC proposed rule (81 FR 45690), in the discussion of the proposed implementation of section 603 of Bipartisan Budget Act of 2015, we noted that because CMHCs also furnish PHP services and are ineligible to be provider-based to a hospital, a nonexcepted off-campus PBD would be eligible for PHP payment if the entity enrolls and bills as a CMHC for payment under the OPPS. We further noted that a hospital may choose to enroll a nonexcepted off-campus PBD as a CMHC, provided it meets all Medicare requirements and conditions of participation.
Commenters expressed concern that without a clear payment mechanism for PHP services furnished by nonexcepted off-campus PBDs, access to partial hospitalization services would be limited, and pointed out the critical role PHPs play in the continuum of mental health care. Many commenters believed that Congress did not intend for partial hospitalization services to no longer be paid for by Medicare when such services are furnished by nonexcepted off-campus PBDs. Several commenters disagreed with the notion of enrolling as a CMHC in order to receive payment for PHP services. These commenters stated that hospital-based PHPs and CMHCs are inherently different in structure, operation, and payment, and noted that the conditions of participation for hospital departments and CMHCs are different. Several commenters requested that CMS find a mechanism to pay hospital-based PHPs in nonexcepted off-campus PBDs.
Because we shared the commenters' concerns, in the CY 2017 OPPS/ASC final rule with comment period and interim final rule with comment period (81 FR 79715, 79717, and 79727), we adopted payment for partial hospitalization items and services furnished by nonexcepted off-campus PBDs under the PFS. When billed in accordance with the CY 2017 interim final rule, these partial hospitalization services are paid at the CMHC per diem rate for APC 5853, for providing three or more partial hospitalization services per day (81 FR 79727).
In the CY 2017 OPPS/ASC proposed rule (81 FR 45681), the CY 2017 OPPS/ASC final rule with comment period, and interim final rule with comment period (81 FR 79717 and 79727), we noted that when a beneficiary receives outpatient services in an off-campus department of a hospital, the total Medicare payment for those services is generally higher than when those same services are provided in a physician's office. Similarly, when partial hospitalization services are provided in a hospital-based PHP, Medicare pays more than when those same services are provided by a CMHC. Our rationale for adopting the CMHC per diem rate for APC 5853 as the PFS payment amount for nonexcepted off-campus PBDs providing PHP services is because CMHCs are freestanding entities that are not part of a hospital, but they provide the same PHP services as hospital-based PHPs (81 FR 79727). This is similar to the differences between freestanding entities paid under the PFS that furnish other services also provided by hospital-based entities. Similar to other entities currently paid for their technical component services under the PFS, we believe CMHCs would typically have lower cost structures than hospital-based PHPs, largely due to lower overhead costs and other indirect costs such as administration, personnel, and security. We believe that paying for nonexcepted hospital-based partial hospitalization services at the lower CMHC per diem rate aligns with section 603 of Bipartisan Budget Act of 2015, while also preserving access to PHP services. In addition, nonexcepted off-campus PBDs will not be required to enroll as CMHCs in order to bill and be paid for providing partial hospitalization services. However, a nonexcepted off-campus PBD that wishes to provide PHP services may still enroll as a CMHC if it chooses to do so and meets the relevant requirements. Finally, we recognize that because hospital-based PHPs are providing partial hospitalization services in the hospital outpatient setting, they can offer benefits that CMHCs do not have, such as an easier patient transition to and from inpatient care, and easier sharing of health information between the PHP and the inpatient staff.
In the CY 2018 PFS proposed rule, we did not propose to require these PHPs to enroll as CMHCs but instead we proposed to continue to pay nonexcepted off-campus PBDs providing PHP items and services under the PFS. Further, in that CY 2018 PFS proposed rule, we proposed to continue to adopt the CMHC per diem rate for APC 5853 as the PFS payment amount for nonexcepted off-campus PBDs providing three or more PHP services per day in CY 2018.
The following is a summary of the public comments received on potential changes to our methodology and our responses:
One commenter had concerns about the accuracy and stability of the CMHC claims data or CMHC rates, and asked for fair and equitable payments. A few commenters suggested alternatives, such as exempting PHP APC codes from section 603 of the Bipartisan Budget Act of 2015 entirely, researching other payment methods, or paying at the hospital-based PHP rate.
Regarding the comment about the accuracy of CMHC claims and rates, we refer readers to the CY 2016 OPPS/ASC final rule with comment period (80 FR 70462 through 70466) and the CY 2017 OPPS/ASC final rule with comment period (81 FR 79680 through 79686) for details on the ratesetting methodology, including policies that we believe result in stable and accurate PHP payment rates. Furthermore, we note that the final CY 2018 CMHC per diem rate is higher than that proposed in the CY 2018 OPPS/ASC proposed rule (82 FR 33639). The final CY 2018 CMHC per diem rate is 68.8 percent of the final CY 2018 hospital-based PHP per diem rate under the OPPS (see the CY 2018 OPPS/ASC final rule with comment period for details). This is a significantly higher percentage of payment than was proposed for most other items or services provided in nonexcepted off-campus PBDs that derive their payment amount from CY 2018 OPPS APC rates, and we believe it will help to address commenters' concerns about ensuring access to valuable PHP services.
In response to the alternatives that commenters suggested, we are unable to pay nonexcepted off-campus PBDs that are PHPs at the same rate that hospital-based PHPs are paid under the OPPS or to exempt PHP APC codes from the requirements of section 603 of the Bipartisan Budget Act of 2015 because doing so would not meet the requirements of the amendments made by section 603 of the Bipartisan Budget Act of 2015. Regarding the comment about considering other payment methodologies for PHP services, we will take these comments under advisement in considering whether to propose a different methodology for PHP services in future rulemaking.
In summary, after considering the public comments, we are finalizing our proposals as proposed. Therefore, in CY 2018, we are identifying the PFS as the applicable payment system for PHP services furnished by a nonexcepted off campus PBDs, and we are setting the PFS payment rate for these PHP services as the per diem rate that would be paid to a CMHC in CY 2018.
The supervision rules that apply for hospitals continue to apply for nonexcepted off-campus PBDs that furnish nonexcepted items and services. The amendments made by section 603 of the Bipartisan Budget Act of 2015 did not change the status of these PBDs, only the status of, and payment mechanism for, the services they furnish. These supervision requirements are specified in § 410.27.
Under the PFS, the beneficiary copayment is generally 20 percent of the fee schedule amount, unless there is an applicable exception in accordance with the statute. All cost-sharing rules that apply under the PFS in accordance with section 1848(g) of the Act and section 1866(a)(2)(A) of the Act continue to apply for all nonexcepted items and services furnished by nonexcepted off-campus PBDs, regardless of the cost-sharing obligation under the OPPS.
We continue to believe the amendments made to the statute by section 603 of the Bipartisan Budget Act of 2015 intended to eliminate the Medicare payment incentive for hospitals to purchase physician offices, convert them to off-campus PBDs, and bill under the OPPS for items and services they furnish there. Therefore, we continue to believe the payment policy under this provision should ultimately equalize payment rates between nonexcepted off-campus PBDs and physician offices to the greatest extent possible, while allowing nonexcepted off-campus PBDs to bill in a straight-forward way for services they furnish.
We note that a full year of claims data regarding the mix of services reported using the “PN” modifier (from CY 2017) will first be available for use in PFS ratesetting for CY 2019. Under the current methodology, we would expect to use that data in order to ensure that Medicare payment to hospitals billing for nonexcepted items and services furnished by nonexcepted off-campus PBDs under the PFS would reflect the relative resources involved in furnishing the items and services relative to other PFS services. We recognize that under our current approach, payment rates would not be equal on a procedure-by-procedure basis. However, the application of the PFS Relativity Adjuster would move toward equalizing payment rates in the aggregate between physician offices and nonexcepted off-campus PBDs to the extent appropriate. Therefore, for certain specialties, service lines, and nonexcepted off-campus PBD types, total Medicare payments for the same services might be either higher or lower when furnished by a nonexcepted off-campus PBD rather than in a physician office.
Depending on the mix of services for particular off-campus PBDs, we remain concerned that such specialty-specific patterns in payment differentials could result in continued incentives for hospitals to buy certain types of
The following is a summary of the public comments received on the potential changes to our methodology and the PFS Relativity Adjuster.
In addition, several commenters stated their concern that CMS's approach in developing the PFS Relativity Adjuster fails to account for the extensive packaging that occurs for outpatient clinic visits (billed using HCPCS code G0463 under the OPPS) and other common services. They stated that additional services are often provided with a single code, and that the PFS Relativity Adjuster does not account for the resources required to furnish these additional services. They note that CMS does not account for packaging that occurs under the OPPS, despite recognizing the importance of such differences between the payment systems. Some commenters offered their own estimates of the value of packaging that occurs under the OPPS for the top 22 HCPCS codes and provided suggestions for incorporating those estimates into our analysis.
After consideration of the public comments, we believe that an approach in which we integrate the code-level comparison for the service most commonly billed in the off-campus PBD setting under the OPPS (a clinic visit reported using HCPCS code G0463), which was the basis of our proposed PFS Relativity Adjuster for CY 2018 of 25 percent, with the comparison of relative PFS to OPPS rates for the top 25 (most frequently billed) major codes, which was the basis of our PFS Relativity Adjuster for CY 2017 of 50 percent, addresses many of the concerns and comments we received.
For this approach, we updated the list of the 25 major codes billed by off-campus hospital departments using the “PO” modifier to reflect a full year of claims data for CY 2016 (see Table 10). We did not exclude HCPCS code G0463 from the analysis, but we retained all other parameters that we described in the CY 2017 interim final rule, including the exclusion of separately payable drugs and biologics, services assigned an OPPS status indicator “A”. We removed HCPCS code 36591 (Collection of blood specimen from a completely implantable venous access device) because, under PFS policies, the code is used only to pay separately under the PFS when no other service was on the claim. We also removed HCPCS code G0009 (Administration of Pneumococcal Vaccine) and HCPCS code G0008 (Administration of influenza vaccine) because there is no payment for these codes under the PFS. Two of these codes, CPT 36591 and HCPCS G0009, were also removed from our calculation of the top major codes when we calculated the PFS Relativity Adjuster in the CY 2017 interim final rule. HCPCS code G0008 was not on the list of the top major codes when we initially analyzed claims data for CY 2016 available through August 26, 2016, but it appears on the list of the top codes that contained a “PO” modifier when we analyzed the same data through the end of CY 2016.
We determined the analogous payment for each of the top major HCPCS codes, including HCPCS code G0463, using the same logic that we applied in our calculation of the top 22 codes for the CY 2017 interim final rule. Table 10 shows data for the OPPS rates, the analogous PFS rates, and the full year utilization for these codes. The resulting utilization-weighted average comparison between the PFS and the OPPS for the top 22 codes, following the approach described above, is 35 percent. In other words, on average, the applicable payment amount under the PFS is 35 percent of the amount that would have been paid under the OPPS.
In the CY 2018 PFS proposed rule, we sought comment on whether a different PFS Relativity Adjuster, such as 40 percent, would reflect a middle ground between the CY 2017 PFS Relativity Adjuster of 50 percent, selected to ensure adequate payment to hospitals, and our proposed CY 2018 PFS Relativity Adjuster of 25 percent, selected to ensure that hospitals are not paid more than others would be paid through the PFS nonfacility rate. Since, as we acknowledged in response to public comments, we are unable at this time to fully calculate the effects of packaging under the OPPS, we believe that a 40 percent PFS Relativity Adjuster, which is an upward adjustment to the 35 percent calculation described above, is appropriate. We are, therefore, finalizing a PFS Relativity Adjuster of 40 percent for CY 2018.
We have previously stated that we consider the PFS Relativity Adjuster to be an interim policy until a complete year of claims data from CY 2017 are available for analysis. Once such data are available, we expect to calculate and propose a more precise payment rate. Additionally, we continue to consider options for nonexcepted off-campus PBDs to bill for nonexcepted items and services using a PFS claim, effectively allowing us to develop and pay a code-specific amount representing the technical component of furnishing a service.
We presented the analysis and reasons that led us to the proposed PFS Relativity Adjuster of 25 percent for CY 2018; and we responded to public comments on that proposal with a revised analysis and the final PFS Relativity Adjuster of 40 percent for CY 2018. We have provided the data required to replicate our analysis, consistently based upon CY 2016 payment rates under the PFS and OPPS, for the CY 2017 interim final, and for the proposed and final CY 2018 PFS relativity adjusters. Furthermore, we have been as transparent as possible in our approach, including the limitations related to data availability, and our inability to develop a precise adjustment to the relative payment rates that would account for differences between the two payment systems, including packaging. We believe we are moving as judiciously as possible, given these limitations, to meet the requirements of the statute, providing public transparency into our policy considerations, and in full accordance with our notice and comment rulemaking obligations. We are finalizing a PFS Relativity Adjuster of 40 percent for CY 2018 as discussed earlier in this section.
Establishing valuations for newly created and revised CPT codes is a routine part of maintaining the PFS. Since the inception of the PFS, it has also been a priority to revalue services regularly to make sure that the payment rates reflect the changing trends in the practice of medicine and current prices for inputs used in the PE calculations. Initially, this was accomplished primarily through the 5-year review process, which resulted in revised work RVUs for CY 1997, CY 2002, CY 2007, and CY 2012, and revised PE RVUs in CY 2001, CY 2006, and CY 2011. Under the 5-year review process, revisions in RVUs were proposed and finalized via rulemaking. In addition to the 5-year reviews, beginning with CY 2009, CMS and the RUC have identified a number of potentially misvalued codes each year using various identification screens, as discussed in section II.E.4 of this final rule. Historically, when we received RUC recommendations, our process had been to establish interim final RVUs for the potentially misvalued codes, new codes, and any other codes for which there were coding changes in the final rule for a year. Then, during the 60-day period following the publication of the final rule, we accepted public comment about those valuations. For services furnished during the calendar year following the publication of interim final rates, we paid for services based upon the interim final values established in the final rule. In the final rule with comment period for the subsequent year, we considered and responded to public comments received on the interim final values, and typically made any appropriate adjustments and finalized those values.
In the CY 2015 PFS final rule with comment period, we finalized a new process for establishing values for new, revised and potentially misvalued codes. Under the new process, we include proposed values for these services in the proposed rule, rather than establishing them as interim final in the final rule with comment period. Beginning with the CY 2017 PFS proposed rule, the new process was applicable to all codes, except for new codes that describe truly new services. For CY 2017, we proposed new values in the CY 2017 PFS proposed rule for the vast majority of new, revised, and potentially misvalued codes for which we received complete RUC recommendations by February 10, 2016. To complete the transition to this new process, for codes for which we established interim final values in the CY 2016 PFS final rule with comment period, we reviewed the comments received during the 60-day public comment period following release of the CY 2016 PFS final rule with comment period, and re-proposed values for those codes in the CY 2017 PFS proposed rule.
We considered public comments received during the 60-day public comment period for the proposed rule before establishing final values in the CY 2017 PFS final rule. As part of our established process, we will adopt interim final values only in the case of wholly new services for which there are no predecessor codes or values and for which we do not receive recommendations in time to propose values. For CY 2017, we did not identify any new codes that described such wholly new services. Therefore, we did not establish any code values on an interim final basis.
For each code identified in this section, we conducted a review that included the current work RVU (if any), RUC-recommended work RVU, intensity, time to furnish the preservice, intraservice, and postservice activities, as well as other components of the service that contribute to the value. Our reviews of recommended work RVUs and time inputs have generally included, but have not been limited to, a review of information provided by the RUC, the Health Care Professionals Advisory Committee (HCPAC), and other public commenters, medical literature, and comparative databases, as well as a comparison with other codes within the PFS, consultation with other physicians and health care professionals within CMS and the federal government, as well as Medicare claims data. We have also assessed the methodology and data used to develop the recommendations submitted to us by the RUC and other public commenters and the rationale for the recommendations. In the CY 2011 PFS final rule with comment period (75 FR 73328 through 73329), we discussed a variety of methodologies and approaches used to develop work RVUs,
Components that we have used in the building block approach may have included preservice, intraservice, or postservice time and post-procedure visits. When referring to a bundled CPT code, the building block components could include the CPT codes that make up the bundled code and the inputs associated with those codes. Magnitude estimation refers to a methodology for valuing work that determines the appropriate work RVU for a service by gauging the total amount of work for that service relative to the work for a similar service across the PFS without explicitly valuing the components of that work. In addition to these methodologies, we have frequently utilized an incremental methodology in which we value a code based upon its incremental difference between another code and another family of codes. The statute specifically defines the work component as the resources in time and intensity required in furnishing the service. Also, the published literature on valuing work has recognized the key role of time in overall work. For particular codes, we have refined the work RVUs in direct proportion to the changes in the best information regarding the time resources involved in furnishing particular services, either considering the total time or the intraservice time.
Several years ago, to aid in the development of preservice time recommendations for new and revised CPT codes, the RUC created standardized preservice time packages. The packages include preservice evaluation time, preservice positioning time, and preservice scrub, dress and wait time. Currently there are preservice time packages for services typically furnished in the facility setting (for example: Preservice time packages reflecting the different combinations of straightforward or difficult procedure, and straightforward or difficult patient). Currently, there are three preservice time packages for services typically furnished in the nonfacility setting.
We developed several standard building block methodologies to value services appropriately when they have common billing patterns. 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 preservice evaluation and postservice time. Our longstanding adjustments have reflected a broad assumption that at least one-third of the work time in both the preservice evaluation and postservice period is duplicative of work furnished during the E/M visit.
Accordingly, in cases where we have believed that the RUC has not adequately accounted for the overlapping activities in the recommended work RVU and/or times, we have adjusted 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 multiplied by the intensity of the work. Preservice evaluation time and postservice time both have a long-established intensity of work per unit of time (IWPUT) of 0.0224, which means that 1 minute of preservice evaluation or postservice time equates to 0.0224 of a work RVU.
Therefore, in many cases when we have removed 2 minutes of preservice time and 2 minutes of postservice time from a procedure to account for the overlap with the same day E/M service, we have also removed a work RVU of 0.09 (4 minutes × 0.0224 IWPUT) if we have not believed the overlap in time had already been accounted for in the work RVU. The RUC has recognized this valuation policy and, in many cases, now addresses the overlap in time and work when a service is typically furnished on the same day as an E/M service.
We note that many commenters and stakeholders have expressed concerns over time with our ongoing adjustment of work RVUs based on changes in the best information we have had regarding the time resources involved in furnishing individual services. We have been particularly concerned with the RUC's and various specialty societies' objections to our approach given the significance of their recommendations to our process for valuing services and since much of the information we have used to make the adjustments is derived from their survey process. We are statutorily obligated to consider both time and intensity in establishing work RVUs for PFS services. As explained in the CY 2016 PFS final rule with comment period (80 FR 70933), we recognize that adjusting work RVUs for changes in time is not always a straightforward process, so we have applied various methodologies to identify several potential work values for individual codes.
We have observed that for many codes reviewed by the RUC, recommended work RVUs have appeared to be incongruous with recommended assumptions regarding the resource costs in time. This has been the case for a significant portion of codes for which we have recently established or proposed work RVUs that are based on refinements to the RUC-recommended values. When we have adjusted work RVUs to account for significant changes in time, we have begun by looking at the change in the time in the context of the RUC-recommended work RVU. When the recommended work RVUs have not appeared to account for significant changes in time, we have employed the different approaches to identify potential values that reconcile the recommended work RVUs with the recommended time values. Many of these methodologies, such as survey data, building block, crosswalks to key reference or similar codes, and magnitude estimation have long been used in developing work RVUs under the PFS. In addition to these, we have sometimes used the relationship between the old time values and the new time values for particular services to identify alternative work RVUs based on changes in time components.
In so doing, rather than ignoring the RUC-recommended value, we have used the recommended values as a starting reference and then applied one of these several methodologies to account for the reductions in time that we believe had not otherwise been reflected in the RUC-recommended value. When we have believed that such changes in time have already been accounted for in the RUC recommendation, then we have not made such adjustments. Likewise, we have not arbitrarily applied time ratios to current work RVUs to calculate proposed work RVUs. We have used the ratios to identify potential work RVUs and considered these work RVUs as potential options relative to the values developed through other options.
We do not imply that the decrease in time as reflected in survey values must equate to a one-to-one or linear decrease in newly valued work RVUs. Instead, we have believed that, since the two components of work are time and intensity, absent an obvious or explicitly stated rationale for why the relative intensity of a given procedure has increased, significant decreases in time should be reflected in decreases to work RVUs. If the RUC recommendation had appeared to disregard or dismiss the
Several stakeholders, including the RUC, in general have objected to our use of these methodologies and deemed our actions in adjusting the recommended work RVUs as inappropriate; other stakeholders have also expressed concerns with CMS refinements to RUC recommended values in general. In the CY 2017 PFS final rule (81 FR 80272 through 80277) we responded in detail to several comments that we received regarding this issue. In the CY 2017 PFS proposed rule, we requested comments regarding potential alternatives to making adjustments that would recognize overall estimates of work in the context of changes in the resource of time for particular services; however, we did not receive any specific potential alternatives as requested.
In developing proposed values for new, revised, and potentially misvalued codes for CY 2018, we considered the lack of alternative approaches to making the adjustments, especially since many stakeholders have routinely urged us to propose and finalize the RUC-recommended values. We also considered the RUC's consistent reassurance that these kinds of concerns (regarding changes in time, for example) had already been considered, and either incorporated or dismissed, as part of the development of their recommended values. These have led us to shift our approach to reviewing RUC recommendations, especially as we believe that the majority of practitioners paid under the PFS, though not necessarily those in any particular specialty, would prefer CMS rely more heavily on RUC recommended values in establishing payment rates under the PFS.
For CY 2018, we generally proposed the RUC-recommended work RVUs for new, revised, and potentially misvalued codes. We proposed these values based on our understanding that the RUC generally considers the kinds of concerns we have historically raised regarding appropriate valuation of work RVUs. However, during our review of these recommended values, we identified some concerns similar to those we have recognized in prior years. Given the relative nature of the PFS and our obligation to ensure that the RVUs reflect relative resource use, we included descriptions of potential approaches we might have taken in developing work RVUs that differ from the RUC-recommended values. We sought comment on both the RUC-recommended values as well as the alternatives considered.
The following is a summary of the public comments received on both the RUC-recommended values as well as the alternatives we considered in developing work RVUs and our responses:
We also want to clarify that as part of our obligation to establish RVUs for the PFS, we annually make an independent assessment of the available recommendations, supporting documentation, and other available information from the RUC and other commenters to determine the appropriate valuations. Where we concur that the RUC recommendations, or recommendations from other commenters, are reasonable and appropriate and are consistent with the time and intensity paradigm of physician work, we propose those values as recommended. Additionally, we will continue to engage with stakeholders, including the RUC, with regard to our approach for accurately valuing codes.
CMS appreciates the efforts of the RUC to deliberate on highly technical matters involving clinical care. The RUC is comprised of 31 physicians, the majority of whom are appointed by major medical specialty societies. Commenters have noted concerns with the range of expertise represented in the RUC membership and have advocated for more balanced representation from across the medical community. Commenters have also suggested that the RUC should consider how to further engage the public in its deliberative processes. CMS encourages the RUC to consider acting on these comments and suggestions in its ongoing deliberations.
We look forward to continuing to engage with stakeholders and commenters, including the RUC, as we prioritize our obligation to value new, revised, and potentially misvalued codes, and will continue to welcome feedback from all interested parties regarding valuation of services for consideration through our rulemaking process. We refer readers to section II.H.4 of this final rule for detailed discussion of the proposed valuation, and alternative valuation considered for specific codes. Table 12 contains a list of codes for which we proposed work RVUs; this includes all codes for which we received RUC recommendations by February 10, 2017. The proposed work RVUs, work time and other payment information for all proposed CY 2018 payable codes are available on the CMS Web site under downloads for the CY 2018 PFS final rule. Table 12 also contains the CPT code descriptors for all proposed, new, revised, and potentially misvalued codes discussed in this section.
On an annual basis, the RUC provides us with recommendations regarding PE inputs for new, revised, and potentially misvalued codes. We review the RUC-recommended direct PE inputs on a code by code basis. Like our review of recommended work RVUs, our review of recommended direct PE inputs generally includes, but is not limited to, a review of information provided by the RUC, HCPAC, and other public commenters, medical literature, and comparative databases, as well as a comparison with other codes within the PFS, and consultation with physicians and health care professionals within CMS and the federal government, as well as Medicare claims data. We also assess the methodology and data used to develop the recommendations submitted to us by the RUC and other public commenters and the rationale for the recommendations. When we determine that the RUC's recommendations appropriately estimate the direct PE inputs (clinical labor, disposable supplies, and medical equipment) required for the typical service, are consistent with the principles of relativity, and reflect our payment policies, we use those direct PE inputs to value a service. If not, we refine the recommended PE inputs to better reflect our estimate of the PE resources required for the service. We also confirm whether CPT codes should have facility and/or nonfacility direct PE inputs and refine the inputs accordingly.
Our review and refinement of RUC-recommended direct PE inputs includes many refinements that are common across codes, as well as refinements that are specific to particular services. Table 13 details our refinements of the RUC's direct PE recommendations at the code-specific level. In this final rule, we address several refinements that are common across codes, and refinements to particular codes are addressed in the portions of this section that are dedicated to particular codes. We note that for each refinement, we indicate the impact on direct costs for that service. We note that, on average, in any case where the impact on the direct cost for a particular refinement is $0.30 or less, the refinement has no impact on the PE RVUs. This calculation considers both the impact on the direct portion of the PE RVU, as well as the impact on the indirect allocator for the average service. We also note that nearly half of the refinements listed in Table 13 result in changes under the $0.30 threshold and are unlikely to result in a change to the RVUs.
We also note that the direct PE inputs for CY 2018 are displayed in the CY 2018 direct PE input database, available on the CMS Web site under the downloads for the CY 2018 PFS final rule at
Some direct PE inputs are directly affected by revisions in work time. Specifically, changes in the intraservice portions of the work time and changes in the number or level of postoperative visits associated with the global periods result in corresponding changes to direct PE inputs. The direct PE input recommendations generally correspond to the work time values associated with services. We believe that inadvertent discrepancies between work time values and direct PE inputs should be refined or adjusted in the establishment of proposed direct PE inputs to resolve the discrepancies.
Prior to CY 2010, the 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 RUC provide equipment times along with the other direct PE recommendations, and we provided the RUC with general
In general, the equipment time inputs correspond to the service period portion of the clinical labor times. We have clarified this principle over several years of rulemaking, indicating that we consider equipment time as the time within the intraservice period when a clinician is using the piece of equipment plus any additional time that the piece of equipment is not available for use for another patient due to its use during the designated procedure. For those services for which we allocate cleaning time to portable equipment items, because the portable equipment does not need to be cleaned in the room where the service is furnished, we do not include that cleaning time for the remaining equipment items, as those items and the room are both available for use for other patients during that time. In addition, when a piece of equipment is typically used during follow-up post- operative visits included in the global period for a service, the equipment time would 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 preservice or postservice tasks performed by clinical labor staff on the day of the procedure (the clinical labor service period) and are typically available for other patients even when one member of the clinical staff may be occupied with a preservice or postservice task related to the procedure. We also note that we believe these same assumptions would apply to inexpensive equipment items that are used in conjunction with and located in a room with non-portable highly technical equipment items since any items in the room in question would be available if the room is not being occupied by a particular patient. For additional information, we refer readers to our discussion of these issues in the CY 2012 PFS final rule with comment period (76 FR 73182) and the CY 2015 PFS final rule with comment period (79 FR 67639).
In general, the preservice, intraservice, and postservice clinical labor minutes associated with clinical labor inputs in the direct PE input database reflect the sum of particular tasks described in the information that accompanies the RUC-recommended direct PE inputs, commonly called the “PE worksheets.” For most of these described tasks, there are a standardized number of minutes, depending on the type of procedure, its typical setting, its global period, and the other procedures with which it is typically reported. The RUC sometimes recommends a number of minutes either greater than or less than the time typically allotted for certain tasks. In those cases, we review the deviations from the standards and any rationale provided for the deviations. When we do not accept the RUC-recommended exceptions, we refine the proposed direct PE inputs to conform to the standard times for those tasks. In addition, in cases when a service is typically billed with an E/M service, we remove the preservice clinical labor tasks to avoid duplicative inputs and to reflect the resource costs of furnishing the typical service.
We refer readers to section II. B. of this final rule for more information regarding the collaborative work of CMS and the RUC in improvements in standardizing clinical labor tasks.
In some cases, the PE worksheets included with the RUC recommendations include items that are not clinical labor, disposable supplies, or medical equipment or that cannot be allocated to individual services or patients. We have addressed these kinds of recommendations in previous rulemaking (78 FR 74242), and we do not use items included in these recommendations as direct PE inputs in the calculation of PE RVUs.
The RUC generally recommends the use of supply and equipment items that already exist in the direct PE input database for new, revised, and potentially misvalued codes. Some recommendations, however, include supply or equipment items that are not currently in the direct PE input database. In these cases, the RUC has historically recommended that a new item be created and has facilitated our pricing of that item by working with the specialty societies to provide us copies of sales invoices. For CY 2018, we received invoices for several new supply and equipment items. Tables 13 and 14 detail the invoices received for new and existing items in the direct PE database. As discussed in section II.B. of this final rule, we encourage stakeholders to review the prices associated with these new and existing items to determine whether these prices appear to be accurate. Where prices appear inaccurate, we encourage stakeholders to provide invoices or other information to improve the accuracy of pricing for these items in the direct PE database during the 60-day public comment period for this final rule. We expect that invoices received outside of the public comment period would be submitted by February 10th of the following year for consideration in future rulemaking, similar to our new process for consideration of RUC recommendations.
We remind stakeholders that due to the relativity inherent in the development of RVUs, reductions in existing prices for any items in the direct PE database increase the pool of direct PE RVUs available to all other PFS services. Tables 13 and 14 also include the number of invoices received, as well as the number of nonfacility allowed services for procedures that use these equipment items. We provide the nonfacility allowed services so that stakeholders will note the impact the particular price might have on PE relativity, as well as to identify items that are used frequently, since we believe that stakeholders are more likely to have better pricing information for items used more frequently. A single invoice may not be reflective of typical costs and we encourage stakeholders to provide additional invoices so that we might identify and use accurate prices in the development of PE RVUs.
In some cases, we do not use the price listed on the invoice that accompanies the recommendation because we identify publicly available alternative prices or information that suggests a different price is more accurate. In these cases, we include this in the discussion of these codes. In other cases, we cannot adequately price a newly recommended item due to inadequate information. Sometimes, no supporting information regarding the price of the item has been included in the recommendation. In other cases, the supporting information does not demonstrate that the item has been purchased at the listed price (for example, vendor price quotes instead of paid invoices). In cases where the information provided on the item allows us to identify clinically appropriate proxy items, we might use existing items as proxies for the newly recommended items. In other cases, we have included the item in the direct PE input database without any associated price. Although including the item without an associated price means that the item does not contribute to the calculation of the proposed PE RVU for particular services, it facilitates our ability to incorporate a price once we obtain information and are able to do so.
Generally speaking, our proposed inputs did not include clinical labor minutes assigned to the service period because the cost of clinical labor during the service period for a procedure in the facility setting is not considered a resource cost to the practitioner since Medicare makes separate payment to the facility for these costs. We address proposed code-specific refinements to clinical labor in the individual code sections.
We note that the public use files for the PFS proposed and final rules for each year display both the services subject to the MPPR lists on diagnostic cardiovascular services, diagnostic imaging services, diagnostic ophthalmology services and therapy services and the list of procedures that meet the definition of imaging under section 1848(b)(4)(B) of the Act, and therefore, are subject to the OPPS cap for the upcoming calendar year. The public use files for CY 2018 are available on the CMS Web site under downloads for the CY 2018 PFS final rule at For more information regarding the history of the MPPR policy, we refer readers to the CY 2014 PFS final rule (78 FR 74261-74263). For more information regarding the history of the OPPS cap, we refer readers to the CY 2007 PFS final rule (71 FR 69659-69662).
In the CY 2016 PFS proposed rule (80 FR 41686), we discussed that in reviewing Medicare claims data, a separate anesthesia service is typically reported more than 50 percent of the time that various colonoscopy procedures are reported. We discussed that given the significant change in relative frequency with which anesthesia codes are reported with colonoscopy services, we believed the relative values of the anesthesia services should be reexamined and proposed to identify CPT codes 00740 (Anesthesia for upper gastrointestinal endoscopic procedures, endoscope introduced proximal to duodenum) and 00810 (Anesthesia for lower intestinal endoscopic procedures, endoscopy introduced distal to duodenum) as potentially misvalued.
For CY 2018, the CPT Editorial Panel is deleting CPT codes 00740 and 00810 and creating new codes for anesthesia services furnished in conjunction with and in support of gastrointestinal endoscopic procedures: Two codes for upper GI procedures, CPT code 00731 (Anesthesia for upper gastrointestinal endoscopic procedures, endoscope introduced proximal to duodenum; not otherwise specified) and CPT code 00732 (Anesthesia for upper gastrointestinal endoscopic procedures, endoscopy introduced proximal to duodenum; endoscopic retrograde cholangiopancreatography (ERCP)); and two codes for lower GI procedures, CPT code 00811 (Anesthesia for lower intestinal endoscopic procedures, endoscope introduced distal to duodenum; not otherwise specified) and CPT code 00812 (Anesthesia for lower intestinal endoscopic procedures, endoscope introduced distal to duodenum; screening colonoscopy); and one code for upper and lower GI procedures, CPT code 00813 (Anesthesia for combined upper and lower gastrointestinal endoscopic procedures, endoscope introduced both proximal to and distal to the duodenum).
In the CY 2018 PFS proposed rule, we proposed the RUC-recommended base units without refinement for CPT codes 00731 (5.00 base units), 00732 (6.00 base units), 00811 (4.00 base units), 00812 (4.00 base units) and 00813 (5.00 base units). We considered 3.00 base units for CPT code 00812 based on our comparison of the surveyed post-induction anesthesia-intensity allocation for CPT code 00812 to codes with similar allocations, such as CPT code 01382 (Anesthesia for diagnostic arthroscopic procedures of knee joint). We found that CPT code 01382, which was also valued with 3 base units, had similar allocations compared to the survey results for CPT code 00812. We received comments from anesthesia providers and professional specialty societies, including the RUC that specifically addressed the codes in this family.
After consideration of comments received that specifically addressed the codes in this family, for CY 2018, we are finalizing 5.00 base units for CPT codes 00731, 6.00 base units for CPT code 00732, 4.00 base units for CPT code 00811, 3.00 base units for CPT code 00812, and 5.00 base units for CPT code 00813.
CPT code 10040 (Acne surgery (
We proposed the RUC-recommended direct PE inputs for CPT code 10040 without refinement. We considered refinements to the clinical labor for “Assist physician in performing procedure” from 10 minutes to 3 minutes. CPT code 10040 previously used about one third of the intraservice work time for this clinical labor activity (5 minutes out of 14 minutes), and the RUC-recommended value of 10 minutes would have increased this to 100 percent of the intraservice work time without rationale for the change. We considered 3 minutes for this clinical labor activity, which is about one third of the intraservice work time (3 minutes out of 10 minutes) and would have maintained the current ratio between clinical labor time and work time. For CY 2018, we proposed the RUC-recommended work RVUs and direct PE inputs for CPT code 10040 and sought comment on our proposed and alternative values.
After consideration of comments received, for CY 2018, we are finalizing the work RVUs and direct PE inputs for CPT code 10040 as proposed.
CPT codes 15732 and 15736 were identified via a screen of high level E/M visits included in their global periods. This screen identified that a CPT code 99214 office visit was included for CPT codes 15732 and 15736 but not included in the other codes in this family. During the CPT Editorial Panel's review process for this family of codes, CPT code 15732 was deleted and replaced with two new codes, CPT codes 15730 and 15733, to better differentiate and describe the work of large muscle flaps performed on patients with head and neck cancer depending on the site where the service was performed.
For CY 2018, we proposed the RUC-recommended work RVUs of 23.00 for CPT code 15734, 17.04 for CPT code 15736, 19.04 for CPT code 15738, 13.50 for CPT code 15730, and 15.68 for CPT code 15733. For CPT code 15730, we considered a work RVU of 12.03, crosswalking to CPT code 36830 (Creation of arteriovenous fistula by other than direct arteriovenous anastomosis (separate procedure); nonautogenous graft (
We considered a work RVU of 14.63 for CPT code 15733 (survey 25th percentile), crosswalking to CPT code 36833 (Revision, open, arteriovenous fistula; with thrombectomy, autogenous or nonautogenous dialysis graft (separate procedure)), which has the same intraservice time, 1 minute of additional total time, and a work RVU of 14.50. We sought comment on the effect that an alternative work RVU of 14.50 would have on relativity among the codes in this family.
We considered refining the clinical labor time for “Check dressings & wound/home care instructions” for CPT code 15730 from 10 minutes to 5 minutes. We sought comment on the typical time input for checking dressings, and whether removing and replacing dressings would typically take place during the intraservice or postservice period.
We also sought comments regarding the use of the new “plate, surgical, mini-compression, 4 hole” (SD189) supply included in CPT code 15730, including whether use of this supply would be typical, and if so, whether it should be included in the work description. We noted that SD189 is mentioned in the direct PE recommendations, but the supply does not appear in the work description. In the work description, the fixation screws are applied to the orbital rim and lateral nasal wall, not the surgical plate.
After consideration of comments received, for CY 2018, we are finalizing the work RVUs and direct PE inputs for the codes in the muscle flaps family as proposed.
CPT code 29445 (Application of rigid total contact leg cast) appeared on a high growth screen of all services with total Medicare utilization of 10,000 or more services that increased by at least 100 percent from 2008 through 2013. This screen also indicated that the code was last surveyed more than 10 years previously, and that the dominant specialty had changed during that time.
For CY 2018, we proposed the RUC-recommended work RVU of 1.78 for CPT code 29445. For the direct PE inputs, we proposed to refine the clinical labor time for “Check dressings & wound/home care instructions” from 5 minutes to 3 minutes. We believed that the additional 2 minutes of clinical labor time that we proposed to remove would take place during the monitoring time following the procedure and be accounted for in that clinical labor time.
We also considered refining the clinical labor time for “Remove cast” from 22 minutes to 11 minutes: 1 minute for room prep, 10 minutes for assisting the physician, and 0 minutes for the additional activities described in the RUC recommendations, which would have only taken place during the initial casting. We had concerns that the RUC-recommended clinical labor regarding the “remove cast” task is based only on an initial visit where a new cast would be applied and 22 minutes may be an appropriate length of time. However, the RUC recommendations suggested that four to twelve cast changes are common for patients, and we sought comment on whether the initial application of a new cast would be typical for CPT code 29445. We reviewed the Medicare claims data for CPT code 29445 and found that three or more castings took place for 52 percent of beneficiaries, which suggests that three or more castings may be the typical case. A single casting only took place for 30 percent of services reported with CPT code 29445.
After consideration of comments received, for CY 2018, we are finalizing the work RVUs and direct PE inputs for CPT code 29445 as proposed.
The RUC reviewed CPT code 29580 since it appeared on the screen for high expenditure services and reviewed CPT code 29581 as part of this family of codes. For CY 2018, the CPT Editorial Panel is deleting two additional codes in the family: CPT codes 29582 (Application of multi-layer compression system; thigh and leg, including ankle and foot, when performed) and 29583 (Application of multi-layer compression system; upper arm and forearm).
For CY 2018, we proposed the RUC-recommended work RVUs for CPT code 29580 (a work RVU of 0.55) and CPT code 29581 (a work RVU of 0.60).
However, we were concerned about the changes in preservice time reflected in the specialty surveys compared to the RUC-recommended work RVUs. For instance, for CPT code 29580, we considered a work RVU of 0.46, crosswalking to CPT code 98925 (Osteopathic manipulative treatment (OMT); 1-2 body regions involved)), which has a work RVU of 0.46 and shares a similar intraservice time. Compared to the specialty survey times, the RUC recommended a slight decrease (9 minutes) in preservice time for CPT code 29580, with the intraservice and immediate postservice times remaining unchanged.
For CPT code 29581, we considered a work RVU of 0.51 [we note that in the CY 2018 PFS proposed rule (82 FR 33991), this was cited as 0.50] by using the RUC-recommended work RVU increment between CPT codes 29580 and 29581 (+0.05), added to the work RVU we considered for CPT code 29580 (0.46), and crosswalking to CPT code 97597 (Debridement (
For CY 2018, we proposed the RUC-recommended work RVUs for CPT codes 29580 and 29581 and sought comment on whether the alternative values we considered would be more appropriate.
After consideration of comments received, we are finalizing the work RVUs and direct PE inputs for these services as proposed.
CPT code 30140 (Submucous resection inferior turbinate, partial or complete, any method) was identified as potentially misvalued on a screen of Harvard-valued codes with utilization over 30,000 in CY 2014. During the review process, the RUC re-surveyed the code as a 0-day global period, based on the presence of a negative intensity value in the initial survey and highly variable postoperative office visits.
For CY 2018, we proposed the RUC-recommended work RVU of 3.00 for CPT code 30140 as a 0-day global code. We also considered a work RVU of 2.68 for CPT code 30140 and sought comment on changes in practice patterns since the code was previously reviewed, service times of comparable services, and whether a work RVU of 2.68 would better maintain relativity among similar codes. We noted that the RUC-recommended work RVU of 3.00 nearly doubles the derived intensity of the code as currently valued. We noted that the RUC recommendations referenced services that had similar service times to CPT code 30140 (CPT code 31240 (Nasal/sinus endoscopy, surgical; with concha bullosa resection), with a work RVU of 2.61; and CPT code 31295 (Nasal/sinus endoscopy, surgical; with dilation of maxillary sinus ostium (
We noted that the initial survey for CPT code 30140 as a 90-day global resulted in a RUC-recommended work RVU of 3.57, while the second survey for the code as a 0-day global resulted in a RUC-recommended work RVU of 3.00, despite the removal of two postoperative office visits of CPT code 99212 and a half discharge visit of CPT code 99238. These removed postoperative visits have a total work RVU of 2.58, which is notably higher than the difference in the RUC-recommended work RVUs between the two surveys.
We also proposed to create equipment codes for three new equipment items based on invoices submitted with the RUC recommendations for CPT code 30140. We proposed to create three new equipment codes based on the invoices submitted for this code family: The 2mm reusable shaver blade (EQ383) at a price of $790, the microdebrider handpiece (EQ384) at a price of $4,760, and the microdebrider console (EQ385) at a price of $9,034.
After consideration of comments received, for CY 2018, we are finalizing the work RVUs and direct PE inputs for CPT code 30140 as proposed.
In the CY 2018 PFS proposed rule, we proposed the RUC-recommended work RVU of 1.10 for CPT code 30901, 1.54 for CPT code 30903, 1.97 for CPT code 30905, and 2.45 for CPT code 30906. We also proposed the RUC-recommended direct PE inputs for CPT codes 30901, 30903, 30905, and 30906, with standard refinements to the equipment times to account for patient monitoring times. We noted that as part of its recommendation, the RUC informed us that the specialty societies presented evidence stating that the 1995 valuations for these services factored in excessive times, specifically to account for infection control procedures that were necessary at that time due to the prevalence of HIV/AIDS. The specialty societies also noted that increased availability and use of blood thinner medications compared to those available in 1995, has increased the difficulty and intensity of these procedures. We sought additional information regarding the presumption that the relative resource intensity of these services specifically would be affected by the commercial availability of additional blood thinner medications. We stated in the CY 2018 PFS proposed rule that we believe blood thinner medications were widely available before 1995 when these codes were last valued. We also sought comments on the prevalence of HIV/AIDS and whether the work related to infection control procedures would be relative across many PFS services or specifically related to nasal hemorrhage control procedures.
For CPT code 30901 (Control nasal hemorrhage, anterior, simple (limited cautery and/or packing) any method), we considered a work RVU of 1.00 (the 25th percentile survey result), crosswalking to CPT code 20606 (Arthrocentesis, aspiration and/or injection, intermediate joint or bursa (
For CPT code 30903 (Control nasal hemorrhage, anterior, complex (extensive cautery and/or packing) any method), we considered a work RVU of 1.30 (the 25th percentile survey result), which would have been further supported by CPT codes 36584 and 51710, which have similar service times to the median survey results. The RUC recommended a decreased total time of 39 minutes compared to the existing total time (70 minutes), with intraservice time dropping from 30 to 15 minutes.
For CPT code 30905 (Control nasal hemorrhage, posterior, with posterior nasal packs and/or cautery, any method; initial), we considered a work RVU of 1.73, using the RUC-recommended work RVU increment between CPT codes 30903 and 30905 (0.43), added to the work RVU we considered for CPT code 30903 (1.30), and crosswalking to CPT code 45321 (Proctosigmoidoscopy, rigid; with decompression of volvulus), which has similar service times. The surveyed intraservice time dropped from 48 minutes to 20 minutes. The RUC recommendations indicated that surveyed service times for CPT code 30905 are longer than for CPT code 30903 since the service is performed to control an arterial posterior bleed. According to the specialty society, arterial posterior bleeds are more difficult to treat and require a more extensive procedure in comparison to services reported with CPT code 30903. We considered using the RUC-recommended work RVU increment between CPT codes 30903 and 30905 (0.43), added to the work RVU we considered for CPT code 30903 (1.30), resulting in a work RVU of 1.73. We sought comment on whether a work RVU of 1.73 would potentially affect relativity among the codes in this family.
For CPT code 30906 (Control nasal hemorrhage, posterior, with posterior nasal packs and/or cautery, any method; subsequent), we considered a work RVU of 2.21, using the RUC-recommended work RVU increment between CPT codes 30905 and 30906 (0.48), added to the work RVU we considered for CPT code 30905 (1.73), and crosswalking to services with similar service times (CPT codes 19281 (Placement of breast localization device(s) (
Given the RUC's consensus, for CY 2018, we proposed the RUC-recommended work RVUs for each code in this family and sought comment on whether our alternative values would be more appropriate.
In October 2016, the CPT Editorial Panel created five new codes (CPT codes 31241, 31241, 31253, 31257, 31259 and 31298) and revised CPT codes 31238, 31254, 31255, 31276, 31287, 31288, 31296, and 31297. CPT codes 31253—31298 are newly bundled services representing services that are frequently reported together. CPT code 31241 represents a new service. The RUC reviewed this family of codes at its January 2017 meeting. For CY 2018, we proposed the RUC-recommended work RVUs for all 15 CPT codes in this family as follows: 4.27 for CPT code 31254, 5.75 for CPT code 31255, 3.11 for CPT code 31256, 4.68 for CPT code 31267, 6.75 for CPT code 31276, 3.50 for CPT code 31287, 4.10 for CPT code 31288, 2.70 for CPT code 31295, 3.10 for CPT code 31296, 2.44 for CPT code 31297, 8.00 for CPT code 31241, 9.00 for CPT code 31253, 8.00 for CPT code 31257, 8.48 for CPT code 31259, and 4.50 for CPT code 31298.
For CPT code 31296, we considered a work RVU of 2.82, supported by a crosswalk to CPT code 36901 (Intro cath dialysis circuit) with an intraservice time of 25 minutes and total time of 66 minutes, similar to the service times for CPT code 31296. We were concerned about the decrease in service time compared to the work RVU and sought comment on whether or not a work RVU of 2.82 might improve relativity with other PFS services.
For CPT code 31256, we considered a work RVU of 2.80, supported by a crosswalk to CPT code 43231 (Esophagoscopy, flexible, transoral; with endoscopic ultrasound examination), which has 30 minutes of intraservice time and 81 minutes of total time, similar to the RUC-recommended service times. We were concerned about the difference in total time between CPT code 31256 and the RUC-recommended crosswalk to CPT code 43247. CPT code 43247 has 30 minutes intraservice time and 58 minutes total time), and CPT code 31256 (30 minutes intraservice time and 83 minutes total time).
For CPT code 31254, we noted the RUC's explanation that this service is more intense than the functional endoscopic sinus surgery on the maxillary or sphenoid sinuses due to the risk of major complications such as injury to the eye muscles, bleeding into the eye or brain fluid leak and, consequently, that the RUC concluded that it should be valued higher than either CPT code 31256 or CPT code 31287. Since CPT code 31256 has the same total time (30 minutes) and intraservice time (30 minutes) as CPT code 31254, we considered whether the incremental difference recommended by the RUC between these two codes (work RVU of 1.16) would reflect the intensity of the service. We considered a work RVU of 2.80 for CPT code 31256, and also considered an alternative work RVU of 3.97 for CPT code 31254.
For CPT code 31287, we considered a work RVU of 3.19 based on the difference between the RUC-recommended work RVU for the maxillary sinus surgery (CPT code 31256) and the sphenoid sinus surgery (CPT code 31287) (difference = 0.28) added to the work RVU that we considered for the base code (CPT code 31256, a work RVU of 2.80). We noted that the magnitude of decreases in
For CPT code 31255, we considered a work RVU of 5.30, based on a crosswalk to CPT codes 36475 (Endovenous rf 1st vein) and 36478 (Endovenous laser 1st vein) since both of these services have the same intraservice times, total times, and work RVUs. We noted that there are several CPT codes with similar total and intraservice times as CPT code 31255 that have lower work RVUs than the RUC's recommended work RVU of 5.75, such as CPT code 36246 (Ins cath abd/l-ext art 2nd), which has 45 minutes intraservice time, 96 minutes total time and a work RVU of 5.02
For CPT code 31276 (Nasal/sinus endoscopy, surgical; with frontal sinus exploration, including removal of tissue from frontal sinus, when performed), we considered a work RVU of 6.30, which is similar to other functional endoscopic surgeries. We noted that the services reported with CPT code 31276 are the most intense and complex of the functional endoscopic surgeries due to the risks of working in the narrow confines in the frontal recess. However, we had concerns regarding the RUC-recommended crosswalk to CPT code 52352 (Cystourethroscopy, with ureteroscopy and/or pyeloscopy; with removal or manipulation of calculus (ureteral catheterization is included)), and sought comment on whether the RUC-recommended decrease in service times was appropriate since CPT code 52352 has 20 minutes more total time than CPT code 31276.
For CPT code 31241 (nasal/sinus endoscopy, surgical; with ligation of Sphenopalatine artery), we had concerns and sought comment regarding the accuracy and applicability of the surveys as the RUC indicated that the specialty society did not use the survey instrument that contained questions about the number and types of visits and that this service requires including a half day discharge day management as the patients typically stay overnight to be monitored for further bleeding. We sought comment on whether inclusion of a half day discharge day visit was typical for this service since services assigned 0-day global periods do not typically include discharge visits. We considered reducing the total time from 142 minutes to 123 minutes by removing the half day discharge. Using the alternative total time of 123 minutes, we found services with similar total and intraservice time (60 minutes) and total time (123 minutes).
We considered a work RVU of 7.30 for CPT code 31241, supported by a direct crosswalk to CPT code 36253 (Superselective catheter placement (one or more second order or higher renal artery branches) renal artery and any accessory renal artery(s) for renal angiography, including arterial puncture, catheterization, fluoroscopy, contrast injection(s), image postprocessing, permanent recording of images, and radiological supervision and interpretation, including pressure gradient measurements when performed, and flush aortogram when performed; unilateral), since CPT code 36253 has a similar total time compared to our alternative total time.
For CPT code 31257, we considered a work RVU of 7.30, based on a crosswalk to CPT code 36253 (Superselective catheter placement (one or more second order or higher renal artery branches) renal artery and any accessory renal artery(s) for renal angiography, including arterial puncture, catheterization, fluoroscopy, contrast injection(s), image postprocessing, permanent recording of images, and radiological supervision and interpretation, including pressure gradient measurements when performed, and flush aortogram when performed; unilateral). We had similar concerns regarding the service times for this service, including the cited reference codes, compared to the RUC-recommended work RVU. We sought comment on whether a work RVU of 7.30 for CPT code 31257 would improve consistency among the combined CPT codes in this family.
CPT code 31259 is a new code representing a combination of the services previously described by CPT codes 31255 and 31288. We noted the changes in overall service times compared to other codes in this family and other PFS services. We considered a work RVU of 7.85 for CPT code 31259, crosswalking to CPT code 93461 (R&l hrt art/ventricle angio), which has identical intraservice times. We sought comment on the effect that this alternative work RVU might have on consistency and rank order compared to the other bundled codes in this family.
CPT code 31298 represents a combination of CPT codes 31296 and 31297. We had concerns about the use of the RUC-recommended comparison codes, CPT codes 47532 and 58558, due to differences in both intraservice and total time compared to the service times for CPT code 31298. We considered a work RVU of 4.10 for CPT code 31298, crosswalking to CPT code 44406 (Colonoscopy w/ultrasound), which has similar service times.
In the CY 2018 PFS proposed rule, we proposed the RUC-recommended work RVUs for each code in this family and sought comment on our alternative values.
Regarding the recommended direct PE inputs, we expressed concern about one of the supply items used in furnishing
In reviewing the RUC recommendations for this family of CPT codes, we noted that the CPT codes in this family are subject to the standard payment adjustment for multiple surgeries. In our analysis of the claims data, we noted that the average number of HCPCS codes in this family reported together on a claim line is approximately 2.89. In addition, about 15 percent of claims have two of the newly bundled CPT codes reported together on a claim line. We expressed concern about the frequency with which the nasal sinus endoscopy CPT codes in this family are billed together. We sought comments on whether we should consider the endobase code adjustments as a better approach to adjusting payment for these services instead of the current multiple procedure payment reduction. For additional information about the payment adjustment under the special rule for multiple endoscopic services, we refer readers to the Medicare Claims Processing Manual, Chapter 23 (available on the CMS Web site at
To estimate utilization for new or newly bundled services in this group of complex codes, we used a different crosswalk to current services than was recommended by the RUC. We believe that the RUC did not sufficiently account for utilization changes that occur when several newly bundled CPT codes describe formerly separate services. We direct readers to the file called “CY 2017 Analytic Crosswalk to CY 2018” on the CMS Web site under downloads for the CY 2018 PFS final rule at
CPT code 31600 was identified as part of a screen of high expenditure services with Medicare allowed charges of $10 million or more that had not been recently reviewed. CPT codes 31601, 31603, 31605, and 31610 were added and reviewed as part of the code family.
We proposed the RUC-recommended work RVUs for all five codes in this family. We proposed work RVUs of 5.56 for CPT code 31600, 8.00 for CPT code 31601, 6.00 for CPT code 31603, 6.45 for CPT code 31605, and 12.00 for CPT code 31610.
We considered a work RVU of 6.50 for CPT code 31601. We sought comment on the effect that this alternative value would have on relativity compared to other PFS services, especially since the survey data do not suggest an increase in the time required to perform the procedure.
We considered a work RVU of 4.77 for CPT code 31605, based on the survey 25th percentile from the combined survey total. We also considered an intraservice work time of 15 minutes, based on the median intraservice work time from the combined survey total for CPT code 31605. We sought comments on the methodology used to determine the RUC-recommended work RVU and intraservice work time. We were concerned that the number of respondents (20) was below the threshold typically required for submission of a survey, and the effect of using survey results only from physicians who had personal experience performing the procedure. CPT code 31605 has a lower intraservice and total time, but a higher work RVU than comparable codes under the PFS. We noted that the next highest 0-day global code with 20 minutes of intraservice time is CPT code 16035 (Escharotomy; initial incision) at a work RVU of 3.74. All other 0-day global codes with a work RVU of 6.45 or greater have at least 40 minutes of intraservice time.
We sought comment on the effect that an alternative work RVU of 4.77 would have on the relativity of this service compared to other services in this family of codes and compared to other PFS services, taking into account that CPT code 31605 describes a difficult and dangerous life-threatening emergency procedure.
We considered a work RVU of 6.50 for CPT code 31610 based on a direct crosswalk to CPT code 31601 (Incision of windpipe). We understand that the RUC considered the possibility of recommending this code be assigned a 0-day global period based on concerns about negative derived intensity. We shared the RUC's concerns with the current construction of CPT code 31610, particularly with the 242 minutes of work time included in the postoperative visits, which is an unusually large amount for a procedure with only 45 minutes of intraservice time. We did not identify any other comparable codes under the PFS with 45 minutes of intraservice time and more than 300 minutes of total time. We sought comment on whether the unusually high volume of physician work time included in the postoperative visits for CPT code 31610 contributed to the negative derived intensity reported by the survey data. Considering that the other codes in this family have 0-day global periods, we considered and sought comment on whether a 0-day global period should be assigned to CPT code 31610. Removal of the postoperative E/M visits from CPT code 31610 would result in an intraservice time of 45 minutes and a total time of 125 minutes, similar to CPT code 31601 with 45 minutes of intraservice time and 135 minutes of total time.
We proposed the RUC-recommended direct PE inputs for all five CPT codes in this family without refinements. As discussed earlier, we considered a 0-day global period for CPT code 31610, which would also have resulted in removal of the clinical labor associated with the postoperative E/M visits, along with the supplies and equipment utilized during those visits. While we remained concerned about the global period assigned to CPT code 31610 and the changes in service times reflected in the specialty surveys compared to the RUC-recommended work RVUs, for CY 2018, we proposed the RUC-recommended work RVUs and direct PE inputs for each code in this family and sought comment on our proposed and alternative values.
After consideration of comments received, for CY 2018, we are finalizing the work RVUs, direct PE inputs, and global periods for the codes in the tracheostomy family as proposed.
CPT code 31645 (Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed with therapeutic aspiration of tracheobronchial tree, initial) was identified as potentially misvalued on a screen of Harvard-valued codes with utilization over 30,000 in CY 2014. CPT code 31646 (Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed with therapeutic aspiration of tracheobronchial tree, subsequent, same hospital stay) was added for review as part of the family of codes, and both were revised to reflect recent changes in how the services are typically performed. For CY 2018, we proposed the RUC-recommended work RVUs of 2.88 for CPT code 31645 and 2.78 for CPT code 31646.
We considered a work RVU of 2.72 for CPT code 31645, crosswalking to CPT code 45347 (Sigmoidoscopy, flexible; with placement of endoscopic stent). We had concerns regarding the decrease in intraservice and total time compared to the current values; we also believe that it is important to note how these related codes have been affected by the creation of separately billable codes for moderate sedation (see the CY 2017 PFS final rule (81 FR 80339)). The RUC recommended a work RVU for CPT code 31645 that is higher than the work RVU for CPT code 31622 (Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; diagnostic, with cell washing, when performed), which is the base procedure for this broader group of codes. We agreed that CPT code 31645 should be valued at a higher work RVU than CPT code 31622; however, we sought comment on whether the work of moderate sedation was inadvertently included in the development of the recommended work RVU. We noted that as part of the CY 2017 PFS final rule (81 FR 80339), we finalized separate payment for moderate sedation. Following the creation of separately billable codes for moderate sedation, CPT code 31622 is currently valued at a work RVU of 2.53, not 2.78 as it was previously valued, and we did not believe it would be appropriate to continue to value CPT code 31645 as though moderate sedation was still an inherent part of the work of this service. As a result, we considered a direct crosswalk to CPT code 45347, which has the same intraservice time and 8 additional minutes of total time, at a work RVU of 2.72.
We considered a work RVU of 2.53 for CPT code 31646, crosswalking to CPT code 31622 (Dx bronchoscope/wash). The RUC recommendation for CPT code 31646 indicated that the code was comparable to CPT code 31622, since they share the same intraservice time and similar total time, and that the recommended work RVU of 2.78 for CPT code 31646 was equal to the work RVU of CPT code 31622 before the CY 2017 changes to reporting of moderate sedation. We agreed with the survey participants that these two codes are comparable to one another, but had concerns about valuation of CPT code 31646 using a cross reference to a code that included moderate sedation. We considered crosswalking CPT code 31646 using the current CY 2017 valuation for CPT code 31622 (a work RVU of 2.53).
For the direct PE inputs, we proposed to remove the oxygen gas (SD084) from CPT code 31645. This supply is included in the separately billable moderate sedation codes, and we proposed to remove the oxygen gas as recommended by the RUC's PE Subcommittee as part of the removal of
We proposed to increase the equipment time for the flexible bronchoscopy fiberscope (ES017) for CPT code 31645 consistent with standard equipment times for scopes. We also proposed to increase the equipment time for the Gomco suction machine (EQ235) and the power table (EF031) consistent with standard equipment times for non-highly technical equipment. For CY 2018, we proposed the RUC-recommended work RVUs for both codes in this family and sought comment on whether we should finalize refined values consistent with the implementation of separately billable codes for moderate sedation.
After consideration of comments received, for CY 2018, we are finalizing the work RVUs and direct PE inputs for the codes in the bronchial aspiration of tracheobronchial tree family as proposed, with the exception of the proposed removal of the oxygen gas and CO2 respiratory profile monitor as detailed above.
For CY 2018, the CPT Editorial Panel modified the descriptor for CPT code 32998 (Ablation therapy for reduction or eradication of 1 or more pulmonary tumor(s) including pleura or chest wall when involved by tumor extension, percutaneous, including imaging guidance when performed, unilateral; radiofrequency) to include imaging guidance. In addition, the panel deleted Category III CPT Code 0304T and replaced it with a new CPT code 32994, to describe ablation therapy for reduction of pulmonary tumor using cryoablation with imaging guidance. In the CY 2018 PFS proposed rule, we proposed the RUC-recommended work RVUs for CPT codes 32998 (a work RVU of 9.03) and 32994 (a work RVU of 9.03).
However, we expressed concerns about the descriptions of the codes and the recommended valuations assuming that imaging guidance is inherent to the procedure. Based on our analysis of claims data from 2014, existing CPT code 32998 is currently reported with one of the three imaging guidance codes (CPT codes 76940, 77013, or 77022) less than 50 percent of the time. We sought comment on whether there is additional information that would help explain why the codes are being bundled despite what is reflected in the Medicare claims data. We considered a work RVU of 7.69 for CPT code 32998, that included approximately one half the value of the imaging guidance in the new codes that describe the work of both the procedure and the image guidance (that is, the sum of the current work RVU for CPT code 32998 and one-half of the work RVU for CPT code 77013 (the imaging guidance code most frequently billed with CPT code 32998 according to 2014 claims data)). We applied the same general rationale regarding the use of imaging guidance for new CPT code 32994. Since the RUC recommended identical work RVUs for these codes, we also considered a work RVU of 7.69 for CPT code 32994.
For CPT codes 32998 and 32994, we proposed to use the RUC-recommended direct PE inputs with standard refinements and sought comment on our proposed values.
After consideration of the public comments, we are finalizing the work RVUs as proposed. With regard to the PE inputs, we note that we applied the standard formulas for equipment times, and we continue to believe that these refinements are reasonable for these codes. An explanation of the standards and formulas for equipment related to direct PE inputs is in the CY 2014 PFS final rule with comment period (79 FR 67557). We are also finalizing the direct PE inputs with standard refinements for these services, as proposed.
For CY 2018, the CPT Editorial Panel deleted Category III CPT Codes 0051T through 0053T and created CPT codes 33927 (Implantation of a total replacement heart system (artificial heart) with recipient cardiectomy), 33929 (Removal of a total replacement heart system (artificial heart) for heart transplantation), and 33928 (Removal and replacement of total replacement heart system (artificial heart)) to report artificial heart system procedures. We proposed the RUC-recommended work RVU of 49.00 for CPT code 33927, and proposed to assign contractor-priced status to CPT codes 33929 and 33928, as recommended by the RUC. We considered assigning contractor-priced status for CPT code 33927. We had concerns regarding the accuracy of the RUC-recommended work valuation for CPT code 33927, due to its low utilization and the resulting difficulties in finding enough practitioners with direct experience of the procedure for the specialty societies to survey. We sought comment on the sufficiency of the survey data, especially since new
After consideration of comments received for CY 2018, we are finalizing the work RVU of 49.00 for CPT code 33927 and finalizing contractor-priced status for CPT codes 33929 and 33928 as proposed.
The CPT/RUC joint workgroup on codes recommended in October 2015 to bundle endovascular abdominal aortic aneurysm repair (EVAR) codes together with radiologic supervision and interpretation codes, since these codes were typically reported together at least 50 percent of the time. The CPT Editorial Panel bundled these services together in September 2016, creating 16 new codes, revising four existing codes, and deleting 14 other codes related to endovascular repair procedures.
We proposed the RUC-recommended work RVUs for all 20 codes in this family. We proposed work RVUs of 23.71 for CPT code 34701, 36.00 for CPT code 34702, 26.52 for CPT code 34703, 45.00 for CPT code 34704, 29.58 for CPT code 34705, 45.00 for CPT code 34706, 22.28 for CPT code 34707, 36.50 for CPT code 34708, 6.50 for CPT code 34709, 15.00 for CPT code 34710, 6.00 for CPT code 34711, 12.00 for CPT code 34712, 2.50 for CPT code 34713, 4.13 for CPT code 34812, 5.25 for CPT code 34714, 7.00 for CPT code 34820, 8.16 for CPT code 34833, 2.65 for CPT code 34834, 6.00 for CPT code 34715, and 7.19 for CPT code 34716. We also proposed the RUC-recommended direct PE inputs without refinement for all 20 codes in the family.
We considered a work RVU of 32.00 for CPT code 34702 based on the survey 25th percentile, and further supported with a crosswalk to CPT code 48000 (Placement of drains, peripancreatic, for acute pancreatitis), which has the same intraservice time of 120 minutes and a work RVU of 31.95. When we compared the RUC-recommended work RVU to similar codes valued under the PFS, we were unable to find any 90-day global services with 120 minutes of intraservice time and approximately 677 minutes of total time that had a work RVU greater than 36.00.
We considered a work RVU of 40.00 for CPT code 34704 based on the survey 25th percentile, crosswalking to CPT code 33534 (Coronary artery bypass, using arterial graft(s); 2 coronary arterial grafts) which has a work RVU of 39.88. CPT code 33534 has 193 minutes of intraservice time, but a lower total time of 717 minutes. When we compared the RUC-recommended work RVU for CPT code 34704 to similar codes paid under the PFS, we were unable to find any 90-day global services with 180 minutes of intraservice time and approximately 737 minutes of total time that had a work RVU greater than 45.00.
We considered a work RVU of 40.00 for CPT code 34706 based on the survey 25th percentile. CPT code 34706 has nearly identical time values to CPT code 34704, with 2 fewer minutes of intraservice time and total time, and the RUC-recommended work RVU was the same for both of these codes. The survey respondents also believed that these two codes had a comparable amount of work, as the survey 25th percentile work RVU was 40.00 for both codes.
We considered a work RVU of 30.00 for CPT code 34708 based on the survey 25th percentile and sought comment on whether a work RVU of 30.00 would improve relativity among the codes in this family. CPT code 34708 has identical intraservice and total times as CPT code 34702. However, we noted that the RUC-recommended work RVU of 36.50 for CPT code 34708 is higher than the RUC-recommended work RVU of 36.00 for CPT code 34702. This is the inverse of the relationship between CPT codes 34707 and 34701, which describe the same procedures in a non-emergent state when a rupture does not take place. CPT code 34707 has a RUC-recommended work RVU of 22.28, while CPT code 34701 has a RUC-recommended work RVU of 23.71. We sought comment on whether the RUC-recommended work RVUs would create a rank order anomaly within the family by reversing the relationship between these paired codes when performed in an emergent state. We noted that if CPT codes 34708 and 34702 were valued at the survey 25th percentile, this potential rank order anomaly disappears; in this scenario, we considered valuing CPT code 34708 at a work RVU of 30.00 and CPT code 34702 at a work RVU of 32.00. We sought comment on whether these alternative work values would improve relativity with the RUC-recommended work RVUs for CPT code 34707 (22.28) and CPT code 34701 (23.71), with an increment of approximately 1.50 to 2.00 RVUs between the two code pairs.
For the eight remaining codes that describe endovascular access procedures, we considered assignment of a 0-day global period, instead of the RUC-recommended add-on (ZZZ) global period and subsequently adding back the preservice and immediate postservice work time, and increasing the work RVU of each code accordingly using a building block methodology. We noted that as add-on procedures, these eight codes would not be subject to the multiple procedure payment discount. We were concerned that the total payment for these services will be increasing in the aggregate based on changes in coding that alter MPPR adjustments, despite the information in the surveys that reflects a decrease in the intraservice time required to perform the procedures, and a decrease in their overall intensity as compared to the current values.
We considered a work RVU of 3.95 for CPT code 34713, based on the RUC-recommended work RVU of 2.50 plus an additional 1.45 work RVUs. This additional work results from the addition of 38 total minutes of preservice work time and 30 minutes of postservice work time based on a crosswalk to CPT code 37224 (Revascularization, endovascular, open or percutaneous, femoral, popliteal artery(s), unilateral; with transluminal angioplasty) as valued by using the building block methodology. Using the same method, we considered a work RVU of:
• 6.48 for CPT code 34812 based on maintaining the current 75 minutes of preservice work time and the current 30 minutes of postservice work time, with a total work RVU of 2.35, added to the RUC-recommended work RVU of 4.13;
• 7.53 for CPT code 34714 with the addition of 75 minutes of preservice work time and 27 minutes of postservice work time to match CPT code 34833;
• 9.46 for CPT code 34820 based on maintaining the current 80 minutes of preservice work time and the current 30 minutes of postservice work time;
• 10.44 for CPT code 34833 based on maintaining the current 75 minutes of preservice work time and the current 27 minutes of postservice work time;
• 5.00 for CPT code 34834 based on maintaining the current 70 minutes of preservice work time and the current 35 minutes of postservice work time;
• 8.35 for CPT code 34715 with the addition of 70 minutes of preservice work time and 35 minutes of postservice work time to match CPT code 34834; and
• 9.47 for CPT code 34716 with the addition of 75 minutes of preservice work time and 27 minutes of postservice work time to match CPT code 34833.
We proposed the RUC-recommended work RVUs and direct PE inputs for each code in this family and sought comment on whether our alternative values would be more appropriate.
After consideration of comments received, for CY 2018, we are finalizing the work RVUs and direct PE inputs for the codes in the endovascular repair procedures family as proposed.
CPT code 36215 was identified as potentially misvalued on a screen of Harvard-valued codes with utilization over 30,000 in CY 2014, as well as on a screen of high expenditure services across specialties with Medicare allowed charges of over $10 million. CPT codes 36216, 36217, and 36218 were added to the family to be reviewed together with CPT code 36215.
We proposed the RUC-recommended work RVUs for each code in this family. We proposed work RVUs of 4.17 for CPT code 36215, 5.27 for CPT code 36216, 6.29 for CPT code 36217, and 1.01 for CPT code 36218.
We also considered refinements to the intraservice work time for CPT code 36217 from 60 minutes to 50 minutes, consistent with the RUC's usual use of the survey median intraservice work time. We had concerns that the use of the recommended survey 75th percentile intraservice work time will not be clinically appropriate for this code, as the 75th percentile time was identical for CPT codes 36216 and 36217, and therefore, the use of this value would not preserve the incremental, linear consistency between the work RVU and the intraservice time within the family.
For the direct PE inputs, we proposed to refine the clinical labor time for the “Post-procedure doppler evaluation (extremity)” activity from 3 minutes to 1 minute for CPT codes 36215, 36216, and 36217. We believed that 1 minute would be more typical for this task, as the practitioner would be able to quickly evaluate if there was an issue with the extremity because there would be visual signs of arterial insufficiency resulting from the procedure.
We proposed to remove the equipment time for the mobile instrument table (EF027) from CPT codes 36215, 36216, and 36217. We believed that the mobile instrument table would be used for moderate sedation, which was removed from these procedures in CY 2017 (see the CY 2017 PFS final rule (81 FR 80339). While we recognized that 180 minutes of post-procedure monitoring time remains in these codes during which the stretcher (EF018), IV infusion pump (EQ032), and 3-channel ECG (EQ011) would remain in use, we did not agree that the mobile instrument table would typically be in use during this period of monitoring. As a result, we proposed to remove this equipment time from these three codes.
While we remained concerned about the use of the survey 75th percentile intraservice work time for CPT code 36217, for CY 2018, we proposed the RUC-recommended work RVUs for each code in this family and sought comment on whether our alternative values would be more appropriate.
After consideration of comments received, for CY 2018, we are finalizing the work RVUs and direct PE inputs for the codes in the selective catheter placement family as proposed.
In September 2016, the CPT Editorial Panel created four new codes to describe the treatment of incompetent veins, and revised existing CPT codes 36470 and 36471. These six codes were reviewed together as part of the same family of procedures. For CY 2018, we proposed the RUC-recommended work RVU for all six codes. We proposed work RVUs of 0.75 for CPT code 36470, 1.50 for CPT code 36471, 3.50 for CPT code 36482, 1.75 for CPT code 36483, 2.35 for CPT code 36465, and 3.00 for CPT code 36466.
We considered a work RVU of 4.38 for CPT code 36482, which would have been based on the RUC-recommended work RVU of 3.50 plus half of the RUC-recommended work RVU of CPT code
We proposed to remove the 2 minutes of clinical labor for the “Setup scope” (CA015) activity and add the same 2 minutes of clinical labor for the “Prepare room, equipment and supplies” (CA013) activity for CPT codes 36482, 36465, and 36466. The RUC-recommended materials stated that these 2 minutes were a proxy for setting up the ultrasound machine, and we believe that this 2 minutes was more accurately described by the “Prepare room, equipment and supplies” (CA013) activity code, since there is no scope equipment utilized in these procedures. We proposed to maintain the Vascular Tech (L054A) clinical labor type for these 2 minutes. We also proposed to refine the clinical labor for the “Check dressings, catheters, wounds” (CA029) activity for CPT codes 36470, 36471, 36482, 36465, and 36466, consistent with the standard times for this clinical labor activity.
We proposed to remove the six individual 4x4 sterile gauze (SG055) supplies and replace them with a 4x4 sterile gauze pack of 10 (SG056) for CPT codes 36470, 36471, 36482, 36465, and 36466. The pack of 10 sterile gauze is cheaper than six individual pieces of sterile gauze, and we did not agree that it would be typical to pay a higher cost for fewer supplies. We also proposed to create three new supply codes in response to the invoices submitted for this family of codes. We proposed to establish a price of $1,495 for the Venaseal glue (SD323) supply, a price of $3,195 for the Varithena foam (SD324) supply, and a price of $40 for the Varithena admin pack (SA125) supply.
We proposed to adjust the equipment times for the surgical light (EF014), the power table (EF031), and the portable ultrasound unit (EQ250) for CPT codes 36482, 36465, and 36466, consistent with the standards for non-highly technical equipment and to reflect the changes in the clinical labor described in this section of the final rule.
While we remained concerned about the creation of a base code and add-on code pairing (CPT codes 36482 and 36483) out of services that are currently reported using an unlisted code, for CY 2018, we proposed the RUC-recommended work RVUs for each code in this family and sought comment on whether our alternative values would be more appropriate.
After consideration of comments received, for CY 2018, we are finalizing the work RVUs and direct PE inputs for the codes in the treatment of incompetent veins family as proposed.
CPT code 36516 was nominated as potentially misvalued in the CY 2016 PFS proposed rule. The CPT Editorial Panel deleted CPT code 36515 and made revisions to CPT code 36516 to include immunoabsorption. CPT codes 36511, 36512, 36513, 36514, and 36522 were added to CPT code 36516 to be reviewed together as part of the therapeutic apheresis family.
For CY 2018, we proposed the RUC-recommended work RVUs for all six codes in the family. We proposed work RVUs of 2.00 for CPT code 36511, 2.00 for CPT 36512, 2.00 for CPT code 36513, 1.81 for CPT code 36514, 1.56 for CPT code 36516, and 1.75 for CPT code 36522.
We proposed to use the RUC-recommended direct PE inputs for these codes without refinement. We considered refining the clinical labor time for the “Prepare room, equipment, supplies” activity from 20 minutes to 10 minutes for CPT codes 36514 and 36522, and from 30 minutes to 10 minutes for CPT code 36516. We also considered refining the clinical labor for the “Prepare and position patient/monitor patient/set up IV” activity from 15 minutes to 10 minutes for these same three codes. In both cases, we considered maintaining the current clinical labor time for CPT codes 36514 and 36516, and adjusting the clinical labor time for CPT code 36522 to match the other two codes in the family. We had concerns about the lack of a rationale provided for these changes in clinical labor time, and whether these clinical labor tasks would typically require this additional time.
We proposed the RUC-recommended work RVUs and to use the RUC-recommended direct PE inputs for each code in this family and sought comment on whether our alternative values would be more appropriate. We also sought comment on whether these procedures were creating a new point of venous access or utilizing a previously placed access.
After consideration of comments received, for CY 2018, we are finalizing the work RVUs and direct PE inputs for the codes in the therapeutic apheresis family as proposed.
CPT code 36556 was identified as part of a screen of high expenditure services with Medicare allowed charges of $10 million or more that had not been recently reviewed. CPT codes 36555, 36620, and 93503 were added for review by the RUC as part of the code family. We proposed the RUC-recommended work RVUs for each code in this family. We proposed work RVUs of 1.93 for CPT code 36555, 1.75 for CPT code 36556, 1.00 for CPT code 36620, and 2.00 for CPT code 93503.
We proposed to remove the clinical labor time for the “Monitor pt. following procedure” activity and the equipment time for the 3-channel ECG (EQ011) for CPT code 36555. CPT code 36555 no longer includes moderate sedation as part of the procedure (see the CY 2017 PFS final rule (81 FR 80339). We proposed to remove the direct PE inputs related to moderate sedation from CPT code 36555 as they would now be included in the separately reported moderate sedation services. We also proposed to refine the equipment times for the exam table (EF023) and the exam light (EQ168) to reflect changes in the clinical labor time.
After consideration of comments received, for CY 2018, we are finalizing the work RVUs and direct PE inputs for the codes in the insertion of catheter family as proposed.
CPT code 36569 was identified as part of a screen of high expenditure services with Medicare allowed charges of $10 million or more that had not been recently reviewed. For CY 2018, we proposed the RUC-recommended work RVU of 1.70 for CPT code 36569.
We proposed to remove the equipment time for the exam table (EF023), as this equipment item is a component part of the radiographic-fluoroscopic room (EL014) included in CPT code 77001 (Fluoroscopic guidance for central venous access device placement, replacement (catheter only or complete), or removal). Because CPT code 36569 is typically billed together with CPT code 77001, we believed that including the additional equipment time for the exam table in CPT code 36569 would be duplicative.
After consideration of comments received, for CY 2018, we are finalizing the work RVUs and direct PE inputs for the codes for CPT code 36569 as proposed, with the exception of the
CPT code 38221 was identified as part of a screen of high expenditure services with Medicare allowed charges of $10 million or more that had not been recently reviewed. The descriptors for CPT codes 38220 and 38221 were revised to reflect changes in practice patterns, and two new CPT codes (38222 and 20939) were created to more accurately describe new services that are now available. For CY 2018, we proposed the RUC-recommended work RVUs for each code in this family. We proposed a work RVU of 1.20 for CPT code 38220, 1.28 for CPT code 38221, 1.44 for CPT code 38222, and 1.16 for CPT code 20939.
We also received a recommendation from the RUC to change the global periods for CPT codes 38220, 38221, and 38222 from XXX global periods to 0-day global periods, even though these codes were surveyed under the XXX global period. We agreed with the recommendation that for these three particular codes, their services were more accurately described when assigned 0-day global periods as opposed to the XXX global status. Therefore, we proposed to assign a 0-day global period to all three codes in this family. We noted, however, that we believed that global period changes must be addressed on an individual basis, especially when the routine survey methodologies rely on assumptions regarding global periods for particular codes. Subsequently, we proposed to refine the preservice work time from 15 minutes of evaluation time to 9 minutes of evaluation time, 1 minute of positioning time, and 5 minutes of scrub, dress, and wait time. We proposed these refinements to the work times for these three codes to more closely align with the preservice times of other recently reviewed 0-day global procedures, such as CPT code 30903 (Control nasal hemorrhage, anterior, complex (extensive cautery and/or packing) any method). We also noted that given our proposal to value CPT code 38222, we proposed to eliminate payment using HCPCS code G0364 for CY 2018 since the changes to the set of CPT codes will now accurately describe the services currently reported by HCPCS code G0364. For CPT code 20939, we considered a work RVU of 1.00 based on a direct crosswalk to CPT codes 64494 (Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) with image guidance (fluoroscopy or CT), lumbar or sacral; second level) and 64495 (Injection(s), diagnostic or therapeutic agent, paravertebral facet (zygapophyseal) joint (or nerves innervating that joint) with image guidance (fluoroscopy or CT), lumbar or sacral; third and any additional level(s)). CPT code 20939 is a global ZZZ add-on code for CPT code 38220, and we were concerned with maintaining relativity among PFS services, considering that an add-on code typically has significantly less intraservice time and total time compared to the base code. We considered an alternative crosswalk to CPT codes 64494 and 64495, which share the same intraservice and total time with CPT code 20939 and have work RVUs of 1.00.
We also proposed to refine the clinical labor for “Lab Tech activities” from 12 minutes to 9 minutes for CPT code 38220, from 7.5 minutes to 7 minutes for CPT code 38221, and from 12.5 minutes to 10 minutes for CPT code 38222. We maintained the current time value for the two existing codes, as we had no reason to believe that the typical duration has increased for these lab activities. We assigned 10 minutes for CPT code 38222 based on the statement in the RUC-recommended materials for the direct PE inputs that this activity takes 0.5 minutes longer than it does in the current version of CPT code 38220. We also proposed to remove the breakout lines for the lab activities. We believe that the breakout of activities into numerous subactivities generally tends to inflate the total time assigned to clinical labor activities and results in values that are not consistent with the analogous times for other PFS services.
We considered refining the clinical labor time for “Provide preservice education/obtain consent” for CPT codes 38220, 38221, and 38222 from 12 minutes to 6 minutes. We had concerns regarding whether 12 minutes would be typical for education and consent prior to these procedures, as much of the patient education takes place following the procedure, in the clinical labor activity described under the “Check dressings & wound/home care instructions” heading. We proposed the RUC-recommended work RVUs for each code in this family and sought comment on whether our alternative values would be more appropriate.
After consideration of comments received, for CY 2018, we are finalizing the work RVUs and direct PE inputs for the codes in the bone marrow aspiration family as proposed. We are not finalizing the proposal to change CPT codes 38220, 38221, and 38222 from XXX global periods to 0-day global periods, and we are not finalizing the related proposal to refine the preservice work time from 15 minutes of evaluation time to 9 minutes of evaluation time, 1 minute of positioning time, and 5 minutes of scrub, dress, and wait time for these three codes.
CPT codes 43286, 43287, and 43288 were created by the CPT Editorial Panel to report esophagectomy via laparoscopic and thoracoscopic approaches. CPT codes 43107, 43112, and 43117 were also reviewed as part of the family with the three new codes. CPT code 43112 was revised to clarify the nature of the service being performed. We proposed the RUC-recommended work RVUs for all six codes in the family. We proposed work RVUs of 52.05 for CPT code 43107, 62.00 for CPT code 43112, 57.50 for CPT code 43117, 55.00 for CPT code 43286, 63.00 for CPT code 43287, and 66.42 for CPT code 43288.
We also proposed the RUC-recommended work times for all six codes in this family. We considered removing 20 minutes from the preservice evaluation work time from all six of the codes in this family. We had concerns as to whether this additional evaluation time should be included for surgical procedures, due to the lack of evidence indicating that it takes longer to review outside imaging and lab reports for surgical services than for non-surgical services. We also considered refining the preservice positioning work time and the immediate postservice work time for all six of the codes in this family consistent with standard preservice and postservice work times allocated to other PFS services.
We had concerns about the presence of two separate surveys conducted for the three new CPT codes. We noted that CPT codes 43286, 43287, and 43288 were surveyed initially in January 2016, and then were surveyed again in October 2016 together with CPT codes 43107, 43112, and 43117 due to concerns about the description of the typical patient in the original vignette and a change in the codes on the reference service list (RSL). We noted that CPT codes 43286 and 43287 had the same median intraservice time on both surveys, while CPT code 43288 had a median intraservice time that was an hour longer on its second survey (420 minutes) as compared to its first survey (360 minutes). We also noted that the total survey time for CPT code 43286 decreased from 1,058 minutes in the first survey to 972 minutes in the second survey, while the median work RVU increased from 50.00 to 65.00. We did not understand how the survey median intraservice time could increase so significantly from the first survey to the second survey for CPT code 43288, or how the surveyed times for CPT code 43286 could be decreasing while the work RVU was simultaneously increasing by 15.00 work RVUs.
Based on our analysis, it appeared that the accompanying RSL was the main difference between the two surveys; the codes on the initial RSL had a median work RVU of 44.18, while the codes on the second RSL had a median work RVU of 59.64. This increase of 15.00 work RVUs between the two RSLs that accompanied the surveys appeared to account for the increase in the work RVUs for the three new codes. We were concerned that the second survey may have overestimated the work required to perform these procedures, as the 25th percentile work RVU of the second survey was higher than the median work RVU of the initial survey for all three codes, despite no change in the median intraservice work time for CPT codes 43286 and 43287.
Given these concerns, we considered a work RVU of 50.00 for CPT code 43286, a work RVU of 60.00 for CPT code 43287, and a work RVU of 61.00 for CPT code 43288, by using the survey median work RVU from the first survey for the three new codes. For CPT codes 43107 and 43117, we considered employing the intraservice time ratio between the laparoscopic version of the procedure represented by the new code and the open version of the same procedure represented by the existing code.
We considered a work RVU of 45.00 for CPT code 43107 based on the intraservice time ratio with CPT code 43286 and a work RVU of 55.00 for CPT code 43117 based on the intraservice time ratio with CPT code 43287. CPT code 43107 has 270 minutes of intraservice time as compared with 300 minutes of intraservice time for CPT code 43286, which produces a ratio of 0.9, and when multiplied by a work RVU of 50.00 (CPT code 43286), results in the proposed work RVU of 45.00. We considered using the same methodology for CPT codes 43117 and 43287.
Finally, we considered a work RVU of 58.94 for CPT code 43112 based on a direct crosswalk to CPT code 46744 (Repair of cloacal anomaly by anorectovaginoplasty and urethroplasty, sacroperineal approach). We noted that the intraservice time ratio when applied to CPT codes 43112 and 43288, the paired McKeown esophagectomy procedures, would have produced a potential work RVU of 52.29, creating a rank order anomaly within the family by establishing a higher work RVU for CPT code 43117 than CPT code 43112, and we were concerned with whether this was an appropriate valuation for the code.
We sought comment on whether the alternative work RVUs that we considered might reflect the relative difference in work more accurately between the six codes in the family. We noted, for example, that these valuations corrected the rank order anomaly between CPT codes 43112 and 43121 as noted in the RUC recommendations.
We proposed the RUC-recommended direct PE inputs for all six codes in the family without refinement. We considered changing the preservice clinical labor type for all six codes from an RN (L051) to an RN/LPN/MTA blend (L037D). We had concerns about whether the use of RN clinical labor would be typical for filling out referral forms or for scheduling space and equipment in the facility. We also
After consideration of comments received, for CY 2018, we are finalizing the work RVUs and direct PE inputs for the codes in the esophagectomy family as proposed.
CPT code 52601 appeared on a screen of potentially misvalued codes, which indicated that it was performed less than 50 percent of the time in the inpatient setting, yet included inpatient hospital E/M services within the global period. For CY 2018, we proposed the RUC-recommended work RVU of 13.16 for CPT code 52601 and proposed to use the RUC-recommended direct PE inputs without refinements.
We considered a work RVU of 12.29 for CPT code 52601 based on a direct crosswalk to CPT code 58541 (Laparoscopy, surgical, supracervical hysterectomy, for uterus 250 g or less), which is one of the reference codes. CPT code 58541 may potentially be a more accurate crosswalk for CPT code 52601 than the RUC-recommended direct crosswalk to CPT code 29828 (Arthroscopy, shoulder, surgical; biceps tenodesis). Although all three of these codes share the same intraservice time of 75 minutes, CPT code 58541 is a closer match in terms of the total time at only 10 minutes difference. CPT code 58541 also shares the same postoperative office visits as CPT code 52601, a pair of CPT code 99213 office visits, while CPT code 29828 also contains two CPT code 99212 office visits that are not present in the reviewed code.
We noted that if we were to use a reverse building block methodology for CPT code 52601 and subtract out the value of the E/M visits being removed, the proposed work RVU would be 11.21. We did not propose this work RVU; however, because as we noted in the CY 2017 PFS final rule (81 FR 80274), we agree that the per-minute intensity of work is not necessarily static over time or even necessarily during the course of a procedure. Instead, we utilize time ratios and building block methodologies to identify potential values that account for changes in time and compare these values to other PFS services for estimates of overall work. When the values we develop reflect a similar derived intensity, we agree that our values are the result of our assessment that the relative intensity of a given service has remained similar. For CPT code 52601, we were concerned about how the RUC-recommended derived intensity of the procedure could be increasing by 30 percent over the current derived intensity, while at the same time the typical site of service was changing from inpatient to outpatient status. In other words, if it was now typical for CPT code 52601 to be performed on an outpatient basis, then we would generally expect the intensity of the procedure to be decreasing, not increasing. We considered a work RVU of 12.29 for CPT code 52601 based on a direct crosswalk to CPT code 58541 (Lsh uterus 250 g or less), and sought comment on whether this alternative value might better reflect relativity.
After consideration of comments received, for CY 2018, we are finalizing the work RVUs and direct PE inputs for CPT code 52601 as proposed.
In October 2016, the CPT Editorial Panel deleted CPT Category III code 0438T and created a new CPT code 55874 (Transperineal placement of biodegradable material, peri-prostatic, single or multiple injection(s), including image guidance, when performed). For CY 2018, we proposed the RUC-recommended work RVU of 3.03 for CPT code 55874.
In reviewing the RUC recommendations, we noted a decrease in preservice time (30 minutes) compared to the current value. In order to account for this change in time, we considered calculating the intraservice time ratio between the key reference code (CPT code 49411), which has an intraservice time of 40 minutes, and the RUC-recommended intraservice time (30 minutes) and multiplying that by the work RVU for CPT code 49411 (3.57), which would have resulted in a work RVU of 2.68. A work RVU of 2.68 would have been further supported by a bracket of two crosswalk codes, CPT code 65779 (Placement of amniotic membrane on the ocular surface; single layer, sutured), which has a work RVU of 2.50 and CPT code 43252 (Esophagogastroduodenoscopy, flexible, transoral; with optical endomicroscopy), which has a work RVU of 2.96. Compared with CPT code 55874, these codes have identical intraservice and similar total times. We sought comment on whether these alternative values should be considered, especially given the changes in time reflected in the survey data.
We received invoices with pricing information regarding two new supply items: “endocavity balloon” and “biodegradeable material kit—periprostatic.” The invoice for the endocavity balloon was $399.00 and the input price on the PE spreadsheet for this supply item was noted as such. We believed that the input price noted on the PE spreadsheet was an error, given that the invoice noted that the price of $399.00 was for a box of ten and the specialty society requested a single unit of this supply item. Therefore, we proposed to use this information to propose for supply item “endocavity balloon” a price of $39.90. The invoice for the “biodegradeable material kit—periprostatic” totaled $2,850.00. We proposed to use this information to propose for the supply item “biodegradeable material kit—periprostatic” a price of $2850.00. We also received an invoice with pricing information regarding the new equipment item “endocavitary US probe” which totaled $16,146.00. We proposed to use this information to propose for equipment item “endocavitary US probe”, a per-minute price of $0.0639. We questioned, given an invoice price of $29,999.00 for this existing equipment item EQ250 (portable ultrasound unit), whether this equipment item includes probes. We sought public comments related to
After consideration of comments received, we are finalizing the following supply and equipment prices: SD325, at a price of $39.90; SA126, at a price of $2850.00; and EQ386, at a price of $16,146.00 (a per-minute price of $0.0639).
After consideration of comments received, we are finalizing the work RVUs and direct PE inputs for CPT code 55874 as proposed.
In October 2015, CPT code 57240 was identified by analysis of the Medicare data from 2011-2013 that indicated that services reported with CPT code 57240 were performed less than 50 percent of the time in the inpatient setting, yet include inpatient hospital E/M services within the global period. The RUC recommended that CPT codes 57240 (Anterior colporrhaphy, repair of cystocele with or without repair of urethrocele), 57250 (Posterior colporrhaphy, repair of rectocele with or without perineorrhaphy), 57260 (Combined anteroposterior colporrhaphy), and 57265 (Combined anteroposterior colporrhaphy; with enterocele repair) be referred to the CPT Editorial Panel. In September 2016, the CPT Editorial Panel revised CPT codes 57240, 57260 and 57265 to preclude separate reporting of follow up cystourethroscopy after colporrhaphy (CPT code 52000).
For CY 2018, we proposed the RUC-recommended work RVUs for CPT code 57240 (a work RVU of 10.08), CPT code 57250 (a work RVU of 10.08), CPT code 57260 (a work RVU of 13.25), and CPT code 57265 (a work RVU of 15.00).
We note that there were changes in service times reflected in the specialty surveys compared to the RUC-recommended work RVUs for CPT code 57240. Specifically, we note that the RUC recommended a 48 minute decrease in total time, compared to the specialty survey total time of 259 minutes. The difference in total time reflected a decrease in preservice time (29 minutes) and inpatient visits (0.5 visits = 19 minutes). We considered a work RVU of 9.77 for CPT code 57240, crosswalking to CPT code 50590 (Lithotripsy, extracorporeal shock wave), which has similar service times. We sought comment on whether CPT code 57250 would be a relevant comparator for CPT code 57240, based on the described elements of each service and existing or surveyed service times, compared to CPT code 57240. We considered a work RVU of 11.47 for CPT code 57260 [we note that in the CY 2018 PFS proposed rule (82 FR 34000), this was cited as CPT code 57265], crosswalking to CPT code 47563 (Laparoscopy, surgical; cholecystectomy with cholangiography) with similar service times. We sought comment on how an alternative work RVU of 11.47 for CPT code 57260 [we note that in the CY 2018 PFS proposed rule (82 FR 34000), this was cited as CPT code 57260] would affect relativity among PFS services, and on whether CPT code 57265 [we note that in the CY 2018 PFS proposed rule (82 FR 34000), this was cited as CPT code 57260] is a relevant comparator for CPT code 57260 [we note that in the CY 2018 PFS proposed rule (82 FR 34000), this was cited as CPT code 57265], considering differences in the described procedures and service times.
We proposed the RUC-recommended direct PE inputs for CPT codes 57240, 57250, 57260 and 57265 without refinements.
After consideration of comments received, we are finalizing the work RVUs as proposed. We are finalizing the proposed direct PE inputs for CPT codes 57240, 57250, 57260 and 57265, without refinement.
CPT code 64418 (Injection, anesthetic agent; suprascapular nerve) was identified by the AMA through their screen of Harvard-valued codes with utilization over 30,000. We proposed the RUC-recommended work RVU of 1.10 and RUC-recommended direct PE inputs without refinement.
After consideration of the comment received that specifically addressed this code, for CY 2018, we are finalizing a work RVU of 1.10 and the proposed direct PE inputs without refinement for CPT code 64418.
The CPT Editorial Panel created two new Category I CPT codes (64912 and 64913) to report the repair of a nerve using a nerve allograft. CPT codes 64910 and 64911 were also reviewed as part of this code family. CPT codes 64912 and 64913 will be placed on the new technology list to be re-reviewed by the RUC in 3 years to ensure correct valuation and utilization assumptions.
For CY 2018, we proposed the RUC-recommended work RVUs for the following codes: A work RVU of 10.52 for CPT code 64910, a work RVU of 14.00 for CPT code 64911, a work RVU of 12.00 for CPT code 64912, and a work RVU of 3.00 for CPT code 64913.
We noted a decrease in preservice time (7 minutes) for CPT code 64910 and considered an alternate work RVU of 10.15, crosswalking to CPT code 15120 (Split-thickness autograft, face, scalp, eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or multiple digits; first 100 sq cm or less, or 1 percent of body area of infants and children (except 15050)), which has similar service times. We sought comments on whether an alternative work RVU of 10.15 for CPT code 64910 would better reflect relativity among PFS services with similar service times.
For CPT code 64911 (Nerve repair; with autogenous vein graft (includes harvest of vein graft), each nerve)), we considered a work RVU of 13.50, by crosswalking to CPT code 31591 (Laryngoplasty, medicalization, unilateral), which has similar service times and a work RVU of 13.56. We sought comments on whether a work RVU of 13.50 for CPT code 64911 would better reflect relativity among other PFS services with similar service times.
The new coding structure for these services increases granularity by including add-on codes that describe each strand of nerve repair. While we recognize that additional granularity may be important and useful for purposes of data collection, the advantages to Medicare for such granularity for purposes of payment are unclear, especially since we are unaware of a payment-related reason for such coding complexity. We considered proposing a bundled status to the new add-on codes and incorporating the relative resources in furnishing the add-on code (CPT code 64913) into the base code (CPT code 64912) based on the utilization assumptions that accompanied the RUC's recommendations. The RUC estimated that CPT code 64912 would have 750 Medicare allowed services in CY 2018, and that the corresponding add-on CPT code 64913 would have 150 Medicare allowed services in CY 2018. Therefore, the RUC estimated that CPT code 64912 will be billed without add-on CPT code 64913 for 80 percent (750/900) of the Medicare allowed services, and that CPT code 64912 will be billed with add-on CPT code time 64913 for 20 percent (150/900) of the Medicare allowed services in CY 2018. To account for the additional work involved in 20 percent of the allowed services, we added a
We proposed the RUC-recommended direct PE inputs for CPT codes 64910, 64911, 64912 and 64913 without refinements.
After consideration of comments received, we are finalizing the work RVUs for CPT codes 64910, 64911, 64912, and 64913 as proposed. We are also finalizing the proposed direct PE inputs for these codes, without refinement.
In CY 2016, CPT code 67820 was identified by the screen for high expenditure services across specialties with Medicare allowed charges of $10 million or more. The screen identified the top 20 codes by specialty in terms of allowed charges, excluding 10- and 90-day global services, anesthesia and E/M services and services reviewed since CY 2010. During the review process, the RUC re-surveyed the code and recommended a work RVU of 0.32, which we proposed in the CY 2018 PFS proposed rule.
The RUC also recommended 15 minutes of preservice time in the facility setting to complete preservice diagnostic and referral forms, coordinate pre-surgery services, schedule space and equipment in the facility, provide preservice education/obtain consent, and follow-up phone calls and prescriptions. We believed it to be atypical for a physician's staff to be performing these activities in a facility-setting with a procedure that has a 0-day global period. Therefore, we proposed removing the time associated with these activities.
We also note that in the course of refining the times associated with the clinical activities referenced above, we inadvertently reduced the time associated with the screening lane (EL006) from 11 minutes to 5 minutes.
CPT codes 70490 and 70492 were identified through the high expenditure services across specialties with Medicare allowed charges of $10 million or more screen. CPT code 70491 was also included for review as part of this code family. For CY 2018, we proposed the RUC-recommended work RVUs of 1.28 for CPT code 70490, 1.38 for CPT code 70491, and 1.62 for CPT code 70492. For CPT code 70490, we considered a work RVU of 1.07 based on a crosswalk to CPT code 72125 (Computed tomography, cervical spine; without contrast material). CPT code 72125 is a non-contrast CT service on a similar anatomical area and has identical intraservice and total times to those recommended by the RUC for CPT code 70490. We also considered work RVUs of 1.17 for CPT code 70491 and 1.41 for CPT code 70492. We sought comment on how relativity among other CT services paid under the PFS would be affected by applying the alternative work RVUs described above for CPT codes in this family.
After consideration of the public comments, we are finalizing the RUC-recommended work RVUs as proposed.
CPT code 70544 was identified by a screen of services across specialties with Medicare allowed charges of $10 million or more. Subsequently, CPT codes 70545 and 70546 were also reviewed as part of this code family. We proposed the RUC-recommended work RVUs of 1.20 for CPT code 70544, 1.20 for CPT code 70545, and 1.48 for CPT code 70546. We also proposed the following refinements to the RUC-recommended direct PE inputs. For the service period clinical labor activity “Provide preservice education/obtain consent,” we proposed 5 minutes for CPT code 70544, 7 minutes for CPT code 70545, and 7 minutes for CPT code 70546 so that the times for this activity are consistent with other magnetic resonance (MR) services performed without-contrast materials, with-contrast materials, and without-and-with contrast materials, respectively. For the clinical labor task “Acquire images,” we proposed using the RUC-recommended clinical time of 26 minutes for CPT code 70544. We considered proposing 20 minutes of clinical time to maintain the relativity among the three codes in this family and for consistency with other MRA and magnetic resonance imaging (MRI) codes, which do not typically assign more clinical labor time to this task for services without contrast material than for services with contrast material. We sought comment as to the appropriate time value for this clinical labor task. For the clinical labor task “Technologist QCs images in PACS, checking all images, reformats, and dose page,” we proposed to refine the clinical labor time from the RUC recommended 4 minutes to 3 minutes to comply with the standards.
After consideration of the comments, we are finalizing these PE refinements as well as the RUC-recommended work RVUs, as proposed.
CPT code 70549 was identified through a high expenditure screen. CPT codes 70547 and 70748 were also reviewed as part of this family of codes. We proposed the RUC-recommended work RVUs of 1.20 for CPT code 70547, 1.50 for CPT code 70548, and 1.80 for CPT code 70549. We also proposed several refinements to the RUC-recommended direct PE inputs for these services. For the service period clinical labor activity “Provide preservice education/obtain consent,” we proposed 5 minutes for CPT code 70547, 7 minutes for CPT code 70548, and 7 minutes for CPT code 70549 so that the times for this activity are consistent with other MR services performed without contrast material, with contrast material, and without-and with contrast material, respectively. For the intraservice clinical labor task acquire images, for CPT code 70547, we proposed to use the RUC-recommended 26 minutes. We considered applying 20 minutes to this clinical labor task, which would have maintained consistency with the 20 minutes recommended by the RUC for CPT code 70548 (the service that includes with-contrast material). We stated concern about the lack of evidence that a non-contrast MRA would require more clinical labor time than the with-contrast MRA service. We sought comment as to the appropriate time value for this clinical labor task. For the clinical labor task “Technologist QCs images in PACS, checking all images, reformats, and dose page,” we proposed to refine the clinical labor time from the RUC recommended 4 minutes to 3 minutes to comply with the standards.
CMS identified this code family through the high expenditures screen. We proposed the RUC-recommended work RVUs of 1.16 for CPT code 71250, 1.24 for CPT code 71260, and 1.38 for CPT code 71270. For CPT code 71250, we considered maintaining the CY 2017 work RVU of 1.02. We stated that we are concerned with the lack of evidence that the physician time or intensity of furnishing this service has changed since it was last valued. In addition, we noted that a comparison to other CT codes indicated that the RUC-recommended work values could be overvalued relative to other CT services and compared to similar, non-contrast CT studies such as CPT codes 72131 (Computed tomography, lumbar spine; without contrast material) and 73700 (Computed tomography, lower extremity; without contrast material), both of which have work RVUs of 1.00. For CPT code 71260, we considered proposing a work RVU of 1.10 by applying the RUC-recommended increment between CPT code 71250 and 71260 (0.08) to CPT code 71260. For CPT code 71270, we considered a work RVU of 1.24 by applying the RUC-recommended increment between CPT codes 71260 and 71270 (0.22) to CPT code 71270. In addition to maintaining relatively among the codes in this family, we considered further supporting these alternative values based on a comparison to other CT studies, such as with-contrast material CT studies, and without-and-with contrast CT studies. While noting our concerns, we proposed the RUC recommended work RVUs for CPT code 71250, 71260, and 71270 and sought comment on whether our alternative values would improve relativity.
After consideration of the public comments, we are finalizing the RUC-recommended values as proposed.
CPT codes 74182 and 72196 were identified as part of the screen of high expenditure services across specialties with Medicare allowed charges of $10 million or more. CPT codes 74181, 74183, 72195, and 72197 were also reviewed as part of this code family. We proposed the RUC-recommended work RVUs of 1.46 for CPT code 72195, 1.73 for CPT code 72196, 2.20 for CPT code 72197, 1.46 for CPT code 74181, 1.73 for CPT code 74182, and 2.20 for CPT code 74183. While we proposed the RUC-recommended direct PE inputs, we considered 30 minutes for clinical labor task “Acquire images” for CPT codes 74181 and 74182, which we stated appeared to be more consistent with the codes in this family and more consistent with other MR codes. We also noted that for CPT codes 74181 and 74182, the clinical labor time for acquired images appears to have been developed through a consensus panel from the specialty society over 15 years ago. Given that these times are estimates based on expert panel consensus rather than survey data, we sought comment on whether using a structure that matches other MR code families would be more appropriate to value these clinical labor times.
CPT codes 73718 and 73720 were identified as part of the screen of high expenditure services, and CPT code 73719 was included for review as part of the code family. We proposed the RUC-recommended work RVUs of 1.35 for CPT code 73718, 1.62 for CPT code 73719, and 2.15 for CPT code 73720. We are also proposing the following refinements to the RUC-recommended direct PE inputs. For the service period clinical labor activity “Provide preservice education/obtain consent,” we proposed 5 minutes for CPT code 73718, 7 minutes for CPT code 73719, and 7 minutes for CPT code 73720. Likewise, for the service period task “Prepare room, equipment, supplies,” we proposed 3 minutes for CPT code 73718, 5 minutes for CPT code 73719, and 5 minutes for CPT code 73720. We proposed these changes to maintain consistency with other MR services without contrast materials, with contrast materials, and without-and-with contrast materials, respectively.
CPT codes 74000 (Radiologic examination, abdomen; single anteroposterior view) and 74022 (Radiologic examination, abdomen; complete acute abdomen series, including supine, erect, and/or decubitus views, single view chest) were identified via a high expenditure screen. The CPT Editorial Panel created CPT codes 7401874018, 7401974019, and 7402174021to replace CPT codes 74000, 74010, and 74020. The RUC suggested a utilization scenario that assumes that 25 percent of services currently reported with CPT code 74010 will be reported with CPT code 74019 and 75 percent will be reported with CPT code 74021; and 75 percent of services currently reported with CPT code 74020 will be reported with CPT code 74019 and 25 percent will be reported with CPT code 74021. In the CY 2018 PFS proposed rule, we stated that we did not identify evidence or a rationale for these assumptions. For
This code family was identified through the $10 million or more screen of high expenditure services. We proposed the RUC-recommended work RVUs of 1.75 for CPT code 75710 and 1.97 for CPT code 75716. We also proposed to use the RUC-recommended direct PE inputs for CPT codes 75710 and 75716, with the following refinements. For the clinical labor task “Technologist QC's images in PACS, checking for all images, reformats, and dose page,” we proposed refinements consistent with the standard clinical labor times for tasks associated with the PACS Workstation. We also proposed to refine the clinical labor by removing the 2 minutes associated with the task “prepare room, equipment, and supplies.” CPT codes 75710 and 75716, which represent radiological supervision and interpretation, are billed with codes that include activities such as needle placement and imaging, and the “prepare room, equipment, supplies,” activity will be accounted for with the codes that are billed with these interpretation codes.
After consideration of the comment we received, we are finalizing these PE refinements as well as the RUC-recommended work RVUs, as proposed.
In the CY 2016 PFS final rule with comment period, CMS identified CPT codes 76519 and 92136 as potentially misvalued on the high expenditure screen. For CY 2018, we proposed the RUC-recommended work RVUs for each code in this family as follows: 0.40 for CPT code 76516, 0.54 for CPT code 76519, and 0.54 for CPT code 92136.
For CPT codes 76519 and 92136, the RUC recommended adding an additional 8 minutes of immediate postservice time for dictating the report of the procedure for the medical record, review and sign report, communicate results to the patient, discussing lens implant options for desired postoperative refractive result, and entering an order for the intraocular lens implant. We considered time and work values that would not include the additional 8 minutes of immediate postservice time in either of these codes, due to the concern that the additional time may not reflect the typical case. Were we to not include those 8 minutes, each of these procedures would have a total time of 14 minutes. We considered applying the total time ratio (decrease from 17 minutes to 14 minutes; ratio of 0.824) to the RUC-recommended work RVU of 0.54, which would have resulted in a work RVU of 0.44 for CPT codes 76519 and 92136. We sought comment on whether these alternative values would improve relativity.
The RUC identified CPT codes 76881 and 76882 for review only of PE inputs. For CPT code 76881, we proposed the RUC-recommended inputs with refinements. We proposed to remove 1 minute from the clinical labor task “Exam documents scanned into PACS. Exam completed in RIS system to generate billing process and to populate images into Radiologist work queue,” because this code does not include any equipment time for the PACS workstation proxy or professional PACS workstation. We noted that the RUC-recommended inputs shift the general ultrasound room from the PE inputs for CPT code 76881 to the PE inputs for CPT code 76882. We proposed to make this change, consistent with the RUC recommendations; however, we sought comment on whether a portable ultrasound unit would be a more accurate PE input for both codes, given that the dominant specialty for both of these services is podiatry, based on available 2016 Medicare claims data. As noted in the CY 2018 PFS proposed rule, we proposed that these codes would not be subject to the phase-in of significant RVU reductions given the significance of this shift of resource costs between codes in the same family and sought comment on this proposed application of the phase-in policy.
Furthermore, these commenters stated that valuing CPT code 76882, which is the limited ultrasound procedure, at a higher price than CPT code 76881, which is the complete ultrasound procedure, represents a rank order anomaly. The RUC disagreed with our statement that podiatry is the dominant
The flow cytometry interpretation family of codes is split into a pair of codes used to describe the technical component of flow cytometry (CPT codes 88184 and 88185) that do not have a work component, and a trio of codes (CPT codes 88187, 88188, and 88189) that do not have direct PE inputs, as they are professional component only services. CPT codes 88184 and 88185 were reviewed by the RUC in April 2014, and their CMS-refined values were included in the CY 2016 PFS final rule with comment period. These codes were reviewed again at the January 2016 RUC meeting, and new recommendations were submitted to CMS as part of the CY 2017 PFS rulemaking cycle. In the CY 2017 PFS final rule (81 FR 80325), we finalized all of the direct PE inputs for CPT codes 88184 and 88185, as proposed, except for the proposed refinement to the dye sublimation printer.
As discussed in the potentially misvalued services section of this final rule (section II.E), we have received conflicting information about the direct PE inputs for CPT codes 88184 (Flow cytometry, cell surface, cytoplasmic, or nuclear marker, technical component only; first marker) and 88185 (Flow cytometry, cell surface, cytoplasmic, or nuclear marker, technical component only; each additional marker). Therefore, in the CY 2018 PFS proposed rule, we proposed these codes as potentially misvalued so that they can be reviewed again because some stakeholders have suggested the clinical labor and supplies that were previously finalized are no longer accurate. In response to the CY 2018 PFS proposed rule, several commenters urged CMS to use the RUC's recommendations for CY 2017 in developing final PE RVUs for these services instead of recommending additional review under the misvalued code initiative. Based on this suggestion from the commenters, which appears to reflect a broad consensus, we have re-examined the CY 2017 RUC-recommended direct PE inputs for these services, in light of the specific comments. In the paragraphs below, we summarize the direct PE inputs that we are changing based on these comments.
After consideration of the comments received as part of the CY 2018 rule cycle, we are updating the direct PE inputs finalized in CY 2017 for CPT codes 88184 and 88185 with the changes detailed above.
CPT codes 88333 and 88334 were surveyed for both work and PE for the CY 2018 rule cycle. We proposed the RUC-recommended work RVU of 1.20 for CPT code 88333 and the RUC-recommended work RVU of 0.73 for CPT code 88334. For the direct PE inputs, we proposed to remove the clinical labor for the “Prepare room. Filter and replenish stains and supplies (including setting up grossing station with colored stains)” activity from CPT code 88333. This clinical labor is not currently included in the direct PE inputs for CPT code 88333, and we believed that this is a form of indirect PE that is not individually allocable to a particular patient for a particular service. While we agreed that replenishing stains and supplies is a necessary task, under the established methodology, we believed that it is more appropriately classified as indirect PE.
We proposed to refine the clinical labor time for “Clean room/equipment following procedure” activity for CPT code 88333, consistent with the standard clinical labor time assigned for room cleaning when used by laboratory services. We sought comments related to the equipment time assigned to the “grossing station w-heavy duty disposal” (EP015) for CPT codes 88333 and 88334. Although the recommended equipment time of 10 minutes maintains the current equipment time assigned to the grossing station, and we had no reason to believe that this time is incorrect, it was unclear to us how this equipment time was derived.
After consideration of comments received, for CY 2018, we are finalizing the work RVUs and direct PE inputs for the codes in the pathology consultation during surgery family as proposed, with the exception of the refinement to the “Prepare room. Filter and replenish stains and supplies (including setting up grossing station with colored stains)” clinical labor time as detailed above. We are also finalizing an add-on global period (ZZZ) for CPT code 88334 as the RUC recommended.
CPT code 77263 was identified through a screen of high expenditure services across specialties. CPT codes 77261 and 77262 were included for review. For CY 2018, we proposed the RUC-recommended work RVUs of 1.30 for CPT code 77261, 2.00 for CPT code 77262, and 3.14 for CPT code 77263. However, we stated that we had concerns regarding the RUC-recommended work RVUs given the decreases in service times as recommended by the RUC and reflected in the survey data compared to the current values. For CPT code 77263, we considered a work RVU of 2.60 based on a crosswalk to CPT code 96111 (Developmental testing, (includes assessment of motor, language, social, adaptive, and/or cognitive functioning by standardized developmental instruments) with interpretation and report), which has an identical intraservice time, and similar total time to the RUC-recommended time values for CPT code 77263. We expressed concern that despite a 15 minute decrease in intraservice time, the RUC did not recommend a work RVU decrease. We noted that the majority of the utilization among the codes in this family would be reported with CPT code 77263. Therefore, we considered using a work RVU of 2.60 for CPT code 77263 as a base for alternative valuations for CPT codes 77261 and 77262 by applying the ratio of the crosswalk work RVU of CPT code 96111 (Developmental test extend) to the RUC-recommended work RVU of CPT code 77263 (that is, 2.60/3.14 = 0.83) to the RUC-recommended work RVU for CPT code 77261 (that is, 0.83 × 1.30 = 1.08) and CPT code 77262 (that is, 0.83 × 2.0 = 1.66), which would have resulted in work RVUs of 1.08 for CPT code 77261 and 1.66 for CPT code 77262. We sought comments on whether the alternative valuation would be more appropriate for these codes.
After consideration of the comments, we are finalizing the RUC-recommended work RVUs as proposed.
CPT codes 88360 and 88361 appeared on a high expenditure services screen across specialties with Medicare allowed charges of over $10 million. We proposed the RUC-recommended work RVU of 0.85 for CPT code 88360 and the RUC-recommended work RVU of 0.95 for CPT code 88361.
We proposed to refine the clinical labor time for the “Enter patient data, computational prep for antibody testing, generate and apply bar codes to slides, and enter data for automated slide stainer” activity for both codes, consistent with the standard time for this clinical labor activity across different pathology services. For CPT code 88361, we also proposed to remove the 1 minute of clinical labor time from the “Performing instrument calibration, instrument qc and start up and shutdown” and the “Gate areas to be counted by the machine” activities. These clinical labor activities do not appear in other recently reviewed computer-assisted pathology codes. We believe that these clinical labor activities would not be typical for CPT code 88361 and are already included in the allocation of indirect PE, consistent with our established methodology.
We proposed to remove the clinical labor time for “Clean room/equipment following procedure” for CPT codes 88360 and 88361, as we believed that this clinical labor is duplicative of the 4 minutes of clinical labor assigned to “Clean equipment and work station in histology lab”. We also proposed to remove the clinical labor time for the “Verify results and complete work load recording logs” and the “Recycle xylene from tissue processor and stainer” activities for CPT codes 88360 and 88361. As we stated in previous rules, such as in the CY 2017 PFS final rule (81 FR 80319), we believed these clinical labor activities were already included in the allocation of indirect PE, consistent with our established methodology.
We proposed to refine the equipment time for the “Benchmark ULTRA auto slide prep & E-Bar Label system” (EP112) from 18 minutes to 16 minutes for both codes. The RUC-recommended equipment time of 18 minutes was an increase of 3 minutes from the current EP112 equipment time to incorporate the equipment time of the “E-Bar II Barcode Slide Label System” (EP113), which the recommended materials have clarified is part of the EP112 equipment item. We proposed to add 1 minute over the current value of 15 minutes to the EP112 equipment time to reach the aforementioned 16 minutes, as we believed that this would be more typical for the slide labeling taking place.
For CPT code 88361, we proposed to maintain the current price of $195,000.00 for the DNA image analyzer (EP001) equipment, as the submitted invoice contained a series of unrelated items that have been crossed out, making it difficult to determine the cost of the equipment. We considered refining the equipment time for the DNA image analyzer from 30 minutes to 5 minutes. The equipment literature for
We also agree with the commenter that we did not finalize a standard clinical labor time for this particular clinical labor task. However, we believe that the clinical labor described here under “generate and apply bar codes to slides” is broadly analogous to the clinical labor task “Complete workload recording logs. Collate slides and paperwork. Deliver to pathologist” in CPT codes 88321, 88323, and 88325, which were addressed in the CY 2017 PFS final rule (81 FR 80325-80326) and were finalized with 1 minute of clinical labor time. Although we agree that the unique nature of pathology and laboratory services can make comparisons across codes more difficult than in other services, we believe the comparison of similar clinical labor activities across different services is important to maintaining the relativity of the direct PE inputs. Since we have typically allocated 1 minute to the labeling of slides in other recently reviewed laboratory services, and we have no reason to believe that CPT codes 88360 and 88361 would not be typical, we are finalizing a clinical labor time of 1 minute for this activity.
After consideration of the comments, we are finalizing our proposed equipment time of 30 minutes instead of the alternative equipment time. We are finalizing a price of $248,946.30 for this equipment, based on the submitted price of $258,042.30 minus the price of the user training ($6,800.00), the instructor-led online training ($646.00) and the shipping and handling costs ($1,650.00). These costs are allocated through the indirect allocation under the established PE methodology. We are also finalizing the name change to the EP001 equipment, as requested by the commenters.
After consideration of comments received, for CY 2018, we are finalizing the work RVUs for the codes in the tumor immunohistochemistry family as proposed. We are finalizing the direct PE inputs for these codes, as proposed, along with the refinements detailed above in response to the comments.
As part of the CY 2016 PFS final rule with comment period (80 FR 70914), several services in this family (reported with CPT codes 93288, 93293, 93294, 93295, and 93296) were identified as potentially misvalued through the high expenditure by specialty screen. Seven of the 21 services in this family involve remote monitoring of cardiovascular devices, and two of these services (reported with CPT codes 93296 and 93299) are valued for PE only. In the CY 2018 PFS proposed rule, we proposed the RUC-recommended work RVUs for the 19 CPT codes in this family that are valued with physician work as follows: 0.65 for CPT code 93279, 0.77 for CPT code 93280, 0.85 for CPT code 93281, 0.85 for CPT code 93282, 1.15 for CPT code 93283, 1.25 for CPT code 93284, 0.52 for CPT code 93285, 0.30 for CPT code 93286, 0.45 for CPT code 93287, 0.43 for CPT code 93288, 0.75 for CPT code 93289, 0.43 for CPT code 93290, 0.37 for CPT code 93291, 0.43 for CPT code 93292, 0.31 for CPT code 93293, 0.60 for CPT code 93294, 0.74 for CPT code 93295, 0.52 for CPT code 93297, and 0.52 for CPT code 93298.
For CPT code 93293, we considered a work RVU of 0.91 (25th percentile survey result) and sought comment on
As noted in this section of the final rule, several of the CPT codes (99392, 99294, 99295, 99297, and 99298) reviewed by the RUC in January 2017 involve remote monitoring services for cardiac devices. We agreed with the RUC that these services are difficult to value considering that the monitoring duration (number of days between 30 and 90) and the average number of transmissions vary. We also noted that these codes were surveyed twice, and in both cases the intraservice and total times were considered by the specialty societies to be inconsistent with existing times. The RUC explained that it extrapolated total and intraservice time data for these codes and warned against making comparisons. Without additional information about the methods and sources used for extrapolation, however, we had no basis for assuming the imputed values are of higher quality and/or accuracy than those from the survey. We did not agree, therefore, that survey results should not be used as a point of comparison in the context of other factors, particularly when they are used to support other considerations.
Although we proposed the RUC-recommended work RVUs for each of these CPT codes, we considered alternative values. The RUC recommended a work RVU of 0.31 for CPT code 93293, which is 0.01 work RVUs lower than the existing work RVU for this code. We have concerns that the amount of the reduction in the work RVU recommended by the RUC may not be consistent with the decrease in total time of 7 minutes. We considered an alternative crosswalk for CPT code 93293 (Pm phone r-strip device eval) (5 minutes intraservice time and 13 minutes total time) to CPT code 94726 (Pulm funct tst plethysmograp), which has 5 minutes intraservice time and 15 minutes total time and a work RVU of 0.26. We sought comments on our proposed and alternative valuations for this code.
For CPT code 93294, we considered a work RVU of 0.55, crosswalking from CPT code 76706 (Us abdl aorta screen aaa), and sought comments on whether it would better align with the RUC-recommended service times. We were concerned that a work RVU of 0.60 may not account for the difference between existing service times and the RUC-recommended service times. Similarly, the RUC recommended a work RVU for CPT code 93294 of 0.60, which is 0.05 work RVUs less than the existing work RVU. The total time for furnishing services reported with CPT code 93294 decreased by 10 minutes, however, and we believe this reduction in time may not be appropriately reflected by a decrease of 0.05 work RVUs. Compared to services with similar total and intraservice times, we identified CPT code 76706 (Us abdl aorta screen aaa) as a potentially more appropriate crosswalk. CPT code 76706 has identical intraservice and total service times as CPT code 93294, with a work RVU of 0.55. We sought comments on whether our alternative value would better reflect the time and intensity involved in furnishing this service.
For CPT code 93295, we considered a work RVU of 0.69, crosswalking to CPT code 76586, which has identical intraservice and total times compared to CPT code 93295. We considered using a work RVU of 0.69 to maintain the differential between CPT code 93295 and the work RVU we considered for the previous code in this family (a work RVU of 0.11 for CPT code 93295). We were concerned about the decrease in service time compared to the work RVU. We noted that the existing intraservice time is 22.5 minutes, compared to the RUC-recommended intraservice time of 10 minutes. We sought comments on whether our alternative value would better reflect the time and intensity involved in furnishing this service.
For CPT code 93298, the RUC recommended a work RVU of 0.52, which is unchanged from the current work RVU for this code. We were concerned about that recommendation given the reduction in both intraservice and total time for this service. The intraservice time decreased from 24 to 7 minutes, while total time decreased from 44 to 17 minutes. We acknowledged that the current times for this CPT code and others in this family are extrapolations. However, without additional information about the extrapolation of data from survey results, we question whether the survey results should be excluded from consideration altogether. We considered a work RVU of 0.37 for CPT code 93297, crosswalking to CPT code 96446 (Chemotx admn prtl cavity). We also considered a work RVU of 0.37 for CPT code 93298 based on a crosswalk to CPT code 96446, since the RUC indicated that the work RVUs for CPT codes 93297 and 93298 should be the same. We sought comment on our proposed valuation and whether our alternative valuation would be more appropriate for this code.
We proposed the RUC-recommended direct PE inputs with the following refinements. We proposed to remove 2 minutes for “review charts” from CPT codes 93279, 93281, 93282, 93283, 93284, 93285, 93286, 93287, 93288, 93289, 93290, 93291, and 93292 to maintain relativity since it is not typically incorporated for similar PFS codes. We also proposed removing 2 minutes for “complete diagnostic forms, lab & X-ray requisitions” for the labor category “med tech/asst” (L026A) for these services because we believe the same activity is being performed by labor category RN/LPN/MTA (L037D). We sought comments regarding whether this row was included in error. For the same group of CPT codes, we also proposed standard refinements for the time for equipment items EF023 and EQ198.
We proposed to use the RUC-recommended direct PE inputs and times for all other CPT codes in this family (CPT codes 93293, 93294, 93295, 93296, 93297, 93298, and 93299) without refinement.
In the CY 2016 PFS final rule with comment period (80 FR 70914), CMS identified CPT code 93306 through the high expenditures screen. Subsequently, the RUC reviewed CPT codes 93307 and 93308, in addition to CPT code 93306, as part of this family of codes that describe transthoracic echocardiograms. In the CY 2018 PFS proposed rule, we proposed the RUC-recommended work RVUs for CPT codes 93306 (a work RVU of 1.50), 93307 (a work RVU of 0.92), and 93308 (a work RVU of 0.53), and proposed the RUC-recommended direct PE inputs for CPT codes 93306, 93307, and 93308 without refinement.
For CPT code 93306 (Echocardiography, transthoracic, real-time with image documentation (2D), includes M-mode recording, when performed, complete, with spectral Doppler echocardiography, and with color flow Doppler echocardiography), we considered maintaining the CY 2017 work RVU of 1.30. The surveyed total time for this code dropped slightly due to changes in the immediate postservice time. The median preservice and intraservice time remained unchanged.
For CPT code 93307 (Echocardiography, transthoracic, real-time with image documentation (2D), includes M-mode recording, when performed, complete, without spectral or color Doppler echocardiography), we considered a work RVU of 0.80, crosswalking to services with similar service times (CPT codes 93880 (Duplex scan of Extracranial arteries; complete bilateral study), 93925 (Duplex scan of lower extremity arteries or arterial bypass grafts; complete bilateral study), 93930 (Duplex scan of upper extremity arteries or arterial bypass grafts; complete bilateral study), 93976 (Duplex scan of arterial inflow and venous outflow of abdominal, pelvic, scrotal contents and/or retroperitoneal organs; limited study), and 93978 (Duplex scan of aorta, inferior vena cava, iliac vasculature or bypass grafts; complete study)). The surveyed total time dropped 3 minutes (from the intraservice time) compared to the existing service times for this code.
For CPT code 93308 (Echocardiography, transthoracic, real-time with image documentation (2D), includes M-mode recording, when performed, follow-up or limited study), we considered a work RVU of 0.43, crosswalking to CPT code 93292 (Interrogation device evaluation (in person) with analysis, review and report by a physician or other qualified health care professional, includes connection, recording and disconnection per patient encounter; wearable defibrillator system) based on similar service times. The surveyed total time dropped by 5 minutes (from the intraservice time) compared to the existing service times for this code.
For CY 2018, we proposed the RUC-recommended work RVUs for CPT codes 93306, 93307, and 93308 and sought comments on whether our alternative values would have better reflected the time and intensity of these services.
After consideration of the comments received that specifically addressed this code family, for CY 2018, we are finalizing a work RVU of 1.50 for CPT code 93306, a work RVU of 0.92 for CPT code 93307, and a work RVU of 0.53 for CPT code 93308, as proposed. We are also finalizing the proposed direct PE inputs without refinement for all codes in this family.
CPT code 93351 was identified as potentially misvalued and the RUC reviewed CPT code 93350 as part of the same code family. In the CY 2018 PFS proposed rule, we proposed the RUC-recommended work RVUs for CPT codes 93350 (a work RVU of 1.46) and 93351 (a work RVU of 1.75).
We proposed the following refinements to the RUC-recommended direct PE inputs for CPT codes 93350 and 93351. For both codes, we applied the standard formula in developing the minutes for equipment item ED053 (professional PACS workstation), which results in 18 minutes for CPT code 93350 and 25 minutes for CPT code 93351. We also proposed standard clinical labor times for providing preservice education/obtaining consent. We did not propose to include clinical labor time for the task setup scope since there is no scope used in the procedure and we did not agree with the RUC's statement that this replicates 5 minutes in CPT code 93015 when the RN prepares patients for 10-lead ECG. We found that there was no corresponding time of 5 minutes for setup scope in the PE inputs for CPT code 93015. We proposed refinements to the equipment time for ED050 (PACS workstation proxy) for CPT code 93351, consistent with our standard equipment times for PACS Workstation Proxy.
We have issued a national coverage determination (NCD) for Medicare
For CY 2018, we proposed to make payment for Medicare-covered SET for the treatment of PAD, consistent with the NCD, reported with CPT code 93668. For CPT code 93668, we proposed to use the most recent RUC-recommended work and direct PE inputs. We are also sought comment on the coding structure and valuation assumptions. Since the RUC has not reviewed CPT code 93668 since 2001, we sought comments on the direct PE inputs assigned to the code, which appear in the direct PE input database. We also noted that CPT code 93668 is a PE-only code and does not include physician work.
CPT prefatory language states that CPT code 93668 may be separately reported with appropriate E/M services, including office and/or outpatient services (CPT codes 99201 through 99215), initial hospital care (CPT codes 99221 through 99223), subsequent hospital care (CPT codes 99231 through 99233), and critical care services (CPT codes 99291 through 99292). Our understanding of CPT's prefatory language is that these E/M codes may only be billed when review or exam of the patient is medically indicated and must conform to all existing E/M documentation requirements. E/M visit codes should not be billed to account for supervision of SET for the treatment of PAD by a physician or other qualified healthcare practitioner. We sought comments on whether to develop professional coding to reflect the supervision of clinical staff, and on the potential overlap with CPT code 99211 (Office or other outpatient visit for the evaluation and management of an established patient, that may not require the presence of a physician or other qualified health care professional. Usually, the presenting problem(s) are minimal. Typically, 5 minutes are spent performing or supervising these services.) and any distinctions between time spent by clinical staff for CPT code 99211 and time spent by clinical staff for CPT code 93668.
After consideration of these public comments, we are finalizing the RUC-recommended values for CPT code 93668, as proposed.
In October 2015, AMA staff assembled a list of all services with total Medicare utilization of 10,000 or more that have increased by at least 100 percent from 2008 through 2013, and these services were identified on that list. The RUC recommended that HCPCS codes G0248, G0249 and G0250, which describe related INR monitoring services, be referred to the CPT Editorial Panel to create Category I codes to describe these services.
For CY 2018, the CPT Editorial Panel is deleting CPT codes 99363 and 99364 and creating new CPT codes 93792 (Patient/caregiver training for initiation of home INR monitoring under the direction of a physician or other qualified health care professional, including face-to-face, use and care of the INR monitor, obtaining blood sample, instructions for reporting home INR test results, and documentation of patient's/caregiver's ability to perform testing and report results) and 93793 (Anticoagulant management for a patient taking warfarin, must include review and interpretation of a new home, office, or lab International Normalized Ratio (INR) test result, patient instructions, dosage adjustment (as needed), and-scheduling of additional test(s) when performed). CPT code 93792 is a technical component-only code. With the creation of CPT codes 93792 and 93793, the RUC recommended that CMS delete HCPCS codes G0248, G0249 and G0250.
For CPT code 93793, we proposed the RUC-recommended work RVU of 0.18. Because HCPCS codes G0248, G0249 and G0250 are used to report related services under a Medicare National Coverage Determination, we did not propose to delete the G-codes.
In reviewing the recommended PE inputs for these services, we obtained updated invoices for prices for particular items. We proposed to use the invoices to update the price of the supply “INR test strip” (SJ055). We obtained publically available pricing information from two vendors. The pricing from one vendor indicated the price for a box of 24 of supply item SJ055 item (INR test strip) is $150.00, which equated to a unit price of $6.25. Pricing from a second vendor indicated the price of a box of 48 of the supply item SJ055 to be $233.00, which equated to a unit price of $5.06. The average price of these two unit prices is $5.66.
Therefore, we proposed to re-price SJ055 from $21.86 to $5.66 for CPT code 93792. We sought public comments on current pricing for the INR test strip supply.
This commenter discussed “home-use” vs “professional-use only” INR test strips, noting that the method CMS used to re-price SJ055 was incorrect because
Furthermore, given that beneficiaries are generally responsible for paying cost-sharing, the re-price of $20.31 recommended by the commenter would increase beneficiary cost-sharing. Also, as discussed in the CY 2017 PFS final rule (81 FR 80525), after reviewing the public comments in response to the CY 1998 PFS proposed rule, we finalized in Phase I significant revisions with respect to the scope of the volume or value standard. We revised our interpretation of the “volume or value” standard for purposes of section 1877 of the Act to permit, among other things, payments based on a unit of service, provided that the unit-based payment is fair market value and does not vary over time (66 FR 876 through 879).
After consideration of the comments received, we will finalize the re-price of SJ055 as proposed, and increase the number of INR test strips by two as recommended by commenters.
After consideration of the comments received, we will finalize the re-price of SJ055 as proposed, but will increase the number of INR test strips by two, as recommended by commenters. We will also increase the number of lancets and alcohol swab-pads by two each, which we believe are typically used to furnish this service. For CPT code 93793, we are finalizing the RUC-recommended work RVU of 0.18 for CY 2018, as proposed.
CPT code 94620 was identified as part of a screen of high expenditure services with Medicare allowed charges of $10 million or more that had not been recently reviewed. CPT code 94621 was added to the family for review. The CPT Editorial Panel deleted CPT code 94620 and split it into two new codes, CPT codes 94617 and 94618, to describe two different tests commonly performed for evaluation of dyspnea. We proposed the RUC-recommended work RVUs of 1.42 for CPT code 94621, 0.70 for CPT code 94617, and 0.48 for CPT code 94618.
We proposed to refine the clinical labor time for the “Provide preservice education/obtain consent” activity from 10 minutes to 5 minutes for CPT code 94621, which is the current time assigned for this task. While we agree that CPT code 94621 requires additional time above the standard for this clinical labor activity, we do not believe that double the current time would be typical for this procedure. We also proposed to refine the clinical labor time for the “Prepare and position patient/monitor patient/set up IV” activity from 5 minutes to 3 minutes for the same code. The standard time for this activity is 2 minutes, and we proposed a value of 3 minutes to reflect 1 minute of additional preparation time above the standard. We believed that additional clinical labor time used for preparation would be included under the 10 minutes assigned to the “Prepare room, equipment, supplies” activity for this code.
We proposed to refine the clinical labor time for the “Complete diagnostic forms, lab & X-ray requisitions” activity, consistent with the standard clinical labor time for this activity. We also proposed to refine the equipment times for CPT codes 94621 and 94617 to account for 1:4 patient monitoring time, and to refine the equipment times for CPT code 94618 consistent with standards for non-highly technical equipment.
We considered refining the clinical labor time for the “pre exercise ECG, VC, Min Vent. Calculation” activity from 27 minutes to 15 minutes for CPT code 94621. We considered proposing this value of 15 minutes based on assigning 5 minutes apiece for the ECG, the MVV, and the spirometry. We believed that each of these three components of this clinical labor activity would typically take no longer than 5 minutes based on a comparison to the use of these tasks in other CPT codes. We also considered refining the clinical labor time for the “Clinical staff performs procedure” activity from 55 minutes to 35 minutes for CPT code 94617 and from 14 minutes to 12 minutes for CPT code 94621. The RUC-recommended materials for the PE inputs state that this clinical labor task consists of performing 5 spirometries at 9 minutes each plus 10 minutes of exercise time for CPT code 94617; we believed that the spirometries typically take 5 minutes each, which would reduce this activity from 55 minutes to 35 minutes. For CPT code 94621, we considered maintaining the current value of 12 minutes due to a lack of justification for increasing the time to 14 minutes.
While we remained concerned about the intraservice period clinical labor times, for CY 2018, we proposed the RUC-recommended work RVUs for each code in this family and sought comment on whether our alternative clinical labor times would better reflect the work and times for these services.
After consideration of comments received, for CY 2018, we are finalizing the work RVUs for the codes in the pulmonary diagnostic tests family as proposed. We are finalizing the direct PE inputs for these codes as proposed along with the refinements detailed above in response to the comments.
In the CY 2016 PFS proposed rule (80 FR 41706), CPT code 95004 was identified through the high expenditures screen as potentially misvalued. The RUC suggested in its comments on the CY 2016 PFS proposed rule (80 FR 41706), that CPT code 95004 should be removed from the list of potentially misvalued codes because it has a work RVU of 0.01 and that it would serve little purpose to survey physician work for this code. The RUC and CMS previously determined that there is physician work involved in providing this service since the physician must interpret the test and prepare a report. In the CY 2016 PFS final rule with comment period (80 FR 70913), CMS reiterated an interest in the review of work and PE for this service.
We note that our interest in stakeholder review of a particular code should not be considered a directive for survey under the RUC process. We intend to more clearly state our interests in the future, so that under similar circumstances, such effort need not be undertaken based on a mistaken impression. To reiterate, we believed that whether or not a code should be surveyed in response to our interest in receiving recommendations regarding the work RVUs should be at the discretion of the RUC and the specialty societies. In many cases, we have used recommendations developed through means other than surveys in developing RVUs. For example, for many PFS services, the direct PE inputs are the primary drivers of overall RVUs and Medicare payment. In most of these cases, the recommended inputs are not derived from survey data. In some cases, especially for resource-intensive and highly technical services, we have expressed some concern about the lack of survey or other broad-based data that we have relied on in developing rates across the PFS for many years.
For CY 2018, we proposed the RUC-recommended work RVU of 0.01 for CPT code 95004.
Regarding direct PE inputs, we proposed to refine the equipment times for the “exam table” (EF023) and the “mayo stand” (EF015) to 79 minutes
After consideration of the comments received, we are finalizing the work RVUs and PE inputs for CPT code 95004, as proposed.
CPT codes 95250 (Ambulatory continuous glucose monitoring of interstitial tissue fluid via a subcutaneous sensor for a minimum of 72 hours; sensor placement, hook-up, calibration of monitor, patient training, removal of sensor, and printout of recording) and 95251 (Ambulatory continuous glucose monitoring of interstitial tissue fluid via a subcutaneous sensor for a minimum of 72 hours; interpretation and report) are used to report the technical and professional component for continuous glucose monitoring. In April 2013, CPT code 95251 was identified through the high volume growth services screen and subsequently this code family was reviewed at the RUC's October 2016 meeting.
For CY 2018, we proposed the RUC-recommended work RVU of 0.70 for CPT code 95251. However, we were concerned and sought comments on whether the 2 minutes of physician preservice time was necessary. Since CPT code 95251 is typically billed with an E/M service on the same day, we believed the 2 minutes of preservice time may be duplicative. Furthermore, we sought comment on whether it would be typical for the physician to spend 2 minutes to obtain the CGM reports for review since we believed the report would typically be obtained by clinical staff on behalf of the physician.
For the direct PE inputs, the RUC submitted 19 invoices to update the price of the medical supply item “glucose monitoring (interstitial) sensor” (SD114) for CPT code 95250. We proposed to use these invoice prices for the glucose monitoring (interstitial) sensor (SD114), with an average cost of $53.08. Therefore, we proposed to use the average price of $53.08 for this supply item.
As part of our review of this service, we obtained publicly available pricing information for the CGM system (EQ125). We reviewed the information provided in a study titled, “The cost-effectiveness of continuous glucose monitoring in type 1 diabetes,” (Huang, SE., O'Grady, M., Basu, A. et al.,
After consideration of the comments received, we are finalizing the work RVUs and PE inputs for CPT codes 95250 and 95251, as proposed. We are also finalizing the PE inputs for CPT code 95249 and will include this code in the CY2018 Medicare Physician Fee Schedule.
In the CY 2017 PFS final rule (81 FR 80330), we discussed that in October 2015, the CPT Editorial Panel created two new PE-only codes, CPT code 96160 (Administration of patient focused health risk assessment instrument (
After consideration of the public comment, we are finalizing the direct PE inputs for CPT codes 96160 and 96161, as proposed.
In the CY 2016 PFS proposed rule, CPT codes 96401 (Chemotherapy administration, subcutaneous or intramuscular; non-hormonal anti-neoplastic), 96402 (Chemotherapy administration, subcutaneous or intramuscular; hormonal anti-neoplastic), 96409 (Chemotherapy administration; intravenous, push technique, single or initial substance/drug), and 96411 (Chemotherapy administration; intravenous, push technique, each additional substance/drug (List separately in addition to code for primary procedure)) were identified through the high expenditure services screen across specialties with Medicare allowed charges of over $10 million.
For CY 2018, we proposed the RUC-recommended work RVUs of 0.21 for CPT code 96401, 0.19 for CPT code 96402, 0.24 for CPT code 96409, and 0.20 for CPT code 96411.
For CPT code 96402, we proposed the RUC-recommended equipment times with refinements for the biohazard hood (EP016) and exam table (EF023) from 31 minutes to 34 minutes to reflect the service period time associated with this code. We proposed the RUC-recommended direct PE inputs for CPT codes 96401, 96409, and 96411 without refinements.
After consideration of comments received, we are finalizing the work RVUs and PE inputs for CPT codes 96401, 96402, 96409, and 96411, as proposed.
CPT code 96910 appeared on a high expenditure services screen across specialties with Medicare allowed charges of over $10 million. It is a PE-only code that does not have a work RVU.
We proposed to refine the clinical labor time for the “Provide preservice education/obtain consent” activity from 3 minutes to 1 minute for CPT code 96910. We believed that 1 minute would be typical for patient education, as CPT code 96910 is a repeat procedure where there would not be a need to obtain consent again. We also proposed to remove the 2 minutes of clinical labor for the “Complete diagnostic forms, lab & X-ray requisitions” activity, as this item is considered indirect PE under our established methodology. We proposed to create a new supply code (SB054) for the sauna suit, and proposed to price at $9.99 based on the submitted invoice. Finally, we also proposed to adjust the equipment times to reflect changes in the clinical labor for CPT code 96910.
We proposed the RUC-recommended clinical labor time of 15 minutes for the “Prepare and position patient/monitor patient/set up IV” activity, the RUC-recommended clinical labor time of 16 minutes for the “Monitor patient during procedure” activity, and the RUC-recommended clinical labor time of 15 minutes for the “Clean room/equipment by physician staff” activity, but we sought additional information regarding the rationale for these values. Given the lack of explanation, we considered using the current clinical labor time of 7 minutes for the “Prepare and position patient/monitor patient/set up IV” activity, the current clinical labor time of 4 minutes for the “Monitor patient during procedure” activity, and the current clinical labor time of 10 minutes for the “Clean room/equipment by physician staff” activity. We sought comment on whether maintaining the current values would improve relativity.
We considered removing the “Single Patient Discard Bag, 400 ml” (SD236) supply and replacing it with the “biohazard specimen transport bag” (SM008). We were concerned about whether the single patient discard bag is the appropriate size for storing the sauna suit used in this procedure, and whether use of a biohazard specimen transport bag would be typical. We sought comments on our proposed and alternative values for these direct PE inputs.
After consideration of comments received, we are finalizing the direct PE inputs for CPT code 96910 as proposed, with the exception of the change to the “Provide preservice education/obtain consent” clinical labor activity, as detailed above.
CPT code 96567 was identified as potentially misvalued through a CMS screen for codes with high expenditures. This code describes a service furnished by clinical staff and does not include physician work. For CY 2018, the CPT Editorial Panel created two new codes, CPT codes 96573 and 96574, to describe photodynamic therapy by external application of light to destroy premalignant skin lesions, including the physician work involved in furnishing the service. CPT codes 96567, 96573, and 96574 were reviewed during the RUC's January 2017 meeting.
For CY 2018, we proposed the RUC-recommended work RVUs for CPT
We proposed the RUC-recommended PE inputs with refinements due to inconsistencies between the stated description of clinical activities and the submitted spreadsheets. First, we proposed to add assist physician clinical staff time to CPT codes 96573 (10 minutes) and 96574 (16 minutes), which is equivalent to the physician intraservice times for these services. For both CPT codes 96573 and 96574, we proposed a reduction from 35 minutes to 17 minutes for clinical activity in the postservice time, consistent with the description of clinical work in the summary of recommendations, which states that the patient receives activation of the affected area with the BLU-U Photodynamic Therapy Illuminator for approximately 17 minutes. For CPT codes 96573 and 96574, we proposed to refine equipment formulas for two items: Power table (EF031) and LumaCare external light with probe set (EQ169), consistent with standards for nonhighly technical equipment. An explanation of the standards and formulas for equipment related to direct PE inputs is in the CY 2014 PFS final rule with comment period (79 FR 67557).
We identified several vendors with publically available prices for supply item LMX 4 percent cream (SH092) for significantly less than the existing $1.60 per gram. Based on our research of vendors, we proposed to set the price of supply item SH092 to $0.78 per gram. Other CPT codes affected by the proposed change in the price of supply item LMX 4 percent cream (SH092) would be: CPT code 46607 (Anoscopy; with high-resolution magnification (HRA) (
In addition, the RUC forwarded an invoice for a new supply item, safety goggles, at $6.00 and requested three goggles each for CPT codes 96573 and 96574. Because we did not have a basis for distinguishing the requested new goggles from the existing UV-blocking goggles, we considered this invoice to be an additional price point for SJ027 rather than an entirely new item. We proposed a price of $4.10 for supply item SJ027 (the average of the two prices for this supply item ($2.30 + $6.00)/2 = $4.10)). Other CPT codes affected by the proposed change in the price of supply item UV-blocking goggles (SJ027) are: CPT code 36522 (Photopheresis, extracorporeal), CPT code 96910 (Photochemotherapy; tar and ultraviolet B (Goeckerman treatment) or petrolatum and ultraviolet B), CPT code 96912 (Photochemotherapy; psoralens and ultraviolet A (PUVA)), and CPT code 96913 (Photochemotherapy (Goeckerman and/or PUVA) for severe photoresponsive dermatoses requiring at least 4-8 hours of care under direct supervision of the physician (includes application of medication and dressings)), CPT code 96920 (Laser treatment for inflammatory skin disease (psoriasis); total area less than 250 sq cm), CPT code 96921 (Laser treatment for inflammatory skin disease (psoriasis); 250 sq cm to 500 sq cm), and CPT code 96922 (Laser treatment for inflammatory skin disease (psoriasis); over 500 sq cm). We sought comments on our proposed PE refinements, including our proposed supply item prices.
In our CY 2015 PFS final rule with comment period (79 FR 67576) and CY 2016 PFS final rule with comment period (80 FR 70917), we identified a total of ten codes through the high expenditure by specialty screen for services primarily furnished by physical and occupational therapists: CPT codes 97032, 97035, 97110, 97112, 97113, 97116, 97140, 97530, 97535, and HCPCS code G0283. An additional nine codes in this PM&R family were identified for review by the physical therapy (PT) and occupational therapy (OT) specialty societies: CPT codes 97012, 97016, 97018, 97022, 97033, 97034, 97533, 97537, and 97542. Many of these code values had not been reviewed since they were established in 1994, 1995 or 1998.
After review during its January 2017 meeting, the HCPAC submitted recommendations to CMS for all 19 codes. While the HCPAC included recommendations for CPT code 97014, we note that this is a code we have not recognized for PFS payment since 2002 when we implemented our wound care electrical stimulation policies. For payment under the PFS, instead of CPT code 97014, we recognize HCPCS code G0281 for wound care electrical stimulation and HCPCS code G0283 for all other electrical stimulation scenarios, when covered. For CY 2018, we proposed the HCPAC recommendations for CPT code 97014, HCPCS code G0283, and HCPCS code G0281.
CMS considers all 19 codes as “always therapy” which means they are always considered to be furnished under a physical therapy (PT), occupational therapy (OT), or speech-language pathology (SLP) plan of care regardless of who furnishes them and the payment amounts are counted towards the appropriate statutory therapy cap—either the therapy cap for PT and SLP services combined, or the single therapy cap for OT services. These “always therapy” codes are also subject to the therapy MPPR.
For CY 2018, we proposed the HCPAC's recommended work RVUs for CPT codes 97012, 97016, 97018, 97022, 97032, 97033, 97034, 97035, 97110, 97112, 97113, 97116, 97140, 97530, 97533, 97535, 97537, 97542, and G0283 (97014).
For supervised modality services reported with CPT codes 97012, 97016, 97018, and 97022, and HCPCS code G0283 (97014), we considered maintaining the current values for these codes rather than the HCPAC recommendations. We note that the work times recommended by the HCPAC reflect use of the survey data even though the HCPAC explained in its recommendations that the survey results were not deemed credible because of a lack of evidence to support higher work RVUs of each survey's 25th percentile or median values. We note total time decreases among these codes ranging from 1 to 8 minutes.
While we proposed the HCPAC-recommended work RVUs and work times for each code in this family, we sought comments on whether maintaining the current times, given the HCPAC's lack of confidence in the survey data, would better reflect the work times for these services.
We proposed to maintain the existing CY 2017 PE inputs for all 19 codes. We noted that section 1848(b)(7) of the Act requires a 50 percent therapy MPPR instead of the 25 percent therapy MPPR established during CY 2011 PFS rulemaking. One of the primary rationales for the MPPR policy developed through the rulemaking process was that the direct PE inputs for these services did not fully recognize the redundant inputs when these services were furnished together, or in multiple units. After reviewing the recommended direct PE inputs, it was evident that they were developed based on an acknowledgement of the efficiencies of services typically furnished together as well as codes billed in multiple units. Given this assessment, we believed that were we to use the recommended inputs to develop the PE RVUs, the 50 percent MPPR on the PE for these services, as required by current law, would functionally duplicate the payment adjustments to account for efficiencies that had already been addressed through code-level valuation. Therefore, for CY 2018, we proposed to retain the existing CY 2017 PE inputs for these services and sought comments on whether there is an alternative approach that would avoid duplicative downward payment adjustments while still allowing for the direct PE inputs to be updated to better reflect current practice.
We noted that we believed that the always therapy codes subject to the therapy MPPR on PE are unique from other therapeutic and diagnostic procedure codes paid under the PFS and subject to MPPRs. For example, unlike most surgical services, these “always therapy” codes are typically billed either with other therapy codes or in multiple units, or both. Generally, MPPRs are used when codes are often, but not typically, furnished with other particular codes. When full sets of related codes are almost all typically billed with other codes, or billed in multiple units, coding and valuation have changed to reflect these practices. For example, new codes have been introduced to describe combined services or some related services are described by add-on codes. In other cases, the MPPR is considered in the valuation for individual services.
The following is a summary of public comments received on our proposal to accept the HCPAC-recommended work RVUs for all 19 PM&R codes and the request for comment for the supervised modality codes—CPT codes 97012, 97016, 97018, and 97022, and HCPCS code G0283 (97014)—to alternatively not accept the work times:
The following is a summary of the public comments received as to whether there is an alternative approach to our proposal to retain the CY 2017 direct PE inputs for always therapy codes that would avoid duplicative downward payment adjustments while still allowing for the direct PE inputs to be updated to better reflect current practice and our responses:
Several other commenters, including the HCPAC, urged us to implement the recommended direct PE inputs. In its comment, the HCPAC assured CMS that the RUC PE Subcommittee understood the 50 percent MPPR and took it into account, in addition to the efficiencies of services billed together, when reviewing the direct PE inputs for these services. The HCPAC noted in its comment letter that the PE inputs were reviewed with the understanding that as a result of the MPPR, a 50 percent reduction is in place for the second and subsequent reporting of a physical medicine and rehabilitation service on the same date of service. The HCPAC comment letter clarified that the PE Subcommittee's recommendations apply to the 22 codes that are subject to the therapy MPPR—the 19 codes in this PM&R section and the three codes for orthotic and prosthetic management services (discussed in the below section).
After consideration of comments received, we are finalizing the HCPAC-recommended work RVUs, including the times, for all 19 PM&R codes as proposed. We are also finalizing to accept the HCPAC recommendations for the direct PE inputs for all 19 codes.
We received HCPAC recommendations for new CPT code 97127 that describes services currently reported under CPT code 97532 (Development of cognitive skills to improve attention, memory, problem solving (includes compensatory training), direct (one-on-one) patient contact, each 15 minutes). CPT code 97532 is scheduled to be deleted for CY 2018 and replaced by CPT code 97127.
The existing code is reported per 15 minutes and the new code is reported once. Under current coding, Medicare utilization for these services is heterogeneous and indicates that practitioners of different disciplines incur significantly different resource costs (especially in time) when furnishing these services to Medicare beneficiaries. As described by both the existing and new code, the service might be appropriately furnished both by therapists under the outpatient therapy (OPT) services benefit (includes physical therapy (PT), occupational therapy (OT) or speech-language pathology (SLP)); and outside the therapy benefit by physicians, certain NPPs, and psychologists. As an OPT service, it can (1) be billed by physicians, certain NPPs, or private practice therapists including physical therapists (PT-PPs), occupational therapists (OT-PPs) and speech-language pathologists (SLP-PPs) in private practice, or (2) be billed by institutional providers (for example, skilled nursing facilities, rehabilitation agencies, outpatient hospitals, etc.) when furnished by therapists working for the institutional providers.
According to the HCPAC, professional claims data indicate that CPT code 97532 was most often billed in 4 units. The HCPAC recommended a work RVU of 1.50 for CPT code 97127, which is only 3.4 times greater than the work RVU for the predecessor code (0.44). Assuming professional billing patterns remain the same, the recommended coding and valuation could result in a significant reduction in overall Medicare payment under the PFS.
However, our analysis of the claims data indicates that the number of units typically reported for the current code suggests a significant difference in the amount of time spent with the patient, depending on which discipline (and implicitly under which benefit) bills Medicare for services described by this single code.
Based on our review of claims data by specialty, SLP-PPs, OT-PPs and PT-PPs furnishing the same services under the OPT benefit would receive overall payment increases due simply to the change in coding because they typically bill for fewer than 4 units, while overall payment for clinical psychologists furnishing therapeutic interventions for cognitive function would decrease because they typically bill in units of four or more.
We sought additional information regarding the potential impact of this coding and payment change prior to proposing its use under the PFS. For CY 2018, we proposed to maintain the current coding and valuation for these cognitive function services. If the CPT Editorial Panel deletes the existing CPT code for CY 2018, we would effectuate this proposal through use of a new a HCPCS code G-code, G0515, which would maintain the descriptor and values from existing CPT code 97532. Under this proposal, new CPT code 97127 would be given a procedure status of “I” (Invalid for Medicare).
We also noted that this change in coding and payment could have significant impact for payment to Medicare institutions for OPT services. Under section 1834(k) of the Act, when reported by Medicare institutional providers, OPT services are paid at PFS non-facility payment rates. Institutional claims data for CPT code 97532 when furnished by the three therapist disciplines show a much higher utilization overall than that for professional claims, but significantly fewer 15 minute units reported. This suggests that outpatient therapy professionals generally spend significantly less time with patients in the institutional setting. Use of the new CPT code could, therefore, result in significant additional expenditure to the Medicare program, as well as other payers, including Medicaid programs, based on the change in coding alone.
The following is a summary of the public comments received on additional information regarding the potential impact of this coding and payment change prior to its use under the PFS and our responses:
After consideration of the public comments, we are finalizing our proposal to create HCPCS code G0515 to mirror the coding and valuation of existing CPT code 97532, instead of adopting CPT code 97127. We will assign CPT code 97127 a status indicator of “I” to indicate that it is “Invalid” for Medicare policy and payment purposes.
We have designated HCPCS code G0515 a as “sometimes therapy” code,
For CY 2018, the CPT Editorial Panel revised the set of codes that comprise the CPT manual's PM&R subsection for orthotic management and prosthetic management at its September 2016 meeting. According to the CPT Editorial Panel, these revisions were made at the request of the specialty societies representing physical and occupational therapists to differentiate between the initial and subsequent encounters and to describe the ongoing management and/or training that is involved in subsequent encounters. These changes include:
• Revising the code descriptors by adding the term “initial encounter” to CPT code 97760 (Orthotic(s) management and training (including assessment and fitting when not otherwise reported), upper extremity(ies), lower extremity(ies) and/or trunk, initial orthotic(s) encounter, each 15 minutes), and CPT code 97761 (Prosthetic(s) training, upper and/or lower extremity(ies), initial prosthetic(s) encounter, each 15 minutes);
• Creating a new CPT code 977X1 (Orthotic(s)/prosthetic(s) management and/or training, upper extremity(ies), lower extremity(ies), and/or trunk, subsequent orthotic(s)/prosthetic(s) encounter, each 15 minutes); and
• Deleting CPT code 97762 (checkout for orthotic/prosthetic use, established patient, each 15 minutes).
Intended for the management and/or training of patients with orthotics and/or prosthetics, CPT codes 97760 and 97761 were previously used to report both the initial and subsequent encounters, that, when furnished under the Medicare outpatient therapy services benefit, included services occurring during the same PT or OT episode of care. CPT code 97762 was used to separately report the assessment and fitting (including any adjustments) of an orthotic or prosthetic for an established patient when these services were not bundled into another code or service. For CY 2018, CPT codes 97760 and 97761 are intended to be reported only for the initial encounter, and CPT code 977X1 is intended to be reported for all other orthotic and/or prosthetic services for an established patient that occur on a “subsequent encounter” or a different date of service from that of the initial encounter service.
The HCPAC submitted work and PE recommendations for CPT codes 97760, 97761, and 977X1 from their January 2017 meeting. For CY 2018, we proposed the HCPAC-recommended work RVU of 0.50 for CPT code 97760, a work RVU of 0.50 for CPT code 97761, and a work RVU of 0.48 for CPT code 977X1. We noted that for budget neutrality purposes, the HCPAC recommendations also included utilization crosswalks for each of the three codes that were each assigned a one-to-one crosswalk to the utilization of the prior codes: All the prior services of CPT codes 97760 and 97761 were each crosswalked to the same newly revised codes; and, all the utilization from CPT code 97762 was crosswalked to the new CPT code 977X1.
For CPT code 977X1, we considered a work RVU of 0.33, crosswalking to CPT code 92508 (Speech/hearing therapy), which has a similar total therapist time (22 minutes). We were concerned and sought comments on the HCPAC one-to-one utilization crosswalk recommendations for all three codes in this family since the utilization assumptions are potentially flawed when viewed in the context of the new CPT code descriptors. For instance, for CPT code 977X1, the new descriptor indicates that the services inherent to CPT code 97762 (over 14,000 in 2015), as well as the new services for subsequent encounters previously reported via CPT codes 97760 and 97761 will also be encompassed, although it is difficult to estimate the number of additional services the latter represents. We were concerned that the HCPAC's valuation is inconsistent with the submitted information regarding how services will be reported under the new coding. We sought comments on our proposed and alternative values for CPT code 977X1. We were also interested in receiving comments from stakeholders and clinicians with expertise in furnishing these orthotic management and/or prosthetics training services about the utilization and types of services that would be furnished under the new CPT coding structure, particularly those of the newly created CPT code 977X1 and how these services differ from the services reported with the predecessor CPT code 97762.
We proposed to maintain the current PE inputs for CPT codes 97760, 97761, and 977X1, as we discussed in our proposals for the PM&R codes discussed above; the same therapy MPPR applies. We proposed the current direct PE inputs for CPT code 97762 and for new CPT code 977X1, though we sought comment as to whether or not a different crosswalk or other adjustment would be appropriate given the change in code descriptor.
The following is a summary of the public comments received as to whether or not a different crosswalk or other adjustment would be appropriate for CPT code 97763 given the change in code descriptor and our responses:
We also note that these codes are designated as “always therapy,” meaning that they always represent therapy services regardless of who furnishes them; and that a GO or GP therapy modifier is always required to indicate that the services are furnished under an OT or PT plan of care, respectively. As “always therapy,” these codes are subject to the therapy MPPR and the statutory therapy caps.
For CY 2017, CMS began making separate payment for HCPCS code G0505 (Assessment and care planning for patients with cognitive impairment) as an interim means of facilitating payment for a CPT code that was forthcoming for CY 2018, eventual CPT code 99483. As part of public comment on the CY 2017 PFS proposed rule, the RUC submitted recommended values for this code, which we adopted in the CY 2017 PFS final rule. For CY 2018, CMS is adopting CPT code 99483, and deleting the interim HCPCS code G0505. As is our longstanding practice, when we propose to accept the RUC-recommended values for a code and did not have any significant concerns, we did not write about this proposal in the preamble to the CY 2018 PFS proposed rule.
For CY 2018, CMS is deleting the interim HCPCS code G0505 and replacing it with CPT code 99483. After consideration of these comments, we are finalizing the new descriptor for CPT code 99483, as proposed. We note that we previously adopted the RUC-recommended values for this service in the CY 2017 PFS final rule and will continue to use the RUC-recommended values with our adoption of CPT code 99483.
In the CY 2017 PFS final rule (81 FR 80230), we established separate
For CY 2018, the CPT Editorial Panel is creating CPT codes 99492, 99493, 99494, and 99484 to describe these services. For CY 2018, we are adopting these CPT codes and deleting HCPCS codes G0502, G0503, G0504, and G0507. We proposed the RUC-recommended work RVUs for each of these CPT codes, which are identical to the current values for HCPCS codes G0502, G0503, G0504, and G0507.
We proposed the RUC-recommended PE inputs, with one refinement. The RUC-recommended values included clinical labor inputs in the facility setting, but we did not propose to include these minutes in developing the facility PE RVUs.
Were we to develop facility PE RVUs for these services that included clinical staff time, when a practitioner working in a provider-based department of a hospital was furnishing these services, both the professional and the hospital would be paid for the same clinical labor costs. We presumed that this aspect of the RUC's recommendation reflects the circumstance where the patient receiving the services spends a significant period of time in a facility setting, but the billing practitioner is nonetheless incurring the cost associated with the non-face-to-face clinical staff time over the course of a month. We recognized that the binary site of service differential may not recognize the different models of this kind of care and may not be appropriate in some cases. We sought comments on how to best address this valuation issue for these and other monthly care management services. We noted that we could consider a range of options for future rulemaking, including allowing separate billing for the professional, technical, and global components of these services to allow practitioners to bill the component of the service they furnish.
We stated in the CY 2017 PFS final rule (81 FR 80236) that the general BHI code (CPT code 99484) may be used to report a range of models of BHI services and that we expected this code to be refined over time as we receive more information about other BHI models in use. We remain interested in how this code is being used and look forward to hearing from stakeholders regarding its use in reporting different models of BHI services. Additionally, we have received inquiries from stakeholders about whether or not professionals who cannot report E/M services to Medicare might nonetheless serve as a primary hub for BHI services. For example, stakeholders have suggested that a clinical psychologist might serve as the primary practitioner that integrates medical care and psychiatric expertise. For purposes of future rulemaking, we sought comment on the circumstances under which this model of care is happening and whether additional coding would be needed to accurately describe and value other models of care.
For CY 2018, CMS is deleting the interim HCPCS codes G0502, G0503, G0504, and G0507 and replacing them with CPT codes 99492, 99493, 99494, and 99484, respectively. After consideration of these comments, for CY 2018, we are finalizing the coding and valuation for CPT codes 99492, 99493, 99494, and 99484, as proposed.
In the CY 2016 PFS final rule with comment period (80 FR 71005), we discussed the CY 2015 valuation of hyperbaric oxygen therapy services (79 FR 67677). Prior to CY 2015, CPT code 99183 was used to report both the professional attendance and supervision, and the costs associated with treatment delivery were included in the nonfacility direct PE inputs for the code. We created HCPCS code G0277 to be used to report the treatment delivery separately, consistent with the OPPS coding mechanism, to allow the use of the same coding structure across multiple settings. In establishing interim final direct PE inputs for HCPCS code G0277, we used the RUC-recommended direct PE inputs for CPT code 99183, which assumed a 120-minute treatment interval and adjusted them to align with the 30-minute treatment interval of HCPCS code G0277. We observed that the quantity of oxygen increased significantly relative to the previous inputs for CPT code 99183.
To better understand why the oxygen supply increased, we reviewed the instruction manual for the Sechrist Model 3600E Hyperbaric Chamber, which was the model noted on the invoice that was included with the RUC
For CY 2018, we received requests from stakeholders to update the direct PE inputs for HCPCS code G0277. In the CY 2016 PFS final rule with comment period (80 FR 71005), we explained that we had previously established values for this service based on information suggesting that the Sechrist Model 3600E Hyperbaric Chamber was typically used in furnishing the service in the non-facility setting. As we noted in that rule, we established the amount of oxygen used in furnishing the service based on use of the equipment item described as part of the RUC recommendation, instead of the RUC-recommended amount of oxygen, which appeared to be based on use of a different equipment product, the Sechrist Model 3200. Based on information received from stakeholders, we proposed in the CY 2018 PFS proposed rule to update both the equipment item and the amount of oxygen so that the amount of oxygen conforms to the RUC-recommended value of 47,600 liters of oxygen, which we divided by 4 to conform to the 30-minute service period for HCPCS code G0277, and that the equipment item is consistent with that recommendation. The proposed direct PE inputs for HCPCS code G0277 were displayed in the proposed CY 2018 direct PE input database, available on the CMS Web site under the downloads for the CY 2018 PFS proposed rule at
We also proposed to exclude this change in direct PE inputs from the calculation of the misvalued code target, since we viewed this proposed change as a refinement of a single recommendation over several years. Since the initial recommendation (79 FR 67677) was undertaken in a year without the misvalued code target, we believed it would be consistent with our previously established policy (80 FR 70923) to exclude this change from the calculation. We noted that this change would represent an increase from the current PE RVUs for this service.
After consideration of the comments received, we are finalizing the direct PE inputs for HCPCS code G0277 as proposed. The direct PE inputs for HCPCS code G0277 are displayed in the CY 2018 final rule direct PE Input database, available on the CMS Web site under the downloads for the CY 2018 PFS final rule at
Many services paid under the PFS are coded to reflect differential resource costs associated with different levels of care. However, this level of granularity is not applied evenly across the PFS. For example, there are far fewer E/M visit codes than there are codes that describe procedures. While not a comprehensive solution to address the differential resource costs of certain E/M visits, prolonged services codes can be used to report medically necessary E/M visits that require additional amounts of time. Like E/M visit codes, many of the Medicare-covered preventive services codes describe a service that has an atypically broad range of potential resource costs, including differential amounts of time required to furnish services. However, unlike for most E/M visit codes, there are not prolonged services codes that apply to Medicare-covered preventive services.
Some stakeholders expressed concerns to CMS regarding the lack of a coding mechanism for practitioners to report the additional time sometimes required to appropriately furnish care to a patient receiving a Medicare-covered preventive service. We noted that Medicare covers a broad range of preventive services, such as a “Welcome to Medicare Preventive Visit”, yearly wellness visits, cancer screenings, and many types of counseling. Medicare beneficiary coinsurance and deductible payments are not applicable for certain Medicare-covered preventive services. Additional information about preventive services covered under Medicare, including whether beneficiary coinsurance or deductible apply, is available on the CMS Web site at
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We proposed that HCPCS codes G0513 and G0514 could only be billed with Medicare-covered preventive services. Beneficiary coinsurance and
We proposed to create prolonged services codes in 30-minute increments instead of the 60-minute increments that apply for the parallel office/outpatient prolonged services codes, since some Medicare-covered preventive services have a shorter duration than E/M visits. For purposes of valuation for both initial and additional 30 minute codes, we proposed to use one half of the current work RVUs and direct PE inputs for CPT code 99354 (Prolonged evaluation and management or psychotherapy service(s) beyond the typical service time of the primary procedure) in the office or other outpatient setting requiring direct patient contact beyond the usual service; first hour (List separately in addition to code for office or other outpatient Evaluation and Management or psychotherapy service)). CPT code 99354 has a total time of 60 minutes and a work RVU of 2.33. Therefore, we proposed a work RVU of 1.17 and 30 minutes of total work time for HCPCS codes G0513 and G0514. We proposed to use one half of the direct PE inputs for CPT code 99354, which resulted in a proposal of 7 minutes of clinical labor type L037D (RN/LPN/MTA) and 15 minutes for equipment type EF031 (table, power) for HCPCS codes G0513 and G0514 as the best reflection of typical direct PE costs. We understood that these specific clinical labor and equipment types may be functioning as proxy inputs for some Medicare-covered preventive services.
We proposed that HCPCS codes G0513 and G0514 be billed for prolonged preventive services beyond the typical service time of the primary procedure. For preventive services with both physician work and PE, we considered the typical service time of the primary procedure to be the intraservice work time used for the purposes of PFS ratesetting. For Medicare-covered preventive services with no face-to-face physician work, the typical time is the service period clinical staff time that best represents the face-to-face time with the patient. The counted time guidelines (derived from the typical times assumed for PFS ratesetting) for all eligible companion Medicare-covered preventive services are available in the file called “CY 2018 Preventive Services Billed with Prolonged Preventives Code” on the CMS Web site under downloads for the CY 2018 PFS final rule at
With regard to HCPCS code G0447, we do not believe that HCPCS codes G0513 and G0514 are coded to be applicable to timed services. We welcome additional input from stakeholders regarding appropriate coding and billing for these services and will consider addressing these issues in future rulemaking. Finally, we note that HCPCS code G0296 is eligible to be billed with prolonged preventive services.
After consideration of comments received, we are finalizing our proposal for prolonged preventive services using HCPCS codes G0513 and G0514 with the work RVUs, work times, direct PE inputs, and requirements for these codes as proposed.
We met with representatives from the American Society of Addiction Medicine (ASAM) in April 2016 to discuss the possibility of making separate payment for insertion and removal of buprenorphine hydrochloride, formulated as a 4-rod, 80 mg, long-acting subdermal drug implant for the treatment of opioid addiction. There are existing CPT codes that broadly describe the insertion and removal of non-biodegradable drug delivery implants (CPT codes 11981 through 11983). However, ASAM contended that the resources associated with the administration of this particular drug are greater than that of other drug delivery implants, stating that the physician must insert four rods using a newly designed applicator and obturator and use a specially designed clamp to remove the four rods, which in some cases requires careful shaving of tissue that has attached to the rods during the 6-month period that the rods have been inserted. They noted that these procedures can have unique challenges associated with treating patients with opioid addiction, who often have complications and/or co-morbidities. They also noted that the FDA has recognized the complexity of the technology and patient needs by establishing regulatory standards to adhere to the protocol and imposing special training requirements on physicians. ASAM indicated that they would pursue an application to the CPT Editorial Panel for new CPT codes.
ASAM informed CMS that the CPT Editorial Panel did not approve its application; therefore, ASAM repeated its request that CMS establish separate payment for the insertion, removal, and removal with reinsertion of the buprenorphine subdermal implants.
To improve payment accuracy, for CY 2018, we proposed to make separate payment for the insertion, removal, and removal with reinsertion of Buprenorphine subdermal implants using HCPCS G codes:
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For HCPCS code G0516, ASAM stated that performing the procedure according to the FDA-required Risk Evaluation and Mitigation Strategies (REMS) program takes approximately 23-25 minutes for the a physician who is not a trainer/proctor for this procedure. They stated that in developing crosswalk recommendations for physician work values, they used a total time of 35-40 minutes, which is based on a preservice time of 10 minutes, an intraservice time of 20-25 minutes, and a postservice time of 5 minutes. Based on ASAM's recommendations, we proposed a work RVU of 1.82 for HCPCS code G0516, which is supported by a direct crosswalk to CPT code 64644 (Chemodenervation of one extremity; 5 or more muscles).
For HCPCS code G0517, ASAM stated that data from physicians who perform this procedure indicated that it takes approximately 15-20 additional minutes compared to the insertion procedure (HCPCS code G0516) based on the FDA-required REMS program for removal of the implant. ASAM noted that this procedure is of a higher intensity compared to CPT code 11982 as this service requires identification and removal of multiple subdermal implants. ASAM stated that in developing crosswalk recommendations for physician work values, they used a total time of 45-60 minutes, which is based on a preservice time of 10 minutes, an intraservice time of 30-45 minutes, and a postservice time of 5 minutes. Based on ASAM's recommendations, we proposed a work RVU of 2.10 for HCPCS code G0517, which is supported by a direct crosswalk to CPT code 96922 (Laser treatment for inflammatory skin disease (psoriasis); over 500 sq cm).
For HCPCS code G0518, ASAM indicated that there is minimal consolidation of effort since the removal of the implants from one arm is followed by insertion of a new set of implants in the contralateral arm. Physician data from those who have performed this procedure indicated that it takes approximately 70 minutes of total intra-service time. ASAM stated that in developing crosswalk recommendations for physician work values, they assumed a preservice evaluation time of 10 minutes (7 minutes for removal and 3 minutes for insertion), positioning of 4 minutes (2 minutes for each arm), and wait time of 2 minutes (1 minute for each arm). ASAM stated that using the multiple surgical procedure rule, they calculated an intraservice time of 40-58 minutes based on 100 percent of the intraservice time for HCPCS code G0517 (30-45 minutes) and 50 percent of the intraservice time for HCPCS code G0516 (0.5 × (20 − 25) = 10 − 13). ASAM used a postservice time of 8 minutes based on 100 percent of the postservice time for the removal arm and 50 percent of the postservice time for the insertion arm, equaling a total time of 58-76 minutes. Based on ASAM's recommendations, we proposed a work RVU of 3.55 for HCPCS code G0518, which is supported by a direct crosswalk to CPT code 31628 (Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed; with transbronchial lung biopsy(s), single lobe).
We proposed to use the direct PE inputs requested by ASAM for HCPCS codes G0516, G0517, and G0518, which are reflected in the Direct PE Inputs public use files for clinical labor, supplies, and equipment, available on the CMS Web site at
In addition to seeking comment on the proposal to make separate payment for these services using HCPCS codes, we also sought comment on the appropriateness and accuracy of our proposed work RVUs and direct PE inputs.
In the CY 2015 PFS final rule with comment period (79 FR 67666 through 67667), we noted that changes to the CPT prefatory language limited the
In the CY 2016 PFS final rule with comment period (80 FR 70955), we noted that the RUC did not review the inputs for SRT procedures, and therefore did not assess whether changes in valuation were appropriate in light of the bundling of associated services. In addition, we solicited recommendations from stakeholders regarding whether or not it would be appropriate to add physician work for this service, even though physician work is not included in other radiation treatment services. As commenters were not in agreement as to whether the service should be valued with physician work, we introduced the possibility of creating a HCPCS G-code to describe total work associated with the course of treatment for these services. The 2016 National Correct Coding Initiative (NCCI) Policy Manual for Medicare Services stated that radiation oncology services may not be separately reported with E/M codes. While this edit is no longer active, stakeholders have stated that MACs have denied claims for E/M services associated with SRT based on the NCCI policy manual language. According to stakeholders, the bundling of services associated with SRT, as well as the confusion regarding the appropriate use of E/M coding to report associated physician work, meant that practitioners were not being accurately paid for planning and treatment management associated with furnishing SRT.
Due to these concerns regarding reporting of services associated with SRT, in the CY 2018 PFS proposed rule, we proposed to make separate payment for the professional planning and management associated with SRT using HCPCS code GRRR1 (Superficial radiation treatment planning and management related services, including but not limited to, when performed, clinical treatment planning (for example, 77261, 77262, 77263), therapeutic radiology simulation-aided field setting (for example, 77280, 77285, 77290, 77293), basic radiation dosimetry calculation (for example, 77300), treatment devices (for example, 77332, 77333, 77334), isodose planning (for example, 77306, 77307, 77316, 77317, 77318), radiation treatment management (for example, 77427, 77431, 77432, 77435, 77469, 77470, 77499), and associated E/M per course of treatment). We proposed for this code to describe the range of professional services associated with a course of SRT, including services similar to those not otherwise separately reportable under CPT guidance and the NCCI manual. To value this code, we included the physician work and time associated with radiation management-related services that we think would be typical for a course of SRT treatment. These services include: CPT code 77261 (Therapeutic radiology treatment planning; simple), CPT code 77280 (Therapeutic radiology simulation-aided field setting; simple), CPT code 77300 (Basic radiation dosimetry calculation, central axis depth dose calculation, TDF, NSD, gap calculation, off axis factor, tissue inhomogeneity factors, calculation of non-ionizing radiation surface and depth dose, as required during course of treatment, only when prescribed by the treating physician), CPT code 77306 (Teletherapy isodose plan; simple (1 or 2 unmodified ports directed to a single area of interest), includes basic dosimetry calculation(s)), CPT code 77332 (Treatment devices, design and construction; simple (simple block, simple bolus)), and CPT code 77427 (Radiation treatment management, 5 treatments). Therefore, for CY 2018, we proposed a work RVU of 7.93 for HCPCS code GRRR1. To develop the proposed direct PE inputs for this code, we proposed to use the RUC-recommended direct PE inputs from the aforementioned codes with several adjustments. We proposed to apply the staff type “RN/LPN/MTA” for all of the clinical labor inputs for this code because we believe that the typical office performing SRT would be staffed with this labor type, rather than with another clinical labor type such as radiation therapists, and we sought comment as to the appropriateness of the staff type “RN/LPN/MTA” for this SRT-related service. Some stakeholders have suggested that many services related to SRT are personally performed by the billing practitioner rather than by clinical staff. We proposed to remove the supply items “gown, patient” and “pillow case” that are associated with CPT code 77280, as these items are included in the minimum multispecialty visit pack that is associated with CPT code 77427. We did not propose to include the equipment items “radiation virtual simulation system,” “room, CT” and “PACS Workstation Proxy” that are associated with CPT code 77280, as we do not believe that a typical office furnishing SRT uses this kind of equipment. Instead, we included additional time for the capital equipment used in delivering SRT in the proposed direct PE inputs.
For “radiation dose therapy plan,” we proposed to apply the clinical labor time that is associated with CPT code 77300 to HCPCS code GRRR1 for purposes of developing a proposed value, but we sought comment as to whether the clinical staff would typically perform the radiation dose therapy planning for this service, or if the physician would perform this and/or other tasks, and, in the case of the latter, what the appropriate physician time would be. Likewise, we solicited comment as to whether the clinical labor associated with the teletherapy isodose plan would be performed by the physician. We proposed to assign 14 minutes each to the equipment items “radiation therapy dosimetry software (Argus QC)”, “computer workstation”, and “3D teletherapy treatment planning” as these are the times assigned to these equipment items for CPT code 77300. We did not propose to include inputs related to radiation physics consultation, described by CPT code 77336, as we think that a typical course of SRT would not require this service, and the typical practitioner providing SRT would not be performing physics consultation, and we sought comment as to whether inputs associated with this code or other inputs used in furnishing analogous services should be included. We did not propose to include the post-operative office visits included in the valuation of CPT code 77427, as we did not believe that a typical course of SRT would require post-operative visits; however, we solicited comment regarding the amount of face-to-face time typically spent by the practitioner with the patient for radiation treatment management associated with SRT. As discussed in the CY 2016 PFS final rule with comment period (80 FR 70924 through
After consideration of the comments received, we are not finalizing our proposal to make separate payment for the planning and management services associated with SRT using HCPCS code GRRR1. We will continue our dialogue with stakeholders to address appropriate coding and payment for professional services associated with SRT.
We note that we did not propose and are not making any changes to the coding or valuation for CPT code 77401 (radiation treatment delivery, superficial and/or ortho voltage, per day) in this final rule. Providers can continue to bill CPT code 77401 as appropriate. However, under the CPT guidance that has been in effect for several years, certain codes used to describe clinical treatment planning, treatment devices, isodose planning, physics consultation, and radiation treatment management cannot be billed in addition to CPT code 77401. These planning and management codes, however, can continue to be billed in addition to other codes involving other types of radiation treatment, such as HCPCS code G6003 (Radiation treatment delivery, single treatment area, single port or parallel opposed ports, simple blocks or no blocks: up to 5 mev) and CPT code 77523 (Proton treatment delivery; intermediate) in accordance with applicable guidance and requirements.
In recent years, we have sought to recognize significant changes in health care practice, especially innovations in the active management and ongoing care of chronically ill patients. We have been engaged in an ongoing incremental effort to identify gaps in appropriate coding and payment for care management/coordination, cognitive services and primary care within the PFS. This has included working with the CPT Editorial Panel (CPT) to develop and value (or revalue) the following service codes:
• Transitional care management (TCM) services (2013).
• Chronic care management services (CCM) (2015, 2017).
• Behavioral health integration (BHI) services (2017).
• Assessment/care planning services for cognitive impairment (2017).
• Prolonged E/M services without direct patient contact (2017).
In response to public feedback regarding the initial implementation of TCM and CCM, in the CY 2017 PFS final rule (81 FR 80225 through 80256), we finalized significant administrative burden reduction for CCM and focused on limiting as much as possible the ways in which Medicare's rules differed from the CPT guidance that generally applies for all payers. We also worked with the CPT Editorial Panel and other stakeholders to develop coding and improve payment accuracy for BHI, cognitive impairment assessment/management, and prolonged services. In the CY 2017 PFS final rule (81 FR 80255), we also reiterated our commitment to addressing disparities for individuals with disabilities and advancing health equity, and noted that we will continue to explore improvements in payment accuracy for services furnished to individuals with disabilities. We look forward to continued work with stakeholders to ensure that the coding and valuation of these services accurately reflects the resource costs involved in furnishing these services. In the CY 2018 PFS proposed rule (82 FR 34078 through 34080), we solicited public comments on ways we might further reduce administrative burden for these and similar services under the PFS.
Most physicians and other billing practitioners bill patient visits to the PFS under a relatively generic set of codes that distinguish level of complexity, site of care, and in some cases, between new or established patients. These codes are called Evaluation and Management (E/M) visit codes. For example, there are generally three levels of hospital and nursing facility inpatient E/M visit codes, and five levels of office or hospital outpatient E/M visit codes, that vary based on complexity. The latter also distinguish whether or not the patient is new to the billing practitioner.
Billing practitioners must maintain information in the medical record to document that they have reported the appropriate level of E/M visit code. CMS maintains guidelines that specify the kind of information that is required to support Medicare payment for each level. According to these documentation guidelines, there are three key components to selecting the appropriate level:
• History of Present Illness (HPI or History);
• Physical Examination (Exam); and
• Medical Decision Making (MDM).
There are two versions of the documentation guidelines, commonly referenced based on the year of their release (the “1995” and “1997” guidelines), available under downloads on the CMS Web site at
Stakeholders have long maintained that both the 1995 and 1997 guidelines are administratively burdensome and outdated with respect to the practice of medicine, stating that they are too complex, ambiguous, and that they fail to distinguish meaningful differences among code levels. In general, we agree that there may be unnecessary burden with these guidelines and that they are potentially outdated, and believe this is especially true for the requirements for the history and the physical exam. The guidelines have not been updated to account for significant changes in technology, especially electronic health record (EHR) use, which presents challenges for data and program integrity and potential upcoding given the frequently automated selection of code level.
Although CMS conducts few audits on E/M visits relative to the volume of PFS services they comprise, we have repeatedly heard from practitioners that compliance with the guidelines is a source of significant audit vulnerability and administrative burden. Our prior attempts to revise the guidelines met with a lack of stakeholder consensus and support, which contributed to the current policy that allows practitioners to use either the 1995 guidelines or 1997 guidelines, resulting in further complexity in determining or selecting the applicable requirements.
We continue to agree with stakeholders that the E/M documentation guidelines should be substantially revised. We believe that a comprehensive reform of E/M documentation guidelines would require a multi-year, collaborative effort among stakeholders. We believe that revised guidelines could both reduce clinical burden and improve documentation in a way that would be more effective in clinical workflows and care coordination. We also think updated E/M guidelines coupled with technological advancements in voice recognition, natural language processing and user-centered design of EHRs could improve documentation for patient care while also meeting requirements for billing and population health management. We recognize that achieving the goal of reduced clinician burden and improved, meaningful documentation for patient care will require both updated E/M guidelines, as well as changes in technology, clinician documentation practices and workflow. We solicited input from a broad array of stakeholders, including patient advocates, on the specific changes we should undertake to reform the guidelines, reduce the associated burden, and better align E/M coding and documentation with the current practice of medicine.
We specifically sought comment on how we might focus on initial changes to the guidelines for the history and physical exam, because we believe documentation for these elements may be more significantly outdated, and that
Although we believed that MDM guidelines may also need to be updated, we stated our belief that in the near term, it may be possible to eliminate the current focus on details of history and physical exam, and allow MDM and/or time to serve as the key determinant of E/M visit level. We sought public comment on this approach. We also sought comment on how such reforms may differentially affect physicians and practitioners of different specialties, including primary care clinicians, and how we could or should account for such effects as we examine this issue.
We noted that there may still be clinical or legal reasons for individual practitioners to document an extended history or physical exam (for example, where there are negative findings for certain body systems in support of differential diagnosis). We additionally sought comment on whether CMS should leave it largely to the discretion of individual practitioners to what degree they should perform and document the history and physical exam.
We also welcomed comments on specific ideas that stakeholders may have on how to update MDM guidelines to foster appropriate documentation for patient care commensurate with the level of patient complexity, while avoiding burdensome documentation requirements and/or inappropriate upcoding.
The following is a summary of the public comments received on the E/M documentation guidelines, and our responses.
There appeared to be some agreement among commenters that the documentation requirements for history and physical exam are particularly outdated. Commenters stated, for example, that they are often required to include or cut-and-paste into the record extraneous documentation detail regarding irrelevant history, review of unaffected systems, and unnecessary (and in some cases burdensome to the patient) physical exam elements, in order to justify an E/M code that most adequately reflects their work. They stated that this information bloats the medical record unnecessarily, increasing the time it takes to find or convey to the reader the most important and relevant clinical information at a given point in time. They said this detracts significantly from spending time on more important patient care activities.
A few commenters believe that the two elements of history and exam could be eliminated entirely, while many commenters believe they needed to be retained, but changed or rolled up somehow into MDM. Some commenters believe that MDM is under-emphasized or could be assigned greater weight, while still recognizing the critical role that history and exam continue to play for patients, especially new patients. Some commenters believe that new guidelines to support MDM-driven E/M documentation need to be in place before requirements for history and exam are eliminated. Some specialties (for example, hematology-oncology and emergency medicine) explained that ensuring adequate performance and documentation of both history and physical exam at every visit is critical to their work for clinical, legal, operational, and other reasons.
Some commenters raised the possibility of allowing flexibility at the practitioner or organization level. For example, one commenter suggested that CMS could encourage the use of unspecified standards, while allowing individual physicians to decide what components of a history and physical exam are required or should be documented for individual patients. Some commenters believe there are clinical reasons to include a history and exam in a patient's record, but they are not needed to determine the E/M code level. Others advised CMS to eliminate all numeric (counted) elements for history and exam in the documentation guidelines and allow physicians to document only what is relevant to the patient's specific diagnosis.
There was no consensus among commenters on changes that would need to be made to MDM and time rules in order for CMS to rely more on these elements (in lieu of history and exam) to justify service level billed. Some commenters recommended clarification of ambiguities or more uniform interpretation of the current MDM guidelines. Others believe the existing criteria for assessing MDM are themselves inadequate, and that while MDM should carry the most weight, it is the hardest to measure meaningfully and is frequently subjective. Some commenters recommended alternatives such as different MDM levels reflecting comorbidity or the intensity of a single, highly active medical condition. Some believe that MDM was a key determinant but not sufficient to stand alone.
Some commenters sought clarification on what CMS was proposing with respect to time. They were unclear how CMS envisioned time coming into play in a different way than it currently does. Commenters had differing views on the advisable role of time in determining code level (alone or in combination with MDM). Some recommended expanding the role of time, for example to enumerate time spent with family or spent taking extended histories rather than just counseling time. Others believe work should not be equated with time, or mentioned that relying on
Some commenters recommended, for immediate relief, that history and exam should not be audited except where there is uncertainty regarding MDM or lack of documentation regarding time. A few commenters suggested alternative E/M service components such as the patient's functional status, review of medications and care coordination. One commenter listed several items they believe deserve CMS' review, even if there is not a broad revision to the guidelines, including perceived overly comprehensive history and exam requirements for the Level 4/5 differential; MDM rules that value a new problem higher than an existing problem, even when it is clinically more minor; MDM rules that do not distinguish medication risk according to how benign the medication is; and the level of audit risk or exposure if less information (history and exam) would be included in the medical record.
Some comments discussed the intersection of the guidelines with EHRs. Some commenters requested alignment of EHR templates with new guidelines, eliminating the need to cut-and-paste medical record information, and eliminating information blocking to outside clinicians (for example, pharmacists seeking information on patient history). There was some support for removing requirements to document social, family and past medical history in the medical record at a given visit when it is already present within an EHR. Similarly, there was support for only requiring full, baseline history and exam at time of first visit/consultation, with updates at subsequent visits only to areas of changes in condition that affect the treatment plan. There was also some support for physicians being allowed to review and cross-reference, or sign off on, certain documentation entered by ancillary staff or technicians, entered directly by patients (such as through a patient portal), or captured automatically by devices.
A number of commenters specified that changes should be effective across all E/M codes of all levels. Some specialties requested particular consideration of care settings other than just outpatient care, such as inpatient or other transitional care settings.
Many commenters urged CMS to proceed cautiously by making changes over a period of multiple years, using a representative task force and additional public forums such as open door forums and listening sessions prior to implementing broad changes. Some commenters suggested that reforming the guidelines is a monumental task that would have a far-reaching impact and needs to be done judiciously since, for example, commercial payers often follow Medicare rules in this area. These commenters stated that, if done correctly, revising the guidelines will be a significant undertaking that is likely to last several years and require an inclusive, transparent, iterative and perhaps transitional process to ensure that all stakeholders across all specialties are involved, that a thoughtful examination of options can take place, and that the benefits and consequences of any potential changes can be identified. Some commenters specified that the CPT Editorial Panel, private insurers and EHR vendors should be involved.
Some commenters recommended clarification and training by CMS of unspecified issues on interpretation of current guidelines, but requested that CMS seek full input before moving forward with any changes, including these clarifications. These commenters stated that even minor changes to the codes or their documentation would require physicians and practices a great deal of time to understand and implement. A number of commenters asked CMS not to make any immediate changes for these or similar reasons.
In the CY 2018 PFS proposed rule (82 FR 34079), we further noted that through letters, meetings, public comment letters in past rulemaking cycles, and other avenues, we have heard from many stakeholders that the E/M code set itself is outdated and needs to be revised. For example, some stakeholders recommend an extensive research effort to revise and revalue E/M services, especially the work inputs (see 81 FR 46200). In prior rulemaking cycles, we acknowledged the limitations of the current E/M code set. In our proposed rule, we agreed that the structure of the underlying code set and its valuation relative to other PFS services are also important issues that we expect to continue to explore, though we stated our immediate focus on revision of the current E/M guidelines in order to reduce unnecessary administrative burden.
In contrast, other commenters believe that the current valuation of all E/M services should be presumed correct, and that the goal of reforming the guidelines is to make them consistent with current medical practice. Several commenters recommended that CMS consider the E/M definitional and valuation issues separate from E/M guideline revision. They believe that changes in the guidelines should not automatically require a review of current valuation. Also several commenters asked CMS to reinstate the specialist consultation codes that were discontinued for payment in 2010.
In the CY 2018 PFS proposed rule, we stated our continued interest in the ongoing work of the medical community and other stakeholders to refine the set of codes used to describe care management services. In section II.H of this final rule, we discuss our final policy to adopt CPT codes for CY 2018 to replace the G-codes we established for several new care management service codes finalized last year, describing cognitive impairment assessment and care planning, and behavioral health integration services. In CY 2018, these codes will be added to the suite of CPT care management service codes we adopted in recent years, including transitional care management and chronic care management (CCM) services. In our proposed rule, we also reiterated our commitment to work with stakeholders on necessary refinements to this code set, especially codes that would describe the professional work involved in caring for complex patients in additional clinical contexts. Also we solicited public comment on ways we might further reduce the burden for practitioners reporting care management services, including through stronger alignment between CMS requirements and CPT guidance for existing and potential new care management service codes.
We received a few comments on ways CMS might further improve CCM services, and approaches that CMS might take more broadly to improve payment for care management services. In this section, we discuss the comments and respond.
Section 1833(g) of the Act (as amended by section 4541 of the Balanced Budget Act of 1997) (Pub. L. 105-33) requires application of annual per beneficiary limitations on the amount of expenses that can be considered as incurred expenses for outpatient therapy services under Medicare Part B, commonly referred to as “therapy caps.” 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. The therapy caps are permanent, meaning that the statute does not specify an end date.
The therapy cap amounts under section 1833(g) of the Act are updated each year based on the MEI. Specifically, the annual caps are calculated by updating the previous year's cap by the MEI for the upcoming calendar year and rounding to the nearest $10.00. Increasing the CY 2017 therapy cap of $1,980 by the CY 2018 adjusted MEI of 1.4 percent and rounding to the nearest $10.00 results in a CY 2018 therapy cap amount of $2,010.
An exceptions process for the therapy caps has been in effect since January 1, 2006. Originally required by section 5107 of the Deficit Reduction Act of 2005 (DRA), which amended section 1833(g)(5) of the Act, the exceptions process for the therapy caps has been extended multiple times through subsequent legislation as described in the CY 2015 PFS final rule with comment period (79 FR 67730). It was most recently extended by section 202 of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10), and is set to expire on December 31, 2017. The MACRA extension of the therapy cap exceptions process includes the application of the therapy caps to outpatient services furnished by hospitals described at section 1833(a)(8)(B) of the Act by continuing the temporary suspension under section 1833(g)(6)(A) of the Act of the statutory exemption for these hospital therapy services that first became effective October 1, 2012 through the enactment of the Middle Class Tax Relief and Jobs Creation Act of 2012 (MCTRJCA) (Pub. L. 112-96).
CMS tracks each beneficiary's incurred expenses annually and counts them toward the therapy caps by applying the PFS rate for each service less any applicable multiple procedure payment reduction (MPPR) amount. As required by section 1833(g)(6)(B) of the Act, added by section 603(b) of the American Taxpayer Relief Act of 2012 (ATRA) (Pub. L. 112-240) and extended by subsequent legislation, the PFS-rate accrual process is applied to outpatient therapy services furnished by CAHs even though they are paid on a cost basis (effective January 1, 2014). As we explained in the CY 2016 PFS final rule with comment period, we use cost-based rates to track each beneficiary's incurred expenses amounts for the outpatient therapy services furnished by the Maryland hospitals paid under the Maryland All-Payer Model, currently being tested under the authority of section 1115A of the Act (effective January 1, 2016). After expenses incurred for the beneficiary's outpatient therapy services for the year have exceeded one or both of the therapy caps, therapy suppliers and providers use the KX modifier on claims for subsequent services to request an exception to the therapy caps. By using the KX modifier, the therapist is attesting that the services above the therapy caps are reasonable and necessary and that there is documentation of medical necessity for the services in the beneficiary's medical record. Claims for outpatient therapy services over the caps without the KX modifier are denied.
Since October 1, 2012, under section 1833(g)(5)(C) of the Act as amended by the Middle Class Tax Relief and Jobs Creation Act of 2012 (MCTRJCA) (Pub. L. 112-96), we have been required to apply a manual medical review process to therapy claims when a beneficiary's incurred expenses for outpatient therapy services exceed a threshold amount of $3,700. Just as there are two separate therapy caps, there are two separate thresholds of $3,700, one for OT services and one for PT and SLP services combined; and incurred expenses are counted towards these thresholds in the same manner as the caps. Under section 1833(g)(5) of the Act, as amended by section 202(b) of the MACRA, not all claims exceeding the therapy thresholds are subject to a manual medical review process as they were before. Instead, we are permitted to do a more targeted medical review on these claims using factors specified in section 1833(g)(5)(E)(ii) of the Act as amended by section 202(b) of the MACRA, including targeting those therapy providers with a high claims denial rate for therapy services or with aberrant billing practices compared to their peers. The manual medical review process required under section 1833(g)(5)(C) of the Act expires at the same time as the exceptions process for therapy caps, on December 31, 2017. For information on the manual medical review process, go to
The statutory authority for the therapy caps exceptions process will expire on December 31, 2017. Under current law, the therapy caps will be applicable in accordance with the statute to all outpatient therapy settings, except for services furnished and billed by outpatient hospitals described under section 1833(a)(8)(B) of the Act. Without a therapy caps exceptions process, the statutory limitation requires that beneficiaries become financially liable for 100 percent of expenses they incur for services that exceed the therapy caps. In addition, without a therapy caps exceptions process, the therapy caps will be applicable without any further medical review, and any use of the KX modifier on claims for these services by providers of outpatient therapy services will have no effect.
We have been engaged in a multi-year examination of coordinated and collaborative care services in professional settings, and as a result established codes and separate payment in the Physician Fee Schedule (PFS) to separately recognize and pay for these important services. As part of this initiative, the CY 2016 PFS proposed rule (80 FR 41708) solicited public comments on (1) improving payment for the professional work of care management services; (2) establishing separate payment for collaborative care, particularly inter-professional consultation between primary care physicians, psychiatrists, and other practitioners; and (3) assessing whether current PFS payment for Chronic Care Management (CCM) services is adequate and whether the administrative burden associated with furnishing and billing these services should be reduced.
As a result of the comments we received in response to our request, we established in the PFS separate payment for complex CCM services, and temporary codes to make separate payment for general behavioral health integration (BHI) services and a psychiatric collaborative care model (CoCM). We established four G codes to
RHC and FQHC visits are face-to-face encounters between a patient and one or more RHC or FQHC practitioners during which time one or more RHC or FQHC qualifying services are furnished. RHC and FQHC practitioners are physicians, nurse practitioners (NPs), physician assistants (PA), certified nurse midwives (CNMs), clinical psychologists, and clinical social workers, and under certain conditions, a registered nurse or licensed practical nurse furnishing care to a homebound RHC or FQHC patient. A Transitional Care Management (TCM) service can also be an RHC or FQHC visit, and a Diabetes Self-Management Training (DSMT) service or a Medical Nutrition Therapy (MNT) service furnished by a certified DSMT or MNT provider may also be an FQHC visit. Only medically-necessary medical, mental health, or qualified preventive health services that require the skill level of an RHC or FQHC practitioner are RHC or FQHC billable visits. Services furnished by auxiliary personnel (for example, nurses, medical assistants, or other clinical personnel acting under the supervision of the RHC or FQHC practitioner) are considered incident to the visit and are included in the per-visit payment.
RHCs are paid an all-inclusive rate (AIR) for medically necessary medical and mental health services and qualified preventive health services furnished on the same day (with some exceptions). In general, the A/B Medicare Administrative Contractor (MAC) calculates the AIR for each RHC by dividing total allowable costs by the total number of visits for all patients. Productivity, payment limits, and other factors are also considered in the calculation. Allowable costs must be reasonable and necessary and may include practitioner compensation, overhead, equipment, space, supplies, personnel, and other costs incident to the delivery of RHC services. The AIR is subject to a payment limit, except for certain provider-based RHCs that have an exception to the payment limit.
FQHCs were paid under the same AIR methodology until October 1, 2014, when, in accordance with section 1834(o) of the Act (as added by section 10501(i)(3) of the Affordable Care Act), they began to transition to an FQHC PPS system in which they are paid based on the lesser of the FQHC PPS rate or their actual charges. The FQHC PPS rate is adjusted for geographic differences in the cost of services by the FQHC PPS geographic adjustment factor (GAF). The rate is increased by 34 percent when an FQHC furnishes care to a patient that is new to the FQHC, or to a beneficiary receiving an Initial Preventive Physical Examination (IPPE) or has an Annual Wellness Visit (AWV).
Both the RHC AIR and FQHC PPS payment rates were designed to reflect the cost of all services and supplies that an RHC or FQHC furnishes to a patient in a single day. The rates are not adjusted for the complexity of the patient health care needs, the length of the visit, or the number or type of practitioners involved in the patient's care.
In the CY 2016 PFS final rule with comment period (80 FR 71080), we finalized policies for payment of CCM services in RHCs and FQHCs. Payment for CCM services in RHCs and FQHCs was effective beginning on January 1, 2016, for RHCs and FQHCs that furnish a minimum of 20 minutes of qualifying CCM services during a calendar month to patients with multiple (two or more) chronic conditions that are expected to last at least 12 months or until the death of the patient, and that would place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline. The requirement that RHC or FQHC services be furnished face-to-face was waived for CCM services.
In the CY 2017 PFS final rule (81 FR 80256), we finalized revisions to the CCM requirements for RHCs and FQHCs. Specifically, we revised § 405.2413(a)(5) and § 405.2415(a)(5) to state that services and supplies furnished incident to CCM and TCM services can be furnished under general supervision of an RHC or FQHC practitioner, consistent with § 410.26(b)(5), which allows CCM and TCM services and supplies to be furnished by clinical staff under general supervision when billed under the PFS. We also revised requirements pertaining to the provision of CCM services, consistent with the same revisions for practitioners billing under the PFS to reduce the burden of furnishing these services and promote beneficiary access to these services. These revisions were effective beginning on January 1, 2017, and included:
• Revising the requirement that CCM be initiated during a comprehensive evaluation and management (E/M), AWV, or IPPE visit, to require a separately billable initiating visit only for new patients or patients that have not had an E/M, AWV, or IPPE visit within the previous year;
• Revising the requirement that CCM services be available 24/7 with an RHC or FQHC practitioner who has access to the patient's electronic care plan, to allow 24/7 access to auxiliary personnel with a means to make contact with an RHC or FQHC practitioner;
• Removing the restriction on faxing information, and no longer requiring that care plan information be available on a 24/7 basis;
• Removing the requirement that clinical summaries must be formatted according to certified EHR technology, and instead requiring that the RHC or FQHC create, exchange, and transmit continuity of care document(s) in a timely manner with other practitioners and providers;
• Removing the description of the format of the care plan that is given to the patient or caregiver; and
• Revising the requirement that RHCs and FQHCs obtain a written agreement that the elements of CCM were discussed, to allowing this information to be documented in the medical record.
In the CY 2017 PFS final rule, we stated that although CCM is typically associated with primary care conditions, patient eligibility is determined by the RHC or FQHC practitioner, and mental health conditions are not excluded. We invited comments on whether an additional code specifically for mental health conditions is necessary for RHCs and FQHCs that want to include beneficiaries with mental health conditions in their CCM services. We received a few comments regarding mental health services in RHCs and FQHCs and appreciate the information that was provided.
The 2016 and 2017 CCM payment rates for RHCs and FQHCs were set annually based on the PFS national non-facility payment rate, and is paid when CPT code 99490 is billed alone or with
Additional information on CCM requirements is available on the CMS Care Management Web page at
As we stated in the CY 2017 PFS final rule (81 FR 80244), the initial claims data for CCM services billed under the PFS showed that although utilization was increasing steadily, use of CPT code 99490 was still relatively low, and interviews with practitioners indicated that many believed that they were exceeding the 20-minute time threshold for billing this code. To pay as accurately as possible and to encourage access to CCM services, the CY 2017 PFS final rule established separate payment for two additional CCM codes, CPT code 99487 and CPT code 99489, effective beginning on January 1, 2017, for practitioners billing under the PFS. These codes are for complex CCM services that reflect additional clinical staff time, more extensive care planning, and higher complexity of the patient.
CPT code 99487 is for complex CCM services. It requires multiple (two or more) chronic conditions expected to last at least 12 months, or until the death of the patient; chronic conditions that place the patient at significant risk of death, acute exacerbation/decompensation, or functional decline; establishment or substantial revision of a comprehensive care plan; moderate or high complexity medical decision making; and 60 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month.
CPT code 99489 is for each additional 30 minutes of clinical staff time directed by a physician or other qualified health care professional, per calendar month.
Practitioners paid under the PFS can bill either complex (CPT code 99487 and CPT code 99489) or non-complex (CPT code 99490) CCM services during a given service period, and can submit only one professional claim for CCM services for that service period.
The types of chronic conditions that are eligible for CCM services are not specified and could include chronic mental health or behavioral health conditions or chronic cognitive disorders as long as the CCM requirements are met. However, because not all behavioral health issues fit into the CCM model, and Medicare beneficiaries with behavioral health conditions often require extensive care management discussions, information-sharing, and planning between a primary care practitioner and a behavioral health specialist, the CY 2017 PFS final rule established HCPCS code G0507 for 20 minutes or more of general BHI services. Payment for this code was effective beginning on January 1, 2017, for practitioners billing under the PFS. Effective January 1, 2018, HCPCS code G0507 is replaced by CPT code 99484.
BHI is a team-based, collaborative approach to care that focuses on integrative treatment of patients with primary care and mental or behavioral health conditions. As finalized in the CY 2017 PFS final rule, requirements for this code include an initial assessment or follow-up monitoring (including the use of applicable validated rating scales); behavioral health care planning in relation to behavioral/psychiatric health problems (including revision for patients who are not progressing or whose status changes); facilitating and coordinating treatment such as psychotherapy, pharmacotherapy, counseling and/or psychiatric consultation; and continuity of care with a designated member of the care team.
Psychiatric CoCM is a specific model of care provided by a primary care team consisting of a primary care provider and a health care manager who works in collaboration with a psychiatric consultant. As finalized in the CY 2017 PFS final rule, we provide Medicare payment for psychiatric CoCM services to practitioners billing under the PFS when these services are directed by a treating physician or other qualified health care professional. We also finalized that the treating physician or other qualified health care professional directs the behavioral health care manager, who must be an individual with formal education or specialized training in behavioral health, including social work, nursing, or psychology, working under the oversight and direction of the physician or qualified health care professional. We finalized that a psychiatric consultant must be a medical professional trained in psychiatry and qualified to prescribe the full range of medications. Finally, psychiatric CoCM services may be furnished to beneficiaries with any psychiatric or behavioral health condition(s) and may include substance use disorders. The three psychiatric CoCM codes established in the CY 2017 PFS final rule were G0502, G0503, and G0504. Effective January 1, 2018, these codes are replaced by CPT codes 99492, 99493, and 99494, respectively.
HCPCS code G0502 is for 70 minutes or more of initial psychiatric CoCM services in the first calendar month of behavioral health care manager activities, in consultation with a psychiatric consultant, and directed by the treating physician or other qualified health care professional. Required elements include: outreach to and treatment of a patient as directed by the treating physician or other qualified health care professional; initial assessment of the patient, including administration of validated rating scales, with the development of an individualized treatment plan; review by the psychiatric consultant with modifications of the plan, if recommended; entering of the patient into a registry and tracking patient follow-up and progress using the registry (with appropriate documentation), participation in weekly caseload consultation with the psychiatric consultant; and provision of brief interventions using evidence-based techniques such as behavioral activation, motivational interviewing, and other focused treatment strategies.
HCPCS code G0503 is for 60 minutes of subsequent psychiatric CoCM services in a subsequent month and includes: Tracking patient follow-up and progress using the registry (with appropriate documentation); participation in weekly caseload consultation with the psychiatric consultant; ongoing collaboration with and coordination of the patient's mental health care with the treating physician
HCPCS code G0504 is for each additional 30 minutes of initial or subsequent psychiatric CoCM services in a calendar month.
To ensure that RHC and FQHC patients have access to new care management services in a manner consistent with the RHC and FQHC per diem payment methodologies, we proposed the establishment of two new G codes for use by RHCs and FQHCs. The first new G code, GCCC1, would be a General Care Management code for RHCs and FQHCs, with the payment amount set at the average of the national non-facility PFS payment rates for CCM (CPT codes 99490 and 99487) and general BHI code G0507. The second new G code for RHCs and FQHCs, GCCC2, would be a Psychiatric CoCM code, with the payment amount set at the average of the national non-facility PFS payment rates for CPT codes G0502 and G0503. (We note that GCCC1 and GCCC2 were placeholder codes and are replaced by G0511 and G0512, respectively, effective January 1, 2018). The following is a detailed discussion of our proposal, as well as alternatives that we considered.
The RHC AIR and the FQHC PPS rate, which include all costs associated with an RHC or FQHC visit, are based on the RHC's and FQHC's costs. Although many RHCs and FQHCs have always provided some coordination of care within and outside their facilities, the type of structured care management services that are now billable under the PFS are generally not included in the RHC AIR or the FQHC PPS rate. Because CCM services are not required to be face-to-face encounters, and do not require the skill level of an RHC or FQHC practitioner, they do not meet the requirements for an RHC or FQHC billable visit. In addition, RHC and FQHC services cannot be separately billed to the PFS. Therefore, in the CY 2016 PFS final rule with comment period, we established payment for CCM services at the PFS national non-facility rate when CPT code 99490 is billed alone or with other payable services on an RHC or FQHC claim to pay for the costs of CCM services that are not already captured in the RHC AIR or the FQHC PPS payment.
When CCM services were first established for RHCs and FQHCs, CPT code 99490 was the only CCM code that was billable under the PFS. Now that there are additional codes for more complex CCM services and for general BHI and psychiatric CoCM services, we believe it is necessary to revise our payment approach for payment of care management services.
RHCs and FQHCs are paid per-visit rates that are not adjusted based on the complexity of a service or the time spent furnishing services, and the payment rate is not designed to be equal to the payment under the PFS for a specific service. We sought to develop a methodology for payment of care management services that is consistent with the RHC and FQHC payment principles of bundling services and not paying for services based on time increments. We also sought to develop a methodology that would support the provision of care management services without creating additional reporting burdens, while promoting beneficiary access to comprehensive CCM and BHI services furnished by RHCs and FQHCs.
Therefore, effective for services furnished on or after January 1, 2018, we proposed to create General Care Management code GCCC1 for RHCs and FQHCs, with the payment amount set at the average of the 3 national non-facility PFS payment rates for the CCM and general BHI codes and updated annually based on the PFS amounts. The 3 codes are:
RHCs and FQHCs could bill the new General Care Management code when the requirements for any of these 3 codes (CPT codes 99490, 99487, or HCPCS code G0507) are met. The General Care Management code would be billed alone or in addition to other services furnished during the RHC or FQHC visit. This code could only be billed once per month per beneficiary, and could not be billed if other care management services (such as TCM or home health care supervision) are billed for the same time period. We note that CPT code 99489 is an add-on code when CPT code 99487 is furnished, and is therefore not included as RHCs and FQHCs are not paid for additional time once the minimum requirements have been met.
As previously noted, the program requirements for RHCs and FQHCs furnishing CCM services were established in the CY 2016 PFS final rule with comment period (80 FR 71080) and revised in the CY 2017 PFS final rule (81 FR 80256). We did not propose any changes to these requirements at this time.
BHI refers to care management services that integrate behavioral health services with primary care and other clinical services. To bill for this service using the proposed General Care Management Code for RHCs and FQHCs, 20 minutes or more of clinical staff time, directed by an RHC or FQHC practitioner, must be furnished per calendar month. We proposed the following requirements for RHCs and FQHCs furnishing BHI services:
•
•
•
•
•
Both CCM and general BHI services are intended to provide a structured and coordinated approach to care management that is not typically included in the RHC's AIR or the FQHC PPS payment methodology. Care management services are directed by the RHC or FQHC primary care practitioner, who remains involved through ongoing oversight, management, collaboration and reassessment, while care management services are typically furnished in a non-face-to-face setting primarily by a non-RHC or FQHC practitioner working under general supervision requirements. Time spent by administrative or clerical staff cannot be counted towards the time required to bill these services.
Table 18 compares the proposed requirements for CCM and general BHI services. We believe that even though there are some differences in the requirements of CCM and general BHI, grouping them together will help to promote integrated care management services for Medicare beneficiaries who have either or both primary care and behavioral health needs. It will also result in the least amount of reporting burden for RHCs and FQHCs because once the 20-minute threshold is met for either CCM or general BHI, reporting and tracking of additional time increments is not required.
If this policy had been adopted for CY 2017, the payment amount for General Care Management for RHCs and FQHCs would have been approximately $61 (CPT 99490 at $42.71, + CPT 99487 at $93.67, + G0507 at $47.73 = $184.11/3 = $61.37). This is more than the CY 2017 PFS national non-facility rates for CPT code 99490 and HCPCS code G0507, and less than the PFS national non-facility rate for CPT code 99487. We believe that this methodology is consistent with the RHC and FQHC payment methodology of averaging costs to determine a payment rate rather than paying for each individual service.
We expect that utilization of care coordination services will continue to increase as more health care practices, including RHCs and FQHCs, implement these services. Because the separate payments for the complex CCM codes have only been implemented this year for practitioners billing under the PFS, we do not have adequate data to determine the frequency of billing for CCM codes CPT codes 99487 by practitioners billing under the PFS compared with CPT code 99490. Although billing practices may vary between physician offices and RHCs and FQHCs (and within and between RHCs and FQHCs), we believe that utilization patterns under the PFS can provide a reasonable proxy for utilization practices in RHCs and FQHCs of care coordination utilization. If the PFS data starts to show definitive trends in billing certain CCM and BHI codes, or if data becomes available that
Psychiatric CoCM is a defined model of care that integrates primary health care services with care management support for patients receiving behavioral health treatment, and includes regular psychiatric inter-specialty consultation with the primary care team, particularly regarding patients whose conditions are not improving. We recognize that the requirements of this model may be challenging for some RHCs and FQHCs, especially those who have difficulty maintaining adequate primary care and mental health staffing in rural and or underserved areas. For those RHCs and FQHCs that choose to offer these services, we believe this model may be particularly helpful, especially for patients with primary care and mental health conditions who have not benefited from standard treatment.
Effective for services furnished on or after January 1, 2018, we proposed to create a psychiatric CoCM code for RHCs and FQHCs, GCCC2, with the payment amount set at the average of the 2 national non-facility PFS payment rates for CoCM codes, to be updated annually based on the PFS amounts. The 2 codes are:
RHCs and FQHCs could bill the new psychiatric CoCM code when the requirements for any of these 2 codes (G0502 or G0503) are met. The psychiatric CoCM code would be billed alone or in addition to other services furnished during the RHC or FQHC visit. To prevent duplication of payment, this code could only be billed once per month per beneficiary, and could not be billed if other care management services, including the proposed General Care Management code, are billed for the same time period. We note that G0504 is an add-on code when G0503 is furnished and is therefore not included as RHCs and FQHCs are not paid for additional time once the minimum requirements have been met.
If this policy had been adopted for CY 2017, the payment amount for psychiatric CoCM for RHCs and FQHCs would have been approximately $134.58 (G0502 at $142.84 + G0503 at $126.33 = $269.17/2 = $134.58).
All care management services, including psychiatric CoCM, require a separately billable initiating visit (E/M, AWV, or IPPE) for new patients or beneficiaries not seen within 1 year prior to commencement of care management services. Prior to commencement of psychiatric CoCM services, the beneficiary must provide consent for this service, including permission to consult with a psychiatric consultant and relevant specialists. Advance consent must also include information on cost sharing for both face-to-face and non-face-to-face services, and acceptance of these requirements must be documented in the medical record.
Patients with mental health, behavioral health, or psychiatric conditions, including substance use disorders, who are being treated by an RHC or FQHC practitioner, may be eligible for psychiatric CoCM services, as determined by the RHC or FQHC practitioner. Psychiatric CoCM services, like CCM and general BHI services, are intended to provide a structured and coordinated approach to care management that is not typically included in the RHC's AIR or the FQHC PPS payment methodology.
The psychiatric CoCM team must include the RHC or FQHC practitioner, a behavioral health care manager, and a psychiatric consultant. Proposed specific requirements of the psychiatric CoCM team are as follows:
For psychiatric CoCM, the RHC or FQHC practitioner may be a primary care physician, NP, PA, or CNM. The psychiatric CoCM requirements of the RHC or FQHC practitioner are to:
• Direct the behavioral health care manager and any other clinical staff;
• Oversee the beneficiary's care, including prescribing medications, providing treatments for medical conditions, and making referrals to specialty care when needed; and
• Remain involved through ongoing oversight, management, collaboration and reassessment.
For psychiatric CoCM, the behavioral health care manager is a designated individual with formal education or specialized training in behavioral health such as social work, nursing, or psychology. A behavioral health care manager in an RHC or FQHC would be expected to have a minimum of a bachelor's degree in a behavioral health field (such as in clinical social work or psychology), or be a clinician with behavioral health training, including RNs and LPNs. The behavioral health care manager furnishes both face-to-face and non-face-to-face services under the general supervision of the RHC or FQHC practitioner and may be employed by or working under contract to the RHC or FQHC. The psychiatric CoCM requirements of the behavioral health care manager are:
• Providing assessment and care management services, including the administration of validated rating scales; behavioral health care planning in relation to behavioral/psychiatric health problems, including revision for patients who are not progressing or whose status changes; provision of brief psychosocial interventions; ongoing collaboration with the RHC or FQHC practitioner; maintenance of the registry; acting in consultation with the psychiatric consultant;
• Being available to provide services face-to-face with the beneficiary; having a continuous relationship with the patient and a collaborative, integrated relationship with the rest of the care team; and
• Being available to contact the patient outside of regular RHC or FQHC hours as necessary to conduct the behavioral health care manager's duties.
For CoCM, a psychiatric consultant is a medical professional trained in psychiatry and qualified to prescribe the full range of medications. The psychiatric consultant is not required to be on site or to have direct contact with the patient and does not prescribe medications or furnish treatment to the beneficiary directly. The CoCM requirements of the psychiatric consultant are:
• Participating in regular reviews of the clinical status of patients receiving psychiatric CoCM services;
• Advising the RHC or FQHC practitioner regarding diagnosis and options for resolving issues with beneficiary adherence and tolerance of behavioral health treatment; making
• Facilitating referral for direct provision of psychiatric care when clinically indicated.
RHCs and FQHCs could bill the new psychiatric CoCM code, GCCC2, when the requirements for HCPCS code G0502 or G0503 are met. This code could only be billed once per month per beneficiary, and could not be billed if other care management services, including the General Care Management code GCCC1, are billed for the same time period.
As with the proposed General Care Management code GCCC1, we would monitor PFS data to determine if a weighted average would be more appropriate in determining the psychiatric CoCM payment rate for RHCs and FQHCs, and whether any additional codes that may be added to the PFS in the future should also be factored into the RHC and FQHC psychiatric CoCM code. Any changes would be done through future rulemaking.
Table 19 compares the proposed requirements for general BHI, which would be billed using the proposed General Care Management code GCCC1, and psychiatric CoCM services, which would be billed using the proposed psychiatric CoCM code, GCCC2.
We considered allowing RHCs and FQHCs to bill for the complex CCM codes, the BHI code, and the psychiatric CoCM codes by allowing the individual CPT or HCPCS codes to be billed on an RHC or FQHC claim, in the same manner as we currently allow CPT code 99490 to be billed on a claim. We do not believe this approach is in the best interest of RHCs and FQHCs. There are now 5 separate care management codes that are applicable to RHCs and FQHCs, and more codes could be added in the future as we learn more about the benefits of non-face-to-face care management services. Each of these codes has specific time increments that must be tracked and reported for payment under the PFS. We believe that grouping the CCM and BHI codes and the psychiatric CoCM codes into 2 G codes is more consistent with the RHC and FQHC payment methodology of averaging actual costs to determine a payment rate and not paying for services based on time increments. It also requires less record keeping, monitoring, and coding expertise, while maintaining the same quality of care standards.
We also considered grouping all 5 codes together into one G code, or developing 3 G codes—one for the CCM codes, one for the BHI code, and one for the psychiatric CoCM codes. We did not choose either of these approaches because CCM and BHI are similar services that complement each other, and grouping them together is consistent with an integrated approach to care with reduced reporting requirements. We also believe that psychiatric CoCM is different enough from both CCM and BHI in its requirements, particularly in staffing and required services, that it warrants a separate G code. We believe that our proposal of creating 2 new G codes to encompass the 5 care management codes is the best option for RHCs and FQHCs now and in the future if new care management codes are developed. We welcomed comments on the proposal.
The following is a summary of the public comments received on our proposal to revise the CCM payment for RHCs and FQHCs and establish requirements and payment for general BHI and psychiatric CoCM services furnished in RHCs and FQHCs, beginning on January 1, 2018. As previously noted, the following code changes will be effective January 1, 2018, and are used in the remainder of this rule:
PMH-NPs are trained to provide a wide range of mental health services, including psychiatric diagnosis and medication treatment for psychiatric disorders. Although NPs are authorized to prescribe controlled substances, their practice authority varies by state and in some states they may have additional requirements or restrictions. We believe that a board-certified PMH-NP would meet the requirements to serve as a psychiatric consultant for an RHC or FQHC that is furnishing psychiatric CoCM services and would assist in making this program more widely available, especially in rural areas.
It is the responsibility of the RHC or FQHC to assure that the behavioral health care manager meets the stated requirements, and to manage any delegation of duties and supervision as appropriate.
CPs and CSWs are RHC and FQHC practitioners and furnish medically-necessary, face-to-face services that may be stand-alone billable visits in RHCs and FQHCs. They can also serve as the behavioral health care manager for general BHI and psychiatric CoCM services. In order to facilitate the integration and coordination of the patient's primary care and mental or behavioral health conditions, these care management services are furnished under the direction of the RHC or FQHC primary care practitioner.
As a result of the public comments, we are finalizing the revisions to CCM payment for RHCs and FQHCs and establishment of requirements and payment for general BHI and psychiatric CoCM services furnished in RHCs and FQHCs, beginning on January 1, 2018, as proposed, except that we are removing the requirement that the behavioral health care manager be available to contact the patient outside of regular RHC or FQHC hours as necessary to conduct the behavioral health care manager's duties.
RHCs and FQHCs will continue to receive payment for CCM services when CPT code 99490 is billed alone or with other payable services on an RHC or FQHC claim for dates of service on or before December 31, 2017. Beginning on January 1, 2018, RHCs and FQHCs must use the new General Care Management code G0511 when billing for CCM or general BHI services, and the new psychiatric CoCM code G0512 when billing for psychiatric CoCM services, either alone or with other payable services on an RHC or FQHC claim. Service lines submitted using CPT 99490 code for dates of service on or after January 1, 2018 will be denied.
Both the current RHC and FQHC payment rate for CCM, and the proposed RHC and FQHC payment rates for General Care Management and Psychiatric CoCM codes, are based on the PFS national non-facility rates. The PFS rates are updated annually, and the new G codes for RHCs and FQHCs would be updated accordingly and finalized when the PFS rates are finalized for the year. No geographic adjustment will be applied to the General Care Management or Psychiatric CoCM G codes. RHCs and FQHCs are required to submit claims for care management services on an institutional claim (electronically per the HIPAA compliant ANSI X12 837I or the Form CMS 1450, also known as the UB-04,) and are not authorized to bill care management services separately to the PFS.
As previously noted, § 405.2413(a)(5) and § 405.2415(a)(5) was revised effective January 1, 2017, to state that services and supplies furnished incident to CCM and TCM services can be furnished under general supervision of an RHC or FQHC practitioner, consistent with § 410.26(b)(5), which allows CCM and TCM services and supplies to be furnished by clinical staff under general supervision when billed under the PFS. Sections 405.2413(a)(5) and 405.2415(a)(5) are now revised to state that services and supplies incident to the services of a physician, NP, PA, or CNM are furnished under the direct supervision of a physician, NP, PA, or CNM, except for TCM, General Care Management, and Psychiatric CoCM services, which can be furnished under general supervision of a physician, NP, PA, or CNM when these services or supplies are furnished by auxiliary personnel, as defined in § 410.26(a)(1).
Section 303(c) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173, enacted on December 8, 2003) revised the payment methodology for most Medicare-covered Part B drugs and biologicals by adding section 1847A to the Act, which established a new average sales price (ASP) drug payment methodology beginning January 1, 2005. Section 303(b) of the MMA specified payments for certain drugs using methodologies other than the ASP pricing methodology. Specifically, section 303(b) of the MMA added section 1842(o)(1)(D)(i) of the Act that required that an infusion drug furnished through an item of DME covered under section 1861(n) of the Act be paid 95 percent of the average wholesale price (AWP) for that drug in effect on October 1, 2003.
Section 5004(a) of the 21st Century Cures Act (Cures Act) (Pub. L. 114-255, enacted on December 13, 2016) revised sections 1842(o)(1)(C) and (D) of the Act, changing the payment methodology for DME infusion drugs from being based on AWP to the methodologies in sections 1847, 1847A, 1847B, or 1881(b)(13) of the Act, as the case may be for the drug or biological. To implement the pricing changes required by section 5004(a) of Cures Act, which modifies the payment for DME infusion drugs to the amount under section 1847A of the Act (ASP drug payment methodology), by the statutorily mandated effective date of January 1, 2017, we incorporated the ASP-based infusion drug payment amounts into the January 2017 quarterly ASP drug pricing files and instructed claims processing contractors to use the updated payment limits for DME infusion drugs.
To conform regulations with the new payment requirements in section
After consideration of the public comment received, we are finalizing our proposal to revise § 414.904(e)(2) to conform with the statutory payment requirements of section 5004(a) of the Cures Act. We are also finalizing our proposal to revise § 414.904(e)(2) to delete the phrase “and is not updated in 2006.”
In the June 23, 2016
Under the CLFS final rule, reporting entities are required to report to us certain applicable information for their component applicable laboratories. The applicable information includes, for each CDLT furnished during a data collection period, the specific HCPCS code associated with the test, each private payor rate for which final payment has been made, and the associated volume of tests performed corresponding to each private payor rate. In general, the payment amount for a test on the CLFS furnished on or after January 1, 2018, will be equal to the weighted median of private payor rates determined for the test, based on the applicable information that is collected during a data collection period and reported to us during a data reporting period.
In the CLFS final rule, we established a data collection period that is the 6 months from January 1 through June 30 during which applicable information is collected and that precedes the data collection period. We established a data reporting period that is the 3-month period, January 1 through March 31, during which a reporting entity reports applicable information to us and that follows the preceding data collection period. The first data collection period was January 1, 2016 through June 30, 2016. The first data reporting period was January 1, 2017 through March 31, 2017. This 6-month data collection period and 3-month data reporting period schedule will be repeated every 3 years for CDLTs that are not advanced diagnostic laboratory tests (ADLTs), and every year for ADLTS that are not new ADLTs.
For the first data reporting period, industry feedback suggested that many reporting entities would not be able to submit a complete set of applicable information to us by the March 31, 2017 deadline, and that entities required additional time to review collected data, address any issues identified during such review, and compile the data into our required reporting format. As a result, on March 30, 2017, we announced that we would exercise enforcement discretion until May 30, 2017, with respect to the data reporting period for reporting applicable information under the Medicare CLFS and the application of the Secretary's potential assessment of civil monetary penalties for failure to report applicable information.
The announcement stated that the enforcement discretion period would not prevent reporting entities prepared to report applicable information from doing so before May 30, 2017. We explained in the announcement that we were committed to the successful implementation of the new private payor rate-based CLFS and looked forward to working with the laboratory industry to ensure accurate payment rates. In recent months, we analyzed the applicable information we received, held our Annual Laboratory Public Meeting, met with the Advisory Panel for Clinical Diagnostic Laboratory tests twice, and posted preliminary CLFS payment rates for calendar year 2018.
In the proposed rule, we solicited public comments from applicable laboratories and reporting entities to better understand the applicable laboratories' experiences with the data reporting, data collection, and other compliance requirements for the first data collection and reporting periods. Specifically, we sought public comment on the following questions:
• Was the CMS data reporting system easy to use? Please describe your overall experience with navigating the CMS data reporting system. For example, describe the aspects of the CMS data reporting system that worked well for your reporting entity and/or any problems the reporting entity experienced with submitting applicable information to us.
• Did the applicable laboratory (or its reporting entity) request and receive assistance from our Help Desk regarding the CMS data reporting system? Please describe your experience with receiving assistance.
• Did the applicable laboratory (or its reporting entity) request and receive assistance from the CMS CLFS Inquiries Mailbox regarding policy questions? Please describe your experience with receiving assistance.
• Did the applicable laboratory (or its reporting entity) use the subregulatory guidance on data reporting provided on the CMS CLFS Web site?
• Was the information that the applicable laboratory was required to report readily available in the applicable laboratory's record systems?
• Did the reporting entity have a manual, automated, or semi-automated remittance process for data reporting?
• If the reporting entity used a manual or semi-automated remittance process for data reporting, what percentage of the process was manual?
• How much time (hours) was required to assemble and report applicable information to CMS?
• Is there any other information that will inform us regarding the reporting, recordkeeping, and other compliance requirements from the first data collection and reporting periods?
We stated in the proposed rule that we were soliciting comments to better understand applicable laboratories' experiences with the data reporting, data collection, and other compliance requirements for the first data collection and reporting periods under the new private payor rate-based CLFS. We believed industry feedback on these issues would help inform us regarding potential refinements to the private payor rate-based CLFS for future data collection and reporting periods. A summary of the public comments we received on our comment solicitation, and our response to those comments, appears below.
• Improve the accessibility of the CMS data reporting system, for example, by removing certain security measures.
• A few commenters indicated that it was administratively burdensome for the reporting entity, that is the Taxpayer Identification Number (TIN) level entity, to report applicable information individually for each of its component applicable laboratories. As an alternative, they suggested that we allow the reporting entity to aggregate applicable information for its components that are applicable laboratories, and enter the aggregated applicable information in the designated column on the CMS data reporting template.
• Change the proportion of data that applicable laboratories are required to report; for example, allow applicable laboratories to report 75 to 80 percent, rather than 100 percent, of their applicable information.
• Change the requirement that applicable laboratories must report data from claims that require manual remittance processes.
• Streamline the identification of user formatting errors and permit real-time file edits in the CMS data reporting system.
• Define terms used in the data reporting system; for example, a few commenters requested CMS provide a definition for the term “CMS Certification Number (CCN)”.
Most of the comments received were out of scope because they did not address experiences with the initial data collection and reporting periods. For example, some commenters recommended that CMS delay implementation of the new private payor rate-based CLFS payment system. A few commenters recommended that we redefine the term “applicable laboratory” to include hospitals, specifically to ensure hospital outreach laboratory data is included in the calculation of the new CLFS rates.
In the CY 2016 Physician Fee Schedule (PFS) final rule with comment period, we finalized a proposal to amend the regulation text at § 414.904(j) to make clear that the payment amount for a biosimilar biological product is based on the ASP of all National Drug Codes (NDCs) assigned to the biosimilar biological products included within the same billing and payment code (80 FR 71096 through 71101). In general, this means that products that rely on a common reference product's biologics license application (that is, FDA's previous finding of safety, purity, and potency for the common reference product) are grouped into the same payment calculation for determining a single ASP payment limit and that a single HCPCS code is used for such biosimilar products. The regulation went into effect on January 1, 2016.
The comments received on the 2016 PFS proposed rule indicated that stakeholders had varying opinions about Medicare payment for biosimilar biological products under Part B. The commenters included individuals, pharmaceutical manufacturers, patient advocate groups, providers, insurers, and members of Congress. A number of commenters opposed a single payment amount for all biosimilars that rely on FDA's finding of safety, purity, and potency for a common reference product. Most of these commenters believed that the proposed regulation would decrease incentives for biosimilar development and that grouping payment for biosimilar biological products is inconsistent with the statute. Some commenters also expressed concerns that prescribers' choices will be limited, that tracking or pharmacovigilance activities will be impaired, and that innovation and product development will be harmed, leading to market consolidation and increased costs for biosimilar biological products. Many commenters who opposed this policy suggested that we determine a payment amount for each biosimilar biological product. These stakeholders have expressed concerns that the finalized policy restricts and threatens the viability of their business models and expressed support for a new solution. Some of these stakeholders believed that determining a payment for each biosimilar product by using individual HCPCS codes, would drive and reward innovators, producing the potential cost savings of at least 10-15
However, some commenters supported our proposed regulation, stating that the potential marketplace for biosimilar biological products is large and it is less risky than the marketplace for reference biologicals. Commenters also expressed concern that separate payment for each biosimilar biological product would result in less competition among manufacturers, which in turn could lead to higher payment amounts for Medicare and beneficiaries. Some commenters stated that separate billing codes could be perceived as a type of price protection and could artificially increase prices for biosimilars. Commenters who supported the proposed regulation suggested that we remain mindful of our policy as the biosimilar biological product marketplace evolves. Several commenters requested that policy decisions be delayed while issues such as naming conventions and interchangeability standards are finalized by the FDA.
In 2015, biological products accounted for the majority (65 percent) of part B spending, which totaled $26 billion including Medicare and beneficiary payments (MedPAC Report to Congress June 2017, page 37). As CMS expected, since the regulation was finalized in 2015, the biosimilar product marketplace has continued to grow, and four biosimilar biological products that are paid under Part B have been licensed, including one product approved in 2017 that is sharing a HCPCS code with another previously licensed biosimilar biological product. Based on the number of biosimilar biological products that are reported to be nearing approval and the approvals made over that past 2 years, we anticipate that several more biosimilar biological products will be licensed for use in the United States during the next year and that during the following years, the marketplace will continue to grow steadily, provided that the approved products are marketed without delay. We also anticipate that biological products will continue to be heavily utilized in Part B. At the same time, we are aware of concerns that current Medicare policy may discourage development of new biosimilars and other innovation in this area potentially resulting in higher costs over time due to a lack of competition in the market place.
In the 2016 PFS final rule, we stated that it is desirable to have fair reimbursement in a healthy marketplace that encourages product development (80 FR 71101). CMS seeks to promote innovation to provide more options to patients and physicians, and competition to drive prices down, recognizing that even though these two goals may be difficult to achieve concurrently, to delink them would be counterproductive.
Although we believe that the United States biosimilar biological product marketplace is still in an early phase (because only a few products are on the market), we are interested in assessing the effects of Medicare payment policy on this important portion of the Part B drug marketplace at this time, particularly for fostering a robust, and competitive marketplace and encouraging the innovation that is necessary to bring more of these products to the marketplace. It is essential to take a measured approach that considers all options given the significant federal spending by Medicare on Part B drugs, the effect of payment policies on program sustainability for taxpayers, health care affordability and access for beneficiaries, and the considerable investment the biosimilar industry reports to be making in the nascent market (the development cost for a biosimilar product is reported by commenters to be approximately $100-200 million). Failure to consider the available options could potentially restrict innovation in the marketplace, increase costs to the American taxpayer, and limit treatment options. With that in mind, it is CMS's goal to further evaluate our policies to be sure they allow for market forces to provide a robust and comprehensive selection of choices for providers and patients at a fair price. Additionally, we are interested in better understanding if and how the differences in biological products and their current regulatory environment should be reflected in Medicare payment policy for biosimilars, particularly as it relates to biosimilars that are licensed for fewer than all indications for which the reference product is licensed or situations where different biosimilars may be licensed for different subsets of indications for which the reference product is licensed.
Thus, in the CY 2018 PFS proposed rule we requested comments regarding our Medicare Part B biosimilar biological product payment policy. This comment solicitation sought new or updated information on the effects of the current biosimilar payment policy that is based on experience with the United States marketplace. We stated that we were particularly interested in obtaining material, such as market analyses or research articles that provide data and insight into the current economics of the biosimilar market place. This includes patient, plan, and manufacturer data both domestic and, where applicable, from European markets that may be more established than, and provide insight for, the current United States market.
We also sought data to demonstrate how individual HCPCS codes could impact the biosimilar market, including innovation, the number of biosimilar products introduced to the market, patient access, and drug spending. Finally, we also sought comment regarding other novel payment policies that would foster competition, increase access, and drive cost savings in the biological product marketplace. These novel options may include legislation, demonstrations, and administrative options. The comment solicitation did not include a proposal to change the existing payment policy.
The following is a summary of the public comments received regarding the effect of payment policies on competition, access, and cost savings in the biological product marketplace and our responses on this issue. We received more than 200 comments in response to the solicitation. In general, comments were very similar to those received during the CY 2016 PFS rulemaking period.
Commenters who agreed with the current Medicare policy believed that grouping biosimilars would provide savings for beneficiaries and for the trust fund through increased competition. These commenters believe that separate billing codes do not foster price competition. The commenters pointed out that ASP-based payments for groups of potentially competing Part B drugs and biologicals remained the same or increased between 2012 and 2017. The commenters also pointed out that the use of separate billing codes would likely lead to high introductory prices. These commenters noted that Part B has already experienced a situation where the initial, WAC-based
Several commenters also discussed issues related to the differences between products in more detail, as well as the interchangeability of biosimilar biological products. Although none of the currently available biosimilars are approved as interchangeable (and finalized FDA guidance on the subject is not yet available), some commenters believed that grouping products for payment could be understood by clinicians and patients that the products could be interchangeable. Some commenters also pointed out that the current biosimilar approval process does not compare biosimilar biological products to each other, rather, only similarity to a reference product is established and the licensing of a biological product under the biosimilar pathway does not mean that the products are interchangeable. Also, commenters noted that biosimilar biological products may be approved for fewer indications than the reference product and that the approved indications within a group of biosimilar biological products with the same reference product may vary. Some commenters believed that blended payment for biosimilar biological products that do not have all the same indications could lead to off-label use.
Many commenters believed that differences between biosimilar biological products that share a common reference product exist and stated that such distinctions, which may affect the clinical use of a product on specific patients, support the need for separate coding and payment for biosimilars under Medicare Part B. Some commenters also associated these concerns with concerns about payment for biosimilar biological products.
Several comments discussed the relationship between costs, prices, and competition in the biologicals and biosimilars market, as follows. Because these products are likely to be expensive and may have different acquisition costs, blended payment was perceived by many commenters as a significant financial risk to the provider because the provider could not be highly certain that the products that would be the best choice for a patient would also be likely to be paid above acquisition cost. These commenters believed that separate codes would lead to more certainty about payment amounts for biosimilar biological products. Some commenters were concerned that “race to the bottom” pricing competition would result from shared codes and lead to prices that could not sustain educational efforts and other activities associated with marketing new and complex biological products, ultimately resulting in manufacturers leaving the United States marketplace. The commenters also noted that the development costs for these products and their manufacturing facilities are estimated to be in the hundreds of millions of dollars.
Commenters also expressed concern about the lack of competition between biosimilars and their reference product. Some commenters who disagreed with CMS's current approach of grouping biosimilar biological products for payment believed that separate codes would lead to opportunities for greater and more direct competition between the reference product and its biosimilar versions.
Other commenters who agreed with current Medicare policy, suggested that payment for biosimilars should be based on grouping the reference product with its corresponding biosimilars in the same billing and payment code and suggested that legislative authority for such a change should be sought by CMS. These commenters opined that combining reference products and corresponding biosimilar biological products into the same billing and payment code would maximize competition for items with similar effects. In the absence of authority to expand grouped payment to include the reference product, most of these commenters agreed with the current approach of grouping biosimilar biological products of the same reference product into the same billing and payment code.
Many of these concerns were brought up in comments on biosimilars made in response to the CY 2016 PFS final rule with comment period. We discussed these issues, including differences between small molecule drugs and biologicals (including biosimilars), generic drugs, and interchangeability in the 2016 final rule. However, as we have further considered the Part B biosimilar biological payment policy and this year's comments, we have become increasingly concerned about the relationship between cost, prices and competition; specifically, many commenters' continued unease regarding the effects of our payment policy on patient and provider choices, as well as the biosimilar marketplace. We have also considered how the payment policy could affect market entry of new biosimilar manufacturers. If payment amounts limit manufacturers' willingness to invest in the development of new biosimilars, it could in the long term, decrease the number of biosimilar biological products that are available to prescribe and thus impair price competition. Given that the United States' biosimilar biological product marketplace is still relatively new, we believe that it is important to maintain a payment policy innovation as well as reasonable pricing for consumers.
We agree that current statutory authority does not permit the inclusion of the reference product in a payment determination calculation for biosimilar biological products paid under Medicare Part B.
One commenter also provided a revised industry estimate from the Biosimilars Forum that projected $50 billion in savings to the Medicare program over 10 years under the existing policy and an additional $15 billion in savings over 10 years if separate codes were used. This estimate, which was referenced by a number of other commenters, assumes higher uptake of biosimilars (up to 65 percent at 10 years, compared to 35 percent with current policy) if separate codes are implemented. Commenters stated that they believe the separate coding approach would create competition and lower prices for the long term. The main reasons for this were: Increased physician confidence (mainly associated with certainty about the payment amount), a number of manufacturers and products in the marketplace, and resources (from the manufacturers) that would encourage uptake.
As discussed earlier in this section, several commenters discussed code consolidation where reference and corresponding biosimilar products would be included in a shared code. Commenters also suggested that value based purchasing models, including outcomes-based pricing and pricing based on negotiations between a vendor and manufacturers, be considered for biosimilar biological products (as well as other drugs). One commenter also stated that paying differently for biosimilars and interchangeable products may create incentives for growth in the marketplace. One manufacturer suggested that the ASP add on percentage could be increased to the 15-20 percent range to encourage uptake.
We also received comments that encouraged consistency between Part B, Part D and Medicaid, and comments that encouraged streamlining and simplification of price reporting, as well as comments on HCPCS coding schedules and deadlines, the use of NDCs on claims, pharmacy substitution activities, coverage, and the FDA naming conventions for biosimilars.
We appreciate the many responses that we received to our comment solicitation. Comments received about the issue of grouping or separating payment for biosimilars of the same reference product were sharply divided, and information provided as support for a given position was also subject to interpretation. For example, a commenter who is opposed to the current policy cited a report (Scott Morton F, Boller LT. Enabling Competition in Pharmaceutical Markets. Hutchins Center. May 2017as evidence that robust competition could reduce costs in the long-term; however, another portion of the report supported MedPAC's June 2017 recommendation to pay biosimilars and reference products under the same code (which CMS does not have the authority to do). We are acknowledging that opinions on the issue of how Part B should pay for biosimilar biological products vary, however, as discussed below, we believe that the solution discussed in the paragraphs below is superior to existing policy.
As we stated previously, we seek to promote innovation, to provide more options to patients and physicians, and to encourage competition to drive prices down. We also stated that our goal for the comment solicitation was to further evaluate our policies to be sure they allow for market forces to provide a robust and comprehensive selection of choices for patients at a fair price. Based on the review of the comments that are summarized above, we are persuaded that changing the Part B biosimilar payment policy to provide for the separate coding and payment for products approved under each individual abbreviated application, rather than grouping all biosimilars with a common reference product into codes, will meet the stated goal. We believe that this policy change will encourage greater manufacturer participation in the marketplace and the introduction of more biosimilar products, thus creating a stable and robust market, driving competition and decreasing uncertainty about access and payment. First, as we have discussed, we anticipate that this policy change will provide physicians with greater certainty about biosimilar payment. We are persuaded that, in turn, this will affect utilization of these products, creating more demand that would help increase competition (compared to the policy that is currently in place). As a result of the policy change we anticipate greater access to biosimilar biological products and we anticipate that more price competition between more products will occur because there will be more products available. The change in policy could lead to additional savings for Medicare and its beneficiaries over the long-term by increasing the utilization of products that are less expensive than reference biologicals. Further, carrying out this policy change as early as possible, rather than waiting, would maximize the benefits described in this paragraph and would bring more certainty to the new and developing marketplace promptly.
In summary, we are persuaded that that there is a program need for assigning Part B biosimilar biological products into separate HCPCS codes, specifically that this policy change will address concerns about a stronger marketplace, access to these drugs in the United States marketplace, provider and patient choice and competition. We also believe that the change in policy will encourage innovation needed to bring more products to the market. We remind readers that our preamble language in the CY 2016 PFS rule with comment period (80 FR 71096) indicated that policy changes could be forthcoming (80 FR 71098).
Thus, in this final rule, we are finalizing the policy to separately code and pay for biological biosimilar products under Medicare Part B; we are not changing regulation text at § 414.904(j). Effective January 1, 2018, newly approved biosimilar biological products with a common reference product will no longer be grouped into the same HCPCS code. We will issue detailed guidance on coding, including
As suggested by commenters who supported both policy approaches, we plan to continue to monitor Part B biosimilar payment and utilization, particularly as they relate to access, including the number of products available to beneficiaries with Part B and cost savings associated with Medicare and beneficiary payments. We also appreciate the comments on novel payment policies that would foster competition, increase access, and drive cost savings in the biological product marketplace.
Section 218(b) of the Protecting Access to Medicare Act (PAMA) amended Title XVIII of the Act to add section 1834(q) of the Act directing us to establish a program to promote the use of appropriate use criteria (AUC) for advanced diagnostic imaging services. The CY 2016 PFS final rule with comment period addressed the initial component of the new Medicare AUC program, specifying applicable AUC. In that rule (80 FR 70886), we established an evidence-based process and transparency requirements for the development of AUC, defined provider-led entities (PLEs) and established the process by which PLEs may become qualified to develop, modify or endorse AUC. The first list of qualified PLEs was posted on the CMS Web site at the end of June 2016 at which time their AUC libraries became specified applicable AUC for purposes of section 1834(q)(2)(A) of the Act. The CY 2017 PFS final rule addressed the second component of this program, specification of qualified clinical decision support mechanisms (CDSMs). In that rule (81 FR 80170), we defined CDSM, identified the requirements CDSMs must meet for qualification including an opportunity for preliminary qualification for mechanisms still working toward full adherence, and established a process by which CDSMs may become qualified. We also defined applicable payment systems under this program, specified the first list of priority clinical areas and identified exceptions to the requirements that ordering professionals consult specified applicable AUC when ordering applicable imaging services. The first list of qualified CDSMs was posted on the CMS Web site in July 2017.
The CY 2018 PFS proposed rule proposed the start date of January 1, 2019 for the Medicare AUC program for advanced diagnostic imaging services. It is on and after this date that ordering professionals must consult specified applicable AUC using a qualified CDSM when ordering applicable imaging services and furnishing professionals must report consultation information on the Medicare claim. This rule also proposed to modify the policy related to significant hardship exceptions and requested public feedback on details regarding how AUC consultation information must be included on the Medicare claim. To further this iterative process of implementation, we also discussed briefly the potential for alignment with other Medicare quality programs.
AUC present information in a manner that links: A specific clinical condition or presentation, one or more services and, an assessment of the appropriateness of the service(s). For purposes of this program AUC is a set or library of individual appropriate use criteria. Each individual criterion is an evidence-based guideline for a particular clinical scenario. Each scenario in turn starts with a patient's presenting symptoms or condition. Evidence-based AUC for imaging can assist clinicians in selecting the imaging study that is most likely to improve health outcomes for patients based on their individual clinical presentation.
AUC need to be integrated as seamlessly as possible into the clinical workflow. CDSMs are the electronic portals through which clinicians access the AUC during the patient workup. While CDSMs can be standalone applications that require direct entry of patient information, they may be more effective when they automatically incorporate information such as specific patient characteristics, laboratory results, and lists of co-morbid diseases from Electronic Health Records (EHRs) and other sources. Ideally, practitioners would interact directly with the CDSM through their primary user interface, thus minimizing interruption to the clinical workflow.
Consistent with descriptions of clinical decision support by the Agency for Healthcare Research and Quality (AHRQ) (
Section 218(b) of the PAMA added a new section 1834(q) of the Act entitled, “Recognizing Appropriate Use Criteria for Certain Imaging Services,” which directs the Secretary to establish a new program to promote the use of AUC. Section 1834(q)(4) of the Act requires ordering professionals to consult with a qualified CDSM for applicable imaging services furnished in an applicable setting and paid for under an applicable payment system; and for the furnishing professional to include on the Medicare claim information about the ordering professional's consultation with a qualified CDSM.
There are four major components of the AUC program under section 1834(q) of the Act, and each component has its own implementation date: (1) Establishment of AUC by November 15, 2015 (section 1834(q)(2) of the Act); (2) identification of mechanisms for consultation with AUC by April 1, 2016 (section 1834(q)(3) of the Act); (3) AUC consultation by ordering professionals, and reporting on AUC consultation by furnishing professionals by January 1, 2017 (section 1834(q)(4) of the Act); and (4) annual identification of outlier ordering professionals for services furnished after January 1, 2017 (section 1834(q)(5) of the Act). We did not identify mechanisms for consultation by April 1, 2016. Therefore, we did not require ordering professionals to consult CDSMs or furnishing professionals to report information on the consultation by the January 1, 2017 date.
In the CY 2016 PFS final rule with comment period, we addressed the first component of the Medicare AUC program under section 1834(q)(2) of the Act—the requirements and process for establishment and specification of applicable AUC, along with relevant aspects of the definitions under section 1834(q)(1) of the Act. This included
In the same rule we established a timeline and process under § 414.94(c)(2) for PLEs to apply to become qualified. Consistent with this timeline the first list of qualified PLEs was published at
In the CY 2017 PFS final rule, we addressed the second major component of the Medicare AUC program—the specification of qualified CDSMs for use by ordering professionals for consultation with specified applicable AUC under section 1834(q)(3) of the Act, along with relevant aspects of the definitions under section 1834(q)(1) of the Act. This included defining the term CDSM and finalizing functionality requirements of mechanisms, upon which qualification is based, as provided in section 1834(q)(3)(B) of the Act and in the CY 2017 PFS final rule. We included an opportunity for mechanisms still working toward full adherence to these requirements to receive preliminary qualification during the preliminary qualification period that begins June 30, 2017, and ends when the AUC consulting and reporting requirements become effective. The preliminarily qualified CDSMs must meet all requirements by that time. We defined CDSM as an interactive, electronic tool for use by clinicians that communicates AUC information to the user and assists them in making the most appropriate treatment decision for a patient's specific clinical condition. Tools may be modules within or available through certified EHR technology (as defined in section 1848(o)(4) of the Act) or private sector mechanisms independent from certified EHR technology or established by the Secretary.
In the CY 2017 PFS final rule we established a timeline and process in § 414.94(g)(2) for CDSM developers to apply to have their CDSMs qualified. Consistent with this timeline, the first list of qualified CDSMs was published at
The third major component of the Medicare AUC program is in section 1834(q)(4) of the Act, Consultation with Applicable Appropriate Use Criteria. This section establishes, beginning January 1, 2017, the requirement for an ordering professional to consult with a qualified CDSM when ordering an applicable imaging service that would be furnished in an applicable setting and paid for under an applicable payment system; and for the furnishing professional to include on the Medicare claim information about the ordering professional's consultation with a qualified CDSM. The statute distinguishes between the ordering and furnishing professional, recognizing that the professional who orders an applicable imaging service is usually not the same professional who bills Medicare for that service when furnished. Since a list of qualified CDSMs was not available by January 1, 2017, we did not require ordering professionals to meet the consultation requirement by that date.
Section 1834(q)(4)(C) of the Act provides for certain exceptions to the AUC consultation and reporting requirements including in the case of certain emergency services, inpatient services paid under Medicare Part A, and ordering professionals who obtain an exception due to a significant hardship. In the CY 2017 PFS final rule, we identified the circumstances specific to ordering professionals under which consulting and reporting requirements are not required. These include orders for applicable imaging services: (1) For emergency services when provided to individuals with emergency medical conditions as defined in section 1867(e)(1) of the Act; (2) for an inpatient and for which payment is made under Medicare Part A; and (3) by ordering professionals who are granted a significant hardship exception to the Medicare EHR Incentive Program payment adjustment for that year under 42 CFR 495.102(d)(4), except for those granted such an exception under § 495.102(d)(4)(iv)(C). We discuss changes to the significant hardship exceptions later in this preamble.
Section 1834(q)(4)(D) of the Act specifies the applicable payment systems for the AUC consultation and reporting requirements, and, in the CY 2017 PFS final rule we defined them as: (1) The physician fee schedule established under section 1848(b) of the Act; (2) the prospective payment system for hospital outpatient department services under section 1833(t) of the Act; and (3) the ambulatory surgical center payment system under section 1833(i) of the Act.
The fourth component of the Medicare AUC program is in section 1834(q)(5) of the Act, Identification of Outlier Ordering Professionals. The identification of outlier ordering professionals under this paragraph facilitates a prior authorization requirement for outlier professionals beginning January 1, 2020, as specified under section 1834(q)(6) of the Act. Given that we proposed a program start date of January 1, 2019, we anticipate that implementation of the prior authorization component would be delayed. We expect to discuss details around outlier calculations and prior authorization in the CY 2019 PFS proposed rule. However, we did finalize in the CY 2017 PFS final rule the first list of priority clinical areas to guide identification of outlier ordering professionals as follows:
• Coronary artery disease (suspected or diagnosed).
• Suspected pulmonary embolism.
• Headache (traumatic and non-traumatic).
• Hip pain.
• Low back pain.
• Shoulder pain (to include suspected rotator cuff injury).
• Cancer of the lung (primary or metastatic, suspected or diagnosed).
• Cervical or neck pain.
As established in § 414.94(e)(4) of our regulations, priority clinical areas may be used in the identification of outlier ordering professionals. By starting to identify these areas now, we believe ordering professionals will have the opportunity to become familiar with
We did not include proposals to expand or modify the list of priority clinical areas in the CY 2018 PFS proposed rule.
In the CY 2018 PFS proposed rule, we proposed to amend § 414.94 of our regulations, “Appropriate Use Criteria for Certain Imaging Services,” to reflect the following policies.
We proposed that ordering professionals must consult specified applicable AUC through qualified CDSMs for applicable imaging services furnished in an applicable setting, paid for under an applicable payment system and ordered on or after January 1, 2019. We proposed this effective date for the consulting and reporting requirements to allow time for ordering practitioners who are not already aligned with a qualified CDSM to research and evaluate the qualified CDSMs so they may make an informed decision. Although there will be an additional rulemaking cycle before the consulting and reporting requirement is effective, we are establishing the date through rulemaking this year because we expect practitioners and other stakeholders to begin preparing themselves to report and we want to ensure all impacted parties have sufficient time to prepare to meet the requirements of this program.
After proposing the timeline and process for qualification of CDSMs in the CY 2017 PFS proposed rule (81 FR 46392), we anticipated that furnishing professionals may begin reporting as early as January 1, 2018. However, we received comments that these timelines did not allow enough time to address the needs of different stakeholder groups. Some commenters requested that we delay the timeline and process to give practitioners sufficient time to obtain a qualified CDSM. Other commenters cited insufficient time for CDSMs to incorporate requirements between the release of the final CDSM requirements and January 1, 2018, and requested that we fully implement the program at a later date. Additionally, in the CY 2017 PFS final rule (81 FR 80411) we discussed commenters' recommendations that we develop and launch an educational campaign, including a Town Hall meeting. Some commenters requesting additional time suggested that, for purposes of both CDSM vendor readiness and practitioner readiness, consulting and reporting requirements should not go into effect for an additional 12-18 months after the initial list of CMS-qualified CDSMs is posted.
By proposing that the consulting and reporting requirements begin on January 1, 2019, we intended to allow needed time for education and outreach efforts, time for practitioners and stakeholders to prepare, and time for CDSMs to continue current strides in being more user-friendly and less burdensome. We note that the statute required publication of qualified CDSMs by April 1, 2016, and required AUC consultation and reporting by January 1, 2017; therefore, our proposal substantially lags the statutory requirements. As noted earlier and in previous rulemaking, a delay in the statutory timeline is necessary to maximize the opportunity for public comment and stakeholder engagement, which is also a statutory requirement, and allow for adequate advance notice to practitioners, beneficiaries, AUC developers, and CDSM developers. This delay is also important to allow time to test and ensure Medicare claims processing systems are ready to accept and process claims that include the necessary AUC consultation information. Failure to test our own processes could result in claims being denied inappropriately or, conversely, being paid inappropriately.
The following is a summary of the public comments received on the proposed effective date for consulting and reporting requirements:
In instances when the furnishing professional must update or modify the order for an advanced diagnostic imaging service, the AUC consultation information provided by the ordering professional with the original order should be reflected on the Medicare claim to demonstrate that the requisite AUC consultation occurred. In future rulemaking, we expect to establish a means to account for instances when the order must be updated or modified. We anticipate addressing this issue in rulemaking to develop policies relating to the identification of outlier ordering professionals, and in order to inform the prior authorization component of this program.
In response to public comments we are further delaying the effective date for the AUC consultation and reporting requirements for this program from January 1, 2019 as proposed to January 1, 2020. We are also finalizing a voluntary period during which early adopters can begin reporting limited consultation information on Medicare claims from July 2018 through December 2019. During the voluntary period there is no requirement for ordering professionals to consult AUC or furnishing professionals to report information related to the consultation. On January 1, 2020, the program will begin with an educational and operations testing period and during this time we will continue to pay claims whether or not they correctly include such information. Ordering professionals must consult specified applicable AUC through qualified CDSMs for applicable imaging services furnished in an applicable setting, paid for under an applicable payment system and ordered on or after January 1, 2020, and furnishing professionals must report the AUC consultation information on the Medicare claim for these services ordered on or after January 1, 2020.
Consistent with section 1834(q)(4)(B) of the Act, we also proposed that furnishing professionals report the following information on Medicare claims for applicable imaging services, furnished in an applicable setting, paid for under an applicable payment system as defined in § 414.94(b), and ordered on or after January 1, 2019: (1) Which qualified CDSM was consulted by the ordering professional; (2) whether the service ordered would adhere to specified applicable AUC, would not adhere to specified applicable AUC, or whether the specified applicable AUC consulted was not applicable to the service ordered; and (3) the NPI of the ordering professional (if different from the furnishing professional).
We believe that, unless a statutory exception applies, an AUC consultation must take place for every order for an applicable imaging service furnished in an applicable setting and paid under an applicable payment system. We further believe that section 1834(q)(4)(B) of the Act accounts for the possibility that AUC may not be available in a particular qualified CDSM to address every applicable imaging service that might be ordered; and thus, the furnishing professional can meet the requirement to report information on the ordering professional's AUC consultation by indicating that AUC is not applicable to the service ordered. We remind readers that, as required under § 414.94(g)(1)(iii), qualified CDSMs must make available, at a minimum, AUC that reasonably address common and important clinical scenarios within all priority clinical areas. As discussed in the CY 2017 PFS final rule (81 FR 80170), the current list of priority clinical areas represents about 40 percent of advanced diagnostic
Section 1834(q)(4)(B) requires that payment may only be made if the claim for the advanced diagnostic imaging service includes the specific information discussed in this final rule. This information, to the extent feasible, is required across claim types (including both the furnishing professional and facility claims) and across all three applicable payment systems (PFS, hospital outpatient prospective payment system and ambulatory surgical center payment system). In other words, we would expect this information to be included on the practitioner claim that includes the professional component of the imaging service and on the hospital outpatient claim for the technical component of the imaging service. Claims for services for which payment is not made under the three identified payment systems would not be required to include consultation related information.
To implement this requirement we proposed to establish a series of HCPCS level 3 codes. These G-codes would describe the specific CDSM that was used by the ordering professional. Ultimately there would be one G-code for every qualified CDSM with the code description including the name of the CDSM. However, because the claims processing system can only recognize new codes quarterly, we may not be able to update the G-code descriptors simultaneously with the announcement of any new qualified CDSMs which is expected to occur in June of each year. To ensure that there is a code available to immediately describe newly qualified CDSMs, we proposed to establish a generic G-code that would be used to report that a qualified CDSM was consulted, but would not identify a specific qualified CDSM; clinicians would only be permitted to use this code if a more specific named code did not yet exist for that clinician's CDSM. Furnishing professionals would report this code temporarily until a specific G-code describing the newly qualified CDSM by name becomes available. We also proposed to establish a G-code to identify circumstances where there was no AUC consultation through a qualified CDSM. The description of this code would indicate that a qualified CDSM was not consulted by the ordering professional.
G-codes would be a line-item on both practitioner claims and facility claims. We would expect that one AUC consultation G-code would be reported for every advanced diagnostic imaging service on the claim. If there are two codes billed for advanced imaging services on the claim then we would expect two G-codes. Each G-code would be expected, on the same claim line, to contain at least one new HCPCS modifier. We proposed to develop a series of modifiers to provide necessary information as to whether, when a CDSM is used to consult AUC: (1) The imaging service would adhere to the applicable appropriate use criteria; (2) the imaging service would not adhere to such criteria; or (3) such criteria were not applicable to the imaging service ordered. We proposed to create additional modifiers to describe situations where an exception applies and a qualified CDSM was not used to consult AUC: (1) The imaging service was ordered for a patient with an emergency medical condition or (2) the ordering professional has a significant hardship exception. Based on this proposal we specifically sought comments on any additional HCPCS modifiers that might be needed to separately identify allowable scenarios for which a qualified CDSM was not consulted by the ordering professional.
The following is a summary of the public comments received on our proposals for the information furnishing professionals must report on the Medicare claim:
Commenters provided various recommendations to CMS that would avoid the combination of reporting through G-codes and modifiers. A commenter suggested that only one G-code be developed to generically identify that a CDSM consultation occurred without identifying the specific mechanism. Another comment pointed out that when the modifiers for consultation exceptions are reported (for example, emergency medical conditions or hardship exceptions) that the modifier should be reporting on the same line as the CPT code for the imaging service as opposed to reporting a G-code.
Many commenters suggested CMS require the unique consultation identifier be appended to the Medicare claim instead of using G-code and modifier combinations. They suggested CMS, along with stakeholders, standardize the identifier to have embedded meaning that is consistent across CDSMs. They further supported the reporting of this identifier on claims so CMS can match the claim with the richer, more robust consultation data that is collected within the CDSM. It is with this more complete information that they suggested that outlier ordering professionals be identified rather than rely solely on information reported on the claim. Commenters generally supported use of the unique identifier as the least administratively burdensome approach to collecting AUC consultation information on Medicare claims.
Other commenters suggested a registry to hold all AUC consultation information across CDSMs and that the information be available to CMS directly from the registry rather than having furnishing professionals report information on the claim. They further suggested that a registry would also include information about consultations that do not result in imaging.
In response to these comments we will not move forward with the G-code and modifier combinations for reporting which CDSM is consulted, adherence, non-adherence or situations where AUC are not applicable. We will further explore and pursue use of the unique consultation identifier for reporting on Medicare claims. However, in order to use such an identifier we must work with stakeholders to develop a standard taxonomy. We expect to conduct stakeholder outreach during 2018 so that such standardization can be accomplished and will discuss such changes in future rulemaking ahead of the 2020 consulting and reporting effective date. We do not anticipate including these identifiers on claims before then. We will conduct outreach to better explore options of where to place such an identifier on practitioner and facility claims for advanced imaging services. We will also explore mechanisms for CMS and qualified CDSMs to share data.
Since we intend to move forward to implement the AUC consultation and reporting requirement under section 1834(q)(4) using the unique AUC consultation identifier, we will not pursue the use of G-codes to identify the consulted CDSM. It is our expectation that the information required for Medicare claims processing and, ultimately, identification of outlier ordering professionals, will be embedded within a standardized unique identifier. AUC adherence, non-adherence and not applicable responses should also be embedded. Therefore, we will not move forward with the creation of modifiers to identify each of those AUC consultation result conditions. We do expect that limited use of modifiers will be required in the future to identify certain exceptions to AUC consultation requirements.
In another section of this preamble we discuss the voluntary reporting period that we proposed to be available from July 2018 through December 2018, and we are extending in this final rule through CY 2019. During the voluntary reporting period, ordering professionals are not required to consult AUC and furnishing professionals are not required to report consultation information on their Medicare claims. Furnishing professionals and facilities reporting AUC consultation information during the voluntary reporting period will have one HCPCS modifier available to them to report on the line level with the CPT code for the advanced diagnostic imaging service. This modifier identifies only that AUC was consulted and not the result of the consultation. We expect this type of limited reporting will be temporary as we move forward to implement the AUC consultation and reporting requirements using the unique AUC consultation identifier.
In response to the public comments, we are not moving forward with requiring reporting of AUC consultation information on Medicare claims using a combination of G-codes and modifiers. Rather, we will evaluate a simplified method of reporting during the voluntary reporting period using a single modifier while we work with stakeholders to explore using a standardized unique AUC consultation identifier.
The following is a summary of public comments received on communication of AUC consultation information between the ordering and furnishing professionals:
Commenters also requested clarification around a number of specific issues. One commenter requested CMS provide instructions on how to handle orders written prior to the effective date for the AUC consultation and reporting requirement when services are furnished after the effective date. One commenter requested clarification around claims processing issues if the imaging test ordered does not match the test performed because the furnishing professional modifies the order. Several commenters requested clarification regarding the obligations on ordering and furnishing professionals along with the consequences during the educational and operations testing period, and specifically asked whether claims will be paid during this period. Commenters also requested clarification on which professional is responsible for the accuracy of reporting, how CMS will ensure this, and the consequences on furnishing professionals if the required information is not obtained after the
There are aspects of the AUC program that are novel for ordering and furnishing professionals. An AUC consultation by an ordering professional and reporting by a furnishing professional has never before been required under Medicare Part B with such a broad application (all professionals ordering and furnishing advanced diagnostic tests). Additional considerations are warranted for the complex communication that is required to convey AUC consultation information from the ordering professional to the furnishing professional and facility that must include that information when billing for the service. Billing systems for furnishing professionals will also need to include the AUC consultation information onto Medicare claims forms. These processes are new for many professionals, and there are many areas for potential missteps and errors. For these reasons an educational and operations testing period is needed. During this period, ordering professionals would consult AUC and furnishing professionals would report AUC consultation information on the claim, but we would continue to pay claims whether or not they correctly include such information. This educational and operations testing period allows professionals to actively participate in the program while avoiding claims denials during the learning curve. It also gives us an opportunity to make any needed claims processing adjustments before payments are impacted.
We believe it is preferable to begin implementation with an educational and operations testing period of a year. We do not expect to continue this educational and operations testing period beyond the first year of the AUC program.
We sought public comments on all aspects of our proposal, and specifically, whether the AUC program requirements should be delayed beyond the proposed start date of January 1, 2019. Although our proposal to start the AUC program with an educational and operations testing period beginning on January 1, 2019 was based in part on comments received in prior rulemaking cycles, it was important to receive comments to help us understand the current readiness of stakeholders. In addition, we proposed that the program begin with an educational and operations testing period and were interested in comments regarding how long, if longer than one year, such a period should be available.
In our proposals, we expected a voluntary reporting period to be available prior to the beginning of the educational and operations testing period and anticipated such voluntary period will begin in July 2018. When the voluntary period becomes available we will make announcements through our educational channels such as the CMS Web site and listservs. It is important to note that the educational and operations testing period is separate from the voluntary reporting period. During the voluntary reporting period, AUC consultation and reporting are not required. However, for applicable imaging services ordered on and after January 1, 2019, we proposed that ordering professionals would be required to consult specified applicable AUC and furnishing professionals would be required to report AUC consultation information on the Medicare claim. We proposed further that the initial year of the AUC consultation and reporting requirement would be an educational and operations testing period during which we would continue to pay claims whether or not they correctly include the required information.
The following is a summary of the public comments received on the proposed start date of January 1, 2019, our proposal to begin with a year long educational and operations testing period, and the inclusion of a voluntary reporting period ahead of the required AUC consultation and reporting start date; and our responses to the comments:
Although commenters pressed the need for predictability in the start of the program and asserted that numerous professionals are ready to begin, or are very close to beginning, to use CDSMs, other commenters focused on the increased burden associated with this program. Those commenters identified the Quality Payment Program as a new program that is currently requiring extra resources and has recently increased burden on the same practitioners and facilities that will be burdened by the AUC program.
Some commenters suggested that, instead of beginning to implement the AUC program broadly, we should begin smaller with focused pilots, or a staged or incremental rollout.
We believe this program can be implemented in a manner that would minimize burden, but this will require additional stakeholder outreach, collaboration and time. For practitioners and facilities that are ready to use qualified CDSMs or that are new to CDSMs and want to practice and refine their workflow, we are providing a voluntary period starting in July of 2018 that runs through CY 2019.
Taking into account the comments related to burden and readiness, we agree with the commenters recommending that the program begin in 2020 with an educational and operations testing period. Providing a start date for implementation of the AUC consultation and reporting requirement will also give some predictability and assurance to practitioners. Given our intention to use the educational and operations testing period to make needed adjustments to the program as well as identify any needs for further guidance and education, we will evaluate whether a second educational and operations testing year is necessary. We believe it is appropriate to retain this option in the event that, to be responsive to stakeholder feedback and the lessons we learn, it is expedient to take additional time to fully implement the AUC consultations and reporting requirements. However, since we currently have qualified PLEs and qualified CDSMs, we expect to be prepared to quickly begin a voluntary participation period. Since the educational and operations testing period will not start until 2020, we are extending the voluntary participation period to 18 months from July 2018 through December 2019.
In response to the public comments, and in addition to delaying the effective date for requiring AUC consultation and reporting as described earlier in this section, we are extending the voluntary period through 2019, so it will begin in July 2018 and end at the end of December 2019. The voluntary period will then be immediately followed by the educational and operations testing period in 2020 during which claims will not be denied for failure to include proper AUC consultation information.
The CY 2017 Merit-based Incentive Payment System and Alternative Payment Model final rule with comment period (Quality Payment Program final rule) (81 FR 77008) finalized policies to implement a new approach to payment for physicians and other eligible clinicians, enacted by the MACRA, that rewards the delivery of high-quality patient care through two avenues: Advanced Alternative Payment Models (APMs) and the Merit-Based Incentive Payment System (MIPS) under the PFS. We expect the Quality Payment Program to evolve over multiple years and to continue iterating on these policies. We also believe the AUC program has the potential to provide new opportunities to improve care delivery by supporting and rewarding clinicians as they find new ways to engage patients, families and caregivers as well as improving care coordination and patient health management.
Therefore, we proposed in the CY 2018 Updates to the Quality Payment Program proposed rule (82 FR 30010) to develop a direct tie between MIPS and the AUC program. In that rule, we proposed to give MIPS credit in the improvement activities performance category to ordering professionals for consulting specified AUC using a qualified CDSM as a high-weight improvement activity for the performance period beginning January 1, 2018 (82 FR 30484). We believe this will incentivize early use of qualified CDSMs to consult AUC by motivated eligible clinicians looking to improve patient care and to better prepare themselves for the AUC program. Although we proposed that the AUC program consultation and reporting requirements would not officially begin until January 1, 2019, we are able to adopt this proposed improvement activity because the first qualified CDSMs were announced in conjunction with the CY 2018 PFS proposed rule; therefore, ordering professionals will be able to begin consulting specified, applicable AUC using those tools.
We also considered how the AUC program could serve to support a quality measure under the MIPS quality performance category, and sought feedback from the public regarding feasibility and value of pursuing this idea further.
The following is a summary of the public comments received on how the AUC program could serve to support a quality measure under the MIPS quality performance category, and feedback regarding feasibility and value of pursuing this idea further; and our responses:
A few commenters stated they look forward to working with us to develop and implement appropriate measures that will further align the AUC program with the Quality Payment Program. Several commenters submitted additional proposals to better align the AUC program to additional MIPS performance categories. One commenter believed that if the certified EHR technology (CEHRT) requirements were expanded to include the requirement for CDSM functionality within computerized physician order entry modules, the alignment between the AUC program and the MIPS ACI performance category would be further reinforced. A few commenters noted the currently available appropriate use measures, including measures for cardiac imaging, and suggested that such measures could be leveraged as models for applying AUC to more areas of advanced diagnostic imaging, which the commenters believed to be responsive to the request to align the AUC program with the Quality Payment Program. One commenter recommended that any potential quality measure developed around AUC would have to meet the standards set for other quality measures—reliability, validity, and testing. Specific suggestions from commenters also included the framework for creation of a new quality measure. For example, commenters suggested that a quality measure could assess whether a clinician consults specified, applicable AUC using a qualified CDSM or other tool. Another proposal included an optional quality measure or bonus points in MIPS if physicians provide feedback to PLEs and CDSMs about why they decided to proceed with ordering an applicable imaging service when it does not adhere to the specified applicable AUC consulted, thus enabling PLEs and CDSMs to learn from user experience. Another commenter recommended that CDSMs could support such feedback and improvement efforts by including applications for practitioners to download to mobile devices, thus allowing ordering professionals to consult AUC using an intuitive flow-chart based interface. One commenter asked that any AUC-related measure provide two points for reporting on appropriate use, suggesting that such a proposal would further incentivize reporting on an appropriate use measure. One commenter suggested that greater alignment with the quality performance category of MIPS could be achieved through utilization of a Qualified Clinical Data Registry (QCDR) that incorporates CDSMs and reports information on the physician's behalf. The commenter believed that a registry approach would be simpler, provide essential data, and potentially avoid clinician burden as a result. Finally, a few commenters strongly urged full alignment of the AUC program with the MIPS cost or quality performance categories and complete discontinuation of the AUC program and its regulatory burden.
In response to public comments, we have finalized this improvement activity in the CY 2018 Updates to the Quality Payment Program final rule and note here that the description was updated such that clinicians attest that they are consulting specified applicable AUC through a qualified CDSM for all applicable imaging services furnished in an applicable setting, paid for under an applicable payment system, and ordered on or after January 1, 2018.
We proposed to modify § 414.94(i)(3) of our regulations to reflect the conclusion of application of the payment adjustments under the Medicare EHR Incentive Program and to substitute an alignment with the advancing care information (ACI) performance category of MIPS. In the CY 2017 PFS final rule, for purposes of the AUC program significant hardship exceptions, we included the following categories from § 495.102(d)(4):
• Insufficient Internet Connectivity (as specified in § 495.102(d)(4)(i)).
• Practicing for less than 2 years (as specified in § 495.102(d)(4)(ii)).
• Extreme and Uncontrollable Circumstances (as specified in § 495.102(d)(4)(iii)).
• Lack of Control over the Availability of CEHRT (as specified in § 495.102(d)(4)(iv)(A)).
• Lack of Face-to-Face Patient Interaction (as specified in § 495.102(d)(4)(iv)(B)).
In addition, in the CY 2017 Quality Payment Program final rule, we finalized a policy (81 FR 77240-77243) to reweight the ACI performance category to zero in the MIPS final score for the year for MIPS eligible clinicians who meet the criteria in one of the listed categories of § 495.102(d)(4), with the exception of the category for clinicians practicing for less than 2 years. Under section 1848(q)(1)(C)(v) of the Act, eligible clinicians who first enroll in Medicare during the performance period for a year and have not previously submitted claims under Medicare are not considered MIPS eligible clinicians, and thus are excluded from MIPS. Therefore, many clinicians who have been practicing for less than 2 years would be excluded from MIPS on the basis that they are new Medicare-enrolled MIPS eligible clinicians as defined in § 414.1305. Because these clinicians are not MIPS eligible clinicians, they would never meet the criteria for re-weighting of their MIPS ACI performance category for the year. Therefore, to implement a hardship exception for purposes of the AUC program that is both operationally consistent and administratively efficient, we proposed to remove as a criterion for a significant hardship exception for the AUC program the criterion specified in § 495.102(d)(4)(ii) of our regulations for those practicing for less than 2 years. We proposed to keep the remaining listed categories including insufficient internet connectivity, extreme and uncontrollable circumstances, lack of control over availability of CEHRT and lack of face to face patient interaction. We noted that section 1843(q)(4)(C)(iii) of the Act only allows the ordering professional to seek a significant hardship exception, not the furnishing professional.
As such, we proposed to amend the AUC significant hardship exception regulation to specify that ordering professionals who are granted re-weighting of the ACI performance category to zero percent of the final score for the year under MIPS per § 414.1380(c)(2) due to circumstances that include the criteria listed in § 495.102(d)(4)(i), (iii), (iv)(A) and (iv)(B) would be excepted from the AUC consultation requirement during the same year that the re-weighting applies for purposes of the MIPS payment adjustment.
There will be scenarios when a clinician's experience of a significant hardship or extraordinary circumstance does not align with the prospective identification of these ordering professionals with reference to MIPS criteria and processes. However, we believe the prospective identification process allows us to apply exceptions in real-time for claims submitted for advanced imaging services. There are timing differences between the MIPS and the AUC program (the MIPS payment adjustment year is based on performance in a prior year while the Medicare AUC program requires real-time AUC consultation and claims-based reporting). In addition to the timing, there will be instances when a clinician who is not a MIPS eligible clinician will need to seek a significant hardship exception to the Medicare AUC program. To accommodate these two separate scenarios, we proposed to establish a process to identify ordering professionals in need of a significant hardship exception to the Medicare AUC program requirements that is outside the MIPS re-weighting process. For purposes of these scenarios, we proposed to use the criteria for clinicians seeking an AUC significant hardship exception described under § 495.102(d)(4) to include (i), (iii), (iv)(A) and (iv)(B) of our regulations. We proposed these criteria to align with the criteria used under MIPS for re-weighting under the ACI performance category, and to provide predictability and consistency to the determination of significant hardship. We further proposed that a significant hardship exception from the Medicare AUC program requirements would be granted for no longer than 12 months, and that we could establish an exception for a shorter period where warranted by the circumstances.
Therefore we proposed that ordering professionals who have not received a re-weighting to zero for the MIPS ACI performance category for the year, but experience one of the circumstances described in § 495.102(d)(4) to include (i), (iii), (iv)(A) and (iv)(B), may be granted an AUC significant hardship exception for no longer than one year.
In addition to these proposals, we invited the public to comment on additional circumstances for which it may be appropriate for an ordering professional to be granted a significant hardship exception under the AUC program.
The following is a summary of the public comments received on our proposed modifications to the AUC program significant hardship regulation language, proposal to grant a significant hardship exception for no longer than 12 months, and additional circumstances for which it may be appropriate for an ordering professional to be granted a significant hardship exception under the AUC program; and our responses:
In contrast, a few commenters did not understand why such hardship exceptions were proposed within two different programs (the AUC program and the MIPS). These same commenters opposed our proposal to exclude from the hardship exception categories under the AUC program the category for clinicians who have been practicing for fewer than 2 years. Other commenters expressed concern that under our proposals all radiologists who meet the lack of face-to-face patient interaction threshold would be excepted from consulting AUC if they order applicable imaging services. In addition, many commenters believed that certain hardships may justifiably last longer than 12 months and the circumstances leading to the initial request for a significant hardship may be uncontrollable by the physician. These commenters opposed the 12-month cap on hardship exemptions and further stated that such an approach is unfair, unjustified, and disproportionately affects rural providers.
A few commenters believed it was unreasonable to recognize eligible clinicians who have their MIPS ACI performance category re-weighted to zero for the reason that the ordering professional practices at multiple locations, without also considering an exception for other practitioners that face challenges to controlling their CEHRT such as ASC-based eligible clinicians. Those commenters support these categories as qualifying for a significant hardship exception under the AUC program. A few commenters believed that we must also include an exception for hospital-based physicians because emergency physicians and practitioners could not purchase a CDSM platform or adopt a free CDSM platform, for implementation in the hospital because they do not have the appropriate authority to make such purchases or to implement a new CDSM for the delivery of emergency medical care provided in the hospital emergency department setting. To this end, commenters urged inclusion of the statutory references to hospital-based physicians and ASC-based MIPS eligible clinicians into existing exceptions from AUC requirements for MIPS eligible clinicians who have their ACI Performance Category reweighted to zero.
We provide responses to the comments below to inform commenters of our current thoughts despite not finalizing the changes we proposed to the significant hardship exception under the AUC program.
To support some of these requests for additional exceptions, commenters noted that a CDSM is a form of health information technology that is routinely incorporated into EHR systems, and that costs are associated with such integration. Commenters also stated that a free tool is an impractical solution for those practices focused on investing in upgrading to certified 2015 Edition EHR technology or unable to afford acquisition of a CDSM that integrates with an EHR system. More than one commenter cited the GAO's 2015 evaluation of the Medicare Imaging Demonstration which reported frustration on the part of ordering professionals when decision support was not integrated with their EHRs. This demonstration was authorized by Congress to test whether clinicians would change their ordering patterns (for example, reducing inappropriate imaging) as a result of using appropriateness guidelines for advanced imaging services through decision support systems.
Some commenters requested consideration for exempting ordering professionals based on a low-volume threshold of services. One commenter requested that if the proposed threshold for what constitutes low volume under the CY 2018 Updates to the Quality Payment Program is finalized, that these eligible clinicians also be excluded from the AUC program. Another commenter submitted an alternative proposal that instead of using the same low volume threshold proposed for MIPS a threshold that more closely reflects advanced diagnostic imaging services and billing would be an acceptable threshold calculation for such an exception. Another commenter recommended adaptation of an exception similar to those used in the Medicare e-prescribing (eRx) program, which allowed individual eligible professionals who had been successful electronic prescribers in 2011, and had reported the G8553 code via claims for less than 10 billable Medicare Part B PFS services provided January 1, 2012 through June 30, 2012 to avoid the 2013 eRx payment adjustment. In addition, one commenter requested a significant hardship exception category for furnishing professionals that furnish a low-volume of advanced imaging services, and supported this request with the statement that it would be unreasonable to forgo any payment for advanced diagnostic imaging services furnished under this program.
As stated earlier we will not move forward with the proposed significant hardship exceptions and will maintain our regulations at § 414.94(i)(3). This current policy provides exceptions from consulting and reporting requirements for orders for applicable imaging services made by ordering professionals who are granted a significant hardship exception to the Medicare EHR Incentive Program payment adjustment for that year. The basis for granting a significant hardship exception to the ordering professional are identified under § 495.102(d)(4) of this chapter, and include the following as discussed in CY2017 PFS final rule: Lacking sufficient Internet access; practicing for less than 2 years, facing extreme and uncontrollable circumstances; practicing at multiple locations and demonstrating inability to control the availability of CEHRT; and, lacking face-to-face or telemedicine interaction with patients and a lack of need for follow up with patients. We believe that during the voluntary reporting period, we will continue to develop our understanding of the workflows of both ordering and furnishing professionals, and in particular how we can apply section 1834(q)(4)(C)(iii) of the Act to support those ordering professionals whose consultation would result in a significant hardship.
Section 1834(q) of the Act includes rapid timelines for establishing a Medicare AUC program for advanced diagnostic imaging services. The impact of this program is extensive as it will apply to every physician or other practitioner who orders or furnishes advanced diagnostic imaging services (for example, magnetic resonance imaging (MRI), computed tomography (CT) or positron emission tomography (PET)). This crosses almost every medical specialty and could have a particular impact on primary care physicians since their scope of practice can be quite broad. Stakeholders have expressed concern that program requirements may inadvertently encourage physicians to order imaging services that they do not believe are right for their patients. The goal of evidence-based AUC is to assist clinicians in ordering the most appropriate imaging service for their patients' specific clinical scenarios. However, to ensure we are implementing the program effectively, we requested public comment on such potential unintended consequences. Additionally, as we continue to develop the AUC program, we continue to engage a variety of stakeholders interested in participating in the development of AUC. We sought comment about how we can continue to engage interested participants, consistent with statutory requirements at section 1834(q) of the Act, in developing AUC in a transparent and scientifically robust manner. We are particularly interested in how qualified PLEs develop or modify AUC in collaboration with non-PLE entities and what additional challenges such entities might face.
The following is a summary of the public comments received on issues we solicited including potential unintended consequences of the AUC program requirements as well as how we can continue to engage interested participants, particularly qualified PLEs in collaboration with non-PLEs, consistent with statutory requirements at section 1834(q) of the Act, in developing AUC in a transparent and scientifically robust manner and our responses:
One commenter noted that organizations where practitioners are involved in day-to-day management or providing strategic direction and can deploy a rigorous evidence-based process for developing AUC should be included. Another commenter stated that CMS prioritizes content developed by clinicians who see patients over those who specialize in reviewing science and developing guidelines so the definition does not account for the fact that clinicians who spend most of their time seeing patients do not have the capacity to develop and regularly update comprehensive care guidelines. One commenter recommended revising the definition to include organizations that develop AUC under the leadership of a structured group of providers who are actively engaged in the practice and delivery of healthcare as the regulatory definition is inappropriately restrictive and limits the organizations that may contribute to provider-developed AUC.
Another commenter recommended that the efforts of PLEs be monitored over the next four years before CMS takes action to establish new directives regarding specific AUC and its development. This commenter stated that PLEs are expected to establish new methods for collaboration over this period of time.
Another commenter noted that there is benefit to collaboration between qualified PLEs and non-qualified PLEs as well as between qualified PLEs. This commenter also stated that collaborations with non-qualified PLEs have highlighted the anxiety of these organizations in being forced to adopt practices that may conflict with established local best practices and reinforce that we should focus on eliminating unnecessary imaging and construct AUC that acknowledge local differences in care settings, expertise and best practices. One commenter states that non-PLEs can bring significant, relevant experience to the AUC development process and support for physicians engaged in medical practice; and that relationships between PLEs and non-PLEs can create significant value leading to improved care provided they are clearly defined and transparent.
One commenter recommended that PLEs should be allowed to delegate the AUC development process to third parties that demonstrate adherence to the AUC program requirements for deploying a multidisciplinary team with the requisite expertise, transparency and managing conflicts of interest.
Because transparency is a critical element of this program, we established specific requirements for qualified PLEs to make information publicly available through their Web sites. We believe qualified PLEs may fulfill transparency requirements and still keep track of who is accessing the information on their Web sites, for example, some qualified PLEs require users to enter basic information and register through the Web site to gain access to AUC information.
Some commenters recommended direct communications with ordering professionals to encourage program compliance as well as focused education and outreach targeting ordering professionals who may not be complying with program requirements during the educational and operations testing period. Citing the lack of awareness of the AUC program and requirements, one commenter suggested CMS leverage existing communication channels to promote awareness as soon as possible and allow professionals sufficient time to adopt workflows that can reduce administrative burden.
We continue to believe the best implementation approach is one that is diligent, maximizes the opportunity for public comment and stakeholder engagement, and allows for adequate advance notice to physicians and practitioners, beneficiaries, AUC developers, and CDSM developers. It is for these reasons we proposed to continue a stepwise approach, adopted through notice and comment rulemaking. In summary, we proposed policies to implement the third component of the AUC program—the consulting and reporting requirements and the effective date on which these requirements would begin. We proposed that ordering professionals must begin consulting specified applicable AUC through qualified CDSMs for applicable imaging services ordered on and after January 1, 2019, and furnishing professionals must begin reporting AUC consultation information on Medicare claims for advanced diagnostic imaging services for which payment is made under an applicable payment system as defined in § 414.94(b) and ordered on or after January 1, 2019. We also proposed modifications to the significant hardship exception to better align these exceptions under the AUC program with those under existing quality programs. We invited the public to submit comments on these proposals.
We believe the changes we are adopting to the policies we proposed in the CY 2018 PFS proposed rule in response to public comments are important to provide more time for ordering and furnishing professionals, qualified PLEs, qualified CDSMs, CMS and other stakeholders to prepare for and support successful participation in the Medicare AUC program. These changes include the following: (1) Extending the voluntary reporting period to 18 months starting July 2018 and continuing through CY 2019; and (2) making the AUC consultation and reporting requirements effective for an educational and operations testing period beginning on January 1, 2020, instead of January 1, 2019 as proposed, to last through CY 2020. We are not finalizing the changes to the significant hardship exceptions in this final rule as we have decided further evaluation is necessary before making changes to our regulations at section 414.94(i)(3). We intend to take into consideration the public comments on our proposals, as well as policies adopted in CY 2018 rulemaking for the Quality Payment Program, and to address significant hardship exceptions for the AUC program in rulemaking for CY 2019. We will reevaluate the proposals regarding what information must be reported on the Medicare claim and will further explore opportunities for stakeholder engagement.
We will continue to post information on our Web site for this program accessible at
Section 1848(a)(8) of the Act provides that for covered professional services furnished by an EP during each of 2015 through 2018, if the EP does not satisfactorily report data on quality
We previously finalized the satisfactory reporting criteria for individual EPs and group practices for the CY 2016 reporting period to avoid the 2018 PQRS payment adjustment in the CY 2016 PFS final rule (80 FR 71140 through 71250) at § 414.90(j)(8) and (9) and § 414.90(k)(5).
Table 18 in the proposed rule summarized the previously finalized satisfactory reporting criteria for individual EPs (see 82 FR 34097) at § 414.90(j)(8) and § 414.90(k)(5).
Table 19 in the proposed rule summarized the previously finalized satisfactory reporting criteria for group practices via the group practice reporting option (GPRO) (see 82 FR 34098 through 34099) at § 414.90(j)(9) and § 414.90(k)(5).
Since we finalized these requirements, we have heard from stakeholders that EPs have had difficulty with the previously finalized satisfactory reporting criteria for the CY 2016 reporting period, which was the final reporting period for the PQRS. Specifically, we have heard from stakeholders through written communications to CMS that EPs have found the requirements complex, and had difficulty in understanding the requirements to be a satisfactory reporter for PQRS. Stakeholders have also requested that the requirements for the CY 2016 reporting period be aligned with those of the Quality Payment Program, specifically the Merit-based Incentive Payment System (MIPS). In particular, we have heard requests to lower the previously finalized requirement from 9 measures across 3 NQS domains, where applicable, to only 6 measures with no domain requirement associated with these measures. While the PQRS and the MIPS are separate programs, we understand that stakeholders would like to see greater continuity between the final year of the PQRS and the beginning of the MIPS.
The final reporting period for the PQRS was CY 2016. The Quality Payment Program, authorized by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), consolidates and replaces three existing programs (the Medicare EHR Incentive Program for EPs, the PQRS, and the Value-Based Payment Modifier (VM)). There are two ways eligible clinicians can participate in this program: (1) Through the MIPS; and (2) through Advanced Alternative Payment Models (APMs). The initial performance period for the MIPS began on January 1, 2017. Under MIPS, there are four connected pillars that affect how MIPS eligible clinicians will be paid by Medicare: Quality; Improvement Activities; Advancing Care Information; and Cost. For more information on the Quality Payment Program, see
Although we understand that the data submission period for the CY 2016 reporting period has already ended and that all data that has been submitted to CMS is based on the previously finalized satisfactory reporting criteria for the CY 2016 reporting period, we revisited our previously finalized policy because we wanted individual EPs and groups to be assessed for purposes of the 2018 PQRS payment adjustment based on satisfactory reporting criteria that are simpler, more understandable, and more consistent with the beginning of MIPS. We believe that such criteria will help clinicians more accurately gauge their readiness for the beginning of MIPS and transition into the Quality Payment Program successfully. Additionally, we want to be responsive to the concerns of the clinician community. Therefore, although we did not propose to collect any additional data for the CY 2016 reporting period, we proposed to modify the criteria we would apply to the data already submitted for the CY 2016 reporting period to determine whether an individual EP or group practice has satisfactorily reported for purposes of avoiding the 2018 PQRS payment adjustment (82 FR 34099).
Specifically, we proposed to revise the previously finalized satisfactory reporting criteria for the CY 2016 reporting period to lower the requirement from 9 measures across 3 NQS domains, where applicable, to only 6 measures with no domain or cross-cutting measure requirement (82 FR 34099). For individual EPs, this would apply to the following reporting mechanisms: Claims, qualified registry (except for measures groups), QCDR, direct EHR product and EHR data submissions vendor product. This would not affect the criteria used to determine whether an individual EP or group practice has satisfactorily reported for purposes of avoiding the 2017 PQRS payment adjustment, with the exception of the criteria applicable to individual EPs and group practices reporting using the secondary reporting period established under § 414.90(j)(1)(ii) for the 2017 PQRS payment adjustment (hereinafter referred to as the “ACO Secondary Reporting Period”), as discussed in section III.F.4. of this final rule.
Table 20 in the proposed rule summarized our proposed modifications to the previously finalized satisfactory reporting criteria for individual EPs to avoid the 2018 PQRS payment adjustment, based on data previously submitted for the CY 2016 reporting period (82 FR 34100). We did not propose to collect any additional data for the CY 2016 reporting period, as the data submission period for the CY 2016 reporting period had already ended. As summarized in Table 20 of the proposed rule, the NQS domain requirement would no longer apply (82 FR 34100). No changes were proposed for the measures groups criteria.
Additionally, we also proposed that individual EPs and group practices reporting via claims or qualified registry, as applicable, would no longer be required to report a cross-cutting measure and that individual EPs and group practices reporting via QCDR would no longer be required to report an outcome or “high priority” measure (that is, for purposes of PQRS, a resource use, patient experience of care, efficiency/appropriate use, or patient safety measure) (82 FR 34100). We note that what is considered to be a “high-priority” measure in PQRS is different from what is considered a “high-priority” measure in MIPS, and we did not propose to align this requirement with MIPS for the last year of PQRS as this could cause confusion. Although certain MIPS eligible clinicians are required to report at least one outcome or other high-priority measure (see § 414.1335(a)(1)(i)), we are also not aligning the PQRS requirements with that MIPS requirement because, although we agree that outcome and
Lastly, where we proposed to lower the requirement to only 6 measures, if less than 6 measures apply to the individual EP or group practice, each measure that is applicable would need to have been reported. We define “applicable” to mean measures relevant to a particular individual EP's or group practice's services or care rendered. As previously finalized, individual EPs and group practices would continue to be subject to the measure application validity (MAV) process (80 FR 71140 through 71145). The MAV process seeks to identify clinically similar measures and creates clusters of measures that can be reported if one of the measures in the cluster is reported. We will maintain the requirement that each required measure be reported for at least 50 percent of the individual EP's or group practice's patients to which the measure applies.
Accordingly, we proposed to revise § 414.90(j)(8) and (k)(5) (82 FR 34101). We believe these proposals will result in fewer individual EPs being subject to the 2018 PQRS payment adjustment, and will impose no additional burden on individual EPs because this data has already been submitted to CMS. We requested comment on these proposals.
The following is a summary of the public comments received on these proposals and our responses:
After consideration of the public comments, we are finalizing the proposal to revise the previously finalized satisfactory reporting criteria for the CY 2016 reporting period to lower the requirement from 9 measures across 3 NQS domains, where applicable, to only 6 measures with no domain or cross-cutting measure requirement. Please see Table 21 for a summary of our final policies. We are also finalizing the revisions at § 414.90(j)(8) and (k)(5) as proposed.
As discussed previously, although we did not propose to collect any additional data for the CY 2016 reporting period, we proposed to modify the satisfactory reporting criteria for the CY 2016 reporting period for purposes of the 2018 PQRS payment adjustment (82 FR 34101). Specifically, we proposed to lower the requirement from 9 measures across 3 NQS domains, where applicable, to only 6 measures with no domain or cross-cutting measure requirement. For group practices, this would apply to the following reporting mechanisms: Qualified registry; QCDR; direct EHR product; and EHR data submissions vendor product. This proposal would not affect the criteria used to determine whether an individual EP or group practice has satisfactorily reported for purposes of avoiding the 2017 PQRS payment adjustment, with the exception of the criteria applicable to individual EPs and group practices reporting using the ACO Secondary Reporting Period, as discussed in section III.F.4. of this final rule.
Table 21 in the proposed rule summarized our proposed modifications to the previously finalized satisfactory reporting criteria for group practices to avoid the 2018 PQRS payment adjustment, based on data previously submitted for the CY 2016 reporting period (82 FR 34101 through 34102). We did not propose to collect any additional data for the CY 2016 reporting period, as the data submission period for the CY 2016 reporting period has already ended. As summarized in Table 21 of the proposed rule, the NQS domain requirement would no longer apply (82 FR 34101 through 34102). No changes were proposed for the Web Interface criteria.
Additionally, as discussed previously, we proposed that individual EPs and group practices reporting via claims and qualified registry, as applicable, would no longer be required to report a cross-cutting measure and that individual EPs and group practices reporting via QCDR would no longer be required to report an outcome or high priority measure. We note that what is considered to be a “high-priority” measure in PQRS is different from what is considered a “high-priority” measure in MIPS, and we did not propose to align this requirement with MIPS for the last year of PQRS as this could cause confusion. Although certain MIPS eligible clinicians are required to report at least one outcome or other high-priority measure (see § 414.1335(a)(1)(i)), we are also not aligning the PQRS requirements with that requirement because, although we agree that outcome and high-priority measures are valuable for reporting, we want to revise the satisfactory reporting criteria for the last year of PQRS to be less complex for individual EPs and groups.
Where we proposed to lower the requirement to only 6 measures, if less than 6 measures apply to the individual EP or group practice, each measure that is applicable would need to have been reported. We define “applicable” to mean measures relevant to a particular individual EP's or group practice's services or care rendered. As previously finalized, individual EPs and group practices would continue to be subject to the MAV process (80 FR 71140 through 71145). The MAV process seeks to identify clinically similar measures and creates clusters of measures that can be reported if one of the measures in the cluster is reported. We would maintain the requirement that each required measure be reported for at least 50 percent of the individual EP's or group practice's patients to which the measure applies.
Lastly, for purposes of the 2018 PQRS payment adjustment, § 414.90(j)(9)(viii) currently provides that if the CAHPS for PQRS survey is applicable to the practice, group practices comprised of 100 or more EPs that register to participate in the GPRO must administer the CAHPS for PQRS survey, regardless of the GPRO reporting mechanism selected. For the reasons discussed previously, we proposed to revise § 414.90(j)(9)(viii) to provide that such group practices may administer the CAHPS for PQRS survey, regardless of the GPRO reporting mechanism selected, but are not required to do so. This change would be consistent with the data submission criteria for the MIPS quality performance category, under which groups may voluntarily elect to participate in the CAHPS for MIPS survey (see § 414.1335(a)(3)(i)). As summarized in Table 21 of the proposed rule (82 FR 34101 through 34102), the previously finalized satisfactory reporting criteria for group practices
Accordingly, we proposed to revise § 414.90(j)(9) and (k)(5) (82 FR 34102). We believe these proposals will result in fewer group practices being subject to the 2018 PQRS payment adjustment, and will impose no additional burden on group practices because this data has already been submitted to CMS. We requested comment on these proposals.
The following is a summary of the public comments received on these proposals and our responses:
After consideration of the public comments, we are finalizing the proposed changes as proposed. We refer readers to Table 22 to view a summary of our final policies. We are also finalizing revisions to § 414.90(j)(9) and (k)(5) as proposed.
As discussed
We previously finalized in the CY 2016 PFS final rule (80 FR 71129 through 71130) a decision to publicly report three data points for the 2018 VM based on 2016 data in the Physician Compare downloadable file in late 2017:
• 2018 VM quality tiers for cost and quality, based on the 2016 data, noting if the EP or group is high, low, or average on cost and quality per the VM.
• A notation of the payment adjustment received based on the cost and quality tiers—upward, downward, or neutral—for each EP or group.
• An indication if the EP or group was eligible to but did not report quality measures to CMS for CY 2016 under PQRS.
In light of the proposals to change the 2016 reporting criteria to avoid the 2018 payment adjustment for PQRS (see section III.F. of this final rule) and subsequent VM proposed policies to hold all physician groups and solo practitioners who met minimum quality reporting requirements harmless from downward payment adjustments for performance under quality-tiering for the last year of the program (see section III.I. of this final rule), and because the revised policies for PQRS and VM in this rule will change the nature of how the PQRS data will be used under the VM, we proposed not to report this data specific to the VM (82 FR 34103). Given the fact that VM data would have been available for posting in the Physician Compare downloadable database for only 1 year and the VM data may not reflect an EP or group's actual performance or payment adjustment given they could have chosen to report fewer measures, we believe that proceeding with the posting of this data could be confusing for the public.
Additionally, we have created other VM data files intended to promote transparency. For each VM performance year, we will publish a Public Use File (PUF) that contains VM performance results of de-identified practices. Supporting documentation for each PUF contains the field name, length, type, label, description, and notes for each variable included in the PUF. The Value Modifier program years 2015 and 2016 (performance year 2013 and 2014) are currently available at
All other previously finalized policies related to 2016 PQRS data available for public reporting on Physician Compare in late 2017 remain unchanged (80 FR 71116 through 71132). Appreciating this, we believe the best course of action is to not move forward with publicly reporting this VM data for 2016. All data required to be reported by law will remain available for public reporting as previously finalized (80 FR 71116
The following is a summary of the public comments received on this proposal and our responses:
Some other commenters did question if this type of data was consistent with the goals of Physician Compare, generally, and others questioned if this type of data was useful for decision-making. For transparency purposes, many of these commenters noted the available aggregated, de-identified data was sufficient.
As a result of the public comments, we are finalizing this proposal, and, as a result, we will not be including VM data in the Physician Compare downloadable database related to the 2018 payment adjustment.
Sections 1848(o), 1853(l) and (m), 1886(n), and 1814(l) of the Act provide the statutory basis for the Medicare incentive payments made to eligible professionals (EPs), Medicare Advantage (MA) organizations (for certain qualifying EPs and hospitals), subsection (d) hospitals, and critical access hospitals (CAHs) that demonstrate meaningful use of certified electronic health record (EHR) technology (CEHRT). Sections 1848(a)(7), 1853(l) and (m), 1886(b)(3)(B), and 1814(l) of the Act also establish downward adjustments to Medicare payments, beginning with calendar or fiscal year (FY) 2015, for EPs, MA organizations, subsection (d) hospitals, and CAHs that are not meaningful users of CEHRT for certain associated reporting periods. Sections 1903(a)(3)(F) and 1903(t) of the Act provide the statutory basis for the Medicaid incentive payments made to EPs and eligible hospitals for the adoption, implementation, upgrade, and meaningful use of CEHRT. We have implemented these statutory provisions in prior rulemakings to establish the Medicare and Medicaid EHR Incentive Programs.
Under these statutory provisions and the regulations at 42 CFR 495.4, one of the requirements of being a meaningful EHR user is successfully reporting the clinical quality measures selected by CMS to CMS or the states, as applicable, in the form and manner specified by CMS or the states, as applicable. Section 1848(o)(2)(B)(iii) of the Act requires that in selecting clinical quality measures (CQMs) for EPs to report under the EHR Incentive Program, and in establishing the form and manner of reporting, the Secretary shall seek to avoid redundant or duplicative reporting otherwise required, including reporting under section 1848(k)(2)(C) of the Act (the Physician Quality Reporting System). As such, we have taken steps to establish alignments among various quality reporting and payment programs that include the submission of CQMs.
Under sections 1848(o)(2)(A)(iii) and 1903(t)(6)(C)(i)(II) of the Act and the definition of “meaningful EHR user” at § 495.4, EPs must report on CQMs selected by CMS using CEHRT, as part of being a meaningful EHR user under the Medicare and Medicaid EHR Incentive Programs. In the final rule titled “Medicare and Medicaid Programs; Electronic Health Record Incentive Program—Stage 3 and Modifications to Meaningful Use in 2015 Through 2017,” we finalized the options for CQM submission for EPs in the Medicare EHR Incentive Program in 2016 as follows (80 FR 62888 through 62889):
• EP Options for Medicare EHR Incentive Program Participation (single program Participation—EHR Incentive Program only):
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• EP Options for Electronic Reporting for Multiple Programs (for example: EHR Incentive Program plus PQRS participation):
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(
For the Medicaid EHR Incentive Program, we specified (80 FR 62888) that states would continue to be responsible for determining whether and how electronic reporting of CQMs would occur, or if they wish to allow reporting through attestation. Any
We maintained a requirement that EPs report 9 CQMs covering at least 3 NQS domains (80 FR 62888 through 62889). This requirement was established in the final rule titled “Medicare and Medicaid Programs; Electronic Health Record Incentive Program—Stage 2” (77 FR 54058).
We also continued (80 FR 62888 through 62889) our existing policy that under Medicare, healthcare providers in any year of participation for the EHR Incentive Program for 2015 through 2017 may electronically report CQM data using the options previously outlined for electronic reporting either for single program participation in the Medicare EHR Incentive Program, or for participation in multiple programs if the requirements of the aligned quality program are also met.
We noted that an EHR certified for CQMs under the 2014 Edition certification criteria does not need to be recertified each time it is updated to a more recent version of the eCQMs (80 FR 62889).
As we discussed in section III.F. in this final rule, since we finalized these requirements, we have heard from stakeholders through written communications that EPs and groups have found the previously finalized reporting criteria for the CY 2016 reporting period to be complex and had difficulty in understanding the requirements to be a satisfactory reporter, and these same EPs and groups subsequently requested that the CQM reporting requirements for EPs and groups participating in the Medicare EHR Incentive Program in 2016 who chose to report CQMs electronically through the Physician Quality Reporting System (PQRS) Portal be aligned with those of the Quality Payment Program, specifically the Merit-based Incentive Payment System (MIPS).
Therefore, although we did not propose to collect any additional data for 2016, we proposed to change the reporting criteria for EPs and groups who chose to electronically report CQMs through the PQRS Portal for purposes of the Medicare EHR Incentive Program. Specifically, we proposed to change the reporting criteria from 9 CQMs covering at least 3 NQS domains to 6 CQMs with no domain requirement. We proposed this change so that the reporting criteria for the Medicare EHR Incentive Program would be in alignment with the modified requirement that we proposed for the final PQRS reporting period (2016) in section III.F. of the proposed rule, as well as the transition year of the Quality Payment Program. We proposed that an EP or group who satisfies the proposed reporting criteria may qualify for the 2016 incentive payment under section 1848(o) of the Act and may avoid the downward payment adjustment in 2017 and/or 2018 under section 1848(a)(7)(A) of the Act, depending on the EP or group's applicable EHR reporting period for the payment adjustment year. This proposed change would help maintain alignment with PQRS per the requirement under section 1848(o)(2)(B)(iii) of the Act for the Secretary to seek to avoid redundant or duplicative reporting otherwise required, including reporting under section 1848(k)(2)(C) of the Act (the PQRS).
We did not propose to change the previously finalized requirements for CQM reporting in 2016 for eligible hospitals and CAHs; or the previously finalized requirements for EPs who chose to report CQMs through attestation in 2016 for the Medicare EHR Incentive Program (80 FR 62888). Our reasoning for not proposing to change the eligible hospital or CAH requirements for CQM reporting is because the changes proposed for PQRS in section III.F. of the proposed rule and the policies established for the transition year of the Quality Payment Program would only affect clinicians and groups, and therefore, there is no reason to change the established policy for eligible hospitals or CAHs. We did not propose to change the requirements for EPs who reported CQMs through attestation because those who attested were successful; therefore, we believe there is no need to change the requirement. Additionally, the Registration and Attestation portal was phased out on October 1, 2017, and is no longer available for use.
The following is a summary of the public comments received on these proposals and our responses:
After consideration of the public comments, we are finalizing the proposal to revise the CQM reporting criteria for EPs from 9 measures across 3 NQS domains to 6 measures with no domain requirement for EPs and groups who chose to electronically report CQMs through the PQRS Portal for purposes of the Medicare EHR Incentive Program in order to align with the proposed PQRS reporting requirements for 2016. An EP or group who satisfies these revised reporting criteria (as well as other EHR Incentive Program requirements) may qualify for the 2016 incentive payment under section
Lastly, we also did not propose to change the previously finalized requirements for 2016 for EPs participating in the Medicaid EHR Incentive Program. At the time that we published the proposed rule, we had already proposed in “Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2018 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Electronic Health Record (EHR) Incentive Program Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Provider-Based Status of Indian Health Service and Tribal Facilities and Organizations; Costs Reporting and Provider Requirements; Agreement Termination Notices” that, for 2017, Medicaid EPs would be required to report on any six CQMs that are relevant to the EP's scope of practice (82 FR 20135). On August 14, 2017, we finalized that proposal (82 FR 38487). In proposing and finalizing that change, we indicated that it is our intention to align CQM requirements for Medicaid EPs with the requirements of Medicare quality improvement programs, to the extent practicable. However, due to the timing of this rulemaking and when any proposed changes for 2016 would take effect (if finalized), we were concerned that the benefits of proposing to extend the policy proposed for Medicare EPs for 2016 to Medicaid EPs for 2016 would not be realized, and the burden on states to implement such a policy would be significant. There is no negative payment adjustment for not participating in the Medicaid EHR Incentive Program, so we explained that it was likely that applying the proposed policy for Medicare EPs to Medicaid EPs for 2016 would benefit Medicaid EPs only if they were able to submit new data to states for a Medicaid EHR incentive payment for 2016. Because we anticipated that most states would have completed processing and paying 2016 Medicaid EHR incentive payments by the time such a proposal (if finalized) would take effect, we explained that we believed that applying this change to the Medicaid EHR Incentive Program for 2016 would significantly burden states. We sought comment on our assessment of the difficulty states might face implementing this policy for 2016 for Medicaid EPs, and on the number of Medicaid EPs who might benefit if we instead decided to apply this policy in the Medicaid EHR Incentive Program for 2016, to the extent that doing so would be legally permissible.
We did not receive any comments related to our request for comment, and are not changing the previously finalized CQM reporting requirements for 2016 for EPs participating in the Medicaid EHR Incentive Program.
Under section 1899 of the Act, we established the Medicare Shared Savings Program (Shared Savings Program) to facilitate coordination and cooperation among health care providers to improve the quality of care for Medicare Fee-For-Service (FFS) beneficiaries and reduce the rate of growth in expenditures under Medicare Parts A and B. Eligible groups of providers and suppliers, including physicians, hospitals, and other health care providers, may participate in the Shared Savings Program by forming or participating in an Accountable Care Organization (ACO). The final rule establishing the Shared Savings Program appeared in the November 2, 2011
In the CY 2018 PFS proposed rule (82 FR 34105 through 34110), we proposed two modifications to the Shared Savings Program beneficiary assignment methodology for performance years beginning on or after January 1, 2019: (1) Revisions to the assignment methodology under 42 CFR part 425, subpart E to reflect the requirement under section 17007 of the 21st Century Cures Act (Pub. L. 114-255, December 13, 2016), that the Secretary determine an appropriate method to assign Medicare FFS beneficiaries to an ACO based on their utilization of services furnished by rural health clinics (RHCs) or federally qualified health centers (FQHCs), and (2) addition of new chronic care management (CCM) and behavioral health integration (BHI) service codes to our definition of primary care services. In addition, we proposed to revise the methodology used in our quality measure validation audits and the way the results of these audits may be used to adjust an ACO's sharing rate (82 FR 34113 through 34114). We also proposed to reserve the discretion to redesignate a measure reported through the CMS Web Interface as pay-for-reporting when substantive changes are made to the measure under the Quality Payment Program (82 FR 34110 through 34113).
We also addressed proposals intended to reduce application burden for stakeholders by reducing certain documentation submission requirements included in the initial Shared Savings Program application and the application for use of the Skilled Nursing Facility (SNF) 3-Day Rule Waiver (82 FR 34114 through 34120). We also proposed to establish specific procedures to address situations where a Taxpayer Identification Number (TIN) that is an ACO participant in more than one ACO begins to submit claims for services used in the beneficiary assignment process and becomes out of
As originally enacted in the Affordable Care Act, section 1899(c) of the Act requires us to assign FFS beneficiaries to an ACO participating in the Shared Savings Program based on the beneficiary's utilization of primary care services rendered by physicians participating in the ACO. We refer readers to the CY 2018 PFS proposed rule (82 FR 34105 through 34108) for an overview of existing policies for assigning beneficiaries to ACOs under the Shared Savings Program consistent with the requirements of section 1899(c) of the Act. The regulations governing the assignment methodology under the Shared Savings Program are in part 425, subpart E. Briefly, in the November 2011 final rule we adopted a claims-based hybrid approach (called preliminary prospective assignment with retrospective reconciliation) for assigning beneficiaries to an ACO (76 FR 67851 through 67870), which is currently applicable to ACOs participating under Track 1 or Track 2 of the Shared Savings Program. Under this approach, beneficiaries are preliminarily assigned to an ACO, based on a two-step assignment methodology, at the beginning of a performance year and quarterly thereafter during the performance year, but the final beneficiary assignment is determined after each performance year based on where beneficiaries chose to receive a plurality of their primary care services during the performance year. Subsequently, in the June 2015 final rule, we implemented an option for ACOs to participate in a new two-sided performance-based risk track, Track 3 (80 FR 32771 through 32781). Under Track 3, beneficiaries are prospectively assigned to an ACO at the beginning of the performance year using the same two-step methodology used in the preliminary prospective assignment approach, based on where the beneficiaries have chosen to receive a plurality of their primary care services during a 12-month assignment window offset from the calendar year that reflects the most recent 12 months for which data are available prior to the start of the performance year. The ACO is held accountable for beneficiaries who are prospectively assigned to it for the performance year. Under limited circumstances, a beneficiary may be excluded from the prospective assignment list during or after the performance year, such as if the beneficiary enrolls in Medicare Advantage during the performance year or no longer lives in the United States or U.S. territories and possessions.
Finally, in the CY 2017 PFS final rule (81 FR 80501 through 80510), we further enhanced the claims-based beneficiary assignment methodology by finalizing a policy under which beneficiaries, beginning in performance year 2017, may designate a “primary clinician” they believe is responsible for coordinating their overall care using
As we noted in the November 2011 final rule, RHC and FQHC claims contain very limited information concerning the individual practitioner, or even the type of health professional (for example, physician, PA, or NP) who provided the service to the beneficiary because this information is not necessary to determine payment rates for services in RHCs and FQHCs (76 FR 67858 through 67861). Therefore, unlike physician fee schedule claims, there is no direct way for us to determine if an RHC or FQHC claim was for a service furnished by a physician at the RHC or FQHC. Despite this difference in claims billing for RHCs and FQHCs, we established a process that allows primary care services furnished in RHCs and FQHCs to be considered in the assignment process for any ACO that includes an RHC or FQHC as an ACO participant. This process is set forth in § 425.404. The special procedures that we have established for using RHC and FQHC services in the assignment methodology are discussed in detail in the June 2015 final rule (80 FR 32755 through 32756). We assign beneficiaries to ACOs that include RHCs or FQHCs as ACO participants in a manner generally consistent with how we assign beneficiaries to other ACOs based on primary care services performed by certain physicians and non-physician practitioners who are ACO professionals in the ACO. However, to address the requirement under section 1899(c) of the Act that beneficiaries be assigned to an ACO based on their use of primary care services furnished by physicians, we require ACOs that include RHCs or FQHCs to identify, through an attestation, the physicians that directly provide patient primary care services in their ACO participant RHCs or FQHCs (see §§ 425.204(c)(5)(iii) and 425.404(a)). We use the combination of the RHC or FQHC ACO participant TIN (and another unique identifier, such as a CCN, when appropriate) and the NPIs of the RHC or FQHC physicians provided to us through the attestation process to identify those beneficiaries who received a primary care service from a physician in the RHC or FQHC and who are therefore eligible to be assigned to the ACO.
This required attestation process for submitting physician identifiers requires more effort to ensure the accuracy of the ACO participant list (including the attestation that includes the physician identifiers) than the level of effort required for ACOs that do not include RHCs and FQHCs. In addition,
Section 17007 of the 21st Century Cures Act amended section 1899(c) of the Act (42 U.S.C. 1395jjj(c)) to require the Secretary to assign beneficiaries to ACOs participating in the Shared Savings Program based not only on their utilization of primary care services furnished by physicians but also on their utilization of services furnished by RHCs and FQHCs, effective for performance years beginning on or after January 1, 2019. The statute provides the Secretary with broad discretion to determine how to incorporate services provided by RHCs and FQHCs into the Shared Savings Program beneficiary assignment methodology.
As explained in the proposed rule (82 FR 34108), we believe that the amendments to section 1899(c) made by 21st Century Cures Act enable us to revise the assignment methodology to address the concerns expressed by certain stakeholders regarding the burdens placed on ACOs that include RHCs and FQHCs as ACO participants. Accordingly, in implementing section 17007 of the 21st Century Cures Act, we indicated that we believe it would be appropriate to reduce operational burdens for ACOs that include RHCs or FQHCs as ACO participants and bring greater consistency to the operational method of using claims to assign beneficiaries to ACOs. To promote participation of RHCs and FQHCs under the Shared Savings Program, we proposed to remove the burdensome attestation requirement and instead treat a service reported on an RHC or FQHC institutional claim as a primary care service furnished by a primary care physician for purposes of the step-wise assignment methodology under 42 CFR part 425, subpart E described in the proposed rule (82 FR 34105 through 34106). Consistent with the 21st Century Cures Act, under this proposal: (1) The requirement for an attestation identifying physicians who directly provide primary care services in each RHC or FQHC that is an ACO participant and/or ACO provider/supplier in the ACO would be removed; (2) all RHC and FQHC claims would be used to establish beneficiary eligibility to be assigned to the ACO; and (3) all RHC and FQHC claims would be included in step 1 of the stepwise assignment methodology. We noted that in considering all services billed under the TIN of the ACO participant RHC or FQHC, we would include services that do not meet the definition of primary care services, and such services would not be limited to those provided by a primary care physician, as defined under program rules. This means that under the proposal, a beneficiary could be furnished any service in an RHC or FQHC only by a nurse practitioner, physician assistant, clinical nurse specialist, or any other practitioner in the RHC or FQHC and still be eligible for assignment to the ACO in which the RHC or FQHC is participating.
More specifically, we proposed the following changes to our regulations: (1) Remove § 425.204(c)(5)(iii) in its entirety; (2) revise § 425.404; and (3) make conforming changes to the definition of primary care physician found at § 425.20. Under our proposal, for performance year 2019 and subsequent performance years, ACOs with ACO participants that are RHCs and FQHCs would no longer be required to submit NPIs or other identifying information for physicians who directly provide primary care services in the ACO participant RHCs and FQHCs as indicated in § 425.204(c)(5)(iii)(A) and § 425.404(a). Therefore, we proposed to remove § 425.204(c)(5)(iii) in its entirety. Additionally, we proposed revisions to § 425.404 to reflect that for performance year 2019 and subsequent performance years, we would assign beneficiaries to ACOs based on services furnished in RHCs or FQHCs consistent with the general assignment methodology in § 425.402, by treating a service reported on an RHC or FQHC institutional claim in the same way as a primary care service performed by a primary care physician. We also proposed to remove revenue center codes from the definition of primary care services (§ 425.20) for performance year 2019 and subsequent performance years because all RHC and FQHC services will be used for purposes of assignment for benchmark and performance years; therefore, it is appropriate to modify our definition of primary care services for performance year 2019 and subsequent years to no longer include revenue center codes. Additionally, because the requirement for an attestation under § 425.404 is also referenced in the definition of primary care physician in § 425.20, we proposed to make a conforming revision to that definition to remove the reference to the attestation requirement for performance year 2019 and subsequent years.
Consistent with how we have implemented other changes to the assignment methodology (see, for example, 80 FR 32757 through 32758), we proposed to adjust all ACO benchmarks at the start of the first performance year in which the new assignment rules are applied so that the ACO benchmarks reflect the use of the same assignment rules as will apply in the performance year. Also, consistent with how we have implemented previous changes to the Shared Savings Program assignment methodology, we would use the new methodology each time assignment is determined for purposes of performance year 2019, including using the new methodology in late CY 2018 to determine the eligibility of ACOs wishing to enter into or renew a participation agreement beginning January 1, 2019.
We sought comments on these proposals. We also invited suggestions on how we might further support participation of RHCs and FQHCs in the Shared Savings Program.
We are finalizing the revisions to our assignment policies for services furnished in FQHCs and RHCs as proposed. Specifically, we are finalizing our proposals to: (1) Remove § 425.204(c)(5)(iii) and modify § 425.404 to eliminate the requirement, for performance year 2019 and subsequent performance years, for ACOs that include an RHC or FQHC as an ACO participant to provide an attestation identifying physicians who directly provide primary care services in each RHC or FQHC that is an ACO participant and/or ACO provider/supplier in the ACO, and make conforming changes to the definition of primary care physician at § 425.20; and (2) for performance year 2019 and subsequent performance years, to: (a) Treat a service reported on an RHC or FQHC claim as if it were a primary care service performed by a primary care physician under the assignment methodology in § 425.402, and (b) remove revenue center codes from the definition of primary care services.
Except as discussed previously in this section of the final rule, for services furnished by RHCs and FQHCs for performance years beginning on or after January 1, 2019, section 1899(c) of the Act requires the Secretary to assign beneficiaries to an ACO “based on their utilization of primary care services” provided by a physician. We currently define primary care services for purposes of the Shared Savings Program in § 425.20 as the set of services identified by the following HCPCS/CPT codes: 99201 through 99215, 99304 through 99318 (excluding claims including the POS 31 modifier), 99319 through 99340, 99341 through 99350, 99495, 99496, 99490, the Welcome to Medicare visit (G0402), and the annual wellness visits (G0438 and G0439). In addition, we have established a cross-walk for these codes to certain revenue center codes used by RHCs and FQHCs (for services furnished prior to January 1, 2011) so that their services can be included in the beneficiary assignment process. Lastly, we include G0463 for services furnished in electing teaching amendment (ETA) hospitals.
In the proposed rule (82 FR 34110), we proposed to revise the definition of primary care services currently located in § 425.20 to include three additional CCM service codes 99487, 99489, and G0506, and four BHI service codes G0502, G0503, G0504 and G0507, beginning in 2018 for performance year 2019 and subsequent performance years and to include these codes when performing beneficiary assignment under § 425.402. The three additional CCM codes reflect the changes in medical practice toward advanced primary care and differ from each other only in the amount of clinical staff service time provided; the complexity of medical decision-making as defined in the Evaluation and Management guidelines (determined by the problems addressed by the reporting practitioner during the month); and the nature of care planning that was performed (establishment or substantial revision of the care plan for complex CCM versus establishment, implementation, revision, or monitoring of the care plan for non-complex CCM). The BHI codes reflect important enhancements in primary care to support improvement and integration of care provided for patients receiving behavioral health treatment.
In addition, we proposed to move the list of primary care service codes currently listed in the definition of “primary care services” in § 425.20 to § 425.400(c). We believe § 425.400, which specifies general requirements related to the assignment methodology and currently contains a cross-reference at § 425.400(c) to the definition of primary care services under § 425.20, is the more appropriate place to specify the particular primary care codes that will be considered in the assignment methodology. We also proposed to reorganize the list of service codes, grouping HCPCS codes, G codes, and revenue center codes together, respectively, by relevant performance year(s). We sought comments on this proposal. In addition, we sought comments as to whether there are any additional existing HCPCS/CPT codes that we should consider adding to the definition of primary care services in future rulemaking for purposes of assignment of beneficiaries to ACOs under the Shared Savings Program. Finally, we also proposed to remove paragraph (3) from the definition of primary care services, rather than move it to § 425.400(c) along with the other paragraphs making up the definition of primary care services. Paragraph (3) indicates that we will include additional codes designated by us as primary care services, including new HCPCS/CPT and revenue center codes and any subsequently modified or replacement codes for the HCPCS/CPT and revenue center codes identified in the definition. We explained that, because we always have the flexibility to propose these changes through rulemaking, this provision is unnecessary.
We are finalizing the policies in this section as proposed, except for the minor corrections to § 425.400(c)(1)(iii) and (iv) described below. Specifically, we are finalizing our proposals to: (1) Revise the definition of primary care services currently located in § 425.20 to include three additional CCM service codes 99487, 99489, and G0506, and four BHI service codes G0502, G0503, G0504 and G0507, beginning in 2018 for performance year 2019 and subsequent performance years and to include these codes when performing beneficiary assignment under § 425.402; (2) move the list of primary care service codes currently included in the definition of primary care services in § 425.20 to § 425.400(c); (3) reorganize the list of service codes, grouping HCPCS codes, G codes, and revenue center codes together, respectively, by relevant performance year(s); and (4) remove paragraph (3) from the definition of primary care services at § 425.20.
Finally, we note that in the proposed rule, we made a typographical error in the proposed regulatory text for § 425.400(c)(1)(iv). Consistent with the discussion in the preamble to the proposed rule, we had intended the listed primary care codes to apply not only “for performance year 2019,” but also for subsequent performance years.” In addition, in the proposed regulatory text for § 425.400(c)(1)(iii), we inadvertently referenced “performance year 2017 and 2018” rather than “performance years 2017 and 2018.” We are making these minor corrections in this final rule.
Section 1899(b)(3)(A) of the Act requires the Secretary to determine appropriate measures to assess the quality of care furnished by ACOs, such as measures of clinical processes and outcomes; patient and, wherever practicable, caregiver experience of care; and utilization, such as rates of hospital admission for ambulatory sensitive conditions. Section 1899(b)(3)(B) of the Act requires ACOs to submit data in a form and manner specified by the Secretary on measures that the Secretary determines necessary for ACOs to report to evaluate the quality of care furnished by ACOs. Section 1899(b)(3)(C) of the Act states that the Secretary shall establish quality performance standards to assess the quality of care furnished by ACOs and seek to improve the quality of care furnished by ACOs over time by specifying higher standards, new measures, or both. We designate the quality performance standard that will apply for each performance year. The quality performance standard is the overall standard the ACO must meet to be eligible for shared savings.
In the November 2011 final rule (76 FR 67973), we initially established a quality performance standard consisting of 33 measures across 4 domains (see § 425.502(d)), including patient experience of care, care coordination/patient safety, preventive health, and at-risk population and a methodology for scoring the measures (see § 425.502(e)). Through the annual rulemaking for the PFS we have reviewed and updated the quality measures reported by ACOs, including adding new measures and retiring measures that had become redundant or no longer met the goals for group reporting, and ensuring that the quality measures reported by ACOs through the CMS Web Interface align with the measures reported through the CMS Web Interface by group practices in other CMS initiatives such as PQRS and the Quality Payment Program. The quality measure set currently includes 31 quality measures (see Tables 42 and 43 at 81 FR 80488 and 80489). We refer readers to the 2018 PFS proposed rule for a detailed discussion of ACO quality reporting requirements and the process we follow under the Shared Savings Program to account for changes to the quality measure set used in establishing the quality performance standard (82 FR 34110 through 34111). To avoid confusion and duplication of rulemaking, and reduce provider burden, we also finalized a policy in the 2017 PFS final rule that future changes to the CMS Web Interface measures will be made through rulemaking for the Quality Payment Program and will be applicable to ACO quality reporting under the Shared Savings Program (81 FR 80499 and 80500). Lastly, we finalized a policy in the CY 2016 PFS final rule with comment period (80 FR 71269) under which we reserve the right to maintain a measure as pay-for-reporting or revert a pay-for-performance measure to pay-for-reporting when the measure owner determines the measure no longer aligns with clinical practice or continued application of the measure may result in patient harm (see § 425.502(a)(5)).
As previously noted in the background section, we have a policy that future changes to the CMS Web Interface measures will be adopted through rulemaking for the Quality Payment Program and will be applicable to ACO quality reporting under the Shared Savings Program (81 FR 80501). We also note that, as discussed in the CY 2017 Quality Payment Program final rule with comment period (81 FR 77136), section 1848(q)(2)(D)(i)(II) of the Act requires the Secretary to update the final list of quality measures from the previous year (and publish an updated list in the
Consistent with the way that we have addressed previous changes to measures, we reviewed the proposed substantive changes to the CMS Web Interface measures included in the CY 2018 Quality Payment Program proposed rule to assess whether the changes, if finalized, would warrant a change in how the measures are used to assess ACO performance under the Shared Savings Program. As part of this review, we considered whether the proposed substantive changes might raise sampling issues or require that we recalculate the measure benchmarks for purposes of the Shared Savings Program. Based on our review of the Quality Payment Program proposals and for the reasons discussed in the CY 2018 PFS proposed rule (82 FR 34112), we did not believe the proposed “substantive” changes to the CMS Web Interface measures would require that we revert these measures to pay-for-reporting for the 2018 performance year. Instead, we indicated that we believe it would be appropriate under the Shared Savings Program to: (1) Update the measure specifications through subregulatory guidance in order to continue to align the measures with the measure specifications used under the Quality Payment Program and the Million Hearts Initiative, and (2) retain the current phase-in schedule for the measures rather than redesignating any of the measures as pay-for-reporting.
However, the statutory directive under the Quality Payment Program to address substantive changes to measures in rulemaking and the proposals in the CY 2018 Quality Payment Program proposed rule to address substantive changes to certain Web Interface measures caused us to evaluate what recourse we might have in the future under the Shared Savings Program rules to revert a measure to pay-for-reporting in instances where a substantive change to the measure makes it inappropriate to hold ACOs accountable for performance on that measure. We anticipate that there could be future substantive changes to the CMS Web Interface measures made under the Quality Payment Program that would give us reason to redesignate a measure as pay-for-reporting under the Shared Savings Program. Currently, although the Shared Savings Program rules afford flexibility to redesignate a measure as pay-for-reporting when the measure owner determines the measure no longer aligns with clinical practice or causes patient harm, there is no discretion to modify how we assess CMS Web Interface measures in the event substantive changes are made to those measures under the Quality Payment Program that make it inappropriate to hold ACOs accountable for performance on the measure. Given the timing of the Quality Payment Program proposals in relationship to the timing for when the quality performance benchmarks must be established under the Shared Savings Program, it may in some cases be necessary to have flexibility to designate a pay-for-performance measure as pay-for-reporting outside the formal rulemaking process just before or following the start of a performance year, consistent with the way in which we have redesignated measures in the past when measure owners have made changes after the start of a performance year. Accordingly, we believe it would be appropriate to modify the Shared Savings Program regulations to provide additional flexibility to address substantive changes to CMS Web Interface measures that are made under the Quality Payment Program and to continue to facilitate alignment of measures with the Quality Payment Program and other CMS initiatives.
Therefore, we proposed to modify § 425.502(a)(5) to include the right for CMS to redesignate a measure as pay-for-reporting when a substantive change to a CMS Web Interface measure is made under the Quality Payment Program that we determine warrants a change in how the measure is used to assess ACO performance for purposes of the Shared Savings Program. This revision would supplement CMS's existing discretion to redesignate a measure as pay-for-reporting when the measure owner determines the measure no longer aligns with clinical practice or causes patient harm. Specifically, we proposed to revise the regulation at § 425.502(a)(5) to reserve CMS's right to redesignate CMS Web Interface measures that have undergone a substantive change as determined under the Quality Payment Program to pay-for-reporting status. Such measures would not necessarily be automatically redesignated as pay-for-reporting when a substantive change occurs (for example, as indicated previously, we do not believe the substantive changes proposed for 2018 present an impediment to holding ACOs accountable for performance on these measures in performance year 2018 and subsequent years); however, in the future, substantive changes made to CMS Web Interface measures under the Quality Payment Program (such as when the substantive change to a measure results in an issue with sampling, calculating performance, or calculating the quality benchmark) may make it inappropriate to hold an ACO accountable for performance on the measure for the time needed for CMS to obtain the information necessary to
We are finalizing this amendment to our regulations as proposed. Specifically, we are modifying § 425.502(a)(5) to include the right for us to redesignate a measure as pay-for-reporting when a substantive change to a CMS Web Interface measure that is used to assess quality performance for the Shared Savings Program is made under the Quality Payment Program.
In the November 2011 final rule, we adopted a regulation at § 425.500(e) under which we retained the right to audit and validate the quality measure data ACOs submit through the CMS Web Interface (76 FR 67893 through 67894). Under this original validation process, we selected a subset of CMS Web Interface measures and a random sample of 30 confirmed and completely reported beneficiaries for each measure in the subset. The ACO was required to provide medical records to support the data reported in the CMS Web Interface for those beneficiaries. A measure-specific audit performance rate was then calculated using a multi-phased audit process. If, at the conclusion of the third phase of the audit, there was a discrepancy greater than 10 percent between the quality data reported and the medical records provided during the audit, the ACO was not given credit for meeting the quality target for any measure(s) for which the mismatch rate existed.
In the CY 2017 PFS final rule (81 FR 80489 through 80492), we revisited the Quality Measures Validation audit process and finalized four improvements to our audit process that addressed the number of records to be reviewed per measure, the number of audit phases, the calculation of an audit match rate, and the consequences if the audit match rate falls below 90 percent. Under the revised process, we will audit enough medical records to achieve a 90 percent confidence interval; conduct the audit in a single phase; and calculate an overall audit match rate. If at the conclusion of the audit process the overall match rate between the quality data reported and the medical records provided by the ACO is less than 90 percent, absent unusual circumstances, we will adjust the ACO's overall quality score proportional to the ACO's audit performance. The audit-adjusted quality score is calculated by multiplying the ACO's overall quality score by the ACO's overall audit match rate. For example, if an ACO's quality score is 75 percent and the ACO's audit match rate is 80 percent, the ACO's audit-adjusted quality score would be 60 percent. The audit-adjusted quality score is the quality score that will be used to determine the percentage of any earned savings that the ACO may share or the percentage of any losses for which the ACO is accountable. Under the revised audit methodology, our intent was to continue to audit a subset of ACOs, which we would identify by looking for data anomalies such as high skip rates, although we retained the flexibility to randomly select ACOs or specific measures for audit as we have done in the past. We also finalized a new requirement at § 425.500(e)(3) that an ACO that has an audit match rate of less than 90 percent may be required to submit a corrective action plan (CAP) under § 425.216 for our approval. In addition, we noted that we would maintain the right, as described in § 425.500(f), to terminate or impose other sanctions on any ACO that does not report quality data accurately, completely, or timely. These new policies applied to quality validation audits beginning in 2017 with the audits of quality reporting for the 2016 performance year.
Since publication of the CY 2017 PFS final rule, we have gained additional experience with the Quality Measures Validation audits, and have performed additional analyses related to these audits. Our analysis of the 2016 Quality Measures Validation audit results for Shared Savings Program ACOs indicates that the average match rate of ACOs audited in calendar year 2016 was 72 percent and the median performance was 80 percent. Typically, during the audit, we review medical record documentation and work with ACOs to better understand the mismatch between what was reported and what was documented and have determined through our analyses that ACOs continue to experience challenges in understanding certain aspects of the
Under our newly finalized single-phase approach to quality measure validation audits, minor errors are more likely to affect the final audit results and impact the calculation of shared savings or shared losses when the overall match rate is below 90 percent. Additionally, we note that the match rate threshold under the Hospital Inpatient Quality Reporting (HIQR) Program is 75 percent. The HIQR validates data submitted by hospitals, which are entities that generally have more experience with quality reporting, greater health record accessibility and integration, and a longer history of validation of quality data submitted to CMS.
As we stated in the proposed rule, in light of our analyses of the 2016 Quality Measures Validation audit results, we believe it is appropriate to consider making additional modifications to our Quality Measures Validation audit process. First, we are concerned that the 90 percent match rate adopted in CY 2017 PFS final rule may be too high and could inappropriately penalize ACOs that make quality data reporting errors that are unrelated to care quality. In the early years of phasing in this new audit methodology, we believe that the match rate should instead be based on actual ACO experience in order to focus on holding ACOs accountable for clinically related mismatches in reporting quality measures as they continue to gain experience with how to measure, report and improve quality under the program. We believe that basing the audit match rate threshold on actual Quality Measures Validation audit results would strike an appropriate balance between ensuring the accuracy of ACO quality reporting while not unduly penalizing ACOs for minor quality reporting errors that are not necessarily indicative of poor quality of care. Accordingly, we believe it would be appropriate to set the audit match rate threshold based on the median match rate (80 percent) for ACOs audited in calendar year 2016 rather than an alternative approach such as the mean match rate because the median match rate would be less affected by data outliers. Therefore, we proposed to revise § 425.500(e)(2) to indicate that if an ACO has a match rate below 80 percent, absent unusual circumstances, we would adjust the ACO's overall quality score proportional to the ACO's audit performance.
Second, we proposed to amend the method by which we adjust an ACO's overall quality score to reflect the ACO's audit performance. Specifically, we proposed to revise the methodology described in the 2017 PFS final rule (81 FR 80490) under which the audit-adjusted quality score is calculated by multiplying the ACO's overall quality score by the ACO's audit match rate. Instead, we proposed that for each percentage point difference between the ACO's match rate and the match rate considered passing the audit, the ACO's overall quality score would be adjusted downward by 1 percent. That is, if we finalize the proposal to establish an 80 percent match rate as the threshold for passing the Quality Measures Validation audit, and the ACO's match rate is 75 percent, then under this proposal we would adjust the ACO's overall quality score downward by 5 percent. To illustrate, assuming a match rate threshold of 80 percent, an ACO with an overall quality score of 90 percent would have an audit-adjusted quality score of 85.50 percent, that is, (90−[.05 × 90]) = 85.50.
Finally, we proposed a conforming change to § 425.500(e)(3) to reflect the 80 percent threshold such that if at the conclusion of the audit process CMS determines there is an audit match rate of less than 80 percent, the ACO may be required to submit a CAP.
We invited comment on the proposed refinements to the process used to validate ACO quality data reporting and to adjust an ACO's overall quality score to reflect the ACO's audit performance. We also sought comment on an alternative approach we considered to address the Quality Measures Validation audit match rate and the resulting impact on an ACO's overall quality score. Consistent with the approach used under the HIQR program, we considered revising § 425.500(e)(2) to provide that we would adjust the ACO's overall quality score if an ACO has a match rate below 75 percent. We did not propose this approach because the median match rate for the Quality Measures Validation audits conducted in calendar year 2016 was 80 percent, suggesting that a match rate of 75 percent may be too low for ACOs.
We are finalizing the policies for ACO Quality Measure Validation audits in this section as proposed. Specifically, we are finalizing our proposals to: (1) Revise § 425.500(e)(2) to indicate that if an ACO has a match rate below 80 percent, absent unusual circumstances, we will adjust the ACO's overall quality score proportional to the ACO's audit performance; (2) revise the methodology used to calculate an ACO's audit-adjusted quality score to provide for a one percent reduction to the ACO's overall quality score for each percentage point difference between the ACO's audit match rate and the 80 percent match rate; and (3) making a conforming change to § 425.500(e)(3) to reflect the 80 percent match rate.
The Medicare SNF benefit is for beneficiaries who require a short-term intensive stay in a SNF, requiring skilled nursing or skilled rehabilitation care, or both. Under section 1861(i) of the Act, beneficiaries must have a prior inpatient hospital stay of no fewer than 3 consecutive days in order to be eligible for Medicare coverage of inpatient SNF care. In the June 2015 final rule (80 FR 32804 through 32806, 32808), we provided ACOs participating in Track 3 with additional flexibility to attempt to increase quality and decrease costs by allowing these ACOs to apply for a waiver of the SNF 3-day rule to permit their prospectively assigned beneficiaries to receive coverage for inpatient SNF care without a prior 3-day inpatient hospital stay when they are admitted to a “SNF affiliate,” that is, a SNF with which the ACO has executed a SNF affiliate agreement, and certain additional eligibility criteria are met (see § 425.612(a)(1)). All other provisions of the statute and regulations regarding Medicare Part A post-hospital extended care services continue to apply. To qualify to use the SNF 3-day rule waiver, ACOs must submit a SNF 3-Day Rule Waiver application that includes supplemental information sufficient to demonstrate that the ACO has the capacity to identify and manage beneficiaries who would be either directly admitted to a SNF or admitted to a SNF after an inpatient hospitalization of fewer than 3 days. Required application materials and other program rules are discussed in detail in the 2018 PFS proposed rule (82 FR 34114 through 34115). We began accepting SNF 3-Day Rule Waiver applications in the summer of 2016 and approved 26 Track 3 ACOs to begin using the SNF 3-day rule waiver under the Shared Savings Program effective January 1, 2017.
As discussed in the proposed rule, the SNF 3-day rule waiver requirements are primarily based on criteria previously developed under the Pioneer ACO Model. As explained in the proposed rule, as a result of our recent experience implementing the waiver in the Next Generation ACO Model and the Shared Savings Program, we believe that the rules governing use of the SNF 3-day rule waiver are generally reasonable. However, based on our initial experiences in reviewing SNF 3-Day Rule Waiver applications, we believe there are two requirements, in particular, that impose an unnecessary burden on applicants, without a sufficient benefit to the administration of the Shared Savings Program.
First, the requirement under § 425.612(a)(1)(i)(A)(
Second, as explained in the proposed rule, we believe that the requirement under § 425.612(a)(1)(i)(C) that an ACO submit documentation demonstrating that each SNF included on its list of SNF affiliates has an overall rating of 3 or higher under the CMS 5-star Quality Rating System is unnecessarily burdensome. In order to meet this requirement, ACOs typically submit a screen shot from the CMS Nursing Home Compare Web site or other Nursing Home Compare information that reflects the star rating for each listed SNF. The submission of this documentation by the ACO does not add value to our review and approval of SNFs included on the ACO's SNF affiliate list. Instead, we obtain the information directly from our CMS Nursing Home Compare Web site during the application review process. In this way, we ensure that the most current information is used during the application review process. We also periodically monitor this information after an ACO has been approved to use the waiver because SNF affiliates are required to maintain an overall rating of 3 stars or higher, under § 425.612(a)(1)(iii)(A). Because we can obtain the required information directly from the CMS Nursing Home Compare Web site, the additional documentation submitted by the ACO as part of its application does not add value to our ability to review and approve SNF affiliates. Accordingly, we proposed to eliminate this documentation submission requirement by removing § 425.612(a)(1)(i)(C).
We sought comments on our proposed changes to the application requirements for the SNF 3-day rule waiver. We also welcomed other suggestions on how we might further decrease the burden for ACOs requesting approval to use the SNF 3-day rule waiver, without compromising our ability to ensure that ACOs and their SNF affiliates have the capacity to identify and manage beneficiaries receiving covered SNF services pursuant to the waiver.
We are finalizing the changes to the SNF 3-Day Rule waiver application procedures in this section as proposed. We are removing § 425.612(a)(1)(i)(A)(
In order to participate in the Shared Savings Program, organizations must meet certain eligibility requirements, including the statutory requirement to define processes to promote evidence-based medicine and patient engagement, report on quality and cost measures, and coordinate care. Additionally, the ACO must demonstrate it meets patient-centeredness criteria specified by the Secretary, such as the use of patient and caregiver assessments or the use of individualized care plans. We discussed and finalized details for ACO eligibility criteria, including the four required processes and patient-centeredness criteria, in the November 2011 final rule (76 FR 67826 and 67827) and made updates to them in the June 2015 final rule (80 FR 32722 through 32725). Section 425.204(c)(1) articulates the supporting documents and materials an ACO must submit to demonstrate that the ACO satisfies the eligibility requirements to participate in the Shared Savings Program.
To obtain a determination regarding whether an ACO meets the requirements to participate in the Shared Savings Program, a prospective ACO must submit a complete application in the form and manner required by us by the deadline established by us (§ 425.202(a)(1)). The content of the application is outlined at § 425.204. Section 425.204(c) states that as part of the application, and upon request thereafter, an ACO must submit to us certain supporting documentation to demonstrate that the ACO satisfies the requirements of the Shared Savings Program. The supporting documentation required to be included in the application is discussed in detail in the proposed rule (82 FR 34116 through 34117).
Once an applicant has submitted the information required under § 425.204, we evaluate it to determine whether the applicant satisfies the Shared Savings Program requirements. We notify ACO applicants during the application review process when information is missing or when supplemental documentation or other information is necessary to make a determination on the ACO's application and provide opportunities for the ACO to submit the requested additional information for review. At the end of the application review process, we approve or deny the application and notify the ACO of our determination.
In conducting Shared Savings Program application reviews, we have found that many of the document submission requirements in § 425.204(c)(1) substantially increase application and review burden without lending significant value to our review of an organization's application to confirm that the ACO meets the eligibility requirements for participation in the Shared Savings Program. We believe it would meet program needs and reduce applicant burden if we were to revise § 425.204(c)(1) to remove the requirement to submit supporting documents or narratives and instead provide that we may request these materials if additional information is needed in order to fully assess the ACO's application before making a decision to approve or deny the application.
To illustrate, as discussed in the proposed rule, we require under § 425.204(c)(1)(ii), as part of the application process, that the ACO submit documentation addressing the required processes and patient centeredness criteria under § 425.112. This requirement is addressed in the Medicare Shared Savings Program Initial Application through the requirement that an applicant ACO submit narratives describing how it will define, establish, implement, evaluate, and periodically update each process (see application on the CMS Web site at
• Process to promote evidence-based medicine. The ACO must describe how it will:
++ Encourage the use of protocols grounded in evidence-based medicine in the case of diagnoses with significant potential for the ACO to achieve quality improvements, while taking into account the circumstances of individual beneficiaries; and
++ Use the internal assessments of this process to continuously improve the ACO's care practices.
• Process to promote beneficiary engagement. The ACO must describe how it will:
++ Evaluate the health needs of its assigned beneficiary population (including consideration of diversity in its patient population) and develop a
++ Communicate clinical knowledge/evidence-based medicine to beneficiaries in a way they can understand;
++ Engage beneficiaries in shared decision-making in ways that consider beneficiaries' unique needs, preferences, values and priorities;
++ Establish written standards for beneficiary access and communication as well as a process for beneficiaries to access their medical records; and
++ Use the internal assessments of this process to continuously improve the ACO's care practices.
• Process to internally report quality and cost metrics. The ACO must describe:
++ How the ACO will use these results to improve care and service over time; and
++ How the ACO will use the internal assessments of this process to continuously improve the ACO's care practices.
• Process to promote coordination of care. The ACO must describe:
++ The ACO's methods and processes to coordinate care throughout an episode of care and during care transitions, such as discharge from a hospital or transfer of care from a primary care physician to a specialist (both inside and outside the ACO).
++ The ACO's individualized care program, along with a sample individual care plan, and explain how the ACO uses this program to promote improved outcomes for, at a minimum, high-risk and multiple chronic-condition patients.
++ How individual care plans take into account the community resources available to beneficiaries.
++ Additional target populations that would benefit from individualized care plans.
++ How the ACO will use the internal assessments of this process to continuously improve the ACO's care practices.
++ How the ACO will encourage and promote use of enabling technologies for improving care coordination for beneficiaries.
++ How the ACO intends to partner with long-term and post-acute care providers, both inside and outside the ACO, to improve care coordination for its assigned beneficiaries.
As we explained in the proposed rule, as a result of our experience in reviewing these narratives, we have determined that while they can be helpful to verify that the ACO has established the required processes and defined patient-centeredness criteria prior to its entry into the Shared Savings Program, the specific details of the processes the ACO has established are not particularly important or relevant for purposes of assessing whether the ACO is eligible to participate in the program. In fact, ACOs have indicated that their initial plans for the processes required under § 425.112 as articulated in their program application often change as a result of obtaining additional information about their ACO participants' and ACO providers/suppliers' processes and gaining additional experience during implementation of the processes. We believe such improvements to ACO processes based on program experience are reasonable to expect and should be encouraged. First, under § 425.112(b), ACOs are required to evaluate and periodically update each process and as they do so, initially implemented processes will necessarily change to accommodate lessons learned. Moreover, once the ACO begins to request claims information and other CMS data and to incorporate this information into its operations, the ACO may discover that certain assumptions it made at the time of application should be adjusted to maximally improve the quality of care or cost efficiencies for the ACO's assigned population. In rare instances, particularly in the early days of the program before stakeholders fully understood the implications of program participation, we found review of such narratives useful to understand the level of an ACO's readiness for participation in the Shared Savings Program. However, such narratives have not been particularly useful in determining if the ACO meets the requirements for participation in the Shared Savings Program. In a vast majority of cases, we now believe it is sufficient that the ACO certify at the time of application that it has defined the required processes and patient centeredness criteria consistent with the requirements specified in section § 425.112. Therefore, we believe it would reduce burden for ACOs, without compromising our ability to determine whether an ACO meets the criteria for participation in the Shared Savings Program, to require that the ACO certify that it meets the requirements in § 425.112, and only submit a narrative or other documentation describing how the ACO will implement the required processes and patient-centeredness criteria upon our request. Further, we do not anticipate that this change would have a significant effect on beneficiaries receiving services from ACO providers/suppliers because as noted earlier, we anticipate that ACOs would update each process as they gain experience and, as they do so, initially implemented processes that might have been reflected in the narrative or other supporting documentation submitted with their application would necessarily change to accommodate lessons learned.
Similarly, as part of the application process, the Shared Savings Program regulations require the ACO to submit materials documenting the ACO's organization and management structure, including an organizational chart, a list of committees (including names of committee members) and their structures, and job descriptions for senior administrative and clinical leaders (§ 425.204(c)(1)(iii)). As we indicated in the proposed rule, we have found the organizational chart useful for purposes of evaluating if an ACO meets eligibility requirements, and anticipate continuing to request this chart from applicants; however, we have found that further detail including lists of committees and job descriptions for senior administrative and clinical leaders have not added particular value to our review and approval of applications. Moreover, the receipt of such materials as part of the ACO's application has not significantly impacted our ability to determine whether the ACO meets the requirements regarding leadership and management in § 425.108. We believe, on balance, that our need for such detailed information from all applicants is outweighed by our desire to reduce application burden. In particular circumstances where additional information would aid our review, we believe our need for such detailed information can be reasonably met by requiring applicants to submit such materials upon our request. As a result, we believe it would be less burdensome for us to require ACO applicants to certify that, for example, they meet the leadership and management requirements found at § 425.108 rather than requiring all ACO applicants to submit detailed materials (such as job descriptions) or narratives about the ACO's committees and leadership.
While we do not anticipate having to routinely request such materials to supplement our review and approval of ACO applications to participate in the Shared Savings Program, we explained in the proposed rule that we believe it is important to retain the discretion to do so in limited cases where such detail could be useful. Therefore, we proposed to make revisions to our application requirements as discussed in the proposed rule (82 FR 34117 through 34120). We also noted that in cases
In the proposed rule, we also explained that we do not believe it is necessary for ACO applicants to submit narratives describing how they would distribute shared savings payments or how the proposed plan would achieve the specific goals of the Shared Savings Program and the general aims of better care for individuals, better health for populations, and lower growth in expenditures, as required by § 425.204(d). Based on our experience, such narratives have not been useful in determining if the ACO meets requirements for participation in the program or whether an ACO's application should be approved. We believe it would be more useful to us and less burdensome for ACOs if we were instead to require that, an ACO, as part of its application to participate in the Shared Savings Program, certify that it has a method and plan to receive shared savings payments and to distribute those payments to its ACO participants and ACO providers/suppliers, as required by the statute. We note, however, that we continue to believe it is useful to stakeholders to know how various ACOs have chosen to use or distribute the shared savings they earn. Therefore, we indicated that in the interest of transparency, we will continue to require ACOs to publicly report information on their dedicated Web pages about their shared savings and shared losses, including information about the total proportion of shared savings invested in infrastructure, redesigned care processes, and other resources to support the three-part aim goals of better health for populations, better care for individuals, and lower growth in expenditures, including the proportion distributed among ACO participants, as required under § 425.308(b)(4).
In light of our experience with the review of the documentation submitted as part of the ACO's initial application, we proposed several modifications to our requirements for document submission. We proposed to retain all requirements related to ACO eligibility criteria and public reporting, as currently specified under the Shared Savings Program regulations. However, to reduce application burden without compromising our ability to evaluate applications effectively for compliance with Shared Savings Program requirements, we proposed to modify certain sections of our regulations that require ACOs to submit supporting materials and documentation at the time of application. Instead of requiring submission of certain materials, narratives, or supporting documentation, we proposed to require ACOs to certify that they meet the applicable eligibility and documentation requirements as specified under our program rules. At the same time, we recognized that there have been instances when the review of supporting documentation and/or narratives has been helpful in making a determination about an ACO's eligibility for participation in the program. Therefore, although we proposed to eliminate the general requirement that ACOs submit certain documentation as part of their initial application to participate in the Shared Savings Program, we proposed to retain the right to request the submission of supporting materials and documentation in cases when such additional information would be useful in making a determination regarding the ACO's application. We indicated that we believe that this proposed modification to the regulations governing ACO applications would introduce additional flexibility that would reduce the level of burden inherent in the Shared Savings Program application process while also ensuring we are still able to appropriately evaluate an ACO's eligibility for program participation.
Accordingly, in order to reduce application burden while retaining flexibility to obtain additional documentation when necessary to determine ACO eligibility and compliance with program rules, we proposed to remove the requirements in §§ 425.204(c)(1) and (d), 425.112(a)(3)(i) and (ii), and 425.112(b)(4)(ii) for the submission of certain specified documents and narratives as part of an ACO's application to participate in the Shared Savings Program. Specifically, we proposed to revise § 425.204(c)(1) to require an ACO, as part of its application, to certify that it satisfies the Shared Savings Program requirements and to submit, upon CMS request, supporting materials (including narratives) and documentation demonstrating that the ACO satisfies program requirements indicated in proposed revised § 425.204(c). Additionally, we proposed to revise § 425.204(d) to indicate that the ACO must certify, as part of its application to participate in the Shared Savings Program, that it has a mechanism and plan to receive and use payments for shared savings, including criteria for distributing shared savings among its ACO participants and ACO providers/suppliers. We also proposed to make a conforming change to remove paragraphs (d)(1) through (3) of § 425.204, which relate to the submission of narratives related to the ACO's use of shared savings payments. This proposal did not include a requirement that the ACO submit information regarding its mechanism and plan for receiving and using shared savings upon request. As explained in the proposed rule, we do not intend to request this information as part of the application process because in our experience, how an ACO intends to use or distribute shared savings has not been a relevant consideration during any application cycle to determine whether the ACO has met the eligibility requirements to participate in the Shared Savings Program. However, we noted that we continue to believe that information on how an ACO uses and distributes its shared savings is useful for the public, and therefore ACOs will continue to be required to publicly report this information under § 425.308(b)(4)(ii).
We also proposed similar changes to the requirements in § 425.112(a)(3)(i), (a)(3)(ii), and (b)(4)(ii) to remove references to the submission of narratives to explain or describe how the ACO will implement the required elements of the ACO's care processes and patient-centeredness criteria. ACOs must still implement these care processes and adopt a focus on patient-centeredness; however, we proposed that they would no longer need to submit descriptions of how they will satisfy these requirements as part of their initial application. We noted, however, that ACOs may still be required to submit upon request a description or documentation sufficient to describe how the ACO will implement the required processes and patient-centeredness criteria found at § 425.112 because under the proposed revisions to § 425.204(c)(1)(ii), CMS would retain the discretion to request such documentation from the ACO at any time.
In summary, we stated that we believe these modifications to the application requirements will significantly reduce the burden of applying to participate in the Shared Savings Program without reducing our ability to ensure that applicants meet the established
Another commenter expressed concern that in the absence of the submission of narratives describing required processes and a rigorous evaluation by CMS, all health systems would be assessed solely based on cost savings and administration. The commenter was concerned that absent a requirement for ACOs to detail how they intend to implement the required processes, a world-class, integrated health care system would, on paper, look the same as a system that had not undertaken improvement activities. Similarly, another commenter noted, “we are concerned that replacing the narrative with a certification may result in some program applicants simply checking the box to say that they have these processes which contain critical patient protections without actually considering whether the ACO is prepared to implement them in the context of the Shared Savings Program.”
We are finalizing the policies in this section as proposed. Specifically, we are finalizing our proposals to: (1) Remove the requirements in §§ 425.204(c)(1) and (d), 425.112(a)(3)(i) and (ii), and 425.112(b)(4)(ii) for the submission of certain specified documents and narratives as part of an ACO's application to participate in the Shared Savings Program; (2) revise § 425.204(d) to indicate that the ACO must certify, as part of its application to participate in the Shared Savings Program, that it has a mechanism and plan to receive and use payments for shared savings; (3) make a conforming change to remove paragraphs (d)(1) through (3) of § 425.204, which relate to the submission of narratives related to the ACO's use of shared savings payments; and (4) make similar changes to the requirements in § 425.112(a)(3)(i), (a)(3)(ii), and (b)(4)(ii) to remove references to the submission of narratives.
Under the Shared Savings Program, ACO participant TINs are not required to be exclusive to one Shared Savings Program ACO unless the TIN submits claims for primary care services used to determine the ACO's assigned population (§ 425.306(b)). The purpose behind this requirement is to ensure that we are able to assign a unique set of beneficiaries to each ACO participating in the Shared Savings Program. Therefore, as part of the Shared Savings Program application process and upon an ACO's request to add an ACO participant TIN, we check the TIN against all other Shared Savings Program ACO participant lists. If the
In a few instances, we have discovered that ACO participant TINs that have been approved to participate in multiple ACOs subsequently began billing for primary care services used in assignment during a benchmark or performance year. Although our program rules permit us to take compliance action against ACOs for violations of Shared Savings Program requirements, they do not specifically address what compliance actions we would impose on ACOs in instances where an ACO participant falls out of compliance with the requirement in § 425.306(b)(2) that an ACO participant TIN that submits claims for primary care services used in assignment be exclusive to a single ACO during a benchmark or performance year, or when non-compliance with this requirement is discovered during the 3-month claims runout for a benchmark or performance year. Moreover, the program rules do not address what modifications to our assignment methodology could be made to account for this overlap.
We believe it is important for ACOs, ACO participants, and ACO providers/suppliers to have updated and accurate information regarding their participation status in the Shared Savings Program. For example, participation in a Shared Savings Program ACO has implications for ACO providers/suppliers under the new Quality Payment Program (see 81 FR 80496 through 80501). The Quality Payment Program replaces a patchwork system of Medicare programs with a flexible system that allows eligible clinicians to choose from two paths that link payments to quality: MIPS and participation in Advanced APMs. The Quality Payment Program, through MIPS and the APM incentive, will impact eligible clinicians' payments beginning in payment year 2019 based on 2017 reporting.
Under the CY 2017 Quality Payment Program final rule with comment period, eligible clinicians participating in Advanced APMs (including Tracks 2 and 3 under the Shared Savings Program) may become Qualifying APM Participants and receive a 5 percent APM Incentive Payment if they have a sufficient percentage of payments for Part B covered professional services, or a sufficient percentage of Medicare patients that are attributable to services furnished through an Advanced APM for a given performance year. In addition to earning a 5 percent APM Incentive Payment, Qualifying APM Participants are not subject to the MIPS reporting requirements and payment adjustment for a given performance year. As a result, revisions to ACO participant lists that occur mid-year or following the end of a benchmark or performance year could have widespread implications not only for the ACO, but also for its ACO providers/suppliers under the Quality Payment Program.
As participation in the Shared Savings Program grows and more ACOs and ACO participants join the program, we believe overlapping TINs are likely to become more common. We also believe that changes to our program rules regarding the claims that will be considered in assigning FFS beneficiaries to an ACO (specifically, the policy finalized in the June 2015 final rule to exclude services furnished by several physician specialty types from the assignment methodology) may result in a greater number of permissible ACO participant TIN overlaps (see 80 FR 32753 and 32754). As a result, we anticipate there could also be an increased number of cases where ACO participant TINs with initially permissible overlaps could become out of compliance with the requirement at § 425.306(b)(2) that an ACO participant TIN be exclusive to a single Shared Savings Program ACO if the TIN bills for primary care services that are used to assign beneficiaries to the ACO. This could occur, for example, if a group practice that initially includes only physician specialty types whose services are excluded from the assignment methodology were to subsequently employ a non-physician practitioner who bills for primary care services. We believe these types of practice arrangements are becoming increasingly common.
Therefore, as we stated in the proposed rule, we believe it is necessary to streamline our approach to handling such situations in order to reduce the burden and uncertainty for ACOs when changes in ACO participant billing practices result in an ACO participant falling out of compliance with the exclusivity requirement at § 425.306(b)(2). Rather than the current policy under which an ACO may be required to remove an overlapping ACO participant and recertify its ACO participant list for the performance year (thus necessitating redetermination of beneficiary assignment and delays in or revisions to benchmark or performance year calculations), we believe it would be less disruptive for ACOs if we were to permit overlapping TINs that begin billing for services used in assignment during a benchmark or performance year (including claims for services furnished during the benchmark of performance year, but submitted during the 3-month claims runout) to remain on the ACO participant lists for all affected ACOs for the remainder of the performance year in which we determine that an overlap exists. For example, assume that, based on an analysis of claims for services furnished in performance year 2018, we were to identify an impermissible overlapping TIN in January 2019 after the ACO participant lists for performance year 2019 had already been certified. Under this proposal, the TIN would be able to remain on the ACO participant lists of all affected ACOs for the 2018 performance year as well as the remainder of performance year 2019. To ensure that an overlapping TIN is not inadvertently used in the assignment algorithm for multiple ACOs when determining where a beneficiary received the plurality of primary care services, which could result in assignment of the same beneficiary to multiple ACOs, we proposed to simply exclude any claims for services furnished by the overlapping TIN from the assignment methodology when conducting final beneficiary assignment for any benchmark or performance year in which the TIN bills Medicare for services used in our assignment methodology. The affected ACOs would be required to resolve the overlap prior to recertification of their ACO participant lists for the subsequent performance year. If the overlap remains unresolved when the ACOs certify their ACO participant lists for the next
Therefore, we proposed to modify our program rules in § 425.306 and subpart E of part 425 to address this issue. We proposed to modify § 425.306(b) to indicate that if, during a benchmark or performance year (including the 3-month claims run out period for such benchmark or performance year), an ACO participant that participates in more than one ACO begins billing for services that would be used in assignment, we would not consider any services billed through that TIN when performing beneficiary assignment for the applicable benchmark or performance year. We also proposed to eliminate the reference to “primary care” in § 425.306(b)(2) when describing the services used to determine the ACO's assigned beneficiary population to conform with our proposal to implement section 17007 of the 21st Century Cures Act under which we would consider all services furnished in RHCs and FQHCs in the assignment methodology starting in the 2019 performance year. In addition, the ACOs in which the overlapping TIN is an ACO participant may be subject to compliance action (as provided under § 425.216) or termination under § 425.218. Compliance actions may include requiring each ACO that includes the TIN as an ACO participant to submit a corrective action plan explaining how the ACO plans to work with the overlapping ACO participant to resolve the overlap for the next performance year. If the overlap remains unresolved by the date specified by us in our request for a corrective action plan, we would remove the overlapping ACO participant TIN from the ACO participant list of each ACO for the subsequent performance year.
We also proposed to revise our general assignment methodology at § 425.400(a)(1) to add new paragraph (a)(1)(iii) to indicate that when we determine final assignment after the end of each benchmark or performance year, we will exclude claims for services furnished during the benchmark or performance year by an ACO participant that participates in more than one ACO. We stated that we believe that this policy will ensure a uniquely assigned beneficiary population for each ACO and prevent the same beneficiaries from being included in determining benchmark or performance year expenditures for more than one ACO.
Based on a review of the comments, we believe that finalization of the proposed policies will ensure that we are able to continue to assign a unique set of beneficiaries to each ACO participating in the Shared Savings Program and avoid making duplicate shared savings payments for ACOs with TINs that participate in more than one ACO, while preserving the flexibility that is currently extended to ACO participants that do not bill for services used in assignment, and recognizing the possibility for mid-year changes in care and billing practices by these ACO participants. We believe that implementing the proposed changes to our process for addressing ACO participant overlaps will improve ACO and ACO participant understanding of our policies and requirements regarding ACO participant exclusivity, while also reducing burden for ACOs that currently must recertify their ACO participant lists and may be subject to retrospective modifications or delays in assignment and other related benchmark or performance year calculations. Additionally, for purposes of the Quality Payment Program, ACO participant TINs and the eligible clinicians that bill through those TINs will have greater certainty regarding whether they qualify as participating in an APM or Advanced APM for a performance year. Under the proposed policy, which we are finalizing, an ACO participant will know for the entire performance year with certainty that it is participating in a particular APM (or Advanced APM) entity.
We are finalizing the proposed changes to our policies for addressing compliance with the ACO participant TIN exclusivity requirement as proposed. Specifically, we are finalizing our proposals to: (1) Modify § 425.306(b) to indicate that if, during a benchmark or performance year (including the 3-month claims run out period for such benchmark or performance year), an ACO participant that participates in more than one ACO begins billing for services that would be used in assignment, we would not consider any services billed through that TIN when performing beneficiary assignment for the applicable benchmark or
Under section 1899(d) of Act, ACOs participating in the Shared Savings Program are accountable for the total Parts A and B costs for the Medicare FFS beneficiaries assigned to the ACO. Therefore, in addition to Medicare Parts A and B claims, we include non-claims based individually beneficiary identifiable payments made from the Medicare Trust Funds when performing financial calculations for the Shared Savings Program, including establishing, adjusting, and updating financial benchmarks and calculating performance year expenditures. We internally track these non-claims based beneficiary identifiable payments through a separate CMS system that receives and stores these non-claims based payments made from the Medicare Trust Funds under a demonstration, pilot or time limited program.
To date, when we perform ACO benchmarking and financial calculations under the Shared Savings Program, we have included (in addition to all Medicare Parts A and B claims) all non-claims based individually beneficiary identifiable payments for the applicable benchmark or performance year that are included in the separate CMS system, including any payments made during the 3-month claims run-out period for the benchmark or performance year. This means that to date we have included in the calculation of historical benchmarks and performance year expenditures some interim payments made under a demonstration, pilot, or time limited program that will be subject to subsequent reconciliation to determine the final payment amount. However, because the various demonstrations, pilots, or time limited programs may have different operational schedules from the Shared Savings Program, it is not possible for us to include all interim and final beneficiary identifiable payments made under these initiatives in benchmarking and financial reconciliation calculations for the Shared Savings Program; and, as a result, these calculations have excluded some interim and final non-claims based beneficiary identifiable payments made under certain demonstrations, pilots, or time limited programs. For example, because of the timing and availability of BPCI non-claims based payment amounts, to date we have included only up to two quarters of interim payment data for BPCI in ACO benchmarking and financial reconciliation calculations for the Shared Savings Program and no final payment amounts.
To date, non-claims based individually beneficiary identifiable payments represent a relatively minor proportion of an ACO's total Part A and B beneficiary expenditure amounts as determined under the Shared Savings Program (mean of 0.09 percent overall impact of ACO non-claims based payments on total per capita expenditures and a mean of 137 person-years in an ACO's assigned beneficiary population with a non-claims based payment during the year; minimum −0.72 percent, 0 person-years; maximum 1.24 percent, 1,865 person-years). For the demonstrations, pilots, or time limited programs that include interim and final reconciliations, the impact of including the non-claims based payments could be positive or negative for an ACO for a given performance year. Additionally, a preliminary analysis suggests that interim payments made under select demonstrations, pilots, or time limited programs fluctuate on a quarterly basis. We refer the reader to the proposed rule (82 FR 34122 through 34123) for further details about the results of this analysis.
Fluctuations in the non-claims based payments for certain initiatives, such as BPCI, have generated stakeholder concern. Further, stakeholders note that the impact of including interim payments in financial calculations may become greater in the future, given the increasingly widespread interest in participation in alternative payment models and the growing number of such models being tested through the CMS Innovation Center. Stakeholders have therefore suggested that we should revise our policies to clarify that only final non-claims based payments made within the 3 months claims run out period under a demonstration, pilot, or time limited program will be included in the calculation of an ACO's benchmark and performance year expenditures.
Our preliminary analysis, as discussed in the background section, suggests that interim non-claims based payments (that is, payments that are subject to reconciliation at a later date) made under a demonstration, pilot, or time limited program can fluctuate significantly from quarter to quarter and may not reflect the actual final reconciled payment amount. Thus, as we stated in the proposed rule, we agree with the stakeholders who have suggested that only final non-claims based payments made under a demonstration, pilot, or time limited program should be included in financial calculations related to benchmarks and performance year expenditures under the Shared Savings Program. We believe this would be a reasonable approach to determining Parts A and B expenditures for assigned beneficiaries for both benchmark and performance years given the uncertain impact of including interim payments that are subject to further reconciliation on financial calculations for the Shared Savings Program. We also agree that use of interim payments made under a demonstration, pilot, or time limited program could have an increasingly large effect on ACO benchmarks and performance year expenditure calculations in the future given widespread stakeholder interest in participating in alternative payment models and CMS interest in testing and expanding additional payment models that may lead to higher quality and more coordinated care at a lower cost to Medicare.
Therefore, we proposed to modify our regulations at §§ 425.602(a)(1)(ii), 425.603(c)(1)(ii), and 425.603(e)(2)(ii) to add new provisions to indicate that, (1) when establishing benchmarks for agreement periods beginning before 2018, we will include all individually beneficiary identifiable payments, including interim payments, made under a demonstration, pilot, or time limited program, (2) for agreement periods beginning in 2018 and subsequent years, we would only include individually beneficiary identifiable payments made under a demonstration, pilot, or time limited program that are final and not subject to further reconciliation, and (3) for the 2018 performance year and subsequent performance years in agreement periods beginning in 2015, 2016, and 2017, the benchmark would be adjusted to reflect only individually beneficiary identifiable final payments made under
We invited comments on this proposal.
We are finalizing the policies in this section as proposed, with the exception of a minor revision to § 425.603(e)(2)(ii)(C) to address a technical error that was made in the proposed rule. In the proposed rule, we inadvertently included a reference to the benchmark in the proposed regulatory text for this provision. However, § 425.603(e) establishes the policies for determining risk adjusted county fee-for-service expenditures, which are used in calculating an ACO's regional fee-for-service expenditures. In this final rule, we are revising the language at § 425.603(e)(2)(ii)(C) to correct this reference.
Section 1848(p) of the Act requires the establishment of a value-based payment modifier (VM) that applies 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, section 1848(p)(7) of the Act provides the Secretary discretion to apply the VM to eligible professionals (EPs) as defined in section 1848(k)(3)(B) of the Act. Section 1848(p)(4)(C) of the Act requires the VM to be budget neutral. The VM and Physician Feedback programs continue our initiative to recognize and reward clinicians based on the quality and cost of care provided to their patients, increase the transparency of health care quality information and to assist clinicians and beneficiaries in improving medical decision-making and health care delivery. As stated in the CY 2016 PFS final rule with comment period (80 FR 71277), the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10) was enacted on April 16, 2015. Under section 1848(p)(4)(B)(iii) of the Act, as amended by section 101(b)(3) of MACRA, the VM shall not be applied to payments for items and services furnished on or after January 1, 2019. Section 1848(q) of the Act, as added by section 101(c) of MACRA, establishes the Merit-based Incentive Payment System (MIPS) that shall apply to payments for items and services furnished on or after January 1, 2019.
In the CY 2013 PFS final rule with comment period, we discussed the goals of the VM and also established that specific principles should govern the implementation of the VM (77 FR 69307). We refer readers to that rule for a detailed discussion. In the CY 2013 PFS final rule with comment period (77 FR 69310), we also finalized policies to phase-in the VM by applying it beginning January 1, 2015, to Medicare PFS payments to physicians in groups of 100 or more EPs. A summary of the existing policies that we finalized for the CY 2015 VM can be found in the CY 2014 PFS proposed rule (78 FR 43486 through 43488). Subsequently, in the CY 2014 PFS final rule with comment period (78 FR 74765 through 74787), we finalized policies to continue the phase-in of the VM by applying it starting January 1, 2016, to payments under the Medicare PFS for physicians in groups of 10 or more EPs. Then, in the CY 2015 PFS final rule with comment period (79 FR 67931 through 67966), we finalized policies to complete the phase-in of the VM by applying it starting January 1, 2017, to payments under the Medicare PFS for physicians in groups of 2 or more EPs and to physician solo practitioners. In the CY 2016 PFS final rule with comment period (80 FR 71277 through 71279), we finalized that in the CY 2018 payment adjustment period, the VM will apply to non-physician EPs who are physician assistants (PAs), nurse practitioners (NPs), clinical nurse specialists (CNSs), and certified registered nurse anesthetists (CRNAs) in groups with 2 or more EPs and to PAs, NPs, CNSs, and CRNAs who are solo practitioners.
In the CY 2016 PFS final rule with comment period (80 FR 71280), we adopted a two-category approach for the CY 2018 VM based on participation in the PQRS by groups and solo practitioners. For the purposes of the CY 2018 VM, Category 1 includes the following groups and solo practitioners:
(1) Groups that meet the criteria to avoid the CY 2018 PQRS payment adjustment as a group practice participating in the PQRS GPRO;
(2) Groups that have at least 50 percent of the group's EPs meet the criteria to avoid the PQRS payment adjustment for CY 2018 as individuals;
(3) Solo practitioners that meet the criteria to avoid the CY 2018 PQRS payment adjustment as individuals; and
(4) Groups and solo practitioners that meet the criteria to avoid the CY 2018 PQRS payment adjustment through participation in a Shared Savings Program ACO, if the ACO in which they participate successfully reports quality data as required by the Shared Savings Program.
Category 2 includes those groups and solo practitioners that are subject to the CY 2018 VM payment adjustment and do not fall within Category 1. Groups in Category 1 have been eligible to receive upward, neutral, or downward adjustments under our quality-tiering methodology, and groups and solo practitioners in Category 2 receive an automatic downward adjustment under the VM.
In the CY 2016 PFS final rule with comment period (80 FR 71288 to 71291), we finalized that we will apply the following adjustments to payments, for items and services furnished under the Medicare PFS in CY 2018, to physicians, PAs, NPs, CNSs, and CRNAs in groups with 10 or more EPs and at least one physician:
• Negative 4 percent (−4.0 percent) for those that fall into Category 2.
• Negative 4 percent (−4.0 percent) under the quality-tiering methodology for those in Category 1 that are classified as low quality/high cost and negative 2 percent (−2.0 percent) for those classified as either low quality/average cost or average quality/high cost.
• An upward adjustment of four times an adjustment factor (+4.0x) under the quality-tiering methodology for those in Category 1 that are classified as high quality/low cost and two times an adjustment factor (+2.0x) for those classified as either average quality/low cost or high quality/average cost.
We finalized that we would apply the following adjustments to payments, for items and services furnished under the Medicare PFS in CY 2018, to physician solo practitioners and physicians, PAs, NPs, CNSs, and CRNAs in groups with 2 to 9 EPs and at least one physician:
• Negative 2 percent (−2.0 percent) to those that fall into Category 2.
• Negative 2 percent (−2.0 percent) under the quality tiering methodology for those in Category 1 that are classified as low quality/high cost and negative 1 percent (−1.0 percent) for those classified as either low quality/average cost or average quality/high cost.
• An upward adjustment of two times an adjustment factor (+2.0x) under the quality-tiering methodology for those in Category 1 that are classified as high quality/low cost and one times an adjustment factor (+1.0x) for those classified as either average quality/low cost or high quality/average cost.
We finalized that we would apply the following adjustments to payments, for items and services furnished under the Medicare PFS in CY 2018, to non-physician solo practitioners who are PAs, NPs, CNSs, and CRNAs and to PAs, NPs, CNSs, and CRNAs in groups comprised solely of non-physician EPs:
• Negative 2 percent (−2.0 percent) for those who fall in Category 2.
• No downward adjustments under the quality-tiering methodology for those in Category 1 in CY 2018.
• An upward adjustment of two times an adjustment factor (+2x) under the quality-tiering methodology for those in Category 1 that are classified as high quality/low cost and one times an adjustment factor (+1.0x) for those classified as either average quality/low cost or high quality/average cost.
In the CY 2017 PFS final rule with comment period (81 FR 80520-80524), we finalized the following, with regard to Medicare Shared Savings Program ACO participant TINs whose ACO did not successfully report quality data on behalf of its EPs for purposes of PQRS as required by the Shared Savings Program under § 425.504 for the CY 2017 and CY 2018 PQRS payment adjustments:
• For the CY 2017 VM payment adjustment period, we will use the data reported to the PQRS by the EPs under the ACO participant TIN (as a group or as individuals) outside of the ACO during the secondary PQRS reporting period in 2016 to determine whether the TIN would fall in Category 1 or Category 2 under the VM.
• We will apply the two-category approach finalized for the CY 2017 VM based on participation in the PQRS by groups and solo practitioners to determine whether groups and solo practitioners that participate in a Shared Savings Program ACO, but report to the PQRS outside of the ACO, would fall in Category 1 or Category 2 under the VM.
• We will assess the individual EP or group's 2016 data submitted outside the ACO and during the secondary PQRS reporting period against the reporting requirements for the CY 2018 PQRS payment adjustment.
As a general summary, we proposed the following modifications to the VM policies for the CY 2018 payment adjustment period:
• Reduce the automatic downward adjustment for groups and solo practitioners in Category 2 (those who do not meet the criteria to avoid the 2018 PQRS payment adjustment as individual solo practitioners, as a group practice, or groups that have at least 50 percent of the group's EPs meet the criteria as individuals) to negative 2 percent (−2.0 percent) for groups with 10 or more EPs and at least one physician, and negative 1 percent (−1.0 percent) for groups with between 2 to 9 EPs, physician solo practitioners, and for groups and solo practitioners that consist only of non-physician EPs.
• Hold all groups and solo practitioners who are in Category 1 (those who meet the criteria to avoid the 2018 PQRS payment adjustment as individual solo practitioners, as a group practice, or groups that have at least 50 percent of the group's EPs meet the criteria as individuals) harmless from downward payment adjustments under quality tiering for the last year of the program.
• To provide a smoother transition to the MIPS and to align incentives across all groups and solo practitioners, reduce the maximum upward adjustment under the quality-tiering methodology to two times an adjustment factor (+2.0x) for groups with 10 or more EPs. This is the same maximum upward adjustment under the quality-tiering methodology that we finalized and will maintain for groups with between 2 to 9 EPs, physician solo practitioners, and for groups and solo practitioners that consist only of non-physician EPs.
As noted in this final rule, under section 1848(p)(4)(B)(iii) of the Act, as amended by section 101(b)(3) of MACRA, the VM shall not be applied to payments for items and services furnished on or after January 1, 2019. Section 1848(q) of the Act, as added by section 101(c) of MACRA, establishes the MIPS that shall apply to payments for items and services furnished on or after January 1, 2019. In the interest of program alignment and providing a smooth transition between the VM and MIPS, as well as aligning with the changes to the policies for satisfactory reporting under the final year of PQRS, modifications to the CY 2018 VM payment adjustments are described in section III.F. of this final rule.
We did not propose any changes to the policies finalized in the CY 2016 PFS final rule with comment period (80 FR 71280) for determining whether a group or solo practitioner is considered to be Category 1 or Category 2 for purposes of the CY 2018 VM. Specifically, we did not propose any change to our existing policy that TINs that avoid the downward payment adjustment under PQRS (either as a group practice participating in the PQRS GPRO or through the individual participation of at least 50 percent of the group's EPs, or as a solo practitioner) will be considered Category 1 under the VM. These TINs therefore will avoid an automatic downward adjustment under the VM.
We proposed modifications to the VM policies for the CY 2018 payment adjustment period. As discussed in greater detail below, we proposed these modifications based on our general policy goals of better alignment and ensuring a smooth transition from the final year of the VM (2018) to the first year of MIPS (2019) as well as continuing to align the VM with the policies established for the PQRS.
As stated in the proposed rule (82 FR 34126), to maintain stability in the payment adjustment amounts applicable under the VM as we transition to the MIPS in 2019, we previously established that we will maintain generally the same VM payment adjustment amounts from the CY 2017 payment adjustment period to the CY 2018 payment adjustment period (80 FR 71288 through 71291). Under our existing policy (80 FR 71290), the estimated funds derived from the application of the downward adjustments to groups and solo practitioners in Category 1 and Category 2 are available to all groups and solo practitioners eligible for upward adjustments under the VM. The upward payment adjustment factor (the “x” factor) is determined after the performance period has ended based on the aggregate amount of downward payment adjustments. As noted in the proposed rule (82 FR 34126), despite our efforts to ensure a smooth transition from the VM to the MIPS, the 2017 VM adjustment factor has resulted in payment adjustments for some groups and solo practitioners that are significantly higher than the maximum upward adjustment under the MIPS, which will apply to payments starting in 2019, after the sunset of the VM in 2018. The magnitude of the 2017 VM adjustment factor is due in large part to the number of physician practices failing to satisfy the criteria to avoid the PQRS payment adjustment (Category 2). Furthermore, we believe it is likely that many physician practices that fail to meet these criteria and as a result are in Category 2 and are subject to automatic downward adjustments under the 2018 VM will be excluded from MIPS in 2019, due to the low-volume threshold. In a MIPS final rule with comment period, we estimated that 53 to 57 percent of Medicare clinicians are expected to be excluded from MIPS because they are: (1) A qualifying Alternative Payment Model participant; (2) an ineligible clinician type; (3) meeting the low-volume threshold; or (4) a newly enrolled clinician (81 FR 77517).
The 2017 VM adjustment factor is 15.48 percent, which is similar to the 2016 VM adjustment factor of 15.92 percent. We would expect, absent any policy change, that the 2018 VM adjustment factor would be similar or higher. The 2018 VM adjustment factor could potentially be higher than the 2017 VM adjustment factor, because non-physician EPs who will be subject to the 2018 VM may be less familiar with quality reporting and may fail to meet the criteria to avoid the CY 2018 PQRS payment adjustment, which would result in a greater number of groups and solo practitioners in Category 2. In addition, groups with 2-9 EPs and solo practitioner physicians will no longer be held harmless from downward adjustments under the quality-tiering methodology in the CY 2018 payment adjustment period.
In section III.F. of this final rule, we are finalizing changes to certain policies for the 2018 PQRS payment adjustment. We discuss the implications of these changes for PQRS with regard to the VM in greater detail below.
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In contrast to the existing policy for 2018 where only non-physician solo practitioners and groups comprised solely of non-physician EPs would be held harmless from downward adjustments under quality-tiering, our proposed policy would mean that all groups and solo practitioners that meet the criteria to avoid the 2018 PQRS payment adjustment would receive either a neutral or upward adjustment based on performance.
The following is a summary of the public comments received on our proposal and our responses:
Furthermore, if we eliminated the downward adjustments for Category 2 groups and solo practitioners, in addition to finalizing the policy to hold all groups and solo practitioners in Category 1 harmless from downward adjustments under the quality-tiering methodology in the CY 2018 payment adjustment period, then there would be no funds available for upward adjustments for the high-performing groups and solo practitioners.
Accordingly, we are finalizing as proposed the policy to hold all groups and solo practitioners in Category 1 harmless from downward adjustments under the quality-tiering methodology in the CY 2018 payment adjustment period.
We also proposed to reduce the maximum upward adjustment under the quality-tiering methodology in CY 2018 from four times an adjustment factor (+4.0x) to two times an adjustment factor (+2.0x) for those classified as high quality/low cost and from two times an adjustment factor (+2.0x) to one times an adjustment factor (+1.0x), for those classified as either average quality/low cost or high quality/average cost. This policy would align the upward adjustments for groups with ten or more eligible professionals with the existing policy for smaller groups and solo practitioners, as well as groups comprised solely of non-physician EPs (80 FR 71290). We proposed this change based on our concern that the 2018 VM adjustment factor (the “x” factor used to determine upward adjustments) could potentially be higher than the 2017 VM adjustment factor, as discussed previously. Lowering the maximum upward adjustment in 2018 would mitigate the effect of a high adjustment factor and ensure a smoother transition from the VM adjustment in 2018 to the MIPS adjustment in 2019. We welcomed public comment on this proposal.
The following is a summary of the public comments received on our proposal and our responses:
Table 23 displays the final 2018 VM adjustments under the quality-tiering methodology, for groups and solo practitioners in Category 1. Under the final policies, groups of any size and composition would be subject to the same upward adjustments under quality tiering and would be held harmless from any downward adjustments based on performance.
Tables 24 through 26 illustrate how the final policies differ from the previously-finalized policies for each group size and composition.
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For physicians, PAs, NPs, CNSs, and CRNAs in groups with 10 or more EPs and at least one physician, we proposed to reduce the automatic downward VM adjustment from negative 4 percent (−4.0 percent) to negative 2 percent (−2.0 percent) for those that fall in Category 2, meaning they did not meet the criteria to avoid the 2018 PQRS payment adjustment.
For physician, PA, NP, CNS, and CRNA solo practitioners; physicians,
We welcomed public comment on these proposals.
The following is a summary of the public comments received on our proposals and our responses:
For the commenter who expressed concern about the impact on groups who invested resources in successful participation in the Value Modifier program, we acknowledge and appreciate the efforts made by those groups and solo practitioners who successfully met the previously-finalized PQRS reporting criteria. We believe that the proposed policy strikes the appropriate balance between incentivizing both quality reporting and the provision of high-quality, efficient care and making a smooth transition to MIPS. In response to the comment that the previously-finalized negative four percent (−4.0 percent) automatic downward adjustment better aligned with MIPS, we note that the MIPS replaces three legacy programs, the PQRS, Value Modifier, and the Medicare EHR Incentive Program for eligible professionals. Under previously-finalized policies for the PQRS and Value Modifier programs, the combined total downward adjustment for not meeting the minimum quality reporting requirements would have been negative six percent (−6.0 percent), which would have exceeded the maximum downward adjustment of negative four percent (−4.0 percent) in the first year of MIPS. Therefore, we are finalizing as proposed that for the CY 2018 payment adjustment period: (1) For physicians, PAs, NPs, CNSs, and CRNAs in groups with 10 or more EPs and at least one physician, to reduce the automatic downward VM adjustment from negative 4 percent (−4.0 percent) to negative 2 percent (−2.0 percent) for those that fall in Category 2, meaning they did not meet the criteria to avoid the 2018 PQRS payment adjustment; and (2) for physician, PA, NP, CNS, and CRNA solo practitioners; physicians, PAs, NPs, CNSs, and CRNAs in groups with 2 to 9 EPs; and for PAs, NPs, CNSs, and CRNAs who are in groups comprised solely of non-physician EPs, to reduce the automatic downward VM adjustment from negative 2 percent (−2.0 percent) to negative 1 percent (−1.0 percent) for those that fall in Category 2.
Section 1848(p) of the Act does not specify the amount of payment that should be subject to the adjustment for the VM; however, section 1848(p)(4)(C) of the Act requires the VM be implemented in a budget neutral manner. In the past, under the VM, we have achieved budget neutrality by increasing payments for some groups and solo practitioners based on high performance and decreasing them for others based on low performance or failing to meet the criteria to avoid the PQRS payment adjustment as a group or as individuals. Under the VM proposals included in the proposed rule for the CY 2018 payment adjustment period, we would not decrease payments to groups and solo practitioners based on performance under the quality-tiering methodology, provided that they are classified as Category 1 under the VM (meaning that they meet the criteria to avoid the CY 2018 PQRS payment adjustment as individual solo practitioners, as a group practice, or as a group that has at least 50 percent of the group's EPs meet the criteria). We would continue to decrease payments to groups and solo practitioners in Category 2 (meaning that they did not meet the criteria to avoid the CY 2018 PQRS payment adjustment as individual solo practitioners, as a group practice, or as a group that has at least 50 percent of the group's EPs meet the criteria). Regardless of the VM proposals for the CY 2018 payment adjustment period, the aggregate expected amount of Medicare spending in any given year for physician and non-physician EP services paid under the Medicare PFS will not change as a result of the application of the VM. As discussed previously, because the VM must be implemented in a budget neutral manner, the amount available for upward adjustments for high performers would decrease under our proposals. In other words, groups and solo practitioners that performed well on cost and quality would receive a smaller increase in payment. For this reason, we sought comment on whether we have appropriately balanced the interests of high and low-performing groups and solo practitioners through this proposed change to the policy.
The following is a summary of the public comments received and our responses:
We proposed to make conforming revisions to §§ 414.1270, and 414.1275(c)(4) and (d)(3) to reflect the proposals described in this section. We sought public comment on these changes to the regulation text. We did not receive any comments on the proposed regulation text; therefore, we are finalizing the revisions as proposed.
The Quality Payment Program (QPP) aims to improve health outcomes, promote smarter spending, minimize burden of participation, and provide fairness and transparency in operations. These aims are centered on improving beneficiary outcomes and engaging patients through patient-centered policies, and enhancing clinician experience through flexible and transparent program design and interactions with easy-to-use program tools.
The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10) was enacted on April 16, 2015. Section 101(f) of MACRA amended section 1848 of the Act to create a new subsection (r) entitled Collaborating with the Physician, Practitioner, and Other Stakeholder Communities to Improve Resource Use Measurement. Section 1848(r)(2) of the Act requires the development of care episode and patient condition groups, and classification codes for such groups. To facilitate the attribution of patients and episodes to one or more clinicians, section 1848(r)(3) of the Act requires the development of patient relationship categories and codes that define and distinguish the relationship and responsibility of a physician or applicable practitioner with a patient at the time of furnishing an item or service. The categories shall include different relationships of the clinician to the patient and reflect various types of responsibility for and frequency of furnishing care. Pursuant to section 1848(r)(3)(C) of the Act, we posted a draft list of patient relationship categories in April 2016 and solicited public comment on the categories and the policy principles that were used in developing them.
Based on the public comments received and consultation with stakeholders and experts regarding the draft list of patient relationship categories posted in April 2016 and the list of modified patient relationship categories posted in December 2016, we posted the operational list of patient relationship categories on May 17, 2017, pursuant to section 1848(r)(3)(E) of the Act, which is available at
• Continuous/Broad Services.
• Continuous/Focused Services.
• Episodic/Broad services.
• Episodic/Focused Services.
• Only as Ordered by Another Clinician.
Section 1848(r)(3)(F) of the Act requires that after the posting of the operational list of patient relationship categories and codes, not later than November 1st of each year (beginning with 2018), the Secretary shall, through rulemaking, make revisions to the operational list of patient relationship categories and codes as the Secretary determines appropriate. The revisions may be based on experience, new information and input from stakeholders. In preparation for potential subsequent revisions by November 1, 2018, we sought comment on the operational list of patient relationship categories available at
Section 1848(r)(4) of the Act requires that claims submitted for items and services furnished by a physician or applicable practitioner on or after January 1, 2018, shall, as determined appropriate by the Secretary, include the applicable codes established for care episode groups, patient condition groups, and patient relationship categories under sections 1848(r)(2) and (3) of the Act, as well as the NPI of the ordering physician or applicable practitioner (if different from the billing physician or applicable practitioner). Applicable practitioners are defined in section 1848(r)(9)(B) of the Act as a physician assistant, nurse practitioner, and clinical nurse specialist (as such terms are defined in section 1861(aa)(5)), and a certified registered nurse anesthetist (as defined in section 1861(bb)(2)), and beginning January 1, 2019, such other eligible professionals (as defined in subsection (k)(3)(B)) as specified by the Secretary.
We have been planning for the use of procedure code modifiers for the reporting of patient relationships codes on Medicare claims. In December 2016, as described above, when we solicited comments on the potential modifications to the patient relationship categories, we also sought comment on the use of Level II Healthcare Common Procedure Coding System (HCPCS) Modifiers for the patient relationship codes. Public comments indicated that Current Procedural Terminology (CPT) Modifiers would be the best way to operationalize the reporting of patient relationship codes.
We worked with the American Medical Association's (AMA) CPT Editorial Panel, which is responsible for maintaining the CPT code set. We submitted an application for the CPT modifiers for reporting of the patient relationship codes. The CPT Editorial Panel, at their June 2017 meeting determined that AMA would not include the modifiers in the CPT code set, pending future finalization of the modifiers by CMS, whereby CMS publishes the modifiers as Level II HCPCS Modifiers. Therefore, we proposed the Level II HCPCS Modifiers
We proposed that Medicare claims submitted for items and services furnished by a physician or applicable practitioner on or after January 1, 2018, should include the applicable HCPCS modifiers in Table 27, as well as the NPI of the ordering physician or applicable practitioner (if different from the billing physician or applicable practitioner). We anticipated there would be a learning curve with the use of the modifiers to report patient relationships, and believed that time would be needed to work with clinicians to ensure they gain experience in using these modifiers. Therefore, for at least an initial period while clinicians gain familiarity, we proposed that the HCPCS modifiers may be voluntarily reported on Medicare claims, and the use and selection of the modifiers would not be a condition of payment. Claims would be paid regardless of whether and how the modifiers are included. We would work with clinicians to educate them about the proper use of the modifiers.
We stated that the use of modifiers to report patient relationships would not change the meaning of the procedure codes used to report items and services and guidelines associated with use of such procedure codes. The modifiers would also not be tied or related to intensity of services (evaluation and management services). Finally, we noted that, although we may work with clinicians to explore incorporating these codes into the QPP in future years, the measures we have proposed and finalized to date, those we have proposed for 2018, and those we are currently developing for future rulemaking for the MIPS performance categories do not require patient relationship codes to properly measure clinicians' quality and resource use in the Medicare program.
We solicited comment on our proposal for voluntary reporting of the HCPCS modifiers on claims submitted for items and services furnished by a physician or applicable practitioner on or after January 1, 2018 and on the proposed list of HCPCS modifiers in Table 27.
The following is a summary of the public comments received on our proposals and our responses:
After consideration of the public comments, we are finalizing our proposal to use the Level II HCPCS Modifiers in Table 27 as the patient relationship codes, which we will add to the operational list of patient relationship categories available at
In the November 15, 2016
The aim of the MDPP expanded model is to continue to test a method of prevention of the onset of type 2 diabetes among Medicare beneficiaries with an indication of prediabetes as defined by the MDPP beneficiary eligibility criteria (finalized at § 410.79(c)(1)). Services available
For a detailed discussion of the DPP model test and the development of aspects of the MDPP expanded model, we refer readers to the CY 2017 PFS proposed rule (“Proposed Expansion of the Diabetes Prevention Program (DPP) Model”) (81 FR 46413 through 46418), and the CY 2017 PFS final rule (81 FR 80459 through 80475).
In the CY 2017 PFS final rule, we responded to and incorporated certain suggestions from the public comments we received that were within the scope of the MDPP proposals presented in the CY 2017 PFS proposed rule. We indicated in that final rule (81 FR 80459) that the MDPP expanded model would be implemented through at least two rounds of rulemaking. In the CY 2017 PFS final rule, we finalized MDPP policies that will enable CDC-recognized organizations to prepare for enrollment, including finalizing the framework for the MDPP expanded model, timeline and definitions for the MDPP expanded model (codified at § 410.79(a) and (b)), beneficiary eligibility criteria (codified at § 410.79(c) and (d)), supplier eligibility criteria and supplier enrollment requirements (codified at § 424.59, proposed to be redesignated as § 424.205). We also identified several issues, including some issues raised by commenters that we deferred to future rulemaking.
In the CY 2017 PFS final rule (81 FR 80465 through 80468), we finalized the structure of MDPP services. We provided that the MDPP core benefit consists of at least 16 weekly core sessions over months 1 through 6 and at least 6 monthly core maintenance sessions over months 7 through 12, furnished regardless of weight loss (§ 410.79(b) and (c)(2)). We also finalized that Medicare will cover ongoing maintenance sessions after the 12-month core set of MDPP services if beneficiaries achieve and maintain the required minimum weight loss of 5 percent. In the CY 2018 PFS proposed rule, we proposed to further revise the structure of MDPP services as a 3-year service period, generally contingent upon a beneficiary's attainment of two performance goals: Achievement and maintenance of weight loss and attendance at a certain number of MDPP sessions (82 FR 34131 through 34132).
As used in this final rule, the term “MDPP services period” refers to the time period in which MDPP services are furnished under the MDPP expanded model over a minimum of 12 consecutive months and a maximum of 24 consecutive months from the date of the first core session the beneficiary attends. We use the term “set of MDPP services” to include the entirety of MDPP services available under the MDPP expanded model, including core sessions, core maintenance sessions, and, subject to § 410.79(c)(3), ongoing maintenance sessions offered over the course of the MDPP services period. For purposes of this final rule and the expanded model, MDPP services are covered under the “additional preventive services” benefit category under section 1861(ddd)(1) of the Act and paid from the Medicare Part B Trust Fund. As indicated in the CY 2017 PFS, we intended to begin supplier enrollment before MDPP services became available, and we finalized an expanded model start date of January 1, 2018.
In the CY 2018 PFS proposed rule, we proposed a new start date for the furnishing of MDPP services within the expanded model of April 1, 2018 (82 FR 34157 through 34158). That is, MDPP suppliers will not be able to furnish MDPP services, or to receive payment for these services, prior to April 1, 2018. We note that we proposed the supplier enrollment and compliance policies become effective on January 1, 2018. This stated that the change to delay the furnishing of MDPP services would allow time for organizations to enroll in Medicare before they begin furnishing and billing for MDPP services.
In the CY 2017 PFS final rule (81 FR 80459), we described a possible payment structure for MDPP services, but deferred full development of the payment structure to future rulemaking. In section III.K.2.d. of this final rule, we discuss our payment structure for MDPP services. This finalized payment structure took into consideration the significant number of public comments we received in response to the possible payment structure we described in the CY 2017 PFS proposed rule, as well as comments received on the CY 2018 PFS proposed rule. We also proposed payment policies for instances in which an MDPP beneficiary switches MDPP suppliers in the CY 2018 PFS proposed rule.
In the CY 2017 PFS final rule (81 FR 80471 through 80474), we required CDC-recognized organizations that will bill Medicare for MDPP services to enroll in Medicare as MDPP suppliers. We also finalized the requirements for coaches furnishing MDPP services. We finalized policies regarding CDC Diabetes Prevention Recognition Program (DPRP) full recognition for MDPP suppliers and we indicated an intention to propose policies in future rulemaking regarding whether a DPP organization without full CDC recognition could enroll as an MDPP supplier. We are finalizing an interim MDPP preliminary recognition standard in section III.K.2.e. of this final rule. Also, in this section of this final rule, we are finalizing revisions to the supplier eligibility and enrollment requirements, including establishment of standards and implementation of appropriate program integrity safeguards. In section III.K.2.f. of this final rule, we are finalizing policies related to MDPP beneficiary engagement incentives furnished by MDPP suppliers.
In the CY 2017 PFS final rule (81 FR 80459), we deferred establishing policies related to organizations delivering “virtual” DPP services, where services are not furnished in person. In section III.K.3. of this final rule, we explain that the MDPP expanded model covers in-person MDPP services (other than ad hoc virtual make-up sessions discussed in section III.K.2.c.iv.(3) of this final rule), and thus, explain why we are not currently finalizing any policies related to MDPP services furnished 100 percent virtually and state that we are considering a separate model under CMS's Innovation Center authority to test and evaluate virtual DPP services.
In the CY 2017 PFS final rule, we established at § 410.79(a) that MDPP services would be available on January 1, 2018. In the CY 2018 PFS proposed rule, we proposed to change § 410.79(a) to state that MDPP services would be available on April 1, 2018. We proposed this change because we want to ensure that MDPP suppliers have sufficient time to enroll in Medicare after the effective date of the CY 2018 PFS final rule.
Therefore, beneficiaries will not be able to receive MDPP services immediately on January 1, 2018 due to the time needed for supplier enrollment. For this reason, we proposed April 1, 2018 as the expanded model start date, which we believe allows a sufficient
The following is a summary of the public comments received on this new proposed expanded model start date and whether 90 days is a sufficient amount of time for organizations to enroll in Medicare and prepare to furnish and bill for MDPP services and our responses:
One commenter expressed concerns about delaying the availability of the services until April and recommended CMS keep the implementation date of January 1, 2018. The commenter stated that because the MDPP was first discussed in the 2017 rulemaking cycle and CMS had finalized a January 1, 2018 start date, CMS and suppliers alike had ample time to plan, enroll, and prepare to operationalize this program. The commenter suggested CMS work with speed and efficiency to make these services available on January 1, 2018, as the agency had previously finalized given the obesity and diabetes prevalence in the United States.
A few commenters suggested CMS delay the model start date beyond April 1, 2018, including several requests to delay until January 1, 2019. Most of the commenters stated the delay was necessary to allow Medicare Advantage (MA) organizations sufficient time to contract with MDPP suppliers thereby ensuring adequate coverage for their members. One commenter suggested delaying the start date to July 1st or October 1st 2018 to allow additional time for suppliers to be trained and in place when the service becomes available to Medicare beneficiaries.
After considering the public comments, we are finalizing, at § 410.79(a), the policy as proposed with an effective date of April 1, 2018 for furnishing MDPP services. Based on the many comments received in support of the proposed date, we believe the 90-day period will allow eligible organizations adequate time to enroll in Medicare as MDPP suppliers and furnish the services to eligible beneficiaries beginning April 1, 2018.
In the CY 2017 PFS final rule, we established the parameters of MDPP services. The policies and terms in this final rule seek to clarify, build on, and at times change these previously finalized policies. In particular, we proposed to refine and add terms related to the different aspects of “MDPP services.” In the CY 2018 PFS proposed rule, we proposed to refine the term “MDPP services” to refer to structured health behavior change sessions that are furnished under the MDPP expanded model with the goal of preventing diabetes among Medicare beneficiaries with prediabetes, and that follow a CDC-approved curriculum (§ 410.79(b)). The sessions provide practical training in long-term dietary change, increased physical activity, and problem-solving strategies for overcoming challenges to maintaining weight loss and a healthy lifestyle.
In the preamble to the CY 2017 PFS final rule, we referenced the set of MDPP services covered under the expanded model as the “MDPP benefit.” In the CY 2018 PFS proposed rule, we proposed to update this terminology. In cases where we would have previously referred to the term “benefit” to describe the entire set of MDPP sessions covered under the MDPP model, we proposed to use the phrase “set of MDPP services.” “Set of MDPP services” means the series of MDPP sessions, composed of core sessions, core maintenance sessions, and ongoing maintenance sessions, offered over the course of the MDPP services period (proposed § 410.79(b)).
In cases where we would have previously used the term “benefit” to describe a period of time, we proposed to refer to the “MDPP services period.” The MDPP services period means the time period, beginning on the date an MDPP beneficiary attends his or her first core session, over which the set of MDPP services is furnished to the MDPP beneficiary, to include the core services period described in § 410.79(c)(2)(i) and, subject to § 410.79(c)(3), one or more ongoing maintenance session intervals during the ongoing services period described in § 410.79(c)(2)(ii) (§ 410.79(b)). The duration of the MDPP services period is discussed further in section III.K.2.c.iv. of this final rule. As noted throughout this section, the term “benefit” would no longer be used. We proposed to remove the term “MDPP core benefit” from the list of definitions.
In the CY 2017 PFS final rule, we included a definition for “core sessions” that referred to the set of core sessions covered under the MDPP expanded model. We proposed to revise the definition for “core sessions,” and instead define the singular “core session” as an MDPP service that is furnished by an MDPP supplier to an MDPP beneficiary during months 1 through 6 of the MDPP services period, is approximately 1 hour in length, and adheres to a CDC-approved DPP curriculum for core sessions (§ 410.79(b)). We believe that having a definition for the individual core session would be more uniform with other MDPP definitions, which are defined in the singular form. We proposed to revise the definition of “core maintenance session” as an MDPP service that is furnished by an MDPP supplier to an MDPP beneficiary during a core maintenance session interval, is approximately 1 hour in length, and adheres to a CDC-approved DPP curriculum for maintenance sessions (under § 410.79(b)).
We proposed to revise the definition of an “ongoing maintenance session” as an MDPP service that is furnished by an MDPP supplier to an MDPP beneficiary during an ongoing maintenance session interval; is approximately 1 hour in length and adheres to a CDC-approved DPP curriculum for maintenance sessions (§ 410.79(b)). The time period over which MDPP suppliers offer ongoing maintenance sessions, which differs from our previously finalized policy, is discussed in section III.K.2.b.i. of this final rule.
We proposed to add a definition for “MDPP session,” which means a core session, a core maintenance session, or
We invited public comments on these proposals.
The following is a summary of the public comments received on these proposals and our responses:
We also decline to adopt commenters' recommendation to permit MA plans flexibility in providing MDPP services so long as the curriculum is similar to the CDC DPRP curriculum described at § 410.79(b) as we believe adequate flexibility is already available to any MDPP supplier. As finalized in this final rule, MDPP services must meet the definition established at § 410.79(b) defining MDPP services as “structured health behavior change sessions that are furnished under the MDPP expanded model with the goal of preventing diabetes among Medicare beneficiaries with prediabetes, and that follow a CDC-approved curriculum. The sessions provide practical training in long-term dietary change, increased physical activity, and problem solving strategies for overcoming challenges to maintaining weight loss and a healthy lifestyle.” We also finalized in the CY 2017 PFS final rule that MDPP suppliers may, consistent with their CDC DPRP recognition, use either the CDC-preferred curriculum as designated by the CDC DPRP Standards or an alternative curriculum approved for use in DPP by the CDC (81 CFR 80467). The CDC preferred curriculum is available at
After considering the public comments, we will finalize all definitions as proposed with the exception of the MDPP Services Period. In response to public comments, we are finalizing the definition of the MDPP Services Period as consisting of a core services period of 1 year and an ongoing maintenance services period of 1 year at (§ 410.79(c)(2)).
In the CY 2017 PFS final rule, we finalized that “MDPP eligible beneficiaries” (a term we proposed to remove and replace with “MDPP beneficiary,” as described further in section III.K.2.c. of this final rule) would have Medicare coverage for ongoing maintenance sessions for an unspecified length of time, provided that they maintained the required minimum weight loss, which is 5 percent weight loss from baseline. Based on public comments indicating the limited administrative and operational capability of many MDPP suppliers to provide ongoing maintenance sessions for an individual indefinitely (81 FR 80467), we stated our intent to propose a limit on the number or duration of ongoing maintenance sessions to be covered in the set of MDPP services in future rulemaking.
In the CY 2018 PFS proposed rule, we proposed a 2-year limit on Medicare coverage for ongoing maintenance sessions (§ 410.79(c)(2)(ii)). The CMS Chief Actuary noted in the certification of the expansion of the DPP model test that continued participation in a DPP after 3 years has generally been untested. In addition, a DPP clinical trial conducted by the National Institutes of Health from 1996 to 2001 followed participants in a DPP for 3 years and found that, at the end of the study, diabetes incidence was reduced by 58 percent in the group that received a DPP lifestyle intervention when compared to the placebo group.
We considered alternatives to this proposal, such as limiting Medicare coverage for ongoing maintenance sessions to 1 year, which would limit the total MDPP services period to 2 years. Because the CDC DPRP does not require organizations to offer ongoing maintenance sessions, we also considered not covering ongoing maintenance sessions at all, which would limit the total MDPP services period to 1 year. However, we believe that beneficiaries can benefit from maintenance sessions beyond the 6 months of core maintenance sessions because weight loss is difficult to achieve and can be even more difficult to sustain. We believe that the behavior changes necessary to sustain weight loss will be more deeply ingrained through beneficiary participation in ongoing maintenance sessions. Existing evidence
We did not consider alternatives that would extend Medicare coverage for ongoing maintenance sessions beyond 2 years, and therefore, create an MDPP services period that would last longer than 3 years. Therefore, we proposed to continue to include ongoing maintenance sessions, but with a limit of up to 2 years. As stated earlier, we believe there is not enough evidence available to support the effectiveness of participation in a DPP beyond 3 years. We also believe, based on public comments received in response to the CY 2017 PFS proposed rule, that many suppliers have limited administrative and operational capacity to offer MDPP ongoing maintenance sessions indefinitely to all MDPP beneficiaries who maintain eligibility. As noted in section III.K.2.e.iv.4 of this final rule, an example of a capacity limit could include a situation where an MDPP supplier has met its class size maximum and therefore could not accept additional beneficiaries. We invited public comments on our proposal and the alternatives we considered.
The following is a summary of the public comments received on our proposal and the alternatives we considered and our responses:
In addition, we appreciate the commenters who pointed out that the absence of new curriculum for ongoing maintenance sessions posed a significant threat to the continued engagement of beneficiaries for a full 24 months. We agree with the assertion made by commenters that the core maintenance curriculum could become too repetitive during a second year of ongoing maintenance resulting in increasingly lower levels of participation among beneficiaries during later intervals. Based on the comments received on our proposals, we also better understand how this could contribute to dwindling enrollment during the ongoing maintenance years and how dwindling enrollment could create significant financial hardships for suppliers. We agree that it would be difficult and possibly economically unsustainable to secure space, staff coaches, and produce materials for classes that were not well attended due to a steady decrease in participants over the course of the ongoing maintenance period. From these comments, we believe finalizing a 2-year requirement for the ongoing services period could have a negative impact on the number of DPP organizations that choose to enroll as MDPP suppliers due to the estimated financial hardships of this requirement.
Therefore, we believe that a modification to our policy to require 1 year of ongoing maintenance following the core services period is both supported by current evidence and responds to the practical considerations of implementing MDPP services by MDPP suppliers.
After considering the public comments, we are finalizing the length of the MDPP Services Period as a 2-year MDPP services period, specifically finalizing that after year 1, suppliers of MDPP would have to offer 1 year of ongoing maintenance sessions to beneficiaries who continue to meet attendance/weight loss goals. Finalizing this alternate proposal reduces administrative burden and financial risk to suppliers while providing up to 1 year of additional support to beneficiaries. Based on our research and echoed by many of the public comments, we received in response to our CY2018 PFS proposed rule, we believe 12 months of ongoing maintenance should solidify the behavior change and help to ensure that weight loss outcomes are sustained.
At § 410.79(b), we proposed to remove the existing definition of “maintenance session bundle,” and to establish new definitions for “core maintenance session interval,” and “ongoing maintenance session interval,” which we believe will more directly reflect the structure of the set of MDPP services, as well as support the policies in this final rule. Through these definition changes, we were seeking to clarify the differences between the two types of intervals. We proposed to define “core maintenance session interval” as one of the two consecutive 3-month time periods during months 7 through 12 of the MDPP services period, during which an MDPP supplier offers an MDPP beneficiary at least 1 core maintenance session per month. We proposed to define “ongoing maintenance session interval” as one of the up to eight consecutive 3-month time periods during the ongoing services period described in § 410.79(c)(2)(ii), during which an MDPP supplier offers at least 1 ongoing maintenance session to an MDPP beneficiary per month.
We made the proposal to use the term “interval” instead of “bundle” because the performance payments are tied to attendance and weight loss performance goals and, in aggregate, constitute the payment to MDPP suppliers for furnishing MDPP services during the MDPP services period, but they do not provide specific payments for a particular subset of sessions. Therefore, we believe that the term “bundle” is not appropriate for describing performance payments for these time intervals. The new terms would allow us to more appropriately describe the relationship of the performance payments to the specific time periods where performance is measured. Furthermore, we proposed to define “make-up session” as a core session, a core maintenance session, or an ongoing maintenance session furnished to an MDPP beneficiary when the MDPP beneficiary misses a regularly scheduled core session, core maintenance session, or ongoing maintenance session (§ 410.79(b)). We proposed to define “virtual make-up session” as a make-up session that is not furnished in person and that is furnished in a manner consistent with the DPRP standards for virtual sessions (§ 410.79(b)). Policies describing the parameters of make-up sessions and virtual make-up sessions are described further in section III.K.2.c.iv.(3) of this final rule.
We proposed an additional term that helps describe key aspects of the MDPP expanded model: “performance goal.” This term refers to an attendance or weight loss goal that an MDPP beneficiary must achieve during the MDPP services period for an MDPP supplier to be paid a performance payment (§ 414.84(a)). Because we proposed this term that more broadly speaks to the performance goals of this expanded model, we proposed to remove the definition of “maintenance of weight loss.” We also proposed to move the definition of “coach” from § 410.79(b) to § 424.205(a) (we proposed in section III.K.2.e to redesignate § 424.59, Requirements for Medicare Diabetes Prevention Program suppliers to § 424.205). We proposed to revise the definition of “MDPP supplier” to mean an entity that is enrolled in Medicare to furnish MDPP services as provided in § 424.59 (redesignated as § 424.205).
We did not receive comments on the proposed revisions to these definitions, and therefore, we are finalizing these revisions as proposed with the exception of the definition for “ongoing maintenance session interval.” In order to align with the finalization of the
In the CY 2017 PFS final rule, we established the eligibility criteria for Medicare beneficiaries to have coverage of the set of MDPP services, codified at § 410.79(c)(1) and (d), respectively. We previously finalized that an individual who met these criteria would be referred as an “MDPP eligible beneficiary.” However, in the CY 2018 PFS proposed rule, we proposed to remove this term, and instead, add the definition of “MDPP beneficiary” to mean a Medicare beneficiary who meets the criteria specified in § 410.79(c)(1)(i), who has initiated the MDPP services period by attending the first core session, and for whom the MDPP services period has not ended as specified in § 410.79(c)(3) (§ 410.79(b)). We believe that this revised definition will provide more clarity about when a beneficiary qualifies to receive MDPP services. We proposed to remove the definition of “MDPP eligible beneficiary” to avoid confusion between the two definitions, and we proposed conforming changes to § 410.79 to remove the term “MDPP eligible beneficiary” and use the term “MDPP beneficiary” in its place, where appropriate.
In the CY 2017 PFS final rule (81 FR 80470), we specified at § 410.79(c)(1) that Medicare beneficiaries are eligible for MDPP services if they meet all of the following criteria:
• Are enrolled in Medicare Part B.
• Have, as of the date of attendance at the first core session, a body mass index (BMI) of at least 25 if not self-identified as Asian or a BMI of at least 23 if self-identified as Asian (please see our discussion of BMI parameters in the CY 2017 PFS final rule at 81 FR 80468).
• Have, within the 12 months prior to attending the first core session, a hemoglobin A1c test with a value between 5.7 and 6.4 percent, a fasting plasma glucose of 110-125 mg/dL, or a 2-hour plasma glucose of 140-199 mg/dL (oral glucose tolerance test).
• Have no previous diagnosis of type 1 or type 2 diabetes (other than gestational diabetes).
• Do not have end-stage renal disease (ESRD).
In the CY 2018 PFS proposed rule, we proposed changes to these eligibility criteria at § 410.79(c)(1) to clarify the eligibility limitations related to previous type 1 or type 2 diabetes diagnosis (described further in section III.K.2.c.ii. of this final rule), move and edit the regulation text that specifies that each beneficiary can only receive the set of MDPP services once in their lifetime (described further in section III.K.2.c.iii. of this final rule), and make changes so that the provisions are specific to an individual beneficiary. We also clarify some of the eligibility criteria.
MedPAC opposed the policy of multiple referral pathways, preferring instead that only a clinician referral be allowed, and required, for each MDPP beneficiary. MedPAC noted that clinician referrals would help ensure clinical appropriateness of MDPP services or integration with other medical services and health maintenance goals. They were also concerned that multiple referral pathways would assist in leading to broad expansion of MDPP services and up-take, far beyond the population for which it is appropriate. MedPAC offered the example of an MDPP supplier conducting an MDPP session for a large group of beneficiaries at a nursing home, without consideration of whether a general weight loss target is clinically appropriate for each beneficiary in that group. Other commenters noted that there was no mention in the proposed rule of a provider referral mechanism or reimbursement, and recommended creating patient referral codes.
We acknowledge the concerns from MedPAC regarding uptake of MDPP services beyond the population for which it is appropriate. We believe the requirement for MDPP suppliers to maintain CDC preliminary or full recognition will provide some level quality assurance. Specifically, maintenance of CDC recognition will require MDPP suppliers to continue to achieve performance standards based on attendance and average weight loss among participants. If an MDPP supplier chose to enroll large numbers of individuals who were clinically inappropriate for MDPP (for example, who lack the cognitive capability to implement the behavior changes), these practices may drive down their average performance data, and negatively affect the supplier's ability to maintain CDC recognition. Nevertheless, we are establishing monitoring mechanisms such that if a supplier was offering MDPP services to large numbers beneficiaries for whom the services may not be appropriate, we could identify this supplier and take appropriate administrative action.
In response to commenter's request to require physician referrals for MDPP services, we note that previous MDPP guidance, the CY 2017 PFS final rule, intentionally does not include a requirement for a physician referral to be eligible for coverage. In that rule, we finalized that we would not require any specific type of referral for the MDPP expanded model test in order to ensure broad program access (81 CFR 80471). In finalizing this policy, we noted that we understood the value of coordinating results from the MDPP with a beneficiary's primary care provider, however, we declined to require this type of coordination because we believe it creates an additional burden for this new supplier type that will discourage DPP organizations from enrolling in Medicare as MDPP suppliers. Furthermore, regarding commenter's request to allow MA plans to arrange for MDPP services as deemed appropriately by the plan, we understand the commenter to be requesting that MA plans be permitted to arrange for MDPP services as deemed medically necessary by the plan, as is the current standard. While general coverage guidelines included in original Medicare manuals and instructions may permit MAOs to arrange for other Parts A and B services as deemed medically necessary by the plan, in the CY 2017 final rule (81 CFR 80468 through 80470) and in this section of this final rule we explicitly designate a set of criteria for determining eligibility for MDPP services. Therefore, to ensure access to MDPP services as a Medicare covered service is consistent with coverage available in Original Medicare, we decline to permit MA plans to modify the eligibility requirements established in this final rule when determining the eligibility of a plan enrollee for coverage of MDPP services.
As we did not propose any substantive changes to the beneficiary eligibility policies, including referral pathways and blood test documentation, we are not finalizing any changes to these policies.
In the CY 2018 PFS proposed rule (82 FR 34133), we noted that we are not excluding beneficiaries with a prior history of gestational diabetes from eligibility for MDPP services, while beneficiaries with a prior history of a diagnosis of type 1 or type 2 diabetes are ineligible. The eligibility criteria are intended to identify a beneficiary at high risk for the development of type 2 diabetes in an individual that has not been diagnosed with type 1 or type 2 diabetes. Gestational diabetes is a condition that develops during pregnancy and typically resolves after delivery, although an individual with a history of gestational diabetes is at increased risk of subsequent type 2 diabetes development and may benefit from the set of MDPP services. Because of the clinical differences between gestational diabetes and type 1 or type 2 diabetes, we determined that it was appropriate not to exclude a beneficiary with a prior history of gestational diabetes from eligibility for MDPP services.
We also proposed (82 FR 34133) that a beneficiary who is diagnosed with ESRD after having begun receiving MDPP services would lose eligibility. We do not believe MDPP services are appropriate for beneficiaries with ESRD because beneficiaries with ESRD require dialysis, and the nutrition requirements for individuals on dialysis are very specific and therefore the MDPP curriculum will not apply.
In summary, we noted that a beneficiary must maintain Medicare Part B coverage and not have ESRD throughout the duration of the MDPP services period to remain eligible to receive coverage for MDPP services. In conjunction with our proposal in the proposed rule related to diabetes diagnosis (explained further in section III.K.2.c.ii. of this final rule), we noted that a beneficiary must meet the eligibility requirements related to prediabetes and diabetes (including BMI, blood test results, and no diagnosis of diabetes other than gestational diabetes) as of the date of attendance at the first core session.
We invited public comments on these clarifications. The following is a summary of the public comments received on these clarifications and our responses:
In response to the commenter who noted a discrepancy in eligibility criteria between CDC and CMS regarding individuals with a previous diagnosis of gestational diabetes, we believe that the commenter was mistaken. CDC has always allowed women with a previous diagnosis of gestational diabetes to participate in the National DPP. If a woman has a previous diagnosis of gestational diabetes and meets the BMI and age criteria, she is eligible for the National DPP and would not need a blood test or an elevated risk test score.
We also note that the DPRP Standards allow women who become pregnant and develop gestational diabetes to continue participation in the national DPP. Similarly, we clarify if a Medicare beneficiary becomes pregnant and develops gestational diabetes while receiving MDPP services, that beneficiary may continue participation in MDPP (as long as the beneficiary continues to meet the applicable performance goals required for eligibility). We encourage commenters to look to the final 2018 DPRP Standards, when available, for any updated information on how gestational diabetes is treated for the purposes of CDC performance data reporting.
Because we did not propose any policies, we are not making any modifications to the beneficiary eligibility criteria related to gestational diabetes and ESRD, at § 410.79(c)(1)(i)(E) and (c)(1)(i)(F), respectively.
In the CY 2017 PFS final rule, we finalized at § 410.79(c)(1) that to be eligible for coverage for the set of MDPP services, a Medicare beneficiary must have prediabetes, as shown through a qualifying BMI and blood test results, and must have no previous diagnosis of type 1 or type 2 diabetes (other than gestational diabetes). We received public comments in response to the CY 2017 PFS proposed rule that asked whether a beneficiary would remain eligible for the set of MDPP services if the beneficiary developed type 2 diabetes during the MDPP services period. In the CY 2017 PFS final rule, we deferred action in response to these public comments and are now addressing them in this final rule.
We proposed in the CY 2018 PFS proposed rule (82 FR 34133 through 34134) that the diabetes diagnosis exclusion applies only at the time of the first core session (that is, if a beneficiary develops diabetes during the MDPP services period, it would not affect the beneficiary's eligibility to continue receiving MDPP services). Specifically, we proposed to revise the eligibility requirements for MDPP services to state that a beneficiary has, as of the date of attendance at the first core session, no previous diagnosis of diabetes, other than gestational diabetes (§ 410.79(c)(1)(i)(E)). This policy proposed was based in part on the fact that the DPP model test, which demonstrated cost savings, did not exclude from the model individuals
Alternatively, we considered deeming any beneficiary who develops diabetes during the MDPP services period to be ineligible to continue to receive coverage for MDPP services because these services are intended to be preventive. If a beneficiary progresses to type 2 diabetes, other treatment options, such as Diabetes Self-Management Training (DSMT), may be more appropriate than services that seek to prevent a condition the beneficiary already has. However, it is important to note that the receipt of MDPP services does not preclude a beneficiary from accessing other treatments for diabetes during the time period that the beneficiary is covered for MDPP services. An MDPP beneficiary who ultimately also receives DSMT at some time during the MDPP services period because he or she develops diabetes after beginning the set of MDPP services will receive different types of information and training. For example, a beneficiary receiving DSMT furnished by certified diabetes educators acquires knowledge for self-care and life style changes including blood sugar monitoring, insulin usage, medication management, and crisis management. In contrast, MDPP services will be furnished by trained coaches who teach beneficiaries with prediabetes how to lower their risk of progressing to type 2 diabetes with methods that do not include medication or other interventions for beneficiaries diagnosed with diabetes. Despite some common elements, the interventions for the MDPP expanded model and the DSMT benefit target different populations and furnish different services.
We sought public comments on our proposal and whether individuals who develop type 2 diabetes during the MDPP services period should continue to be eligible for coverage of MDPP services for the full duration of the MDPP services period.
The following is a summary of the public comments received on the proposal that if a beneficiary develops type 2 diabetes during the MDPP services period, it would not affect the beneficiary's eligibility to continue receiving MDPP services and our responses:
In response to the comments, we are finalizing our proposal, without modification, that the diabetes diagnosis exclusion applies only as of the date of attendance at the first core session, (that is, if a beneficiary develops diabetes during the MDPP services period, it would not affect the beneficiary's eligibility to continue receiving MDPP services) at § 410.79(c)(1)(i)(E).
In the CY 2017 PFS final rule, we specified that coverage for the set of core MDPP services is available only once per lifetime for each MDPP beneficiary (codified at § 410.79(d)(1)). In the CY 2018 PFS proposed rule, we proposed to delete § 410.79(d)(1) and move this provision to § 410.79(c)(1)(i)(B) to place it with other MDPP beneficiary eligibility criteria. We also proposed to edit this provision to specify that coverage for the full set of MDPP services, inclusive of ongoing maintenance sessions as opposed to only core MDPP services, is available only once per lifetime per MDPP beneficiary (82 FR 34134). Since we had proposed to limit the ongoing services period to 2 years (which we are finalizing as 1 year), we believed that this revision is necessary to clarify that coverage for the entire set of MDPP services is subject to this limitation—otherwise, the once-per-lifetime limitation has no practical effect because an MDPP beneficiary could continue to attend ongoing maintenance sessions long after the MDPP beneficiary has completed the core services period. In addition, for the reasons stated previously, we do not have evidence to support coverage of MDPP services for more than 3 years. We also are clarifying that the once-per-lifetime coverage limit applies to a beneficiary who receives a set of MDPP services under the MDPP model expansion. This limitation would not apply to beneficiaries who participated in a DPP as part of the DPP model test unless they receive the set of MDPP services under the MDPP expanded model. We invited public comments on our proposal.
The following is a summary of the public comments received on the proposed provision that coverage for the full set of MDPP services, inclusive of ongoing maintenance sessions as opposed to only core MDPP services, is available only once-per-lifetime per MDPP beneficiary and our responses:
Some commenters recommended that beneficiaries be allowed to re-enroll in MDPP services. Others recommended providing exceptions to the once-per lifetime limit in the case of a major life event, allowing a 6- to 12-month waiting period for a beneficiary to re-enroll in MDPP after stopping (similar to Medicare's obesity counseling benefit), or both approaches. One commenter recommended that CMS allow MDPP beneficiaries to participate in an introductory session where beneficiaries can learn the requirements of the program and coaches can assess a beneficiary's readiness for change before initiating core sessions. The commenter recommended that CMS allow a beneficiary the opportunity to withdraw within 30 days from the start of the core services period without triggering the once-per-lifetime limitation so that those MDPP beneficiaries who may not be ready to complete the program may withdraw from MDPP and participate at a later time. Another commenter suggested that CMS and CDC identify and encourage the use of a validated “readiness to change” assessment instrument and a “life stress” assessment instrument to engage beneficiaries in a shared decision-making process so that individuals commit to the MDPP at a time they are most likely to succeed in the program. Some commenters also encouraged CMS to study the effect of allowing beneficiaries to enroll in the program multiple times.
In finalizing the once-per-lifetime limitation on MDPP services in the CY 2017 PFS final rule, we added in flexibility for beneficiaries by not including any attendance requirements for beneficiary eligibility in the first year of core services following the first core session. Therefore, beneficiaries can attend as many or as few sessions as the beneficiary wishes in the first year, and as long as they meet the 5 percent weight loss goal in months 10-12, they are eligible for ongoing maintenance sessions. If an unexpected or life-altering event does occur during the core services period, the beneficiary is not required to attend a certain number of sessions. The beneficiary can take a break and begin attending MDPP sessions again within the first year. The beneficiary could also still be eligible for ongoing maintenance sessions, as long as the beneficiary begins attending sessions again and meets the 5 percent weight loss goal in months 10-12. Additionally, in this rule, we are finalizing the ability for beneficiaries to attend in-person or virtual make-up sessions if they miss a regularly scheduled session. We believe that these policies provide flexibility for beneficiaries who experience difficulty
We appreciate the comments received recommending the allowance of an introductory session and 30-day window to withdraw, as well as the use of an assessment tool to assess if the beneficiary is ready to start MDPP services, so that the beneficiary can understand the eligibility requirements and determine if he or she is ready to begin. We note that suppliers may speak to beneficiaries about their readiness while assessing them for eligibility or before the beneficiary begins MDPP services. This could include the use of any tools that the supplier may have to help a beneficiary make their own determination about whether to commit to the MDPP services period or not. However, MDPP suppliers may not use these tools to screen beneficiaries for their perceived ability to successfully complete the MDPP performance goals. Selecting beneficiaries based on these purposes would not comply with the MDPP supplier standard proposed (and which we are finalizing) in § 424.205(d)(8), which prohibits an MDPP supplier from denying an MDPP beneficiary access to MDPP services during the MDPP services period, including on the basis of the beneficiary's weight, health status, or achievement of performance goals, with few exceptions. We also note that in § 424.205(d)(11), which we are finalizing in this final rule, the supplier standards require MDPP suppliers to provide an MDPP beneficiary information about the MDPP set of services prior to beginning furnishing such services. This information must include eligibility requirements throughout the MDPP services period, including the once-per-lifetime limitation. We believe that this information will supply the beneficiary with the necessary information to make an informed decision on whether to begin MDPP services.
We acknowledge commenters' concerns on life altering events precluding a beneficiary's participation and understand that there will be circumstances that preclude an individual from participating. As stated previously, we believe the ability for a beneficiary to attend in-person and virtual make up sessions could assist in some of these circumstances. Additionally, because only 2.4 percent of participants in the DPP model test re-enrolled in the model while the model test was still active, we believe that the number of beneficiaries requesting to re-enroll in MDPP will be quite small. However, we plan to monitor the once-per-lifetime limitation to consider whether an exceptions policy for beneficiaries who experience life-altering events is necessary, and if appropriate, we will address this issue in future rulemaking.
In the CY 2017 PFS final rule, we stated that beneficiaries could self-report to MDPP suppliers that they had not previously received MDPP services. We recognize that self-reported information may not be the most reliable source for MDPP suppliers to use before submitting claims for MDPP beneficiaries, and there is a risk that information that is inaccurately self-reported could result in the denial of payments for MDPP services. In the CY 2018 PFS proposed rule, we noted that we were considering ways MDPP suppliers would be able to reliably verify if a beneficiary has received MDPP services from another supplier, such as through a standardized tracker (82 FR 34134), and we sought public comments on any additional ways MDPP suppliers could access this information. We noted that we intend to provide administrative guidance on any resources to assist MDPP suppliers in identifying beneficiaries' previous receipt of covered MDPP sessions, as appropriate.
The following is a summary of the public comments received on ways that MDPP suppliers can reliably verify if a beneficiary has received coverage of MDPP services from another supplier and our responses:
Some commenters requested that CMS document whether an individual has previously received MDPP services, and make this information available to MDPP suppliers to check a beneficiary's previous MDPP service use, at the federal level. One commenter suggested that CMS could build a beneficiary-level database that would contain information about MDPP status. The database could include the beneficiary's first name, last name, and birthdate so that MDPP suppliers could look up a beneficiary based on those three variables in order to identify his or her eligibility and program status based on time-to-date and MDPP sessions already furnished in the MDPP services period. The commenter recommended against the use of social security numbers in this context, due to data security concerns. For looking up beneficiaries where those three pieces of information identify multiple individuals, the commenter suggested that a hotline could be set up and MDPP suppliers could call in to verify eligibility of a specific beneficiary for MDPP services. Another commenter similarly recommended building a master database for MDPP suppliers to use to verify MDPP use, and that CMS permit self-reporting until such a database exists. One commenter noted that CMS could consider leveraging state and local health information exchanges, where they exist, to transfer beneficiary information on MDPP service use.
Commenters were divided on CMS designing a paper tracker, such as the one mentioned in the CY 2018 PFS proposed rule, that beneficiaries could take with them to a new supplier to share information. One commenter recommended that CMS develop such a tracker to assist in data sharing between MDPP suppliers. However, this commenter also noted that for potential, small, and new DPP suppliers that typically have limited staff, the administrative processes involved with such a tracker may be burdensome. Another commenter raised concerns about such a tracker, noting that beneficiaries could lose their trackers and possibly modify results.
We agree that a beneficiary-level data system could provide a useful way for MDPP suppliers to check whether an MDPP beneficiary had previously received MDPP services both before a beneficiary starts receiving MDPP services and when an MDPP beneficiary switches MDPP suppliers. When we considered creating such a data system, we recognized that it would need to contain data beyond what we will receive in claims data (such as baseline weight), and therefore, would require that MDPP suppliers continuously submit updated beneficiary information to us to populate the system. We believe
Given these various stakeholder views and our considerations about what a data system would entail, we believe that creating an additional data system for MDPP suppliers to verify beneficiary eligibility would be inconsistent with commenters' general requests for fewer, rather than additional, data submission requirements (please see more information at III.K.2.d.v of this final rule). Thus, we do not intend on creating a beneficiary-level data system at this time. Instead, we are exploring an electronic mechanism using claims data and existing CMS systems that MDPP suppliers could access to verify beneficiaries' prior receipt of MDPP services and plan to provide additional information on this mechanism in future guidance, as appropriate. In addition, we are still considering developing a paper tracker that an MDPP beneficiary can take with them between suppliers to prevent disruption in MDPP services. However, as described in section III.K.2.d.v of this final rule, a supplier accepting a new beneficiary in the middle of his or her services period would need to obtain the beneficiary's previous MDPP records to verify data such as baseline weight or weight loss from baseline that is necessary before the new supplier could submit any performance payments. Obtaining this documentation would be necessary to satisfy the MDPP supplier requirement at § 424.205(g) that an MDPP supplier shall maintain documentation that includes services furnished and body weight measurements.
After consideration of the public comments, we are finalizing the once-per-lifetime limitation on MDPP services as proposed at § 410.79(c)(1)(i)(B). However, we plan to monitor this policy to consider whether an exceptions policy for beneficiaries who experience life-altering events is necessary, and if appropriate, we will address this issue in future rulemaking. We did not make any proposals regarding ways that MDPP suppliers can reliably verify if a beneficiary has received coverage of MDPP services from another supplier, and intend to release future guidance on this, as appropriate.
In the CY 2017 PFS final rule, we specified the minimum number and frequency of sessions that MPP suppliers must offer to MDPP beneficiaries (codified at § 410.79(c)(2)(i) and (c)(2)(ii)). We finalized that MDPP suppliers must furnish ongoing maintenance session intervals to MDPP eligible beneficiaries who have maintained 5 percent weight loss from their baseline weight as measured during the previous maintenance session interval. As defined at § 410.79(b), “baseline weight” is the MDPP beneficiary's body weight recorded during that beneficiary's first core session.
However, because in the CY 2018 PFS proposed rule, we proposed to tie payment for MDPP services to the beneficiary's achievement of performance goals, we proposed additional changes to tie the beneficiary's eligibility for continued coverage of ongoing maintenance
As discussed in section III.K.2.b. of this final rule, we are revising § 410.79(c)(2), which describes MDPP services periods, to specify that the MDPP services period means the time period, beginning on the date an MDPP beneficiary attends his or her first core session, over which the set of MDPP services is furnished to the MDPP beneficiary, to include the core services period described in § 410.79(c)(2)(i) and, subject to § 410.79(c)(3), up to 4 ongoing maintenance session intervals during the ongoing services period described in § 410.79(c)(2)(ii).
We proposed to revise § 410.79(c)(2) to specify that there are 2 service periods in which Medicare will cover MDPP services for a beneficiary: The core services period; and the ongoing services period (82 FR 34134 through 34135). Together these would make up the MDPP services period. The core services period is the first 12 months of the MDPP services period, and consists of core sessions and core maintenance sessions. There are 16 core sessions that are offered at least a week apart in months 1 through 6, beginning on the date of attendance at the first core session. Core maintenance sessions are offered at least once per month in months 7 through 12 of the core services period. We proposed to move the requirements for MDPP suppliers to offer these services to § 424.205(d)(10) because they are more appropriately included among other requirements for MDPP suppliers. Consistent with our policies finalized in the CY 2017 PFS final rule, we do not condition coverage for the core services period upon weight loss or attendance. However, we note that an MDPP beneficiary must attend at least 1 core session to initiate the MDPP services period.
These proposals were consistent with CDC's 1-year curriculum, divided into two 6-month periods. We recognize that framing the MDPP services period in terms of months may cause some confusion because the CDC terminology uses weeks. However, we stated that we believe that framing the MDPP services period in months would better align with our payment structure. We did not make eligibility for the core maintenance sessions contingent upon an attendance-based performance goal; because the CDC DPP curriculum covers 12 months of sessions, we stated that we believe that coverage for the 12 months of the core services period should be available to all MDPP beneficiaries, regardless of attendance. The 12-month CDC DPP curriculum is based on evidence from the original DPP randomized clinical trial, and the curriculum used in that trial, which achieved a 58 percent reduction in type 2 diabetes risk (with 71 percent reduction in those over age 60).
As discussed in section III.K.2.e.iv.4 of this final rule, MDPP suppliers must offer a minimum of 16 core sessions, no more frequently than once each week, in months 1 through 6, and at least 1 core maintenance session each month in months 7 through 12 of the core services period. However, some MDPP suppliers may choose to furnish more than the minimum number of sessions, and these coverage parameters would allow beneficiaries to receive more than the minimum number of sessions if the MDPP supplier elects to furnish them.
We did not receive comments on the proposed description revisions for the MDPP services periods, and therefore, are finalizing these proposals at § 410.79(c)(2). However, we note that we are finalizing changes at § 410.79(c)(2) to reflect that we are finalizing shortening the ongoing services period from 2 years to 1 year. We are also finalizing the movement of requirements for MDPP suppliers to offer these services to § 424.205(d)(10) because they are more appropriately included among other requirements for MDPP suppliers.
As discussed in section III.K.2.b.i. of this final rule, we proposed at § 410.79(c)(2)(ii) that the ongoing services period consists of up to eight 3-month ongoing maintenance session intervals offered during months 13 through 36 of the MDPP services period; however, we are modifying this proposal to finalize that the ongoing services period consists of up to
Our existing regulations at § 410.79(b) state that Medicare will cover MDPP services in the first 12 months of the MDPP services period, without regard to a beneficiary's achievement of performance goals, whereas § 410.79(d)(2) specifies that, for coverage of ongoing maintenance sessions, the beneficiary must have achieved weight loss of 5 percent from his or her baseline weight. In the CY 2018 PFS proposed rule, we proposed to delete § 410.79(d)(2) and move this provision to § 410.79(c)(1) with other MDPP beneficiary eligibility criteria. We also proposed to add paragraph (c)(1)(ii) to § 410.79 to specify that beneficiaries must also attend at least one in-person core maintenance session in months 10 through 12 of the MDPP services period and achieve or maintain required minimum weight loss at a minimum of one in-person session during the final core maintenance session interval to be eligible for coverage of the first ongoing maintenance session interval. We proposed to establish that a beneficiary must attend at least one in-person core maintenance session in months 10 through 12 of the MDPP services period because, as stated in the CY 2017 PFS final rule, an MDPP beneficiary must achieve at least 5 percent weight loss from baseline at least once during the previous maintenance session interval to have coverage of an ongoing maintenance session.
Because we proposed that weight measurements used for determining beneficiary eligibility for coverage or supplier payment must be taken in person by an MDPP supplier at an MDPP core maintenance or ongoing maintenance session (§ 410.79(c)(1)(iv)), a beneficiary must attend at least one in-person core maintenance session during months 10 through 12 to have his or her weight measured to determine whether he or she qualifies for coverage of the first ongoing maintenance session interval. We believe that in-person measurements are the most feasible method for weight ascertainment at this time for services where the beneficiary would have regular in-person sessions with the MDPP supplier. We believe that self-reported weight loss is not reliable for the purposes of determining continued coverage of MDPP services for a beneficiary. We invited public comments on these proposals.
The following is a summary of the public comments received on eligibility for the ongoing services period and our responses:
After consideration of the comments received, we are finalizing the eligibility criteria for the ongoing services period as proposed at § 410.79(c)(1)(ii). We are also finalizing changes to the definition of “ongoing maintenance session interval” at § 410.79(b) to reflect shortening the ongoing services period from 2 years to 1 year.
In addition to achieving weight loss performance goals, as previously finalized in the CY 2017 PFS final rule § 410.79(d)(2) (now finalized at § 410.79(c)(1)(ii) and (c)(1)(iii)), we proposed that beneficiaries must also meet an attendance-related performance goal in order for Medicare to cover ongoing maintenance session intervals. We proposed to add paragraph (c)(1)(iii) to § 410.79 to specify that for coverage of ongoing maintenance session intervals 2 through 8, an MDPP beneficiary must attend at least three ongoing maintenance sessions during the previous ongoing maintenance session interval, at least one of which must be an in-person ongoing maintenance session to record an in-person weight measurement, in addition to maintaining 5 percent weight loss from baseline at least once during the previous ongoing maintenance session interval.
We believe that adding an attendance-related performance goal during the ongoing services period is important because it will provide an incentive to keep MDPP beneficiaries engaged after the core services period. MDPP beneficiaries who meet the specified attendance and weight loss goals will have Medicare coverage of ongoing maintenance sessions, which are a part of the set of MDPP services, but not a part of the CDC DPP curriculum. We believe that the subsequent attendance goal requirements during ongoing maintenance session intervals will motivate beneficiaries to take on more individual responsibility for their behavior changes over time because coverage of these services is dependent upon their attendance and achievement and maintenance of weight loss.
In addition, this policy closely aligns with our policy for supplier payment for ongoing maintenance session intervals. As described further in section III.K.2.d.iii.5. of this final rule, we proposed that a supplier would be paid for furnishing an ongoing maintenance session interval only if the MDPP beneficiary both attended three sessions, as well as maintained a 5 percent weight loss from baseline measured at least once in that interval. However, in light of our proposal to pay MDPP suppliers upon the beneficiary's attendance of three ongoing maintenance sessions (in addition to maintaining at least a 5 percent weight loss), we believe that we similarly need to have attendance goals for beneficiaries to continue to have coverage of ongoing maintenance sessions and mitigate the supplier's risk of providing services without payment. Without requiring attendance, an MDPP beneficiary who maintained 5 percent weight loss but only attended two ongoing maintenance sessions in an ongoing maintenance session interval would be eligible for coverage of ongoing maintenance sessions, but the supplier would not receive payment for furnishing that ongoing maintenance session interval. In effect, the MDPP supplier could be required to furnish up to 12 months (finalized in this final rule at § 410.79(c)(2)(ii)) of MDPP services without payment. For this reason, we proposed to require beneficiaries to attend all three sessions within an ongoing maintenance session interval to have coverage of the subsequent interval.
We considered an alternative where a beneficiary would have continued coverage of ongoing maintenance session intervals if he or she attends at least one in-person ongoing maintenance session during an ongoing maintenance session interval, as long as that beneficiary maintained at least 5 percent weight loss from baseline at least once during that interval. However, we do not believe that this alternative would align with our proposed supplier payment requirements for ongoing maintenance sessions discussed in section III.K.2.d.iii.5 of this final rule, which would require suppliers to furnish, and the beneficiary to attend, all three sessions of the ongoing maintenance session interval for the supplier to receive payment for that interval. We invited public comments on our proposal and the alternative we considered.
The following is a summary of the public comments received on our proposal to add attendance requirements for beneficiary eligibility for ongoing maintenance session intervals 2-8 and our responses:
Many commenters noted that requiring perfect attendance at ongoing maintenance sessions (that is, 3 out of 3 ongoing maintenance sessions per interval) places too much burden on beneficiaries. These commenters noted that requiring perfect attendance at ongoing maintenance sessions is an unrealistic expectation, given that certain life events, often beyond the beneficiary's control, could prevent the beneficiary from attending a session. These commenters noted that this fact, combined with the limited number of allowed virtual make-up sessions and the once-per-lifetime limitation on MDPP services, could limit beneficiary access to MDPP services. These factors have the potential to permanently disqualify the beneficiary from receiving additional MDPP services, even if the beneficiary maintained weight loss. Additionally, commenters noted that MDPP suppliers may need to offer additional ongoing maintenance
Commenters who provided this information on the challenge of having perfect attendance often recommended allowing beneficiaries to maintain eligibility if they attend 2 out of 3, rather than 3 out of 3, ongoing maintenance sessions per interval, in addition to maintaining 5 percent weight loss. Some commenters recommended that beneficiaries only be required to attend 1 out of 3 ongoing maintenance sessions per interval, in addition to maintaining 5 percent weight loss, to be eligible for the next interval.
We also understand based on comments that there could be scenarios in which attendance at an in-person monthly session may be challenging and impractical for a beneficiary, due to transportation barriers or some other life event, and if the supplier did not offer make-up sessions (because they are not required), the beneficiary could lose coverage for the next interval even if they are engaged and maintain weight loss. We also understand that if MDPP suppliers believe additional ongoing maintenance sessions beyond the monthly sessions are needed to ensure that beneficiaries meet attendance goals, this would be costly and potentially limit supplier participation. Although make-up sessions are an option for MDPP suppliers, we share the concern commenters raised about the potential burden placed on suppliers to make accommodations for beneficiaries who miss a session in order to maintain their eligibility.
Since the performance goals of the MDPP expanded model are more heavily weighted towards outcomes (that is, weight loss) than process measures (that is, attendance), and the specific outcome during the ongoing services period is maintenance of weight loss, which is required both for the ongoing maintenance session interval performance payment and coverage of the next ongoing maintenance session interval, we believe reducing the attendance requirements by 1 session allows sufficient flexibility to beneficiaries and suppliers without misattributing a beneficiary's maintenance of weight loss to other activities occurring outside of MDPP, during the ongoing services period. While in section III.K.2.d.iii.(3) of this final rule we describe our final policy which increases the attendance-based performance payment amounts for core sessions, we believe that placing more emphasis on weight loss maintenance, rather than attendance, during the ongoing services period maintains the integrity of the program while providing beneficiaries and suppliers more flexibility. We believe this modification will still provide an incentive to keep MDPP beneficiaries engaged after the core services period.
We note that we are aligning these eligibility requirements with our finalized payment structure, described more in section III.K.2.d.3 of this final rule. As discussed in section III.K.2.c.iv.2.b of the CY 2018 PFS proposed rule, we find it important to align attendance goals for beneficiaries to maintain eligibility for ongoing maintenance sessions with performance goals required for payment during ongoing maintenance sessions. Without requiring the same number of attendance goals, an MDPP beneficiary who maintained 5 percent weight loss but only attended two ongoing maintenance sessions in an ongoing maintenance session interval would be eligible for coverage of ongoing maintenance sessions, but the supplier would not receive payment for furnishing that ongoing maintenance session interval. In effect, the MDPP supplier could be required to furnish up to 12 months (finalized in this final rule at § 410.79(c)(2)(ii)) of MDPP services without payment. To alleviate this concern, we are aligning our finalized payment policies, described more in section III.K.2.d.3 of this final rule, to align with our finalized eligibility policies.
After consideration of the public comments, we are finalizing that an MDPP beneficiary must attend at least 2 ongoing maintenance sessions per ongoing maintenance session interval (and achieve a 5 percent weight loss during at least one in-person session during the interval) to be eligible for subsequent ongoing maintenance session interval after the first. This policy will be finalized at § 410.79(c)(1)(iii).
After consideration of the public comments, we are finalizing that an MDPP beneficiary must only attend 2 ongoing maintenance sessions per ongoing maintenance session interval (and maintain 5 percent weight loss during one in-person session) to be eligible for the next ongoing maintenance session interval. This policy will be finalized at § 410.79(c)(1)(iii).
In the CY 2018 PFS proposed rule, we proposed to add § 410.79(c)(3) to specify that coverage of the MDPP services period would end upon completion of the core services period for a beneficiary that is not eligible for the first ongoing maintenance session interval as proposed under § 410.79(c)(1)(ii); that is, if the beneficiary does not attend at least 1 in-person core maintenance session during the second core maintenance session interval and/or does not achieve the required minimum weight loss during this interval (82 FR 34136). For any beneficiary who is eligible for at least 1 ongoing maintenance sessions interval, but who does not meet the requirements for coverage of a subsequent interval based on failure to meet attendance or weight loss goals proposed at § 410.79(c)(1)(iii), the beneficiary's coverage of the set of MDPP services would end upon completion of his or her current ongoing maintenance session interval. It is important to note that performance payments, discussed in section III.K.2.d.iii.5. of this final rule, will be tied to the achievement of the same performance goals a beneficiary must meet to have coverage for the ongoing maintenance session intervals. Therefore, if an MDPP beneficiary does not meet weight loss or attendance goals to have coverage of the subsequent ongoing maintenance session interval, the supplier will not receive payment for that ongoing maintenance session interval or any subsequent performance payments related to that beneficiary.
We did not receive comments on our proposal to add specifications on when coverage of the MDPP services period ends, and therefore, are finalizing our policies as proposed at § 410.79(c)(3). We note that we are finalizing changes at § 410.79(c)(3) to reflect shortening the ongoing services period from 2 years to 1 year (so now there are only four intervals).
In the CY 2017 PFS final rule (81 FR 80470), we confirmed that a beneficiary may change MDPP suppliers at any time. However, we deferred to future rulemaking specific policies to address coverage of and payment for MDPP services when beneficiaries change MDPP suppliers. In the CY 2018 PFS proposed rule, we clarified that a beneficiary may change MDPP suppliers at any time during his or her MDPP services period, subject to beneficiary eligibility requirements (82 FR 34136). Based on evidence from the CDC DPRP, we believe that the instances of beneficiaries changing MDPP suppliers will be relatively infrequent. However, we intend to monitor how often beneficiaries change MDPP suppliers, as well as MDPP suppliers' billing patterns to detect any aberrant billing patterns suggestive of fraudulent or discriminatory practices. Payment policies related to when a beneficiary changes MDPP suppliers are discussed in section III.K.2.d.v. of this final rule.
The following is a summary of the public comments received on our clarifications about beneficiaries changing suppliers and our responses:
Since we did not propose any changes to the policy that beneficiaries may change suppliers at any time during the MDPP services period, we are not finalizing any changes to this policy.
In the CY 2018 PFS proposed rule, we proposed at § 410.79(d)(1) that suppliers may offer make-up sessions to an MDPP beneficiary who missed a regularly scheduled session (82 FR 34136 through 34137). We proposed to define, at § 410.79(b), “make-up session” to mean a core session, core maintenance session, or ongoing maintenance session furnished to an MDPP beneficiary when the MDPP beneficiary misses a regularly scheduled core session, core maintenance session, or ongoing maintenance session. We proposed that make-up sessions may be delivered in person or virtually, although virtual make-up sessions are subject to
We proposed that the curriculum delivered during a make-up session must address the same CDC-approved DPP curriculum topic as the session that the beneficiary missed (§ 410.79(d)(1)(i)). To be consistent with CDC's proposed 2018 DPRP Standards,
There is a growing area of research examining the effectiveness of DPP delivered virtually. CDC began recognizing Virtual DPP organizations in 2015 and emerging evidence suggests that virtual delivery of DPP services can show similarly successful participant weight loss and health benefits to DPP delivered in other settings, including among Medicare-age participants.
First, as indicated by the applicable definition, we proposed virtual make-up sessions must be furnished in a manner consistent with CDC's DPRP Standards for virtual sessions (§ 410.79(d)(2)(i)). To align with CDC's DPRP Standards, virtual make-up sessions refer to any modality, or method of furnishing MDPP services, that is not in person. This includes, but is not limited to:
(1) Furnishing services online where the behavior change program is furnished 100 percent online, with participants accessing course resources and a coach via a computer, laptop, tablet, smart phone, or other device with Internet access. This modality requires that the MDPP beneficiary have an Internet connection to participate in all aspects of the virtual make-up session;
(2) Furnishing services online with other means of support by a coach (for example, telecommunications, video conferencing). This modality requires that the MDPP beneficiary have an Internet connection for some aspects of the virtual make-up session, but not all; and
(3) Distance learning, where a coach is present in one location and participants are calling, video-conferencing, or otherwise using telecommunications technology to access the coach from another location. This modality does not require that the MDPP beneficiary have an Internet connection for any of the aspects of the virtual make-up session.
By defining MDPP virtual make-up sessions as being consistent with CDC's DPRP Standards for virtual sessions, we allowed our proposed definition to change over time as such standards are updated.
Second, we proposed that a supplier may only offer virtual make-up sessions based on an individual MDPP beneficiary's request (§ 410.79(d)(2)(ii)). A supplier may not cancel a regularly scheduled MDPP session and offer the session to all MDPP beneficiaries virtually. However, the supplier may cancel a regularly scheduled MDPP session and offer the session to all MDPP beneficiaries in person. We believe that this is necessary to ensure that the MDPP expanded model remains a model predominantly furnished in person. Individual beneficiary needs may be accommodated, but suppliers should not use virtual make-up sessions as a means to move toward virtually-delivered MDPP sessions more generally.
Third, to further ensure that MDPP services are largely furnished in-person, we proposed at § 410.79(d)(2)(iii) that a supplier may offer: (a) No more than 4 virtual make-up sessions within the core services period to an MDPP beneficiary, of which no more than 2 virtual make-up sessions may be core maintenance sessions; and (b) no more than 3 virtual make-up sessions that are ongoing maintenance sessions to an MDPP beneficiary during any rolling 12-month time period. At § 410.79(d)(3), we proposed that these same limitations on the number of virtual make-up sessions also apply for the purposes of determining whether a beneficiary has attended a sufficient number of MDPP sessions in order to be eligible for ongoing maintenance sessions (§ 410.79(c)(1)) and for assessing whether a beneficiary has met the attendance-related performance goals used to determine whether an MDPP supplier is eligible to receive a performance payment (§ 414.84(b)). The limitation on the number of virtual make-up sessions is not applicable to in-person make-up sessions.
We assume not all suppliers will have the ability to offer virtual make-up sessions, and we are not requiring suppliers to offer virtual make-up sessions. Conversely, an MDPP supplier could offer only virtual make-up sessions and no in-person make up sessions if the supplier chooses as long as the proposed limits for these sessions are not exceeded. We believe that allowing fewer than these proposed number of virtual make-up sessions will make it difficult for suppliers to meet DPRP Standards, and therefore remain enrolled as an eligible MDPP supplier. However, the DPP model test only offered in-person sessions (no virtual sessions) and therefore the MDPP expanded model is intended to predominantly offer services in person. Allowing more than the proposed number of virtual make-up sessions would not support an evaluation of an in-person MDPP model, as described further in this section. We sought comment on our proposals and specifically on the proposed limitations on virtual make-up sessions.
We considered the following alternatives to this proposal. We considered not allowing any make-up sessions to be furnished virtually. However, we believe that this would place undue restrictions on MDPP suppliers who are willing and offer virtual make-up sessions to MDPP
We also considered allowing an MDPP supplier to furnish between 1 and 3 sessions within the core services period and either 1 or 2 ongoing maintenance sessions each year as virtual make-up sessions per MDPP beneficiary. However, we believe that allowing fewer sessions to be furnished as virtual make-up sessions than proposed would not provide sufficient flexibility for MDPP suppliers to meet CDC's DPRP Standards, which require organizations to meet attendance requirements for their panel of participants. Organizations may struggle to meet DPRP attendance requirements without the flexibility to provide virtual make-up sessions.
We also considered permitting suppliers to offer any number of virtual make-up sessions, and for attendance at any number of virtual make-up sessions to count toward attendance goals. However, as stated previously, since the DPP model test only offered DPP services in person, the MDPP expanded model is intended to predominantly offer MDPP sessions in person as well. Therefore we believe that it is important to limit the number of virtual make-up sessions so that MDPP beneficiaries are predominantly receiving MDPP sessions in person.
We proposed that the payment policies detailed in section III.K.2.d. of this final rule apply to virtual make-up sessions. Specifically, as indicated in sections III.K.2.c.iv and III.K.2.d.iii.10.b. of this final rule, weight measurements used for the purposes of determining the achievement or maintenance of weight loss for weight loss performance payments, or for determining eligibility for coverage of ongoing maintenance sessions, would be required to be taken at an in-person session, not during a virtual make-up session. As noted at § 410.79(d)(3), make-up sessions are counted toward performance goals for both eligibility and payment, which specify that at least one ongoing maintenance session per ongoing maintenance session interval must be attended in person for the purposes of in-person weight measurement. We sought public comments on these proposals and the alternatives considered.
The following is a summary of the public comments received on our proposals regarding make-up sessions, and specifically on the limitations on virtual make-up sessions, and our responses:
We appreciate the commenter's request for flexibility by allowing weight measurement to be taken in-person, but outside of an MDPP session, by any member of a care delivery team within a month of the MDPP session. However, we believe that requiring weight measurement to be taken by an MDPP supplier during an MDPP session is the most appropriate and reliable method for weight measurement to ensure accuracy. We have not proposed any program integrity safeguards about transferring weight measurement between providers, suppliers, or care delivery teams, nor do we expect MDPP suppliers to have systems in place to facilitate such information transfer. We also believe that weight must be measured on the same date and at the time of the MDPP session to ensure that weight measurement falls within the correct time frame or interval for the purposes of eligibility and payment. If a member of the beneficiary's care delivery team is also part of the MDPP supplier's organization, for example serving as the DPP coordinator or coach, then this type of arrangement is appropriate, as long as the conditions for weight measurement are met.
We re-emphasize that that virtual make-up sessions cannot be used to record weight for the purposes of beneficiary eligibility for or during ongoing services period or payment, due to the concerns we have laid in this section out regarding any measurement that is not taken in person. This is why we are finalizing in this final rule, discussed in section III.K.2.c.iv.a and III.K.2.c.iv.b, that a beneficiary must attend at least one in-person core maintenance session during the final core maintenance session interval and at least one in-person ongoing maintenance session during each ongoing maintenance session interval in order to have weight recorded in person for the purposes of eligibility and payment (§ 410.79(c)(1)(ii) and (c)(1)(iii)).
After consideration of the public comments received, we are finalizing our proposals on make-up sessions at § 410.79(d). We are finalizing changes to these policies to reflect shortening the ongoing services period from 2 years to 1 year.
In the CY 2017 PFS proposed rule (81 FR 46415 through 46416), we discussed a potential MDPP payment structure and the associated payment amounts and sought information from the public to inform future MDPP proposals. We received a number of public comments on these topics and considered this information in the development of our proposals for the MDPP payment structure, payment amounts, and related issues.
We proposed to pay for the set of MDPP services through a performance-based payment methodology that makes periodic performance payments to MDPP suppliers during the MDPP services period. The aggregate of all performance payments constitutes the total performance-based payment amount for the set of MDPP services. We proposed a maximum total performance payment amount per beneficiary for the set of MDPP services of $810. Performance payments would be made to MDPP suppliers periodically during the course of a beneficiary's MDPP services period based upon a number of factors, including the beneficiary's completion of a specified number of MDPP sessions and the achievement of
The aggregate amount of the performance payments proposed would equal the total performance-based payment amount for the set of MDPP services during the MDPP services period, including core sessions, core maintenance sessions, and ongoing maintenance sessions. Even though these performance payments would be made periodically and in amounts that would not be evenly distributed across the course of sessions furnished during the MDPP services period, payment for each session would be included in the total performance-based payment amount. For example, the proposed performance payment of $25 that would be paid to MDPP suppliers upon furnishing the first MDPP core session is relatively large on a per-session basis compared to other attendance-based performance payments (as calculated on a per-session basis) ranging from approximately $3 to $20 made during the MDPP services period. However, the performance payment for the first core session would make payment for some of the MDPP supplier resources used in furnishing the first session, as well as make a partial prospective payment attributable to the MDPP supplier furnishing subsequent sessions.
Once the required minimum weight loss is achieved and the 12-month core services period, described at proposed § 410.79(c)(2)(i), concludes, we would make additional 3-month interval performance payments for ongoing maintenance sessions when the required minimum weight loss is maintained, whereas no additional interval performance payments would be made for ongoing maintenance sessions if the required minimum weight loss is not maintained. Finally, when a beneficiary achieves a significant percentage of weight loss, specifically a level of 5 percent (the required minimum weight loss) or 9 percent, we proposed to make additional performance payments to the MDPP supplier. This proposal would provide performance payments in addition to the performance payments we may have already made for the previous MDPP sessions furnished to the beneficiary because those sessions resulted in the beneficiary achieving the weight loss performance goal.
In total, based on our consultation with DPP organizations holding commercial contracts, review of information related to DPP organizations that currently hold or are in the process of obtaining CDC recognition, and comments received on the discussion of the payment structure and payment amounts for the set of MDPP services included in the CY 2017 PFS proposed rule (81 FR 46415 through 46416), we believed that the proposed performance-based payment methodology would pay MDPP suppliers appropriately for the resources used in furnishing MDPP services throughout the MDPP services period. We noted that we sought public comment on the payment structure and payment amounts for the set of MDPP services in the CY 2017 PFS proposed rule, and we used the information provided by commenters in developing the proposed performance-based payments included in the CY 2018 PFS proposed rule (82 FR 34138 through 34152).
In the proposed performance-based payment structure, it is important to note that a beneficiary's performance goals would not be considered in the same way for beneficiary coverage and supplier payment during each specific period within the MDPP services period. During the core services period, a beneficiary would not be required to achieve attendance and/or weight loss performance goals for coverage of MDPP services, although a beneficiary would be required to achieve specified performance goals for an MDPP supplier to receive performance payments during this period. In contrast, achieving performance goals would be required for both coverage of MDPP services and performance payments during the ongoing services period.
For example, a supplier would be required to offer a minimum of 16 core sessions during the core services period according to § 410.79(c)(2)(i), but a beneficiary would not need to achieve an attendance or weight loss performance goal to be eligible for coverage of core maintenance sessions. However, MDPP supplier performance payments during the core services period would be based on the beneficiary's achievement of attendance and/or weight loss performance goals. During the ongoing services period, achievement of performance goals would affect both coverage and supplier payment. We noted that a beneficiary would need to attend at least 1 core session to initiate the core services period, and attend at least 1 core maintenance session during the final core maintenance session interval to determine whether he or she has achieved the required minimum weight loss to have coverage of ongoing maintenance sessions. Because we proposed, as discussed in section III.K.2.d.iii.4 of the proposed rule (82 FR 34143 through 34145) to make a performance payment for core maintenance sessions only when the beneficiary attends at least 3 sessions within a 3-month interval, it is possible that an MDPP supplier would not be paid a separate performance payment for the second core maintenance session interval, but the beneficiary would still have coverage of the first ongoing maintenance session interval. This would occur if the beneficiary attended only 1 or 2 core maintenance sessions during the second core maintenance session interval and achieved or maintained the required minimum weight loss as measured at 1 of those 2 sessions.
Commenters on the discussion of payment for MDPP services in the CY 2017 PFS proposed rule (81 FR 46415 through 46416) expressed a variety of perspectives on the performance-based payment methodology presented in that proposed rule. We describe the comments on the prior discussion as background for our proposals for the performance-based payment methodology for MDPP services that was included in the CY 2018 PFS proposed rule (82 FR 34137 through 34155).
In summary, commenters on the CY 2017 PFS proposed rule recommended that a sustainable payment rate structure for MDPP services should mirror performance-based payment models in the existing employer marketplace. They requested that we not tie Medicare payment to weight loss or that we make separate weight loss and attendance payments; that we tie payment to aggregate, rather than individual, beneficiary weight loss; or that we tie payment to other factors besides or in addition to weight loss. Some commenters requested that we provide information on how the payment rates included in the CY 2017 PFS proposed rule discussion were determined due to their concerns that the amount of MDPP payments was not consistent with payments for other similar services. Multiple commenters urged that higher payments be made at the beginning of the MDPP services period to cover program start-up costs, that we decrease supplier financial risk by providing sufficient payment for beneficiaries who do not achieve weight loss performance
The proposed MDPP payment structure in the CY 2018 PFS proposed rule was generally similar to that which was discussed in the CY 2017 PFS proposed rule (81 FR 46415 through 46416). However, the proposed performance payment amounts for core sessions, core maintenance session 3-month intervals, and ongoing maintenance session 3-month intervals differed somewhat based on our consideration of the comments received in response to the CY 2017 PFS proposed rule in the context of our policy goal to prioritize the achievement and maintenance of the required minimum weight loss that is associated with a reduction in the incidence of type 2 diabetes. We proposed a payment structure for MDPP services that is performance-based in relation to two meaningful performance goals.
First, the proposed payment structure valued beneficiary weight loss most significantly. Weight loss is a key indicator of success among individuals enrolled in a DPP due to the strong association between weight loss and reduction in the risk of type 2 diabetes.
In addition to weight loss, we considered linking other criteria such as hemoglobin A1c level to MDPP performance payments, or using aggregate, instead of individual, weight loss for MDPP payments. However, the MDPP expanded model was determined to meet the statutory requirements for expansion, with certification of the DPP model test based on findings that demonstrated that weight loss was associated with reductions in Medicare expenditures. Although elevated hemoglobin A1c levels were included as part of the beneficiary eligibility criteria in the DPP model test, hemoglobin A1c levels were not evaluated post-intervention in that model. Therefore, we did not propose to use hemoglobin A1c blood values in the performance-based payment methodology for MDPP services under the MDPP expanded model, which is based on certification of the DPP model test. We further noted that the CDC does not require post-MDPP services hemoglobin A1c blood values to be determined as part of its 2015 DPRP Standards or its proposed 2018 DPRP Standards, and we aim to align with the CDC's DPRP Standards as much as possible. While 5 percent weight loss is considered a performance measure for CDC recognition, the CDC does not examine pre-post DPP differences in hemoglobin A1c as part of its DPRP Standards.
The proposed MDPP payment structure would incentivize MDPP suppliers to prioritize the achievement and maintenance of beneficiary weight loss by furnishing MDPP services, and provide a balance between performance-based payments related to weight loss and session attendance. We believed that it would be inappropriate for payment to be tied to attendance alone because weight loss is more directly associated with a reduction in the incidence of type 2 diabetes than attendance at MDPP sessions. We further believed that the proposed performance-based payment structure based on individual beneficiary success, rather than average weight loss across all MDPP beneficiaries who receive MDPP services from an MDPP supplier, would maximize the focus of MDPP suppliers on the achievement of the performance goals for all beneficiaries, including those beneficiaries who experience challenges with achieving attendance and/or weight loss performance goals. Therefore, we did not believe it would be appropriate to use aggregate beneficiary information (that is, average weight loss) in the proposed performance-based payment methodology.
We proposed to establish the rules governing payment for MDPP services at new § 414.84. At proposed § 414.84(a), we proposed to define “performance goal” as an attendance or weight loss goal that an MDPP beneficiary must achieve for an MDPP supplier to be paid a performance payment. We proposed to define “performance payment” as a payment to an MDPP supplier for furnishing certain MDPP services when an MDPP beneficiary achieves the applicable performance goal. These definitions were used in our proposals for payment of MDPP services.
To align with the once-per-lifetime policy, we proposed at § 414.84(b) that each performance payment made based on attendance of a specified number of core sessions, for a specific 3-month core maintenance or ongoing maintenance interval during the MDPP services period, or for achieving a weight loss performance goal, would be made only once per MDPP beneficiary.
The following is a summary of the public comments received on the proposals for the definitions of performance goal and performance payment for MDPP services and our responses:
Other commenters expressed concern that the focus on weight loss as the MDPP supplier's outcome valued in the performance-based payment methodology could lead to weight cycling, which could in turn lead to health risks for beneficiaries other than type 2 diabetes. The commenters claimed that weight loss and attendance are confounded measures when both are used as performance goals in the payment methodology because they are linked. They urged CMS to avoid double counting by using attendance alone as the performance goal for performance payments instead of both weight loss and attendance.
Some commenters encouraged CMS to focus the performance goals valued in the payment methodology on improving beneficiary behaviors rather than weight loss. Several commenters recommended that certain DPP organizations, including tribal health programs, have the flexibility to determine their own diabetes prevention measures of success that would be the performance goals upon which payment would be based. In addition to advocating that CMS utilize hemoglobin A1c blood values to assess DPP outcomes, a few commenters suggested that CMS consider adopting other variables, including reduced hypertension risk, lower BMI, increased intake of healthy foods, increased rate of physical activity, or successful reduction of other risk factors. The commenters claimed that incorporating these variables in the MDPP expanded model performance-based payment methodology would reflect beneficiary adherence to healthy behaviors taught in the DPP curriculum. One commenter recommended that CMS supplement performance payments for core sessions with an additional payment for those sessions that include physical activity, in order accommodate and recognize beneficiaries who may fluctuate in weight loss due to thyroid and hormonal imbalances, stress, sleep disorders, or gastrointestinal issues, but who are otherwise achieving improved healthy behaviors through physical activity. Finally, another commenter urged CMS to explore, via a pilot, additional measures that reflect a possible mechanism associated with an MDPP supplier's success in furnishing MDPP services, such as increased beneficiary self-efficacy or activation and reduced social isolation, which the commenter noted would be likely to have spillover benefits for general health.
In response to the commenters who expressed concern about the potential for negative health effects of a focus on weight loss as a performance goal for the MDPP expanded model, we note that certification of the DPP model test was based on findings that demonstrated that weight loss was associated with reductions in Medicare expenditures, and the DPP Randomized Control Trial showed that people at risk for developing type 2 diabetes can prevent or delay the onset of type 2 diabetes by losing a modest amount of weight through diet and exercise. The CDC's DPRP Standards, where 5 percent weight loss is considered a performance measure, were developed with this science in mind. Therefore, we continue to believe that weight loss is an appropriate performance goal for use in the MDPP expanded model performance-based payment methodology.
In addition, while we acknowledge that there is an association between attendance and weight loss, the two performance goals proposed for use in the MDPP payment methodology, we remain committed to valuing weight loss in the methodology based on the evidence that achievement of the required minimum weight loss leads to a reduction in the incidence of type 2 diabetes. Weight loss is a key indicator of success among individuals enrolled in a DPP due to the strong association between weight loss and reduction in the risk of type 2 diabetes.
For the same reasons that we are not using hemoglobin A1c as a performance goal for the MDPP expanded model, we also will not include any of the other additional parameters recommended by the commenters to value a DPP
We will not supplement performance payments for core sessions with additional payments for specific modalities (such as physical activity) offered during sessions, because the MDPP expanded model methodology is already performance-based in nature. Although health behavior changes, including dietary changes and physical activity, are components of the DPP curriculum taught during sessions, the MDPP expanded model was certified based on the close link between weight loss outcomes and a reduced incidence of type 2 diabetes and lower Medicare expenditures. Therefore, it would not be appropriate for us to specifically value in the performance-based payment methodology intermediate health behavior changes such as physical activity changes. Moreover, we are finalizing the requirements for the MDPP expanded model in this final rule, and therefore, are not pursuing through this rulemaking other models or pilots that reflect possible additional mechanisms associated with an MDPP supplier's success in reducing a beneficiary's incidence of type 2 diabetes.
After considering the public comments received, we are finalizing the proposals, without modification, for the definitions of performance goal and performance payment at § 414.84(a).
As displayed in Table 28, we proposed a maximum total performance payment amount per beneficiary for the set of MDPP services of $810. This amount is the aggregate of the maximum proposed performance payments for core sessions, core maintenance sessions, and ongoing maintenance sessions furnished to MDPP beneficiaries who achieve weight loss of at least 9 percent over the proposed 36 months of the MDPP services period. This performance payment amount would be made for a minimum of 46 MDPP sessions required to be offered to the beneficiary in the set of MDPP services. Although CMS would make performance payments to MDPP suppliers at intervals throughout the MDPP services period in varying amounts, payment for each session furnished would be included in the total performance payment amount a supplier was paid for the set of MDPP services furnished to an MDPP beneficiary.
Although we did not propose that payment for MDPP services utilize a fee-for-service payment methodology, we noted that, estimated on a per-session basis, the maximum MDPP payment amount for achievement of all the performance goals would equate to approximately $18 per session. For comparison, Medicare pays under the PFS approximately $10 (excluding physician work and malpractice) for CPT code 98962 (Education and training for patient self-management by a qualified, nonphysician health care professional using a standardized curriculum, face-to-face with the patient (could include caregiver/family) each 30 minutes; 5-8 patients), a service that may bear some resemblance to an MDPP session furnished by an MDPP supplier, although an MDPP session would be furnished by a coach (not necessarily a health care professional), has a duration of 1 hour, and has no explicit limitation on group size.
However, this estimated per-session MDPP payment amount would result only from the furnishing of MDPP services to those beneficiaries who achieve all of the attendance and weight loss performance goals under the proposed performance-based payment methodology for MDPP services. For beneficiaries who do not achieve all of the performance goals, the estimated per-session MDPP payment amount would generally be significantly lower, with the amount based upon the actual attendance and weight loss performance of the beneficiary. The differences between the estimated MDPP per-session payment amounts and between the MDPP and PFS payment amounts would result from the proposed performance-based methodology for MDPP services based on the MDPP beneficiary's achievement of performance goals, that differs from the PFS where payments are based on suppliers' relative resources used to furnish services. We believed that the estimated per-session MDPP payment amounts under our proposal for beneficiaries who achieve specified attendance and weight loss performance goals were appropriate in the context of a performance-based payment methodology for the set of MDPP services.
Finally, we noted that there are also some administrative costs that MDPP suppliers would bear to enroll in Medicare and ensure compliance with the requirements for furnishing MDPP services. The total MDPP performance payment across all Medicare beneficiaries would provide some payment for the resources that would be used by MDPP suppliers to meet the administrative requirements for furnishing MDPP services.
In terms of the proposed distribution of the maximum total performance payment amount for MDPP services across the types of performance payments, as discussed in detail in sections III.K.2.d.iii.(3) and (4) of the proposed rule (82 FR 34141 through 34145) and displayed in Table 28, we proposed that, for those beneficiaries achieving the highest core services period performance goals, approximately 13 percent of the maximum of $810 would be paid for attendance at core sessions during the initial 6 months of the core services period, while approximately 15 percent would be paid for core maintenance sessions during months 7 to 12 of the core services period. We believed that payment of a similar percentage of the maximum total performance payment amount during the initial 6 months of the core services period for beneficiaries who meet attendance performance goals and during months 7 to 12 for beneficiaries who meet both weight loss and attendance performance goals would be appropriate to balance performance payment for attendance and weight loss throughout the core services period.
In addition, as discussed in detail in section III.K.2.d.iii.(5) of the proposed rule (82 FR 34145 through 34146), we proposed that approximately 49 percent of the maximum of $810 would be paid for ongoing maintenance sessions over a
Finally, due to the importance of weight loss as a meaningful outcome of MDPP services because of its association with a reduction in the incidence of type 2 diabetes, as discussed in detail in section III.K.2.d.iii.(6) of the proposed rule (82 FR 34146), we proposed that 23 percent of the maximum total performance payment amount would be paid for weight loss performance payments to provide additional payments for MDPP sessions that are effective (that is, lead to specified percentages of weight loss). We noted that, in the DPP model test, 44.7 percent of participants achieved 5 percent weight loss, which under our proposal would result in a weight loss performance payment of approximately 20 percent of the maximum total performance payment amount.
Table 28 summarizes the proposed maximum total amount and distribution of performance payments for the set of MDPP services.
We invited public comments on our proposals for the maximum total performance payment amount and the distribution of performance payments for MDPP services across the set of MDPP services.
The following is a summary of the public comments received on the proposals for the maximum total performance payment amount and the distribution of performance payments for MDPP services across the set of MDPP services and our responses:
A few commenters recommended that CMS make a payment for each MDPP session, at least for the first 12 months of the MDPP services period. In addition, several of the commenters urged CMS to couple this payment policy with a bonus for achievement of the required minimum weight loss at the end of the core services period. Another commenter requested that CMS provide information on how the proposed performance payment amounts were determined, similar to information published in the Medicare PFS rules for any services covered under the Part B Medicare program. The commenter observed that the proposal for the MDPP expanded model contained extensive information on payment amounts but did not clearly explain the derivation of the proposed performance payment amounts. One commenter stated that services reported under the Medicare program using CPT code 98962 (Education and training for patient self-management by a qualified, nonphysician health care professional using a standardized curriculum, face-to-face with the patient (could include caregiver/family) each 30 minutes; 5-8 patients), a CPT code CMS referenced in the proposed rule, have been proven to be ineffective in changing behavior, yet the supplier is paid the full PFS amount regardless of outcomes. The commenter noted that trained DPP coaches have shown excellent results and, therefore, should be paid equal to or more on an hourly basis as the service reported under this CPT code, which the commenter stated would equate to $20 per hour.
One commenter urged CMS to reconfigure the proposed performance-based payment methodology to allow for add-on payments based on practice size and geographic location. The commenter noted that an additional payment for solo or small practices, as well as for practices in rural or underserved areas, would significantly expand the reach and effectiveness of MDPP services and enable primary care physicians to continue to drive the health care system through a focus on
Another commenter recommended that CMS pay all MDPP suppliers, or at a minimum community-based organizations and small suppliers, based on aggregate, rather than individual, beneficiary performance on attendance and weight. Several commenters emphasized their perspective that performance-based payment that relies heavily on individual patient outcomes would be most likely to succeed when directed at large institutions with multiple sources of revenue where reallocation, cross-subsidy, and assuming financial risk are possible. The commenters noted that small MDPP suppliers would be unlikely to be able to support performance-based payment structures such as CMS proposed for the MDPP expanded model that are premised on a very low payment per evidence-based service, with small sample sizes that make performance payments based on individual beneficiary achievement of performance goals unreliable.
Another commenter noted that evidence to support the effectiveness of pay-for-performance through using the achievement of individual patient outcomes to financially incentivize the appropriate delivery of evidence-based services is mixed. The commenter claimed that there are some reports of no impact on the delivery of evidence-based services and other reports of initial improvements that fail to be sustained in comparison with changes in the practices of other providers over time. The commenter stated that pay-for-performance methodologies for individual health care providers have largely been based on process measures about the delivery of appropriate services, rather than the patient outcomes that result. They concluded that moving to pay-for-performance for an outcome measure like weight loss for Medicare payment as CMS proposed for the MDPP expanded model is an experimental rather than an evidence-based payment strategy, while MDPP services themselves are evidence-based and, therefore, should be paid through an evidence-based approach.
Given the differences between such a performance-based payment methodology and payment under the FFS Medicare payment methodologies, we are not able to provide information on determining MDPP performance payment amounts that is similar to information published in the Medicare PFS rules for other Part B services where payments are related to the relative resources used by suppliers to furnish those services, nor are comparisons to payment on an hourly basis with PFS services possible. The MDPP expanded model uses a fundamentally different payment methodology than the FFS Medicare payment methodologies because it provides a balance of performance-based payments related to weight loss and session attendance, and does not use a resource-based payment methodology for MDPP services. We respond specifically to comments on the proposed distribution of performance payments across the set of MDPP services in the subsequent response in this section and provide more information about our final performance payment and bridge payment amounts in sections III.K.2.d.iii.(3) through (6) and III.K.2.d.v. of this final rule.
Under the performance-based methodology, we believe it is appropriate to pay MDPP suppliers, regardless of size or geographic location, the same performance payment for each beneficiary who achieves the same performance goals because achievement of the required minimum weight loss leads to a reduced incidence of type 2 diabetes for beneficiaries.
Moreover, payment of performance payments based on aggregate beneficiary achievement of performance goals would not sufficiently incentivize MDPP suppliers to engage all beneficiaries in working to achieve the performance goals of the MDPP expanded model. We acknowledge that MDPP suppliers furnishing MDPP services to a small number of beneficiaries may experience more payment variation than larger suppliers under our proposed methodology that relies on the achievement of performance goals by individual beneficiaries to determine the payment amounts. However, we maintain our strong interest in incentivizing MDPP suppliers to work to engage all beneficiaries in achieving the attendance and weight loss performance goals of the MDPP expanded model, despite our understanding that this may put some suppliers at greater financial risk than others. Therefore, we will not provide performance payments based on aggregate beneficiary achievement of performance goals.
We note that the MDPP expanded model was determined to meet the statutory requirements for expansion, with certification of the DPP model test based on findings that weight loss was associated with reductions in Medicare expenditures. In response to the commenter who was concerned that the MDPP expanded model performance-based payment methodology is not evidence-based, we emphasize that we intend to evaluate the MDPP expanded model, which will pay for MDPP services under this payment methodology, using a combination of encounter and claims data to analyze the long-term utilization of services by beneficiaries who have received MDPP services. Moreover, we will continue to assess whether the MDPP expanded model is expected to improve the quality of care without increasing spending, reduce spending without reducing the quality of care, or improve the quality of care and reduce spending, and we will terminate or modify the MDPP expanded model if the expanded model is not expected to meet these criteria.
Many commenters acknowledged that they anticipated significant attrition of MDPP beneficiaries over the maximum 36-month MDPP services period. The commenters expected that MDPP suppliers would not receive the full $400 that CMS proposed as the maximum aggregate performance payment for ongoing maintenance session intervals in the ongoing services period during months 13 to 36 as Medicare beneficiaries reduced their participation in MDPP services because they were no longer eligible for coverage based on their lack of adherence to attendance requirements over the long duration of the period. Most commenters with this perspective also urged CMS either not to include ongoing maintenance sessions in the MDPP expanded model or to reduce the proposed 24 months of the ongoing services period to 12 months. Under both scenarios, the commenters urged CMS to redistribute the performance payments that would have been made for ongoing maintenance session intervals to increase performance payments during the first 12 months of the MDPP services period, especially to core session performance payments.
Multiple commenters requested that MDPP suppliers be paid when MDPP supplier resources are used. They stressed that MDPP suppliers incur significant cost prior to the first core session, including hiring and training coaches, printing the CDC curriculum and nutrition logs, and potentially securing class space. The commenters claimed that most MDPP supplier costs (for example, administration, staffing, beneficiary engagement, marketing, materials, and recruitment) are expended up front in the initial 6 months of the MDPP services period, regardless of whether beneficiaries achieve the required minimum weight loss performance goal. Under the proposal, the commenters concluded that MDPP suppliers would be faced with covering their initial DPP expenses without timely payment, which could preclude some entities from becoming MDPP suppliers.
Several commenters urged CMS to pay MDPP suppliers based on attendance alone for the full 12-month core services period, with higher amounts in the first 6 months because they claimed that the majority of the costs associated with professional staff labor are incurred in this time period due to the DPP curriculum being delivered in weekly sessions. Other commenters recommended that the large majority of payment for MDPP services, up to 70 percent for those beneficiaries achieving 5 percent weight loss, be paid during the first 12 months of a beneficiary's MDPP services period. Some commenters stated that the performance payment should be based on completion of the 12-month core services period, rather than on the achievement of weight loss goals that may be affected by factors outside the MDPP beneficiary's or MDPP supplier's control.
A number of commenters estimated the MDPP supplier cost of furnishing MDPP services for the core services period as greater than $500 per beneficiary. One commenter claimed that payment to DPP organizations in the DPP model test, in the NIH Randomized Control Trial, and the private sector were all substantially higher than the average proposed first year per beneficiary payment of $255 that a high-performing DPP organization would anticipate under the MDPP expanded model (to calculate the $255 average payment, the commenter assumed 50 percent of beneficiaries achieve 5 percent weight loss, and all beneficiaries attend 16 sessions in months 1 to 6 and 6 sessions in months 7 to 12). Another commenter further observed that the DPP model test did not include the significant administrative, operational, and reporting requirements necessary to become a Medicare supplier and adhere to the MDPP expanded model requirements that CMS proposed. The commenters concluded that the significant disparity between the proposed payment for MDPP services and actual needed MDPP supplier investment would impact the MDPP expanded model outcomes, including the MDPP beneficiary's achievement of performance goals and the MDPP supplier's fidelity to the quality of its DPP, in addition to reducing the cost-effectiveness and efficiency of MDPP services.
Moreover, several commenters claimed that the significant MDPP supplier infrastructure that would be required by CMS' proposals and the associated administrative costs to sustain a 12- to 36-month MDPP services period for each MDPP beneficiary would create a burden for most community-based DPP organizations, resulting in barriers to participation in the MDPP expanded model for small or new DPP organizations. Therefore, they reasoned that the proposed distribution of performance payments may be inadequate to support MDPP suppliers in general and may be biased towards organizations with greater resources. The commenters concluded that this bias could further restrict an already limited in-person network of DPP organizations and reduce the opportunity for competition among DPP organizations.
Other commenters reported that a typical performance bonus is 10 to 20 percent of a person's salary for achieving exemplary results, whereas CMS proposed that 85 percent of the maximum total performance payment amount for MDPP services would be based on the achievement of the required minimum weight loss. Several commenters stated that the goal of securing CDC's DPRP full recognition should be a sufficient incentive for MDPP supplier engagement in beneficiary weight loss efforts, because ultimately without this recognition, the DPP organization would not be eligible to be an MDPP supplier that can furnish and bill for MDPP services.
We appreciate the information provided by the commenters about the amount of payment made by other payers for DPP services, as well as their estimates of MDPP supplier costs for furnishing MDPP services. However, we note that unlike FFS Medicare payment methodologies, we are not providing payments for MDPP services based on the relative resources used by MDPP suppliers but rather using a performance-based payment methodology that is based on the individual MDPP beneficiary's achievement of performance goals. We also do not believe that it would be appropriate to set payment for MDPP services based primarily on historical payments received by DPP organizations under clinical trials or other models where the beneficiary population and other program requirements and activities were not the same as those under the MDPP expanded model. For example, the design features of the NIH Randomized Control Trial differ from the MDPP expanded model, including the personnel teaching the curriculum
However, we agree with commenters that the distribution of the maximum total performance payment amount over the set of MDPP services should be revised to shift a higher percentage to the core services period, especially the first 6 months of the MDPP services period. We believe this shift is appropriate in view of the frequent sessions that must be offered to MDPP beneficiaries by MDPP suppliers during months 1 to 6 for beneficiary achievement of attendance performance goals and the aggressive pursuit of performance goals that we expect to occur during the first 12 months of the MDPP services period, where coverage for MDPP services ends altogether if the beneficiary does not achieve the required minimum weight loss within that 12-month time period. Based on the information provided by the commenters, we believe this revised distribution better accounts for the weight loss trajectory of the typical MDPP beneficiary, where weight loss occurs slowly over many months, while ensuring ongoing financial support for the MDPP supplier that must provide access to MDPP services and teach the DPP curriculum to beneficiaries while the beneficiaries are working to lose weight.
We are specifically increasing the performance payments for attendance at 4 and 9 core sessions and the core maintenance session interval performance payments for those beneficiaries who do not achieve or maintain the required minimum weight loss, consistent with the requests of some commenters as discussed in detail in sections III.K.2.d.iii.(3) and (4) of this final rule, respectively. In comparison with the approximately 50 percent that we proposed, these changes result in about 70 percent of the maximum total performance payment amount for the MDPP services period being available during the first 12 months of the MDPP services period for beneficiaries who achieve the required minimum weight loss within the first 6 months, as some commenters also requested.
We considered making the distributional changes to shift a higher percentage of the maximum total performance payment amount for the set of MDPP services to the core services period by redistributing only those performance payments that would have been made during months 1 to 24 of the MDPP services period, in order to shift a higher percentage of those payments to the first 6 months of the core services period. However, such a redistribution would have required reducing the performance payments for core maintenance and ongoing maintenance session intervals from the amounts we proposed, while commenters supported the proposed amounts or recommended higher payment amounts, as discussed in sections III.K.2.d.iii.(4) and (5) of this final rule. It would also have reduced the maximum total performance payment amount to $610 from the $810 that we proposed, due to the elimination of ongoing maintenance session interval performance payments of $50 per interval for the 4 intervals that would have occurred during months 25 to 36 of the MDPP services period.
Instead, we are shifting a higher percentage of the maximum total performance payment amount to the core services period by partially redistributing the performance payments that would have been made during months 25 to 36 of the MDPP services period to the core services period because the ongoing services period has been reduced from 24 to 12 months. This approach allows us to finalize performance payments for core maintenance and ongoing maintenance session intervals that are no lower than the amounts we proposed and results in a smaller reduction to $670 for the maximum total performance payment amount.
In considering opportunities to revise the performance payment amounts in response to the perspectives provided by the commenters, we intend for our redistribution to have a minimal impact on the estimated Medicare expenditures for MDPP services; therefore, we are not redistributing the full amount of $200 that would have been the maximum performance payment amount for months 25 to 36 of the MDPP services period. Rather, we are only partially redistributing payments from the full amount of $200 because our expectation (based on the results of the DPP model test and information from the commenters) is that a higher number of beneficiaries will attend the sessions during the core services period than the number who would have attended the sessions during months 25 to 36 of the ongoing services period, due both to beneficiary attrition over the long duration of the MDPP services period and the coverage requirements for beneficiaries during the ongoing services period. Thus, we believe that redistributing the full amount of $200 to the core services period would result in significantly higher expenditures for the MDPP expanded model than a partial redistribution that more closely reflects performance payments we would have made if the ongoing services period continued through month 36. Therefore, in order to maintain a similar estimate of aggregate Medicare expenditures for MDPP services under our final distribution of performance payments, the final maximum total performance payment amount is necessarily lower than the $810 we proposed.
The partial redistribution of $60 to the performance payments for attendance at 4 and 9 core sessions and $10 to the core maintenance session interval performance payments for beneficiaries who do not achieve or maintain the required minimum weight loss means that the final maximum total performance payment amount for a beneficiary is $670 under the MDPP expanded model. As was also true for our proposals, in the context of estimates of future Medicare savings from the MDPP expanded model, the redistribution of dollars across the set of MDPP services under our final policies takes into account estimates of total Medicare expenditures under the MDPP expanded model for MDPP beneficiaries and estimates of future reductions in spending for those beneficiaries that would occur from their reduced incidence of type 2 diabetes.
Based on the final performance payments displayed in Table 29, and assuming 50 percent of an MDPP supplier's MDPP beneficiaries achieve the required minimum weight loss within the first 6 months of the core services period (the assumption made by one commenter for ease of estimation, which we also use because it is close to the 44.7 percent of participants in the DPP model test who achieved 5 percent weight loss and)
As explained previously, we are not redistributing to the other performance payments amounts the full amount of $200 that would have been the maximum total per-beneficiary performance payment for months 25 to 36 of the MDPP services period. This means that the final maximum total performance amount for a beneficiary is $670 under the MDPP expanded model, lower than the $810 we proposed. The final lower maximum total performance payment amount results from our expectation that the ongoing maintenance session interval performance payments for months 25 to 36 of the MDPP services period would have been made for fewer beneficiaries than the increased performance payments that will be made in the first 12 months of the MDPP services period under our final policies, due both to beneficiary attrition over the long duration of the MDPP services period and the policy that performance payments for ongoing maintenance session intervals require the beneficiary to meet both attendance and weight loss performance goals during each interval. As was also true for our proposals, in the context of estimates of future Medicare savings from the MDPP expanded model, the redistribution of dollars across the set of MDPP services under our final policies takes into account estimates of total Medicare expenditures under the MDPP expanded model for MDPP beneficiaries and estimates of future reductions in spending for those beneficiaries that would occur from their reduced incidence of type 2 diabetes.
After considering the public comments received, we are finalizing the proposals for the maximum total performance payment amount and the distribution of performance payments for MDPP services across the set of MDPP services, with modifications. Based on our discussions in sections III.K.2.d.iii.(3) through (6) of this final rule regarding weight loss performance payments and changes to the performance payments for core sessions, core maintenance session intervals for beneficiaries who do not achieve or maintain the required minimum weight loss, and ongoing maintenance session intervals to reflect the final 12-month ongoing services period policy (discussed in section III.K.2.b.i of this final rule), the final maximum total performance payment amount for the set of MDPP services is $670. The changes to the specific types of performance payments in this final rule that sum to the maximum total performance payment amount for the set of MDPP services result in a substantial increase in the percentage of the maximum total performance payment amount available during the 12-month core services period. The largest absolute percentage increase by type of performance payment is in the first 6 months of the MDPP services period when core sessions are furnished. There is also a significant absolute percentage decrease in the maximum total performance payment amount for ongoing maintenance session intervals, which reflects the shortening of the ongoing services period duration from 24 months to 12 months. The final maximum total performance payment amount and distribution of performance payments for MDPP services are displayed in Table 29.
In the CY 2018 PFS proposed rule (82 FR 34141), we discussed our understanding that social risk factors such as income, education, race and ethnicity, employment, disability, community resources, and social support play a major role in health. The Office of the Assistant Secretary for Planning and Evaluation (ASPE) and the National Academies of Sciences, Engineering, and Medicine recently released reports on the issue of accounting for social risk factors in CMS programs.
In the CY 2017 PFS final rule (81 FR 80466), we acknowledged commenters' concerns regarding the potential unintended consequences if the MDPP expanded model were to result in low-
We proposed an MDPP payment structure for the set of MDPP services that is similar to the structure presented in the CY 2017 PFS proposed rule (81 FR 46416), where performance payments are tied to attendance at MDPP sessions and/or weight loss. Based on information provided to us by stakeholders, we acknowledged that tying performance payment to a specific threshold of weight loss and/or attendance may make achieving the performance goals required for the highest performance payments and beneficiary eligibility for coverage of ongoing maintenance sessions more challenging for MDPP suppliers furnishing services to individuals with social risk factors. We noted that our proposal for beneficiary engagement incentives as discussed in section III.K.2.f. of the proposed rule (82 FR 34166 through 34171) would provide MDPP suppliers with the flexibility under certain conditions to furnish in-kind patient engagement incentives, such as transportation, to support beneficiaries in achieving the MDPP expanded model performance goals, including session attendance and weight loss. We expected that these beneficiary engagement incentives may be helpful to MDPP suppliers furnishing services to beneficiaries, including those with social risk factors that could increase their risk of not achieving the MDPP performance goals.
We did not propose to risk-adjust MDPP payments for social risk factors or to adopt additional special payment policies to specifically encourage MDPP suppliers to furnish sessions to beneficiaries with social risk factors because, for the MDPP expanded model, we do not believe that such approaches are necessary to ensure access to MDPP services for all beneficiaries. This is because we believe that the proposed performance goals upon which the performance payments for the set of MDPP services would be based, as well as the payment policies that recognize that weight loss is a gradual process that may occur slowly over the 12 months of the core services period, should allow MDPP suppliers sufficient time to work with all eligible beneficiaries, including beneficiaries with social risk factors, toward achieving the attendance and weight loss performance goals of the MDPP expanded model. However, we noted that we may consider proposing additional payment policies for the MDPP expanded model in the future, as appropriate.
We requested comments about social risk factors in the context of the set of MDPP services that could inform any future considerations of additional payment policies for the MDPP expanded model. We also invited public comments on other types of strategies that we could utilize throughout the testing of the MDPP expanded model to assist MDPP suppliers in providing robust access to MDPP services for beneficiaries with social risk factors, such as learning activities to share best practices among MDPP suppliers in providing the set of MDPP services.
The following is a summary of the public comments received on social risk factors in the context of MDPP services and other types of strategies that we could utilize through the testing of the MDPP expanded model to assist MDPP suppliers in providing access to MDPP services for beneficiaries with social risk factors and our responses:
The commenters urged CMS to take into account the socioeconomic status of MDPP beneficiaries and how this may impact their achievement of performance goals more generally, and risk-adjust for these factors. One commenter suggested that CMS provide a supplemental payment of 25 percent to MDPP suppliers for furnishing MDPP services in geographies or to groups who, based on the literature, have a higher prevalence of type 2 diabetes in their community, and/or are less likely to complete the set of MDPP services. The commenter recommended that this supplemental payment should be tied to aggregate attendance, rather than weight loss, in order to promote the delivery of MDPP services by community-based organizations that can make ancillary supportive services available to beneficiaries that the commenter stated may lead to greater success in priority communities. As an alternative to this approach, the commenter presented options for tying enhanced payments to individual MDPP suppliers that would pay suppliers different amounts based on the specific population enrolled with a DPP organization.
Other commenters who acknowledged that CMS did not propose to move forward with risk-adjustment for social risk factors in the MDPP expanded model in CY 2018 encouraged CMS to be mindful of how social influences may impact some MDPP beneficiaries and encouraged the Agency to consider risk-adjustment or other methods to appropriately account for social risk factors in future years in the performance-based payment methodology. In contrast, several commenters noted that risk-stratification of payments based on social risk factors is not necessary for the success of the MDPP expanded model and may lead to discrimination in the model.
Many commenters presented social factors that they state influence health, including income, education, race and ethnicity, employment, disability, and social supports. Other commenters cited research which suggested that addressing socioeconomic factors increases both the sustainability and impact on overall health of efforts to prevent and manage chronic conditions, particularly type 2 diabetes. One commenter identified the following social risk factors as potentially influencing patient outcomes
Several commenters stressed their commitment to furnishing MDPP services to all individuals who qualify for these services, regardless of their ability to pay or the timeline in which they achieve performance goals, including working hard to address issues like access and affordability that may make it difficult for people to enroll and continue to receive services from the DPP organization. The commenters emphasized that MDPP suppliers must be willing to put time and resources into additional or customized services to meet the needs of communities with social risk factors and drive people to enroll and continue to participate in a lengthy behavior change program like the set of MDPP services. Several commenters encouraged CMS to continue to align with the CDC's DPRP Standards to encourage and/or incentivize MDPP suppliers, through transparent policies, to furnish MDPP services in low-income areas.
One commenter recommended that CMS develop a list of social risk factors for MDPP suppliers to capture so suppliers can develop a process to query beneficiaries about these issues. Several commenters stated that while the MDPP expanded model proposals regarding beneficiary engagement incentives would provide MDPP suppliers with some flexibility to support different beneficiary needs, it is unclear if this policy will be sufficient to allow MDPP suppliers to appropriately assist low-income or other disadvantaged populations who have less access to programs and resources.
In response to the commenter who requested that CMS present references to the data about the effects on disparities on which the proposals for the MDPP expanded model were based, we note that we have adapted model policies to support national expansion and in response to public comments; therefore, we do not currently have existing evidence specific to the effects on disparities of the totality of model design parameters that are being finalized in this final rule. To the extent possible with existing data, sub-group analyses, including beneficiary characteristics such as race and ethnicity, will be conducted at part of the evaluation of the MDPP expanded model.
We will review the information about social risk factors provided by the commenters, as well as our early implementation experience with the MDPP expanded model and other information we receive in the future from stakeholders, as we consider potential proposals for additional payment policies for the MDPP expanded model in the future.
The payment structure presented in the CY 2017 PFS proposed rule (81 FR 46415 through 46416) would have made attendance-based payments of $25 for the first core session, $50 for 4 total core sessions, and $100 for 9 total core sessions. Based on our consideration of information provided in the public comments on CY 2017 PFS proposed rule and our increased emphasis in the performance payments on the achievement and maintenance of the required minimum weight loss as the outcome of MDPP services, our proposal for the attendance-based performance payments for 4 and 9 core sessions differed from these payment amounts. We proposed that an MDPP supplier would be paid a $25 performance payment the first time it furnishes an MDPP session to an MDPP beneficiary as displayed in Table 30. This performance payment would be available once per beneficiary for the beneficiary's first core session.
We proposed that an MDPP supplier would be paid the performance payment upon furnishing the first core session to a beneficiary who initiates the MDPP services period, regardless of whether the MDPP supplier qualifies for any of the additional performance payments for that beneficiary. Additional performance payments would depend upon the beneficiary's achievement of the performance goals for attendance and/or weight loss. We believed that making the first performance payment based on beneficiary attendance at the first core session would be appropriate because the MDPP supplier would use significant resources to furnish the first session, including collecting administrative information on the beneficiary who is not already known to the supplier, regardless of whether the beneficiary goes on to receive further MDPP services from that supplier.
On a per-session basis, the performance payment for the first MDPP core session would be the highest performance payment amount for any core session during the core services period. Of note, the first core session performance payment also would provide some payment for MDPP supplier activities to encourage the beneficiary's attendance at additional core sessions following the first session. Such supplier activities could include sending electronic messages or making reminder phone calls about upcoming sessions or providing transportation to the next session under the beneficiary engagement incentives policy proposed in section III.K.2.f. of the proposed rule (82 FR 34166 through 34171). It is only through attendance at the first core session with an MDPP supplier that a beneficiary initiates the MDPP services period and has the potential to achieve weight loss through receiving MDPP services.
Further, we proposed that suppliers would be paid a performance payment for the interval (which we refer to as an “interval performance payment” to distinguish it from other performance payments, such as the performance payment upon an MDPP beneficiary's achievement of the required minimum weight loss, that would not require attendance at multiple sessions) upon a beneficiary's attendance at 4 total core sessions, and again upon a beneficiary's attendance at 9 total core sessions—that is, attendance of 5 more core sessions after having attended his or her first 4. We proposed an interval performance payment of $30 upon a beneficiary attending 4 core sessions and an interval performance payment of $50 upon a beneficiary attending 9 core sessions as displayed in Table 30. Although an MDPP supplier must offer at least 16 core sessions to a beneficiary during the initial 6 months of the MDPP core services period, we did not propose any other interval performance payment for the core sessions after the performance payment for attendance at 9 core sessions. We noted that while these
On a per-session basis, the payments for attendance at 4 total core sessions and 9 total core sessions would be approximately $10 and $4 to $10, respectively, depending upon the number of sessions attended by the beneficiary beyond the 9 required for the second interval performance payment up to the maximum of 16 core sessions that must be offered to the beneficiary by the MDPP supplier during the initial 6 months of the MDPP core services period. Because the performance payments for core sessions would be based solely on the achievement of attendance performance goals, we believed that these per-session performance payment amounts that would be lower than the proposed performance payment amount for the first core session would still be appropriate because we expected that fewer MDPP supplier resources would be used to furnish sessions to beneficiaries with whom the MDPP supplier has an established relationship. The per-session payment amounts for core sessions were set based on attendance at these sessions, which is associated with ultimate achievement of the required minimum weight loss.
We proposed to make the first interval performance payment for core sessions when the beneficiary has attended 4 core sessions for the following reasons. First, beneficiary attendance at 4 core sessions was a significant attendance milestone in the evaluation of the DPP model test, which provided evidence that meeting this milestone is tied to weight loss outcomes.
We proposed to make the second interval performance payment when the beneficiary has attended 9 core sessions because attending a higher amount of sessions in the initial 6 months of the MDPP core services period, beginning at session 9, has been shown to greatly improve weight loss outcomes. Specifically, according to CDC data, there is a 125 percent increase in weight loss comparing beneficiaries who attend 4 to 8 sessions (1.6 percent weight loss on average) and beneficiaries who attend 9 to 16 sessions (3.6 percent weight loss on average).
MDPP suppliers would be paid these performance payments when beneficiaries achieve these core session attendance performance goals, regardless of weight loss. Although we proposed to base performance payments during the MDPP services period substantially on weight loss, which is directly associated with a significant decrease in the incidence of type 2 diabetes, we recognized that weight loss is a gradual process and that MDPP suppliers would utilize resources to furnish MDPP services during the period of time when the beneficiary is losing weight. Therefore, we proposed that performance payments for beneficiary attendance at core sessions during the first 6 months of the core services period be based on attendance only.
The proposed maximum total performance payment to MDPP suppliers for furnishing MDPP core sessions would be $105 per beneficiary, as displayed in Table 30.
We considered alternatives to this payment structure for core sessions, such as making higher payments for attendance at the earlier sessions to provide MDPP suppliers with additional funds for the resources necessary for start-up of the MDPP expanded model. We stated that although we understood that there are some up-front supplier costs associated with implementing the MDPP expanded model, we believed that these costs would disproportionately be related to start-up and not generally be ongoing costs borne by the MDPP supplier. In
The proposed attendance-based performance payments for MDPP core sessions were included at proposed § 414.84(b)(1), (2), and (3). We invited public comments on these proposals. We also invited public comments on the alternative considered.
The following is a summary of the public comments received on the proposals for attendance-based performance payments for MDPP core sessions and the alternative considered and our responses:
Several commenters requested that CMS review its proposed payment structure for core sessions and, in their view, better balance the amount of money an MDPP supplier would receive for the first session by moving portions of the proposed performance payments for attendance at the fourth session and ninth core session, as well as for core maintenance session intervals, earlier in a beneficiary's MDPP services period to increase payment for the first core session. Another commenter urged CMS to rebalance the attendance-based performance payments for the core sessions to provide 25 percent for the first core session to cover outreach and other start-up costs.
As discussed in section III.K.2.d.ii. of this final rule, we will provide payment for the set of MDPP services through a performance-based payment methodology that makes periodic performance payments to MDPP suppliers during the MDPP services period. The aggregate of all performance payments constitutes the total performance-based payment amount for the set of MDPP services. We understand that MDPP suppliers will experience some early set up costs and ongoing costs for activities such as outreach to get Medicare beneficiaries to obtain MDPP services from the supplier and that the MDPP supplier may need to bear these resource costs before receiving significant payment from Medicare for MDPP services. We appreciate that the timing of the performance payments and MDPP suppliers' use of resources for furnishing MDPP services are not fully aligned. Because the MDPP expanded model relies on a performance-based payment methodology that is heavily weighted toward the outcome of the required minimum weight loss that is associated with a reduced incidence of type 2 diabetes, MDPP suppliers will need to bear these resource costs until suppliers begin to receive significant performance payments from CMS. However, we expect that the total performance payment amounts received by MDPP suppliers for the set of MDPP services will provide funds to MDPP suppliers for carrying out these initial and ongoing activities, not just the payment for the first core session furnished to an MDPP beneficiary in the MDPP services period.
We note that the proposed performance payment for the first core session of $25 was the highest performance payment, on a per-session basis, of any of the other proposed core session performance payments. As discussed in the subsequent response to comments, we are finalizing higher performance payments for attendance at 4 and 9 core sessions than we proposed, but $25 is still higher than those final core session performance payments on a per-session basis. Therefore, we believe that the $25 performance payment for beneficiary attendance at the first core session already recognizes some of the startup costs and the more intense resources used by MDPP suppliers early in their participation as MDPP suppliers and in the beneficiary's MDPP services period, respectively.
In addition, given the performance goal of attendance at only one core session for the first core session performance payment, we believe that a performance payment higher than $25 for the first core session could incentivize MDPP suppliers to furnish the first core session to a large number of beneficiaries who are eligible for MDPP services but who may not have a full understanding of the DPP and its expectations or who are not ready to commit to the full DPP. Such an MDPP supplier practice could result in fewer beneficiaries benefiting from MDPP services by achieving the required minimum weight loss that reduces their risk of type 2 diabetes. Thus, we continue to believe that a performance payment of $25 for attendance at the first core session is the most appropriate payment amount for beneficiary achievement of this attendance performance goal.
Therefore, the commenters recommended that CMS reallocate performance payments from the performance payments for 5 percent weight loss and core maintenance session intervals to the first 16 weeks of the MDPP services period when the majority of costs are incurred by the DPP organization. Some commenters specifically recommended the redistribution of $60 to payment for core sessions from the proposed $160 performance payment for achievement of the required minimum weight loss, which would result in a total performance payment for attendance at core sessions of $165, compared to the $105 that CMS proposed (the sum of the performance payments for attendance at the first, 4, and 9 core sessions).
Some commenters supported making core session performance payments after beneficiary attendance at the fourth and ninth core sessions as CMS proposed, based on the evidence cited by the commenters that if a beneficiary completes his or her fourth core session, he or she is more likely to remain in the DPP for the full 12-month core services period.
We appreciate the detailed information presented by the commenters on the critical need to appropriately engage beneficiaries in the first 6 months of the MDPP services period in order to support beneficiaries in achieving the core session attendance performance goals, as well as the information on the number and intensity of MDPP supplier activities necessary during this period in order to meet these goals. After reviewing these descriptions, we believe that it is appropriate to increase the final performance payment amounts from the proposed $30 and $50 for attendance at 4 and 9 core sessions, respectively. The increased core session attendance-based payment amounts reflect the importance of these core session attendance milestones to ultimate MDPP beneficiary achievement of the required minimum weight loss, given the association between greater session attendance and achievement of weight loss. In addition, we note that as a result of these performance payment increases during the first 6 months of the MDPP services period, greater payment for beneficiaries who achieve the performance goals will be available to MDPP suppliers in months 1 to 6 of the core services period that may result in more timely and substantial financial support during that time period for the high intensity of supplier activities needed to promote further beneficiary achievement of performance goals. We recognize that MDPP suppliers will be working diligently throughout this 6-month period to engage beneficiaries, encourage attendance, teach the weekly DPP curriculum, and support beneficiary behavior change through beneficiary engagement incentives and other activities.
Therefore, in view of our final policy that shortens the maximum ongoing services period from 24 to 12 months as discussed in section III.K.2.b.i. of this final rule, we will redistribute some of the funds that would have been available for ongoing maintenance session interval performance payments for months 25 to 36 of the MDPP services period to the 4 and 9 core session attendance-based performance payments.
Because we consider both these milestones to be of similar importance in recognizing beneficiary achievement of attendance performance goals that are associated with completion of the 12-month core services period and achievement of the required minimum weight loss, we are increasing both performance payments by 70 to 80 percent from the proposed amounts, resulting in final attendance-based performance payments for 4 and 9 core sessions of $50 and $90, respectively. While the commenters did not specifically recommend these payment amounts for attendance at 4 and 9 core sessions, several commenters specifically urged us to increase the total payment for core sessions (attendance at the first, 4, and 9 core sessions) from the $105 that we proposed to $165, which would represent a substantial increase in the performance payments for core session attendance. As discussed in the previous response to comments, we are not increasing the performance payment for attendance at the first core session from the $25 payment amount that we proposed. However, we will increase the total attendance-based payment for core sessions from $105 to $165 as recommended by the commenters through proportionately similar increases in the performance payments for attendance at 4 and 9 core sessions.
We believe that increasing the final 4 and 9 session attendance-based performance payments by 70 to 80 percent from the proposed amounts represents a significant increase in the performance payments for attendance at 4 and 9 core sessions that is consistent with the requests of the commenters for increased total payment for attendance at core sessions. Moreover, the final performance payment amounts appropriately recognize the importance of meeting these core session attendance milestones that are linked to the achievement of the required minimum weight loss that leads to a reduction in incidence of type 2 diabetes and reduced Medicare expenditures.
After considering the public comments received, we are finalizing the proposals for the performance payments for core sessions at § 414.84(b)(1), (2), and (3), with modifications. We are finalizing the performance payment for the first core session attended at $25 as we proposed. We are increasing the performance payment for 4 core sessions attended to $50 and the performance payment for 9 core sessions attended to $90. These final performance payment amounts result in a total attendance-based performance payment amount for MDPP services furnished to an MDPP beneficiary in the first 6 months of the core services period of $165, an increase of approximately 60 percent over the proposed total performance payment amount of $105 for the 6-month period of core sessions. The final attendance-based performance payments for MDPP core sessions are displayed in Table 31.
We proposed that performance payments for core maintenance sessions would be tied to the beneficiary's achievement of attendance and weight loss performance goals during a core maintenance session interval. A core maintenance session interval, as we proposed to define it at § 410.79(b), would mean one of the two consecutive 3-month time periods during months 7 through 12 of the MDPP services period, during which an MDPP supplier offers at least 1 core maintenance session per month to an MDPP beneficiary.
The payment structure presented in the CY 2017 PFS proposed rule (81 FR 46415 through 46416) would have required the MDPP beneficiary to attend 3 core maintenance sessions and achieve or maintain a minimum 5 percent weight loss for a $45 payment to be made to an MDPP supplier for the core maintenance session interval. If 5 percent weight loss was not achieved or maintained during the core maintenance session interval, no separate performance payment would be made. MDPP suppliers would still have been required to offer (and furnish if the beneficiary attended) MDPP services during core maintenance intervals to beneficiaries regardless of weight loss. Based on our consideration of information provided in the public comments on the CY 2017 PFS proposed rule and our increased emphasis in the performance payments on the achievement and maintenance of the required minimum weight loss as the outcome of MDPP services, our proposal for the performance payments for core maintenance sessions differed from the payment amounts included in the CY 2017 PFS proposed rule (81 FR 46415 through 46416).
For the MDPP expanded model, we proposed performance payments amounts for core maintenance session intervals that would value achievement of both session attendance and the required minimum weight loss, with an emphasis on achieving the weight loss performance goal. We proposed that an MDPP supplier would be paid a performance payment for a core maintenance session interval if a beneficiary achieves the performance goal of attending at least 3 core maintenance sessions during the interval. The specific performance payment amount would be determined by whether the beneficiary has also achieved or maintained the required minimum weight loss within the interval. The achievement or maintenance of the required minimum weight loss within the 3-month core maintenance session interval would be determined based on a measurement taken in-person during any 1 session within that 3-month interval. We proposed that MDPP suppliers would be paid a performance payment for no more than 2 core maintenance session intervals for each MDPP beneficiary.
As discussed previously, we recognized that weight loss is a process that may still be ongoing for some beneficiaries during the final months of the core services period. According to an analysis of participant data from CDC's DPRP, the longer a participant remains in the lifestyle change program, the greater his or her average weight loss achieved.
Of further note, the National DPP's core maintenance sessions were developed based on results from the original 2002 DPP Randomized Control Trial and CDC's DPRP Standards were developed with this science in mind.
Therefore, we believed that providing no performance payment to MDPP suppliers for furnishing core maintenance sessions to beneficiaries who have not achieved the required minimum weight loss prior to or during months 7 to 12 of the core services period could reduce the opportunity for MDPP beneficiaries to achieve the weight loss performance goal. Such a payment methodology could reduce the likelihood that MDPP suppliers would continue to work to engage beneficiaries in the weight loss process if those beneficiaries had not achieved the required minimum weight loss after completion of the initial 6 months of the MDPP core services period. We noted that, as finalized in the CY 2017 PFS final rule (81 FR 80459), suppliers must offer a minimum of 1 core maintenance session per month in months 7 to 12 of the core services period to eligible beneficiaries, regardless of the beneficiary's weight loss. We further believed that it would be possible for some beneficiaries to have achieved the required minimum weight loss performance goal by the time the core sessions have been completed, and we wanted to incentivize MDPP suppliers to work toward the weight loss performance goal in that timeframe. However, we believed that it would also be appropriate to place some value on achieving attendance performance goals alone through performance payments for core maintenance session intervals so that MDPP suppliers continue to work to engage all beneficiaries in striving to achieve the required minimum weight loss performance goal.
As discussed in section III.K.2.d.iii.(2)(a) of the proposed rule (82 FR 34139 through 34141), we proposed that the maximum total performance payment for MDPP core maintenance sessions would be $120 for beneficiaries who achieve both the attendance and weight loss performance goals during months 7 to 12 of the core services period. Specifically, we proposed to pay MDPP suppliers $60 for a core maintenance session interval if a beneficiary attends 3 sessions and achieves or maintains the required minimum weight loss during that interval, and to pay MDPP suppliers $10 for a core maintenance session interval if the beneficiary attends 3 sessions but does not achieve or maintain the required minimum weight loss during that core maintenance session interval.
As compared to the payment amounts with and without achievement or maintenance of the required minimum weight loss that were presented for core maintenance session intervals in the CY 2017 PFS proposed rule (81 FR 46415 through 46416), these proposed payment amounts are both higher. As discussed previously, we believed that it would be appropriate in months 7 to 12 of the core services period to provide some performance payment for achievement of attendance performance goals even if the required minimum weight loss is not achieved, in order to provide the greatest opportunity for beneficiaries to achieve the required minimum weight loss over the full core services period. In addition, we proposed a higher payment amount for core maintenance session intervals with achievement or maintenance of the required minimum weight loss to recognize that achievement and maintenance of the required minimum weight loss are necessary for the reduced incidence of type 2 diabetes and to encourage MDPP suppliers to work to engage beneficiaries in achieving weight loss and sustaining their weight loss over time.
Proposed performance payments for the core maintenance session intervals are displayed in Table 32. On a per-session basis, these payments would be approximately $20 and $3, respectively. Although both of these payment amounts would provide payment to MDPP suppliers for the resources involved with furnishing core maintenance sessions, we believed that the relatively high per-session performance payment of $20 in comparison to the per-session performance payment amounts for core sessions would be appropriate due to the achievement or maintenance of both the required minimum weight loss and beneficiary attendance at core maintenance sessions, as compared to core sessions where the performance payment would be based solely on attendance. On the other hand, we believed that the relatively low per-session payment amount in our core maintenance session interval performance payment proposal for core maintenance sessions for those beneficiaries who do not achieve the weight loss performance goal, while providing some performance payment for attendance at core maintenance sessions by beneficiaries still working to achieve the required minimum weight loss, would be appropriate because these sessions have not yet resulted in those beneficiaries achieving the weight loss performance goal.
The proposed core maintenance session interval performance payments for core maintenance sessions were included at proposed § 414.84(b)(4). We invited public comments on these proposals.
The following is a summary of the public comments received on the proposals for core maintenance session interval performance payments for core maintenance sessions and our responses:
The commenters speculated that in order to promote 100 percent attendance of 3 sessions in a 3-month core maintenance session interval, MDPP suppliers might have to offer more sessions in that interval to accommodate the schedules of the MDPP beneficiaries. They added that offering additional sessions would lead to greater MDPP supplier cost that would not be covered by the proposed performance payments for core maintenance session intervals. Therefore, the commenters urged CMS to change the attendance requirement for core maintenance session intervals from 3 to 2 sessions in order for performance payments to be made, in order to address scenarios where beneficiaries were unable to attend one monthly session in a 3-month period of
Several commenters recommended that CMS increase the performance payments for core maintenance session intervals, especially for beneficiaries who have not achieved or maintained the required minimum weight loss. The commenters opposed the use of combined weight loss and attendance performance goals to determine the performance payment amount for the interval during months 7 through 12 of the core services period. Most commenters addressing this issue recommended that CMS make the same performance payment, suggesting values that ranged from the proposed $60 to higher amounts such as $72.50, for core maintenance session intervals for beneficiaries who achieved or maintained the requirement minimum weight loss and those who did not meet the weight loss performance goal because MDPP suppliers are required to offer these sessions to all MDPP beneficiaries.
The commenters stated that providing the same payment for core maintenance session intervals, regardless of the achievement of the weight loss performance goal, would better align beneficiary eligibility with payment for core maintenance sessions. Under such an approach, similar to the first 6 months of the core services period, performance payments in months 7 through 12 would be attendance-based in order not to penalize MDPP suppliers financially for the MDPP beneficiary's weight loss performance because weight loss could reasonably occur over the first 12 months of the MDPP core services period, not just the first 6 months. The commenters described significant administrative costs for necessary MDPP supplier activities during months 7 through 12, including the required tracking of Medicare beneficiaries, in-person weigh-ins, and outreach to enrollees to ensure attendance is high. The commenters stated that these administrative activities could actually increase the MDPP supplier's per-session costs in comparison with months 1 through 6 of the core services period where core sessions must be offered weekly to MDPP beneficiaries.
We continue to believe that it is important after making attendance-based performance payments for months 1 to 6 of the MDPP services period to begin to base performance payments in part on the achievement of weight loss beginning in month 7 of the core services period, a time by which we expect some beneficiaries to have achieved the required minimum weight loss outcome goal for MDPP services. Our expectation is supported by findings from the CDC's DPRP that it takes an average of 17 DPP sessions attended to exceed the required minimum weight loss.
Thus, we do not believe it would be appropriate to make a performance payment of $60 for session attendance alone in months 7 to 12 of the core services period at the same payment amount that we are finalizing for beneficiaries who meet both the attendance and weight loss performance goals. However, we appreciate the interest of the commenters in a substantial increase from the $10 that we proposed as the core maintenance session interval performance payment for beneficiaries who are attending sessions that must be offered by the MDPP supplier and still working to achieve the required minimum weight loss. Given the considerable expected engagement of MDPP suppliers with MDPP beneficiaries who are still working to achieve the required minimum weight loss at the end of the first 6 months of the core services period, we agree with the commenters that it would be appropriate to provide a higher core maintenance session interval performance payment for beneficiaries who meet the attendance performance goal for these intervals but have not yet achieved the required minimum weight loss. However, we also intend for our performance-based payment amounts for months 7 to 12 of the core services period to financially incentivize high engagement of MDPP suppliers with the MDPP beneficiaries to whom they are offering sessions toward the goal of achieving or maintaining the required minimum weight loss.
Therefore, we believe that a performance payment of $15 for core maintenance session interval performance payments for those beneficiaries who do not achieve or maintain the required minimum weight loss during the interval but meet the interval attendance performance goal appropriately balances these objectives. We note that this payment amount reflects a significant increase of 50 percent over our proposed payment amount, yet the sizeable difference between the $60 and $15 performance payments that continues to exist for core maintenance session interval performance payments for beneficiaries who do or do not achieve or maintain the required minimum weight loss, respectively, will strongly incentivize MDPP suppliers to engage with MDPP beneficiaries to work toward achieving or maintaining the required minimum weight loss throughout the 3-month core maintenance session intervals.
Because MDPP suppliers must offer, at a minimum, monthly core maintenance sessions to all MDPP beneficiaries during months 7 to 12, regardless of the beneficiary's attendance or achievement of weight loss, we agree with the commenters that it is appropriate to reduce the
We made no proposals to change the coverage policy under circumstances where an MDPP beneficiary's attendance at sessions that must be offered by the MDPP supplier is too low to result in a performance payment to that supplier. We further note that the CDC DPRP Standards require that DPP-eligible individuals be able to access the core maintenance sessions, regardless of weight loss, in order for an organization to maintain CDC DPRP recognition. Our final policy at § 424.205(b)(1) specifies that to enroll in Medicare as an MDPP supplier, an entity must have and maintain MDPP preliminary recognition or full CDC DPRP recognition. Therefore, we are not requiring the achievement of attendance or weight loss performance goals during the first core maintenance session interval for the MDPP beneficiary to have coverage of the second core maintenance session interval, which is consistent with the CDC DPRP Standards for core maintenance session access. Because the achievement of performance goals is required for performance payments for core maintenance session intervals, eligibility and payment are not aligned during months 7 through 12 of the MDPP services period.
After considering the public comments received, we are finalizing the proposals for core maintenance session interval performance payments for core maintenance sessions at § 414.84(b)(4), with modifications. We will pay MDPP suppliers $60 for a core maintenance session 3-month interval if a beneficiary attends at least 2 sessions during the interval and achieves or maintains the required minimum weight loss during that interval, and pay MDPP suppliers $15 for a core maintenance session interval if the beneficiary attends at least 2 sessions but does not achieve or maintain the required minimum weight loss during that core maintenance session interval. The final performance payments for core maintenance session intervals are displayed in Table 33.
Similar to our proposal for the payment of core maintenance session intervals described previously, we proposed to make performance payments to MDPP suppliers for 3-month ongoing maintenance session intervals. This payment would be made when suppliers furnish ongoing maintenance sessions during the 24 months of the ongoing services period after the 12-month MDPP core services period ends. We proposed that an MDPP supplier would be paid a performance payment for an ongoing maintenance session interval if an MDPP beneficiary achieves the performance goals of attending at least 3 ongoing maintenance sessions and maintaining the required minimum weight loss from baseline measured in-person during a session at least once within that interval. Under this proposal, an MDPP supplier would not be paid a performance payment unless the beneficiary has achieved both of these
The payment structure presented in the CY 2017 PFS proposed rule (81 FR 46415 through 46416) would have required the MDPP beneficiary to attend 3 ongoing maintenance sessions and maintain the required minimum weight loss for a $45 payment to be made to an MDPP supplier for the ongoing maintenance session interval. Based on our consideration of information provided in the public comments on the CY 2017 PFS proposed rule and our increased emphasis in the performance payments on the achievement and maintenance of weight loss as the outcome of MDPP services, our proposal for the performance payment for ongoing maintenance session intervals differed from that payment amount.
We proposed that MDPP suppliers could be paid up to 8 performance payments of $50 each for ongoing maintenance session intervals. Just like the other proposals for performance payments, we proposed this payment in CY 2018 dollars to ensure consistency in calendar year dollars among performance payments for a given calendar year. However, we noted that no ongoing maintenance session interval payments, available only for intervals in the ongoing services period during months 13 through 36 of an MDPP beneficiary's MDPP services period, would be made in CY 2018 based on our proposal discussed in section III.K.2.a. of the proposed rule (82 FR 34141) that MDPP services be available on April 1, 2018. Under this proposal, MDPP services would only be available for 9 months of CY 2018 so no MDPP beneficiaries would attend ongoing maintenance sessions in CY 2018. The first ongoing maintenance session interval performance payments would be made in CY 2019 and would equal $50 adjusted by the percent change in the Consumer Price Index for All Urban Consumers (CPI-U) (U.S. city average) for the 12-month period ending June 30th, 2018, as discussed in section III.K.2.d.iii.(9) of the proposed rule (82 FR 34147 through 34148).
This proposed payment amount would be somewhat higher than the potential payment discussed in the CY 2017 PFS proposed rule (81 FR 46415 through 46416) to recognize that maintenance of the required minimum weight loss is necessary for the reduced incidence of type 2 diabetes and to encourage MDPP suppliers to work to engage beneficiaries in sustaining their weight loss over time. The maximum total performance payment for MDPP ongoing maintenance sessions would be $400, as displayed in Table 34. On a per-session basis, this payment would be approximately $17, which we believed would be appropriate for MDPP suppliers that furnish ongoing maintenance sessions to beneficiaries who maintain the required minimum weight loss during ongoing maintenance session interval. We noted that this per-session payment amount would be somewhat lower than the $20 per-session payment amount included in the core maintenance session interval performance payment for beneficiaries who achieve attendance and weight loss performance goals during the 3-month intervals in months 7 to 12 of the MDPP core services period. Like the proposed performance payment for core maintenance session intervals, the proposed performance payment for ongoing maintenance session intervals would value both attendance and weight loss. However, we believed it is likely that the required minimum weight loss would be first achieved during core maintenance session intervals, and we also believed that a somewhat higher per-session payment amount would be appropriate under these circumstances. In contrast, we believed that a somewhat lower per-session payment amount for ongoing maintenance sessions during intervals where the required minimum weight loss is maintained, rather than achieved, would be appropriate.
We considered an alternative policy in which an MDPP supplier would receive a payment for an ongoing maintenance session interval so long as the beneficiary attended at least 1 ongoing maintenance session during the interval and maintained the required minimum loss. In this scenario, we considered that the MDPP supplier would still be required to offer at least 2 additional ongoing maintenance sessions (at least one per month) to the beneficiary over the 3-month interval. However, we believed that the goal of ongoing maintenance sessions is to promote both sustained beneficiary engagement and weight loss and, therefore, we believed that ongoing maintenance session interval performance payments should be tied to achieving both attendance and weight loss performance goals.
The proposed payment policy also would align with the coverage limitations for ongoing maintenance sessions at § 410.79(c)(1)(iii) in that beneficiaries also would be required to attend all 3 sessions within a given ongoing maintenance session 3-month interval to be covered for the subsequent 3-month interval. We noted that the proposed coverage and payment policies would be aligned for ongoing maintenance session intervals, where attendance at 3 sessions within an interval would be required for a performance payment as well as for coverage of ongoing maintenance sessions in the next interval. In contrast, MDPP suppliers would be required to offer core maintenance sessions in both core maintenance session intervals for all beneficiaries, regardless of a beneficiary's attendance at core maintenance sessions, although attendance would be required for a performance payment to be made for the core maintenance session interval.
The proposed ongoing maintenance session interval performance payments for ongoing maintenance sessions were included at proposed § 414.84(b)(5). We invited public comments on these proposals. We also invited public comments on the alternative considered.
The following is a summary of the public comments received on the proposals for ongoing maintenance session interval performance payments for ongoing maintenance sessions and the alternative considered and our responses:
Several commenters expressed concern that if an MDPP beneficiary in an ongoing maintenance session 3-month interval does not achieve the 3 session attendance goal and/or does not maintain the required minimum weight loss, the MDPP supplier would not receive the performance payment for that interval. The commenters stated that MDPP suppliers would expend resources to furnish MDPP services to the MDPP beneficiary during the 3-month interval but bear the financial risk under the proposal of not getting paid if the beneficiary fails to attend at least 3 sessions and maintain the required minimum weight loss. They further noted that to achieve beneficiary attendance of 3 sessions during the 3-month interval, MDPP suppliers would likely have to offer more than 3 ongoing maintenance sessions to MDPP beneficiaries during that time period. The commenters urged CMS to change the attendance requirement for performance payment for ongoing maintenance session intervals to 2 of the 3 sessions that must be offered, in order to help more beneficiaries stay in the DPP and reduce the financial risk to the MDPP supplier. Particularly over the 24-month long ongoing services period that CMS proposed, the commenters stated that monthly beneficiary attendance could be hard to sustain and in actuality not be important, especially if the MDPP beneficiary maintains the required minimum weight loss throughout that time period.
In the proposed rule (82 FR 34145), we considered an alternative policy in which an MDPP supplier would receive a performance payment for an ongoing maintenance session interval so long as the beneficiary attended at least 1 ongoing maintenance session during the interval and maintained the required minimum weight loss, which is similar to the requests of some of the commenters that the performance payment require attendance at 2 ongoing maintenance sessions, rather than 3. However, we note that we continue to believe that the goal of ongoing maintenance sessions is to promote both sustained beneficiary engagement and weight loss and, therefore, we believe that ongoing maintenance session interval performance payments should be tied to achieving both weight loss and significant attendance performance goals. However, because MDPP suppliers must offer, at a minimum, monthly ongoing maintenance sessions to all MDPP beneficiaries with coverage of each 3-month ongoing maintenance session interval during months 13 to 24 of the MDPP services period, regardless of the beneficiary's attendance or maintenance of weight loss, we believe it is appropriate to reduce the attendance requirement for the performance payments during this time period from 3 to 2 sessions per interval.
Our reasoning for this decision is similar to our rationale for finalizing a core maintenance session interval attendance performance goal of 2 sessions for the core maintenance session interval performance payments as discussed in section III.K.2.d.iii.(4) of this final rule. Lowering the required session attendance for the performance payments during the ongoing services period will provide additional flexibility to beneficiaries to allow them to balance life events and DPP session attendance, without the decisions of beneficiaries who maintain the required minimum weight loss resulting in financial consequences for MDPP suppliers that must offer sessions regardless of actual attendance. We believe that attendance of 2 sessions in an ongoing maintenance session 3-month interval still represents substantial beneficiary engagement that promotes the integration of behavior change longer-term into a beneficiary's lifestyle in order for him or her to maintain the required minimum weight loss.
We also believe that the final shorter ongoing services period makes beneficiary attendance at 2 sessions in each 3-month interval feasible. We acknowledge that the MDPP supplier bears some risk that an MDPP beneficiary who must be offered a minimum of 3 sessions during an ongoing maintenance session interval will not attend 2 sessions and/or will not maintain the required minimum weight loss during that interval so the MDPP supplier would not receive an ongoing maintenance session interval performance payment for that interval for that beneficiary. However, we pay for the set of MDPP services through a performance-based payment methodology that makes periodic performance payments to MDPP suppliers during the MDPP services period, and the aggregate of all performance payments constitutes the total performance-based payment amount for the set of MDPP services.
Moreover, we continue to believe that maintaining the required minimum weight loss is an appropriate performance goal that must be met for an ongoing services interval performance payment to be made, given that the first ongoing maintenance session interval begins 12 months after the beginning of the MDPP services period. At that point at least half way through the maximum length of the beneficiary's MDPP services period, providing a performance payment for attendance alone would not be consistent with our emphasis in the MDPP expanded model on the achievement of the outcome of weight loss.
We note that the final attendance and weight loss performance goals for ongoing maintenance session interval performance payments are aligned with beneficiary eligibility for the subsequent ongoing maintenance session interval, a consistency that will incentivize MDPP suppliers to sustain their efforts regarding beneficiary engagement and minimize MDPP supplier and beneficiary confusion about MDPP services during the ongoing services period. Due to this alignment, the MDPP
We appreciate the support of the commenters for the proposed ongoing maintenance session interval performance payment amount of $50. Given our emphasis in the MDPP expanded model on the achievement of the required minimum weight loss that results in a reduced incidence of type 2 diabetes, we believe it is appropriate to adopt this payment amount under the performance-based payment methodology because the performance payment is only made if the beneficiary maintains the required minimum weight loss. Reducing the payment amount would lessen our emphasis on maintaining weight loss, which would be contrary to our interest in improving the health of beneficiaries through MDPP services that ultimately lead to lower Medicare expenditures.
After considering the public comments received, we are finalizing the proposals for ongoing maintenance session interval performance payments for ongoing maintenance sessions at § 414.84(b)(5), with modifications. We will pay MDPP suppliers $50 for an ongoing maintenance session 3-month interval if a beneficiary attends at least 2 sessions during the interval and maintains the required minimum weight loss during that interval. The final performance payments for ongoing maintenance session intervals are displayed in Table 35.
We proposed that if a beneficiary achieves the required minimum weight loss measured at any session attended during the core services period, an MDPP supplier would be paid the weight loss performance payment of $160 displayed in Table 36. As discussed in section III.K.2.d.iii.(2)(a) of the proposed rule (82 FR 34139 through 34141), we proposed that 23 percent of the maximum total performance payment amount for the set of MDPP services would be paid for the achievement of weight loss, regardless of session attendance, because weight loss is the most important outcome for the MDPP expanded model. The proposed performance payment of $160 for the required minimum weight loss, which constitutes approximately 90 percent of the maximum total weight loss performance payment, was proposed to be the large majority of the available weight loss performance payment based on the strong evidence for the association of the required minimum weight loss with a reduction in the incidence of type 2 diabetes.
We noted that this association is evidenced by the CDC's National DPP, which is based on the 2002 DPP Randomized Control Trial and follow-up efficacy trials.
We also proposed that, in addition to the weight loss performance payment for the required minimum weight loss, an MDPP supplier would be paid an additional weight loss performance payment of $25 if the beneficiary achieves at least 9 percent weight loss from his or her baseline weight at any time during the MDPP services period as displayed in Table 36. We proposed this additional weight loss performance payment based on information from stakeholders that commercial payers paying for DPPs frequently include an incentive payment for 9 percent weight loss as an incentive to try to encourage greater and/or continued weight loss and behavior change. We believed that making an additional weight loss performance payment for 9 percent weight loss at any time during the MDPP services period would provide an additional incentive for MDPP suppliers to continue weight loss efforts with beneficiaries, especially during the ongoing services period, which may extend for a period of up to 24 months.
We proposed that MDPP suppliers may submit claims for these weight loss performance payments on the date when the beneficiary first reaches the
The proposed weight loss performance payments were included at proposed § 414.84(b)(6) and (7). We invited public comments on these proposals.
The following is a summary of the public comments received on the proposals for weight loss performance payments and our responses:
Several commenters recommended that CMS gradually phase-in the percentage of weight loss required for the first weight loss performance payment during implementation of the MDPP expanded model, to allow MDPP suppliers to follow a learning curve in starting up their DPP. One scenario described by the commenters would provide a performance payment for 3 percent weight loss in the DPP organization's first year in the MDPP expanded model, 4 percent in the second year, and 5 percent in the third year and thereafter.
A few commenters requested that CMS eliminate the weight loss performance payment entirely to help avoid putting MDPP suppliers serving low-resources communities at immediate risk. Alternatively, the commenters suggested that CMS could guarantee the amount of weight loss performance payment for MDPP suppliers below a certain volume of beneficiaries, while making the payment for weight loss based on actual performance for MDPP suppliers of a larger size or to MDPP suppliers in a pooled group so that random variation in beneficiary weight loss could be overcome. Another commenter noted that a beneficiary's weight can fluctuate during the MDPP services period and, as such, a general downward trend in weight may be a more valid measure of progress than a percentage weight loss over a prescribed interval.
One commenter pointed out that professional care guidelines about weight loss do not translate population health averages to individual treatment targets, and in using 5 percent weight loss as the performance goal to determine payment for an individual Medicare beneficiary, the commenters observed that CMS did not value the significant health benefit for individual beneficiaries of lower levels of weight loss. The commenter further noted that the 5 percent weight loss performance payment per MDPP beneficiary did not align with the CDC's DPRP Standards, which are DPP-wide achievement of an average of 5 percent weight loss across those patients who attend 4 or more sessions.
Several commenters urged CMS to reduce the proposed amount of the 5 percent weight loss performance payment to approximately 10 percent of the maximum available total performance payment per beneficiary from the 20 percent CMS proposed and redistribute the dollars to attendance-based payments for sessions during the core services period.
Furthermore, because there is no specific number of beneficiaries per MDPP supplier, we do not believe it would be appropriate to make weight loss performance payments based on program-wide achievement of 5 percent weight loss, rather than individual beneficiary weight loss, because this would reduce an MDPP supplier's incentive to actively help each beneficiary to meet the required minimum weight loss, particular if a few beneficiaries lost a large percentage of their weight. While we aim to maintain consistency to the extent possible with CDC's DPRP Standards, we note that standards for full recognition status, which require
In response to the commenters who urged us to reduce the proposed 5 percent weight loss performance payment from 20 percent to 10 percent of the maximum total performance payment amount per beneficiary and redistribute the dollars to attendance-based payments in the core services period, we continue to emphasize that the achievement and maintenance of the required minimum weight loss is the outcome of MDPP services that is associated with a reduction in the incidence of type 2 diabetes. Therefore, we do not believe it would be appropriate to reduce the amount of the performance payment for 5 percent weight loss to less than the $160 we proposed, because that would reduce the emphasis on the weight loss outcome in the performance payments.
However, as discussed in section III.K.2.d.iii.(5) of this final rule, the maximum total performance payment for ongoing maintenance session intervals has been reduced due to the shortening of the ongoing services period from the 24 months that we proposed to 12 months in this final rule. Dollars for performance payments that would have been made for ongoing maintenance session intervals in months 25 to 36 of the MDPP services period have been partially redistributed to attendance-based performance payments for core sessions during the first 6 months of the MDPP services period, as discussed in section III.K.2.d.iii.(3) of this final rule. This is consistent with the interests of the commenters who requested a redistribution of a portion of the 5 percent weight loss performance payment in order to increase attendance-based payments for sessions in the core services period. Finally, we note that because the maximum total performance payment amount per beneficiary is $670 as discussed in section III.K.2.d.iii.(2)(a) of this final rule, which is lower than the $810 that we proposed, the final $160 5 percent weight loss performance payment is actually a higher percentage (24 percent) than the proposed 20 percent of the maximum total performance payment amount.
We recognize that 9 percent weight loss may not be realistic or appropriate for every MDPP beneficiary. However, by finalizing the performance payment for 9 percent weight loss as $25, which is less than 4 percent of the maximum total performance payment amount available for an MDPP beneficiary, we will not provide such a high incentive to MDPP suppliers that we risk MDPP suppliers encouraging continued weight loss for those beneficiaries who are unlikely to benefit from weight loss beyond the required minimum.
After considering the public comments received, we are finalizing our proposals, without modification, for the weight loss performance payments at § 414.84(b)(6) and (7). The final weight loss performance payments are displayed in Table 37.
In summary, for furnishing MDPP services during the MDPP services period, we proposed that MDPP suppliers could be paid a minimum of $25 per beneficiary (if the beneficiary attends the first core session) and a maximum total of $810 per beneficiary (if the beneficiary achieves all performance goals, maintains eligibility for 36 months, and does not change MDPP suppliers). Table 38 summarizes all of the proposed performance payments for the set of MDPP services that were discussed in sections III.K.2.d.iii.(3) through (6) of the proposed rule (82 FR 34141 through 34146).
We proposed that the payment methodology for MDPP services be performance-based in relation to the achievement of the performance goals of session attendance and weight loss. While we acknowledge that licensed health professionals have training and a scope of practice that extends beyond community health workers who are trained DPP coaches, for purposes of the performance payments for MDPP services we see no reason to value in the payment methodology the MDPP beneficiary's achievement of the same performance goals differently based on additional credentials of the coach who furnished the session that resulted in the performance goal being met. The literature does not demonstrate that DPP sessions furnished by coaches with additional credentials result in greater achievement of patient outcomes than sessions furnished by coaches without additional credentials, where all coaches meet the CDC's DPRP Standards.
Therefore, we are not adopting any requirements to govern how an MAO pays its network providers—either in amount or structure—for MDPP services and believe that existing law adequately addresses when an out-of-network provider furnishes covered MDPP services. We note that as it appears unlikely that any MDPP services would be furnished as emergency or urgently needed services, we anticipate that the out-of-network payment requirements would be applicable only for MA private fee-for-service plans, MA point-of-service (POS) plans, or MA preferred provider organization (PPO) plans that regularly cover out-of-network services. Under these existing authorities, MA plans currently have flexibility in their payment methodologies for Part B services furnished to MA plan enrollees through network providers. Because MDPP services are covered under Part B, MA plans will have this same payment flexibility for MDPP services furnished by network providers to MA plan enrollees.
Table 39 summarizes all of the final performance payments for the set of MDPP services that were individually finalized in sections III.K.2.d.iii.(3) through (6) of this final rule.
Although Medicare is a national program, it frequently adjusts fee-for-service payments to hospitals, physicians, and other providers and suppliers according to the geographic locations in which they furnish services. These adjustments generally account for differences in the relative costs of doing business in different geographic areas compared to the national average. For example, section 1886(d)(3)(E) of the Act requires that, as part of the methodology for determining prospective payments to hospitals, the Secretary must adjust the standardized amounts for area differences in hospital wage levels by a factor (established by the Secretary) reflecting the relative hospital wage level in the geographic area of the hospital compared to the national average hospital wage level. This adjustment factor for hospitals is the wage index, and we currently define hospital geographic areas (labor market areas) based on the definitions of Core-Based Statistical Areas (CBSAs) established by the Office of Management and Budget. Similarly, a geographic adjustment is also made for services paid under the PFS, and a geographic practice cost index (GPCI) has been established for every Medicare PFS payment locality, many of which are statewide, for each of the three components of a service's relative value units (that is, the relative value units for work, practice expense, and malpractice).
We proposed to make performance-based payments to MDPP suppliers in intervals based on achievement of performance goals, rather than fee-for-service payments for individual services furnished. Although we intended for those performance payments to make
Therefore, we did not propose geographic adjustment of performance payments for MDPP services. However, we invited public comments on issues related to geographic adjustment of payment for MDPP services in the context of the MDPP performance-based payment methodology, including appropriate sources of information for determining any geographic cost differences. We noted that we may consider proposing additional payment policies for the MDPP expanded model in the future. We requested that commenters submitting information on these issues provide justification, including any relevant analysis, to support any suggestions regarding potential future geographic adjustment of performance-based payments for MDPP services.
The following is a summary of the public comments received on issues related to geographic adjustment of payment for MDPP services in the context of the proposed MDPP performance-based payment methodology, including appropriate sources of information for determining any geographic cost differences, and our responses:
We will review the suggestions provided by the commenters, as well as our early implementation experience with the MDPP expanded model and other information we receive in the future from stakeholders, as we consider proposing additional payment policies for the MDPP expanded model in the future, as appropriate.
First, MDPP services are available under the MDPP expanded model, which has been expanded in duration and scope under section 1115A(c) of the Act. Therefore, while a new service, coverage of MDPP services does not result from a legislative change or a national coverage determination. Second, we recognize that MA plans may negotiate contracts with MDPP suppliers that require the MA plan to pay more than the payments finalized in this final rule (that would pay MDPP suppliers a maximum total performance payment amount of $670 in CY 2018, as described in section III.K.2.d.iii.(2)(a) of this final rule, for furnishing MDPP services to fee-for-service beneficiaries). However, even where an MA plan enters into a contract that pays MDPP suppliers an amount that is substantially higher than the amount that would result from the policies finalized in this final rule, the costs associated with MDPP services objectively fail to rise to the level of a “significant increase” in the costs of providing benefits under contracts entered into under section 1857 of the Act. Further, the CY 2017 PFS final rule adopting the set of MDPP services as an additional preventive benefit under Part B (published in the November 15, 2016
To account for inflation, we proposed to update MDPP payment amounts annually based on the CPI-U. The CPI-U is a measure of the average change over time in prices paid for a market basket of consumer goods and services, and is a measure of economy-wide inflation. There are no statutory requirements for the update factor for payments for MDPP services so there is no requirement that a productivity adjustment be applied to the MDPP services update factor as there are for certain other Medicare-covered items and services where prices are updated by the CPI-U, such as the Clinical Laboratory Fee Schedule; Durable Medical Equipment, Prosthetics/Orthotics, and Supplies Fee Schedule; Ambulance Fee Schedule; and
We considered using other indices such as the Medicare Economic Index (MEI) to update the MDPP payment amounts. The MEI measures price changes in the inputs required to operate a self-employed physician practice. We did not believe that the MEI would be appropriate to update MDPP payment amounts because MDPP suppliers are not similar to self-employed physician practices. We noted that the CPI-U by definition is an economy-wide measure of inflation and, therefore, in the absence of an appropriate specific index for MDPP services, we believed the CPI-U to be the most technically appropriate index available to update payments for MDPP services. We further noted that the CPI-U is used to update Medicare payments for other Medicare-covered items and services, such as ambulance, clinical laboratory, and ambulatory surgical center services.
We proposed to update MDPP performance payments and the bridge payment (a proposed one-time payment to an MDPP supplier for furnishing its first session to an MDPP beneficiary who has previously received MDPP services from a different MDPP supplier as discussed in detail in section III.K.2.d.v. of the proposed rule (82 FR 34153 through 34155)) that may be paid to MDPP suppliers in the following manner:
• Beginning in CY 2019 and each year forward, the performance payment and bridge payment amounts would be adjusted by the 12-month percent change in the CPI-U (U.S. city average) for the period ending June 30th of the year preceding the update year. The percent change update would be calculated based on the level of precision of the index as published by the Bureau of Labor Statistics and applied based on one decimal place of precision. The annual MDPP services payment update would be published by CMS transmittal.
The proposed methodology to update MDPP performance payments and the bridge payment was included at proposed § 414.84(d). We invited public comments on this proposal.
The following is a summary of the public comments received on the proposal for the methodology to update MDPP performance payments and the bridge payment and our responses:
After considering the public comments received, we are finalizing the proposal, without modification, to update MDPP performance payments and the bridge payment at § 414.84(d).
We proposed that performance payments and bridge payments to MDPP suppliers for MDPP services would be made only on an assignment-related basis in accordance with § 424.55. As described in Chapter 1, Section 30.3 of the Medicare Claims Processing Manual,
Consistent with our established requirements for these other types of suppliers, some of whom are similar to MDPP suppliers in that they furnish a limited breadth of Medicare-covered services, we believed that it would be appropriate to require all MDPP suppliers, whether they are participating or not participating in Medicare, to accept assignment. We also believed that making performance payments for MDPP services solely on an assignment-related basis would be the most appropriate methodology, given the proposed performance-based MDPP payment methodology which would be based on the achievement of weight loss and/or attendance performance goals and not based on the MDPP supplier resource expended to furnish individual MDPP services. We further noted that as finalized in the CY 2017 PFS final rule (81 FR 80464), MDPP services are additional preventive services under section 1861(ddd) of the Act and, therefore, consistent with section 1833(a)(1)(W) of the Act, are not subject to the Medicare Part B coinsurance or deductible. Under our proposal, Medicare would pay 100 percent of the Medicare allowed charge for MDPP services furnished to MDPP beneficiaries, and a beneficiary would have no liability for covered MDPP services. MDPP suppliers would be required to accept the Medicare allowed charge as payment in full and would not be able to bill or collect from the beneficiary any amount.
Finally, to minimize the potential administrative burden on beneficiaries related to payment for MDPP services on an assignment-related basis, we proposed that for purposes of claims for services submitted by an MDPP supplier, Medicare would deem such claims to have been assigned by the beneficiary (or the person authorized to request payment on the beneficiary's behalf) and the assignment accepted by the MDPP supplier. This proposed treatment of claims from MDPP suppliers in new § 424.55(d) would be consistent with the current exception in § 424.55(c) regarding payment to a supplier, which specifies that when payment under the Act can only be made on an assignment-related basis or when payment is for services furnished by a participating physician or supplier, the beneficiary (or the person authorized to request payment on the beneficiary's behalf) is not required to assign the claim to the supplier in order for an assignment to be effective.
The proposed assignment-related basis for performance payments and bridge payments made to MDPP suppliers was included at proposed § 414.84(b) and (c). The proposal not to require the beneficiary to assign the claim for MDPP services to the MDPP supplier in order for assignment to be
The following is a summary of the public comments received on the proposals for the assignment-related basis for performance payments and bridge payments made to MDPP suppliers and the proposal not to require the beneficiary to assign the claim for MDPP services to the MDPP supplier in order for assignment to be effective and our responses:
After considering the public comments received, we are finalizing the proposals, without modification, to make performance payments and bridge payments to MDPP suppliers on an assignment-related basis at § 414.84(b) and (c). In additional, we are finalizing the proposal, without modification, not to require the beneficiary to assign the claim for MDPP services to the MDPP supplier in order for assignment to be effective at § 424.55(d).
We proposed that MDPP suppliers may only submit claims for a performance payment or bridge payment for MDPP services when all of the requirements for the payment are met. Claims for services that do not meet these requirements will not be paid. In accordance with § 424.80, we reminded MDPP suppliers that there are exceptions to the prohibition of reassignment of claims by suppliers for certain arrangements provided the applicable requirements are met. We noted that Medicare may pay an agent who furnishes billing and collection services to the supplier if the conditions of § 424.80(b)(5) are met.
Proposed requirements for performance payments and the bridge payment included that the MDPP services were furnished to a beneficiary eligible for MDPP services as specified at § 410.79(c) and that the MDPP supplier complies with all applicable enrollment and program requirements. In addition, we proposed that the MDPP services must be furnished by an eligible coach on or after his or her coach eligibility start date and, if applicable, before his or her coach eligibility end date, and the MDPP supplier must submit the National Provider Identifier (NPI) of the coach on MDPP claims. We described additional details on how eligible coach information would be processed in section III.K.2.d.iii.(10)(d) of the proposed rule (82 FR 34151 through 34152). All specific additional proposed requirements for the performance payment or bridge payment, as discussed in sections III.K.2.d.iii.(3) through (6) and III.K.2.d.v. of the proposed rule (34141 through 34146 and 34153 through 34155), would also need to be met.
In order to submit a claim for a performance payment under the MDPP expanded model, the billing supplier is required to have documentation in the beneficiary's MDPP record, as specified in proposed § 424.205(g), that all requirements for the payment, including the achievement of the performance goal(s) applicable to the performance payment, have been met. We noted that the billing supplier's MDPP record for the beneficiary may include a copy of the beneficiary's MDPP record from a previous MDPP supplier that has been provided to the billing supplier at the request of the MDPP beneficiary. If an MDPP supplier is submitting a claim for an interval performance payment based on attendance at more than one session, this copy of the MDPP record from the previous MDPP supplier may be used as part of the billing supplier's documentation demonstrating that the attendance or weight loss performance goal for the performance payment was achieved. We noted that as we finalized at § 424.59(b) in the CY 2017 PFS final rule (proposed to be redesignated and amended at § 424.205(g)), MDPP suppliers are required to maintain and handle any personally identifiable information (PII) and protected health information (PHI) in compliance with HIPAA, other applicable state and federal privacy laws, and CMS standards. Therefore, MDPP suppliers must follow these rules, as applicable, when providing any copies of information from a beneficiary's MDPP records to another MDPP supplier.
We proposed that any weight loss measurement taken and recorded by an MDPP supplier for the purposes of performance payments must be taken in-person during an MDPP core session, core maintenance session, or ongoing maintenance session by the MDPP supplier during the MDPP services period. We believed that in-person measurements would be the most feasible method for weight ascertainment at this time for services because the beneficiary would attend regular in-person sessions with the MDPP supplier. Moreover, we believed that self-reported weight loss would not be reliable for the purposes of performance payment in the MDPP expanded model. This proposal also would apply to our proposed policy regarding virtual make-up sessions, described in detail in section III.K.2.c.iv.(3) of the proposed rule (82 FR 34136 through 34137), meaning that weight loss could not be measured or reported during a virtual make-up session for the purpose of the MDPP supplier submitting a claim for a performance payment. We also proposed to require that weight loss be measured in-person at an MDPP session to align with CDC's DPRP standards, which require for in-person sessions that weight be measured in-person at the session.
In addition, we noted that the achievement or maintenance of the required minimum weight loss that determines the performance payment amount for a core maintenance session interval and the maintenance of the required minimum weight loss that determines whether a performance payment for an ongoing maintenance session interval would be made must be determined by an in-person weight measurement at a session furnished during the applicable interval. Thus, for these interval performance payments, achievement of the performance goal for minimum weight loss would not need to be determined based on attendance at a session furnished by the MDPP supplier billing for that performance payment. However, as discussed previously, if achievement of the performance goal for minimum weight loss was measured at a session furnished by a previous MDPP supplier in the interval, the subsequent supplier must have documentation through a copy of the beneficiary's MDPP record from that previous supplier that the weight loss performance goal was met in the interval to bill for the interval performance payment. Finally, the performance payments for the required
Furthermore, we proposed that the beneficiary must achieve the applicable attendance performance goal for core session, core maintenance session interval, or ongoing maintenance session interval performance payments upon attendance at a session furnished by the MDPP supplier billing for that specific performance payment. An MDPP supplier could only bill for a performance payment on the date the beneficiary has achieved all performance goals associated with that performance payment. We noted that in order to bill for an interval performance payment that is based on attendance, the MDPP supplier that furnished the session where the attendance goal is met would bill for the performance payment, even if that supplier did not itself furnish all sessions attended by the MDPP beneficiary during that interval. In these circumstances, as discussed previously, if attendance at a session furnished by a previous MDPP supplier occurred in the interval, the subsequent supplier must have documentation through a copy of the beneficiary's MDPP record from that previous supplier of the session attendance in order to bill for the interval performance payment based on attendance at that session. An MDPP supplier may not bill for an interval performance payment when the MDPP supplier does not furnish the session where the attendance goal is met.
For all interval performance payments, we proposed that the performance payment would be based on the date the MDPP supplier furnished the session where the interval attendance performance goal is met. Thus, for those intervals where the performance payment would be based on MDPP beneficiary session attendance that spans 2 calendar years, the interval performance payment would be the amount applicable to the later calendar year, reflecting the annual update from the prior year as discussed in section III.K.2.d.iii.(9) of the proposed rule (82 FR 34147 through 34148).
The proposed conditions for payment by CMS of performance payments and bridge payments to MDPP suppliers were included at proposed § 414.84(b) and (c). We invited public comments on these proposals.
We received no public comments specific to the proposed conditions for payment of performance payments and bridge payments to MDPP suppliers.
We are finalizing the proposals, without modification, for the conditions for payment of performance payments and bridge payments to MDPP suppliers at § 414.84(b) and (c).
We proposed to establish 19 unique Healthcare Common Procedure Coding System (HCPCS) G-codes so that MDPP suppliers may submit claims for payment when all the requirements for billing the codes have been met. Our proposal for the HCPCS G-codes is displayed in Table 40.
We noted that each MDPP supplier would be able to bill one of the 18 payable HCPCS G-codes on the date when all the requirements for billing the code have been met, including the session attendance for specific core and ongoing maintenance session intervals and achievement and/or maintenance of weight loss, as applicable to the specific HCPCS G-code. One of the proposed HCPCS G-codes would be nonpayable and assigned a payment amount of $0 because it would only be reported on a claim that also includes a payable HCPCS G-code for MDPP services as described subsequently.
HCPCS G-codes GXXX1 through GXXX3 and GXXX8 through GXX17 may each be paid only once in a beneficiary's lifetime, and the Medicare claims processing system would ensure that no more than one of each specific performance payment per beneficiary reported with these HCPCS G-codes is made. In addition, because only one performance payment may be made for each core maintenance session interval per beneficiary, the claims processing system would also ensure that no more than one unit of HCPCS code GXXX4 or GXXX6 and no more than one unit of HCPCS code GXXX5 or GXXX7 was paid in a beneficiary's lifetime.
Due to these lifetime limitations on payment for certain HCPCS codes for each beneficiary, in the circumstances where two MDPP suppliers furnished sessions during the MDPP services period and both MDPP suppliers met all requirements for billing the same HCPCS G-code, based on our operational processes, we would pay the first valid claim received and deny the second claim. The first valid claim received for a beneficiary for a given HCPCS G-code with a lifetime limitation would be determined through the CMS' Common Working File (CWF), which processes claims for all MACs.
Based on information from the CDC's national DPP, we expected that circumstances where a beneficiary changes MDPP suppliers during the MDPP services period would be uncommon. In addition, in view of the typical structure of DPPs where core sessions are offered weekly for the first 6 months of the core services period, and then offered monthly, we believed it would be rare for more than one MDPP supplier to meet the requirements for billing for the same once-per-lifetime performance payment. However, as an example an MDPP beneficiary could maintain the required minimum weight loss throughout the first core maintenance session interval and attend 3 sessions furnished by one MDPP supplier in the first 1
Finally, as discussed in section III.K.2.d.v. of the proposed rule (82 FR 34153 through 34155), we did not propose to limit the number of bridge payments, which would be reported with HCPCS code GXX18, that may be paid for an MDPP beneficiary who changes MDPP suppliers during the MDPP services period.
We also stated that we plan to issue specific billing instructions to MDPP suppliers for those 14 proposed HCPCS G-codes (excluding GXXX1, GXXX8, GXXX9, GXX18, and GXX19) that represent an interval performance payment where attendance at more than 1 session is required for the performance payment to be made. Suppliers would report the applicable HCPCS G-code as a line-item on the claim on the date the session was furnished where the interval attendance goal was met. On the same claim, suppliers would also report 1 line-item of HCPCS code GXXX19 for each other session furnished by the supplier during the interval that was not previously reported on a claim but that counts toward achievement of the attendance performance goal for the applicable HCPCS G-code.
When billing for a HCPCS G-code that represents a cumulative number of MDPP sessions where some sessions already have been reported on a previous claim, only the sessions not previously reported on a claim would be reported by the MDPP supplier. For example, HCPCS code GXXX3 (9 total core sessions attended) would be used to bill for 9 core sessions attended, and the line-item of HCPCS code GXXX3 would represent the 9th core session furnished. Separate line-items of HCPCS code GXX19 would be reported on the same claim only for the 5th through 8th core sessions furnished by the MDPP supplier. Claims for HCPCS codes GXXX1 (1st core session attended) and GXXX2 (4 core sessions attended) would already have been submitted, and those claims would have included line-items for the 1st core session, and for the 2nd, 3rd, and 4th core sessions.
We believed that instructing MDPP suppliers to report a line-item for each session on a single claim submitted for an interval performance payment would simplify the tracking and administrative activities of MDPP suppliers and the reporting of the coach NPI on claims for MDPP services furnished to beneficiaries as discussed in section III.K.2.d.iii.(10)(d) of the proposed rule (82 FR 34151 through 34152). We further believed that there should be no significant administrative burden for MDPP suppliers to include information on all sessions they furnished on interval performance payment claims for two reasons. First, the documentation requirements for MDPP sessions at § 424.205(g), including the beneficiary's eligibility, specific session topics attended, the NPI of the coach who furnished the session attended, the date and place of service of sessions attended, and weight, would require the MDPP supplier to document and retain this information. Therefore, MDPP suppliers would have documentation of the date of each session and the NPI of the furnishing coach for reporting on each line-item on the claim for the interval performance payment. Second, MDPP suppliers would be instructed not to submit separate claims for each session represented in an interval performance payment. All sessions would be reported on the single claim that would be submitted for the interval performance payment.
In the case of an MDPP supplier submitting a claim for an interval performance payment where the billing supplier did not furnish all the sessions attributable to the interval because another supplier had furnished some of the first sessions in the interval, the billing supplier would report on the claim only the sessions it furnished. However, the supplier would need to maintain MDPP records documenting that all requirements, including session attendance and achievement or maintenance of weight loss, if applicable, for billing the HCPCS G-code for the interval for the beneficiary were met. Any sessions covered by the interval performance payment HCPCS G-code but not furnished by the supplier submitting the claim for that interval would not be reported as separate line-items on the claim. However, the billing supplier would need to maintain in the beneficiary's MDPP record a copy of his or her MDPP record from the previous supplier in order to consider sessions furnished by the previous supplier in determining that the performance goal(s) for the interval performance payment were met.
Although the NPIs of the coaches who furnished such sessions that would not be reported as separate line-items would also not be recorded on the claim, the billing supplier would still be required to maintain documentation in the beneficiary's MDPP record of the NPI of each coach who furnished each session through a copy of the beneficiary's MDPP record about those sessions from the previous supplier. Therefore, upon medical review, CMS and its contractors would be able to review and assess the remaining coaches who furnished sessions to Medicare beneficiaries associated with a claim submitted for a given interval performance payment HCPCS G-code, but who do not have an NPI reported on the claim. Because we expected it to be uncommon for suppliers not to furnish all sessions attributable to an interval and due to the administrative burden that could result from a requirement that an MDPP supplier report specific information on sessions on a claim that the particular supplier did not itself furnish, we believed that the program integrity risk associated with the limitation in the completeness of information from administrative claims data under this scenario would be low. However, we would monitor the completeness of reporting line-items on claims for interval performance payments and may consider revising our billing instructions in the future if we determine that we lack information from administrative claims on a significant number of sessions furnished to MDPP beneficiaries.
We invited public comments on the proposals to create 19 HCPCS G-codes for billing for the performance payments and bridge payment.
The following is a summary of the public comments received on the proposals to create 19 HCPCS G-codes for billing for the performance payments and bridge payment and our responses:
A number of commenters recommended that CMS reduce the number of HCPCS G-codes for MDPP services from the 19 new codes proposed. Several commenters urged CMS to provide payment for each MDPP session furnished by streamlining coding to only establish a separate HCPCS G-code for each type of session (core, core maintenance, and ongoing maintenance), coupled with a performance payment when the required minimum weight loss is achieved, in order to substantially simplify coding and billing. One commenter requested that CMS align the MDPP expanded model HCPCS codes and billing requirements with established Medicare diabetes self-management education and training services codes and billing policies. Another commenter reasoned that the more CMS can simplify the coding requirements for the MDPP expanded model and work to align the billing and coding processes with private health plans, the better the chance of broader, more meaningful access to and participation in MDPP services for patients. In contrast, a commenter reported that the claims submission and payment processes have been difficult to date for DPP organizations to implement under current private health plan processes and, therefore, encouraged CMS to streamline its proposed processes.
Several commenters urged CMS to pay separately for the MDPP supplier administrative resources necessary to deliver MDPP services, including the preparation and submission of claims. One commenter noted that community-based organizations may be unfamiliar with Medicare billing requirements and recommended that CMS provide separate payment for an entity that serves as an Integrator between MDPP suppliers, CMS, and other payers.
We also understand that entities that enroll in Medicare as MDPP suppliers and have not previously billed Medicare for services will have a learning curve in preparing claims. However, we view this learning as unavoidable with the enrollment as MDPP suppliers of different types of organizations that do not already furnish other types of services to Medicare beneficiaries. We are committed to providing clear guidance to MDPP suppliers on coding and billing for MDPP services to support suppliers' implementation of the most efficient and accurate processes for their respective organizations.
Claim preparation and submission is the responsibility of the MDPP supplier or their billing agent, and Medicare may pay the MDPP supplier or an agent who furnishes billing and collection services to the supplier if the conditions of § 424.80(b)(5) are met. We will not make separate payments to MDPP suppliers for the administrative activities related to claims preparation and submission, nor will we provide separate payments to an entity that serves as an Integrator between CMS, MDPP suppliers, and other payers. MDPP suppliers will bear the cost of these activities.
As several commenters recognized, one of the more significant challenges for MDPP suppliers in billing correctly will be identifying and tracking where the beneficiary is in the MDPP services period, which defines what MDPP services must be offered to the beneficiary, as well as the HCPCS G-codes that can be reported for
In terms of the alignment of the MDPP expanded model HCPCS G-codes and billing requirements with those currently used for diabetes self-management education and training services, we note that diabetes self-management education and training services are subject to different requirements than MDPP services that are paid based on a performance-based payment methodology specifically established for this expanded model. Therefore, the codes and billing requirements for these different services are not aligned. In terms of alignment with processes used by private payers, the commenters did not provide specific information regarding these processes that we understand, in some cases, are based on invoices and not based on claims. While we appreciate the interest of the commenters in using similar claims processes for all patients in a DPP, regardless of payer, to reduce confusion and administrative burden on the MDPP supplier, this is not feasible given the specific requirements that apply to MDPP services furnished under the MDPP expanded model and the standard CMS claims processing systems upon which the MACs rely to process and pay Medicare claims.
Regarding the requests of some commenters that we reduce the number of HCPCS G-codes to have only a single code for each type of session, we note that our operational processes will edit in the claims processing system to ensure that we make only a maximum of one of each type of performance payment per beneficiary due to the lifetime limitation on MDPP services. Moreover, only the MDPP supplier submitting the claim for a performance payment will know whether or not the beneficiary has achieved or maintained the required minimum weight loss, as the beneficiary's weight is not submitted on administrative claims. Because the majority of the performance payments are in some way related to the achievement or maintenance of the required minimum weight loss, either through identifying whether or not any performance payment should be made or determining the specific performance payment amount to be paid, and the MDPP supplier has documentation of the beneficiary's weight for each session furnished in-person, we believe the MDPP supplier is in the best position to prepare an accurate claim that identifies the specific performance payment that applies to the MDPP services furnished to the beneficiary.
Therefore, each performance payment and the bridge payment require separate payable HCPCS G-codes to be reported on claims to allow editing in the claims processing system for the once-per-lifetime limitation on the performance payment and to apply the policies for the bridge payment. Additionally, a nonpayable HCPCS G-code must be reported as a separate line-item on a claim for a payable HCPCS G-code for each additional session furnished by the billing supplier that counts toward achievement of the attendance performance goal for the payable HCPCS G-code so that we are able to monitor for compliance with the attendance requirement for the performance payment. While we proposed 19 new HCPCS G-codes for the MDPP expanded model, because we are finalizing an ongoing services period maximum duration of 12 months, rather than the 24 months that we proposed, 4 of the proposed HCPCS G-codes for reporting MDPP services in months 25 to 36 of the ongoing services period are not needed. Therefore, we are establishing 15 new HCPCS G-codes, effective April 1, 2018, for the MDPP expanded model. The final HCPCS G-codes and their long descriptors are displayed in Table 41.
We will monitor the frequency of circumstances where we receive two claims from different MDPP suppliers for the same performance payment for the same MDPP beneficiary and, if
Given the commenter's questions about the circumstances when an MDPP supplier may charge a beneficiary for DPP services furnished when the beneficiary is not eligible for MDPP services, we want to further clarify which DPP services are considered covered as a part of the set of MDPP services and, therefore, charging beneficiaries for these services furnished during the MDPP services period would not be permitted. As defined at § 410.79(a) and (c)(2), the core services period consists of,
These provisions establish the minimum number of sessions an MDPP supplier must offer during these months as a part of the set of MDPP services, as required at § 424.205(d)(10), but do not establish an upper limit on the number of MDPP sessions that can be offered under these time periods. An MDPP supplier may offer sessions beyond what are required under the MDPP expanded model. However, any additional MDPP services offered beyond the minimum required during the core and ongoing services periods would still be subject to the requirements at § 410.79(a) and (c)(2) and, as an additional preventive service, no cost-sharing can be applied to MDPP services. Thus, an MDPP supplier may not charge an MDPP beneficiary for any additional MDPP services furnished beyond the minimum that must be offered during the core services period or during the ongoing services period, provided that the beneficiary is eligible for MDPP services and is in his or her MDPP services period.
After considering the public comments received, we are finalizing the proposals to establish new HCPCS
In the CY 2018 PFS proposed rule (82 FR 34151), we also invited public comment on matters related to billing instructions for MDPP suppliers that we plan to issue to require the reporting of additional session line-items on claims for MDPP services so that information on the date and coach NPI for each session furnished by the billing supplier would be submitted on claims. However, we noted that we intend to provide additional claims submission instructions in guidance.
The following is a summary of the public comments received on matters related to billing instructions for MDPP suppliers that we plan to issue to require reporting additional session line-items on claims for MDPP services so that information on the date and coach NPI for each session furnished by the billing supplier would be submitted on claims and our responses:
In the CY 2017 PFS final rule, we established the policy that coaches will not enroll in Medicare for purposes of furnishing MDPP services, but that they will be required to obtain NPIs. Further details on these policies are described in section III.K.2.e.iii. of the proposed rule (82 FR 34158 through 34166).
As stated in Chapter 26, Section 10.4 of the Medicare Claims Processing Manual,
Although only MDPP suppliers, not coaches, would be subject to potential Medicare administrative actions related to payments the suppliers may receive, we believed that our proposal to require the NPI of the coach who furnished the session to be reported as the rendering provider for each line-item HCPCS G-code on a claim for MDPP services would provide us with a number of program integrity protections, including the ability to monitor MDPP coach activity to identify suspected fraud or other improper payments and to determine the need for medical review or investigation as appropriate. We would only process claims for payment of MDPP services when all of the coach NPIs reported on the claim are associated with eligible coaches who have been submitted on the coach roster in the MDPP supplier's enrollment application, and when all of the coaches have successfully completed Medicare's screening processes. We would also only process claims for payment of MDPP services furnished by a coach on or after his or her coach eligibility start date, and, if applicable, prior to his or her coach eligibility end date, as the definitions of these terms were included in proposed § 424.205(a).
Without such program integrity protections, we would lack a sufficient method to verify that payment is being made for services furnished by a coach who has met the requirements outlined in section III.K.2.e.iii. of the proposed rule (82 FR 34158 through 34166). This verification would help protect both Medicare beneficiaries and the Medicare Trust Funds. Including coach NPIs on claims could also encourage accuracy in reporting on the achievement of beneficiary attendance and/or weight loss performance goals because both CMS and MDPP suppliers would be able to identify on the claim in question which coaches furnished the sessions attributable to the performance payment. In addition, because the accuracy of information reported on the claim would ultimately be the MDPP supplier's responsibility and the MDPP supplier would attest to the accuracy of each claim submitted, including the relevant coach NPIs on the claim could assist the MDPP supplier when conducting internal monitoring of claim accuracy.
These proposed requirements for reporting the coach NPI as the rendering provider on session line-items included on claims for performance payments and bridge payments to MDPP suppliers were included at proposed § 414.84(b) and (c). We invited public comments on these proposals.
The following is a summary of the public comments received on the proposals for the requirements for reporting the coach NPI as the rendering provider on session line-items included on claims for performance payments and bridge payments to MDPP suppliers and our responses:
As in the DPP model test under section 1115A(b) of the Act, MDPP services are based on a CDC-approved DPP curriculum and, therefore, MDPP suppliers must offer sessions in accordance with that curriculum. We are finalizing a performance-based payment methodology for MDPP services, which ties most payments to outcomes—in this case, weight loss and session attendance—to help incentivize suppliers to be engaged in their beneficiaries' weight loss efforts. Given this methodology, we recognize that there will be an inherent amount of supplier financial risk, and that coverage of sessions and supplier requirements and payment will not always align under the MDPP expanded model final polices. This section clarifies how these elements fit together in the MDPP expanded model under its final policies, as displayed in Table 42.
Once an MDPP supplier enrolls in Medicare to furnish MDPP services, it must offer the set of MDPP services in accordance with the MDPP supplier standards (noted in section III.K.2.e.iv.(4) of this final rule and at § 424.205(d)), including that it must offer at least 16 core sessions, furnished no more frequently than once per week, over the first 6 months of the MDPP core services period; at least 1 core maintenance session per month over months 7 to 12 of the MDPP core services period; and at least 1 ongoing maintenance session per month for up to 12 additional months (months 13 through 24 of the MDPP services period), if the beneficiary maintains eligibility for coverage of ongoing maintenance sessions. We recognize that beneficiaries might not attend these sessions. However, they must be made available, in accordance with CDC's DPRP Standards, to beneficiaries as long as they are eligible for coverage of MDPP services. We further note that the set of MDPP services must be furnished in compliance with all applicable federal laws and regulations.
Although a beneficiary is not required to use MDPP services at all, the MDPP services period is initiated by the beneficiary attending his or her first core session, which begins the MDPP services period timeline. To qualify for coverage of ongoing maintenance sessions, a beneficiary also needs to attend at least 1 session during the final core maintenance session interval where in-person weight measurement is performed that demonstrates the achievement or maintenance of the required minimum weight loss.
All of the final performance payments except for the weight loss performance payments require the achievement of an attendance performance goal, and if a beneficiary does not achieve attendance performance goals, an MDPP supplier will not be paid a performance payment that relies on achieving those goals. For example, if a beneficiary does not attend 2 sessions in the first core maintenance session interval, a supplier will not be paid a performance payment for the interval that spans months 7 to 9 of the MDPP core services period. However, a supplier must offer at least 1 core maintenance session per month to the beneficiary to ensure that the beneficiary has the opportunity to attend. Furthermore, although the
In the CY 2017 PFS final rule (81 FR 80470), we confirmed that a beneficiary may change MDPP suppliers at any time. However, we deferred specific policies regarding attribution of beneficiaries who change MDPP suppliers as related to payment to future rulemaking. We subsequently made proposals for payment policies when a beneficiary changes MDPP suppliers during the MDPP services period in the proposed rule (82 FR 34153 through 34155).
At proposed § 414.84(a), we proposed to define “bridge payment” as a one-time payment to an MDPP supplier for furnishing its first MDPP services session to an MDPP beneficiary who has previously received one or more MDPP services from a different MDPP supplier. We used this definition in the proposed MDPP payment policies for the circumstances when a beneficiary changes MDPP suppliers for any reason during the MDPP services period after the beneficiary has attended at least the first core session.
In cases where the beneficiary changes MDPP suppliers, there would be a shift in accountability for offering the set of MDPP services for which the beneficiary is eligible for coverage from one MDPP supplier to a subsequent MDPP supplier. Similar to our proposal for a performance payment to an MDPP supplier that furnishes the first core session to an MDPP beneficiary who initiates the MDPP services period as discussed in section III.K.2.d.iii.(3) of the proposed rule (82 FR 34141 through 34143), we proposed that an MDPP supplier would be paid a bridge payment of $25 for furnishing its first session to an MDPP beneficiary who has previously received MDPP services from a different MDPP supplier, regardless of whether the MDPP supplier is paid any performance payments for that beneficiary. A subsequent MDPP supplier would be paid this bridge payment after furnishing the first session to a beneficiary and billing the appropriate HCPCS G-code only if the supplier did not furnish the first core session to the MDPP beneficiary.
We believed that making a bridge payment that would be the same amount as the performance payment for the first core session discussed in section III.K.2.d.iii.(3) of the proposed rule (82 FR 34141 through 34143) would be appropriate because we expected the MDPP supplier's resources used to be similar under both of these circumstances. The subsequent supplier would expend resources for furnishing a first session to a beneficiary, including collecting administrative information on the beneficiary who is not already known to the supplier, regardless of whether the beneficiary goes on to receive further MDPP sessions from that supplier.
We proposed that the bridge payment would be paid to the subsequent MDPP supplier any time a beneficiary changes suppliers during the MDPP services period, regardless of when during the core services period or ongoing services period the beneficiary changes MDPP suppliers. The bridge payment was not intended to be a performance payment, which could be paid to the subsequent MDPP supplier in addition to the bridge payment if a beneficiary achieves a performance goal while receiving MDPP services from that the subsequent supplier. Rather, the bridge payment would account for the financial risk a subsequent MDPP supplier takes on by furnishing services to a beneficiary changing MDPP suppliers during the MDPP services period. We believed that when suppliers furnish MDPP services to MDPP beneficiaries in these circumstances, they generally would not have the same opportunity for performance payments that they would have if the beneficiary had been receiving MDPP services from the supplier from the beginning of the MDPP services period because certain performance goals, such as the required minimum weight loss, might already have been achieved by the beneficiary. The proposed bridge payment policy would play an important role in ensuring access to MDPP services and freedom of choice of MDPP suppliers for those beneficiaries who either choose to or must change suppliers during the MDPP services period.
If we were to only make performance payments for MDPP services as proposed in sections III.K.2.d.iii.(3) through (6) of the proposed rule (82 FR 34141 through 34146) and not make a bridge payment to a subsequent supplier when an MDPP beneficiary changes suppliers during the MDPP services period, access problems could result due to the number of scenarios where subsequent MDPP suppliers offering and furnishing MDPP services would be paid no performance payment for the sessions furnished. We provided the following examples to illustrate such scenarios.
• A beneficiary changes from MDPP supplier A to MDPP supplier B after attending core session 4; attends core sessions 5 to 8 with supplier B; and then decides not to attend any more MDPP sessions. Supplier B does not meet the requirements for billing for the performance payment for the 9th core session because only 8 core sessions were attended, despite supplier B offering and furnishing core sessions 5 to 8.
• A beneficiary who has not met the required minimum weight loss performance goal changes from MDPP supplier A to MDPP supplier B after completing the first 3-month core maintenance session interval; attends 2 core maintenance sessions in months 9 through 12 with supplier B; and then fails to attend the 3rd core maintenance session in this interval. Supplier B does not meet the requirements for billing for the performance payment for the second core maintenance session interval despite offering and furnishing core maintenance sessions and the beneficiary eligibility for coverage of MDPP services then ends after month 12, the end of the core services period.
We believed that circumstances like these examples where subsequent MDPP suppliers would receive no payment for sessions furnished to MDPP beneficiaries who change suppliers during the MDPP services period in the absence of the bridge payment policy could lead to those MDPP suppliers preferentially seeking to furnish the remaining MDPP services during the MDPP services period to beneficiaries who have either already achieved the required minimum weight loss, or whom they believe will attend sessions and achieve weight loss, because the required minimum weight loss is tied to eligibility for ongoing maintenance sessions and higher performance payment for core maintenance session intervals.
We noted that we proposed in section III.K.2.e.iv.(4) of the proposed rule (82 FR 34163 through 34164) that MDPP suppliers may not deny access to MDPP services to eligible beneficiaries based on any reason other than the supplier's own capacity limits to furnish MDPP services to additional beneficiaries and on a discretionary basis if a beneficiary significantly disrupts the session for other participants or becomes abusive. However, MDPP suppliers could comply with this access requirement,
We considered an alternative policy in which the bridge payment would only be made in circumstances where the subsequent supplier would not be paid a performance payment that is based on attendance at the first session furnished by that supplier. For example, under this alternative if a beneficiary attends the first session during the ongoing maintenance session interval for months 13 through 15 at one MDPP supplier and then changes to a subsequent MDPP supplier that furnishes 2 additional ongoing maintenance sessions within that same interval and the beneficiary maintains the required minimum weight loss, the subsequent supplier would
We proposed that an MDPP supplier could be paid either one performance payment for furnishing the first core session or one bridge payment per beneficiary, but not both. We proposed this policy because we believed that the potential to be paid both a performance payment for the first core session and a bridge payment, or multiple bridge payments, for the same beneficiary, could increase the risk of MDPP suppliers encouraging discontinuous care patterns. Such patterns could hinder the achievement of the required minimum weight loss that leads to a reduction in the incidence of type 2 diabetes and could lead to increased Medicare expenditures for MDPP services. Financial incentives resulting from the potential for multiple bridge payments to a single supplier for one beneficiary could lead MDPP suppliers to encourage beneficiaries to repeatedly change among them between sessions during the MDPP services period so that the suppliers may repeatedly bill for bridge payments. We believed that limiting the bridge payment to one per beneficiary per supplier and making it available for payment only if the performance payment for the first core session was not paid to that same supplier helps mitigate this risk. However, we did not propose to limit the number of MDPP suppliers that may be paid a bridge payment for a particular beneficiary because we are not proposing to limit beneficiary freedom of choice for MDPP suppliers. We proposed only to limit the bridge payments that a particular MDPP supplier may be paid for each MDPP beneficiary to one.
Although this proposed limit was intended to provide some protection against MDPP suppliers encouraging certain care patterns for the purposes of their financial gain alone, we understood there may be organizations enrolled in Medicare as the same supplier type but under separate MDPP supplier enrollment records that are part of a larger franchise or umbrella organization with shared financial interests. We noted that there is some program integrity risk that these organizations could coordinate to bill multiple bridge payments that would ultimately increase total MDPP payments to separately enrolled MDPP suppliers to serve the financial interests of the umbrella organization. This scenario could occur if MDPP suppliers systematically encourage beneficiaries to change suppliers for the purpose of being paid the bridge payment.
Although we believed that organizations under a larger umbrella organization may have a greater financial incentive and opportunity to engage in this behavior, we understood that any two or more MDPP suppliers could coordinate in this way, potentially affecting large numbers of MDPP beneficiaries. To mitigate this risk, we proposed to prohibit MDPP suppliers and other individuals or entities performing functions or services related to MDPP services on an MDPP supplier's behalf from unduly coercing an MDPP beneficiary's decision to change or not to change to a different MDPP supplier, including through the use of pressure, intimidation, or bribery as described further in section III.K.2.e.iv.(4) of the proposed rule (82 FR 34163 through 34164). We would monitor MDPP supplier billing patterns to detect how frequently bridge payments are paid and to determine whether patterns exists that may suggest fraudulent activity regarding bridge payment claim submissions across suppliers, conducting audits, medical reviews, and investigations as appropriate.
In the CY 2017 PFS final rule, we finalized at § 410.79(b) that a beneficiary's baseline weight refers to the MDPP beneficiary's body weight recorded during that beneficiary's first core session. This definition applies to determine weight loss throughout the MDPP services period. Additionally, the once-per-lifetime policy finalized at § 410.79(d)(1) applies if a beneficiary changes MDPP suppliers, and the services furnished by the subsequent supplier would begin where the beneficiary left off with the previous supplier. We recognized that these policies could require the beneficiary to request that a copy of his or her MDPP record be provided by the previous supplier to the subsequent supplier so that the subsequent supplier could determine whether the beneficiary achieves or maintains the required minimum weight loss and has information about the MDPP services already furnished. We also finalized at § 424.59(b) (proposed to be redesignated and amended as § 424.205(g)) that an MDPP supplier shall maintain documentation that includes services furnished and body weight measurements. Finally, we finalized at § 424.59(b) (proposed to be redesignated and amended as § 424.205(g)) that MDPP suppliers are required to maintain and handle any beneficiary PII and PHI in compliance with HIPAA, other applicable privacy laws and CMS standards. Any sharing of information from a beneficiary's MDPP record between MDPP suppliers must follow these rules, as applicable.
The proposed bridge payment was included at proposed § 414.84(c). We invited public comments on this proposal and the alternative considered. The following is a summary of the public comments received on the proposals for the bridge payment, and the alternative considered and our responses:
One commenter stated that although CMS proposed that only one bridge payment per MDPP supplier per beneficiary would be made, they believe that a performance payment for the first core session and a bridge payment to the same MDPP supplier may be needed under some circumstances, as well as two bridge payments to an MDPP supplier for an MDPP beneficiary under other circumstances. The commenter described the example of a beneficiary who enrolls with an MDPP supplier in Colorado, moves to Florida for the winter where the beneficiary continues MDPP services with another MDPP supplier in that state, and then returns to Colorado and wants to complete the DPP with the first MDPP supplier. The commenter pointed out the under the proposal, the Florida MDPP supplier would receive a bridge payment while the Colorado MDPP supplier would not, despite the need for the Colorado supplier to reengage the beneficiary when the beneficiary returned to Colorado after spending the winter in Florida. Therefore, the commenter urged CMS to allow a performance payment for the first core session and a bridge payment to be made for a single MDPP beneficiary to an MDPP supplier, as well as to allow two bridge payments per beneficiary per supplier to be made.
One commenter who expressed concern about the amount of switching between MDPP suppliers that could occur during a beneficiary's 36-month long MDPP services period urged CMS to limit changing suppliers to no more than two switches per beneficiary during any 1 year of the MDPP services period. Another commenter requested that CMS clarify how it will track how many times beneficiaries switch MDPP suppliers and whether there would be any limit on the number of times a beneficiary could switch MDPP suppliers.
Given this established policy which allows beneficiaries to change MDPP suppliers at any time during the MDPP services period, our bridge payment proposal was intended to partially account for the financial risk a subsequent MDPP supplier takes on by furnishing services to a beneficiary changing MDPP suppliers during the MDPP services period. We appreciate the concerns of the commenter about the potential for beneficiaries to change MDPP suppliers at will, thereby reducing continuity of care and the ability of MDPP suppliers to track the progress of MDPP beneficiaries in their DPPs. However, we understand from many commenters that beneficiaries switching MDPP suppliers during the MDPP services period may occur for a variety of reasons, including the relatively frequent circumstances where beneficiaries reside seasonally in different areas of the country. Therefore, we continue to believe that providing one bridge payment per beneficiary per MDPP supplier of $25 does not financially incentivize MDPP suppliers to encourage unnecessary switching but, instead, responds to the needs of beneficiaries and MDPP suppliers by reducing potential barriers to switching.
Furthermore, we expect that our different payment policies for core sessions, core maintenance session intervals, and ongoing maintenance session intervals that rely upon attendance at several sessions within a period of time and for weight loss performance payments will encourage the transfer of MDPP beneficiary records from a previous supplier to the subsequent supplier, which should facilitate continuity of care throughout the beneficiary's MDPP services period. For example, in order for a subsequent MDPP supplier to bill for a weight loss performance payment, to bill correctly for a core maintenance session interval performance payment, or to determine a beneficiary's eligibility for coverage and payment of an ongoing maintenance session interval, the subsequent MDPP supplier will need to acquire the MDPP beneficiary record from the previous supplier to have documentation of the beneficiary's baseline weight. In addition, in order to bill for an interval performance payment that requires attendance at multiple sessions and fully reflects the beneficiary's session attendance, the subsequent MDPP supplier will need to acquire the MDPP beneficiary record from the previous supplier to have documentation of sessions furnished by that supplier that count towards achievement of the attendance performance goal for the interval performance payment that will be billed by the subsequent MDPP supplier.
In response to the commenter who presented a scenario where one supplier furnished MDPP services to a beneficiary, the beneficiary then switched to a subsequent supplier that furnished sessions and was paid a bridge payment, and the beneficiary then switched back to the first MDPP supplier, we do not believe it would be appropriate to make a bridge payment to the first supplier in this scenario. We do not believe the financial risk or the supplier resources required for the first supplier to resume accountability for a beneficiary's MDPP services when that supplier already has a relationship with the beneficiary are so substantial that making a bridge payment to the first supplier would be appropriate, given that the first supplier would already have been paid the performance payment for the beneficiary's first core session. In addition, financial incentives resulting from the potential for two (or more) bridge payments to a single supplier for one beneficiary could lead MDPP suppliers to encourage beneficiaries to unnecessarily change among them between sessions during the MDPP services period so that the suppliers may bill for bridge payments. We believe that limiting the bridge payment to one per beneficiary per supplier and making it available for payment only if the performance payment for the first core session was not paid to that same supplier helps mitigate this risk.
We also do not believe it would be appropriate to limit the number of times a beneficiary can switch MDPP suppliers during the MDPP services period in order to preserve beneficiary access to care and freedom of choice.
However, we continue to believe a bridge payment in the amount of $25 is appropriate for the MDPP expanded model. While we acknowledge based on the commenters' description that the activities and resources required for a subsequent MDPP supplier to enroll an MDPP beneficiary in its DPP are somewhat different from those of the previous MDPP supplier that furnished the MDPP beneficiary's first core session, we continue to believe there is sufficient similarity between furnishing the first core session in the MDPP services period and furnishing the first session to an MDPP beneficiary who has previously received MDPP services from another supplier that the payment amounts should be the same.
We note that as discussed in section III.K.2.d.iii.(3) of this final rule, we are finalizing $25 as the performance payment for the first core session. In addition, as discussed in section III.K.2.d.ii. of this final rule, we are paying for the set of MDPP services through a performance-based payment methodology that makes periodic performance payments to MDPP suppliers during the MDPP services period. The aggregate of all performance payments constitutes the total performance-based payment amount for the set of MDPP services. The subsequent MDPP supplier, like the previous MDPP supplier, will have the opportunity to be paid performance payments based on where the beneficiary is in the MDPP services period when the beneficiary enrolls with the subsequent MDPP supplier and on the performance goals achieved by the beneficiary which receiving MDPP services from the subsequent supplier. The aggregate of the bridge payment and performance payments to the subsequent supplier will constitute the total performance-based payment amount for the MDPP services furnished to the MDPP beneficiary by the subsequent MDPP supplier.
One commenter requested clarification about a specific scenario where the commenter was concerned that supplier B's payment could be penalized when a beneficiary switches suppliers. In the example presented by the commenter, the beneficiary attends 16 core sessions (months 1 to 6) with supplier A and achieves and maintains the required minimum weight loss. The beneficiary transfers to supplier B closer to her home and, in transferring, misses the first monthly (month 7) core maintenance session, but then attends 3 sessions (months 8 to 10) in a row. The commenter requested that CMS clarify if supplier B would still receive a bridge payment, since the month 7 session was not attended. The commenter further requested that CMS provide information about whether supplier B would be paid for the full second core maintenance session interval if the beneficiary completes 3 sessions in months 11 to 13; whether supplier B should bill only for months 10 to 12; or whether performance payments for core maintenance sessions intervals would not be made to supplier B because the beneficiary did not attend the month 7 session.
Because the beneficiary has already achieved the required minimum weight loss and ongoing maintenance sessions must only be offered monthly to the beneficiary, we do not believe that the resources used by the subsequent supplier are so substantial that subsequent suppliers will be unable to offer these sessions to beneficiaries. An MDPP beneficiary who has achieved the required minimum weight loss will already be knowledgeable about the health behavior changes taught in MDPP sessions and will have experienced success incorporating these changes in a meaningful way in his or her own life such that weight loss results. Thus, we expect that subsequent MDPP suppliers offering monthly sessions to these beneficiaries during the ongoing services period will not have to work particularly hard to engage these beneficiaries. In addition, the subsequent MDPP supplier knows they will be paid a bridge payment for the first session furnished and they may also be paid ongoing maintenance session interval performance payments if the beneficiary meets the performance goals for those payments in the future.
In the specific scenario where the beneficiary transfers to subsequent supplier B and misses the month 7 core maintenance session but resumes attending monthly sessions in month 8, supplier B can bill the bridge payment for its first session furnished to the beneficiary, which would be the month 8 core maintenance session. With respect to the beneficiary's month count that defines the core maintenance session interval in the core services period, that does not change based on when the beneficiary attends core maintenance sessions furnished by any MDPP supplier. Therefore, the beneficiary's core maintenance session intervals would always be months 7 to 9 and months 10 to 12 from the date the first core session was furnished to the beneficiary by supplier A.
As finalized in section III.K.2.d.iii.(4) of this final rule, we are adopting a 2-session attendance performance goal for the core maintenance session interval performance payment. Therefore, in the specific scenario described by the commenter where the beneficiary switches suppliers and does not attend any core maintenance session in month 7, but attends core maintenance sessions in months 8 and 9 furnished by supplier B, in addition to the bridge payment to supplier B, supplier B would also bill and be paid for the appropriate HCPCS G-code for the first core maintenance session interval (months 7 to 9) based on whether or not the required minimum weight loss was maintained (in the commenter's scenario, the required minimum weight loss was achieved with supplier A prior to month 7, and 2 core maintenance sessions were furnished by supplier B in months 8 and 9). Similarly, and regardless of the beneficiary's attendance at core maintenance sessions in months 7 to 9, supplier B would bill and be paid for the appropriate HCPCS G-code for the second core maintenance session interval (months 10 to12) if the beneficiary attends at least 2 sessions furnished by supplier B in that 3-month period and the interval performance payment amount would be based on whether or not the required minimum weight loss was maintained.
After considering the public comments received, we are finalizing the proposals, without modification, for the bridge payment at § 414.84(c).
In the proposed rule (82 FR 34155), we also discussed ways to streamline the sharing of information between suppliers about a beneficiary's progress in the MDPP services period when a beneficiary switches suppliers, such as through the development of a model tracker that logs the contact information of a beneficiary's previous supplier and/or coach, and the beneficiary's attendance and weight loss. Beneficiaries could take the tracker with them if they change suppliers during the MDPP services period. Such a tracker would not supplant the previous supplier's beneficiary MDPP record which the subsequent supplier would need to have a copy of in order to consider sessions furnished by the previous supplier in determining whether the subsequent supplier could bill for a performance payment that was based in part on those prior sessions as discussed in section III.K.2.d.iii.(10)(b) of the proposed rule (82 FR 34148 through 34149). If the subsequent supplier did not have the beneficiary's MDPP record from the previous supplier, the subsequent supplier could not use information from the sessions furnished by the previous supplier, such as weight or session attendance, to determine that the performance goals for a performance payment were met so that the subsequent supplier could bill for the performance payment. However, it might help facilitate the process for subsequent suppliers to enroll beneficiaries partway through the MDPP services period while the subsequent supplier is coordinating with the previous supplier to obtain a copy of the beneficiary's MDPP record from that supplier. We invited public comments on additional ways this data sharing could be streamlined between suppliers.
The following is a summary of the public comments received on additional ways information sharing could be streamlined between suppliers regarding beneficiaries switching MDPP suppliers during the MDPP services period and our responses:
The commenters requested that CMS provide greater detail on how the handoff between an MDPP beneficiary's current MDPP supplier to a subsequent MDPP supplier should occur when a beneficiary changes suppliers. Specifically, they sought additional written guidance on the required information to be transmitted and the format and method of transmission in order for a proper transition of a beneficiary from one MDPP supplier to the subsequent MDPP supplier to occur, especially given their expectation that transitions may be common for Medicare beneficiaries who live in different locations in the summer and winter months. The commenters urged CMS to provide this guidance to avert potential HIPAA issues when transferring protected health information among MDPP suppliers, especially when many MDPP suppliers will be new to the healthcare environment and lack prior experience with performing HIPAA compliant transfers.
While several commenters described a number of challenges related to the transfer of beneficiary information between MDPP suppliers and requested additional guidance from CMS, one commenter presented an approach to facilitating the transfer of information that would be based on encouraging beneficiaries to switch among MDPP suppliers within a supplier network that uses a shared data-management solution. The commenter reported that there are several DPP organizations all around the country that use a single data platform. They suggested that DPP organizations within a single supplier network could develop a simple process within their current platform that would allow the MDPP services information to be transferred from one supplier to
We appreciate that certain networks have independently worked towards use of a single data platform by all DPP organizations in the network that could facilitate the transfer of MDPP services information for beneficiaries who may switch among suppliers in a single network.
While we are not adopting any specific MDPP beneficiary information transfer policies or data systems at this time, we acknowledge the concerns raised by the commenters about subsequent MDPP suppliers having correct and timely information about MDPP beneficiaries enrolling in the subsequent supplier's DPP in the middle of the MDPP services period, given our policy that allows full beneficiary freedom of choice of MDPP supplier. As discussed in more detail in section III.K.2.c.iii of this final rule, we are exploring using existing CMS systems for MDPP suppliers to verify beneficiaries' use of prior MDPP services and plan to provide additional information on this mechanism in future guidance, as appropriate. However, this eligibility check will not supplant the need for MDPP suppliers to maintain documentation as described at § 424.205(g). We note that health care providers often exchange clinical data when their patients seek care from different providers, and we do not view the need for subsequent MDPP suppliers to obtain beneficiary-level MDPP services data from a previous MDPP supplier as a unique circumstance.
We remind subsequent MDPP suppliers that in order to submit a claim for a performance payment under the MDPP expanded model, the billing supplier must have documentation in the beneficiary's MDPP record that all requirements, including the achievement of the performance goal(s) applicable to the performance payment, have been met. The billing supplier's MDPP record for the beneficiary may include a copy of the beneficiary's MDPP record from a previous MDPP supplier that has been provided to the billing supplier at the request of the MDPP beneficiary. If an MDPP supplier is submitting a claim for a performance payment based on the achievement or maintenance of the required minimum weight loss or an interval performance payment based on attendance at more than one session, the copy of the MDPP record from the previous MDPP supplier may be used as part of the billing supplier's documentation demonstrating that the attendance or weight loss performance goal for the performance payment was achieved.
In terms of how MDPP suppliers transfer beneficiary data in a HIPAA-compliant manner, we recommend that MDPP suppliers consult with counsel to determine whether they qualify as a HIPAA-covered entity, and, if so, how to manage and transfer data appropriately based on applicability of HIPAA, other applicable state and federal privacy laws, and CMS standards as required. Resources already exist to help provide guidance on these issues and are available at
The current CDC 2015 Diabetes Prevention Recognition Program (DPRP) Standards do not have standards for preliminary recognition. In the CY 2017 PFS final rule, we indicated that we would align the CDC's DPRP Standards and the set of MDPP services, to the extent possible. It will not be possible for CMS to permit DPP organizations to enroll as MDPP suppliers based on achievement of any new CDC standard through this rulemaking because any updates to the CDC Standards are not expected to go into effect until 2018.
However, our intent is to allow organizations that do not yet have full recognition, but have demonstrated a capacity to furnish DPP services, to enroll in Medicare as of the effective date of the enrollment policies in this rule. We believe this will increase access to MDPP services. For this reason, we proposed, at § 424.205(c), to establish an MDPP interim preliminary recognition standard to permit DPP organizations who meet this standard to enroll in Medicare even if they do not have full CDC recognition. This MDPP interim preliminary recognition standard will be hereafter referred to as “interim preliminary recognition.” As we stated in CY 2017 PFS final rule, our intent with this policy is to bridge the gap until such time as any CDC preliminary recognition standards are established following publication of the their DPRP Standards in 2018. Once we have established the transition process with CDC, we would expect DPP organizations that seek to enroll into Medicare to obtain CDC preliminary recognition, but MDPP suppliers who have enrolled in Medicare with interim preliminary recognition would maintain their enrollment eligibility as an MDPP supplier.
We proposed, at § 424.205(c)(1)(ii)(B), that DPP organizations with pending CDC recognition that meet the following additional criteria would meet the interim preliminary recognition standard:
• The organization must continue to follow the current 2015 CDC DPRP Standards for data submission and submit a full 12 months of performance data to CDC on at least one completed cohort (see Appendix D, 2015 CDC DPRP Standards,
• The 12-month data submission to CDC includes at least 5 participants who attended at least 3 sessions in the first 6 months, and whose time from first session attended to last session of the lifestyle change program was at least 9 months; and
• Of the participants eligible for evaluation in the first criterion, at least 60 percent attended at least 9 sessions in months 1 through 6 and at least 60 percent attended at least 3 sessions in months 7 through 12.
All data requirements reflect current reporting requirements to progress from pending recognition to full recognition through CDC's DPRP; no new data collection would be required.
To implement the interim preliminary recognition standard, DPP organizations
Our regulations at § 424.59 (redesignated and amended at § 424.205 in this final rule) specify that a DPP organization with full CDC recognition is eligible for enrollment as an MDPP supplier if it also meets all of the other conditions for enrollment in § 424.59(a) (redesignated and amended at § 424.205(b) in this final rule). We proposed that organizations that meet the MDPP interim preliminary recognition standard, in section III.K.2.e.i.(1) of this final rule, and meet all other enrollment conditions would also be eligible to enroll as an MDPP supplier.
We also proposed that DPP organizations would be eligible to enroll as an MDPP supplier if they meet CDC DPRP Standards for preliminary recognition, once any such standards go into effect (§ 424.205(c)(2)(i)). We anticipate that CDC's preliminary recognition standards will be established on or after January 1, 2018. After the effective date of any updated CDC standards, we proposed that MDPP suppliers who have enrolled in Medicare with MDPP interim preliminary recognition would continue to be eligible for MDPP enrollment (assuming they continue to meet all other requirements for enrollment, described in § 424.205(b)). We intend to ensure that any transition an MDPP supplier may make from interim preliminary recognition to CDC preliminary recognition does not disrupt its status as an MDPP supplier. We will address possible transition issues in future rulemaking or guidance, as appropriate.
We considered an alternative to wait until new CDC DPRP Standards are effective to allow organizations other than those with full recognition to enroll as MDPP suppliers. However, as indicated in the CY 2017 PFS final rule, based on CDC data we believe that waiting until the new DPRP Standards are effective would limit the number of organizations with demonstrated capacity to furnish the set of MDPP services from enrolling in Medicare when enrollment starts and offering MDPP services once they become effective. We invited public comments on this MDPP interim preliminary recognition standard, including performance standards, and the use of this standard as a condition for enrollment in Medicare, and the alternative considered.
The following is a summary of the public comments received on the MDPP interim preliminary recognition standard, including performance standards, and the use of this standard as a condition for enrollment in Medicare proposal and the alternative considered and our responses:
A commenter requested that a master database of those organizations that meet this new standard be made publicly available well in advance of the effective date of when MDPP services can be delivered and payments made to give suppliers more time to appropriately arrange for the MDPP on behalf of its members.
To increase awareness of the process, the criteria, and the period of time it takes programs to become CDC-recognized and then implement MDPP, we intend to provide MDPP supplier support through webinars and other types of guidance and education tools. We will continue to coordinate with CDC to provide relevant resources regarding both CDC recognition as it relates to the MDPP expanded model for organizations preparing to become MDPP suppliers.
We disagree that there is a lack of data about the inclusion of individuals who attend 3 sessions (versus 4) as part of the DPRP data submission. CDC DPRP data show no difference in average percent weight loss for those who attend 3 sessions compared to 4, and therefore we believe including participants who have attended at least 3 sessions as compared to 4 will provide data to make an appropriate assessment for the purposes of MDPP preliminary recognition. Furthermore, by allowing organizations to submit data on individuals who have attended 3 sessions (versus 4), we are increasing the number of organizations who are potentially eligible to achieve interim preliminary recognition.
In response to the comments about phasing out interim preliminary recognition as CDC updates its Standards, we reiterate our intent to align data requirements with CDC Standards. The proposed CDC 2018 Standards include the same requirements for CDC preliminary recognition as we proposed for interim preliminary recognition.
We disagree that allowing MDPP suppliers whose MDPP billing authority has been revoked should still provide MDPP services to beneficiaries. When their supplier's MDPP billing authority has been revoked beneficiaries may switch to a new MDPP supplier so they can complete their program.
In response to the comment regarding establishing a performance metric for interim preliminary recognition, we proposed standards for interim preliminary recognition (which are the same standards CDC has proposed for preliminary recognition in their 2018 DPRP standards) that rely on attendance based measures, not weight loss. We discussed in the CY 2017 PFS final rule (section III.J.7.b of this final rule) that we believed that full recognitions status, which relies on weight loss measures, would be challenging for many organizations to meet initially and, without broadening the eligibility for an MDPP supplier to enroll, we may limit the number of MDPP suppliers available for beneficiaries to access MDPP services. We continue to believe the standards we are finalizing for interim preliminary recognition will adequately assess DPP organizations' capacity to become MDPP suppliers, and thereby increase the numbers of eligible organizations that beneficiaries can access for MDPP services.
Updates to the CDC Standards are not expected to go into effect until 2018, and we are working closely with CDC on maintaining our alignment between interim preliminary recognition and its proposed standards in the 2018 DPRP Standards.
We acknowledge the major contributions of the Special Diabetes Programs for Indians (SDPI) Diabetes Prevention Program (DPP) Demonstration Projects and the many resources—such as the SDPI Diabetes Prevention Toolkit—insights, and lessons learned these projects have contributed on both a local and national level. However, we decline grandfathering in the SDPI programs and making an exception to the MDPP requirements. We do not believe a separate type of recognition can be created for SDPI programs without compromising our intent to rely on the CDC's DPRP. Through the DPRP, CDC is responsible for carrying out a quality assurance function at the national level. Under the CDC's DPRP, we will enroll CDC-recognized organizations that are standardized in delivering the evidence-based behavior change program with quality and fidelity to the original science and subsequent translation studies achieving the outcomes proven to prevent or delay onset of type 2 diabetes. The nine requirements in the DPRP Standards apply equally to all organizations that apply for CDC recognition, regardless of size, experience, capacity, or populations served. We know from CDC that DPRP data collected to date indicate that all types of organizations are successful in achieving full recognition, and that CDC could not meet its obligation to ensure quality of recognized organizations enrolling as MDPP suppliers if each organization was allowed to use a different set of measures.
We recommend that tribal organizations work with CDC to help tribal organizations offering the SDPI lifestyle change program, meet the DPRP Standards set by CDC. We welcome continued consultation with tribes and tribal organizations as required by the CMS Tribal Consultation Policy.
Regarding other commenters' recommendations to lift the requirement that suppliers who provide MDPP services be Medicare-enrolled, we decline to adopt the commenters' proposals to eliminate the Medicare enrollment requirement for MDPP supplier-MAOs or for MDPP suppliers with whom MAOs contract to furnish MDPP services. In the CY 2017 PFS final rule, we also finalized the requirement that CDC-recognized organizations that will bill Medicare for MDPP services must enroll in Medicare as MDPP suppliers. MAOs must comply with 42 CFR part 422, subpart E in their relationships with providers; regulations in that subpart generally prohibit employing or contracting with individuals who are excluded from Medicare and require MA organizations to provide basic benefits (that is, Part A and Part B services) only through health care providers that meet the applicable requirements of Title XVIII. We previously issued guidance following the CY 2017 PFS final rule in a November 23, 2016 HPMS guidance memo that we now reiterate. In that HPMS memo, we established that, in order to provide MDPP services, a Medicare health plan such as an MA plan, may choose to contract with an organization that is Medicare-enrolled as an MDPP supplier, or become Medicare-enrolled as an MDPP supplier itself. MA plans that choose to contract with outside Medicare-enrolled MDPP suppliers should follow their normal protocols in accordance with applicable regulations. Medicare health plans that choose to become Medicare-enrolled MDPP suppliers are subject to the supplier enrollment eligibility requirements finalized in this final rule at § 424.205.
After considering the public comments, we are finalizing our proposals, without modification, for MDPP preliminary recognition under the MDPP expanded model at § 424.210(c).
As described in section III.K.2.a. of the CY 2018 proposed rule (82 FR 34131), we proposed to change the start date of the MDPP expanded model to April 1, 2018. All other policies not related to the furnishing or billing of MDPP services would, if finalized, be effective January 1, 2018. Thus, although MDPP suppliers would not be able to begin furnishing MDPP services on January 1, 2018, MDPP supplier enrollment would begin on January 1, 2018, if these proposals are finalized. In the CY 2017 PFS final rule, we established that any organization wishing to furnish MDPP services must enroll as an MDPP supplier, regardless of any existing enrollment in Medicare. As indicated in section J.4. of the CY 2017 PFS final rule, we believe that including an effective date for enrollment that precedes the implementation date for MDPP services is necessary to allow organizations sufficient time to enroll as MDPP suppliers. Thus, MDPP services would only become available after there is sufficient time to enroll MDPP suppliers that will furnish those services.
The following is a summary of the public comments received on the date MDPP suppliers are able to enroll.
After consideration of the comments received on the MDPP supplier enrollment start date, we are finalizing this policy as proposed. MDPP supplier enrollment shall begin on January 1, 2018, when the policies in § 424.205 that enable MDPP supplier enrollment become effective.
Under § 424.502, the definition of enroll/enrollment means “the process that Medicare uses to establish eligibility to submit claims for Medicare-covered items and services, and the process that Medicare uses to establish eligibility to order or certify Medicare-covered items and services.” Thus, the purpose of enrollment is to establish billing privileges in Medicare. In accordance with our proposal that MDPP services will be available
We proposed that for MDPP supplier enrollment applications that are submitted and subsequently approved, the effective date for billing privileges would be the date the application was submitted. However, for applications submitted and subsequently approved prior to April 1, 2018, we proposed that the effective date for billing privileges would be April 1, 2018. This is consistent with other suppliers like physicians, non-physician practitioner organizations, ambulance suppliers, and independent diagnostic testing facilities (IDTFs). However, unlike physicians, non-physician practitioner organizations, and ambulance suppliers who may bill for services for a limited period of time—generally for about thirty days—prior to their effective date if circumstances precluded enrollment in advance of providing services to Medicare beneficiaries, MDPP suppliers would not be permitted to retrospectively bill for services rendered prior to their effective date for billing privileges. Given that MDPP suppliers do not furnish services with immediate impacts on health like the aforementioned Part B suppliers, we chose to utilize the approach of IDTFs. We proposed that as a condition of enrollment, MDPP suppliers would be required to certify in their enrollment application that they are in compliance and will continue to remain in compliance with all MDPP supplier standards that we described in section III.K.2.e.iv of the proposed rule (82 FR 34159 through 34160). Therefore, an MDPP supplier could begin furnishing services on the date the application was submitted, with the goal of having their application subsequently approved. However, we proposed that payment for those services would depend upon whether the enrollment application is subsequently approved.
We proposed that for any enrollment application that is denied under § 424.530(a)(1) for non-compliance, but then subsequently approved due to the submission of a corrective action plan (CAP), the effective date of enrollment would be the date of the CAP submission. This is also consistent with practices for existing suppliers, and institutes an appropriate safeguard for Medicare beneficiaries and the program at-large by prohibiting services from being furnished from suppliers who are non-compliant. We acknowledged, however, that if a supplier began furnishing services the date it submitted its application, but was then denied enrollment, it would not be paid for any services it furnished prior to the date it submitted the CAP, if approved. However, as described in section III.K.2.e.iv of this final rule (§ 424.205(d)), upon submitting its enrollment application, an MDPP supplier certifies that—to its knowledge—it meets and agrees to continue to meet the following MDPP supplier standards, and all other applicable Medicare requirements. Thus, at the time the MDPP supplier applicant submits its application, it should believe that its enrollment application will be approved. Examples of actions the MDPP supplier could take to improve its certainty and increase the probability that the application will be approved may include reviewing any MDPP supplier supporting documentation to fully understand MDPP supplier enrollment requirements and accompanying CMS guidance or supplier support materials, confirming compliance with the MDPP supplier standards in this rule (including conducting background checks for those who would be screened by CMS during the enrollment process as required under § 424.518(c) and § 424.205(d)(3)), and conducting a thorough review of the enrollment application to ensure the submitted application is accurate.
We also proposed that if an MDPP supplier adds a new administrative location (defined and discussed further section III.K.2.e.iii.(2) of this section of the final rule) that resulted in a new enrollment record or Provider Transaction Access Number (PTAN), the effective date for billing privileges would be the date the MDPP supplier began its MDPP operations at that location. We believe that this is appropriate given that it follows a similar approach for an effective date that applies to when physician organizations, non-physician practitioner organizations, ambulance suppliers, and IDTFs add a new practice location to an existing enrollment record. Though the definition of administrative location differs from that of practice location, it provides a similar function. We sought comments on these proposals.
We received no comments on our proposals on the effective date for billing privileges, and are finalizing these policies as proposed under § 424.205(f).
We proposed to require the use of a new, CMS-approved enrollment application specific to MDPP suppliers. We believe that the creation of a new application will be more easily navigated by and reduce the burden on new, non-traditional suppliers because the new enrollment application will only solicit information relevant to the MDPP supplier type. As this new enrollment application is being created specifically for the MDPP expanded model, we have determined that this new enrollment application is exempt from the Paperwork Reduction Act in accordance with section 1115A(d)(3) of the Act. Further, this enrollment application would be considered an “enrollment application” for purposes of part 424 subpart P, and therefore, all existing regulations and administrative guidance that govern the CMS-855 enrollment applications would apply to this new form, unless otherwise specified. We also considered an alternative option to amend the current CMS-855B Medicare Enrollment Application for Clinics/Group Practices and Certain Other Suppliers (CMS-855B) for MDPP supplier enrollment, but we determined that the existing length and complexity of the CMS-855B enrollment application and its applicability to other non-MDPP suppliers may add burdens or unnecessary confusion to MDPP suppliers given that many sections of the current CMS-855B enrollment application would not apply to MDPP suppliers. In addition, we would need to add new sections to solicit information specific to MDPP suppliers, which would only further increase the length of the CMS-855B enrollment application. We invited public comments on this proposal.
The following is a summary of the public comments received on the proposal to require the use of a new, CMS-approved enrollment application specific to MDPP suppliers and our responses:
We understand commenters' requests to have expedited access to the enrollment application. Given that many policies related to or specified on the application are being finalized through this rule, we cannot publish the enrollment application prior to the publication of this final rule. However, we agree that having access to the application prior to the enrollment start date will better assist prospective MDPP suppliers preparing to enroll in Medicare, and will plan to release the application as soon as possible following the publication of this final rule. For this reason, we specified in our proposal that we intend for the information collected on the MDPP supplier enrollment application to build off of what is collected on the 855-B for all supplier types, and proposed additional information collection requirements specific to MDPP suppliers in this rule. Until we are able to make the new enrollment application available, we believe that reviewing the existing 855B enrollment form should begin assisting prospective MDPP suppliers in their enrollment preparation. In an effort to disclose information on the enrollment application at our earliest opportunity, we can announce that the MDPP enrollment application will be entitled Form CMS-20134, Medicare Enrollment Application, MDPP Suppliers. Additional information on the enrollment application's availability will be announced publicly via the CMS Web site and other methods as applicable and appropriate.
We clarify that we are not considering exemptions for MDPP supplier enrollment. We appreciate commenters who expressed a desire for CMS to reconsider the policies previously finalized in the CY 2017 PFS, but these policies are out of scope of the proposed rule, and we are not reconsidering previously finalized policies at this time. For our rationale on this previous policy decision, please reference section III.J.7.a of the CY 2017 PFS final rule where we addressed these comments.
After considering the public comments, we are finalizing the proposal to create an MDPP supplier specific enrollment application, as proposed.
On the new MDPP enrollment application, we intend to solicit information specific to MDPP suppliers, as well as information consistent with existing reporting requirements applicable to all suppliers who enroll through the CMS-855B enrollment application, while excluding all reporting requirements that do not apply to MDPP suppliers. As a Medicare supplier enrolling under part 424 subpart P, MDPP suppliers are required to provide complete and accurate information on the MDPP enrollment application, or be subject to enrollment denial under § 424.530(a)(4) or revocation under § 424.535(a)(4). This requirement would include all information solicited on the MDPP-specific enrollment application. The MDPP-specific enrollment application is under development and will be available prior to its use. While the application is being developed, we indicate some of the information we intend to include on the MDPP enrollment application, as further described in this section.
As finalized in the CY 2017 PFS final rule, § 424.59(a)(5) requires that MDPP suppliers submit the active and valid NPIs of all coaches who will furnish services on the supplier's behalf, as well as their first name, last name, and SSN (in the proposed rule, § 424.59(a)(5) was proposed to be redesignated and amended at § 424.205(b)(4)). We proposed, at § 424.205(b)(4), to require that MDPP suppliers provide this identifying information of the coaches directly through the enrollment application. This information will be used to complete background checks of the coaches. To accompany the coach identifying information, we proposed to require MDPP suppliers to provide an eligibility start and end date, if applicable, for each coach on the supplier's roster. Coach eligibility start and end dates are described at length in section III.K.2.e.iv.(2). As described in more detail in section III.K.2.e.iv., the background checks would be used to prevent MDPP suppliers from allowing coaches to furnish MDPP services when certain adverse histories may indicate potential to harm Medicare beneficiaries or undermine program integrity. We outline further details on our proposed enforcement of this provision in section III.K.2.e.iv. of this final rule.
To enable us to conduct background checks of coaches, we proposed that MDPP suppliers also submit to CMS the date of birth of all coaches who will furnish MDPP services (§ 424.205(b)(4)). Combined with other identifying information, date of birth plays a critical role in validating an individual's identity. By collecting date of birth, we would be able to more accurately screen coaches, including accurately conducting a background check, and distinguishing them in the Provider Enrollment, Chain and Ownership System (PECOS). In addition, we want to ensure that we have the capability to most accurately identify individuals reported on the form. To mitigate potential confusion or error found when individuals have common names, we are proposing to collect coach's middle initial (if applicable) on the enrollment application (§ 424.205(b)(4)). We believe that this will help to lessen the possibility that CMS or its contractors misattribute the background of one individual for another.
We proposed, at § 424.205(d)(4), that MDPP suppliers would identify their administrative location(s) by reporting these location(s) on their enrollment application. We proposed, at § 424.205(a), to define administrative location as the physical location associated with the supplier's operations, from where coaches are dispatched or based, and where MDPP services may or may not be furnished. We proposed that an MDPP supplier must have at least one such administrative location, and report any additional administrative locations of the supplier, if MDPP services are either furnished at these locations and/or if the location reflects from where coaches are dispatched or based. For example, if an MDPP supplier operated 2 locations, but only 1 of the 2 locations associated with the entity offered MDPP, only the location offering MDPP would be considered an administrative location. If coaches began offering MDPP in community settings (described in the subsequent paragraph and defined at § 424.205(a), but were dispatched and/or based out of the other non-administrative location, then this location would then be considered under the definition of an administrative location, and would need to be reported on the MDPP enrollment application within 90 days of the change. Given that MDPP suppliers are categorized as high risk under § 424.518, these administrative locations may be subject to site visits prior to approval of an enrollment application. Collecting information on the MDPP supplier's administrative location (regardless whether they furnish services in this location) is important because we may utilize this information to verify that the organization is operational per requirements under proposed § 424.205(d)(4) and (6), discussed in detail in section III.K.2.e.iii.(3) of this final rule.
Although we recognize that many suppliers furnish MDPP services outside of their administrative locations in community settings, we proposed to only require enrollment of the administrative locations. In § 424.205(a), we define “community setting” as a location where the MDPP supplier furnishes MDPP services outside of their administrative locations. A community setting is a location open to the public, not primarily associated with the supplier. Community settings may include, for example, church basements or multipurpose rooms in recreation centers. When determining whether a location is considered an administrative location or a community setting, MDPP suppliers should consider whether their organizational entity is the primary user of that space and whether coaches are based or dispatched from this location. If so, the location would be considered an administrative location, even if this location dually serves as a community setting. In comparison, community settings are locations not primarily associated with the supplier where many activities occur, including MDPP services.
We sought public comments on these proposals.
The following is a summary of the public comments received on these proposals regarding what information CMS will collect on the MDPP supplier enrollment application and our responses:
In the absence of public comments on our proposal to collect the date of birth and middle initials, if applicable, of MDPP coaches or our proposal to collect coach identifying information from their roster through the MDPP supplier enrollment application, we are finalizing these policies as proposed.
We do not agree with the commenter who noted that our proposed definitions of administrative locations do not align with how DPP organizations currently operate. Though the commenter suggested a program coordinator, not a coach, may dispatch coaches to furnish sessions, this scenario would not disqualify the location from where the coordination dispatched the coach from being an administrative location. We clarify that we take no policy position on who dispatches the coaches, be they another coach, program coordinator, or other personnel working on behalf of the MDPP supplier. Our proposed definition of the administrative location means any physical location associated with the suppliers' primary business operations, regardless of whether coaches furnish MDPP services from that location or not. If the location serves as the supplier's primary operations, but MDPP services are furnished elsewhere, we assume that the supplier or individuals working on its behalf will dispatch coaches from this location, potentially house MDPP related materials at this location, or utilize this location to store records. We purposefully sought to define administrative location to accommodate the non-traditional nature and diversity of settings among current DPP organizations.
After considering the public comments, we are finalizing the requirement to report an MDPP supplier's administrative location(s) and community setting(s) on the enrollment application with minor amendments to the definition of an administrative location to provide greater clarity.
We proposed, at § 424.205(d)(5), that MDPP suppliers must update their enrollment application within 30 days of any changes of ownership, changes to the coach roster, or new final adverse action history of any individual or entity required to report such information on the enrollment application. We proposed that MDPP suppliers report all other changes to information required on the enrollment application within 90 days of the reportable event. Timely reporting and updating of information plays a critical role in our ability to protect Medicare beneficiaries and protect the integrity of the Medicare program and Trust Funds. We believe that these requirements are fair and consistent with existing reporting requirements for other Medicare suppliers.
All suppliers are required to report changes of ownership and new adverse action history within 30 days. Adding the requirement that any changes to the coach roster be reported within 30 days is consistent with IDTFs requirements at § 410.33(g)(2). Although IDTFs differ from MDPP suppliers in many ways, IDTFs must report a roster of supervising physicians who serve functions on the supplier's behalf and must also report changes to this roster within 30 days. Given this similarity with IDTFs, we modeled our approach after this process. However, we note that while MDPP suppliers would be required to submit changes to the coach roster within 30 days, we would encourage them to submit such changes as soon as possible, due to reasoning explained further in section III.K.2.e.iv.(2) of this final rule.
We invited public comments on these proposals. We received no comments on our proposals relating to the timelines under which MDPP suppliers must update their enrollment applications, and thus are finalizing these policies as proposed at § 424.205(d)(5).
In the CY 2017 PFS final rule, we finalized that MDPP suppliers would enroll in Medicare. We solicited comments on, but did not propose or finalize, an applicable application fee associated with the MDPP supplier's enrollment. In this final rule, we proposed to amend the definition of “institutional provider” as defined under § 424.502, to include MDPP suppliers such that, § 424.514, which governs the application fee, would similarly apply to MDPP suppliers. “Institutional providers” that are initially enrolling in Medicare, revalidating their enrollment, or adding a new Medicare practice location are required to submit a fee with their enrollment application. We highlight that while we proposed to include MDPP suppliers as an institutional provider, MDPP suppliers utilize administrative locations, not practice locations, and therefore the fee would not apply when adding a new administrative location to an existing enrollment record. The application fee is adjusted annually, and additional information about how the adjustment is calculated may be found in the November 7, 2016
The following is a summary of the public comment received on the proposal to amend the definition of institutional provider for the purposes of applying an enrollment application fee, as well as our response.
After considering the public comments, we are finalizing our amendment to the definition of institutional providers to include MDPP suppliers. Though the meaning of the proposal remains the same, now that we have finalized the creation of an MDPP supplier specific form, CMS-2013, we will amend the language at § 424.502 from the proposed which referenced any enrollment application designated for MDPP suppliers to refer to CMS-20134.
We proposed to establish standards that MDPP suppliers must meet and remain in compliance with to be eligible to receive payment under the MDPP expanded model (described in 82 FR 34159 through 34160 and proposed at § 424.205(d)). These supplier standards would build on the conditions for enrollment established under existing § 424.59(a) (which in this final rule is redesignated and amended at § 424.205(b)), as well as any existing Medicare requirements that apply to all suppliers. We proposed that an MDPP supplier wishing to participate in the MDPP expanded model must adhere to current Medicare MDPP supplier requirements as outlined in § 424.59 (redesignated as § 424.205), as well as all other requirements that apply to Medicare providers and suppliers. MDPP suppliers may choose to utilize a third party administrator, billing agent, or other entity to comply with the requirements of § 424.59 (redesignated as § 424.205). Regardless of any use of such entities, any failure to comply with the standards of § 424.205(d) or other relevant Medicare requirements, may result in an enrollment denial under § 424.530(a)(1), revocation of the MDPP supplier for non-compliance under § 424.535(a)(1) or other revocation authority, as appropriate (as in § 424.205(g)). Consistent with existing regulations, we proposed that MDPP suppliers would have appeal rights under part 498.
We stated that we believe that the standards outlined in this section are generally consistent with standards established for other Medicare suppliers while adding safeguards to help ensure compliance with MDPP rules and regulations specific to this expanded model. Because this expanded model would pay MDPP suppliers based on a beneficiary's achievement of performance goals, we stated that we believe that it is prudent to include additional requirements consistent with the Office of Inspector's General's compliance guidance,
The following is a summary of the public comments and our responses regarding the proposal to establish standards for MDPP suppliers' general eligibility to furnish services to Medicare beneficiaries and program integrity safeguards that would protect both Medicare beneficiaries and the Medicare program:
For example, some of the MDPP supplier standards provide preemptive measures to dissuade organizations that may seek to enroll as an MDPP supplier without planning to actually furnish services, but instead, with the intention of fraudulently billing Medicare for MDPP services not rendered. For example, requiring a working phone number that is listed in association with the supplier and having a physical location with signage associated with the supplier's legal business or doing business as name. These standards have also been implemented with other supplier types to avoid “shell” companies from being able to enroll. The supplier standard proposed at § 424.205(d)(1) prevents an organization with a for-cause termination in Medicaid from replicating the same behavior in Medicare that had them terminated in Medicaid. A supplier standard at § 424.205(d)(8) prohibits the MDPP supplier from proactively selecting beneficiaries who they perceive to be more likely to successfully meet the performance goals, which would subsequently generate more funds for the supplier. Another supplier standard at § 424.205(d)(10) ensures that an MDPP supplier offers all services for which an MDPP beneficiary is eligible, which would prevent a supplier that may otherwise seek to cease providing the time investment of offering services to a beneficiary who they believe is unlikely to meet performance goals, and therefore resulting in less reimbursement for the supplier. We have included safeguards to ensure that MDPP suppliers do not engage in this type of discriminatory behavior that could limit access for certain beneficiaries who would benefit from receiving MDPP on the basis of the supplier's own financial benefit.
We believe that establishing these standards also plays an important role in enabling CMS to enforce certain actions and take appropriate administrative action when a supplier fails to comply.
Though MedPAC did not comment on these standards directly, we believe that the both the standards supplier standards and our ability to deny or revoke an MDPP suppliers' enrollment if they fail to comply aligns with their recommendation to utilize all available program integrity tools.
After considering the public comments received, we are finalizing our policy to establish MDPP supplier standards at § 424.205(d), as proposed. Note that the specific MDPP supplier standard proposals outlined in the paragraphs of § 424.205(d) are discussed further through this section of the final rule.
In addition to establishing standards for MDPP suppliers with respect to their delivery of MDPP services, we also proposed standards for MDPP suppliers' general eligibility to furnish services to Medicare beneficiaries. These standards would establish program integrity safeguards that would protect both Medicare beneficiaries and the Medicare program. We proposed that MDPP suppliers must not currently have their billing privileges terminated for-cause from any State Medicaid program or be excluded from any State Medicaid program (§ 424.205(d)(2)). If a supplier's Medicaid billing privileges are currently terminated from or the supplier is excluded from any State Medicaid program, we stated that we do not believe that supplier should be able to furnish Medicare services. We stated that we believe that this is warranted given that a supplier's improper behavior in another federal health care program may be duplicated in Medicare. We stated that we believe that this requirement would mitigate the MDPP expanded model's susceptibility to fraud, waste, and abuse. Consistent with all standards in this section, any MDPP supplier who does not meet this requirement would be subject to a Medicare enrollment denial or revocation. We believe that this standard would serve to ensure continuity of safeguards across federal health care programs, and will help preserve the integrity of the Medicare program and protect beneficiaries by prohibiting suppliers found to be noncompliant in one federal health care program from enrolling in and furnishing services in another.
We sought comments on this proposal.
We received no comments on our proposal prohibiting that MDPP suppliers from being terminated for-cause or being excluded from a State Medicaid agency. Therefore, we are finalizing policies to prevent MDPP suppliers from having previous terminations or exclusions from State Medicaid Agencies as proposed at § 424.205(d)(2).
At § 424.205(d)(3), we proposed that the MDPP supplier must report coach information on its enrollment application and the MDPP supplier must only permit MDPP services to be furnished by individual coaches who meet the eligibility criteria. At § 424.205(e)(1), we proposed that MDPP coach eligibility criteria require that a coach must not:
• Currently have his or her Medicare billing privileges revoked and whose reenrollment bar has not yet expired. We believe that this proposed supplier standard would protect beneficiaries from receiving MDPP services from individuals already prohibited from furnishing other Medicare services. If an individual is precluded from maintaining enrollment in Medicare for a non-MDPP service, we believe that it is prudent that they similarly not furnish MDPP services.
• Currently have his or her Medicaid billing privileges terminated for-cause or be excluded from any State Medicaid Agency (§ 424.205(e)(1)(ii)). We believe that this proposed supplier standard is warranted given that an individual's improper behavior in another federal health care program may be duplicated in Medicare. We do not believe that we should permit MDPP suppliers to allow coaches with current for-cause terminations or exclusions in Medicaid to furnish MDPP services to Medicare beneficiaries.
• Currently be excluded from any other federal health care program, as defined in § 1001.2 of this chapter, in accordance with section 1128, 1128A, 1156, 1842, 1862, 1867 or 1892 of the Act. This includes, but is not limited to, the Office of Inspector General (OIG)'s List of Excluded Individuals and Entities (LEIE). We proposed this supplier standard for similar reasons we proposed not to permit coaches with revocations from Medicare or current exclusions from Medicaid to furnish MDPP services.
• Currently be debarred, suspended, or otherwise excluded from participating in any other federal procurement or non-procurement program or activity in accordance with the Federal Acquisition Streamlining Act implementing regulations and the Department of Health and Human Services non-procurement common rule at 45 CFR part 76. We note that this includes individuals who have an active status on the General Service Administration's System for Award Management list. We may also utilize the Bureau of the Fiscal Service, U.S. Department of the Treasury's Do Not Pay (DNP) List as a resource for determining which individuals fall under this category. The Improper Payments Elimination and Recovery Improvement Act (IPERIA) of 2012 established the DNP to support Federal agencies with their efforts to prevent and detect improper payments by aggregating various data sources for pre-award, pre-payment eligibility verification. Data sources included in this list include Credit Alert System, Death Master File, LEIE, Office of Foreign Assets Control (OFAC), System for Award Management (SAM) Entity Registration Records, and SAM Exclusion Records. We believe that we may utilize the DNP as a method of determining whether a coach is excluded from participating in any other federal procurement or nonprocurement programs. Although coaches will not directly be receiving payment from us for furnishing MDPP services, we do not believe that payment should be made to MDPP suppliers for services furnished by individuals excluded from federal procurement or nonprocurement programs, particularly given that MDPP payments rely on beneficiary's achievement of performance goals that the coaches will document. Although the MDPP supplier is ultimately responsible for attesting to all claims submitted for MDPP services, we do not believe that it would be prudent to permit MDPP suppliers to allow coaches excluded from other federal procurement programs to furnish MDPP services.
• Have, in the previous 10 years, one of the following state or federal felony convictions:
++ Crimes against persons, such as murder, rape, assault, and other similar crimes for which the individual was convicted, as defined under 42 CFR 1001.2, had a guilty plea or adjudicated pretrial diversion.
++ Financial crimes, such as extortion, embezzlement, income tax evasion, insurance fraud and other similar crimes for which the individual was convicted, as defined under § 1001.2, had a guilty plea or adjudicated pretrial diversion.
++ Any felony that placed the Medicare program or its beneficiaries at immediate risk, such as a malpractice suit that results in the individual being convicted, as defined under § 1001.2, having a guilty plea or having adjudicated pretrial diversion of criminal neglect or misconduct.
++ Any felonies that for which the individual was convicted, as defined under § 1001.2, had a guilty plea or adjudicated pretrial diversion that would result in mandatory exclusion under section 1128(a) of the Act.
We proposed that CMS will screen each individual identified on the roster of coaches included with the supplier's enrollment application to verify that the individual coach does not meet any of these conditions and that the coach can provide MDPP services on behalf of an MDPP supplier (§ 424.205(e)(2)). We proposed these requirements as a means to ensure the integrity and safety of the Medicare program and the beneficiaries whom we serve. We have selected these types of felony convictions based on the risk we believed they could pose to the Medicare program and our beneficiaries. Additionally, it is consistent with existing criteria that we use to determine felonies that are detrimental to the best interest of the program and its beneficiaries as described in § 424.535(a)(3)(ii). Although we selected these criteria to be consistent with how we evaluate other individuals, we also sought to create a more definite list such that MDPP suppliers would have the ability to conduct background checks on coaches prior to, as well as potentially after enrolling in Medicare, to avoid receiving an enrollment denial or revocation due to failure to meet this standard. Although coaches are not directly enrolled, and therefore, not directly receiving payment, we stated that we believe that it is prudent to prohibit MDPP suppliers from utilizing individuals convicted of certain felonies to furnish services to Medicare beneficiaries. Because coaches will be directly interacting with beneficiaries, recording their attendance and weight loss, we believe that a coach's trustworthiness is vital. Consequentially, we do not believe that such coaches should have a criminal history such as those described in § 424.535(a)(3)(ii).
Coaches that meet any of these criteria would be considered ineligible to furnish MDPP services, and therefore, could not be on an MDPP supplier's roster. Coaches whose information was submitted in an MDPP supplier's enrollment application, screened, and
If after screening, CMS or its contractors determine that a coach is eligible to furnish MDPP services, the coach would be assigned an eligibility start date, similar to a supplier's enrollment effective date. We proposed to define coach eligibility start date as follows: The start date indicated by the MDPP supplier when submitting an eligible coach's information on the MDPP enrollment application (§ 424.205(a)). On the enrollment application, the MDPP supplier will include a date indicating when the coach began furnishing MDPP services. Consistent with § 424.205(d)(5), the MDPP supplier must report changes to the coach roster on its enrollment application, including any new coaches added, within 30 days of such a change. Thus, the start date associated with any new coach information must be within 30 days of the date the MDPP supplier actually reports the change on its application. If the coach has not yet begun furnishing MDPP services, the MDPP supplier should indicate the date the supplier is reporting the information. Though the date reflects either when the coach began furnishing services or when the coach could ultimately be determined as eligible to begin furnishing services, after the enrollment application was submitted, CMS must still determine whether the coach is eligible (§ 424.205(e)(2). If we determine the coach to be eligible, then his or her eligibility start date would be the date the MDPP supplier indicated on its enrollment application. We described in III.K.2.d.(10)(d) of the proposed rule (82 FR 34149 through 34152) that payment can be made for services furnished by this coach on or after his or her eligibility start date.
However, if a coach was determined to be ineligible at the onset, the coach would have its eligibility start and end date on the same date, effectively never being eligible to furnish MDPP services. If the coach later became ineligible, he or she would be assigned an eligibility end date. Consistent with § 414.84, payment for MDPP services is made only if such services are furnished by an eligible coach, on or after his or her coach eligibility start date and, if applicable, before his or her coach eligibility end date, to an MDPP beneficiary. This could pose a situation in which an MDPP supplier could submit an updated coach roster that includes a new coach, and allow him or her to begin furnishing services based on the belief that he or she is eligible. Should, after screening, CMS or its contractors determine that the coach is ineligible, the MDPP supplier could be revoked for non-compliance. Though the MDPP supplier would have an opportunity to submit a corrective action plan that removes the ineligible coach from their enrollment application, any claims for services furnished by the ineligible coach would be denied, and the MDPP supplier would not be paid for such services. For this reason, we encourage suppliers to report changes to the coach roster as soon as possible. If the MDPP supplier submits a claim that includes a coach NPI for a coach we have not yet determined to be an eligible coach for furnishing MDPP services as of the date of service, the claim will be rejected, and the supplier will need to refile the claim with the same information once CMS has made the eligibility determination. If at that time, CMS determined the coach to be ineligible, the claim for the service provided by the coach will be denied, as described in section III.K.2.d.iii.(10)(d) of the proposed rule (82 FR 34149 through 34152).
We stated that we believe that the majority of the coach ineligibility criteria described in this section is crafted in such a way that the MDPP supplier could, with reasonable certainty, conduct an independent background check on the coach, to determine whether he or she meets the ineligibility criteria. If the MDPP supplier has any uncertainty about whether the coach meets the ineligibility criteria, they may wish to preclude the coach from furnishing services to Medicare beneficiaries until CMS determines that the coach is eligible. This would avoid a potential situation of a coach furnishing services for which the MDPP supplier could not get paid. If the MDPP supplier believes the coach is eligible and wishes to allow the coach to furnish services prior CMS determining his or her eligibility, then the MDPP supplier would assume the risk not receiving payment for claims for serviced rendered by the ineligible coach.
If a coach no longer provides MDPP services for an MDPP supplier, the supplier must remove that coach from its roster and indicate the date of such event to designate an eligibility end date for that coach. If the MDPP supplier voluntarily terminates its Medicare enrollment or is revoked, CMS will automatically reflect the date of this action as the coach's eligibility end date for that MDPP supplier. We proposed to define coach ineligibility end date as follows, the end date indicated by the MDPP supplier in submitting a change to the supplier's MDPP enrollment application that removed the coach's information, or the date the supplier itself was revoked from or withdrew its Medicare enrollment as an MDPP supplier.
We proposed that CMS or its contractors would determine whether coaches submitted on MDPP rosters satisfy the previously stated criteria by using the identifying information MDPP suppliers submit on their enrollment applications (including any changes that MDPP suppliers would be required to report). This information would be checked against internal and publicly available data sources. We proposed that, upon identification of evidence that a coach met any ineligibility criteria, we may take administrative action to deny or revoke the MDPP supplier's enrollment as appropriate under §§ 424.530(a)(1) and 424.535(a)(1) (proposed at § 424.205(g)(1)(ii)). Consistent with existing enrollment denial and revocation actions, we would notify the prospective or enrolled MDPP supplier via an enrollment denial or revocation notification and include the specific reason for the administrative action. The enrollment denial or revocation notification detailing the findings and the reasoning for the determination would follow requirements under § 488.18. Consistent with similar processes at §§ 424.530(c) and 424.535(e), we proposed that an MDPP supplier could respond to the enrollment denial or revocation by submitting a corrective action plan (CAP) that would include the removal of the coach from its roster within 30 days of receiving the enrollment denial or revocation notification, and therefore, come into compliance and enroll or maintain its enrollment status. If MDPP suppliers believe that the decision was made in error, they could exercise existing appeal rights under part 498.
We also proposed that if we determine that an MDPP supplier has continued to allow an ineligible coach to furnish MDPP services after having submitted a CAP removing the coach from its roster to enroll or maintain
Although any individual may be eligible to become a DPP coach, provided that they meet requirements and trainings as dictated by the CDC's DPRP Standards, an individual can only become an eligible coach for purposes of furnishing MDPP services after having their required identifying information submitted on an MDPP supplier's enrollment application, being screened by CMS or its contractors, and as a result, being determined to be eligible to furnish MDPP services on behalf of an MDPP supplier. If CMS or its contractors deem a coach ineligible, this would apply only to the furnishing of MDPP services and would not preclude the DPP organization from continuing to allow this individual to furnish administrative services or DPP sessions to non-Medicare beneficiaries. However, serving as a coach for Medicare beneficiaries would be prohibited and would be subject the MDPP supplier to this revocation authority.
We proposed this new revocation authority due to the novel program integrity risks that would be posed by MDPP suppliers who knowingly continue to permit ineligible coaches to furnish MDPP services to Medicare beneficiaries. We stated that we believe that this new basis for revocation is necessary because coaches are not enrolled in Medicare, even though they will undergo background checks by CMS or its contractors and must meet specified criteria. Although we considered using existing revocation authorities under § 424.535(a)(1) (related to noncompliance), § 424.535(a)(4) (related to false or misleading information), and § 424.535(a)(9) (related to failure to report), we determined that these authorities were too general for purposes of specifically addressing MDPP coaches who become ineligible to furnish MDPP services. We proposed that this revocation authority would follow similar requirements under § 424.535(c), (g), and (h). We stated that we do not believe that § 424.535(e) (related to reversal of the revocation) should apply in this case, given that the MDPP supplier already had an opportunity to remove the coach from their roster by submitting a CAP, but continued to allow the ineligible coach to furnish MDPP services. The proposals that we would apply from the provisions of § 424.535 stated in this section are as follows:
• The revocation becomes effective 30 days after CMS or the CMS contractor mails notice of its determination to the MDPP supplier;
• For the revocation authority, MDPP suppliers are barred from participating in the Medicare program from the date of the revocation until the end of the re-enrollment bar, which begins 30 days after CMS or its contractor mails notice of the revocation and lasts a minimum of 1 year, but not greater than 3 years, depending on the severity of the basis for revocation; and
• A revoked MDPP supplier must, within 60 calendar days after the effective date of revocation, submit all claims for items and services furnished before the date of the revocation letter.
We believe that these proposals would appropriately govern this new revocation authority, given the consistency with existing revocation authorities. Given these consistencies, we stated that we do not believe that these proposals place an undue burden on MDPP suppliers, and any burden established would be warranted given the violation of the supplier standards that jeopardize both the integrity of the Medicare program and the safety of its beneficiaries.
We invited public comments on these proposals.
While the commenter is correct in that our proposals will hold suppliers accountable for having ineligible coaches on their roster, and thus MDPP suppliers should independently verify eligibility, we disagree with the commenter's view that MDPP suppliers have this responsibility rather than CMS. Our proposal under § 424.205(e)(2) highlights that CMS ultimately determines coach eligibility through screening. Thus, while the commenter highlighted a need for a standardized, national credentialing body for MDPP suppliers, we view this as a method of quality assurance to determine an individual's capability to successfully meet the requirements of being a coach. As previously stated in a separate comment response, we rely on CDC to implement quality assurance related to MDPP, and they have not created a national credentialing system or suggested that doing so would improve the quality of the program. In contrast, concerns exist that the creation of such a system would create a barrier to entry that could ultimately drive down the number of available coaches. In the absence of the CDC identifying a need for such a system, we believe that CMS conducting screening for MDPP coaches to determine eligibility would sufficiently address program integrity concerns without creating a bottleneck in the supply of coaches. Though not equivalent to creating a national credentialing system our proposals would establish a standard and streamlined system to check for MDPP coach eligibility run by CMS, and not individual suppliers. Therefore, we will not modify our proposals.
After considering the public comments, we are finalizing all polices related to MDPP coach eligibility as proposed at paragraphs § 424.205(d)(3), (e), and (h)(1)(v).
We proposed a number of requirements that would help ensure that MDPP suppliers are operational, have the resources necessary to furnish MDPP services, and are in compliance with MDPP supplier standards. At § 424.205(d)(4), we proposed that, regardless of whether the MDPP supplier furnishes services solely in community settings, it must maintain at least one administrative location (82 FR 34163). All administrative locations maintained by the MDPP supplier must be on an appropriate site available to the public and must be reported on the CMS-approved enrollment application. We proposed that this administration location may not be a private residence. We proposed that an appropriate site must have signage posted on the exterior of the building, as well as be open for business and have employees, staff, or volunteers present during operational hours. For the purposes of this requirement, such signage may include, for example, the MDPP supplier's legal business name or its “doing business as” (DBA) name, as well as hours of operation. This proposal sought to utilize measurable objective indicators to determine that organizations are legitimately operating and able to furnish MDPP services to Medicare beneficiaries. We stated that we believe that, regardless of whether the MDPP supplier furnishes services at its administrative location, establishing a physical location is necessary for associated requirements for furnishing MDPP services, including recordkeeping requirements, training facilities, and storage for any educational materials distributed during sessions.
We proposed, at § 424.205(d)(6), that a MDPP supplier must maintain a primary business telephone number listed under the name of the organization in public view. Public view could signify, for example, that the phone number is listed on a Web site, on flyers and materials. This policy would require that calls must not automatically go to the answering machine or utilize an answering service during posted business hours. The purpose of this requirement is to help verify that the organization is a legitimate organization and not simply posing as an organization and seeking to bill Medicare fraudulently.
We further proposed, at § 424.205(d)(7), that an MDPP supplier must not knowingly sell to or allow another individual or entity to use its billing number, consistent with § 424.535(a)(7). We included this proposal to avoid a situation in which another entity uses an existing MDPP supplier's billing number. We stated that we believe that this policy plays an important role in ensuring that payments are only being made to the intended recipient who has met all of the supplier and compliance standards and that we continue to hold entities responsible for maintaining compliance. Otherwise, we risk making payments to suppliers potentially engaging in fraudulent or potentially harmful behavior.
We stated that we believe that the requirements in this section would not pose an undue burden on MDPP suppliers as they are minimum requirements for any functional, operational organization. By establishing these requirements, we believe that we would ensure that MDPP suppliers that do not meet the baseline requirements for an operational organization would not be permitted to furnish MDPP services to or receive payment for such services. We proposed, at § 424.205(d)(15), that an MDPP supplier must permit CMS or its agents to conduct onsite inspections to ascertain the supplier's compliance with these standards. Although we believe that any operational business that truly furnishes MDPP services would be able to meet these requirements, we invited public comments on any aspects of these standards.
The following is a summary of the public comments received on our proposals for requirements that would help ensure that MDPP suppliers are operational, have the resources necessary to furnish MDPP services, and are in compliance with MDPP supplier standards and our responses:
Based on commenters' feedback, we understand that the proposed policy would not serve its intended goal, and therefore, we will amend the proposal to allow multiple methods that an MDPP supplier could use to demonstrate its association with a specific location. We believe that by restructuring the MDPP supplier requirement to require that MDPP suppliers have signage posted on the exterior of the building or suite, in a building directory, or on materials located inside of the building provides sufficient flexibility such that any MDPP supplier who truly is operational would not need to change their current operations in order to meet this supplier standard.
To clarify, when we noted that the proposal at § 424.205(d)(6), would require that calls must not automatically go to the answering machine or utilize an answering service during posted business hours, we did not intend to add this as a standalone requirement. This sentence was intended to convey that by requiring MDPP suppliers to maintain a primary business telephone that operates either at administrative locations or directly where services are furnished, MDPP suppliers could not, by default use an answering machine or answering service as their primary contact number. We did not mean to suggest that MDPP suppliers may never use an answering machine. Thus, while we expect that MDPP suppliers may allow phone calls to go to an answering machine or service during operational hours, we believe the standard as proposed at § 424.205(d)(6) will achieve the intended goal of providing a mechanism to ensure that MDPP suppliers are operational. We believe that this clarification addresses concerns raised by commenters, and we thus will finalize the policy as proposed.
After considering the public comments, we are finalizing the policy requiring MDPP suppliers to have at least one administrative location at an appropriate site, as proposed at § 424.205(d)(4); however, we are modifying § 424.205(d)(4)(i) to allow for increased flexibility for signage requirements. After clarifying commenters' confusion about telephone requirements, we are finalizing policies as proposed at § 424.205(d)(6). We received no comments on the proposal that MDPP suppliers may not knowingly sell to or allow another individual or entity to use its supplier billing number, and thus are finalizing as proposed at § 424.205(d)(7).
We proposed, at § 424.205(d)(8), that MDPP suppliers may not deny access to MDPP services to eligible beneficiaries based on any reason other than the supplier's own self-determined and published capacity limits to furnish MDPP services to additional people and, on a discretionary basis, if a beneficiary significantly disrupts the session for other participants or becomes abusive (82 FR 34163 through 34164). Given that we do not yet currently have data on optimal class size for MDPP services, we are currently allowing MDPP suppliers to self-determine any upper limitation on class size. Should they establish such a limit and intend to turn beneficiaries away once the capacity limit is reached, the MDPP supplier must have previously made this limit publicly available; for example, denoting the limit in any brochures, Web sites, or other materials that outline their MDPP services. We proposed that MDPP suppliers must maintain a record of the number of eligible Medicare beneficiaries turned away for each of these reasons, as well as the date the beneficiary was informed. We further proposed that if an MDPP supplier denies a Medicare beneficiary access citing disruptive or abusive behavior, details of the occurrence(s), including date(s) of the behavior, any remediation efforts taken by the supplier, and final action (for example, dismissal from an MDPP session or denial from future sessions) must be documented in the beneficiary's MDPP records and adhere to documentation requirements outlined in § 424.205(g). We note that one supplier's decision to dismiss a beneficiary for this purpose would not prevent that beneficiary from switching to another MDPP supplier.
We stated that we will seek to monitor compliance with this requirement, and investigate further if necessary, based on beneficiary complaints, rates of access denials citing capacity limits in comparison to estimated capacity based on claims submitted, as well as monitoring claims for success rates for achieving performance goals that are higher than what would be expected for a typical Medicare population. Illustrative examples of capacity limits could include that the MDPP supplier has met its self-determined and published class size maximum, or that the supplier is providing MDPP sessions in cohorts and does not have a new or upcoming cohort at the time the beneficiary is seeking MDPP services. Furnishing MDPP services in a cohort means that the DPP curriculum is delivered among a single group, or cohort, from start to finish with sessions furnished in a specific order, and not allowing any new individuals to join once the cohort has begun.
Given that our payment structure for MDPP services relies on the achievement of weight loss and attendance goals, there may be incentives for MDPP suppliers to seek to serve only those beneficiaries for which they are more likely to earn performance payments. This, in turn, could result in discriminatory treatment of beneficiaries. Through this supplier standard, we would expressly prohibit MDPP suppliers from conditioning access to MDPP services on the basis of a beneficiary's weight or health status (except as provided in our regulations). We also would prohibit MDPP suppliers from conditioning access to MDPP services on the basis of a beneficiary's achievement of performance goals, except where the beneficiary becomes ineligible for additional sessions as a result of not meeting those goals, as discussed elsewhere in this final rule. We stated that we believe that it is appropriate to prohibit suppliers from denying access to MDPP services except in certain limited circumstances. If a supplier were to deny access to a beneficiary citing lack of capacity, but then furnish MDPP services to a different beneficiary, this may signal a violation of such standards. In addition, and for the same reasons, we proposed to prohibit MDPP suppliers, including any coaches or entities performing functions or furnishing services related to MDPP services on their behalf, from unduly coercing a beneficiary's decision to change or not change to a different or specific MDPP supplier, including through the use of pressure, intimidation, or bribery in § 424.205(d)(9). Information that may result in a beneficiary changing to a different MDPP supplier provided in response to a beneficiary's request for information would not violate this provision.
The CY 2017 PFS final rule, at § 424.79, established the set of services included in the expanded model, but did not stipulate that once a supplier began furnishing such services to a beneficiary, that it must continue to offer them to the beneficiary as a part of the MDPP expanded model. We proposed, at § 424.205(d)(10), that MDPP suppliers must offer and provide beneficiary access to the
We also solicited public comments on a potential future policy to require a specific class size limit for MDPP sessions. Although we acknowledge that MDPP services may be successfully furnished in group settings, we stated that we believe that it is important to ensure that the group's size is appropriately set such that each beneficiary gains the necessary interaction with the coach furnishing the session to properly learn the curriculum. We considered different mechanisms to ensure this program objective, and requested public comments on considerations to date. The mechanism that currently seems most viable would require a limitation on the number of total attendees in a given session taught by an individual coach. Based on CDC's experience with the DPP program and review of the literature on appropriate class sizes for educational settings, we considered including a class size limitation of 30 participants per coach in a given session (including Medicare beneficiaries). Given that limited data currently exist on this type of requirement among DPP sessions, we solicited public comments on what an appropriate class size limitation would be, including any evidence to support such a proposal.
Furthermore, we solicited public comments on how MDPP suppliers who furnish sessions in no specific sequential order and allow drop ins would balance the requirement of providing beneficiary access with a class size requirement for a given session. For example, if a supplier offers classes multiple times a week and gives beneficiaries flexibility regarding when to participate, we questioned whether a certain class size limitation could force a supplier to turn away a beneficiary seeking to attend a session at a time when attendance is high, and in so doing potentially discourage attendance at MDPP classes. In addition, we are unsure of any implications that would result from establishing a class size restriction for MDPP services while acknowledging that MDPP beneficiaries may participate in DPP sessions with non-Medicare beneficiaries who may not face the same class size limitation. Given these considerations, we solicited public comments on how we could structure a proposal in the future that would achieve the programmatic goals of effectively furnishing the DPP curriculum to Medicare beneficiaries in a manner and setting that contributes to positive behavioral changes and ultimately less progression to type 2 diabetes. In providing comments on this approach, we encouraged the submission of data and evidence to justify what specific class size would be appropriate for MDPP suppliers.
The following provides a summary of and our response to the public comments received on our proposals to prohibit MDPP suppliers from denying access to MDPP beneficiaries with limited exceptions, to require that MDPP suppliers document when they deny a beneficiary access under two of these exceptions, and to prohibit MDPP suppliers or individuals working on its
Furthermore, we believe that even in absence of a specific policy imposed by CMS, MDPP suppliers have incentives to furnish MDPP in smaller class sizes that are more conducive to engaging beneficiaries in behavioral change practices that will lead to weight loss and lowered diabetes risk. We believe that the payment structure rewards MDPP suppliers when MDPP beneficiaries meet weight loss goals. Thus, high levels of beneficiary engagement are to the benefit of both MDPP suppliers and beneficiaries, in order to achieve this weight loss. Based on experience with performance in the DPP indicating that beneficiary engagement plays a critical role with sustained attendance and weight loss, we believe that MDPP suppliers have greater incentives to furnish sessions in smaller settings with high levels of engagement than to furnish sessions with a high volume of participants, but low levels of engagement.
In addition to the importance of both sustained attendance and weight loss for MDPP payment, it also plays a significant role in maintaining CDC recognition. If suppliers conduct large sessions, beneficiary engagement is likely to be lower. Stakeholders have suggested that this may result in decreased attendance and/or failure to lose weight. If a supplier is furnishing MDPP services in extremely large classes where a large proportion of participants either do not attend or lose 5 percent of their body weight, this will negatively impact DPRP performance data that are necessary to maintaining recognition status. Should a supplier lose its recognition status, it will no longer be eligible for enrollment in Medicare.
Taken together, we believe that MDPP suppliers have larger incentives—both financial for MDPP reimbursement and sustainability of recognition status based on DPRP performance requirements—to furnish small sessions rather than large sessions. If some suppliers initially offer larger classes, we believe that lower per beneficiary reimbursement and threat of lost CDC recognition will motivate suppliers to self-correct. Regardless of this belief, we will monitor for activities that would indicate if an MDPP supplier is furnishing services in an overly large group. As a result of this monitoring and/or if we receive evidence to support an appropriate class size limitation, we may reconsider imposing a class size limit at a later date.
Though we specifically utilized the word capacity in order to capture the diversity of MDPP delivery styles, we understand that by framing this requirement as “lacking capacity” may have signified that a maximum number of participants had been reached, though in the scenario raised by the commenter, an MDPP supplier may consider furnishing MDPP services through cohorts, and once they have commenced, the capacity can be considered reached for additional MDPP beneficiaries. To more appropriately capture the above listed examples of capacity, we will modify the proposal such that an MDPP supplier may deny access to a beneficiary if the MDPP supplier lacks the self-determined and publicly-posted capacity. Though we discussed the need to publicly post the capacity in our proposal, we would like to emphasize this point by including it in our regulation. Additionally, we are changing the language from “an additional” beneficiary to “a given beneficiary” in the circumstance where an MDPP supplier establishes a minimum capacity to which to furnish services to beneficiaries, given that
The exceptions found at § 424.205(d)(8)(i)(A) (beneficiary no longer meets eligibility criteria for MDPP services) and § 424.205(d)(8)(i)(C) (MDPP beneficiary significantly disrupts the session for other MDPP beneficiaries or becomes abusive) would not apply to the example provided by the commenter. However, § 424.205(d)(8)(i)(B) warrants further discussion. Under this provision, an MDPP supplier may deny an MDPP beneficiary access to MDPP services where the MDPP supplier lacks the self-determined and publicly-posted capacity to furnish MDPP services to a given MDPP beneficiary. A supplier's “capacity” to furnish MDPP services encompasses several categories of capabilities that ultimately impact a supplier's capacity to furnish MDPP services to a MDPP beneficiary. For instance, a supplier could lack capacity to furnish MDPP services to a given MDPP beneficiary where the MDPP supplier lacks adequate physical space to accommodate the MDPP beneficiary if the MDPP supplier determines that its enrollment is at capacity for the space. Additionally, a supplier could lack capacity to furnish MDPP services to a given MDPP beneficiary where there are a finite number of coaches to hire to provide MDPP services, which in turn would reasonably limit the number of MDPP cohorts or classes that the MDPP supplier could provide as well as the number of MDPP beneficiaries that the MDPP supplier could accommodate.
Furthermore, an MDPP supplier could lack capacity to furnish MDPP services to a MDPP beneficiary where the MDPP supplier lacks business processes that would be required to furnish services to a MDPP beneficiary. In such a case, the MDPP supplier would need to determine that the burden of implementing the necessary business process rises to the level of a capacity limitation within the meaning of § 424.205(d)(8)(i)(B). It is this type of capacity that we believe to be at issue in the example provided by the commenter as where an MA plan that is part of an integrated system furnishes MDPP services to MA plan enrollees in the role of an MDPP supplier, the MA plan may lack a number of business processes that would be required to furnish MDPP services to non-enrollees and bill Original Medicare on a fee-for-service basis for those services.
Some of these required business processes could not reasonably be determined to rise to the level of a capacity limitation, such as the need for the MDPP supplier to develop processes to request and receive medical information from non-enrollees to determine eligibility for MDPP services. As an integrated system that is both payer and provider, the MDPP supplier would not need such processes as it would be able to pull lab values or recorded weights to determine eligibility for MDPP services from the enrollee's own health records kept by the system. Yet, such processes would be in place for the MA plan of which the MDPP supplier is apart given that the plan would commonly need to request and accept medical information on new enrollees. So, while this is an example of a business process that the MDPP supplier would be required to develop to serve non-enrollees, it likely does not rise to the level of a capacity limitation if it is a business process that the MA plan as a whole already has in place for the MDPP supplier to adopt as well.
However, the need for other business processes could reasonably be determined to rise to the level of a capacity limitation. For instance, MA plans do not bill Original Medicare on a fee-for-service basis for services provided to enrollees, and therefore lack the capacity to perform an operational requirement that would be necessary if the MA plan, as part of an integrated system, were to furnish MDPP services to non-enrollees under their MDPP supplier role. Given the administrative burdens associated with implementing the business processes required to bill fee-for-service Medicare, an MDPP supplier in this instance would be reasonable in determining that the complete lack of such a business process would rise to the level of a capacity limitation. As we believe that commenter's example is permitted under an existing exception to § 424.205(d)(8), we decline to adopt commenter's recommendation to articulate an additional, specific exception for an MDPP supplier that is part of an MA plan operating within an integrated system that wishes to exclusively provide MDPP services to its enrollees. However, we may continue to evaluate this issue for future rulemaking, as appropriate.
Though we do not wish to subject other Medicare beneficiaries to disruptive or abusive behaviors, we agree with the commenter that individuals with those behaviors, either as a result of SMI or otherwise, who are eligible for MDPP services generally should have access to such services. MDPP sessions are furnished by coaches who do not have medical training beyond what the DPRP requires. Should an individual with SMI become abusive, it does not seem appropriate to require that the supplier continue to furnish services to that beneficiary. In such a scenario, the beneficiary may be better suited to be under the care of a professional with specific training to appropriately work with beneficiaries with SMI. Furthermore, given that MDPP coaches furnish sessions in a group setting, we must also consider the needs of all participating beneficiaries. With these considerations in mind, we believe that our original proposal is appropriate.
Furthermore, we would like to take this opportunity to clarify our proposal. Under § 424.205(d)(8)(ii), an MDPP supplier must maintain a record of the number of MDPP beneficiaries for whom it declined access for the reasons outlined in § 424.205(d)(8)(i)(B) and (C), to include the date each such beneficiary was declined access. If a beneficiary is denied under § 424.305(d)(8)(i)(B), stating in the record “self-determined capacity” alone as the reason the beneficiary was denied would not sufficiently address the documentation requirements. As stated in the proposal, we intended this documentation to provide insight into the specific capacity reasons a beneficiary was denied to ensure that it aligned with the MDPP supplier's previously published capacity limits.
After considering the public comments, we are finalizing the policies as proposed under § 424.205(d)(8) as proposed except to modify § 424.205(d)(8)(i)(B) to state the MDPP supplier lacks the self-determined and publicly-posted capacity to furnish MDPP services to a given MDPP beneficiary. Given no feedback from commenters, are finalizing § 424.205(d)(9) and § 424.205(d)(10) as proposed, with a modification to § 424.205(d)(10) to align with changes in proposals at § 410.79(c)(2) where ongoing maintenance sessions are only available for eligible beneficiaries for one year, rather than the proposed two.
We proposed, at § 424.205(d)(11), that MDPP suppliers must provide information about the MDPP expanded model to each beneficiary to whom it wishes to begin furnishing MDPP services (82 FR 34164 through 34165). This included detailed information on coverage for the set of MDPP services, the once-per-lifetime limit, on eligibility requirements, and the MDPP supplier standards. We recognized that many aspects of the MDPP expanded model are novel for both beneficiaries and suppliers, and we desire that both parties are well informed. Therefore, we stated that we believe that requiring the supplier to fully disclose information about the MDPP expanded model, coverage, and the MDPP supplier standards will help inform all parties. We intend to provide a specific template for the MDPP supplier to use to disclose this information to the beneficiaries. For this reason, we stated that we do not believe that requiring this type of disclosure places a significant burden on the supplier. Although we believed that this approach will help to address the policy goals of the MDPP expanded model, we invited public comments on this approach, particularly upon the provision of a standard CMS disclosure notification as compared to CMS providing MDPP suppliers with information they could use to their own disclosure notification materials. Along these lines, we highlight that we also intend to publish information on the MDPP expanded model in the 2019 Medicare & You Handbook.
We invited public comments on these proposals.
The following is a summary of the public comments received on these proposals and our responses:
We are clarifying in this final rule that the disclosure requirements we proposed at § 424.205(d)(11) specified that, before the initial core session is furnished, the MDPP supplier must disclose detailed information about the set of MDPP services to each MDPP beneficiary to whom it wishes to begin furnishing MDPP services. At § 424.205(d)(11)(i) and (d)(11)(ii), this requirement then goes on to specify that this disclosure must include eligibility requirements as outlined under § 410.79(c)(1) and the MDPP supplier standards overall. In our proposal, we intended that detailed information about the set of MDPP services included which services, at minimum, were covered in the MDPP set of services. Given that the supplier standard proposed and finalized at § 424.205(d)(10) outlines these services, and MDPP suppliers must disclose their standards to beneficiaries, we believe that under our ordinary proposal, MDPP suppliers have provide MDPP coverage information to beneficiaries. However, to avoid any potential uncertainly, we are amending our proposed supplier standard to explicitly require that the MDPP supplier disclose MDPP coverage information, in addition to information on eligibility and MDPP supplier requirements. Though we believe that this requirement was already implicit in the proposal, we believe that clarifying this point to more overtly stipulate that MDPP suppliers disclose coverage information will only help MDPP suppliers understand and comply with the disclosure requirements. Furthermore, we believe that providing this clarity to ensure that all suppliers are disclosing MDPP coverage information to beneficiaries aligns with the request that CMS make efforts to standardize practices across suppliers. Given the discussion on MDPP suppliers' ability to furnish more than the minimum required sessions during the core services period, but their inability to charge beneficiaries as discussed further in section III.K.2.d.iii.(10)(c) of this rule, we believe that this adjustment to our proposal is warranted to ensure MDPP beneficiaries are as informed as possible.
After considering the public comments, we are finalizing the supplier standard regarding disclosure as proposed at § 424.205(d)(11), with a modification to specifically highlight that detailed information about the set of MDPP services not only includes eligibility and supplier standards, as previously proposed, but also minimum coverage requirements under § 410.79(c)(2).
We proposed at § 424.205(d)(12) that MDPP suppliers must answer Medicare beneficiaries' questions about MDPP services and respond to MDPP related complaints within a reasonable timeframe in § 424.205(d)(12) (82 FR 34165). We also proposed that MDPP suppliers implement a complaint resolution protocol and maintain documentation of all beneficiary contact regarding such complaints, including the name and Medicare Beneficiary Identifier of the beneficiary, a summary of the complaint, related correspondences, notes of actions taken, and the names and/or NPIs of individuals who took such action on behalf of the MDPP supplier. We proposed that this information must be kept at a supplier's administrative location and made available to CMS or its contractors upon request. These records would adhere to the same recordkeeping requirements in § 424.205(g), and therefore, would need to be maintained for 10 years. Although other records are typically required to be held only for 7 years (per § 424.516(f)), given that the MDPP expanded model includes beneficiary engagement incentives (described further in section III.K.2.f.v.) which require an extended documentation requirement, we considered it important to align all recordkeeping requirements for the MDPP expanded model. As noted earlier in this section, we proposed at § 424.205(d)(15) that an MDPP supplier must allow CMS or its agents to conduct recordkeeping reviews to ascertain the supplier's compliance with these standards, as well as documentation requirements as outlined in § 424.205(g).
We stated that we believe our proposal that MDPP suppliers must answer, respond to, and document beneficiary complaints and resolutions establishes a tracking mechanism to determine whether or not suppliers are adequately addressing beneficiary concerns. We find this requirement particularly important given that complaint procedures provide a good way to ensure best practices by suppliers. Although we acknowledged that this method requires the MDPP suppliers to self-attest to their response to complaints, we stated that requiring such documentation as a required Medicare standard can help to build accountability to following through with complaint resolution. Additionally, mandating that suppliers take and maintain records of complaints may help to address situations where beneficiaries raise issues with us directly after failing to receive resolution from the supplier.
We stated that we believe that requiring this documentation would provide an additional mechanism for us to ensure that the supplier is fully disclosing information pertinent to the supplier standards, specifically those regarding beneficiary access, and other concerns. As an additional benefit of this policy, if a beneficiary is denied access, the MDPP supplier would be required to demonstrate the reasoning behind this approach, and we could have an opportunity to review if this reasoning complied with the standard under § 424.205(d)(8).
This approach is consistent with supplier standards for other Medicare suppliers, including those for Durable Medical Equipment Prosthetics, Orthotics, and Supplies (DMEPOS) suppliers. Given that CMS has imposed similar standards regarding supplier responsibility for addressing beneficiaries' complaints among other supplier types, we stated that we do not believe that requiring a similar such requirement poses an undue burden on MDPP suppliers. Rather, we believed that this approach can facilitate beneficiary satisfaction with the services suppliers furnish by requiring that beneficiary complaints are acknowledged, resolved, and tracked appropriately. We stated that we believe that this approach will help ensure that the supplier is meeting beneficiaries' needs as they relate to the MDPP expanded model. In addition, we stated that we believe that this will help ensure the integrity of the MDPP expanded model.
We invited public comments on these proposals.
We received no comments on our proposals requiring that MDPP suppliers respond to MDPP beneficiaries' questions and concerns within a timely manner or that they complete and maintain a complaint resolution protocol. Similarly, we
In the CY 2017 PFS final rule, we finalized a requirement for MDPP suppliers to maintain and submit to CMS a crosswalk file that documented how the beneficiary identifiers submitted to CMS for billing and the beneficiary identifiers submitted to CDC for session-level performance data linked to the same beneficiary as a documentation retention and provision requirement (formerly § 424.59(b), redesignated and amended at § 424.205(d)(13)) in this final rule) (82 FR 34165 through 34166). CMS will use this crosswalk for evaluation purposes so CMS can review session level data that MDPP suppliers provide to CDC to supplement the claims data we receive directly from MDPP suppliers. We indicated that we would provide additional information on format and frequency of this reporting requirement in future rulemaking or administrative guidance as appropriate. We proposed the maintenance and submission of the crosswalk as an MDPP supplier standard and are providing additional details regarding the format and frequency.
We proposed that the crosswalk file would contain Medicare Health Insurance Claims Numbers or Medicare Beneficiary Identifiers and the unique participant identifier assigned by the organization, for the purposes of CDC performance data reporting, for each beneficiary receiving MDPP services (§ 424.205(d)(13)). Beneficiaries for whom at least one Medicare claim was submitted by an MDPP supplier would be required to be included in the crosswalk. We proposed that the crosswalk be supplied to CMS, or our contractor, beginning 6 months after the organization begins furnishing MDPP services, and quarterly thereafter. The crosswalk would be maintained in a spreadsheet (for example, an Excel file or a CSV file), in a form and manner as specified by CMS. We invited public comments on this approach.
The following is a summary of the public comments received on this approach and our responses.
Rather that propose any new requirements in this rule, we sought to provide clarity on the information that MDPP suppliers must submit on the crosswalk and its frequency. In efforts to streamline data submission requirements for the crosswalk across all MDPP suppliers, we are further clarifying the requirement we outlined in the proposed rule (82 FR 34165 through 34166), that data must be submitted 6 months after an MDPP supplier begins furnishing services, and quarterly thereafter. Rather than apply crosswalk submission dates on a per supplier basis, which could conceivably result in different suppliers submitting their crosswalks each month of the year, moving forward, we intend to establish four distinct periods where MDPP supplier crosswalks are accepted. With this change in mind, we are adapting our proposal such that MDPP suppliers will become eligible to submit their crosswalk beginning 6 months after they begin furnishing services and must submit at the closest quarter, and continue submitting on a quarterly basis thereafter. We hope that streamlining the submission periods across all suppliers will decrease confusion among suppliers and work to alleviate some of the burden associated with the crosswalk submission. We will provide details on this submission process through guidance, as appropriate.
Additionally, to enable evaluation of MDPP services for a beneficiary's entire MDPP services period (that is, up to 2 years), we proposed that MDPP suppliers must submit performance data for any beneficiaries who attend ongoing maintenance sessions in a manner and form as specified by CMS (proposed § 424.205(d)(14)). This proposal served to ensure that MDPP suppliers provide session-level data for ongoing maintenance sessions that are consistent with the data they are already providing to CDC for the core MDPP services period. This requirement is necessary given that session-level performance data plays a critical role in the Innovation Center's evaluation of the entirety of the MDPP expanded model. Without such data, the Innovation Center would lack any streamlined method of obtaining session-level data for ongoing maintenance sessions furnished to MDPP beneficiaries. We proposed that this performance data must align with the performance date elements as required by CDC for the DPRP standards. We solicited public comments on this approach.
We received no comments on our proposal requiring MDPP suppliers to submit session-level data, consistent with performance data MDPP suppliers are already providing to CDC, for ongoing maintenance sessions. Thus, without any stakeholder input on this policy, we are finalizing as proposed at § 424.205(d)(14). However, in light of concerns regarding the multiple and distinct data submission requirements MDPP suppliers must submit to CMS and CDC, we clarify that such MDPP suppliers shall submit any performance data for ongoing maintenance sessions, as required under § 424.205(d)(14) to CDC along with the performance data they would already provide per the DPRP standards. We recognize stakeholders concerns raised both in this rule and in our previous policy proposals regarding potential burden associated with multiple and distinct submission requirements, and thus we will plan to align our requirements for data submission under this requirement with the DPRP data submission requirements for the initial core services period. We believe that this alignment with CDC will alleviate some of the potential burden associated with this MDPP supplier standard. We will release additional information through guidance, as appropriate.
We are finalizing our policies as proposed at § 424.205(d)(13) and (14). However, this rule provided an update to the manner and form MDPP suppliers must submit the crosswalk § 424.205(d)(13) that would provide greater consistency across suppliers.
In the CY 2017 PFS final rule, we specified that newly enrolling MDPP suppliers as high categorical risk in accordance with § 424.518(c), but we did not address the risk level of MDPP suppliers upon revalidation. Section 6401(a) of the Affordable Care Act established that all Medicare suppliers must revalidate their enrollments as a program integrity measure. Upon revalidation, suppliers are screened for their continued enrollment in Medicare. Although MDPP suppliers enroll at the high risk level, we proposed, at § 424.205(b)(3)(ii), that MDPP suppliers would revalidate under a moderate risk level in accordance with § 424.518(b)(2). We believe that this approach is appropriate, given that fingerprint-based criminal history record checks through the Federal Bureau of Investigation's (FBI) Integrated Automated Fingerprint Identification System (IAFIS) requirement for “high” categorical risk will have already been completed upon initial enrollment. In addition, we believe that this approach is appropriate, given its consistency with other providers and suppliers who initially enroll under “high” categorical risk, but revalidate under “moderate” categorical risk, such as DMEPOS suppliers and Home Health Agencies. We also proposed, at § 424.205(b)(6), as a condition of enrollment, that MDPP suppliers must revalidate their enrollment every 3 years, consistent with DMEPOS suppliers who are initially screened under “high” categorical risk screening level (82 FR 34166). We welcomed public comments on these proposals.
The following is a summary of the public comments on the proposals to require that MDPP suppliers revalidate every 3 years at moderate categorical risk:
While a similar number of commenters expressed support for our original proposal, as well as recommended an alternative proposal that would require less frequent revalidations, we considered this proposal within the context of broader comments regarding the high degree of supplier burden as a result of our cumulative requirements. Though not expressly made in response to this proposal on revalidation, commenters frequently noted that the number of MDPP supplier requirements and burden from those requirements could potentially dissuade prospective MDPP suppliers from deciding to enroll. In light of these concerns and our desire to enable a strong supplier base to meet beneficiary demand for MDPP services, we looked for opportunities where we could alter requirements for MDPP suppliers to alleviate supplier burden without posing vulnerabilities to the integrity of the Medicare program or the safety of our beneficiaries. Ultimately, we determined that decreasing the frequency with which MDPP suppliers revalidate could achieve this balance. As such, we are modifying our proposal such that MDPP suppliers will be required to revalidate every 5 years, instead of the proposed 3 years. That said, we acknowledge MedPAC's concerns against the potential for fraud and abuse, as well as their encouragement to apply all program integrity safeguards possible for this new expanded model and the suppliers who furnish it. Therefore, we will continue to monitor the level of risk posed by MDPP suppliers and will consider revalidating more frequently in the future, if appropriate.
Additionally, given the novelty of this model expansion, we are considering utilizing a provisional period of enhanced oversight authority under section 1866(j)(3) of the Act to monitor for program integrity safeguards. Should we take this approach, CMS would assume the responsibility of conducting any oversight action as a way of avoiding adding any increased burden to MDPP suppliers. We believe that this approach to require that MDPP suppliers revalidate less frequently, and instead, for CMS to assume responsibility for enhanced monitoring demonstrates our commitment to respond to stakeholder comments to both protect the Medicare program and its beneficiaries against fraud, waste, and abuse and also to avoid unnecessary burdens to the suppliers who service our beneficiaries.
After considering the public comments, we are finalizing our proposal at § 424.205(b)(3)(ii) that
We proposed that the following requirements would apply to records related to a MDPP supplier's compliance with the MDPP expanded model (codified at § 424.59(b), redesignated as amended at § 424.205(g)) (82 FR 34166). We stated that we believe that these proposals would increase supplier recordkeeping accuracy, and clarify documentation retention requirements. Specifically, we proposed that an MDPP supplier must:
• Provide to CMS or its contractors, the OIG, and the Comptroller General or their designee(s) scheduled and unscheduled access to all books, contracts, records, documents, and other evidence sufficient to enable the audit, evaluation, inspection, or investigation of the supplier's compliance with MDPP requirements, including the MDPP expanded model requirements for in-kind beneficiary incentive engagements found in § 424.210 in the event that the MDPP supplier chooses to offer such incentives to any MDPP beneficiary.
• Maintain all such books, contracts, records, documents, and other evidence for a period of 10 years from the last day of the MDPP beneficiary's receipt of MDPP services furnished by the MDPP supplier or from the date of completion of any audit, evaluation, inspection, or investigation, whichever is later, unless—
++ CMS determines that there is a special need to retain a particular record or group of records for a longer period and notifies the MDPP supplier at least 30 calendar days before the normal disposition rate; or
++ There has been a dispute or allegation of fraud or similar fault, as defined at § 405.902, against the MDPP supplier, in which case the records must be maintained for an additional 6 years from the date of any resulting final resolution of the dispute or allegation of fraud or similar fault.
We stated that we believe these proposals increase the likelihood of operationalizing MDPP program integrity strategies that include audits, evaluations, inspections, or investigations, and that they provide additional clarity on documentation retention for ongoing program integrity. In addition, in the CY 2017 PFS we established supplier requirements for documentation and recordkeeping (codified at § 424.59(b), redesignated and amended at § 424.205(g). In this final rule, we are revising these requirements to improve clarity. We proposed at § 424.205(g)(1) and (g)(2) to require that documentation must be established contemporaneous to the furnished MDPP services, which we believe is important for accuracy. We also proposed that for the initial core session, these records must include the following organizational information:
• The organizational name, CDC DPRP organization number, and organizational NPI;
• Basic beneficiary information including but not limited to beneficiary name, HICN, and age; and
• Evidence that each such beneficiary satisfied the eligibility requirements under § 410.79(c) at the time of service.
For each additional session, we proposed that these records must include:
• Documentation of the type of session, whether a core session, a core maintenance session, an ongoing maintenance session, an in-person make-up session, or a virtual make-up session.
• Identification of which CDC-approved DPRP curriculum was associated with each session.
• The NPI of the coach who furnished the session.
• The date and place of service of the session.
• Each MDPP's beneficiary's weight and date weight taken, in a form and manner as specified by CMS.
We stated that we believe that this information will play an important role in documenting the provision of MDPP services and fidelity to the requirements established for the expanded model. Finally, at § 424.205(g)(4), we proposed that MDPP suppliers must maintain and handle any beneficiary Personally Identifiable Information (PII) and Personal Health Information (PHI) in compliance with HIPAA, other state and federal privacy laws, and CMS standards. We believe these proposals will improve supplier recordkeeping accuracy and lessen the possibility of incomplete records and supplier recordkeeping variations.
We invited public comments on our proposed documentation and maintenance of records requirements, including whether additional or different requirements may provide better program integrity safeguards.
The following is a summary of the public comments received on our proposal for documentation and maintenance of records requirements, including whether additional or different requirements may provide better program integrity safeguards and our responses:
To more clearly state that the requirement at § 424.205(g), we are amending the language to require that MDPP suppliers maintain and handle any beneficiary information related to MDPP, including Personally Identifiable Information (PII) and Protected Health Information (PHI), as appropriate under HIPAA, other applicable state and federal privacy laws, and CMS standards. That said, we would highlight the “related to MDPP services” language. We hope that this language more clearly explains that this provisions applies only to beneficiary information related to MDPP, and not information collected by the MDPP supplier for other services they may provide. Any data an MDPP supplier would receive as a function of their non-MDPP related business would not be “related to MDPP services” if those non-MDPP business functions are truly separate from the MDPP ones. We believe that this clarification addresses the commenter's concern of how they would handle information related to their non-MDPP activities. Additionally, we hope that shifting the language from “in compliance with” to “as required under” more clearly signals that we are not imposing any additional requirements to comply with laws or standards that would not otherwise already apply to the MDPP supplier's handling or maintenance of beneficiary information. We proposed a requirement at § 424.205(g)(4) to be more consistent with language at § 424.205(g), and to state that an MDPP supplier must maintain all documentation related to participation in the MDPP in accordance with all applicable Federal and State laws. We recommend that any prospective MDPP supplier applicants consult with counsel to determine whether they qualify as a HIPAA Covered Entity, and, if so, how it will comply with HIPAA as applicable to beneficiary information related to MDPP as opposed to other information collected for non-MDPP related purposes.
After considering the public comments, we are finalizing the proposals under § 424.205(g) with a modification at § 424.205(g) for additional clarity. We are finalizing that under § 424.205(g)(4), MDPP suppliers must maintain and handle any beneficiary information related to MDPP, including PII and PHI, as would be required under HIPAA, other applicable state and federal privacy laws, and CMS standards.
In the proposed rule (82 FR 34166), we stated our belief that the MDPP expanded model would encourage MDPP suppliers to furnish high quality and engaging health behavior change services to MDPP beneficiaries that lead to improved beneficiary health and reductions in Medicare spending. We believe that one mechanism that may be useful to the MDPP suppliers in achieving these goals would be allowing MDPP suppliers to furnish certain in-kind items and services to their MDPP beneficiaries during the core services period and ongoing services period (described at proposed § 410.79(c)(2)). Under such an approach, the costs of these beneficiary engagement incentives would be borne by the MDPP supplier. However, we believe that certain conditions on these incentives would be necessary to ensure that they would be furnished solely for the purpose of achieving the MDPP goal of engaging beneficiaries in making sustainable, healthy behavior changes to reduce their risk of type 2 diabetes.
We proposed to establish the rules governing the furnishing of beneficiary engagement incentives to MDPP beneficiaries under the MDPP expanded model at new § 424.210. As discussed in section III.K.2.a. of the proposed rule (82 FR 34131), we proposed that MDPP services would be available beginning on April 1, 2018.
We proposed that if an MDPP supplier offers an in-kind beneficiary engagement incentive, the item or service offered as an incentive must be furnished by an MDPP supplier to an MDPP beneficiary during the engagement incentive period. An engagement incentive period would begin when an MDPP supplier furnishes any MDPP service to an MDPP beneficiary. We proposed at § 424.210(a) that the term “engagement incentive period” means the period of time during which an MDPP supplier may furnish in-kind beneficiary engagement incentives to a given MDPP beneficiary to whom the MDPP supplier is furnishing MDPP services. The engagement incentive period would end upon the earliest of the following: The beneficiary's MDPP services period ends (as specified in proposed § 410.79(c)(3)) for any reason; the MDPP supplier knows the MDPP beneficiary will no longer be receiving MDPP services from the MDPP supplier; or the MDPP supplier has not had direct contact, either in person, by telephone, or via other telecommunications technology, with the MDPP beneficiary for more than 90 consecutive calendar days during the MDPP services period.
We proposed that items and services may only be furnished as in-kind beneficiary engagement incentives during the engagement incentive period. This was to ensure that the flexibilities that MDPP suppliers would have under these proposed regulations to furnish free items and services to Medicare beneficiaries only apply while the beneficiary is an MDPP beneficiary being offered MDPP services by that MDPP supplier. Once the MDPP beneficiary's engagement incentive period ends with an MDPP supplier, all existing laws and regulations would apply to the furnishing of free items and services to a Medicare beneficiary by the entity that is an MDPP supplier. Limiting the furnishing of beneficiary engagement incentives under the MDPP expanded model to the engagement incentive period with a particular MDPP supplier would serve as a safeguard against the furnishing of free items and services to Medicare beneficiaries to steer them toward particular providers, suppliers, or other services, rather than to engage MDPP beneficiaries in healthy behavior changes that reduce their incidence of type 2 diabetes.
During the course of the MDPP services period, we noted that an MDPP beneficiary may begin and end multiple engagement incentive periods, and, to the extent feasible, the MDPP beneficiary would not be in more than one engagement incentive period at the same time. For example, where, after receiving MDPP services from MDPP supplier A, an MDPP beneficiary notifies MDPP supplier A that he or she has chosen to receive MDPP services from MDPP supplier B and subsequently receives MDPP services from MDPP supplier B, the first engagement incentive period ends when
These proposals for the definitions specific to beneficiary engagement incentives were included at proposed § 424.210(a). We invited public comments on these proposed definitions specific to furnishing in-kind beneficiary engagement incentives.
The following is a summary of the public comments received on the proposals for definitions specific to furnishing in-kind beneficiary engagement incentives and our responses:
After considering the public comments received, we are finalizing the proposals, without modification, for the definitions specific to furnishing in-kind beneficiary engagement incentives at § 424.210(a).
We proposed, at § 424.210(b), that an MDPP supplier may choose to furnish items or services as in-kind beneficiary engagement incentives to an MDPP beneficiary only during the engagement incentive period, subject to a number of additional conditions as program safeguards. Under this proposal, the in-kind items and services furnished as beneficiary engagement incentives under the MDPP expanded model would not be Medicare-covered items or services, nor would they be any cost-sharing amounts for Medicare-covered items or services.
We proposed that the engagement incentive must be furnished directly by an MDPP supplier or by an agent of the MDPP supplier under the MDPP supplier's direction and control, such as a coach, to an MDPP beneficiary. As established in the § 410.79(b) in the CY 2017 PFS final rule, coach refers to an individual who furnishes MDPP services on behalf of an MDPP supplier as an employee, contractor, or volunteer. We considered whether this policy on beneficiary engagement incentives should extend to entities other than MDPP suppliers and their agents that may refer to or furnish MDPP services during an engagement incentive period. However, given that MDPP suppliers maintain the responsibility to ensure the integrity of MDPP programs and would be best positioned to comply with beneficiary engagement incentive documentation and technology retrieval requirements proposed at § 424.210(e) and (c), respectively, we believed that they would be best suited to furnished beneficiary engagement incentives.
We proposed that the item or service furnished as a beneficiary engagement incentive must be reasonably connected to the CDC-approved curriculum taught by an MDPP supplier to an MDPP beneficiary during a core session, a core maintenance session, or an ongoing maintenance session. For example, under this proposal, an MDPP supplier could furnish beneficiary engagement incentives such as gym memberships to reduce barriers associated with beneficiary achievement of physical activity recommended as part of the CDC-approved curriculum, but they
We also proposed that the beneficiary engagement incentive must be a preventive care item or service, or an item or service that advances a clinical goal for an MDPP beneficiary as described in section III.K.2.f.iv. of the proposed rule (82 FR 34169 through 34170) by engaging him or her in better managing his or her own health. This would ensure that a relationship between the incentive and the goals of the MDPP expanded model exists so that the beneficiary engagement incentive is necessary for testing the MDPP expanded model. Under this proposed condition, we noted that beneficiary engagement incentives may not be offered to an MDPP beneficiary as a reward for achievement of a specified outcome, such as losing weight or attending a certain number of sessions, unless the beneficiary engagement incentive meets all the proposed conditions, including that it is reasonably connected to the CDC-approved DPP curriculum furnished to the MDPP beneficiary during a core session, a core maintenance session, or an ongoing maintenance session by the MDPP supplier and that it is a preventive care item or service or it advances a clinical goal for an MDPP beneficiary by engaging him or her in better managing his or her own health. Furnishing in-kind patient engagement incentives upon achievement of an outcome may not advance a clinical goal for an MDPP beneficiary by engaging him or her in better managing his or her own health unless there are clinical goals that the incentive itself can continue to advance.
We further proposed that the item or service furnished as a beneficiary engagement incentive must not be tied to the receipt of items or services outside the MDPP services, and that the item or service must not be tied to the receipt of items or services from a particular provider, supplier, or coach. These provisions would provide safeguards against the furnishing of in-kind beneficiary engagement incentives to steer beneficiaries toward certain providers, suppliers, or coaches for services outside MDPP services.
We noted that in some circumstances, an item or service may be linked to an MDPP supplier and be offered to the MDPP supplier's MDPP beneficiaries as part of the CDC-approved curriculum that must be furnished during the MDPP services period, rather than being offered to steer the MDPP beneficiary to a particular provider, supplier, or coach. In these situations, we believed that the item or service may be furnished as a beneficiary engagement incentive without violating the requirement that the item or service not be tied to the receipt of the items or services from a particular provider, supplier, or coach. For instance, where an MDPP supplier offers a gym membership as a beneficiary engagement incentive, we understood that the gym membership must be tied to a particular supplier of services so that the beneficiary can use the membership. However, in this case, the gym membership would be linked to the MDPP supplier that, in compliance with the curriculum that must be furnished during the MDPP services period, would be teaching MDPP beneficiaries how to utilize a physical fitness regime to meet the MDPP goal of reducing an MDPP beneficiary's risk of developing diabetes, rather than being furnished to steer the MDPP beneficiary to a particular supplier. Therefore, we believed that gym memberships may be furnished as a beneficiary engagement incentive without violating the requirement that the item or service not be tied to the receipt of items or services from a particular provider, supplier, or coach, as long as the gym membership is reasonably connected to the CDC-approved curriculum and not being furnished to steer the MDPP beneficiary to a particular supplier.
We proposed that, in general, the availability of the items or services furnished as beneficiary engagement incentives must not be advertised or promoted as in-kind beneficiary engagement incentives available to an MDPP beneficiary receiving MDPP services from the MDPP supplier. However, an MDPP beneficiary may be made aware of the availability of the items or services at the time the MDPP beneficiary could reasonably benefit from them during the engagement incentive period. This condition would provide a safeguard against the advertisement of in-kind patient engagement incentives to beneficiaries based on their perceived ability to meet the performance goals of attendance and weight loss as described at proposed § 414.84(a) and associated with the MDPP performance payments proposed at § 414.84(b). The proposed payment structure for MDPP services largely would rely on the achievement of these performance goals. Therefore, advertising patient engagement incentives to encourage participation of MDPP-eligible beneficiaries most likely to meet the attendance and weight loss performance goals could produce financial gain for MDPP suppliers that would not be related to the quality and efficacy of the MDPP supplier's MDPP services.
In addition, prohibiting the advertisement or promotion of in-kind beneficiary engagement incentives available to an MDPP beneficiary receiving MDPP services from the MDPP supplier (except that an MDPP beneficiary may be made aware of the availability of the items or services at the time the MDPP beneficiary could reasonably benefit from them during the engagement incentive period) would provide a safeguard against using the incentive to steer a beneficiary toward a particular MDPP supplier. Beneficiaries would not be made aware of the availability of beneficiary engagement incentives until the MDPP beneficiary was in an engagement incentive period, which would begin when an MDPP supplier furnished its first MDPP service to the beneficiary. At that point in time, the beneficiary would have already selected that MDPP supplier to furnish his or her MDPP services so the incentive could not be used to steer the beneficiary to that MDPP supplier. We noted that we did not intend for beneficiary engagement incentives proposed for the MDPP expanded model to alter an MDPP supplier's market share for an MDPP or non-MDPP item or service.
Finally, we proposed that the cost of the items or services offered as in-kind
These proposals for the general conditions for in-kind beneficiary engagement incentives were included at proposed § 424.210(b). We invited public comments on these proposed general conditions for furnishing beneficiary engagement incentives. In addition, we invited public comments on additional or alternative program integrity safeguards.
The following is a summary of the public comments received on the proposals for the general conditions for in-kind beneficiary engagement incentives and our responses:
To address their concerns about MDPP suppliers having funds to furnish beneficiary engagement incentives, several commenters recommended that CMS alter the proposal that the costs of the beneficiary engagement incentives be borne by the MDPP supplier. The commenters urged CMS to pay MDPP suppliers for furnishing beneficiary engagement incentives such as transportation, child care for grandchildren, and other incentives that support session attendance, especially for MDPP suppliers serving high-risk populations. One commenter observed that CMS currently allows payment to be made for transportation to medical appointments in some Medicaid populations. Another commenter advocated for direct payment by CMS to MDPP suppliers for tools such as digital scales and fitness trackers, noting they are useful to DPP participants, whether enrolled in virtual or in-person programs.
Finally, one commenter stated that consumer engagement in services and programs occurs in a well-designed, evidence-based program that offers easily accessible services that consumers need. The commenter urged CMS to shift its focus away from the detailed proposed conditions for beneficiary engagement incentives that could be furnished by MDPP suppliers to engage MDPP beneficiaries to instead focus on establishing the right MDPP services, making appropriate MDPP services payments, and minimizing the administrative burden associated with becoming an MDPP supplier.
We understand that some MDPP suppliers may not have funds available that allow them to furnish beneficiary engagement incentives to MDPP beneficiaries, especially early in the supplier's experience furnishing MDPP services. However, once an MDPP supplier begins to receive performance payments from CMS for MDPP beneficiary achievement of performance goals, the supplier may have more information about the potential for beneficiary engagement incentives to reduce barriers to MDPP beneficiary achievement of performance goals, as well as additional funds that may be used for these incentives. For those MDPP suppliers with funds that may potentially be used to furnish in-kind incentives, this experience may allow the MDPP supplier to make a more informed decision on furnishing beneficiary engagement incentives versus other MDPP supplier investments that have the potential to improve beneficiaries' achievement of performance goals under the MDPP expanded model.
While we acknowledge the suggestions of some commenters that CMS pay directly for certain beneficiary engagement incentives, we do not believe it would be appropriate in the context of the performance-based payment methodology for MDPP services discussed in section III.K.2.d. of this final rule for CMS to pay MDPP
If the MDPP supplier determines that the incentive being considered is reasonably connected to the DPP curriculum furnished to a beneficiary during a session, the MDPP supplier must also make a determination about whether the incentive meets the other requirements for beneficiary engagement incentives under the MDPP expanded model before deciding whether or not to furnish the item or service to the beneficiary as a beneficiary engagement incentive. Through information from claims for MDPP services and the MDPP supplier documentation required under the MDPP expanded model, we plan to monitor beneficiary engagement incentives furnished to MDPP beneficiaries by MDPP suppliers for compliance with the final conditions for the incentives, including that incentives furnished to MDPP beneficiaries are reasonably connected to the DPP curriculum furnished to those beneficiaries during sessions.
In response to the concerns about MDPP suppliers lacking sufficient resources to furnish beneficiary engagement incentives early on in the MDPP services period before receiving performance payments, we note that there is no requirement that MDPP suppliers furnish beneficiary engagement incentives. Thus, MDPP suppliers could wait until they have amassed enough payments to bear the costs of the incentives or forgo furnishing incentives to MDPP beneficiaries altogether.
We proposed at § 424.210(b)(7) that the cost of the item or service furnished as a beneficiary engagement incentive must not be shifted to another Federal health care program, as defined at section 1128B(f) of the Act, but did not explicitly prohibit cost-shifting to MDPP beneficiaries. Shifting the cost of beneficiary engagement incentives to MDPP beneficiaries would not be permitted under our proposal, and we agree with the commenters that MDPP beneficiaries should not bear any of these costs. Therefore, in view of the concerns of the commenters over the potential for MDPP suppliers to shift the costs of beneficiary engagement incentives to MDPP beneficiaries and our interest in safeguarding against such a shift, we believe it would be appropriate to add an additional condition in new § 424.210(b)(8) to specify that the cost of the item or service furnished as a beneficiary engagement incentive must not be shifted to an MDPP beneficiary. For example, under this condition the beneficiary engagement incentive structure used by an MDPP supplier may not financially penalize an MDPP beneficiary through a cost to the beneficiary for lack of adherence to health behavior changes taught in the DPP curriculum or failure to achieve performance goals.
As we stated in the proposed rule (82 FR 34168) in the context of our proposal that the beneficiary engagement incentive must be a preventive care item or service, or an item or service that advances a clinical goal for an MDPP beneficiary by engaging him or her in better managing his or her own health, beneficiary engagement incentives may not be offered to an MDPP beneficiary as a reward for achievement of a specified outcome, such as losing weight or attending a certain number of sessions, unless the beneficiary engagement incentive meets all the proposed conditions, including that it is reasonably connected to the CDC-approved DPP curriculum furnished to the MDPP beneficiary during a core session, a core maintenance session, or an ongoing maintenance session by the MDPP supplier. Similarly, beneficiary engagement incentive structures that financially penalize beneficiaries for lack of adherence to health behavior changes taught in the DPP curriculum or failure to achieve a performance goal would not meet the requirements for beneficiary engagement incentives under the MDPP expanded model, including that the item or service be a preventive care item or service or an item or service that advances a clinical goal for an MDPP beneficiary by engaging him or her in betting managing his or her own health. Such an approach would shift all or part of the cost of the beneficiary engagement incentive to the MDPP beneficiary, which is explicitly not permitted under the new condition we are finalizing at § 424.210(b)(8).
In addition, we proposed a number of other conditions for beneficiary engagement incentives discussed throughout this section that provide program safeguards, including protection against competition among MDPP suppliers for beneficiaries based on the value of incentives and not based on the quality or clinical outcomes of MDPP services.
Therefore, regarding the potential for retail gift cards, including supermarket gift cards, to be furnished by MDPP suppliers as beneficiary engagement incentives, we encourage MDPP suppliers considering furnishing these items to assess whether the specific gift
After considering the public comments received, we are finalizing the proposals for the general conditions for in-kind beneficiary engagement incentives at § 424.210(b), with modifications. We are adding another condition for beneficiary engagement incentives at § 424.210(b)(8) that specifies that the cost of the item or service must not be shifted to an MDPP beneficiary.
In some cases, items or services involving technology may be useful as beneficiary engagement incentives because they can advance a clinical goal of the MDPP expanded model by engaging an MDPP beneficiary in managing his or her health. However, in the proposed rule (82 FR 34169) we stated our belief that specific enhanced safeguards are necessary for these items and services to prevent abuse.
First, we proposed that items or services involving technology furnished by an MDPP supplier to its MDPP beneficiary may not, in the aggregate, exceed $1,000 in retail value for any one MDPP beneficiary. We believed that this proposed limit would be appropriate, in conjunction with our proposed enhanced requirements for items of technology with a retail value greater than $100 as discussed subsequently. The proposed $1,000 limitation would allow sufficient MDPP supplier flexibility to furnish items or services involving technology as beneficiary engagement incentives to improve the likelihood of the beneficiary's achievement and maintenance of the required minimum weight loss.
For example, under this proposal, an MDPP beneficiary who begins receiving MDPP services from an MDPP supplier and who, after receiving MDPP services from that MDPP supplier, is furnished items or services of technology with a total retail value of $1,000 may not receive additional items or services of technology from that MDPP supplier. Therefore, an MDPP beneficiary may receive from an MDPP supplier a tablet valued at $700 that is preloaded with weight loss and fitness tracking apps that would support the beneficiary's weight loss goals under the MDPP expanded model and also receive from the same MDPP supplier a fitness tracking watch valued at $200 that uploads and monitors fitness data to the tablet, but he or she could not then receive additional items of technology from the MDPP supplier with an aggregate retail value greater than $100 as this would exceed the $1,000 limit.
In addition, we proposed that if the same MDPP beneficiary chooses to receive MDPP services from another MDPP supplier, the subsequent supplier would be under no obligation to determine the value of any items or services of technology furnished to the MDPP beneficiary by other MDPP suppliers, and may furnish items or services of technology to the MDPP beneficiary so long as those items or services furnished by the subsequent
We further proposed that items or services involving technology furnished to an MDPP beneficiary must be the minimum necessary to advance a clinical goal for MDPP beneficiaries as discussed in section III.K.2.f.iv. of the proposed rule (82 FR 34169 through 34170).
We proposed enhanced requirements for items of technology exceeding $100 in retail value as an additional safeguard against misuse of these items as beneficiary engagement incentives. In the proposed rule (82 FR 34169), we stated our belief that it would be inappropriate for MDPP suppliers to furnish items of technology with a retail value of over $100 for beneficiaries' permanent use because the high value of these items could unduly influence the beneficiary to continue to receive MDPP services from that supplier, or to receive items or services from the supplier other than MDPP services. Therefore, we proposed that items of technology with a retail value of over $100 would remain the property of the MDPP supplier and be retrieved from the MDPP beneficiary at the end of the engagement incentive period. We did not believe that this requirement would substantially increase the administrative burden on MDPP suppliers because a central facilitator of the success of an MDPP beneficiary in meeting MDPP performance goals is the MDPP supplier's ability to maintain contact with the MDPP beneficiary and engage him or her in MDPP services. We noted that items of technology with a retail value of $100 or less could be furnished as beneficiary engagement incentives and would remain the property of the beneficiary. In the case of these items of a technology with a lower retail value, we believed that the administrative burden of retrieving these items would outweigh the program integrity benefits of retrieval.
We further proposed that the MDPP supplier must document all technology retrieval attempts, including the ultimate date of retrieval. However, because we understood that MDPP suppliers may not always be able to retrieve these items, such as when a beneficiary dies or moves to another geographic area, documented, diligent, good faith attempts to retrieve items of technology would be deemed to meet the retrieval requirement.
Our proposals for enhanced requirements for technology furnished to MDPP beneficiaries as beneficiary engagement incentives under the MDPP expanded model were included at proposed § 424.210(c). We invited public comments on our proposed requirements for beneficiary engagement incentives that involve technology and welcomed comments on additional or alternative program integrity safeguards for this type of beneficiary engagement incentive, including whether the proposed financial thresholds were reasonable, necessary, and appropriate.
The following is a summary of the public comments received on the proposals for the requirements for beneficiary engagement incentives that involve technology and our responses:
For example, we believe that the $100 retail value retrieval threshold for items involving technology would allow some types of electronic tablets that could be furnished to an MDPP beneficiary for activity and dietary monitoring during an engagement incentive period to remain the property of the beneficiary for permanent use following the end of that period. In addition, we believe the $1,000 aggregate limit on the retail value of items and services involving technology that may be furnished by one MDPP supplier to an MDPP beneficiary is sufficiently high to allow MDPP suppliers the flexibility to furnish a wide range of items and services involving technology that advance the goals of the MDPP expanded model, without significantly risking suppliers furnishing more broadly used technology that is more valuable to the beneficiary than reasonably necessary for the DPP curriculum being taught.
One commenter who urged CMS not to adopt a retail value dollar threshold for items that can remain the property of the beneficiary provided a list of potential beneficiary engagement incentives, including pedometers, water bottles, memberships at health clubs and exercise facilities, blood sugar monitors, slow cookers, and stretch bands, and claimed that it would not currently be the practice of DPP organizations to collect these items after the end of the program because reusing them is not practical and storing them would serve no purpose.
In response to the commenter who disagreed with the retrieval of items involving technology of any retail value and provided a list of potential beneficiary engagement incentives where the commenter concluded that these items would generally not be reused and their storage would serve no purpose upon retrieval, we emphasize that the threshold of $100 maximum retail value for items that can remain in the MDPP beneficiary's permanent possession applies only to items involving technology, not to other types of beneficiary engagement incentives. We do not believe that the list of potential incentives provided by the commenter generally included items involving technology with a retail value of greater than $100 to which retrieval would apply.
Finally, we note that items involving technology with a retail value of greater than $100 that are furnished as beneficiary engagement incentives under the MDPP expanded model would always be the property of the MDPP supplier, and it would be up to the MDPP supplier to make all decisions about the item's treatment upon return and further use. To the extent the item of technology returned to the MDPP supplier includes PII, MDPP suppliers are required to maintain and handle any PII and PHI in compliance with HIPAA, as applicable, other applicable state and federal privacy laws, and CMS standards.
In the proposed rule (82 FR 34169), we included an example of an MDPP beneficiary who receives from an MDPP supplier a tablet valued at $700 that is preloaded with weight loss and fitness tracking apps that would support the beneficiary's weight loss goals under the MDPP expanded model. It was our expectation that the principal use for such a tablet would be related to the DPP curriculum being taught to the MDPP beneficiary and the advancement of the MDPP expanded model's clinical goals for that beneficiary. To the extent the tablet is also populated with apps whose uses extend far beyond the DPP curriculum and clinical goals of the MDPP expanded model, consistent with our discussion of a smartphone, we do not believe such a tablet would be reasonably necessary for the DPP curriculum being taught to the MDPP beneficiary, and we further do not believe it would be the minimum technology necessary to advance a clinical goal for the MDPP beneficiary.
After considering the public comments received, we are finalizing the proposals, without modification, for enhanced requirements for items and services involving technology furnished to MDPP beneficiaries as beneficiary engagement incentives under the MDPP expanded model at § 424.210(c).
As established at § 410.79(b) in the CY 2017 PFS final rule, MDPP services furnished to MDPP beneficiaries must follow a CDC-approved curriculum, which outlines required and recommended topics for structured health behavior change sessions offered as MDPP services with the goal of preventing diabetes through long-lasting health behavior change. MDPP suppliers seeking recognition under the CDC's DPRP must furnish either the CDC-preferred curriculum, based on the current evidence base, or may develop their own curriculum. MDPP suppliers that wish to develop their own curriculum must submit it to the CDC for approval. This requirement ensures that all curricula furnished to MDPP beneficiaries meet the DPRP's curriculum content requirements and are based on evidence from efficacy and effectiveness trials consistent with the current evidence base. To be consistent with the current evidence base, all curricula offered by MDPP suppliers must furnish MDPP services focused on the overarching goal of preventing type 2 diabetes in persons at high risk for diabetes because they have prediabetes. This requires MDPP suppliers to emphasize the need to make lasting health behavior changes, rather than simply completing a one-time set of MDPP services that result in the required minimum weight loss during the MDPP services period. MDPP services must also emphasize long-term improvements in nutrition and physical activity that contribute to beneficiaries sustaining weight loss. Therefore, in the proposed rule (82 FR 34170) we stated our belief that in-kind patient engagement incentives may appropriately be furnished to support and motivate MDPP beneficiaries in achieving dietary and health behavior change and to teach MDPP beneficiaries to problem-solve strategies to overcome challenges to maintaining weight loss and healthy behaviors, as well as to assist MDPP beneficiaries in meeting the attendance and weight loss performance goals of the MDPP expanded model.
Therefore, we proposed that the following would be the clinical goals of the MDPP expanded model, which may be advanced through beneficiary engagement incentives:
• Beneficiary attendance at MDPP core sessions, core maintenance sessions, or ongoing maintenance sessions during the MDPP services period.
• Beneficiary weight loss.
• Long-term dietary change for the beneficiary.
• Beneficiary adherence to long-term health behavior changes.
We noted that under this proposal, the MDPP supplier may not furnish multiple free meals or meal replacement services to an MDPP beneficiary over a substantial portion of the engagement incentive period because such a practice would not advance a clinical goal for an MDPP beneficiary by engaging him or her in better managing his or her own health.
When a beneficiary engagement incentive does not qualify as a preventive care item or service, our proposals for the clinical goals of the MDPP expanded model that a beneficiary engagement incentive must be intended to advance were included at proposed § 424.210(d). We invited public comments on our proposed clinical goals of the MDPP expanded model, as well as whether the advancement of additional or different clinical goals through beneficiary engagement incentives may better advance the overarching goals of the MDPP expanded model, while maintaining appropriate program integrity safeguards.
We received no public comments on the proposals for the clinical goals of the MDPP expanded model.
We are finalizing the proposals, without modification, for the clinical goals of the MDPP expanded model that a beneficiary incentive must be intended to advance at § 424.210(d).
As a program safeguard against misuse of beneficiary engagement incentives under the MDPP expanded model, we proposed that, in addition to the documentation requirements for MDPP suppliers at proposed § 424.205(g), MDPP suppliers must maintain documentation of items and services furnished as beneficiary engagement incentives that individually exceed $25 in retail value. We recognized that an MDPP beneficiary could receive many incentives that are each of low dollar value but in the aggregate constitute an excessively high value to the beneficiary. Therefore, we believed that it would be important to incorporate a documentation threshold at a modest level for all beneficiary incentives in order to monitor compliance with the proposed conditions for furnishing these items and services. Moreover, we believed that the proposed $25 retail value threshold would strike an appropriate balance between beneficiary and program protections and MDPP supplier administrative burden.
In addition, we proposed to require that the documentation must be established contemporaneously with the furnishing of the items and services and must include at least the date the incentive was furnished; the identity of the beneficiary to whom the item or service was furnished; the agent of the supplier that furnished the item or service, if applicable; a description of the item or service; the retail value of the beneficiary engagement incentive; and documentation establishing that the item or service was furnished to the MDPP beneficiary during the engagement incentive period.
In addition to the requirements in the previous paragraph, we further proposed that the documentation regarding items or services furnished to the MDPP beneficiary for use on an ongoing basis during the engagement incentive period, including items of technology exceeding $100 in retail value, must also include contemporaneous documentation establishing that the MDPP beneficiary is in the engagement incentive period throughout the time period that the MDPP beneficiary possesses or has access to the item or service furnished by the MDPP supplier. For example, if an MDPP supplier furnishes a gym membership to an MDPP beneficiary, the MDPP supplier would need to maintain contemporaneous documentation establishing that the MDPP beneficiary is in the engagement incentive period throughout the time period that the MDPP beneficiary has access to the gym via the membership furnished by the MDPP supplier.
In addition to the above requirements, we further proposed that the documentation regarding items of technology exceeding $100 in retail value that MSPP suppliers would be required to retrieve from the MDPP beneficiary must also include contemporaneous documentation of any attempts to retrieve the item of technology furnished by the MDPP supplier from the MDPP beneficiary as required at proposed § 424.210(c)(3)(ii). We reiterated that under our proposal documented, diligent, good faith attempts to retrieve items of technology would be deemed to meet the retrieval requirement. Finally, we proposed that the MDPP supplier must retain and provide access to the required documentation in accordance with proposed § 424.205(g).
Our proposals for the documentation requirements for beneficiary engagement incentives under the MDPP expanded model were included at proposed § 424.210(e). We invited public comments on our proposed documentation requirements, including whether additional or different documentation requirements may provide better program integrity safeguards.
The following is a summary of the public comments received on the proposals for the documentation requirements for beneficiary engagement incentives under the MDPP expanded model and our responses:
In contrast, other commenters stated that the proposal to require documentation of beneficiary engagement incentives that are in-kind with a retail value of greater than $25 would lead to an undue reporting burden for MDPP suppliers because of the large number of these incentives that could be furnished to an MDPP beneficiary. The commenters further stated the documentation burden would be particularly onerous for small suppliers with limited infrastructure and staffing. Multiple commenters claimed that while the administrative burden posed by the proposed documentation and tracking requirements would be large, the documentation would be of limited value to the ongoing work and effort of MDPP suppliers. The commenters urged CMS to not require documentation of beneficiary engagement incentives of any retail value.
We do not believe it would be appropriate to require documentation of all beneficiary engagement incentives of any retail value for purposes of data collection about incentives as recommended by some commenters, in view of the greater administrative burden this would place upon MDPP suppliers. We also do not believe that requiring no documentation of beneficiary engagement incentives of any retail value would be appropriate because we would be unable to monitor for compliance with the conditions for furnishing these items or services.
Given the substantial flexibilities we will be affording MDPP suppliers to furnish beneficiary engagement incentives under the MDPP expanded model, we believe that requiring documentation of items and services with a retail value of greater than $25 is a reasonable responsibility for MDPP suppliers to assume. Our rationale for establishing documentation requirements for beneficiary engagement incentives is based on establishing program safeguards against misuse of beneficiary engagement incentives under the MDPP expanded model and not based primarily on the
In order to monitor for compliance with the conditions for these incentives, we need information on the date the incentive was furnished; the identity of the beneficiary to whom the item or service was furnished; the agent of the supplier that furnished the item or service, if applicable; a description of the item or service; the retail value of the beneficiary engagement incentive; and documentation establishing that the item or service was furnished to the MDPP beneficiary during the engagement incentive period. The complexity of the coding that would be required to allow all of this information to be reported on administrative claims would be great, and we believe such a reporting methodology for beneficiary engagement incentives would lead to significantly greater administrative burden on MDPP suppliers than our proposed documentation approach. Therefore, we do not believe it would be feasible for MDPP suppliers to report on administrative claims all of the information about beneficiary engagement incentives that is necessary for us to monitor compliance with the conditions for these incentives that have been adopted to protect beneficiaries and the program from their misuse.
After considering the public comments received, we are finalizing the proposals, without modification, for the documentation requirements for beneficiary engagement incentives under the MDPP expanded model at § 424.210(e). Table 43 summarizes the final documentation requirements for beneficiary engagement incentives under the MDPP expanded model.
Certain arrangements between MDPP suppliers and beneficiaries may implicate the civil monetary penalty (CMP) law (sections 1128A(a)(5), (b)(1) and (b)(2) of the Act), or the Federal Anti-kickback statute (section 1128B(b)(1) and (2) of the Act). In many cases, arrangements that implicate these laws can be structured to comply with them by using existing safe harbors and exceptions. Section 1115A(d)(1) of the Act authorizes the Secretary to waive certain specified fraud and abuse laws as may be necessary solely for purposes of testing of models under section 1115A(b) of the Act. A waiver is not needed for an arrangement that does not implicate the fraud and abuse laws or that implicates the fraud and abuse laws, but either fits within an existing exception or safe harbor, as applicable, or does not otherwise violate the law. Accordingly, under section 1115A(d)(1) of the Act, the Secretary will consider whether waivers of certain fraud and abuse laws are necessary for the MDPP expanded model. Such waivers, if any, would be promulgated separately from this proposed regulation by OIG (as to sections 1128A and 1128B of the Act), to which the respective authorities have been delegated.
Because of the close nexus between the final regulations governing the structure and operations of the MDPP expanded model and the development of any fraud and abuse waivers necessary to carry out the provisions of the model, CMS and OIG may, when considering the need for or scope of any waivers, consider comments submitted in response to the proposed rule and the provisions of the final rule. No waivers of any fraud and abuse authorities are being issued in this final rule.
The CDC's DPRP Standards allow evidence-based DPP curricula to be furnished through a variety of modes, including through remote technologies. Similar to the description noted in section III.K.2.c.iv.3 of this final rule with respect to virtual make-up sessions, virtual DPP refers to any modality, or method of furnishing MDPP services, that is not in person. This includes, but is not limited to:
(1) Furnishing services online where the behavior change program is furnished 100 percent online, with participants accessing course resources and lifestyle coach via a computer, laptop, tablet, smart phone, or other device with internet access. This modality requires an internet connection to participate in all aspects of the DPP;
(2) Furnishing services online with other means of support by a coach (for example, telecommunications, video conferencing). This modality requires an internet connection for some aspects of the DPP, but not all; and
(3) Distance learning, where a coach is present in one location and participants are calling, video-conferencing, or otherwise using telecommunications technology to access the coach from another location. This modality does not require any internet connection for any of the aspects of the DPP.
These types of delivery modes are hereafter referred to as “virtual,” and DPP furnished
We acknowledge that the public comments in response to the MDPP expanded model in the CY 2017 PFS proposed rule supported the inclusion of virtual DPP in the MDPP expanded model. Many commenters stated that this proposal would increase access to MDPP services, referenced emerging evidence that suggests virtual DPP may be as effective as DPP furnished in a community setting, and stated that virtual delivery may be preferable to some beneficiaries. In the CY 2017 PFS final rule, we deferred policies pertinent to virtual DPP to future rulemaking.
Although in the CY 2018 PFS proposed rule, we proposed to allow a limited number of virtual make-up sessions in the MDPP expanded model (82 FR 34136 through 34137), we did not propose to include virtual DPP services (that is, DPP furnished
We noted that some DPP organizations currently offer DPP services through a combination of in-person and virtual delivery. We are finalizing to only allow this combination of delivery subject to the requirements on virtual make-up
An organization may furnish separate DPPs where some participants receive only in-person DPP services, others receive only virtual DPP services, and others receive a combination program where some sessions are offered in person and others virtually. If an organization that offers multiple distinct DPPs through different delivery modes enrolls as an MDPP supplier, we proposed that only DPP services furnished in person will be paid in the MDPP expanded model, with the exception of virtual make-up sessions as discussed in section III.K.2.c.iv.3 of this final rule.
The following is a summary of the public comments received on virtual DPP services and our responses:
We intend to evaluate the MDPP expanded model using a combination of encounter and claims data to analyze the long-term utilization of services by beneficiaries who have received the MDPP services. As discussed in the CY 2017 PFS final rule, we will continue to assess whether the MDPP expanded model is expected to improve the quality of care without increasing spending, reduce spending without reducing the quality of care, or improve the quality of care and reduce spending, and we will terminate or modify the MDPP expanded model if the expanded model is not expected to meet these criteria.
Among other possible questions we might explore, our analysis will specifically look at long-term utilization and expenditures that might suggest subsequent treatment of diabetes. We intend to use beneficiary-level encounter data and program data furnished by CDC and will match these data to Medicare claims using the crosswalk finalized at § 424.59(b)(3) of the CY 2017 PFS final rule (redesignated and amended at § 424.205(d)(13)). As with other Innovation Center model evaluation reports (which are currently published online at
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:
• EPO and other dialysis-related drugs furnished in or by an ESRD facility (§ 411.355(g)).
• Preventive screening tests, immunizations, or vaccines (§ 411.355(h)).
The definition of DHS at § 411.351 excludes services for which payment is made 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). With respect to ESRD services,
Additionally, ESRD-related oral-only drugs, which are drugs or biologicals with no injectable equivalents or other forms of administration other than an oral form, were scheduled to be paid under ESRD PPS beginning January 1, 2014 (75 FR 49044). However, there have been several delays of the implementation of payment of these drugs under ESRD PPS. Most recently, on December 19, 2014, section 204 of the Stephen Beck, Jr., Achieving a Better Life Experience Act of 2014 (ABLE) (Pub. L. 113-295) was enacted and delayed the inclusion of these oral-only drugs under the ESRD PPS until 2025. Until that time, such drugs furnished in or by an ESRD facility are not paid as part of a composite rate and thus, are DHS.
We revised the description of the CPT/HCPCS codes related to the exceptions at §§ 411.355(g) and (h) to reflect more accurately the purpose for including these codes on the Code List. The revisions are intended to clarify that these sections of the Code List are not lists of CPT/HCPCS codes to which the physician self-referral law simply does not apply; rather, rather they are comprehensive lists of designated health services to which the exceptions at § 411.355(g) and (h) may apply. The exception at § 411.355(g) protects certain designated health services that are dialysis-related outpatient prescription drugs furnished in or by an ESRD facility and that satisfy the requirements of the exception. The exception at § 411.355(h) protects certain designated health services that are furnished as preventive screening tests, immunizations, or vaccines and that satisfy the requirements of the exception. As noted at § 411.355(g)(1) and (h)(4), the exceptions may be utilized only for designated health services included in the applicable sections of the Code List. The revised section descriptions reflect the language of § 411.355(g)(1) and (h)(4). These Code List sections represent the entire universe of CPT/HCPCS codes eligible for the exceptions at § 411.355(g) and (h), and the exceptions may not be utilized to protect referrals and claims submission for any other designated health service or category of designated health services.
The Code List was last updated in Tables 45 and 46 of the CY 2017 PFS final rule (81 FR 80534).
We received no comments relating to the Code List that became effective January 1, 2017.
The updated, comprehensive Code List effective January 1, 2018, is available 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 44 and 45 identify the additions and deletions, respectively, to the comprehensive Code List that become effective January 1, 2018. Tables 44 and 45 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).
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. chapter 35), we are required to publish a 30-day notice in the
We solicited comments in the notice of proposed rulemaking that published in the
To derive average costs, we used data from the U.S. Bureau of Labor Statistics' May 2016 National Occupational Employment and Wage Estimates for all salary estimates (
As indicated, we are adjusting our employee hourly wage estimates by a factor of 100 percent. This is necessarily a rough adjustment, both because fringe benefits and overhead costs vary significantly from employer to employer, and because methods of estimating these costs vary widely from study to study. Nonetheless, there is no practical alternative and we believe that doubling the hourly wage to estimate total cost is a reasonably accurate estimation method.
In §§ 410.79, 414.84, 424.200, 424.205, 424.210, 424.502, 424.516, 424.518 and 424.55 of this final rule, we finalize policies necessary to implement the Medicare Diabetes Prevention Program (MDPP) Expanded Model, which is aimed at preventing the onset of type 2 diabetes among Medicare beneficiaries with an indication of prediabetes. Section 1115A(d)(3) of the Act exempts Innovation Center model tests and expansions, which include the MDPP expanded model, from the provisions of the PRA. Specifically, this section provides that the provisions of the PRA does not apply to the testing and evaluation of Innovation Center models or to the expansion of such models.
We proposed to revise § 414.94(i)(3) by reiterating the availability of a significant hardship exception for
Consistent with section 1834(q)(4)(A) of the Act (as amended by section 218(b) of the PAMA), § 414.94(j) proposed to require that ordering professionals consult specified applicable AUC through a qualified clinical decision support mechanism (CDSM) for applicable imaging services ordered on or after January 1, 2019. We proposed a one-time burden associated with a possible 6-month voluntary consulting period beginning sometime in 2018, as well as a mandatory annual burden beginning January 1, 2019. In response to public comments requesting more time to prepare before requiring AUC consultation and claims reporting, we have finalized an effective date of January 1, 2020, for the consulting requirement under this program. The voluntary consulting period will begin as early as July 2018 and last through 2019, thus extending the 6-month period proposed to 18 months.
General practitioners make up a large group of practitioners who order applicable imaging services and would be required to consult AUC under this program so we use “family and general practitioner” from the BLS occupation title (see Wages, above) to calculate the following cost estimates. As noted in our response to comments, we conducted an initial analysis of recalculations based on volume weighted averages specific to different specialties using the BLS May 2016 National Occupational Employment and Wage Estimates, which would include both higher paid physicians and lower paid non-physician practitioners as advanced diagnostic imaging services are ordered by a variety of medical professionals. For these estimates and using Medicare claims data derived from the Chronic Conditions Warehouse 2014 Part B non-institutional claim which we have used in prior rulemaking to inform existing policy under this program, we identified five occupations in the BLS estimates that most closely align with the practitioner specialties that order applicable imaging services. Because the BLS occupations do not provide all specialty specific estimates, the most specific occupations we were able to use to describe practitioner specialties that order applicable imaging services and their respective weighting based on order percentages identified in an analysis of the claims data are as follows: Physicians and Surgeons, All Others (69.57%), Internist, General (14.06%), Family and General Practitioners (10.53%), Physician Assistants (3.13%) and Nurse Practitioners (2.71%). Using these weights and the wage estimates for these practitioners, our burden estimates would be slightly lower. As such and because the program has not yet begun, we determined that the original methodology using Family and General Practitioners was a reasonable estimate. We will continue to monitor our estimates and could revisit for more precision once the program has begun.
During the 18-month voluntary participation period, we estimate 10,230,000 responses in the form of consultations based on market research from current applicants for the qualification of their CDSMs for advanced diagnostic imaging services. Based on feedback from CDSMs with experience in AUC consultation as well as standards recommended by the Office of the National Coordinator (ONC) and the Healthcare Information Management Systems Society (HIMSS), we estimate it would take 2 minutes at $193.08/hr for a family and general practitioner to use a qualified CDSM to consult specified applicable AUC. Per consultation, we estimate 2 minutes (0.033 hr) at a cost of $6.37 (0.033 hr × $193.08/hr). In aggregate, we estimate a one-time burden of 337,590 hours (0.033 hr × 10,230,000 consultations) at a cost of $65,181,877.20 (337,590 hr × $193.08/hr).
Annually, we estimate 112,530 hours (337,590 hr/3 yr) at a cost of $21,727,292.40 ($65,181,877.20/3 yr). We are annualizing the one-time burden (by dividing our estimates by OMB's 3-year approval period) since we do not anticipate any additional burden after the 18-month voluntary participation period ends.
Beginning January 1, 2020, we anticipate 43,181,818 responses in the form of consultations based on the aforementioned market research, as well as Medicare claims data for advanced diagnostic imaging services. As noted above, we estimate it would take 2 minutes (0.033 hr) at $193.08/hr for a family and general practitioner to use a qualified CDSM to consult specified applicable AUC. In this regard, we estimate 0.033 hours per consultation at a cost of $6.37 (0.033 hr × $193.08/hr). In aggregate, we estimate an annual burden of 1,425,000 hours (0.033 hr × 43,181,818 consultations) at a cost of $275,139,000 (1,425,000 hr × $193.08/hr).
The consultation requirements and burden have been submitted to OMB for approval under control number 0938-New (CMS-10654).
Consistent with section 1834(q)(4)(B) of the Act, we also proposed to implement a one-time 6-month voluntary reporting period beginning sometime in 2018, as well as a mandatory annual reporting requirement beginning January 1, 2019. Specifically, § 414.94(k) proposed to require that furnishing professionals report on the Medicare claims for advanced diagnostic imaging services, paid for under an applicable payment system (as defined in § 414.94(b)) and ordered on or after January 1, 2019, the following information: (1) Identify which qualified CDSM was consulted by the ordering professional; (2) identify whether the service ordered would adhere to specified applicable AUC, would not adhere to specified applicable AUC, or whether specified applicable AUC was not applicable to the service ordered; and (3) identify the NPI of the ordering professional (if different from the furnishing professional). As noted earlier in this section, in response to public comment the voluntary period has been extended to 18 months and the effective date for the AUC consulting and reporting requirements will be January 1, 2020. The reporting requirement will not have any impact on any Medicare claim forms because the forms' currently approved data fields, instructions, and burden are not expected to change. Consequently, there is no need for review by OMB under the authority of the PRA.
The timing and implementation of the voluntary consultation and reporting period is dependent on the readiness of the Medicare claims systems to accept and process claims including AUC consultation information. Currently, 99 percent of all Medicare claims are submitted electronically as a result of The Administrative Simplification Compliance Act amendment to section 1862(a) of the Act, which prescribes that no payment may be made under Part B of the Medicare Program for any expenses incurred for items or services for which a claim is received in a non-electronic form. Consequently, absent an applicable exception, paper claims
Based on the proposed consulting and reporting requirements, we received comments on our proposed estimates. We have included a summary of the comments received below, and note that we have finalized our policy in § 414.94(j) and (k) (82 FR 34195). We are largely adopting the proposed collection of information provisions with minimal changes to reflect the extension of the voluntary reporting period discussed earlier in this section.
Section 1899(e) of the Act provides that chapter 35 of title 44 of the U.S. Code, which includes such provisions as the PRA, does not apply to the Shared Savings Program.
We have submitted a copy of this rule to OMB for its review of the rule's information collection and burden requirements. The requirements are not effective until they have been approved by the OMB.
To obtain copies of the supporting statement and any related forms for the collections discussed above, please visit CMS's Web site at Web site address
This final rule makes payment and policy changes under the Medicare PFS and implements required statutory changes under the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), the Achieving a Better Life Experience Act (ABLE), the Protecting Access to Medicare Act of 2014 (PAMA), section 603 of the Bipartisan Budget Act of 2015, and the Consolidated Appropriations Act of 2016. This final rule also makes changes to payment policy and other related policies for Medicare Part B, Part D, and Medicare Advantage.
We 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, 2013), 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), the Congressional Review Act (5 U.S.C. 804(2)), and Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs (January 30, 2017).
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 in this section, that the PFS provisions included in this final rule would 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 prepared an 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, practitioners and most other providers and suppliers are small entities, either by nonprofit status or by having annual revenues that qualify for small business status under the Small Business Administration standards. (For details see the SBA's Web site at
The RFA requires that we analyze regulatory options for small businesses and other entities. We prepare a regulatory flexibility analysis unless we certify that a rule would not have a significant economic impact on a substantial number of small entities. The analysis must include a justification concerning the reason action is being taken, the kinds and number of small entities the rule affects, and an explanation of any meaningful options that achieve the objectives with less significant adverse economic impact on the small entities.
Approximately 95 percent of practitioners, other providers, and suppliers are considered to be small entities, based upon the SBA standards. There are over 1 million physicians, other practitioners, and medical suppliers that receive Medicare payment under the PFS. Because many of the affected entities are small entities, the analysis and discussion provided in this section, as well as elsewhere in this final rule is intended to comply with the RFA requirements regarding significant impact on a substantial number of small entities.
For example, the effects of changes to payment rates for practitioners, other providers, and suppliers are discussed in V.C. of this final rule. Alternative options considered to the proposed payment rates are discussed generally in section V.F of this final rule, while specific alternatives for individual codes are discussed throughout this rule, especially in section II.H.
In addition, section 1102(b) of the Act requires us to prepare an RIA 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 did not prepare an analysis for section 1102(b) of the Act because we determined, and the Secretary certified, that this final 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 2017, that threshold is approximately $148 million. This final rule will impose no mandates on state, local, or tribal governments or on the private sector.
Executive Order 13132 establishes certain requirements that an agency must meet when it issues a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments,
Executive Order 13771, entitled Reducing Regulation and Controlling Regulatory Costs (82 FR 9339), was issued on January 30, 2017. This final rule is considered an E.O. 13771 regulatory action because it is expected to result in regulatory costs.
We 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; 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, we are implementing a variety of changes to our regulations, payments, or payment policies to ensure that our payment systems reflect changes in medical practice and the relative value of services, and implementing statutory provisions. We provide information for each of the policy changes in the relevant sections of this final rule. We are unaware of any relevant federal rules that duplicate, overlap, or conflict with this final rule. The relevant sections of this final rule contain a description of significant alternatives if applicable.
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 budget neutrality.
Our estimates of changes in Medicare expenditures for PFS services compare payment rates for CY 2017 with payment rates for CY 2018 using CY 2016 Medicare utilization. The payment impacts in this final rule reflect averages by specialty based on Medicare utilization. The payment impact for an individual practitioner could vary from the average and would depend on the mix of services he or she furnishes. The average percentage change in total revenues would be less than the impact displayed here because practitioners and other entities generally furnish services to both Medicare and non-Medicare patients. In addition, practitioners and other entities may receive substantial Medicare revenues for services under other Medicare payment systems. For instance, independent laboratories receive approximately 83 percent of their Medicare revenues from clinical laboratory services that are paid under the Clinical Laboratory Fee Schedule.
The annual update to the PFS conversion factor (CF) was previously calculated based on a statutory formula; for details about this formula, we refer readers to the CY 2015 PFS final rule with comment period (79 FR 67741 through 67742). Section 101(a) of the MACRA repealed the previous statutory update formula and amended section 1848(d) of the Act to specify the update adjustment factors for calendar years 2015 and beyond. For CY 2018, the specified update is 0.5 percent before applying other adjustments.
Section 220(d) of the PAMA added a new paragraph at section 1848(c)(2)(O) of the Act to establish an annual target for reductions in PFS expenditures resulting from adjustments to relative values of misvalued codes. Under section 1848(c)(2)(O)(ii) of the Act, if the net reduction in expenditures for the year is equal to or greater than the target for the year, reduced expenditures attributable to such adjustments shall be redistributed in a budget-neutral manner within the PFS in accordance with the existing budget neutrality requirement under section 1848(c)(2)(B)(ii)(II) of the Act. Section 1848(c)(2)(O)(iii) of the Act specifies that, if the estimated net reduction in PFS expenditures for the year is less than the target for the year, an amount equal to the target recapture amount shall not be taken into account when applying the budget neutrality requirements specified in section 1848(c)(2)(B)(ii)(II) of the Act. We estimate the CY 2018 net reduction in expenditures resulting from adjustments to relative values of misvalued codes to be 0.41 percent. Since this amount does not meet the 0.5 percent target under section 1848(c)(2)(O)(v) of the Act, payments under the fee schedule must be reduced by the difference between the target for the year and the estimated net reduction in expenditures, known as the target recapture amount. As a result, we estimate that the CY 2018 target recapture amount will produce a reduction to the conversion factor of −0.09 percent.
To calculate the final conversion factor for this year, we multiplied the product of the current year conversion factor and the update adjustment factor by the target recapture amount and the budget neutrality adjustment described in the preceding paragraphs. We estimate the CY 2018 PFS conversion factor to be 35.9996, which reflects the budget neutrality adjustment under section 1848(c)(2)(B)(ii)(II), the 0.5 percent update adjustment factor specified under section 1848(d)(18) of the Act, and the −0.09 percent target recapture amount required under section 1848(c)(2)(O)(iv) of the Act. We estimate the CY 2018 anesthesia conversion factor to be 22.1887, which reflects the same overall PFS adjustments with the addition of anesthesia-specific PE and MP adjustments.
Table 50 shows the payment impact on PFS services of the proposals contained in this final rule. To the extent that there are year-to-year changes in the volume and mix of services provided by practitioners, the actual impact on total Medicare revenues would be different from those shown in Table 50 (CY 2018 PFS Estimated Impact on Total Allowed Charges by Specialty). The following is an explanation of the information represented in Table 50.
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The most widespread specialty impacts of the final RVU changes are generally related to the changes to RVUs for specific services resulting from the Misvalued Code Initiative, including finalized RVUs for new and revised codes. The estimated impacts for some specialties, including behavioral health specialists, radiation oncology, and podiatry, reflect increases relative to other physician specialties. These increases can largely be attributed to increases in value for particular services following the recommendations from the American Medical Association (AMA)'s Relative Value Scale Update Committee (RUC) and CMS review and the change in allocation of indirect practice expense RVUs for office-based, face-to-face behavioral health services.
The estimated impacts for several specialties, including diagnostic testing facilities, allergy/immunology, physical/occupational therapy, otolaryngology, anesthesiology, and nurse anesthetists reflect decreases in payments relative to payment to other physician specialties as a result of revaluation of individual procedures reviewed by the AMA's RUC and CMS, decreases in relative payment as a result of the updates to prices for particular medical supplies, and continued implementation of previously finalized code-level reductions that are being phased-in over several years. For independent laboratories, it is important to note that these entities receive approximately 83 percent of their Medicare revenues from services that are paid under the Clinical Laboratory Fee Schedule. As a result, the estimated 1 percent reduction for CY 2018 is only applicable to approximately 17 percent of the Medicare payment to these entities.
The estimated impacts for many specialties are increases relative to the rates published in the proposed rule due to the decision to retain the professional liability premium data (from CY 2015) that was used for CY 2017, as opposed to utilizing the updated data for CY 2018 that were used to calculate the rates in the proposed rule. The estimated decrease to the physical/occupational therapy specialty as compared to the impacts in the proposed rule resulted from the decision to finalize the direct PE inputs recommended by the Health Care Professionals Advisory Committee (HCPAC) for approximately two dozen therapy codes reviewed in CY 2018, as opposed to retaining the CY 2017 direct PE inputs for these codes as proposed.
We often receive comments regarding the changes in RVUs displayed on the specialty impact table, including comments received in response to the proposed rates. We remind stakeholders that although the estimated impacts are displayed at the specialty level, typically the changes are driven by the valuation of a relatively small number of new and/or potentially misvalued codes. The percentages in the table are based upon aggregate estimated PFS allowed charges summed across all services furnished by physicians, practitioners, and suppliers within a specialty to arrive at the total allowed charges for the specialty, and compared to the same summed total from the previous calendar year. They are therefore averages, and may not necessarily be representative of what is happening to the particular services furnished by a single practitioner within any given specialty.
Column F of Table 50 displays the estimated CY 2018 impact on total allowed charges, by specialty, of all the RVU changes. A table showing the estimated impact of all of the changes on total payments for selected high volume procedures is available under “downloads” on the CY 2018 PFS final rule Web site at
As discussed in section II.D. of this final rule, we are adding several new codes to the list of Medicare telehealth services. Although we expect these changes to have the potential to increase access to care in rural areas, based on recent telehealth utilization of services already on the list, including services similar to the proposed additions, we estimate there will only be a negligible impact on PFS expenditures from the proposed additions. For example, for services already on the list, they are furnished via telehealth, on average, less than 0.1 percent of the time they are reported overall.
In addition, as discussed in section II.D. of this final rule, we are making CPT code 99091 separately payable for CY 2018. We note that this change will be implemented in a budget neutral manner, and we estimate that there will be a negligible impact on PFS expenditures from making this code separately payable.
As discussed in section II.G of this final rule, for CY 2018, we are finalizing a PFS Relativity Adjuster of 40 percent, meaning that nonexcepted items and services furnished by nonexcepted off-campus PBDs would be paid under the PFS at a rate that is 40 percent of the OPPS rate. We estimate that this change will result in total Medicare Part B savings of $12 million for CY 2018 relative to maintaining the CY 2017 PFS Relativity Adjuster for CY 2018.
As discussed in section III.A of this final rule, we finalized the establishment of two new G codes for use by RHCs and FQHCs. The first new G code is a General Care Management code for RHCs and FQHCs with the payment amount set at the average of the 3 national non-facility PFS payment rates for the CCM and general BHI codes. The second new G code for RHCs and FQHCs is a Psychiatric CoCM code with the payment amount set at the average of the 2 national non-facility PFS payment rates for psychiatric CoCM services. The payment rate for each code will be updated annually, based on the national non-facility PFS payment rates for each code contained in the G code.
The methodology for payment of care coordination services is consistent with the RHC and FQHC payment principles of not paying for services based on time increments. It does not create additional reporting burden and is expected to promote beneficiary access to comprehensive care management services furnished by RHCs and FQHCs.
Establishment of the RHC and FQHC General Care Management code, which includes all levels of CCM and general BHI services, is projected to increase Medicare spending by $2.2 million in CY 2018 and by $25.5 million over 10 years. This estimate is based on the proposed per service allowed charge increase (from approximately $42.71 to $61.37) applied to historical 2017 CCM and BHI volume in RHCs and FQHCs. This volume was adjusted with an assumed 10 percent behavioral volume increase to reflect the increase in allowed charges per service.
Establishment of the RHC and FQHC Psychiatric CoCM code, which includes all levels of psychiatric CoCM services, is projected to increase Medicare spending by approximately $100,000 in CY 2018 and $4.0 million over 10 years. Because psychiatric CoCM is not billable currently by RHCs or FQHCs and is also new to practitioners billing under the PFS, this estimate is based on first quarter 2017 PFS psychiatric CoCM claims of 0.06 percent of psychiatric E/M visits, adjusted to an ultimate average rate of 0.28 percent based on the pattern of increase in CCM services in the PFS found in the first two and a half years of implementation. This rate was then applied to the number of 2017 RHC and FQHC mental health visits to get an estimate of CoCM volume, and then projected forward on a per-capita basis. PFS price updates were applied to the initial approximate $135 psychiatric CoCM payment amount to project future costs.
The combined increase in Medicare spending for both new G codes is estimated to be approximately $2.2 million in 2018, and approximately $29.5 million over 10 years. Although these services are expected to increase quality and improve efficiency over time, the programs are still new and the data is not available yet to demonstrate any cost savings. Therefore, no healthcare cost reductions were assumed as a result of increased care management.
As
As discussed in section III.B. of this final rule, we are finalizing our proposal to conform the regulation text at § 414.904(e)(2) to section 5004 of the Cures Act, which transitioned payment for DME infusion drugs from AWP-based pricing to the ASP-pricing methodology on January 1, 2017. Table 52 shows the effect of changes in drug payments to DME suppliers. We estimate adoption of the ASP+6 pricing methodology will result in total Medicare Part B savings ranging over the 10-year period from $40 million in FY 2017 to $110 million in FY 2026
In section III.D. of this rule we discussed the payment of biosimilar biological products under section 1847A of the Act. We explained that under the current Medicare Part B policy, the payment amount for a biosimilar biological product is based on the ASP of all National Drug Codes (NDCs) assigned to the biosimilar biological products included within the same billing and payment code. However, in this final rule, we are finalizing the policy to separately code and pay for biological biosimilar products under Medicare Part B. Effective on January 1, 2018, newly approved biosimilar biological products with a common reference product will no longer be grouped into the same billing code.
In the 2016 PFS rule, we stated that we anticipate that biosimilar biological products will have lower ASPs than the corresponding reference products (80 FR 71362). We also expected that Medicare would realize savings from the utilization of biosimilar biological products. However, we have limited experience under Medicare Part B with biosimilar biological products that have been approved under the FDA's biosimilar approval pathway. There are four approved Part B biosimilars: limited claims data on two is available, the third product was marketed in July 2017, the fourth is not yet marketed, and it is not clear when marketing will begin. Further, it is not clear how many more biosimilar products will be approved, when approval and marketing of various products will occur, what the market penetration of biosimilars in Medicare Part B will be, and what the cost differences between the biosimilars as well as the price differences between the biosimilars and the reference products will be. Therefore, with limited data, we are not able to quantify with certainty the potential savings or costs to Medicare Part B from changes to current policy. Similarly, we are not able to quantify the impact, if any, on physician offices that administer biosimilar biological products or the costs to beneficiaries.
Based on our limited experience with the first two biosimilar products marketed in the United States, filgrastim and infliximab, once ASP-based payment amounts take effect, savings (relative to the reference product) are realized under the current policy. However, as discussed in section III.D. of this rule, we believe that a policy that could potentially increase provider and patient choice is superior to existing policy and may lead to additional cost savings. If payment amounts limit manufacturers' willingness to invest in the development of new biosimilars, it could in the long term decrease the number of biosimilar biological products that are available to prescribe and thus impair price competition. Given that the United States' biosimilar biological product marketplace is still relatively new, it is important to have a payment policy that supports innovation, as well as reasonable pricing for consumers. The change in policy is expected to lead to greater competition and more products in the marketplace. We present a hypothetical example below to illustrate what would need to occur in the market for this policy change to achieve cost savings for Medicare.
We have assumed that biosimilar biological products will provide between 5 and 30 percent cost savings relative to the reference biological product. These differences are consistent with our limited experience in Part B with the biosimilar version of filgrastim and very limited experience with the first biosimilar version of infliximab, as well as comments received in the rule and estimates in the lay press. Uptake rates for the current policy are also consistent with our limited experience and commenters estimates. For simplicity and the purpose of this example, we have assumed that the Medicare payment amounts for biosimilar biological products will be comparable in both the grouped and separate code scenario. The slightly higher payment amounts for biosimilar biological products under the separate code scenario at year 1 (compared to payments for a grouped code) are expected because first quarter payment for each separately coded product would be based on Wholesale Acquisition Cost (WAC). However, this would be offset by a greater number of licensed biosimilar biological products by year 10 and higher uptake by year 10. The overall savings from using separate codes is expected to be greater over the 5 year period because the greater number of biosimilar biological products available in the marketplace is expected to provide greater choice for providers, and this should result in greater uptake of the products. In summary, Table 53 is intended to illustrate that at year 10 compared to current policy, separate codes are anticipated to decrease reference product prices (or at least keep them stable) and increase the number of products and uptake of biosimilars at year 10. In order to more clearly illustrate these points we assumed that payment amounts in this example would remain stable. However, as stated in section II.D. of this rule, over the long term, if the policy leads to greater competition and more products in the marketplace, we believe that it is reasonable to anticipate that the higher initial payments will be offset by savings. A greater uptake of products with a lower payment amount than a reference product is expected to yield overall savings. We note that savings could also occur from lower payment amounts due to increased competition.
The economics literature seems to indicate that the competition and pricing outcomes of reference pricing policies are quite dependent on market characteristics and other parameters. (See, for example, Brekke
• Could small-molecule pharmaceutical pricing, utilization and models apply to the biosimilar product context? Although the literature on biosimilars is currently much less extensive than the literature on small-molecule drugs, are there studies that are relevant to the policy question of Medicare's biosimilars pricing?
• To what extent can experience with nationwide reference pricing (for example, in Europe) inform pricing policy implemented by Medicare, which is one of several payers?
• What are the key parameters for determining the optimal tradeoff between short-run price savings and long-run incentives to innovate? What insights on this question can be gleaned from the optimal patent exclusivity literature or other strains of research?
We are finalizing the effective date of January 1, 2020 on which the appropriate use criteria (AUC) consulting and reporting requirements will begin, and extending the voluntary consulting and reporting period to 18 months. We are not finalizing the proposed modifications to the significant hardship exception, but anticipate proposing policies in rulemaking for CY 2019 to address commenters' concerns and better align exceptions under the AUC program with those under existing quality programs. In the COI section of this document, we estimate the consulting requirement to result in an annual burden of 1,425,000 hours at a cost of $275,139,000. These updates to the AUC program will not result in claims denials in CY 2018, and thus, these proposals would not impact CY 2018 physician payments under the PFS. The Congressional Budget Office estimates that section 218 of the PAMA would save approximately $200 million over 10 years from FY 2014 through 2024, which could be the result of identification of outlier ordering professionals and also includes section 218(a) of the PAMA, which is a payment deduction for computed tomography equipment that is not up to a current technology standard. CMS has not estimated a score as such consultation and reporting is not required for FY 2018. Because we have not yet proposed a mechanism or calculation for outlier ordering professional identification and prior authorization, we are unable to quantify that impact at this time. We will provide an impact statement when applicable in future rulemaking.
We previously discussed the burden estimate for PQRS regarding the satisfactory reporting criteria for the CY 2016 reporting period, which applies to the 2018 PQRS payment adjustment, in the CY 2016 PFS final rule (see 80 FR 71362 through 71367). The burden estimates for reporting that data have not changed since these data for the CY 2016 reporting period have already been reported; therefore, there are no added burden estimates for the policy change discussed in section III.F of this final rule.
Amending the policy to reduce the amount of measures needed to satisfactorily report to avoid the 2018 PQRS payment adjustment from 9 measures across 3 NQS domains to 6 measures (see section III.F. of this final rule) would increase the amount of satisfactory reporters for the CY 2016 reporting period, which would decrease those subject to the 2018 PQRS payment adjustment. Using data from the CY 2015 reporting period as the basis for our estimates, there were roughly 525,000 eligible professionals who failed the PQRS reporting requirements for the CY 2015 reporting period and received a downward payment adjustment in 2017 (see
Based on the estimated average payment adjustment of $937.02 in program year 2015, which was negative 2 percent based on 2015 PFS charges, an estimated ($937.02 × 23,625 = $22,137,097.50) would be the amount all EPs would receive as a result of not being subject to the 2018 PQRS payment adjustment due to the amended policy in this final rule for the CY 2016
Previous burden impacts were discussed in the Medicare EHR Incentive Program Stage 2 final rule (77 FR 54126 through 54133). The burden estimates for reporting that data have not changed; therefore, there are no added burden estimates for the policy change discussed in section III.G. of this final rule.
The changes in section III.G. of this final rule for the Medicare EHR Incentive Program for EPs reporting CQMs would have no additional estimated impacts as they would neither increase or decrease the number of successful meaningful EHR users in the Medicare EHR Incentive Program for EPs. Under this policy, the number of CQMs required to meet EHR Incentive Program requirements would not change for those EPs reporting their CQMs by attestation, thus the previously reported burden estimates for those EPs remains unchanged. For those EPs submitting CQMs electronically, this policy would reduce their reporting requirement from 9 measures across 3 NQS domains to 6 measures with no domain requirement. Based on our analysis of the data already reported for CY 2016, no additional EPs would have successfully demonstrated meaningful use.
We proposed certain modifications to our rules regarding ACO assignment and financial calculations, quality measures and quality validation audits, TIN overlaps, and application requirements. Specifically we proposed: (1) Modifications to how services furnished by RHCs and FQHCs are used for purposes of beneficiary assignment to an ACO as a result of the 21st Century Cures Act, including reducing reporting burden for ACOs that include RHCs and FQHCs; (2) modifications to the assignment methodology to include new chronic care management and behavioral health integration codes in our definition of primary care services; (3) a policy to improve the quality validation audit process and, absent unusual circumstances, to use the results to proportionally modify an ACO's overall quality score; (4) a policy to address substantive changes to quality measures made under the Quality Payment Program; (5) revisions to our application requirements to reduce burden for ACO applicants seeking to participate in the Shared Savings Program and for ACOs applying to use the SNF 3-Day Rule Waiver; (6) changes to our ACO participant TIN overlap policies, specifically, to address situations in which overlapping ACO participant TINs begin billing for services that are used in beneficiary assignment during a benchmark or performance year; and (7) a policy to use only final beneficiary identifiable non-claims based payments in establishing benchmarks and performing financial reconciliation.
We are finalizing these proposed policies in this final rule. Although we believe the final policies will reduce burden for participating ACOs and applicants, we do not anticipate any significant economic impact for these policies in terms of overall program costs or savings.
Section 1848(p) of the Act requires that we establish a value-based payment modifier (VM) 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. Section 1848(p)(4)(C) of the Act requires the VM to be budget neutral. Budget-neutrality means that, in aggregate, the increased payments to high performing physicians and groups equal the reduced payments to low performing physicians and groups, as well as those physicians and groups that failed to avoid the PQRS payment adjustment as a group or as individuals. The final payment adjustment period for the Value Modifier will be CY 2018 after which it will be replaced by the payment adjustments under the Merit-based Incentive Payment System (MIPS).
In the CY 2016 PFS final rule with comment period (80 FR 71277 and 71279), we established that, beginning with the CY 2018 payment adjustment period, the VM will apply to nonphysician EPs who are physician assistants (PAs), nurse practitioners (NPs), clinical nurse specialists (CNSs), and certified registered nurse anesthetists (CRNAs) in groups with 2 or more EPs and to PAs, NPs, CNSs, and CRNAs who are solo practitioners.
We also previously finalized that, in CY 2018, the VM will be waived for groups and solo practitioners, as identified by their Taxpayer Identification Number (TIN), if at least one EP who billed for Medicare PFS items and services under the TIN during 2016 participated in the Pioneer ACO Model, the Comprehensive Primary Care initiative, Next Generation ACO Model, the Oncology Care Model, or the Comprehensive ESRD Care Initiative in 2016 (80 FR 71286 through 71288).
In the CY 2016 PFS final rule with comment period (80 FR 71280), we adopted a two-category approach for the CY 2018 VM based on participation in the PQRS by groups and solo practitioners. For the purposes of the CY 2018 VM, Category 1 represents groups and solo practitioners subject to the VM who met the criteria to avoid the CY 2018 PQRS payment adjustment (a) as a group practice participating in the PQRS GPRO, (b) groups that had at least 50 percent of the group's EPs meet the criteria to avoid the CY 2018 PQRS payment adjustment as individuals, (c) solo practitioners that met the criteria to avoid the CY 2018 PQRS payment adjustment as individuals, and (d) groups and solo practitioners that participated in a Shared Savings Program ACO, if the ACO in which they participated successfully reported quality data as required by the Shared Savings Program. Category 2 represents those groups and solo practitioners that are subject to the CY 2018 VM payment adjustment and do not fall within Category 1.
In section III.I. of this final rule, we are finalizing the proposed policy to reduce the CY 2018 VM payment adjustment amount for groups and solo practitioners in Category 2. We are finalizing that the automatic payment adjustment would be reduced from −4.0 percent to −2.0 percent for physicians, PAs, NPs, CNSs, and CRNAs in groups with 10 or more EPs and at least one physician and from −2.0 percent to −1.0 percent for physicians, PAs, NPs, CNSs, and CRNAs in groups with 2 to 9 EPs; PAs, NPs, CNSs, and CRNAs in groups comprised solely of nonphysician EPs; and physicians, PAs, NPs, CNSs, and CRNAs who are solo practitioners.
Additionally, in section III.I. in this final rule, we are finalizing the proposed policy that, under quality-tiering, which is the methodology for evaluating performance on quality and cost measures for the VM, there will be no downward adjustments for groups or solo practitioners in Category 1 for the VM for CY 2018. We are also finalizing the proposed policy to reduce the maximum upward adjustment under the quality-tiering methodology in CY 2018 for physicians, PAs, NPs, CNSs, and CRNAs in groups with 10 or more EPs and at least one physician that are
As in previous years of the program, under the quality-tiering methodology, each group and solo practitioner's quality and cost composites will continue to be classified into high, average, and low categories depending upon whether the composites are at least one standard deviation above or below the mean and statistically different from the mean. We will compare their quality of care composite classification with the cost composite classification to determine their VM adjustment for the CY 2018 payment adjustment period according to the amounts in Table 54.
Under the quality-tiering methodology, for groups and solo practitioners that participated in a Shared Savings ACO that successfully reports quality data for CY 2016, the cost composite will be classified as “Average” and the quality of care composite will continue to be based on ACO-level quality measures. We will compare their quality of care composite classification with the “Average” cost composite classification to determine their VM adjustment for the CY 2018 payment adjustment period. For groups and solo practitioners that participate in a Shared Savings Program ACO that did not successfully report quality data for CY 2016 and are Category 1 as a result of quality data reported to the PQRS outside of the ACO, the quality and cost composites will continue to be classified as “Average”.
To achieve budget neutrality, we first aggregate the automatic downward payment adjustments of −1.0 percent or −2.0 percent for groups and solo practitioners subject to the VM that fall within Category 2. Using the aggregate downward payment adjustment amount, we then calculate the upward payment adjustment factor (x). Additionally, as we have done when calculating the upward payment adjustment factor for the 2017 VM, we will also incorporate adjustments made for estimated changes in physician behavior, including anticipated changes in the volume and/or intensity of services delivered and shifting of services to TINs that receive higher VM adjustments, and estimated impact of pending PQRS and VM informal reviews. These calculations will be done after the performance period has ended and announced around the start of the payment adjustment year after the informal review period ends.
On September 18, 2017, we made the 2016 Annual QRURs available to all groups and solo practitioners based on their performance in CY 2016. We also completed a preliminary analysis (based on results included in the 2016 Annual QRURs and prior to accounting for the informal review process) of the impact of the VM in CY 2018 on physicians, PAs, NPs, CNSs, and CRNAs in groups with 2 or more EPs and physicians, PAs, NPs, CNSs, and CRNAs who are solo practitioners based on their performance in CY 2016. A summary of the results for groups and solo practitioners subject to the 2018 VM is presented below.
There are 180,621 groups and solo practitioners (as identified by their TIN) consisting of 1,121,857 physicians, PAs, NPs, CNSs, and CRNAs whose payments under the Medicare PFS will be subject to the VM in the CY 2018 payment adjustment period. These counts include both TINs that participated in a Shared Savings Program ACO in CY 2016 and TINs that did not. Of all the physicians, PAs, NPs, CNSs, and CRNAs subject to the CY 2018 VM, approximately 75 percent (838,376) are in TINs that met the criteria for inclusion in Category 1 and are subject to the quality-tiering methodology in order to calculate their CY 2018 VM; and approximately 25 percent (283,481) are in TINs that are Category 2.
Physicians, PAs, NPs, CNSs, and CRNAs in Category 2 TINs with between 1 to 9 EPs and at least one physician and PAs, NPs, CNSs, and CRNAs in Category 2 TINs comprised solely of non-physician EPs will be subject to an automatic −1.0 percent payment adjustment, while physicians, PAs, NPs, CNSs, and CRNAs in Category 2 TINs with 10 or more EPs and at least one physician will be subject to an automatic −2.0 percent payment adjustment under the VM during the CY 2018 payment adjustment period for failing to meet the criteria to avoid the CY 2018 PQRS payment adjustment. The number of physicians, PAs, NPs, CNSs, and CRNAs receiving an automatic downward payment adjustment because their TIN failed to meet the criteria to avoid the PQRS adjustment declined by 8 percentage points to 25 percent for the 2018 VM (based on 2016 performance), down from 33 percent for the 2017 VM, despite the expansion of the VM from all physicians to all physicians and NPs, PAs, CNSs, and CRNAs in the 2018 payment year. We believe it is likely that many TINs that failed to meet the criteria to avoid the PQRS adjustment and as a result are in Category 2 and are subject to automatic downward payment adjustments under the CY 2018 VM will be excluded from MIPS in CY 2019, due to the low-volume threshold. Furthermore, the lower percent of clinicians who do not meet the criteria to avoid the PQRS adjustment, coupled with lower downward adjustments and upward adjustments based on performance will likely result in payment adjustments that are more in line with MIPS level adjustments.
For physicians, PAs, NPs, CNSs, and CRNAs (838,376) that are in Category 1 TINs (77,337) in CY 2018, Table 55 shows their distribution into the various
The numbers presented above are preliminary numbers and may be subject to change as a result of the informal review process. In early 2018, after the conclusion of the informal review period, we will release updates to the number of TINs receiving upward, neutral, and downward adjustments, along with the adjustment factor for the CY 2018 VM on the CMS Web site at
We proposed that Medicare claims submitted for items and services furnished by a physician or applicable practitioner on or after January 1, 2018, should voluntarily include any of these five HCPCS modifiers: X1 (Continuous/broad services), X2 (Continuous/focused services) X3 (Episodic/broad services, X4 (Episodic/focused services) and X5 (Only as ordered by another physician). In addition to the modifiers, Medicare claims should include the NPI of the ordering physician or applicable practitioner (if different from the billing physician or applicable practitioner). Our plan is not to tie the collection of the codes with payment until we are sure clinicians have gained ample experience and education in using these modifiers. Therefore, there is no impact to CY 2018 physician payments under the PFS. There may be a burden associated with clinicians and their administrative staff having to learn which codes to use and how to submit them properly.
CMS will provide a voluntary 25-minute training/instruction manual and a one-time 60-minute (1 hour) webinar for practice manager or billing/coding staff who seek further knowledge to be able to report these new HCPCS modifiers correctly. Although there are a total of five HCPCS modifiers, we expect one out of the five usually will be reported.
For a practice manager or billing/coding staff who may voluntarily study the whole 25 minutes training document, we estimate a one-time total cost burden of training of $150.00 × 0.25hrs = $37.50 for the reading of the coding manual, and a burden of $150.00 × 1hr = $150.00 for participating in the webinar (or later watching the recorded webinar videos), totaling an overall burden of training of $150.00 + $37.50 = $187.50. The practice manager or billing/coding staff who may decide to study only one HCPCS modifier or only the whole training manual or participate in just the webinar may experience a lesser burden than the estimate provided above, resulting in a lower information burden cost.
In section III.K of the preamble of this final rule, we discuss our proposals to further implement the MDPP expanded model under the authority of section 1115A of the Act, which authorizes the Innovation Center to test innovative payment and service delivery models to reduce program expenditures while preserving or enhancing the quality of care furnished to Medicare, Medicaid and CHIP beneficiaries. The MDPP expanded model was established in the November 15, 2016 MDPP final rule (81 CFR 80459 through 80483) as an additional preventive service with a model effective date of January 1, 2018. Many of the policies for the MDPP expanded model were deferred to future rulemaking and, therefore, are being finalized in this rule. On March 14, 2016, the Office of the Actuary (OACT) published a certification memorandum setting out the conditions for expansion of the Medicare Diabetes Prevention Program (MDPP). This regulatory impact assessment is not an updated certification; rather, it is based on estimates of this final rule and provides a revised 10-year savings estimate of $182 million which differs slightly from the 10-year savings estimate of $186 million included in the proposed rule. The $4 million reduction in savings can be explained by two factors. First, CMS is finalizing more payment for the MDPP services based on beneficiary attendance and weight loss. Thus, this increases projected costs and reduces projected savings. Second, we are finalizing a MDPP service period of 2 years. A shortened period of maintenance sessions available slightly reduces long term program effectiveness while also reducing potential savings. However, reducing the program length from 3 years to 2 years cuts the total possible payment for each participant from $810 to $670 which offsets most of the costs of higher performance payments and reduced effectiveness.
Diabetes affects more than 25 percent of Americans aged 65 or older and its prevalence is projected to increase approximately two-fold for all U.S. adults (ages 18-79) by 2050 if current trends continue.
The MDPP expanded model is expected to have a positive impact on beneficiaries' health that will generally lead to reduced beneficiary spending on Part A, Part B, and Part D health care services over time due to a reduced need for Part A, Part B, and Part D services. This regulatory impact analysis does not include anticipated savings from Medicare Part D. As a new preventive service, the MDPP services are available to eligible Medicare beneficiaries without cost-sharing. The CDC estimates that approximately 50 percent of adults aged 65 and over living in the United States have prediabetes and that awareness of the condition among those who have it is relatively low—approximately 15 percent for the general population.
To arrive at our participation estimate we developed projections for pent-up demand and ongoing demand. To develop the projection for pent-up demand we first analyzed data from the CDC National Diabetes Prevention Recognition Program (DPRP). Specifically, we analyzed State-by-State DPRP in-person utilization for ages 65 or older in 2015. Because the Health Care Innovation Award (HCIA) DPP model test was still serving beneficiaries during this period, and the HCIA DPP organizations are also part of the DPRP, we used its enrollment data to inform what Medicare beneficiary participation may look like when Medicare pays for MDPP services. Given that HCIA participation seemed to drive most of the DPRP participation in an HCIA awardee's region, we determined that a well-defined HCIA region would be a reasonable proxy for the rest of the nation. We found the state with the highest HCIA saturation, and calculated the percentage of fee for service beneficiaries that received services from a DPRP DPP. This percentage was applied to all fee for service beneficiaries nationwide in order to get a national pent-up demand estimate. We added this pent-up demand to a stable level of demand based on the number of new beneficiaries utilizing the obesity management benefit each year. Given the limited nationwide Medicare DPP participation data, there is a great amount of uncertainty in these estimates.
We believe that the eligibility criteria for continued participation in the set of MDPP services incentivizes beneficiaries to lose 5-percent body weight from baseline. Beneficiaries are incentivized to lose weight because continued eligibility for the services after the first 12 months is contingent upon achieving 5-percent weight loss and the set of MDPP services is a once per lifetime set of services. In addition to prevention of type 2 diabetes, we believe participating beneficiaries would likely receive other possible health benefits including prevention of obesity for those who are overweight upon receiving MDPP services, prevention of sleep apnea, and reduced risk for heart disease, coronary artery disease and stroke.
Currently, more than 1,400 organizations nationally are providing DPP services with some level of recognition through the CDC. Service delivery is primarily to individuals with private or employer-sponsored insurance, as well as some Medicare Advantage plans. The majority of existing DPP organizations are not participating in the Medicare program. We anticipate that the addition of MDPP services as new preventive services in Medicare would result in growth in the market, including growth in the number of individuals served per year by existing DPP suppliers, as well as the introduction of new suppliers into the market. There are burdens associated with obtaining CDC recognition and enrolling into Medicare as an MDPP supplier. There is also burden associated with submitting claims to Medicare for payment. Below we have provided an estimate of the financial burden to suppliers.
To derive average costs for use throughout the subsequent sections, we used data from the U.S. Bureau of Labor Statistics' May 2016 National Occupational Employment and Wage Estimates for all salary estimates (
Our regulations at § 424.205 provide that an entity is eligible to enroll in Medicare as an MDPP supplier if it has MDPP interim preliminary recognition, as determined by CMS. In order to receive MDPP interim preliminary recognition, we finalized that the entity must have pending CDC recognition and must submit a full 12 months of data on at least one completed cohort of participants to CDC (among other criteria). In order to receive pending recognition from CDC, organizations are required to submit an application for recognition to CDC and agree to CDC's curriculum, duration and intensity requirements. CMMI plans to engage CDC's services to assist CMMI in administering its interim preliminary recognition standard. CMMI would make the final determination of which entities qualify to receive interim preliminary recognition.
The burden associated with the preceding requirements is the time for MDPP supplier staff to: Submit an application for pending recognition to CDC and then collect and submit a full 12 months of data (including session attendance, body weight documentation, physical activity minutes documentation, and weight loss achieved) on at least one completed cohort of participants to CDC for the purposes of being evaluated for interim preliminary recognition.
We estimate that it will take a medical records and health information technician 12 hours, at $39.84/hour to collect and report these data for one cohort of participants, and an office or administrative worker 1 hour, at $32.62/hour, to complete the CDC application for pending recognition. The estimated cost per supplier to achieve interim preliminary recognition is $510.70.
Our regulations at § 424.205 and § 424.59 will require that an MDPP supplier certify in its enrollment application that it meets a set of standards. This application will be designated as CMS-20134. As this new enrollment application is being created specifically for the MDPP expanded model, we have determined that it is exempt from the Paperwork Reduction Act in accordance with section 1115A(d)(3) of the Act. We estimate that it will take an office or administrative support worker 3 hours, at $32.62/hour, to complete the MDPP supplier enrollment application using the internet-based Provider Enrollment, Chain and Ownership System (PECOS). The provider/supplier enrollment fee for CY 2017 is $560. We note that in accordance with § 424.514 MDPP suppliers may submit a written request to CMS for a hardship exception to the application fee. CMS determines such exceptions on a case-by-case basis. The estimated cost to complete the MDPP supplier enrollment application, without a hardship exception, is $654.62. If a provider is granted a hardship exception from the enrollment fee, then the estimated cost to complete the enrollment process is $94.62.
We also note that access to the HIPAA Eligibility Transaction System (HETS), which a supplier could use to check factors of eligibility for the MDPP services, including the beneficiary's Part B eligibility and whether the beneficiary is eligible for Medicare based on end-stage renal disease (as described in § 406.13), is free to suppliers, as long as they are active Medicare fee-for-service providers or suppliers in PECOS.
Suppliers also will be required to maintain documentation of all beneficiary contact regarding complaints or questions, as specified in § 424.205(d)(11), and maintain and submit to CMS a crosswalk file that indicates how participant identifications for the purposes of CDC performance data correspond to beneficiary identifiers (Medicare Beneficiary Identifiers or beneficiary health insurance claims numbers) for each beneficiary receiving MDPP services. We estimate that creating and maintaining documentation of beneficiary contact regarding complaints or questions will take an
Our regulations at § 424.205 also will require that suppliers meet a set of standards that includes maintaining a physical facility on an appropriate site and maintaining a primary business telephone that is operating at the appropriate site. Because we have no way to estimate how many beneficiaries each MDPP supplier may provide the set of MDPP services to, and we expect this will differ based on many factors, including but not limited to the size of the supplier, the number of coaches the supplier employs, the physical space the supplier uses to furnish MDPP services, and the supplier's geographic location, we have not included an overall cost for these requirements in this burden estimate.
Our regulations at § 414.84 specify the payments MDPP suppliers may be eligible to receive for furnishing MDPP services and meeting performance targets related to beneficiary weight loss and/or attendance. MDPP suppliers would be paid by CMS by submitting claims for MDPP beneficiaries using claim form CMS-1500 (
The set of MDPP services is an optional set of services for beneficiaries who meet the eligibility requirements described elsewhere in the final rule. MDPP services will be furnished by a new supplier type in Medicare. The CDC recognizes DPPs nationwide; these programs effectively deliver lifestyle-changing services that reduce the incidence of type 2 diabetes. The number of CDC-recognized DPPs is growing rapidly, increasing by nearly 90 percent from September 2015 to March 2017. The historical participation rate suggests that the vast majority of these organizations are not serving a significant volume of new participants, aside from those served in the DPP model test.
This estimate is based on the initial methodology used for the estimate of the MDPP expanded model as set out in the certification memorandum, but with differences in several program features including the payment parameters. It also includes the impact of improved longevity among those who participate in the MDPP expanded model. This cost of improved longevity was ignored for certification purposes, as noted in that memorandum.
The model is dependent on the number of eligible participants, the annual take-up rate, and the savings per participant, all of which are uncertain. The methodology determines gross savings as the result of an assumed reduction in the number of beneficiaries transitioning from prediabetes to diabetes and a marginal cost difference between the individuals with diabetes and those that are prediabetic. The Office of the Actuary assumed that the initial savings per beneficiary for avoiding diabetes is $3,000 per year. The progression rate from prediabetes to diabetes absent the intervention is expected to be roughly 5 percent per year. Based on observed results, we assume that the set of MDPP services will reduce the progression rate among those receiving the services by 50 percent in the first year and that the reduction will be 5 percent less in each subsequent year until leveling off at a rate of 5 percent. Due to a cessation of payments for participating beneficiaries after 2 years, there is an additional reduction of 5 percent in the third year. The program costs in this estimate include payments to MDPP suppliers in the initial year of the MDPP services period and in the maintenance year. Overall, the payments under the expanded model would occur for a maximum of 2 years, but the expected reduction in medical costs would occur over a long period following the intervention. For the leading cohort of 2018, we would expect savings in excess of costs by 2019 (the second year), with cumulative savings by 2021 (after 3 years). Yearly net savings reduce slightly each subsequent year but do not result in a cost to Medicare during the 10-year projection window.
Table 57 shows the 10-year impact of the MDPP expanded model, net of payments to MDPP providers but gross of any other model costs, based on our expected enrollment per year. The 10-year impact is a savings to Medicare of $182 million. The estimate is expected to cross into a cumulative savings to Medicare in the sixth year of the MDPP expanded model.
MDPP is a new Medicare expanded model that was tested in the HCIA DPP model using a small percentage of the population. As a result, the estimated impact from the expanded MDPP model is very uncertain. In particular, it is unknown how many beneficiaries will be interested in participating in MDPP and how quickly MDPP suppliers available will be able to serve those individuals. To understand how various participation scenarios would affect the financial results, we have prepared the estimates under two other participation scenarios. The first shows the results if half of the beneficiaries shown in the best estimate participate, and the second uses twice as many beneficiaries. The details are shown in Tables 58 and 59.
In conclusion, we estimate that the 10-year impact of the MDPP expanded model, net of payments to MDPP providers but gross of any other program costs, based on our expected enrollment per year would be a savings to Medicare of $182 million. The estimate is expected to cross into a cumulative savings to Medicare in the sixth year of the MDPP expanded model.
We acknowledge that costs will be higher for suppliers that are new to delivering DPP as costs would be higher for starting up any new business. In addition, our performance-based payment structure does not incorporate start-up costs as such costs are typically considered the cost of doing business.
This final rule contains a range of policies, including some provisions related to specific statutory provisions. The preceding preamble provides descriptions of the statutory provisions that are addressed, identifies those policies when discretion has been exercised, presents rationale for our final policies and, where relevant, alternatives that were considered. For purposes of the payment impact on PFS services of the policies contained in this final rule, we presented the estimated impact on total allowed charges by specialty. The alternatives we considered, as discussed in the preceding preamble sections, would result in different payment rates, and therefore, result in different estimates than those shown in Table 49 (CY 2018 PFS Estimated Impact on Total Allowed Charges by Specialty).
There are a number of changes in this final rule that would have an effect on beneficiaries. In general, we believe that many of these changes, including those intended to improve accuracy in payment through regular updates to the inputs used to calculate payments under the PFS, would have a positive impact and improve the quality and value of care provided to Medicare beneficiaries.
For example, in finalizing our policies to provide separate payment for codes describing the insertion and removal of drug implants to treat opioid addiction, as well as a code describing remote patient monitoring, we are improving Medicare beneficiary access to these important services. This rule also finalizes policies necessary for the implementation of the Medicare Diabetes Prevention Program expanded model which is expected to improve the quality of patient care for Medicare beneficiaries and make MDPP services available to beneficiaries in addition to existing Medicare services. MDPP services are designated under the MDPP expanded model to be covered as additional preventive services under Medicare, as defined in section 1861(ddd) of the Act, and therefore not subject to cost-sharing. These new covered services for beneficiaries under the MDPP expanded model will have a positive impact on the health of beneficiaries because they are expected to be effective in preventing diabetes onset through attendance of MDPP sessions and weight loss. More details can be found in section III.K of this final rule, and the CY 2017 PFS (81 CFR 80170 through 80562). These and all other improvements to payment accuracy that we are finalizing for CY 2018 are described in greater detail in this final rule.
Most of the aforementioned proposed policy changes could result in a change in beneficiary liability as 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 our public use file Impact on Payment for Selected Procedures available on the CMS Web site at
If regulations impose administrative costs on private entities, such as the time needed to read and interpret this rule, we should estimate the cost associated with regulatory review. Due to the uncertainty involved with accurately quantifying the number of entities that will review the rule, we assume that the total number of unique commenters on last year's rule will be the number of reviewers of this rule. We acknowledge that this assumption may understate or overstate the costs of reviewing this rule. It is possible that not all commenters reviewed last year's rule in detail, and it is also possible that some reviewers chose not to comment on the rule. For these reasons we thought that the number of past commenters would be a fair estimate of the number of reviewers of this rule. We welcomed any comments on the approach in estimating the number of entities which will review this rule.
We also recognize that different types of entities are in many cases affected by mutually exclusive sections of this rule, and therefore for the purposes of our estimate we assume that each reviewer reads approximately 50 percent of the rule. We sought comments on this assumption.
Using the wage information from the BLS for medical and health service managers (Code 11-9111), we estimate that the cost of reviewing this rule is $105.16 per hour, including overhead and fringe benefits
As required by OMB Circular A-4 (available at
The analysis in the previous sections, together with the remainder of this preamble, provided an initial Regulatory Flexibility Analysis. The previous analysis, together with the preceding portion of this preamble, provides a Regulatory Impact Analysis. In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.
Administrative practice and procedure, Health facilities, Health professions, Kidney diseases, Medical devices, Medicare, Reporting and recordkeeping requirements, Rural areas, X-rays.
Health facilities, Health professions, Kidney diseases, Laboratories, Medicare, Reporting and recordkeeping requirements, Rural areas, X-rays.
Administrative practice and procedure, Biologics, Drugs, Health facilities, Health professions, Kidney diseases, Medicare, Reporting and recordkeeping requirements.
Emergency medical services, Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements.
Administrative practice and procedure, Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services amends 42 CFR chapter IV as set forth below:
Secs. 205(a), 1102, 1861, 1862(a), 1869, 1871, 1874, 1881, and 1886(k) of the Social Security Act (42 U.S.C. 405(a), 1302, 1395x, 1395y(a), 1395ff, 1395hh, 1395kk, 1395rr and 1395ww(k)), and sec. 353 of the Public Health Service Act (42 U.S.C. 263a).
(a) * * *
(5) Furnished under the direct supervision of a physician, except that services and supplies furnished incident to Transitional Care Management, General Care Management, and the Psychiatric Collaborative Care Model can be furnished under general supervision of a physician when these services or supplies are furnished by auxiliary personnel, as defined in § 410.26(a)(1) of this chapter.
(a) * * *
(5) Furnished under the direct supervision of a nurse practitioner, physician assistant, or certified nurse-midwife, except that services and supplies furnished incident to Transitional Care Management, General Care Management, and the Psychiatric Collaborative Care model can be furnished under general supervision of a nurse practitioner, physician assistant, or certified nurse-midwife, when these services or supplies are furnished by auxiliary personnel, as defined in § 410.26(a)(1) of this chapter.
Secs. 1102, 1834, 1871, 1881, and 1893 of the Social Security Act (42 U.S.C. 1302, 1395m, 1395hh, 1395rr, and 1395ddd).
The revisions and additions read as follows:
(a) Medicare Diabetes Prevention Program (MDPP) services will be available beginning on April 1, 2018.
(b) * * *
(i) Is furnished by an MDPP supplier to an MDPP beneficiary during a core maintenance session interval;
(ii) Is approximately 1 hour in length; and
(iii) Adheres to a CDC-approved DPP curriculum for maintenance sessions.
(i) Is furnished by an MDPP supplier to an MDPP beneficiary during months 1 through 6 of the MDPP services period;
(ii) Is approximately 1 hour in length; and
(iii) Adheres to a CDC-approved DPP curriculum for core sessions.
(i) Is furnished by an MDPP supplier to an MDPP beneficiary during an ongoing maintenance session interval;
(ii) Is approximately 1 hour in length; and
(iii) Adheres to a CDC-approved DPP curriculum for maintenance sessions.
(c) Coverage for
(A) Is enrolled under Medicare Part B;
(B) Attended the first core session within the most recent 12-month time period and, prior to attending this first core session, had not previously received the set of MDPP services in his or her lifetime;
(C) Has, on the date of attendance at the first core session, a body mass index (BMI) of at least 25 if not self-identified as Asian or a BMI of at least 23 if self-identified as Asian;
(D) Has received, within the 12-month time period prior to the date of attendance at the first core session, a hemoglobin A1c test with a value of between 5.7 and 6.4 percent, a fasting plasma glucose test with a value of between 110 and 125 mg/dL, or a 2-hour plasma glucose test (oral glucose tolerance test) with a value of between 140 and 199 mg/dL;
(E) Has, as of the date of attendance at the first core session, no previous diagnosis of diabetes, other than gestational diabetes; and
(F) Does not have end-stage renal disease (ESRD).
(ii) An MDPP beneficiary is eligible for the first ongoing maintenance session interval only if the beneficiary:
(A) Attends at least one in-person core maintenance session during the final core maintenance session interval; and
(B) Achieves or maintains the required minimum weight loss at a minimum of one in-person core maintenance session during the final core maintenance session interval.
(iii) An MDPP beneficiary is eligible for a subsequent ongoing maintenance session interval only if the beneficiary:
(A) Attends at least two ongoing maintenance sessions during the previous ongoing maintenance session interval, including at least one in-person ongoing maintenance session; and
(B) Maintains the required minimum weight loss at a minimum of one in-person ongoing maintenance session furnished during the previous ongoing maintenance session interval.
(iv) Weight measurements used to determine the achievement or maintenance of the required minimum weight loss must be taken in person by an MDPP supplier during an MDPP session.
(2)
(i) The core services period, which is the first 12 months of the MDPP services period, and consists of:
(A) At least 16 core sessions offered at least one week apart during months
(B) Two 3-month core maintenance session intervals offered during months 7 through 12 of the MDPP services period.
(ii) Subject to paragraph (c)(3) of this section, the ongoing services period, which consists of up to four 3-month ongoing maintenance session intervals offered during months 13 through 24 of the MDPP services period.
(3)
(ii) If the MDPP beneficiary qualifies for the first ongoing maintenance session interval as described in paragraph (c)(3)(i) of this section, the MDPP services period ends upon completion of this first ongoing maintenance session interval or any subsequent ongoing maintenance session interval, unless the beneficiary meets the eligibility requirements under paragraph (c)(1)(iii) of this section.
(iii) Unless sooner ended in accordance with this paragraph (c)(3), the MDPP services period ends automatically upon the completion of the fourth ongoing maintenance session interval.
(d)
(i) The curriculum furnished during the make-up session must address the same CDC-approved DPP curriculum topic as the regularly scheduled session that the beneficiary missed;
(ii) The MDPP supplier may furnish to the beneficiary a maximum of one make-up session on the same day as a regularly scheduled session; and
(iii) The MDPP supplier may furnish to the beneficiary a maximum of one make-up session per week.
(2) An MDPP supplier may offer virtual make-up sessions only if consistent with the requirements in paragraph (d)(1) of this section. Virtual make-up sessions are also subject to the following requirements:
(i) Virtual make-up sessions must be furnished in a manner consistent with the DPRP standards for virtual sessions;
(ii) An MDPP supplier may only offer virtual make-up sessions based on an individual MDPP beneficiary's request; and
(iii) An MDPP supplier may offer to an MDPP beneficiary:
(A) No more than 4 virtual make-up sessions within the core services period described in paragraph (c)(2)(i) of this section, of which no more than 2 virtual make-up sessions are core maintenance sessions; and
(B) No more than 3 virtual make-up sessions that are ongoing maintenance sessions.
(3) Make-up sessions furnished in accordance with paragraph (d)(1) of this section that an MDPP beneficiary attends in person are counted toward meeting the attendance requirements described in paragraph (c)(1) of this section and toward achieving the performance goals described in § 414.84(b) of this chapter as if the MDPP beneficiary attended a regularly scheduled session. Virtual make-up sessions furnished in accordance with paragraph (d)(2) of this section are also counted toward such attendance requirements and performance goals, subject to the following limitations:
(i) The MDPP beneficiary receives no more than 4 virtual make-up sessions within the core services period described in paragraph (c)(2)(i) of this section, of which no more than 2 virtual make-up sessions may be core maintenance sessions; and
(ii) The MDPP beneficiary receives no more than 3 virtual make-up sessions that are ongoing maintenance sessions.
Secs. 1102, 1871, and 1881(b)(l) of the Social Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(l)).
(a)
(b)
(1)
(i) For a first core session furnished April 1 through December 31, 2018. $25.
(ii) For a first core session furnished during a calendar year subsequent to CY 2018. The performance payment amount specified in this paragraph for the prior year, adjusted as specified in paragraph (d) of this section.
(2)
(i) For a fourth core session furnished April 1 through December 31, 2018. $50.
(ii) For a fourth core session furnished during a calendar year subsequent to CY 2018. The performance payment amount specified in this paragraph for the prior year, adjusted as specified in paragraph (d) of this section.
(3)
(i) For a ninth core session furnished April 1 through December 31, 2018. $90.
(ii) For a ninth core session furnished during a calendar year subsequent to CY 2018. The performance payment amount specified in this paragraph for the prior year, adjusted as specified in paragraph (d) of this section.
(4)
(i) If the beneficiary also achieves or maintains the required minimum weight loss as measured in-person during a core maintenance session furnished during the applicable core maintenance session interval:
(A) For a second core maintenance session furnished April 1 through December 31, 2018. $60.
(B) For a second core maintenance session furnished during a calendar year subsequent to CY 2018. The performance payment amount specified in this paragraph for the prior year, adjusted as specified in paragraph (d) of this section.
(ii) If the beneficiary does not achieve or maintain the required minimum weight loss as measured in-person during a core maintenance session furnished during the applicable core maintenance session interval:
(A) For a second core maintenance session furnished April 1 through December 31, 2018. $15.
(B) For a second core maintenance session furnished during a calendar year subsequent to CY 2018. The performance payment amount specified in this paragraph for the prior year, adjusted as specified in paragraph (d) of this section.
(5)
(i) For a second ongoing maintenance session furnished April 1 through December 31, 2018. $50.
(ii) For a second ongoing maintenance session furnished during a calendar year subsequent to CY 2018. The performance payment amount specified in this paragraph for the prior year, adjusted as specified in paragraph (d) of this section.
(6)
(i) For a core session or core maintenance session, as applicable, furnished April 1 through December 31, 2018. $160.
(ii) For a core session or core maintenance session, as applicable, furnished during a calendar year subsequent to CY 2018. The performance payment amount specified in this paragraph for the prior year, adjusted as specified in paragraph (d) of this section.
(7)
(i) For a core session, core maintenance session, or ongoing maintenance session, as applicable, furnished April 1 through December 31, 2018. $25.
(ii) For a core session, core maintenance session, or ongoing maintenance session, as applicable, furnished during a calendar year subsequent to CY 2018. The performance payment amount specified in this paragraph for the prior year, adjusted as specified in paragraph (d) of this section.
(c)
(1) For a core session, core maintenance session, or ongoing maintenance session, as applicable, furnished April 1 through December 31, 2018. $25.
(2) For a core session, core maintenance session, or ongoing maintenance session, as applicable, furnished during a calendar year subsequent to CY 2018. The bridge payment amount specified in this paragraph for the prior year, adjusted as specified in paragraph (d) of this section.
(d)
(j) * * *
(8) * * *
(i) * * *
(A) * * *
(
(ii) * * *
(A) * * *
(
(
(iii)
(iv)
(9) * * *
(ii)
(iii)
(iv)
(v)
(vi)
(viii) If the CAHPS for PQRS survey is applicable to the practice, group practices comprised of 100 or more eligible professionals that register to participate in the GPRO may administer the CAHPS for PQRS survey, regardless of the GPRO reporting mechanism selected.
(k) * * *
(3)
(5) * * *
(i)
(ii)
(j)
(k)
(1) The qualified CDSM consulted by the ordering professional.
(2) Information indicating:
(i) Whether the service ordered would adhere to specified applicable AUC;
(ii) Whether the service ordered would not adhere to specified applicable AUC; or
(iii) Whether the specified applicable AUC consulted was not applicable to the service ordered.
(3) The NPI of the ordering professional who consulted specified applicable AUC as required in paragraph (j) of this section, if different from the furnishing professional.
(e) * * *
(2)
(d) * * *
(1) A downward payment adjustment of −1.0 percent will be applied to a solo practitioner, a group with two to nine eligible professionals, and a group consisting only of nonphysician eligible professionals subject to the value-based payment modifier and no physicians; and a downward payment adjustment of −2.0 percent will be applied to a group with 10 or more eligible professionals and at least one physician if, during the applicable performance period as defined in § 414.1215, the following apply:
(i) For groups:
(A) Such group does not meet the criteria as a group to avoid the PQRS payment adjustment for CY 2018 as specified by CMS; and
(B) Fifty percent of the eligible professionals in such group do not meet the criteria as individuals to avoid the PQRS payment adjustment for CY 2018 as specified by CMS.
(ii) For solo practitioners, such solo practitioner does not meet the criteria as an individual to avoid the PQRS payment adjustment for CY 2018 as specified by CMS.
(c) * * *
(4) The following value-based payment modifier percentages apply to the CY 2018 payment adjustment period, for physicians, physician assistants, nurse practitioners, clinical nurse specialists, and certified registered nurse anesthetists who are solo practitioners or who are in groups of any size:
(d) * * *
(3) * * *
(i) Classified as high quality/low cost receive an upward adjustment of +3x (rather than +2x); and
(ii) Classified as either high quality/average cost or average quality/low cost receive an upward adjustment of +2x (rather than +1x).
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
(d) For purposes of claims for services submitted by an MDPP supplier (as defined at § 410.79(b) of this chapter), Medicare deems such claims to have been assigned by the beneficiary (or the person authorized to request payment on the beneficiary's behalf) and the assignment accepted by the MDPP supplier.
This subpart specifies the requirements for Medicare Diabetes Prevention Program suppliers and beneficiary engagement incentives under the Medicare Diabetes Prevention Program expanded model.
(a)
(b)
(1) Has either an MDPP preliminary recognition, as defined in paragraph (c)(1) of this section or a full CDC DPRP recognition.
(2) Maintains an active and valid TIN and NPI at the organizational level.
(3) Has passed screening requirements as follows:
(i) Upon initial enrollment, at a “high” categorical risk in accordance with § 424.518(c)(2); and
(ii) Upon revalidation, at a “moderate” categorical risk in accordance with § 424.518(b)(2).
(4) Maintains, and submits to CMS through the CMS-approved enrollment application, a roster of all coaches who will be furnishing MDPP services on the entity's behalf that includes each coach's first and last names, middle initial (if applicable), date of birth, Social Security Number (SSN), active and valid NPI, coach eligibility start date, and coach eligibility end date (if applicable). This roster must be updated in accordance with paragraph (d)(5) of this section.
(5) Meets and certifies in its CMS-approved enrollment application that it meets and will continue to meet the supplier enrollment standards described in paragraph (d) of this section.
(6) Revalidates its Medicare enrollment every 5 years after the effective date of enrollment.
(c)
(1) Any preliminary recognition established by CDC for the purposes of the DPRP; or
(2) An MDPP interim preliminary recognition.
(i)
(ii)
(A) The entity has pending CDC recognition.
(B) The entity submits a full 12 months of performance data to CDC on at least one completed cohort. The 12 month data submission includes at least 5 participants who attended at least 3 sessions in the first 6 months and whose time from first session attended to last session of the lifestyle change program was at least 9 months, at least 60 percent of whom attended at least 9 sessions in months 1 through 6, and at least 60 percent of whom attended at least 3 sessions in months 7 through 12.
(d)
(1) The MDPP supplier must have and maintain MDPP preliminary recognition, as defined under paragraph (c)(1) of this section, or a full CDC DPRP recognition.
(2) The MDPP supplier must not currently have its billing privileges terminated for-cause or be excluded by a State Medicaid agency.
(3) The MDPP supplier must not include on the roster of coaches, described in paragraph (b)(4) of this section and updated in accordance with paragraph (d)(5) of this section, nor permit MDPP services to be furnished by, any individual coach who meets any of ineligibility criteria outlined in paragraph (e)(1) of this section.
(4) The MDPP supplier must maintain at least one administrative location. All administrative locations maintained by the MDPP supplier must be located at an appropriate site and be reported on the CMS-approved enrollment application. An appropriate site for such an administrative location would include all of the following characteristics:
(i) Signage posted on the exterior of the building or suite, in a building directory, or on materials located inside of the building. Such signage may include, for example, the MDPP supplier's legal business name or DBA, as well as hours of operation.
(ii) Open for business during stated operational hours.
(iii) Employees, staff, or volunteers present during operational hours; and
(iv) Not a private residence.
(5) The MDPP supplier must update its enrollment application within 30 days of any changes of ownership, changes to the coach roster (including due to coach ineligibility or because the coach is no longer an employee, contractor, or volunteer of the MDPP supplier), and final adverse action history, and report all other changes, including but not limited to changes in the MDPP supplier's administrative location(s), to CMS within 90 days of the reportable event.
(6) The MDPP supplier must maintain a primary business telephone that operates either at administrative locations described in paragraph (d)(4) of this section or directly where services are furnished, if services are furnished in community settings. The associated telephone number must be listed with either the legal or doing business as name of the supplier in public view, including on Web sites, flyers, and materials.
(7) The MDPP supplier must not knowingly sell to or allow another individual or entity to use its supplier billing number.
(8) Subject to paragraph (d)(8)(i) of this section, the MDPP supplier must not deny an MDPP beneficiary access to MDPP services during the MDPP services period described in § 410.79(c)(2) of this chapter, including on the basis of the beneficiary's weight, health status, or achievement of performance goals.
(i) Suppliers may deny an MDPP beneficiary access to MDPP services during the MDPP services period only under one of the following conditions:
(A) The MDPP beneficiary no longer meets the eligibility criteria for MDPP services under § 410.79(c)(1) of this chapter.
(B) The MDPP supplier lacks the self-determined publicly-posted capacity to furnish MDPP services to a given MDPP beneficiary.
(C) The MDPP supplier determines that the MDPP beneficiary significantly disrupts the session for other MDPP beneficiaries or becomes abusive.
(ii) MDPP suppliers must maintain a record of the number of MDPP beneficiaries for whom it declined access away for the reasons outlined in paragraphs (d)(8)(i)(B) and (C) of this section, to include the date each such beneficiary was declined access. For beneficiaries who were declined access for the reasons described in paragraph (d)(8)(i)(C) of this section, the MDPP supplier must document details of the occurrence(s), including date(s) of the behavior, any remediation efforts taken by the MDPP supplier, and final action (for example, dismissal from an MDPP session or denial from future sessions) in the beneficiary's MDPP records.
(9) The MDPP supplier and other individuals or entities performing functions or services related to MDPP services on the MDPP supplier's behalf must not unduly coerce an MDPP beneficiary's decision to change or not to change to a different MDPP supplier, including through the use of pressure, intimidation, or bribery.
(10) Except as allowed under paragraph (d)(8) of this section, the MDPP supplier must offer an MDPP beneficiary no fewer than all of the following:
(i) 16 in-person core sessions no more frequently than weekly for the first 6 months of the MDPP services period, which beginnings on the date of attendance at the first such core session.
(ii) 1 in-person core maintenance session each month during months 7 through 12 (6 months total) of the MDPP services period.
(iii) 1 in-person ongoing maintenance session each month for months 13 through 24 of the MDPP services period, as long as the beneficiary maintains eligibility to receive such services in accordance with § 410.79(c)(1)(ii) and (iii) of this chapter.
(11) Before the initial core session is furnished, the MDPP supplier must disclose detailed information about the set of MDPP services to each MDPP beneficiary to whom it wishes to begin furnishing MDPP services. Such information must include all of the following:
(i) Eligibility requirements under § 410.79(c)(1) of this chapter, including the once-per-lifetime nature of MDPP services.
(ii) Minimum coverage requirements under § 410.79(c)(2).
(iii) The MDPP supplier standards as specified in paragraph (d) of this section.
(12) The MDPP supplier must answer MDPP beneficiaries' questions about MDPP services and respond to MDPP-related complaints within a reasonable timeframe. An MDPP supplier must implement a complaint resolution protocol and maintain documentation of all beneficiary contact regarding such complaints, including the name and Medicare Beneficiary Identifier of the beneficiary, a summary of the complaint, related correspondences, notes of actions taken, and the names and/or NPIs of individuals who took such actions on behalf of the MDPP supplier. Failure to maintain a complaint resolution protocol or to retain information regarding MDPP related complaints in accordance with paragraph (g) of this section may be considered evidence that the MPPP supplier standards have not been met. This information must be kept at each administrative location and made available to CMS or its contractors upon request.
(13) The MDPP supplier must maintain a crosswalk file which indicates how beneficiary identifications for the purposes of CDC performance data requirements correspond to corresponding beneficiary health insurance claims numbers or Medicare Beneficiary Identifiers for each MDPP beneficiary receiving MDPP services from the MDPP supplier. The MDPP supplier must submit the crosswalk file to CMS or its contractor.
(14) The MDPP supplier must submit performance data for MDPP beneficiaries who attend ongoing maintenance sessions with data elements consistent with the CDC's DPRP standards for data elements required for the core services period.
(15) The MDPP supplier must allow CMS or its agents to conduct onsite inspections or recordkeeping reviews in order to ascertain the MDPP supplier's
(e)
(i) Currently have Medicare billing privileges revoked and be currently subject to the reenrollment bar.
(ii) Currently have its Medicaid billing privileges terminated for-cause or be excluded by a State Medicaid agency.
(iii) Currently be excluded from any other Federal health care program, as defined in 42 CFR 1001.2, in accordance with section 1128, 1128A, 1156, 1842, 1862, 1867 or 1892 of the Act.
(iv) Currently be debarred, suspended, or otherwise excluded from participating in any other Federal procurement or nonprocurement program or activity in accordance with the Federal Acquisition Streamlining Act implementing regulations and the Department of Health and Human Services nonprocurement common rule at 45 CFR part 76.
(v) Have, in the previous 10 years, one of the following State or Federal felony convictions:
(A) Crimes against persons, such as murder, rape, assault, and other similar crimes for which the individual was convicted, as defined under 42 CFR 1001.2, had a guilty plea or adjudicated pretrial diversion.
(B) Financial crimes, such as extortion, embezzlement, income tax evasion, insurance fraud and other similar crimes for which the individual was convicted, as defined under 42 CFR 1001.2, had a guilty plea or adjudicated pretrial diversion.
(C) Any felony that placed Medicare or its beneficiaries at immediate risk, such as a malpractice suit that results in the individual being convicted, as defined under 42 CFR 1001.2, had a guilty plea or adjudicated pretrial diversion of criminal neglect or misconduct.
(D) Any felonies for which the individual was convicted, as defined under 42 CFR 1001.2, had a guilty plea or adjudicated pretrial diversion that would result in mandatory exclusion under section 1128(a) of the Act.
(2)
(f)
(i) The later of—
(A) The date of filing of a Medicare enrollment application that was subsequently approved by a Medicare contractor;
(B) The date of filing of a corrective action plan that was subsequently approved by a Medicare contractor; or
(C) The date that the supplier first began furnishing services at a new administrative location that resulted in a new enrollment record or Provider Transaction Access Number.
(ii) Under no circumstances should the effective date of billing privileges for any MDPP supplier be prior to April 1, 2018.
(2) For any newly established administrative locations that do not result in a new enrollment record or Provider Transaction Access Number, the existing billing privilege effective date for their Provider Transaction Access Number will apply, but not earlier than April 1, 2018.
(g)
(1) The documentation for the first core session must be established contemporaneous with the furnishing of MDPP services and must include at least all of the following:
(i) Organizational information, including MDPP supplier name, CDC DPRP number, and NPI.
(ii) Basic beneficiary information for each MDPP beneficiary in attendance, including but not limited to beneficiary name, HICN, or MBI, age.
(iii) Evidence that each such beneficiary satisfied the eligibility requirements under § 410.79(c) of this chapter at the time of service.
(2) The documentation for each MDPP session attended by an MDPP must be established contemporaneous with the furnishing of MDPP services and must include at least all of the following:
(i) Documentation of the type of session, whether a core session, a core maintenance session, an ongoing maintenance session, an in-person make-up session, or a virtual make-up session.
(ii) Identification of which CDC-approved DPRP curriculum was associated with the session.
(iii) The NPI of the coach who furnished the session.
(iv) The date and place of service of the session.
(v) Each MDPP's beneficiary's weight and date weight taken, in a form and manner as specified by CMS.
(3) If an MDPP supplier chooses to offer in-kind beneficiary engagement incentives to MDPP beneficiaries as permitted under § 424.210, the records maintained by the MDPP supplier in accordance with this section must also include the information required by § 424.210(e).
(4) An MDPP supplier is required to maintain and handle any beneficiary information related to MDPP, including Personally Identifiable Information (PII) and Protected Health Information (PHI), as would be required under HIPAA, other applicable state and federal privacy laws, and CMS standards.
(5) The MDPP supplier's records must include an attestation from the MDPP supplier that, as applicable, the MDPP beneficiary for which it is submitting a claim—
(i) Has attended their first, fourth or ninth core session, as applicable, if the claim submitted is for a performance payment under § 414.84(b)(1), (2), or (3) of this chapter.
(ii) Has attended at least three core maintenance sessions, achieved required minimum weight loss, or both, as applicable, if the claim submitted is for a performance payment under § 414.84(b)(4) of this chapter.
(iii) Has achieved the required minimum weight loss and attended at least three ongoing maintenance
(iv) Has achieved required minimum weight loss as measured in-person during a core session or core maintenance session furnished by that supplier, if the claim submitted is for a performance payment under § 414.84(b)(6) of this chapter.
(v) Has achieved at least a 9-percent weight loss percentage as measured in-person during a core session, core maintenance session, or ongoing maintenance session furnished by that supplier, if the claim submitted is for a performance payment under § 414.84(b)(7) of this chapter.
(6) The MDPP supplier must maintain all records required under this section for a period of 10 years from the last day of the MDPP beneficiary's receipt of MDPP services provided by the MDPP supplier or from the date of completion of any audit, evaluation, inspection, or investigation, whichever is later, unless either of the following apply:
(i) CMS determines that there is a special need to retain a particular record or group of records for a longer period and notifies the MDPP supplier at least 30 calendar days before the normal disposition rate; or
(ii) There has been a dispute or allegation of fraud or similar fault against the MDPP supplier, in which case the records must be maintained for an additional 6 years from the date of any resulting final resolution of the dispute or allegation of fraud or similar fault, as defined at § 405.902 of this chapter.
(h)
(i)
(A) An enrollment denial under this paragraph (h)(1)(i) is considered an enrollment denial under § 424.530(a)(1).
(B) A revocation under this paragraph (h)(1)(i) is considered a revocation under § 424.535(a)(1).
(C) An MDPP supplier that does not satisfy the requirements in paragraph (b)(1) of this section may become eligible to bill for MDPP services again if it successfully achieves MDPP preliminary recognition or full CDC DPRP recognition, and successfully enrolls again in Medicare as an MDPP supplier after any applicable reenrollment bar has expired.
(ii)
(A) An enrollment denial under this paragraph (h)(1)(ii) is considered an enrollment denial under § 424.530(a)(1).
(B) A revocation under this paragraph (h)(1)(ii) is considered a revocation under § 424.535(a)(1).
(iii)
(iv)
(v)
(B) Revocation under this paragraph (h)(1)(v) is subject to the following requirements:
(
(
(
(2) An MDPP supplier may appeal an enrollment denial or revocation decision in accordance with the procedures specified in part 498 of this chapter. References to suppliers in that section apply to MDPP suppliers.
(a)
(i) The MDPP beneficiary's MDPP services period ends as described in § 410.79(c)(3) of this chapter.
(ii) The MDPP supplier knows the MDPP beneficiary will no longer be receiving MDPP services from the MDPP supplier.
(iii) The MDPP supplier has not had direct contact, either in-person, by telephone, or via other telecommunications technology, with the MDPP beneficiary for more than 90 consecutive calendar days during the MDPP services period.
(b)
(1) The item or service must be furnished directly to an MDPP beneficiary by an MDPP supplier or by an agent of the MDPP supplier, such as a coach, under the MDPP supplier's direction and control.
(2) The item or service must be reasonably connected to the CDC-approved DPP curriculum furnished to the MDPP beneficiary during a core session, core maintenance session, or ongoing maintenance session furnished by the MDPP supplier.
(3) The item or service must be a preventive care item or service or an item or service that advances a clinical goal, as specified in paragraph (d) of this section, for an MDPP beneficiary by engaging him or her in better managing his or her own health.
(4) The item or service must not be tied to the receipt of items or services outside of the MDPP services.
(5) The item or service must not be tied to the receipt of items or services from a particular provider, supplier, or coach.
(6) The availability of the item or service must not be advertised or promoted as an in-kind beneficiary
(7) The cost of the item or service must not be shifted to another Federal health care program, as defined at section 1128B(f) of the Act.
(8) The cost of the item or service must not be shifted to an MDPP beneficiary.
(c)
(1) Items or services involving technology may not, in the aggregate, exceed $1,000 in retail value for any one MDPP beneficiary.
(2) Items or services involving technology must be the minimum necessary to advance a clinical goal, as specified in paragraph (d) of this section, for an MDPP beneficiary.
(3) Items involving technology exceeding $100 in retail value must—
(i) Remain the property of the MDPP supplier; and
(ii) Be retrieved from the MDPP beneficiary at the end of the engagement incentive period. The MDPP supplier must document all retrieval attempts, including the ultimate date of retrieval, in accordance with paragraph (e)(3) of this section. Documented diligent, good faith attempts to retrieve items of technology will be deemed to meet the retrieval requirement.
(d)
(1) Attendance at core sessions, core maintenance sessions, or ongoing maintenance sessions.
(2) Weight loss.
(3) Long-term dietary change.
(4) Adherence to long-term health behavior changes.
(e)
(1) The documentation must be established contemporaneous with the furnishing of the in-kind items and services and must include at least the following:
(i) The date the item or service is furnished.
(ii) The identity of the MDPP beneficiary to whom the item or service is furnished.
(iii) The agent of the MDPP supplier that furnished the item or service, if applicable.
(iv) A description of the item or service.
(v) The retail value of the item or service.
(vi) Documentation establishing that the item or service was furnished to the MDPP beneficiary during the engagement incentive period.
(2) Documentation regarding items or services that are furnished to the MDPP beneficiary for use on an ongoing basis during the engagement incentive period, including items involving technology exceeding $100 in retail value, must also include contemporaneous documentation establishing that the MDPP beneficiary is in the engagement incentive period throughout the time period that the MDPP beneficiary possesses or has access to the item or service furnished by the MDPP supplier.
(3) The documentation regarding items involving technology exceeding $100 in retail value must also include contemporaneous documentation of any attempt to retrieve the item as required by paragraph (c)(3)(ii) of this section.
(4) The MDPP supplier must retain and provide access to the documentation required in this section in accordance with § 424.205(g).
(e)
(b) * * *
(1) * * *
(xi) Revalidating MDPP suppliers.
(c) * * *
(1) * * *
(iii) Prospective (newly enrolling) MDPP suppliers
Secs. 1102, 1106, 1871, and 1899 of the Social Security Act (42 U.S.C. 1302, 1306 1395hh, and 1395jjjj).
(1) For performance years 2012 through 2015, a physician included in an attestation by the ACO as provided under § 425.404 for services furnished in an FQHC or RHC, or a physician who has a primary care specialty designation of internal medicine, general practice, family practice, or geriatric medicine;
(2) For performance years 2016 through 2018, a physician included in an attestation by the ACO as provided under § 425.404 for services furnished in an FQHC or RHC, or a physician who has a primary care specialty designation of internal medicine, general practice, family practice, geriatric medicine, or pediatric medicine; and
(3) For performance year 2019 and subsequent years, a physician who has a primary care specialty designation of internal medicine, general practice, family practice, geriatric medicine, or pediatric medicine.
The revision reads as follows:
(b) * * *
(4) * * *
(ii) Have a written plan to:
(A) Implement an individualized care program that promotes improved outcomes for, at a minimum, the ACO's high-risk and multiple chronic condition patients.
(B) Identify additional target populations that would benefit from individualized care plans. Individualized care plans must take into account the community resources available to the individual.
(C) Encourage and promote use of enabling technologies for improving care coordination for beneficiaries. Enabling technologies may include one or more of the following:
(
(
(
(
(D) Partner with long-term and post-acute care providers, both inside and outside the ACO, to improve care coordination for its assigned beneficiaries.
The revisions read as follows:
(c) * * *
(1) As part of its application, an ACO must certify that the ACO satisfies the requirements set forth in this part. Upon request, the ACO must submit the following supporting materials to demonstrate that it satisfies the requirements set forth in this part:
(d)
(b) * * *
(2) Each ACO participant that submits claims for services used to determine the ACO's assigned population under subpart E of this part must be exclusive to one Shared Savings Program ACO. If, during a benchmark or performance year (including the 3-month claims runout for such benchmark or performance year), an ACO participant that participates in more than one ACO submits claims for services used in assignment under subpart E of this part, then:
(i) CMS will not consider any services billed through the TIN of the ACO participant when performing assignment under subpart E of this part for the benchmark or performance year.
(ii) The ACO may be subject to the pre-termination actions set forth in § 425.216, termination under § 425.218, or both.
(a) * * *
(1) * * *
(iii) In determining final assignment for a benchmark or performance year, CMS will exclude any services furnished during the benchmark or performance year that are billed through the TIN of an ACO participant that is an ACO participant in more than one ACO.
(c) Primary care services for purposes of assigning beneficiaries are identified by selected HCPCS/CPT codes, or revenue center codes.
(1) Primary care service codes are as follows:
(i) For performance years 2012 through 2015:
(A) CPT codes:
(
(
(
(B) HCPCS codes G0402 (the code for the Welcome to Medicare visit) and G0438 and G0439 (codes for the annual wellness visits).
(C) Revenue center codes 0521, 0522, 0524, and 0525 submitted by FQHCs (for services furnished prior to January 1, 2011), or by RHCs.
(ii) For performance year 2016 as follows:
(A) CPT codes:
(
(
(
(
(B) HCPCS codes:
(
(
(
(C) Revenue center codes 0521, 0522, 0524, and 0525 submitted by FQHCs (for services furnished prior to January 1, 2011), or by RHCs.
(iii) For performance years 2017 and 2018 as follows:
(A) CPT codes:
(
(
(
(
(
(B) HCPCS Codes:
(
(
(
(C) Revenue center codes 0521, 0522, 0524, and 0525 submitted by FQHCs (for services furnished prior to January 1, 2011), or by RHCs.
(iv) For performance year 2019 and subsequent performance years as follows:
(A) CPT codes:
(
(
(
(
(
(
(B) HCPCS Codes:
(
(
(
(
(
The revisions read as follows:
(a) For performance years 2012 through 2018—
(1) Such ACOs are required to identify, through an attestation, physicians who directly provide primary care services in each FQHC or RHC that is an ACO participant and/or ACO provider/supplier in the ACO.
(2) Under the assignment methodology in § 425.402, CMS treats a service reported on an FQHC/RHC claim as a primary care service—
(i) If the claim includes a HCPCS or revenue center code that meets the definition of primary care services under § 425.20;
(ii) Performed by a primary care physician if the NPI of a physician identified in the attestation provided under paragraph (a)(1) of this section is reported on the claim for a primary care service (as described in paragraph (a)(2)(i) of this section) as the attending provider; and
(iii) Performed by a non-physician ACO professional if the NPI reported on the claim for a primary care service (as described in paragraph (a)(2)(i) of this section) as the attending provider is an ACO professional but is not identified in the attestation provided under paragraph (a)(1) of this section.
(b) For performance year 2019 and subsequent performance years, under the assignment methodology in § 425.402, CMS treats a service reported on an FQHC/RHC claim as a primary care service performed by a primary care physician.
(a) * * *
(1) * * *
(ii) * * *
(A) For agreement periods beginning before 2018, this calculation considers all individually beneficiary identifiable payments, including interim payments, made under a demonstration, pilot or time limited program.
(B) For agreement periods beginning in 2018 and subsequent years, this calculation considers individually beneficiary identifiable final payments made under a demonstration, pilot or time limited program.
(C) For the 2018 performance year and subsequent performance years in agreement periods beginning in 2015, 2016 and 2017, the benchmark is adjusted to reflect only individually beneficiary identifiable final payments made under a demonstration, pilot or time limited program.
(c) * * *
(1) * * *
(ii) * * *
(A) For agreement periods beginning before 2018, considers all individually beneficiary identifiable payments, including interim payments, made under a demonstration, pilot or time limited program.
(B) For agreement periods beginning in 2018 and subsequent years, considers individually beneficiary identifiable final payments made under a demonstration, pilot or time limited program.
(C) For the 2018 and 2019 performance years in agreement periods beginning in 2017, the benchmark is adjusted to reflect only individually beneficiary identifiable final payments made under a demonstration, pilot or time limited program.
(e) * * *
(2) * * *
(ii) * * *
(A) For agreement periods beginning before 2018, considers all individually beneficiary identifiable payments, including interim payments, made under a demonstration, pilot or time limited program.
(B) For agreement periods beginning in 2018 and subsequent years, considers individually beneficiary identifiable final payments made under a demonstration, pilot or time limited program.
(C) For the 2018 and 2019 performance years in agreement periods beginning in 2017, risk adjusted county fee-for-service expenditures are adjusted to reflect only individually beneficiary identifiable final payments made under a demonstration, pilot or time limited program.
(a) * * *
(6) * * *
(ii) * * *
(A) For performance years beginning before 2018, these calculations will take into consideration all individually beneficiary identifiable payments, including interim payments, made under a demonstration, pilot or time limited program.
(B) For performance year 2018 and subsequent performance years, these calculations will take into consideration individually beneficiary identifiable final payments made under a demonstration, pilot or time limited program.
(a) * * *
(6) * * *
(ii) * * *
(A) For performance years beginning before 2018, these calculations will take into consideration all individually beneficiary identifiable payments, including interim payments, made under a demonstration, pilot or time limited program.
(B) For performance year 2018 and subsequent performance years, these calculations will take into consideration individually beneficiary identifiable final payments made under a demonstration, pilot or time limited program.
(a) * * *
(6) * * *
(ii) * * *
(A) For performance years beginning before 2018, these calculations will take into consideration all individually beneficiary identifiable payments, including interim payments, made under a demonstration, pilot or time limited program.
(B) For performance year 2018 and subsequent performance years, these calculations will take into consideration individually beneficiary identifiable final payments made under a demonstration, pilot or time limited program.
Office of Postsecondary Education, Department of Education.
Final rule.
On July 1, 2014, the HEAL Program was transferred from the U.S. Department of Health and Human Services (HHS) to the U.S. Department of Education (the Department). To reflect this transfer and to facilitate the servicing of all HEAL loans that are currently held by the Department, the Secretary adds the HEAL Program regulations to the Department's chapter in the Code of Federal Regulations (CFR).
These final regulations are effective November 15, 2017.
Ms. Vanessa Freeman, U.S. Department of Education, 400 Maryland Avenue SW., Room 6W236, Washington, DC 20202. Telephone: (202) 453-7378 or by email:
If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), you may call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.
Lenders such as banks, savings and loan associations, credit unions, pension funds, State agencies, HEAL schools, and insurance companies made HEAL loans, which were insured by the Federal Government against loss due to borrowers' death, disability, bankruptcy, and default. The purpose of the program was to ensure the availability of funds for loans to eligible students who need to borrow money to pay for their educational costs.
Authorization to fund new HEAL loans to students expired September 30, 1998. Provisions of the HEAL legislation allowing for the refinancing or consolidation of existing HEAL loans expired September 30, 2004. However, the reporting, notification, and recordkeeping burden associated with refinancing HEAL loans, servicing outstanding loans, and administering and monitoring of the HEAL Program regulations continues. On July 1, 2014, the HEAL Program was transferred from HHS to the Department. To reflect this transfer and to facilitate the servicing of HEAL loans that are currently held by the Department, the Secretary adds the HEAL Program regulations that are currently part of HHS's regulations (42 CFR part 60) to Title 34 Subpart B Chapter VI Part 681 of the CFR. Consistent with this regulatory action, HHS intends to remove the HEAL Program regulations from its regulations.
In adding the HEAL Program regulations to Title 34 of the CFR, we have made a limited number of technical changes to the regulations. It is important to note, we have removed references to the making of HEAL loans to streamline the regulations and avoid confusion, where possible. However, in many places we have retained those provisions, even though there is no authority to fund new HEAL loans, because those provisions may continue to form the basis of a claim by a lender, holder, borrower, or the Secretary relating to an outstanding HEAL loan. In addition, we note that the Consolidated Appropriations Act, 2014 provided that, in servicing, collecting, and enforcing HEAL loans, all the authorities under part B of title IV of the Federal Family Education Loan Program (FFELP program) would be available. Accordingly, we have made a number of technical changes to conform the HEAL Program servicing, collection, and enforcement regulations with those in the FFELP program regulations.
Specifically, the changes to the final regulations include:
• Revising § 681.1(c) to specifically note that administrative wage garnishment (AWG) may be used as a method of loan collection for HEAL loans, in accordance with the Consolidated Appropriations Act, 2014;
• Deleting outdated references in § 681.8(b)(3) to reflect the phaseout of the HEAL program and that no new HEAL loans have been issued since September 30, 1998;
• Revising § 681.11(f)(6) by adding a cross-reference to include title IV repayment plans available for FFELP borrowers for eligible HEAL loans, in accordance with the Consolidated Appropriations Act, 2014;
• Revising § 681.18 to reflect that HEAL loans may be consolidated in accordance with section 525 of the Consolidated Appropriations Act, 2014;
• Revising § 681.20(a) by deleting the reference to the statute of limitations on collection of HEAL loans in accordance with 42 U.S.C 292f(i);
• Revising § 681.20(d) by adding a cross-reference to update the procedures and standards to determine if a borrower is totally and permanently disabled in accordance with section 525(d) of the Consolidated Appropriations Act, 2014;
• Revising § 681.34(c) by deleting outdated information and modernizing the language to reflect current practices related to how a lender may contact HEAL loan borrowers to obtain updated information;
• Revising § 681.34(d) to reflect current practices related to skip tracing procedures for HEAL loans as outlined in § 682.411 and in accordance with section 525 of the Consolidated Appropriations Act, 2014;
• Revising § 681.35(a)(2) by deleting obsolete information related to actions a lender may take to contact a delinquent HEAL loan borrower;
• Revising § 681.35(g)(2) to reflect current practices for lenders that obtain public records electronically rather than requiring submission of paperwork from a HEAL loan borrower;
• Revising § 681.38(a)(3) by deleting obsolete information and to reflect that all HEAL loans are currently in repayment;
• Revising § 681.39(a) by adding a cross-reference to update the death discharge procedures for HEAL loan borrowers in accordance with section 525 of the Consolidated Appropriations Act, 2014;
• Revising § 681.39(b) to reference the Department's total and permanent disability discharge procedures in accordance with the Consolidated Appropriations Act, 2014;
• Updating references related to publication of HEAL loan data to reflect the Department's student aid Web site as an online resource;
• Changing references to HHS to the Department or the Department's servicer, as appropriate;
• Changing HHS OMB control numbers for information collections to the Department's control numbers; and
• Making technical changes such as updating the names of student loan servicing companies and medical associations.
We are not making any significant substantive changes to the HEAL regulations. The regulations are being transferred from HHS's regulations at 42 CFR part 60 to the Department's regulations at 34 CFR part 681 to reflect the Department's authority to administer and service outstanding HEAL loans. For more information on the substance of the regulations please see the final rule published in the
Under Executive Order 12866, the Secretary must determine whether this regulatory action is “significant” and, therefore, subject to the requirements of the Executive order and subject to review by the Office of Management and Budget (OMB). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action likely to result in a rule that may—
(1) Have an annual effect on the economy of $100 million or more, or adversely affect a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal governments or communities in a material way (also referred to as an “economically significant” rule);
(2) Create serious inconsistency or otherwise interfere with an action taken or planned by another agency;
(3) Materially alter the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or
(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles stated in the Executive order.
This regulatory action is not a significant regulatory action subject to review by OMB under section 3(f) of Executive Order 12866.
Under Executive Order 13771, for each new regulation that the Department proposes for notice and comment or otherwise promulgates that is a significant regulatory action under Executive Order 12866 and that imposes total costs greater than zero, it must identify two deregulatory actions. For FY 2017, any new incremental costs associated with a new regulation must be fully offset by the elimination of existing costs through deregulatory actions. The final regulations are not a significant regulatory action. Therefore, the requirements of Executive Order 13771 do not apply.
We have also reviewed these regulations under Executive Order 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, Executive Order 13563 requires that an agency—
(1) Propose or adopt regulations only upon a reasoned determination that their benefits justify their costs (recognizing that some benefits and costs are difficult to quantify);
(2) Tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives and taking into account—among other things and to the extent practicable—the costs of cumulative regulations;
(3) In choosing among alternative regulatory approaches, select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity);
(4) To the extent feasible, specify performance objectives, rather than the behavior or manner of compliance a regulated entity must adopt; and
(5) Identify and assess available alternatives to direct regulation, including economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or provide information that enables the public to make choices.
Executive Order 13563 also requires an agency “to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” The Office of Information and Regulatory Affairs of OMB has emphasized that these techniques may include “identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes.”
We are issuing these final regulations only on a reasoned determination that their benefits would justify their costs. In choosing among alternative regulatory approaches, we selected those approaches that would maximize net benefits. Based on the analysis that follows, the Department believes that these final regulations are consistent with the principles in Executive Order 13563.
We have also determined that this regulatory action would not unduly interfere with State, local, and Tribal governments in the exercise of their governmental functions.
In accordance with the applicable Executive orders, the Department has assessed the potential costs and benefits, both quantitative and qualitative, of this regulatory action. The final regulations are not expected to have a significant impact on Federal, State, or local government, institutions, or borrowers. The potential costs associated with this regulatory action are those resulting from statutory requirements and those we have determined are necessary for administering the Department's programs and activities. The final regulations support the Department's efforts to facilitate the servicing of student loans and consolidate Federal student loan oversight.
Elsewhere in this document under
In this Regulatory Impact Analysis we discuss the need for regulatory action; costs, benefits, and transfers; net budget impacts, assumptions, limitations, and data sources; and regulatory alternatives we considered.
Section 525 of the Consolidated Appropriations Act, 2014 establishes the need for regulatory action. This legislation authorizes, and the final regulations reflect, the transfer of the collection of HEAL loans from HHS to the Department effective July 1, 2014. As part of this transfer, the Department also received information collections from HHS required to operate the program. As of December 31, 2016, there were 22,265 HEAL loans outstanding; 11,390 unique borrowers; and a total value of $187,029,585.
The final regulations are not expected to have a significant economic impact
The final regulations reflect that, as of July 1, 2014, borrowers' loans are insured by the Department rather than HHS. The final regulations do not change borrowers' loan servicers or lenders nor do they cause any change in cost or benefit for borrowers.
These final regulations reflect that, as of July 1, 2014, in the event of borrower default, death, disability, or bankruptcy, lenders and loan holders file insurance claims with the Department, rather than HHS. The final regulations do not impact the future incidence of these events; therefore, we do not estimate any change in lenders' costs or benefits as a result of the regulations.
The final regulations do not change the lenders or borrowers for any loan servicers. Therefore, we do not estimate any change in loan servicers' costs or benefits as a result of the regulations.
All aspects of administering the HEAL Program transferred from HHS to the Department. This includes program costs the Department incurs and proceeds it receives. Therefore, we do not anticipate any additional costs or benefits to the Federal government as a result of the final regulations.
The final regulations are not expected to have a significant net budget impact. No change in costs or benefits to borrowers, lenders, or loan servicers is expected as a result of the regulations. The final regulations do reflect the change in the insurer of the HEAL loans and the department to which lenders submit insurance claims; however, these changes are transfers within the Federal government and result in no change in fiscal burden to lenders or the Federal government. Based on this, the Department estimates no significant net budget impact from the final regulations.
We considered HEAL Program data obtained from FSA to assess whether the final regulations affect the costs or benefits to borrowers, the Federal government, lenders, and loan servicers. Because we determined that the final regulations only result in transfers, we did not include the data in the Regulatory Impact Analysis.
The transfer of the HEAL Program was authorized by section 525 of the Consolidated Appropriations Act, 2014. To reflect this transfer and to facilitate the servicing of all HEAL loans that are currently held by the Department, the Secretary adds the HEAL Program regulations to Title 34 Subpart B Chapter VI Part 681 of the CFR. The final regulations reflect the program's transfer to the Department and make the other technical changes described under
Executive Order 12866 and the Presidential memorandum “Plain Language in Government Writing” require each agency to write regulations that are easy to understand.
The Secretary invites comments on how to make these regulations easier to understand, including answers to questions such as the following:
• Are the requirements in the regulations clearly stated?
• Do the regulations contain technical terms or other wording that interferes with their clarity?
• Does the format of the regulations (grouping and order of sections, use of headings, paragraphing, etc.) aid or reduce their clarity?
• Would the regulations be easier to understand if we divided them into more (but shorter) sections? (A “section” is preceded by the symbol “§ ” and a numbered heading; for example, § 681.39.)
• Could the description of the regulations in the
• What else could we do to make the regulations easier to understand?
Send any comments that concern how the Department could make these regulations easier to understand to the program contact person listed under
Under the Administrative Procedure Act (APA) (5 U.S.C. 553), the Department generally offers interested parties the opportunity to comment on proposed regulations. However, the APA provides that an agency is not required to conduct notice and comment rulemaking when the agency for good cause finds that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest. 5 U.S.C. 553(b)(B). Rulemaking is “unnecessary” when the agency is issuing a minor rule in which the public is not particularly interested. It applies in those situations in which “the administrative rule is a routine determination, insignificant in nature and impact, and inconsequential to the industry and to the public.”
There is good cause here for waiving rulemaking under the APA. Rulemaking is unnecessary because this rulemaking merely transfers the HEAL Program regulations from HHS to the Department in accordance with section 525 of the Consolidated Appropriations Act, 2014. The final regulations reflect the program's transfer to the Department and make the other technical changes described under
The APA also generally requires that regulations be published at least 30 days before their effective date, unless the agency has good cause to implement its regulations sooner (5 U.S.C. 553(d)(3)). Again, because the final regulations merely implement the statutory mandate to transfer the HEAL Program from HHS to the Department, the Secretary is also waiving the 30-day delay in the effective date of these regulatory changes under 5 U.S.C. 553(d)(3).
For the same reasons, the Secretary has determined, under section 492(b)(2) of the Higher Education Act of 1965, as amended, that these regulations should not be subject to negotiated rulemaking.
The Regulatory Flexibility Act does not apply to this rulemaking because there is good cause to waive notice and comment under 5 U.S.C. 553.
As part of its continuing effort to reduce paperwork and respondent burden, the Department provides the general public and Federal agencies with an opportunity to comment on proposed and continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)). This helps ensure that: The public understands the Department's collection instructions, respondents can provide the requested data in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are
The authorization to fund new HEAL loans to students expired September 30, 1998. Section 525 of the Consolidated Appropriations Act, 2014, transferred the servicing, collecting, and enforcing of the HEAL loans from HHS to the Department. To fulfill this mandate, the Department reviewed the regulations and approved forms and then requested and received the transfer of the pertinent OMB approved information collections from HHS to the Department. This was completed in June 2014.
Information collection 1845-0125 contains information collection requirements pertaining to the regulatory language.
This filing also identifies separate information collections under 1845-0124, 1845-0126, 1845-0127, and 1845-0128 pertaining to required forms and reporting mechanisms. Since the transfer of the necessary ICRs from HHS, the Department has renewed each of the aforementioned collections.
A Federal agency may not conduct or sponsor a collection of information unless OMB approves the collection under the PRA and the corresponding information collection instrument displays a currently valid OMB control number. Notwithstanding any other provision of law, no person is required to comply with, or is subject to penalty for failure to comply with, a collection of information if the collection instrument does not display a currently valid OMB control number.
In the final regulations, we have displayed the control numbers assigned by OMB to any information collection requirements contained in the regulations.
The language in the final regulations contains information collection requirements that have been assigned OMB Control number 1845-0125. The following figures represent revised information as of December 31, 2016, which we obtained from HOPS.
The calculations below represent updated figures since the latest renewal of the 1845-0125 collection in August, 2016, with an expiration date of August 31, 2019. The changes included here are due to an updating of the number of borrowers and loan holders but there has been no change to the regulatory language associated with this collection. We will be requesting a nonsubstantive change clearance for the updated figures.
This is a summary of the reporting, notification, and recordkeeping burden associated with the information collection in the supporting statement. The estimate for this information collection burden is based on 14 HEAL loan holders in the program; and a current cumulative total of 11,390 individuals with outstanding loans requiring a variety of servicing transactions depending on loan status,
The final regulations contain reporting, recordkeeping, and notification requirements. As each of the noted ICRs was approved by OMB prior to the transfer of HEAL Program to the Department, the table below identifies the affected party and burden assessment approved by OMB by the ICR number.
This program is subject to Executive Order 12372 and the regulations in 34 CFR part 79. One of the objectives of the Executive order is to foster an intergovernmental partnership and a strengthened federalism. The Executive order relies on processes developed by State and local governments for coordination and review of proposed Federal financial assistance.
This document provides early notification of our specific plans and actions for this program.
Based on our own review, we have determined that the final regulations do not require transmission of information that any other agency or authority of the United States gathers or makes available.
The official version of this document is the document published in the
You may also access documents of the Department published in the
Educational study programs, Health professions, Loan programs—education, Loan programs—health, Medical and dental schools, Reporting and recordkeeping requirements, Student aid.
Sec. 215, Pub. L. 78-410, 58 Stat. 690, as amended, 63 Stat. 35 (42 U.S.C. 216); secs. 727-739A, Pub. L. 78-410, 90 Stat. 2243, as amended, 93 Stat. 582, 99 Stat. 529-532, 102 Stat. 3122-3125 (42 U.S.C. 294-294
(a) The Health Education Assistance Loan (HEAL) program is a program of Federal insurance of educational loans that were made to graduate students in the fields of medicine, osteopathic medicine, dentistry, veterinary medicine, optometry, podiatric medicine, pharmacy, public health, chiropractic, health administration, and clinical psychology. The basic purpose of the program is to encourage lenders to make loans to students in these fields who desire to borrow money to pay for their educational costs. In addition, certain nonstudents (such as doctors serving as interns or residents) could borrow in order to pay the current interest charges accruing on earlier HEAL loans. By taking a HEAL loan, the borrower is obligated to repay the lender or holder the full amount of the money borrowed, plus all interest which accrues on the loan.
(b) HEAL loans were made by schools, banks, credit unions, State agencies, and other institutions eligible as lenders under § 681.30. HEAL school eligibility is described in § 681.50.
(c) The Secretary insures each lender or holder for the losses of principal and interest it may incur in the event that a borrower dies; becomes totally and permanently disabled; files for bankruptcy under chapter 11 or 13 of the Bankruptcy Act; files for bankruptcy under chapter 7 of the Bankruptcy Act and files a compliant to determine the dischargeability of the HEAL loan; or defaults on his or her loan. In these instances, if the lender or holder has complied with all HEAL statutes and regulations and with the lender's or holder's insurance contract, then the Secretary pays the amount of the loss to the lender or holder and the borrower's loan is assigned to the Secretary. Only after assignment does the Secretary become the holder of the HEAL loan and the Secretary will use all collection methods legally authorized to obtain repayment of the HEAL loan, including, but not limited to, reporting the borrower's default on the loan to consumer credit reporting agencies, certifying the debt for offset in the Treasury Offset Program (TOP), using available methods to locate the debtor, utilizing administrative wage garnishment, and referring the debt to the Department of Justice for litigation.
(d) Any person who knowingly makes a false statement or misrepresentation in a HEAL loan transaction, bribes or attempts to bribe a Federal official, fraudulently obtains a HEAL loan, or commits any other illegal action in connection with a HEAL loan is subject to possible fine and imprisonment under Federal statute.
(e) In counting the number of days allowed to comply with any provisions of these regulations, Saturdays, Sundays, and holidays are to be included. However, if a due date falls on a Saturday, Sunday, or Federal holiday, the due date is the next Federal work day.
To receive a HEAL loan, a student must satisfy the following requirements:
(a) He or she must be a citizen, national, or lawful permanent resident of the United States, permanent resident of the Trust Territory of the Pacific Islands (the Republic of Palau), the Republic of the Marshall Islands, the Federated States of Micronesia, the Commonwealth of the Northern Mariana Islands, or American Samoa, or lawful permanent resident of the Commonwealth of Puerto Rico, the Virgin Islands or Guam;
(b) He or she must be enrolled or accepted for enrollment at a HEAL school in a course of study that leads to one of the following degrees:
(1) Doctor of Medicine.
(2) Doctor of Osteopathic Medicine.
(3) Doctor of Dentistry or equivalent degree.
(4) Doctor of Veterinary Medicine or equivalent degree.
(5) Doctor of Optometry or equivalent degree.
(6) Doctor of Podiatric Medicine or equivalent degree.
(7) Bachelor or Master of Science in Pharmacy or equivalent degree.
(8) Graduate or equivalent degree in Public Health.
(9) Doctor of Chiropractic or equivalent degree.
(10) Doctoral degree in Clinical Psychology.
(11) Masters or doctoral degree in Health Administration.
(c) He or she must be carrying or plan to carry, during the period for which the loan is intended, the normal work load of a full-time student, as determined by the school. The student's work load may include any combination of courses, work experience, research or special studies that the school considers sufficient to classify the student as full time.
(d) If currently enrolled in school, he or she must be in good standing, as determined by the school.
(e)(1) In the case of a pharmacy student, he or she must have satisfactorily completed 3 years of training toward the pharmacy degree. These 3 years of training may have been taken at the pharmacy school or at a different school whose credits are accepted on transfer by the pharmacy school.
(2) The Doctor of Pharmacy degree is considered to be an equivalent degree if it is taken in a school that does not require the Bachelor or Master of Science in pharmacy as a prerequisite for the Doctor of Pharmacy degree.
(f) In the case of a medical, dental or osteopathic student enrolled in a 6-year program that the student may enter directly from secondary school, the student must be enrolled in the last 4 years of the program.
(g) He or she must agree that all funds received under the proposed loan will be used solely for tuition, other reasonable educational expenses, including fees, books, supplies and equipment, and laboratory expenses, reasonable living expenses, reasonable transportation costs (only to the extent that they are directly related to the borrower's education), and the HEAL insurance premium.
(h) He or she must require the loan to pursue the course of study at the school. This determination of the maximum amount of the loan will be made by the school, applying the considerations in § 681.51(f).
(i) If required under section 3 of the Military Selective Service Act to present himself for and submit to registration under such section, he must have presented himself and submitted to registration under such section.
To receive a HEAL loan, a person who is not a student must satisfy all of the following requirements:
(a) He or she must have received a HEAL loan prior to August 13, 1981, for which he or she is required to make payments of interest, but not principal, during the period for which the new loan is intended. This may be the grace period or a period of internship, residency, or deferment.
(b) He or she must continue to meet the citizenship, nationality, or residency qualifications required of student borrowers.
(c) He or she must agree that all funds received under the proposed loan will be used solely for payment of currently accruing interest on HEAL loans and the HEAL insurance premium.
(d) If required under section 3 of the Military Selective Service Act to present himself for and submit to registration under such section, he must have
(a)(1)(i) A student seeking a HEAL loan applies to a participating lender for a HEAL loan by submitting an application form supplied by the school.
(ii) The applicant must fill out the applicant sections of the form completely and accurately.
(2) The student applicant must have been informed of the Federal debt collection policies and procedures in accordance with the Health and Human Services (HHS) Claims Collection Regulation (45 CFR part 30) prior to the student receiving the loan. The applicant must sign a certification statement attesting that the applicant has been notified of the actions the Federal Government can take in the event that the applicant fails to meet the scheduled payments. This signed statement must be maintained by the school and the lender or holder as part of the borrower's official record.
(3) A student applicant must have his or her school complete a portion of the application providing information relating to:
(i) The applicant's eligibility for the loan;
(ii) The cost of his or her education; and
(iii) The total financial resources that are actually available to the applicant for his or her costs of education for the period covered by the proposed HEAL loan, as determined in accordance with § 681.51(f), and other student aid that the applicant has received or will receive for the period covered by the proposed HEAL loan.
(4) The student applicant must certify on the application that the information provided reflects the applicant's total financial resources actually available for his or her costs of education for the period covered by the proposed HEAL loan and the applicant's total indebtedness, and that the applicant has no other financial resources that are available to the applicant or that the applicant will receive for the period covered by the proposed HEAL loan.
(5) A student applicant must certify on the application that if required under section 3 of the Military Selective Service Act to present himself for and submit to registration under such section, he has presented himself and submitted to registration under such section.
(b) The applicant pursuing a full-time course of study at an institution of higher education that is a “participating school” in the Guaranteed Student Loan Program but is not pursuing a course of study listed in § 681.5(b), applies for a HEAL loan as a nonstudent under paragraph (c) of this section.
(c)(1)(i) A nonstudent seeking a HEAL loan applies to a participating lender for a HEAL loan by submitting an application form supplied by the lender.
(ii) The applicant must fill out the applicant sections of the form completely and accurately.
(2) The nonstudent applicant must have been informed of the Federal debt collection policies and procedures in accordance with HHS' Claims Collection Regulation (45 CFR part 30) prior to the nonstudent receiving the loan. The applicant must sign a certification statement attesting that the applicant has been notified of the actions the Federal Government can take in the event that the applicant fails to meet the scheduled payments. This signed statement will be maintained by the lender or holder as part of the borrower's official record.
(3) A nonstudent applicant must have his or her employer or institution, whichever is relevant, certify on the application that the applicant is:
(i) Enrolled as a full-time student in an eligible school, as described in § 681.12;
(ii) A participant in an accredited internship or residency program, as described in § 681.11(a);
(iii) A member of the Armed Forces of the United States;
(iv) A Peace Corps volunteer;
(v) A member of the National Health Service Corps; or
(vi) A full-time VISTA volunteer under Title I of the Domestic Volunteer Service Act of 1973.
(4) The nonstudent applicant seeking a HEAL loan during the grace period applies to the lender directly.
(5) A nonstudent applicant must certify on the application that if required under section 3 of the Military Selective Service Act to present himself for and submit to registration under such section, he has presented himself and submitted to registration under such section.
(6) The nonstudent applicant must have certified on the application that the information provided reflects the applicant's total financial resources and indebtedness. (Approved by the Office of Management and Budget under control numbers 0915-0038 and 1845-0125).
(a)
(2) The lender must provide the borrower with a copy of the completed promissory note when the loan is made. The lender or holder must return the original note to the borrower when the loan is paid in full.
(3) A lender must disburse HEAL loan proceeds as described in § 681.33(f).
(4) The lender or holder must provide the borrower with a copy of the repayment schedule before repayment begins.
(5) If the loan is sold from one lender or holder to another lender or holder, or if the loan is serviced by a party other than the lender or holder, the buyer must notify the borrower within 30 days of the transaction.
(6) The borrower does not have to begin repayment until 9 full months after leaving school or an accredited internship or residency program as described in § 681.11.
(7) The borrower is entitled to deferment from repayment of the principal and interest installments during periods described in § 681.12.
(8) The borrower may prepay the whole or any portion of the loan at any time without penalty.
(9) The lender or holder must allow the borrower to repay a HEAL loan according to a graduated repayment schedule.
(10) The borrower's total loan obligation is cancelled in the event of death or total and permanent disability.
(11) To assist the borrower in avoiding default, the lender or holder may grant the borrower forbearance. Forbearance, including circumstances in which the lender or holder must grant forbearance, is more fully described in § 681.37.
(12) Any borrower who received a fixed interest rate HEAL loan in excess of 12 percent per year could have entered into an agreement with the lender which made this loan for the reissuance of the loan in accordance with section 739A of the Public Health Service Act (the Act).
(b)
(2) The borrower must pay all interest charges on the loan as required by the lender or holder.
(3) The borrower must immediately notify the lender or holder in writing in the event of:
(i) Change of address;
(ii) Change of name; or
(iii) Change of status that authorizes deferment.
(4) The borrower must repay the loan in accordance with the repayment schedule.
(5) A borrower may not have a HEAL loan discharged in bankruptcy during the first 5 years of the repayment period. This prohibition against the discharge of a HEAL loan applies to bankruptcy under
(6) If the borrower fails to make payments on the loan on time, the total amount to be repaid by the borrower may be increased by additional interest, late charges, attorney's fees, court costs, and other collection charges. In addition, the Secretary may offset amounts attributable to an unpaid loan from reimbursements or payment for health services provided under any Federal law to a defaulted borrower practicing his or her profession.
(a)
(1) A student enrolled in a school of medicine, osteopathic medicine, dentistry, veterinary medicine, optometry or podiatric medicine may borrow up to $80,000 under this part. The amount received may not exceed $20,000 in any academic year.
(2) A student enrolled in a school of public health, pharmacy, or chiropractic, or a graduate program in health administration, clinical psychology, or allied health, may borrow up to $50,000 under this part. The amount received may not exceed $12,500 per academic year.
(3) For purposes of this paragraph, an academic year means the traditional approximately 9-month September-to-June annual session. For the purpose of computing academic year equivalents for students who, during a 12-month period, attend for a longer period than the traditional academic year, the academic year will be considered to be 9 months in length.
(4) The student's estimated cost of attendance shall not exceed the estimated cost of attendance of all students in like circumstances pursuing a similar curriculum at that school.
(b)
(1) In no case may an eligible nonstudent borrower receive a loan that is greater than the sum of the HEAL insurance premium plus the interest that is expected to accrue and must be paid on the borrower's HEAL loans during the period for which the new loan is intended.
(2) An eligible nonstudent in the field of medicine, osteopathic medicine, dentistry, veterinary medicine, optometry, or podiatric medicine may borrow up to $80,000 under this part including loans obtained while the borrower was a student. The loan amount may not exceed $20,000 in any 12-month period.
(3) An eligible nonstudent in the field of pharmacy, public health, chiropractic, health administration, or clinical psychology may borrow up to $50,000 under this part including loans obtained while the borrower was a student. The loan amount received under this part may not exceed $12,500 in any 12-month period.
(a)
(i)
(ii)
(iii)
(2) An accredited internship or residency program must be approved by one of the following accrediting agencies:
(i) Accreditation Council for Graduate Medical Education.
(ii) Council on Optometric Education.
(iii) Commission on Accreditation of Dental and Dental Auxiliary Programs.
(iv) American Osteopathic Association.
(v) Council on Podiatry Education.
(vi) American Council on Pharmaceutical Education.
(vii) Council on Education for Public Health.
(viii) American College of Veterinary Surgeons.
(ix) Council on Chiropractic Education.
(b)
(1) For a HEAL borrower who received any HEAL loan prior to October 22, 1985, periods of deferment (as described in § 681.12) are not included when calculating the 10 to 25 or 33 year limitations.
(2) For a borrower who receives his or her first HEAL loan on or after October 22, 1985, periods of deferment (as described in § 681.12) are included when calculating the 33 year limitation, but are not included when calculating the 10 to 25 year limitation.
(c)
(d)
(e)
(f)
(2) The purpose of a supplemental repayment agreement is to permit a lender or holder, at its option, to offer a borrower a repayment schedule based on other than equal or graduated payments. (For example, a supplemental repayment agreement may base the amount of the borrower's payments on his or her income.)
(3) The supplemental schedule must contain terms which, according to the Secretary, do not unduly burden the borrower and do not extend the Secretary's insurance liability beyond the number of years specified in paragraph (b) of this section. The supplemental schedule must be approved by the Secretary prior to the start of repayment.
(4) The lender or holder may establish a supplemental repayment agreement over the borrower's objection only if the borrower's written consent to enter into a supplemental agreement was obtained by the lender at the time the loan was made.
(5) A lender or holder may assign a loan subject to a supplemental repayment agreement only if it specifically notifies the buyer of the terms of the supplemental agreement. In such cases, the loan and the supplemental agreement must be assigned together.
(6) As authorized by section 525 of the Consolidated Appropriations Act, 2014, any repayment plan available under part B of title IV of the HEA (the Federal Family Education Loan Program (FFELP)) is available for servicing, collecting, or enforcing HEAL loans. Such repayment plans are set forth in 34 CFR part 682, and in particular in §§ 682.102, 682.209, and 682.215.
(a) After the repayment period has commenced, installments of principal and interest need not be paid during any period:
(1) During which the borrower is pursuing a full-time course of study at a HEAL school or at an institution of higher education that is a “participating school” in the William D. Ford Federal Direct Loan Program;
(2) Up to 4 years during which the borrower is a participant in an accredited internship or residency program, as described in § 681.11(a)(2). For a borrower who receives his or her first HEAL loan on or after October 22, 1985, this total of 4 years for an internship or residency program includes any period of postponement of the repayment period, as described in § 681.11(a)(1);
(3) Up to 3 years during which the borrower is a member of the Armed Forces of the United States;
(4) Up to 3 years during which the borrower is in service as a volunteer under the Peace Corps Act;
(5) Up to 3 years during which the borrower is a member of the National Health Service Corps; or
(6) Up to 3 years during which the borrower is a full-time volunteer under title I of the Domestic Volunteer Service Act of 1973.
(b) For any HEAL loan received on or after October 22, 1985, after the repayment period has commenced, installments of principal and interest need not be paid during any period for up to 2 years during which the borrower is a participant in:
(1) A fellowship training program, which:
(i) Is directly related to the discipline for which the borrower received the HEAL loan;
(ii) Begins within 12 months after the borrower ceases to be a participant in an accredited internship or residency program, as described in § 681.11(a)(2), or prior to the completion of the borrower's participation in such program;
(iii) Is a full-time activity in research or research training or health care policy;
(iv) Is not a part of, an extension of, or associated with an internship or residency program, as described in § 681.11(a)(2);
(v) Pays no stipend or one which is not more than the annual stipend level established by the Public Health Service for the payment of uniform levels of financial support for trainees receiving graduate and professional training under Public Health Service grants, as in effect at the time the borrower requests the deferment; and
(vi) Is a formally established fellowship program which was not created for a specific individual; or
(2) A full-time educational activity at an institution defined by section 435(b) of the HEA which:
(i) Is directly related to the discipline for which the borrower received the HEAL loan;
(ii) Begins within 12 months after the borrower ceases to be a participant in an accredited internship or residency program, as described in § 681.11(a)(2), or prior to the completion of the borrower's participation in such program;
(iii) Is not a part of, an extension of, or associated with an internship or residency program, as described in § 681.11(a)(2); and
(iv) Is required for licensure, registration, or certification in the State in which the borrower intends to practice the discipline for which the borrower received the HEAL loan.
(c)(1) To receive a deferment, including a deferral of the onset of the repayment period (see § 681.11(a)), a borrower must at least 30 days prior to, but not more than 60 days prior to, the onset of the activity and annually thereafter, submit to the lender or holder evidence of his or her status in the deferment activity and evidence that verifies deferment eligibility of the activity (with the full expectation that the borrower will begin the activity). It is the responsibility of the borrower to provide the lender or holder with all required information or other information regarding the requested deferment. If written evidence that verifies eligibility of the activity and the borrower for the deferment, including a certification from an authorized official (
(2) For those activities described in paragraphs (b)(1) or (b)(2) of this section, the borrower may request that the Secretary review a decision by the lender or holder denying the deferment by sending to the Secretary copies of the application for deferment and the lender's or holder's denial of the request. However, if information submitted to the lender or holder conflicts with other information available to the lender or holder, to indicate that the borrower fails to meet the requirements for deferment, the borrower may not request a review until such conflicts have been resolved. During the review process, the lender or holder must comply with any requests for information made by the Secretary. If the Secretary determines that the fellowship or educational activity is eligible for deferment and so notifies the lender or holder, the lender or holder must approve the deferment.
(a)
(1) For all loans made on or after October 22, 1985, for each calendar quarter, the Secretary determines the maximum annual HEAL interest rate by determining the average of the bond equivalent rates reported for the 91-day U.S. Treasury bills auctioned for the preceding calendar quarter, adding 3 percentage points, and rounding that amount to the next higher one-eighth of 1 percent.
(2) Interest that is calculated on a fixed rate basis is determined for the life of the loan during the calendar quarter in which the loan is executed. It may not exceed the rate determined for that quarter by the Secretary under paragraph (a)(1) of this section.
(3) Interest that is calculated on a variable rate basis varies every calendar quarter throughout the life of the loan as the market price of U.S. Treasury bills changes. For any quarter it may not exceed the rate determined by the Secretary under paragraph (a)(1) of this section.
(4) The Secretary announces the rate determined under paragraph (a)(1) of this section on a quarterly basis through a notice published on the Department's student aid Web site at
(b)
(c)
(d)
(a)
(2) The lender may charge the borrower an amount equal to the cost of the insurance premium. The cost of the insurance premium may be charged to the borrower by the lender in the form of a one-time special charge with no subsequent adjustments required. The lender may bill the borrower separately for the insurance premium or may deduct an amount attributable to it from the loan proceeds before the loan is disbursed. In either case, the lender must clearly identify to the borrower the amount of the insurance premium and the method of calculation.
(3) If the lender does not pay the insurance premium on or before 30 days after disbursement of the loan, a late fee will be charged on a daily basis at the same rate as the interest rate that the lender charges for the HEAL loan for which the insurance premium is past due. The lender may not pass on this late fee to the borrower.
(4) HEAL insurance coverage ceases to be effective if the insurance premium is not paid within 60 days of the disbursement of the loan.
(5) Except in cases of error, premiums are not refundable by the Secretary, and need not be refunded by the lender to the borrower, even if the borrower graduates or withdraws from the school, defaults, dies or becomes totally and permanently disabled.
(b)
(c)
(2)
(3)
(a)
(b)
(c)
Neither a lender nor a school may obtain a borrower's power of attorney or other authorization to endorse a disbursement check on behalf of a borrower. The borrower must personally endorse the check and may not authorize anyone else to endorse it on his or her behalf.
(a) A HEAL loan must be made without security.
(b) With one exception, it must also be made without endorsement. If a borrower is a minor and cannot under State law create a legally binding obligation by his or her own signature, a lender may require an endorsement by another person on the borrower's HEAL note. For purposes of this paragraph, an “endorsement” means a signature of anyone other than the borrower who is to assume either primary or secondary liability on the note.
HEAL loans may be consolidated as permitted in 34 CFR 685.220.
All HEAL forms are approved by the Secretary and may not be changed without prior approval by the Secretary. HEAL forms shall not be signed in blank by a borrower, a school, a lender or holder, or an agent of any of these. The Secretary may prescribe who must complete the forms, and when and to whom the forms must be sent. All HEAL forms must contain a statement that any person who knowingly makes a false statement or misrepresentation in a HEAL loan transaction, bribes or attempts to bribe a Federal official, fraudulently obtains a HEAL loan, or commits any other illegal action in connection with a HEAL loan is subject to possible fine and imprisonment under Federal statute.
After paying a default claim on a HEAL loan, the Secretary attempts to collect from the borrower and any valid endorser in accordance with the Federal Claims Collection Standards (4 CFR parts 101 through 105), the Office of Management and Budget Circular A-129, issued January 2013, and the Department's Claims Collection Regulation (34 CFR parts 30, 31, and 34). The Secretary attempts collection of all unpaid principal, interest, penalties, administrative costs, and other charges or fees, except in the following situations:
(a)
(b)
(c)
(d)
(a)
(b)
(2) When a lender receives a school refund check for a loan it no longer holds, the lender must transfer that payment to the holder of the loan and either inform the borrower about the refund check and where it was sent or, if the borrower's address is unknown, notify the current holder that the borrower was not informed. The current holder must provide the borrower with a written notice of the refund payment.
(a) A HEAL lender may hold loans under the HEAL program.
(b) The following types of organizations were eligible to apply to the Secretary to be HEAL lenders:
(1) A financial or credit institution (including a bank, savings and loan association, credit union, or insurance company) which is subject to examination and supervision in its capacity as a lender by an agency of the United States or of the State in which it has its principal place of business;
(2) A pension fund approved by the Secretary;
(3) An agency or instrumentality of a State; and
(4) A private nonprofit entity, designated by the State, regulated by the State, and approved by the Secretary.
(c) The following types of organizations are eligible to apply to the Secretary to be HEAL holders:
(1) Public entities in the business of purchasing student loans;
(2) Navient (formerly known as the Student Loan Marketing Association, or “Sallie Mae”); and
(3) Other eligible lenders.
(d) HEAL holders must comply with any provisions in the regulations required of HEAL lenders including, but not limited to, provisions regarding applications, contracts, and due diligence.
(a) In order to be a HEAL lender or holder, an eligible organization must submit an application to the Secretary annually.
(b) In determining whether to enter into an insurance contract with an applicant and what the terms of that contract should be, the Secretary may consider the following criteria:
(1) Whether the applicant is capable of complying with the requirements in the HEAL regulations applicable to lenders and holders;
(2) The amount and rate of loans which are currently delinquent or in default, if the applicant has had prior experience with similar Federal or State student loan programs; and
(3) The financial resources of the applicant.
(c) The applicant must develop and follow written procedures for servicing and collecting HEAL loans. These procedures must be reviewed during the biennial audit required by § 681.42(d). If the applicant uses procedures more stringent than those required by §§ 681.34 and 681.35 for its other loans of comparable dollar value, on which it has no Federal, State, or other third party guarantee, it must include those more stringent procedures in its written procedures for servicing and collecting its HEAL loans.
(d) The applicant must submit sufficient materials with his or her application to enable the Secretary to fairly evaluate the application in accordance with these criteria.
(a)(1) If the Secretary approves an application to be a HEAL lender or holder, the Secretary and the lender or holder must sign an insurance contract. Under this contract, the lender or holder agrees to comply with all the laws, regulations, and other requirements applicable to its participation in the HEAL program and the Secretary agrees to insure each eligible HEAL loan held by the lender or holder against the borrower's default, death, total and permanent disability, bankruptcy under chapter 11 or 13 of the Bankruptcy Act, or bankruptcy under chapter 7 of the Bankruptcy Act when the borrower files a complaint to determine the dischargeability of the HEAL loan. The Secretary's insurance covers 100 percent of the lender's or holder's losses on both unpaid principal and interest, except to the extent that a borrower may have a defense on the loan other than infancy.
(2) HEAL insurance, however, is not unconditional. The Secretary issues HEAL insurance on the implied representations of the lender that all the requirements for the initial insurability of the loan have been met. HEAL insurance is further conditioned upon compliance by the holder of the loan with the HEAL statute and regulations, the lender's or holder's insurance contract, and its own loan management procedures set forth in writing pursuant to § 681.31(c). The contract may contain a limit on the duration of the contract and the number or amount of HEAL loans a lender may make or hold. Each HEAL lender has either a standard insurance contract or a comprehensive insurance contract with the Secretary, as described below.
(b)
(c)(1)
(2) The Secretary will revoke the comprehensive contract of any lender who utilizes procedures which are inconsistent with the HEAL statute and regulations, the lender's insurance contract, or its own loan management procedures set forth in writing pursuant to § 681.31(c), and require that such lenders disburse HEAL loans only under a standard contract. When the Secretary determines that the lender is in compliance with the HEAL statute and regulations and its own loan management procedures set forth in writing pursuant to § 681.31(c), the lender may reapply for a comprehensive contract.
(3) In providing comprehensive contracts, the Secretary shall give priority to eligible lenders that:
(i) Make loans to students at interest rates below the rates prevailing during the period involved; or
(ii) Make loans under terms that are otherwise favorable to the student relative to the terms under which eligible lenders are generally making loans during the period involved.
The loan-making process includes the processing of necessary forms, the approval of a borrower for a loan, determination of a borrower's creditworthiness, the determination of the loan amount (not to exceed the amount approved by the school), the explanation to a borrower of his or her responsibilities under the loan, the execution of the promissory note, and the disbursement of the loan proceeds. A lender may rely in good faith upon statements of an applicant and the HEAL school contained in the loan application papers, except where those statements are in conflict with information obtained from the report on the applicant's credit history, or other information available to the lender. Except where the statements are in conflict with information obtained from the applicant's credit history or other information available to the lender, a lender making loans to nonstudent borrowers may rely in good faith upon statements by the borrower and authorizing officials of internship, residency, or other programs for which a borrower may receive a deferment.
(a)
(b)
(c)
(1) A report of the applicant's credit history obtained from an appropriate consumer credit reporting agency, which must be used in making the determinations required by paragraph (c) of this section; and
(2) For student applicants only, the certification made by the applicant's school under § 681.51(e).
(d)
(e)
(2) The lender must explain to the borrower that the loan must be repaid and that the loan proceeds may be applied toward educational expenses only.
(f)
(i) To a student borrower, by means of a check or draft payable jointly to the student borrower and the HEAL school. Except where a lender is also a school, a lender must mail the check or draft to the school. A lender may not disburse the loan proceeds earlier than is reasonably necessary to meet the cost of education for the period for which the loan is made.
(ii) To a nonstudent borrower, by means of a check or draft payable to the borrower. However, when a previous loan is held by a different lender, the current lender must make the HEAL loan disbursement check or draft payable jointly to the borrower and the holder of the previous HEAL loan for which interest is payable.
(2) Effective July 1, 1987, a lender must disburse the HEAL loan proceeds in two or more installments unless the loan is intended to cover a period of no more than one-half an academic year. The amount disbursed at one time must correspond to the borrower's educational expenses for the period for which the disbursement is made, and must be indicated by the school on the borrower's application. If the loan is intended for more than one-half an academic year, the school must indicate on the borrower's application both the approximate dates of disbursement and the amount the borrower will need on each such date. In no case may the lender disburse the proceeds earlier than is reasonably necessary to meet the costs of education for the period for which the disbursement or the loan is made.
(g) If the lender determines that the applicant is not creditworthy, pursuant to paragraph (c) of this section, the lender must not approve the HEAL loan request. If the applicant is a student, the lender must notify the applicant and the applicant's school named on the application form of the denial of a HEAL loan, stating the reason for the denial.
(h) The lender must report a borrower's HEAL indebtedness to one or more national credit bureaus within 120 days of the date the final disbursement on the loan is made.
HEAL loan account servicing involves the proper maintenance of records, and the proper review and management of accounts. Generally accepted account servicing standards ensure that collections are received and accounted for, delinquent accounts are identified promptly, and reports are produced comparing actual results to previously established objectives.
(a)
(b)
(2) Terms of repayment are established in a written schedule that is made a part of, and subject to the terms of, the borrower's original HEAL note.
(3) The lender or holder may not surrender the original promissory note to the borrower until the loan is paid in full. At that time, the lender or holder must give the borrower the original promissory note.
(c)
(d)
A lender or holder must exercise due diligence in the collection of a HEAL loan with respect to both a borrower and any endorser. In order to exercise due diligence, a lender or holder must implement the following procedures when a borrower fails to honor his or her payment obligations:
(a) When a borrower is delinquent in making a payment, the lender or holder
(b) When a borrower is 90 days delinquent in making a payment, the lender or holder must immediately request preclaim assistance from the Department's servicer. The Secretary does not pay a default claim if the lender or holder fails to request preclaim assistance.
(c) Prior to the filing of a default claim, a lender or holder must use, at a minimum, collection practices that are at least as extensive and effective as those used by the lender or holder in the collection of its other loans. These practices must include, but need not be limited to:
(1) Using collection agents, which may include its own collection department or other internal collection agents;
(2) Immediately notifying an appropriate consumer credit reporting agency regarding accounts overdue by more than 60 days; and
(3) Commencing and prosecuting an action for default unless:
(i) In the determination of the Secretary that:
(A) The lender or holder has made reasonable efforts to serve process on the borrower involved and has been unsuccessful in these efforts; or
(B) Prosecution of such an action would be fruitless because of the financial or other circumstances of the borrower;
(ii) For loans made before November 4, 1988, the loan involved was made in an amount of less than $5,000; or
(iii) For loans made on or after November 4, 1988, the loan involved was made in an amount of less than $2,500.
(d) If the Secretary's preclaim assistance locates the borrower, the lender or holder must implement the loan collection procedures described in this section. When the Secretary's preclaim assistance is unable to locate the borrower, a default claim may be filed by the lender as described in § 681.40. The Secretary does not pay a default claim if the lender or holder has not complied with the HEAL statute and regulations or the lender's or holder's insurance contract.
(e) If a lender or holder does not sue the borrower, it must send a final demand letter to the borrower and any endorser at least 30 days before a default claim is filed.
(f) If a lender or holder sues a defaulted borrower or endorser, it may first apply the proceeds of any judgment against its reasonable attorney's fees and court costs, whether or not the judgment provides for these fees and costs.
(g)
(i) For any loan for which the lender or holder had not begun to litigate against the borrower prior to the imposition of the automatic stay, the period of the automatic stay is to be considered as an extended forbearance authorized by the Secretary, in addition to the 2-year period of forbearance which lenders and holders are authorized to grant without prior approval from the Secretary. Only periods of delinquency following the date of receipt (as documented by a date stamp) of the discharge of debtor notice (or other written notification from the court or the borrower's attorney of the end of the automatic stay imposed by the Bankruptcy Court) can be included in determining default, as described in § 681.40(c)(1)(i). The lender or holder must attempt to reestablish repayment terms with the borrower in writing no more than 30 days after receipt of the discharge of debtor notice (or other written notification from the court or the borrower's attorney of the end of the automatic stay imposed by the Bankruptcy Court), in accordance with the procedures followed at the end of a forbearance period. If the borrower fails to make a payment as scheduled, the lender or holder must attempt to obtain repayment through written and telephone contacts in accordance with the intervals established in paragraph (a)(1) of this section, and must perform the other HEAL loan collection activities required in this section, before filing a default claim.
(ii) For any loan for which the lender or holder had begun to litigate against the borrower prior to the imposition of the automatic stay, the lender or holder must, upon written notification from the court or the borrower's attorney that the bankruptcy proceedings have been completed, either resume litigation or treat the loan in accordance with paragraph (g)(1)(i) of this section.
(2) If the lender or holder has not received written notification of discharge within 12 months of the date that the borrower filed for bankruptcy, the lender or holder must contact the court and the borrower's attorney (if known) within 30 days to determine if the bankruptcy proceedings have been completed. If no response is received within 30 days of the date of these contacts, the lender or holder must resume its collection efforts, in accordance with paragraph (g)(1) of this section. If a written response from the court or the borrower's attorney indicates that the bankruptcy proceedings are still underway, the lender or holder is not to pursue further collection efforts until receipt of written notice of discharge, except that follow-up in accordance with this paragraph must be done at least once every 12 months until the bankruptcy proceedings have been completed. A lender or holder may utilize PACER (Public Access to Court Electronic Records) in place of contact with the court and/or borrower's attorney.
(3) If, despite the lender or holder's compliance with required procedures, a loan subject to the requirements of paragraph (g)(1) of this section is discharged, the lender or holder must file a claim with the Secretary within 10 days of the initial date of receipt (as documented by a date stamp) of written notification of the discharge from the court or the borrower's attorney, in accordance with the procedures set forth in § 681.40(c)(4). The lender or holder also must file with the bankruptcy court an objection to the discharge of the HEAL loan, and must
The delegation of functions to a servicing agency or other party does not relieve a lender or holder of its responsibilities under the HEAL program.
(a)
(1) Except as provided in paragraph (a)(2) of this section, a lender or holder must grant forbearance whenever the borrower is temporarily unable to make scheduled payments on a HEAL loan and the borrower continues to repay the loan in an amount commensurate with his or her ability to repay the loan. Any circumstance which affects the borrower's ability to repay the loan must be fully documented.
(2) If the lender or holder determines that the default of the borrower is inevitable and that forbearance will be ineffective in preventing default, the lender or holder may submit a claim to the Secretary rather than grant forbearance. If the Secretary is not in agreement with the determination of the lender or holder, the claim will be returned to the lender or holder as disapproved and forbearance must be granted.
(b) A lender or holder must exercise forbearance in accordance with terms that are consistent with the 25- and 33-year limitations on the length of repayment (described in § 681.11) if the lender or holder and borrower agree in writing to the new terms. Each forbearance period may not exceed 6 months.
(c) A lender or holder may also exercise forbearance for periods of up to 6 months in accordance with terms that are inconsistent with the minimum annual payment requirement if the lender or holder complies with the requirements listed in paragraphs (c)(1) through (4) of this section. Subsequent renewals of the forbearance must also be documented in accordance with the following requirements:
(1) The lender or holder must reasonably believe that the borrower intends to repay the loan but is currently unable to make payments in accordance with the terms of the loan note. The lender or holder must state the basis for its belief in writing and maintain that statement in its loan file on that borrower.
(2) Both the borrower and an authorized official of the lender or holder must sign a written agreement of forbearance.
(3) If the agreement between the borrower and lender or holder provides for forbearance of all payments, the lender or holder must contact the borrower at least every 3 months during the period of forbearance in order to remind the borrower of the outstanding obligation to repay.
(4) The total period of forbearance (with or without interruption) granted by the lender or holder to any borrower must not exceed 2 years. However, when the borrower and the lender or holder believe that there are bona fide reasons why this period should be extended, the lender or holder may request a reasonable extension beyond the 2-year period from the Secretary. This request must document the reasons why the extension should be granted. The lender or holder may grant the extension for the approved time period if the Secretary approves the extension request.
A HEAL note may not be assigned except to another HEAL lender or organization as specified in § 681.30 and except as provided in § 681.40. In this section “seller” means any kind of assignor and “buyer” means any kind of assignee.
(a)
(1) The Secretary; and
(2) The borrower. The notice to the borrower must contain a clear statement of all the borrower's rights and responsibilities which arise from the assignment of the loan, including a statement regarding the consequences of making payments to the seller subsequent to receipt of the notice.
(b)
(c)
(d)
(a)
(b)
(a) A lender or holder must file an insurance claim on a form approved by the Secretary. The lender or holder must attach to the claim all documentation necessary to litigate a default, including any documents required to be submitted by the Federal Claims Collection Standards, and which the Secretary may require. Failure to submit the required documentation and to comply with the HEAL statute and regulations or the lender's or holder's insurance contract will result in a claim not being honored. The Secretary may deny a claim that is not filed within the period specified in this section. The Secretary requires for all claims at least the following documentation:
(1) The original promissory note;
(2) An assignment to the United States of America of all right, title, and interest of the lender or holder in the note;
(3) The loan application;
(4) The history of the loan activities from the date of loan disbursement through the date of claim, including any payments made; and
(5) A Borrower Status Form (HEAL-508), documenting each deferment granted under § 681.12 or a written statement from an appropriate official stating that the borrower was engaged in an activity for which he or she was entitled to receive a deferment at the time the deferment was granted.
(b) The Secretary's payment of a claim is contingent upon receipt of all required documentation and an assignment to the United States of America of all right, title, and interest of the lender or holder in the note underlying the claim. The lender or holder must warrant that the loan is eligible for HEAL insurance.
(c) In addition, the lender or holder must comply with the following requirements for the filing of default, death, disability, and bankruptcy claims:
(1)
(i) If a lender or holder determines that it is not appropriate to commence and prosecute an action against a default borrower pursuant to § 681.35(c)(3), it must file a default claim with the Secretary within 30 days after a loan has been determined to be in default.
(ii) If a lender files suit against a defaulted borrower and does not pursue collection of the judgment obtained as a result of the suit, it must file a default claim with the Secretary within 60 days of the date of issuance of the judgment. If a lender or holder files suit against a defaulted borrower, and pursues collection of the judgment obtained as a result of the suit, these collection activities must begin within 60 days of the date of issuance of the judgment. If the lender or holder is unable to collect the full amount of principal and interest owed, a claim must be filed within 30 days of completion of the post-judgment collection activities. In either case, the lender or holder must assign the judgment to the Secretary as part of the default claim.
(iii) In addition to the documentation required for all claims, the lender or holder must submit with its default claim at least the following:
(A) Repayment schedule(s);
(B) A collection history, if any;
(C) A final demand letter;
(D) The original or a copy of all correspondence relevant to the HEAL loan to or from the borrower (whether received by the original lender, a subsequent holder, or an independent servicing agent);
(E) A claims collection litigation report; and
(F) If the defaulted borrower filed for bankruptcy under chapter 7 of the Bankruptcy Act and did not file a complaint to determine the dischargeability of the loan, all documents sent to or received from the bankruptcy court, including evidence which shows the period of the bankruptcy proceedings.
(iv) If a lender or holder files a default claim on a loan and subsequently receives written notice from the court or the borrower's attorney that the borrower has filed for bankruptcy under chapter 11 or 13 of the Bankruptcy Act, or under chapter 7 with a complaint to determine the dischargeability of the loan, the lender or holder must file that notice with the Secretary within 10 days of the lender or holder's initial date of receipt, as documented by a date stamp. If the borrower is declaring bankruptcy under chapter 7 of the Bankruptcy Act, and has not filed a complaint to determine the dischargeability of the loan, the lender or holder must file the written notice with the Secretary within 30 days of the lender's or holder's initial date of receipt, as documented by a date stamp. If the Secretary has not paid the claim at the time the lender or holder receives that notice, upon receipt of the notice, the lender or holder must file with the bankruptcy court a proof of claim, if applicable, and an objection to the discharge or compromise of the HEAL loan. If the Secretary has paid the claim, the lender or holder must file a statement with the court notifying it that the loan is owned by the Secretary.
(2)
(3)
(4)
(i) Repayment schedule(s);
(ii) A collection history, if any;
(iii) A proof of claim, where applicable;
(iv) An assignment to the United States of America of its proof of claim, where applicable;
(v) All pertinent documents sent to or received from the bankruptcy court;
(vi) A statement of any facts of which the lender is aware that may form the basis for an objection to the bankrupt's discharge or an exception to the discharge;
(vii) The notice of the first meeting or creditors, or an explanation as to why this is not included;
(viii) In cases where there is defective service, a declaration or affidavit attesting to the fact that the lender or holder was not directly served with the notice of meeting of creditors. This declaration or affidavit must also indicate when and how the lender or holder learned of the bankruptcy; and
(ix) In cases where there is defective service due to the borrower's failure to list the proper creditor, a copy of the letter sent to the borrower at the time of purchase of the HEAL loan by the current holder, or a sample letter with documentation indicating when the letter was sent to the borrower.
(a)
(b)
(c)
(2) If the loan for which a claim is filed was originally made by a school but the claim is filed by another lender of holder that obtained the note by assignment, the Secretary deducts from the claim an amount equal to any unpaid refund that the school owed the borrower prior to the assignment.
(d)
(e)
(1) If the lender or holder failed to submit a claim within the required period after the borrower's default; death; total and permanent disability; or filing of a petition in bankruptcy under chapter 11 or 13 of the Bankruptcy Act, or under chapter 7 where the borrower files a complaint to determine the dischargeability of the HEAL loan; the Secretary does not pay interest that accrued between the end of that period and the date the Secretary received the claim.
(2) If the Secretary returned the claim to the lender or holder for additional documentation necessary for the approval of the claim, the Secretary pays interest only for the first 30 days following the return of the claim to the lender or holder.
(a)
(i) The loan application;
(ii) The original promissory note;
(iii) The repayment schedule agreement;
(iv) Evidence of each disbursement of loan proceeds;
(v) Notices of changes in a borrower's address and status as a full-time student;
(vi) Evidence of the borrower's eligibility for a deferment;
(vii) The borrower's signed statement describing his or her rights and responsibilities in connection with a HEAL loan;
(viii) The documents required for the exercise of forbearance;
(ix) Documentation of the assignment of the loan; and
(x) Evidence of a borrower's creditworthiness, including the borrower's credit report.
(2) The lender or holder must maintain for each borrower a payment history showing the date and amount of each payment received on the borrower's behalf, and the amounts of each payment attributable to principal and interest. A lender or holder must also maintain for each loan a collection history showing the date and subject of each communication with a borrower or
(3) A lender or holder must retain the records required for each loan for not less than 5 years following the date the loan is repaid in full by the borrower. However, in particular cases the Secretary may require the retention of records beyond this minimum period. A lender or holder must keep the original copy of an unpaid promissory note, but may store all other records in microform or computer format.
(4) The lender or holder must maintain accurate and complete records on each HEAL borrower and related school activities required by the HEAL program. All HEAL records shall be maintained under security and protected from fire, flood, water leakage, other environmental threats, electronic data system failures or power fluctuations, unauthorized intrusion for use, and theft.
(b)
(c)
(d) The lender or holder must comply with the Department's biennial audit requirements of section 705 of the Act.
(e) Any lender or holder who has information which indicates potential or actual commission of fraud or other offenses against the United States, involving these loan funds, must promptly provide this information to the appropriate Regional Office of Inspector General for Investigations.
(a) The Secretary may limit, suspend, or terminate the eligibility under the HEAL program of an otherwise eligible lender or holder that violates or fails to comply with any provision of the Act, these regulations, or agreements with the Secretary concerning the HEAL program. Prior to terminating a lender or holder's participation in the program, the Secretary will provide the entity an opportunity for a hearing in accordance with the procedures under paragraph (b) of this section.
(b)(1) The Secretary will provide any lender or holder subject to termination with a written notice, sent by certified mail, specifying his or her intention to terminate the lender or holder's participation in the program and stating that the entity may request, within 30 days of the receipt of this notice, a formal hearing. If the entity requests a hearing, it must, within 90 days of the receipt of the notice, submit material, factual issues in dispute to demonstrate that there is cause for a hearing. These issues must be both substantive and relevant. The hearing will be held in the Washington, DC metropolitan area. The Secretary will deny a hearing if:
(i) The request for a hearing is untimely (
(ii) The lender or holder does not provide a statement of material, factual issues in dispute within the 90-day required period; or
(iii) The statement of factual issues in dispute is frivolous or inconsequential.
(2) In the event that the Secretary denies a hearing, the Secretary will send a written denial, by certified mail, to the lender or holder setting forth the reasons for denial. If a hearing is denied, or if as a result of the hearing, termination is still determined to be necessary, the lender or holder will be terminated from participation in the program. An entity will be permitted to reapply for participation in the program when it demonstrates, and the Secretary agrees, that it is in compliance with all HEAL requirements.
(c) This section does not apply to a determination that a HEAL lender fails to meet the statutory definition of an “eligible lender.”
(d) This section also does not apply to administrative action by the Department of Education based on any alleged violation of:
(1) Title VI of the Civil Rights Act of 1964, which is governed by 34 CFR part 100;
(2) Title IX of the Education Amendments of 1972, which is governed by 34 CFR part 106;
(3) The Family Educational Rights and Privacy Act of 1974 (section 444 of the General Education Provisions Act, as amended), which is governed by 34 CFR part 99; or
(4) Title XI of the Right to Financial Privacy Act of 1978, Public Law 95-630 (12 U.S.C. 3401-3422).
(a) In order to participate in the HEAL program, a school must enter into a written agreement with the Secretary. In the agreement, the school promises to comply with provisions of the HEAL law and the HEAL regulations. For initial entry into this agreement and for the agreement to remain in effect, a school must satisfy the following requirements:
(1)(i) The school must be legally authorized within a State to conduct a course of study leading to one of the following degrees:
(A) Doctor of Medicine.
(B) Doctor of Osteopathic Medicine.
(C) Doctor of Dentistry or equivalent degree.
(D) Bachelor or Master of Science in Pharmacy or equivalent degree.
(E) Doctor of Optometry or equivalent degree.
(F) Doctor of Veterinary Medicine or equivalent degree.
(G) Doctor of Podiatric Medicine or equivalent degree.
(H) Graduate or equivalent degree in Public Health.
(I) Doctor of Chiropractic or equivalent degree.
(J) Doctoral degree of Clinical Psychology.
(K) Masters or doctoral degree in Health Administration.
(ii) For the purposes of this section, the term “State” includes, in addition to the several States, the District of Columbia, the Commonwealth of Puerto Rico, the Commonwealth of the Northern Mariana Islands, the Virgin Islands, Guam, American Samoa, the Trust Territory of the Pacific Islands (the Republic of Palau), the Republic of the Marshall Islands, and the Federated States of Micronesia.
(2)(i) The school must be accredited by a recognized agency approved for that course of study by the Secretary of Education, as described in paragraph (a)(2)(ii) of this section, except where a school is not eligible for accreditation solely because it is too new. A new school is eligible if the Secretary of Education determines that it can reasonably expect to be accredited before the beginning of the academic year following the normal graduation date of its first entering class. The Secretary of Education makes this determination after consulting with the appropriate accrediting agency and receiving reasonable assurance to that effect.
(ii) The approved accrediting agencies are:
(A) Liaison Committee on Medical Education.
(B) American Osteopathic Association, Bureau of Professional Education.
(C) American Dental Association, Commission on Dental Accreditation.
(D) American Veterinary Medical Association, Council on Education.
(E) American Optometric Association, Council on Optometric Education.
(F) American Podiatric Medical Association, Council on Podiatric Medical Education.
(G) Accreditation Council for Pharmacy Education.
(H) Council on Education for Public Health.
(I) Council on Chiropractic Education, Commission on Accreditation.
(J) Accrediting Commission on Accreditation of Healthcare Management Education.
(K) American Psychological Association, Committee on Accreditation.
(b) If a HEAL school undergoes a change of controlling ownership or form of control, its agreement automatically expires at the time of that change. The school must enter into a new agreement with the Secretary in order to continue its participation in the HEAL program.
When the student completes his or her portion of the student loan application and submits it to the school, the school must do the following:
(a) Accurately and completely fill out its portion of the HEAL application;
(b) Verify, to the best of its ability, the information provided by the student on the HEAL application, including, but not limited to, citizenship status and Social Security number. To comply with this requirement, the school may request that the student provide a certified copy of his or her birth certificate, his or her naturalization papers, and an original Social Security card or copy issued by the Federal Government, or other documentation that the school may require. The school must assure that the applicant's I-151 or I-551 is attached to the application, if the applicant is required to possess such identification by the United States;
(c) Certify that the student is eligible to receive a HEAL loan, according to the requirements of § 681.5;
(d) Review the financial aid transcript from each institution previously attended by the applicant on at least a half-time basis to determine whether the applicant is in default on any loans or owes a refund on any grants. The school may not approve the HEAL application or disburse HEAL funds if the borrower is in default on any loans or owes a refund on any educational grants, unless satisfactory arrangements have been made between the borrower and the affected lender or school to resolve the default or the refund on the grant. If the financial aid transcript has been requested, but has not been received at the time the applicant submits his or her first HEAL application, the school may approve the application and disburse the first HEAL installment prior to receipt of the transcript. Each financial aid transcript must include at least the following data:
(1) Student's name;
(2) Amounts and sources of loans and grants previously received by the student for study at an institution of higher education;
(3) Whether the student is in default on any of these loans, or owes a refund on any grants;
(4) Certification from each institution attended by the student that the student has received no financial aid, if applicable; and
(5) From each institution attended, the signature of an official authorized by the institution to sign such transcripts on behalf of the institution;
(e) State that it has no reason to believe that the borrower may not be willing to repay the HEAL loan;
(f) Make reasonable determinations of the maximum loan amount approvable, based on the student's circumstances. The student applicant determines the amount he or she wishes to borrow, up to this maximum amount. Only then may the school certify an eligible application. In determining the maximum loan amount approvable, the school will calculate the difference between:
(1) The total financial resources available to the applicant for his or her costs of education for the period covered by the proposed HEAL loan, and other student aid that the applicant has received or will receive during the period covered by the proposed HEAL loan. To determine the total financial resources available to the applicant for his or her costs of education for the period covered by the proposed HEAL loan (including familial, spousal, or personal income or other financial assistance that the applicant has received or will receive), the school must consider information provided through one of the national need analysis systems or any other procedure approved by the Secretary of Education, in addition to any other information which the school has regarding the student's financial situation. The school may make adjustments to the need analysis information only when necessary to accurately reflect the applicant's actual resources, and must maintain in the borrower's record documentation to support the basis for any adjustments to the need analysis information; and
(2) The costs reasonably necessary for each student to pursue the same or similar curriculum or program within the same class year at the school for the period covered by the proposed HEAL loan, using a standard student budget. The school must maintain in its general office records the criteria used to develop each standard student budget. Adjustments to the standard student budget may be made only to the extent that they are necessary for the student to complete his or her education, and documentation must be maintained in the borrower's record to support the basis for any adjustments to the standard student budget.
(g) Comply with the requirements of § 681.61.
(a) When a school receives from a HEAL lender a loan disbursement check or draft payable jointly to the school and to one of its students, it must:
(1) If the school receives the instrument after the student is enrolled, obtain the student's endorsement, retain that portion of funds due the school, and disburse the remaining funds to the student.
(2) If the school receives the instrument before the student is enrolled, it must, prior to endorsing the instrument, send the instrument to the student to endorse and return to the school. The school may then retain that portion of funds then due the school but must hold the remaining funds for disbursement to the student at the time of enrollment. However, if the student is unable to meet other educational expenses due before the time of enrollment, the school may obtain the student's endorsement and disburse to the student that portion of funds required to meet these other educational expenses.
(b) If a school determines that a student does not plan to enroll, the school must return a loan disbursement check or draft to the lender within 30 days of this determination.
Each school must notify the holder of a HEAL loan of any change in the student's enrollment status within 30 days following the change in status. Each notice must contain the student's
A participating school must pay that portion of a refund that is allocable to a HEAL loan directly to the original lender (or to a subsequent holder of the loan note, if the school has knowledge of the holder's identity). At the same time, the school must provide to the borrower written notice that it is doing so.
Each school must establish and maintain administrative and fiscal procedures necessary to achieve the following objectives:
(a) Proper and efficient administration of the funds received from students who have HEAL loans;
(b) Protection of the rights of students under the HEAL program;
(c) Protection of the United States from unreasonable risk of loss due to defaults; and
(d) Compliance with applicable requirements for HEAL schools.
(a) In addition to complying with the requirements of section 739(b) of the Act, each school must maintain an accurate, complete, and easily retrievable record with respect to each student who has a HEAL loan. The record must contain all of the following information:
(1) Student's name, address, academic standing and period of attendance;
(2) Name of the HEAL lender, amount of the loan, and the period for which the HEAL loan was intended;
(3) If a noncitizen, documentation of the student's alien registration status;
(4) Amount and source of other financial assistance received by the student during the period for which the HEAL loan was made;
(5) Date the school receives the HEAL check or draft and the date it either gives it to the student or returns it to the lender (if the school is not the lender);
(6) Date the school disburses the loan to a student (if the school is the lender);
(7) Date the school signs the loan check or draft (if the school is a copayee);
(8) Amount of tuition, fees and other charges paid by the student to the school for the academic period covered by the loan and the dates of payment;
(9) Photocopy of each HEAL check or draft received by the student;
(10) Documentation of each entrance interview, including the date of the entrance interview and the signature of the borrower indicating that the entrance interview was conducted;
(11) Documentation of the exit interview, including the date of the exit interview and the signature of the borrower indicating that the exit interview was conducted, or documentation of the date that the school mailed exit interview materials to the borrower if the borrower failed to report for the exit interview;
(12) A photocopy made by the school of the borrower's I-151 or I-551, if the borrower is required to possess such identification by the United States, or other documentation, if obtained by the school, to verify citizenship status and Social Security number (
(13) Documentation of the calculations made which compare the financial resources of the applicant with the cost of his or her education at the school;
(14) Copy(s) of the borrower's financial aid transcript(s);
(15) The standard budget used for the student, and documentation to support the basis for any deviations made to the standard budget;
(16) Copies of all correspondence between the school and the borrower or between the school and the lender or its assignee regarding the loan;
(17) Copy of each form used by the school in connection with the loan; and
(18) Expected postgraduate destination of borrower.
(b) The school must maintain the record for not less than 5 years following the date the student graduates, withdraws or fails to enroll as a full-time student. The school may store the records in microform or computer format.
(c) The school must comply with the Department's biennial audit requirements of section 705 of the Act.
(d) The school must develop and follow written procedures for the receipt, verification of amount, and disbursement of HEAL checks or drafts. These procedures must be maintained in the school's policies and procedures manuals or other general office records.
A school must submit reports to the Secretary at the times and in the manner the Secretary may reasonably prescribe. The school must retain a copy of each report for not less than 5 years following the report's completion, unless otherwise directed by the Secretary. A school must also make available to a HEAL lender or holder, upon the lender's or holder's request, the name, address, postgraduate destination and other reasonable identifying information for each of the school's students who has a HEAL loan.
For the purposes of audit and examination, a HEAL school must provide the Secretary of Education, the Comptroller General of the United States, and any of their authorized representatives access to the records that the school is required to keep and to any documents and records pertinent to the administration of the HEAL program.
In the event a school ceases to participate in the HEAL program, the school (or its successor, in the case of a school which undergoes a change in ownership) must retain all required HEAL records and provide the Secretary of Education, the Comptroller General of the United States, and any of their authorized representatives access to them.
(a) The Secretary may limit, suspend, or terminate the eligibility under the HEAL program of an otherwise eligible school that violates or fails to comply with any provision of the Act, these regulations, or agreements with the Secretary concerning the HEAL program. Prior to terminating a school's
(b)(1) The Secretary will provide any school subject to termination with a written notice, sent by certified mail, specifying his or her intention to terminate the school's participation in the program and stating that the school may request, within 30 days of the receipt of this notice, a formal hearing. If the school requests a hearing, it must, within 90 days of the receipt of the notice, submit material, factual issues in dispute to demonstrate that there is cause for a hearing. These issues must be both substantive and relevant. The hearing will be held in the Washington, DC metropolitan area. The Secretary will deny a hearing if:
(i) The request for a hearing is untimely (
(ii) The school does not provide a statement of material, factual issues in dispute within the 90-day required period; or
(iii) The statement of factual issues in dispute is frivolous or inconsequential.
(2) In the event that the Secretary denies a hearing, the Secretary will send a written denial, by certified mail, to the school setting forth the reasons for denial. If a hearing is denied, or if as a result of the hearing, termination is still determined to be necessary, the school will be terminated from participation in the program. A school will be permitted to reapply for participation in the program when it demonstrates, and the Secretary agrees, that it is in compliance with all HEAL requirements.
(c) This section does not apply to a determination that a HEAL school fails to meet the statutory definition of an “eligible school.”
(d) This section does not apply to administrative action by the Department of Education based on any alleged violation of the Family Educational Rights and Privacy Act of 1974 (section 444 of the General Education Provisions Act, as amended), as governed by 34 CFR part 99.
(a) A HEAL school is required to carry out the following activities for each HEAL applicant or borrower:
(1) Conduct and document an entrance interview with each student (individually or in groups) no later than prior to the loan recipient's first HEAL disbursement in each academic year that the loan recipient obtains a HEAL loan. The school must inform the loan recipient during the entrance interview of his or her rights and responsibilities under a HEAL loan, including the consequences for noncompliance with those responsibilities, and must gather personal information which would assist in locating the loan recipient should he or she depart from the school without receiving an exit interview. A school may meet this requirement through correspondence where the school determines that a face-to-face meeting is impracticable.
(2) Conduct and document an exit interview with each HEAL loan recipient (individually or in groups) within the final academic term of the loan recipient's enrollment prior to his or her anticipated graduation date or other departure date from the school. The school must inform the loan recipient in the exit interview of his or her rights and responsibilities under each HEAL loan, including the consequences for noncompliance with those responsibilities. The school must also collect personal information from the loan recipient which would assist the school or the lender or holder in skiptracing activities and to direct the loan recipient to contact the lender or holder concerning specific repayment terms and options. A copy of the documentation of the exit interview, including the personal information collected for skiptracing activities, and any other information required by the Secretary regarding the exit interview must be sent to the lender or holder of each HEAL loan within 30 days of the exit interview. If the loan recipient departs from the school prior to the anticipated date or does not receive an exit interview, the exit interview information must be mailed to the loan recipient by the school within 30 days of the school's knowledge of the departure or the anticipated departure date, whichever is earlier. The school must request that the loan recipient forward any required information (
(3) Verify the accuracy and completeness of information provided by each student on the HEAL loan application, particularly in regard to the HEAL eligibility requirements, by comparing the information with previous loan applications or other records or information provided by the student to the school. Notify the potential lender of any discrepancies which were not resolved between the school and the student.
(4) Develop and implement procedures relating to check receipt and release which keep these functions separate from the application preparation and approval process and assure that the amount of the HEAL loan check(s) does(do) not exceed the approved total amount of the loan and the statutory maximums. Checks must not be cashed without the borrower's personal endorsement. Documentation of these procedures and their usage shall be maintained by the school.
(5) Maintain accurate and complete records on each HEAL borrower and related school activities required by the HEAL program. All HEAL records shall be properly safeguarded and protected from environmental threats and unauthorized intrusion for use and theft.
(6) Maintain documentation of the criteria used to develop the school's standard student budgets in the school's general records, readily available for audit purposes, and maintain in each HEAL borrower's record a copy of the standard budget which was actually used in the determination of the maximum loan amount approvable for the student, as described in § 681.51.
(7) Notify the lender or its assignee of any changes in the student's name, address, status, or other information pertinent to the HEAL loan not more than 30 days after receiving information indicating such a change.
(b) Any school which has information which indicates potential or actual commission of fraud or other offenses against the United States involving these loan funds must promptly provide this information to the appropriate Regional Office of Inspector General for Investigations.
(c) The school will be considered responsible and the Secretary may seek reimbursement from any school for the amount of a loan in default on which the Secretary has paid an insurance claim, if the Secretary finds that the school did not comply with the applicable HEAL statute and regulations, or its written agreement with the Secretary. The Secretary may excuse certain defects if the school satisfies the Secretary that the defect did not contribute to the default or prejudice the Secretary's attempt to collect the loan from the borrower.
(d) A school is authorized to withhold services from a HEAL borrower who is in default on a HEAL loan received while enrolled in that school, except in instances where the borrower has filed for bankruptcy. Such services may include, but are not limited to academic
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration |